You are on page 1of 404

Pediatric Drug

Directory
Pediatric Drug
Directory 8th Edition

Suraj Gupte MD FIAP


Professor and Head, Postgraduate Department of Pediatrics
Mamata Medical College/Mamata General and Superspecialty Hospitals
Khammam, Andhra Pradesh, India
E-mail: drsurajgupte@gmail.com, surajgupte@rediffmail.com
recentadvances@yahoo.co.uk, Website: www.drsurajgupte.com
Honorary Director: Pediatric Education Network
Editor: The Short Textbook of Pediatrics; Textbooks of Pediatric Emergencies, Neonatal Emergencies,
Pediatric Nutrition, and Pediatric Gastroenterology, Hepatology and Nutrition, Pediatric Infectious
Diseases, Influenza: Complete Spectrum, Towards MRCPCH Part II (Theory) Examination, Pediatric
Yearbook (Series), Newer Horizons in Tropical Pediatrics, etc.
Author: Differential Diagnosis in Pediatrics, Instructive Case Studies in Pediatrics, Influenza, Perspectives
in Influenza, Pediatric Drug Directory, Infant Feeding, Speaking of Child Care,The Baby Book: The Parents
Guide from Birth to Infancy
Co-editor: Asian Journal of Maternity and Child Health (Manila, Philippines)
Section and Guest Editor: Pediatrics Today (New Delhi)
Editorial Advisor: Asian Journal of Pediatrics Practice (New Delhi)
Editorial Advisory Board Member/Reviewer: Indian Journal of Pediatrics (New Delhi), Indian Pediatrics (New
Delhi), Synopsis (Detroit, USA), Indian Journal of Pediatric Gastroenterology, Hepatology and Nutrition
(Jaipur), Maternal and Child Nutrition (Preston, UK), Journal of Pediatric Infectious Diseases (Turkey)
Examiner: National Board of Examinations (NBE) for DNB, New Delhi; All India Institute of Medical Sciences
(AIIMS), New Delhi; Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh;
Sher-i-Kashmir Institute of Medical Sciences (SKIMS), Srinagar; Indira Gandhi National Open University
(IGNOU), New Delhi, India
Pediatric Faculty Selection Expert: All India Institute of Medical Sciences (AIIMS), Punjab Public Service
Commission, Jammu and Kashmir Public Service Commission, Union Public Service Commission, etc.

Novy Gupte MD
Drug Safety Physician, APCER Pharma India Limited
New Delhi, India
E-mail: drnovyguptesg@in.com

Advisor Emeritus
Rita Smith MRCP FRCP PhD
Executive Director-Gen, Child Health Study Group
Founder-Director, Inter-country Pharmacovigilance Initiative
London, England

Foreword
John Brown

JAYPEE BROTHERS Medical Publishers (P) Ltd


New Delhi London Philadelphia Panama

Jaypee Brothers Medical Publishers (P) Ltd.


Headquarters
Jaypee Brothers Medical Publishers (P) Ltd.
4838/24, Ansari Road, Daryaganj
New Delhi 110 002, India
Phone: +91-11-43574357
Fax: +91-11-43574314
Email: jaypee@jaypeebrothers.com
Overseas Offices
J.P. Medical Ltd. Jaypee-Highlights Medical Publishers Inc.
83, Victoria Street, London City of Knowledge, Bld. 237, Clayton
SW1H 0HW (UK) Panama City, Panama
Phone: +44-2031708910 Phone: +1 507-301-0496
Fax: +02-03-0086180 Fax: +1 507-301-0499
Email: info@jpmedpub.com Email: cservice@jphmedical.com
Jaypee Medical Inc. Jaypee Brothers Medical Publishers (P) Ltd.
The Bourse 17/1-B, Babar Road, Block-B, Shaymali
111, South Independence Mall East Mohammadpur, Dhaka-1207
Suite 835, Philadelphia, PA 19106, USA Bangladesh
Phone: +1 267-519-9789 Mobile: +08801912003485
Email: jpmed.us@gmail.com Email: jaypeedhaka@gmail.com
Jaypee Brothers Medical Publishers (P) Ltd.
Bhotahity, Kathmandu, Nepal
Phone: +977-9741283608
Email: kathmandu@jaypeebrothers.com
Website: www.jaypeebrothers.com
Website: www.jaypeedigital.com
2014, Manu Gupte, Executive Editor
The views and opinions expressed in this book are solely those of the original contributor(s)/
author(s) and do not necessarily represent those of editor(s) of the book.
All rights reserved. No part of this publication may be reproduced, stored or transmitted in any form
or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior
permission in writing of the publishers/editors.
All brand names and product names used in this book are trade names, service marks, trademarks
or registered trademarks of their respective owners. The publisher is not associated with any
product or vendor mentioned in this book.
Medical knowledge and practice change constantly. This book is designed to provide accurate,
authoritative information about the subject matter in question. However, readers are advised to
check the most current information available on procedures included and check information from
the manufacturer of each product to be administered, to verify the recommended dose, formula,
method and duration of administration, adverse effects and contraindications. It is the responsibility
of the practitioner to take all appropriate safety precautions. Neither the publisher nor the author(s)/
editor(s) assume any liability for any injury and/or damage to persons or property arising from or
related to use of material in this book.
This book is sold on the understanding that the publisher is not engaged in providing professional
medical services. If such advice or services are required, the services of a competent medical
professional should be sought.
Every effort has been made where necessary to contact holders of copyright to obtain permission
to reproduce copyright material. If any have been inadvertently overlooked, the publisher will be
pleased to make the necessary arrangements at the first opportunity.
Inquiries for bulk sales may be solicited at: jaypee@jaypeebrothers.com
Pediatric Drug Directory
First Edition: May 1979; Second Edition: Jan. 1980; Third Edition: May 1982; Fourth Edition:
Sept. 1984; Fifth Edition: Sept. 1986; Sixth Edition: Jan. 1991; Seventh Edition: 2001
Eighth Edition: 2014
ISBN 978-93-5152-155-6
Printed at
Dedicated to
Everybody striving to contribute to child health
and welfare for a brighter future globally
Foreword

I feel much honored in critically reviewing the drafts of the eighth


edition of the Pediatric Drug Directory by the Indias well-known
pediatric educationist and author, Professor Suraj Gupte, and his
young, enterprising daughter, Dr Novy Gupte. Dr Rita Smith who had
coauthored the first seven editions has opted for the role as an Advisor
Emeritus.
This book provides a plethora of handy information eagerly
sought by all those involved in the pharmacotherapy of sick children
including neonates and adolescents. Salient clinical pharmacological
features of such new molecules as fifth generation cephalosporins
(ceftarolin, ceftobiprole), non-penicillin non-cephalosporin beta-
lactams (aztreonam, imipenem-cilastatin, meropenem), tigecycline,
dalbavancin, oritavancin, etc. find a due incorporation in the text.
Addition of a fine, brief and to-the-point chapter on pediatric
emergencies in the new edition is a wise step. This may well be further
expanded in the future edition.
Over and above the excellent contents, the presentation is simple,
lucid and to-the-point. Rational division of the contents in sections,
chapters and listing of the drugs of various groups in alphabetic order
are of great help to the reader. Additionally, a comprehensive index
facilitates easy and speedy access to and retrieval of the requisite
information.
In my considered opinion, Drs Suraj Gupte and Novy Guptes
Pediatric Drug Directory is a strongly recommended treatise for the
undergraduates, pediatric postgraduates/scholars, and practitioners
of child health and disease not only in India but elsewhere also, on
account of the wealth of information it provides on different aspects
of pediatric drug therapy.
 John Brown MD FAAP MPH
Professor
 Clinical Pharmacology and Child Health
 State University of New York
 Buffalo, New York, USA
Preface to the Eighth Edition

The eighth edition of the Pediatric Drug Directory has been extensively
revised, updated and enlarged in keeping with the changing concepts
and advances in the field as also to meet the growing needs of the
readers who include not only the medical students, residents and
pediatricians but also general practitioners and family physicians
having a pediatric clientage.
Section 1 deals with an overview of the basics of pediatric
drug therapy, including principles, pharmacodynamics and
pharmacokinetics, drug monitoring, etc.
Section 2 specifically provides salient information about general
medications, beginning with analgesics and antipyretics through
antihypertensives to miscellaneous drugs.
Section 3 embarks on antimicrobials including antibiotics, antiviral,
antifungal and antiparasitic drugs.
Section 4 is a spotlight on drugs employed in neonatology.
Section 5 gives guidelines on standard therapeutic approach to
neonatal and pediatric emergencies.
Section 6 provides useful information related to pediatric drug
therapy, including Indias national and IAP immunization schedules.
A plethora of appendices provide the useful information related
to pediatric drug therapy and Indias National Immunization Schedule
and Indian Academy of Pediatrics (IAP) Immunization Time Table/
Schedule are incorporated.
Additionally, a glossary of abbreviations and index have been
incorporated.
Over and above the essential details of the drugs, adverse drug
reactions (ADRs), precautions, drug interactions and contraindications
have been particularly included, as and when warranted, in the
interest of safety for the sick child.
Heres wishing you all a fruitful reading and referencing in the
larger interest of the child patients needing drug therapy.
 Suraj Gupte
 Novy Gupte
Preface to the First Edition

Drugs, says Professor Harry C Shirkey, are our fine servants and awful
masters. This holds nowhere as good as in pediatric practice. Their
injudicious use in infants and children can indeed prove disastrous.
Yet, the most troublesome to the freshers in the field of pediatrics,
as also to the general practitioners who care for children as well, is
the pediatric drug therapy. Which drug to give to a particular patient?
The brand name? How available? How much to give? Side effects? The
young doctorsmany not-so-young alsosure feel puzzled.
Pediatric Drug Directory aims to be the answer. It provides the
much-needed information as pointed out above plus much more.
Section 1the largestdeals with the brand names, availability,
dosage and side effect of the important drugs. As a rule, drugs are
arranged alphabetically according to the generic names. Section 2
deals with drugs excreted into the breast milk, Section 3 with drugs
that discolor the stools and Section 4 with drugs that discolor the
urine. Drugs likely to cause hemolysis in G6PD deficient individuals
are listed in Section 5. Sections 6 and 7 deal with the WHOs urban and
rural immunization schedules. The important patent formulary and
surface area chart are the other highlights.
Dr (Mrs) VV Gujral has been gracious enough to advance highly
useful criticism and to write the Foreword to the book.
While thanking all those who helped us in compiling this directory,
we sincerely look forward to constructive criticism and suggestions
from the readers. That will be a vital contribution to the subsequent
editions.
 Suraj Gupte
 Rita Smith
Acknowledgments

We gratefully express our indebtedness to:


The Indian Academy of Pediatrics (IAP), American Academy
of Pediatrics (AAP) and Ministry of Health and Family Welfare,
Government of India, for access to their publications/websites.
The international series, Recent Advances in Pediatrics, for using
some state-of-the-art material published in its various volumes.
Nelson Textbook of Pediatrics for using some state-of-the-art
material.
Goodman and Gillmans Pharmacologic Basis of Therapeutics for
using some state-of-the-art material.
The managements/administrations of Narayana Medical College
and Hospitals, Nellore, Andhra Pradesh, India, and the Principal
and Head of the Department of Pharmacology, Therapeutics and
Toxicology, Government Medical College and Associated Hospitals,
Jammu, Jammu and Kashmir, India, for providing motivation and
moral support for completing this project.
The management and administration of Mamata Medical College
and Hospitals, Khammam, Andhra Pradesh, India, especially
Mr Ajay Kumar, Chairman, and Mr K Sreedhar, Director (Estt), and
the Dean/Principal, Dr K Koteshwer Rao, for providing motivation
and moral support for completing this project.
Dr Gagan Hans, Psychiatrist, Lady Hardinge Medical College
(LHMC) and Hospitals, New Delhi, India, for voluntary help at
various stages of development of this book, including inputs
concerning neuropsychiatric drugs.
Dr Rita Smith, who actively shared the editorship from the inception
through the eighth edition of the book, for graciously agreeing to be
the Advisor Emeritus in spite of her overwhelming commitments in
other academic endeavors, including pharmacovigilance initiative
globally.
The Executive Editor, Manu Gupte, for excellent coordination in
handling the project.
The publisher, M/s Jaypee Brothers Medical Publishers (P) Ltd, New
Delhi, India, and their staff for admirable and skillful production
qualities of the book.
Contents

