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Therapeutic Index

Beximco Pharmaceuticals Ltd.


T H E R A P E U T I C I N D E X

Published in March 2004

Copyright © 2004 all rights reserved

Compiled and Published by


Medical Department
Beximco Pharmaceuticals Ltd.

Design and Computer Graphics by


DTP, Medical Department

Printed by
Shuktara Printers, Gazipur

PTG-235/02-04/5000 SHUK
O UR M ISSION
OUR MISSION
ISSION

E ach of our activities must benefit and add value to the


common wealth of our society. We firmly believe that, in
the final analysis we are accountable to each of the
constituents with whom we interact; namely: our employees,
our customers, our business associates, our fellow citizens
and our shareholders.

History
Key milestones

1976 Registration of the company


1980 Started manufacturing and marketing of licensee
products of Bayer AG of Germany and Upjohn Inc.
of USA
1983 Launching its own products
1985 Listing in the Dhaka Stock Exchange (DSE) as a
Public Limited Company (PLC)
1990 Commissioning of Basic Chemical unit
1992 Started export operation with Active Pharmaceutical
Ingredients (APIs)
1993 First export market operation with Finished
Pharmaceutical Products
1994-95 The first pharmaceutical company in the country to
receive ‘National Export Trophy (Gold)’
1996 Introduction of Sustained Release dosage form in
the market

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O U R M I S S I O N

1997 Commissioning of Metered Dose Inhaler (MDI)


plant and introduction of Suppository dosage form
1998 Introduction of Metered Dose Nasal Spray
1998-99 Received ‘National Export Trophy (Gold)’
1999 UNICEF approval of BPL as an enlisted supplier
1999-00 Received ‘National Export Trophy (Gold)’
2000 Contract manufacturing agreement of Metered
Dose Inhaler (MDI) with Glaxo SmithKline
2001 Introduction of small volume parenteral products
(Injectables) and Establishment of Analgesic-
Antiinflammatory bulk-drug plant
2002 The first Bangladeshi company to supply
pharmaceuticals to Raffles Hospital of Singapore

The Profile
Corporate Headquarters : 17 Dhanmondi R/A, Road No. 2,
Dhaka 1205, Bangladesh
Operational Headquarter : 19 Dhanmondi R/A, Road No. 7,
Dhaka 1205, Bangladesh
Factory : Auspara, Tongi, Gazipur
Business Lines : Manufacturing and marketing of
pharmaceutical finished products and Active Pharmaceutical
Ingredients (APIs)
Overseas Offices and Associates : UK, USA, Pakistan, Nepal,
Myanmar, Singapore, Kenya, Yemen.
Export Outlets : Bhutan, Georgia, Germany, Hong Kong,
Iran, Iraq, Kenya, Malaysia, Myanmar, Nepal, Pakistan,
Russia, Singapore, South Korea, Taiwan, Thailand, Ukraine,
Vietnam and Yemen.
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O U R M I S S I O N

International Marketing
In BPL we are proactive in our approach to aggressively
search for new avenues in the international market place:
Beximco Pharma is the pioneer in entering the CIS countries.
BPL is the first pharmaceutical company in Bangladesh to
receive National Export Trophy Gold in 1998.

In Pakistan, BPL took proactive measures in launching its


products with Multimedia CD-ROM replacing the age-old
printed promotional materials.

In Myanmar, BPL further consolidated its position by


donating Medical Information Kiosks to the Myanmar
Medical Association.

Beximco Pharma is the only Bangladeshi pharmaceutical


company operating in Singapore market- one of the most
stringent and regulated markets in Asia.

Beximco Pharma was the first company from Bangladesh to


enter the African Market.

We are delighted and proud of our pioneering achievements.


More than that, we have probably fulfilled a national
aspiration of turning an import dependent country into an
exporter of quality medicines. Despite the fact that there is
no incentive for pharmaceutical export in Bangladesh, till
today, we have not deviated from our proactive and
pioneering role in international marketing.

Our journey that began amidst many obstacles has now


expanded to nineteen countries. In 2002, BPL’s major
emphasis in international marketing was to consolidate and
grow in all its existing overseas markets by ensuring
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O U R M I S S I O N

sustainable competitive advantage over our competitors and


competitive brands. In 2002, we were awarded a tender order
for our Neoceptin R for the whole year’s consumption of
Raffles Hospital- the most prestigious hospital in Singapore.
We have also supplied our product in KK Women’s and
Children’s Hospital in Singapore. In order to expand our
product portfolio in Myanmar, we have launched
liquid/bottle items by organizing a huge scientific seminar.
We have supplied our products to Shaukat Khanum
Memorial Cancer Hospital & Research Center and Aga Khan
University Hospital- the two renowned institutions in
Pakistan. In Kenya, we have started supplying to Mission for
Essential Drugs and Supplies (MEDS)- the largest institution
and Kenyatta Hospital -the largest hospital in Kenya.
While consolidating in all our existing overseas markets, we
are determined to continue deploying our efforts and
resources to develop new overseas markets in Asia, Africa,
and Europe. As a part of our ongoing new market
exploration activities, in 2002 we participated in all major
exhibitions held in Russia, Ukraine, Afghanistan and Nepal.
For evaluating business opportunities in new overseas
markets, we conducted market research in various markets in
Asia and Europe.
The Leading Health Care
Company in Bangladesh

Beximco Pharmaceuticals
Ltd. is a member of the
Beximco Group- the largest
private sector business
conglomerate of Bangladesh,
comprising 8 divisions and over 22000 employees. BPL, the
largest pharmaceutical as well as bulk drug manufacturer of
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O U R M I S S I O N

Bangladesh started its journey back in 1980 with


manufacturing and marketing of licensee products of Bayer
AG, Germany and Upjohn Inc. of USA. BPL launched 6 of
its own products in 1983. We strongly believe in high quality
and cost-effective medicine. We are proud to become first
enlisted supplier to international bodies like UNICEF,
UNDP, WHO and ICDDR,B.

The National Recognition for Excellence


In addition to local market, BPL’s export
activities are there in nineteen countries of
three continents- Asia, Europe and Africa. For
its outstanding export performance, BPL
received Bangladesh’s highest award for export,
the National Export Trophy, Gold in 1994-95.
BPL is the first pharmaceutical company in Bangladesh to
receive such an award. BPL was also awarded National
Export Trophy Gold for two consecutive years 1998-1999 &
1999-2000. BPL is the record three times winner of this
national highest recognition for export.

Committed to Serve
BPL’s commitment is to always offer the best, both in quality
and services to its customers. Quality is the measure of
excellence in the field of pharmaceutical products. BPL feels
that it has an incalculable social liability of providing safe,
efficacious and highest quality drugs. Equipped with the
latest & the most advanced state-of-the-art technologies BPL
team is committed to serve its customers. Through the
highest quality drugs BPL has succeeded in gaining the
confidence & trust of doctors & patients all over the country.

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O U R M I S S I O N

BPL- A Company with Vision for


Tomorrow
BPL has transformed its activities,
culture, style and philosophy to meet
the demands of the new millennium.
Business diversifications that are
strategically important for a sustained
growth are results of its vision of the
future. Several new bulk drug facilities are being developed
to backward integrate their high volume products. A USFDA
standard multi-million dollar pharmaceutical formulation
plant is nearing completion. This would be one of the most
modern plants in this region.

Our Differential Edge


• World class manufacturing facilities
• Highest cGMP standards
• Outstanding product quality
• Sophisticated formulation technology
• Diversified and hightech dosage forms & products
• Significant investment in R&D
• Excellent customer services
• Responsible care for the environment
• Commitment to the people & the society

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CONTENTS IN BRAND N AME
C O N T E N T S I N B R A N D N A M E

BRAND NAME G ENERIC NAME


Aeronid Inhaler Budesonide BP 1
Alendon Tablet Alendronate Sodium BP 6
Alphin DS Tablet Albendazole USP 9
Amdocal Tablet Amlodipine Besylate INN 11
Anustat Ointment Cinchocaine Hydrochloride BP, 14
Hydrocortisone BP, Neomycin
Sulphate USP and Esculin
Apresin Tablet Fluphenazine Hydrochloride BP and 16
Nortriptyline Hydrochloride BP
Arbit Tablet Irbesartan INN 18
Aristocal Tablet Calcium Carbonate BP 20
Aristoferon Syrup Ferrous Sulphate BP 22
Aristofol-Fe Tablet Ferrous Fumarate BP and 24
Folic Acid USP
Aristoplex Syrup Vitamin B Complex 26
Aristovit-B Tablet Vitamin B Complex 28
Aristovit-M Tablet Multivitamin and Mineral 29
Aristovit-X Tablet Antioxidant, Vitamin, and Mineral 31
Arixon IV/IM Injection Ceftriaxone Sodium USP 33
Arlin Tablet/Suspension Linezolid INN 36
Ascobex Tablet Ascorbic Acid USP 39
Atova Tablet Atorvastatin Calcium INN 41
Atrizin Tablet/Syrup Cetirizine Hydrochloride BP 46
Avastin Tablet Simvastatin USP 48
Avidro Tablet Pizotifen Malate BP 51
Avifanz Tablet Efavirenz INN 53
Avifix Tablet Nelfinavir Mesylate INN 58
Avilam Tablet Lamivudine INN 64
Avitron V Tablet Thiamine Hydrochloride USP 68
Axodin Tablet Fexofenadine Hydrochloride INN 70
Azithrocin Capsule Azithromycin USP 74
/Tablet/Suspension
Azmasol Inhaler Salbutamol BP 77
Bexidal Tablet Mebhydrolin Napadisylate BPC 80
Bexitrol-F Inhaler Fluticasone Propionate BP and 81
Salmeterol Xinafoate INN
Bexitrol Inhaler Salmeterol Xinafoate INN 84

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C O N T E N T S I N B R A N D N A M E

B RAND NAME G ENERIC NAME


Bextrum Tablet High potency Multivitamin and 87
Multimineral
Bronkolax Tablet Salbutamol Sulphate BP 89
/Syrup
Cardopril Tablet Captopril USP 91
Carocet Tablet Beta Carotene, Ascorbic Acid USP and 94
dl-alpha-Tocopheryl Acetate
Carofol-Z Capsule Carbonyl Iron INN, Folic Acid BP and 96
Zinc Sulphate Monohydrate USP
Cephalen Capsule Cefalexin BP 98
/Suspension
Cerivin Tablet Vinpocetine INN 101
Clobex Capsule/Syrup Cloxacillin Sodium BP 103
Cosmotrin Cream Tretinoin USP 105
Cox B Capsule Celecoxib INN 107
Curin Tablet Levocetrizine Dihydrochloride INN 112
Decacycline Capsule Tetracycline Hydrochloride BP 114
Decomit Inhaler Beclomethasone Dipropionate BP 116
Decomit Nasal Spray Beclomethasone Dipropionate BP 119
Deflux Tablet Domperidone Maleate BP/ 121
/Suspension Domperidone BP
/Paediatric Drops
Dextromethorphan Dextromethorphan Hydrobromide BP 123
Syrup
Diactin Tablet Glipizide BP 124
Diaglit Tablet Pioglitazone Hydrochloride INN 130
Diapro Tablet Gliclazide BP 133
Diaryl Tablet Glimepiride INN 136
Diavix Tablet Lamivudine INN and Zidovudine USP 140
Dilapress Tablet Carvedilol BP 144
Ecotrim Cream Econazole Nitrate BP and 147
Triamcinolone Acetonide BP
Efol-ER Capsule Ferrous Sulphate BP, Folic Acid USP 149
and Zinc Sulphate
Monohydrate USP
Enaril Tablet Enalapril Maleate USP 152
Epilep Tablet Carbamazepine BP 155
Eplon Capsule Zaleplon INN 158

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C O N T E N T S I N B R A N D N A M E

BRAND NAME GENERIC N AME

Etrocin Tablet Erythromycin USP 162


/Suspension
Evo Tablet Levofloxacin Hemihydrate INN 166
Fertil Tablet Clomiphene Citrate USP 168
Fibril Capsule Gemfibrozil USP 171
Filmet Tablet Metronidazole BP/Metronidazole 173
/Suspension Benzoate BP
Flatameal-DS Tablet Aluminium Hydroxide Gel USP, 175
/Suspension Magnesium Hydroxide BP and
Simethicone USP
Flubex Capsule/Syrup Flucloxacillin Sodium BP 176
Formula E Tablet Vitamin E USP 178
Frelax Powder Polyethylene Glycol 3350 USP NF 181
Frenxit Tablet Flupentixol Dihydrochloride BP and 184
Melitracen Hydrochloride INN
Fungistin Suspension Nystatin BP 186
Furasep Cream Nitrofurazone USP 188
Fusidic Plus Ointment Sodium Fusidate BP and 189
Hydrocortisone Acetate BP
Gastalfet Tablet Sucralfate USP 191
Gentosep Cream Gentamicin Sulphate BP 193
Hefolin SR Capsule Ferrous Sulphate BP and 194
Folic Acid BP
Inarzin Tablet Cinnarizine BP 196
Informet LA Tablet Metformin Hydrochloride BP 198
Intracef Capsule Cephradine BP 201
/Suspension
/Paediatric Drops
Intracef Injection Cephradine USP 204
Ipramid Inhaler Ipratropium Bromide BP 207
Isofloxin Tablet Pefloxacin Mesilate BP 210
Keolax Tablet Clobazam BP 213
Lactameal Tablet Aluminium Hydroxide Gel USP and 215
/Suspension Magnesium Hydroxide BP
Larnox LA Tablet Aminophylline BP 216
Lucidol Capsule Tramadol Hydrochloride BP 219
Megadox Capsule Doxycycline Hydrochloride BP 222

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C O N T E N T S I N B R A N D N A M E

BRAND NAME G ENERIC NAME

Megatrim DS Tablet Trimethoprim BP and 225


Sulfamethoxazole BP
Megatrim Suspension Trimethoprim BP and 225
Sulfamethoxazole BP
Melphin Tablet Pyrantel Pamoate USP 229
/Suspension
Modipran Capsule Fluoxetine Hydrochloride BP 231
Momento Tablet/Syrup Desloratadine INN 234
Monate Tablet Isosorbide Mononitrate BP 237
Monocast Tablet Montelucast Sodium INN 239
Napa Tablet/Syrup Paracetamol BP 244
/Suppository
/Paediatric drops
Nazolin Nasal Spray Oxymetazoline Hydrochloride USP 246
Nebactil Suspension Nalidixic Acid BP 248
Neo Kit Clarithromycin USP, Omeprazole BP 250
and Metronidazole BP
Neocard Tablet Diltiazem Hydrochloride USP 252
Neoceptin R Tablet Ranitidine Hydrochloride USP 254
/Syrup
Neodrop Simethicone USP 256
Paediatric Drops
Neofloxin Tablet Ciprofloxacin Hydrochloride USP 258
Neopril Tablet Lisinopril USP 263
Neosten Cream Clotrimazole BP 269
Neosten VT Clotrimazole BP 271
Nightus Tablet Bromazepam BP 273
Noscab Cream Permethrin INN 275
Nuprafen Tablet Naproxen USP 277
Odrel Tablet Clopidogrel Bisulfate INN 280
Omastin Capsule Fluconazole INN 282
/Suspension
Opton Tablet Esomeprazole Magnesium 286
Trihydrate INN
Pacet Tablet Amiodarone Hydrochloride BP 289
Pedeamin Syrup Diphenhydramine Hydrochloride BP 292

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C O N T E N T S I N B R A N D N A M E

BRAND NAME G ENERIC NAME

Pregvit Capsule Ferrous Sulphate BP, Folic Acid USP, 294


Thiamine Mononitrate USP,
Riboflavin USP, Nicotinamide USP,
Pyridoxine Hydrochloride USP &
Ascorbic Acid USP
Premil Tablet Repaglinide USP 296
Pretin Tablet Loratadine INN 300
Primace Capsule Ramipril BP 302
Proceptin-20 Capsule Omeprazole BP 305
Prosan Tablet Losartan Potassium INN 308
Prosfin Tablet Finasteride USP 310
Protolan Capsule Lansoprazole USP 313
Recox Tablet Rofecoxib INN 316
Recur Tablet Finasteride USP 319
Reflon Tablet Glucosamine Hydrochloride USP 321
Relentus Tablet Tizanidine Hydrochloride INN 323
Resitone Tablet Spironolactone BP and Frusemide BP 325
Reumafen Tablet lbuprofen BP 327
/Suspension
Rolacin Tablet Clarithromycin USP 330
Rostil Tablet Mebeverine Hydrochloride BP 333
Sensipin Tablet Clozapine BP 335
Serelose Solution Lactulose Solution BP 339
Sibulin Capsule Sibutramine Hydrochloride 341
Monohydrate INN
Spanil Tablet Hyoscine Butylbromide BP 344
Sparlin Tablet Sparfloxacin INN 345
Spulyt Tablet/Syrup Bromhexine Hydrochloride BP 347
Tamona Tablet Tamoxifen Citrate BP 349
Taverin Tablet Drotaverine Hydrochloride INN 353
Terbex Cream/Tablet Terbinafine Hydrochloride INN 355
Tofen Tablet/Syrup Ketotifen Fumarate BP 357
Triocim Capsule Cefixime Trithydrate USP 359
/Suspension
Triovix Tablet Lamivudine INN, Zidovudine USP 361
and Nevirapine INN

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C O N T E N T S I N B R A N D N A M E

BRAND NAME GENERIC NAME

Tripec Syrup Guaifenesin BP, Pseudoephedrine 364


Hydrochloride BP and Triprolidine
Hydrochloride BP
Tycil Capsule Amoxicillin Trihydrate BP 366
/Suspension
/Paediatric Drops
Tycil DS Suspension Amoxicillin Trihydrate BP 366
Tynisol Drops Multivitamin 369
Ultrafen Tablet Diclofenac Sodium BP/Diclofenac 371
/Suppository/Gel Diethylamine BP
Uricon Tablet Oxybutynin Chloride USP 374
Uroflo Capsule Tamsulosin Hydrochloride INN 377
Valcap Capsule Valsartan INN 379
V-Cox Tablet Valdecoxib INN 382
Xynofen-100 SR Capsule Ketoprofen BP 386
Yamadin Tablet Famotidine USP 389
Zedex-DS Syrup Zinc Sulphate Monohydrate USP 391
Zocil Tablet Cilostazol INN 393
Zukast Tablet Zafirlukast INN 395
Zymet Tablet Pancreatin BP 401

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CONTENTS IN THERAPEUTIC GROUP
C O N T E N T S I N T H E R A P E U T I C G R O U P

BRAND NAME G ENERIC NAME

Analgesic & Antipyretic


Napa Tablet/Syrup Paracetamol 244
/Suppository
/Paediatric drops

Anthelmintic
Alphin DS Tablet Albendazole 9
Melphin Tablet/Suspension Pyrantel Pamoate 229

Anti-acne preparation
Cosmotrin Cream Tretinoin 105

Anti-osteoarthritic preparation
Reflon Tablet Glucosamine Hydrochloride 321

Anti-asthma preparation
Aeronid Inhaler Budesonide 1
Azmasol Inhaler Salbutamol 77
Bexitrol-F Inhaler Fluticasone Propionate and 81
Salmeterol Xinafoate
Bexitrol Inhaler Salmeterol Xinafoate 84
Bronkolax Tablet/Syrup Salbutamol Sulphate 89
Decomit Nasal Spray Beclomethasone 119
Dipropionate
Ipramid Inhaler Ipratropium Bromide 207
Larnox LA Tablet Aminophylline 216

Anti-cancer preparation
Tamona Tablet Tamoxifen Citrate 349

Antidepressant
Apresin Tablet Fluphenazine Hydrochloride 16
and Nortriptyline
Hydrochloride

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C O N T E N T S I N T H E R A P E U T I C G R O U P

BRAND NAME G ENERIC NAME

Frenxit Tablet Flupentixol Dihydrochloride 184


and Melitracen
Hydrochloride
Modipran Capsule Fluoxetine Hydrochloride 231
Sensipin Tablet Clozapine 335

Antidiabetic preparation
Diactin Tablet Glipizide 124
Diaglit Tablet Pioglitazone Hydrochloride 130
Diapro Tablet Gliclazide 133
Diaryl Tablet Glimepiride 136
Informet LA Tablet Metformin Hydrochloride 198
Premil Tablet Repaglinide 296

Anti-emetic preparation
Deflux Tablet/Suspension Domperidone Maleate 121
/Paediatric Drops

Anti-epileptic preparation
Epilep Tablet Carbamazepine 155

Anti-haemorrhoidal preparation
Anustat Ointment Cinchocaine Hydrochloride, 14
Hydrocortisone,
Neomycin Sulphate
and Esculin

Anti-histamine preparation
Atrizin Tablet/Syrup Cetirizine Hydrochloride 46
Axodin Tablet Fexofenadine Hydrochloide 70
Bexidal Tablet Mebhydrolin Napadisylate 80
Curin Tablet Levocetrizine Dihydrochloride 112
Momento Tablet/Syrup Desloratadine 234
Pedeamin Syrup Diphenhydramine 292
Hydrochloride
Pretin Tablet Loratadine 300

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C O N T E N T S I N T H E R A P E U T I C G R O U P

B RAND NAME GENERIC NAME

Anti-HIV preparation
Avifanz Tablet Efavirenz 53
Avifix Tablet Nelfinavir Mesylate 58
Avilam Tablet Lamivudine 64
Diavix Tablet Lamivudine and 140
Zidovudine
Triovix Tablet Lamivudine, Zidovudine 361
and Nevirapine

Anti-microbial preparation

Antibacterials
Arixon IV/IM Injection Ceftriaxone Sodium 33
Arlin Tablet/Suspension Linezolid 36
Azithrocin Capsule/Tablet Azithromycin 74
/Suspension
Cephalen Capsule Cephalexin 98
/Suspension
Clobex Capsule/Syrup Cloxacillin Sodium 103
Decacycline Capsule Tetracycline Hydrochloride 114
Etrocin Tablet/Suspension Erythromycin 162
Evo Tablet Levofloxacin Hemihydrate 166
Filmet Tablet/Suspension Metronidazole/ 173
Metronidazole Benzoate
Flubex Capsule/Syrup Flucloxacillin Sodium 176
Furasep Cream Nitrofurazone 188
Fusidic Plus Ointment Sodium Fusidate and 189
Hydrocortisone Acetate
Gentosep Cream Gentamicin Sulphate 193
Intracef Capsule Cephradine 201
/Suspension
/Paediatric Drops
Intracef Injection Cephradine 204
Isofloxin Tablet Pefloxacin Mesilate 210
Megadox Capsule Doxycycline Hydrochloride 222

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C O N T E N T S I N B R A N D N A M E

BRAND NAME G ENERIC NAME


Aeronid Inhaler Budesonide BP 1
Alendon Tablet Alendronate Sodium BP 6
Alphin DS Tablet Albendazole USP 9
Amdocal Tablet Amlodipine Besylate INN 11
Anustat Ointment Cinchocaine Hydrochloride BP, 14
Hydrocortisone BP, Neomycin
Sulphate USP and Esculin
Apresin Tablet Fluphenazine Hydrochloride BP and 16
Nortriptyline Hydrochloride BP
Arbit Tablet Irbesartan INN 18
Aristocal Tablet Calcium Carbonate BP 20
Aristoferon Syrup Ferrous Sulphate BP 22
Aristofol-Fe Tablet Ferrous Fumarate BP and 24
Folic Acid USP
Aristoplex Syrup Vitamin B Complex 26
Aristovit-B Tablet Vitamin B Complex 28
Aristovit-M Tablet Multivitamin and Mineral 29
Aristovit-X Tablet Antioxidant, Vitamin, and Mineral 31
Arixon IV/IM Injection Ceftriaxone Sodium USP 33
Arlin Tablet/Suspension Linezolid INN 36
Ascobex Tablet Ascorbic Acid USP 39
Atova Tablet Atorvastatin Calcium INN 41
Atrizin Tablet/Syrup Cetirizine Hydrochloride BP 46
Avastin Tablet Simvastatin USP 48
Avidro Tablet Pizotifen Malate BP 51
Avifanz Tablet Efavirenz INN 53
Avifix Tablet Nelfinavir Mesylate INN 58
Avilam Tablet Lamivudine INN 64
Avitron V Tablet Thiamine Hydrochloride USP 68
Axodin Tablet Fexofenadine Hydrochloride INN 70
Azithrocin Capsule Azithromycin USP 74
/Tablet/Suspension
Azmasol Inhaler Salbutamol BP 77
Bexidal Tablet Mebhydrolin Napadisylate BPC 80
Bexitrol-F Inhaler Fluticasone Propionate BP and 81
Salmeterol Xinafoate INN
Bexitrol Inhaler Salmeterol Xinafoate INN 84

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C O N T E N T S I N B R A N D N A M E

B RAND NAME G ENERIC NAME


Bextrum Tablet High potency Multivitamin and 87
Multimineral
Bronkolax Tablet Salbutamol Sulphate BP 89
/Syrup
Cardopril Tablet Captopril USP 91
Carocet Tablet Beta Carotene, Ascorbic Acid USP and 94
dl-alpha-Tocopheryl Acetate
Carofol-Z Capsule Carbonyl Iron INN, Folic Acid BP and 96
Zinc Sulphate Monohydrate USP
Cephalen Capsule Cefalexin BP 98
/Suspension
Cerivin Tablet Vinpocetine INN 101
Clobex Capsule/Syrup Cloxacillin Sodium BP 103
Cosmotrin Cream Tretinoin USP 105
Cox B Capsule Celecoxib INN 107
Curin Tablet Levocetrizine Dihydrochloride INN 112
Decacycline Capsule Tetracycline Hydrochloride BP 114
Decomit Inhaler Beclomethasone Dipropionate BP 116
Decomit Nasal Spray Beclomethasone Dipropionate BP 119
Deflux Tablet Domperidone Maleate BP/ 121
/Suspension Domperidone BP
/Paediatric Drops
Dextromethorphan Dextromethorphan Hydrobromide BP 123
Syrup
Diactin Tablet Glipizide BP 124
Diaglit Tablet Pioglitazone Hydrochloride INN 130
Diapro Tablet Gliclazide BP 133
Diaryl Tablet Glimepiride INN 136
Diavix Tablet Lamivudine INN and Zidovudine USP 140
Dilapress Tablet Carvedilol BP 144
Ecotrim Cream Econazole Nitrate BP and 147
Triamcinolone Acetonide BP
Efol-ER Capsule Ferrous Sulphate BP, Folic Acid USP 149
and Zinc Sulphate
Monohydrate USP
Enaril Tablet Enalapril Maleate USP 152
Epilep Tablet Carbamazepine BP 155
Eplon Capsule Zaleplon INN 158

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C O N T E N T S I N B R A N D N A M E

BRAND NAME G ENERIC NAME

Etrocin Tablet Erythromycin USP 162


/Suspension
Evo Tablet Levofloxacin Hemihydrate INN 166
Fertil Tablet Clomiphene Citrate USP 168
Fibril Capsule Gemfibrozil USP 171
Filmet Tablet Metronidazole BP/Metronidazole 173
/Suspension Benzoate BP
Flatameal-DS Tablet Aluminium Hydroxide Gel USP, 175
/Suspension Magnesium Hydroxide BP and
Simethicone USP
Flubex Capsule/Syrup Flucloxacillin Sodium BP 176
Formula E Tablet Vitamin E USP 178
Frelax Powder Polyethylene Glycol 3350 USP NF 181
Frenxit Tablet Flupentixol Dihydrochloride BP and 184
Melitracen Hydrochloride INN
Fungistin Suspension Nystatin BP 186
Furasep Cream Nitrofurazone USP 188
Fusidic Plus Ointment Sodium Fusidate BP and 189
Hydrocortisone Acetate BP
Gastalfet Tablet Sucralfate USP 191
Gentosep Cream Gentamicin Sulphate BP 193
Hefolin SR Capsule Ferrous Sulphate BP and 194
Folic Acid BP
Inarzin Tablet Cinnarizine BP 196
Informet LA Tablet Metformin Hydrochloride BP 198
Intracef Capsule Cephradine BP 201
/Suspension
/Paediatric Drops
Intracef Injection Cephradine USP 204
Ipramid Inhaler Ipratropium Bromide BP 207
Isofloxin Tablet Pefloxacin Mesilate BP 210
Keolax Tablet Clobazam BP 213
Lactameal Tablet Aluminium Hydroxide Gel USP and 215
/Suspension Magnesium Hydroxide BP
Larnox LA Tablet Aminophylline BP 216
Lucidol Capsule Tramadol Hydrochloride BP 219
Megadox Capsule Doxycycline Hydrochloride BP 222

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C O N T E N T S I N B R A N D N A M E

BRAND NAME G ENERIC NAME

Megatrim DS Tablet Trimethoprim BP and 225


Sulfamethoxazole BP
Megatrim Suspension Trimethoprim BP and 225
Sulfamethoxazole BP
Melphin Tablet Pyrantel Pamoate USP 229
/Suspension
Modipran Capsule Fluoxetine Hydrochloride BP 231
Momento Tablet/Syrup Desloratadine INN 234
Monate Tablet Isosorbide Mononitrate BP 237
Monocast Tablet Montelucast Sodium INN 239
Napa Tablet/Syrup Paracetamol BP 244
/Suppository
/Paediatric drops
Nazolin Nasal Spray Oxymetazoline Hydrochloride USP 246
Nebactil Suspension Nalidixic Acid BP 248
Neo Kit Clarithromycin USP, Omeprazole BP 250
and Metronidazole BP
Neocard Tablet Diltiazem Hydrochloride USP 252
Neoceptin R Tablet Ranitidine Hydrochloride USP 254
/Syrup
Neodrop Simethicone USP 256
Paediatric Drops
Neofloxin Tablet Ciprofloxacin Hydrochloride USP 258
Neopril Tablet Lisinopril USP 263
Neosten Cream Clotrimazole BP 269
Neosten VT Clotrimazole BP 271
Nightus Tablet Bromazepam BP 273
Noscab Cream Permethrin INN 275
Nuprafen Tablet Naproxen USP 277
Odrel Tablet Clopidogrel Bisulfate INN 280
Omastin Capsule Fluconazole INN 282
/Suspension
Opton Tablet Esomeprazole Magnesium 286
Trihydrate INN
Pacet Tablet Amiodarone Hydrochloride BP 289
Pedeamin Syrup Diphenhydramine Hydrochloride BP 292

xviii
C O N T E N T S I N T H E R A P E U T I C G R O U P

BRAND NAME G ENERIC NAME

Anti-microbial preparation

Megatrim DS Tablet Trimethoprim and 225


Sulfamethoxazole
Megatrim Suspension Trimethoprim and 225
Sulfamethoxazole
Nebactil Suspension Nalidixic Acid 248
Neo Kit Clarithromycin, Omeprazole 250
and Metronidazole
Neofloxin Tablet Ciprofloxacin Hydrochloride 258
Rolacin Tablet Clarithromycin 330
Sparlin Tablet Sparfloxacin 345
Triocim Capsule/Suspension Cefixime Trihydrate 359
Tycil Capsule/Suspension Amoxicillin Trihydrate 366
/Paediatric Drops
Tycil DS Suspension Amoxicillin Trihydrate 366

Antifungals
Ecotrim Cream Econazole Nitrate and 147
Triamcinolone Acetonide
Fungistin Suspension Nystatin 186
Neosten Cream Clotrimazole 269
Neosten VT Clotrimazole 271
Omastin Capsules Fluconazole 282
/Suspension
Terbex Cream/Tablet Terbinafine Hydrochloride 355

Antidermatophytes
Noscab Cream Permethrin 275

Anti-migraine preparation
Avidro Tablet Pizotifen Malate 51

Anti-obesity preparation
Sibulin Capsule Sibutramine Hydrochloride 341

xxvi
C O N T E N T S I N B R A N D N A M E

BRAND NAME GENERIC N AME

Pregvit Capsule Ferrous Sulphate BP, Folic Acid USP, 294


Thiamine Mononitrate USP,
Riboflavin USP, Nicotinamide USP,
Pyridoxine Hydrochloride USP &
Ascorbic Acid USP
Premil Tablet Repaglinide USP 296
Pretin Tablet Loratadine INN 300
Primace Capsule Ramipril BP 302
Proceptin-20 Capsule Omeprazole BP 305
Prosan Tablet Losartan Potassium INN 308
Prosfin Tablet Finasteride USP 310
Protolan Capsule Lansoprazole USP 313
Recox Tablet Rofecoxib INN 316
Recur Tablet Finasteride USP 319
Reflon Tablet Glucosamine Hydrochloride USP 321
Relentus Tablet Tizanidine Hydrochloride INN 323
Resitone Tablet Spironolactone BP and Frusemide BP 325
Reumafen Tablet lbuprofen BP 327
/Suspension
Rolacin Tablet Clarithromycin USP 330
Rostil Tablet Mebeverine Hydrochloride BP 333
Sensipin Tablet Clozapine BP 335
Serelose Solution Lactulose Solution BP 339
Sibulin Capsule Sibutramine Hydrochloride 341
Monohydrate INN
Spanil Tablet Hyoscine Butylbromide BP 344
Sparlin Tablet Sparfloxacin INN 345
Spulyt Tablet/Syrup Bromhexine Hydrochloride BP 347
Tamona Tablet Tamoxifen Citrate BP 349
Taverin Tablet Drotaverine Hydrochloride INN 353
Terbex Cream/Tablet Terbinafine Hydrochloride INN 355
Tofen Tablet/Syrup Ketotifen Fumarate BP 357
Triocim Capsule Cefixime Trithydrate USP 359
/Suspension
Triovix Tablet Lamivudine INN, Zidovudine USP 361
and Nevirapine INN

xix
C O N T E N T S I N T H E R A P E U T I C G R O U P

BRAND NAME G ENERIC NAME

Antioxidant
Carocet Tablet Beta Carotene, Ascorbic Acid 94
and dl-alpha-Tocopheryl Acetate

Anti-platelet aggregation preparation


Odrel Tablet Clopidogrel Bisulphate 280

Anti-resorptive preparation
Alendon Tablet Alendronate Sodium 6

Anti-spasmodic
Rostil Tablet Mebeverine Hydrochloride 333
Spanil Tablet Hyoscine Butylbromide 344
Taverin Tablet Drotaverine Hydrochloride 353
Uricon Tablet Oxybutynin Choloride 374

Antitussive
Dextromethorphan Syrup Dextromethorphan 123
Hydrobromide
Spulyt Tablet/Syrup Bromhexine Hydrochloride 347
Tripec Syrup Guaifenesin, Pseudoephedrine 364
& Triprolidine

Anxiolytics preparation
Eplon Capsule Zaleplon 158
Keolax Tablet Clobazam 213
Nightus Tablet Bromazepam 273

Asthma Prophylactic
Monocast Tablet Montelukast Sodium 239
Tofen Tablet/Syrup Ketotifen Fumarate 357
Zukast Tablet Zafirlukast 395

Cardiovascular preparation
Amdocal Tablet Amlodipine Besylate 11
Arbit Tablet Irbesartan 18
Cardopril Tablet Captopril 91

xxvii
C O N T E N T S I N B R A N D N A M E

BRAND NAME G ENERIC NAME

Tripec Syrup Guaifenesin BP, Pseudoephedrine 364


Hydrochloride BP and Triprolidine
Hydrochloride BP
Tycil Capsule Amoxicillin Trihydrate BP 366
/Suspension
/Paediatric Drops
Tycil DS Suspension Amoxicillin Trihydrate BP 366
Tynisol Drops Multivitamin 369
Ultrafen Tablet Diclofenac Sodium BP/Diclofenac 371
/Suppository/Gel Diethylamine BP
Uricon Tablet Oxybutynin Chloride USP 374
Uroflo Capsule Tamsulosin Hydrochloride INN 377
Valcap Capsule Valsartan INN 379
V-Cox Tablet Valdecoxib INN 382
Xynofen-100 SR Capsule Ketoprofen BP 386
Yamadin Tablet Famotidine USP 389
Zedex-DS Syrup Zinc Sulphate Monohydrate USP 391
Zocil Tablet Cilostazol INN 393
Zukast Tablet Zafirlukast INN 395
Zymet Tablet Pancreatin BP 401

xx
THERAPEUTIC I NDEX
T H E R A P E U T I C I N D E X

Aeronid ®
Inhaler

Description
Budesonide BP, the active ingredient of Aeronid Inhaler, is a
corticosteroid designated that exhibits potent glucocorticoid activity and
weak mineralocorticoid activity. Corticosteroids have been shown to have
a wide range of inhibitory activities against multiple cell types (e.g., mast
cells, eosinophils, neutrophils, macrophages, and lymphocytes) and
mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines)
involved in allergic and non-allergic-mediated inflammation. These anti-
inflammatory actions of budesonide contribute to their efficacy in
asthma.

Indications
Aeronid Inhaler is indicated for the maintenance treatment of asthma as
prophylactic therapy in adult and paediatric patients six years of age or
older. It is also indicated for patients requiring oral corticosteroid therapy
for asthma, many of those patients may be able to reduce or eliminate
their requirement for oral corticosteroids over time.

Aeronid Inhaler is NOT indicated for the relief of acute bronchospasm.

Dosage and Administration


Aeronid Inhaler should be administered by the orally inhaled route in
asthmatic patients age 6 years and older. Individual patients will
experience a variable onset and degree of symptom relief. Generally,
Aeronid Inhaler has a relatively rapid onset of action for an inhaled
corticosteroid. Improvement in asthma control following inhaled
administration of Aeronid Inhaler can occur within 24 hours of initiation
of treatment, although maximum benefit may not be achieved for 1 to 2
weeks, or longer. The safety and efficacy of Aeronid Inhaler when
administered in excess of recommended doses have not been established.

The recommended starting dose and the highest recommended dose of


Aeronid Inhaler, based on prior asthma therapy, are listed in the following
table.

1
T H E R A P E U T I C I N D E X

Previous Recommended Highest


Therapy Starting Dose Recommended Dose
Adults: Bronchodilators 200 to 400 µg 400 µg twice daily
alone twice daily
Inhaled 200 to 400 µg 800 µg twice daily
Corticosteroids* twice daily
Oral 400 to 800 µg 800 µg twice daily
Corticosteroids twice daily

Children: Bronchodilators 200 µg twice daily 400 µg twice daily


alone
Inhaled 200 to 400 µg 400 µg twice daily
Corticosteroids* twice daily
Oral The highest recommended dose in children
Corticosteroids is 400 µg twice daily

*In patients with mild to moderate asthma who are well controlled on inhaled
corticosteroids, dosing with Aeronid Inhaler 200 µg or 400 µg once daily may be
considered. Aeronid Inhaler can be administered once daily either in the morning
or in the evening.

If the once-daily treatment with Aeronid Inhaler does not provide


adequate control of asthma symptoms, the total daily dose should be
increased and/or administered in divided doses.

Patients Maintained on Chronic Oral Corticosteroids


Initially, Aeronid Inhaler should be used concurrently with the patient’s
usual maintenance dose of systemic corticosteroid. After approximately
one week, gradual withdrawal of the systemic corticosteroid is started by
reducing the daily or alternate daily dose. The next reduction is made after
an interval of one or two weeks, depending on the response of the
patient. Generally, these decrements should not exceed 2.5 mg of
prednisone or its equivalent. A slow rate of withdrawal is strongly
recommended. During reduction of oral corticosteroids, patients should
be carefully monitored for asthma instability, including objective measures
of airway function, and for adrenal insufficiency. During withdrawal,
some patients may experience symptoms of systemic corticosteroid

2
T H E R A P E U T I C I N D E X

withdrawal, e.g., joint and/or muscular pain, lassitude and depression,


despite maintenance or even improvement in pulmonary function. Such
patients should be encouraged to continue with Aeronid Inhaler but
should be monitored for objective signs of adrenal insufficiency. If
evidence of adrenal insufficiency occurs, the systemic corticosteroid dose
should be increased temporarily and thereafter withdrawal should be
continued more slowly. During periods of stress or a severe asthma
attack, transferred patients may require supplementary treatment with
systemic corticosteroids.

Contraindication
Budesonide inhalation aerosol is contraindicated in the primary treatment
of status asthmaticus or other acute episodes of asthma where intensive
measures are required.

Hypersensitivity to Budesonide contraindicates the use of Aeronid


Inhaler.

Precautions
During withdrawal from oral corticosteroids, some patients may
experience symptoms of systemically active corticosteroid withdrawal,
e.g., joint and/or muscular pain, lassitude, and depression, despite
maintenance or even improvement of respiratory function.

Aeronid Inhaler will often permit control of asthma symptoms with less
suppression of hypothalamic-pituitary-adrenal (HPA) function than
therapeutically equivalent oral doses of prednisone. Since budesonide is
absorbed into the circulation and can be systemically active at higher
doses, the full beneficial effects of Aeronid Inhaler in minimizing HPA
dysfunction may be expected only when recommended dosages are not
exceeded and individual patients are titrated to the lowest effective dose.
Since individual sensitivity to effects on cortisol production exists,
physicians should consider this fact when prescribing Aeronid Inhaler.

Because of the possibility of systemic absorption of inhaled


corticosteroids, patients treated with these drugs should be observed
carefully for any evidence of systemic corticosteroid effects. Particular
care should be taken in observing patients postoperatively or during
periods of stress for evidence of inadequate adrenal response.

3
T H E R A P E U T I C I N D E X

It is possible that systemic corticosteroid effects such as hypercorticism


and adrenal suppression may appear in a small number of patients,
particularly at higher doses. If such changes occur, Aeronid Inhaler
should be reduced slowly, consistent with accepted procedures for
management of asthma symptoms and for tapering of systemic steroids.

A reduction of growth velocity in children or teenagers may occur as a


result of inadequate control of chronic diseases such as asthma or from
use of corticosteroids for treatment. Physicians should closely follow the
growth of all paediatric patients taking corticosteroids by any route and
weigh the benefits of corticosteroid therapy and asthma control against
the possibility of growth suppression.

Although patients in clinical trials have received Aeronid Inhaler on a


continuous basis for periods of 1 to 2 years, the long-term local and
systemic effects of Aeronid Inhaler in human subjects are not completely
known. In particular, the effects resulting from chronic use of Aeronid
Inhaler on developmental or immunological processes in the mouth,
pharynx, trachea, and lung are unknown.

In clinical trials with Aeronid Inhaler, localized infections with Candida


albicans occurred in the mouth and pharynx in some patients. If
oropharyngeal candidiasis develops, it should be treated with appropriate
local or systemic (i.e., oral) antifungal therapy while still continuing with
Aeronid Inhaler therapy, but at times therapy with Aeronid Inhaler may
need to be temporarily interrupted under close medical supervision.

Inhaled corticosteroids should be used with caution, if at all, in patients


with active or quiescent tuberculosis infection of the respiratory tract,
untreated systemic fungal, bacterial, viral or parasitic infections; or ocular
herpes simplex.

Rare instances of glaucoma, increased intraocular pressure, and cataracts


have been reported following the administration of inhaled
corticosteroids.

Side Effects
The following adverse reactions were reported in patients treated with
Aeronid Inhaler.

4
T H E R A P E U T I C I N D E X

General : Headache, flu-like syndrome, pain, back pain, fever, neck pain,
asthenia; Respiratory system : Respiratory tract infections, pharyngitis,
sinusitis, rhinitis, voice alteration, cough aggravation; Digestive System : Oral
candidiasis, dyspepsia, gastroenteritis, nausea, abdominal pain, dry mouth,
vomiting; Metabolic and Nutritional : Weight gain; Musculoskeletal : Fracture,
myalgia, arthralgia; Nervous system : Syncope, hypertonia, migraine; Skin :
Ecchymosis; Psychiatric : Insomnia; Resistance Mechanisms : Infection; Special
Senses : Taste perversion.

Paediatric Studies
There were no clinically relevant differences in the pattern or severity of
adverse events in children compared with those reported in adults.

Adverse event reports from other sources : Rare adverse events reported include
immediate and delayed hypersensitivity reactions including rash, contact
dermatitis, urticaria, angioedema and bronchospasm; symptoms of
hypocorticism and hypercorticism; psychiatric symptoms including
depression, aggressive reactions, irritability, anxiety and psychosis.

Pharmaceutical Precautions
Pressurized canister, do not puncture, break or incinerate even when
apparently empty. Avoid storage in direct sunlight or heat. Store below
30o C. Keep away from eyes and children.

Commercial Pack
Aeronid 100 Inhaler : Each canister contains 200 metered doses, each
containing 100 µg Budesonide BP.

Aeronid 200 Inhaler : Each canister contains 200 metered doses, each
containing 200 µg Budesonide BP.

5
T H E R A P E U T I C I N D E X

Alendon®
Tablet

Description
Alendon is a preparation of Alendronic Acid, a biphosphonate used in
the treatment and prevention of osteoporosis in post-menopausal
women.

Indications
Alendon is indicated for:
♦ Treatment and prevention of osteoporosis in post-menopausal women

♦ For the treatment of osteoporosis, Alendon increases bone mass and


reduces the incidence of fractures, including those of the hip and spine
(vertebral compression fractures)
♦ For the prevention of osteoporosis, Alendon may be considered in
postmenopausal women who are at risk of developing osteoporosis
and for whom the desired clinical outcome is to maintain bone mass
and to reduce the risk of future fracture
♦ Treatment to increase bone mass in men with osteoporosis
♦ Treatment of glucocorticoid-induced osteoporosis in men and women
receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or
greater of prednisone and who have low bone mineral density. Patients
treated with glucocorticoids should receive adequate amounts of
calcium and vitamin D
♦ Treatment of Paget’s disease of bone in men and women

Dosage and Administration


Treatment of osteoporosis in postmenopausal women
The recommended dose is one Alendon 70 tablet (70 mg) once weekly or
one Alendon tablet (10 mg) once daily.

Treatment to increase bone mass in men with osteoporosis


The recommended dose is one Alendon tablet (10 mg) once daily.
Alternatively, one Alendon 70 tablet (70 mg) once weekly may be
considered.

6
T H E R A P E U T I C I N D E X

Prevention of osteoporosis in postmenopausal women


The recommended dose is 35 mg once weekly or 5 mg once daily. The
safety of treatment and prevention of osteoporosis with Alendronic Acid
has been studied for up to 7 years.

Treatment of glucocorticoid-induced osteoporosis in men and women


The recommended dose is 5 mg once daily, except for postmenopausal
women not receiving estrogen, for whom the recommended dose is 10
mg once daily.

Paget’s disease of bone in men and women


The recommended treatment regimen is 40 mg once a day for six months.

Mode of Administration
Swallow the tablet with a full glass of water at least 30 minutes before
breakfast (and any other oral medication) on empty stomach. Patients
should remain stand or sit upright for at least 30 minutes after taking the
tablet and should not be down before eating the first meal of the day. Do
not take the tablet at bedtime. Hypocalcemia should be corrected before
starting the therapy.

Precautions
Use in elderly : No dosage adjustment is required for elderly patients.
Because in clinical study there was no evidence of age-related differences
in the efficacy or safety profiles of Alendronic Acid.
Children : It is not recommended for use.
Pregnant women : Alendronate should not be given to pregnant women.
Contraindication
Hypocalcemia; Renal impairment; Vitamin D deficiency; Active
gastrointestinal problem such as dysphagia, oesophago-duodenitis or
ulcer; Pregnancy and breast feeding and Hypersensitivity to any
components of the tablet.

Overdosage
No such information on overdosage with Alendronate.

7
T H E R A P E U T I C I N D E X

Side Effects
The commonest symptomatic side effects are constipation, diarrhoea,
esophageal ulcer, flatulence, dysphagia, musculoskeletal pain, headache,
rarely rash, erythema, transient decrease in serum calcium and phosphate,
nausea, vomiting, peptic ulceration, hypersensitivity reactions including
urticaria and angioedema.

Drug Interactions
The incidence of upper gastrointestinal side effects are increased with the
concomitant use of non-steroidal anti-inflammatory agents and aspirin.
Absorption of Alendronate is reduced in the presence of antacids and
calcium supplements.

Commercial Pack
Alendon 70 Tablet : Box containing 30 tablets in 3 x 10’s blister strips.
Each tablet contains Alendronate Sodium BP equivalent to 70 mg of
Alendronic Acid.

Alendon 10 Tablet : Box containing 30 tablets in 3 x 10’s blister strips.


Each tablet contains Alendronate Sodium BP equivalent to 10 mg of
Alendronic Acid.

8
T H E R A P E U T I C I N D E X

Alphin ®DS
Tablet

Description
Alphin DS (Albendazole) is a broad spectrum anthelmintic available as
chewable tablets, each containing 400 mg of Albendazole USP. It is a very
potent benzimidazole carbamate anthelmintic used in the treatment of
various intestinal worm infestations and hydatid disease.

Indications
Alphin DS (Albendazole) is indicated in
- Ascariasis, Trichuriasis, Strongyloidiasis and Hookworm infestations
- Enterobiasis, Capillariasis, Cysticercosis and Cutaneous larva migrans
- Hydatid disease
- Surgery as an adjunct therapy (either pre-or post-operatively)

Dosage and Administration


The usual dose for adults and children aged 2 years or over with ascariasis
(roundworm), hookworm infestations, trichuriasis (whipworm) and
cutaneous larva migrans is 400 mg as a single dose. In strongyloidiasis,
400 mg is given daily for 3 consecutive days. This may be repeated after 3
weeks if necessary. In enterobiasis (pinworm, threadworm), children aged
2 years or more have been given a single dose of 100 mg repeated after 7
days; the adult dose is 400 mg repeated after 7 days. In hydatid disease, the
usual dose is 400 mg twice daily for adults. This is mostly given for 28-day
cycles with a 2-week interval between cycles. The number of cycles ranges
from 1 to 12, though 3 cycles may be sufficient for most cysts.

Side Effects
Gastrointestinal disturbances, headache and dizziness have been reported
during treatment. These symptoms are usually mild and resolve without
treatment. Rash, fever and rarely alopecia may occur during treatment.

Contraindication
Albendazole is absolutely contraindicated during pregnancy.

9
T H E R A P E U T I C I N D E X

Precautions
Elevations in hepatic enzyme levels and reversible reduction in total white
cell count have occasionally been reported. These changes appear to be
more common during treatment of E. multilocularis.

Drug Interactions
Albendazole has been shown to induce liver enzymes of the cytochrome
P450 system responsible for its own metabolism. There is, therefore, a
theoretical risk of interaction with Theophylline, anticonvulsants,
anticoagulants, oral contraceptives and oral hypoglycaemics. Care should
therefore be exercised during the introduction of Albendazole in patients
receiving the above groups of compounds.

Overdosage
There is no experience of overdosage. Gastric lavage may be performed
in the first two to three hours after ingestion. No specific antidote is
known. However, symptomatic treatment and general supportive
measures should be undertaken as required.

Commercial Pack
Alphin DS Tablet : Box containing 50 chewable tablets in 5 x 10's
aluminium strips, each chewable tablet contains Albendazole USP 400 mg.

10
T H E R A P E U T I C I N D E X

Amdocal®
Tablet

Description
Amdocal (Amlodipine) is a dihydropyridine calcium antagonist, with a
long duration of action, used for the treatment of hypertension and
angina pectoris.

Indications
Hypertension
Amdocal is indicated for the treatment of hypertension. It may be used
alone or in combination with other antihypertensive agents.

Stable Agina
Amdocal is indicated for the treatment of stable angina. Amdocal may be
used alone or in combination with other antianginal agents.

Vasospastic Angina
Amdocal is indicated for the treatment of confirmed or suspected
vasospastic angina. Amdocal may be used as single therapy or in
combination with other antianginal drugs.

Dosage and Administration


The usual initial antihypertensive oral dose is 5 mg once daily with a
maximum dose of 10 mg once daily. Elderly individuals or patients with
hepatic insufficiency may be started on 2.5 mg once daily dose and this
dose may be used when adding Amdocal to other antihypertensive
therapy.

Dosage should be adjusted according to each patient’s need

The recommended dose for stable or vasospastic angina is 5-10 mg, with
the lower dose suggested in the elderly and in patients with hepatic
insufficiency.

Contraindication
Amlodipine is contraindicated in patients with known hypersensitivity to
Amlodipine.

11
T H E R A P E U T I C I N D E X

Precautions
General : Since the vasodilatation induced by Amlodipine is gradual in
onset, acute hypotension has rarely been reported after oral
administration of Amlodipine. Nonetheless, caution should be exercised
when administering Amlodipine with any other peripheral vasodilator
particularly in patients with severe aortic stenosis.

Use in Patient with Congestive Heart Failure : Although haemodynamic


studies and a controlled trial in Class-II-III heart failure patients have
shown that Amlodipine did not lead to clinical deterioration as measured
by exercise tolerance, left ventricular ejection fraction and clinical
symptomatology in general, all calcium channel blockers should be used
with caution in patients with heart failure.

β-blocker withdrawal : Amlodipine gives no protection against the danger


of abrupt β-blocker withdrawal; any such withdrawal should be gradual
reduction of the dose of β-blocker.

Hepatic Failure : Since Amlodipine is extensively metabolized by the liver,


so caution should be exercised when administering Amlodipine to
patients with hepatic impairment.

Drug interactions
No significant drug interaction.

Side Effects
Peripheral oedema may occasionally be severe but is fully reversible. As
with other calcium antagonist drugs, peripheral oedema and skin
erythema occur in a proportion of patients (5-10%) and facial flushing in
2-5% of patients. Complaint of fatigue was also reported more frequently
than in placebo-treated patients.

There is evidence that these effects are more common in patients treated
with doses greater than 10 mg daily.

Overdosage
In humans, experience with intentional overdosage of Amlodipine is
limited. If massive overdosage occurs, active cardiac and respiratory

12
T H E R A P E U T I C I N D E X

monitoring should be instituted. Frequent blood pressure measurements


are essential.

Commercial Pack
Amdocal-5 Tablet : Box containing 5 blister strips of 10 tablets, each
tablet contains Amlodipine Besylate INN equivalent to Amlodipine 5 mg.

Amdocal-10 Tablet : Box containing 3 blister strips of 10 tablets, each


tablet contains Amlodipine Besylate INN equivalent to Amlodipine 10 mg.

13
T H E R A P E U T I C I N D E X

Anustat®
Ointment

Description
Pale yellow coloured homogenous ointment containing in each gram :
Cinchocaine Hydrochloride BP 5 mg, Hydrocortisone BP 5 mg,
Neomycin Sulphate USP equivalent to Neomycin 10 mg, Esculin
Sesquihydrate Ger. P. equivalent to Esculin 10 mg.

Action
It provides an excellent combination of anti-inflammatory, anti-allergic
and antipruritic action of corticosteroid, antibacterial action of locally
effective antibiotic Neomycin, local anaesthetic action of Cinchocaine
and skin protective action of Esculin.

Indications
Internal and external haemorrhoid, anal fissure, anal pruritus, perianal
eczema, proctitis, pre-operative and post-operative treatment of
haemorrhoidectomy, post-partum haemorrhoidal condition and as
prophylaxis in between attacks.

Dosage and Application


A small quantity of the ointment should be applied with finger in the
painful pruritic area in the morning and evening and after each stool. For
deep application nozzle should be attached to the tube and inserted to full
extent and should be squeezed gently from the lower end while
withdrawing.

Side Effects and Warning


Side effects which have been reported for individual constituents may
occur and appropriate precautions should be taken when using Anustat.

Like most of the steroids under certain circumstances hydrocortisone


may be absorbed in sufficient amount to produce systemic effects. So,
long term use should be avoided. Adrenal suppression may occur even
without occlusion. When used for prolonged period striae may occur.

14
T H E R A P E U T I C I N D E X

Skin sensitisation may occur due to Neomycin. Absorption of the


antibiotic from wound or inflamed skin may occur and this may affect the
hearing irreversibly. Hence Anustat should not be given to extensively
damaged skin.

Contraindication
Sensitivity to any one of the constituents of Anustat.

Pregnancy
Topical steroid should not be used extensively in pregnancy.

Commercial Pack
Anustat Ointment : 15 g ointment in sealed aluminium tube with nozzle
for application.

15
T H E R A P E U T I C I N D E X

Apresin ®
Tablet

Description
Fluphenazine Hydrochloride BP and Nortriptyline Hydrochloride BP
combination has been found as an effective preparation for the patients
suffering from "anxiety" or "depression" or both. Fluphenazine is a
tranquilizer of the phenothiazine type. Nortriptyline is a tricyclic
antidepressant having less sedative action. This combination helps to
restore functional ability without developing any drug dependence.

Dosage and Administration


Adults : One Apresin tablet (Fluphenazine HCl 0.5 mg and Nortriptyline 10
mg as Nortriptyline HCl) 2 to 3 times daily.

Indications
- Mild to moderate mixed anxiety/depression
- Emotional disturbance
- Sleep disorder
- Gastric problems

Contraindication
It is contraindicated in :
- History of gradual epilepsy or organic brain damage
- Blood dyscrasia
- Severe cardiac insufficiency
- Renal or liver damage
- Patients taking monoamine oxidase inhibitor (MAOI)
- Younger children
- Hypersensitivity to any component of the preparation

Adverse Effects
Tardive dyskinesias have been reported in phenothiazine therapy; usually
after prolonged courses given at doses adequately to control psychotic
illness. Blood dyscrasia, malignant neuroleptic syndrome and sudden
death have been reported rarely. Agranulocytosis is a rare but potentially
fatal adverse effect of Nortriptyline Hydrochloride.

16
T H E R A P E U T I C I N D E X

Use in Pregnancy and Lactation


The safety in human pregnancy has not been yet established. The use of
this drug in lactation is not recommended, as it is excreted in breast-milk.

Precautions
Precautions should be taken in patients with glaucoma, prostate
enlargement, cardiac failure and myocardial infarction, and in concurrent
administration with CNS depressants. The drug may impair alertness and
abilities to drive a car or operate machinery.

Drug Interactions
Interactions with barbiturates, alcohol, and narcotic drugs may occur, so
central depressants should be administered with caution.

Pharmaceutical Precautions
Store in a cool place below 25o C. Keep out of the reach of children.

Commercial Pack
Apresin Tablet : Box containing 10 blister strips of 10 film coated tablets.
Each tablet contains Fluphenazine Hydrochloride BP 0.5 mg and
Nortriptyline 10 mg as Nortriptyline Hydrochloride BP.

17
T H E R A P E U T I C I N D E X

Arbit®
Tablet

Description
Arbit (Irbesartan) is an antihypertensive drug. It antagonizes angiotensin
II receptor (AT1 subtype).

Indications
Arbit is indicated for the treatment of hypertension. It may be used alone
or in combination with other antihypertensive agents.

Dosage and Administration


The recommended initial dose of Arbit is 150 mg once daily. Patients
requiring further reduction in blood pressure should be treated to 300 mg
once daily. Arbit may be administered with or without food.

Contraindication
Arbit is contraindicated in patients who are hypersensitive to any
component of this product.

Side Effects
In placebo-controlled clinical trials the adverse event, which occurred in
at least 1% of patients treated with Irbesartan and at a higher incidence
versus placebo, included diarrhoea, dyspepsia, trauma, fatigue, and upper
respiratory infection. Irbesartan use was not associated with an increased
incidence of dry cough, as is typically associated with ACE inhibitor use.
Rare side effects are urticaria, angioedema, jaundice, hyperkalaemia, and
increased liver function tests.

Use in Special Populations


Paediatric : There is no data on safety and effectiveness of Irbesartan in
children.

Geriatric : In elderly subjects (age 65-80 years), no dosage adjustment is


necessary.

Renal Insufficiency : No dosage adjustment is necessary in patients with


mild to severe renal impairment.

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T H E R A P E U T I C I N D E X

Hepatic Insufficiency : No dosage adjustment is necessary in patients with


hepatic insufficiency.

Pregnancy and Nursing Mothers : When pregnancy is detected, Arbit


should be discontinued as soon as possible. It is not known whether
Irbesartan is excreted in human milk, so it should not be prescribed
during lactation.

Drug Interactions
No significant drug interaction has been found in studies with
Hydrochlorothiazide, Digoxin, Warfarin, and Nifedipine.

Overdosage
No data is available in regard to overdosage in humans. However, daily
doses of 900 mg for 8 weeks were well-tolerated. The most likely
manifestations of overdosage are expected to be hypotension.

Pharmaceutical Precautions
Store at temperature between 15°C and 30°C.

Commercial Pack
Arbit 75 Tablet : Box containing 30 tablets in 3 x 10's blister strips. Each
tablet contains Irbesartan INN 75 mg.

Arbit 150 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Each
tablet contains Irbesartan INN 150 mg.

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T H E R A P E U T I C I N D E X

Aristocal®
Tablet

Description
Aristocal contains Calcium Carbonate that is used as dietary calcium
supplement, and to sequester phosphorus in the intestine to reduce total
body phosphate accumulation in chronic renal failure. Each Aristocal
tablet contains 1250 mg Calcium Carbonate BP equivalent to 500 mg
elemental Calcium.

Indications
♦ For dietary calcium supplement when it is deficient
♦ As a phosphate binder in chronic renal failure

♦ As an adjunct therapy in the arrest or slowing down of bone


demineralization in osteoporosis.

Dosage and Administration


Adults and Elderly : Dietary deficiency- 2 to 3 tablets daily. As Phosphate
binder- Dose as required by the individual patient depending on serum
calcium and phosphate levels. Adjunct to osteoporosis therapy- 2 to 3
tablets daily.

Contraindication
♦ Hypercalcaemia and hyperparathyroidism
♦ Renal calculi and nephrolithiasis
♦ Zollinger-Ellision syndrome and other causes of gastric acid
hypersecretion.

Adverse Effects
Mild gastrointestinal disturbances (e.g. flatulence, abdominal pain,
constipation) may occur. Hypercalcaemia and alkalosis are rarely
produced with large doses.

Precautions
In mild hypercalciuria or renal failure or stone formation in urinary tract,
adequate checks must be kept on urinary calcium excretion. If necessary
the dosage should be reduced or calcium therapy discontinued.

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T H E R A P E U T I C I N D E X

Use in Pregnancy and Lactation


Calcium containing drugs are used widely in pregnancy by way of oral
calcium supplementation. Calcium Carbonate can be used in lactating
women too.

Drug Interactions
Calcium Carbonate may enhance the cardiac effects of Digoxin and other
cardiac glycosides if systemic hypercalcaemia occurs. It may interfere with
the absorption of concomitantly administered Tetracycline preparations.
Modification of vitamin D therapy may be required to avoid
hypercalcaemia when Calcium Carbonate is used as a phosphate binder in
chronic renal failure. Concurrent administration of Calcium Carbonate
reduces total absorption and peak serum levels of Ciprofloxacin.

Pharmaceutical Precautions
Store in a cool and dry place. Keep out of the reach of children.

Commercial Pack
Aristocal Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Each
tablet contains Calcium Carbonate BP equivalent to 500 mg elemental
Calcium.

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T H E R A P E U T I C I N D E X

Aristoferon ®
Syrup

Description
Aristoferon is a haematinic preparation of Ferrous Sulphate available as
raspberry flavored syrup. Each 5 ml of syrup contains 200 mg of Ferrous
Sulphate BP.

Ferrous Sulphate has the general properties of iron salts and is one of the
most widely used iron salts in the treatment of iron deficiency anaemia.

Indications
Aristoferon is indicated in the treatment and prevention of iron
deficiency anaemia and anaemia of pregnancy where routine
administration of iron is necessary.

Dosage and Administration


Adult
Initial therapeutic dose : 3-4½ teaspoonful daily in divided doses or as
prescribed by the physician.

Maintenance dose : 1½ teaspoonful daily, but if needed up to 1.8


g (9 teaspoonful) daily can be given.

Children
♦Under 1 year : ¼ th teaspoonful thrice daily or as directed by physician
♦1-5 years : 1 teaspoonful thrice daily
♦6-12 years : 1½ teaspoonful twice daily

Note :
i) Mix with water or fruit juice to avoid temporary staining of teeth.
ii) Do not mix with milk.

Contraindication
♦ Iron therapy is contraindicated in haemachromatosis and
haemosiderosis.
♦ It should not be given to patients receiving repeated blood transfusion
or with anaemia not produced by iron deficiency.

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T H E R A P E U T I C I N D E X

Precautions
Should be administered with caution when given to patients with iron
storage or iron absorption disease, haemoglobinopathies or existing
gastrointestinal disease. Absorption of iron salt and Tetracycline is
diminished when taken concomitantly by mouth. If treatment with both
drugs is required iron salt should be given 3 hours before or 2 hours after
Tetracycline. Absorption of iron is also decreased in the presence of
Antacids or when taken with tea.

Side Effects
Therapeutic doses of iron may cause gastrointestinal symptoms like
diarrhoea, nausea and vomiting. Although iron is better absorbed between
meals, side effects can be reduced by taking it with or immediately after
food. Continuous administration may sometimes cause constipation. Iron
containing liquid medication may cause temporary staining of teeth (this
is less likely when diluted).

Commercial Pack
Aristoferon Syrup : Aristoferon 200 ml syrup in glass bottle, each 5 ml
containing 200 mg of Ferrous Sulphate BP.

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T H E R A P E U T I C I N D E X

Aristofol-Fe ®
Tablet

Description
Each sugar coated Aristofol-Fe tablet contains 308 mg of Ferrous
Fumarate BP (eqv. to 100 mg of elemental iron) and 350 µg of Folic Acid
USP. Iron and Folic Acid are required for normal haemopoiesis.

Indications
Prophylaxis and treatment of iron deficiency anaemia in pregnancy.
Prevention of megaloblastic anaemia of pregnancy.

Dosage and Administration


♦ In anaemia usual dose is one tablet daily.

♦ In severe or refractory iron deficiency anaemia, one tablet twice daily


may be given.

♦ In Pregnancy, it is recommended that Aristofol-Fe should be started at


the first antenatal consultation and continued until 3 months after
delivery.

Contraindication
Aristofol-Fe is contraindicated in megaloblastic anaemia due to vitamin
B 12 deficiency.

Precautions
Administration of Aristofol-Fe during the first trimester of pregnancy
may be undesirable. Very few pregnant women are not protected by
physiological doses of folic acid. If anaemia is developed despite
prophylaxis with Aristofol-Fe, patients should be investigated further.
Some postgastrectomy patients show poor absorption of iron. Care is
needed when treating patients with peptic ulcer. When Aristofol-Fe and
Tetracycline are taken concomitantly, absorption of both drugs are
reduced. Concurrent administration of antacid may reduce absorption of
iron. Serum anticonvulsant levels may be reduced by administration of
folate.

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T H E R A P E U T I C I N D E X

Side Effects
Gastrointestinal disorders and allergic reactions have been reported.

Treatment of Overdosage
Ingestion of an overdose of iron orally requires emergency treatment
along the following lines. Vomiting should be induced immediately,
followed (as soon as possible) by parenteral injection of Desferrioxamine
Mesylate and then gastric lavage. In the mean time it is helpful to give milk
and or 5% sodium bi-carbonate solution by mouth. Intramuscular
desferrioxamine injection may be given. A desferrioxamine solution (5 g
in 50-100 ml) may be left in the stomach. If Desferrioxamine is not
available, 300 ml of 1% to 5% sodium bi-carbonate solution should be
left in the stomach. Fluid replacement is essential.

Commercial Pack
Aristofol-Fe Tablet : Box containing 100 tablets in 10 x 10’s blister strips.
Each sugar coated Aristofol-Fe tablet contains 308 mg of Ferrous
fumarate (eqv. to 100 mg of elemental iron) and 350 µg of Folic Acid.

25
T H E R A P E U T I C I N D E X

Aristoplex®
Syrup

Description
Aristoplex is a liquid preparation of Vitamin B-Complex. Each 5 ml
Aristoplex syrup contains:

Thiamine Hydrochloride BP 5 mg
(Vitamin B1)
Riboflavin (Vitamin B2 ) USP 2 mg
Pyridoxine Hydrochloride BP 2 mg
(Vitamin B6)
Nicotinamide BP 20 mg

Indications
♦ Prevention and treatment of Vitamin B-Complex deficiency states,
manifested by glossitis, stomatitis, cheilosis, beriberi and polyneuritis.

♦ Maintenance of normal growth and health during the early days of


children.

♦ Apathy and anorexia in elderly patients.

♦ Prevention of vitamin deficiencies, particularly when depletion is


suspected;
- Pregnancy and lactation
- Convalescence during debilitating illness
- Patients on restricted diets

Dosage and Administration


Adults and Elderly : One to two 5 ml spoonful syrup three times a day.
Children : One 5 ml spoonful syrup three times a day. Infants : One 5
ml spoonful syrup daily.

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T H E R A P E U T I C I N D E X

Contraindication
Known hypersensitivity to any of the active constituents.

Precautions
Pyridoxine may reduce the therapeutic efficacy of Levodopa.

Use in Pregnancy and Lactation


As with all medicines, careful considerations should be given before the
administration of B-Complex preparations during the first trimester of
pregnancy. Vitamins are excreted in breast milk.

Pharmaceutical Precautions
Store in a cool place. The syrup should be protected from light.

Commercial Pack
Aristoplex Syrup : Aristoplex syrup is available in 100 ml and 200 ml
amber glass bottle. Each 5 ml Aristoplex syrup contains multivitamin.

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T H E R A P E U T I C I N D E X

Aristovit®-B
Tablet

Description
Aristovit-B is a sugar coated tablet containing different B-Vitamins. Each
tablet contains 20 mg of Nicotinamide USP, 2 mg of Pyridoxine
Hydrochloride USP, 2 mg of Riboflavin USP and 5 mg of Thiamine
Mononitrate USP.

Indications
Aristovit-B is indicated in the treatment and prevention of Vitamin B
deficiencies, particularly when depletion is suspected, such as in case of
pregnancy and lactation, convalescence following debilitating illness and
in restricted diet.

Dosage and Administration


One or two tablets three times daily.

Contraindication
Contraindicated in case of hypersensitivity to any of the active
ingredients of Aristovit-B.

Precaution
Should be given cautiously to patients taking Levodopa as Pyridoxine
reduces the effect of Levodopa.

Commercial Pack
Aristovit-B Tablet : Bottle containing 45 sugar coated tablets. Each sugar
coated tablet contains different B-Vitamin.

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T H E R A P E U T I C I N D E X

Aristovit®-M
Tablet

Description
Aristovit-M is sugar-coated multivitamin-mineral tablet.

Each tablet contains :

Vitamin A USP 1.5 mg


Vitamin D USP 10 µg
Thiamine Mononitrate (B1) USP 1.5 mg
Riboflavin USP 1.7 mg
Ascorbic Acid USP 60 mg
Nicotinamide USP 20 mg
Pyridoxine HCl (B6) USP 2 mg
Folic Acid USP 0.4 mg
Calcium Pantothenate USP 10.92 mg
Cyanocobalamin (B12) USP 6 µg
Vitamin E USP 10.05mg
Ferrous Sulphate USP 50 mg
Potassium Iodide USP 196 µg
Potassium Sulphate BP 11.14 mg
Manganese Sulphate Monohydrate USP 1 mg
Cupric Sulphate Pentahydrate USP 2 mg
Zinc Sulphate USP 37.04 mg

Indications
Deficiency states in acute and chronic disease. Conditions regarding
specific support : pregnancy, lactation, menopause, during treatment with
antibiotics. The comprehensive formulae of Aristovit-M assures liberal
amounts of important vitamins, minerals and trace elements needed by
the body during periods of increased energy requirements such as in
disease and convalescence.

Dosage and Administration


One tablet daily or as advised by the physician.

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T H E R A P E U T I C I N D E X

Contraindication
Supplemental vitamins and minerals should not be prescribed for patients
with haemochromatosis or Wilson’s disease.

Hypersensitivity to any of the active ingredients is a contraindication.


Excessive doses of vitamin A and D can lead to hypervitaminosis. When
multivitamin preparations are prescribed allowance must be made for
vitamins from other sources. This is particularly important during the first
trimester of pregnancy when large doses of Vitamin A may be
teratogenic.

Iron and Zinc chelate with Tetracyclines and absorption of all three
agents may be impaired.

Side Effects
Multivitamin preparation with ordinary doses of component are usually
nontoxic.

Precautions
Aristovit-M may be used in patients being treated for Parkinson’s disease
with a Levodopa preparation which includes a dopa-decarboxylase
inhibitor (e.g. Carbidopa, Benserazide). But precautions should be taken
Pyridoxine acts as an antagonist of Levodopa.

Pharmaceutical Precautions
Store in a cool and dry place at a temperature not exceeding 25°C and
protect from light.

Commercial Pack
Aristovit-M Tablet : Bottle containing 30 sugar coated tablets. Each sugar
coated tablet contains multivitamin and mineral.

30
T H E R A P E U T I C I N D E X

Aristovit®-X
Tablet

Description
Aristovit-X is a special formulation comprising of important vitamin,
anti-oxidants and minerals. Each tablet contains:

Vitamin A 2000 IU
Vitamin E 50 IU
Vitamin K 75.00 µg
Vitamin C 200.00 mg
Zinc 15.00 mg
Copper 1.00 mg
Manganese 3.00 mg
Selenium 70.00 µg

Indications
Aristovit-X is a once-daily tablet indicated for use to develop immune
system, help prevent the well-known deficiency diseases such as scurvy,
beriberi, pellagra and others, prevent certain types of cancer by blocking
the formation of cancer causing substances in the body. It is also capable
of combating cardiovascular and immunological disorders. Aristovit-X
helps strengthen immune system, keeping free from sickness and allowing
a better, harder workout.

Dosage and Administration


Aristovit-X may be administered once daily or as indicated by the
physician.

Contraindication
Aristovit-X is contraindicated in patients with a known hypersensitivity to
any of the ingredients.

Side Effects
Generally well tolerated.

31
T H E R A P E U T I C I N D E X

Precautions
Excess vitamin A intake may be toxic and may increase the risk of birth
defects. Pregnant women and women who may become pregnant should
not exceed total 5000 IU of vitamin A (retinyl palmitate) per day.

Drug Interactions
No drug interactions have been reported.

Use in Pregnancy and Lactation


Aristovit-X is recommended in pregnancy and lactation

Pharmaceutical Precautions
Tablets should be stored below 25 οC and protected from light and
moisture.

Commercial Pack
Aristovit-X Tablet : Plastic bottle containing 30 film coated tablets. Each
tablet contains multivitamin, antioxidants and minerals.

32
T H E R A P E U T I C I N D E X

Arixon®
Injection

Description
Arixon (Ceftriaxone) is highly stable to most β-lactamase, both
penicillinases and cephalosporinases of Gram-positive and Gram-
negative bacteria. The action of Arixon is bactericidal which inhibits the
cell wall synthesis. It is most effective against the following
microorganisms:

Gram-positive bacteria: Staphylococcus aureus (including penicillinase


producing strains), Staphylococcus epidermis, Streptococcus, Streptococcus
pneumoniae, Streptococcus bovis.

Gram-negative bacteria: Escherichia coli, Haemophilus influenzae (including


penicillinase-producing strains), Neisseria gonorrhoeae, Neisseria meningitidis,
Proteus mirabilis, Proteus vulgaris.

Indications
It is indicated for the treatment of sepsis; meningitis; abdominal
infections (peritonitis, infections of the biliary and gastrointestinal tracts),
infections of the bones, joints, soft tissue, skin and/or wounds infections
in patients with impaired defense mechanism; renal and urinary tract
infections; respiratory tract infections, particularly pneumonia, and ear,
nose and throat infections, and genital infections including gonorrhoea.

Dosage and Administration


Adults and children over twelve years : The usual dosage is 1 to 2 g of Arixon
administered once daily in 24 hours. In severe cases infections caused by
moderately sensitive organisms, the dose may be increased to 4 g once daily.

Neonates, infants and children up to 12 years : For Neonates (up to 2 weeks) a


daily dose of 20-50 mg/kg body weight, not to exceed 50 mg/kg on
account of the immaturity of the infants is advised. For children with
body weight of 50 kg or more, the usual adult dose should be used.

33
T H E R A P E U T I C I N D E X

Elderly patients : The dosage recommended for adults require no


modification in case of geriatric patients.

Duration of Therapy
The duration of therapy varies according to the course of the diseases. As
with antibiotic therapy in general administration, Arixon should be
continued for a minimum of 48-72 hours after the patient has become
afebrile or evidence of bacterial eradication has been obtained. For the
treatment of gonorrhoea, a single intramuscular dose of 250 mg Arixon
is recommended.

Precautions
As with other cephalosporins anaphylactic shock cannot be ruled out
even if a thorough patient history is taken. Anaphylactic shock requires
immediate counter measures.

Side Effects
Diarrhoea, nausea, vomiting, stomatitis and glossitis.

Pharmaceutical Precautions
Arixon should be stored at below 30o C.

Commercial Pack
Arixon 250 mg IM Injection : Each box containing one vial of
Ceftriaxone Sodium USP equivalent to Ceftriaxone 250 mg and one
ampoule of 2 ml Lignocaine Injection BP 1%.

Arixon 500 mg IM Injection : Each box containing one vial of


Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg and one
ampoule of 2 ml Lignocaine Injection BP 1%.

Arixon 1 g IM Injection : Each box containing one vial of Ceftriaxone


Sodium USP equivalent to Ceftriaxone 1 g and one ampoule of 3.5 ml
Lignocaine Injection BP 1%.

Arixon 250 mg IV Injection : Each box containing one vial of


Ceftriaxone Sodium USP equivalent to Ceftriaxone 250 mg and one
ampoule of 5 ml Water for Injection BP.

34
T H E R A P E U T I C I N D E X

Arixon 500 mg IV Injection : Each box containing one vial of


Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg and one
ampoule of 5 ml Water for Injection BP.

Arixon 1 g IV Injection : Each box containing one vial of Ceftriaxone


Sodium USP equivalent to Ceftriaxone 1 g and one ampoule of 10 ml
Water for Injection BP.

35
T H E R A P E U T I C I N D E X

Arlin®
Tablet/Suspension

Description
Arlin contain Linezolid, which is a synthetic antibacterial agent of the
oxazolidinone class. Arlin film coated tablets for oral administration
contain 400 mg or 600 mg Linezolid. Arlin oral suspension is supplied as
powder for reconstitution into a suspension for oral administration.

Indications
Vancomycin-Resistant Enterococcus faecium infections, including cases with
concurrent bacteremia. Nosocomial pneumonia caused by Staphylococcus
aureus (methicillin-susceptible and -resistant strains), or Streptococcus
pneumoniae (penicillin-susceptible strains). Combination therapy may be
clinically indicated if the documented or presumptive pathogens include
Gram-negative organisms. Complicated skin and skin structure infections
caused by Staphylococcus aureus (methicillin-susceptible and -resistant
strains), Streptococcus pyogenes, or Streptococcus agalactiae. Uncomplicated skin
and skin structure infections caused by Staphylococcus aureus (methicillin-
susceptible only) or Streptococcus pyogenes. Community-acquired pneumonia
caused by Streptococcus pneumoniae (penicillin-susceptible strains only),
including cases with concurrent bacteremia, or Staphylococcus aureus
(methicillin-susceptible strains only).

Dosage and Administration

i) Vancomycin- resistant Enterococcus faecium infections, including


concurrent bacteremia, recommended dose is 600 mg 12 hourly for
14 to 28 days.
ii) Nosocomial pneumonia, Complicated skin and skin structure
infections, and Community-acquired pneumonia, including concurrent
bacteremia, recommended dose is 600 mg 12 hourly for 10 to 14 days.
iii) Uncomplicated skin and skin structure infections recommended dose
is 400 mg 2 hourly for 10 to 14 days.

36
T H E R A P E U T I C I N D E X

Contraindication
Arlin formulations are contraindicated for use in patients who have
known hypersensitivity to Linezolid or any of the other product
components.

Side Effects
Most of the adverse events reported with Arlin are mild to moderate in
intensity. The most common adverse events in patients treated with Arlin
were diarrhoea, headache and nausea. Other adverse events included oral
moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized
abdominal pain, pruritus, and tongue discolouration.

Use in Pregnancy and Lactation


There are no adequate and well-controlled studies in pregnant women.
Arlin should be used during pregnancy only if the potential benefit
justifies the potential risk to the foetus. It is not known whether Linezolid
is excreted in human milk. Because many drugs are excreted in human
milk, caution should be exercised when Arlin is administered to a lactating
woman.

Drug Interactions
Monoamine Oxidase Inhibitors: Linezolid is a reversible, nonselective
inhibitor of monoamine oxidase. Therefore, Linezolid has the potential
for interaction with adrenergic and serotonergic agents.

Adrenergic Agents : Some individuals receiving Arlin may experience a


reversible enhancement of the pressor response to sympathomimetic
agents, vasopressor or dopaminergic agents. Commonly used drugs such
as Phenylpropanolamine and Pseudoephedrine have been specifically
studied. Initial doses of adrenergic agents, such as Dopamine or
Epinephrine, should be reduced and titrated to achieve the desired
response.

Serotonergic Agents : Co-administration of Linezolid and serotonergic


agents was not associated with serotonin syndrome in studies. Since there
is limited experience with concomitant administration of Linezolid and
serotonergic agents, physicians should be alert to the possibility of signs
and symptoms of serotonin syndrome (e.g. hyperpyrexia and cognitive
dysfunction) in patients receiving such concomitant therapy.

37
T H E R A P E U T I C I N D E X

Overdosage
In the event of overdosage, supportive care is advised with maintenance of
glomerular filtration. Haemodialysis may facilitate more rapid elimination
of Linezolid.

Pharmaceutical Precautions
Store at temperature between 15o C and 30o C.

Commercial Pack
Arlin 400 Tablet : Box containing 20 tablets in 2 x 10's blister strips. Each
film coated tablet contains Linezolid INN 400 mg.

Arlin 600 Tablet : Box containing 20 tablets in 2 x 10's blister strips. Each
film coated tablet contains Linezolid INN 600 mg.

Arlin Powder for Suspension : Dry Powder in amber glass bottle for
reconstitution into 100 ml Suspension. After reconstitution each 5 ml
contains Linezolid INN 100 mg.

38
T H E R A P E U T I C I N D E X

Ascobex ®
Tablet

Description
Ascobex tablet contains Ascorbic Acid USP 100 mg, Sodium Ascorbate
USP 168.75 mg, the combination is equivalent to 250 mg of Ascorbic
Acid (Vitamin C).

Ascorbic Acid (Vitamin C) is essential for synthesis of collagen and


intracellular materials. It is involved in important metabolic reactions.
Deficiency may arise due to decrease in absorption or increase in
requirement due to certain physiological conditions such as pregnancy,
lactation, post-operative state, growing age etc.

Ascobex can be used to treat vitamin C deficiency and in those conditions


where there is an increased requirement of vitamin C. Ascobex is also
used as an antioxidant vitamin.

Indications
Vitamin C deficiency disorders, pregnancy, lactation, post-operative or
other wound healing state, infection, growing age, thyrotoxicosis, and
common cold. Being an antioxidant vitamin, it protects against
cardiovascular diseases, atherosclerosis, malignancy and it has been found
to delay the aging process. It has been found that in case of diabetes,
there is an increase in requirement of vitamin C, Ascobex is also indicated
in that condition.

Dosage
♦ In scurvy : 4 tablets 2 to 3 times daily
♦ In wound healing : 2-4 tablets 2 to 3 times daily
♦ In other conditions : 1-2 tablets daily

Precautions
Should be given with caution to patient with hyperoxaluria. Tolerance may
be induced in patients taking higher doses.

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T H E R A P E U T I C I N D E X

Side Effects
Ascorbic acid does not seem to have any important adverse effects at
dosages less than 4 mg/day. Larger dose may cause diarrhea or formation
of renal calculi of calcium oxalate in patients with renal impairment.
Ingestion of more than 600 mg daily have a diuretic action.

Commercial Pack
Ascobex Tablet : Box containing 200 tablets in 10 X 20’s blister strips,
each tablet contains Ascorbic Acid USP 100 mg, Sodium ascorbate USP
168.75 mg, the combination is equivalent to 250 mg of Ascorbic Acid
(Vitamin C).

40
T H E R A P E U T I C I N D E X

Atova ®
Tablet

Description
Atova (Atorvastatin Calcium) is a synthetic lipid-lowering agent. It is an
inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA). This
enzyme catalyzes the conversion of HMG-CoA to mevatonate, an early
and rate limiting step in the synthesis of cholesterol.

Indications
Atova is indicated as an adjunct to diet to reduce elevated total
cholesterol, low density lipoprotein-cholesterol (LDL-C), apolipoprotein
B and triglyceride (TG) levels in patients with primary
hypercholesterolaemia (heterozygous familial and non familial) and mixed
dyslipidaemia (Fredrickson Types lla and llb).

Atova is indicated as adjunctive therapy to diet for the treatment of


patients with elevated serum triglyceride levels (Fredrickson Type IV).

Atova is indicated for the treatment of patients with primary


dysbetalipoproteinaemia (Fredrickson Type III) who do not respond
adequately to diet.

Atova is also indicated to reduce total-C and LDL-C in patients with


homozygous familial hypercholesterolaemia as an adjunct to other lipid
lowering treatments (e.g. LDL apheresis) or if such treatments are
unavailable.

Therapy with lipid altering agent should be a component of multiple risk


factor intervention in individuals at increased risk for atherosclerotic
vascular disease due to hypercholesterolaemia. Lipid altering agents
should be used in addition to a diet restricted in saturated fat and
cholesterol only when the response to diet and other nonpharmacological
measures have been inadequate (see Table 1). At the time of
hospitalization for an acute coronary event, consideration can be given to
initiating drug therapy at discharge if the LDL-C level is >130 mg/dl
[National Cholesterol Education Program (NCEP) Adult Treatment
Panel II (ATP II)].

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T H E R A P E U T I C I N D E X

Prior to initiating therapy with Atova, secondary causes for


hypercholesterolaemia (e.g., poorly controlled diabetes mellitus,
hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver
disease, other drug therapy, and alcoholism) should be excluded, and a
lipid profile performed to measure total-C, LDL-C, HDL-C, and TG. For
patients with TG<400 mg/dl (<4.5 mmol/L), LDL-C can be estimated
using the following equation: LDL-C=total-C (0.20 x [TG] + HDL-C).
For TG levels >400 mg/dl (>4.5 mmol/L), this equation is less accurate
and LDL-C concentrations should be determined by ultracentrifugation.
Atorvastatin has not been studied in conditions where the major
lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types
I and V).

TABLE 1 - NCEP GUIDELINES FOR LIPID MANAGEMENT


Definite Two or More LDL-Cholesterol mg/dl (mmol/L)
Atherosclerotic Other
Diseasea Risk Factorsb
Initiation Level Minimum Goal
No No >190 (>4.9) <160 (<4.1)

No Yes >160 (>4.1) <130 (<3.4)

Yes Yes or No >130 c (>3.4) <100 (<2.6)

a. Coronary heart disease or peripheral vascular disease (including symptomatic carotid


artery disease).

b. Other risk factors for coronary heart disease (CHD) include: age (males >45 years;
females >55 years or premature menopause without estrogen replacement therapy);
family history of premature CHD; current cigarette smoking; hypertension;
confirmed HDL-C < 35 mg/dl (< 0.91 mmol/L); and diabetes mellitus. Subtract 1
risk factor if HDL-C is > 60 mg/dl (>1.6 mmol/L).

c. In CHD patients with LDL-C levels 100 to 129 mg/dl, the physician should exercise
clinical judgement in deciding whether to initiate drug treatment.

Dosage and Administration


Adults : The patient should be placed on a standard cholesterol-lowering
diet before receiving Atova and should continue on this diet during
treatment with Atova.

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T H E R A P E U T I C I N D E X

Hypercholesterolaemia (Heterozygous Familial and Nonfamilial) and


Mixed Dyslipidaemia (Fredrickson Types IIa and IIb) : The
recommended starting dose of Atova is 10 mg daily. The dosage range is
10 to 80 mg once daily. Atova can be administered as a single dose at any
time of the day with or without food. Therapy should be individualized
according to goal of therapy and response. After initiation and/or upon
titration of Atova, lipid levels should be analyzed within 2 to 4 weeks and
dosage adjusted accordingly.

Since the goal of treatment is to lower LDL-C, the LDL-C levels should
be used to initiate and assess treatment response. Only if LDL-C levels
are not available, total-C should be used to monitor therapy.

Homozygous Familial Hypercholesterolaemia : The dosage of Atova in


patients with homozygous Familial Hypercholesterolaemia is 10 to 80 mg
daily. Atova should be used as an adjunct to other lipid-lowering
treatments (e.g. LDL apheresis) in these patients or if such treatments are
unavoidable.

Patients with renal insufficiency: Renal disease has no influence on the


plasma concentrations or lipid effects of Atorvastatin; thus no
adjustment of dose is required. Haemodialysis is not expected to
significantly enhance the clearance of Atorvastatin since the drug is
extensively bound to plasma proteins.

Patients with hepatic dysfunction: In patients with moderate to severe


hepatic dysfunction, the therapeutic response to Atorvastatin is
unaffected but exposure to the drug is greatly increased. C max increases by
approximately 16 fold and AUC (0-24) by approximately 11 fold.
Therefore, caution should be exercised in patients who consume
substantial quantities of alcohol and/or have a history of liver disease.

Contraindication
Hypersensitivity to any component of this medication. Active liver
disease or unexplained persistent elevations of serum transaminases
exceeding three times the upper limit of normal.

Use in Pregnancy and Lactation


Safety in pregnancy has not been established. Rare reports of congenital

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T H E R A P E U T I C I N D E X

anomalies have been reported following intrauterine exposure to HMG-


CoA reductase inhibitors.

HMG-CoA reductase inhibitors are not recommended for use during


pregnancy. An interval of 1 month should be allowed from stopping
Atorvastatin treatment to conception in the event of planning a
pregnancy.

Use of HMG-CoA reductase inhibitors during breast feeding is not


recommended, because of the potential for serious adverse effects in
nursing infants.

Use in Special Population


Children : Safety and efficacy of Atorvastatin have not been established
in children.

Geriatrics : Efficacy and safety in older patients using recommended


doses is similar to that seen in the general population.

Carcinogenicity/mutagenicity
Atorvastatin was not found to be carcinogenic in rats; the maximum dose
used was 63 fold higher than the highest human dose (80 mg/day) on a
mg/kg body weight basis.

Precautions
Rhabdomyolysis with acute renal failure secondary to myoglobinuria has
been reported with other drugs in this class. Atorvastatin may cause an
elevation in serum creatinephosphokinase (CPK) levels. This should be
considered in the differential diagnosis of chest pain in patients on
therapy with Atorvastatin. Uncomplicated myalgia has been reported in
Atorvastatin-treated patients. Atorvastatin therapy should be
discontinued if markedly elevated CPK levels occur or myopathy is
diagnosed or suspected.

The risk of myopathy during treatment with other drugs in this class is
increased with concurrent administration of Cyclosporin, fibric acid
derivatives, Erythromycin, Niacin, or azole anti-fungals. Patients should
be advised to report promptly any unexplained muscle pain, tenderness or
weakness, particularly if accompanied by malaise or fever.

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T H E R A P E U T I C I N D E X

Side Effects
Atorvastatin is generally well tolerated. Adverse effects reported
commonly include constipation, flatulence, dyspepsia, abdominal pain,
headache, nausea, myalgia, diarrhoea, asthenia and insomnia.

Dose related and reversible elevated serum alanine transaminase (ALT)


levels have been reported in approximately 1.3% of patients receiving
Atorvastatin.

Elevated serum CPK levels have been reported in some patients on


Atorvastatin but only in rare cases patients may have muscle pain,
tenderness or weakness. Other side effects reported in clinical trials (not
all effects have necessarily been associated with Atorvastatin therapy)
include muscle cramps, myopathy, paresthesia, peripheral neuropathy,
pancreatitis, hepatitis, cholestatic jaundice, anorexia, vomiting, pruritus,
rash, impotence, hyperglycaemia and hypoglycaemia. Chest pain,
dizziness, angina and allergic reactions have been reported in isolated
cases.

Overdosage
There is no specific treatment available for Atorvastatin overdosage.
General supportive measures should be adopted as required. Liver
function tests and serum CPK levels should be monitored. Due to
extensive drug binding to plasma proteins, haemodialysis is not expected
to significantly enhance Atorvastatin clearance.

Pharmaceutical Precautions
Storage below 20o C, protected from moisture.

Commercial Pack
Atova 10 Tablet : Box containing 10 tablets in 1 x 10’s blister strip, each
tablet contains Atorvastatin Calcium INN equivalent to Atorvastatin 10
mg.

Atova 20 Tablet : Box containing 10 tablets in 1 x 10’s blister strip, each


tablet contains Atorvastatin Calcium INN equivalent to Atorvastatin 20 mg.

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T H E R A P E U T I C I N D E X

Atrizin®
Tablet/Syrup

Description
Atrizin is available in both tablet and syrup form. Each film coated tablet
contains Cetirizine Hydrochloride BP 10 mg and each 5 ml cherry
flavoured syrup contains 5 mg of Cetirizine Hydrochloride BP. Cetirizine
is a piperazine derivative and a potent functional antagonist of histamine
H 1 receptors. Atrizin is a long acting antihistamine. Central sedation or
antimuscarinic effects do not generally occur with the usual doses of
Atrizin.

Indications
Atrizin is indicated for the prevention and symptomatic relief of allergic
manifestations, such as:
- Seasonal allergic rhinitis
- Perennial allergic rhinitis
- Chronic idiopathic urticaria

Dosage and Administration


Atrizin tablet : Adults and children over 12 years- 10 mg (1 tablet) once daily.

Atrizin syrup: Adult and Children over 6 years- 10 mg (2 teaspoonful) daily.


Child 2-6 years- 5 mg (1 teaspoonful) daily or 2.5 mg (½ teaspoonful) twice
daily.

The maximum recommended dose is 20 mg (2 tablets or 4 teaspoonful)


daily. Cetirizine is safe for use in the elderly patients. Less frequent dosing
is advised in patients with reduced creatinine clearance.

Contraindication
Cetirizine is contraindicated in patients who have shown hypersensitivity
or idiosyncrasy to it or its parent compound- Hydroxyzine.

Adverse Reaction
No potentially life threatening effects have been encountered.

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T H E R A P E U T I C I N D E X

Acute Overdosage
In the occasional cases patient taking a massive intentional overdose (150-
300 mg), sedation has been the only adverse effect and complete recovery
has ensured. Like other H1 receptor antagonists, Cetirizine has no specific
antidote.

Precautions
Neonates : The drug is not usually administered to neonates.

Children : Cetirizine is effective and well tolerated in children. No special


precautions are required in children over 6 years of age.

Use in Pregnancy and Lactation


Cetirizine is not teratogenic in animals. Since the animal studies are not
always predictive of human response, it should be used only if the
potential benefit justifies the potential risk to the foetus. The extent of
Cetirizine excretion in human breast milk is unknown but some animal
studies have shown excretion in breast milk. Nursing mothers are advised
not to take this medication.

Drug Interaction
There are no reports of hazardous interactions with other drugs to date.
Concomitant administration with alcohol or Diazepam does not impair
psychomotor performance any more than the impairment of
performance produced by alcohol alone.

Commercial Pack
Atrizin Tablet : Box containing 10 blister strips of 10 film coated tablets,
each tablet contains Cetirizine Hydrochloride BP 10 mg.

Atrizin Syrup : Amber glass bottle containing 60 ml syrup. Each 5 ml


syrup contains Cetirizine Hydrochloride BP 5 mg .

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T H E R A P E U T I C I N D E X

Avastin ®
Tablet

Description
Avastin is a preparation of Simvastatin which acts as a cholesterol
lowering agent. Avastin inhibits 3-hydroxy-3-methylglutaryl coenzyme A
(HMG-CoA) reductase, an enzyme which catalyses the biosynthesis of
cholesterol.

Mode of Action
The main mechanism of reduction of low density lipoprotein (LDL)
cholesterol is that, following inhibition of HMG-CoA reductase activity,
the LDL receptor density on the liver cells is increased and this leads to
an increased removal of LDL cholesterol from the plasma and increased
catabolism of LDL cholesterol. In addition, there is a reduction in very
low-density lipoprotein (VLDL) cholesterol and reduced formation of
LDL from VLDL.

Indications
Avastin is indicated in patients with primary hypercholesterolaemia who
have not responded adequately to diet and other appropriate measures.

To reduce incidence of clinical coronary events and slow progression of


coronary atherosclerosis in patients with coronary heart disease and
cholesterol concentration of 5.5 mmol/litre or greater.

Dosage and Administration


The patients should be placed on a standard cholesterol-lowering diet
before receiving Avastin and maintained on it during treatment.

Doses should be individualized according to baseline LDL-cholesterol


levels, the recommended goal of therapy and the patient’s response.
Adjustment of dosage should be at intervals of 4 weeks or more. In
hypercholesterolaemia, the recommended starting dose is 5-10 mg once a
day in the evening. The recommended dose range is 5-40 mg per day as a
single dose in the evening.

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T H E R A P E U T I C I N D E X

The patients with coronary heart disease and hypercholesterolaemia, the


starting dose should be 20 mg once a day in the evening.

Safety and effectiveness in children and adolescents have not been


established.

Contraindication
Hypersensitivity to any component of the preparation; Active liver
disease; Pregnancy and lactation; women of child-bearing potential unless
adequately protected by contraception; in patients with the homozygous
form of familial hypercholesterolaemia, in whom there is a complete
absence of LDL receptors.

As Simvastatin has only a moderate triglyceride-lowering effect, it is not


indicated where hypertriglyceridaemia is the abnormality of most
concern.

Side Effects
Avastin is generally well tolerated, no potentially life-threatening effects
have been reported. Headache, fatigue, insomnia, gastrointestinal effects
like nausea, constipation or diarrhoea, flatulence, dyspepsia, abdominal
cramps, and muscular effects like myalgia, myositis and myopathy have
been reported. Rare cases of rhabdomyolysis with acute renal failure
secondary to myoglobinuria have been associated with Simvastatin
therapy. Hepatitis, pancreatitis, rash, angioedema have also been
reported.

Drug Interactions
Digoxin : Concomitant administration of Simvastatin and Digoxin in
normal volunteers resulted in a slight elevation (less than 0.3 ng/ml) in
drug concentrations in plasma compared to concomitant administration
of placebo and Digoxin.

Coumarin derivatives : The administration of Simvastatin appeared to


enhance slightly the anticoagulant effect of Warfarin (mean changes in
prothrombin time less than two seconds) in normal volunteers
maintained in a state of low therapeutic anticoagulation.

Others : In clinical studies, Simvastatin was used concomitantly with


angiotensin-converting enzyme (ACE) inhibitors, β-blockers, calcium
channel blockers, diuretics and non-steroidal

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T H E R A P E U T I C I N D E X

anti-inflammatory drugs (NSAIDs) without evidence of clinically


significant adverse interactions.

Precautions
Monitor liver function before and during treatment; History of liver
disease (avoid if active); High alcohol intake; Avoid pregnancy during and
for 1 month after treatment; Advise patients to report if there is any
muscle pain. Simvastatin should be discontinued if markedly elevated
CPK levels occur or if myopathy is diagnosed.

Overdosage
There are no data available on overdose. No antidote is available. General
measures should be adopted and liver function should be monitored.

Commercial Pack
Avastin Tablet : Box containing 30 film coated tablets in 3 x 10’s blister
strips, each tablet contains Simvastatin USP 10 mg.

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T H E R A P E U T I C I N D E X

Avidro®
Tablet

Description
Avidro is the brand name of Pizotifen, which is a tricyclic compound
having antiserotoninergic and antihistaminic effects together with a weak
anticholinergic action. Pizotifen inhibit the permeability-increasing effects
of serotonin and histamine on the affected cranial vessels, thereby
checking the transudation of plasmakinin so that pain threshold of the
receptors is maintained at normal levels. In the sequence of events
leading to the migraine attack, depletion of plasma serotonin contributes
to loss of tone in the extra-cranial vessels. Pizotifen inhibits serotonin re-
uptake by the platelets, thus maintaining plasma serotonin and preventing
the loss of tone and passive distension of the extra-cranial arteries.

Indications
It is used as prophylactic treatment of vascular headaches of the migraine
types, such as classic migraine, common migraine and cluster headache.

Dosage and Administration


Adult : Usually 1.5 mg daily, which may be taken as a single dose at night
or in three divided doses. Dose should be adjusted to individual patient's
requirements. Up to a maximum of 4.5 mg daily and up to 3 mg may be
given as a single dose daily.

Children : Up to 1.5 mg daily, usually in divided dose, and daily 1 mg as a


single dose has been given at night using 0.5 mg tablet.

Duration of treatment : 3-6 months; minimum one month to observe the


benefit.

Contraindication
Although its anticholinergic activity is relatively weak, Pizotifen should
probably not be administered in presence of narrow angle glaucoma or
prostate hypertrophy. It should not be given in patients with
hypersensitivity to this drug.

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T H E R A P E U T I C I N D E X

Use in Pregnancy and Lactation


Information of using Pizotifen in pregnancy is limited, so it should only
be used during pregnancy under compelling circumstances and it is not
recommended to the nursing mother.

Side Effects
Drowsiness is the most common side effect and also increased appetite,
which may lead to increase in body weight. Other side effects are,
dizziness, dry mouth, nausea, constipation, which are rare. In children
central nervous system (CNS) stimulation may occur.

Precautions
Patients should be cautioned about the possibility of drowsiness and
informed of its significance in driving vehicles and operation of
machineries. Pizotifen may enhance the central effects of sedatives,
hypnotic, antihistamines and alcohol. Dose adjustment may be required in
patients with renal insufficiency.

Commercial Pack
Avidro 0.5 Tablet : Box containing 10 x 10's tablets in blister strips. Each
film coated tablet contains Pizotifen Malate BP equivalent to Pizotifen 0.5
mg.

Avidro 1.5 Tablet : Box containing 5 x 10's tablets in blister strips. Each
film coated tablet contains Pizotifen Malate BP equivalent to Pizotifen 1.5 mg.

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T H E R A P E U T I C I N D E X

Avifanz ®
Tablet

Description
Avifanz is the brand name for Efavirenz. Efavirenz, a synthetic anti-
retroviral agent, is a non-nucleoside reverse transcriptase inhibitor. While
Efavirenz is pharmacologically related to other non-nucleoside reverse
transcriptase inhibitors, Efavirenz differs structurally from these drugs
and also differs structurally from other currently available anti-retroviral
agents.

Indications
Avifanz in combination with other antiretroviral agents is indicated for
the treatment of human immunodeficiency virus-1 (HIV-1) infection.
This indication is based on analysis of plasma HIV-RNA levels and CD4
cell counts in controlled studies of up to 24 weeks in duration. At present,
there are no results from controlled trials evaluating long-term
suppression of HIV- RNA with Avifanz.

Dosage and Administration


Adults : The recommended dosage of Avifanz is 600 mg orally, once daily,
in combination with a protease inhibitor and/or nucleoside analogue
reverse transcriptase inhibitors (NRTIs). Avifanz may be taken with or
without food; however, a high fat meal may increase the absorption of
Avifanz and should be avoided.

In order to improve the tolerability of nervous system side effects,


bedtime dosing is recommended during the first two to four weeks of
therapy and in patients who continue to experience these symptoms.
Avifanz must be given in combination with other antiretroviral
medications.

Paediatric Patients : The following table describes the recommended dose of


Avifanz for paediatric patients 3 years of age or older and weighing
between 10 to 40 kg. The recommended dosage of Avifanz for paediatric
patients weighing greater than 40 kg is 600 mg, once daily.

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T H E R A P E U T I C I N D E X

Body Weight Avifanz

Kilogram Pound Dose (mg)


10 to < 15 22 to < 33 200
15 to < 20 33 to < 44 250
20 to < 25 44 to < 55 300
25 to < 32.5 55 to < 71.5 350
32.5 to < 40 71.5 to < 88 400
40< 88< 600

Paediatric Dose to be Administered Once Daily

Contraindication
Efavirenz is contraindicated in patients with known hypersensitivity to
the drug or any ingredient in formulation.

Warning and Precautions


The drug should not be used in pregnant women or who plan to become
pregnant, and also in lactating women. High fat foods may cause
unwanted increases in drug effect, so avoid taking this drug with high-fat
foods.

Regular, periodic measurement plasma HIV-1 RNA levels and CD4+ T-


cell counts is necessary to determine the risk of disease progression and
to determine when to modify anti-retroviral agent regimens. Patients
should be advised that Efavirenz has not been shown to reduce the risk
of transmission of HIV to others via sexual contact or blood
contamination and so the practices designed to prevent transmission of
HIV should be maintained during anti-retroviral therapy. Efavirenz
should always be administered in conjunction with other anti-retroviral
agent and should not be used alone in the treatment of HIV infection.
Although Efavirenz used in combination with other anti-retroviral agents
appears to be well tolerated, patients should be monitored closely for
adverse effects during combination therapy. The usual precautions and
contraindication of the other anti-retrovirals in the regimen should be
considered during combination therapy; Efavirenz should not be added as
sole agent to a failing regimen. Whenever a change in anti-retroviral
therapy is considered because of therapeutic failure, at least 2
components of the previous regimen should be changed since adding a

54
T H E R A P E U T I C I N D E X

single new agent may predispose to the development of viral resistance.


Use of an entirely new regimen containing at least 3 drugs is preferred.
The effect of Efavirenz therapy on subsequent therapy with other non-
nucleoside reverse transcriptase inhibitors remains to be determined.
Because cross-resistance occurs among non-nucleoside reverse
transcriptase inhibitors, most clinicians suggest that individuals who
experience disease progression while receiving one of the agents (e.g.,
Delavirdine, Efavirenz, Nevirapine) should not be switched to another
agent in the class. As Efavirenz has been associated with adverse CNS
effect, patients should be advised that the drug may impair their ability to
perform hazardous activities requiring mental alertness or physical
coordination such as operating machinery or driving a motor vehicle. In
addition, patients receiving Efavirenz should be informed that there is a
potential for additive CNS effects if they use Efavirenz concomitantly
with psychoactive drugs or alcohol. Patients should be advised to contact
their clinician if they experience delusions, inappropriate behaviour, or
acute depression while receiving Efavirenz; discontinuance of the drug
may be necessary in patients who experience such CNS effects. Efavirenz
is metabolized in the liver; the drug should be used with caution in patents
with hepatic impairment. Serum hepatic enzyme concentrations should
be monitored during Efavirenz therapy in patients who have, or may have,
Hepatitis B and/or C virus infection, in patients receiving concomitant
Ritonavir and in patients receiving concomitant therapy with hepatotoxic
drug(s). In patients with serum hepatic enzyme concentrations more than
5 times the upper limit of normal, the benefits of continued Efavirenz
therapy versus the risks of hepatotoxicity should be considered. Because
increases in serum cholesterol concentration have occurred in individuals
receiving Efavirenz, cholesterol monitoring should be considered in
patients receiving the drug. Because of the risk of foetal malformations,
Efavirenz should not be used in women who are or may become pregnant
unless no other therapeutic options exist.

Precautions
Efavirenz may cause drowsiness or dizziness. Alcohol may intensify this
effect.

Paediatric Precautions
Safety and efficacy of Efavirenz in neonates and children younger than 3
years of age or who weigh less than 13 kg have not been evaluated.

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T H E R A P E U T I C I N D E X

Adverse effects including CNS, gastrointestinal and dermatologic effects


reported in children receiving Efavirenz are similar to those reported in
adults receiving the drug. Adverse CNS effects occurred in 9% of
children receiving Efavirenz. In clinical studies rash has been reported
more frequently in children than adults (40 vs 27.3% ) and the incidence
of moderate to severe rash has been greater in children than adults.
Because of the high incidence of dermatologic reactions in children,
antihistamines may be used for the prevention of rash when initiating
Efavirenz therapy in children; however, the efficacy of such a strategy has
not been determined.

Side Effects
Central Nervous System (CNS) : Dizziness, impaired concentration,
abnormal dreams and insomnia have been reported in about 52% of
adults receiving Efavirenz 600 mg once daily. In clinical studies these
adverse effects were reported in 26% of adults in the control groups not
receiving Efavirenz. In adults receiving Efavirenz, these CNS effects were
described as mild (do not interfere with daily activities) in 31.4%,
moderate (may interfere with daily activities) in 17.8% or severe (interrupt
usual daily activities) in 2.6% cases. Adverse nervous system effects
generally begin during the first 1-2 days of drug therapy, improve with
continued therapy and usually resolve after the first 1-2 days of therapy.
Adverse CNS effects may be more tolerable if the daily dose of Efavirenz
is administered at bedtime, especially during the first 2-4 weeks of therapy
and in patients who continue to experience such effects. Fatigue has been
reported in up to 7% of adults receiving the drug in clinical studies.

Severe acute depression, sometimes accompanied by suicidal ideation/


attempts, has been reported rarely in patients receiving Efavirenz in
clinical studies.

Adverse CNS effects reported in less than 2% of patients receiving


Efavirenz include ataxia, confusion, impaired coordination, migraine
headache, neuralgia, paresthesia, peripheral neuropathy, seizures, speech
disorder, tremor, or vertigo. In addition, aggravated depression, agitation,
amnesia, anxiety, apathy, emotional liability, euphoria, hallucination, or
psychosis has occurred in less than 2% of Efavirenz-treated patients.

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T H E R A P E U T I C I N D E X

Adverse CNS effects occurred in 9% of children receiving Efavirenz in


clinical studies.

Dermatologic reactions : Rash has occurred in 27. 3% of adults receiving


Efavirenz in clinical studies and in 17% of adults in control groups not
receiving the drug. Pruritus or increased sweating has been reported in 1-
2% of patients receiving the drug. Allergic reaction, alopecia, eczema,
folliculities, skin exfoliation or urticaria has occurred in lees than 2% of
patients receiving the drug.

Gastrointestinal : Nausea or diarrhoea has been reported in up to 12% of


adults receiving the drug. Vomiting, dyspepsia, abdominal pain, or
flatulence has occurred in some Efavirenz-treated adults. Dry mouth or
taste change has been reported in up to 2% of patients receiving the drug.

Hepatic : Hepatitis occurred in less than 2% of patients receiving the drug.

Cardiovascular : While the clinical importance remains to be determined,


total serum cholesterol concentrations have been increased 10-20% in
healthy individuals receiving the drug. Hot flushes, flushing, palpitations,
tachycardia, or thrombophlebitis has been reported in less than 2%, of
patients receiving the drug.

Pharmaceutical Precautions
Store in a cool dry place. Keep out of reach of children.

Commercial Pack
Avifanz Tablet : Each box contains 1 x 10’s tablets in blister strip. Each
tablet contains Efavirenz INN 600 mg.

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T H E R A P E U T I C I N D E X

Avifix®
Tablet

Description
Avifix (Nelfinavir Mesylate), a human immunodeficiency virus (HIV)
protease inhibitor, is available as film coated tablet in 250 mg strength (as
Nelfinavir free base).

Indications
Avifix is indicated for the treatment of HIV infection when antiretroviral
therapy is warranted.

Dosage and Administration


Adults: The recommended dose is 1250 mg (five 250 mg tablets) twice
daily or 750 mg (three 250 mg tablets) three times daily. Avifix should be
taken with meal. Antiviral activity is enhanced when Avifix is administered
in combination with nucleoside analogues. Therefore, it is recommended
that Avifix be used in combination with nucleoside analogues.

Paediatric Patients : The recommended oral dose of Avifix for paediatric


patients 2 to 13 years of age is 20-30 mg/kg per dose, three times daily
with a meal.

Contraindication
Avifix is contraindicated in patients with clinically significant
hypersensitivity to any of its components.

Co-administration of Avifix is contraindicated with drugs that are highly


dependent on cytochrome P450 3A (CYP3A) for clearance and for which
elevated plasma concentrations are associated with serious and/or life-
threatening adverse events.

Warning and Precautions


Avifix should not be administered concurrently with Terfenadine,
Astemizole, Cisapride, Triazolam, Midazolam, ergot derivatives,
Amiodarone or Quinidine because Avifix may affect the hepatic
metabolism of these drugs and create potential for serious and/or life-
threatening adverse events.

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T H E R A P E U T I C I N D E X

New onset diabetes mellitus, exacerbation of pre-existing diabetes


mellitus and hyperglycaemia have been reported during post-marketing
surveillance in HIV-infected patients receiving protease inhibitor therapy.
Some patients required either initiation or dose adjustments of insulin or
oral hypoglycemic agents for treatment of these events. In some cases
diabetic ketoacidosis has occurred. In those patients who discontinued
protease inhibitor therapy, hyperglycaemia persisted in some cases.

Precautions for Special Population


Hepatic Impairment : Nelfinavir is principally metabolized by the liver.
Therefore, caution should be exercised when administering this drug to
patients with hepatic impairment.

Haemophilias : There have been reports of increased bleeding, including


spontaneous skin haematomas and haemarthrosis, in patients with
haemophilia type A and B treated with protease inhibitors. In some
patients, additional factor VIII was given. In more than half of the
reported cases, treatment with protease inhibitors was continued or
reintroduced. A causal relationship has not been established.

Paediatric : A similar adverse event profile was seen during the paediatric
clinical trial as in adult patients. The evaluation of the antiviral activity of
Nelfinavir in paediatric patients is ongoing. The safety, effectiveness and
pharmacokinetics of Nelfinavir have not been evaluated in paediatric
patients below the age of 2 years.

Use in Pregnancy and Lactation


There are no adequate and well-controlled studies in pregnant women. To
avoid postnatal transmission of HIV, the US Public Health Service
Centers for Disease Control and Prevention advises HIV-infected women
not to breast feed their infants.

Side Effects
The safety of Nelfinavir was studied in over 1500 patients who received
the drug either alone or in combination with nucleoside analogues. The
majority of adverse events were of mild intensity. The most frequently
reported adverse event among patients receiving Nelfinavir was
diarrhoea, which was generally of mild to moderate intensity.

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T H E R A P E U T I C I N D E X

Adverse events occurring in less than 2% of patients receiving Nelfinavir


in all phase II/III clinical trials are considered at least possibly related or
of unknown relationship to treatment. They are listed below-

General : abdominal pain, accidental injury, allergic reaction, asthenia,


back pain, fever, headache, malaise, pain and redistribution/accumulation
of body fat.

Digestive System : anorexia, dyspepsia, epigastric pain, gastrointestinal


bleeding, hepatitis, mouth ulceration, pancreatitis and vomiting.

Haematologic : anaemia, leucopenia and thrombocytopenia.

Metabolic/Nutritional : increase in alkaline phosphate, amylase, CPK,


lactic dehydrogenase, asparpate transaminase (AST), ALT and gamma
glutamyl transpeptidase. Hyperlipaemia, hyperuricaemia, hyperglycaemia,
hypoglycaemia, dehydration, and abnormal liver function tests.

Musculoskeletal System : arthralgia, arthritis, cramps, myalgia, myasthenia


and myopathy.

Nervous System : anxiety, depression, dizziness, emotional lability,


hyperkinesia, insomnia, migraine, paresthesia, seizures, sleep disorder,
somnolence and suicide ideation.

Respiratory System : dyspnoea, pharyngitis, rhinitis and sinusitis.

Skin/Appendages : dermatitis, folliculitis, fungal dermatitis,


maculopapular rash, pruitus, sweating, and urticaria.

Special Senses : acute iritis and eye disorder.

Urogenital System : kidney calculas, sexual dysfunction and urine


abnormality.

Overdosage
Human experience of acute overdose with Avifix is limited. There is no

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T H E R A P E U T I C I N D E X

specific antidote for overdose with Avifix. If indicated, elimination of


unabsorbed drug should be achieved by emesis or gastric lavage.
Administration of activated charcoal may also be used to aid removal of
unabsorbed drug. Since Nelfinavir is highly protein bound, dialysis is
unlikely to significantly remove the drug from blood.

Drug Interactions
Nelfinavir is an inhibitor of CYP3A (cytochrome P450 3A). Co-
administration of Avifix and drugs primarily metabolized by CYP3A (e.g.,
dihydropyridine calcium channel blockers) may result in increased plasma
concentrations of the other drug that could increase or prolong both its
therapeutic and adverse effects. Co-administration of drugs that inhibit
CYP3A may increase Nelfinavir plasma concentration.

Drugs that Should not be Co-administered with Avifix

Class Drug
Antiarrhythmics Amiodarone, Quinidine
Antihistamines Astemizole, Terfenadine
Antimigraine Ergot derivatives
Antimycobacterial agents Rifampin
Benzodiazepines Midazolam, Triazolam
Gastrointestinal motility agents Cisapride

Drugs which Require a Dose Reduction when Co-administered with Avifix

Class Drug
Antimycobacterial agents Rifabutin

Based on known metabolic profiles, clinically significant drug interactions


are not expected between Avifix and Dapsone,
Trimethoprim/Sulfamethoxazole, Clarithromycin, Erythromycin,
Itraconazole or Fluconazole.

Anti-HIV Protease Inhibitors


Indinavir : Co-administration of Indinavir with Nelfinavir resulted in an
83% increase in Nelfinavir plasma AUC and a 51% increase in Indinavir
plasma antioxidant capacity (AC). Currently, there are no safety and
efficacy data available from the use of this combination.

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Other Potentially Clinically Significant Drug Interactions with Avifix *

Anticonvulsants : Carbamazepine May decrease Nelfinavir plasma


concentrations**

Anti-HIV protease inhibitors : Indinavir May increase Nelfinavir plasma


concentrations

Oral contraceptives : Ethinyloestradiol Plasma concentrations may be


decreased by Avifix

* This table is not all inclusive


** Avifix may not be effective due to decreased Nelfinavir plasma concentrations in patients
taking these agents concomitantly

Ritonavir : Co-administration of Ritonavir with Avifix resulted in a 152%


increase in Nelfinavir plasma (area under the plasma concentration x time
curve) AUC and very little change in Ritonavir plasma AC. Currently,
there are no safety and efficacy data available from the use of this
combination.

Saquinavir : Co-administration of Saquinavir (using an experimental soft-


gelatin capsule formulation of Saquinavir 1200 mg) with Avifix resulted
in an 18% increase in Nelfinavir plasma AUC and a 4-fold increase in
Saquinavir plasma AC. If used in combination with Saquinavir hard
gelatin capsules at the recommended dose of 600 mg tid, no dose
adjustments are needed. Currently, there are no safety and efficacy data
available from the use of this combination with antifungal agents.

Anti-HIV Reverse Transcriptase Inhibitors


Didanosine : It is recommended that Didanosine be administered on an
empty stomach; therefore, Nelfinavir should be administered (with food)
one hour after or more than two hours before Didanosine.

Zidovudine : Co-administration of Zidovudine and Lamivudine with Avifix


resulted in a 35% decrease in Zidovudine plasma AC. A dose adjustment
is not needed when Zidovudine is administered with Avifix.

Little or no change in the pharmacokinetics of either drug was observed


when Avifix was co-administered with Lamivudine or Stavudine.

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T H E R A P E U T I C I N D E X

Pharmaceutical Precautions
Store below 30° C in a dry place. Keep out of reach of children.

Commercial Pack
Avifix Tablet : Each box contains 1 x 10’s tablets in blister strip. Each
tablet contains Nelfinavir Mesylate INN equivalent to 250 mg Nelfinavir.

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T H E R A P E U T I C I N D E X

Avilam®
Tablet

Description
Avilam(formerly known as 3TC) is the brand name for Lamivudine, a
synthetic nucleoside analogue with activity against HIV.

Indications
Avilamin combination with Zidovudine is indicated for the treatment of
HIV infection.

Dosage and Administration


Adults and Adolescents (12 to 16 years) : The recommended oral dose of
Avilam for adults and adolescents is 150 mg twice daily administered in
combination with Zidovudine. For adults with low body weights (less
than 50 kg or 110 lb), the recommended oral dose of Avilam is 2 mg/kg
twice daily administered in combination with Zidovudine. No data are
available to support a dosage recommendation for adolescents with low
body weight (less than 50 kg).

Paediatric Patients : The recommended oral dose of Avilam for paediatric


patients of age between 3 months to up to 12 years is 4 mg/kg twice daily
(up to a maximum of 150 mg twice a day) administered in combination
with Zidovudine.

Dose Adjustment
It is recommended that doses of Avilam be adjusted in accordance with
renal function in patients older than age 16 years (see following table).
Insufficient data are available to recommend a dosage of Avilam in
patients undergoing dialysis.

Contraindication
Avilam is contraindicated in patients with previously demonstrated
clinically significant hypersensitivity to any of the components of the
product.

Warning and Precautions


In paediatric patients with a history of pancreatitis or other significant
risk factors for the development of pancreatitis, the combination of

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T H E R A P E U T I C I N D E X

Table : Adjustment of Dosage of Avilam in Accordance with


Creatinine Clearance
Creatinine Clearance (mL/min) Recommended Dosage of Avilam
>50 150 mg twice daily
30-49 150 mg once daily
15-29 150 mg first dose, then 100 mg once daily
5-14 150 mg first dose, then 50 mg once daily
<5 50 mg first dose, then 25 mg once daily

Avilam and Zidovudine should be used with extreme caution and only if
there is no satisfactory alternative therapy. Treatment with Avilam should
be stopped immediately if there are clinical signs, symptoms, or
laboratory abnormalities suggestive of pancreatitis.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal


cases, have been reported with the use of antiretroviral nucleoside
analogues alone or in combination, including Lamivudine. A majority of
these cases have been in women. Caution should be exercised when
administering Avilam to any patient, and particularly to those with known
risk factors for liver disease. Treatment with Avilam should be suspended
in any patient who develops clinical or laboratory findings suggestive of
lactic acidosis or hepatotoxicity.

Reduction of the dosage of Avilam is recommended for patients with


impaired renal function.

In clinical trials and postmarketing experience, some patients with HIV


infection who have chronic liver disease due to hepatitis B virus infection
experienced clinical or laboratory evidence of recurrent hepatitis upon
discontinuation of Lamivudine. Consequences may be more severe in
patients with decompensated liver disease.

Use in Pregnancy and Lactation


Animal reproductive toxicity studies are not always predictive of human
response. There are no adequate and well-controlled studies in pregnant
women. Lamivudine should be used during pregnancy only if the
potential benefits outweigh the risks. The US Public Health Service
Centers for Disease Control and Prevention recommend that HIV-
infected mothers should not breast feed their infants to avoid the risk of
postnatal transmission of HIV infection.

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Side Effects
Adults : Selected clinical adverse events with a >5% frequency during
therapy with Lamivudine 150 mg bid plus Zidovudine 200 mg tid
compared with Zidovudine are listed in the following table.

Selected Clinical Adverse Events (>5% Frequency) in Four Controlled Clinical Trials

Adverse Event Lamivudine 150 mg bid Zidovudine


plus Zidovudine (n = 230)
(n = 251)

General
Headache 35 % 27 %
Malaise and fatigue 27 % 23 %
Fever or chills 10 % 12 %
Digestive
Nausea and vomiting 33 % 29%
Diarrhoea 18 % 22%
Anorexia and/or decreased appetite 10% 7%
Abdominal pain 9% 11%
Abdominal cramps 6% 3%
Dyspepsia 5% 5%
Nervous system
Neuropathy 12% 10%
Insomnia and other sleep disorders 11% 7%
Dizziness 10% 4%
Depressive disorders 9% 4%

Respiratory
Nasal signs and symptoms 20% 11%
Cough 18% 13%
Skin
Skin rashes 9% 6%
Musculoskeletal
12% 10%
Musculoskeletal pain
8% 6%
Myalgia
5% 5%
Arthralgia

Observed During Clinical Practice :


The events identified during use of the drug in clinical practice include alopecia,
anaphylaxis, hyperglycaemia, lactic acidosis and hepatic steatosis, peripheral neuropathy,
pruritus, rash, urticaria, and weakness.

Overdosage
There is no known antidote for Lamivudine. It is not known whether
Lamivudine can be removed by peritoneal dialysis or haemodialysis.

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T H E R A P E U T I C I N D E X

Pharmaceutical Precautions
Store in a cool dry place. Protect from light.
Keep out of reach of children.

Commercial Pack
Avilam Tablet : Each box contains 1 x 10’s tablets in blister strip. Each
tablet contains Lamivudine INN 150 mg.

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Avitron® V
Tablet

Description
Avitron V tablet contains Vitamin B1 or Thiamine Hydrochloride USP.
Thiamine Hydrochloride is a water soluble vitamin belongs to vitamin B-
complex family. Thiamine in the form of Thiamine Pyrophosphate (also
known as cocarboxylase), is the co-enzyme for decarboxylation of α-keto
acids. Thiamine pyrophosphate also acts as the co-enzyme of
transketolase in the direct oxidation pathway of glucose metabolism. In
thiamine deficiency, pyruvic acid and lactic acid accumulate in tissues.
Thiamine deficiency affects the peripheral nervous system, the
gastrointestinal tract, and the cardiovascular system.

Thiamine is not stored in the body, intracellular thiamine is present almost


entirely as the co-enzyme moiety of active enzymes. Thiamine
requirement is related to carbohydrate intake and the metabolic rate. A
daily intake of 400 mg thiamine per 1000 kcal is recommended. The total
requirement increases during periods of active growth or heavy physical
labour, during pregnancy and lactation, in pathological conditions such as
fever and hyperthyroidism and in other conditions causing increased
metabolism.

Indications
Avitron V is indicated in the treatment of the various manifestations of
thiamine deficiency such as beriberi (wet or dry) and Wernicke's
encephalopathy, neuritis associated with pregnancy and pellagra.
Supplementary thiamine may be indicated prophylactically in conditions
where there is low dietary intake or low gastrointestinal absorption of
thiamine, and increased thiamine requirement periods e.g.
- active growth
- heavy physical labour
- pregnancy and lactation
- in pathological conditions such as fever and hyperthyroidism and other
conditions causing increased metabolism.

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T H E R A P E U T I C I N D E X

Dosage and Administration


Mild chronic deficiency : 10-25 mg daily
Severe deficiency : 200-300 mg daily or as advised by the physician

Contraindication
Thiamine is contraindicated in patients with known hypersensitivity to it.

Side Effects
Vitamin B1 does not have adverse effects when given orally. A feeling of
warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness etc.
may occur.

Pregnancy and Lactation


Thiamine is safe in pregnant women and recommended for the treatment
of neuritis in pregnancy. Although it is not known if thiamine is excreted
in breast milk, the drug may be taken safely during lactation.

Pharmaceutical Precaution
Store in a cool and dry place, protected from light.

Commercial Pack
Avitron V Tablet : Box containing 25 blister strips of 10 tablets. Each
tablet contains Thiamine Hydrochloride USP 100 mg.

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T H E R A P E U T I C I N D E X

Axodin®
Tablet

Description
Axodin (Fexofenadine), a pharmacologically active metabolite of
Terfenadine, is a non-sedating antihistamine with selective peripheral H1
receptor antagonist activity.

Fexofenadine Hydrochloride is rapidly absorbed into the body following


oral administration, with T max occurring at approximately 1-3 hours post
dose. The mean Cmax value was approximately 427 ng/ml and 494 ng/ml
following the administration of a 120 mg and 180 mg dose (once daily)
respectively.

Fexofenadine is 60-70% plasma protein bound. Fexofenadine undergoes


negligible metabolism, as it was the only major compound identified in
urine and faeces of animal and human. The plasma concentration profiles
of Fexofenadine follow a bi-exponential decline with a terminal
elimination half-life ranging from 11 to 16 hours after multiple dosing.
The single and multiple dose pharmacokinetics of Fexofenadine are linear
between 40 mg and 240 mg taken daily. The major route of elimination is
believed to be via biliary excretion while up to 10% of ingested dose is
excreted unchanged through the urine.

Indications
Axodin is indicated for the relief of symptoms associated with allergic
rhinitis and allergic skin conditions e.g. chronic urticaria.

Dosage and Administration


♦ Allergic rhinitis
Children 6 to 11 years
The recommended dose of Fexofenadine Hydrochloride is 30 mg twice
daily.

Adults and children aged 12 years and over


The recommended dose of Fexofenadine Hydrochloride for adults and
children aged 12 years and over is 120 mg once daily.

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T H E R A P E U T I C I N D E X

♦ Allergic skin conditions, e.g. chronic urticaria


Children 6 to 11 years
The recommended dose of Fexofenadine Hydrochloride is 30 mg twice
daily.

Adults and children 12 years and over


The recommended dose of Fexofenadine Hydrochloride for adults and
children aged 12 years and over is 180 mg once daily.

Children under 6 years of age


The efficacy and safety of Fexofenadine Hydrochloride has not been
studied in children under 6.

Use in Special Risk Group


Studies in special risk groups (elderly and patients with renal or hepatic
impairment) indicate that it is not necessary to adjust the dose of
Fexofenadine Hydrochloride in these patients.

Contraindication
The product is contraindicated in patients with known hypersensitivity to
any of its ingredients.

Drug Interactions
Fexofenadine does not undergo hepatic bio-transformation and is
therefore unlikely to interact with drugs that rely upon hepatic
metabolism. Fexofenadine Hydrochloride at doses of 120 mg twice daily
has been safely co-administered with Erythromycin (500 mg three times
daily) and Ketoconazole (400 mg once daily) under steady state conditions
in healthy volunteers. A two fold increase in the level of plasma
Fexofenadine was observed after co-administration of Erythromycin or
Ketoconazole but this was not associated with any increase in adverse
event or effects on the QT interval, compared to that seen when the
drugs were given alone.

Animal studies have shown that the increase in plasma level of


Fexofenadine observed after co-administration of Erythromycin or
Ketoconazole appears to be due to an increase in gastrointestinal
absorption.

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T H E R A P E U T I C I N D E X

Side Effects
In placebo-controlled trials, adverse events were comparable in
Fexofenadine and placebo treated patients. Adverse events reported with
Fexofenadine include-
Common : headache, Uncommon : fatigue, drowsiness, nausea, tachycardia,
palpitations, dry mouth, dyspepsia and gastrointestinal disturbances
(including diarrhoea), Rare : taste, disturbances, anaphylactic reactions,
dyspnoea, chest tightness, increased hair loss/hair thinning,
photosensitivity, dysmenorrhoea, menstrual disorders, Others : As with
other non-sedating antihistamines, dizziness, nervousness, agitation, sleep
disorders, insomnia or paroniria may infrequently be reported by patients.
The incidence of such reports under Fexofenadine was similar to the
incidence under placebo.

Effects on ability to Drive and Use Machines


On the basis of the pharmacodynamics profile and reported adverse
events it is unlikely that Fexofenadine Hydrochloride will produce an
effect on the ability to drive or use machines. In objective tests,
Fexofenadine Hydrochloride has been shown to have no significant
effects on central nervous system function. This means that patients may
drive or perform tasks that require concentration.

Overdosage
Most reports of Fexofenadine Hydrochloride overdose contain limited
information. However, dizziness, drowsiness and dry mouth have been
reported. Single doses up to 800 mg and doses up to 690 mg bid for 1
month or 240 mg qid for 1 year were studied in healthy subjects without
the development of clinically significant adverse events as compared to
placebo.

Use in Pregnancy and Lactation


Fexofenadine should be used in pregnancy only if the potential benefit
outweighs the potential risk to the foetus. There are no data on the
content of human milk after administering Fexofenadine Hydrochloride.
However, when Terfenadine was administered to nursing mothers
Fexofenadine was found to cross into human breast milk. Therefore
Fexofenadine is not recommended for mothers breast feeding their
babies.

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T H E R A P E U T I C I N D E X

Pharmaceutical Precautions
Store in cool and dry place. Keep away from children.

Commercial Pack
Axodin 60 Tablet : Each tablet contains Fexofenadine Hydrochloride
60 mg in 10 x 5 blister strips.

Axodin 120 Tablet : Each tablet contains Fexofenadine Hydrochloride


120 mg in 10 x 5 blister strips.

Axodin 180 Tablet : Each tablet contains Fexofenadine Hydrochloride


180 mg in 10 x 3 blister strips.

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Azithrocin®
Capsule/Tablet/Suspension

Description
Azithrocin contains Azithromycin USP. It is an azalide antibiotic active
against Gram-positive and Gram-negative organisms. Azithromycin
interferes with ribosome function in susceptible bacteria by inhibiting the
translocation of peptides.

Indications
Azithrocin (Azithromycin) is indicated for infections caused by
susceptible organisms, in upper respiratory tract infections including
sinusitis, pharyngitis and tonsillitis, in lower respiratory tract infections
including bronchitis and pneumonia, skin and soft tissue infections, and
otitis media.

Azithrocin is indicated in the treatment of uncomplicated genital


infections due to Chlamydia trachomatis.

Dosage and Administration


Adult : Azithrocin should be given as 500 mg once-daily orally for 3 days
or as an alternative, given over 5 days with 500 mg on day 1, then 250 mg
on days 2-5.

For sexually transmitted diseases caused by Chlamydia trachomatis in adults,


the dose is 1 g given as a single dose.

Normal adult dose is recommended for elderly patients.

For children over 6 months recommended dose is 10 mg/kg once daily


for 3 days; or if body weight is 15-25 kg : 200 mg once daily for 3 days, if
body weight is 26-35 kg : 300 mg once daily for 3 days, if body weight is
36-45 kg : 400 mg once daily for 3 days.

As common with many other antibiotics, Azithrocin should be taken at


least 1 hour before or 2 hours after meal and antacid.

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T H E R A P E U T I C I N D E X

Contraindication
Azithromycin is contraindicated in patients hypersensitive to
Azithromycin or any other macrolide antibiotic. Co-administration of
ergot derivatives and Azithromycin is contraindicated. Azithromycin is
contraindicated in patients with hepatic diseases.

Side Effects
Azithromycin is well tolerated with a low incidence of side effects.
Majority of the side effects were mild to moderate in nature and of
gastrointestinal in origin with nausea, abdominal discomfort, vomiting,
flatulence and diarrhoea. Allergic reactions such as rash have occurred
and there have also been rare reports of serious hypersensitivity reactions.
Reversible elevations in liver transaminases have been seen with a
frequency similar to the comparative macrolides and penicillins used in
clinical trials. Transient mild reductions in neutrophil counts have
occasionally been observed in clinical trials, although a causal relationship
to Azithromycin has not been established.

Precautions
As with any antibiotic, observation for signs of superinfection with non-
susceptible organisms, including fungi, is recommended. No dose
adjustment is needed in patients with renal impairment.

Use in Pregnancy and Lactation


Animal reproduction studies have demonstrated that Azithromycin
crosses the placenta, but have revealed no evidence of harm to the foetus.
There are no adequate and well controlled studies in pregnant women.
Since animal reproduction studies are not always predictive of human
response, Azithromycin should be used during pregnancy only if
adequate alternatives are not available. No data on secretion of
Azithromycin in breast milk is available, so, Azithromycin should only be
used in lactating mothers where adequate alternatives are not available.

Drug Interactions
Azithromycin absorption is reduced in presence of food and antacid. So,
Azithromycin should be administered 1 hour before or 2 hours after
taking food or antacid. In patients receiving ergot alkaloids, Azithromycin
should be avoided concurrently because of the possibility of ergotism
resulting from interaction of Azithromycin with the cytochrome P450

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T H E R A P E U T I C I N D E X

system. However, no cases of such interaction have been reported.


Macrolides have been known to increase the plasma concentration of
Digoxin and Cyclosporin. Therefore, if co-administration is necessary,
caution should be exercised and serum level of Digoxin and Cyclosporin
should be checked. There have been no pharmacokinetic drug
interactions between Azithromycin and Warfarin, Theophylline,
Carbamazepine, Methylprednisolone and Cimetidine.

Overdosage
There is no data on overdosage with Azithromycin. Typical symptoms of
overdosage with macrolide antibiotics include hearing loss, severe nausea,
vomiting and diarrhoea. Gastric lavage and general supportive measures
are indicated.

Commercial Pack
Azithrocin Capsule : Box containing 1 x 10’s blister strip, each capsule
contains Azithromycin USP equivalent to 250 mg anhydrous
Azithromycin.

Azithrocin 500 Tablet : Box containing 1 x 3’s blister strip, each film
coated tablet contains Azithromycin USP equivalent to 500 mg
anhydrous Azithromycin.

Azithrocin Suspension : Dry powder in glass bottle for reconstitution into


15 ml of suspension. After reconstitution each 5 ml contains
Azithromycin USP equivalent to 200 mg anhydrous Azithromycin.

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Azmasol ®
Inhaler

Description
Salbutamol BP, the active ingredient of Azmasol Inhaler, is a ß2 -
adrenoceptor agonist used in the treatment of asthma and other forms of
diffuse reversible airways obstruction.

Indications
Azmasol (Salbutamol) inhaler is indicated for the treatment and
prophylaxis of bronchial asthma and for the treatment of reversible
airways obstruction associated with bronchitis and emphysema. Azmasol
inhaler may be used to relieve attacks of acute dyspnoea and may also be
taken prophylactically before exertion or to prevent exercise-induced-
asthma. It is suitable for treating bronchospasm in patients with
coexisting heart disease or hypertension, including those taking β-
blockers, because of its selective action on the bronchial receptors and
lack of effects on the cardiovascular system. Salbutamol is a
sympathomimetic agent which has a highly selective action on β-
adrenergic receptors in bronchial muscle. At therapeutic levels, it has little
effect on cardiac receptors.

Dosage and Administration


Adults
i) For the relief of acute bronchospasm and for managing intermittent
episodes of asthma : one or two inhalation as a single dose

ii) For chronic maintenance or prophylactic therapy : two inhalations


three or four times daily

iii) For prevention of exercise induced bronchospasm : two inhalations


before exertion.

Children
For relief of acute bronchospasm, management of episodic asthma and
for prevention of exercise induced bronchospasm : one inhalation; for
routine maintenance and prophylaxis : one inhalation three or four times
daily, increasing if necessary to two inhalations three or four times daily.

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T H E R A P E U T I C I N D E X

Elderly
The dosage is the same as that for adults.

Contraindication
Although intravenous Salbutamol, and occasionally Salbutamol tablets,
are used in the management of premature labour uncomplicated by
conditions such as placenta praevia, ante-partum haemorrhage or
toxaemia of pregnancy, Salbutamol inhaler preparations are not
appropriate for managing premature labour. Salbutamol preparation
should not be used for threatened abortion during the first or second
trimesters of pregnancy. Salbutamol inhaler is contraindicated in patients
with a history of hypersensitivity to any of its components.

Precautions
In the event of previously effective dose of Salbutamol inhaler failing to
give relief for at least three hours, the patient should be advised to seek
medical advice in order that any necessary additional steps may be taken.
Salbutamol should be administered cautiously to patients suffering from
thyrotoxicosis.

As with other inhalation therapy, the potential for paradoxical


bronchospasm should be kept in mind. If it occurs, the preparation
should be discontinued immediately and alternative therapy should be
instituted.

Side Effects
Mild tremor and headache have been rarely reported. These usually
disappear with continuous treatment. There have been very rare reports
of transient muscle cramp. Hypersensitivity reactions including
angioedema, urticaria, bronchospasm, hypotension and collapse have
been reported very rarely.

Pharmaceutical Precaution
Pressurized canister, do not puncture, break or incinerate even when
apparently empty.

Avoid storage in direct sunlight or heat. Store below 30°C. Keep away
from eyes. Keep away from children.

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T H E R A P E U T I C I N D E X

Commercial Pack
Azmasol Inhaler : Each canister contains 200 measured doses, each
containing 100 µg of Salbutamol BP.

Azmasol Refill Can : Each canister contains 200 measured doses, each
containing 100 µg of Salbutamol BP.

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T H E R A P E U T I C I N D E X

Bexidal®
Tablet

Description
Each tablet contains Mebhydrolin 50 mg as Mebhydrolin Napadisylate
BPC.

Indications
Allergic diseases or symptoms, such as urticaria, pruritus of various
origin, eczema, drug rash, allergic conjunctivitis, dermatitis of nutritional
origin, hay fever, vasomotor rhinitis, allergic asthma.

Dosage and Administration


Unless otherwise prescribed, the following doses are recommended:
Adults and children over 10 years .................. 2-6 tablets daily
Children from 5-10 years ............................. 2-4 tablets daily
Children from 2-5 years ............................ 1-3 tablets daily
Children up to 2 years ................................. 1-2 tablets daily

Treatment should be given in several single doses daily. Bexidal may be


swallowed during or shortly after meals. For children, the tablets may be
crushed and mixed with food.