Section 1Basics of Pharmacotherapy in Neonates,


Infants and Children

1. Principles 1

2. Rational Drug Therapy 11

3. Therapeutic Drug Monitoring 14

4. Certain Golden Rules in Pediatric Drug Therapy 17

Section 2 General Medications

5. Analgesics/Antipyretics/Nonsteroid Anti-inflammatory
Drugs (NSAIDs) 18

6. Antiasthma Drugs/Bronchodilators 25

7. Antihistamines 31

8. Nasal Decongestants 39

9. Antitussives 41

10. Gastrointestinal Tract Drugs 42

11. Central Nervous System Drugs 53

12. Anticonvulsants 56

13. Cardiovascular Drugs (Cardiotonics) 68

14. Diuretics 77

15. Anticoagulants 81
xvi Pediatric Drug Directory

16. Drugs for Endocrinal Disorders/


Hormones/Enzymes 84

17. Antihypertensive Drugs 94

18. Immunoglobulins 100

19. Hematinics 106

20. Vitamins 110

21. Trace Elements 114

22. Anticancer Drugs 117

23. Antitoxins 124

24. Miscellaneous 126

Section 3 Drugs for Infections and Infestations

25. Antibacterial Drugs 132

26. Antimycobacterial Drugs 184

27. Antiviral Drugs 198

28. Antifungal Drugs 210

29. Antimalarial Drugs 215

30. Antiparasitic (Intestinal) Drugs 223

31. Antiparasitic (Extraintestinal) Drugs 233

Section 4 Drug Therapy in Neonates

32. Emergency Drugs in Neonates 237

33. Drug Dosage in Neonates 239


Contents xvii

Section 5 Pharmacotherapy in Emergencies

34. Important Emergency Drugs 253

35. Pharmacotherapy of Common Emergencies 254

Section 6 Vaccines

36. Conventional and New Vaccines for Routine Use 271

37. Combination Vaccines 297

Appendices Useful Information Related to


Pediatric Drug Therapy

Appendix 1: Specific Antidotes 301


Appendix 2: Various Solutions Used in the
Treatment of Dehydration and
Dyselectrolytemia 303
Appendix 3: Drugs Likely to Have Adverse
Effects on the Fetus When
Consumed During Pregnancy 305
Appendix 4: Drugs in Treatment/Prevention of
Fetal Disease 307
Appendix 5: Therapeutic Range of Some Drugs 308
Appendix 6: Drugs Excreted into Breast Milk 310
Appendix 7: Drugs that Discolor the Stools 313
Appendix 8: Drugs that Discolor the Urine 314
Appendix 9: Drugs Likely to Cause
Hemolysis in G6PD Deficiency 316
Appendix 10: Drugs that may Cause Specific
Side Effects 317
Appendix 11: ADRs Specific to Certain Drugs 318
Appendix 12: Nomogram for
Estimation of Surface Area 340
xviii Pediatric Drug Directory

Appendix 13: Drug Groups with Adverse


Effects on Vitamin Status 341
Appendix 14: Potential Drug Interaction with
Chemotherapy 342
Appendix 15: Banned Single Dose
Drug Combinations (in India) 344
Appendix 16: Banned Fixed Dose Drug
Combinations with Other
Agents (in India) 346
Appendix 17: Immunization Schedules 347
Appendix 18: Indian Academy of Pediatrics (IAP)
Immunization Recommendations 348
Appendix 19: Adverse Events Following Immunization 357

Glossary of Abbreviations 359


Index 361
Section 1
Basics of Pharmacotherapy in
Neonates, Infants and Children
Chapter

1
Principles

A child is not a mini adult! And, a neonate is not a mini childat


least from the angle of drug therapy and dosage that are based
on not only the indication but also on the pharmacokinetics and
pharmacodynamics. As a result of studies related to developmental
pharmacokinetics, today we know that:
Pharmacokinetics are quite immature in the neonates, especially
preterm, low birth weight (lbw) infants and and infants suffering
from intrauterine growth retardation (IUGR).
During age 1 to 12 months, there is an improvement in the
maturity.
During age 1 to 4 years, these are nearly stabilized.
During age 5 to 11 years, these are even somewhat above the
status in adults.
During adolescence, these are fully matured.
The old practice of drug prescribing in neonates, infants and children
just by arbitrary modification of the adult dose was by all means
erroneous and ill-founded.
Most of the factors influencing the drug disposition are unique
in neonates and infants who represent the most fragile group due to
physiological instabilities and increased potentials for toxic effects as
compared to children and adults. However, only limited work has been
done in these areas in pediatric age group, leaving quite a few gray areas
for elucidation. This age group should, therefore, receive special attention
for pharmacokinetic, pharmacodynamic and toxicologic research.

Certain Definitions
The term, pharmacokinetics, implies the quantitative evaluation
of various components of a drugs disposition, e.g. absorption,
2 Section 1: Basics of Pharmacotherapy in Neonates, Infants and Children

distribution, metabolism and excretion. Precisely, pharmacokinetics


refers to what the body does to the drug. It is, thus, a mathematical
expression of the time course of movements in the body. A drugs
pharmacologic effects, toxic effects or both correlate best with its
concentration in blood or some other biologic fluid rather than the
administered absolute dose. The dose and dose interval to attain a
defined target concentration for the desired pharmacological effect is
based on pharmacokinetics.
The term, pharmacodynamics, denotes the correlation of
pharmacological response to a measured drug concentration in blood
or some other body fluid that reflects the drug concentration at the
receptor site. In short, pharmacokinetics refers to what the drug does
to the body.
Rational prescribing is dictated by the pharmaco kinetics and
pharmacodynamics of the drug. An additional factor of paramount
importance is age of the subject.

Applied Clinical Pharmacokinetics and Drug Therapy


The drugs pharmacologic effects, toxic effects or both correlate well
with its concentration in a biologic fluid rather than the absolute dose
administered.
As a rule, amount of drug in the body (usually measured in terms
of serum concentration) is determined by the dose administered. This
is called principle of linear or first order pharmacokinetics.
Some such drugs as phenytoin, salicylates and alcohol do not
follow this principle. Though they exhibit first order or linear principle
at low dose, with increasing dose, their elimination pathway becomes
saturated and the drug concentration in blood changes dispropor
tionately to the dose administered. Such drugs are, therefore, said
to follow the principle of zero order (the so-called Michaelis-Menten
kinetics).

Drug Absorption and Bioavailability


The drugs bioavailability is the fraction of the amount absorbed
following extravascular drug administration relative to intravenous
(IV) administration, the drug administered by latter route being
considered as 100 percent bioavailable. It is calculated as the ratio of
Chapter 1: Principles 3

the area under drug concentration time curve (AUC) determined after
extravascular drug administration to the drug AUC obtained after IV
administration as shown below:

AUC (oral)
Bioavailability =
AUC (IV)

Volume of Distribution
The distribution of drugs in blood depends mainly on its lipid
solubility, isonization, pH of blood, available protein binding capacity
and difference in the regional blood flow.
Whereas lipid-soluble drugs are, as a rule, distributed throughout
the extracellular and intracellular spaces, the water-soluble drugs are
distributed mainly in the extracellular space and hardly in the CSF or
other body fluids.
As far as the selective distribution of drugs is concerned, it occurs
as a result of protein-binding in blood (penicillins) and in tissues
(mepacrine). In case of such drugs as are not bound to proteins
(insulin), distribution remains confined to the extracellular space.
Obviously, these drugs can be utilized to measure extracellular space.
The drugs which get speedily absorbed from the gastrointestinal
tract on account of their lipid solubility readily diffuse into the CSF and
brain tissue.
The drugs which get poorly absorbed from the gastrointestinal
tract (streptomycin, neostigmine), demonstrate poor penetration into
various body fluids.
A noteworthy point is that, in case of inflamed meninges, there is
a remarkable elevation in the penetration of all drugs into the CSF.
The initial dose or loading dose is not influenced by the drug
clearance or elimination from the body. Thus, the initial dose remains
the same for subjects with normal renal function as for those with
compromised renal function.

Metabolism
Once the drug has performed its action (effectively or otherwise), it
has got to be metabolized and finally excreted. Liver is the major site
of drug metabolism which occurs in two phases:
4 Section 1: Basics of Pharmacotherapy in Neonates, Infants and Children

1. Conversion to pharmacologically-inactive substances


2. Conversion to pharmacologically-active substances (prednisone,
cortisone, imipramine, cyclophosphamide, imipramine).
Drugs are chiefly metabolized by enzymes in hepatic microsomes
and to some extent, by the enzymes in blood and elsewhere in the body.
In the nonsynthetic reaction, the molecule is changed by oxidation,
reduction or hydrolysis. In the synthetic reaction, the molecule is
conjugated with other substances like glucuronic acid (glucuronidation),
acetic acid (acetylation), sulfate (ethereal sulfate formation), etc.
Just a word about enzyme induction. Such drugs as phenobarbital,
phenytoin, alcohol, DDT and phenybutazone are examples of enzyme-
inducers. Enzyme induction by alcohol consumption causes excessive
breakdown of phenobarbital. As a result alcoholics develop tolerance
to it. On the other hand, INH, anticoagulants and phenylbutazone
depress enzyme induc tion and, thus, the phenytoin metabolism.
Phenytoin toxicity even with recommended doses may, therefore,
occur in such subjects.

Elimination Half-life
The term, half-life, denotes time required for half the amount of
drug present in body fluid to be cleared. It is expressed as t and is
frequently employed to determine a drugs dosage intervals. It may
also be employed to find the time required to attain the steady-state
concentration. By the latter term is meant the point at which the
amount of drug dose is equivalent to the amount of drug cleared from
the body. Table 1.1 shows the relationship between different half-lives
and steady-state concentration.

Table 1.1: Correlation between half-lives and steady-state


concentrations
Half-lives Steady-state concentration (%)
Three 87.5
Four 93.8
Five 100
Chapter 1: Principles 5

Clearance
It means the amount of drug removed from the body per unit of time.
It is influenced by the integrity of blood flow and by the functional
ability of the organs involved in removing the drug from the body.
Renal excretion: Plasma protein-binding of drug, glomerular filtration
rate, back diffusion from glomerular filtration, active renal tubular
reabsorption and active renal tubular secretion influence the renal
excretion of drugs.
Biliary excretion: Penicillin, rifampicin, erythromycin and tetracyclines
are examples of drugs excreted in bile. An important feature of such
drugs is that they are often reabsorbed into circulation (the so-called
enterohepatic cycle), thereby prolonging their half-life. Finally, they
are excreted in urine.
Pulmonary excretion: The examples of drugs excreted through lungs
are volatile lipid-soluble anesthetics and metabolites.
Excretion in breast milk: Drugs ingested by lactating mother and
excreted in breast milk so as to harm the baby include antithyroid
agents (propylthiouracil is an exception), cytotoxic agents, radioactive
substances, lithium, bromocriptine and phenelzine.

Drug-drug Interaction
The term drug-drug interaction is applied when two or more drugs
administered to a particular patient modify the pharmacokinetic and
pharmacodynamic properties of each through combined interaction.
The resultant effects may be unpredictable clinical responses or toxic
effects. Box 1.1 lists the different types of drug-drug interactions.

Therapeutic Drug Monitoring


Adjustment of the dose on the basis of clinical response and
measurement of concentration of the drug in serum or plasma is
called therapeutic drug monitoring. Such an approach is termed
target concentration strategy. In this strategy, a drugs pharmacologic
or toxicologic response can be directly related to a specific serum
concentration range.
6 Section 1: Basics of Pharmacotherapy in Neonates, Infants and Children

Box 1.1: Various types of drug-drug interactions


Drug inactivation when compounds are mixed together physically
before administration as in syringes, infusion tubing or parenteral fluid
preparations.
Disposition characteristics of one compound are influenced by those
of another, one drug reducing the rate but not the overall absorption,
or a drug displacing the other drug from its protein-binding sites while
concomitantly retarding its elimination from the body.
Metabolic-based drug-drug interaction as a result of competition by two
compounds for the same metabolic site.
Competition by the drugs for the same receptor or physiologic system,
thereby altering the patients response to drug therapy.

Therapeutic drug monitoring is neither necessary not feasible for


all drugs.
For more details, see Chapter 3.

Characteristics of Various Routes of Drug Administration


Intravenous Route
Absorption: Effect is large immediate.
Special indication: Excellent for emergency situations, for administering
large amounts and for irritating agents that can be given in a diluted
form.
Limitations: Expensive, requiring assistance of an expert for
administration; unsuitable for oily preparations; boosts vulnerability
to superimposed infection.

Oral Route
Absorption: Most drugs are absorbed by passive diffusion, only some
by active transport or facilitated diffusion; preferred route; influenced
by a number of factors (Table 1.2).
Special indication: Most natural, convenient, economical and safe
route.
Limitations: There usually is a considerable lag period before action
at the target level starts; it cannot be employed in uncooperative
Chapter 1: Principles 7

Table 1.2: Factors having a bearing on oral absorption of drugs


Physiologic factor Newborn Infant Child/
adolescent
Gastric acid secretion Reduced Normal Normal
Gastric emptying time Reduced Increased Increased
Gastrointestinal motility Reduced Normal Normal
Biliary function Reduced Normal Normal
Microbial flora Acquiring Adult Adult
pattern pattern

subjects; bioavailability is somewhat erroneous since some drugs may


be inactivated by gastric juices whereas most drugs are metabolized
in the liver after absorption.

Intramuscular Route
Absorption: Quite fast for aqueous solutions.
Special indication: Most suitable for oily preparations (vitamin A) and
some irritating substances (iron-dextran complex).
Limitations: May cause local necrosis, induration or even abscess; may
precipitate otherwise abortive poliomyelitis; not advisable in bleeding
diathesis and for such drugs as phenytoin and chloramphenicol which
have erratic absorption.

Subcutaneous Route
Absorption: Quite fast for aqueous solutions.
Special indication: Appropriate for certain insoluble suspensions and
implantation of solid pellets.
Limitations: Not appropriate when large volumes are to be admini
stered; local pain and induration may occur.

Sublingual Route
Absorption: Quite fast absorption of lipid-soluble agents.
8 Section 1: Basics of Pharmacotherapy in Neonates, Infants and Children

Specific indication: When it is desirable to bypass liver.


Limitations: Utility limited to drugs requiring direct effect on heart
(nitroglycerine).