Bexidal is essentially free from secondary sedative-hypnotic effects. It


does not impair psycho-physical efficiency to any appreciable degree.

Contraindication
♦ Caution is required while driving or operating heavy machinery
♦ Concomitant use of CNS depressant or alcohol
♦ Patients to whom Mebhydrolin has previously been suspected to have
agranulocytosis or neutropenia
♦ First trimester of pregnancy

Commercial Pack
Bexidal Tablet : Box containing 20 aluminium strips of 10 tablets. Each
tablet contains Mebhydrolin 50 mg as Mebhydrolin Napadisylate BPC.

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T H E R A P E U T I C I N D E X

Bexitrol-F ®
Inhaler

Description
Bexitrol-F metered dose inhaler is a combination of Salmeterol Xinafoate
INN and Fluticasone Propionate BP. Salmeterol Xinafoate is a selective,
long acting β2 agonist used in the treatment of asthma and other forms
of diffuse airways obstruction. Fluticasone Propionate is a corticosteroid
with mainly glucocorticoid activity. Fluticasone Propionate is stated to
exert a topical effect on the lungs without systematic effects at usual dose.

Indications
Bexitrol-F is indicated in the regular treatment of asthma where use of a
combination product (long-acting β 2 agonist and inhaled corticosteroid)
is appropriate. Other indication of Bexitrol-F is patients with frequent
asthmatic episodes requiring bronchodilators or those with asthmatic
episodes at night.

Pharmacodynamic Properties
Mechanism of action : Bexitrol-F contains Salmeterol and Fluticasone
Propionate, which have different modes of action. Salmeterol protects
against symptoms, Fluticasone Propionate improves lung function and
prevents exacerbations of the condition. Bexitrol-F can offer a more
convenient regime for patients on concurrent β-agonist and inhaled
corticosteroid therapy. The mechanisms of action of both drugs are
discussed below:

Salmeterol : Salmeterol is a selective long-acting (12 hour) β2 -


adrenoceptor agonist with a long side chain which binds to the exo-site
of the receptor.

Fluticasone Propionate : Fluticasone Propionate given by inhalation at


recommended doses has a potent glucocorticoid anti-inflammatory
action within the lungs, resulting in reduced symptoms and exacerbations
of asthma, without the adverse effects observed when corticosteroids are
administered systemically.

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T H E R A P E U T I C I N D E X

Recommended Doses
Adults and adolescents 12 years and older-
The recommended dose is two puffs of Bexitrol-F twice daily or as
prescribed by the physicians.

Contraindication
Bexitrol-F is contraindicated in patients with a history of hypersensitivity
to any of the ingredients of the product.

Special Warning and Precautions


Consideration should be given to additional corticosteroid therapies, and
administration of antibiotics if an infection is present. As with all inhaled
medication containing corticosteroids, Bexitrol-F should be administered
with caution in patients with active or quiescent pulmonary tuberculosis.
Bexitrol-F should be administered with caution in patients with
thyrotoxicosis. Orally inhaled corticosteroids may cause a reduction in
growth velocity when administered to paediatric patients. The long-term
effects of this reduction including the impact of final adult height are
unknown.

Drug Interactions
Both non-selective and selective β-blockers should be avoided in patients
with asthma, unless there are compelling reasons for their use. Due to the
very low plasma concentrations achieved after inhaled dosing clinically
significant drug interactions are unlikely. Care should be taken when co-
administering known strong CYP3A4 (cytocrome P450 3A4) inhibitors
(e.g. Ketoconazole, Ritonavir), as there is potential for increased systemic
exposure to Fluticasone Propionate.

Use in Pregnancy and Lactation


There is insufficient experience of the use of Salmeterol Xinafoate and
Fluticasone Propionate in human pregnancy and lactation. There are no
data available for human breast milk.

Administration of drugs during pregnancy and lactation should only be


considered if the expected benefit to the mother is greater than any
possible risk to the foetus or child.

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Side Effects
As Bexitrol-F contains Salmeterol and Fluticasone Propionate, the type
and severity of adverse reactions associated with each of the compounds
may be expected. There is no incidence of additional adverse events
following concurrent administration of the two compounds. Adverse
events, which have been associated with Salmeterol or Fluticasone
Propionate, are given below.

Salmeterol : The pharmacological side effects of β2 agonist treatment, such


as tremor, subjective palpitations and headache, have been reported, but
tend to be transient and reduced with regular therapy. Cardiac arrhythmia
(including atrial fibrillation, supraventricular tachycardia and extra
systoles) may occur, usually in susceptible patients. There have been
reports of oropharyngeal irritation, arthralgia and hypersensitivity
reactions, including rash, oedema and angioedema. There have been rare
reports of muscle cramps.

Fluticasone Propionate : Hoarseness and candidiasis (thrush) of the mouth


and throat can occur in some patients. Both hoarseness and incidence of
candidiasis may be relieved by gargling with water after use of Bexitrol-F
Inhaler. Cutaneous hypersensitivity reactions have been reported. Rare
cases of facial and oropharyngeal oedema have been reported.

Overdosage
There are no data available from clinical trials on overdosage with this
combination drug.

Pharmaceutical Precaution
Pressurized canister, do not puncture, break or incinerate even when
apparently empty. Avoid storage in direct sunlight or heat.

Store below 30o C. Keep away from eyes. Keep away from children.

Commercial Pack
Bexitrol-F Inhaler : Each canister contains 120 metered doses, each
containing Salmeterol Xinafoate INN equivalent to 25 µg Salmeterol and
Fluticasone Propionate BP 250 µg.

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Bexitrol ®
Inhaler

Description
Salmeterol Xinafoate INN, the active ingredient of Bexitrol Inhaler, is a
selective, long acting ß2 -agonist used in the treatment of asthma and
other forms of diffuse airways obstruction. Bexitrol Inhaler is a metered
dose aerosol unit containing a micro-crystalline suspension of Salmeterol
in a mixture of propellant with lecithin.

Indications
Bexitrol (Salmeterol) is a long-acting ß2-agonist which is considerably
more potent, selective and long-acting compared with traditionally used
bronchodilators. Bexitrol protects against asthma induced by histamine or
methacholine for a period of at least 12 hours in adults and children.
Furthermore, long-acting ß2 -agonist show a more than 4-fold greater
potency than short-acting agents (for example, Salbutamol) against
histamine-induced bronchoconstriction. Bexitrol has the potential to
improve the treatment of patients with asthma; the drug provides
prolonged bronchodilation and decrease asthma symptoms and the need
for short acting ß2-agonist, independently of concomitant steroid use.
Studies have consistently reported improved control of nocturnal asthma
with long-acting ß2-agonist compared with other anti-asthma drugs.
Bexitrol is indicated for the long term regular treatment of reversible
airways obstruction (including nocturnal and exercise-induced asthma)
and chronic bronchitis. In paediatric asthma, the use of Bexitrol may
avoid exposure of children to Theophylline or high-dose corticosteroids,
with their attendant risks.

Dosage and Administration


The recommended dose is 50 µg (2 puffs) twice daily, although in severe
disease the dose may be increased to 100 µg twice daily. The drug should
not be used on an ‘as required’ basis, although on account of its efficacy
in nocturnal and exercise induced asthma, single dose administration may
be considered as a treatment option.

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Contraindication
Patients with thyrotoxicosis. Special caution should be exercised in
patients with cardiac problems predisposing to arrythmias. The drug is
ineffective in patients taking non-selective ß-blocking drugs.

Precautions
Bronchodilators should not be the only or the main treatment in patients
with severe or unstable asthma. Severe asthma requires regular medical
assessment, including lung function testing, as patients are at risk of
severe attack or even death. Physicians should consider using oral
corticosteroid therapy and/or the maximum recommended dose of
inhaled corticosteroid in these patients. Increasing use of
bronchodilators, in particular short-acting inhaled ß2 -agonist to relieve
symptoms indicates deterioration of asthma control. If patients find that
short acting bronchodilator treatment becomes less effective or they need
more inhalation than usual, medical attention must be sought. In this
situation patients should be reassessed and consideration given to the
need for increased anti-inflammatory therapy (e.g. higher doses of inhaled
corticosteroid or a course of oral corticosteroids). Severe exacerbation of
asthma must be treated in the normal way. Salmeterol inhaler is not
designed to relieve acute asthmatic symptoms, for which an inhaled short
-acting bronchodilator is required. Patients should be advised to have
such rescue medication available. Potentially serious hypokalaemia may
result from ß 2-agonist therapy. Particular caution is advised in acute severe
asthma as this effect may be potentiated by concomitant treatment with
xanthine derivatives, steroids and diuretics. It is recommended that serum
potassium levels are monitored in such situations.

Side Effects
No severe irreversible adverse effect is known although systemic ß2 -
agonist effects of Salmeterol may last up to 12 hours. Inhaled dose of
Salmeterol up to 400 µg given to healthy volunteers produced significant
systemic side effects, the majority of which were pharmacologically
predictable. Response observed with 100 µg Salmeterol were similar to
those observed with 400 µg Salmeterol. Hypokalaemia, tremor and
palpitations may all occur but only at doses of Salmeterol exceeding that
recommended.

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Pharmaceutical Precaution
Store below 30°C, keep out of the reach of children.

Commercial Pack
Bexitrol Inhaler : Each canister contains 200 metered doses, each
containing Salmeterol Xinafoate INN equivalent to 25 µg Salmeterol.

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Bextrum®
Tablet

Description
Bextrum is a special formulation comprising of important vitamins,
antioxidants and minerals. Each film-coated tablet contains:

Vitamin A 2700 IU
Vitamin E 30 IU
Vitamin K 65.00 µg
Vitamin C 120.00 mg
Thiamine Mononitrate 3.40 mg
Riboflavin 3.40 mg
Folic Acid 800 µg
Niacin 40.00 mg
Pantothenic Acid 20.00 mg
Pyridoxine Hydrochloride 10.00 mg
Iron 30.00 mg
Zinc 25.00 mg
Copper 2.00 mg
Manganese 1.20 µg
Iodine 175.00 µg
Selenium 12.50 µg
Molybdenum 25.00 µg
Chromium 25.00 µg
Inositol 50.00 mg
Quercetin 54.00 µg
Indications
Bextrum is a once-daily tablet indicated for use to improve the nutritional
status of women throughout pregnancy and in the postnatal period for
both lactating and non-lactating mothers. This preparation can also be
beneficial in improving the nutritional status of women prior to
conception. Bextrum tablet maintains a healthy body and active lifestyle
and keeps nutrition covered for all.

Dosage and Administration


Bextrum may be administered once daily or as indicated by the physician.

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Contraindication
Bextrum is contraindicated in patients with a known hypersensitivity to
any of the ingredients.

Side Effects
Generally well tolerated.

Precautions
Long-term intake of high levels of vitamin A (excluding that source from
β carotene) may increase the risk of osteoporosis in postmenopausal
women.

Drug Interactions
No drug interactions have been reported.

Use in Pregnancy and Lactation


Bextrum is recommended in pregnancy and lactation.

Pharmaceutical Precaution
Tablets should be stored below 25 oC and protected from light and
moisture.

Commercial Pack
Bextrum Tablet : Plastic bottle containing 30 tablets. Each tablet contains
multivitamin and multimineral.

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Bronkolax®
Tablet/Syrup

Description
Bronkolax (Salbutamol) is a synthetic sympathomimetic agent having β 2-
adrenergic activity and selective action on receptors of bronchial smooth
muscle. It is used for the treatment of reversible obstruction of the
airways.

Indications
Bronkolax is indicated for the relief of bronchospasm in bronchial
asthma, bronchitis, emphysema and also in bronchospasm where heart
disease or hypertension is co-existing.

Dosage and Administration


Adults
Recommended dose is 2-4 mg, 3-4 times daily; in some patients higher
doses up to 8 mg may be given.

Children
Recommended dose for age group-
2-6 years : 1 mg, 3-4 times daily
6-12 years : 2 mg, 3-4 times daily
Over 12 years : 2-4 mg, 3-4 times daily

Contraindication
It should not be prescribed with β blocking drugs.

Bronkolax should not be used for prevention of premature labour


associated with toxemia of pregnancy or antepartum hemorrhage or for
threatened abortion during the first and second trimester of pregnancy.

Precautions
Bronkolax should be given with caution to hypersusceptible patients or
those with hyperthyroidism, in patients with diabetes mellitus, serious
cardiovascular disorders or hypertension. In asthmatic patients, whose
condition deteriorates despite Salbutamol therapy, alternative or
additional therapy including corticosteroids should be instituted

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promptly. Adverse metabolic effects of high doses of Salbutamol may be


exacerbated by concomitant administration of high doses of
corticosteroids. Hypokalemia associated with high doses of Salbutamol
may result in increased susceptibility to digitalis-induced cardiac
arrhythmias. Concomitant administration of Aminophylline may enhance
the effects of Salbutamol. Long term treatment may increase the risk of
dental caries and hence adequate dental hygiene should be maintained.

Side Effects
Salbutamol may cause fine tremor of skeletal muscle (particularly the
hands), palpitations, and muscle cramps. Slight tachycardia, headache, and
peripheral vasodilation have been reported after large doses. Salbutamol
may cause hypokalemia and hypoglycaemia. Sometimes hypersensitivity
reactions including paradoxical bronchospasm, urticaria and angioedema
may occur.

Treatment of Overdosage
The preferred antidote for overdosage with Salbutamol is a
cardioselective beta blocking agent, but beta blocking drugs should be
used with caution in patients with a history of bronchospasm.

Commercial Pack
Bronkolax-2 Tablet : Box containing 100 tablet in 10 x 10’s blister strips,
each contains Salbutamol Sulphate BP equivalent to 2 mg Salbutamol.

Bronkolax-4 Tablet : Box containing 100 tablet in 10 x 10’s blister strips,


each contains Salbutamol Sulphate BP equivalent to 4 mg Salbutamol.

Bronkolax Syrup : 100 ml in glass bottle, each 5 ml contains Salbutamol


Sulphate BP equivalent to 2 mg Salbutamol.

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Cardopril®
Tablet

Description
Cardopril (Captopril) is the first of a new class of antihypertensive agents,
a highly specific competitive inhibitor of angiotensin I converting
enzyme. Cardopril is available in 25 mg and 50 mg, as double scored
tablets for oral administration.

Indications
♦ Hypertension : Mild to moderate hypertension as an adjunct to thiazide
therapy in patients who have not responded effectively to thiazide
treatment alone.
♦ Severe hypertension : Where standard therapy has failed.

Cardopril is effective alone or in combination with other antihypertensive


agents especially thiazide type of diuretics. The blood pressure lowering
effect of Cardopril and thiazides are approximately additive.
♦ Congestive heart failure : It is also used as an adjunct to the treatment of
severe congestive heart failure.

Dosage and Administration


♦ Hypertension : Treatment with Cardopril should be at the lowest
effective dose, which should be titrated according to the need of the
patient.

Mild to moderate hypertension- In mild to moderate hypertension


Cardopril therapy should be used as an adjunct to thiazide therapy.
Starting dose is 12.5 mg twice daily. The usual maintenance dose is 25
mg twice daily.

Severe hypertension- Starting dose is 12.5 mg twice daily and can be


increased incrementally to a maximum of 50 mg thrice daily.

♦ Heart failure : In congestive heart failure an initial dose of 6.25 mg to


12.5 mg is given under close medical supervision.

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The usual maintenance dose is 25 mg thrice daily and should not exceed
50 mg thrice daily.

Side Effects
Haematological : neutropenia, anaemia and thrombocytopenia.

Renal : proteinuria, elevated blood urea and creatinine, elevated serum


potassium and acidosis.

Cardiovascular : hypotension, tachycardia.

Skin : rashes usually pruritic, may occur.

Gastrointestinal : Reversible and usually self limiting taste impairment


has been reported. Stomatitis resembling aphthous ulcers has also been
reported.

Drug Interactions
♦ Diuretics: Diuretics potentiate the antihypertensive effect of
Captopril. Potassium sparing diuretics (Triamterene, Amiloride and
Spironolactone) or potassium supplements may cause significant
increase in serum potassium.

♦ Vasodilators: Captopril has been reported to act synergistically with


peripheral vasodilators such as Minoxidil.

♦ Non-steroidal anti-inflammatory agents: Concomitant therapy with


Indomethacin and possibly other anti-inflammatory drugs may reduce
the antihypertensive effect of Captopril.

♦ Others: Caution should be exercised in prescribing Captopril for


patients receiving concomitant therapy with immuno-suppressant,
procainamide, allopurinol and other drugs known to cause
neutropenia especially in patients with impaired renal function.

Contraindication
A history of previous hypersensitivity to Captopril.

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Precautions
Captopril should be used with great caution in patients with impaired
renal function particularly if reno-vascular disease is present or suspected
and in patient with collagen vascular disorders such as systemic lupus
erythematosus or scleroderma. Captopril should not be used during
pregnancy.

Commercial Pack
Cardopril-25 Tablet : Box containing 100 tablets in 10 x 10’s blister strip,
each tablet contains 25 mg of Captopril USP.

Cardopril-50 Tablet : Box containing 100 tablets in 10 x 10’s blister strip,


each tablet contains 50 mg of Captopril USP.

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Carocet®
Tablet

Description
Carocet is a chewable tablet which contains a combination of three
antioxidant vitamins. Each tablet contains β Carotene (pharma grade) 6
mg, Ascorbic Acid USP and Sodium Ascorbate USP equivalent to
Ascorbic Acid (Vitamin C) 200 mg and Vitamin E preparation USP
equivalent to dl-alpha-Tocopheryl Acetate (Vitamin E) 50 mg.

Indications
Antioxidant vitamins are used in a wide range of conditions where free
radical damage is playing a role. Antioxidant vitamin combination is used
in the prevention of coronary heart diseases, certain types of cancer,
aging as well as free radical damage caused by excessive exercise, illness,
certain medications, air pollution, smoke, radiation and pesticides. The
main role of the antioxidant vitamins is as follows:

β-carotene prevents free radical formation by quenching singlet oxygen, a


highly reactive form of oxygen. Vitamin C is another free radical
scavenger which deactivates free radicals. It works specially in the plasma,
lung fluid, aqueous humour and interstitial fluid. It can increase white
blood cell activity; play important roles in the biochemistry of antibodies,
prostaglandin E1, B- and T-lymphocytes, and interferon. Vitamin E also
scavenges free radicals in the blood along with β-carotene and vitamin C.
Moreover, vitamin E is essential to protect us against some of the ill
effects of smog and smoke. In relation to other nutrients vitamin E
protects vitamin A from being destroyed in the body.

Dosage and Administration


Dosage varies according to individual’s need. The usual recommended
dose is two tablets daily or as advised by the physician. The dose can be
increased up to four tablets daily.

Side Effects
β carotene is comparatively safe even at high and prolonged exposure.
Individuals who routinely ingest large amounts of carotenoids can
develop hypercarotenosis, which is characterized by a yellowish

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colouration of the skin and a very high concentration of carotenoids in


the plasma. This benign condition, although resembling jaundice,
gradually disappears upon correcting the excessive intake of carotenoids.
Vitamin C is generally a safe drug for human use in normal doses. Larger
doses may lead to gastrointestinal tract upset and renal stone formation.
Vitamin E is considered safe even in large doses. Doses over 800 mg may
cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance
to bacterial infection and transiently raised blood pressure.

Contraindication
There is no absolute contraindication.

Warning and Precautions


There are some evidences that β-carotene may cause harm to heavy
smokers and alcoholics. Therefore, caution should be exercised in these
cases. Vitamin C should be given with caution to patients with
hyperoxaluria. Vitamin E should be used with caution in patients taking
anticoagulant drugs, because vitamin E may enhance the anticoagulant
activity of these drugs.

Use in Pregnancy and Lactation


β carotene, vitamin C and vitamin E have no teratogenic effects in
humans. However, like any other drugs caution should be taken in
prescribing to pregnant women.

Drug Interactions
Cholestyramine, Colestipol, Neomycin cause decreased absorption of β
carotene. Circulating vitamin C levels have been shown to be reduced
during prolonged administration of certain drugs including oral
contraceptives containing Oestrogen, Tetracycline and Aspirin. The
decrease in vitamin C level may be due to drug-induced impaired
absorption or increased utilization of the vitamin for drug metabolism.
Vitamin E may enhance the anticoagulant activity of anticoagulant drugs.
High doses of vitamin E can impair intestinal absorption of vitamins A
and K.

Overdosage
No cases have been reported.
Commercial Pack
Carocet Tablet : Bottle containing 20 tablets.

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Carofol®-Z
Capsule

Description
Carofol-Z capsule contains Carbonyl Iron INN 50 mg, Folic Acid BP
0.50 mg and Zinc Sulphate Monohydrate USP 61.80 mg. Most ordinary
iron products contain iron salts that may cause gastric irritation. But
Carofol-Z capsule contains pure iron micro particles called carbonyl iron.
This advanced formula is specially designed to be well absorbed, gentle
on the stomach and offers enhanced safety in case of an accidental
overdose. Folic Acid and Zinc supplementation are also important during
pregnancy as because Folic Acid helps to prevent the risk of birth defects
like neural tube defects (NTDs) and low birth weight (LBW). Zinc is an
important factor to maintain a healthy immune system.

Indications
The capsule is indicated for the treatment of iron deficiency or iron
deficiency anemia, folic acid and zinc deficiency. It is also indicated for
prophylactic use when inadequate diet calls for supplementary Zinc, Folic
Acid and Iron specially during pregnancy.

Dosage and Administration


Treatment
2 to 4 capsules a day or as prescribed by the physician.

Prophylaxis
Adult and elderly : Usually once daily. In severe cases, two capsules a day
may be required as prescribed by the physician.

Children aged over one year: One capsule a day, the capsule may be
opened and the pellets may be mixed with soft, cool food but they must
not be chewed.

Contraindication
It is contraindicated in patients with haemolytic anaemia and in condition
with increased hypersensitivity to any of its components and increased
body iron content.

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Side Effects
Side effects of Iron, Folic Acid and Zinc supplementation are mild and
transient. These include epigastric pain, nausea, constipation, vomiting,
diarrhoea etc. The capsule is specially designed to reduce the possibility
of gastrointestinal irritation.

Drug Interactions
Iron chelates with Tetracycline. Since oral Iron products interfere with
absorption of oral Tetracycline antibiotics, these products should not be
taken within hours of each other. Occasional gastrointestinal discomfort
may be minimized by taking it with meals. Absorption of Iron may be
impaired by concurrent administrations of Penicillamine and antacid.

Overdosage
Overdosage of Iron is dangerous, particularly in children and requires
immediate attention. Gastric lavage should be carried out in the early
stages, vomiting may also be induced. Zinc Sulphate in gross overdosage
is corrosive. Symptoms are those of gastrointestinal irritation, leading in
severe cases to haemorrhagic corrosion of the mucosa and possible later
stricture formation. Demulcent such as milk should be given. Chelating
agents such as Dimercaprol, Penicillamine or Edetic acid have been
recommended. The extended release capsule presentation may delay
excessive absorption of Iron and Zinc and allow more time for initiation
of appropriate counter measures.

Precautions
Care should be taken in patients who may develop Iron overload, such as
those with haemochromatosis, haemolytic anaemia or red cell aplasia. In
patients with renal failure, a risk of Zinc accumulation may exist.

Pharmaceutical Precaution
Store capsules in cool and dry place. Keep out of reach of children.

Commercial Pack
Carofol-Z capsule : Box containing 50 capsules in 5 x 10's blister strips.
Each capsule contains Carbonyl Iron INN 50 mg, Folic Acid BP 0.05 mg
and Zinc Sulphate Monohydrate USP 61.80 mg.

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Cephalen®
Capsule/Suspension

Description
Cephalen (Cefalexin) is a semisynthetic antibiotic of the cephalosporin
group, intended for oral administration which has a bactericidal activity
against a wide range of Gram-positive and Gram-negative organisms.
Cephalen is acid stable and may be given regardless of meal. It is rapidly
absorbed after oral administration and peak serum level is obtained after
one hour. It is mainly excreted in the urine.

Indications
Cephalen is indicated for the treatment of the following infections when
caused by susceptible organisms.

Respiratory tract infections : Acute and chronic bronchitis and infected


bronchiectasis.

Genito-urinary tract infections : Acute and chronic nephritis, cystitis, urethritis


and prostatitis, prophylaxis of recurrent urinary tract infections.

Skin and soft tissue infections : Caused by staphylococci and/or streptococci.

Ear, Nose and Throat infections : Otitis media, mastoiditis, sinusitis, follicular
tonsillitis and pharyngitis.

Bone infections : Caused by staphylococci and/or P. mirabilis.

Dosage and Administration


Adult : The usual dose is 250 mg to 500 mg every 6 hour. For skin and
soft tissue infections, streptococcal pharyngitis and uncomplicated
cystitis, in patients over 15 years of age, 500 mg of the drug may be
administered every 12 hour. In severe or deep seated infections the dose
can be increased up to 3 g to 6 g daily.

Children : The dosage range is 25-100 mg/kg/day in divided doses to a


maximum of 4 g daily (please note the table below ).

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Children’s weight Recommended Dose

10 kg ( 22 Ibs) 62.5 mg to 125 mg qid or 125 mg to 250 mg bid


20 kg ( 44 Ibs) 125 mg to 250 mg qid or 250 mg to 500 mg bid
40 kg ( 88 Ibs) 250 mg to 500 mg qid or 500 mg to 1 g bid

For streptococcal pharyngitis, skin and soft tissue infections and in


patients over 1 year of age the total daily dose may be divided and
administered every 12 hour. In the therapy of otitis media 75-100
mg/kg/day in four divided doses may be required. In the treatment of
beta haemolytic streptococcal infections a therapeutic dosage of the drug
should be given at least for 10 days.

Contraindication
Cephalen is contraindicated in patients with known hypersensitivity to the
cephalosporin group of antibiotics.

Side Effects
Side effects include nausea, vomiting, diarrhoea and abdominal
discomfort. Symptoms of pseudomembranous colitis may appear either
during or after antibiotic treatment. Skin rash, angioedema, rise in serum
aminotransferases, eosinophilia, neutropenia have been reported very
rarely. Superinfection with resistant micro-organisms, particularly candida
may follow the treatment.

Precautions
Cefalexin should be given with caution in patients with renal impairment.
Under such condition, careful clinical observation should be made
because safe dosage may be lower than the usually recommended. The
urine of patients receiving Cefalexin may give a false positive reaction for
glucose with copper reduction reagent. Positive results to Coombs’ test
have been reported.

Although there is no evidence of teratogenicity in animal tests, Cefalexin


may be used during pregnancy when it is considered essential. Cefalexin
is found in the milk of nursing mothers, hence caution should be taken
when it is administered to nursing mothers.

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Commercial Pack
Cephalen-250 Capsule : Box containing 10 x 10’s blister strips. Each
capsule contains Cefalexin BP equivalent to anhydrous Cefalexin 250 mg.

Cephalen-500 Capsule : Box containing 5 x 10’s blister strips. Each


capsule contains Cefalexin BP equivalent to anhydrous Cefalexin 500 mg.

Cephalen Suspension : Dry powder in amber glass bottle for


reconstitution into 100 ml suspension. After reconstitution each 5 ml
contains Cefalexin BP equivalent to anhydrous Cefalexin 125 mg.

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Cerivin®
Tablet

Description
Cerivin (Vinpocetine) increases cerebral metabolism: it increases the
glucose and O2 consumption; improves cerebral hypoxia tolerance; shifts
glucose metabolism to the energetically more favourable aerobic pathway,
but it increases the anaerobic pathway as well; it elevates the ATP
concentration and the ATP/AMP ratio in the brain, and elevates the
cerebral norepinephrine, dopamine and serotonin levels.

Vinpocetine considerably improves cerebral microcirculation by


inhibiting platelet aggregation, reducing the pathologically increased
blood viscosity, and increases erythrocyte derformability; it also promotes
O 2 transport into the tissues by reducing the O 2 affinity of erythrocytes.

It selectively and intensely increases cerebral blood flow and the share of
the brain in cardiac output, it reduces cerebral vascular resistance without
affecting systemic circulation (blood pressure, heart rate, cardiac output,
total peripheral resistance), it does not elicit steal phenomenon, on the
contrary, it primarily improves the blood supply of the injured, ischaemic
area while it remains unchanged in the intact areas (inverse steal effect), it
further increases blood flow which is already increased as a result of
hypoxia.

Indications
All forms of acute and chronic cerebral circulatory insufficiency: TIA
(Transient Ischaemic Attack), reversible ischaemic neurological deficiency,
progressive stroke, completed stroke, post-apoplectic conditions, multi-
infarct dementia, cerebral arteriosclerosis, post traumatic, hypertensive
encephalopathy etc.

For the reduction of psychic or neurological symptoms of cerebral


insufficiency (e.g. memory disturbances, dizziness, headache, aphasia,
apraxia, locomotor disorders etc.).

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Ophthalmology: It can be used for the treatment of vascular disorders of


the choroid and retina due to arteriosclerosis, vasospasm, macular
degeneration, arterial or venous thrombosis or embolism, and glaucoma
secondary to the above mentioned disorders.

Otology: For the treatment of impaired hearing of vascular or toxic


(iatrogenic) origin, presbyacusis, Meniere’s disease, cochleovestibular
neuritis, tinnitus and dizziness of labyrinth origin.

For the treatment of vasovegetative symptoms of climacteric syndrome.

Dosage and Administration


Cerivin is taken 1-2 tablets three times daily with meals. The maintenance
dose is 1 tablet three times daily over long periods.

Side Effects
Cerivin is well tolerated. In some cases transient fall of blood pressure
and tachycardia may occur.

Contraindication
Cerivin is contraindicated in pregnancy and lactation.

Precautions
Because Cerivin can reduce the ability of blood to clot, those individuals
with a tendency to bleed should avoid Vinpocetine.

Drug Interactions
Slight changes in prothrombin time have been noted in those adding
Vinpocetine to Warfarin dosing. The changes appear minimal. There are
no other interactions reported so far. Therefore, it can be applied in
combinations.

Commercial Pack
Cerivin Tablet : Box containing 100 tablets in 10 x 10’s blister strips. Each
tablet contains Vinpocetine INN 5 mg.

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Clobex®
Capsule/Syrup

Description
Clobex (Cloxacillin) is a beta-lactamase resistant antibacterial agent with
bactericidal activity against most Gram-positive organisms and Neisseria
spp. It is also effective against beta-lactamase producing Gram-negative
organisms when given with Ampicillin.

Indications
Clobex is indicated for the treatment of infections caused by Gram-
positive organisms including infections caused by beta-lactamase
producing Staphylococci such as :

♦ Skin and soft tissue infections : Boils, Abscesses, Carbuncles,


Furunculosis, Cellulitis, Infected wounds, Infected burns, Otitis media
and externa, Protection of skin graft and Skin infections like ulcer,
eczema, acne, etc.

♦ Respiratory tract infections : Pneumonia, Lung abscess, Empyema,


Sinusitis, Pharyngitis and Tonsillitis.

♦ Other infections caused by sensitive organisms : Osteomyelitis,


Enteritis, Endocarditis, Urinary tract infection, Meningitis and
Septicaemia.

Dosage and Administration


Adult : Usual dose is 500 mg 6 hourly daily

Children (2-10 years) : 250 mg 6 hourly daily

Children (up to 2 years) : 125 mg (i.e. 1 measuring spoonful of


Clobex Syrup) 6 hourly daily

Dose may be doubled in severe infection and should be taken at least 30


minutes before food.

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Contraindication
Clobex should not be given to patients known to be hypersensitive to
penicillin.

Precautions
Clobex should be given with caution to patients with known history of
allergy.

Side Effects
Common side effects are skin rash, transient diarrhoea, nausea,
heartburn, pruritus and disturbance of blood electrolyte. Rarely
anaphylactic shock.

Commercial Pack
Clobex Capsule : Box containing 100 capsules in 10 x 10’s foil strips, each
capsule containing Cloxacillin Sodium BP equivalent to 500 mg
Cloxacillin.

Clobex Syrup : Dry powder in glass bottle for reconstitution into 100 ml
syrup. After reconstitution each 5 ml contains Cloxacillin Sodium BP
equivalent to 125 mg Cloxacillin.

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Cosmotrin®
Cream

Description
Cosmotrin cream is a topical anti-acne preparation containing Tretinoin
USP 0.025%. Each gram Cosmotrin cream contains Tretinoin USP 0.25 mg.

Pharmacology
Although the exact mode of action of Tretinoin is unknown, but current
evidence suggests that topical Tretinoin decreases cohesiveness of
follicular epithelial cells with decreased microcomedo formation.
Additionally Tretinoin stimulates mitotic activity and increases turnover
of follicular epithelial cells, causing extrusion of the comedones, papules
and pustules.

Indications
For topical application in the treatment of acne vulgaris in which
comedones, papules and pustules predominate.

Dosage and Application


Cosmotrin cream should be applied sparingly to the whole affected area
once or twice daily. The skin should be thoroughly cleaned and dried
before application. Patient should be advised that 6 to 8 weeks of
treatment may be required before a therapeutic effect is observed.
Moisturisers and cosmetics may be used during treatment with Cosmotrin
cream but should not be applied to the skin at the same time. Astringent
toiletries should be avoided.

Contraindication
Tretinoin is contraindicated to those who are highly sensitive to any of
the ingredients. This cream should not be used in patients with a personal
or family history of cutaneous epithelioma (skin cancer).

Use in Pregnancy and Lactation


There is an inadequate evidence of the safety of topically applied
Tretinoin cream during pregnancy. Tretinoin has been associated with
teratogenicity in human when administered systemically. So, the cream
should not be used during pregnancy and lactation.

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Side Effects
Initial external application of Tretinoin generally may cause burning or
slight irritation. Erythema and peeling at the site of application. If
irritation becomes severe and persists, discontinue application and consult
physician, if necessary.

Drug Interactions
Other topical acne treatments should be used with caution during
treatment with Tretinoin. Particular caution should be exercised when
using preparation containing a peeling agent for example benzoyl
peroxide. It is also possible to apply Tretinoin and benzoyl peroxide
alternately. The suggested regimens are either Tretinoin in the morning
and benzoyl peroxide in the evening or the preparations should be used
on alternate days.

Precautions
Avoid contact of Tretinoin with lips, mouth, eyes, eyelids, nostrils or
other mucous membrane. If contact in these areas occur, careful washing
with water is recommended. Apply the cream to sensitive areas of skin,
such as the neck, with caution. Do not use it on broken, eczematous or
sun burned skin.

Pharmaceutical Precaution
Keep out of the reach of children. Keep in a cool and dry place, protect
from light.

Commercial Pack
Cosmotrin Cream : Tube containing 10 g cream, each gram contains
Tretinoin USP 0.25 mg.

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Cox ®B
Capsule

Description
Cox B (Celecoxib) is a selective cyclooxygenase-2 (COX-2) inhibitor, non-
steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory,
analgesic and antipyretic properties. The mechanism of action of
Celecoxib is believed to be due to the inhibition of prostaglandin
synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At
therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1
(COX-1) isoenzyme.

Indications
♦ For the relief of the signs and symptoms of osteoarthritis.
♦ For the relief of the signs and symptoms of rheumatoid arthritis.
♦ For the regression and prevention of colorectal adenomatous polyps
in patients with familial adenomatous polyposis (FAP).

Dosage and Administration


Osteoarthritis : The recommended oral dose is 200 mg per day
administered as a single dose or as 100 mg twice daily.

Rheumatoid arthritis : The recommended oral dose is 100 to 200 mg


twice daily.

Familial adenomatous polyposis (FAP) : Usual medical care for FAP


patients should be continued while on Cox B. To reduce the number of
adenomatous colorectal polyps in patients with FAP, the recommended
oral dose is 400 mg (2 x 200 mg capsules) twice daily to be taken with
food.

Contraindication
Cox B is contraindicated in patients with known hypersensitivity to
Celecoxib. It should not be given to patients who have demonstrated
allergic-type reactions to Sulfonamides (Celecoxib contains a sulfonamide
side chain). Celecoxib should not be given to patients who have
demonstrated asthma, urticaria or allergic-type reactions after taking
Aspirin or other

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NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have


been reported in such patients.

Adverse Reactions
Adverse events occurring in ≥ 2% of patients at recommended doses- Abdominal
pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%,
back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%,
dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%,
rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash
2.2%.

The following adverse events occurred in 0.1-1.9% of patients-


General : Allergy aggravated, allergic reaction, asthenia, chest pain,
oedema generalized, face oedema, fatigue, fever, hot flushes, influenza-
like symptoms, pain, peripheral pain.

Gastrointestinal : Constipation, diverticulitis, dysphagia, oesophagitis,


gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids,
hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder,
vomiting.

Cardiovascular : Aggravated hypertension, angina pectoris, coronary


artery disease, myocardial infarction.

Nervous system : Leg cramps, hypertonia, hypoesthesia, migraine,


neuralgia, neuropathy, paresthesia, vertigo.

Female reproductive system : Breast fibroadenosis, breast neoplasm,


breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis.

Male reproductive system : Prostatic disorder.

Resistance mechanism disorders : Herpes simplex, herpes zoster, bacterial


infection, fungal infection, infection of soft tissue, viral infection,
moniliasis, moniliasis genital, otitis media.

Hearing and vestibular : Deafness, ear abnormality, earache, tinnitus.

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Heart rate and rhythm : Palpitation, tachycardia.

Respiratory : Bronchitis, bronchospasm, bronchospasm aggravated,


coughing, dyspnoea, laryngitis, pneumonia.

Liver and biliary system : Peptic function abnormal, increased AST and
ALT.

Musculoskeletal : Arthralgia, arthrosis, accidental fracture, myalgia, neck


stiffness, synovitis, tendinitis.

Urinary system : Albuminuria, cystitis, dysuria, haematuria, micturition


frequency, renal calculus, urinary incontinence, urinary tract infection.

Metabolic and nutritional : Blood urea nitrogen (BUN), CPK, creatinine,


alkaline phosphatase, are increased. Hypercholesterolaemia,
hyperglycaemia, hypokalaemia. Body weight is also increased.

Psychiatric : Anorexia, anxiety, increased appetite, depression,


nervousness, somnolence.

Haemic : Anaemia, ecchymosis, epistaxis, thrombocythaemia.

Skin and appendages : Alopecia, dermatitis, photosensitivity reaction,


pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin,
increased sweating, urticaria.

Application site disorders : Cellulitis, contact dermatitis, skin nodule.

Special senses : Taste perversion.

Vision : Blurred vision, cataract, conjunctivitis, eye pain, glaucoma.

Use in Special Population


Geriatric : Dose adjustment in the elderly is not generally necessary.

However, for patients of less than 50 kg in body weight, initiate therapy


at the lowest recommended dose.

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Paediatric : The safety and efficacy of Celecoxib is not established in


paediatric patients.

Hepatic Insufficiency : Cox B capsules should be introduced at a reduced


dose in patients with moderate hepatic impairment. The use of Celecoxib
in patients with severe hepatic impairment is not recommended.

Pregnancy : Cox B should be used during pregnancy only if the potential


benefit justifies the potential risk of the foetus. In late pregnancy (third
trimester), Celecoxib should be avoided because it may cause premature
closure of the ductus arteriosis.

Precautions
Cox B, at doses up to 200 mg bid, can be administered without regard to
timing of meal. Higher doses (400 mg bid) should be administered with
food.

Co-administration of Cox B with an aluminium and magnesium-


containing antacid should be avoided, because they may reduce the
amount of Celecoxib that the body absorbs.

Drug Interactions
ACE inhibitors : Reports suggest that NSAIDs may diminish the
antihypertensive effect of ACE inhibitors. This interaction should be
given into consideration in patients taking Cox B concomitantly with
ACE inhibitors. Frusemide : NSAIDs can reduce the natriuretic effect of
frusemide and thiazides in some patients. Aspirin : Cox B can be used with
low dose Aspirin. However, concomitant administration of Aspirin with
Cox B may result in an increased rate of gastrointestinal ulceration or
similar complications, compared to the use of Cox B alone. Fluconazole :
Concomitant administration of Fluconazole at 200 mg qid resulted in a
two-fold increase in Celecoxib plasma concentration. Cox B should be
introduced at the lowest recommended dose in patients receiving
Fluconazole. Lithium : Patients on Lithium treatment should be closely
monitored when Cox B is introduced or withdrawn. Warfarin : Caution
should be used when administering Cox B with Warfarin since these
patients are at increased risk of bleeding complications.

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Overdosage
Symptoms following NSAID overdoses are usually limited to lethargy,
drowsiness, nausea, vomiting, and epigastric pain, which are generally
reversible with supportive care. Gastrointestinal bleeding can occur.
Hypertension, acute renal failure, respiratory depression and coma may
occur, but are rare. Anaphylactoid reactions have been reported with
therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care
following an NSAID overdose. There are no specific antidotes. Emesis
and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children)
and/or osmotic cathartic may be indicated in patients seen within 4 hours
of ingestion with symptoms or following a large overdose.

Pharmaceutical Precaution
Store at temperature between 15οC and 30οC.

Commercial Pack
Cox B-100 Capsule : Box containing 50 capsules in 5 x 10’s blister strips.
Each capsule contains Celecoxib INN 100 mg.

Cox B-200 Capsule : Box containing 50 capsules in 5 x 10’s blister strips.


Each capsule contains Celecoxib INN 200 mg.

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Curin ®
Tablet

Description
Curin tablet is a preparation of Levocetrizine Dihydrochloride.
Levocetrizine is the active (levo) isomer of Cetrizine. It is a new highly
effective and well-tolerated non-sedating antihistamine with potent
antiallergic properties. It has a two-fold higher affinity for H1-receptors
than Cetirizine. Levocetirizine has a rapid and long-lasting action,
allowing once-a-day administration.

Indications
Curin is indicated in the treatment of symptoms associated with allergic
conditions such as seasonal allergic rhinitis, perennial allergic rhinitis and
chronic idiopathic urticaria.

Dosage and Administration


Adults & children over 6 years of age : One Curin tablet (Levocetrizine
Dihydrochloride 5 mg) once daily.
Patients with renal impairment : The recommended dose in patients with
moderate renal impairment is one Curin tablet every two days. In those
with sever renal impairment, the dose interval should be increased to
every three days. Patients with end-stage renal disease should not be given
Levocetirizine.

Side Effects
Generally Levocetirizine is well tolerated. However, a few side effects like
headache, dry mouth, fatigue and skin rash have been reported rarely.

Contraindications
Curin is contraindicated in patients who are hypersensitive to this
medication or to any of its ingredients.

Use in Pregnancy and Lactation:


The safety of Levocetirizine in pregnancy has not been established.
Therefore, it should be used with caution during pregnancy and only if
the potential benefits to the mother outweigh any risks to the fetus.

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Levocetirizine passes into breast milk. So, it should be used with caution
in nursing mothers and only if the expected benefit to the mother is
greater than the positive risk to the nursing infant.

Pediatric Use
Not recommended for use in children less than 6 years of age.

Overdosage
No clinically relevant adverse events have been reported in case of
overdosage. However, in the event of overdosage, symptomatic and
supportive treatment is recommended.

Pharmaceuticals Precautions
Keep out of reach of children. Keep in a cool dry place.

Commercial Pack
Curin Tablet : Each box contains 10 blister strips of 10 tablets. Each film
coated tablet contains Levocetrizine Dihydrochloride INN 5 mg.

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Decacycline®
Capsule

Description
Decacycline contains Tetracycline Hydrochloride BP. Tetracycline
Hydrochloride is a broad spectrum antibiotic. It is active against a wide
range of Gram-positive and Gram-negative bacteria and even some that
are resistant to penicillins. It is primarily bacteriostatic in activity. Due to
increasing bacterial resistance, Tetracycline use has been decreased.
However, it remains the treatment of choice for infections caused by
Chlamydia, Rickettsiae, Mycoplasma and Brucella. When penicillin is
contraindicated, Tetracycline is an alternative drug in treatment of
infections caused by Neisseria gonorrhoeae, Treponema pallidum and Treponema
pertenue.

Indications
Decacycline is indicated in the infections caused by Tetracycline sensitive
microorganisms.

Respiratory tract infections: Acute and chronic bronchitis, lobar and


bronchopneumonia, atypical pneumonia, lung abscess.

Gastro-intestinal infections: Amoebic dysentery, bacillary dysentery, enteritis,


hepatic infections, cholangitis, and cholecystitis.

Genito-urinary infections: Pyelonephritis (acute and chronic), cystitis,


urethritis, and epididymitis, non-gonococcal urethritis, gonorrhoea.

Soft tissue infections: Mild to moderate acne, typhus fever.

Other infections: Trachoma, psittacosis, whooping cough, brucellosis (in


combination with other antibacterial drugs), rickettsial fevers,
actinomycosis, anthrax, Rocky Mountain spotted fever etc.

Dosage and Administration


Adults : Usual dose is 250 mg every 6 hours and can be increased in severe
infection to 500 mg every 6-8 hours. In case of primary, secondary or

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latent syphilis : 500 mg every 6 hours for 14-21 days. Non-gonococcal


urethritis : 500 mg every 6 hours for 7-14 days. Brucellosis : 500 mg 4
times/day for 3 weeks (accompanied by other antibacterial drugs). Severe
acne (long term therapy) : Initially, 1 g/day in divided doses. For
maintenance 125-500 mg/day should be given.

Children (over 12 years of age) : Daily dose is 10-20 mg/lb (25-50


mg/kg) in 4 equal doses.

Contraindication
Decacycline is contraindicated in renal impairment, during pregnancy and
lactation, children under 12 years of age, systemic lupus erythematosus
and hypersensitivity to any other Tetracyclines.

Side Effects
Gastrointestinal side effects especially nausea, vomiting and diarrhoea are
most frequently reported. Glossitis, stomatitis, vaginitis or Staphylococcal
enterocolitis may occur. Anaphylaxis may occur on rare occasions.

Pharmaceutical Precaution
Store in a cool and dry place. Keep out of the reach of children.

Use in Pregnancy and Lactation


Tetracycline should be avoided in pregnant women, because of the risk of
both staining of teeth and effect on bone growth in the foetus.
Tetracycline has been found in the breast milk of lactating mothers. There
is probably negligible absorption of Tetracycline by breasted infants,
because of chelation by the calcium in milk.

Commercial Pack
Decacycline Capsule : Box containing 10 blister strips of 10 capsule, each
capsule contains Tetracycline Hydrochloride BP 250 mg.

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Decomit®
Inhaler

Description
The active ingredient of Decomit Inhaler (Beclomethasone Dipropionate
BP) is a synthetic halogenated corticosteroid with anti-inflammatory
activity.

Indications
Decomit Inhaler (Beclomethasone Dipropionate BP) given by inhalation
has a potent anti-inflammatory action within the lungs without the side
effects observed when steroids are administered systemically.

Decomit inhaler is indicated for the management of patients with


bronchial asthma including :

♦ Patients whose asthma is becoming worse and is inadequately


controlled by bronchodilator therapy alone

♦ Patients whose asthma is not controlled by the combined use of


bronchodilator and Sodium Cromoglycate

♦ Patients with severe asthma being treated with systemic corticosteroids


or synthetic or actual adrenocorticotrophic hormone (ACTH)

Dosage and Administration


It may take 1-3 months to achieve maximum therapeutic benefit from any
corticosteroid inhalation therapy. Patients should be given a starting dose
of inhaled Beclomethasone Dipropionate that is appropriate for the
severity of their disease. The dose may then be adjusted until control is
achieved or reduced to the minimum effective dose according to
individual response.

Adults : The usual recommended maintenance dose is 100-250 µg given


three or four times a day. Alternatively, 200-500 µg given twice daily has
been effective in some patients. In patients with severe asthma, it is
advisable to start with 600 to 1000 µg a day and reduce the dose according

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T H E R A P E U T I C I N D E X

to the response of the patients. High dose (up to 2000 µg daily) may
control asthmatics not adequately controlled with more conventional
doses. In patients receiving doses of 1500 µg or more, adrenal
suppression (though may not be clinically significant) may occur which
should be balanced against the therapeutic advantages.

Children : The usual starting dose is 100 µg twice daily. Some patients may
require 100 µg three to four times daily (or 200 µg twice daily). Total dose
for children should not exceed 500 µg daily.

Contraindication
Hypersensitivity to Beclomethasone is a contraindication; and special care
is necessary in patients with active or quiescent pulmonary tuberculosis.

Precautions
Patients should be instructed about proper use of the inhalers to ensure
that the drug reaches the target areas within the lungs. They should also
be made aware that Beclomethasone inhaler has to be used regularly for
optimum benefit. Patients should be made aware of the prophylactic
nature of therapy with Beclomethasone inhaler and that it should be
taken regularly, even when they are asymptomatic.

The maximum daily administration of Beclomethasone inhaler should


not exceed 1 mg. Significant reduction in plasma cortisone levels has been
reported in patients who receive twice this amount.

Side Effects
Candidiasis of the mouth and throat (thrush) occurs in some patients, the
incidence of which is increased with doses greater than 400 µg
Beclomethasone Dipropionate per day. Patients with high blood levels of
Candida precipitins, indicating a previous infection, are most likely to
develop this complication. Some patients may find it helpful to rinse their
mouth thoroughly with water after using the inhaler. Symptomatic
candidiasis can be treated with topical antifungal therapy whilst still
continuing the Beclomethasone inhaler.

In some patients, inhaled Beclomethasone Dipropionate may cause


hoarseness or throat irritation. It may be helpful to rinse mouth with
water immediately after inhalation.

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As with other inhalation therapy, the potential for paradoxical


bronchospasm should be kept in mind. If it occurs, the preparation
should be discontinued immediately and alternative therapy instituted.

Pharmaceutical Precaution
Store below 30° C, keep out of the reach of children.

Commercial Pack
Decomit 100 Inhaler : Each canister contains 200 metered doses, each
containing 100 µg of Beclomethasone Dipropionate BP.

Decomit 250 Inhaler : Each canister contains 200 metered doses, each
containing 250 µg of Beclomethasone Dipropionate BP.

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Decomit®
Nasal Spray

Description
Beclomethasone Dipropionate BP, the active ingredient of Decomit nasal
spray, is an anti-inflammatory steroid having the chemical name 9-chloro-
11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione21-
dipropionate. Decomit nasal spray is a metered dose manual pump spray
unit containing a microcrystalline suspension of Beclomethasone
Dipropionate in a mixture of suspending agents.

Indications
Decomit nasal spray is indicated for the prophylaxis and treatment of
perennial and seasonal allergic rhinitis including hay fever and vasomotor
rhinitis. Beclomethasone Dipropionate nasal spray is also indicated for the
prevention of recurrence of nasal polyps following surgical removal.

Dosage and Administration

Decomit nasal spray is for administration by the intranasal route only

Adults and children : The recommended dosage is two applications into


each nostril twice daily. For some patients, a dosage regimen of a single
application into each nostril three or four times daily may be preferred.
Total daily administration should not normally exceed eight applications.
For full therapeutic benefit, regular usage is essential. The cooperation of
the patient should be sought to comply with the regular dosage schedule
and it should be explained that maximum effect may not be obtained
within the first few applications.

For children under six years, there are insufficient clinical data to
recommend its use.

Contraindication
Decomit nasal spray is contraindicated in patients with a history of
hypersensitivity to any of its components.

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Precautions
Infections of the nasal passages and paranasal sinuses should be
appropriately treated but do not constitute a specific contraindication to
treatment with Decomit nasal spray.

Care must be taken while transferring patients from systemic steroid


treatment to Decomit nasal spray if there is any reason to suppose that
their adrenal function is impaired.

Systemic effects may rarely occur. These include hypothalamic-pituitary-


adrenal (HPA) suppression and growth retardation in children.

Although Decomit nasal spray will control seasonal allergic rhinitis in


most cases, an abnormally heavy challenge of summer allergens may, in
certain instances, necessitate appropriate additional therapy particularly to
control eye symptoms.

Side Effects
As with other nasal sprays, dryness and irritation of the nose and throat,
unpleasant taste and smell and epistaxis have been reported rarely.

Rare cases of raised intra-ocular pressure or glaucoma in association with


intranasal formulations of Beclomethasone Dipropionate have been
reported.

Pharmaceutical Precaution
Decomit nasal spray should be stored at a temperature below 30°C.
Protect from frost and direct sunlight.

Commercial Pack
Decomit Nasal Spray : Each bottle contains 200 metered doses, each
containing 50 µg of Beclomethasone Dipropionate BP.

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Deflux ®
Tablet/Suspension/Paediatric Drops

Description
Deflux (Domperidone) is a dopamine antagonist. As it does not enter the
central nervous system, its effect is confined to the periphery and acts
principally at the receptor in the chemoreceptor trigger zone.

Indications
♦ Stimulation of gut motility in
- Non-ulcer dyspepsia
- Oesophageal reflux, reflux oesophagitis and gastritis
- Diabetic gastroparesis
- Functional dyspepsia
- Speeding barium transit in follow through radiological studies

♦ Prevention and symptomatic relief of acute nausea and vomiting from


any cause including cytotoxic therapy, radiotherapy and anti-
parkinsonism therapy

♦ In the prophylactic treatment of migraine

Dosage and Administration


The recommended oral dose for Adults: 10-20 mg every 4-8 hours daily;
Children: 0.2-0.4 mg/kg every 4-8 hours daily. Note that Domperidone
should be taken 15-30 minutes before meal. For acute vomiting and
nausea, maximum period of treatment is 12 weeks. Use in children is
restricted to nausea and vomiting following cytotoxic drugs or
radiotherapy.

Contraindication
Deflux is contraindicated to the patients who have hypersensitivity to this
drug and in case of neonates.

Precautions
Deflux should be used with absolute caution in case of children because
there may be an increased risk of extra-pyramidal reactions in young
children because of an incompletely developed blood brain barrier.

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Side Effects
Domperidone may produce hyperprolactinaemia (1.3% frequency). This
may result in galactorrhoea, breast enlargement, soreness and reduced
libido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness,
drowsiness (0.4%), diarrhoea (0.2%), skin rash and itching (0.1%) may
occur during treatment with Domperidone. Extra-pyramidal reactions are
seen in 0.05% of patients in clinical studies.

Use in Pregnancy and Lactation


The safety of Domperidone has not been proven and it is therefore not
recommended during pregnancy. Animal studies have not demonstrated
teratogenic effects on the foetus.

Domperidone may precipitate galactorrhoea and improve post-natal


lactation. It is secreted in breast milk but in very small quantities,
insufficient to be considered harmful.

Drug Interactions
Domperidone may reduce the hypoprolactinaemic effect of
bromocriptine. Anti-muscarinics and opioid analgesics may antagonize
the action of Domperidone on gastrointestinal function.

Overdosage
There is no reported case of overdosage.

Commercial Pack
Deflux Tablet : Box containing 10 x 10’s blister strips. Each tablet
contains Domperidone Maleate BP equivalent to 10 mg Domperidone.

Deflux Suspension : Bottle containing 100 ml of suspension. Each 5 ml


contains Domperidone BP 5 mg.

Deflux Paediatric Drops : Bottle containing 15 ml of drops. Each ml


contains Domperidone BP 5 mg.

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Dextromethorphan ®
Syrup

Description
Dextromethorphan Syrup is cherry flavoured liquid, containing in each 5
ml, 10 mg Dextromethorphan Hydrobromide BP. Dextromethorphan (d-
3-methoxy-N-methylmorphinan) is the d-isomer of the codeine analogue
of levorphanol. It is a cough suppressant.

Indications
As antitussive.

Dosage
1-3 teaspoonful 1-4 times daily or as advised by the physician.

Warning
Not for children use.

Contraindication
Liver disease.

Precautions
Should be administered with caution to asthmatic patient.

Side Effects
Occasionally Dextromethorphan hydrobromide may cause drowsiness,
dizziness, excitation, mental confusion and gastrointestinal disturbance.
Very high doses may produce respiratory depression. Abuses of
Dextromethorphan have been reported in few cases, but there does not
appear to be any evidence of dependence of the morphine type.

Commercial Pack
Dextromethorphan Syrup: 100 ml syrup in glass bottle, each 5 ml
contains 10 mg of Dextromethorphan Hydrobromide BP.

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Diactin®
Tablet

Description
Diactin (Glipizide) is an oral blood glucose lowering drug of the
sulfonylurea class which causes hypoglycaemia by stimulating release of
insulin from pancreatic β cells and by increasing the sensitivity of
peripheral tissues to insulin.

Indications
Diactin (Glipizide) is indicated as an adjunct to diet for the control of
hyperglycaemia and its associated symptomatology in the treatment of
non-insulin-dependent diabetes mellitus (NIDDM type II) when diet
modification has not been proved effective on its own. In certain patients
who are receiving insulin, the concurrent use of Glipizide would allow a
reduction in the daily dose of insulin.

Use of Glipizide must be viewed by both the physician and patient as a


treatment in addition to diet and not as a substitute for diet or as a
convenient mechanism for avoiding dietary restraint. Furthermore, short
term administration may be required if diet control alone results in
transient control of blood glucose level.

During maintenance, if satisfactory lowering of blood glucose is no


longer achieved, use of Glipizide should be discontinued.

Dosage and Administration


Like any other oral hypoglycaemic agent, dosage of Diactin is not fixed
and may be adjusted through periodic monitoring of blood glucose level.

Short term administration of Glipizide may be sufficient during periods


of transient loss of control of blood glucose in patients, usually
controlled well on diet.

In general, Diactin should be given approximately 30 minutes before a


meal to achieve the maximum reduction in postprandial hyperglycaemia.

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Initial dose : The recommended starting dose is 5 mg, given before


breakfast. Geriatric patients or those with liver disease may be started on
2.5 mg.

Dosage adjustments : Dosage adjustment may be done at intervals of


several days by an increment of 2.5-5 mg, as determined by blood glucose
response. If response to a single dose is not satisfactory, dividing that
dose might prove effective. The maximum recommended once daily dose
is 15 mg. Doses above 15 mg should ordinarily be divided and given
before meals of adequate caloric content. The maximum recommended
total daily dose is 40 mg.

Maintenance : Some patients may be effectively controlled on a once daily


regimen, while others show better response with divided dosing. Total
daily dose above 30 mg have been safely given on bid basis to long-term
patients. Patients can usually be stabilized on a dosage ranging from 2.5
to 30 mg daily.

In elderly, debilitated or malnourished patients, and patients with impaired


renal or hepatic function, the initial and maintenance dosing should be
conservative to avoid hypoglycaemic reactions.

Patients Receiving Insulin :


Many stable non-insulin-dependent diabetic patients receiving Insulin
may be safely placed on Glipizide if the physician decides to do so.

Patients receiving other oral hypoglycaemic agents :


As with other sulfonylurea, no transition period is necessary while
transferring patients to Glipizide. Patients should be observed carefully
for any possible hypoglycaemic effect due to overlapping of drug effects.

Contraindication
Diactin is contraindicated in the following conditions :

♦ Patients who are hypersensitive to Glipizide or any component of the


product
♦ Juvenile onset diabetes
♦ Severe or unstable ‘brittle’ diabetes

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♦ Diabetes complicated by ketosis and acidosis, major surgery, severe


sepsis or severe trauma
♦ Severe renal, hepatic or thyroid impairment, co-existent renal and
hepatic disease

Precautions
Hypoglycaemia : All sulfonylurea drugs are capable of producing severe
hypoglycaemia. Proper patient selection, dosage and instructions are
important to avoid hypoglycaemic episodes. Renal or hepatic insufficiency
may cause elevated blood levels of Glipizide and the latter may also
diminish gluconeogenic capacity, both of which increase the risk of
serious hypoglycaemic reactions. Elderly, debilitated or malnourished
patients and those with adrenal or pituitary insufficiency are particularly
susceptible to the hypoglycaemic actions of glucose lowering drugs.

Renal and Hepatic Disease : The metabolism and excretion of Glipizide may
be slowed in patients with impaired renal and/or hepatic function. These
patients may suffer from prolonged hypoglycaemia and appropriate
measures should be instituted.

Loss of Control on Blood Glucose : When a patient stabilized on any


antidiabetic regimen is exposed to stress such as fever, trauma, infection
or surgery, a loss of control on blood glucose may occur. At that time it
may be necessary to discontinue Glipizide and administer Insulin.

The effectiveness of any oral hypoglycaemic drug including Glipizide, in


lowering blood glucose to a desired level, decreases in many patients over
a period of time, which may be due to secondary failure, i.e., progression
of the severity of the diabetes or diminished responsiveness to the drug.

Side Effects
The majority of side effects have been dose-related, transient, and
responded to dose reduction or withdrawal of the medication.

Hypoglycaemia : See "Precautions" and "Overdosage" section.

Gastrointestinal : Gastrointestinal complaints were reported with the


following approximate incidences like nausea, diarrhoea, constipation and

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gastralgia. They appear to be dose related and usually disappear on


division or reduction of dosage.

Cholestatic jaundice may occur rarely with these kind of drugs and
Glipizide should be discontinued if this occurs.

Dermatological : Allergic skin reactions including erythema, morbilliform


or maculopapular eruption, urticaria, pruritus and eczema have been
reported. They frequently disappear with continued therapy. However, if
they persist, the drug should be discontinued.
Haematologic : Leucopenia, agranulocytosis, thrombocytopenia,
haemolytic anaemia, aplastic anaemia and pancytopenia have been
reported with sulfonylureas.

Metabolic : Hepatic porphyria and disulfiram like reactions have been


reported with sulfonylurea.

Endocrine Reactions : Cases of hyponatraemia and the syndrome of


inappropriate antidiuretic hormone (SIADH) secretion have been
reported with this and other sulfonylureas.

Miscellaneous : Dizziness, drowsiness and headache have been reported


in patients treated with Glipizide. They are usually transient and seldom
require discontinuation of therapy.

Warning
The administration of oral hypoglycaemic drugs has been reported to be
associated with increased cardiovascular mortality as compared to
treatment with diet alone or diet plus Insulin. Although the study report
was based on use of Tolbutamide only, but from a safety point of view
this warning may also be applied for other oral hypoglycaemic agents.
Patients should be instructed to take their meals regularly and not to
exercise excessively without additional calorie intake.

Overdosage
Overdosage of sulfonylurea including Glipizide can produce
hypoglycaemia. Mild hypoglycaemic symptoms without loss of
consciousness or neurologic findings should be treated aggressively with
oral glucose and adjustments in drug dosage and/or meal patterns. Close
monitoring should be continued until the physician is assured that

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the patient is out of danger. Severe hypoglycaemic reactions with coma,


seizure, or other neurological impairment occur infrequently, but
constitute medical emergencies requiring immediate hospitalization. If
hypoglycaemic coma is diagnosed or suspected, the patient should be
given a rapid intravenous injection of concentrated (50%) glucose
solution. This should be followed by a continuous infusion of a more
dilute (10%) glucose solution at a rate that will maintain the blood
glucose at a level above 100 mg/dl.

Patients should be closely monitored for a minimum of 24 to 48 hours


since hypoglycaemia may recur after apparent clinical recovery. Clearance
of Glipizide from plasma would be prolonged in persons with liver
disease. Because of the extensive protein binding of Glipizide, dialysis is
unlikely to be of benefit.

Drug Interactions
The hypoglycaemic action of sulfonylurea may be potentiated by certain
drugs including non-steroidal anti-inflammatory agents and other drugs
that are highly protein bound e.g. Salicylates, Sulfonamides,
Chloramphenicol, Probenecid, Coumarins, Monoamine Oxidase
Inhibitors, and β-adrenergic blocking agents. When such drugs are
administered to a patient receiving Glipizide, the patients should be
observed closely for hypoglycaemia. When such drugs are withdrawn
from a patient receiving Glipizide, the patient should be observed closely
for loss of control on blood glucose.

Certain drugs tend to produce hyperglycaemia and may lead to loss of


control on blood glucose. These drugs include the thiazides and other
diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens,
oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium
channel blocking drugs and Isoniazid. When such drugs are administered
to or withdrawn from a patient receiving Glipizide, the patient should be
closely observed for loss of control on blood glucose. Diabetic control
may be altered also in patients treated with cyclophosphamide.

Use in Pregnancy and Lactation


Glipizide was found to be mildly foetotoxic in rat reproductive studies at
all dose levels (5-50 mg/kg) like other sulfonylureas. There are no
adequate and well controlled studies in pregnant women. Glipizide should

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be used during pregnancy only if the potential benefit justifies the


potential risk to the foetus. Because recent information suggests that
abnormal blood glucose levels during pregnancy are associated with a
higher incidence of congenital abnormalities, many experts recommend
to use Insulin during pregnancy to maintain blood glucose levels as close
to normal as possible.

Although it is not known whether Glipizide is excreted in human milk,


some sulfonylurea drugs are known to be so. Breast feeding is not
therefore recommended while taking this medication.

Precautions
Prolonged severe hypoglycaemia (4-10 days) has been reported in
neonates born to mothers who were receiving sulfonylurea (e.g. Glipizide)
at the time of delivery. So, if Glipizide is used during pregnancy, it should
be discontinued at least one month before the expected delivery date.

In children safety and effectiveness have not been established.

Information for Patients


Patients should be informed of the potential risks and advantages of
Glipizide and of alternative modes of therapy. They should also be
informed about the importance of adhering to dietary instructions, of a
regular exercise programme, and of regular testing of urine and/or blood
glucose.

The risks of hypoglycaemia, its symptoms and treatment, and conditions


those predispose to its development should be explained to patients and
responsible family members. Primary and secondary failure should also be
explained.

Pharmaceutical Precaution
Store below 25° C.

Commercial Pack
Diactin Tablet : Box containing 10 aluminium strips of 10 tablets. Each
tablet contains Glipizide BP 5 mg.

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Diaglit®
Tablet

Description
Diaglit (Pioglitazone) is a member of the newest class of oral antidiabetic
agent called thiazolidinediones. It depends on the presence of Insulin for
its mechanism of action. Pioglitazone decreases Insulin resistance in the
periphery and in the liver, resulting in increased Insulin-dependent
glucose disposal and decreased hepatic glucose output. It also improves
abnormality in lipid metabolism by activating peroxisome proliferator-
activated receptor gamma (PPAR-γ).

Indications
Diaglit is indicated as an adjunct to diet and exercise to improve glycaemic
control in patients with type II diabetes (NIDDM). Diaglit is indicated for
monotherapy and also indicated for use in combination with sulfonylurea,
Metformin or Insulin when diet and exercise plus the single agent does
not result in adequate glycaemic control.

Dosage and Administration


Diaglit can be taken once daily without regard to meals. The management
of antidiabetic therapy should be individualized. Diaglit monotherapy
may be initiated at 15 mg or 30 mg once daily dosages in patients not
adequately controlled with diet and exercise alone. For patients who
respond inadequately to the initial dose of Pioglitazone, the dose can be
increased up to 45 mg once daily. For patients not responding adequately
to monotherapy, combination therapy should be considered.

Maximum recommended daily dose of Diaglit should not exceed 45 mg


since doses higher than 45 mg have not been studied in placebo-
controlled clinical studies. Besides, no placebo-controlled clinical studies
of more than 30 mg once daily have been conducted in combination
therapy.

Side Effects
The overall incidence and types of adverse events reported in placebo
controlled clinical trials of Pioglitazone monotherapy at doses of 7.5 mg,

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15 mg, 30 mg or 45 mg once daily are upper respiratory tract infection


(13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorder
(5.3%), and pharyngitis (5.1%).

Precautions
Pioglitazone exerts its antihyperglycaemic effect only in the presence of
Insulin. Therefore, it should not be used in Type-1 diabetes or for the
treatment of diabetic ketoacidosis. Pioglitazone should be used with
caution in case of combination antidiabetic therapy and hepatic
insufficiency. Liver enzyme should be monitored regularly.

Use in Pregnancy and Lactation


There are no adequate and well controlled studies in pregnant women.
Pioglitazone should be used during pregnancy only if the potential
benefit justifies the potential risk to the foetus. It is not known whether
Pioglitazone is secreted in human milk. As many drugs are excreted in
human milk, it should not be administered to a lactating women.

Contraindication
Diaglit is contraindicated in patients with known hypersensitivity to any
of its components.

Drug Interactions
Administration of thiazolidinediones with an oral contraceptive
containing ethinyl estradiol and norethindrone reduces the plasma
concentration of both hormones by approximately 30% which could
result in loss of contraception.

Overdosage
In the event of overdosage, appropriate supportive treatment should be
initiated according to patient’s clinical signs and symptoms.

Pharmaceutical Precaution
Store at 25o C. Keep in a cool and dry place, away from direct sunlight.
Keep out of the reach of children.

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Commercial Pack
Diaglit 15 Tablet : Box containing 30 tablets in 3 x 10’s blister strips, each
tablet contains Pioglitazone Hydrochloride INN equivalent to
Pioglitazone 15 mg.

Diaglit 30 Tablet : Box containing 30 tablets in 3 x 10’s blister strips, each


tablet contains Pioglitazone Hydrochloride INN equivalent to
Pioglitazone 30 mg.

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Diapro ®
Tablet

Description
Diapro (Gliclazide) is a second generation sulfonylurea that has
hypoglycaemic and potentially useful haemobiological properties. It
stimulates the influx of calcium ions into pancreatic β cells and as a result
increases Insulin secretion. Moreover, in vivo studies have demonstrated
changes in thrombin-induced platelet aggregation in NIDDM patients
treated with gliclazide.

Indications
Non-insulin dependent diabetes mellitus (type-II) when dietary
modification has failed.

Dosage and Administration


Initially 40-80 mg daily, adjusted according to response; up to 160 mg as
a single dose, with breakfast; higher doses divided; maximum 320 mg
daily.

Adverse Reactions
Potentially life-threatening effects- All hypoglycaemic agents have the
potential to cause severe hypoglycaemia and may cause severe brain
damage or death. Gliclazide used in standard dose is less likely than
Glyburide to cause hypoglycaemia. Hypoglycaemia may be favoured by
concurrent conditions such as hepatic and renal disease, malnutrition,
anorexia, senility, alcohol intoxication or adrenal and pituitary
insufficiency.

Severe or irreversible adverse effects- Approximately 2% of patients have


been withdrawn from therapy because of adverse reactions, namely
hypoglycaemia (overdose effect), gastrointestinal disturbances and
dermatological reactions.

Symptomatic adverse effects- Headache, gastrointestinal upsets, nausea


and dizziness have been reported and skin reactions, including rash,

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pruritus, erythema and bullous eruptions may occur. Abnormalities of


liver function are not uncommon.

High Risk Group


♦ Neonates- The drug is not used in neonates.

♦ Nursing mothers- The drug should not be used by lactating mothers.

♦ Children- Gliclazide is contraindicated in children.

♦ Pregnant women- Gliclazide, as other sulfonylurea, is contraindicated


for use in pregnant women. No teratogenic changes have been found
in animals or human, but diabetes can be controlled more effectively in
pregnancy by Insulin than by oral hypoglycaemic agents.
♦ Elderly- All sulfonylureas should be used with caution in the elderly
because of the greater likelihood of their missing meals and the more
severe outcome of significant hypoglycaemia.
♦ Concurrent disease- Definite hepatic disease should contraindicate the
use of Gliclazide, since it is almost completely metabolized in the liver.
Renal disease does not appear significantly to alter the
pharmacokinetics, although it may be wise to limit the maximum dose
when serum creatinine starts to rise.

Drug Interactions
Potentially hazardous interactions- These may be divided into those
which will tend to increase the hypoglycaemic effect and those tending to
oppose it. In the first category come drugs which displace the
sulfonylurea from protein binding, such as Aspirin, non-steroidal anti-
inflammatory drugs, Phenylbutazone, Clofibrate, Sulfonamides and
Coumarin anticoagulants; or which inhibit, hepatic microsomal enzymes,
for example Cimetidine, sulfonamides, imidazole antifungal agents and
the Monoamine Oxidase Inhibitors (MAOI), which may increase the
hypoglycaemic effect of Gliclazide. Any effects, which result from
protein-binding displacement, are transient, lasting from 12-24 h. Regular
concomitant doses of these agents together with a constant dose of
Gliclazide would not cause problems.

The hypoglycaemic action of sulfonylureas may be opposed by the


induction of hepatic enzymes, which metabolize the drug causing lower
plasma concentrations and less hypoglycaemic effect. Common inducers
include Rifampicin, barbiturates, Phenytoin and alcohol, or by drugs that

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inhibit the release or action of Insulin, e.g. thiazide diuretics, dizoxide,


glucocorticoids, oestrogens or sympathomimetic drugs. Early symptoms
of hypoglycaemia such as tremor, sweating and tachycardia may be
masked by β-adrenoreceptor blocking drugs, such as Propranolol
allowing severe hypoglycaemic episodes without preceding warning
symptoms. If β-adrenoreceptor blocking drugs are required the more
selective types, such as Metoprolol or Atenolol, are preferred in the
diabetic patient.

Pharmaceutical Precaution
Store below 250 C.

Commercial Pack
Diapro Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Each
tablet contains Gliclazide BP 80 mg.

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Diaryl®
Tablet

Description
Diaryl (Glimepiride) tablets are an oral blood-glucose-lowering drug of
the sulfonylurea class. Chemically, glimepiride is identified as 1-[[p-[2-(3-
ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-
3-(trans-4-methylcyclohexyl) urea.

Pharmacology
The primary mechanism of action of Glimepiride is lowering of blood
glucose by stimulating the release of insulin from functioning pancreatic
β cells. In addition, extra-pancreatic effects may also play vital role in the
activity of Glimepiride. Administration of Diaryl can lead to increase
sensitivity of peripheral tissues to insulin. After oral administration.
Glimepiride is completely (100%) absorbed from gastrointestinal tract.
When Glimepiride is given with meals, the mean T max is slightly increased
(12%) and the mean Cmax and AUC are slightly decreased. Glimepiride is
completely metabolized by oxidative biotransformation after oral dose.
When 14 C-Glimepride is given orally, approximately 60% of the total
radioactivity is recovered in the urine in 7 days and 80-90% of the
metabolites are recovered in the urine.

Indications
Non-insulin dependent (type-III) diabetes, whenever blood sugar levels
cannot be controlled adequately by diet, physical exercise and weight
reduction.

Diaryl is also indicated for use in combination with Insulin to lower blood
glucose in patients whose hyperglycaemia can not be controlled by diet
and exercise or in conjunction with an oral hypoglycaemic agent.

Dosage and Administration


In principle, the dosage of Diaryl is governed by the desired blood sugar
level. The dosage of Diaryl must be the lowest which is sufficient to
achieve the desired metabolic control.

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The initial and the maintenance doses are set based on the results of
regular checking of glucose in blood and urine. Monitoring of glucose
levels in blood and urine also serves to detect either primary or secondary
failure of therapy.

Initial dose and dose titration : Usual initial dose is 1 mg once daily. If
necessary, the daily dose can be increased. Any increase can be based on
regular blood sugar monitoring, and should be gradual, i.e., at intervals of
one to two weeks and carried out stepwise at follows: 1 mg-2 mg-3 mg-4
mg-6 mg.

Dose range in patients with well controlled diabetes: Usual dose range in
patients with well controlled diabetes is 1 to 4 mg daily.

Distribution of doses : Timing and distribution of doses are decided by


the physician, in consideration of the patient's current life style. Normally,
a single daily dose is sufficient. This should be taken immediately before
a substantial breakfast or - if none is taken - immediately before the first
main meals. It is very important not to skip meals after taking the drug.

Secondary dosage adjustment : As the control of diabetes improves,


sensitivity to insulin increases; therefore, Diaryl requirement may fall as
treatment proceeds. To avoid hypoglycaemia, timely dose reduction or
cessation of Glimepiride therapy must be considered.

A dose adjustment must also be considered whenever the patient's weight


or life style changes, or other factors arise which cause an increased
susceptibility to hypo- or hyperglycaemia.

Changeover from other oral antidiabetics to Diaryl : There is no exact


dosage relationship between Glimepiride and other oral blood sugar
lowering agents. When substituting Glimepride for other such agents, the
initial daily dose is 1 mg; this applies even in changeover from the
maximum dose of other oral blood sugar lowering agents. Any dose
increase should be in accordance with guideline given above in initial dose
and dose titration.

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Consideration must be given to the potency and duration of action of the


previous blood sugar lowering agent. It may be necessary to interrupt
treatment to avoid additive effects which would increase the risk of
hypoglycaemia.

Administration : Diaryl tablet must be swallowed without chewing and


with sufficient amount of liquid (approximately ½ glass).

Contraindication
Glimepiride is not suitable for the treatment of insulin dependent (type-
I) diabetes mellitus, or of diabetic pre-coma or coma. Glimepiride must
not be used in patients hypersensitive to Glimepiride or other
sulphonylureas.

Precautions
In the initial weeks of treatment, the risk of hypoglycaemia may be
increased and necessitates careful monitoring. If such risk is present it
may be necessary to adjust the dosage of Glimepiride. Hypoglycaemia
can almost always be promptly controlled by immediate intake of
carbohydrates (glucose or sugar, e.g. sugar sweetened fruit juice or sugar
sweetened tea).

Side Effects
Hypoglycaemia, temporary visual impairment, nausea, vomiting,
diarrhoea, abdominal pain, urticaria, fall in blood pressure.

Drug Interactions
Potentiation of the blood-sugar-lowering effect may occur with Insulin
and other oral anti-diabetics, ACE inhibitors, Allopurinol, anabolic
steroids and male sex hormones, Chloramphenicol, coumarin derivatives,
Fluoxetine, MAO inhibitors, Miconazole, Para-aminosalicyclic acid,
Pentoxifylline (high dose parenteral), Phenylbutazone, Oxyphenbutazone,
quinolones, salicylates, Sulfonamides, tetracyclines, β blockers.

Weakening of the blood-sugar-lowering effect may occur with


Acetazolamide, barbiturates, corticosteroids, Diazoxide, diuretics,
Epinephrine and other sympathomimetic agents, laxative, oestrogens and
progestogens, phenothiazines, Phenytoin, Rifampicin, and thyroid
hormones.

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H 2 -receptor antagonists, Clonidine and Reserpine may lead to either


potentiation or weakening of the blood-sugar-lowering effect.

Both acute and chronic alcohol intake may potentiate or weaken the
blood-sugar-lowering action of Glimepiride unpredictably.

Use in Pregnancy and Lactation


Glimepiride must not be taken during pregnancy; a changeover to Insulin
is necessary. Patients planning a pregnancy must inform their physician,
and should changeover to Insulin.

Ingestion of Glimepiride with breast milk may harm the child. Therefore,
Glimepiride must not be taken by lactating women. Either a changeover
or a complete discontinuation of breast-feeding is necessary.

Commercial Pack
Diaryl 1 Tablet : Each box contains 3 x 10’s tablets in blister strips. Each
tablet contains Glimepiride INN 1 mg.

Diaryl 2 Tablet : Each box contains 3 x 10’s tablets in blister strips. Each
tablet contains Glimepiride INN 2 mg.

Diaryl 1 Tablet : Each tablet contains Glimepiride INN 1 mg. Diaryl 2:


Each tablet contains Glimepiride INN 2 mg

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Diavix®
Tablet

Description
Diavix Tablets are combination tablets containing Lamivudine INN 150
mg and Zidovudine USP 300 mg.

Indications
Diavix is indicated for the treatment of HIV infection.

Dosage and Administration


The recommended oral dose of Diavix for adults and adolescents (at least
12 years of age) is one tablet (containing 150 mg of Lamivudine and 300
mg of Zidovudine) twice daily.

Dose Adjustment : As it is a fixed-dose combination, Diavix should not be


prescribed for patients requiring dosage adjustment such as those with
reduced renal function (creatinine clearance <50 ml/min), those with low
body weight (<50 kg or 110 lb), or those experiencing dose-limiting
adverse events.

Diavix is not recommended for patients with impaired hepatic function,


as Diavix is a fixed-dose combination that cannot be adjusted for this
patient population.

Contraindication
Diavix Tablets are contraindicated in patients with previously
demonstrated clinically significant hypersensitivity to any of the
components of the product.

General : Reduction of doses of Lamivudine is recommended for patients


with low body weight (less than 50 kg or 110 lb); therefore, patients with
low body weight should not receive Diavix.

Warning and Precautions


Zidovudine, one of the two active ingredients in Diavix, has been
associated with haematologic toxicity including neutropenia and severe

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T H E R A P E U T I C I N D E X

anaemia, particularly in patients with advanced HIV disease. Prolonged


use of Zidovudine has been associated with symptomatic myopathy.

Post-treatment Exacerbations of Hepatitis : In clinical trials in non-HIV-


infected patients treated with Lamivudine for chronic hepatitis B, clinical
and laboratory evidence of exacerbations of hepatitis have occurred after
discontinuation of Lamivudine. These exacerbations have been detected
primarily by serum ALT elevations in addition to re-emergence of
hepatitis B viral DNA (HBV DNA). Although most events appear to
have been self-limited, fatalities have been reported in some cases. Similar
events have been reported from post-marketing experience after changes
from Lamivudine-containing HIV treatment regimens to non-
Lamivudine-containing regimens in patients infected with both HIV and
HBV. Patients should be closely monitored with both clinical and
laboratory follow-up for at least several months after stopping treatment.
There is insufficient evidence to determine whether re-initiation of
Lamivudine alters the course of post-treatment exacerbations of
hepatitis.

Ordinarily, Diavix should not be administered concomitantly with either


Lamivudine or Zidovudine.

Bone Marrow Suppression : Diavix should be used with caution in bone


marrow compromised patients evidenced by granulocyte count <1,000
cells/mm 3 or haemoglobin <9.5 g/dl.

Frequent blood counts are strongly recommended in patients with


advanced HIV disease who are treated with Diavix. For HIV-infected
individuals and patients with asymptomatic or early HIV disease, periodic
blood counts are recommended.

Lactic Acidosis/Severe Hepatomegaly with Steatosis : Lactic acidosis and severe


hepatomegaly with steatosis, including fatal cases have been reported with
the use of antiretroviral nucleoside analogues alone or in combination,
including Zidovudine and Lamivudine. A majority of these cases have
been in women. Caution should be exercised when administering Diavix
to any patient, and particularly to those with known risk factors for liver
disease. Treatment with Diavix should be suspended in any patient who

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develops clinical or laboratory findings suggestive of lactic acidosis or


hepatotoxicity.

Patients with HIV and Hepatitis B Virus Co-infection : Safety and efficacy of
Lamivudine have not been established for treatment of chronic hepatitis
B in patients dually infected with HIV and HBV. In non-HIV-infected
patients treated with Lamivudine for chronic hepatitis B, emergence of
Lamivudine-resistant HBV has been detected and has been associated
with diminished treatment response. Emergence of hepatitis B virus
variants associated with resistance to Lamivudine has also been reported
in HIV-infected patients who have received Lamivudine-containing
antiretroviral regimens in the presence of concurrent infection with
hepatitis B virus. Post-treatment exacerbations of hepatitis have also been
reported.

Side Effects
General : Headache, malaise, fatigue, fever or chills, weakness.
Gastrointestinal : Nausea and vomiting, diarrhoea, anorexia and/or
decreased appetite, abdominal pain or cramps, dyspepsia. Nervous system :
Neuropathy, insomnia and other sleep disorders, dizziness, depressive
disorders. Respiratory : Nasal signs and symptoms, cough. Skin : Skin
rashes. Musculoskeletal : Musculoskeletal pain, myalgia, arthralgia.

The following events have been chosen for inclusion due to their
seriousness, frequency of reporting, causal connection to Lamivudine
and/or Zidovudine or a combination of these factors. Cardiovascular :
Cardiomyopathy, vasculitis. Endocrine and Metabolic : Gynaecomastia,
hyperglycaemia. Gastrointestinal : Oral mucosal pigmentation, stomatitis.
Haemic and Lymphatic : Aplastic anaemia, anaemia, lymphadenopathy, pure
red cell aplasia, spleenomegaly. Hepatic and Pancreatic : Lactic acidosis and
hepatic steatosis, steatosis, pancreatitis, post-treatment exacerbation of
hepatitis B infection. Hypersensitivity : Sensitisation reactions (including
anaphylaxis), urticaria. Musculoskeletal : Muscle weakness, elevation of
creatinephosphokinase (CPK), rhabdomyolysis. Nervous system :
Paraesthesia, peripheral neuropathy, seizures. Respiratory system : Abnormal
breath sounds/wheezing. Skin : Alopecia, erythema multiforme, Stevens-
Johnson syndrome.

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Overdose
There is no experience of overdosage with Lamivudine and Zidovudine
combination. However, there are limited data available on the
consequences of ingestion of acute overdoses of Lamivudine and
Zidovudine in humans. No fatalities occurred, and all patients recovered.
No special signs or symptoms have been identified following such
overdosage.

If overdosage occurs the patients should be monitored for evidence of


toxicity, and standard supportive treatment applied as necessary. Since
Lamivudine is dialysable, continuous haemodialysis could be used in the
treatment of overdosage, although this has not been studied.
Haemodialysis and peritoneal dialysis appear to have a limited effect on
elimination of Zidovudine, but enhance the elimination of the
glucuronide metabolite.

Pharmaceutical Precaution
Store in a cool dry place. Protect from light.
Keep out of reach of children.

Commercial Pack
Diavix Tablets : Each tablet contains Lamivudine INN 150 mg and
Zidovudine USP 300 mg. Each box contains 1 x 10’s tablets in blister
strip.

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Dilapress ®
Tablet

Description
Dilapress (Carvedilol) is a cardiovascular drug which mainly acts as
neurohormonal antagonist consisting of non-selective β-blockade, α1-
blockade and antioxidant properties.

Indications
Dilapress is indicated for the treatment of essential hypertension. It can
be used alone or in combination with other antihypertensive agents,
especially thiazide type of diuretics.

Dilapress is also indicated for the treatment of mild to moderate heart


failure, to reduce the progression of disease, to reduce mortality and
cardiovascular hospitalization.

Dilapress may be used in patients unable to tolerate an ACE inhibitor.

Dilapress may be used in patients who are not receiving digitalis,


hydralazine or nitrate therapy.

Dosage and Administration


In essential hypertension initially 12.5 mg once daily for 2 days is
recommended. Thereafter the recommended dose is 25 mg once daily. If
necessary the dose may be further increased at intervals of at least 2
weeks to maximum 50 mg daily in single or divided doses. In elderly
patients the initial dose of 12.5 mg daily may provide satisfactory control.

In heart failure, initially 3.125 mg twice daily may be given for 2 weeks,
dose may be increased at intervals of at least 2 weeks to 6.25 mg twice
daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may
be increased to highest dose tolerated, maximum 25 mg twice daily in
patients less than 85 kg body weight and 50 mg twice daily in patients over
85 kg.

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In angina pectoris the recommended dose for initiation of therapy is 12.5


mg twice daily for the first 2 days. Thereafter, the recommended dose is
25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg
daily in divided doses.

Contraindication
Dilapress must not be used in patients with New York Heart Association
(NYHA) class IV decompensated heart failure requiring intravenous
inotropic support, Asthma, Chronic obstructive pulmonary disease
(COPD) with a bronchospastic component, 2nd or 3rd degree AV block,
sick sinus syndrome (unless a permanent pacemaker is in place),
cardiogenic shock or severe bradycardia. Therapy is not to be initiated in
severe heart failure.

Side Effects
Dizziness, headache, fatigue, gastrointestinal disturbances, postural
hypotension, peripheral oedema, bradycardia, dry mouth, dry eyes, eye
irritation or disturbed vision, impotence, disturbances of micturition,
influenza-like symptoms. Rarely angina, AV block, exacerbation of
intermittent claudication or Raynaud’s phenomenon, allergic skin
reactions, nasal stuffiness, wheezing, depressed mood, sleep disturbances,
paresthesia, heart failure, changes in liver enzymes, thrombocytopenia,
leucopenia are also reported.

Precautions
Take precaution in hepatic impairment, and in heart failure monitor
clinical status for 2-3 hours after initiation and after increasing each dose.
Before increasing dose ensure that the renal function and heart failure are
not deteriorating.

Use in Pregnancy and Lactation


Carvedilol should not be used during pregnancy as no studies have been
performed in this group. Carvedilol and its metabolites are excreted in
breast milk. Therefore, breastfeeding is not recommended during
administration of Carvedilol.

Drug Interactions
As with other anti-hypertensive, there is a potential for pronounced
hypotension during general anaesthesia.

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As with other agents with β-blocking activity, Carvedilol may potentiate


the effect of other concomitant administered drugs that are anti-
hypertensive in action or have hypotension as part of their adverse effect
profile. As with other drugs with β-blocking activity, caution should be
exercised when administered Class I anti-arrhythmic drugs or calcium
antagonists such as Verapamil. These drugs should be administered
intravenously.

Plasma Digoxin levels may be increased in patients to whom Carvedilol


and Digoxin are co-administered. Increased monitoring of Digoxin levels
is recommended when initiating, adjusting or discontinuing Carvedilol.

Care should be required in those receiving inducers of mixed function


oxidase e.g. Rifampicin, as serum levels of Carvedilol may be reduced.

Pharmaceutical Precaution
Store at temperature between 150 C to 300 C.

Commercial Pack
Dilapress 6.25 Tablet : Box containing 30 tablets in 3 x 10’s blister strips.
Each tablet contains Carvedilol BP 6.25 mg.

Dilapress 12.5 Tablet : Box containing 30 tablets in 3 x 10’s blister strips.


Each tablet contains Carvedilol BP 12.5 mg.

Dilapress 25 Tablet : Box containing 30 tablets in 3 x 10’s blister strips.


Each tablet contains Carvedilol BP 25 mg.

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Ecotrim®
Cream

Description
Ecotrim cream is a soft white cream containing 1% Econazole Nitrate BP
and 0.1% Triamcinolone Acetonide BP.

Indications
Econazole Nitrate is a broad spectrum antifungal agent. It is effective
against various dermatophytes, yeasts and moulds. Moreover, it has
activity against Gram-positive bacteria. Triamcinolone Acetonide is a
potent corticosteroid with anti-inflammatory, antipruritic and antiallergic
activity.

The more important indications of Ecotrim are dermatomycosis caused


by dermatophytol yeast and fungus with clear inflammatory and allergic
symptoms such as various eczematous mycosis, diaper dermatitis, eczema
marginatum, intertrigo, folliculitis, tricophytica and sycosis barbae.
Ecotrim is also indicated for the treatment of mycosis present in various
folds of the body.

Dosage and Application


The cream should be applied by gently rubbing into the skin with the
finger once or twice daily for 14 days or as directed by a registered
physician.

Contraindication
Like all preparations containing corticosteroids, Ecotrim cream should
not be used on tubercular skin infections or in viral diseases (e.g. herpes,
vaccinia, and varicella).

Use in Pregnancy
The use of corticosteroids during pregnancy has not been established.
Topical steroids should not be used extensively in pregnancy, i.e. in large
amounts or for prolonged periods.

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Precautions
Long term continuous steroid therapy should be avoided since adrenal
suppression can occur, particularly when infants or children are treated or
when occlusive dressings are applied. Discontinuation of the medication
is advised if hypersensitivity occurs.

Side Effects
Ecotrim cream is well tolerated, even to sensitive skin. Burning sensation,
pruritis and redness of skin have rarely been reported.

Additional Information
♦ The infected area should be kept clean and dry during treatment

♦ Keep the medication out of reach of children

♦ To be dispensed only upon the prescription of a registered physician

Commercial Pack
Ecotrim Cream : Tube containing 10 g cream, each gram contains
Econazole Nitrate BP 10 mg and Triamcinolone Acetonide BP 1 mg.

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Efol®ER
Capsule

Description
Each Efol extended release capsule contains 150 mg of Dried Ferrous
Sulphate BP equivalent to 47 mg Iron, 500 µg Folic Acid USP and 61.8
mg of Zinc Sulphate Monohydrate USP equivalent to 22.5 mg Zinc. It is
a clear, transparent capsule filled with a mixture of red, pale yellow, pink
and white pellets. This capsule is especially formulated for extended
release of iron over a period of several hours and that of zinc over one
to two hours.

Indications
Efol ER is indicated for the treatment of iron, folic acid and zinc
deficiency. Efol ER is also indicated on prophylaxis of iron deficiency
especially when inadequate diet calls for supplementary zinc and iron
during pregnancy.

Dosage and Administration


Prophylaxis
♦ Adult
One capsule a day. In more severe cases, two capsules a day may be
required as prescribed by the physician.

♦ Elderly
Dosage as above.

♦ Children aged over 1 year


One capsule a day, the capsule may be opened and the pellets can be
mixed with soft cool food but they must not be chewed.

Treatment
Recommended dose is 2 to 4 capsules a day or as prescribed by the
physician.

Contraindication
It is contraindicated in patients with haemolytic anaemia and in conditions

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with increased hypersensitivity to any of its components and increased


body iron content.

Use in Pregnancy
Administration in first trimester of pregnancy should be avoided unless
definite evidence of iron deficiency is observed. Prophylaxis of iron
deficiency is justified during the remainder of pregnancy specifically
when zinc supplementation is required.

Side Effects
Side effects of iron, folic acid and zinc supplementation are mild and
transient. These include epigastric pain, nausea, constipation, vomiting,
diarrhoea etc. The blended Efol ER capsule is especially designed to
reduce the possibility of gastrointestinal irritation.

Drug Interactions
Iron chelates with Tetracycline. Since oral iron products interfere with
absorption of oral Tetracycline, these products should not be taken
within two hours of each other. Occasional gastrointestinal discomfort
may be minimized by taking with meals. Absorption of iron may be
impaired by concurrent administrations of penicillamine and antacid. In
patients with renal failure, a risk of zinc accumulation may exist.

Overdosage
Overdosage of iron is dangerous, particularly in children and requires
immediate attention. Gastric lavage should be carried out in the early
stages, vomiting may also be induced. Zinc Sulphate in gross overdosage
is corrosive. Symptoms are those of gastrointestinal irritation, leading in
severe cases to haemorrhagic corrosion of the mucosa and possible later
stricture formation. Demulcent such as milk should be given. Chelating
agents such as Dimercaprol, Penicillamine or Edetic acid have been
recommended. The extended release capsule presentation may delay
excessive absorption of iron and zinc and allow more time for initiation
of appropriate counter measures.

Precautions
Care should be taken in patients who may develop iron overload, such as
those with haemochromatosis, haemolytic anaemia or red cell aplasia.

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Failure to respond to treatment may indicate other causes of anaemia and


should be further investigated.

Pharmaceutical Precaution
Store in a dry place below 25ºC and protect from sunlight. Keep out of
the reach of children.

Commercial Pack
Efol ER Capsule : Box containing 50 capsules in 5 x 10's blister strips.
Each capsule contains Dried Ferrous Sulphate BP 150 mg equivalent to
Iron 47 mg, Folic Acid USP 500 µg and Zinc Sulphate Monohydrate USP
61.8 mg equivalent to Zinc 22.5 mg.

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Enaril®
Tablet

Description
Enaril (Enalapril Maleate) is the maleate salt of Enalapril, the ethyl ester
of a long-acting angiotensin-converting enzyme (ACE) inhibitor,
enalaprilat. It is highly effective in the management of hypertension and
heart failure.

Indications
Enaril is indicated for the treatment of all grades of essential
hypertension, renovascular hypertension and heart failure.

Dosage and administration


Essential and Renovascular Hypertension : Treatment should be initiated with
5 mg once a day. Where concomitant therapy is a diuretic, the
recommended initial dose of Enaril is 2.5 mg. The dose should be titrated
to give optimum control of blood pressure. The usual maintenance dose
is 10-20 mg given once daily. In severe hypertension, the dosage may be
increased incrementally to a maximum of 40 mg once daily.

Heart Failure : Enaril can be used as an adjunctive therapy with non-


potassium-sparing diuretics and/or digitalis. The recommended starting
dose of Enaril is 2.5 mg once daily. The dose of Enaril should be
gradually increased depending upon tolerability to the recommended
maintenance dose (10-20 mg) given as a single or twice daily dose.

The absorption of Enaril is not affected by food. The maximum daily


dose is 40 mg.

Use in the elderly (over 65 years) : The starting dose should be 2.5 mg. Enaril
is effective in the treatment of hypertension in the elderly. The dose
should be titrated according to need for the control of blood pressure.

Contraindication
Pregnancy : Enalapril is contraindicated in pregnancy and treatment
should be stopped if pregnancy is suspected, because it has been found
to be foetotoxic in rabbits.

Hypersensitivity : Enaril is also contraindicated in patients who are

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hypersensitive to any component of this product and in patients with a


history of angioneurotic oedema relating to previous treatment with an
ACE inhibitor.

Precautions
Hypotension : Symptomatic hypotension has been reported mainly in
patients with severe heart failure. In these patients, by discontinuing
diuretic therapy or significantly reducing the diuretic dose for two to three
days prior to initiating Enalapril, the possibility of this occurrence is
reduced. By initiating therapy with a small dose (2.5 mg), the duration of
any hypotensive effect may be lessened.

If hypotension develops, the patient should be placed in a supine


position. Volume repletion with oral fluids or intravenous normal saline
may be required.

Impaired renal function : Enalapril should be used with caution in


patients with renal insufficiency as they may require reduced or less
frequent doses. Renal failure has been reported in association with
Enalapril and has been mainly in patients with severe congestive heart
failure or underlying renal disease, including renal artery stenosis. If
recognized promptly and treated appropriately, renal failure is usually
reversible.

Angioneurotic oedema : Angioneurotic oedema has been reported with


ACE inhibitors including Enalapril. In such cases, Enaril should be
discontinued immediately and appropriate monitoring should be
instituted to ensure complete resolution of symptoms prior to dismissing
the patient. Where swelling is confined to the face, lips and mouth, the
condition will usually resolve without further treatment, although
antihistamines may be useful in relieving symptoms. However, where
there is involvement of the tongue, glottis or larynx, likely to cause
airways obstruction, appropriate therapy such as subcutaneous adrenaline
1:1000 (0.5 ml) should be administered promptly.

Cough : Cough has been reported with the use of ACE inhibitors.

Surgery/Anaesthesia : In patients undergoing major surgery or during


anaesthesia with agents that produce hypotension, Enalapril blocks

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angiotensin II formation secondary to compensatory renin release. This


may lead to hypotension which can be corrected by volume expansion.

Lactating mothers : Enalapril and Enalaprilat are excreted in breast milk;


caution should be exercised if Enaril is given to lactating mothers.

Drug Interactions
Combination with other antihypertensive agents such as β-blockers,
Methyldopa, calcium antagonists and diuretics may increase the
antihypertensive efficacy. Adrenergic-blocking drugs should only be
combined with Enalapril under careful supervision. Concomitant
Propranolol may reduce the bioavailability of Enalapril, but this does not
appear to be of any clinical significance. Concomitant therapy with
Lithium may increase the serum Lithium concentration.

Side Effects
The commonly reported side effects are dizziness and headache. Other
side effects occurring less frequently include orthostatic hypotension,
nausea, rash, cough etc.

Cardiovascular : Myocardial infarction or cerebrovascular accident,


possibly secondary to severe hypotension in high-risk patients.
Palpitation, rhythm disturbances. Gastrointestinal : Abdominal pain,
dyspepsia, hepatitis, jaundice. Nervous system : Confusion, nervousness,
insomnia, somnolence. Respiratory : Sore throat, hoarseness of voice.
Skin : Urticaria, pruritus. Special senses : Blurred vision. Renal : Oliguria,
renal dysfunction, renal failure are reported in rare cases.

Overdosage
Limited data are available for overdosage in humans. The most prominent
feature of overdosage is hypotension, for which the usual treatment
would be intravenous infusion of normal saline solution. Enaril can be
removed from general circulation by haemodialysis.

Pharmaceutical Precaution
Store in a dry place below 25 °C, protected from light.

Commercial Pack
Enaril Tablet : Box containing 10 blister strips of 10 tablets, each tablet
contains 5 mg of Enalapril Maleate USP.

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Epilep®
Tablet

Description
Carbamazepine is an iminodibenzyl derivative with anticonvulsant
properties and its structure is related to the tricyclic antidepressants. It is
a white or yellowish-white, crystalline, almost odourless powder which is
tasteless or with a slightly bitter taste.

Indications
Carbamazepine is indicated in all forms of epilepsy except myoclonic and
absence seizures, trigeminal neuralgia, mood disorder, aggression and
diabetes insipidus.

Dosage and Administration


Epilepsy :
Dosage in adults : 100-200 mg once or twice daily and this is then
gradually increased by 200 mg daily every week. The best response is
often obtained with doses of 800-1200 mg daily. In some instances 1600
mg or even 2000 mg daily may be necessary.

Dosage in children : The dose in children is determined on the basis of


body weight (10-20 mg/kg) and age. Children up to 1 year of age : 100-
300 mg daily in two to four divided doses. Children between 1 to 5 years
of age: 200-400 mg daily in two to four divided doses. Children between
6 to 10 years of age : 400-600 mg daily in two to four divided doses.
Children between 11 to 15 years of age : 600-1000 mg daily in two to four
divided doses.

Trigeminal neuralgia : The initial dose is usually 200 mg daily. In some


instances a dose of 1600 mg daily is necessary.

Mood disorder : In patients unresponsive to Lithium therapy, a starting dose


of 400-600 mg daily is used.

Diabetes insipidus : 200 mg two to three times daily. In children the dose
should be determined according to body weight (10-20 mg/kg).

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Side Effects

Potentially life-threatening Severe or irreversible Symptomatic

Aplastic anaemia, Generalized erythematous Dizziness, Ataxia,


Agranulocytosis, Fatal hepatitis, skin rashes, Transient Headache, Diplopia,
Severe exfoliative dermatitis, leucopenia, Drowsiness, Nausea,
Toxic epidermal necrolysis, Thrombocytopenia, Vomiting, Asthenia
Stevens-Johnson syndrome, Oliguria, Haematuria,
Lupus erythematosus Proteinuria, Renal failure,
Bradycardia, Heart failure

Precautions
Carbamazepine should be used with caution in cardiovascular disease,
hepatic or renal disorders, changing treatment from Carbamazepine to
another antiepileptic drug, haematological disorder, glaucoma etc.

Drug Interactions

Drugs Effects
Anticoagulants Reduced anticoagulant effect
Oral contraceptive Increased contraceptive effect
Propoxyphene Interference with the metabolism and clearance
of Carbamazepine
Fluvoamine Provoked symptomatic Carbamazepine toxicity
MAO Inhibitors Increased incidence of cardiac arrhythmias
Anticonvulsants Induction of hepatic microsomal enzyme
Alcohol CNS side effects of Carbamazepine possibly
increased
Doxycycline Shorter half-life of Doxycycline
Salicylic Acid Increased free Carbamazepine concentration
in plasma
Vitamin D Interference with the metabolism of Vitamin D
Lithium Neurotoxic reactions have been occurred.

Contraindication
Previous sensitivity to Carbamazepine or structurally related drugs,
atrioventricular conduction abnormalities, history of previous bone
marrow depression or of intermittent porphyria.

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Use in Pregnancy and Lactation


There is definite evidence of risk to the human foetus, but this may be
overweighed by the therapeutic benefit for the mother. Pregnant women
with epilepsy should be kept under close surveillance. Pregnancy
decreased the plasma concentration of Carbamazepine. This is largely the
result of an increase in the rate of metabolism. It may therefore be
necessary to increase the dose of Carbamazepine during pregnancy in
order to maintain a satisfactory clinical response. Carbamazepine and its
main metabolite, Carbamazepine-10, 11-epoxide, are both present in
breast milk of nursing mothers in concentrations of between 30-60% of
those in plasma. Breast-feeding is not contraindicated, however, because
the amount of drug ingested by the breasted infant is too small to cause
any adverse pharmacological effects.

Acute Overdosage
Doses of up to 20 g are known to have been taken but no deaths have
been reported. The symptoms of overdosage include erythema of the
face, tremor, ataxia, psychomotor restlessness, changes in blood pressure,
muscle hypotonia, and dilatation of the pupils, unconsciousness and
convulsions.

Pharmaceutical Precaution
Store at 25 oC. Keep in a cool and dry place, away from direct sunlight.

Commercial Pack
Epilep Tablet : Each box contains 5 x 10’s tablets in blister strips. Each
tablet contains Carbamazepine BP 200 mg.

Epilep CR Tablet : Each box contains 5 x 10’s tablets in blister strips.


Each CR tablet contains Carbamazepine BP 200 mg.

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Eplon®
Capsule

Description
Eplon (Zaleplon) is a newer non-benzodiazepine hypnotic from the
pyrazolopyrimidine class. So, its chemical structure is unrelated to
benzodiazepines, barbiturates, or other drugs with known hypnotic
properties. It interacts with the gamma aminobutyric acid-benzodiazepine
(GABA-BZ) receptor complex.

Indication
Eplon is indicated for the short-term treatment of insomnia. Eplon has
been shown to decrease the time to sleep onset for up to 30 days in
controlled clinical trials.

Dosage and administration


The dose of Eplon should be individualized. The recommended dose of
Eplon for most non-elderly adults is 10 mg. For certain low weight
individuals, 5 mg may be a sufficient dose. Although the risk of certain
adverse events associated with the use of Eplon appears to be dose
dependent, the 20 mg dose has been shown to be adequately tolerated and
may be considered for occasional patient who does not benefit from a
trial of lower dose. Dosage above 20 mg has not been adequately
evaluated and is not recommended.

Eplon should be taken immediately before bedtime. Taking Eplon with or


immediately after a heavy, high-fat meal results in slower absorption and
would be expected to reduce the effect of Eplon on sleep latency. Elderly
patients and debilitated patients appear to be more sensitive to the effects
of hypnotic, and respond to 5 mg of Eplon. The recommended dose for
these patients is therefore 5 mg. Doses over 10 mg are not recommended.

For patients with mild to moderate renal impairment no dose adjustment


is necessary.

An initial dose of 5 mg should be given to patients concomitantly taking


Cimetidine because Zaleplon clearance is reduced in this population.

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Contraindication
None known.

Side Effects
Side effects of Eplon appear to be dose related. So, it is important to use
the lowest possible effective dose, specially in the elderly. The side effects
are usually mild and transient, the most common are diarrhoea, nausea,
vomiting, vertigo, headache, asthenia, nightmare etc.

Precautions
Timing of drug administration : Eplon should be taken immediately before
bedtime or after the patient has gone to bed.

Use in the elderly and/or debilitated patients : Impaired motor and/or cognitive
performance after repeated exposure or unusual sensitivity to
sedative/hypnotic drugs is a concern in the treatment of elderly and/or
debilitated patients. A dose of 5 mg is recommended for elderly patients
to decrease the possibility of side effects. Elderly and/or debilitated
patients should be monitored closely.

Use in patients with concomitant illness : Eplon should be used with caution in
patients with diseases or conditions that could affect metabolism or
haemodynamic responses.

Although preliminary studies did not reveal respiratory depressant effects


at hypnotic doses of Zaleplon in normal subjects, caution should be
observed if Zaleplon is prescribed to patients with compromised
respiratory function, because sedative/hypnotic have the capacity to
depress respiratory drive. However, patients with compromised
respiration due to preexisting illness should be monitored carefully. The
dose of Eplon should be reduced to 5 mg in patients with mild to
moderate hepatic impairment. It is not recommended for use in patients
with severe hepatic impairment.

No dose adjustment is necessary in patients with mild to moderate renal


impairment. Zaleplon has not been adequately studied in patients with
severe renal impairment.

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Use in patients with depression : As with other sedative/hypnotic drugs,


Eplon should be administered with caution to patients exhibiting signs or
symptoms of depression.

Use in Pregnancy and Lactation


There are no studies of Zaleplon in pregnant women; therefore, it is not
recommended for use in women during pregnancy. Eplon has no
established use in labour and delivery.

A study in lactating mothers indicated that the clearance and half-life of


Zaleplon is similar to that in young normal subjects. A small amount of
Zaleplon is excreted in breast milk, with the highest excreted amount
occurring during a feeding at approximately 1 hour after Zaleplon
administration. Since the small amount of the drug from breast milk may
result in potentially important concentrations in infants, and because the
effects of Zaleplon on a nursing infant are not known, it is not
recommended in nursing mothers.

Paediatric Use
The safety and effectiveness of Zaleplon in paediatric patients have not
been established.

Overdosage
It is usually manifested by degrees of central nervous system depression
ranging from drowsiness to coma. In mild cases, symptoms include
drowsiness, mental confusion, and lethargy; in more serious cases,
symptoms may include ataxia, hypotonia, hypotension, respiratory
depression, rarely coma, and very rarely death.

Drug Interactions
Zaleplon has been shown to have minimal effects on the kinetic of
Warfarin, Imipramine, Ethanol, Ibuprofen, Diphenhydramine,
Thioridazine, and Digoxin.

Pharmaceutical Precaution
Store at controlled room temperature, 20 οC-25οC.

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Commercial Pack
Eplon 5 Capsule : Box containing 3 x 10’s capsule in blister strips. Each
capsule contains 5 mg Zaleplon INN.

Eplon 10 Capsule : Box containing 3 x 10’s capsule in blister strips. Each


capsule contains 10 mg Zaleplon INN.

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Etrocin®
Tablet/Suspension

Description
Etrocin suspension is a preparation of Erythromycin Ethylsuccinate.
After reconstitution each 5 ml contains Erythromycin Ethylsuccinate
USP equivalent to 125 mg Erythromycin. Enteric-coated Etrocin tablet is
a preparation of Erythromycin USP and is available in potencies of 250
and 500 mg.

Antimicrobial Actions
Its range of antimicrobial action is similar to that of penicillin. It is active
against most Gram-positive and some Gram-negative bacteria including
Neisseria species, Haemophilus influenzae and Bordetella pertussis, against
spirochete and some rickettsiae and chlamydia. Micoplasma pneumoniae is
very sensitive to Erythromycin, Streptococcus pneumoniae and haemolytic
streptococci are highly sensitive but streptococci (including those
resistant to penicillin) are rather less sensitive. Although the
Enterobacteriaceae are generally resistant to Erythromycin, some strains
of Escherichia coli and Klebsiella species have been reported to be sensitive
at an alkaline pH. The Gram-negative bacterium responsible for
legionnaire’s disease known as Legionella pneumophila is reported to be
sensitive to Erythromycin.

Indications
Etrocin is highly effective in the treatment of a great variety of clinical
infections caused by Erythromycin sensitive organisms. Upper Respiratory
Tract infections : Tonsillitis, peritonsillar abscess, pharyngitis, laryngitis,
sinusitis, secondary infections in cold and influenza. Lower Respiratory Tract
infections : Tracheitis, acute and chronic bronchitis, pneumonia (lobar
pneumonia, broncho-pneumonia, primary atypical pneumonia),
bronchiectasis, legionnaire’s disease. Ear infection : Otitis media and otitis
externa, mastoiditis. Oral infection : Gingivitis, Vincent’s angina. Eye
infection: Blepharitis. Skin and Soft Tissue infections : Boils and carbuncles,
paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas. Gastro-
intestinal infections : Cholecystitis, staphylococcal enterocolitis. Prophylactic
use : Pre- and post-operative trauma, burns, rheumatic fever. Other

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infections: Osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma


venereum, diphtheria, prostatitis, scarlet fever.

Dosage and Administration


In case of suspension, optimum blood levels are obtained, when doses
are given on an empty stomach. Etrocin tablet can be given before, during
or after meal.

Adults and children over 8 years : 250-500 mg every 6 hours or 0.5 -1 g


every 12 hours. This may be increased up to 4 g per day according to the
severity of infection.

Elderly : Same as for adults.

Children : Age, weight and severity of infection are important factors in


determining the correct dosage.

The usual regimen is 30-50 mg/kg/day in divided doses or as directed by


the physician. For more severe infections this dosage may be doubled. If
administration on a twice daily schedule is desirable, one half of the total
daily dose may be given every 12 hours, one hour before meal.

Amoebic dysentery : Adult- 250-500 mg four times daily for 10 to 14 days.


Children- 30-50 mg/kg/day in divided doses for 10-14 days.

Pertussis : Although optimum dosage and duration of treatment have not


been established, doses of Erythromycin utilized in reported clinical
studies were 40-50 mg/kg/day given in divided doses for 5-14 days.

Streptococcal infections : In the treatment of group A beta haemolytic


streptococcal infections, therapeutic dosage of Erythromycin should be
administered for at least 10 days.

Prophylaxis : In continuous prophylaxis of streptococcal infections in


persons with a history of rheumatic heart disease, the dosage is 250 mg
twice daily.

When Etrocin is used prior to surgery to prevent endocarditis caused by


α-haemolytic streptococci, a recommended schedule for children- 20

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mg/kg 1.5-2 hours pre-operatively and 10 mg/kg every six hours for
eight doses post-operatively. For adults the dose is 1 g, 1.5-2 hours pre-
operatively and 500 mg every six hours for eight doses post-operatively.

Contraindication
It is contraindicated in patients hypersensitive to Erythromycin.

Warning
Since Erythromycin is metabolized principally by the liver, caution should
be exercised in administering the antibiotic to patient with impaired
hepatic function. There have been reports of hepatic dysfunction with or
without jaundice occurring in patients taking oral Erythromycin.

Use in Pregnancy and Lactation


Clinical and laboratory studies have no evidence of teratogenecity or
toxicity. However, caution should be exercised when prescribing for the
pregnant women. Erythromycin is readily excreted in breast milk.

Precautions
The use of Erythromycin in patients who are receiving concomitant high
doses of Theophylline may be associated with Theophylline toxicity due
to increase level of Theophylline in the serum. If symptoms of toxicity
develop, the dose of Theophylline should be reduced.

Side Effects
Serious side effects are rare. The most frequent side effects of
Erythromycin preparation are gastrointestinal (e.g. abdominal cramping
and discomfort) and these are dose related. Nausea, vomiting and
diarrhoea occur infrequently with usual oral doses.

Mild allergic reactions such as urticaria and other skin rashes, have
occurred. Serious allergic reactions, including anaphylaxis have been
reported.

Overdosage
Symptoms are mainly confined to nausea, vomiting and diarrhoea.
General management may consist of supportive therapy.

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Pharmaceutical Precaution
Keep the container tightly closed and protected from light. Store in a cool
and dry place. Suspension should be shaken well before use.

Commercial Pack
Etrocin Tablet : Box containing 100 enteric-coated tablets in 10 x 10’s
blister strips, each tablet contains 250 mg Erythromycin USP.

Etrocin-500 Tablet : Box containing 50 enteric-coated tablets in 5 x 10’s


blister strips, each tablet contains 500 mg Erythromycin USP.

Etrocin Suspension : Bottle containing dry powder for 100 ml


suspension. After reconstitution each 5 ml contains Erythromycin
Ethylsuccinate USP equivalent to 125 mg Erythromycin.

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Evo®
Tablet

Description
Evo (Levofloxacin) is a synthetic, broad-spectrum antibacterial agent.
Chemically Levofloxacin is a chiral fluorinated carboxyquinolone.

Indications
Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus
influenzae, or Moraxella catarrhalis. Acute bacterial exacerbation of chronic
bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus
influenzae, Klebsiella pneumoniae or Moraxella catarrhalis. Community acquired
pneumoniae due to Staphylococcus aureus , Streptococcus pneumoniae,
Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia
pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae. Complicated
urinary tract infections due to E. coli, Klebsiella pneumoniae or Staphylococcus
saprophyticus. Acute pyelonephriits caused by E. coli. Uncomplicated and
complicated skin and skin structure infections including abscesses,
cellulitis, furuncles, impetigo, pyoderma, wound infections, due to
Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus
faecalis.
Dosage and Administration
Acute sinusitis : 500 mg once daily for 10-14 days. Exacerbation of
chronic bronchitis : 250-500 mg daily for 7-10 days. Community acquired
penumonia : 500 mg once or twice daily for 7-14 days. Complicated
urinary- tract infections and acute pyelonephritis : 250 mg daily for 7-10
days. Uncomplicated skin and soft-tissue infections : 500 mg once daily
for 7-10 days. Complicated skin and soft-tissue infections : 750 mg once
daily for 7-14 days.

Contraindication
Levofloxacin is contraindicated in patients with a history of
hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any
other components of this products.

Precaution
While taking Levofloxacin adequate amount of water should be drunk to
avoid risk of crystalluria. Dose adjustment should be taken during

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Levofloxacin ingestion in presence of renal insufficiency and hepatic


insufficiency.

Side Effects
Levofloxacin is generally well tolerated. However, a few side effects can
usually be seen. Side effects include nausea, vomiting, diarrhoea,
abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%).
Side effects that may be seen very rarely include tremors, depression,
anxiety, confusion etc.

Use in Pregnancy and Lactation


Levofloxacin is not recommended for use during pregnancy or during
lactation, as the effects on the unborn child or nursing infant are
unknown.

Use in Children
Not recommended for children.

Drug Interactions
Antacids, Iron and multivitamin preparations with Zinc- reduce
absorption of Levofloxacin. NSAIDs may increase the risk of CNS
stimulation and convulsive seizures. Warfarin may increase the risk of
bleeding.

Overdosage
Levofloxacin exhibits a low potential for acute toxicity. However, in the
events of an acute overdosage, the stomach should be emptied. The
patients should be kept under observation and appropriate hydration
should be maintained.

Pharmaceutical Precaution
Store in a cool and dry place, away from sunlight.

Commercial Pack
Evo 250 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Each
film coated tablet contains Levofloxacin Hemihydrate INN equivalent to
Levofloxacin-250 mg.

Evo 500 Tablet : Box containing 20 tablets in 2 x 10’s blister strips. Each
film coated tablet contains Levofloxacin Hemihydrate INN equivalent to
Levofloxacin 500 mg.

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Fertil®
Tablet

Description
Fertil (Clomiphene Citrate USP) is an orally administered, non-steroidal,
ovulatory stimulant. Each tablet contains Clomiphene Citrate USP 50 mg.
Clomiphene Citrate is the first non-steroid preparation that in many
patients induces ovulation which has failed. Clomiphene Citrate
stimulates the increased secretion of both gonadotropins (FSH and LH),
which induce the maturation of the ovarian follicle, ovulation and the
subsequent normal function of the corpus luteum. It is most probably
that Clomiphene Citrate stimulates the production of the releasing factor
for gonadotropins in the hypothalamus, that induce the increasing
secretion of FSH and LH. After oral administration, Clomiphene Citrate
is readily absorbed from the gastrointestinal tract. Biological half-life in
the plasma is 5-7 days. It is partly metabolized in the liver, and through
the bile is excreted in the faeces. A part is reabsorbed and enters the
enterohepatic recirculation pool.

Indications
Fertil is indicated for the treatment of ovulatory failure in women desiring
pregnancy whose partners are fertile and potent. The following
syndromes are most commonly associated with ovulatory failure:
polycystic ovary syndrome, amenorrhoea with galactorrhoea, psychogenic
amenorrhoea, some forms of secondary amenorrhoea of undetermined
etiology, and post-oral-contraceptive amenorrhoea. Other possible causes
of infertility should be excluded before giving Clomiphene Citrate. Fertil
is indicated in the treatment of menorrhagia caused by hyperplastic
endometrium.

Dosage and Administration


The usual dose for the first course of Fertil is 50 mg (1 tablet) a day for
5 days in the early follicular phase of the cycle, following normal
menstruation or a progestagen-induced withdrawal bleeding. Many
regimes have been used, but most common begin either on day 2 or day
5. If this dose induces ovulation, there is no need to increase the dose in
the following courses. If this dose induces ovulation, but pregnancy does

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not occur, stimulation with Clomiphene Citrate is to be continued, but up


to 6 stimulative courses. If the first course does not induce ovulation, the
second course should be started with 100 mg a day (2 tablets of 50 mg
taken in a single dose) for 5 days. If ovulation is not induced, 2 more
stimulative courses of the same dose should be given. If the next three
stimulative courses do not produce a successful result, the therapeutic trial
is considered to be finished. If ovulation is induced, but pregnancy does
not occur, maximum 6 courses with Fertil are recommended. However, if
menstrual bleeding does not occur, the patient should be examined
carefully for the possible pregnancy, and the next course of therapy
should be delayed until the correct diagnosis has been determined.

Contraindication
Fertil is contraindicated during pregnancy, in patients with liver disease,
ovarian cysts, bleeding of undetermined origin, and in patients with
neoplasms of endometrium.

Side Effects
Clomiphene Citrate is well tolerated. However a few side effects like
dizziness, headache, nausea, vomiting, depression, fatigue, insomnia,
vasomotor flushing, and allergic reaction may occur. Rarely ovarian
enlargement and cyst formation may occur. All these effects disappear
promptly after the treatment is discontinued.

Precautions
Clomiphene Citrate is not to be used for longer maintenance therapy. If
ovarian enlargement occurs, the next Fertil course is not to be given until
the ovaries return to their pretreatment size and the dosage of the next
course may be reduced. Fertil should be used with caution with alcoholic
drinks and antidepressants. There is a minimal chance of multiple
pregnancies, about which the patient should be warned.

Drug Interactions
There are no significant drug interactions with Clomiphene Citrate.

Use in Pregnancy and Lactation


Fertil should not be administered during pregnancy. It is not known
whether Fertil is excreted in human milk. Because many drugs are

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excreted in human milk, caution should be exercised if Fertil is


administered to a nursing woman. In some patients, Fertil may reduce
lactation.

Pharmaceutical Precaution
Tablets should be stored below 25 oC and protected from light and
moisture.

Commercial Pack
Fertil Tablet : Box containing 50 tablets in blister strip. Each tablet
contains Clomiphene Citrate USP 50 mg.

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Fibril®
Capsule

Description
Fibril containing Gemfibrozil is an antilipemic agent. Gemfibrozil
decreases serum triglycerides in healthy individuals and in patients with
hypertriglyceridemia. It decreases very low density lipoprotein (VLD)-
triglyceride concentration. HDL-triglyceride usually decreases slightly.
Gemfibrozil usually increases the HDL-cholesterol fraction in healthy
individuals and in patients with hyperlipoproteinemia, an action that may
be beneficial in slowing the progression of atherosclerosis and in
reducing the risk of coronary heart disease.

Gemfibrozil also inhibits synthesis of VLDL carrier apolipoprotein B,


leading to a decrease in VLDL production. The drug inhibits lipolysis of
fat in adipose tissue and decreases the hepatic uptake of plasma free fatty
acids, thereby reducing hepatic triglyceride production.

Gemfibrozil is rapidly and completely absorbed from the Gastro-


intestinal tract. Peak concentration in plasma occurs within 1 to 2 hours;
the half-life is about 1.5 hours. About 70% of a dose is excreted in the
urine little is excreted in the faeces.

Indications
Fibril is used as a hypolipidaemic agent in conjunction with dietary
modification. It is recommended in the treatment of type IIa, type III,
type IV, and type V hyperlipoproteinaemia.

Dosage and Administration


The usual dose, by mouth is 1.2g daily in 2 divided doses given 30 minutes
before morning and evening meal. The dosage range may vary between
0.9-1.5g daily or as advised by the physician.

Contraindication
It is contraindicated in case of alcoholism, hepatic impairment, gallstone,
pregnancy and in patients hypersensitive to Gemfibrozil.

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Precaution
Risk benefit must be considered in case of lactating mother. Before
initiating long term treatment lipid profile, blood counts, renal activity,
annual eye examination and liver function test should be done.

Side Effects
The most frequent adverse effect involves the Gastro-intestinal tract.
Abdominal pain and epigastric pain or dyspepsia are common adverse
Gastro-intestinal effects. Other adverse reactions include pruritus, rash,
headache, dizziness, blurred vision, painful extremities and rarely myalgia.

Commercial Pack
Fibril Capsule : Box containing 3x10 capsules in strip pack. Each capsule
contains Gemfibrozil USP 300 mg.

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Filmet®
Tablet/Suspension

Description
Filmet is the brand of Metronidazole in 200, 400 and 800 mg film coated
tablets and lemon flavoured suspension. The special film coating is to
mask the characteristic bitterness of Metronidazole which may
sometimes cause nausea. Filmet has antiprotozoal action and is effective
against Trichomonas vaginalis, Entamoeba histolytica, Giardia intestinalis and
anaerobic bacteria.

Indications
- Urogenital trichomoniasis in the female and male
- Intestinal and extra-intestinal amoebiasis
- Giardiasis
- Anaerobic bacterial infections
- Non-specific vaginitis
- Anaerobically-infected ulcers and pressure sores

Dosage and Administration


Indications Duration Adults and Children Children Children Children
in days over 10 years 7-10 yrs. 3-7 yrs. 1-3 yrs.

Amoebic dysentery 5 to 10 800 mg tid 400 mg tid 200 mg qid 200 mg tid
or 2 2 g once daily

Asymptomatic 5 to 10 400-800 mg tid 200-400 mg tid 100-200 mg qid. 100-200 mg t.i.d


amebiasis

Hepatic and 5 to 10 400-800 mg tid 200-400 mg tid 100-200 mg tid 100-200 mg t.id
extraintestinal or 2 2-2.4 g once daily
amebiasis

Giardiasis 3 2 g once daily 1 g once daily 600 mg once daily 500 mg once daily
100 mg bid 50 mg tid
Trichomoniasis 7 200 mg tid 100 mg t.id
consort treatments or 2 800 mg-morning and
recommended or 1 1.2 g-evening
2 g single dose

Vincent’s infection 3 200 mg tid or 100 mg tid 100 mg tid 50 mg tid


400 mg bid
Anaerobic infection 7 400 mg tid
7.5 mg/kg body weight in divided doses
Non-specific 7 400 mg tid
vaginitis

Leg ulcer and 1 2 g single dose


pressure sore 7 400 mg tid

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Side Effects
Side effects of Metronidazole include gastrointestinal discomfort, nausea,
coated tongue, dryness of mouth and unpleasant metallic or bitter taste,
headache, pruritus and skin rashes and less frequently, vertigo, depression,
insomnia, drowsiness, urethral discomfort, and darkening of the urine.
Occasionally there may be temporary moderate leucopenia. Peripheral
neuropathy has been reported in patients on prolonged therapy.

Precautions
Metronidazole should not be used in patients with blood dyscrasia. It is
suggested that it should not be given in the first three months of
pregnancy. When given in conjunction with alcohol, Metronidazole may
provoke a disulfiram like effect.

Contraindication
Filmet is contraindicated in patients with prior history of hypersensitivity
to Metronidazole or other Nitroimidazole derivatives.

Commercial Pack
Filmet 200 Tablet : 10 blister strips of 10 film coated tablets, each tablet
contains 200 mg Metronidazole BP.

Filmet 400 Tablet : 10 blister strips of 10 film coated tablets, each tablet
contains 400 mg Metronidazole BP.

Filmet DS Tablet : 10 blister strips of 10 film coated tablets, each tablet


contains 800 mg Metronidazole BP.

Filmet Suspension : 60 ml suspension in amber glass bottle, each 5 ml


contains Metronidazole Benzoate BP 320 mg equivalent to 200 mg
Metronidazole.

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Flatameal®-DS
Tablet/Suspension

Description
Flatameal -DS is an antacid and antiflatulent containing a combination of
Aluminium Hydroxide Gel USP, Magnesium Hydroxide BP and
Simethicone USP.

Indications
Flatameal-DS is indicated for dyspepsia, hyperacidity, gastric and
duodenal ulcer, gastritis; also indicated for the relief of flatulence,
abdominal distention and windy colic.

Dosage and Administration


1-2 tablets of Flatameal-DS to be chewed or 1-2 teaspoonful of
Flatameal-DS Suspension to be taken one hour after meals and at bed
time or as directed by the physician.

Precautions
- Drugs containing Aluminium Hydroxide should not be taken
concomitantly with any form of Tetracycline, as the absorption of the
later may be affected.

- Aluminium Hydroxide may also reduce the absorption of Digoxin.

Commercial Pack
Flatameal-DS Tablets : Box containing 20 blister strips of 10 tablets, each
tablet contains 400 mg dried Aluminium Hydroxide Gel USP, 400 mg
Magnesium Hydroxide BP and 30 mg Simethicone USP.

Flatameal-DS Suspension : 200 ml suspension in glass bottle, each 5 ml


contains Aluminium Hydroxide Gel USP equivalent to 200 mg
Aluminium Oxide, 400 mg Magnesium Hydroxide BP and 30 mg
Simethicone USP.

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Flubex ®
Capsule/Syrup

Description
Flubex is a preparation of Flucloxacillin. It acts in similar way to Penicillin
by inhibiting bacterial cell wall synthesis.

Indications
Flubex is indicated for the treatment of infections due to Gram-positive
organisms, including infections caused by β-lactamase producing
staphylococci. Typical indications include:

Respiratory tract infections : Pneumonia, lung abscess, empyema, sinusitis,


pharyngitis, tonsillitis.

Skin and soft tissue infections : Boils, abscesses, carbuncles, furunculosis,


infected skin conditions e.g. ulcer, eczema, acne, cellulitis, infected
wounds, infected burns etc.

Other infections caused by Flucloxacillin-sensitive organisms : Osteomyelitis,


enteritis, endocarditis, urinary tract infection, meningitis, septicaemia.

Flucloxacillin is also indicated for use as a prophylactic agent during major


surgical procedures where appropriate; for example, cardiothoracic and
orthopaedic surgery.

Dosage and Administration


Doses should be administered half an hour before meals.

Adult (including elderly patients) : 250 mg four times daily. Dose may be
increased in severe infections. In osteomyelitis, endocarditis- up to 8 g
daily, in divided doses six to eight hourly.

Children : 2-10 years- half of adult dose; Under 2 years- one fourth of
adult dose.

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Contraindication
Flucloxacillin is contraindicated for those who have hypersensitivity to
penicillins.

Use in Pregnancy and Lactation


Animal studies with Flucloxacillin have shown no teratogenic effects. The
use of Flucloxacillin in pregnancy should be reserved for cases considered
essential by the clinician.

Side Effects
Side effects, as with other penicillins, are uncommon and mainly of mild
and transitory in nature. Gastrointestinal upsets (e.g. nausea, diarrhoea)
and skin rashes have been reported. If a skin rash occurs, treatment
should be discontinued. Hepatitis and cholestatic jaundice have been
rarely reported.

Overdosage
Problems of overdosage with Flucloxacillin are unlikely to occur. In case
of overdosage patient should be treated symptomatically.

Pharmaceutical Precaution
Store in a cool and dry place.
Keep out of the reach of children.

Commercial Pack
Flubex-250 Capsule : Box containing 5 strips of 10 capsules. Each capsule
contains Flucloxacillin Sodium BP equivalent to Flucloxacillin 250 mg.

Flubex-500 Capsule : Box containing 3 strips of 10 capsules, each capsule


contains Flucloxacillin Sodium BP equivalent to Flucloxacillin 500 mg.

Flubex Powder for Syrup : Dry powder in amber glass bottle for
reconstitution into 100 ml syrup. After reconstitution, each 5 ml contains
Flucloxacillin Sodium BP equivalent to Flucloxacillin 125 mg.

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Formula®E
Tablet

Description
Formula-E (Vitamin E) is a crackable tablet with chocolate taste. Each
tablet contains Vitamin E USP (dl-alpha tocopheryl acetate) 200 mg.

Indications
As a dietary supplement and for prophylactic use :
♦ To meet raised requirements (e.g. pregnancy and lactation period, high
dietary intake of polyunsaturated fatty acids, etc).

♦ For prevention of vitamin E deficiency due to malabsorption


syndromes caused by pancreatic, hepatobiliary and gastrointestinal
disorders.

Therapeutic use :
♦ Haemolytic anaemia due to vitamin E deficiency (in premature
infants).
♦ Intermittent claudication.

Also Formula-E has been found to be effective in preventing and


alleviating the symptoms of the following conditions :-

In internal medicine : Thromboangiitis obliterans, varicose ulcers, myocardial


insufficiency, fibrositis, Dupuytren’s contracture, Peyronie’s disease, male
infertility, dyslipoproteinaemia with low HDL cholesterol and high LDL
cholesterol.

In gynaecology and obstetrics : Habitual abortion, tendency to premature


delivery, habitual stillbirth, threatened abortion, menopausal disorders,
pruritus vulvae, kraurosis vulvae.

In dermatology : Lupus erythematosus, granuloma annulare, acrodermatosis,


atrophicans progressiva, scleroderma.

Dosage and Administration


Dosage varies according to individual’s need. The following dosages are
recommended in different indications.

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T H E R A P E U T I C I N D E X

As a supplement or prophylactic use:-


♦ Increased requirements: 100-300 mg daily

♦ Malabsorption syndromes: 100-300 mg daily

♦ Haemolytic anaemia in premature infants: 100-200 mg/kg body weight

♦ Intermittent claudication: 300-600 mg daily.

Other indications and dosages are the following:-


♦ Thromboangiitis obliterans, varicose ulcers, myocardial insufficiency :
300-600 mg daily
♦ Fibrositis, Dupuytren’s contracture, Peyronie’s disease,
dyslipoproteinaemia with low HDL cholesterol and high LDL
cholesterol. : 200-300 mg daily
♦ Male infertility : 100-200 mg daily

♦ Habitual abortion, tendency to premature delivery, habitual stillbirth :


100 mg daily from the beginning of pregnancy as a prophylaxis, with
hormone therapy if required
♦ Threatened abortion : 100 mg every 6 hours until the crisis is over

♦ Menopausal disorders, pruritus vulvae, kraurosis vulvae : 100-200 mg


daily
♦ Lupus erythematosus, granuloma annulare, acrodermatosis, dermatitis
atrophicans diffuse progressiva, scleroderma : 100-300 mg daily.

Side Effects
Vitamin E is very well tolerated. As a rule, daily doses of up to 800 mg
do not induce any adverse reactions. Only a dose approaching 1 g may
give rise to transient gastrointestinal symptoms like nausea, flatulence,
diarrhoea, etc. There have so far been no reports of any changes in
laboratory parameters as a result of vitamin E administration.

Contraindication
There is no absolute contraindication.

Warning and Precautions


Vitamin E may enhance the anticoagulant activity of anticoagulant drugs.

Use in Pregnancy and Lactation


Vitamin E may be used in pregnancy in the normally recommended dose,

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T H E R A P E U T I C I N D E X

but the safety of high-dose therapy has not been established. There
appears to be no contraindication to breast feeding by mothers taking the
normally recommended dose.

Drug Interactions
In animal studies very high doses of vitamin E were shown to limit the
absorption of vitamin A and K.

Overdosage
Vitamin E hypervitaminosis is unknown.

Commercial Pack
Formula-E Tablet : Bottle containing 15 tablets. Each tablet contains
Vitamin E USP (dl-alpha tocopheryl acetate) 200 mg.

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Frelax®
Powder

Description
Frelax (Polyethylene Glycol USP) is a powder for solution and is a
synthetic polyglycol having an average molecular weight of 3350. Below
55°C it is a free flowing white powder freely soluble in water. It is an
osmotic agent for the treatment of constipation.

Indications
Frelax is indicated for the treatment of constipation. This product should
be used for 2 weeks or less or as directed by a physician.

Dosage and Administration


The usual dose of Frelax is 17 g (about 1 heaping tablespoon) of powder
per day (or as directed by physician) in 8 ounces (approximately 240 ml,
one glass) of water, juice, coke, coffee, or tea.

Side Effects
Nausea, abdominal bloating, cramping and flatulence may occur. High
doses may produce diarrhoea and excessive stool frequency, particularly
in elderly patients. Patients taking other medications containing
polyethylene glycol have occasionally developed urticaria suggestive of an
allergic reaction.

Contraindication
Frelax is contraindicated in patients with known or suspected bowel
obstruction and patients known to be allergic to polyethylene glycol.

Precautions
General: Patients presenting with complaints of constipation should have
a thorough medical history and physical examination to detect associated
metabolic, endocrine and neurogenic conditions, and medications. A
diagnostic evaluation should include a structural examination of the
colon. Patients should be educated about good defaecating and eating
habits (such as high fiber diets) and lifestyle changes (adequate dietary

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T H E R A P E U T I C I N D E X

fiber and fluid intake, regular exercise) which may produce more regular
bowel habits.

Polyethylene glycol should be administered after being dissolved in


approximately 8 ounces of water, juice, coke, coffee, or tea.

Pediatric : Safety and effectiveness in pediatric patients has not been


established.

Geriatric : There is no evidence for special considerations when


Polyethylene glycol is administered to elderly patients. In geriatric nursing
home patients a higher incidence of diarrhoea occurred at the
recommended 17 g dose. If diarrhoea occurs Polyethylene glycol should
be discontinued.

Use in Pregnancy and Lactation


Pregnancy Category C : Animal reproductive studies have not been
performed with polyethylene glycol. It is also not known whether Frelax
can cause fetal harm when administered to a pregnant woman, or can
effect reproductive capacity. Frelax should only be administered to a
pregnant woman if clearly needed. There is no information on the use of
polyethylene glycol while nursing. Consultation with a physician is
necessary in case of breast feeding.

Drug Interactions
No specific drug interactions have been demonstrated.

Overdosage
There have been no reports of accidental overdose. In the event of
overdose diarrhoea would be the expected major event. Dehydration may
occurred. Medication should be terminated immediately and plenty of
fluids should be administered.

Information to the Patient


Frelax is a prescription only laxative that has been prescribed by physician
to treat constipation. The person for whom it is prescribed should only
use this product.

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How to take?
The dose of Frelax is 17 g each day or as directed by physician. It should
always be taken by mouth. Measure the dose using the supplied cap, stir
and dissolve in a glass (8 ounces or 240 ml) of water, juice, coke, coffee
or tea. Taking more than the prescribed dose may cause loss of fluid due
to severe diarrhoea. Each bottle is supplied with a measuring cap that is
used to measure 17 g or 8.5 g of laxative powder when filled up to the
indicated line.

How long should it be taken?


Frelax achieves its best results when used between one and two weeks. It
may be discontinued after several satisfactory bowel movements. Should
unusual cramps, bloating or diarrhoea occur, consultation with physician
is needed. Frelax is intended for up to a two-week course of therapy. It
should not be used for a longer time unless directed by a physician.

After successfully completing the Frelax therapy (usually between one and
two weeks) discussion with a physician is needed to change lifestyle that
may produce more regular bowel habits (adequate dietary and fluid intake,
regular exercise).

Commercial Pack
Frelax Powder : Each bottle contains 85 g of Polyethylene Glycol 3350
USP NF powder for solution. The cap on each bottle is marked with a
measuring line and may be used to measure a single dose of 17 g or 8.5 g
of powder for reconstitution into solution. After reconstitution 240 ml
solution contains 17 g of Polyethylene Glycol.

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Frenxit®
Tablet

Description
Frenxit is a preparation of Flupentixol and Melitracen. Flupentixol- is a
neuroleptic with anxiolytic and antidepressant properties when given in
small doses, and Melitracen- a bipolar thymoleptic with activating
properties in low doses. In combination the compound renders a
preparation with antidepressant, anxiolytic and activating properties.

Indications
♦ Anxiety ♦ Depression ♦ Apathy. Others are- Psychogenic depression,
Depressive neuroses, Masked depression, Psychosomatic affections
accompanied by anxiety and apathy, Menopausal depression. Dysphoria
and depression in alcoholics and drug addicts.

Dosage and Administration


Adults: Usually 2 tablets daily (morning and noon). In severe cases the
morning dose may be increased to 2 tablets. Elderly patients: 1 tablet in
the morning. Maintenance dose: Usually 1 tablet in the morning. In cases
of insomnia or severe restlessness additional treatment with a sedative in
the acute phase is recommended. Second dose should not be taken after
4 pm.

Contraindication
The immediate recovery phase after myocardial infarction. Defects in
bundle-branch conduction. Untreated narrow angle glaucoma. Acute
alcohol, barbiturate and opiate intoxication. Flupentixol and Melitracen
should not be given to patients who have received a MAO-inhibitor
within two weeks. Not recommended for excitable patient since its
activating effect may lead to exaggeration of these characteristics.

Precautions
If previously the patient has been treated with tranquilizers with sedative
effects these should be withdrawn gradually.

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Use in Pregnancy and Lactation


Flupentixol and Melitracen should preferably not be given during
pregnancy and lactation.

Side Effects
In the recommended doses side effects are rare. These could be transient
restlessness and insomnia.