Rectal Route
Absorption: Quite prompt absorption.
Specific indication: Appropriate for subjects with persistent vomiting
and in unconscious state; very effective for controlling acute seizures
(rectal diazepam).

Intrathecal
Absorption: Prompt action at targeted site (CNS).
Special indication: For prompt local effect in meningitis and other CNS
infections.
Limitations: Not practicable for administering large doses of drugs;
may cause chemical or iatrogenic meningitis.

Pulmonary (Aerosol, Nebulization)


Absorption: Quite prompt local as well as systemic effect.
Special indication: For direct absorption and action, bypassing the liver.
Limitations: Particle size has got to vary between 1 micron and 7 mic
rons (< 1 micron is likely to be exhaled whereas > 7 microns is unlikely
to reach small bronchi); poor ability to regulate dose; not always
practicable in small children.

Drug Dosing and its Calculation


The best way of calculating drug dose is in terms of surface area.
However, it is quite cumbersome and not always practicable. Therefore,
in practice, drug dose is usually calculated according to body weight in
children. This approach is practical but not ideal because even within
a population of similar age and weight, drug requirement may differ
on account of maturational differences in absorption, metabolism and
elimination.
Chapter 1: Principles 9

According to the famous Clarks rule, pediatric drug dose can


be calculated if we know the adult dose but it is now infrequently
employed because of its limitations.
Childs dose as percentage of adult dose = Surface area in m2 60
Childs dose = Surface area/1.7 adult dose or weight (lbs)/100 adult
dose

Untoward Effects of Drugs


The term, side effects, denotes undesirable effects, e.g. drowsiness
caused by antihistamines, dryness of mouth because of
decongestant therapy or diarrhea secondary to ampicillin therapy.
The term, intolerance, refers to the unwanted effects due to low
threshold to normal pharmacologic action.
The term, idiosyncracy, means that a genetic abnormality (G6PD
deficiency, porphyria) predisposes an individual to a qualitative
abnormal reaction to certain drug(s).
The term, secondary effects, denotes indirect conse quences
following a prolonged use of certain drugs.
The term, hypersensitive, relates to anaphylactoid shock (penicillin,
serum), urticarial rash, angioneurotic edema, serum sickness
syndrome and pulmonary reactions (antigen-antibody reaction).

Maternal Medication and Fetus


As a rule, the pregnant woman should receive no medication as all
medication is potentially risky to the fetus, especially during the first
trimester of pregnancy. A drug apparently safe for the mother may
not be same for her growing baby in utero. In Appendix 3 is provided
a list of drugs that are likely to have teratogenic effect on the fetus.
The golden rule is to prescribe for the pregnant woman only when
its beneficial effect outweighs the risk for the fetus. Even in such a
situation, attempt should be to prescribe a drug that has withstood
the test of time or a drug which is likely to be least risky.

Maternal Medication and Breastfeeding


Many drugs are excreted to some extent into the breast milk and,
naturally, ingested by the nursing infant. Some of them may have
10 Section 1: Basics of Pharmacotherapy in Neonates, Infants and Children

adverse effects on the neonate and the infant (Table 1.3). The nursing
mother must, therefore, never consume any medication without
obtaining an approval of the pediatrician. In certain special situations,
a sample of breast milk may be analyzed to get an idea about the
amount of drug the infant is receiving or about the likely drug effects
on the infant.

Table 1.3: Maternal medication that may harm the baby


who is on breastfeeding
Agent Adverse effect(s)
Antithyroids Hypothyroidism
Phenobarbital Drowsiness, rickets, rash,
methemoglobinemia
Diphenylhydantoin sodium Rickets, rash, methemoglobinemia
Diazepam Drowsiness, rise in serum bilirubin
Laxatives (e.g. cascara) Loose motions
Penicillin Rash
Narcotics Withdrawal symptoms
Theophylline Irritability
Lithium Hypotonia
Sulfas Drug rash, hemolysis
Salicylates Rash, interference in platelet
function
Oral contraceptives Failure to thrive, gynecomastia
Chapter

2
Rational Drug Therapy

The phrase, rational drug therapy, denotes drug treatment on


sensible and sound reasoning. Understandably, irrationality in drug
therapy may result from:
Use of an unnecessary drug
Wrong choice of drug
Inappropriate dosage and route of administration
Poor prescribing.
Reasons for irrational drug therapy include:
Inappropriate model prescriber
Undue pressures
Unfair practices
Personal ambitions and life goals
Myths.
The irrational drug therapy is most dangerous when it comes to
the abuse of antimicrobial agents leading to increasing antimicrobial
resistance of varying degrees and magnitudes. The seriousness of the
problem compelled the World Health Organization to declare 7th
April 2011 as the World Health Day with the theme Antimicrobial
Resistance : No Action Today, No Cure Tomorrow.

General
The following considerations are important in regard to rational anti
biotic therapy:
Variation in etiologic pathogens among age groups.
Microbiologic diagnosis (isolation of the pathogen from sterile
body site) with sensitivity testing which should logically determine
the choice of an antimicrobial agent. In its absence, clinical
12 Section 1: Basics of Pharmacotherapy in Neonates, Infants and Children

diagnosis with projection of the most likely pathogen(s) may


determine the choice of antibiotic(s) which is, at beat, empirical.
Age-appropriate antibiotic dose, dosing frequency and route of
administration.
Toxicity of the drug(s) likely to be effective.
Immunologic status since immunocompromised status may
render the child more susceptible to microbes that are considered
benign in immunocompetent children.
Likelihood of CNS involvement in certain infections (e.g. Haemo
philus influenzae type b, Pneumococcus and Meningococcus)
pointing to more aggressive antimicrobial therapy.
Presence of a foreign body enhances the risk of bacterial infection.
Pattern of antimicrobial resistance in the community occurring
through several modifications of the bacterial genome such as:
Enzyme inactivation of the antibiotic
Reduced cell membrane permeability to intracellularly active
antibiotics
Efflux of antibiotic out of the bacteria
Protection or alteration of the antibiotic target site
Excessive production of the target site
Passing the antimicrobial site of action.
As a reflection of the route of administration, drug absorption,
volume of distribution and drug elimination half-life and drug-drug
interactions (altering enzymatic inactivation of an antibiotic or causing
antimicrobial synergism or antagonism), serum levels of antibiotic.
Target serum levels appropriate for different antibiotics are available.

Special Situations
In Neonates
Empiric antimicrobial selection should take into consideration the
fact that likely pathogens are typically acquired around the time of
delivery and, therefore, from the maternal birth passage, e.g. E. coli,
Group B Streptococcus (GBS), L. monocytogenes. Since these pathogens
may cause meningitis, therapy must include antibiotic(s) that crosses
the blood-brain barrier and, thereby, covers CNS infection in case
meningitis remains on the card.
Chapter 2: Rational Drug Therapy 13

In Infants and Children


The pathogens relevant in infants and toddlers include H. influenzae
type b, Streptococcus pneumoniae, Meningococcus, Staphylococcus
aureus.
Among older children, additional pathogens include M. catarrhalis,
nontypeable strains of H. influenzae, Mycoplasma pneumoniae, Group
A Streptococcus (GAS), Enterococcus and Salmonella.

Immunocompromised Subjects
In immunocompromised states or in situations of prolonged
hospital stay, such pathogens as Pseudomonas aeruginosa, Klebsiella
pneumoniae, Enterobacter (E. faecalis, E. faecium), Serratia and E. coli
assume particular importance as opportunistic pathogens. Treatment
of these infections becomes extremely difficult on account of
antimicrobial resistance, including resistance to vancomycin.

Medical Devices-associated Infections


Indwelling medical devices (venous catheter, ventriculoperitoneal
shunt, stent) predispose to infection with S. aureus and coagulase-
negative Staphylococcus. Management warrants not only appropriate
antibiotic therapy but also removal/replacement of the offending
(colonized) prosthetic gadget.
Chapter

3
Therapeutic Drug
Monitoring

Therapeutic drug monitoring is based on measuring the concentration


of prescribed drugs in serum or plasma in order to provide a rational
basis for dosage adjustment in individual patients.
Drugs with the following characteristics are commonly monitored:
Drugs with a good relationship between plasma concentration
and clinical effects, e.g. theophylline.
Drugs with well-defined therapeutic and toxic levels for plasma
drug concentrations, e.g. phenytoin.
Drugs with a narrow therapeutic index where toxic con cen
trations are very close to effective concentrations, e.g. digoxin.
Drugs for which there is no easily measured clinical response and/
or failure of response is all or nothing, e.g. anticonvulsants and
antiarrhythmic drugs.
Drugs for which the pharmacological response is difficult to
quantify, e.g. cyclosporin.
Drugs for which plasma concentration has prognostic significance
in over dosage, e.g. paracetamol.
Drugs fulfilling some or all of the above criteria are listed in
Table 3.1.
Chapter 3: Therapeutic Drug Monitoring 15

Table 3.1: Salient features of drugs commonly needing


therapeutic monitoring
Drugs Sampling Time to reach Therapeutic plasma
time(s) steady state1 concentration range
(micromol/L3) (mg/L2)
Minimum Maximum
Aminoglycosides
Amikacin 30 minutes 35 2030
Gentamicin after a dose 12 510
Netilmicin and just prior 12 510
of next dose
Tobramycin 12 510
Antiarrhythmics
Amiodarone Prior to next 1 month3 0.62.0 1.03.0
dose
Disopyramide 24 hours 37 9-20
Flecainide 3 days 0.20.8 0.52.0
Lignocaine 12 hours 1.55 621
Mexiletine 2 days 0.72.3 413
Procainamide 16 hours 310 1035
Quinidine 24 hours 36 1018
Sotalol 48 hours 1.03.0 3.29.7
Anticonvulsants
Carbamazepine Prior to next 6 days 612 2550
dose
Clonazepam4 5 days 0.0250.075 0.080.24
Ethosuximide 8 days 50100 300700
Phenobarbitone 2 weeks 1540 45130
Phenytoin 57 days 1020 4080
Valproate4 40 hours 50100 300600
Antidepressants
Amitriptyline Prior to next 3 days
dose
Imipramine 2 days Varies if metabolites are
measured; discuss with
laboratory
Nortriptyline 5 days
Contd...
16 Section 1: Basics of Pharmacotherapy in Neonates, Infants and Children

Contd...
Drugs Sampling Time to Therapeutic plasma
time(s) reach concentration range
(micromol/L3) steady (mg/L2)
state1
Minimum Maximum
Others
Digoxin 68 hours 7 days 12.5 1.33.2
after morning (microgram/L)
dose
(nanomol/L)
Lithium 12 hours after 34 days 0.81
(mmol/L) last dose
Salicylate Prior to next 25 days 150250 12
(mmol/L) dose
Theophylline 36 hours 1020 55110
Cyclosporin 2 days Varies with method
Time (after starting drug or changing dose) to reach steady state during normal
1

therapeutic use of the drug (given at usual dose intervals)


Unless specified otherwise
2

Although the half-life of amiodarone is up to 10 weeks in some patients, the measured


3

plasma concentration appears to reach a relatively constant value by one month


Therapeutic plasma concentration ranges for clonazepam and valproate are very
4

approximate.
Chapter

4
Certain Golden Rules in
Pediatric Drug Therapy

Make sure not to overprescribe, keeping the number of drugs to


the minimum.
Aim at employing once or twice daily administration as far as
possible.
Never allow more than two intravenous infusion lines running at
a time unless, of course, it becomes absolutely essential in very
critically-sick subjects. In the latter situation, label each IV line with
the drug running through it.
Ensure recording the amount of fluid administered by every
syringe pump by inspecting the movement of the syringe and the
administration site every hour or so.
Avoid changing the IV fluid regimen beyond twice a day.
Avoid flushing drugs or fluid through an established IV line with a
temporary charge of the setting of the infusion pump.
Never put more than double the amount of the drug in the syringe
meant for injection.
Employ an extra precaution against giving excess sodium to the
neonate.
In neonates in particular, administration of potentially lethal drugs
like digoxin or chloramphenicol should be avoided.
Section 2
General Medications

Analgesics/ Chapter

5
Antipyretics/Nonsteroid
Anti-inflammatory Drugs
(NSAIDs)

Acetaminophen (Paracetamol)
Brand Names: Aminol, Calpol, Crocin, Metacin, Pyrigesic, Tylenol
Indications: Analgesic, antipyretic, anti-inflammatory.
Available as:
Tablet 500 mg
Syrup 120 mg/teaspoonful
Drops 10 mg/drop.
Dose: 15 mg/kg/dose (O); 25 to 50 mg/kg/day in 4 divided doses.
ADRs: Drowsiness, headache, hyperventilation, renal stone,
methemoglobinemia, hemolysis, fever, neutropenia, jaundice.
Precaution: Avoid in renal or hepatic impairment. Overdose may
cause reversible icterus. Massive overdose produces a toxic
metabolite which may lead to hepatic necrosis.

Acetylsalicylic Acid
Brand Names: Aspirin, Disprin, Micropyrin, Mejoral
Indications: Analgesic, antipyretic, anti-inflammatory.
Available as: Tablets 350 mg, 75 mg.
Dose:
30 to 65 mg/kg/day (O) in 4 to 6 divided doses as antipyretic;
65 mg/year of age/dose (O) as analgesic
65 to 130 mg/kg/day (O) in 4 divided doses for rheumatic
fever (the initial dose should be towards the upper limit of the
range).
ADRs: Deep and rapid respiration (air hunger), gastric irritation,
hyperacidity, pain abdomen, nausea, vomiting, tinnitus,
fever, cyanosis, pharyngoconjunctival fever (PCF), twitching,
Chapter 5: Analgesics/Antipyretics/Nonsteroid Anti-inflammatory Drugs (NSAIDs) 19

convulsions, rigidity, coma, Reye syndrome (especially in children


with chickenpox or other exanthemata).
Precaution: Avoid the drug on empty stomach and in children
under 12 years especially in viral exanthemata like chickenpox.