Drug Interactions
Flupentixol and Melitracen may enhance the response to alcohol,
barbiturates and other CNS depressants. Simultaneous administration of
MAO-inhibitors may cause hypertensive crisis. Neuroleptics and
thymoleptics reduce the antihypertensive effect of guanethidine and
similar acting compounds and thymoleptics enhance the effects of
adrenaline and noradrenaline.

Overdosage
Symptoms : In cases of overdosage the symptoms of intoxication by
Melitracen, especially of anticholinergic nature, dominate. More rarely
extrapyramidal symptoms due to Flupentixol occur.

Treatment : It should be symptomatic and supportive. Gastric lavage


should be carried out as soon as possible and activated charcoal may be
administered. Measures aimed at supporting the respiratory and
cardiovascular systems should be instituted. Epinephrine (adrenaline)
must not be used for such patients. Convulsions may be treated with
Diazepam and extrapyramidal symptoms with Biperiden.

Commercial Pack
Frenxit Tablet : Box containing 100 tablets in 10 x 10’s blister strips. Each
film coated tablet contains Flupentixol Dihydrochloride BP equivalent to
0.5 mg Flupentixol and Melitracen Hydrochloride INN equivalent to 10
mg Melitracen.

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Fungistin®
Suspension

Description
Fungistin oral suspension is an antifungal antibiotic which is both
fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast
like fungi.

Fungistin oral suspension is banana flavoured, ready to use suspension


containing 100,000 units of Nystatin BP per ml.

Indications
Suspension for the prevention and treatment of candidal infection of the
oral cavity, oesophagus and intestinal tract caused by Candida albicans
(monilia) it provides effective prophylaxis against oral candidiasis in those
born of mothers with vaginal candidiasis.

Dosage and Administration


Adults:
Dosage range: 1-6 ml four times daily.

For the treatment of denture sores, and oral infections, in adults caused
by C. albicans, 1-2 ml of the suspension should be dropped into the mouth
four times daily, it should be kept in contact with the affected area as long
as possible.

Older people with intestinal candidiasis may be given 5 ml of the


suspension four times a day.

Children:
Dosage range: 1-6 ml four times daily in children
1-2 ml four times daily infants

In intestinal and oral candidiasis (thrush) in infants and children, 1-2 ml


should be dropped into the mouth four times a day. The longer the
suspension is kept in contact with the affected area in the mouth before
swallowing, the greater will be its effect.

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For prophylaxis of oral candidiasis in the newborn the suggested dose is


1 ml once daily.

Administration should be continued for 48 hours after clinical cure to


prevent relapse.

Contraindication
There are no known contraindication to the use of Nystatin except
hypersensitivity to the drug.

Precautions
Use in pregnancy: Absorption of Fungistin from the gastrointestinal tract
is negligible, therefore no special precautions apply in pregnancy.

Side Effects
Nausea, vomiting and diarrhoea have occasionally been reported with
doses of Nystatin exceeding 4 to 5 million units daily. No systemic effects
or allergic reactions have been associated with its oral use.

Overdosage
Since the absorption of Nystatin from the gastro-intestinal tract is
negligible, overdosage causes no systemic toxicity.

Pharmaceutical Precaution
Dilution : Not recommended as this may reduce therapeutic efficacy.

Commercial Pack
Fungistin Oral Suspension : 12 ml suspension in amber glass bottle with
graduated dropper, each ml contains 100,000 units of Nystatin BP.

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Furasep®
Cream

Description
Furasep cream is a preparation of 0.2% Nitrofurazone. Nitrofurazone is
a broad spectrum topical antibacterial agent indicated for the treatment of
mixed skin infections of superficial wounds and diseases of the skin.

Indications
Furasep is indicated in the infectious conditions of the skin such as burns,
wounds, ulcers, skin infections and skin grafting.

Dosage and Application


To be applied directly to the lesion or on gauze first; 2-3 times daily or as
advised by the physician.

Side Effects
Sensitization and generalized allergic skin reactions may be produced after
few days of initial application. Cross sensitization to other Nitrofurazone
derivatives may occur. Intolerance to Nitrofurazone necessitating
withdrawal has been encountered.

Contraindication and Warning


Furasep is contraindicated to patients with known sensitivity to
Nitrofurazone. It is not advisable to use Furasep after the infection is
cured. It should be used with caution in patients with known or suspected
renal impairment.

Commercial Pack
Furasep Cream : Tube containing 20 g cream, each gram contains
Nitrofurazone USP 2 mg.

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T H E R A P E U T I C I N D E X

Fusidic Plus ®
Ointment

Description
Fusidic Plus is a topical steroid-antibiotic ointment. It contains Sodium
Fusidate BP 2% and Hydrocortisone Acetate BP 1%.

Indications
Eczema and dermatitis with secondary bacterial infections, including
atopic eczema, primary irritant dermatitis and allergic and seborrhoeic
dermatitis where the organisms are known to be or believed to be
sensitive to Fusidic Acid.

Dosage and Application


Adults and Children :
Uncovered lesions- apply gently 3 to 4 times daily.
Covered lesions - less frequent applications may be adequate.

Contraindication
Contraindicated in patients with hypersensitivity to Fusidic Acid or its
salts. Also contraindicated in cases of primary bacterial, viral and fungal
infections.

Precautions
As with all topical antibiotics, bacterial resistance and contact sensitization
may occur. These risks may increase with extended or recurrent
application. Caution should be exercised when used near the eye. Steroid-
antibiotic combinations should not be used for more than seven days
without clinical improvement since in this situation occult extension of
the infection may occur due to the masking of the steroid. Similarly,
steroids may also mask hypersensitivity reactions. Long-term continuous
use should be avoided in infants, and adrenal suppression can occur.

Use in Pregnancy and Lactation


There is inadequate evidence of safety in pregnancy and nursing mothers.
Use requires benefit to be weighed against possible hazards to the foetus.

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Side Effects
Hypersensitivity reactions in the form of skin rashes and mild stinging
irritation on application have been reported rarely.

Commercial Pack
Fusidic Plus Ointment : It is supplied in aluminium tube of 10 g and 20
g capacity. Each gram of Fusidic Plus ointment contains Sodium Fusidate
BP 20 mg and Hydrocortisone Acetate BP 10 mg.

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Gastalfet®
Tablet

Description
Gastalfet tablet contains 500 mg of Sucralfate (basic aluminium salt of
sucrose octa sulphate).

Indications
For the treatment of duodenal ulcer, gastric ulcer and chronic gastritis.

Dosage and Administration


Adult: Usual dose 1 gram 4 times daily to be taken 1 hour before meals
and at bed time. Maximum daily dose is 8 grams. Four to six weeks
treatment is usually needed for ulcer healing but up to twelve weeks may
be necessary in resistant cases. Antacids may be used as required for relief
of pain, but should not be taken half an hour before or after Gastalfet.

Elderly: There are no special dosage requirements for elderly patients but
as with all medicines the lowest effective dose should be used.

Safety and efficacy in children have not been established.

Contraindication
There are no known contraindication.

Precautions
The product should only be used with caution in patients with renal
dysfunction.

Use in Pregnancy and Lactation


Although animal studies show no evidence of foetal malformation, safety
in pregnant women has not been established and Gastalfet should be used
in pregnancy only if clearly needed.

It is not known whether this drug is excreted in human milk. Caution


should be taken when Sucralfate is administered to nursing mothers.

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T H E R A P E U T I C I N D E X

Drug Interaction
Concomitant use of Sucralfate may reduce the bioavailability of certain
drugs as has been observed in animal studies with Tetracycline, Phenytoin
and Cimetidine and in human studies with Digoxin. Administration of
Gastalfet with any of these drugs should be separated by two hours. Since
Sucralfate may hinder Warfarin absorption, caution should be taken when
these two drugs are used together.

Side Effects
The incidence and severity of side effects from Sucralfate are very low.
Mild side effect like constipation has been reported in some patients.

Overdosage
There is no experience in human with overdosage.

Commercial Pack
Gastalfet Tablet : Box containing 10 blister strips of 10 tablets, each tablet
contains Sucralfate USP 500 mg.

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Gentosep®
Cream

Description
Gentosep is a preparation of Gentamicin Sulphate which is a water
soluble antibiotic of the aminoglycoside group, active against a wide
variety of pathogenic Gram-positive and Gram-negative microorganisms.

Indications
Gentosep cream is indicated for the topical treatment of the primary and
secondary bacterial infections of the skin caused by the organisms
sensitive to Gentamicin. Gentosep may clear infections that have not
responded to other topical antibiotics.

Dosage and Application


A small amount of Gentosep should be applied gently to the affected
areas three to four times daily. The area treated may be covered with a
gauze dressing if desired. Before applying the medication the affected
area should be properly cleaned.

Side Effects
Gentosep cream is well tolerated. There has been no evidence of
irritation and sensitization after using Gentosep cream.

Contraindication
Gentosep is contraindicated in individuals with a history of
hypersensitivity to any of its components.

Precautions
Use of topical antibiotics occasionally cause overgrowth of
nonsusceptible organisms including fungi. If this occurs or if irritation,
sensitisation or super infection develops, treatment with Gentosep should
be discontinued and appropriate therapy should be instituted.

Commercial Pack
Gentosep Cream : Each gram contains Gentamicin Sulphate BP
equivalent to 3 mg Gentamicin base in sealed tubes of 15 grams.

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Hefolin®SR
Capsule

Description
Each Hefolin sustained release capsule contains 150 mg Ferrous Sulphate
BP equivalent to 47 mg Iron and 500 µg of Folic Acid BP. Hefolin SR is
a transparent capsule filled with colourful pellets. The iron is specially
formulated for sustained release over a period of several hours.

Indications
Hefolin SR capsule is a haematinic preparation indicated in the treatment
of iron and folic acid deficiency states. Hefolin SR is used as a prophylaxis
of iron deficiency in pregnancy and after subtotal or total gastrectomy.

Dosage and Administration


As a Prophylaxis
Adult : One capsule daily. In more severe cases, two capsules a day may
be required or as prescribed by the physician. In Elderly patient same as
adult dose. Children aged over 1 year : One capsule a day, the capsule may
be opened and the pellets mixed with soft cool food but they must not be
chewed.

As a Treatment
2 to 4 capsules a day or as prescribed by the physician.

Contraindication
It is contraindicated in patients with hypersensitivity to any of its
components.

Precautions
Caution should be taken in patients with haemochromatosis, haemolytic
anaemia or red cell aplasia as they may cause high blood iron
concentrations. In case of pregnant women and lactating mothers, it is
better to seek the advice of a health professional before using this
product.

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T H E R A P E U T I C I N D E X

Drug Interactions
Iron chelates with Tetracycline. Since oral Iron products interfere with
absorption of oral tetracycline antibiotics, these product should not be
taken within two hours of each other. Occasional gastrointestinal
discomfort may be minimized by taking with meals. Absorption of iron
may be impaired by concurrent administrations of penicillamine and
antacid.

Side Effects
Although Hefolin SR capsule is designed to minimize gastrointestinal side
effects, in some cases anorexia, nausea, abdominal discomfort,
constipation may be encountered.

Overdosage
Gastric lavage should be carried out in the early stages and vomiting may
also be induced if needed. Oral Desferrioxamine (2 g for a child and 5 g
for an adult) should be given. If the patient is in shock or coma
Desferrioxamine should be administered by IV or IM route.

Pharmaceutical Precaution
Keep in a cool and dry place below 25o C and protect from sunlight. Keep
out of reach of children.

Commercial Pack
Hefolin SR Capsule : Box containing 10 x 10’s blister strips. Each capsule
contains 150 mg Ferrous Sulphate BP equivalent to 47 mg Iron and 500
µg Folic Acid BP.

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Inarzin ®
Tablet

Description
Inarzin is a preparation of Cinnarizine which acts as an antihistamine,
labyrinthine sedative and a peripheral antivasoconstrictor. Each tablet
contains Cinnarizine BP 15 mg.

Mode of Action
Inarzin (Cinnarizine) is a selective calcium antagonist, inhibiting the influx
of Ca2+ intracellularly. It prevents the Ca 2+-dependent contraction of
arterial smooth muscle by inhibiting Ca 2+ influx through smooth muscle
calcium channels and thereby, improves vestibular symptoms and
prevents peripheral arterial disease.

Indications
Inarzin is indicated for :
- The control of vestibular symptoms such as vertigo, tinnitus, nausea
and vomiting as seen in Meniere’s disease
- The prophylaxis and control of motion sickness
- The long-term treatment of peripheral arterial disease

Dosage and Administration


The recommended dose for treatment of vestibular symptoms in adults
and children over 12 years is 30 mg (2 tablets) three times daily. For
children from 5 to 12 years half the adult dose is recommended, i.e.
15 mg (1 tablet) three times daily.

For prophylaxis of motion sickness, 30 mg (2 tablets) should be taken 2


hours before travel and then 15 mg (1 tablet) every 8 hours during the
journey. Children from 5 to 12 years, should take half the adult dose.

In the management of peripheral arterial disease, the recommended


starting dose is 75 mg (5 tablets) three times daily. Maintenance dose is 75
mg (5 tablets) two to three times daily depending upon the therapeutic
response. Inarzin should preferably be taken after meals.

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Contraindication
- Known hypersensitivity to Cinnarizine
- Parkinson’s disease
- Hypotension

Side Effects
Drowsiness and gastrointestinal disturbances may occur. These are
usually transient. In rare cases, headache, dry mouth, etc. may occur.

Drug Interaction
Concurrent use of alcohol, CNS depressants or tricyclic antidepressants
may potentiate the sedative effects of either these drugs or of
Cinnarizine. Therefore, it is advisable to avoid these drugs while taking
Cinnarizine.

Use in Special Population


Neonates : Cinnarizine is not indicated in neonates

Pregnant women : The safety of Cinnarizine in human pregnancy has not


been established. Therefore, it is not advisable to administer Cinnarizine
in pregnancy.

Nursing mothers : It is not known if Cinnarizine is excreted in human


breast milk. Use of Cinnarizine during breast-feeding is not advised.

Overdosage
Vomiting, drowsiness, tremor, etc. may occur. There is no specific
antidote to Cinnarizine, but in the event of overdosage, gastric lavage and
the administration of activated charcoal may help.

Pharmaceutical Precaution
Store at room temperature.

Commercial Pack
Inarzin Tablet : Box containing 100 tablets in 10 x 10’s blister strips, each
tablet containing Cinnarizine BP 15 mg.

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Informet ®LA
Tablet

Description
Informet LA (Metformin Hydrochloride) belongs to biguanide class of
oral antidiabetic drugs. It decreases hepatic glucose production, decreases
intestinal absorption of glucose and improves insulin sensitivity. Unlike
sulfonylureas, Metformin does not produce hypoglycaemia. It is the drug
of first choice in obese patients.

Indications
Metformin Hydrochloride, as monotherapy, is indicated as an adjunct to
diet to lower blood glucose in patients with non-insulin-dependent
diabetes mellitus (NIDDM) whose hyperglycaemia cannot be
satisfactorily managed on diet alone. Metformin Hydrochloride may use
concomitantly with a sulfonylurea when diet and Metformin
Hydrochloride or sulfonylureas alone do not result in adequate glycaemic
control.

Dosage and Administration


The usual starting dose of Informet LA (Metformin Hydrochloride long
acting) is 500 mg once daily with the evening meal. Dose increments
should be made 500 mg weekly, up to a maximum of 2000 mg once daily
with the evening meal. If glycaemic control is not achieved on Informet
LA 2000 mg once daily, a trial of Informet LA 1000 mg twice daily should
be considered.

When transferring patients from standard oral hypoglycaemic agents


other than Chlorpropamide to Metformin HCl, no transition period
generally is necessary. When transferring patients from Chlorpropamide,
care should be exercised during the first two weeks because of the
prolonged retention of Chlorpropamide in the body, leading to
overlapping drug effects and possible hypoglycaemia.

Side Effects
Diarrhoea, nausea, vomiting, abdominal bloating, flatulence, and anorexia
are the most common side effects to Metformin Hydrochloride. Lactic
acidosis also rarely occurs.

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Contraindication
Metformin Hydrochloride is contraindicated in patients with renal disease
or renal dysfunction, congestive heart failure, known hypersensitivity,
acute or chronic metabolic acidosis, including diabetic ketoacidosis, with
or without coma.

Precautions
Metformin Hydrochloride therapy should be temporarily suspended for
any surgical procedure (except minor procedures not associated with
restricted intake of food and fluids) and should not be restarted until the
patient’s oral intake has resumed and renal function has been evaluated as
normal. It should be used with caution in case of excessive alcohol intake
and hepatic insufficiency. It should be temporarily discontinued in
patients undergoing radiologic studies involving intravascular
administration of iodinated contrast materials, because use of such
products may result in acute alteration of renal function.

Use in Special Population


Pregnancy : Safety in pregnant women has not been established. Any
decision to use this drug should be balanced against the benefits and risks.

Nursing Mothers : It is not known whether Metformin Hydrochloride is


secreted in human milk.

Paediatric and Geriatric use : Safety and effectiveness in paediatric


patients have not been established. Dosage adjustment should be based
on a careful assessment of renal function in elderly patients.

Drug Interactions
Nifedipine : Nifedipine appears to enhance the absorption of Metformin.
Metformin has minimal effects on Nifedipine.

Others : Certain drugs tend to produce hyperglycaemia and may lead to


loss of glycaemic control. These drugs include thiazide and other
diuretics, corticosteroids, phenothiazines, oestrogens, oral contraceptives,
Phenytoin, Nicotinic acid, sympathomimetics, calcium channel blocking
drugs, and Isoniazid. When such drugs are administered to a patient
receiving Metformin HCl, the patient should be closely observed to
maintain adequate glycaemic control.

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Overdosage
Hypoglycaemia has not been seen even with ingestion of up to 85 grams
of Metformin HCl, although lactic acidosis has occurred in such
circumstances. Haemodialysis may be useful for removal of accumulated
drug from patients in whom Metformin overdosage is suspected.

Pharmaceutical Precaution
Store at 15 0-25 0 C. Keep in a cool and dry place. Keep out of the reach
of children.

Commercial Pack
Informet LA Tablet : Box containing 100 tablets in 10 x 10’s blister strips.
Each long acting tablet contains Metformin Hydrochloride BP 500 mg.

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T H E R A P E U T I C I N D E X

Intracef®
Capsule/Suspension/Paediatric Drops

Description
Intracef (Cephradine) is a semisynthetic first generation cephalosporin
antibiotic that works in a similar way to penicillin by inhibiting bacterial
cell wall synthesis. The chemical name of Cephradine is [6R-[6 α,
7 β (R*)]]7-[(Amino- 1,4-cyclohexadien-l-yl)-acetyl) amino-3-methyl-8-
oxo-5-thia-1-azabicyclo[4.2.0]-oct-2 -ene-2-carboxylic acid.

Indications
Intracef is a broad spectrum bactericidal antibiotic active against both
Gram-positive and Gram-negative bacteria. It is also highly active against
most strains of penicillinase-producing staphylococci.

Intracef is indicated for the treatment of the following infections when


caused by susceptible organisms.

♦ The upper and lower respiratory tract infections - pharyngitis, sinusitis,


otitis media, tonsillitis, laryngo-tracheo-bronchitis, acute and chronic
bronchitis, lobar pneumonia

♦ Gastrointestinal tract infections

♦ Urinary tract infections- cystitis, urethritis, pyelonephritis

♦ Skin and soft tissue infections- abscess, cellulitis, furunculosis and


impetigo

♦ Prophylaxis for surgical procedures associated with high risk of


disastrous consequences of infection.

Intracef is also of value where postoperative infections would be


disastrous and where patients have a reduced host resistance to bacterial
infection. Protection is best ensured by achieving adequate local tissue
concentrations at the time of contamination is likely to occur. Thus,
Intracef should be administered immediately prior to surgery and
continued during the postoperative period.

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T H E R A P E U T I C I N D E X

Dosage and Administration


Intracef may be given regardless of meals.

Adults : For urinary tract infections the usual dose is 500 mg four times
daily or 1 g twice daily; severe or chronic infections may require larger
dose. Prolonged intensive therapy is needed for complications such as
prostatitis and epididymitis. For respiratory tract infections and skin and
soft tissue infections the usual dose is 250 mg or 500 mg four times daily
or 500 mg or 1g twice daily depending on the severity and site of
infection.

Children : The usual dose is from 25 to 50 mg/kg/day total, given in two


or four equally divided doses.

For otitis media daily dose from 75 to 100 mg/kg body weight in divided
doses every 6 to 12 hours are recommended. Maximum dose is 4 g per
day.

Elderly : There are no specific dosage recommendations or precautions


for use in the elderly except as with other drugs to monitor those patients
with impaired renal or hepatic function.

Dosage in renal impairment : A modified dosage schedule is necessary in


patients with decreased renal function. Each patient should be considered
individually; the following modified dosage schedule is recommended as
a guideline, based on the creatinine clearance (ml/min/1.73m2 ). In adults,
the initial loading dose is 750 mg of Intracef and the maintenance dose
is 500 mg at the time intervals listed below :

Creatinine clearance Time interval

More than 20 ml/min 6-12 hours


15-19 ml/min 12-24 hours
10-14 ml/min 24-40 hours
5-9 ml/min 40-50 hours
Less than 5 ml/min 50-70 hours

Further modification of the dosage schedule may be necessary in children.

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T H E R A P E U T I C I N D E X

Side Effects
Rarely Cephradine may induce a hypersensitivity reaction and gastro-
intestinal disturbances which include nausea, vomiting, diarrhoea,
glossitis, heartburn, dizziness, abdominal pain, candidal overgrowth,
vaginitis, urticaria, skin rashes, joint pain and oedema. As with other
cephalosporins, mild transient eosinophilia, leucopenia and neutropenia,
rarely positive direct Coombs’ test and pseudomembraneous colitis have
been reported.

Drug Interactions
The cephalosporins are potentially nephrotoxic (particularly
Cephaloridine) and may enhance the nephrotoxicity of aminoglycoside
antibiotics such as Gentamicin and Tobramycin. One should be cautious
about the use of any cephalosporin with Frusemide and Ethacrynic Acid.
Use in Pregnancy and Lactation
No teratogenicity has been demonstrated in animals, but safety in
pregnancy has not been established. Cephradine is excreted in breast milk
and should be used with caution in lactating mothers.

Contraindication
Patients with known hypersensitivity to cephalosporin antibiotics.
Warning and Precautions
There is evidence of partial cross-allergenicity between penicillins and the
cephalosporins. Therefore Cephradine should be used with caution in
patients with known hypersensitivity to penicillins.

Commercial Pack
Intracef 250 Capsule : Box containing 5 x 10’s blister strips. Each capsule
contains Cephradine BP 250 mg.

Intracef 500 Capsule : Box containing 4 x 10’s blister strips. Each capsule
contains Cephradine BP 500 mg.
Intracef Suspension : Each amber glass bottle contains dry powder for
100 ml suspension. After reconstitution each 5 ml contains Cephradine
BP 125 mg.

Intracef Paediatric Drops : Each amber glass bottle contains dry powder
for 15 ml paediatric drops. After reconstitution each 1.25 ml contains
Cephradine BP 125 mg.

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Intracef®
Injection

Description
Intracef (Cephradine) is a semisynthetic first generation cephalosporin
antibiotic that works in a similar way to penicillin by inhibiting bacterial
cell wall synthesis. The chemical name of Cephradine is [6R-[6 α,
7 β (R*)]]7-[(Amino- 1,4-cyclohexadien-l-yl)-acetyl) amino-3-methyl-8-
oxo-5-thia-1-azabicyclo[4.2.0]-oct-2 -ene-2-carboxylic acid.

Indications
Intracef is indicated for use primarily in the treatment of infections of
the respiratory tract, genitourinary tract, soft tissue and skin, blood
stream, and bones, caused by susceptible organisms as listed below:

Staphylococcus aureus (penicillin sensitive and penicillinase producing


strains); Group-A Beta-haemolytic streptococci; Pneumococci;
Haemophilus influenzae; Escherichia coli and other coliform bacteria;
Klebsiella species; Proteus mirabilis.

Intracef is also effective in cases of peritonitis.

Bacteriology studies to determine the causative organisms and their


sensitivity to Cephradine should be performed. Therapy may be instituted
prior to receiving the results of the sensitivity test.

Intracef is effective prophylactically, to avoid infections due to susceptible


organisms in patients about to undergo ceasarian section or vaginal
hysterectomy.

Intracef is primarily indicated for those patients unable to tolerate oral


medication. It is also indicated for intravenous use either by direct
intravenous injection or by intravenous infusion for the treatment of
serious and life threatening infections.

Intracef is also of value where postoperative infections would be


disastrous and where patients have a reduced host resistance to bacterial
infection. Thus, Intracef should be administered immediately prior to
surgery and continued during the postoperative period.

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T H E R A P E U T I C I N D E X

Dosage and Administration


Adults: The usual dose of Intracef for injection is 2 to 4 g daily in four
equally divided doses intramuscularly or intravenously (e.g. 500 mg to 1 g
four times daily). A dosage of 500 mg four times a day is adequate in
uncomplicated pneumonia, furunculosis with cellulitis, and most urinary
tract infections. In severe infections, the dose may be increased by giving
injections every four hours or by increasing the dose.

The maximum dose should not exceed 8 g per day.

The recommended dose for surgical prophylaxis is either a single 2 g dose


given 1 hour before surgery or a regimen of 1 g given one hour before
surgery followed by a second dose 4 hours later. Additional doses of 1 g
may be given every 4 hours until vital signs are stabilized.

Infants and Children: The usual dose range is 50 to 100 mg/kg/day in


equally divided doses four times a day and should be regulated by age,
mass of the patient, and severity of the infection being treated.

Elderly : There are no specific dosage recommendations or precautions


for use in the elderly except as with other drugs to monitor those patients
with impaired renal or hepatic function.

Dosage in renal impairment : A modified dosage schedule is necessary in


patients with decreased renal function. Each patient should be considered
individually; the following modified dosage schedule is recommended as
a guideline, based on the creatinine clearance (ml/min/1.73m2 ). In adults,
the initial loading dose is 750 mg of Intracef (Cephradine) and the
maintenance dose is 500 mg at the time intervals listed below :

Creatinine clearance Dose Time interval

More than 20 ml/min 500 mg 6 hours


5-20 ml/min 250 mg 6 hours
Less than 5 ml/min 250 mg 12 hours

Further modification of the dosage schedule may be necessary in children

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T H E R A P E U T I C I N D E X

Side Effects
Rarely Cephradine may induce a hypersensitivity reaction and gastro-
intestinal disturbances which include nausea, vomiting,
diarrhoea,glossitis, heartburn, dizziness, abdominal pain, candidal
overgrowth, vaginitis, urticaria, skin rashes, joint pain and oedema. As
with other cephalosporins, mild transient eosinophilia, leucopenia and
neutropenia, rarely positive direct Coombs test and pseudomembraneous
colitis have been reported.

Drug Interactions
The cephalosporins are potentially nephrotoxic (particularly
cephaloridine) and may enhance the nephrotoxicity of aminoglycoside
antibiotics such as gentamicin and tobramycin. One should be cautious
about the use of any cephalosporin with frusemide and ethacrynic acid.
Use in pregnancy and lactation

No teratogenicity has been demonstrated in animals, but safety in


pregnancy has not been established. Cephradine is excreted in breast milk
and should be used with caution in lactating mothers.

Contraindication
Patients with known hypersensitivity to cephalosporin antibiotics.

Warning and Precautions


There is evidence of partial cross-allergenicity between penicillins and the
cephalosporins. Therefore Cephradine should be used with caution in
patients with known hypersensitivity to penicillins.

Commercial Pack
Intracef 250 Injection: Each box contains 10 combipacks. Each
combipack contains 1 vial of Cephradine with Arginine equivalent to
Cephradine USP 250 mg and 1 ampoule of 5 ml Water for Injection BP.

Intracef 500 Injection: Each box contains 10 combipacks. Each


combipack contains 1 vial of Cephradine with Arginine equivalent to
Cephradine USP 500 mg and 1 ampoule of 5 ml Water for Injection BP.

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Ipramid ®
Inhaler

Description
Ipratropium Bromide BP, the active ingredient in Ipramid Inhaler, is an
anticholinergic (parasympatholytic) agent that appears to inhibit vagally-
mediated reflexes by antagonizing the action of acetylcholine, the
transmitter agent released from the vagus nerve.

Anticholinergics prevent the increases in intracellular concentration of


cyclic guanosine monophosphate (cyclic GMP) that are caused by
interaction of acetylcholine with the muscarinic receptor on bronchial
smooth muscle.

The bronchodilation following inhalation of Ipratropium Bromide is


primarily a local, site-specific effect and not a systemic one.

Indications
Ipratropium Bromide inhaler administered either alone or with other
bronchodilators, especially beta adrenergics, is indicated as a
bronchodilator for maintenance treatment of bronchospasm associated
with chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and emphysema.

Dosage and Administration


Adults : 20-40 µg, in early treatment up to 80 µg at a time, 3-4 times daily.

Children : up to 6 years 20 µg 3 times daily, 6-12 years 20-40 µg 3 times


daily.

Contraindication
Ipratropium Bromide inhalation aerosol is contraindicated in patients
with a history of hypersensitivity to soya lecithin or related food products
such as soya bean and peanut.

Ipratropium Bromide is contraindicated in known or suspected cases of


hypersensitivity to Ipratropium Bromide, or to atropine and its
derivatives.

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Precautions
Ipratropium Bromide should be used with caution in patients with
narrow-angle glaucoma, prostatic hypertrophy or bladder-neck
obstruction.

Use in Pregnancy and Lactation


Pregnancy Category B : Because animal reproduction studies are not
always predictive of human response, Ipratropium Bromide should be
used during pregnancy only if clearly needed.

Nursing Mothers : It is not known whether Ipratropium Bromide is


excreted in human milk. Although lipid-insoluble quaternary bases pass
into breast milk, it is unlikely that Ipratropium Bromide would reach the
infant to a significant extent, especially when taken by inhalation since
Ipratropium Bromide is not well absorbed systematically after inhalation
or oral administration. However, because many drugs are excreted in
human milk, caution should be exercised when Ipratropium Bromide is
administered to a nursing woman.

Pediatric Use : Safety and effectiveness in children below the age of 12


have not been established.

Side Effects
General : Headache, pain, influenza-like symptoms, back pain, chest pain;
Cardiovascular : Hypertension may be aggravated; Central and Peripheral
Nervous System: Dizziness, insomnia, tremor, nervousness;
Gastrointestinal : Mouth dryness, nausea, constipation; Musculo-skeletal
System : Arthritis; Respiratory System (Upper) : pharyngitis, rhinitis,
sinusitis; Respiratory System (Lower) : Coughing, dyspnoea, bronchitis,
bronchospasm.

Additional adverse reactions reported in less than three percent of the


patients treated with Ipratropium Bromide include tachycardia,
palpitations, eye pain, urinary retention, urinary tract infection and
urticaria. A single case of anaphylaxis thought to be possibly related to
Ipratropium Bromide has been reported. Cases of precipitation or
worsening of narrow-angle glaucoma and acute eye pain have been
reported.

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Lower respiratory adverse reactions (bronchitis, dyspnoea and


bronchospasm) were the most common events leading to discontinuation
of Ipratropium Bromide therapy in the 12-week trials. Headache, mouth
dryness and aggravation of COPD symptoms are more common when
the total daily dose of Ipratropium Bromide equals or exceeds 2,000 µg.

Pharmaceutical Precaution
Pressurized canister, do not puncture, break or incinerate even when
apparently empty. Avoid storage in direct sunlight or heat. Store below 30 0
C. Keep away from eyes. Keep away from children.

Commercial Pack
Ipramid Inhaler : Each canister contains 200 metered doses, each
containing 20 µg Ipratropium Bromide BP.

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Isofloxin®
Tablet

Description
Isofloxin is a film coated tablet. Each tablet contains Pefloxacin Mesilate
BP equivalent to 400 mg Pefloxacin.

Indications
Isofloxin is indicated for the treatment of single or mixed infections
caused by two or more susceptible organisms. It can also be used for
infections caused by organisms resistant to other antibiotics including
aminoglycoside, penicillin and cephalosporin.

Isofloxin is indicated for the treatment of the following infections caused


by sensitive bacteria-

Severe systemic infection : Septicaemia, bacteraemia, peritonitis, infections in


immunosuppressed patients with haematological or solid tumors and in
patients in intensive care unit with specific problems such as infected
burns.

Urinary tract infection : Uncomplicated and complicated urethritis, cystitis,


pyelonephritis, prostatitis, epididymitis.

Respiratory tract infection : Lobar and bronchopneumonia, acute and


chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis,
empyema.

Gastrointestinal infection : Enteric fever, infective diarrhoea.

Infections of the biliary system : Cholangitis, cholecystitis, empyema of the gall


bladder.

Skin and soft tissue infection : Infected ulcers, wound infections, abscesses,
cellulitis, otitis externa, erysipelas, infected burns.

Eye, ear, nose and throat infection : Otitis media, sinusitis, mastoiditis,
tonsillitis.

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Intra abdominal infection : Peritonitis, intra abdominal abscesses.

Bone and joint infection : Osteomyelitis, septic arthritis.

Pelvic infection : Salpingitis, endometritis, pelvic inflammatory diseases.

Gonorrhoea : Including urethral, rectal and pharyngeal gonorrhoea caused


by β-lactamase producing organisms or organisms moderately sensitive to
penicillin.

Dosage and Administration


The usual dose is 400 mg twice daily (morning and evening) by mouth in
most infections. Dosage should be adjusted for adults with hepatic
insufficiency. Patients should take the drug with meals to avoid
gastrointestinal disturbances.

Contraindication
Pefloxacin is contraindicated in patients who have shown hypersensitivity
to Pefloxacin or other quinolones. Pefloxacin is also contraindicated in
children and growing adolescents except where the benefits of treatment
exceed the risks, in pregnant women, nursing mothers and in patients with
glucose-6-phosphate dehydrogenase deficiency.

Side Effects
Gastrointestinal disturbances e.g. nausea, diarrhoea, vomiting, dyspepsia,
abdominal pain. Disturbance of the central nervous system (CNS) e.g.
dizziness, headache, tiredness, confusion, convulsions. Hypersensitivity
reactions e.g. skin rashes, pruritus. The other reactions have also been
reported are joint pain, mild photosensitivity and thrombocytopenia (at
doses of 1600 mg daily).

Drug Interactions
Antacids may interfere with absorption of Pefloxacin resulting in serum
and urine levels lower than desired, so concurrent administration of these
agents with Pefloxacin should be avoided.

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Precautions
Avoid exposure to sunlight and ultraviolet radiation during treatment with
Pefloxacin because of the risk of photosensitivity reactions. Dosage
readjustment is required in severe hepatic insufficiency.

Commercial Pack
Isofloxin Tablet : Box containing 5 aluminium strips of 10 film coated
tablets. Each tablet contains Pefloxacin Mesilate BP equivalent to
Pefloxacin 400 mg.

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Keolax®
Tablet

Description
Keolax contains Clobazam, an active ingredient which is a
benzodiazepine derivative with actions and uses similar to those of
Diazepam. Each tablet contains Clobazam BP 10 mg.

Indications
Keolax is indicated for the relief of acute or chronic anxiety, tension and
agitation. Physical symptoms associated with an underlying anxiety state,
phobias and psychosomatic disorders may all respond to treatment with
Clobazam. Keolax may be used together with antidepressants in the
treatment of anxiety associated with depression. Keolax has also been
shown to have a beneficial effect in the treatment of sleep disturbances
associated with anxiety and may be used as adjunctive therapy in epilepsy.

Dosage and Administration


The usual anxiolytic dose for adult is 20-30 mg daily in divided doses or
as a single dose given at night. Doses of up to 60 mg daily have been used
in the treatment of adult in patients with severe anxiety.

Elderly : Doses of 20 mg daily may be used in the elderly patients with


anxiety.

Children : In children aged 3 years or over, doses should not exceed half
the recommended adult dose. There is insufficient experience of the use
of Clobazam under three years of age to enable any doses
recommendation to be made.

Contraindication
Clobazam should not be used in patients known to be hypersensitive to
benzodiazepines.

Precautions
Clobazam is a benzodiazepine derivative and in common with other
members of this group, may potentiate the effect of central nervous

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system depressant drugs such as alcohol, analgesics, hypnotic and


neuroleptics.

Addition of Clobazam to anticonvulsant medication may cause a change


in plasma levels of these drugs. The ability to drive or operate machinery
may be impaired in individuals who are particularly sensitive to the effects
of Clobazam or in patients taking high doses of the drug. Clobazam
should be used in reduced doses in patients with impaired renal or hepatic
function.

Use in Pregnancy and Lactation


There is a little information on the use of Clobazam in early pregnancy
but no untoward effects have been found in animal studies. However,
there are reports of a possible malformations in infants due to the
administration of other benzodiazepines in early pregnancy.

Clobazam has been detected in the breast milk of nursing mothers, but
the effect on the neonate is not known.

Overdosage
Muscle weakness, ataxia, drowsiness and sedation may occur after
ingestion of very high doses, the patient may lose consciousness. The
treatment of overdosage is symptomatic, stomach should be emptied as
soon as possible by gastric lavage and general supportive measures should
be undertaken as necessary.

Side Effects
Keolax is generally well tolerated. Side effects such as drowsiness or
dryness of mouth have been reported. These are more likely to occur at
the beginning of treatment or a reduction in dose.

Pharmaceutical Precaution
Keolax should be stored in a cool and dry place.

Commercial Pack
Keolax Tablet : Box containing 100 tablets in 10 x 10’s blister strips. Each
tablet contains Clobazam BP 10 mg.

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Lactameal®
Tablet/Suspension

Description
Lactameal is an antacid containing a combination of Aluminium
Hydroxide Gel USP and Magnesium Hydroxide BP.

Indications
Hyperacidity, gastric and duodenal ulcer, gastritis.

Dosage and Administration


2 Lactameal tablets or 2 teaspoonful of Lactameal suspension one hour
after meals and at bed time or as directed by the physician.

Commercial Pack
Lactameal Tablet : Box containing 20 blister strips of 10 tablets, each
tablet contains 250 mg Dried Aluminium Hydroxide Gel USP and 400 mg
Magnesium Hydroxide BP.

Lactameal Suspension : 200 ml suspension in glass bottle, each 5 ml


contains Aluminium Hydroxide Gel USP equivalent to 175 mg
Aluminium Oxide and 225 mg Magnesium Hydroxide BP.

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Larnox® LA
Tablet

Description
Larnox LA (Aminophylline) is a stable mixture or combination of
Theophylline and Ethylenediamine. Ethylenediamine confers greater
solubility in water.

Indications
It is indicated for the treatment and prophylaxis of bronchospasm
associated with asthma, emphysema and chronic bronchitis. Also
indicated in adults for the treatment of cardiac asthma and left ventricular
or congestive cardiac failure.

Dosage and Administration


Larnox LA tablet possess a slow release mechanism, in which
Aminophylline is released to give an effective therapeutic blood levels,
lasting up to 12 hours. The recommended initial dose is 1 tablet (350 mg
Aminophylline) every 12 hours. The dosage may be gradually increased to
a maximum of 2 tablets (700 mg Aminophylline) twice a day depending
on the patient’s response.

Note: Tablets should be swallowed whole and not chewed because of the
structure of the tablet.

Contraindication
Aminophylline should not be administered to patients with
hypersensitivity to xanthines or ethylenediamine. It should not be
administered to patients with active peptic ulcer, since it may increase the
volume and acidity of gastric secretions.

Side Effects
The most common adverse effects are gastric irritation, nausea, vomiting,
epigastric pain and tremor. These are usually early signs of toxicity;
however, with high doses, ventricular arrhythmias or seizures may be the
first signs to appear. Adverse reactions include: Gastrointestinal- nausea,
vomiting, epigastric pain, haematemesis, diarrhoea, anorexia, intestinal

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bleeding and reactivation of peptic ulcer. Central Nervous System- headache,


irritability, restlessness, insomnia, twitching, convulsion and reflex
hyperexcitability. Cardiovascular- palpitation, tachycardia, hypotension,
circulatory failure, ventricular arrhythmias, and flushing. Renal-
albuminuria, diuresis and haematuria. Others- hyperglycaemia, tachypnoea
and inappropriate ADH syndrome.

Precautions
Aminophylline should be given with caution to patients with peptic
ulceration, hyperthyroidism, hypertension, cardiac arrhythmias or other
cardiovascular disease, or epilepsy, as these conditions may be
exacerbated. They should also be given with caution to patients with heart
failure, hepatic dysfunction, chronic alcoholism, acute febrile illness,
neonates and the elderly.

Use in Pregnancy and Lactation


Theophylline crosses the placental barrier and also passes freely into
breast milk, where concentrations are similar to plasma levels. Safe use in
pregnancy has not been established. Therefore, use of Aminophylline in
pregnant women should be balanced against the risk.

Drug Interactions
β-blockers (e.g., Propranolol) may oppose the effects of Aminophylline.
barbiturates, Phenytoin and smoking may decrease Theophylline levels in
blood or circulation.

Overdosage
Toxic effects of overdosage are frequent vomiting, anorexia, unusual
thirst, maniacal agitation leading in the most severe cases to convulsions,
shock and death. After Aminophylline overdosage by mouth the stomach
may be emptied by lavage if within 2 hours of the overdose. Elimination
may be enhanced by repeated oral doses of activated charcoal regardless
of the route of Theophylline overdose. An osmotic laxative may also be
considered, especially if modified-release preparations have been taken.
Treatment should be symptomatic and supportive. Serum Theophylline
concentrations should be monitored, and if modified release preparations
have been taken monitoring should be prolonged.

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Pharmaceutical Precaution
Store at 25o C. Keep in a cool and dry place, away from direct sunlight.
Keep out of the reach of children.

Commercial Pack
Larnox LA Tablet : Box containing 50 tablets in 5 x10’s blister strips; each
tablet contains Aminophylline BP 350 mg.

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Lucidol®
Capsule

Description
Lucidol (Tramadol Hydrochloride) is a centrally acting analgesic.
Tramadol is a synthetic analog of codeine. However, Tramadol has a
lower affinity for opioid receptor than codeine. It is less potential for
abuse or respiratory depression than other opiate agonist, but both may
occur.

Indications
Lucidol is indicated for the management of moderate to severe pain.

Dosages and Administration


For the treatment of painful conditions, Lucidol 50 mg to 100 mg can be
administered as needed for relief every four to six hours, not to exceed
400 mg per day. For moderate pain, Lucidol 50 mg may be adequate as the
initial dose, and for more severe pain, Lucidol 100 mg is usually more
effective as the initial dose.

Contraindication
Lucidol should not be administered to patients who have previously
demonstrated hypersensitivity to tramadol, any other component of this
product, or opioids. It is also contraindicated in cases of acute
intoxication with alcohol, hypnotic, centrally acting analgesics, opioids or
psychotropic drugs.

Side Effects
Most common side effects (Incidence 1% to less than 5% in clinical trails)
are malaise, vasodilatation, anxiety, confusion, coordination disturbance,
euphoria, nervousness, sleep disorder, abdominal pain, anorexia,
flatulence, hypertonia, skin rash, visual disturbance, urinary retention,
urinary frequency, and menopausal symptoms.

Other infrequently reported side effects are abnormal ECG,


hypertension, myocardial ischaemia, palpitations, migraine,
gastrointestinal bleeding etc.

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Precautions
Lucidol should be administered cautiously in patients at risk for
respiratory depression. When large doses of Lucidol are administered
with anesthetic medications or alcohol, respiratory depression may result.
Lucidol should be used with caution in patients with increased intracranial
pressure or head injury. Pupillary changes (miosis) from Tramadol may
obscure the existence, extent, or course of intracranial pathology.

Lucidol is not recommended for patients who are dependent on opioids.


Patients who have recently taken substantial amounts of opioids may
experience withdrawal symptoms.

Impaired renal function results in a decreased rate and extent of excretion


of Tramadol and its active metabolite. In patients with creatinine
clearances of less than 30 ml/min, dosing reduction is recommended

Overdosage
Serious potential consequences of overdosage are respiratory depression
and seizure. In treating an overdose, primary attention should be given to
maintaining adequate ventilation along with general supportive treatment.
Haemodialysis is not expected to be helpful in an overdose because it
removes less than 7% of the administered dose in a 4-hour dialysis
period.

Use in Pregnancy and Lactation


Tramadol should not be used in pregnant women prior to or during labor
unless the potential benefits outweigh the risks. Safe use in pregnancy has
not been established. Chronic use during pregnancy may lead to physical
dependence and post-partum withdrawal symptoms in the newborn.

Tramadol is not recommended for obstetrical preoperative medication or


for post-delivery analgesia in nursing mothers because its safety in infants
and newborns has not been studied.

Paediatric Use
The paediatric use of Tramadol is not recommended because safety and
efficacy in patients under 16 years age have not been established.

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Commercial Pack
Lucidol Capsule : Box containing 3 x 10’s capsules in blister strips. Each
capsule contains Tramadol Hydrochloride BP 50 mg.

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Megadox®
Capsule

Description
Megadox contains Doxycycline Hydrochloride BP. Doxycycline
Hydrochloride is a semisynthetic tetracycline antibiotic with broad
spectrum activity. It is primarily a bacteriostatic antibiotic. It has a similar
spectrum of activity to other tetracyclines but in particular is more active
against Staphylococcus aureus and Nocardia. The drug is often active against
penicillin-resistant strains of Staphylococcus aureus and against strains of
those organisms that are resistant to other Tetracyclines.

Certain gram-negative strains of E. coli, Proteus mirabilis and Klebsiella,


which are often resistant to Tetracycline, may be sensitive to Doxycycline.
In addition, 70-90% of the various anaerobes are sensitive to Doxycycline
and Bacteroides fragilis is more likely to be sensitive to Doxycycline than to
other tetracyclines.

Doxycycline is active against most strains of Haemophilus influenzae and is


particularly useful for infections with H. ducreyi, Actinomyces, Brucella
and Vibrio cholerae. It is also active against Nocardia, Chlamydia,
Mycoplasma and a wide range of Rickettsiae. Doxycycline is active against
spirochetes such as Borellia recurrentis, Treponema pallidum and Treponema
pertenue. It is also active against Plasmodium falciparum.

Indications
Megadox is indicated in the following infections caused by susceptible
microorganisms:

♦ Pneumonia and other respiratory tract infections caused by Klebsiella,


Pneumococci and Mycoplasma pneumoniae
♦ Gastrointestinal infections
♦ Genitourinary tract infections
♦ Soft tissue infections
♦ Ophthalmic infections (trachoma) caused by Chlamydia trachomatis
♦ Acne

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♦ Prophylaxis of Plasmodium falciparum malaria


♦ Miscellaneous group of infections : Prostatitis, Psittacosis, Trigonitis,
Louse borne typhus, Plague etc.

Dosage and Administration


Adults : Usual dose is 200 mg on first day, then 100 mg daily for 7-10 days.
Severe infections (including refractory urinary tract infections) 200 mg
daily for 10 days. Acne : 100 mg daily. Uncomplicated genital chlamydia,
non-gonococcal urethritis : 100 mg twice daily for 7-21 days (14-21 days
in pelvic inflammatory disease).

Contraindication
Doxycycline Hydrochloride is contraindicated in pregnancy, nursing
mother, children under 12 years of age and in patients with known
hypersensitivity to any of the Tetracyclines.

Side Effects
Since Megadox is virtually completely absorbed, side effects of the lower
bowel particularly diarrhoea have been infrequent. Gastrointestinal
effects e.g., anorexia, nausea, diarrhoea, vomiting, glossitis, dysphagia,
enterocolitis and anogenital inflammatory lesions have been reported
occasionally. Hypersensitivity reactions e.g., urticaria, angioneurotic
oedema, anaphylactic purpura, pericarditis and exacerbation of systemic
lupus erythematosus may occur. Haemolytic anaemia, thrombocytopenia,
neutropenia and eosinophilia have also been reported. On rare occasions,
anaphylaxis may occur. In case of overdose, discontinue medication, treat
symptomatically and institute supportive measures.

Pharmaceutical Precaution
Store in a cool and dry place. Keep out of the reach of children.

High Risk Groups


Neonates and children : Tetracycline may cause permanent discoloration
of the teeth and so is contraindicated for neonates and children under 12
years.

Nursing Mother : Tetracyclines enter breast milk, and mothers taking


these drugs should not breastfeed their child.

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Pregnant women : Tetracycline should be avoided in pregnant women,


because of the risk of both staining and effect on bone growth in the
foetus.

Elderly : No special precautions are necessary in the elderly.

Commercial Pack
Megadox Capsule : Box containing 10 blister strips of 10 capsules, each
capsule contains Doxycycline Hydrochloride BP equivalent to 100 mg
Doxycycline.

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Megatrim®DS
Tablet
Megatrim®
Suspension

Description
Megatrim is a broad spectrum antibacterial drug containing
Trimethoprim BP and Sulfamethoxazole BP in a 1:5 fixed combination.

Each Megatrim DS tablet contains 160 mg Trimethoprim BP and 800 mg


Sulfamethoxazole BP.

Each 5 ml of Megatrim Suspension contains 40 mg Trimethoprim BP


and 200 mg Sulfamethoxazole BP.

Indications
Megatrim is bactericidal in vitro to a wide range of Gram-positive and
Gram-negative organisms, including Streptococcus, Staphylococcus,
Pneumococcus, Neisseria, B. catarrhalis, Escherichia coli, Klebsiella, Proteus
spp., Haemophilus, Salmonella, Shigella, Vibrio cholerae, Brucella,
Pneumocystis carinii, Nocardia and Bordetella. A particularly high degree of
activity is exhibited against Haemophilus influenzae, E. coli and Proteus spp.,
making Megatrim particularly suitable for the treatment of chronic
bronchitis and urinary tract infections.

Megatrim exerts its bactericidal action by the sequential blockade of two


bacterial enzyme systems in the biosynthesis of folinic acid in the micro-
organisms. The synergy thus produced accounts for the high degree of
bactericidal activity.

Indications
Respiratory tract infections, including acute and chronic bronchitis
(treatment and prophylaxis), bronchiectasis, lung abscess, lobar and
broncho-pneumonia, Pneumocystis carinii pneumonitis, sinusitis and otitis
media.

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Genito-urinary tract infections, including urethritis, acute and chronic


cystitis, pyelonephritis, prostatitis and gonorrhoea.

Gastro-intestinal tract infections, caused by Salmonella typhi and Salmonella


paratyphi, including the chronic carrier state.

Other infections, caused by a wide range of organisms confirmed to be


susceptible to Megatrim and where the therapeutic benefits are
considered to outweigh the possible occurrence of adverse events. Such
infections include acute and chronic osteomyelitis, acute brucellosis, skin
infections including pyoderma, abscesses and wound infections,
septicaemia, bacillary dysentery and cholera (as an adjuvant to fluid and
electrolyte replacement), nocardiosis and mycetoma.

Dosage and Administration

Dosage Guideline

Megatrim-DS tablet :
Adults and children over 12 years

Usual dosage One Megatrim-DS tablet twice daily

High dosage for severe 1½ Megatrim-DS tablets, twice daily


infections and septicaemia

Uncomplicated gonorrhoea 2 Megatrim-DS tablets 12 hourly for 2 days or 2½


Megatrim DS tablets with 8-12 hours’ intervals
between the doses
Minimum dosage for long- ½ Megatrim-DS tablet twice daily
term treatment (>14 days)

Megatrim Suspension
Children
6-12 years 1-2 teaspoonful twice daily

2-5 years ½-1 teaspoonful twice daily

up to 2 years ½ teaspoonful twice daily

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Duration of therapy : In acute infections, apart from gonorrhoea,


Megatrim DS should be given for at least 5 days or until the patient has
been symptom-free for 2 days. Treatment for prostatitis and acute
brucellosis should be maintained for a period of at least 4 weeks, whilst
in nocardiosis and mycetoma, dosage guideline requires long-term
therapy.

Contraindication
- Hypersensitivity to Trimethoprim or Sulphonamides.

- Patients with documented megaloblastic anaemia due to folate


deficiency.

- Patients showing marked liver parenchymal damage, blood dyscrasia,


severe renal insufficiency, glucose 6-phosphate dehydrogenase
deficiency.

- Pregnancy and during the nursing period, because sulphonamides pass


the placenta and are excreted in the breast milk and may cause
kernicterus.

Side Effects
The side effects like crystalluria, allergic reactions, haemolysis,
thrombocytopenia, neutropenia, agranulocytosis etc. have been reported
rarely with Sulfamethoxazole-Trimethoprim combination. Other side
effects are less serious in nature such as malaise, headache, nausea and
vomiting. These are normally transient and do not require withdrawal of
treatment.

Precautions
Prolonged full dose treatment with Sulfamethoxazole-Trimethoprim
combination is associated with the risk of macrocytic anaemia due to the
drug’s interference in the conversion of folic acid into folinic acid. If this
occurs, it can be reversed by giving folinic acid.

Care should be taken when giving this combination to diabetic patients


receiving sulphonylurea drug for possible potentiation of action of
sulphonylurea.

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Commercial Pack
Megatrim-DS Tablet : Box containing 10 blister strips of 10 tablets. Each
Megatrim DS tablet contains 160 mg Trimethoprim BP and 800 mg
Sulfamethoxazole BP.

Megatrim Suspension : 60 ml suspension in amber glass bottle. Each 5


ml of Suspension contains 40 mg Trimethoprim BP and 200 mg
Sulfamethoxazole BP.

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Melphin®
Tablet/Suspension

Description
Melphin contains Pyrantel Pamoate USP. It is an anthelmintic effective
against Ascaris lumbricoides (roundworm). Enterobius vermicularis (pinworm),
Ancylostoma duodenale/Necator americanus (hookworm) and
Trichostrongylus.
Indications
Melphin is specifically indicated for the treatment of infestations caused
by Ascaris lumbricoides, Enterobius vermicularis, Ancylostoma duodenale/Necator
americanus and Trichostrongylus.

Melphin may be used for the treatment of infestations with one or more
of these parasites in both adults and children.
Dosage and Administration
Melphin is given orally at anytime without regard to ingestion of food or
beverages. A single dose of 11 mg/kg body weight, to a maximum of 1 g,
should be given to treat infestations caused by the parasites mentioned
above. In the case of Pinworm, it is often wise to repeat the dose after an
interval of 2 weeks.

Contraindication
Since Pyrantel Pamoate has not been studied in pregnant women, use of
Melphin in such patients is normally contraindicated. Melphin is not
recommended for children below 1 year of age.

Side Effects
Melphin is well tolerated in recommended dosage. When given in large
dosage, Melphin may cause gastrointestinal upset such as anorexia,
nausea, vomiting and diarrhoea. Other side effects that may occur in rare
occasions are headache, dizziness and rash.

Precautions
Since Pyrantel Pamoate and Piperazine appear to be mutually
antagonistic, Melphin should not be given together with Piperazine.
Melphin should be kept out of the reach of children.

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Commercial Pack
Melphin Tablets : Box containing 100 tablets in 10 x 10’s aluminium strips,
each tablet contains Pyrantel Pamoate USP equivalent to 125 mg Pyrantel.

Melphin Suspension : 10 ml suspension in amber glass bottle, each ml


contains Pyrantel Pamoate USP equivalent to 50 mg Pyrantel.

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Modipran ®
Capsule

Description
Modipran is a preparation of Fluoxetine Hydrochloride BP containing 20
mg of Fluoxetine per hard gelatin capsule.

Fluoxetine Hydrochloride is a selective inhibitor of serotonin reuptake in


presynaptic neurons and is used as an antidepressant with very long half
life.

Indications
Modipran (Fluoxetine Hydrochloride) is indicated for the treatment of
depressive illness, bulimia nervosa and obsessive compulsive disorder.

Dosage and Administration


Initial treatment :
Recent studies suggest that 20 mg/day of Fluoxetine may be sufficient to
obtain satisfactory antidepressant response. Consequently, a dose of 20
mg/day administered in the morning is recommended as the initial dose.

A dose increase may be considered after several weeks if no clinical


improvement is observed. Dosage above 20 mg/day, should be
administered on a bid schedule (i.e. morning and noon) and should not
exceed a maximum dose of 80 mg/day. As with other antidepressants, the
full antidepressant effect may be delayed until 4 weeks of treatment or
longer. As with many other medications, a lower or less frequent dosage
should be used in patients with renal and/or hepatic impairment.

A lower or less frequent dosage should also be considered for patients,


such as elderly, with concurrent disease or on multiple medication. A
recommended maximum dose for elderly patients is 60 mg per day.

Maintenance Treatment :
It is generally agreed among expert psychopharmacologists that acute
episode of depression requires several months or longer sustained
pharmacologic therapy.

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Fluoxetine is also used in dosage of 60 mg daily for the management of


bulimia nervosa.

Contraindication
Modipran (Fluoxetine Hydrochloride) is contraindicated in patients
known to be hypersensitive to it.

Monoamine Oxidase Inhibitors : There have been reports of serious,


sometimes fatal reactions (including hyperthermia, rigidity, myoclonus,
autonomic instability with possible rapid fluctuations of vital signs and
changes of mental status that include extreme agitation progressing to
delirium and coma) in patients receiving fluoxetine in combination with
monoamine oxidase inhibitors (MAOIs), and in patients who have
recently discontinued fluoxetine and are then started on an MAOIs. Some
cases presented with features resembling neuroleptic malignant
syndrome. Therefore, Modipran should not be used in combination with
a MAOI, or within 14 days of discontinuing therapy with an MAOI. Since
fluoxetine and its major metabolites have very long elimination half-lives,
at least 5 weeks should be allowed after stopping fluoxetine and before
starting an MAOI.

Warning
A small percentage (4%) of patients have been found to develop rash
and/or urticaria associated with fever, leukocytosis, arthralgia, oedema,
carpal tunnel syndrome, respiratory distress, lymphadenopathy,
proteinuria and mild transaminase elevation. Most patients improved
promptly with discontinuation of the drug and/or adjunctive treatment
with antihistamines or steroids.

There were also rare cases of serious cutaneous systemic illness and
serum sickness. Other events include bronchospasm, angioedema,
fibrosis, vasculitis with rash, and involvement of lung, kidney and liver.

Use in Pregnancy and Lactation


In animal studies, no teratogenicity or harmful effect was found. Because
animal reproductive studies are not always predictive of human
responses, fluoxetine should be used in pregnancy only if clearly needed.

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As Fluoxetine is excreted in human milk, caution should be exercised


when Fluoxetine is administered to nursing women.

Precautions
As Fluoxetine undergoes hepatic metabolism and renal excretion, it
should be used with caution and in reduced doses in patients with
impaired hepatic or renal function. Because of its epileptogenic effect, it
should be used with caution in patients with epilepsy or a history of such
disorders. Fluoxetine may alter glycaemic control and therefore caution is
also warranted in diabetic subjects.

Depressed patients with suicidal tendencies should be carefully


supervised during treatment. Fluoxetine is not usually considered a
suitable form of therapy for the depressive component of bipolar (manic
depressive) illness as mania may be precipitated.

Use in Children: Safety and effectiveness in children have not been


established.

Side Effects
Gastrointestinal : Nausea, vomiting, dyspepsia, dry mouth, and diarrhoea.

Neurological : Anxiety, nervousness, insomnia/drowsiness and fatigue.

Others : Excessive sweating, pruritus, skin rashes associated with liver,


kidney and lung involvement. It has therefore been advised that fluoxetine
therapy should be discontinued in any patient who develops a skin rash.

Overdosage
In overdosage nausea, vomiting and excitation of the central nervous
system are considered to be prominent features; death has been reported.
Treatment involves emesis induction or gastric lavage followed by
symptomatic and supportive therapy. Forced diuresis, dialysis,
haemoperfusion and exchange transfusion are unlikely to be of benefit.

Commercial Pack
Modipran Capsule : Box containing 10 aluminium strips of 10 capsules.
Each capsule contains Fluoxetine Hydrochloride BP equivalent to
Fluoxetine 20 mg.

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Momento®
Tablet/Syrup

Description
Momento (Desloratadine) is a potent, rapidly effective, long-acting, non-
sedative antihistamine with selective H1 receptor histamine antagonist
activity. It is an orally administered drug. Each film-coated Momento
tablet contains Desloratadine INN 5 mg. Each 5 ml Syrup contains
Desloratadine INN 2.5 mg.

Indications
Allergic Rhinitis : Momento is indicated for the relief of the nasal and
non-nasal symptoms of allergic rhinitis (Both seasonal and perennial) in
patients 12 years of age and older.

Chronic Idiopathic Urticaria : Momento is also indicated for the


symptomatic relief of pruritus, reduction in the number of hives, and size
of hives, in patients with chronic idiopathic urticaria 12 years of age and
older.

Dosage and Administration


Adult and Children over 12 years :
One 5 mg tablet or 2 teaspoonful once daily

Child 6-11 years :


½ tablet or 1 teaspoonful once daily

Child 2-5 years :


½ teaspoonful daily

In patients with liver or renal impairment, a starting dose of one 5 mg


tablet every other day is recommended based on pharmacokinetic data.

Adverse Effects
In general it is well tolerated. Clinical trials suggest a very low rate of
adverse effects associated with Desloratadine administration. Among the
very few adverse effects commonly reported by small percentage of

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patients are dry mouth, fatigue, myalgia, and somnolence. Less common
side effects may include headache, nausea, dizziness, dyspepsia,
pharyngitis etc.

Contraindication
Momento is contraindicated in patients who are hypersensitive to this
medication or to any of its ingredients.

Precautions
Pregnancy Category C : Desloratadine was not teratogenic in rats or rabbits
at doses higher enough to produce an AUC, which is 210-230 times the
AUC in human at the recommended daily oral dose. There are, however,
no adequate and well-controlled studies of Desloratadine in pregnant
women. Because animal reproduction studies are not always predictive of
human response, Desloratadine should be used during pregnancy only if
clearly needed.

Nursing Mothers : Desloratadine passes into breast milk, therefore a


decision should be made whether to discontinue nursing or to discontinue
Momento, taking into account the importance of the drug to the mother.

Paediatric Use : The safety and effectiveness of Desloratadine in pediatric


patients under 12 years of age have not been established.

Geriatric Use : In general, dose selection for an elderly patient should be


cautious, taking into account of the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or other
drug therapy.

Drug Interaction
Concomitant administration of Erythromycin, Ketoconazole,
Azithromycin, Fluoxetine, and Cimetidine with Desloratadine increased
the plasma concentration of Desloratadine. But there were no clinically
relevant changes in the safety profile of Desloratadine.

Overdosage
No clinically relevant adverse events were reported. In the event of
overdose, consider standard measures to remove any unabsorbed drug.

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Symptomatic and supportive treatment is recommended. Desloratadine


and 3-hydroxydesloratadine are not eliminated by haemodialysis.

Pharmaceutical Precaution
Store at a temperature between 2 °C and 25°C. It is heat sensitive, so avoid
exposure at or above 30°C.

Commercial Pack
Momento Tablet : Each box contains 10 blister strips of 10 tablets. Each
tablet contains Desloratadine INN 5 mg.

Momento Syrup : 60 ml syrup in amber glass bottle, each 5 ml contains


Desloratadine INN 2.5 mg.

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Monate®
Tablet

Description
Isosorbide Mononitrate is an organic nitrate. It is a vasodilator, active on
both arteries and veins. Each tablet contains Isosorbide Mononitrate BP
20 mg.

Dosage and Administration


Adults : The recommended dosage is from 20 to 120 mg daily in divided
doses. The majority of patients will require a dosage in the range of 40 to
60 mg daily in divided doses. The tablets should be taken with fluid and
swallowed whole without chewing.

Elderly : There is no evidence to suggest an adjustment of dose. However,


caution may be required in elderly patients who are known to be
susceptible to the effects of hypotensive medication.

Children : The safety and efficacy of Isosorbide Mononitrate in children


has not been established.

Indications
Monate tablets are indicated for prophylaxis of angina pectoris and as an
adjunct to treatment of heart failure.

Contraindication
Isosorbide Mononitrate is contraindicated in patients with a known
hypersensitivity to Isosorbide Mononitrate or Isosorbide Dinitrate. It is
also contraindicated in cases of marked low blood pressure, shock and
acute myocardial infarction with low left ventricular filling pressure.

Adverse Reactions
A number of nitrate-related adverse effects may occur during treatment
including headache and feelings of dizziness. The incidence of such
effects is normally highest at the commencement of treatment and tends
to decline with time. In highly sensitive patients hypertension may occur,
especially after a high dose. Other reactions, including feelings of

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weakness, nausea or vomiting may occur occasionally. Side effects that


have been associated with Isosorbide Dinitrate (e.g. flushing, postural
hypotension, dry rash, exfoliative dermatitis) may also occur.

Precautions
Isosorbide Mononitrate tablet is not indicated for the relief of an acute
attack when sublingual or buccal Glyceryl Trinitrate tablets or spray
should be used. In the case of acute myocardial infarction, Isosorbide
Mononitrate tablets should be continued only under strict medical
supervision. Since a rebound phenomenon cannot be excluded, therapy
with Isosorbide Mononitrate should be terminated gradually rather than
stopping abruptly.

Use in Pregnancy and Lactation


No data have been reported which would indicate the possibility of
adverse effects resulting from the use of organic nitrates in pregnancy.
However, safety in pregnancy has not been established. There is no
information on excretion of Isosorbide Mononitrate in breast milk. Use
in pregnancy and lactation is not recommended unless considered
essential by the physician.

Drug Interactions
Orthostatic hypotension may occur with combined use of calcium
channel blockers, antihypertensive agents, phenothiazines or tricyclic
antidepressants. Use of alcohol with Isosorbide Mononitrate may
produce severe hypotension and collapse.

Pharmaceutical Precaution
Store at a temperature between 15o and 30o C.

Commercial Pack
Monate Tablet : Box containing 100 tablets in 10 x 10’s blister strips. Each
tablet contains Isosorbide Mononitrate BP 20 mg.

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Monocast®
Tablet

Description
The active ingredient of Monocast tablet is Montelukast Sodium INN.
Montelukast is a selective and orally active leukotriene receptor antagonist
that inhibits the cysteinyl leukotriene CysLT1 receptor. Each Monocast 10
film coated tablet contains Montelukast Sodium INN equivalent to 10 mg
Montelukast. Each Monocast 5 chewable tablet contains Montelukast
Sodium INN equivalent to 5 mg Montelukast. Each Monocast 4 chewable
tablet contains Montelukast Sodium INN equivalent to 4 mg
Montelukast.

Mechanism of Action
The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of
arachidonic acid metabolism and are released from various cells, including
mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene
(CysLT) receptors. The CysLT type-1 (CysLT1) receptor is found in the
human airway (including airway smooth muscle cells and airway
macrophages) and on other pro-inflammatory cells (including eosinophils
and certain myeloid stem cells). CysLTs have been correlated with the
pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-
mediated effects include airway oedema, smooth muscle contraction, and
altered cellular activity associated with the inflammatory process. In
allergic rhinitis, CysLTs are released from the nasal mucosa after allergen
exposure during both early and late-phase reactions and are associated
with symptoms of allergic rhinitis. Intranasal challenge with CysLTs has
been shown to increase nasal airway resistance and symptoms of nasal
obstruction.

Montelukast is an orally active compound that binds with high affinity


and selectivity to the CysLT1 receptor (in preference to other
pharmacologically important airway receptors, such as the prostanoid,
cholinergic, or β-adrenergic receptors). Montelukast inhibits physiologic
actions of LTD4 at the CysLT1 receptor without any agonist activity.

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T H E R A P E U T I C I N D E X

Indications
Monocast is indicated for the prophylaxis and chronic treatment of
asthma in adults and paediatric patients 12 months of age and older.

Monocast is indicated for the relief of symptoms of seasonal allergic


rhinitis in adults and paediatric patients 2 years of age and older.

Dosage and Administration


General Information : Monocast should be taken once daily. For asthma,
the dose should be taken in the evening. For seasonal allergic rhinitis, the
time of administration may be individualized to suit patients’ needs.
Patients with both asthma and seasonal allergic rhinitis should take only
one tablet daily in the evening.

Adults and Adolescents 15 years of age and older with asthma or seasonal
allergic rhinitis : The dosage is one 10 mg tablet daily.

Paediatric patients 6 to 14 years of age with asthma or seasonal allergic


rhinitis : The dosage is one 5 mg chewable tablet daily. No dosage
adjustment within this age group is necessary.

Paediatric patients 2 to 5 years of age with asthma or seasonal allergic


rhinitis : The dosage is one 4 mg chewable tablet daily.

Paediatric patients 12 to 23 months of age with asthma : The dosage is


one 4 mg chewable tablet daily to be taken in the evening. Safety and
effectiveness in paediatric patients younger than 12 months of age have
not been established.

Contraindication
Hypersensitivity to any component of this product.

Side Effects
Adolescents and Adults 15 years of age and older : In placebo-controlled
clinical trials, Montelukast has been evaluated for safety in approximately
2600 adolescent and adult patients of 15 years and older, the following
adverse experiences reported with Montelukast occurred in greater than
or equal to 1% of patients. General : Asthenia/fatigue, Fever, Pain;

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Gastrointestinal: Dyspepsia, Gastroenteritis; Nervous System/Psychiatric :


Dizziness, Headache; Respiratory System: Congestion, Cough, Influenza;
Skin: Rash; Laboratory adverse experiences : ALT increase, AST increase,
Pyuria.

Paediatric patients 6 to 14 years of age : In paediatric patients receiving


montelukast, the following events occurred with a frequency ≥ 2% are
diarrhoea, laryngitis, pharyngitis, nausea, otitis, sinusitis, and viral
infection. With prolonged treatment, the adverse profile did not change
significantly.

Precautions
General : Montelukast is not indicated for use in the reversal of
bronchospasm in acute asthma attacks, including status asthmaticus.
Patients should be advised to have appropriate rescue medication
available. Therapy with Montelukast can be continued during acute
exacerbation of asthma.