Codeine
A narcotic analgesic and cough suppressant.
Indications: Narcotic analgesic.
Available as: Tablets 15, 30, 60 mg/mL.
Dose: 1 to 1.5 mg/kg/day for suppression of cough; 3 mg/kg/day
for sedation or pain.
ADRs: Addiction, excitement, convulsions, depression and coma.

Dextropropoxyphene HCl
Brand Name: Proxyvon
Indications: Moderate to severe pain.
Available as: 65 mg in combination with other analgesics such as
paracetamol and ibuprofen.
Dose: 2 to 4 mg/kg/day in 2 divided doses.
ADRs: Central nervous system (CNS) depression, nausea, vomiting,
mild addiction.
Caution: Avoid in infants, with alcohol and in pregnancy.
Contraindications: Hepatic insufficiency.

Diclofenac Sodium
Brand Names: Voveran, Diclomax
An aryl acetic acid derivative.
Indications: As a strong anti-inflammatory analgesic.
Available as:
Tablets 25, 50 mg
Injection 25 mg/mL.
Dose: 25 to 50 mg/day in 2 divided doses.
ADRs: Gastrointestinal (GI) upset, neurologic manifestations.
Contraindications: Peptic ulcer, gastrointestinal bleeding, aspirin-
induced allergies.
20 Section 2: General Medications

Precaution: Avoid in dyspepsia, gastrointestinal disorders, liver


disease, renal disease, blood coagulation disorders.

Fentanyl Citrate
Brand Names: Duragesic, Sublimaze
A potent narcotic analgesic that binds to opium receptors; its 0.1 mg
= 10 mg of morphine.
Indications: Narcotic analgesia; preoperative medication.
Available as: Lozenges; transdermal (not yet in India); Injection (IV,
IM).
Dose:
For neonates/infants: 1 to 4 mcg/kg/dose, may repeat q 2 to 4
hr; continuous infusion 0.5 to 5 mcg/kg/hr
Children: 1 to 3 mcg/kg/dose, may repeat q 30 to 60 min;
continuous infusion 1 to 5 mcg/kg/hr.
ADRs: Nausea, vomiting, constipation, respiratory depression, CNS
depression, hypotension, bradycardia, urinary tract/biliary tract
spasm.
Precaution: In case of infusion, be slow. Else, skeletal muscle and chest
wall rigidity may cause poor ventilation and respiratory distress.

Ibuprofen
Brand Names: Brufen, Ibugesic, Ibucon, Ibusynth, Ibutab
Indications: As a strong anti-inflammatory, analgesic and anti-
pyretic agent in rheumatic and nonrheumatic conditions. Also
indicated in cystic fibrosis as long-term therapy.
Conditions characterized by pain and inflammation.
Available as:
Tablets 200, 400, 600 mg
Suspension 100 mg/teaspoonful.
Dose: 20 mg/kg/day in 3 divided doses.
ADRs: Gastrointestinal intolerance/bleeding, dyspepsia rash,
thrombocytopenia.
Contraindications: Peptic ulcer, aspirin-induced allergy bronchial
asthma.
Precaution: Avoid in subjects on anticoagulant and/or thiazide
therapy.
Chapter 5: Analgesics/Antipyretics/Nonsteroid Anti-inflammatory Drugs (NSAIDs) 21

Indomethacin
Brand Names: Indocap, Indocin, Indomethacin
An indole derivative.
Indications: As anti-inflammatory analgesic; in patent ductus
arteriosus in preterms.
Available as:
Capsules 25, 50, 75 mg
Injection 1 mg/vial.
Dose:
For analgesis: 3 mg/kg/day (O) as analgesic in 3 divided doses.
0.2 mg/kg/dose (IV, O) every 8 hours for 3 doses.
For ductus closure: 0.2 mg/kg/dose (IV) TDS x 3 days.
ADRs: Nausea, vomiting, epigastric pain, gastrointestinal bleeding,
icterus, headache, light headedness, leukopenia, thrombocyto
penia, aplastic anemia, tinnitus, rash, pruritus, blurred vision, corneal
deposits, retinal disturbances.
Contraindications: Gastrointestinal bleeding, peptic ulcer, aspirin-
induced allergy/asthma.
Precaution: Avoid in psychiatric disorders, epilepsy, anticoagulant
therapy.

Mefenamic Acid
Brand Names: Meftal, Ponstan
An anthranilic acid derivative.
Indications: For relief of pain and as an antipyretic.
Available as:
Capsules 250 and 500 mg
Tablet 125 mg
Syrup 125 mg/5 mL.
Dose: 8 mg/kg/dose; 20 to 25 mg/kg/day in 3 divided doses.
ADRs: Nausea, vomiting, diarrhea, dyspepsia, abdominal dis
comfort, rash, hemolysis, leukopenia.
22 Section 2: General Medications

Morphine Sulfate
A powerful narcotic analgesic.
Indications: Severe pain; myocardial infarction.
Available as:
Tablets 60, 100 mg
Injection 60 mg.
Dose: 0.1 to 0.2 mg/kg/dose (SC, IM, IV).
ADRs: Nausea, vomiting, gross CNS depression, coma, miosis,
cyanosis, tremors, convulsions, slow and shallow respiration.
Caution: In the event of respiratory depression, the specific
antidote (Naloxone), which should always be kept ready, needs to
be administered. It is administered 0.1 mg/kg with a maximum of
2 mg (IV). If need be, a repeat shot may be given after 2 to 3 min.

Nimesulide
Brand Names: Nimulid, Nise, Nimeril, Nimfast, Zolandin
Indications: A nonsteroidal anti-inflammatory drug (NSAID), also
useful as an antipyretic and analgesic agent.
Available as:
Tablets 50,100 mg
Syrup 50 mg/5 mL.
Dose: 5 mg/kg/day in 2 or 3 divided doses (O).
ADRs: Nausea, vomiting, diarrhea, heartburn, headache, rash,
pruritus, dizziness, somnolence, hepatic dysfunction (even acute
hepatic failure). Moderate renal insufficiency.
Drug interaction: Frusemide, valproic acid, methotrexate,
tolbutamide.
Contraindications: Active peptic ulcer, moderate to severe hepatic
insufficiency.
Precaution: In view of reported instances of acute liver failure as
one of its adverse effects, routine use of nimesulide (especially
in situations where a safer analgesic can be employed) may be
discouraged.
Chapter 5: Analgesics/Antipyretics/Nonsteroid Anti-inflammatory Drugs (NSAIDs) 23

Naproxen
Brand Names: Artagen, Naxid, Naprosyn, Nalyxan
Indications: As a strong analgesic; juvenile rheumatoid arthritis (JRA)
Available as: Tablets 250, 500 mg.
Dose: 10 to 20 mg/kg/day (O) in 2 divided doses (higher dose is for JRA)
ADRs: Rash, constipation, tinnitus, headache, drowsiness.
Contraindications: Active peptic ulcer, aspirin allergy, NSAID
allergy, advanced renal insufficiency.
Precaution: Avoid
In gastrointestinal lesions
In infants < 6 months
 Concomitant administration of hydantoin and other anti
convulsants and anticoagulants.

Pentazocine HCl
Brand Name: Fortwin
Indications: A strong analgesic, only 1/3rd to 1/6th as powerful as
morphine and slightly more powerful than codeine.
Available as:
Tablets 25 mg
Injection 30 mg/mL.
Dose: 0.5 to 1.0 mg/kg/day (O, IM, IV) q 4 hr.
ADRs: Nausea, vomiting, bloating, flushing, vertigo.
Contraindications: Head injury, respiratory depression, RIP, por
phyria.

Pethidine
A powerful narcotic analgesic.
Indications: Severe pain.
Available as: Injection 100 mg.
Dose: 1 to 2 mg/kg/day (IM).
ADR: Addiction.
24 Section 2: General Medications

Piroxicam
Brand Names: Dolonex, Piricam, Pirox
Indications: Juvenile rheumatoid arthritis (chronic)
Dose:
< 15 kg 5 mg OD
15 to 25 kg 10 mg OD
26 to 45 kg 15 mg OD
45 kg 20 mg OD.
ADRs: Nausea, anorexia, rash, pruritus, heartburn, edema, CNS
manifestations.
Contraindications: Active peptic ulcer, aspirin and other NSAID
allergy.

Rofecoxib
Brand Names: Rodif, Rofetab, Roff, Rofiz
A COX-2 inhibitor that has less GI side-effects and that does not inhibit
platelet aggregation.
Indications: Rheumatoid arthritis.
Available as: Tablets 12.5, 25 and 50 mg.
Dose: 25 to 650 mg/day OD or in 2 divided doses.
ADRs: Cardiovascular adverse effects.
Precaution: Best avoided in children.
Chapter

6
Antiasthma Drugs/
Bronchodilators

Adrenaline (Epinephrine)
A sympthomimetic agent:
Indications: Bronchial asthma. Also cardiac arrest, cardiac asthma,
severe bradycardia, anaphylaxis, croup, laryngeal edema.
Available as: 1 in 1,000 aqueous solution, 1 mg/mL.
Dose: For relief of bronchospasm, 0.01 mL/kg/dose (IM, SC) with a
maximum of 0.5 mL/dose. Repeat every 10 to 20 minutes for 3 or 4
times, or every 3 to 4 hours prn.
ADRs: Nausea, vomiting, anxiety, restlessness, tachycardia, angina,
hypertension, tremors, cold extremities, gangrene.
Precaution: Avoid its use in nervous or anxious patients, or those
having hypertension, hyperthyroidism, ischemic heart disease, or
in conjunction with trichlorethylene, halothane, cyclopropane, or
monoamine oxidase inhibitors.

Aminophylline
Indications: Bronchodilator, neonatal apnea.
Available as:
Tablets 100 mg, 200 mg
Injection 25 mg/mL.
Dose:
4 to 6 mg/kg/dose (IM, IV); 12 mg/kg/day (IM, IV) in 3 or 4 divided
dose; 10 mg/kg/dose (O), to be repeated every 6 to 8 hours
An alternative and better method for controlling the acute
attack of bronchial asthma consists in giving 4 to 6 mg/kg of
aminophylline in over 15 minutes as an intravenous infusion.
Then, continue giving 0.6 to 1 mL/kg every hour as a constant
infusion
26 Section 2: General Medications

For apneic attacks in newborn, the dose is 4 to 6 mg/kg/day (O)


in 4 divided doses.
ADRs: Restlessness, palpitation, dizziness, nausea, hypotension,
shock, cardiac arrest, sudden death (usually secondary to very
rapid injection).
Caution: ECG monitoring desirable.

Cromoglycate Disodium
Brand Names : Cremolyn, Ifiral, Intal
Indication: Prophylaxis of acute asthmatic attack. It reduces airway
hyperactivity and inhibits mast cell degranulation (blocking
mediator release).
Available as: Rotacap 20 mg.
Dose:
Inhalation of 1 rotacape TDS for 4 to 6 weeks
Repeat course after 3 to 6 months.
ADRs:Transient bronchospasm.
Precaution: Avoid in children below 5 years.
Keep a specific bronchodilator injection handy for use in the event
of bronchospasm developing as a side effect of cromoglycate.

Montelukast
Brand Names: Romilast, Montair, Ventair
A singular leukotriene receptor blocker, employed as an add-on
therapy in moderate asthma (chronic/recurrent):
Indications: For prevention and treatment of chronic/recurrent/
persistent bronchial asthma; also in nasobronchial allergy.
Available as: Tablets 4, 5, 10 mg.
Dose:
2 to 5 years: 4 mg (O) OD in the morning
6 to 14 years: 5 mg OD in the morning
15 years and above: 10 mg OD in the morning.
Drug interactions: Phenobarbital, phenytoin, rifampicin, drugs
metabolized by CYP2C8 such as rosiglitazone.
ADRs: Headache, dizziness, dyspepsia, fatigue; raised liver
enzymes.
Chapter 6: Antiasthma Drugs/Bronchodilators 27

Contraindication: Pregnancy.
Precaution: For best outcome, it should be administered in the
evening. Do not employ as a substitute for oral or inhaled steroid
therapy.

Magnesium Sulfate
Indication: Acute severe asthma; also acute severe malnutrition.
Available as: Injection 1, 10, 25, 50 percent 1 mL ampoule.
Dose: 25 mg/kg IV infusion in about 30 minutes.
ADRs: Hypermagnesemia, hypotension, respiratory depression,
diarrhea.
Contraindications: Severe renal impairment, heart block,
myocardial disease.
Precautions: Renal insufficiency, concurrent therapy with digoxin.
Antidote: IV calcium gluconate.

Orciprenaline Sulfate
Brand Name: Alupent
Indication: Bronchial asthma.
Available as:
Injection 1 mL containing 0.5, 1.0 mg
Syrup 2 mg/mL
Tablets 10, 20 mg.
Dose: 0.02 mg/kg/dose (IM), 2 to 3 mg/kg/day (O) in 4 divided
doses.
ADRs: Palpitations, restlessness, finger tremors, nausea sleep
disturbances, headache, flushing, allergic reactions, extrasystoles.
Precaution: Avoid concurrent use of sympathomimetics or MAO
inhibitors.
Contraindication: Thyrotoxicosis.
Antidote: A beta blocker agent.

Salbutamol
Brand Names: Asthalin, Bronkotab, Bronkosyrup, Brethmol, Salbetol)
Indications: Bronchial asthma; other lung conditions accompanied
by significant bronchospasm.
28 Section 2: General Medications

Available as:
Tablets 2, 4 mg
Syrup 2 mg/5 mL.
Dose: 0.2 to 0.4 mg/kg/day q 8 hr.
ADRs: Fine tremors (most remarkable in hands) tachycardia,
headache, tenseness, arrhythmias.

Terbutaline Sulfate
Brand Names: Bricanyl, Bronkine
Indications: Bronchospasm as in bronchial asthma.
Available as:
Tablets 2.5 and 5 mg
Suspension 1.5 mg/teaspoonful
Injection (SC) 0.5 mg/mL.
Dose: 0.2 mg/kg/day (O), 0.005 mg/kg/dose (SC). IV infusion may
be given in difficult cases.
ADRs: Nervousness, muscle tremors, headache, tachycardia,
palpitation, drowsiness, nausea, vomiting and sweating. These side
effects are usually mild, their frequency reducing with continued
therapy. No or little cardiac side effects since it has selective action
on beta-2 receptors in bronchial muscles and relatively slight
effect on beta-1 receptors in the heart.
Contraindications: Thyrotoxicosis, known hypersensitivity to
sympathomimetic amines, arrhythmias.
Caution: As with all sympathomimetic stimulants, it should be
used with special caution in patients with hypertension, coronary
artery disease, CCF, hyperthyroidism on diabetes mellitus.

Theophylline
Brand Names: Etophylate, Broncordil, Deriphyllin
Indications: Bronchospasm, apnea of prematurity.
Available as:
Tablets 100, 200 mg
Elixir 30, 125 mg/5 mL
Injection 110 mg/mL.
Dose: 10 to 20 mg/kg/day (O) in 2 to 3 divided doses. 5 mg/kg/
dose (IM, IV, SC).
Chapter 6: Antiasthma Drugs/Bronchodilators 29

ADRs: GIT upset, hypotension, cardiovascular collapse, increased


gastric and urine excretion, irritability, tremors, convulsions.
Precaution: Reduce dose by 50 percent in viral illness, high fever
(>102F), cor pulmonale, concurrent administration of drugs like
macrolids, quinolones, cimetidine, verapamil, ibuprofen.

Zafirlukast
Brand Name: Zuvair
Indications: Add-on therapy in persistent asthma showing poor
response to conventional therapy; asthma prophylaxis.
Available as: Tablets 10, 20 mg.
Dose: 10 mg BD.
ADRs: Headache, dizziness, GI upset, dyspepsia, fatigue; raised liver
enzymes.
Drug interactions: Warfarin, theophylline, aspirin, erythromycin,
smoking.
Contraindication: Pregnancy, lactation; hepatic/renal impairment.
Precaution: Administer on empty stomach.

Inhalation Therapy
Beclomethasone Dipropionate
Brand Names: Beclate Inhaler, Beclate nasal spray
Indications: Persistent asthma, allergic and vasomotor rhinitis,
nasal polyposis (sheer symptomatic).
Dose:
Metered dose inhaler
i. Mild asthma 200 to 400 mcg/day in 2 to 4 divided doses
ii. Moderate asthma 400 to 800 mcg/day in 2 to 4 divided
doses
iii. Severe asthma 800 to 1000 mcg/day in 2 to 4 divided doses
iv. The inhalation therapy needs to be continued for 10 to 12
weeks.
Nasal spray: 50 mcg dose of spray OD or BD
ADRs: Hoarseness, superadded funus infection (candidiasis)
involving mouth and throat.
Caution: Mouth and throat wash after every inhalation/spray.
30 Section 2: General Medications

Budesonide
Brand Name: Pulmicort inhaler
Indications: Persistent asthma, croup.
Dose:
Mild asthma 100 to 400 mcg/day in 2 divided doses
Moderate asthma 400 to 600 mcg/day in 2 divided doses
Severe 600 to 800 mcg/day in 2 divided doses.

Ipratropium Bromide
Brand Name: Duolin meter dose inhaler
Ipravent respirator solution for nebulization
Dose: 1 to 2 puffs TDS.
For nebulization: 250 mcg, diluted in 2 mL saline, administered
over 10 minutes every 20 minutes 3 doses. This should be
followed by 250 mcg nebulization over 2 to 4 hours.

Salmeterol
Brand Names: Salmeter, Serobid MDI
A beta-2 agonist. A long-acting bronchodilator meant for use >4 years
of age:
Indications: Exercise-induced asthma, nocturnal asthma.
Dose: 50 to 100 mcg/day.
ADRs: Palpitations/tachycardia, headache, tremors.
Precaution: Avoid in children < 4 years.

Terbutaline
Brand Names: Bricanyl MDI, Bricanyl nebulizing solution
Availability:
MDI 250 mcg/metred dose
Nebulizing solution 10 mg/mL.
Dose:
Inhalation: 1 to 2 puffs 3 to 4 times daily
Nebulization: < 20 kg weight 2.5 mg
> 20 kg weight 5 mg.
Chapter

7
Antihistamines

Astemizole
Brand Names: Stemiz, Astelong
Indications: Antihistaminic agent.
Available as:
Tablet 10 mg
Suspension 10 mg/5 mL.
Dose: 0.2 mg/kg as a single dose on empty stomach as first thing in
the morning.
ADRs: Very safe; drowsiness, if at all, is only slight.
Caution: Avoid in children under 6 years of age.

Cetirizine Dihydrochloride
Brand Names: Alerid, Cetriwal
Indications: As an antiallergic; symptomatic treatment of perennial
and seasonal rhinitis, urticaria.
Available as: Tab 10 mg.
Dose:
2.5 to 5 mg for age group 2 to 6 years
5 to 10 mg for age group 6 to 12 years.
ADRs: Drowsiness, dryness of mouth, headache, dizziness,
agitation, gastrointestinal disturbance. Infrequently, aggressive
reactions, seizures, somnolence, fatigue, arthralgia, diarrhea,
bronchospasm, epistaxis, irritability, insomnia.
Contraindication: Hypersensitivity to hydroxyzine, lactation.
Caution: Avoid in children under 2 years, and renal and hepatic
impairment.
Drug interaction: CNS depressants.
32 Section 2: General Medications

Chlorpheniramine Maleate
Brand Name: Piriton
Indication: Antiallergic.
Available as:
Tablet 4 mg
Syrup 2.5 mg/5 mL
Injection 10,100 mg/mL.
Dose: 0.35 mg/kg/day (O,SC) in 4 divided doses. As a single stat
dose and for prolonged action 0.2 mg/kg (O).
ADRs: Drowsiness.

Clemastine Fumarate
Brand Names: Clamist, Tavergyl
Indications: Allergy, especially pertaining to conjunctiva and skin;
allergic rhinitis.
Available as:
Tablets 1, 1.34 mg
Syrup 0.67, 0.5 mg/5 mL.
Dose:
2 to 6 yr 0.05 mg/kg/day q BD or TDS
6 to 12 yr 0.5 mg/dose q BD
12 yr 1 mg/dose q BD.
ADRs: Dryness of mouth, constipation, drowsiness, headache,
dizziness.
Contraindications: Narrow angle glaucoma, bladder-neck
obstruction.
Precaution: Avoid in infants and children < 2 yr.

Cyproheptadine HCl
Brand Names: Practin, Periactin, Ciplactin, Peritol, Ciproval
Indications: Antiallergic (urticaria, hay fever), appetite stimulant.
Available as:
Tablet 4 mg
Syrup 2 mg/5 mL.
Dose: 0.25 mg/kg/day in 3 or 4 divided doses.
Chapter 7: Antihistamines 33

ADRs: Drowsiness, nausea, dry mouth, paradoxical excitement,


gastritis, hypotension, dizziness, anticholinergic effects, blood
dyscrasias.
Contraindications: Glaucoma, asthma, urinary retention, lactation.
Precaution: Asthma, hypertension, high intraocular tension, hyper
thyroidism, hypertension, cardiovascular disease.

Dimethindene Maleate
Brand Name: Foristal
Indications: Allergic states (allergic dermatoses, pruritic and ocular
allergies).
Available as: Tablets 1mg, 2.5 mg (sustained action).
Dose:
1 mg TDS
2.5 mg BD.
ADRs: Drowsiness, dryness of mouth.
Contraindications: Epilepsy, vulnerability to urinary retention.
Contraindication: Lactation.
Precaution: Avoid in children < 6 years.

Diphenhydramine HCl
Brand Name: Benadryl
Indications: Antiallergic, sedative; antidote in phenothiazine
toxicity/idiosyncrasy.
Available as:
Capsules 25, 50 mg
Elixir 12.5 mg/5 mL.
Dose: 5 (46) mg/kg/day in 3 to 4 divided doses.
ADRs: Drowsiness, dryness of mouth, nausea, nervousness; very
infrequently thrombocytopenia.
Drug interaction: CNS depressants (including alcohol).
Contraindications: Asthma, narrow-angle glaucoma, obstructive
urinary tract and gastrointestinal conditions.
Caution: Lactation, myasthenia gravis; avoid driving/handling
machinery.
34 Section 2: General Medications

Fexofenadine
Brand Name: Allegra
Indications: Allergic rhinitis and dermatological conditions.
Available as:
Tabs 120, 180 mg
Susp 30 mg/5 mL.
Dose:
< 12 yr 30 mg BD
12 yr 60 mg BD.
ADRs: Drowsiness, dryness of mouth, throat and nose, headache,
dizziness, nausea, tachycardia, palpitations, fatigue, diarrhea,
backache, dyspnea, taste disturbance, menstrual problems,
anaphylactoid reactions.
Drug interaction: Antacids containing aluminum or magnesium,
erythromycin, ketoconazole, fruit juices.
Contraindication: Lactation.

Hydroxyzine HCl
Brand Name: Atarax
Indications: Pruritus, urticaria, dermatoses; premedication in
surgery.
Available as:
Tablets 10 mg, 25 mg
Syrup 10 mg/5 mL
Drops 6 mg/mL
Inj 25 mg/mL.
Dose:
2 mg/day (O) q 6 hr
1 yr 0.5 to 1 mg/kg/dose (IM) q 4 to 6 hr.
ADRs: Drowsiness, anticholinergic effect, involuntary motor
activity at high doses.
Drug interaction: CNS depressants (including alcohol), coumarin
anticoagulants.
Contraindication: Lactation.
Caution: Avoid under age of 1 yr when it may precipitatve acute
porphyria and cause ECG abnormalities.
Chapter 7: Antihistamines 35

Ketotifen
Brand Name: Ketasma
Indications: Allergic rhinitis, allergic conjunctivitis and allergic
bronchial asthma for prophylaxis.
Available as: Tablet 1 mg.
Dose: 0.5 mg BD. Gradually, the dose should be built up to 1 to 2
mg BD.
ADRs: Drowsiness, dizziness, dryness of mouth, impaired reactions;
very infrequently cystitis, hepatitis, seizures.
Drug interaction: CNS depressants (including alcohol).
Contraindication: Lactation.
Caution: The drug should be taken after food.
Avoid in epileptic subjects.

Levocetirizine
Levo form of cetirizine and is long-acting with minimal sedation.
Brand Name: Teczine
Indications: Seasonal and perennial allergic rhinitis; chronic
urticaria.
Available as: Tablet 5 mg.
Dose:
< 6 yr 0.125 mg/kg/day OD
6 yr 2.5 OD.
ADRs: Somnolence, dryness of mouth, fatigue, rhinitis, arthralgia,
migraine.
Caution: Avoid in children < 6 years.

Loratadine
Brand Names: Lorfast, Loridin, Lorin
Indications: H1-receptor antagonist antihistamine, indicated in
treatment of allergic symptoms.
Available as:
Tablet 10 mg
Syrup 5 mg/5 mL.
36 Section 2: General Medications

Dose:
Weight < 30 kg5 mg/day
Weight > 30 kg10 mg/day.
ADRs: Somnolence, headache, depression, anxiety, easy fatigability.
Contraindications: < 3 years.
Caution: Avoid combining with agents inhibiting hepatic enzymes.
Else, prolonged QT interval may develop.

Methdilazine HCl
Brand Name: Dilosyn
Indications: Allergy, pruritus, neurodermatitis.
Available as:
Tablet 8 mg
Syrup 4 mg/5 mL
Injection 22.5 mg/mL.
ADRs: Drowsiness, CNS stimulation, impaired alertness, seizures,
hypotension, arrhythmias, gastrointestinal and genitourinary upset.
Drug interaction: Levodopa, CNS depressants, MAO inhibitors,
phenothiazines, adrenaline, thiazide diuretics.
Contraindications: Dehydration, coma, concomitant high dose
antidepressants, levodopa; jaundice; avoid in children < 3 years.
Caution: Narrow-angle glaucoma, lactation, obstructive gas
trointestinal and genitourinary conditions, lactation.