While the dose of inhaled corticosteroid may be reduced gradually under


medical supervision, montelukast should not be abruptly substituted for
inhaled or oral corticosteroids. Montelukast should not be used as
monotherapy for the treatment and management of exercise-induced
bronchospasm. Patients who have exacerbation of asthma after exercise
should continue to use their usual regimen of inhaled ß-agonist as
prophylaxis and have available for rescue a short-acting inhaled ß-agonist.
Patients with known Aspirin sensitivity should continue avoidance of
aspirin or non-steroidal anti-inflammatory agents while taking
Montelukast. Although montelukast is effective in improving airway
function in asthmatics with documented aspirin sensitivity, it has not been
shown to truncate bronchoconstrictor response to aspirin and other non-
steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients.

Eosinophilic Conditions : In rare cases, patients on therapy with


Montelukast may present with systemic eosinophilia, sometimes
presenting with clinical features of vasculitis consistent with Churg-
Strauss syndrome, a condition which is often treated with systemic
corticosteroid therapy. These events usually, but not always, have been
associated with the reduction of oral corticosteroid therapy. Physicians

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T H E R A P E U T I C I N D E X

should be alert to eosinophilia, vasculitic rash, worsening pulmonary


symptoms, cardiac complications, and/or neuropathy presenting in their
patients. A causal association between montelukast and these underlying
conditions has not been established.

Paediatric Use
Safety and efficacy of Montelukast has been established in adequate and
well-controlled studies in paediatric patients with asthma and allergic
rhinitis between age 1 to 14 years. Long-term trials evaluating the effect
of chronic administration of Montelukast on linear growth in paediatric
patients have not been conducted.

Geriatric Use
Of the total number of subjects in clinical studies of Montelukast, 3.5%
were 65 years of age and over and 0.4% were 75 years of age and over.
No overall differences in safety or effectiveness were observed between
these subjects and younger subjects, and other reported clinical
experience has not identified differences in responses between the elderly
and younger patients. But greater sensitivity of some older individuals
cannot be ruled out.

Use in Pregnancy and Lactation


Montelukast crosses the placenta following oral dosing in rats and rabbits.
There are, however, no adequate and well-controlled studies in pregnant
women. Because animal reproduction studies are not always predictive of
human response, Montelukast should be used during pregnancy only if
clearly needed.

It is not known if Montelukast is excreted in human milk. Because many


drugs are excreted in human milk, caution should be exercised when
Montelukast is given to a nursing mother.

Drug Interactions
Montelukast has been administered with other therapies routinely used in
the prophylaxis and chronic treatment of asthma with no apparent
increase in adverse reactions. In drug-interaction studies, the
recommended clinical dose of montelukast did not have clinically

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important effects on the pharmacokinetics of the following drugs:


Theophylline, Prednisolone, oral contraceptives (norethindrone 1
mg/ethinyl estradiol 35 µg), Terfenadine, Digoxin, and Warfarin.

Although additional specific interaction studies were not performed,


Montelukast was used concomitantly with a wide range of commonly
prescribed drugs in clinical studies without clinically evident adverse
interactions. These medications included thyroid hormones, sedative
hypnotic, non-steroidal anti-inflammatory agents, benzodiazepines, and
decongestants.

Phenobarbital, which induces hepatic metabolism, decreased the AUC of


Montelukast approximately 40% following a single 10 mg dose of
Montelukast. No dosage adjustment for Montelukast is recommended. It
is reasonable to employ appropriate clinical monitoring when potent
cytochrome P450 enzyme inducers, such as Phenobarbital or Rifampin,
are co-administered with Montelukast.

Overdosage
There were no adverse experiences reported in the majority of
overdosage reports. The most frequent adverse experiences observed
were thirst, somnolence, hyperkinesia, and abdominal pain. It is not
known whether Montelukast is removed by peritoneal dialysis or
haemodialysis.

Commercial Pack
Monocast 10 Tablet : Box containing 1 blister strip of 10 film coated
tablets. Each tablet contains Montelukast Sodium INN equivalent to 10
mg Montelukast.

Monocast 5 Tablet : Box containing 2 blister strips of 20 chewable tablets.


Each tablet contains Montelukast Sodium INN equivalent to 5 mg
Montelukast.

Monocast 4 Tablet : Box containing 2 blister strips of 20 chewable tablets.


Each tablet contains Montelukast Sodium INN equivalent to 4 mg
Montelukast.

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Napa®
Tablet/Syrup/Drops/Suppository

Description
Napa (Paracetamol) is a fast acting and safe analgesic with marked
antipyretic property. It is specially suitable for patients who, for any
reason, can not tolerate aspirin or other analgesics.

Indications
All conditions requiring relief from pain and fever such as neuritis,
neuralgia, headache, earache, toothache, pain due to rheumatic disorder,
cold, influenza, dysmenorrhoea, post-vaccination pain and fever of
children etc. Napa suppositories are used for rapid symptomatic
management of pain and fever. It is given as rectal suppository for mild
to moderate pain and for pyrexia.

Dosage and Administrations


Tablets : Adults- 1-2 tablets 3-4 times daily; Syrup : Adults- 4-8 measuring
spoonful 3-4 times daily; Children- 6-12 years- 2-4 measuring spoonful 3-
4 times daily, 1-5 years- 1-2 measuring spoonful 3-4 times daily. Up to 1
year- ½-1 measuring spoonful 3-4 times daily. Paediatric drops : Neonates
and children- 0-3 months- 0-5 ml, 4-11 months- 1 ml, 12-23 months- 1.5
ml, 2-3 years- 2 ml 4-5 years- 3 ml four times daily or as directed by
physicians. Suppositories : Children- 1-5 years- 125-250 mg, 6-12 years- 250-
500 mg, up to 4 times daily.

Contraindication
Paracetamol is contraindicated in patients with severe renal function
impairment and hepatic disease (Viral Hepatitis).

Precautions
Paracetamol should be given with care to patients with impaired kidney or
liver function. Paracetamol should be given with care to patients taking
other drugs that affect the liver.

Side Effects
Side effects of paracetamol are usually mild, though haematological
reactions including thrombocytopenia, leucopenia, pancytopenia,

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T H E R A P E U T I C I N D E X

neutropenia, and agranulocytosis have been reported. Pancreatitis, skin


rashes, and other allergic reactions occur occasionally.

Overdosage
Symptoms of paracetamol overdose in the first 24 hours are pallor,
nausea, vomiting, anorexia and abdominal pain. Liver damage may
become apparent 12 to 40 hours after ingestion. Abnormalities of glucose
metabolism and metabolic acidosis may occur.

Commercial Pack
Napa Tablet : Box containing 50 blister strips of 10 tablets, each contains
500 mg Paracetamol BP.

Napa Syrup : Bottle containing 60 ml syrup, each 5 ml contains 120 mg


Paracetamol BP.

Napa Paediatric Drops : Bottle containing 15 ml drops, each ml contains


80 mg Paracetamol BP.

Napa 125 Suppository : Box containing 4 foils of 5 suppositories (4 x 5’s),


each containing 125 mg Paracetamol BP.

Napa 250 Suppository : Box containing 4 foils of 5 suppositories (4 x 5’s),


each contains 250 mg Paracetamol BP.

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Nazolin ®
Nasal Spray

Description
Oxymetazoline Hydrochloride, the active ingredient of Nazolin nasal
spray, is a sympathomimetic amine of the imidazoline class. The chemical
name of the active ingredient is 3-[(4,5-Dihydro-1 H-imidazole-2-
yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethylphenol hydrochloride.

Indications
♦ As a nasal decongestant in allergic rhinitis, with or without the addition
of topical antihistamines or sodium cromoglycate.
♦ As a nasal decongestant in sinusitis where there is evidence of
obstruction of osteal opening to the sinuses.
♦ As nasal decongestant in otitis media where there is evidence of
obstruction of eustachian tube, especially in subacute serous otitis
media ('glue ear') and otitic barotrauma.
♦ As a decongestant in an infective rhinitis(e.g. an acute viral upper
respiratory tract infection). Where there is a secondary bacterial
infection, there is no evidence of benefit.

Dosage and Administration


For nasal use, 2-3 sprays should be instilled into each nostril twice daily.
The nasal spray can be used with the patient in the upright position.
Sprays are generally unsuitable for young children because of the small
size of their nostril. A treatment course should not normally exceed three
to five days, and on no account should it be continued for longer than two
weeks because of the risk of developing ‘rhinitis medicamentosa'.

Contraindication
♦ As a sympathomimetic, oxymetazoline should not be used in patients
being simultaneously treated with monoamine oxidase inhibitor
therapy.
♦ Narrow-angle glaucoma.
♦ The safety of use in pregnancy has not fully been established and
administration of oxymetazoline during that time should be avoided
unless absolutely essential.

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T H E R A P E U T I C I N D E X

Precautions
The drug should be used with caution in patients suffering from
Coronary artery disease, Hypertension, Hyperthyroidism and Diabetes
mellitus.

Side Effects
Used correctly (as an intranasal application), the local vasoconstriction
produced by the drug inhibits the absorption and a systemic action is
unlikely. If, however, some of the drops are swallowed, they can be
absorbed from the gastrointestinal tract and a systemic effect can be
produced. In children an overdose, if swallowed and absorbed, has been
reported to cause sedation. As oxymetazoline is an α2 adrenergic agonist,
it might be expected to produce effects similar to those of clonidine, with
a short-lived rise in pressure caused by a peripheral action, followed by
more prolonged hypotension and sedation as a result of inhibition of
sympathetic outflow from brain.

Overuse is associated with a more persistent rhinitis related to the


rebound phenomenon- the condition known as ‘rhinitis medicamentosa’.
It is claimed that, because of its more prolonged action, oxymetazoline is
less likely to cause rebound congestion than other decongestants.

Stinging, discomfort or a dryness locally in the nose or eye is encountered


infrequently. If the symptoms persist, the discomfort from the use of the
drops probably outweighs any advantage they may confer. Headache has
been reported, albeit infrequently, as has tachycardia.

Pharmaceutical Precaution
Nazolin nasal spray should be stored at a temperature below 30o C.
Protect from frost and direct sunlight.

Commercial Pack
Nazolin Nasal Spray : Each bottle contains 200 metered doses of 0.05%
aqueous nasal preparation of Oxymetazoline Hydrochloride USP in a
total volume of 10 ml. Each actuation delivers 0.05 ml containing 25 µg
of Oxymetazoline Hydrochloride.

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Nebactil®
Suspension

Description
Nebactil contains Nalidixic Acid BP. Nebactil is available in suspension
form. Each 5 ml suspension contains 300 mg of Nalidixic Acid BP. It is
a bactericidal DNA gyrase inhibitor.

Indications
Nalidixic Acid is indicated in-
w Urinary tract infections caused by susceptible Gram-negative
microorganisms, including the majority of Proteus strains, Klebsiella,
Enterobacter spp. and E. coli.
w Gastrointestinal infections caused by Salmonella and Shigella.

Dosage and Administration


Adult : Initial therapy : 1 g 4 times/day (Total dose 4 g/day) for 1 or 2
weeks. Prolonged therapy : May be reduced to 2 g/day after the initial
treatment period.

Children : 3 months to 12 years of age: Initial therapy : 55 mg/kg/day in


4 equally divided doses.

Prolonged therapy : May be reduced to 33 mg/kg/day

Contraindication
Nebactil is contraindicated to known hypersensitivity to Nalidixic Acid,
history of convulsive disorders and patients with porphyria.

Relative Contraindication
Should be used with caution in patients with liver and renal disease. Also
in glucose 6-phosphate dehydrogenase deficiency.

Side Effects
Central Nervous System : Drowsiness, weakness, headache, dizziness,
vertigo, toxic psychosis, brief convulsion (rare). Ophthalmic : Reversible
subjective visual disturbances occur infrequently (generally with each dose
during the first few days) and over brightness of lights, change in colour

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perception, focusing difficulty, decrease in visual acuity and double vision.


Gastrointestinal : Abdominal pain, nausea, vomiting, diarrhoea.
Hypersensitivity : Rash, pruritus, urticaria, angioedema, arthralgia with
joint stiffness and swelling, anaphylactoid reaction (rare). Haematologic :
Thrombocytopenia, leucopenia or haemolytic anaemia, sometimes
associated with glucose 6-phosphate dehydrogenase deficiency (rare).
Miscellaneous : Cholestatic jaundice, cholestasis, paraesthesia, metabolic
acidosis (rare), photosensitivity reactions (eg. erythema and painful bullae
on exposed skin surfaces).

Precautions
General : Should be used with caution in liver disease, epilepsy or severe
cerebral arteriosclerosis patients. Periodic blood counts and renal and
liver function test should be performed if treatment is continued for >2
weeks. If bacterial resistance emerges, rapid change of drug should be
made.

Children : Should not be used to infants <3 months of age.

Use in Pregnancy and Lactation


Nalidixic Acid is DNA-gyrase inhibitor which is capable of causing DNA
damage, and there is possibility that it may cause cartilage damage. Thus,
it is best to avoid using in pregnancy.

Commercial Pack
Nebactil Suspension : Bottle contains 50 ml of oral suspension. Each 5
ml contains 300 mg of Nalidixic Acid BP.

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Neo Kit®

Description
Helicobacter pylori is implicated in the etiology of gastritis and peptic
ulceration in humans. It is found in 90% cases of duodenal ulcer, 90%
cases of chronic antral gastritis and 70% cases of gastric ulcer.

Conventional H2 receptor antagonists do not suppress or eradicate


H. pylori and has a high rate of ulcer recurrence. The standard triple
therapy regimens have proved to be effective for eradicating H. pylori.

Each Neo Kit contains-


Clarithromycin USP 500 mg : 1 Tablet
Omeprazole BP 20 mg : 1 Capsule
Metronidazole BP 400 mg : 1 Tablet

Indications
Neo Kit is indicated in the eradication of H. pylori in active chronic
gastritis, duodenal and gastric ulcers.

Dosage and Administration


One Neo Kit (2 tablets and 1 capsule in one blister strip) twice daily (12
hourly) for 7 days.

Contraindication
Neo Kit is contraindicated in patients with known hypersensitivity to
Clarithromycin, Omeprazole and Metronidazole.

Side Effects
The drugs of the Neo Kit are well tolerated. Side effects may be that of
Clarithromycin, Omeprazole and Metronidazole which include nausea,
vomiting, diarrhoea and abdominal pain. Other side effects include
unpleasant metallic or bitter taste, headache, drowsiness, vertigo,
constipation, abdominal colic and flatulence but are rare.

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Precautions
Caution should be exercised in administering Clarithromycin in patients
with impaired hepatic and renal functions. Prolonged or repeated use of
Clarithromycin may result in an overgrowth of non-susceptible bacteria
or fungi. Proton pump inhibitors should be used in caution in patients
with liver disease, during pregnancy and lactation. Metronidazole should
not be used in patients with blood dyscrasia. It is suggested that
Metronidazole should not be given in the first three months of
pregnancy.

Use in Pregnancy and Lactation


Neo Kit should be used with caution during pregnancy and lactation only
if the potential benefit justifies the risk.

Use in Children
Safety and effectiveness in children have not been established.

Drug Interactions
Clarithromycin: Concomitant administration with Theophylline has been
associated with increased serum Theophylline level. Effects of Digoxin
and Warfarin may be potentiated with concomitant administration of
Clarithromycin.

Omeprazole: Effects of Warfarin enhanced and absorption of


Ketoconazole reduced by Omeprazole.

Metronidazole: The effect of Warfarin enhanced by Metronidazole.

Commercial Pack
Neo Kit : Box containing 14 kits. Each kit contains one tablet of
Clarithromycin USP 500 mg , one capsule of Omeprazole BP 20 mg and
one tablet of Metronidazole BP 400 mg.

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Neocard®
Tablet

Description
Neocard (Diltiazem Hydrochloride) tablet is available in potencies of 30
mg and 60 mg for oral administration.

Indications
Neocard is a calcium antagonist. It is indicated for the prophylaxis and
treatment of classical and vasospastic angina pectoris and hypertension,
myocardial infarction, coronary artery spasm, hypertension, cardiac
arrhythmias, Raynaud’s phenomenon, oesophagal motility disorder, and
migraine.

Dosage and Administration


General: Usual dose is 60 mg three times daily. However patient responses
may vary and dosage requirements can differ significantly between
individual patients. If necessary the divided dose may be increased to 180-
360 mg/day. Dosage may also be started as 30 mg four times daily and
increasing at 1 to 2 days intervals until the optimum response is achieved.
Higher doses up to 480 mg/day have been used with benefit in some
patients especially in unstable angina. There is no evidence of any
decrease in efficacy at these high doses. Neocard has not been reported
to precipitate angina.

Elderly and patients with impaired hepatic or renal function: The


recommended starting dose is 60 mg twice daily. The heart rate should be
measured regularly in these groups of patients and the dose should not
be increased if the heart rate falls below 50 beats per minute.

Children: Not recommended.

Contraindication
Diltiazem Hydrochloride is contraindicated in pregnant women or those
of child bearing potential, patients with sick sinus syndromes, patients
with second or third degree AV block, patients with severe bradycardia
and patients who demonstrated hypersensitivity to the drug.

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Precautions
Patients with mild bradycardia or a prolonged PR interval should be
observed closely. Neocard does not have a significant myocardial
depressant effect and is well tolerated in patients with poor left ventricular
function. The drug should be used with caution in patients with impaired
hepatic or renal function.

Drug Interactions
Diltiazem Hydrochloride should be carefully administered in case of
concomitant use with the following drugs.
♦ Anti-hypertensive agents : effects of anti-hypertensive agents are
enhanced
♦ Propranolol : concentration of propranolol may be increased

♦ Carbamazepine : plasma level of Carbamazepine may be increased and


it may cause Carbamazepine induced toxic symptoms such as
sleepiness, nausea, vomiting, vertigo etc.
♦ Digoxin preparations : plasma level of Digoxin is increased

♦ Cyclosporin: may increase serum cyclosporin concentration by 75% or


more.

Side Effects
Diltiazem Hydrochloride produces few side effects and these are usually
mild. Oedema, nausea, headache, finger swelling, skin rash, dizziness and
asthenia have been reported. Other adverse effects include bradycardia,
AV block, hypotension, gastrointestinal symptom, hyperactivity with
associated psychiatric symptoms and mild elevation of liver function
tests.
Overdosage
Experience of overdosage in man is limited and spontaneous recovery
has been seen in reported cases. However, observation in coronary care
unit (CCU) is advisable with corrective measures available for possible
hypotension and conduction disturbances.

Commercial Pack
Neocard-30 Tablet : Box containing 10 blister strips of 10 tablets, each
tablet contains Diltiazem Hydrochloride USP 30 mg.

Neocard-60 Tablet : Box containing 10 blister strips of 10 tablets, each


tablet contains Diltiazem Hydrochloride USP 60 mg.

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Neoceptin®R
Tablet/Syrup

Description
The active ingredient of Neoceptin R is Ranitidine. Neoceptin R is a
histamine H2 receptor antagonist. It inhibits basal and stimulated
secretion of gastric acid. Neoceptin R is rapidly absorbed after oral
administration. Food or antacid does not interfere its absorption.

Indications
Neoceptin R is indicated for the treatment of duodenal ulcer, benign
gastric ulcer, post-operative ulcer, reflux oesophagitis, Zollinger-Ellison
Syndrome and in other conditions where reduction of gastric acidity is
beneficial.

Dosage and Administration


Duodenal and Gastric Ulcer : The usual dosage is 150 mg twice daily taken
in the morning and evening or 300 mg as a single daily dose at night for
4 to 8 weeks.

Reflux Oesophagitis : 150 mg twice daily or 300 mg at bed time for up to 8


weeks.

Zollinger-Ellison Syndrome : 150 mg 3 times daily and increased if necessary


up to 6 g daily in divided doses. Dosage should be continued as long as
clinically indicated.

Episodic Dyspepsia : 150 mg twice daily or 300 mg at bed time for up to 6


weeks.

Maintenance : 150 mg at night for preventing recurrences.

Child (peptic ulcer) : 2-4 mg/kg twice daily, maximum 300 mg daily.

Side Effects
Neoceptin R is well tolerated and side effects are usually uncommon.
Altered bowel habit, dizziness, rash, tiredness, reversible confusional
states, headache, decreased blood counts, muscle or joint pain have rarely
been reported.

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Precautions
Ranitidine should be given in reduced dosage to patients with impaired
renal and hepatic function.

Use in Pregnancy and Lactation


Ranitidine crosses the placenta. But there is no evidence of impaired
fertility or harm to the foetus due to Ranitidine. Like other drugs,
Neoceptin R should only be used during pregnancy if considered
essential. Ranitidine is excreted in human breast milk. Caution should be
exercised when the drug is administered to a nursing mother.

Pharmaceutical Precaution
Store in a cool and dry place. Protect from light.

Commercial Pack
Neoceptin R-150 Tablet : Box containing 100 tablets in 10 x 10’s Alu-Alu
form packs. Each round, bi-convex, film coated tablet contains Ranitidine
Hydrochloride USP equivalent to Ranitidine 150 mg.

Neoceptin R-300 Tablet : Box containing 100 tablets in 10 x 10’s


aluminium strips. Each round, bi-convex, film coated tablet contains
Ranitidine Hydrochloride USP equivalent to Ranitidine 300 mg.

Neoceptin R Syrup : Bottle containing 100 ml sugar free syrup. Each 5 ml


contains Ranitidine Hydrochloride USP equivalent to Ranitidine 75 mg.

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Neodrop ®
Drops

Description
Neodrop (Simethicone) is used as an antiflatulent to relieve symptoms
commonly referred to gas including upper gastrointestinal bloating,
fullness or stuffed feeling. The clinical use of Neodrop is based on its
antifoam properties. Its defoaming action relieves flatulence by
dispensing and preventing the formation of mucous surrounded gas
pockets in the gastrointestinal tract. Neodrop acts in the stomach and
intestines to change the surface tension of gas bubbles, enabling them to
coalesce; thus gas is freed and eliminated more easily by belching or
passing flatus. Neodrop aids in the elimination of gas from the
gastrointestinal tract and can be used to reduce postoperative gas pains.
Neodrop can also be used prior to gastroscopy to enhance visualization
and prior to radiography of the intestine to reduce gas shadows.

Indications
Flatulence, abdominal distention, fullness, gas and windy colic : Neodrop
(Simethicone) is an excellent and effective antiflatulent. It is used for
relief of the painful symptoms of excess gas in the digestive tract. Such
gas is frequently caused by excessive swallowing of air or by eating foods
that disagree. Neodrop is especially acts in the stomach and intestines of
infants and child. Thus Neodrop enables freeing and eliminating the gas
more easily by belching or passing flatus.

Large bowel preparation : Addition of Neodrop to a polyethylene glycol


bowel preparation produces symptomatic improvement prior to
investigation in patients undergoing colonoscopy.

Treatment of poisoning : Neodrop has an anecdotal use as an antifoaming


agent in the management of accidental ingestion of foaming detergents.

Dosage and Administration


Take after meals and at bedtime. Can be given with infant’s feeds.
Children less than 2 years of age- 20 mg (0.3 ml Neodrop drops) 4 times

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daily up to 240 mg (3.6 ml Neodrop drops)/day. Children: 2-12 years of


age- 40 mg (0.6 ml Neodrop drops) 4 times daily. Adults: 40-80 mg (0.6
ml-1.2 ml Neodrop drops) 4 times daily, up to 500 mg (7.5 ml Neodrop
drops)/day.

Side Effect
Simethicone is physiologically inert and no adverse effect has been noted
after oral ingestion.

Precautions
Do not exceed 12 doses per day except under the advice and supervision
of a physician.

Drug Interaction
There is no evidence that simethicone modifies the effect of other drugs.
The defoaming effect of simethicone is reduced by antacids such as
Aluminium Hydroxide and Magnesium Carbonate, which absorb the
Silicone.

Use in Pregnancy and Lactation


No data are available to suggest any harmful effects on pregnant women.

Pharmaceutical Precaution
Should be stored in well-closed bottle, protected from light, and at a
temperature not exceeding 30oC. Keep the medicine out of the reach of
children.

Commercial Pack
Neodrop Paediatric Drops : Bottle containing 15 ml Simethicone drops
with a plastic dropper. Each ml drop contains Simethicone USP 67 mg.

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Neofloxin®
Tablet

Description
Ciprofloxacin, a fluoroquinolone, is an extremely broad spectrum DNA
gyrase inhibitor antimicrobial agent. The active ingredient of Neofloxin
is Ciprofloxacin Hydrochloride USP.

Indications
Neofloxin is indicated for the treatment of single infection or mixed
infections caused by two or more susceptible organisms. It can also be
used for infections caused by organisms resistant to other antibiotics
including aminoglycosides, penicillins and cephalosporins. As
antibacterial concentrations of Ciprofloxacin are obtained in serum and
body tissues as well as in the urine following administration by mouth,
Ciprofloxacin has been suggested for use in the treatment of a wide range
of infections caused by susceptible organisms including infections of the
urinary, respiratory and gastrointestinal tracts, gonorrhoea and
septicaemia. The extensive tissue penetration of Neofloxin combined
with its enhanced antibacterial activity (including antipseudomonal
activity), enables Ciprofloxacin to be used alone (pending sensitivity
results) or in combination with an aminoglycoside or with beta-lactam
antibiotics for instance when severe neutropenia is present or with an
antibiotic active against anaerobes where the presence of Bacteroides fragilis
is suspected. Neofloxin is indicated for the treatment of the following
infections caused by sensitive bacteria :

Severe systemic infections : Septicaemia, bacteraemia, peritonitis, infections in


immunosuppressed patients with haematological or solid tumors and in
patients in intensive care unit with specific problems such as infected
burns.

Respiratory tract infections : Lobar and bronchopneumonia, acute, and


chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis,
empyaema.

Urinary tract infections : Uncomplicated and complicated urethritis, cystitis,


pyelonephritis, prostatitis, epididymitis.

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Skin and soft tissue infections : Infected ulcers, wound infections, abscesses,
cellulitis, otitis externa, erysipelas, infected burns.

Gastro-intestinal infections : Enteric fever, infective diarrhoea.

Infection of the biliary tract : Cholangitis, cholecystitis, empyaema of the gall


bladder.

Intra abdominal infections : Peritonitis, intra-abdominal abscesses.

Bone and joint infections : Osteomyelitis, septic arthritis.

Pelvic infections : Salpingitis, endometritis, pelvic inflammatory diseases.

Eye, ear, nose and throat infections : Otitis media, sinusitis, mastoiditis,
tonsillitis.

Genito-urinary tract infection : Gonorrhoea (urethral, rectal and pharyngeal)


caused by beta-lactamase producing organisms or organisms moderately
sensitive to penicillin.

In vitro studies have shown that the antibacterial action of Ciprofloxacin


results from the inhibition of bacterial DNA gyrase. This mode of action
differs from that of penicillins. Organisms resistant to cephalosporins,
aminoglycosides and tetracyclines are generally sensitive to Ciprofloxacin.

Dosage and Administration


General dosage recommendations
The dosage of Ciprofloxacin is determined by the severity and type of
infection, the sensitivity of the causative organism(s) and the age, weight
and renal function of the patient.

Adults : The dosage range for adults is 100-750 mg twice daily. In


infections of the urinary tract : 250-500 mg twice daily. In respiratory tract
infections : 250-750 mg twice daily for both upper and lower respiratory
tract infections. For the treatment of known Streptococcal pneumoniae
infection, the recommended dosage is 750 mg twice daily. In gonorrhoea
: a single dose of 250 or 500 mg. In the majority other infections, 500-750
mg twice daily should be administered. Cystic fibrosis : In adults with
pseudomonal infections of the lower respiratory tract, the normal dose is
750 mg twice

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T H E R A P E U T I C I N D E X

daily. As the pharmacokinetics of Ciprofloxacin remain unchanged in


patients with cystic fibrosis, the low body weight of these patients would
be fallen into consideration when determining dosage. Impaired renal
function : Dosage adjustment are not usually required except in patients
with severe renal impairment (serum creatinine >265 µmol/l or
creatinine clearance <20 ml/minute). If adjustment is necessary, this may
be achieved by reducing the total daily dose by half, although monitoring
of drug serum levels provide the most reliable basis for dose adjustment.

Dose adjustment
Elderly : Although higher Ciprofloxacin serum levels are found in the
elderly, no adjustment of dosage is necessary. Adolescents and children :
As with other drugs in its class, Ciprofloxacin has been shown to cause
arthropathy in weight bearing joints of immature animals. Although the
relevance of this to man is unknown, its use in children, growing children
and growing adolescents is not recommended. However, where the
benefit of using Ciprofloxacin is considered to out weigh this potential
risk, the dosage should be 7.5-15 mg/kg/day depending upon the severity
of infection, administered in two divided doses.

Duration of treatment
The duration of treatment depends upon the severity of infection, clinical
response and bacteriological findings. For acute infections the usual
treatment period is 5 to 10 days with Neofloxin tablets. Generally
treatment should be continued for 3 days after the signs and symptoms of
the infection have disappeared.

Contraindication
Ciprofloxacin is contraindicated in patients who have shown
hypersensitivity to Ciprofloxacin or other quinolones. Ciprofloxacin is
also contraindicated in children and growing adolescents except where the
benefits of treatment exceed the risks.

Warning and Precautions


Ciprofloxacin should be used with caution in patients with a history of
convulsive disorders. Crystalluria related to the use of Ciprofloxacin has
been observed only rarely. Patients receiving Ciprofloxacin should be well
hydrated and excessive alkalinity of the urine should be avoided.

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T H E R A P E U T I C I N D E X

Drug interactions
Concurrent administration of Ciprofloxacin with Theophylline may lead
to elevated plasma concentrations of Theophylline and prolongation of
its elimination half-life. This may result in increased risk of Theophylline
related adverse reactions. If concomitant use cannot be avoided plasma
levels of Theophylline should be monitored and dosage adjustments
made as appropriate.

Antacids containing Magnesium Hydroxide or Aluminium Hydroxide


may interfere with the absorption of Ciprofloxacin resulting in serum and
urine levels lower than desired, concurrent administration of these agents
with Ciprofloxacin should be avoided. Probenecid interferes with renal
tubular secretion of Ciprofloxacin and produces an increase in the level
of Ciprofloxacin in the serum. This should be considered if patients are
receiving both drugs concomitantly. As with other broad spectrum
antibiotics prolonged use of Ciprofloxacin may result in overgrowth of
nonsusceptible organism. Repeated evaluation of the patient’s condition
and microbial susceptibility testing is essential. If superinfection occurs
during therapy, appropriate measures should be taken.

Information for Patients


Patients should be advised that Ciprofloxacin may be taken with or
without meals. The preferred time of dosing is two hours after a meal.
Patients should also be advised to drink fluids liberally and not take
antacids containing magnesium or aluminium concomitantly or within
two hours after dosing. Ciprofloxacin may cause dizziness and light-
headedness, therefore patients should know how they react to this drug
before they operate an automobile or machinery or engage in activities
requiring mental alertness or coordination.

Use in Pregnancy and Lactation


Reproduction studies performed in mice, rats and rabbits using parenteral
and oral administration did not reveal any evidence of teratogenicity,
impairment of fertility or impairment of peri/post natal development.
However as with other quinolones, Ciprofloxacin has been shown to
cause arthropathy in immature animals and therefore its use during
pregnancy is not recommended. Studies in rats have indicated that
Ciprofloxacin is secreted in milk, administration to nursing mothers is
thus not recommended.

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T H E R A P E U T I C I N D E X

Overdosage
No information on overdosage is available. Routine measures such as
gastric lavage should be performed as soon as possible after ingestion of
Neofloxin tablets. Serum levels of Ciprofloxacin are reduced by dialysis.

Side Effects
Gastrointestinal : Nausea, diarrhoea, vomiting, dyspepsia, abdominal
pain. Central nervous system : Dizziness, headache, tiredness, confusion,
convulsions. Hypersensitivity reactions : Skin rashes, pruritus and possible
systemic reactions. The following other reactions have also been reported,
joint pain, mild photosensitivity and transient increase in liver enzymes
(particularly in patients with previous liver damage) serum bilirubin, urea
or creatinine levels.

Commercial Pack
Neofloxin Tablet : Box containing 5 blister strips of 10 film coated
tablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalent
to Ciprofloxacin 250 mg.

Neofloxin-500 Tablet : Box containing 4 blister strips of 10 film coated


tablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalent
to Ciprofloxacin 500 mg.

Neofloxin-750 Tablet : Box containing 3 blister strips of 10 film coated


tablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalent
to Ciprofloxacin 750 mg.

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T H E R A P E U T I C I N D E X

Neopril®
Tablet

Description
Neopril is a preparation of Lisinopril USP. Neopril is available in
potencies of 5 mg and 10 mg tablet.

Indications
Neopril (Lisinopril) is indicated for treatment of all grades of essential
hypertension and renovascular hypertension, where standard therapy is
ineffective or inappropriate because of adverse events. Neopril may be
used alone or with other antihypertensive agents.

Neopril is also indicated in the treatment of congestive heart failure as


adjunctive therapy with non-potassium sparing diuretics and, where
appropriate, with digitalis.

Dosage and Administration


Since absorption of Lisinopril is not affected by food, Neopril may be
administered before, during or after meal.

Essential Hypertension
The usual recommended starting dose is 10 mg once a day. Dosage
should be adjusted according to blood pressure response. The usual
effective maintenance dose is 20 mg administered in a single daily dose.
The maximum dose used in long term, controlled clinical trial was 80
mg/day, but does not appear to give a greater effect.

A lower starting dose is required in presence of renal impairment, in


patients in whom diuretic therapy cannot be discontinued, patients who
are volume and/or salt-depleted for any reason, and in patients with
renovascular hypertension.

Diuretic Treated Patients


Symptomatic hypotension may occur occasionally following initial dose
of Neopril. The diuretic should be discontinued, if possible, for two or
three days before starting therapy with Lisinopril to reduce the likelihood
of hypotension.

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T H E R A P E U T I C I N D E X

If the diuretic cannot be discontinued, an initial dose of 5 mg should be


used under medical supervision for at least 2 hours and until the blood
pressure has stabilized for at least an additional hour.

Use in Elderly
Blood pressure response and adverse experiences were similar in younger
and older patients. Pharmacokinetic studies, however, indicate that
maximum blood levels and area under the plasma concentration time
curve (AUC) are doubled in older patients, so that dosage adjustment
should be made with particular caution.

Dosage Adjustment in Renal Impairment :

Dosage adjustment should be based on creatinine clearance in case of


renal impairment " -

Renal status Creatinine clearance Initial dose


ml/min mg/day

Normal Renal Function 30 ml/min 10 mg


to mild impairment

Moderate to severe 10-30 ml/min 5 mg


impairment

Dialysis Patients <10 ml/min 2.5 mg

Renovascular Hypertension
Some patients with renovascular hypertension, especially those with
bilateral renal artery stenosis or stenosis of the artery to a solitary kidney,
may develop an exaggerated response to the first dose of Neopril.
Therefore, a lower starting dose of 2.5 or 5 mg is recommended.
Thereafter, the dosage may be adjusted according to the blood pressure
response.

Congestive Heart Failure


In patients, not adequately controlled by digitalis and/or diuretics,
Neopril may be added with a starting dose of 2.5 mg once a day. The

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T H E R A P E U T I C I N D E X

usual effective dosage range is 5 to 20 mg per day administered in a single


daily dose.

Contraindication
Neopril is contraindicated in pregnancy and treatment should be stopped
if pregnancy is suspected, because it has been shown to be foetotoxic in
rabbits.

Neopril is also contraindicated in patients who are hypersensitive to any


component of this product and in patients with a history of
angioneurotic oedema relating to previous treatment with an angiotensin-
converting enzyme (ACE) inhibitor.

Precautions
Hypotension : Excessive hypotension was rarely seen in uncomplicated
hypertensive patients. However, because of the potential fall in blood
pressure in patients with severe congestive heart failure with or without
associated renal insufficiency, therapy should be started under very close
medical supervision. Such patients should be followed closely for the first
two weeks of treatment and whenever the dose of Neopril and/or
diuretic is increased. Similar considerations should be applied to patients
with ischaemic heart disease or cerebrovascular disease in whom an
excessive fall in blood pressure could result in a myocardial infarction or
cerebrovascular accident.

If hypotension occurs, the patient should be placed in supine position


and if necessary receive an intravenous infusion of normal saline. A
transient hypotensive response is not a contraindication to further doses
which usually can be given without difficulty once the blood pressure has
increased after volume expansion.

Renal Function Impairment : In patients with congestive heart failure,


hypotension following the initiation of therapy with ACE inhibitors may
lead to some further impairment in renal function. Reversible acute renal
failure has been reported in this situation.

Reversible increase of blood urea and serum creatinine have been


reported in some patients with bilateral renal artery stenosis or stenosis of
the artery to a solitary kidney.

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T H E R A P E U T I C I N D E X

Hypersensitivity/Angioneurotic Oedema : Angioneurotic oedema of the face,


extremities, lips, tongue, glottis and/or larynx has been reported rarely in
patients treated with ACE inhibitors, including Neopril. In such cases
lisinopril should be discontinued promptly and appropriate monitoring
should be instituted to ensure complete resolution of symptoms prior to
dismissal of the patient. In those instances where swelling is confined to
the face and lips, the condition generally resolves without treatment,
although antihistamines have been useful in relieving symptoms.

Angioneurotic oedema associated with laryngeal oedema may be fatal.


Where there is involvement of the tongue, glottis and larynx, likely to
cause airway obstruction, appropriate therapy such as subcutaneous
adrenaline solution 1:1000 (0.3 ml to 0.5 ml) should be administered
promptly.

Cough : Cough has been reported with the use of ACE inhibitors.

Surgery/Anaesthesia : In patients undergoing major surgery or during


anaesthesia with agents that produce hypotension, Neopril may block
angiotensin II formation, secondary to compensatory renin release. If
hypotension occurs and is considered to be due to this mechanism, it can
be corrected by volume expansion.

Paediatric Use : Safety and effectiveness of Lisinopril have not been


established.

Diuretics : When a diuretic is added to the therapy of a patient receiving


Lisinopril, the antihypertensive effect is usually additive.

Patients already on diuretics and especially those in whom diuretic therapy


was recently instituted may occasionally experience an excessive reduction
of blood pressure when Lisinopril is added. The possibility of
symptomatic hypotension with Lisinopril can be minimized by
discontinuing the diuretic prior to initiation of treatment with Lisinopril.

Other Agents : Indomethacin may diminish the antihypertensive efficacy of


concomitantly administered Lisinopril.

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T H E R A P E U T I C I N D E X

Lisinopril has been used concomitantly with nitrates without evidence of


clinically significant adverse interactions.

Use in Pregnancy and Lactation


There is no adequate and well controlled studies of Lisinopril in pregnant
women. However, data are available that indicate that ACE inhibitors can
cause foetal and neonatal morbidity and mortality when administered to
pregnant women; therefore, the use of Lisinopril during pregnancy is not
recommended unless needed in a situation where other drugs cannot be
used or are ineffective.

Lisinopril crosses the human placenta. Infants whose mothers have taken
Lisinopril should be closely observed. It is not known whether exposure,
limited to the first trimester, can adversely affect foetal outcome.
However, complications including foetal hypotension, renal failure and
oligohydramnios have been reported when Lisinopril was used during the
later stages of pregnancy. Hyperkalaemia and/or skull hypoplasia has
occurred with the use of other ACE inhibitors during the second and
third trimesters. Maternal oligohydramnios, presumably representing
decreased renal function in the foetus may result in limb contracture and
craniofacial deformations. If oligohydramnios is observed Lisinopril
should be discontinued unless it is considered life saving for the mother.

It is not known whether Lisinopril is secreted in human milk. Because


many drugs are secreted in human milk, caution should be exercised if
Lisinopril is given to nursing mother.

Overdosage
There is no data on overdosage in human. The most likely manifestation
of overdose would be hypotension, for which the usual treatment would
be intravenous infusion of normal saline. Lisinopril may be removed
from the general circulation by haemodialysis.

Side Effects
The most frequent clinical side-effects of Lisinopril in controlled trials
were dizziness, headache, diarrhoea, fatigue, cough and nausea. Other side
effects occurring less frequently were orthostatic effects (including
hypotension), rash etc.

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Cardiovascular : Myocardial infarction or cerebrovascular accident possibly


secondary to excessive hypotension in high risk patients. Palpitation and
tachycardia may be developed.

Gastrointestinal tract : Abdominal pain, dry mouth, hepatitis, jaundice.

Nervous system : Mood alteration, mental confusion.

Respiratory tract : Bronchitis, pharyngeal pain.

Special senses : Blurred vision.

Urogenital tract : Uraemia, oliguria/anuria renal dysfunction, acute renal


failure in rare cases.

A symptom complex with Lisinopril has been reported which may


include fever, vasculitis, myalgia, arthralgia/arthritis, a positive ANA,
elevated ESR, eosinophilia, and leukocytosis. Rash, photosensitivity or
other dermatological manifestations may also occur.

Pharmaceutical Precaution
Store at room temperature.

Commercial Pack
Neopril-5 Tablet : Box containing 10 blister strips of 10 tablets, each
tablet contains Lisinopril USP equivalent to 5 mg anhydrous Lisinopril.

Neopril-10 Tablet : Box containing 5 blister strips of 10 tablets, each


tablet contains Lisinopril USP equivalent to 10 mg anhydrous Lisinopril.

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Neosten®
Cream

Description
Neosten (Clotrimazole) has a reliable action on dermatophytes, yeasts and
other fungi. Neosten cream contains 1.0% Clotrimazole BP.

Indications
The confirmed indications for Neosten include :
♦ all dermatomycoses due to dermatophytes (e.g. Trichophyton species)

♦ all dermatomycoses due to yeasts (Candida species)

♦ dermatomycoses due to moulds and other fungi

♦ skin diseases showing superinfections with these fungi.

The above mentioned dermatomycoses include interdigital mycoses (e.g.


Athlete’s foot), paronychias (associated with nail mycoses), mycoses in
skin folds, candida vulvitis, candida balanitis, pityriasis versicolour,
erythrasma.
Application and Usage
Wash skin with soap and water and dry thoroughly. Apply a thin layer of
the cream 2-3 times daily and gently massage over affected area as
directed by the doctor. For Athlete’s foot, pay special attention to the
spaces between the toes. Best results in Athlete’s foot and ringworm are
usually obtained with 4 weeks use of this product. The cream should be
applied two or three times daily for one month or for at least two weeks
after the disappearance of all signs of infection. If satisfactory results
have not occurred within these times consultation with doctor is essential.

For best results, follow directions and continue treatment for length of
time indicated.
The duration of treatment varies; it depends among other factors on the
extent and localization of the disease.

Recommended duration of treatment :


Dermatomycoses : 3-4 weeks
Candida vulvitis and candida balanitis : 1-2 weeks
Erythrasma and pityriasis versicolor (approx.) : 3 weeks

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In fungal infection of the feet, to prevent relapses, treatment should be


continued for about 2 weeks beyond the disappearance of all signs of
disease.

Neosten cream is odourless, can be washed off and does not stain.

Tolerance
When applied topically Neosten cream is well tolerated. With external
application systemic effects are not observed. Local irritation or burning
sensation may occur in a very few cases but these symptoms are not
considered harmful.

Commercial Pack
Neosten Cream : Tube containing 20 g cream, each gram contains
Clotrimazole BP 10 mg.

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Neosten®VT
Vaginal Tablet

Description
Neosten VT acts reliably on dermatophytes, yeasts and other fungi; it is
also effective against Trichomonas vaginalis and Gram-positive
microorganisms (streptococci/staphylococci) and Gram-negative
microorganisms (Bacteroides/Haemophilus vaginalis). Each Neosten vaginal
tablet contains Clotrimazole BP 0.2 g. It has broad-spectrum antimycotic
with fungicidal and trichomonacidal action.

Indications
♦ Infectious vaginal discharge

♦ Vaginitis due to fungi (mainly Candida and/or Trichomonas)

♦ Superinfections with Neosten VT-sensitive bacteria

Dosage and Application


In general, a 3-day treatment is sufficient for candida vaginitis. On three
consecutive nights, one Neosten vaginal tablet is inserted as deeply as
possible into the vagina. This is best achieved when lying on one’s back
with the knees slightly bent. If necessary, one Neosten vaginal tablet daily
can be used unhesitatingly for 6-12 days.

Treatment should be timed so as to avoid the menstrual period and be


finished before the onset of menstruation.

To avoid reinfection, the partner should undergo local treatment with


Neosten cream at the same time.

Tolerance
Since there is practically no Neosten absorption through the vaginal skin,
no systemic effects are expected. The local tolerance of Neosten vaginal
tablets is generally good. Local irritation or burning sensation may occur
in a very few cases but these symptoms are not considered harmful.

Experimental and clinical studies on the use of Neosten vaginal tablets


during pregnancy gave no indication of harmful effect on mother and

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child. The use of Neosten VT during the last 4-6 weeks of pregnancy is
recommended for the purpose of sanitation of the birth canal.

Commercial Pack
Neosten VT : Pack containing 3 vaginal tablets of Clotrimazole BP 0.2 g,
each sealed in aluminium strip with applicator.

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Nightus ®
Tablet

Description
Nightus tablet contains Bromazepam BP 3 mg. It is a global anxiolytic
with smooth and superior efficacy. Unlike other benzodiazepines it has
least side effects. Bromazepam reaches peak plasma concentrations within
two hours after oral administration. Bromazepam is metabolized in the
liver. It effectively removes anxiety and anxiety related various
physiological problems.

Indications
Nightus is indicated for the following indications :

♦ Emotional disturbance such as anxiety and tension states, for anxiety in


depressed patients, nervous tension, restlessness anxiety and tension
related insomnia.
♦ Functional disturbances of the cardiovascular and respiratory systems
such as pseudo angina pectoris, tachycardia, hypertension,
hyperventilation.
♦ Functional disturbances of the gastrointestinal tract such as irritable
bowel syndrome, ulcerative colitis, epigastric pain, spasm.
♦ Other psychosomatic disturbances such as psychogenic headache.

Dosage and Administration


Recommended dose is 1.5-12 mg three times daily. The dose depends on
according to condition or patient response, and also side effect profile.
Average outpatient dosage : 1.5-3 mg three times a day. Severe
cases/hospital 5-12 mg two to three times daily. Reduce dose in half for
elderly.

Contraindication
Bromazepam is contraindicated in patients with known hypersensitivity to
benzodiazepines. It is also contraindicated in severe respiratory failure,
myasthenia graves and severe liver failure.

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Precautions
Bromazepam should be used cautiously in respiratory diseases, muscle
weakness, and history of alcohol or drug abuse.

Side Effects
Drowsiness, lightheadedness in the next day, confusion, ataxia and
amnesia may occur.

Use in Pregnancy and Lactation


The administration of Bromazepam is rarely justified in women and child
bearing potential. Bromazepam should be avoided during breast feeding.

Drug Interaction
Phenothiazines, barbiturates, MAO inhibitors and psychoactive drugs
may potentiate the action of Bromazepam and should not be given
concurrently.

Commercial Pack
Nightus Tablet : Box containing 10 x 10 tablets in a blister pack. Each
tablet contains Bromazepam BP 3mg.

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Noscab®
Cream

Description
Noscab cream is a preparation of 5% (w/w) Permethrin INN.
Permethrin is a photo stable synthetic pyrethroid that possesses a broad
spectrum of insecticidal activity and is generally rated as the safest
insecticide because of its low primary toxicity.

Along with the pediculicidal activity Permethrin has ovicidal and


scabicidal activity. The insect rapidly absorbs Permethrin via mouth,
respiratory tract or the intact cuticle. Although the primary target tissue is
the nervous system, insects are killed by a complex series of reactions in
various organs such as metabolic exhaustion and paralysis of the nervous
system. Permethrin induces electrochemical abnormalities across the
membranes of excitable cells, leading to sensory hyperexcitability in
coordination and prostration.

Indications
Noscab is indicated for the treatment of scabies.

Dosage and Application


♦ Adults and children (over 12 years)- A full tube

♦ Children aged 6-12 years- up to half of a tube

♦ Children aged 1-5 years- up to one fourth of a tube

♦ Children aged 2 months to 1 year- up to one eighth of a tube

Patients of >2 months of age can use Noscab cream. Cream should be
applied to clean, dry and cool skin. If the body is hot due to warm bath
or any other reason, skin should be allowed to cool down. It should be
applied to the whole body excluding head. The whole body should be
washed thoroughly 8-12 hours after treatment. Adults and children above
12 years will use a full tube as a single dose. If necessary maximum two
tubes can be used as a single dose.

The cream should not be applied to the vicinity of mouth and areas close
to the eyes.

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Contraindication
Permethrin is contraindicated in patients with known hypersensitivity to
the product, its components, other pyrethroids or pyrethrins.

Precautions
Noscab is not an eye irritant, but the cream itself may cause marked
irritation. Nursing staff who routinely apply Noscab, may wear gloves to
avoid any possible irritation to the hands.

Side Effects
In scabies patients, skin discomfort, usually described as burning, stinging
or tingling occurs in a few individuals soon after the cream is applied.
Other transient effects are erythema, numbness, rash and pruritus.

Overdosage
There is no reports of overdosage with Permethrin. It is possible that
excessive application of Permethrin might result in localized adverse
reactions or more severe skin reactions.

Drug Interactions
The treatment of eczematous like reactions with corticosteroids should
be withheld prior to treatment with Permethrin, as there is a risk of
exacerbating the scabies infestation by reducing the immune response to
the mite.

Use in Pregnancy and Lactation


There are limited data on the use of Permethrin in pregnancy which
provide no indication of any risk to the foetus. Furthermore, the amount
of Permethrin absorbed systemically following a whole body application
is extremely low. The negative mutagenicity tests and the very low
mammalian toxicity would suggest that any risk to the foetus following
treatment with Permethrin is minimal. Consideration should be given to
discontinuing nursing temporarily or to withholding the drug while the
mother is nursing, although drug levels in breast milk following topical
application are likely to be very low.

Commercial Pack
Noscab Cream : Each pack has a tube containing 25 g of Noscab cream.
Each gram contains Permethrin INN 50 mg.

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Nuprafen®
Tablet

Description
Nuprafen (Naproxen), a non-steroidal anti-inflammatory agent, is a
preparation of (+)-6-Methoxy-a-methyl-2-naphthalene acetic acid. It has
analgesic, anti-inflammatory and antipyretic properties. It is an inhibitor
of prostaglandin synthetase.

Indications
Nuprafen is indicated in mild to moderate pain such as dysmenorrhoea,
migraine and for the treatment of rheumatoid arthritis, osteoarthritis
(degenerative arthritis), ankylosing spondylitis, juvenile rheumatoid
arthritis, acute gout, and acute musculoskeletal disorders.

Dosage and Administration


Adults : For rheumatoid arthritis, osteoarthritis and ankylosing
spondylitis, the usual dose is 500 mg to 1 g per day taken in two divided
doses at 12 hour intervals. For mild to moderate pain such as primary
dysmenorrhoea, acute tendinitis and bursitis, the usual initial dose is 500
mg followed by 250 mg every 6 or 8 hours. The total daily dose should
not exceed 1250 mg.

In acute gout an initial dose of 750 mg followed by 250 mg every 8 hours


has been suggested until the attack subsides.

For juvenile arthritis : A dose of 10 mg/kg body weight daily in 2 divided


doses in children over 5 years of age has been recommended.

In the acute phase of the following cases a loading dose of 750 mg per
day is recommended.

♦ In patients reporting severe night time pain and morning stiffness.


♦ In patients being switched to Nuprafen (Naproxen) from a high dose
of another anti-rheumatic compound.
♦ In osteo-arthrosis where pain is the predominant symptom.

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Contraindication
The drug is contraindicated in patients who are allergic to Naproxen or
Naproxen Sodium. It is also contraindicated in patients in whom Aspirin
or other non-steroidal anti-inflammatory/analgesic drug induce the
symptoms of asthma, rhinitis and nasal polyps.

Drug Interactions
Due to the high plasma protein binding of Naproxen, patients
simultaneously receiving Hydantoin, anti-coagulants or a highly protein
bound sulphonamide should be observed for signs of overdosage of
these drugs. Naproxen and other non-steroidal anti-inflammatory drugs
(NSAIDs) can reduce the antihypertensive effect of Propranolol and
other β- blockers. Probenecid given concurrently, increases the plasma
level of Naproxen and extends its plasma half life considerably.

Side Effects
Occasional skin rashes and angioedema have been reported. The
following additional occurrences have been reported with Naproxen :
nausea, vomiting, abdominal discomfort, epigastric distress, headache,
inability to concentrate, insomnia, tinnitus and vertigo.

Thrombocytopenia, jaundice, aplastic anaemia, haemolytic anaemia,


peptic ulceration, fatal hepatitis, hearing impairment, cognitive
dysfunction, anaphylactic reactions to Naproxen and Naproxen sodium
formulations and nephropathy may occur rarely.

Mild peripheral oedema has been observed in a few patients receiving


Naproxen. Although sodium retention has not been reported in
metabolic studies, it is possible that patients with questionable or
compromised cardiac function may be at a greater risk when taking
Naproxen.

Use in Pregnancy and Lactation


There are no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human
response, Naproxen should be used during pregnancy only if the
potential benefits justify the potential risks to the foetus. The Naproxen
anion has been found in the milk of lactating women. Because of the
possible adverse effects of prostaglandin-inhibiting drugs on neonates,
use in nursing mothers should be avoided.

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Overdosage
Significant overdosage of the drug may be characterized by drowsiness,
heartburn, indigestion, nausea or vomiting.

No evidence of toxicity has been reported 5-15 months after ingestion of


the drug for three to seven days with doses up to 3 g/day.

Pharmaceutical Precaution
Protect from heat and direct sunlight.

Commercial Pack
Nuprafen 250 Tablet : Box containing 10 blister strips of 10 tablets, each
tablet contains 250 mg of Naproxen USP.

Nuprafen 500 Tablet : Box containing 5 blister strips of 10 tablets, each


tablet contains 500 mg of Naproxen USP.

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Odrel®
Tablet

Description
Odrel (Clopidogrel) is an inhibitor of ADP-induced platelet aggregation
acting by direct inhibition of adenosine diphosphate (ADP) binding to its
receptor and of the subsequent ADP-mediated activation of the
glycoprotein GPIIb/IIIa complex. Each tablet contains Clopidogrel
Bisulfate INN equivalent to 75 mg Clopidogrel.

Indications
Odrel is indicated for the reduction of atherosclerotic events (myocardial
infarction, stroke and vascular death) in patients with atherosclerosis
documented by recent stroke, recent myocardial infarction or established
peripheral arterial disease.

Dosage and Administration


The recommended dose of Odrel is 75 mg once daily with or without
food. No dosage adjustment is necessary for elderly patients or patients
with renal disease.

Contraindication
The use of Odrel is contraindicated in the following conditions :
i) Hypersensitivity to any component of the product and ii) Active
pathological bleeding such as peptic ulcer or intracranial haemorrhage.

Side Effects
The most common clinically important side effects are pruritus, purpura,
diarrhoea and rash. Infrequent events include intracranial haemorrhage
(0.4%) and severe neutropaenia (0.04%).

Use in Special Population


Hepatic impaired patients : Odrel should be used with caution in this
population.

Paediatric patients : Safety and effectiveness in the paediatric population


have not been established.

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Pregnancy : Animal studies revealed no evidence of impaired fertility or


foetotoxicity due to Clopidogrel. There are, however, no adequate and
well-controlled studies in pregnant women. Because animal studies are
not always predictive of a human response, Odrel should be used during
pregnancy only if clearly needed.

Precautions
As with other antiplatelet agents, Odrel should be used with caution in
patients who may be at risk of increased bleeding from trauma, surgery
or other pathological conditions. If a patient is to undergo surgery and an
antiplatelet effect is not desired, Odrel should be discontinued 7 days
prior to surgery.

Odrel prolongs the bleeding time. Patients should be told that it might
take them longer than usual to stop bleeding when they take Odrel and
that they should report any unusual bleeding to their physician.

Drug Interactions
Concomitant administration of Clopidogrel with NSAIDs, Warfarin or
Heparin should be undertaken with caution.

Overdosage
No adverse events were reported after single oral administration of 600
mg (equivalent to 8 standard 75 mg tablets) of Clopidogrel in healthy
volunteers. The bleeding time was prolonged by a factor of 1.7, which is
similar to that typically observed with the therapeutic dose of 75 mg of
Clopidogrel per day. If quick reversal is required, platelet transfusion may
be appropriate to reverse the pharmacological effects.

Pharmaceutical Precaution
Store at temperature between 15o C and 30o C.

Commercial Pack
Odrel Tablet : Box containing 10 tablets in 1 x 10’s blister strip. Each
tablets contains Clopidogrel Bisulfate INN equivalent to 75 mg of
Clopidogrel.

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Omastin®
Capsule/Suspension

Description
Omastin (Fluconazole) is a triazole antifungal agent. It is a potent and
selective inhibitor of fungal cytochrome P450 dependent enzymes
necessary for the synthesis of ergosterol.

Indications
♦ Vaginal Candidiasis

♦ Oropharyngeal Candidiasis

♦ Oesophageal Candidiasis

♦ Systemic Candidiasis and Cryptococcal infection

♦ Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea

♦ Kerion

♦ Pityriasis versicolor

♦ Onychomycosis

Dosage and Administration


Recommended dosages are given below, and this regimen is
recommended from early infection to severe infections.
→ 150 mg as a single dose or 200 mg in 1st day followed by 100 mg daily

for 14 days
→ 200
→ mg in 1st day followed by 100 mg daily for 14-30 days.
→ 400
→ mg in 1st day followed by 200 mg daily for 28 days or longer based
on clinical response
→ 150
→ mg weekly for 4-6 weeks
→ 50
→ mg daily for 20 days
→ 400
→ mg as a single dose
→ 150
→ mg weekly for 12 months.

Child over 1 year


♦ In Superficial Candidiasis- 1-2 mg/kg daily

♦ In Systemic Candidiasis and Cryptococcal infection- 3-6 mg/kg daily

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In serious life threatening infections up to 12 mg/kg daily has been given


to children aged 5-13 years (Maximum 400 mg daily)

Age Average weight Dose/Day


1 year 9 kg ½ spoonful
1-2 years 12 kg 1 spoonful
2-3 years 14 kg 1½ spoonful
3-4 years 16 kg 2 spoonful
4-6 years 20 kg 2½ spoonful
The daily dose of Omastin should be based on the nature and severity of
the fungal infection. Most cases of fungal infections require multiple dose
therapy. Treatment should be continued until clinical parameters or
laboratory tests indicate that active fungal infection has subsided. An
inadequate period of treatment may lead to recurrence of active
infection. Immuno-compromised patients usually require maintenance
therapy to prevent relapse.
Other indications
♦ Fungal urinary tract infections
♦ Disseminated candidiasis
♦ Prophylaxis for fungal infection in neutropenic cancer patients.
♦ Acute treatment of other systemic fungal infections such as
coccidioidomycosis and histoplasmosis

Use in the Elderly


The normal dose should be used if there is no evidence of renal
impairment.

Use in Renal Impairment


No adjustment in single dose therapy is required. In multiple dose therapy
of patients with renal impairment, normal doses should be given on days
1 and 2 of treatment and thereafter the dosage intervals should be
modified as follows:
Creatinine clearance Dosage interval
(ml/min) (hours)
>41 24
21-40 48
10-20 72
Patients receiving regular One dose after every
dialysis dialysis session

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Paediatric Use
Few formal studies have been done in children. Doses of 3-6 mg/kg daily
have been used without serious adverse reactions being reported. Renal
clearance in children may be proportionately more rapid than in adults
and doses up to 12 mg/kg is recommended.

Effects on Liver
For the liver as a potential target organ, the available data indicate that,
Fluconazole is not predictable hepatotoxic drug in man. In man, including
those with existing hypercholesterolaemia, serum cholesterol is not
adversely affected by Fluconazole.

Use in Pregnancy and Lactation


Adverse foetal effects have been seen in animals only at doses ranging
from 80 mg/kg to 320 mg/kg with maternal toxicity. These levels are 20-
60 times the recommended therapeutic use. Still Fluconazole should be
used in pregnancy only if the potential benefit justifies the possible risk
to the foetus.

Fluconazole is secreted in human milk at concentrations similar to


plasma. Therefore, the use of fluconazole in nursing mother is not
recommended.

Contraindication
Fluconazole should not be used in patients with known hypersensitivity
to Fluconazole or to related triazole compounds.

Drug Interactions
Fluconazole acts by inhibiting fungal cytochrome P450 enzymes. It is
much less active against mammalian P450 enzymes, still potential exists
for interaction with drugs that are metabolized by P450.
♦ Cyclosporin
Some data suggest that Fluconazole increases cyclosporin levels.
♦ Phenytoin
Fluconazole significantly increases Phenytoin levels.
♦ Anticoagulants
Fluconazole has shown to prolong prothrombin time in subjects
receiving Warfarin.

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♦ Oral hypoglycaemics
Fluconazole has been shown to prolong the serum half life of
concomitantly administered Tolbutamide. However no adverse
effect on serum glucose levels was seen.
♦ Rifampicin
Decreases levels of Fluconazole.
♦ Oral contraceptives
No clinically significant interactions have been seen.

Side Effects
Therapy with Fluconazole is well tolerated. In 4000 patients receiving
Fluconazole for various indications and for durations of 7 days or more,
the incidence of side effects were 16% . Only 1.5% of subjects required
discontinuation of medication. The most common adverse events were
related to the gastrointestinal system : nausea (3.7%), abdominal pain
(1.17%), vomiting (1.7%) and diarrhoea (1.5%). Headache (1.9%) and
skin rash (1.8%) were also seen. It should be noted that approximately
one third of this group were patients with acquired immunodeficiency
syndrome (AIDS) and severe systemic disorders. Therefore the data may
not be applicable to patients receiving Fluconazole for the treatment of
superficial mycoses.

Overdosage
In the case of overdose, supportive measures and gastric lavage should be
instituted. If deemed necessary, a 3 hours haemodialysis will decrease
plasma levels by about 50%.

Pharmaceutical Precaution
Omastin should be stored below 30°C.

Commercial Pack
Omastin-50 Capsule : Box containing 5 aluminium strips of 10 capsules,
each capsule contains Fluconazole INN 50 mg.

Omastin-150 Capsule : Box containing 2 blister strips of 10 capsules, each


capsule contains Fluconazole INN 150 mg.

Omastin Suspension : Dry powder in glass bottle for reconstitution into


35 ml of suspension. After reconstitution, each 5 ml contains Fluconazole
INN 50 mg.

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Opton®
Tablet

Description
Esomeprazole is the S-isomer of Omeprazole. It reduces gastric acid
secretion through a specific targeted mechanism of action. It is a specific
inhibitor of the acid pump in the parietal cell. Each enteric coated tablet
contains 20 mg Esomeprazole INN (as Magnesium Trihydrate).

Indications
♦ Healing of erosive oesophagitis
♦ Long-term management of Oesophagitis

♦ Symptomatic gastro-oesophageal reflux disease (GERD)

♦ H. pylori Eradication for treatment of duodenal ulcer. (Triple Therapy


with Esomeprazole, Clarithromycin and Amoxicillin).

Dosage and Administration


Healing of erosive oesophagitis : 20 mg or 40 mg once daily for 4 to 8
Weeks. For those patients who have not healed after 4-8 weeks of
treatment, an additional 4-8 week course of Esomeprazole may be
considered.

Long-term management of oesophagitis : 20 mg once daily.

Symptomatic GERD : 20 mg once daily for 4 weeks.

H. pylori eradication for treatment of duodenal ulcer : Triple Therapy- 20


mg Esomeprazole once daily with 500 mg Clarithromycin twice daily, and
1 g Amoxicillin twice daily for 7-10 days.

Contraindication
Patients with known hypersensitivity to any component of the
formulation.

Side Effects
In general, Esomeprazole is well tolerated in both short and long-term
use. Common adverse events are headache and diarrhoea. Other side

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T H E R A P E U T I C I N D E X

effects include nausea, flatulence, abdominal pain, constipation, and dry


mouth.

Use in Special Population


Geriatric : Dosage adjustment is not necessary.

Pediatric : Safety and effectiveness in paediatric patients have not been


established.
Hepatic Insufficiency : No dosage adjustment is recommended for
patients with mild to moderate hepatic insufficiency. However, in patients
with severe hepatic insufficiency a dose of 20 mg once daily should not
be exceeded.

Renal Insufficiency : Dosage adjustment is not necessary.

Use in Pregnancy and Lactation


There are no adequate and well-controlled studies in pregnant women.
This drug should be used during pregnancy only if clearly needed. The
excretion of Esomeprazole in human milk has not been studied. Because
Esomeprazole is likely to be excreted in human milk, a decision should be
made whether to discontinue the drug.

Overdosage
There is no experience to date with deliberate overdose. Data are limited
but single doses of 80 mg Esomeprazole were uneventful. Esomeprazole
is extensively plasma protein bound and is therefore not readily dialysable.
As in any case of overdose, treatment should be symptomatic and general
supportive measures should be utilized.

Drug Interactions
Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole
may interfere with the absorption of drugs where gastric pH is an
important determinant of bioavailability (eg, Ketoconazole, Iron salts and
Digoxin).

Pharmaceutical Precaution
Store at temperature between 15οC and 30 οC.

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T H E R A P E U T I C I N D E X

Commercial Pack
Opton Tablet : Box containing 3 x 10 tablets in aluminium form pack.
Each tablet contains 20 mg Esomeprazole INN as (Magnesium
Trihydrate).

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Pacet®
Tablet

Description
Pacet (Amiodarone Hydrochloride) is used to correct abnormal rhythms
of the heart. Amiodarone is considered a "broad spectrum"
antiarrhythmic medication. The most important electrical effects of the
drug includes : a delay in the rate at which the heart’s electrical system
"recharges" after the heart contracts (repolarization); a prolongation in
the electrical phase during which the heart’s muscle cells are electrically
stimulated (action potential); a slowing of the speed of electrical
conduction (how fast each individual impulse is conducted through the
heart’s electrical system); a reduction in the rapidity of firing of the
normal generator of electrical impulses in the heart (the heart’s
pacemaker); and a slowing of conduction through various specialized
electrical pathways (called accessory pathways). In addition to being an
antiarrhythmic medication, Amiodarone also causes blood vessels to
dilate. Because of this effect it also may be of benefit in patients with
congestive heart failure. This effect can result in drop of blood pressure.

Indications
Amiodarone is used for many serious arrhythmias of the heart including
ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and atrial
flutter.

Dosage
Oral dose is 200 mg 3 times daily for 1 week reduced to 200 mg twice
daily or the minimum required to control arrhythmia. Amiodarone is
usually given in several daily doses to minimize stomach upset which is
seen more frequently with higher doses. For this same reason, it is also
recommended that Amiodarone should be taken with meals.

Side Effects
The most severe side effects of Amiodarone therapy are related to the
lungs. These reactions can be fatal. Patients should report any symptoms
of cough, fever, or painful breathing. Although quite rare, fatal liver
toxicity may occur with Amiodarone therapy.

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Reversible corneal microdeposits (sometimes with night glare), rarely


impaired vision due to optic neuritis; peripheral neuropathy and
myopathy (usually reversible on withdrawal); bradycardia and conduction
disturbances; phototoxicity and rarely persistent skin discolouration;
hypothyroidism, hyperthyroidism; raised serum transaminases; jaundice,
hepatitis and cirrhosis are reported.

Other rare complaints are nausea, vomiting, metallic taste, tremor,


sweating, vertigo, headache, sleeplessness, fatigue, alopecia, benign raised
intracranial pressure, ataxia, rashes, vasculitis, renal involvement,
thrombocytopenia, haemolytic or aplastic anaemia. In some cases, dose of
Amiodarone may be reduced. In other cases, Amiodarone therapy may
need to be stopped.

Use in Pregnancy and Lactation


In general, Amiodarone should not be administered during pregnancy
because there have been reports of hypo- or hyperthyroidism in infants
from oral Amiodarone use during pregnancy. If Amiodarone use is
considered essential, however, the patient should be warned of the risk to
the foetus. The safe use of Amiodarone in lactating women has not been
established.

Drug Interactions
Amiodarone may interact with β-blockers such as Atenolol, Propranolol,
Metoprolol, or certain calcium channel blockers, such as Verapamil or
Diltiazem, resulting in an excessively slow heart rate. Amiodarone
increases the blood levels of Digoxin when the two drugs are given
together. Flecainide blood concentrations increase by more than 50%
with Amiodarone. Procainamide and Quinidine concentrations increase
by 30-50% during the first week of Amiodarone therapy. Amiodarone
also can interact with tricyclic antidepressants (TCA). Amiodarone
interacts with Warfarin and increases the risk of bleeding. Amiodarone
inhibits the metabolism of Dextromethorphan.

Pharmaceutical Precaution
Tablets should be kept at room temperature, less than 30 °C.

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Commercial Pack
Pacet 100 Tablet : Box containing 3 x 10’s tablets in blister strips. Each
tablet contains Amiodarone Hydrochloride BP 100 mg.

Pacet 200 Tablet : Box containing 3 x 10’s tablets in blister strips. Each
tablet contains Amiodarone Hydrochloride BP 200 mg.

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Pedeamin ®
Syrup

Description
Amber glass bottle containing 100 ml syrup. Each 5 ml contains 10 mg
Diphenhydramine Hydrochloride BP.

Indications
Pedeamin is indicated for the treatment of following :
♦ Seasonal, perennial, vasomotor rhinitis
♦ Urticaria, angioneurotic oedema, anaphylaxis
♦ Pruiritic conditions
♦ Premedication for emesis and motion sickness
♦ Miscellaneous include Ménière’s disease and parkinsonism

Dosage and Administration


Adult
→ Most allergic conditions are controlled in adult with 25-50 mg three
times a day with a further 50 mg at night.
Children
→ 1 to 5 years of age : 5 mg i.e., 2.5 ml of elixir 4 times a day

→ More than 6 years of age : 10 mg i.e. 5 ml of elixir 4 times a day

Contraindication
♦ Any patients in whom drowsiness is undesirable e.g. drivers, machine
operators.
♦ Concomitant consumption of alcohol or central nervous system (CNS)
depressants will potentiate drowsiness.
♦ Patients with known hypersensitivity to Diphenhydramine or any
components of the product.
♦ Care should be taken in administration during pregnancy.