Pheniramine Maleate
Brand Names: Avil, Avil Retard
Indications: Allergy, allergic dermatitis, common cold, insect
bite; emergency allergic disorders, anaphylactic shock, severe
angioneurotic edema
Available as:
Tablets 25 mg, 50 mg, 75 mg
Injection 22.75 mg/mL.
Dose: 1 to 5 mg/kg/day (O, IM).
ADRs: Sedation, anticholinergic effects, blurred vision, agra
nulocytosis, increased ICP, muscle weakness, rarely hemolytic
anemia.
Chapter 7: Antihistamines 37

Drug interactions: Anticholinergics (atropine), alcohol, MAO in


hibitors, CNS depressants.

Promethazine HCl
Brand Name: Phenergan
Indications: For mild sedation; vomiting, motion sickness.
Available as:
Tab 10, 25 mg
Syrup 5 mg/5 mL
Inj 25 mg/mL.
Indications: Vomiting, motion sickness, mild sedation for a
procedure.
Dose:
Vomiting 0.5 mg/kg/dose (O, IM, IV, R) q 4 to 6 hr
Motion sickness 0.5 mg/kg/dose (O) 30 min prior to beginning
of travel
ADRs: Drowsiness, dizziness, disorientation, dryness of mouth,
photosensitivity, excitation, seizures, gastrointestinal upset,
blurred vision, blood dyscrasia, jaundice, agranulocytosis, hypo-/
hypertension, severe tissue injury from IV injection.
Drug interaction: CNS depressants, anticholinergics, MAO inhibitors,
alcohol.
Caution: Bronchitis, hypertensive crisis, epilepsy, glaucoma,
impaired respiratory, renal or hepatic function, obstructive
gastrointestinal or urinary tract conditions, bone marrow
depression.

Pseudoephedrine
Brand Name: Sudafed
Indications: As decongestant in URI.
Available as:
Tab 60 mg
Syrup 30 mg/5 mL.
Dose:
< 12 yr 4 mg/kg/day q 6 to 8 hr
12 yr 30 to 60 mg/dose q 6 to 8 hr.
38 Section 2: General Medications

ADRs: CNS stimulation, insomnia, nervousness, excitability,


palpitations, fixed drug eruption.
Drug interaction: MAO inhibitors, antacids, kaolin.
Contraindications: Diabetes, cardiovascular disease, uncontrolled
hypertension, pregnancy.
Precaution: Avoid concomitant use of MAO inhibitors to cut down
risk of hypertensive reactions including hypertensive crisis.
Special remarks: The use of pseudoephedrine in the pharma
industry is now discouraged on account of its abuse as a CNS
stimulant (like amphetamine and dexedrine).

Terfenadine
Brand Name: Terfed
Indications: An antihistaminic employed for symptomatic treat
ment of perianal and seasonal allergies, especially allergic rhinitis;
less sedation than with earlier antihistaminics.
Available as:
Tabs 60, 120
Susp 30 mg/teaspoonful.
Dose:
3 to 6 years30 mg/day in 2 divided doses
6 to 12 years60 mg/day in 2 divided doses
Adolescents120 mg/day in 2 divided doses.
ADRs: Dry mouth, muscle cramps, syncope, tremors, sweating,
abdominal pain, dyspepsia, headache, dizziness, gastrointestinal
upset, rash, alopecia, anaphylaxis, angioedema, palpitations, visual
disturbances, bronchospasm, paresthesia, ventricular arrhythmias
in high doses in cases with hepatic dysfunction, dyselectrolytemia
or QT prolongation.
Contraindications: Liver and heart disease, concomitant use of
such drugs as macrolides, ketoconazole or itraconazole.
Caution: Ventricular arrhythmias, electrolyte disturbances, hepatic
impairment.
Chapter

8
Nasal Decongestants

Phenylpropanolamine (PPA)
A popular nasal decongestant employed in various preparations. Now,
it stands condemned because of the risk of CNS bleeding (ascribed to
it in certain studies).

Pseudoephedrine Hydrochloride
Brand Name: Sudafed
Indications: Upper respiratory congestion, including that of nasal
mucosa and sinuses.
Available as:
Tablets 30, 60 mg
Syrup 30 mg/5 mL.
Dose: 3 to 5 mg/kg/day in 4 divided doses.
ADRs: Hypertensive reactions, palpitations, tachycardia, tremors,
sweating, flushing, headache, nervousness, insomnia.

Oxymetazoline HCl
Brand Names: Nasivion, Sinarest
Indications: Nasal congestion.
Available as: Nasal drops, 0.05, 0.0250.01%.
Dose: 1 to 2 drops into each nostril one or twice daily.
ASDRs: Local stinging or burning, sneezing, dryness of mouth or
throat, rebound congestion or rhinitis, headache, drowsiness,
palpitations.
Contraindications: Rhinitis sicca, glaucoma.
Precaution: Avoid prolonged use.
40 Section 2: General Medications

Xylometazoline HCl
Brand Names: Nasalin, Otrivin
Indications: Congestion of upper respiratory mucosa, especially
that of nose and sinuses.
Available as: Nasal drops 0.05 percent for pediatrics use.
Dose: 1 to 2 drops into each nostril once or twice daily.
ADRs: Local stinging or burning, sneezing, dryness of mouth or
throat, rebound congestion or rhinitis, headache, drowsiness,
palpitations.
Contraindications: Rhinitis sicca, glaucoma.
Precaution: Avoid prolonged use > 1 week.
Chapter

9
Antitussives

By definition, antitussives are drugs that suppress cough by acting


on the CNS and peripheral nervous system, e.g. a large group of
opioid and nonopioid drugs. Because the cough reflex is necessary
for clearing the upper respiratory tract of obstructive secretions,
antitussives should not be used with a productive cough. Codeine
phosphate and hydrocodone bitartrate are potent opioid antitussives.
Dextromethorphan hydrobromide is an effective antitussive with no
dependence liability. Antitussives are administered orally, usually in a
syrup with a mucolytic or expectorant and alcohol, or, sometimes in a
capsule with an antihistaminic and a mild analgesic.

Dextromethorphan Hydrochloride
Brand Names: Lastuss, Suppressa
Indications: A d-isomer of a codeine isomer, employed as an
antitussive agent; believed to be free of addictive effect.
Available as: As such and as a principle ingredient in cough
suppressants such as Actifed DM, Alex cough formula.
Dose: 1 to 2 mg/kg/day (O) in 3 to 4 divided doses.
ADRs: CNS depression or excitement, sleep disturbances,
hallucinations.
Precaution: Do not exceed a maximum dose of 60 mg/day.
Chapter

10
Gastrointestinal Tract
Drugs

Antiemetics

Promethazine Hydrochloride
Brand Name: Phenergan
Indications: Vomiting, motion sickness; for obtaining tranquillizing
effect and sedation.
Available as:
Tablet 10 mg
Elixir 5 mg/5 mL
Injection 25 mg/mL.
Dose: 0.5 mg/kg/dose (O, IM).
ADRs: Allergic reactions, confusion, dizziness, disorientation,
somnolence, headache, tremors, twitching, ataxia, solar dermatitis,
dystonia.
Antidote: For dystonic reaction, it is chlorpromazine.

Prochlorperazine (Stemetil)
Available as:
Tablets 5, 25 mg
Injection 12.5 mg/mL.
Dose:
> 2 years or > 10 kg 0.4 mg/kg/day (O) q 6 to 8 hr
0.2 mg/kg/day (IM) q 6-8 hr.
ADRs: Orthostatic hypotension. Extrapyramidal symptoms.
Chapter 10: Gastrointestinal Tract Drugs 43

Trifluoprerazine
Brand Names: Manocalm, Neocalm, Trazine, Siquil
Indications: Vomiting, motion sickness, for sleep.
Available as:
Tablet 10 mg
Injection 10, 20 mg/mL.
Dose: 0.5 to 0.2 mg/kg/day (O), 0.25 mg/kg/day (IM).
ADRs: Faintness, palpitations, nasal stuffiness, dry mouth, con
stipation, orthostatic hypotension, hyper- or hypothermia,
agranulocytosis, pigmentary degeneration of retina, extra

pyramidel syndromes, espcially dystonic reactions.
Contraindications: Hepatic dysfunction, coma, bone marrow
depression.

Metoclopramide HCl
Brand Names: Perinorm, Reglan, Maxeron
Indications: As an antiemetic; as a galactagogue; as an appetizer
and weight-gaining agent; gastritis, reflux esophagitis;
hyperacidity; heartburn; dyspepsia; chalasia; hiccup.
Available as:
Tablet 10 mg
Liquid 5 mg/5 mL
Injection 5 mg/mL.
Dose: 0.5 mg/kg/day in 3 divided doses. After first year, may give
up to 1 mg/kg/day.
ADRs: Extrapyramidal manifestations (spasticity, nuchal rigidity,
oculogyric crisis, nystagmus, protrusion of tongue, opisthotonos),
somnolence, nervousness, asthenia, gynecomastia, lactorrhea,
diarrhea, motor restlessness.
Antidote: Diazepam.
Contraindication: Epilepsy.
Precaution: Avoid its concurrent use with a phenothiazine or
atropine and other anticholinergic agents.
44 Section 2: General Medications

Domperidone
Brand Names: Domperon, Domstal, Gastractiv
Indications: Nausea and vomiting, gastric motility disorders (reflux
esophagitis, duodenogastric reflux, dyspeptic symptoms).
Available as:
Tablet 10 mg
Suspension 1 mg/mL.
Dose: 0.2 to 0.4 mg/kg at 4 to 8 hours intervals.
ADRs: Mild abdominal cramps, rarely extrapyramidal manifestations,
rise in serum prolactin.
Precaution: Avoid concomitant administration of anticholinergic
agents.

Ondansetron HCl
Brand Names: Emeset (Cipla), Vomiof (Stadmed)
Indications: Best indicated in chemotherapy and radiotherapy-
induced vomiting; may be employed for controlling vomiting in
other conditions.
Available as:
Tablets 4, 8 mg
Syrup 2 mg/5 mL
Injection 2 mg/mL.
Dose:
< 4 years 2 mg (O) q 4 hr
4 to 12 years 4 mg (O) q 4 hr
>12 years 8 mg (O) q 4 hr.
ADRs: Constipation, headache, flushing, liver dysfunction, seizures,
arthralgia.
Contraindications: Hypersensitivity, liver dysfunction, nausea and
vomiting during postoperative period.
Chapter 10: Gastrointestinal Tract Drugs 45

Antispasmodics

Oxyphenonium Bromide
Brand Name: Antrenyl
Indications: Antispasmodic, useful in peptic ulcer, gastritis,
hyperacidity, hypermotility.
Available as:
Tablets 5, 10 mg
Drops 10 mg/mL.
Dose:
1 to 2 tablets 4 times daily
2 to 6 yrs: 5 to 8 drops 1 to 3 times daily
6 to 12 yrs: 8 to 15 drops 1 to 3 times daily.
ADRs: Mild blurring of vision, dry mouth, dizziness, tremors, urinary
retention.

Dicyclomine
Brand Name: Colimex
Indications: An anticholinergic agent effective as an antispasmodic
in colic and irritable bowel syndrome.
Available as:
Tablet 20 mg
Suspension 10 mg/5 mL (usually in combination with
paracetamol or a NSAID).
Dose:
5 mg/dose in infants above 6 months
10 mg/dose in children
40 mg/dose in adolescents.
The dose may be repeated every 6 to 8 hourly.
ADRs: Blurring of vision, dryness of mouth, drowsiness, retention
of urine.
Contraindications: Obstructive uropathy, obstructive gastrointesti
nal disease, paralytic ileus, intestinal atony, severe ulcerative colitis,
myasthenia gravis, infants under 6 months.
Precaution: Gastroesophageal reflux with reflux esophagitis.
46 Section 2: General Medications

Atropine Sulfate
Indications: Antispasmodic, antiarrhythmic, premedi cation in
anesthesia.
Available as:
Tablets 0.3, 0.4 and 0.6 mg
Injection 0.6 mg/mL.
Dose: 0.01 mg/kg/dose (SC) with a maximum of 0.4 mg/dose.
Repeat every 4 to 6 hours prn.
ADRs: Dryness of mouth, flushing, fever, tachycardia, blurring of
vision, photophobia, dilated pupils, rash, constipation, retention
of urine, CNS manifestations like restlessness and delirium.

Drotaverine HCl
Brand Names: Drotin, Drovin
Indication: Antispasmodic
Available as:
Tablets 40, 80 mg
Injection 20 mg/mL.
Dose:
1 to 6 years 20 mg TDS
6 years 40 mg TDS.
Drug interaction: Reduces therapeutic effect of levodopa.
Contraindications: Severe renal, hepatic and cardiac insufficiency.
ADRs: Anticholinergic effects.
Caution: Monitor renal and hepatic status.

Hyoscine Butyl Bromide


Brand Name: Buscopan
Indications: Antispasmodic (gastrointestinal and biliary tract),
esophagospasm and cardiospasm, colonic motility disorders; hiccup.
Available as:
Tablet 10 mg
Suppositories 7.5, 10 mg
Injection 20 mg/mL.
Chapter 10: Gastrointestinal Tract Drugs 47

Dose:
6 to 12 years 10 mg (O) TDS
Later 10 to 20 mg (O) TDS
Injection 10 to 20 mg (IM, IV).
ADRs: Anticholinergic effects, vision disturbances, tachycardia,
palpitations.
Contraindications: Glaucoma, myasthenia gravis.
Precaution: Pregnancy.