Use in Pregnancy and Lactation


Diphenhydramine cross the placenta. There has been a suggestion that
Diphenhydramine ingestion during pregnancy is associated with a higher
incidence of cleft palate. As for all drugs care should be taken when
prescribing Diphenhydramine during pregnancy and lactation.

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Side Effects
Side-effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurred
vision, diplopia, euphoria, and epigastric discomfort.

Drug Interactions
Diphenhydramine administration significantly reduces the absorption of
the antituberculous agent para-aminosalicyclic acid (PAS) from the
gastrointestinal tract.

CNS depressants may potentiate the sedative action of


Diphenhydramine. Anticholinergic drugs may potentiate
Diphenhydramine’s anticholinergic side effects.

Commercial Pack
Pedeamin Syrup : Amber glass bottle containing 100 ml syrup. Each 5 ml
contains 10 mg Diphenhydramine Hydrochloride BP.

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Pregvit®
Capsule

Description
Pregvit is a special preparation of Iron, Folic Acid, Vitamin B complex,
and Vitamin C. Iron is presented in timed release form to escape gastric
irritation. Each extended release capsule contains :
♦ Ferrous Sulphate BP 150 mg
♦ Folic Acid USP 0.5 mg
♦ Thiamine Mononitrate (vitamin B1) USP 2 mg
♦ Riboflavin (vitamin B2) USP 2 mg
♦ Nicotinamide (vitamin B3) USP 10 mg
♦ Pyridoxine Hydrochloride (vitamin B6) USP 1 mg
♦ Ascorbic Acid (vitamin C) USP 50 mg

Indications and Uses


Pregvit is indicated for the treatment and prophylaxis of Iron, Folic Acid,
Vitamin B complex and Vitamin C deficiency, or to meet extra need of
these vitamins and minerals especially in pregnancy or when planning for
pregnancy.

Dosage and Administration


Recommended adult dose is one capsule daily. In more severe deficiency
states, 2 capsules a day may be required or as directed by the physician.

Contraindication
This product is contraindicated in patients with a known hypersensitivity
to any of the ingredients. Iron therapy is contraindicated in
haemachromatosis and haemosiderosis, and in patients receiving repeated
blood transfusion or with anaemia not not due to by iron deficiency.

Should be given cautiously to patients taking Levodopa as one of the


ingredients of Pregvit (Pyridoxine) reduces the effect of Levodopa.

Side Effects
Generally well tolerated. However, a few gastrointestinal disorders and
allergic reactions may be occurred.

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Use in Pregnancy and Lactation


It is recommended during pregnancy and lactation.

Drug Interactions
Care should be taken when given to patients with Iron storage or Iron
absorption disease. Iron form chelates with antacids and Tetracycline and
absorption of all these may be impaired if taken concurrently.

Overdosage
Overdosage of Iron is dangerous, particularly in children and requires
immediate attention. Gastric lavage should be carried out in the early
stages, vomiting may also be induced.

Pharmaceutical Precaution
Store in a dry place below 25ºC. Protect from light and Keep out of reach
of children.

Commercial Pack
Pregvit Capsule : Each box contains 5 blister strips of 10 capsules each.
Each extended release capsule contains Ferrous Sulphate BP 150 mg,
Folic Acid USP 0.5 mg, Thiamine Mononitrate (vitamin B1) USP 2 mg,
Riboflavin (vitamin B2) USP 2 mg, Nicotinamide (vitamin B3) USP 10
mg, Pyridoxine Hydrochloride (vitamin B6) USP 1 mg, Ascorbic Acid
(vitamin C) USP 50 mg.

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Premil®
Tablet

Description
The active ingredient of Premil is Repaglinide. Repaglinide belongs to a
new class of oral antidiabetic drug called meglitinide which stimulates
insulin release from β-cells of pancreas.

Indications
Premil is indicated as an adjunct to diet and exercise to lower the blood
glucose level in patients with type 2 diabetes mellitus (NIDDM) whose
hyperglycaemia cannot be controlled satisfactorily by diet and exercise
alone. It is also indicated for use in combination with Metformin to lower
blood glucose in patients whose hyperglycaemia cannot be controlled by
exercise, diet, and either Repaglinide or Metformin alone.

Mechanism of Action
Repaglinide binds to specific receptors in the ß-cell membrane leading to
the closure of ATP-dependent K+ channels and the depolarization of ß-
cell membrane. This in turn, leads to Ca++ influx, increased intracellular
Ca+ + and the stimulation of insulin secretion.

Therapeutic Advantage
Premil is taken in relation to meal i.e. one meal one dose, no meal no dose.
Many oral blood glucose-lowering drugs release insulin throughout the
day, irrespective of taking meal or not. This may lead to hypoglycaemia if
a meal is missed or delayed. But Premil is different because it is taken
before meals. Premil begins to work very quickly to increase insulin level
while the food is digested and glucose enters the blood stream. Premil
helps body release insulin to handle the blood glucose from that meal.
Premil leaves the blood stream quickly, so that body doesn’t keep releasing
insulin. Thus it helps to release insulin when it is needed. Moreover, it
gives the flexibility to plan medication around meals instead of planning
meals around medication.

Dosage and Administration


Premil has to be taken just before or up to 30 minutes before the meal.
Premil can be taken two, three or four times a day, depending on how

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many meals are taken. If a meal is missed, Premil should also be avoided.
If an extra meal is taken, an extra dose of Premil should be taken with
that meal. If a dose of Premil is missed, it should not be taken between
meals. Rather the usual dose should be taken before the next meal.

The dose ranges from 0.5 to 4 mg before each meal. The starting dose of
Repaglinide in patients with HbA1c <8% is 0.5 mg before each meal. In
patients with HbA1c >8% the starting dose is 1 or 2 mg before each meal.
The dose may be increased gradually up to 4 mg before each meal.

Side Effects
Hypoglycaemia is possible with all blood glucose-lowering drugs. If there
are symptoms of low blood glucose (for example, headache, dizziness,
tiredness, nervousness or shakiness, rapid heartbeat, or nausea), blood
glucose should be tested right away. If it is low (less than 70 mg/dl on a
home glucose meter), a simple carbohydrate food (for example, orange
juice, quick-dissolving sugar, candies, or glucose tablets) should be taken.
If the symptoms do not go away, doctor should be informed.

Some of the other common symptoms reported by patients taking


Repaglinide include cold and flu-like symptoms, diarrhoea, joint ache, and
back pain.

There is some evidence that oral diabetes drugs may increase the risk of
heart problems. But experts are not sure what the real risk is, if any, from
taking oral diabetes medicine.

Drug Interactions
The dose of Premil may need to be adjusted, if taken with other
medications. The possible interactions of Repaglinide with other drugs
are : i) Inhibitors of the cytochrome P450 enzyme system (azole
antifungals and macrolides) may lead to lower Repaglinide clearance and
longer half life. ii) Inducers of the cytochrome P450 enzyme system
(Rifampin, Phenobarbital, Carbamazepine, Troglitazone, etc.) may
accelerate Repaglinide metabolism and shorten its effect. iii) Cimetidine
has no significant effect on Repaglinide absorption or clearance. iv)
Repaglinide has no significant effect on Digoxin, Theophyllin, or
Warfarin. v) Highly protein-bound drugs (e.g., NSAIDs) may increase the
plasma level of unbound Repaglinide and potentiate its glucose-lowering
effect. Thus, co-administration of these drugs with Repaglinide may

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increase the risk of hypoglycaemia. vi) The risk of hypoglycaemia may


also be increased when hypoglycaemic agents are co-administered with
certain drugs such as salicylates, sulfonamides, Chloramphenicol,
coumarins, Probenecid, monoamine oxidase (MAO) inhibitors, and beta
adrenergic blockers.

Contraindication
Premil is contraindicated in patients with diabetic ketoacidosis, with or
without coma, in patients with type I diabetes and in patients with known
hypersensitivity to any of the components of the product.

Precautions
Premil should also be used with caution in renal and hepatic insufficiency.
In pregnancy, safety of Repaglinide has not been established. Hence,
Premil should be used during pregnancy only if it is clearly needed. It is
not known whether Repaglinide is excreted in human milk. Because many
drugs are excreted in human milk and because of potential for serious
adverse reactions in nursing infants from Repaglinide, a decision should
be made whether to discontinue nursing or the drug, taking into account
the importance of the drug to the mother.

Accidental Overdosage
In clinical trials patients receiving up to 80 mg of Repaglinide developed
few adverse effects other than lowering of blood glucose. Hypoglycaemia
did not occur when meals were given with these high doses.
Hypoglycaemic symptoms without loss of consciousness or neurologic
findings should be treated aggressively with oral glucose. Patients should
be closely monitored for a minimum of 24 to 48 hours, since
hypoglycaemia may recur after apparent clinical recovery. There is no
evidence that Repaglinide is dialysable using haemodialysis. Severe
hypoglycaemic reactions with coma, seizure or other neurological
impairment occur infrequently but constitute medical emergencies
requiring immediate hospitalization. If hypoglycaemic coma is diagnosed
or suspected, the patient should be given a rapid intravenous injection of
concentrated (50%) glucose solution. This should be followed by a
continuous infusion of more dilute (10%) glucose solution at a rate that
will maintain the blood glucose at a level above 100 mg/dl.

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Pharmaceutical Precaution
Premil should be stored at room temperature away from moisture. Like
all other medications, Premil should be kept out of the reach of children.

Commercial Pack
Premil 0.5 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Each
tablet contains Repaglinide USP 0.5 mg.

Premil 1 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Each


tablet contains Repaglinide USP 1 mg.

Premil 2 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Each


tablet contains Repaglinide USP 2 mg.

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Pretin ®
Tablet

Description
Pretin is a potent, rapidly effective and long-acting non-sedative,
histamine H1 receptor antagonist, with anti-allergic properties. Each
tablet contains 10 mg of Loratadine INN.

Indications
Pretin is indicated for-
♦ Seasonal allergic rhinitis
♦ Perennial allergic rhinitis

♦ Sneezing, rhinorrhoea and itching

♦ Ocular itching and burning

♦ Chronic urticaria and other allergic dermatologic disorders

Dosage and Administration


Adult and children above 12 years of age : 10 mg (1 Pretin tablet) once-
a-day

Children
→ 6 - 12 year : 10 mg (1 Pretin tablet) once-a-day
→ 2 - 5 year : 5 mg (½ Pretin tablet) once-a-day

Safety and efficacy of Loratadine in children below 2 years of age have


not yet been established.

Contraindication
Loratadine is contraindicated in patients who have hypersensitivity or
idiosyncrasy to any of its component.

Side Effects
Potentially life threatening effects : No effects of this kind have been
encountered.

Acute overdose : No cases of acute overdose have been reported.

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Severe or irreversible side effects : No effects of this kind have been


reported.

Symptomatic side effects : Clinical trials suggest a very low rate of adverse
effects, comparable to placebo, in particular for CNS effects (including
sedation) and anticholinergic activity.

The lack of sedation by Loratadine was further confirmed by special


psychomotor studies such as the driving performance test.

Precautions
Neonates : The drug is not normally used in neonates

Lactating mothers : Like other H1 receptor antagonists, Loratadine is also


excreted in breast milk, so lactating mothers are advised not to take the
drug.

Children : There are no special precautions required for young children


over 2 years. But the safety and efficacy of Loratadine in children below
2 years of age have not yet been established.

Pregnant women : Although Loratadine was not found to be teratogenic in


animals, safe use of Loratadine during pregnancy has not been established.
There have been no case reports of any adverse foetal consequences. The
drug should be used only if the potential benefit justifies the potential risk
to the foetus.

Drug Interactions
There are no reports of potentially hazardous interactions with other
drugs to date. Psychomotor performance studies show that unlike other
H 1 receptor antagonists, Loratadine does not potentiate the effect of
alcohol when administered concomitantly with it.

Commercial Pack
Pretin Tablet : Box containing 10 blister strips of 10 tablets. Each tablet
contains Loratadine INN 10 mg.

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Primace®
Capsule

Description
Primace (Ramipril) is an angiotensin-converting enzyme (ACE) inhibitor,
which after hydrolysis to ramiprilat, blocks the conversion of angiotensin
I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE
by Ramipril results in decreased plasma angiotensin II, which leads to
decreased vasopressor activity and decreased aldosterone secretion. Thus
Ramipril exerts its antihypertensive activity. It is also effective in the
management of heart failure and reduction of the risk of stroke,
myocardial infarction and death from cardiovascular events. It is long
acting and well tolerated, so, can be used in long term therapy.

Indications
Primace is indicated in the following cases-
- Mild to severe hypertension
- Heart failure.
- To reduce the risk of stroke, myocardial infarction and death from
cardiovascular events in patients with a history of cardiovascular
disease.

Dosage and Administration


Hypertension: For the management of hypertension initial dose of
Primace is 1.25 mg daily, can be increased with an interval of 1-2 weeks;
usual dosage range is 2.5-5 mg daily up to a maximum of 10 mg daily.

Heart failure: In this case initial dose of Primace is 1.25 mg once daily
under supervision; dosage can be increased at intervals of 1-2 weeks;
maximum of 10 mg daily can be taken and if necessary in 2 divided doses.

For prophylaxis and after myocardial infarction (3-10 days after


infarction): Initial dose of Primace is 2.5 mg twice daily; can be increased
to 5 mg twice daily after 2 days; 2.5 mg to 5 mg twice daily for
maintenance.

Dosage in renal impairment: For the patient with hypertension and renal
impairment the recommended initial dose is 1.25 mg Primace once daily.

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Subsequent dosage should be titrated according to individual tolerance


and blood pressure response, up to a maximum of 5 mg daily. For the
patients with heart failure and renal impairment, the recommended dose
is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily
and up to a maximum dose of 2.5 mg twice daily depending upon clinical
response and tolerability.

Contraindication
Ramipril is contraindicated in patients who are hypersensitive to any
component of this product and in patients with a history of angioedema
related to previous treatment with ACE inhibitor.

Precautions
Ramipril should be used with caution in patients with impaired renal
function, hyperkalaemia, hypotension, and impaired hepatic function.

Side Effects
Ramipril is generally well tolerated. Dizziness, headache, fatigue and
asthenia are commonly reported side effects. Other side effects occurring
less frequently include symptomatic hypotension, cough, nausea,
vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc.
Angioneurotic oedema, anaphylactic reactions and hyperkalaemia have
also been reported rarely.

Use in Pregnancy and Lactation


Insufficient data is available for the use of Ramipril in pregnant and
lactating mothers. Therefore, the use of Ramipril in pregnancy and
lactation is not advisable.

Use in Children
No information is yet available in the use of Ramipril in children.

Drug Interactions
Concomitant administration with diuretics may lead to serious
hypotension, and in addition dangerous hyperkalaemia with potassium
sparing diuretics. Concomitant therapy with Lithium may increase the
serum Lithium concentration. NSAIDs may reduce the antihypertensive
effect of Ramipril and cause deterioration of renal function.

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Overdosage
Limited data on human overdosage are available. The most likely clinical
manifestations would be symptoms attributable to hypotension. Because
the hypotensive effect of Ramipril is achieved through vasodilation and
effective hypovolemia, it is reasonable to treat Ramipril overdose by
infusion of normal saline solution.

Commercial Pack
Primace 1.25 Capsule : Box contains 3 blister strips of 10 capsules. Each
capsule contains 1.25 mg of Ramipril BP.

Primace 2.50 Capsule : Box contains 3 blister strips of 10 capsules. Each


capsule contains 2.50 mg of Ramipril BP.

Primace 5 Capsule : Each box contains 3 blister strips of 10 capsules.


Each capsule contains 5 mg of Ramipril BP.

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Proceptin® -20
Capsule

Description
Proceptin capsule contains 20 mg of Omeprazole BP as enteric coated
granules.

Indications
Proceptin offers significant therapeutic gains in the treatment of acid
related diseases. Healing rates are high in duodenal ulcer, gastric ulcer and
erosive reflux oesophagitis; acid production is controlled effectively in
Zollinger-Ellison Syndrome, and symptom relief is prompt and sustained
in all indications.

Less clear-cut indications where benefit might be expected but where data
are limited include : ♦ Prevention of stress ulceration, ♦ Prevention of
acid aspiration syndrome and ♦ Treatment of upper gastrointestinal
bleeding.

Note : In comparative studies, Omeprazole has been found to produce


faster symptom relief and higher healing rates in a greater percentage of
patients than either Cimetidine or ranitidine, confirming the ‘therapeutic
gains’ achievable with Proceptin over existing therapies.

Dosage and Administration


Duodenal ulcer : 20 mg once daily for 4 weeks. In severe cases, 40 mg
once daily for 4 weeks.
Gastric ulcer : 20 mg once daily for 8 weeks. In severe cases, 40 mg once
daily for 8 weeks.

Erosive Reflux Oesophagitis : 20 mg once daily for 4 weeks. For those


not fully healed, to be continued for 4 more weeks.
Refractory Reflux Oesophagitis : 40 mg once daily for 8 weeks.

Zollinger-Ellison Syndrome : 60 mg once daily, adjusted individually and


continued as long as necessary.

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Most patients will be effectively controlled with 20-120 mg daily. Dosage


above 80 mg should be divided and given twice daily. Long-term
maintenance treatment with Proceptin is not recommended. Impaired
renal or hepatic function : Adjustment is not required. Patients with
severe liver disease should not require more than 20 mg Omeprazole
daily.

Contraindication
Omeprazole capsule is contraindicated in patients with known
hypersensitivity to any component of the formulation.

Use in Pregnancy and Lactation


There are no adequate or well controlled studies in this group of patients.
Omeprazole should not be given during pregnancy and lactation unless its
use is considered essential.

Paediatric Use
Safety and effectiveness in children have not been established.

Adverse Effects
Side effects reported with Omeprazole in clinical studies have included
nausea, diarrhoea, constipation, flatulence, abdominal colic, paraesthesia,
dizziness and headache but are rare. Skin rashes, leucopenia and transient
elevation of plasma activation of hepatic amino-transferases have been
observed occasionally in few patients and there has been no consistent
relationship with treatment.

Toxicology
In two 24-months carcinogenicity studies in rats, Omeprazole at daily
doses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day (approximately 4 to 352
times the human dose, based on a patient weight of 50 kg and a human
dose of 20 mg) produced gastric entero-chromaffin like (ECL) cell
carcinoids in a dose related manner in both male and female rats. No
treatment related mucosal changes have been observed in patients treated
continuously for periods up to 4 years.

Precautions
Symptomatic responses to therapy with Omeprazole does not preclude
the presence of gastric malignancy.

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Warning
In long-term (2 years) studies in rats, Omeprazole produced a dose related
increase in gastric carcinoid tumours. While available endoscopic
evaluations and histologic examinations of biopsy specimens from
human stomachs have not detected a risk from short-term exposure to
Omeprazole, further human data on the effects of sustained
hypochlorhydria and hypergastrinemia are needed to rule out the
possibility of an increased risk for the development of tumours in
humans receiving long-term therapy with Omeprazole.

Drug Interactions
Omeprazole can delay the elimination of Diazepam, Phenytoin and
Warfarin. Monitoring of patients receiving Warfarin or Phenytoin is
recommended and a reduction of Warfarin or Phenytoin dose may be
necessary when Omeprazole is added to treatment. Omeprazole does not
interfere with Theophylline or Propranolol metabolism.

Information for Patients


Proceptin should be taken before meals. Patients should be cautioned that
the capsules should not be opened, chewed or crushed and should be
swallowed whole.

Commercial Pack
Proceptin-20 Capsule : Box contains 3 blister strips of 10 capsules, each
capsule contains 20 mg of Omeprazole BP as enteric coated granules.

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Prosan®
Tablet

Description
Prosan (Losartan Potassium) is an angiotensin-II receptor (type AT1)
antagonist. Angiotensin-II is a potent vasoconstrictor, the primary
vasoactive hormone of the renin-angiotensin system and an important
component in the pathophysiology of hypertension. Losartan and its
principal active metabolite block the vasoconstrictor and aldosterone
secreting effects of angiotensin-II by selectively blocking the binding of
angiotensin-II to the AT1 receptor found in many tissues.

Indications
It is indicated for the treatment of hypertension. It may be used alone or
in combination with other antihypertensive agents.

Dosage and Administration


The usual starting dose is 50 mg once daily, with 25 mg used in patients
with possible depletion of intravascular volume (e.g., patients treated with
diuretics) and patients with a history of hepatic impairment. It can be
administered once or twice daily with total daily doses ranging from 25
mg to 100 mg.

Contraindication
Losartan Potassium is contraindicated in patients who are hypersensitive
to the active ingredient or any component of the drug.

Adverse Reactions
In clinical trials, dizziness was the only side effect reported that occurred
with an incidence greater than placebo in 1% patients treated with
Losartan. Rarely, rash was reported, although the incidence in controlled
clinical trials was less than placebo. Angioedema, involving swelling of the
face, lips and/or tongue, has been reported rarely in patients treated with
Losartan. The incidence of cough is similar to placebo and significantly
lower than that observed with ACE inhibitors.

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Use in Special Population


Children : There are no data on the safety or efficacy of Losartan in
children.

Pregnant women : Prosan must be discontinued as soon as possible when


pregnancy is detected. It should not be prescribed during lactation, as
there is no information in human on the passage of Losartan into breast
milk.

Elderly : In elderly patients up to 75 years of age, no dosage adjustment is


necessary.

Drug Interactions
No drug interactions of clinical significance have been identified.
Compounds that have been studied in clinical pharmacokinetic trials
include Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine,
Ketoconazole, and Phenobarbital.

Overdosage
Limited data are available regarding overdosage in human. The most likely
manifestation of overdosage would be hypotension and tachycardia.
Supportive treatment should include repletion of the intravascular fluids.

Pharmaceutical Precaution
Store in a dry place, at temperature between 15 oC and 30 oC. Keep away
from light.

Commercial Pack
Prosan 25 Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Each
tablet contains Losartan Potassium INN 25 mg.

Prosan 50 Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Each


tablet contains Losartan Potassium INN 50 mg.

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Prosfin®
Tablet

Description
Prosfin is a preparation of Finasteride, a competitive inhibitor of the 5α-
reductase enzyme which is used in the treatment of benign prostatic
hyperplasia. It is selective for 5α-reductase type-2 enzyme and has no
affinity for androgen receptors.

Indications
Prosfin is indicated for the treatment and control of benign prostatic
hyperplasia (BPH)-
♦ to cause regression of the enlarged prostate

♦ to improve urinary flow

♦ to improve the symptoms associated with BPH.

Mode of Action
The development of the prostate gland and subsequent BPH is
dependent upon conversion of testosterone to dihydrotestosterone
(DHT) within the prostate. Prosfin belongs to a new class of specific
inhibitors of 5α-reductase, an intracellular enzyme, which metabolizes
testosterone into the more potent androgen, DHT. Finasteride has no
affinity for the androgen receptor.

Dosage and Administration


The recommended dosage is one 5 mg tablet daily.

Although early improvement may be seen, treatment for at least six


months may be necessary to assess whether a beneficial response has
been achieved. Thereafter, treatment should be continued.

Use in renal insufficiency : Dosage adjustments are not necessary in


patients with renal insufficiency since pharmacokinetic studies did not
indicate any change in the disposition of Finasteride.

Use in hepatic insufficiency : There are no data available in patients with


hepatic insufficiency.

Use in the elderly : No dosage adjustment is required in elderly patients.

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Precautions
General : Since the beneficial response to Finasteride may not be
manifested immediately, patients with large residual urine volume and/or
severely diminished urinary flow should be carefully monitored for
obstructive uropathy.

Prostate cancer : Digital rectal examination, as well as, other evaluations for
prostate cancer, should be performed on patients with BPH prior to
initiating therapy with Finasteride and periodically thereafter. Finasteride
causes a decrease in serum concentration of markers of prostatic cancer
such as prostate specific antigen (PSA); therefore, reduction of serum
levels of these markers in patients with BPH treated with Finasteride does
not rule out concomitant prostate cancer. No clinical benefit has yet been
demonstrated in patients with prostate cancer treated with Finasteride.

Contraindication
Hypersensitivity to any component of this medication. Finasteride use is
also contraindicated in women and paediatric patient.

Warning
Crushed or broken Finasteride tablets should not be handled by women
who are or may become pregnant; in addition, since it is present in semen,
male patients should wear a condom or otherwise avoid exposure of
female sexual partner who have the potential to become pregnant.

Pharmaceutical Precaution
Store at room temperature below 30° C. Protect from light.

Drug Interactions
No clinically important drug interactions have been identified. Finasteride
does not appear to significantly affect the cytochrome P450 linked drug
metabolizing enzyme system. Compounds which have been tested in man
include Propranolol, Digoxin, Glibenclamide, Warfarin, Theophylline,
and antipyrine.

Side Effects
Finasteride is well tolerated. In clinical studies, the following adverse
experiences have been reported as possibly drug related in 1% of patients

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treated for 12 months with 5 mg Finasteride daily : impotence (3.7%),


decreased libido (3.3%), and decreased volume of ejaculate (2.8%).

Overdosage
No specific treatment of overdosage with Finasteride is recommended.
Patients have received single doses of Finasteride up to 400 mg and
multiple doses of Finasteride up to 80 mg/day for up to three months
without any adverse effects.

Commercial Pack
Prosfin Tablet : Box containing 3 blister strips of 10 tablets, each tablet
contains Finasteride USP 5 mg.

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Protolan®
Capsule

Description
Protolan (Lansoprazole) is a proton pump inhibitor. It is an irreversible
inhibitor of the parietal cell H+-K+ ATPase, which leads to profound
inhibition of gastric acid secretion.

Indications
♦ Duodenal ulcer

♦ Gastric ulcer

♦ Oesophagitis/Ulceration

♦ Zollinger-Ellison syndrome

♦ Resistant ulcers and oesophagitis

♦ Eradication of Helicobacter pylori in the treatment of peptic ulcer (in


combination with antibiotics)

Dosage and Administration


→ Benign gastric ulcer : 30 mg daily in the morning for 8 weeks

→ Duodenal ulcer : 30 mg daily in the morning for 4 weeks; maintenance


15 mg daily

→ NSAID-associated duodenal or gastric ulcer : 15-30 mg daily for 4


weeks, followed by a further 4 weeks if not fully healed

→ Zollinger-Ellison syndrome (and other hypersecretory conditions) :


Initially 60 mg once daily adjusted according to response; daily doses of
120 mg or more is given in two divided doses

→ Gastro-oesophageal reflux disease : 30 mg daily in the morning for 4


weeks, followed by a further 4 weeks if not fully healed; maintenance
15-30 mg daily

→ Acid-related dyspepsia : 15-30 mg daily in the morning for 2-4 weeks.

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Contraindication
The use of Protolan is contraindicated in patients with a history of
hypersensitivity to any of the ingredients of Protolan capsule.

Side Effects
Potentially life-threatening effects : None has been recorded.

Acute overdosage : None has been reported.

Severe or irreversible adverse effects : The possible induction of carcinoid


tumors by profound acid suppression, and a rise in serum gastrin may
occur. There is a rise in serum gastrin levels in the first 3 months of
treatment, which are then maintained though at a lower level than those
found in pernicious anaemia. Long- term treatment with a proton pump
inhibitor in patients with Helicobacter pylori infection may accelerate the
development of atrophic gastritis.

Symptomatic adverse effect : Dose dependent diarrhoea occurs with an


incidence of about 4% at 30 mg per day, rising to 8% at 60 mg per day.
Headache occurs in 2-3% of treated patients.

Use in Special Population


Neonates : There is no relevant human data. The drug is not recommended
for use in neonates.

Children : The youngest person to have received Lansoprazole in clinical


trials was 13 years old.

Pregnant women : There is no relevant human data.

The elderly : No problems have been encountered in clinical use and there
has been no increase in adverse drug reaction in the elderly.

Drug Interactions
Lansoprazole appears to be a selective inhibitor of the cytochrome P450
monooxygenase system; there may be an effect on hepatic clearance, but
there have been no reports to date of clinically relevant interactions.
There is some uncertainty over the effect of Lansoprazole on the oral
combined contraceptive pill.

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Commercial Pack
Protolan-15 Capsule : Box containing 30 capsules in 3 x 10’s blister strips.
Each capsule contains Lansoprazole USP 15 mg as enteric coated
granules.

Protolan-30 Capsule : Box containing 30 capsules in 3 x 10’s blister strips.


Each capsule contains Lansoprazole USP 30 mg as enteric coated
granules.

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Recox ®
Tablet

Description
Rofecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, non-
steroidal anti-inflammatory drug (NSAID). By selectively inhibiting the
cyclooxygenase-2 (COX-2) enzyme, it shows analgesic, antipyretic, and
anti-inflammatory action.

Indications
♦ For the treatment of acute mild or moderate pain including bone pain,
dental pain, and orthopaedic surgical pain
♦ For the treatment of primary dysmenorrhoea

♦ For the relief of the signs and symptoms of osteoarthritis

♦ For the relief of the signs and symptoms of rheumatoid arthritis

Dosage and Administration


Recox is administered orally. The lowest dose of Recox should be sought
for each patient.

For the relief of acute pain and treatment of primary dysmenorrhoea :


The recommended initial dose of Rofecoxib is 50 mg once daily.
Subsequent doses should be 25 to 50 mg once daily. The maximum
recommended daily dose is 50 mg.

Osteoarthritis : The recommended starting dose of Rofecoxib is 12.5 mg


once daily. Some patients may receive additional benefit by increasing the
dose to 25 mg once daily. The maximum recommended daily dose is 25
mg.

Rheumatoid arthritis :The recommended dose of Rofecoxib is 50 mg


once daily. The maximum recommended daily dose is 50 mg twice daily.

Contraindication
Recox is contraindicated in patients with known hypersensitivity to Rofecoxib.
Recox should not be given to patients who have experienced asthma, urticaria,
or allergic-type reactions after taking Aspirin or other NSAIDs.

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Side Effects
Common side effects of Rofecoxib, with an incidence greater than
placebo include : dizziness, sinusitis, back pain, fatigue, and bronchitis.
Infrequent side effects are headache, maculopapular rash, dermatitis, and
anorexia.

Use in Special Population


Geriatric : Dose adjustment in the elderly is not generally necessary.
However, therapy should be initiated at the lowest recommended dose.

Paediatric : The safety and efficacy of Rofecoxib is not established in


paediatric patients.

Hepatic Insufficiency : No dosage adjustment is required in patients with


mild to moderate hepatic insufficiency. The safety and efficacy of
Rofecoxib in patients with severe hepatic impairment have not been
studied.

Pregnancy : In third trimester of pregnancy, Rofecoxib should be avoided


because it may cause premature closure of the ductus arteriosus.

Precautions
Recox can be administered with or without food.

Drug Interactions
ACE Inhibitors : Reports suggest that non-steroidal anti-inflammatory
drugs (NSAIDs) may diminish the antihypertensive effect of angiotensin-
converting enzyme (ACE) inhibitors.

Aspirin : Concomitant administration of low-dose Aspirin with Rofecoxib


may result in an increased rate of gastrointestinal ulceration or other
complications, compared to use of Rofecoxib alone.

Frusemide : Clinical studies have shown that NSAIDs can reduce the
natriuretic effect of Frusemide and thiazides in some patients.

Lithium : NSAIDs have produced an elevation of plasma Lithium levels


and a reduction in renal Lithium clearance. Thus, when Rofecoxib and

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Lithium are administered concurrently, subjects should be observed


carefully for signs of Lithium toxicity.

Rifampicin : Co-administration of Rofecoxib with Rifampicin 600 mg daily


may produce a 50% decrease in Rofecoxib plasma concentrations.

Warfarin : Anticoagulant activity should be monitored, particularly in the


first few days after initiating or changing Rofecoxib therapy in patients
receiving Warfarin or similar agents. Bleeding events and increases in
prothrombin time, have been reported, predominantly in the elderly
patients.

Overdosage
Administration of up to 1000 mg of Rofecoxib per day did not result in
serious toxicity. In the event of overdose, it is reasonable to employ the
usual supportive measures, e.g., remove unabsorbed material from the
gastrointestinal tract, employ clinical monitoring, and institute supportive
therapy, if required.

Pharmaceutical Precaution
Store at temperature between 15o C and 30o C.

Commercial Pack
Recox 12.5 Tablet : Box containing 50 tablets in 5 x 10’s blister strips.
Each tablet contains Rofecoxib INN 12.5 mg.

Recox 25 Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Each


tablet contains Rofecoxib INN 25 mg.

Recox 50 Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Each


tablet contains Rofecoxib INN 50 mg.

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Recur ®
Tablet

Description
Recur is a preparation of Finasteride, a competitive inhibitor of steroid
Type II 5α-reductase, an intracellular enzyme that converts the androgen
testosterone into 5α-dihydrotestosterone (DHT).

Mode of Action
Finasteride is a competitive and specific inhibitor of Type II 5α-
reductase, an intracellular enzyme that converts the androgen testosterone
into DHT. Finasteride has no affinity for the androgen receptor and has
no androgenic or antiandrogenic effects. Inhibition of Type II 5α-
reductase blocks the conversion of testosterone to DHT, resulting in
significant decreases in serum and tissue DHT concentrations. In men
with male pattern hair loss, the balding scalp contains miniaturized hair
follicles and increased amounts of DHT compared with hairy scalp.
Administration of Finasteride decreases scalp and serum DHT
concentrations in these men.

Indications
Recur is indicated for the treatment of male pattern hair loss (androgenic
alopecia) in MEN ONLY.

Dosage and Administration


The recommended dosage is 1 mg once a day. Recur may be administered
with or without meals. In general, daily use for three months or more is
necessary before benefit is observed. Continued use is recommended to
sustain benefit. Withdrawal of treatment leads to reversal of effect within
12 months.

Contraindication
Hypersensitivity to any component of this medication. Finasteride use is
also contraindicated in women and paediatric patient.

Precautions
Caution should be used in the administration of Recur in patients with
liver function abnormalities, as Finasteride is metabolized extensively in

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the liver. Women who are or may potentially be pregnant should not
handle crushed or broken tablets of Recur.

Drug Interactions
No drug interactions of clinical importance have been identified.

Side Effects
Finasteride is well tolerated. In clinical studies, the following adverse
reactions were reported as possibly drug related in >1% of patients
treated for 12 months with Finasteride 1 mg daily : decreased libido
(1.8%), erectile dysfunction (1.3%), ejaculation disorder (1.2%) and
decreased volume of ejaculate (0.8%).

Overdosage
In clinical studies, single dose of Finasteride up to 400 mg and multiple
doses of Finasteride up to 80 mg/day for three months did not result in
adverse reactions. Until further experience is obtained, no specific
treatment for an overdose with Finasteride can be recommended.

Pharmaceutical Precaution
Store at room temperature, 15o to 30 oC. Protect from moisture.

Commercial Pack
Recur Tablet : Box containing 3 blister strips of 10 tablets, each tablet
contains Finasteride USP 1 mg.

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Reflon®
Tablet

Description
Reflon film coated tablet contains Glucosamine Hydrochloride USP.
Glucosamine is a naturally occurring compound for the body's
production of point lubricants and shock-absorbers necessary to
maintain healthy cartilage and joint function. Glucosamine Hydrochloride
is a prodrug for glucosamine that is well absorbed after oral
administration and diffuses into several tissues, including bones and
articular cartilages. The active ingredient in the treatment of osteoarthritis
is glucosamine.

Data supports Glucosamine as the first anti-osteoarthritic drug that treats


both sign and symptoms of osteoarthritis and modifies disease
progression. It is as effective as NSAIDs with significantly better
tolerability and clinical compliance.

Indications
♦ Indicated for the treatment of osteoarthritis of knee, hip, spine, and
other locations.
♦ As dietary supplement

Dosage and Administration


One (500 mg) tablet three times daily or as directed by the physicians. A
single dose of 1500 mg daily may also be effective. Obese individuals may
need higher doses, based on body weight.

Contraindication
There are no known contraindication for Glucosamine. But proven
hypersensitivity to Glucosamine is a contraindication.

Precautions
Diabetics are advised to monitor blood glucose levels regularly while
taking Glucosamine. No special studies were performed in patients
with renal and/or hepatic insufficiency. The toxicological and
pharmacokinetic profile of the product does not indicate limitations for

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these patients. However administration of Glucosamine to these patients


with severe hepatic or renal insufficiency should be under appropriate
medical supervision.

Side Effects
Safety studies with Glucosamine show no demonstrable toxicity. Rarely
occurring side effects like mild and reversible intestinal flatulence are
almost like placebo.

Use in Pregnancy and Lactation


Women who are pregnant or who could become pregnant should not
supplement with glucosamine. Glucosamine has not been studied enough
to determine their effects on a developing fetus. And no studies have
evaluated the use of Glucosamine during pregnancy or lactation. It
should be taken with caution and medical advice during pregnancy and
lactation.

Drug Interactions
There have been no reports of significant drug interactions of
Glucosamine with antibiotics/antidepressants/antihypertensives/nitrates
/antiarrythmics/anxiolytic/hypoglycaemic agents/anti-secretives.

Commercial Pack
Reflon Tablet : Each box contains 10 blister strips or 10 tablets. Each film
coated tablet contains Glucosamine Hydrochloride USP equivalent to 500
mg Glucosamine.

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Relentus ®
Tablet

Description
Tizanidine Hydrochloride is a centrally acting skeletal muscle relaxant.
Each tablet contains Tizanidine Hydrochloride INN equivalent to 2 mg
Tizanidine.

Indications
It is used in the symptomatic treatment of painful muscle spasm
associated with musculoskeletal conditions and as an adjunct in the
management of spasticity associated with multiple sclerosis or spinal cord
disorders.

Dosage and Administration


The usual initial daily dose is 2 mg as a single dose. The daily dose may be
increased thereafter according to response in steps of 2 mg at intervals of
at least 3 to 4 days, usually up to 24 mg daily given in 3 to 4 divided doses.
The maximum recommended dose is 36 mg daily.

Contraindication
Tizanidine Hydrochloride is contraindicated to the patients who have
known hypersensitivity to this drug and in case of severe hepatic
impairment.

Precautions
Patients with impaired kidney or liver function; when patients drive a
vehicle or operate machinery.

Side Effects
Tizanidine Hydrochloride may cause drowsiness, fatigue, dizziness, dry
mouth, nausea, gastrointestinal disturbances, hypotension. Bradycardia,
insomnia, hallucinations and altered liver enzymes, and rarely acute
hepatitis have also been reported.

Drug Interactions
Alcohol or other CNS depressants may enhance the CNS effects of
Tizanidine. There may be an additive hypotensive effect when Tizanidine
is used in patients receiving antihypertensive therapy.

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Use in Children
Experience in children is limited and the use of Tizanidine in this patient
group is not recommended.

Use in Elderly
Renal clearance in the elderly may in some cases be significantly
decreased. Caution is therefore indicated when using in elderly patients.

Use in Pregnancy and Lactation


Tizanidine has no teratogenic effects in rats and rabbits. As there have
been no controlled studies in pregnant women, however, it should not be
used during pregnancy unless the benefit clearly outweighs the risk.
Although only small amounts of Tizanidine are excreted in animal milk,
lactating women should not take Tizanidine.

Commercial Pack
Relentus Tablet : Box containing 3 blister strips of 10 tablets, each tablet
contains Tizanidine Hydrochloride INN equivalent to 2 mg Tizanidine.

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Resitone ®
Tablet

Description
Resitone is a combination of a potassium sparing diuretic, Spironolactone
and a loop diuretic, Frusemide. This combination produces synergistic or
additive diuretic effects. Frusemide component inhibits the
+ + -
Na /K /2Cl co-transporter in the ascending limb of Loop of Henle
and blocks the reabsorption of sodium, potassium and chloride ions
thereby increasing the quantity of sodium and the volume of water
excreted in the urine. Spironolactone component inhibits the
reabsorption of sodium and excretion of potassium at the distal tubule by
blocking the action of aldosterone. So the excretion of sodium is
increased and the excess loss of potassium, induced by Frusemide is
decreased.

Indications
Resitone is indicated for the treatment of
- Oedema
- Congestive heart failure
- Liver cirrhosis with ascites
- Essential hypertension
- Hyperaldosteronism

Dosage and Administration


1 to 4 tablets daily (50 to 200 mg of Spironolactone and 20 to 80 mg of
Frusemide) according to the patient’s response.

Contraindication
Resitone is contraindicated in patients with a history of hypersensitivity
to Spironolactone or Frusemide. It is also contraindicated in acute renal
insufficiency, anuria, and Hyperkalemia.

Side Effects
Fatigue, blood disorders, skin rashes, diarrhoea, constipation, nausea,
vomiting, abdominal pain, hyperglycaemia, hypotension, gynaecomastia,
irregular menstrual cycle, disturbances in the levels of electrolyte in the
blood, and impotence may occur.

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Precautions
It is recommended that individuals taking this medicine have their fluid
and electrolyte balance monitored regularly. Resitone should be used with
caution in diabetes, enlarged prostate, hypotension and hypovolaemia.

Use in Pregnancy and Lactation


Resitone should be used with caution during pregnancy and only if
expected benefit to mother is greater than the possible risk to the foetus.
It is recommended that mothers should avoid using this medicine while
breast feeding.

Drug Interactions
When taken together with ACE inhibitors or potassium salts there is an
increased risk of hyperkalaemia. Spironolactone increases the levels of
cardiac glycosides such as Digoxin in the blood and this may result in
digitalis toxicity. Corticosteroids may cause hypokalaemia if they are used
with Spironolactone. When taken together with drugs that decrease blood
pressure there is an increased risk of significant lowering of blood
pressure and may cause fainting, especially when given with the first dose
of ACE inhibitors (e.g. Captopril). The blood pressure lowering and
diuretic effects of Frusemide may be reduced or abolished when used
together with Indomethacin and possibly other non-steroidal anti-
inflammatory drugs (NSAIDs).

Pharmaceutical Precaution
Store between 15ο C to 25ο C. Keep in a cool dry place. Keep out of the
reach of children

Commercial Pack
Resitone Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Each
tablet contains Spironolactone BP 50 mg and Frusemide BP 20 mg.

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Reumafen ®
Tablet/Suspension

Description
Reumafen (Ibuprofen) is chemically (±)-2-(p-isobutylphenyl) propionic
acid. It is a non-steroidal anti-inflammatory agent with analgesic and
antipyretic properties.

After oral administration, Ibuprofen is rapidly and almost completely


absorbed. Peak serum levels are achieved between 1 and 2 hours after
dosing. Ibuprofen is excreted in the urine and excretion is completed
within 24 hour.

Indications
Reumafen is indicated for the treatment of-
♦ rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and other
non-rheumatoid arthropathies
♦ non-articular rheumatic conditions such as frozen shoulder, bursitis,
tendinitis, tenosynovitis and low back pain
♦ soft tissue injuries such as sprain, strain and post-operative pain

♦ dysmenorrhoea

♦ dental pain

♦ cold and fever

Dosage and Administration


For children
20 mg per kg body weight daily in divided doses. In children weighing less
than 30 kg the total daily dosage should not exceed 500 mg. If
gastrointestinal disturbances occur Reumafen should be given with food
or milk. 1-2 years : ½ tea spoonful (2.5 ml) 3-4 times daily; 3-7 years : 1
tea spoonful (5 ml) 3-4 times daily; 8-12 years : 2 tea spoonful (10 ml) 3-
4 times daily.

For adult
For arthritic pain : The dosage range is from 0.9 to 2.4 g per day. The usual
dose is 400 mg, 3-4 times per day, preferably after food.

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T H E R A P E U T I C I N D E X

The dose may be raised to a maximum of 2.4 g daily depending on the


severity of symptom at the time of initiating drug therapy or as patients
fail to respond. After a satisfactory response has been achieved the dose
should be reviewed and adjusted as required and tapered gradually.

For mild to moderate pain : 400 mg 6 hourly or as demanded by the


condition.

For dysmenorrhoea : 400 mg every 4 hours or as demanded by the condition.

Contraindication
Reumafen should not be given to patients with hypersensitivity to
lbuprofen and to individuals who show nasal polyps, angioedema,
bronchospastic reactivity to Aspirin or other non-steroidal anti-
inflammatory drug.

Precautions
Reumafen should be given with caution to patients with bleeding
disorders, cardiovascular diseases, peptic ulceration or a history of such
ulceration and in those who are receiving coumarin anticoagulants and in
patients with renal or hepatic impairment.

Use in Pregnancy and Lactation


Reumafen is not recommended during pregnancy or for use in nursing
mothers.

Side Effects
Usually Reumafen has a low incidence of side effects. The most frequent
side effects are gastrointestinal disturbances. Peptic ulceration and
gastrointestinal bleeding have occasionally been reported. Other side
effects include headache, dizziness, nervousness, skin rash, pruritus,
drowsiness, insomnia, blurred vision and other ocular reactions,
hypersensitivity reaction, abnormal liver function test, impairment of
renal function, agranulocytosis and thrombocytopenia.

Overdosage
Gastric lavage, correction of blood electrolyte (if necessary). There is no
specific antidote for Ibuprofen.

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T H E R A P E U T I C I N D E X

Pharmaceutical Precaution
Keep in a cool and dry place. Keep out of the reach of children.

Commercial Pack
Reumafen-200 Tablet : Box containing 100 sugar coated tablets in 10 x
10's blister strips, each tablet contains Ibuprofen BP 200 mg.

Reumafen-400 Tablet : Box containing 100 sugar coated tablets in 10 x


10's blister strips, each tablet contains Ibuprofen BP 400 mg.

Reumafen Suspension : 100 ml suspension in amber glass bottle. Each 5


ml contains Ibuprofen BP 100 mg.

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Rolacin®
Tablet

Description
Rolacin (Clarithromycin) is a semisynthetic antibiotic of macrolide group,
available as 250 mg and 500 mg film coated tablet. It binds to the 50S
ribosomal subunit of susceptible bacteria and suppresses its protein
synthesis. Rolacin is highly effective against a wide range of aerobic and
anaerobic Gram-positive and Gram-negative bacteria. The active
ingredient of Rolacin is Clarithromycin USP.

Indications
Rolacin (Clarithromycin) is indicated for the treatment of mild to
moderate infections caused by susceptible strains of the microorganisms
listed below-
♦ Upper respiratory tract infections : pharyngitis and tonsillitis due to
Streptococcus pyogenes, Acute maxillary sinusitis due to Streptococcus
pneumoniae

♦ Lower respiratory tract infections : pneumonia due to Mycoplasma


pneumoniae or Streptococcus pneumoniae, Acute exacerbation of chronic
bronchitis

♦ Uncomplicated skin and skin structure infections due to Staphylococcus


aureus or Streptococcus pyogenes

♦ Acute otitis media

♦ As an adjunct in the treatment of duodenal ulcers for the eradication


of H. pylori.

Dosage and Administration


Adult : Recommended dosage in adults is 250 mg every 12 hours for 7
days. In severe cases, dosage may be increased up to 500 mg every 12
hours for up to 14 days.

In patients with renal impairment with creatinine clearance <30 ml/ min,
the dosage should be reduced by half.

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Eradication of H. pylori :
Rolacin-500 (Clarithromycin) 1 Tablet twice daily
Proceptin-20 (Omeprazole) 1 Capsule twice daily
Filmet-400 (Metronidazole) 1 Tablet twice daily
(For 7-day treatment regimen)

Dosage schedule of Children :-


Body weight under 8 kg : 7.5 mg/kg twice daily
8-11 kg (1 to 2 years) : 62.5 mg twice daily
12-19 kg (3 to 6 years) : 125 mg twice daily
20-29 kg (7 to 9 years) : 187.5 mg twice daily
Children older than 10 years : 250 mg twice daily

The usual duration of treatment is 7 to 14 days depending on the


pathogen involved and the severity of infection.

Contraindication
It is contraindicated in patients with known hypersensitivity to
Clarithromycin or any other macrolide antibiotics.

Side Effects
Rolacin is generally well tolerated. Commonly reported side effects
include nausea, vomiting, diarrhoea, abdominal pain, stomatitis and
glossitis. Other side effects include allergic reactions and headache.

Precautions
Clarithromycin is principally excreted by the liver and kidney. Caution
should be exercised in administering this antibiotic to patients with
impaired hepatic and renal functions. Prolonged or repeated use of
Clarithromycin may result in an overgrowth of non-susceptible bacteria
or fungi. If superinfection occurs, Clarithromycin should be discontinued
and appropriate therapy instituted. Concomitant administration with
Theophylline has been associated with increased serum Theophylline
level. Effects of Digoxin and Warfarin may be potentiated with
concomitant administration of Clarithromycin.

Drug Interactions
Clarithromycin should not be prescribed with Terfenadine and Cisapride.

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T H E R A P E U T I C I N D E X

Commercial Pack
Rolacin Tablet : Box containing 20 tablets in 2 x 10’s blister strips. Each
film coated tablet contains Clarithromycin USP 250 mg.

Rolacin-500 Tablet : Box containing 10 tablets in 1 x 10’s blister strip.


Each film coated tablet contains Clarithromycin USP 500 mg.

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Rostil®
Tablet

Description
Rostil is a musculotropic antispasmodic agent available as film coated
tablet, each containing 135 mg of Mebeverine Hydrochloride BP. It acts
directly on smooth muscle of gastrointestinal tract and is used to treat
bowel spasm.

Indications
Rostil is indicated :

♦ for the symptomatic relief of irritable bowel syndrome


♦ other conditions include;
- Chronic irritable colon
- Spastic constipation
- Mucous colitis
- Colicky abdominal pain and cramps
- Persistent non-specific diarrhoea

Dosage and Administration


Adults (including elderly) : One tablet three times a day, preferably 20
minutes before meals. After a period of several weeks when the desired
effect has been obtained, the dosage may be gradually reduced.

Side Effects
There are no known life-threatening toxic effects of Rostil. There are few
reported cases of overdose with Mebeverine.

Contraindication
None known.

Use in Special Population


Neonates : Not recommended for neonates.

Children : The preparation is only recommended for children over 10


years.

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T H E R A P E U T I C I N D E X

Pregnant woman : No teratogenicity has been shown in animal


experiments and there are no known teratogenic effects in human.

Drug Interactions
None known.

Overdosage
On theoretical grounds it may be predicted that CNS excitability will
occur in cases of overdosage. No specific antidote is known; gastric
lavage and symptomatic treatment is recommended.

Commercial Pack
Rostil Tablet : Box containing 5 blister strips of 10 tablets, each tablet
contains Mebeverine Hydrochloride BP 135 mg.

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Sensipin®
Tablet

Description
Sensipin tablet contains Clozapine BP 25 mg, which is an atypical
neuroleptic and a dibenzodiazepine.

Indications
Sensipin is indicated for- Refractory psychoses, psychotic patients with
severe extrapyramidal symptoms with other treatments, and psychotic
patients with severe tardive dyskinesia with other treatments.

Dosage and Administration


To minimize the incidence of adverse effects, Sensipin should be
introduced gradually, beginning with low doses and increasing according
to response.

Initial Treatment : It is recommended that treatment with Sensipin should


begin with one-half of a 25 mg tablet (12.5 mg) once or twice daily and
then be continued with daily dosage increments of 25-50 mg/day, if well-
tolerated, to achieve a target dose of 300-450 mg/day by the end of two
weeks. Subsequent dosage increments should be made not more than
once or twice weekly, in increments not to exceed 100 mg. Most patients
are expected to respond to 200-450 mg daily, a larger proportion may be
given at night.

Maintenance dose : Once a therapeutic response has been obtained, a


gradual reduction of dosage to a maintenance dose of 150 to 300 mg
daily may be made. Daily maintenance doses of 200 mg or less may be
given as a single dose in the evening. Where possible, Sensipin should be
withdrawn gradually over a 1-2 week period.

Discontinuation of treatment : In the event of planned termination of


Sensipin therapy, gradual reduction in dose is recommended over a 1-2
week period. However, if a patient’s medical condition requires abrupt
discontinuation (e.g. Leucopenia), the patient should be carefully
observed for the recurrence of psychotic symptoms.

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Contraindication
Sensipin is contraindicated in patients with myeloproliferative disorders,
uncontrolled epilepsy, or with a history of Clozapine induced
agranulocytosis or severe granulocytopenia. As with more typical
antipsychotic drugs, Sensipin is contraindicated in severe central nervous
system (CNS) depression or comatose states from any causes. Sensipin
should not be used simultaneously with other agents having a well-known
potential to cause agranulocytosis or otherwise suppress bone marrow
function. The mechanism of Clozapine induced agranulocytosis is
unknown; nonetheless, it is possible that causative factors may interact
synergistically to increase the risk and/or severity of bone marrow
suppression.

Side Effects
Potentially life-threatening effects : Clozapine can cause reversible neutropenia
which may progress to a potentially fatal agranulocytosis; the greatest risk
is from the second to the sixth month of treatment. All patients
undergoing treatment should have weekly differential white cell counts.
Agranulocytosis is reversible on drug withdrawal but potentially fatal if
unheeded or undetected. Acute overdosage : No case of this kind has been
reported. Severe or irreversible adverse effects : Toxic delirium can occur in
about 3% of patients. Symptomatic adverse effects : Sedation and syncope
from hypotension may occur especially at the start of treatment. The drug
has been reported to cause influenza like syndrome. Extrapyramidal
disorders including tardive dyskinesia appear to be rare or absent with
Sensipin. Sensipin has little effect on prolactin secretion; endocrine and
sexual dysfunction are uncommon.

Overdosage
Human experience : The most commonly reported signs and symptoms
associated with Clozapine overdoses are altered states of consciousness,
including drowsiness, delirium and coma; tachycardia; hypotension;
respiratory depression or failure; hypersalivation. Aspiration pneumonia
and cardiac arrhythmias have also been reported. Seizures have occurred
in a minority of reported cases. Fatal overdoses have been reported with
Clozapine, generally at doses above 2500 mg.

Management of overdosage : Establish and maintain airways; ensure adequate

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oxygenation and ventilation. Activated charcoal, which may be used with


sorbitol, may be as or more effective than emesis or lavage and should be
considered in treating overdosage. Cardiac and vital signs monitoring is
recommended along with general symptomatic and supportive measures.
There are no specific antidotes for Clozapine. Forced diuresis, dialysis,
haemoperfusion and exchange transfusion are unlikely to be of benefit.
In managing overdosage, the physician should consider the possibility of
multiple drug involvement.

Precautions
General : Because of the significant risk of agranulocytosis and seizure, the
extended treatment failing to show an acceptable level of clinical response
should ordinarily be avoided. In addition, the need for continuing
treatment in patients exhibiting beneficial clinical responses should be
periodically re-evaluated.

Fever : During Clozapine therapy, patients may experience transient


temperature elevations above 100.4ºF with the peak incidence within the
first 3 weeks of treatment. On occasion, there may be an associated
increase or decrease in WBC count. Patients with fever should be carefully
evaluated to rule out the possibility of an underlying infectious process or
the development of agranulocytosis. In presence of high fever, the
possibility of Neuroleptic Malignant Syndrome (NMS) must be
considered.

Anticholinergic toxicity : Clozapine has very potent anticholinergic effects


and great care should be exercised in using this drug in presence of
prostatic enlargement or narrow angle glaucoma. In addition, Clozapine
use has been associated with varying degrees of impairment of intestinal
peristalsis, ranging from constipation to intestinal obstruction, faecal
impaction and paralytic ileus.

Interference with cognitive and motor performance : Because of initial sedation,


Clozapine may impair mental and/or physical abilities, especially during
the first few days of therapy. The recommendations for gradual dose
escalation should be carefully adhered to, and patients be cautioned about
activities requiring alertness.

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Use in patients with concomitant illness : Clinical experience with Clozapine in


patients with concomitant systemic diseases is limited. Nevertheless,
caution is advisable in using Clozapine in patients with hepatic, renal or
cardiac disease.

Use in patients undergoing general anaesthesia : Caution is advised in patients


being administered general anaesthesia because of the CNS effects of
Clozapine. Checking with the anaesthesiologist is required regarding
continuation of Clozapine therapy in a patient scheduled for surgery.

Drug Interactions
The risk of using Clozapine in combination with other drugs has not
been systematically evaluated. The mechanism of Clozapine induced
agranulocytosis is unknown; nonetheless, the possibility that causative
factors may interact synergistically to increase the risk and/or severity of
bone marrow suppression warrants consideration. Therefore, Clozapine
should not be used with other agents having a well-known potential to
suppress bone marrow function. Given the primary CNS effects of
Clozapine, caution is advised in using it concomitantly with other CNS
active drugs or alcohol. Orthostatic hypotension in patients taking
Clozapine can, in rare cases, be accompanied by profound collapse and
respiratory and/or cardiac arrest. Although it has not been established
that there is an interaction between Clozapine and benzodiazepines or
other psychotropics, caution is advised when Clozapine is initiated in
patients taking a benzodiazepine or any other psychotropic drug.

Commercial Pack
Sensipin Tablet : Box containing 3 blister strips of 10 tablets, each tablet
contains Clozapine BP 25 mg.

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Serelose ®
Solution

Deascription
Serelose is a brand of Lactulose, a hyperosmolar laxative- an effective
treatment approach for constipation. It is a non-absorbable disaccharide
which draws water into the bowel; causes distention through fluid
accumulation, thus promotes soft stool and accelerates bowel motion.

What is Constipation?
Constipation is a common problem with a variety of possible causes. This
term may be used to describe several different symptoms. The normal
frequency of stool passage is from three times a day to once in every three
days. Going more than three days without a bowel movement is therefore
considered abnormal. Some people feel miserable if they do not defaecate
on a daily basis. Others may go a week or longer without any ill effects.
Hard stool, straining to pass, or a sense of incomplete evacuation may
also be termed constipation. Constipation may worsen with time because
of the disease process. If a person feels uncomfortable as a result of
bowel problems then treatment is justified to relieve or minimize these
symptoms.

Indications
♦ Constipation
♦ Hepatic encephalopathy

Dosage and Administration


Adults (including elderly) : 3 tea spoonful or 15 ml twice daily
Children 5 to 10 years : 2 tea spoonful or 10 ml twice daily
Children under 5 years : 1 tea spoonful or 5 ml twice daily
Babies under 1 year : ½ tea spoonful or 2.5 ml twice daily
(paediatric dose should be given after
breakfast)

Each dose of Serelose may, if necessary, be taken with water or fruit


juices, usually once a day, preferably in the morning. If a dose is forgotten

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T H E R A P E U T I C I N D E X

it should be taken as soon as one remembers up to 8 hours before


bedtime. If later, wait for next scheduled dose (don’t double this dose).
Don’t take at bedtime. Usual time lapse before drug works is 30 minutes
to 3 hours.

Overdosage
Symptoms of overdosage include fluid depletion, weakness, vomiting,
fainting etc. Overdosage is unlikely to threaten life. If one takes much
larger amount than prescribed, consultation with physician is essential.

Side Effects
Life threatening : None expected; Common : Increased thirst, cramps, nausea,
diarrhoea, flatulence; Infrequent : Irregular heart beat, muscle cramps; Rare
: Dizziness, confusion, fatigue, weakness.

Safety
Serelose is safe in the long term and has been used effectively even in frail
elderly patients.

Precautions
It should be avoided if one is allergic to any hyperosmotic laxative, have
symptoms of appendicitis, inflammatory bowel diseases or intestinal
blockage, have missed a bowel movement for only 1 or 2 days. Adverse
reactions over age 60 year may be more frequent and severe than in
younger persons. In pregnancy no proven problems were detected. Avoid
the drug if possible. Consultation with physician is required. It has no side
effect during breast feeding. Lactulose oral solution could be used in
infants and children only under medical supervision. It should not be
used to ‘flush out’ the system or as a ‘tonic'.

Commercial pack
Serelose Solution : Each amber glass bottle contains 100 ml Serelose
solution. Each 5 ml contains Lactulose solution BP equivalent to 3.35 g
Lactulose.

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Sibulin®
Capsule

Description
Sibulin is an orally administered agent for the treatment of obesity. Each
capsule contains 5 mg of Sibutramine Hydrochloride Monohydrate INN.

Indications
Sibulin is indicated for the management of obesity including weight loss
and maintenance of weight loss and should be used in conjunction with
a reduced calorie diet. Sibulin is recommended for obese patients with an
initial body mass index 30 kg/m2 or 27 kg/m2 in the presence of other
risk factors (e.g. hypertension, diabetes, dyslipidaemia). [Metric
conversion are as follows : 2.2 pounds = 1 kg and inches x 2.54 = meter.]

Dosage and Administration


The recommended starting dose of Sibulin is 10 mg administered once
daily with or without food. If there is inadequate weight loss the dose may
be titrated after four weeks to a total of 15 mg once daily. The 5 mg dose
should be reserved for patients who do not tolerate the 10 mg dose.

Contraindication
Sibulin is contraindicated in patients receiving monoamine oxidase
inhibitors (MAOIs) antidepressants, with hypersensitivity to Sibutramine
or any of the ingredients of Sibulin, who have anorexia nervosa, and in
those taking other centrally acting appetite suppressant drugs.

Side Effects
In placebo-controlled obesity studies the most common events were dry
mouth, anorexia, insomnia and constipation.

Use in Special Population


Paediatric : The safety and effectiveness of Sibulin in paediatric patients
under 16 years old has not been established.

Renal Insufficiency : Sibulin should not be used in patients with severe renal
impairment.

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Hepatic Insufficiency : Dosage adjustment in patients with mild to moderate


hepatic impairment is not required. Sibulin should not be used in patients
with severe hepatic dysfunction.
Use in Pregnancy and Lactation
The use of Sibulin during pregnancy is not recommended. Women of
child-bearing potential should employ adequate contraception while
taking Sibulin. It is not known whether Sibutramine or its metabolites are
excreted in human milk. Sibulin is not recommended for use in nursing
mothers.

Drug Interactions
Because Sibulin inhibits serotonin reuptake it should not be administered
with other serotonergic agents such as Fluoxetine, Fluvoxamine,
Paroxetine, Sertraline and Venlafaxine. Because Sibulin inhibits serotonin
reuptake, Sibulin should not be used concomitantly with monoamine
oxidase inhibitors MAOIs e.g. Phenelzine and Selegiline. At least 2 weeks
should elapse between discontinuation of a MAOI and initiation of
treatment with Sibulin. Similarly at least 2 weeks should elapse between
discontinuation of Sibulin and initiation of treatment with MAOI. The
rare but serious constellation of symptoms termed serotonin syndrome
has also been reported with the concomitant use of two serotonin
reuptake inhibitors.

Warning
Sibulin substantially increases blood pressure in some patients. Regular
monitoring of blood pressure is required when prescribing Sibulin.
Sibulin should not be used in patients with a history of coronary artery
disease, congestive heart failure, arrhythmias or stroke.

Because Sibulin can cause mydriasis, it should be used with caution in


patients with narrow angle glaucoma.

Organic causes of obesity (e.g. hypothyroidism) should be excluded


before prescribing Sibulin.

Overdosage
There is no specific antidote to Sibulin. Treatment should consist of
general measures employed in the management of overdosage, an airway
should be established, cardiac and vital sign monitoring is recommended;

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general symptomatic and supportive measures should be instituted.


Cautious use of β-blockers may be indicated to control elevated blood
pressure or tachycardia.

Pharmaceutical Precaution
Store at temperature between 15o C and 30oC.

Commercial Pack
Sibulin Capsule : Box containing 60 capsules in 6 x 10’s blister strips. Each
capsule contains Sibutramine Hydrochloride Monohydrate INN 5 mg.

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Spanil®
Tablet

Description
Spanil is an antispasmodic containing in each tablet 10 mg of Hyoscine
Butylbromide BP. Hyoscine Butylbromide is a competitive antagonist of
acetylcholine at postganglionic parasympathetic nerve endings. It relaxes
smooth muscles of the hollow organs of the abdominal and pelvic
cavities.

Indications
It is indicated for the following conditions :

♦ Spasm of the gastrointestinal tract


♦ Spasm of the genito-urinary tract
♦ Spasmodic dysmenorrhoea

Dosage and Administration


Adult : 1-2 tablets 3-4 times daily
Children (6-12 years) : 1 tablet 3 times daily

Contraindication
Spanil should not be given to patients suffering from glaucoma.

Precautions
Should be used with caution during 1st trimester of pregnancy.

Side Effects
Dryness of mouth and tachycardia have been reported infrequently
during treatment with Hyoscine Butylbromide.

Commercial Pack
Spanil Tablet : Box containing 10 blister strips of 10 film coated tablets,
each tablet contains 10 mg of Hyoscine Butylbromide BP.

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Sparlin ®
Tablet

Description
Sparlin (Sparfloxacin) is a synthetic, broad-spectrum antibacterial agent
from the fluoroquinolone family. It has been reported to be more active
in vitro than other fluoroquinolones against some Gram-positive
organisms (such as Streptococcus pneumoniae and Staphylococcus aureus),
Mycobacteria and Chlamydia spp. Each Sparlin tablet contains
Sparfloxacin INN 200 mg.

Indications
Sparlin is indicated for the treatment of the following infections due to
susceptible microorganisms:

♦ Upper and lower respiratory tract infections including sinusitis, acute


exacerbation of chronic bronchitis, community and hospital acquired
pneumonia.

♦ Urinary tract infections including gonococcal and non-gonococcal


urethritis, chancroid and other sexually transmitted diseases.

♦ Skin and soft tissue infections.

♦ Prophylactic use in different urological and ophthalmic operations.

Dosage and Administration


The recommended daily adult dose is two tablets (400 mg) on first day as
a loading dose, followed by one tablet (200 mg) daily as a maintenance
dose. Duration of maintenance treatment is 5 to 10 days. It can be taken
with or without food.

Use in Children, Pregnancy and Lactation


It is not recommended for children below 12 years of age. Sparfloxacin
should be administered in pregnant women and lactating mother only if
the potential maternal benefits justify the risks to the foetus/neonate.

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Contraindication
Hypersensitivity to fluoroquinolones including Sparfloxacin. It is also
contraindicated in patients with known QTc prolongation or in those
with pre-arrhythmic conditions (e.g., hypokalaemia, significant
bradycardia, congestive heart failure, atrial fibrillation or other cardiac
disease).

Precautions
Renal disease, gastric ulcers, concomitant use of NSAIDs. In renal failure
of third degree severity (creatinine clearance <30 ml/min) dosage
modification is recommended- 400 mg on 1st day, 200 mg on 2nd and 3rd
day followed by 200 mg every 48 hours. Because fluoroquinolones have
been associated with tendon rupture, Sparfloxacin should be discontinued
at the first sign of tendon pain. Exposure to UV radiation during
treatment should be avoided.

Side Effects
Side effects are mild, transient and seldom. These are allergic reactions;
photosensitization; gastrointestinal disorders including nausea, vomiting,
diarrhoea; headache and sleep disturbance at the start of treatment.

Drug Interactions
On concomitant use with Quinidine, Sotalol, Erythromycin, Astemizole,
Terfenadine, vinca alkaloids there is increased risk of arrhythmia. Salts,
oxides and hydroxides of Magnesium, Aluminium and Calcium decrease
absorption of Sparfloxacin.

Commercial Pack
Sparlin Tablet : Box containing 1 blister strip of 10 tablets, each tablet
contains Sparfloxacin INN 200 mg.

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Spulyt ®
Tablet/Syrup

Description
Spulyt (Bromhexine Hydrochloride) is a highly effective expectorant.

Indications
Spulyt is indicated in the treatment of respiratory disorders associated
with productive cough. These include; tracheobronchitis, bronchitis with
emphysema, bronchiectasis, bronchitis with bronchospasm, chronic
inflammatory pulmonary conditions and pneumoconiosis.

Dosage and Administration


Spulyt tablet
Adults and Children over 10 years : 8-16 mg 3 times daily.

Spulyt syrup
Adults: The recommended daily dose is 2 to 4 tea spoonfuls 3 times.
Initially 4 tea spoonfuls 3 times daily and then as required.

Children: Suggested dosage for children under 2 years is ¼ tea spoonful


3 times daily, for 2-5 years is ½ tea spoonful 3 times daily and for children
aged 5-10 years 1 tea spoonful 3 times daily.

Side Effects
Gastrointestinal side effects may occur occasionally with Bromhexine
Hydrochloride, and a transient rise in serum aminotransferase values has
been reported. Other reported adverse effects include headache,
dizziness, sweating and skin rash.

Precautions
Since Bromhexine Hydrochloride may disrupt the gastric mucosa so
Bromhexine Hydrochloride should be used with care in patients with a
history of peptic ulceration. Care is also advisable in asthmatic patients.

Contraindication
Contraindicated to those who are hypersensitive to Bromhexine
Hydrochloride.

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Pharmaceutical Precaution
Store below 25οC. Protect from light. Keep the container tightly closed.

Commercial Pack
Spulyt Tablet : Each box contains 10 blister strips of 10 tablets. Each
tablet contains Bromhexine Hydrochloride BP 8 mg.

Spulyt Syrup : Bottle containing 100 ml syrup. Each 5 ml contains


Bromhexine Hydrochloride BP 4 mg.

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Tamona®
Tablet

Description
Tamona (Tamoxifen) is a non-steroidal, triphenylene-based drug which
displays a complex spectrum of oestrogen antagonist and oestrogen
agonist-like pharmacological effects in different tissues. In breast cancer
patients, at the tumour level, Tamoxifen acts primarily as an
antioestrogen, preventing oestrogen binding to the oestrogen receptor.
Additionally Tamoxifen has been reported to lead to maintenance of
bone mineral density in postmenopausal women of the order of 10-20%.
Additionally Tamoxifen has been reported to lead to maintenance of
bone mineral density in postmenopausal women.

Pharmacology
After oral administration, Tamona (Tamoxifen) is absorbed rapidly with
maximum serum concentrations attained within 4-7 hours. Steady state
concentrations (about 300 mg/ml) are achieved after four weeks
treatment with 40 mg daily. The drug is highly protein bound to serum
albumin (99%). Metabolism is by hydroxylation, demethylation and
conjugation, giving rise to several metabolites which have a similar
pharmacological profile to the parent compound and thus contribute to
the therapeutic effect. Excretion occurs primarily via the faeces and an
elimination half-life of approximately seven days has been calculated for
the drug itself, whereas that for N-desmethyltamoxifen, the principal
circulating metabolite, is 14 days.