Pipenzolate Methyl Bromide


Brand Name: Pipcal
Available as: Drops 4 mg/mL (in combination with same amount of
dimethyl polysiloxane)
Dose:
On an average 2.5 to 5 mg (O) TDS
< 6 months 4 drops before a feed
6 months to 1 year, 8 to 10 drops before a feed
1 to 3 years, 16 drops before a feed.
ADRs: Practically none.

Propantheline Bromide
Brand Name: Pro-banthine
Available as: Tablet 15 mg.
Dose: 15 mg TDS, preferably an hour before main meals.
Caution: Do not exceed total dose of 120 mg/day.
ADRs: Drowsiness, GI upset, palpitations, urinary hesitancy and
retention, anhidrosis, constipation, dryness of skin.
Stool softeners

Lactulose
Brand Name: Livo Luk
Indications: For reducing systemic ammonia concentration in
impaired hepatic function. It is a nonabsorbable sugar which is
degraded to lactic acid and acetic acid, causing an acid pH and
ammonia ion trapping. Also, indicated in constipation.
Available as: 3.325 g/5 mL as syrup.
48 Section 2: General Medications

Dose:
Infants 2.5 to 10 mL/day in 3 to 4 divided doses (O, PR)
Children 40 to 90 mL/day in 3 to 4 divided doses (O, PR).
ADRs: Intestinal cramps, flatulence.
Contraindications: Galactosemia, subjects on low galactose diets or
on galactose-free or lactose-free diets, disaccharidase deficiency,
intestinal obstruction.
Precaution: Doses need to be adjusted to produce 2 to 3 loose
motions/day.
Drug interaction: Neomycin, antacids, oral chemotherapy.
Antidiarrheals

Furazolidone
Brand Name: Furoxone
Indications: Nonspecific diarrhea, bacterial diarrhea, diarrhea
associated with giardiasis, cholera.
Available as:
Tablet 100 mg
Syrup 33.5 mg/5 mL.
Dose: 6 to 8 mg/kg/day (O) in 3 to 4 divided doses.
ADRs: GIT upset, hemolytic anemia, rash, hypotension, headache,
nausea, vomiting, fever, arthralgia.

Colistin Sulfate
Brand Name: Walamycin
Indications: Acute bacterial diarrhea due to gram-negative
organisms, especially neomycin-resistant E. coli.
Available as: Suspension 12.5 mg/5 mL.
Dose: 5 to 8 mg/kg/day (O) in divided doses.
ADRs: Pruritus, dizziness, vertigo, slurred speech, tingling
sensations, circumoral paresthesia or numbness, renal damage,
hypersensitivity.

Loperamide HCl
Brand Names: Lopamide, Imodium, Pelopem, Diatlop, Loparet
Indications: Symptomatic relief of diarrhea through the antimotility
and antisecretory action on gut.
Chapter 10: Gastrointestinal Tract Drugs 49

Available as:
Tablet/capsule 2 mg
Liquid 0.2 mg/mL.
Dose: 0.3 mg/kg/day; 0.1 mg/kg/dose.
ADRs: Dryness of mouth, abdominal cramps, drowsiness, con
stipation, vomiting, dizziness, headache, gastric distention, rash,
increased micturition.
Precaution: Avoid in infants and small children.

Diphenoxylate Hydrochloride
Brand Name: Lomotil
Indications: Symptomatic control of diarrhea.
Available as:
Tablet 2.5 mg
Liquid 2.5 mg/5 mL
Drops 0.5 mg/mL (15 drops). Subtherapeutic dose of atropine
also added to the proprietary preparation.
Dose: 0.2 to 0.3 mg/kg/day in divided doses.
ADRs: Drowsiness, constipation, flushing, nausea, vomiting, rash,
restlessness, insomnia, narcosis, respiratory depression, paralytic
ileus.
Precaution: Avoid in infants and children under 6 years.
Contraindications: Atropine or diphenoxylate intolerance/allergy,
pseudomembranous enterocolitis, jaundice.

Racecadotril
Brand Names: Enuff, Lomorest, Racotil
An inhibitor of enkephalinase, it prevents water and electrolyte losses
in diarrheas.
Indication: Secretory diarrhea.
Available as:
Sachets 10 mg, 30 mg
Capsule 100 mg.
Dose: 1.5 mg/kg (O) TDS.
ADRs: Vomiting, constipation, headache, vertigo, abdominal pain,
hypokalemia, bacterial overgrowth, toxic megacolon thirst.
Contraindications: Pregnancy, lactation, renal insufficiency.
50 Section 2: General Medications

Antacids/Antiulcers

Aluminum Hydroxide
Brand Name: Aludrox
Indications: Antacid.
Available as:
Tablet 840 mg
Gel 350 mg/teaspoonful.
Dose: 20 to 5 mg/kg/day in 4 to 5 divided doses.
ADRs: Constipation, encephalopathy when administered to subjects
with uremia because of aluminum deposits formed in the brain.

Ranitidine
Brand Names: Ranitin, Ranitiget, Ranial
Indications: Gastric/duodenal ulcer, stress ulcer, reflux esophagitis.
Available as:
Tablets 150 mg, 300 mg
Injection 25 mg/mL.
Dose: 1 to 4 mg/kg/day (O, IM, IV) in 2 to 3 divided doses.
ADRs: Impaired renal function.
Contraindication: Malignancy.
Precaution: Reduce dose in poor renal and hepatic function.

Valethamate Bromide
Brand Name: Epidosin
Indications: Gastritis, peptic ulcer.
Available as: Dragees 10 mg.
Dose: 1 to 2 dragees twice or thrice daily.
ADRs: Dryness of mouth, visual disturbances palpitations.

Sucralfate
Brand Names: Ulcekon, Sucrace
Indications: Duodenal and gastric ulcers.
Available as: Tablet 1 g.
Dose: 1 tab BID 1 hour before food in grown-up children.
Chapter 10: Gastrointestinal Tract Drugs 51

ADR: Constipation.
Precaution: Avoid in severe renal dysfunction.

Cimetidine
Brand Name: Tagamet
Indications: For inhibiting gastric acid secretions; stress ulcers.
Available as: Tablet 200 mg.
Dose: 20 to 40 mg/kg/day in divided doses, preferably with every
meal.
ADRs: With limited experience in pediatric practice, none recorded
so far. However, the likely side effects include constipation,
diarrhea, headache, vertigo, drug rash, gynecomastia, confusion,
arthralgia, muscle pain, granulocytopenia.
Drug interactions: Antacids (containing Mg, Ca, Al), sucraflate,
theophylline, probenecid, warfarin, cyclosporine.
Contraindications: Hypersensitivity to quinolones.
Precaution:
Avoid the drug 1 to 2 hours before and 4 hours after the
antacids.
Avoid with theophylline and nonsteroidal anti-inflammatory
drugs (NSAIDs).
Avoid in epileptics.
Caution: In subjects with renal failure, the dose must be reduced.

Probiotics
Live bacterial products that promote growth of normal flora of the gut
and displace pathogenic bacteria. The examples of the commonly used
bacteria in the products are Saccharomyces boulardii, Lactobacillus
acidophilus and Lactobacillus sporogenes.
Brand Names: Econorm, Ecoflora, Darolac
Indications: As adjuncts to antidiarrheal therapy, broadspectrum
antibiotic therapy; ever-increasing spectrum of other indications
include inflammatory bowel disease (IBD), necrotizing enterocolitis,
Helicobacter pylori gastritis, irritable bowel syndrome, and infantile
colic, etc.
52 Section 2: General Medications

Available as: Sachets tablets.


Dose: 3 to 9 billion organisms/day in 2 to 3 divided doses.
ADRs: Infrequent. Nausea, vomiting, constipation, hyperactivity,
aggression. Rarely, sepsis.
Contraindication: Septicemia.

Anthelmintics and Antiprotozoal Drugs


High incidence of infestation of the gastrointestinal tract in children
with helminths (say roundworms, tapeworms) and protozoa
(say, Giardia lamblia, E. histolytica), especially in resource-limited
communities, contributes considerably to abdominal complaints,
poor appetite and growth retardation. Drugs for these infestations are
dealt with in Chapter 30.
Chapter

11
Central Nervous System
Drugs

Amitriptyline
Brand Names: Tryptanol, Sarotena, Amiline, Amitryn
Indications: Depression, nocturnal enuresis.
Available as: Tablets 10, 25 mg.
Dose: 1.5 mg/kg/day in depression, 10 to 25 mg at bedtime in
enuresis.
ADRs: Signs of atropinism like dilated pupils, malar flushing, dry
mouth, hyperpyrexia, urinary retention, drowsiness agitation,
hallucination, convulsions, coma, tachycardia, bundle branch
block, CCF, allergic skin rash, black tongue, parotid swelling,
gynecomastia, alopecia.
Contraindications: Narrow-angle glaucoma, severe heart disease,
cardiovascular insufficiency and retention of urine.

Chloral Hydrate
Brand Names: Acquachloral, Noctec, Somnos
Indications: Sedative and hypnotic.
Available as: 250, 500 mg/5 mL.
Dose: 10 to 20 mg/kg/dose (O, R), 25 mg/kg/day (O, R) as sedative,
50 mg/kg/day (O, R) as hypnotic in divided doses with a maximum
of 2 g/dose.
ADRs: GIT upset, excitement, delirium, hypersensitivity, hepatic
and renal dysfunction.

Chlorpromazine Hydrochloride
Brand Name: Largactil
Indications: Tranquillizer, often used for sedative effect.
54 Section 2: General Medications

Available as:
Tablets 10, 25, 100 mg
Syrup 5, 25 mg/5 mL
Injections 25 mg/mL ampoule.
Dose: 0.5 to 1 mg/kg/dose (O, IM, 2 mg/kg/day (O) in 4 to 6 divided
doses.
ADRs: Extrapyramidal symptoms, sweating, salivation, pallor,
jaundice, constipation, photosensitivity, retention of urine, blood
dyscrasia.

Chlordiazepoxide
Brand Names: Librium, Equibrom
Indications: Tranquillizer.
Available as: Tablets 5 and 10 mg.
Dose: 0.5 mg/kg/day (O) in divided doses.
ADRs: Excitement, drowsiness, confusion, rash, GIT upset, ataxia,
hepatic dysfunction, blood dyscrasias.

Imipramine
Brand Names: Depsonil, Tofranil
Indications: Nocturnal enuresis, depression.
Available as: Tablet 25 mg.
Dose:
1.5 mg/kg/day (O) in 2 to 4 divided doses
In enuresis, 25 mg/day at bedtime for 2 months.
ADRs: Rash, sweating, hypotension, heart block, jaundice, leuko
penia, fine tremors, reactions resembling atropine toxicity.

Haloperidol
Brand Names: Serenace, Depidol
Indications: Anxiety, tension, reactive anxiety-depression, as such
or in association with neurosis or other psychosomatic disorders,
rheumatic chorea.
Available as:
Tablets 0.25, 1.5, 5 and 10 mg
Drops 0.1 mg/drop (2 mg/mL), 10 mg/5 mL.
Chapter 11: Central Nervous System Drugs 55

Dose: 0.05 mg/kg/day; usually the daily dose varies between 1 and
5 mg.
ADRs: Slight drowsiness, extrapyramidal manifestations.
Caution: Avoid using this agent in a patient who is already on a
CNS depressant; also in patients with basal ganglia lesions and
below 12 years of age.

Nitroxazepine HCl
Brand Name: Sintamil
Indications: Nocturnal enuresis; depression.
Available as: Tablets 25, 75 mg.
Dose: 25 mg to 50 mg HS.
ADRs: Constipation, dryness of mouth, giddiness, headache,
burning sensation, restlessness, skin rash, excessive perspiration,
tremors and palpitations.
Caution: Avoid its use in epilepsy, liver or kidney damage,
cardiovascular disorders, glaucoma, urinary retention and suicidal
tendency.
Contraindication: Concurrent use of monoamine oxidase inhibitors.

Pyritinol (Pyrithioxine)
Brand Name: Encephabol
Indications: ADHD, MBD, postencephalitic sequelae, perinatal
distress.
Available as:
Tablets 100, 200 mg
Suspension 80.5 mg/5 mL.
Dose: Infants2.5 mL, 1 to 3 times a day. Children2.5 to 5 mL (or
tablet) thrice daily. Give for at least 3 to 4 weeks.
ADRs: Pruritus, rash, GIT upset, disturbed taste, rise in body
temperature, leukopenia, thrombocytopenia, hepatotoxicity,
albuminuria, myasthenia-like symptoms.
Chapter

12
Anticonvulsants

Phenobarbital Sodium
Brand Names: Gardenal, Luminal
Indications: Seizures (neonatal, tonic-clonic, prophylaxis of febrile
seizures, epilepsy); for sedation; for sleep.
Available as:
Tablets 15, 30, 60, 100 mg
Syrup 20 mg/5 mL
Injection 100, 200 mg/mL.
Dose:
15 to 20 mg/kg/dose (IV boluds) over 15 to 30 minutes for an
acute attack of convulsions. Subsequently, 5 mg/kg every 15
to 30 minutes. Total dose must not exceed 30 mg/kg/day.
3 to 5 mg/kg/day (O, IV) in divided doses as maintenance
therapy or for sedation.
ADRs: Rash, vertige, idiosyncrasy, respiratory depression, drowsiness,
rickets during prolonged therapy, behavior problems, paradoxical
hyperactivity.
Drug interaction: Valproic acid, chloramphenicol, felbamate, ster
oids, griseofulvin.
Contraindications: Porphyria, asthma (severe), hepatic insufficiency,
renal insufficiency.