Indications
Tamona is indicated for the treatment of breast cancer.

Dosage and Administration


Adults (including elderly): The dosage range is 20 to 40 mg daily, given
either in divided doses twice daily or as a single dose once daily.

Contraindication
Tamona must not be administered during pregnancy. Tamona should not
be given to patients who have experienced hypersensitivity to the product
or any of its ingredients.

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T H E R A P E U T I C I N D E X

Side Effects
Side effects can be classified as either due to the pharmacological action
of the drug, e.g. hot flushes, vaginal bleeding, vaginal discharge, pruritus
vulvae and tumour flare or as more general side effects, e.g.
gastrointestinal intolerance, headache, light-headedness and occasionally
fluid retention and alopecia. When such side effects are severe, it may be
possible to control them by a simple reduction of dosage (within the
recommended dose range) without loss of control of the disease.

Skin rashes including isolated reports of erythema multiforme, Stevens-


Johnson syndrome and bullous pemphigoid and rare hypersensitivity
reactions, including angioedema have been reported. A small number of
patients with bony metastases have developed hypercalcaemia on
initiation of therapy.

Falls in platelet count, usually only to 80,000-90,000 per/mm3 but


occasionally lower, have been reported in patients taking Tamona for
breast cancer.

A number of cases of visual disturbances including infrequent reports of


corneal changes and retinopathy have been described in patients receiving
Tamoxifen therapy. An increased incidence of cataracts has been
reported in association with the administration of the drug. Uterine
fibroids and endometrial changes including hyperplasia and polyps have
been reported. Cystic ovarian swellings have occasionally been observed
in premenopausal women receiving Tamoxifen.

Leucopenia has been observed following the administration of


Tamoxifen, sometimes in association with anaemia and/or
thrombocytopenia. Neutropenia has been reported on rare occasions; this
can sometimes be severe. There is evidence of an increased incidence of
thromboembolic events including deep vein thrombosis and pulmonary
embolism during Tamoxifen therapy.

Tamoxifen has been associated with changes in liver enzyme levels and on
rare occasions with a spectrum of more severe liver abnormalities,
including fatty liver, cholestasis and hepatitis.

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Rarely, elevation of serum triglyceride levels, in some cases with


pancreatitis, may be associated with the use of Tamoxifen.

Overdosage
On theoretical grounds, overdosage would be expected to cause
enhancement of the pharmacological effects mentioned above.
Observations in animals show that extreme overdosage (100-200 times
recommended daily dose) may produce oestrogenic effects. There is no
specific antidote to overdosage and treatment must be symptomatic.

Precautions
Menstruation is suppressed in a proportion of premenopausal women
receiving Tamoxifen for the treatment of breast cancer. An increased
incidence of endometrial cancer has seen reported in association with
Tamoxifen treatment. The underlying mechanism is unknown, but may
be related to the oestrogen-like effect of Tamona. Any patients receiving
or having previously received Tamona, who report abnormal
gynecological symptoms, especially vaginal bleeding, should be promptly
investigated.

A number of second primary tumors, occurring at sites other than the


endometrium and the opposite breast, have been reported in clinical trials,
following the treatment of breast cancer patients with Tamoxifen. No
causal link has been established and the clinical significance of these
observations remains unclear.

Drug Interactions
When Tamoxifen is used in combination with coumarin type
anticoagulants, a significant increase in anticoagulant effect may occur.
Where such co-administration is initiated, careful monitoring of the
patient is recommended. When Tamoxifen is used in combination with
cytotoxic agents, there is an increased risk of thromboembolic events.

Use in Pregnancy and Lactation


Tamoxifen must not be administered during pregnancy. There have been
a small number of reports of spontaneous abortions, birth defects and
foetal deaths after women have taken Tamoxifen, although no causal
relationship has been established. Reproductive toxicology studies in rats,
rabbits and monkeys have shown no teratogenic potential.

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T H E R A P E U T I C I N D E X

Women should be advised not to become pregnant whilst taking Tamona


and should use barrier or other nonhormonal contraceptive methods if
sexually active. Premenopausal patients must be carefully examined
before treatment to exclude pregnancy. Women should be informed of
the potential risks to the foetus, if they want to become pregnant whilst
taking Tamona or within two months of cessation of therapy.

It is not known if Tamoxifen is excreted in human milk and therefore the


drug is not recommended during lactation. The decision to discontinue
Tamona should take into account in case of the importance of the drug
to the lactating mother.

Commercial Pack
Tamona 10 Tablet: Box containing 30 tablets in 3 x 10’s Alu-Alu form
packs. Each tablet contains Tamoxifen Citrate BP equivalent to 10 mg of
Tamoxifen.

Tamona 20 Tablet : Box containing 30 tablets in 3 x 10’s Alu. Alu. form


packs. Each tablet contains Tamoxifen Citrate BP equivalent to 20 mg of
Tamoxifen.

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T H E R A P E U T I C I N D E X

Taverin®
Tablet

Description
Each tablet contains Drotaverine Hydrochloride INN 40 mg. Taverin is
a potent synthetic antispasmodic which is readily absorbed from the
intestine. Like papaverine, it acts directly on the smooth muscle fibers,
exceeding however, the antispasmodic effect of the standard
preparations. Taverin is characterized by a rapid onset of actions which is
very advantageous in cases of acute painful spastic conditions. In addition
to its spasmolytic and vasodilatory actions, Taverin elicits a selective
blockade of cardiac β-receptors.

Indications
Taverin is indicated in the following indications :
i) Spastic conditions of the gastrointestinal tract: irritable bowel
syndrome, tensmus in dysentery; biliary colics and spastic conditions of
the biliary tract such as cholecystolithiasis, cholecystitis, cholangitis; ii)
Renal colics and spastic conditions of the urogenital tract: nephrolithiasis,
ureterolithiasis, pyelitis, cystitis; iii) Spastic conditions of the uterus:
dysmenorrhoea, imminent abortion, uterine tetanus.

Owing to its freedom from cardiotoxic and hypotensive effects as well as


its specificity of cardiac adrenolytic action. For this reason Taverin is of
outstanding value in the treatment of coronary insufficiency and angina
pectoris.

Dosage and Administration


The average dose for adults is daily three-times 1 to 2 tablets. Children
should be given smaller doses according to age and body weight. Small
children should receive once or twice daily ¼ - ½ tablet, older children ½
to 1 tablet daily. In peptic ulcer it is expedient to combine Taverin with
atropine or atropine-like compounds.

Contraindication
Hypersensivity to Drotaverine or any of the components of Taverin.

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T H E R A P E U T I C I N D E X

Side Effects
The common side effects are headache, dizziness, rhinitis, sinusitis,
gastrointestinal upset, nausea, pharyngitis, oedema and fatigue.

Use in Pregnancy and Lactation


As with most drugs, the use of Drotaverine Hydrochloride should be
avoided during pregnancy and lactation unless essential.

Pharmaceutical Precaution
Should be kept away from moisture and heat and out of the reach of
children.

Commercial Pack
Taverin Tablet: Box containing 100 tablets in 10 x 10’s blister strips. Each
tablet contains Drotaverine Hydrochloride INN 40 mg.

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Terbex®
Cream/Tablet

Description
Terbex is a preparation of Terbinafine Hydrochloride. Terbinafine is an
allylamine with a range of antifungal activity. It is fungicidal against
dermatophytes, moulds and certain dimorphic fungi. Terbinafine is either
fungicidal or fungistatic against yeasts, depending on the species.
Terbinafine interferes with fungal ergosterol biosynthesis by inhibiting
squalene epoxidase in the fungal cell membrane at an early stage. This
leads to a deficiency in ergosterol and to intracellular accumulation of
squalene, resulting in fungal cell death. Terbinafine is highly effective in
fungal infections of the skin, hair and nails caused by Trichophyton spp.,
Microsporum spp. and Epidermophyton floccosum. It is also effective against
yeast infections of the skin, principally those caused by the genus candida.
Topical terbinafine appears to be effective in pityriasis versicolor due to
Pityrosporum arbiculare.

Indications
Terbex cream is indicated for the treatment of the following
dermatological infections : interdigital tenia pedis (Athlete’s foot), tenia
cruris (jock itch) or tenia corporis (ring worm) due to susceptible
organisms and planter tenia pedis (mocasin type) due to Trichophyton spp.

Terbex tablet is indicated for the treatment of onychomycosis of the toe


nail or finger nail due to dermatophytes and also by non-dermatophyte
fungi.

Dosage, Application and Administration


Topical application of Terbex cream to affected areas once or twice daily
for 1-2 weeks may be adequate for fungal infections of the skin but
certain infections may require oral Terbex tablet therapy.

Usual duration of treatment of Terbex cream in Tinea corporis and Tinea


cruris : 1-2 weeks. In Tinea pedis : 2-4 weeks (One week of treatment will
normally suffice if the cream is applied twice daily.). In Cutaneous
candidiasis : 1-2 weeks and in Pityriasis (tinea) versicolor : 2 weeks.

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T H E R A P E U T I C I N D E X

To prevent relapses in fungal infection, treatment should be continued for


a adequate length of time. To apply Terbex cream clean and dry the
affected areas thoroughly and apply the cream once or twice a day to the
affected skin and surrounding area in a thin layer and rub in lightly. In the
case of intertriginous infections the application may be covered with a
gauze strip, especially at night.

Oral administration of Terbex tablet is essential for hair or nail infections.


The usual oral dose is 1 Terbex tablet (250 mg) daily for 2 to 12 weeks
depending upon the infection. Finger nail onychomycosis : 1 Terbex
tablet (250 mg) once daily for 6 weeks. Toe nail onychomycosis : 1 Terbex
tablet (250 mg) once daily for 12 weeks.

Use in Children
Experience with topical Terbex in children is limited and its use cannot
therefore be recommended.

Contraindication
Hypersensitivity to Terbinafine or any of the excipients in the
preparation.

Side Effects
In general, the side effects are mild, transient and do not lead to
discontinuation of therapy. The side effects reported include
gastrointestinal disturbances (diarrhoea, dyspepsia, and abdominal pain),
rashes etc. Rarely, cases of symptomatic hepatobiliary dysfunction
including cholestatic hepatitis have been reported. Besides, there have
been isolated reports of serious skin reactions. If progressive skin rash
occurs, treatment should be discontinued.

Commercial Pack
Terbex Cream : Tubes containing 5 g cream, each gram contains
Terbinafine Hydrochloride INN 10 mg.

Terbex Tablet : Box containing 1 blister strip of 10 tablets, each tablet


contains Terbinafine Hydrochloride INN equivalent to 250 mg
Terbinafine.

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Tofen®
Tablet/Syrup

Description
Tofen is a preparation of Ketotifen, which has antiallergic properties and
has been used similarly, to Sodium Chromoglycate in the prophylactic
treatment of asthma. It also has the properties of an antihistamine.
Tofen possesses marked anti-anaphylactic properties and is effective in
preventing asthmatic attack. Tofen exerts sustained inhibitory effect on
histamine reactions, which can be clearly dissociated from its anti-
anaphylactic properties. Experimental investigations in asthmatic subjects
have shown that Ketotifen is as effective orally as administered by
inhalation as a selective mast cell stabilizer. Antihistamines were
ineffective in those tests. The effectiveness of Ketotifen has been studied
in long term clinical trials. Asthma attacks were reduced in number,
severity and duration and in some cases, the patients were completely
freed from attacks. Progressive reduction of corticosteroids and/or
bronchodilators was also possible. The prophylactic activity of Tofen may
take several weeks to become fully established. Tofen will not abort
established attacks of asthma.

Indications
♦ Prophylactic treatment of bronchial asthma.
♦ Symptomatic treatment of allergic conditions including rhinitis and
conjunctivitis.

Dosage and Administration


Adults : 1 mg twice daily with food. If necessary the dose may be
increased to 2 mg twice daily in severe cases. Children above 2 (two) years
: 1 mg twice daily with food. Patient’s known to be easily sedated should
begin treatment with 0.5 to 1 mg at night for the first few days or as
directed by the physician. Use in elderly : Same as adult dose or as advised
by the physician.

Contraindication
A reversible fall in the platelet count has been observed in a few patients
receiving Ketotifen concomitantly with oral antidiabetic agent and it has

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been suggested that this combination should therefore be avoided.

Use in Pregnancy and Lactation


Although there is no evidence of any teratogenic effect,
recommendations for Ketotifen in pregnancy or when breastfeeding can
not be given.

Precautions
It is important to continue the previous treatment for a minimum of two
weeks after starting Tofen to avoid the possibility of exacerbation of
asthma. This applies specially to systemic corticosteroids and ACTH
because of the possible existence of adrenocortical insufficiency in
steroid dependent patient. If intercurrent infection occurs, Tofen
treatment must be supplemented by specific antimicrobial therapy.
During the first day of treatment with Tofen, reactions may be impaired
and patients should be warned not to take charge of vehicle or machinery
until the effect of Tofen treatment on the individual is known. Patient
should be advised to avoid alcoholic drinks. Tofen may potentiate the
effects of sedatives, hypnotic, antihistamines and alcohol.

Overdosage
The reported features of overdosage include confusion, drowsiness,
nystagmus, headache and disorientation. Bradycardia and respiratory
depression should be watched for. Elimination of the drug with gastric
lavage or emessis is recommended. Otherwise general supportive
treatment shall be instituted.

Side Effects
Drowsiness and in isolated cases, dry mouth and slight dizziness may
occur at the beginning of treatment, but usually disappear spontaneously
after a few days.

Pharmaceutical Precaution
Tofen tablet should be protected from heat and moisture.

Commercial Pack
Tofen Tablet : Box containing 10 blister strips of 10 tablets, each tablet
contains Ketotifen Fumarate BP equivalent to 1 mg Ketotifen.
Tofen Syrup : 100 ml syrup in amber glass bottle, each 5 ml contains
Ketotifen Fumarate BP equivalent to 1 mg Ketotifen.

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Triocim®
Capsule/Suspension

Description
Triocim (Cefixime) is a broad spectrum cephalosporin antibiotic of third
generation for oral administration. It is a bactericidal antibiotic and is
stable to hydrolysis by many β-lactamases. Triocim kills bacteria by
interfering in the synthesis of the bacterial cell wall. 40-50% of an oral
dose is absorbed from gastrointestinal tract, whether taken with meals or
not. The plasma half life is usually about 3 to 4 hours and may be
prolonged when there is renal impairment. Triocim is mainly excreted
unchanged in bile and urine.

Indications
♦ Upper and lower respiratory tract infections

♦ Urinary tract infections

♦ Gonococcal urethritis

♦ Acute otitis media

Dosage and Administration


Adult dose : 1 or 2 capsule as a single dose or in two divided doses daily
for 7 to 14 days, according to the severity of infection.

Child dose : 8 mg/kg daily as a single dose or in two divided doses for 7
to 14 days according to the severity of infection age of the children.

½ -1 year : 3.75 ml or 75 mg
1-4 year : 5 ml or 100 mg
5 -10 year : 10 ml or 200 mg
Above 10 year : Adult dose

Side Effects
Triocim is generally well tolerated. The majority of adverse reactions
observed in clinical trials were mild and self limiting in nature. Among
them diarrhoea, changes in the colour of stool, nausea, abdominal pain,
dyspepsia, headache, dizziness, elevation of serum amylase may occur.

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Contraindication
Patients with known hypersensitivity to cephalosporin group of drugs.

Precautions
Triocim should be prescribed with caution in individuals with a history of
gastrointestinal diseases, particularly colitis. Dosage adjustment is only
necessary in severe renal failure. In pregnancy no data are available, so it
is probably best to avoid using the drug during pregnancy and by the
nursing mothers.

Drug Interactions
No data are available.

Commercial Pack
Triocim Capsule : Box containing 3 x 4’s capsule in strip. Each capsule
contains Cefixime Trithydrate USP equivalent to Cefixime 200 mg.

Triocim Suspension : Bottle containing dry powder for preparation of 50


ml suspension. After reconstitution, each 5 ml contains Cefixime
Trithydrate USP equivalent to Cefixime 100 mg.

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Triovix®
Tablet

Description
Each Triovix tablet contains Lamivudine INN 150 mg, Zidovudine USP
300 mg and Nevirapine INN 200 mg. A fixed dose combination of
Lamivudine, Zidovudine and Nevirapine is recommended for Human
Immunodeficiency Virus-1 (HIV-1) infected patients who are able to
tolerate standard doses of Lamivudine, Zidovudine and Nevirapine for at
least 2 weeks prior to switching over to this fixed dose combination.
Patients should have demonstrated adequate tolerability to Nevirapine.
Indications
A fixed dose combination of Lamivudine, Zidovudine and Nevirapine is
recommended for HIV-1 infected patients who are able to tolerate
maintenance therapy with Nevirapine 200 mg twice daily. All three drugs
are to be administered twice daily and each tablet contains half of the
daily dose for each component. Twice daily formulation in single tablet
for three drugs is convenient for patients to take, ensuring higher rate of
compliance.

Dosage and Administration


For treatment of HIV Infection.

Adult dosage : One tablet twice daily. This fixed dose combination is not
recommended for patients who have not been on initial lower dose of
Nevirapine 200 mg once daily for 2 weeks and or have not tolerated this
dose. After successful therapy with low dose Nevirapine for two weeks,
patients can be switched over to 200 mg bid dose provided they have not
demonstrated any hypersensitivity reaction (rash, abnormal liver function
tests) during their initial exposure to Nevirapine. Monitoring of patients
for their liver function tests etc. is desirable prior to initiating therapy with
Nevirapine and monitoring at frequent intervals once therapy with fixed
dose combination is continued.
Dosage adjustment :
Lamivudine : For patients with low body weight (<50 kg) where dosage
adjustment may be required, it is preferable not to use this fixed dose
combination.

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Zidovudine : Because it is a fixed-dose combination, this should not be


prescribed for patients requiring dosage adjustment such as those with
reduced renal function (creatinine clearance 50 ml/min) or those
experiencing dose-limiting adverse events.

Nevirapine : For patients who experience severe rash or rash with


constitutional complaints during the initial low dose Nevirapine phase of
14 days with once daily dose of 200 mg; neither, dose should be increased
to twice daily nor they should receive triple fixed dose combination until
the rash is resolved. Similarly for patients with abnormal liver function
tests, Nevirapine therapy should be stopped till liver function return to
normal and careful restart is advisable after extended observation. In
event of recurrence, Nevirapine therapy can not be restarted.

For patients where Nevirapine therapy has to be restarted after an


interruption, daily dose of Nevirapine 200 mg for 14 days should be
followed with twice daily dose in absence of any hypersensitivity reaction.
Studies have not been documented to suggest dosage of Nevirapine in
patients with hepatic dysfunction, renal insufficiency or undergoing
dialysis.

Contraindication
History of hypersensitivity to Lamivudine, Zidovudine, Nevirapine and
to any of the excipients available in formulation. Not to be used as initial
therapy because initial therapy requires 200 mg once daily of Nevirapine
whereas fixed dose combination allows for 200 mg twice daily of
Nevirapine.

Warning and Precautions


For the following conditions, assess risk to patient and take action as
needed, chronic hepatitis B, hepatomegaly with steatosis, lactic acidosis,
liver function impairment, severe renal function impairment, peripheral
neuropathy.

Side Effects
Lamivudine : Pancreatitis, paresthesia, peripheral neuropathy, cough,
dizziness, fatigue, gastrointestinal problems, headache, insomnia, anaemia,
neutropenia, drug induced skin, rash, hair loss.

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Zidovudine : Headache (which may be severe, has been reported in up


to 63% of patients receiving Zidovudine and asthenia has been reported
in 9-69%), malaise and fatigue, fever or chills, nausea (61% cases),
diaphoresis, dyspnoea, rash and taste perversion have been reported. Skin
rashes and myalgia has been reported in patients receiving Zidovudine.
Myopathy and myositis with pathologic changes similar to that produced
by HIV infection, have been associated with prolonged use of
Zidovudine. The major adverse effect is bone marrow toxicity resulting in
severe anaemia and/or neutropenia. Patients with low serum folate or
vitamin B12 concentrations may be at increased risk for developing bone
marrow toxicity during Zidovudine therapy. There also are limited data
suggesting that bone marrow of patients with fulminant acquired
immunodeficiency syndrome (AIDS) may be more sensitive to
Zidovudine-induced toxicity than that of patients with less advanced
disease (eg, AIDS-related complex [ARC]). Anaemia and
granulocytopenia usually resolve when Zidovudine is discontinued or
when dosage is decreased. Lactic acidosis (in the absence of hypoxaemia)
and severe hapatomegaly with steatosis, including some fatalities, have
been reported in patients receiving Zidovudine.

Nevirapine : More frequent incidences are skin rash, diarrhoea,


gastrointestinal problems, headache, nausea and stomach pain. Incidence
of less frequents are aphthous stomatitis, fever, hepatitis and Stevens-
Johnson syndrome.

Pharmaceutical Precaution
Store in a cool dry place. Protect from light. Keep out of reach of
children.

Commercial Pack
Triovix Tablet : Each box contains 1 x 10’s tablets in Blister strip. Each
tablet contains Lamivudine INN 150 mg, Zidovudine USP 300 mg and
Nevirapine INN 200 mg.

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Tripec®
Syrup

Description
Tripec is a combination preparation of three active ingredients namely
Guaifenesin, Pseudoephedrine Hydrochloride BP and Triprolidine
Hydrochloride BP. Guaifenesin reduces the viscosity of tenacious sputum
and is used as an expectorant. Pseudoephedrine is a decongestant as well
as a bronchodilator for the upper respiratory tract, which gives
symptomatic relief of nasal congestion. Triprolidine is an antihistamine;
it is used for the symptomatic relief of hypersensitivity reactions
including rhinitis, conjunctivitis and urticaria. Tripec is highly palatable
orange flavoured syrup.

Indications
Tripec is indicated for the symptomatic relief of upper respiratory tract
disorders associated with common cold, allergy and other viral infections.
It is used for the symptomatic treatment of productive cough. Tripec is
also used to relieve symptoms of upper respiratory tract allergies e.g.
sneezing, rhinorrhoea and pruritus of nose, eyes and throat.

Dosage and Administration


Adult and Children over 12 years : 2 tea spoonful thrice daily

Between ages 6-12 years : 1 tea spoonful thrice daily

Between ages 2-5 years : ½ tea spoonful thrice daily,

or as directed by the physician.

Contraindication
Tripec is contraindicated in the cases of known hypersensitivity to any of
its constituents, cardiovascular disease including hypertension, lower
respiratory symptoms including asthma, monoamine oxidase inhibitor
(MAOI) therapy.

Warning and Precautions


As with any other antihistamine therapy, Tripec may cause drowsiness. If
affected, patients should be advised not to drive or operate machinery.

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Concomitant administration of alcohol or other centrally acting sedatives


should be avoided. Although Pseudoephedrine has no pressor effects in
normotensive patients but Tripec should be used with caution to patients
suffering from mild to moderate hypertension. Moreover, caution should
also be exercised in the following disease conditions- hypertension and
heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure,
prostatic enlargement, severe renal and hepatic impairment. This
preparation should not be used for persistent or chronic cough, which
occurs with smoking, asthma or emphysema or where excessive
secretions accompany cough, unless directed by a physician.

Side Effects
CNS depression or excitation, drowsiness (reported most frequently),
sleep disturbances, hallucinations (rarely reported), skin rashes with or
without irritation, tachycardia, dryness of mouth, nose and throat have
occasionally been reported.

Use in Pregnancy
Pseudoephedrine, Triprolidine and Guaifenesin have been in widespread
use without any report of ill-consequences during pregnancy. But
cautions should be exercised by balancing the potential benefit of
treatment to the mother against any possible hazards to the developing
foetus.

Pharmaceutical Precaution
Store below 25o C, protected from light. Do not refrigerate.

Commercial Pack
Tripec Syrup : Amber coloured glass bottle containing 100 ml highly
palatable orange flavoured syrup, each 5 ml of which contains
Guaifenesin BP 100 mg, Pseudoephedrine Hydrochloride BP 30 mg and
Triprolidine Hydrochloride BP 1.25 mg.

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Tycil®
Capsule/Suspension/Paediatric Drops

Description
Tycil contains Amoxicillin (as trihydrate BP) which is chemically D(-)-µ-
amino-p-hydroxybenzylpenicillin. It is a broad-spectrum, bactericidal
antibiotic similar to Ampicillin in the spectrum of activity but is better
absorbed when taken orally and produces a higher blood level.

Indications
Tycil is indicated in the following bacterial infections-
♦ Infections of the respiratory tract and ear : Laryngitis, Pharyngitis, Tonsillitis,
Sinusitis, chronic and acute Bronchitis, Pneumonia and Otitis media.
♦ Infections of the Biliary and Gastrointestinal tract : Salmonellosis, including
the carrier stage, Cholecystitis, Peritonitis.
♦ Infections of the Genito-urinary tract : Nephritis, Pyelitis, Pyelonephritis,
Cystitis, Urethritis and Gonorrhoea, Bacteriuria in pregnancy.
Gynaecological infections including Puerperal sepsis and Septic
abortion.
♦ Skin and soft tissue infections : Boils, Carbuncles, Cellulitis.
♦ Prophylaxis of endocarditis : Tycil may be used for the prevention of
developing bacterial endocarditis, associated with procedures such as
dental extraction.
♦ Others : Pre- and post-operative prophylaxis and treatment of infections,
Septicaemia, Osteomyelitis.
Dosage and Administration
Adult dosage (including elderly patients) :
♦ Standard dosage : It is 250 mg three times daily, increasing up to 500 mg
three times daily for more severe infections.
♦ Severe or recurrent infection of the respiratory tract : A dosage of 3 g
twice daily is recommended in appropriate cases. (Maximum
recommended oral dosage is 6 g daily in divided doses).
♦ Uncomplicated acute urinary tract infection : A single dose of 3 g.

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♦ Gonorrhoea : A single dose of 3 g, often with 1 g probenecid in the


treatment of uncomplicated gonorrhoea in areas where the pathogen is
sensitive to Amoxicillin.

♦ Prophylaxis of endocarditis in susceptible patients : A single dose of 3


g about 1 hour before procedures such as dental extraction.

Children dosage:
♦ Children up to 10 years of age may be given the equivalent of 125 to
250 mg three times daily.
♦ Children weighing 20 kg or more should be given doses according to
the recommended dosage for adults.
♦ Children under 20 kg body weight a dose of 20 to 40 mg per kg daily
has been suggested.
♦ In prophylaxis of endocarditis, children may be given half of the adult
dose, i.e., 1.5 g about 1 hour before procedures such as dental
extraction.

Contraindication
Tycil is contraindicated in patients with known hypersensitivity to
penicillins.

Side Effects
Side effects, as with other penicillins, are rare and usually of mild and
transient in nature. Skin rashes may appear to some patients. This must be
reported to the physician and treatment should be discontinued.
Gastrointestinal complaints such as diarrhoea have occasionally been
observed. These usually subside on continuation of therapy. Incidence of
persistent diarrhoea should be reported to the physician.

Precautions
In presence of gastrointestinal diseases such as diarrhoea and vomiting,
absorption of oral preparation is doubtful. Like all broad-spectrum
antibiotics, superinfection may occur in association with Amoxicillin. In
such cases treatment with Amoxicillin should be discontinued and
appropriate therapy to combat superinfection should be instituted.

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Commercial Pack
Tycil-500 Capsule : Box containing 5 blister strips of 10 capsules, each
capsule contains Amoxicillin Trihydrate BP equivalent to 500 mg
Amoxicillin.

Tycil-250 Capsule : Box containing 10 blister strips of 10 capsules, each


capsule contains Amoxicillin Trihydrate BP equivalent to 250 mg
Amoxicillin.

Tycil Suspension : Dry powder in amber glass bottle for reconstitution


into 100 ml suspension. After reconstitution, each 5 ml contains
Amoxicillin Trihydrate BP equivalent to 125 mg Amoxicillin.

Tycil DS Suspension : Dry powder in amber glass bottle for reconstitution


into 100 ml suspension. After reconstitution, each 5 ml contains
Amoxicillin Trihydrate BP equivalent to 250 mg Amoxicillin.

Tycil Paediatric Drops : Dry powder in amber glass bottle for


reconstitution into 15 ml suspension. After reconstitution, each 1.25 ml
contains Amoxicillin Trihydrate BP equivalent to 125 mg Amoxicillin.

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Tynisol ®
Drops

Description
Tynisol is a liquid preparation of multivitamin.

Each 0.6 ml contains:


Vitamin A 1.2 mg
Vitamin D 10 µg
Vitamin C 50 mg
Thiamine Hydrochloride 1 mg
Riboflavin 0.5 mg
Pyridoxine Hydrochloride 1 mg
Niacinamide 5 mg
Dexpanthenol 3 mg

Indications
For prevention and treatment of vitamin deficiency in children and
infants.

Dosage and Administration


Below 1 year : 9-10 drops (0.3 ml), 1 year and above : 23-25 drops (1.0 ml)
once daily or as advised by the physicians.

Contraindication
Supplemental vitamins should not be prescribed for patients with
haemochromatosis or Wilson’s disease.

Hypersensitivity to any of the active ingredients is a contraindication.


Excessive doses of vitamin A and D can lead to hypervitaminosis. When
multivitamin preparations are prescribed allowance must be made for
vitamins from other sources.

Side Effects
Multivitamin preparation with ordinary doses of component are usually
nontoxic.

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T H E R A P E U T I C I N D E X

Pharmaceutical Precaution
Keep in cool and dry place. Protect from light. Keep out of the reach of
children.

Commercial Pack
Tynisol Multivitamin Drops : Tynisol drops is available in 15 ml amber
glass bottle. Each 0.6 ml Tynisol drops contains multivitamin.

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Ultrafen®
Tablet/Suppository/Gel

Description
Diclofenac is a non-steroidal anti-inflammatory agent with marked
analgesic, anti-inflammatory and antipyretic properties.

Indications
Rheumatoid arthritis, osteoarthritis, low back pain and other acute
musculo-skeletal disorders such as frozen shoulder, tendinitis, teno-
synovitis, bursitis, sprain, strain and dislocation, ankylosing spondylitis,
acute gout, pain in orthopaedics, dental and other minor surgery.

Dosage and Administration


Adults:
→ Enteric coated tablet- A total of 75-150 mg daily given in two or three
divided doses.
→ Sustained release tablets- One tablet daily, taken whole with liquid,
preferably during meal.
→ Suppositories- 75-150 mg daily in divided doses.

→ Gel- Depending on the painful site to be treated, 2-4 g gel may be


applied 3-4 times daily.

Children:
→ Enteric coated tablet : 1-3 mg/kg per day in divided doses.

→ Sustained release tablets : Not recommended.

→ Suppositories : 1-3 mg/kg body weight in divided doses.

Contraindication
Ultrafen should not be given in patients with previous hypersensitivity to
Diclofenac. Ultrafen should not be given to asthmatic patients and in
whom attacks of asthma, urticaria or acute rhinitis are precipitated by
Aspirin or other NSAIDs.

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Precautions
Ultrafen should not be prescribed to pregnant women unless there is
compelling reason for doing so. Patients with a history of peptic ulcer,
haematemesis, melaena, bleeding diathesis or with severe hepatic or renal
insufficiency, should be kept under close surveillance. If abnormal liver
function tests persist or worsen, clinical signs and symptoms consistent
with liver disease or if other manifestations occur (eosinophilia, rash),
Ultrafen should be discontinued. Use of Ultrafen in patients with hepatic
porphyria may trigger an attack.

Side Effects
Epigastric pain, nausea and diarrhoea, headache and slight dizziness may
be complained by some patients. These are often transient, disappearing
with continuation of medication.

Occasionally skin rash, peripheral oedema and abnormalities of serum


transaminase have been reported.

Very rarely reported side effects include activation of peptic ulcer,


haematemesis or melaena, blood dyscrasia (in course of extensive usage).
There have been isolated reports of anaphylactoid reactions.

Accidental overdosage and treatment


There is no known antidote to Ultrafen. Haemodialysis is unlikely to
decrease plasma concentration due to high degree of protein binding.

Pharmaceutical Precaution
Store in a cool dry place. Store suppositories below 30°C, keep out of
reach of children.

Commercial Pack
Ultrafen-25 Tablet : Box containing 10 blister strips of 10 enteric coated
tablets, each tablet contains Diclofenac Sodium BP 25 mg.

Ultrafen-50 Tablet : Box containing 10 blister strips of 10 enteric coated


tablets, each tablet contains Diclofenac Sodium BP 50 mg.

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Ultrafen 100 SR tablet : Box containing 10 blister strips of 10 sustained


release tablets, each tablet contains Diclofenac Sodium BP 100 mg.

Ultrafen 12.5 Suppository : Box containing 10 suppositories (2 x 5’s), each


suppository contains Diclofenac Sodium BP 12.5 mg.

Ultrafen 50 Suppository : Box containing 10 suppositories (2 x 5’s), each


suppository contains Diclofenac Sodium BP 50 mg.
Ultrafen 10 Gel : Tube containing 10 g Gel, each gram contains
Diclofenac Diethylamine BP equivalent to Diclofenac Sodium 10 mg.

Ultrafen 25 Gel : Tube containing 25 g Gel, each gram contains


Diclofenac Diethylamine BP equivalent to Diclofenac Sodium 10 mg.

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Uricon®
Tablet

Description
Uricon (Oxybutynin Chloride) is an antispasmodic, anticholinergic agent.
Each Uricon tablet contains 5 mg of Oxybutynin Chloride USP,
formulated as a once-a-day controlled release tablet for oral
administration. Oxybutynin Chloride relaxes bladder smooth muscle. In
patients with conditions characterized by involuntary bladder
contractions, Oxybutynin Chloride increases bladder capacity, diminishes
the frequency of uninhibited contractions of the detrusor muscle, and
delays the initial desire to void. Uricon thus decreases urgency and the
frequency of both incontinent episodes and voluntary urination.

Indications
Uricon is a once-daily controlled release tablet indicated for the treatment
of overactive bladder with symptoms of urinary incontinence, urgency
for urination, frequent urination and nocturnal enuresis.

Dosage and Administration


Uricon may be administered with or without food. The recommended
starting dose of Uricon is 5 mg once daily. Dosage may be adjusted in 5
mg increments to achieve a balance of efficacy and tolerability (up to a
maximum of 30 mg/day). In general, dosage adjustment may proceed at
approximately weekly intervals.

Contraindication
Oxybutynin is contraindicated in patients with urinary retention, gastric
retention, or uncontrolled narrow angle glaucoma and in patients who are
at risk for these conditions. Uricon is also contraindicated in patients who
have demonstrated hypersensitivity to the drug itself or other
components of the product.

Side Effects
The incidence of dry mouth may occur which is dose-related. Abdominal
pain, dry nasal and sinus mucous membranes, back pain, hypertension,
palpitation, vasodilatation, flatulence, gastro-oesophageal reflux,

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insomnia, nervousness, confusion, cough, sinusitis, bronchitis, dry skin,


rash, impaired urination (hesitancy), urinary retention, etc. may be
reported.

Precautions
Uricon should be used with caution in patients with hepatic or renal
impairment, clinically significant bladder outflow obstruction because of
the risk of urinary retention, gastrointestinal obstructive disorders
because of the risk of gastric retention, conditions such as ulcerative
colitis, intestinal atony, and myasthenia gravis, gastro-oesophageal reflux
and/or who are concurrently taking drugs (such as bisphosphonates) that
can cause or exacerbate oesophagitis.

Drug Interactions
The concomitant use of Oxybutynin with other anticholinergic drugs or
with other agents which produce dry mouth, constipation, drowsiness,
and/or other anticholinergic-like effects may increase the frequency
and/or severity of such effects. Anticholinergic agents may potentially
alter the absorption of some concomitantly administered drugs due to
anticholinergic effects on gastrointestinal motility.

Pharmacokinetic studies with patients concomitantly receiving


cytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g.
Ketoconazole, Itraconazole, and Miconazole) or macrolide antibiotics
(e.g. Erythromycin and Clarithromycin), have not been performed. No
specific drug-drug interaction studies have been performed with
Oxybutynin.

Use in Pregnancy and Lactation


The safety of Oxybutynin administration to women who are or who may
become pregnant has not been established. Therefore, Oxybutynin
should not be given to pregnant women unless, the probable clinical
benefits outweigh the possible hazards. It is not known whether
Oxybutynin is excreted in human milk. Because many drugs are excreted
in human milk, caution should be exercised when Oxybutynin is
administered to a nursing woman.

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Pharmaceutical Precaution
Tablets should be stored below 25o C and protected from light and
moisture.

Commercial Pack
Uricon Tablet : Box containing 30 tablets in 3 x 10's blister strips. Each
controlled release tablet contains Oxybutynin Chloride USP 5 mg.

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Uroflo®
Capsule

Description
Uroflo (Tamsulosin Hydrochloride) is a sulfonamethylamine derivative
α 1A adrenergic blocking agent. The drug is pharmacologically related to
Doxazosin, Prazosin, and Terazosin; however, unlike these drugs,
Tamsulosin has higher affinity and selectivity for the α1A adrenergic
receptors, which are mainly located in nonvascular smooth muscle (e.g.
prostate), than for α1A adrenergic receptors located in vascular smooth
muscle. Such selectivity of Tamsulosin for α1A receptors may result in a
reduced incidence of adverse cardiovascular effects (e.g. syncope,
dizziness, and hypotension).

Indications
Uroflo is used in benign prostatic hyperplasia (BPH). It relaxes smooth
muscle in BPH producing an increase in urinary flow rate and an
improvement in obstructive symptoms.

Dosage and Administration


Uroflo 400 µg once daily is recommended for the treatment of signs and
symptoms of BPH. It should be administered approximately one and
half-hour following the same meal each day.

For those patients who fail to respond to the 400 µg dose after 2 to 4
weeks of dosing, the dose of Uroflo can be increased to 800 µg once
daily.

Contraindication
Uroflo capsules are contraindicated in patients known to be
hypersensitive to Tamsulosin or any component of the product. Uroflo
should be avoided in patients with a history of orthostatic hypotension
and syncope.

Side Effects
Side effects of Tamsulosin include drowsiness, asthenia, depression,
headache, dry mouth, nausea, vomiting, diarrhoea, constipation, oedema,

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blurred vision, rhinitis, erectile disorders, tachycardia and palpitation.


Hypersensitivity reactions including rash, pruritus, angioedema have been
reported in some cases.

Precautions
Uroflo should be avoided in patients with a history of orthostatic
hypotension and syncope. Caution may be taken in the elderly and in
patients with hepatic and renal impairment.

Use in Pregnancy and Lactation


Uroflo is not indicated for use in women.

Drug Interactions
The pharmacokinetic and pharmacodynamics interactions between
Tamsulosin (Uroflo) and other alpha-adrenergic blocking agents have not
been determined. However, interactions may be expected and it should
not be used in combination with other alpha-adrenergic blocking agents.
The pharmacokinetic interaction between Cimetidine and Tamsulosin
was investigated. Caution should be exercised with concomitant
administration of Warfarin and Tamsulosin.

Pharmaceutical Precaution
Store at controlled room temperature 20°C to 25°C. Keep away from
children.

Commercial Pack
Uroflo Capsule : Each box containing 20 capsules in 2 x 10's blister strips.
Each modified release capsule contains Tamsulosin Hydrochloride INN
400 µg.

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Valcap®
Capsule

Description
Valcap (Valsartan) is a nonpeptide, orally active, and specific angiotensin
II antagonist acting on the AT1 receptor subtype. Valsartan is chemically
described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-
yl]methyl]-L-valine.

Indications
For the treatment of hypertension. It may be used alone or in
combination with other antihypertensive agents.

Dosage and Administration


The recommended dose of Valcap is 80 mg once daily, irrespective of
race, age, or gender. The antihypertensive effect is substantially present
within 2 weeks and maximal effects are seen after 4 weeks. In patients
whose blood pressure is not adequately controlled, the daily dose may be
increased to 160 mg or 320 mg or a diuretic may be added. Addition of a
diuretic has a greater effect than dose increases beyond 80 mg.

No dosage adjustment is required for patients with renal impairment or


for patients with hepatic insufficiency of non-biliary origin and without
cholestasis. Valcap may also be administered with other antihypertensive
agents. The safety and efficacy of Valcap have not been established in
children.

Contraindication
Hypersensivity to Valsartan or any of the components of the product.

Drug Interactions
No drug interactions of clinical significance have been found.
Compounds which have been studied in clinical trials include Cimetidine,
Warfarin, Frusemide, Digoxin, Atenolol, Indomethacin,
Hydrochlorothiazide, Amlodipine, Glibenclamide.

As Valcap is not metabolized to a significant extent, clinically relevant

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drug-drug interactions in the form of metabolic induction or inhibition


of the cytochrome P450 system are not expected with Valsartan.
Although valsartan is highly bound to plasma proteins, in vitro studies have
not shown any interaction at this level with a range of molecules which
are also highly protein bound, such as Diclofenac, Frusemide, and
Warfarin. Concomitant use of potassium sparing diuretics (e.g.
Spironolactone, Triamterene, Amilorid) potassium supplements, or salt
substitutes containing potassium may lead to increase in serum
potassium. If co-medication is considered necessary, caution is advisable.

Side Effects
The overall incidence of adverse experiences with Valsartan was similar
to placebo. The common side effects are headache, dizziness, rhinitis,
sinusitis, gastrointestinal upset, nausea, rhinitis, sinusitis, pharyngitis,
oedema and fatigue. Dose-related orthostatic effects were seen in less
than 1% of patients. An increase in the incidence of dizziness was
observed in patients treated with Valsartan 320 mg compared to 80-160
mg.

Use in Pregnancy and Lactation


Due to the mechanisms of action of angiotenin II antagonists, a risk for
the foetus cannot be excluded. In utero exposure to angiotensin
converting enzyme (ACE) inhibitors given to pregnant women during the
2nd and 3rd trimesters has been reported to cause foetal injury, including
hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible
renal failure, and death. As for any drug that also acts directly on the renin
angiotensin-aldosterone system (RAAS). When pregnancy is detected,
Valcap should be discontinued as soon as possible.

It is not known whether Valsartan is excreted in human milk. Valsartan


was excreted in the milk of lactating rats. Thus, it is not advisable to use
Valcap in lactating mothers.

Overdosage
Although there is no experience of overdose with Valcap, the major sign
that might be expected is marked hypotension and tachycardia. If the
ingestion is recent, vomiting should be induced. Otherwise, the usual
treatment would be intravenous infusion of normal saline solution.

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Valsartan is unlikely to be removed by haemodialysis.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use
No overall difference in the efficacy or safety of Valsartan was observed
in this patient population, but greater sensitivity of some older individuals
cannot be ruled out.

Pharmaceutical Precaution
Should be kept away from moisture and heat. Keep out of the reach of
children.

Commercial Pack
Valcap Capsule : Box containing 30 capsules in 3 x 10's blister strips. Each
capsule contains Valsartan INN 80 mg.

Valcap 160 Capsule : Box containing 30 capsules in 2 x 10's blister strips.


Each capsule contains Valsartan INN 160 mg.

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V-Cox®
Tablet

Description
V-cox (Valdecoxib) is a non-steroidal anti-inflammatory drug (NSAID)
that exhibits anti-inflammatory, analgesic and antipyretic properties. The
mechanism of action is believed to be due to inhibition of prostaglandin
synthesis primarily through inhibition of the enzyme cyclooxygenase-2
(COX-2). At therapeutic plasma concentration in human Valdecoxib does
not inhibit cyclooxygenase-1 (COX-1).

Indications
V-cox is indicated :

♦ For relief of the signs and symptoms of osteoarthritis (OA) and adult
rheumatoid arthritis (RA).

♦ For the treatment of primary dysmenorrhoea.

Dosage and Administration


Osteoarthritis and Adult Rheumatoid Arthritis
The recommended dose of V-cox for the relief of the signs and
symptoms of arthritis is 10 mg once daily.
Primary Dysmenorrhoea
The recommended dose of V-cox for treatment of primary
dysmenorrhoea is 20 mg twice daily, or as needed.

Paediatric Use
Safety and effectiveness of V-cox in paediatric patients below the age of
18 years have not been evaluated.

Contraindication
Valdecoxib is contraindicated in patients with known hypersensitivity to
Valdecoxib or any component of the product. It should not be given to
patients who have experienced asthma, urticaria, or allergic-type reactions
after taking Aspirin or non-steroidal anti-inflammatory drugs
(NSAIDs). Valdecoxib should not be given to patients who have
demonstrated allergic-type reactions to sulfonamides.

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Precautions
Treatment with Valdecoxib should be initiated with caution in patients
with mild to moderate hepatic impairment and fluid retention. The use of
Valdecoxib in patients with severe hepatic impairment is not
recommended.

No information is available regarding the safe use of Valdecoxib in


patients with advanced kidney disease. Therefore, treatment with V-cox is
not recommended in these patients. If therapy with V-cox must be
initiated, close monitoring of the patient's kidney function is advisable.

Side Effects
Gastrointestinal events include abdominal fullness, abdominal pain,
diarrhoea, dyspepsia, flatulence and nausea. Valdecoxib may cause
dizziness and headache. In few cases, it may cause back pain, peripheral
oedema, influenza-like syndrome, and hypertension. Myalgia, sinusitis and
skin rash may occur. In the seven osteoarthritis and rheumatoid arthritis
controlled studies, the adverse events occurred in 0.1-1.9% of patients
treated with V-cox 10 -20 mg daily.

Drug Interactions
Aspirin : Concomitant administration of Aspirin with Valdecoxib may
result in an increased risk of gastrointestinal ulceration and complications
compared to Valdecoxib alone.

Methotrexate : Valdecoxib 10 mg bid did not show a significant effect on


the plasma exposure or renal clearance of Methotrexate.

ACE inhibitors : Reports suggest that NSAIDs may diminish the


antihypertensive effect of ACE inhibitors. This interaction should be
given consideration in patients taking Valdecoxib concomitantly with
ACE inhibitors.

Frusemide : Clinical studies, as well as post-marketing observations, have


shown that NSAIDs can reduce the effect of Frusemide and thiazides in
some patients. This response has been attributed to inhibition of renal
prostaglandin synthesis.

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Anticonvulsants : Anticonvulsant drug interaction studies with


Valdecoxib have not been conducted. As with other drugs, routine
monitoring should be performed when therapy with Valdecoxib is either
initiated or discontinued in patients on anticonvulsant therapy.

Fluconazole and Ketoconazole : Concomitant single dose administration


of Valdecoxib 20 mg with multiple doses of Ketoconazole and
Fluconazole produced a significant increase in action of Valdecoxib.

Use in Pregnancy and Lactation


There are no studies in pregnant women. However, Valdecoxib crosses
the placenta in rats and rabbits. V-cox should be used during pregnancy
only if the potential benefit justifies the potential risk to the foetus. The
effects of V-cox on labour and delivery in pregnant women are unknown.
V-cox is contraindicated in nursing mother.

Overdosage
Symptoms following acute NSAID overdoses are usually limited to
lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are
generally reversible with supportive care. Gastrointestinal bleeding can
occur. Hypertension, acute renal failure, respiratory depression and coma
may occur, but are rare. Anaphylactoid reactions have been reported with
therapeutic ingestion of NSAIDs, and may occur following an overdose.

Warning
Serious gastrointestinal toxicity such as bleeding, ulceration and
perforation of the stomach, small intestine or large intestine can occur at
any time with or without warning symptoms in patients treated with
NSAIDs. Minor gastrointestinal problems such as dyspepsia are common
and may also occur at any time during NSAID therapy.

General Information
V-cox can be taken with or without food. Any food had no significant
effect on either the peak plasma concentration or extent of
absorption of Valdecoxib. No significant effect on either the rate or
extent of absorption of Valdecoxib has occurred by concomitant
administration of Valdecoxib with antacid (aluminium/magnesium
hydroxide).

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Pharmaceutical Precaution
Store at 25°C. Keep away from children.

Commercial Pack
V-cox 10 Tablet : Box containing 10 x 10's tablets in blister strips. Each
film coated tablet contains Valdecoxib INN 10 mg.

V-cox 20 Tablet : Box containing 5 x 10's tablets in blister strips. Each


film coated tablet contains Valdecoxib INN 20 mg.

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Xynofen-100 SR
Capsule

Description
Xynofen-100 SR (Ketoprofen) is a derivative of propionic acid which is
widely used in the treatment of patients with rheumatic diseases. It is a
potent non-steroidal anti-inflammatory analgesic agent and a strong
inhibitor of prostaglandin synthetase.

Indications
♦ Rheumatic diseases : for anti-inflammatory and analgesic use in
rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.
♦ Periarticular and musculoskeletal indications : for analgesia in bursitis,
tendinitis, synovitis, tenosynovitis, lumbago.
♦ Prophylaxis and treatment of migraine headache.
♦ Surgical and traumatic uses : for analgesic action after sports injuries,
orthopaedic manipulations, dental extraction, surgery.
♦ Infectious diseases : for analgesic, anti-inflammatory and antipyretic
purposes.
♦ Gynaecological uses : in dysmenorrhoea, following IUCD insertion and
for uterine relaxation and analgesia in the post-partum, non-nursing
mother.

Dosage and Administration


Xynofen-100 SR is administered orally, in the dose of 100-200 mg once
daily, usually with food, depending on patient weight and on severity of
symptoms.

Contraindication
♦ Hypersensitivity to Ketoprofen

♦ Patients with rhinitis, nasal polyps and asthma associated with Aspirin
may show cross sensitivity with other NSAIDs including Ketoprofen
♦ Patients with active ulceration or chronic dyspepsia
♦ Severe renal insufficiency

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Side Effects
Minor side effects are variable in severity and frequency, consisting mostly
of gastrointestinal problems such as gastrointestinal discomfort, nausea,
diarrhoea and occasionally bleeding and ulceration. Dyspepsia may be
minimized by taking this drug with food or milk.

Other minor side effects such as headache, dizziness, mild confusion,


vertigo, drowsiness, oedema, mood change and insomnia may occur less
commonly.

Major side effects involving other organ systems such as haematological


reactions, hepatic or renal damage, dermatological reactions,
bronchospasm and anaphylaxis are exceedingly rare.

In all cases of major side effects Xynofen-100 SR should be withdrawn at


once.

Precautions
Inhibition of renal prostaglandin synthesis by NSAIDs may interfere with
renal function especially in the presence of existing renal disease.
Ketoprofen should therefore be used with caution in patients with renal
impairment. To minimize gastric intolerance, Xynofen-100 SR capsule
should always be taken with food.

Use in Pregnancy and Lactation


The drug should not be used in pregnancy unless clearly needed. It is not
recommended for nursing mother as it is excreted through breast milk.

Drug Interactions
Warfarin, Sulphonamide, Hydantoin : Ketoprofen is highly protein
bound. Theoretically, interaction is possible following concomitant use of
other protein bound drugs, for example anticoagulants, sulphonamides,
and hydantoin.

Digoxin, Methotrexate, Cyclosporin : Like other NSAIDs, Ketoprofen,


through effects on renal prostaglandin, may cause increased toxicity of
certain drugs. Serum levels of Digoxin and Methotrexate may be elevated;
also there may be increased nephrotoxicity with Cyclosporin when used
concomitantly with Ketoprofen.

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Aspirin : Concomitant administration of Aspirin and Ketoprofen is not


recommended as it decreases the plasma concentration of Ketoprofen.

Lithium : Ketoprofen decreases the renal clearance of Lithium and


increases the plasma level of Lithium. So, Lithium toxicity may develop.

Diuretics : Ketoprofen may reduce the activity of the diuretics.

ß-blockers : Ketoprofen may reduce the antihypertensive effect of ß-


blockers.

Oral hypoglycaemics : Ketoprofen may alter the response to insulin or


oral hypoglycaemic agents.

Overdosage
In case of acute overdosage, it is recommended that stomach be emptied
by vomiting or lavage. The use of activated charcoal orally may also be
helpful.

Commercial Pack
Xynofen-100 SR Capsule : Box containing 50 capsules in 5 x 10’s blister
strips, each capsule contains Ketoprofen BP 100 mg as sustained release
pellets.

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Yamadin®
Tablet

Description
The active ingredient of Yamadin-20 and Yamadin-40 tablet is
Famotidine. Famotidine is a novel, highly specific and potent competitive
H 2 receptor antagonist. It has a rapid onset and prolonged duration of
action. After oral administration, the onset of the antisecretory effect
occurs within one hour and lasts for at least 12 hours by doses of 40 mg.
Famotidine reduces the acid and pepsin content, as well as the volume of
basal, nocturnal and stimulated gastric secretion. Food or antacid does
not interfere its absorption.

Indications
Yamadin is indicated in-
♦ Short term treatment of active duodenal ulcer and benign gastric ulcer
♦ Maintenance therapy for prevention of relapses of duodenal ulceration
♦ Gastro-oesophageal reflux disease
♦ Zollinger-Ellison Syndrome

Dosage and Administration


Duodenal ulcer : 40 mg at night for 4 to 8 weeks; Benign gastric ulcer : 40
mg at night for 4 to 8 weeks; Maintenance therapy : 20 mg at night for
preventing the recurrences of duodenal ulceration; Gastro-oesophageal
reflux disease : 20 mg twice daily for 6 to 12 weeks; Zollinger-Ellison
Syndrome : The recommended starting dose is 20 mg every six hours.

Dosage should then be adjusted to individual response. Doses up to 160


mg every six hours have been administered to some patients without the
development of significant adverse effects.

Dosage can be administered irrespective of meals. Antacids may be given


concomitantly if needed.

Side Effects
Yamadin is generally well tolerated and side effects are uncommon.
Dizziness, headache, constipation and diarrhoea have been reported

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rarely. Other side effects reported less frequently include dry mouth,
nausea and/or vomiting, rash, abdominal discomfort, anorexia and
fatigue.

Contraindication
There are no known contraindication to Yamadin. If any evidence of
hypersensitivity appear, the therapy should be discontinued and
consultation with physician is required.

Precautions
Dosage reduction should be considered or interval between doses should
be prolonged if creatinine clearance falls to or below 30 ml/min.

Use in Pregnancy and Lactation


There are no adequate, well-controlled studies on Famotidine in
pregnancy, but it is known to cross the placenta and should be prescribed
only if clearly needed. It is not known whether Famotidine is secreted
into human milk, nursing mothers should either stop nursing or stop
taking the drug.

Drug Interactions
Yamadin does not interact with the cytochrome P450 linked drug
metabolizing enzyme system. So, no interactions have been found in man
with Warfarin, Theophylline, Phenytoin, Diazepam, Propranolol,
Aminopyrine or antipyrine.

Pharmaceutical Precaution
Store in a dry place below 25 0 C.

Commercial Pack
Yamadin-20 Tablet : Each round, film coated tablet contains 20 mg
Famotidine USP. Box containing 10 blister strips of 10 tablets.

Yamadin-40 Tablet : Each round, film coated tablet contains 40 mg


Famotidine USP. Box containing 10 blister strips of 10 tablets.

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Zedex®DS
Syrup

Description
Zedex DS (Zinc Sulphate) is a source of Zinc which is an essential trace
element and involved in a number of body enzyme systems. Zinc salts are
used as supplements to correct Zinc deficiencies. The consequences of
Zinc deficiency are malformations of the brain, eyes, bones, heart and
other organs. Zinc is essential for the formation and function of the
immune system. Systems influenced by Zinc include the reproductive,
neurologic, immune, dermatologic and gastrointestinal systems.

Indications
♦ Zinc deficiency states
♦ Growth retardation, respiratory tract infection, alopecia, dermatitis,
diarrhoea, immunologic dysfunction, psychological disturbances,
gonadal atrophy, impaired spermatogenesis, congenital malformations,
acrodermatitis enteropathica.

Dosage and Administration


→ Children under 10 kg
→ : 22.5 mg (2¼ tea spoonful) daily in
divided doses.
→ Children within 10 to 30 kg
→ : 22.5 mg (2¼ tea spoonful) 1 to 3
times daily after food.
→ Adults and children over 30 kg
→ : 45 mg (4½ tea spoonful) 1 to 3
times daily after food or as directed by the physician.

Side Effects
♦ Zinc salts may cause abdominal pain and dyspepsia.
♦ Prolonged use may lead to copper deficiency and anaemia.
♦ It can be converted to the corrosive Zinc Chloride, and it is this
corrosive action that accounts for the acute toxicity of the soluble Zinc
salts.

Drug Interactions
Zinc may inhibit the absorption of concurrently administered
Tetracyclines, therefore, an interval of at least 3 hours should be allowed
while taking these products.

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Contraindication
It is contraindicated in patients with hypersensitivity to Zinc.

Special Warning and Precautions


Accumulation of Zinc may occur in case of renal failure.

Overdosage
Zinc sulphate is corrosive in overdosage. Symptoms are corrosion and
inflammation of the mucous membrane of the mouth and stomach;
ulceration of the stomach followed by perforation may occur. Gastric
lavage and emesis should be avoided. Demulcent such as milk should be
given. Chelating agents such as sodium edetate may be useful.

Pharmaceutical Precaution
Store in a cool and dry place, keep away from light.

Commercial Pack
Zedex DS Syrup : 100 ml syrup in amber glass bottle. Each 5 ml contains
Zinc Sulphate Monohydrate USP equivalent to 10 mg of elemental Zinc.

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Zocil®
Tablet

Description
Cilostazol (Zocil) is a quinolinone derivative. The mechanism of action is
to specifically inhibit cellular phosphodiesterase III (PDE III) and
suppress cAMP degradation with a resultant increase in cAMP in platelets
and blood vessels, leading to inhibition of platelet aggregation and
vasodilation.

Indications
Zocil is indicated for the reduction of symptoms of intermittent
claudication, as indicated by an increased walking distance.

Dosage and Administration


The recommended dosage of Zocil is 100 mg bid, taken at least half an
hour before or two hours after breakfast and dinner. A dose of 50 mg bid
should be considered during coadministration of Ketoconazole,
Itraconazole, Erythromycin, and Diltiazem.

Side Effects
The most common side effects are headache, diarrhoea, vomiting, leg
cramps, rash etc. The less frequent side effects are anorexia and oedema.

Contraindication
Zocil is contraindicated in patients with congestive heart failure of any
severity. Zocil is also contraindicated in patients with known or suspected
hypersensitivity to any of its components.

Precautions
Zocil should be used with caution in patients with any degree of heart
failure. There is no information with respect to the efficacy or safety of
the concurrent use of Cilostazol and Clopidogrel.

Use in Pregnancy and Lactation


There are no adequate and well-controlled studies in pregnant women.
Transfer of Cilostazol into milk has been reported in experimental

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animals. Because of the potential risk to nursing infants, a decision should


be made to discontinue nursing or to discontinue Zocil.

Paediatric Use
The safety and effectiveness of Zocil in paediatric patients have not been
established.

Drug Interactions
Pharmacokinetic studies have demonstrated that Omeprazole and
Erythromycin significantly increased the systemic exposure of Cilostazol
and/or its major metabolites. Population pharmacokinetic studies showed
higher concentrations of Cilostazol among patients concurrently treated
with Diltiazem.

Overdosage
Information on acute overdosage with Zocil in humans is limited. The
signs and symptoms of an acute overdose are severe headache, diarrhoea,
hypotension, tachycardia, and possibly cardiac arrhythmias. The patient
should be carefully observed and given supportive treatment.

Pharmaceutical Precaution
Keep in a cool (25 oC) and dry place. Keep out of the reach of children.

Commercial Pack
Zocil 50 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Each
tablet contains Cilostazol INN 50 mg.

Zocil 100 Tablet : Box containing 20 tablets in 2 x 10’s blister strips. Each
tablet contains Cilostazol INN 100 mg.

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Zukast®
Tablet

Description
Zukast (Zafirlukast) is a synthetic, selective peptide leukotriene receptor
antagonist (LTRA) that acts as a prophylactic agent against inflammation
in asthma.
Cysteinyl leukotriene production and receptor occupation have been
correlated with the pathophysiology of asthma, including airway oedema,
smooth muscle constriction, and altered cellular activity associated with
the inflammatory process, which contribute to the signs and symptoms of
asthma.

Indications
Zukast is indicated for the treatment of asthma.

Dosage and Administration


Zukast should be taken continuously. Children under 7 years of age : There is
no clinical experience of the use of Zukast in children under 7 years of
age until safety information is available. Children over 7 years through 11 years
of age : The recommended dose of Zukast in this age group is 10 mg twice
daily. Adult and children aged 12 years and over : The dosage is one 20 mg
tablet twice daily. This dosage should not be exceeded. Higher doses may
be associated with elevations of one or more liver enzymes consistent
with hepatotoxicity. As food may reduce the bioavailability of Zafirlukast,
Zukast should not be taken with meals. Elderly : The clearance of
Zafirlukast is significantly reduced in elderly patients (over 65 years old),
and Cmax and AUC are approximately double than those of younger
adults. However, accumulation of Zafirlukast is not greater than that seen
in multiple-dose trials conducted in adult subjects with asthma and the
consequences of the altered kinetic in the elderly are unknown. Clinical
experience with Zukast in the elderly (over 65 years) is limited and caution
is recommended until further information is available.

No dosage adjustment is necessary in patients with mild renal


impairment.

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Contraindication
Zukast should not be given to patients who have previously experienced
hypersensitivity to the product or any of its ingredients. Zukast is
contraindicated in patients with a history of moderate or severe renal
impairment. Zukast is contraindicated in patients with hepatic
impairment or cirrhosis; it has not been studied in patients with hepatitis
or in long term studies of patients with cirrhosis. Zukast is
contraindicated in children under 7 years of age until safety information
is available.

Warning and Precautions


Zukast should be taken regularly to achieve benefit, even during
symptom-free periods. Zukast therapy should normally be continued
during acute exacerbations of asthma. Zukast does not allow a reduction
in existing steroid treatment. As with inhaled steroids and cromones
(disodium cromoglycate, nedocromil sodium), Zukast is not indicated for
use in the reversal of bronchospasm in acute asthma attacks. Zukast has
not been evaluated in the treatment of labile (brittle) or unstable asthma.

Cases of Churg-Strauss Syndrome have been reported in association with


Zukast usage. A causal relationship has neither been confirmed nor
refuted. If a patient develops a Churg-Strauss Syndrome type illness,
Zukast should be stopped, a re-challenge test should not be performed
and treatment should not be restarted.

Elevations in serum transaminases can occur during treatment with


Zukast. These are usually asymptomatic and transient but could
represent early evidence of hepatotoxicity.

If clinical symptoms or signs suggestive of liver dysfunction occur (e.g.


nausea, vomiting, right upper quadrant pain, fatigue, lethargy, flu-like
symptoms, enlarged liver, pruritus and jaundice), the serum
transaminases, in particular serum ALT, should be measured and the
patient managed accordingly. A decision to discontinue Zukast should be
individualized to the patient’s condition, weighing the risk of hepatic
dysfunction against the clinical benefit of Zukast to the patient.

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T H E R A P E U T I C I N D E X

Drug Interactions
Zukast may be administered with other therapies routinely used in the
management of asthma and allergy. Inhaled steroids, inhaled and oral
bronchodilator therapy, antibiotics and antihistamines are examples of
agents which have been co-administered with Zukast without adverse
interaction.

Zukast may be administered with oral contraceptives without adverse


interaction. Co-administration with Warfarin results in an increase in
maximum prothrombin time by approximately 35%. It is therefore
recommended that if Zukast is co-administered with Warfarin,
prothrombin time should be closely monitored. The interaction is
probably due to an inhibition by Zafirlukast of the cytochrome P450 2C9
enzyme system. In clinical trials co-administration with Theophylline
resulted in decreased plasma levels of Zafirlukast, by approximately 30%,
but with no effect on plasma Theophylline levels. However, during post-
marketing surveillance, there have been rare cases of patients
experiencing increased Theophylline levels when co-administered with
Zafirlukast.

Co-administration with Terfenadine resulted in a 54% decrease in AUC


for Zafirlukast, but with no effect on plasma terfenadine levels. Co-
administration with Acetylsalicylic acid (650 mg four times a day) may
result in increased plasma levels of Zafirlukast, by approximately 45%.

Co-administration with Erythromycin will result in decreased plasma


levels of Zafirlukast, by approximately 40%. The clearance of Zafirlukast
in smokers may be increased by approximately 20%.

Use in Pregnancy and Lactation


The safety of Zukast in human pregnancy has not been established. In
animal studies, Zafirlukast did not have any apparent effect on fertility
and did not appear to have any teratogenic or selective toxic effect on the
foetus. The potential risks should be weighed against the benefits of
continuing therapy during pregnancy and Zukast should be used during
pregnancy only if clearly needed. Zafirlukast is excreted in human breast
milk. Zukast should not be administered to nursing mothers.

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Side Effects
Effect on ability to drive or operate machinery : There is no evidence that
Zukast affects the ability to drive and use machinery. Administration of
Zukast in clinical trials against placebo has been associated with headache
(9.9% vs. 9.0%) or gastrointestinal disturbance (nausea 2.6% vs. 2.2%,
vomiting 1.2% vs. 1.0%, diarrhoea 2.3% vs. 1.8%, abdominal pain 1.6%
vs. 1.2%). These symptoms are usually mild and do not necessitate
withdrawal from therapy. During post-marketing experience, bruising,
bleeding disorders, including menorrhagia (rare), thrombocytopaenia and
agranulocytosis (very rare) have also been reported.

Hypersensitivity reactions, including urticaria and angioedema have been


reported. Rashes, including blistering, have also been reported. The
above events have usually resolved during continued treatment or
following cessation of therapy.

Infrequently, elevated serum transaminase levels have been observed in


clinical trials against placebo with Zafirlukast (increased AST 1.0% vs.
0.9%, increased AST 0.6% vs. 0.6%); at recommended doses the
incidence was equivalent to placebo. Rarely the transaminase profile has
been consistent with drug-induced hepatitis, which resolved following
cessation of Zukast therapy. During post-marketing experience there
have been rare reports of hepatitis, with or without elevated bilirubin
levels. These cases were usually reversible.

In placebo-controlled clinical trials, an increased incidence of infection


has been observed in elderly patients given Zafirlukast (7.8% vs. 1.4%).
Infections were usually mild, predominantly affecting the respiratory
tract.

Overdosage
No information exists with regard to the effects of overdosage of Zukast
in humans. Management should be supportive. Removal of excess
medication by gastric lavage may be helpful.

Pharmacological Properties
The cysteinyl leukotrienes (LTC4, LTD4 and LTE4) are potent
inflammatory eicosanoids released from various cells including mast cells

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and eosinophils. These important pro-asthmatic mediators bind to


cysteinyl leukotriene receptors found in the human airway.

Leukotriene production and receptor occupation has been implicated in


the pathophysiology of asthma. Effects include smooth muscle
contraction, airway oedema and altered cell activity associated with the
inflammatory process, including eosinophil influx to the lung.

Zukast is a competitive, highly selective and potent oral peptide


leukotriene antagonist of LTC4, LTD4 and LTE4 components of slow
reacting substance of anaphylaxis. In vitro studies have shown that Zukast
antagonizes the contractile activity of all three peptide leukotrienes
(leukotriene C4, D4 and E4) in human conducting airway smooth muscle
to the same extent. Animal studies have shown Zafirlukast to be effective
in preventing peptide leukotriene-induced increases in vascular
permeability, which give rise to oedema in the airways, and to inhibit
peptide leukotriene-induced influx of eosinophils into airways. The
specificity of Zukast has been shown by its action on leukotriene
receptors and not prostaglandin, thromboxane, histamin, and cholinergic
receptors.

Peak plasma concentrations of Zafirlukast are achieved approximately 3


hours after oral administration of Zukast. Administration of Zukast with
food increased the variability in the bioavailability of Zafirlukast and
reduced bioavailability in most (75%) subjects. The net reduction was
approximately 40%. Following twice-daily administration of Zukast (30
to 80 mg bid), accumulation of Zafirlukast in plasma was low (not
detectable - 2.9 times first dose values; mean 1.45; median 1.27). The
terminal half-life of Zafirlukast is approximately 10 hours. Steady-state
plasma concentrations of Zafirlukast were proportional to the dose and
predictable from single-dose pharmacokinetic data. Zafirlukast is
approximately 99% protein bound to human plasma proteins,
predominantly albumin, over the concentration range 0.25 to 4.0 µg/ml.

Zafirlukast is extensively metabolized. Following a radiolabelled dose the


urinary excretion accounts for approximately 10% dose and faecal
excretion for 89%. Zafirlukast is not detected in urine.

Elderly subjects and subjects with stable alcoholic cirrhosis demonstrated


an approximately two-fold increase in C max and AUC compared to

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normal subjects given the same doses of Zukast. There are no significant
differences in the pharmacokinetics of Zafirlukast in patients with mild
renal impairment and in normal subjects.

Pharmaceutical Precaution
Store below 30o C. Protect from light and moisture.

Commercial Pack
Zukast Tablet : Box containing 10 tablets in 1 x 10’s alu-alu form pack,
each tablet contains Zafirlukast INN 20 mg.

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Zymet®
Tablet

Description
Zymet is a preparation of mammalian pancreas containing enzyme
protease, lipase and amylase activity. Each gram of pancreatin contains
1400 FIP units of protease activity, 20000 FIP units of lipase activity and
24000 FIP units of amylase activity.

Use
To compensate for reduced intestinal enzyme activity in pancreatic
deficiency states.

Indications
Children : In children with reduced or absence of pancreatic exocrine
secretion, and Cystic fibrosis.
Adults : In the conditions with deficient pancreatic exocrine function
such as
♦ Following pancreatectomy
♦ Following total gastrectomy
♦ Chronic pancreatitis.

Dosage and Administration


1-3 tablets daily with meal or as per direction of the physician.
Side Effects
Zymet may cause buccal and perianal soreness, particularly in infants.
Hypersensitivity reactions have been reported; these may be sneezing,
lacrimation or skin rashes.

Precautions
Zymet should be used with caution in patients known to be allergic to
animal protein.
Pharmaceutical Precaution
Keep in a cool, dry place. Keep out of the reach of children.

Commercial Pack
Zymet Tablet : Box containing 100 tablets in 10 x 10’s blister strips, each
sugar and enteric coated tablet contains Pancreatin BP 325 mg.

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