Primidone
Brand Name: Mysoline
Indications: Epilepsy: partial seizures, tonic-clonic seizures.
Available as:
Tablet 250 mg
Chapter 12: Anticonvulsants 57

Suspension 250 mg/5 mL.


Dose: 40 to 50 mg/kg/day in divided doses.
ADRs: Nausea, drowsiness, giddiness, rash, megaloblastic anemia,
ataxia, polyuria, oculomotor paresis.

Ethosuximide
Brand Name: Zarontin
Indication: Absence sezures (petit mal).
Available as:
Capsule 250 mg
Syrup 250 mg/5 mL.
Dose: 15 mg/kg/day 9 (O) q 12 hr. Increase in weekly increments
until absence attacks seize. This usally happens at a dose varying
between 20 and 40 mg/kg/day. This dose should be continued.
Usually, the dose of 250 mg/day for < 6 years and 500 mg/day for
> 6 years with a maximum of 1500 g/day suffices.
ADRs: Rash, gastritis, vomiting, mental dullness, suicidal ideation,
eosinophilia, hematuria, nephrotic syndrome, blood dyscrasias.
Drug interaction: INH, other anticonvulsants.
Contraindications: Porphyeria, pregnancy.
Caution: Hepatic and renal dysfunction, lactation.

Carbamazepine
Brand Names: Tegrital, Mazetol
Indications: Seizure disorder, trigeminal neuralgia.
Available as:
Tablets 100, 200, 400 mg
Syrup 100 mg/5 mL in 2 to 3 divided doses.
Dose: 10 to 20 mg/kg/day (O).
ADRs: Nausea, anorexia, drowsiness, cardiomegaly, hypertension,
rash, bone marrow depression, difficulty in accommodation.
Contraindications: Known hypersensitivity to drug or tricyclic
compounds, A-V block, with or within 2 weeks of MAI therapy,
glaucoma, alcoholism, psychosis.
Caution: Liver or renal disease, blood dyscrasias.
58 Section 2: General Medications

Phenytoin (Diphenylhydantoin Sodium)


Brand Names: Dilantin, Epileptin, Epsolin, Eptoin
Indications: Epilepsy; IV infusion in status epilepticus; ventricular
tachyarrhythmia.
Available as:
Capsules 100 mg
Suspension 100 mg/5 mL
Injection (IV,IM) 100 mg/mL.
Dose: 3 to 8 mg/kg/day (O) as single dose or in 2 divided doses; 10
to 15 mg/kg (IV, IM).
ADRs: Hyperplasia of gums, rash, blood dyscrasia, bone marrow
depression, liver damage, neurologic manifestations (nystagmus,
choreoathetosis and hyperactivity), lymphadenopathy, arthropathy,
nephrosis.

Fosphenytoin
Brand Names: Fosolin, Fosphen
A water-soluble prodrug of phenytoin (1 mg phenytoin = 1.5 mg
fosphenytoin).
Indications: Acute seizures (tonic-clonic, partial), status epilepticus.
Available as: Injection (IV,IM), 50 mg/mL.
Dose:
Emergency 15 to 20 mg/kg (IV)
Nonemergency 10 to 15 mg/kg (IV, IM)
Maintenance dose 4 to 6 mg/kg/day (IV, IM)
IV infusion rate should not exceed 3 mg/kg/minute.
ADRs: Cardiovascular collapse, hypotension; hyperplasia of gums,
rash, blood dyscrasia, bone marrow depression, liver damage,
neurologic mani festations (nystagmus, choreoathetosis and
hyperactivity), lymphadenopathy, arthropathy, nephrosis.
Contraindication: Porphyria.
Precaution: Make sure IV infusion rate remains < 3 mg/kg/min.
Chapter 12: Anticonvulsants 59

Diazepam
Brand Names: Calmpose, Valium, Tenavil, Direc 2
Indications: Symptomatic relief of anxiety; muscle relaxation; acute
convulsive episode; chronic prophylaxis for febrile convulsions.
Available as:
Tablets 2, 5 mg
Syrup 2 mg/5 mL
Injection 5 mg/mL
Rectal 2 mg/mL.
Dose:
0.1 to 0.3 mg/kg/dose (IM, IV) or 1 mg/year of age to a
maximum of 10 mg
0.1 to 0.8 mg/kg/day (O) in 3 to 4 divided doses
0.5 mg/kg/dose (R) (Fig. 12.1).
ADRs: Rise in ocular tension, hypersensitivity, drowsiness,
ataxia, nervousness, hiccough, fall in BP, respiratory depression,
thrombophlebitis; local mecha nical irritation in case of rectal
diazepam.
Caution: Do not mix diazepam with other drugs. Also do not
dilute it.

Valproate
Brand Name: Valparin
Indications: Epilepsy.
Available as:
Tablet 200 mg
Syrup 200 mg/5 mL.
Dose: Start with 15 mg/kg/day in 2 to 3 divided doses. May
increase dose by weekly increments of 5 to 10 mg/kg/day up to a
maximum recommended dose of 30 mg/kg/day.
ADRs: Anorexia, nausea, vomiting, sedation, ataxia, incoordination,
hepatotoxicity.
Caution: Concomitant use with clonazepam may lead to petit mal
(absence) status.
60 Section 2: General Medications

1 4
The medicine Turn the patient on side, facing you

2 5
Fix the applicator on to the syringe Bend upper leg forward to expose
rectum

3 6
Draw out required amount of the Separate buttocks to expose rectum
solution from the bottle
Chapter 12: Anticonvulsants 61

7 9
Lubricate the applicator using a Remove the syringe and the
suitable lubricator. Gently insert applicator slowly from the rectum
the applicator completely into the
rectum. For children under 15 kg
insert only half way

8 10
Empty the solution in the syringe Press the patients buttocks together
completely by slowly pressing the for a few minutes to prevent leakage
piston of the syringe until it stops

11
Keep person on side facing you, note
time and continue to observe
Fig. 12.1: Directions for administration of rectal diazepam (Direc 2)
62 Section 2: General Medications

Clobazam
Brand Names: Clozam, Lobazam, Frisium (Aventis)
Indications: Febrile seizure prophylaxis; add-on anticonvulsant
in generalized tonic-clonic, complex partial, generalized tonic,
absence, myoclonic and atonic seizures and Lennox Gestaut
syndrome.
Dose: Febrile seizures prophylaxis: 1 mg/kg/day q 12 hr 2 days
Other situations: Initial 0.1 mg/kg/day
Maintenance 0.3 mg/kg/day OD (preferably bedtime) or q 12 hr.
ADRs: Dryness of mouth, constipation, anxiety, impaired con
sciousness asthenia/poor weight gain, tiredness, insomnia,
tremors.
Contraindications: Hypersensitivity to benzodiazepines, myasthenia
gravis.

Clonazepam
Brand Names: Clotrin, Rivotril,
Indications: Anticonvulsant (focal, resistant petit mal, myoclonus).
Available as: Tablets 0.5, 1 and 2 mg.
Dose: 0.01 to 0.03 mg/kg/day (O) q 8 to 12 hr. The dose should be
increased by increments of 0.25 to 0.5 mg until a maximum of
0.2 mg/kg/day is attained.
ADRs: Syndrome of drowsiness, somnolence, fatigue and lethargy
occurs in one-half of the users. Muscular incoordination, ataxia,
hypotonia, dysarthria, dizziness, behavior disturbances in the
form of irritability, aggression and hyperactivity, both anorexia
and hyperphagia. Increased salivary and bronchial secretion and
exacerbation of seizures are the other undesirable reaction that
have been encountered.
Contraindications: Advanced liver disease, sleep apnea, respiratory
depression, acute pulmonary insufficiency, acute narrow-angle
glaucoma.
Caution: Do not use together with valproate to safeguard against
petit mal status.
Drug interaction: Alcohol, CNS stimulants depressants, anti
convulsants, cimetidine, disulfiram, anticholenergics.
Chapter 12: Anticonvulsants 63

Gabapentin
Brand Names: Gabapin, Neurontin
Add-on therapy
Indications: Partial seizures, diabetic neuropathy.
Dose: 15 mg/kg/day q 8 hr followed by increase in increments to
30 to 60 mg/kg/day q 8 hr.
ADR: Nausea, vomiting, rhinitis, dizziness, somnolence, tiredness,
ataxia, headache, diplopia, nystagmus, tremors.
Caution: Avoid < 12 years of age.

Lamotrigine
Brand Names: Lametec, Lamitor
As add-on therapy with valproate
Indications: Partial seizures, generalized seizures, absence seizures
(atypical), tonic-clonic seizures, atonic generalized seizures; Rett
syndrome.
Available as: Tablets 2.5, 5, 25, 50, 100 mg.
ADRs: Hypersensitivity skin rash/reaction which may turn out to be
life-threatening.
Contraindications: Advanced liver dysfunction.

Levetiracetam
Brand Names: Kepra, Levilex, Levroxa, Torleva
Indications: Refractory partial seizures, tonic-clonic seizures,
absence seizures, myoclonic seizures.
Available as:
Tablets 250, 500, 750, 1000 mg
Syrup 100 mg/mL.
Dose: 10 mg/kg/day q 12 hr followed by an increase by 10 mg/kg
every week until 40 mg/kg/day is reached.
ADRs: Nervousness, somnolence children < 6 months.
Contraindication: Infants < 6 months of age.
64 Section 2: General Medications

Lorazepam
Brand Name: Lorpose
A benzodiazepine possessing sedative and antianxiety property;
effective in status epilepticus
Indications: Poorly or uncontrolled status epilepticus.
Available as: Tablets 1 mg, 2 mg.
Dose: Sedation 0.05 mg/kg/dose.
Status epilepticus: 0.05 mg/kg/dose (IV, IM), to be repeated after
15 to 20 minutes and again after another 15 to 20 minutes if
indicated.
ADRs: CNS depression, impaired alertness, amnesia, dependence.
Contraindication: Hypersensitivity to benzodiazepines, sleep
disorder (apnea), respiratory depression, narrow angle glaucoma.
Drug interaction: Alcohol, other CNS depressants.

Midazolam
Brand Names: Mezolam, Fulsed
Indications: Poorly or uncontrolled status epilepticus.
Available as: Injection 1, 5 mg/mL.
Dose:
Intranasal (pending establishment of IV access) 0.2 mg/kg
Buccal (pending establishment of IV access) 0.3 mg/kg
After IV access is established: A bolus of 0.2 mg/kg (IV, IM)
followed by 0.1 to 0.2 mg/kg/hr.
ADRs: Respiratory depression, narrow angle glaucoma.

Nitrazepam
Brand Names: Nitravan, Nitravet
Indications: Partial epilepsy, infantile spasms (salam seizures),
partial epilepsy; also as hypnotic in insomnia.
Available as: Tablets 2.5, 5, 10 mg.
Dose: 0.25 to 1 mg/kg/day (O) OD or q 12 hr.
ADRs: Paradoxical stimulation, behavior problems, irritability,
excessive sweating, blurring of vision, dryness of mouth, urinary
incontinence.
Chapter 12: Anticonvulsants 65

Contraindications: Porphyria, myasthenia gravis, acute narrow


angle glaucoma, benzodiazepine hypersensitivity.

Oxcarbazepine
Brand Names: Oxycarb, Selzic
A keto derivative of carbamazepine
Indications: Partial, seizures, generalized tonic-clonic seizures.
Available as:
Tablets 150, 300, 600 mg
Syrup 300 mg/5 mL.
Dose: 8 to 10 mg/kg/day which should be increased in increments
of 10 mg/kg every week to a maximum of 40 mg/kg/day.
ADRs: Rash, headache, easy fatigability, dizziness, ataxia, hypona
tremia
Caution: Reduce dose to one-half in renal insufficiency/failure
Avoid in children < 6 years of age.

Paraldehyde
Brand Name: Available under generic name only
Indications: Status epilepticus, for sedation.
Available as: Injection 2, 5 and 10 mL, each mL providing 1 g.
Dose: 0.1 to 0.2 mL/kg/dose or 1 mL/year/dose (O, IM, IV), 0.3 to 0.6
mL/kg/dose (R).
(Higher limit of dose is for hypnotic or anticonvulsant effect and
the lower for simple sedation).
ADRs: Very bad smell from breath, gastric irritation, pulmonary
hemorrhage, respiratory depression, cardiac depression, cardiac
failure, hepatotoxicity.
Caution: Do not use a plastic syringe for administering paraldehyde.

Topiramate
Brand Names: Topamac, Topamax, Topex
Indications: Refractory partial seizures, primary generalized tonic-
clonic seizures, absence seizures, infantile myoclonic seizures
(Salaam seizures, West syndrome), LennoxGastaut syndrome.
This is best employed as an add-on therapy.
66 Section 2: General Medications

Available as: Tablets 25, 100 mg.


Dose:
Seizures: 1 mg/kg/day. Increase in increments to 3 to 9 mg/kg/
day OD or q 12 hr
Migraine prophylaxis: 0.5 mg/kg/day.
ADRs: Nausea, anorexia, weight loss, dizziness, headache, ataxia.
Drug interaction: Phenytoin, carbamazepine, valproic acid, CNS
depressants, carbonic anhydrase inhibitors, anticholinergics.
Contraindication: Lactation.
Caution: Avoid administering with other carbonic anhydrase
inhibitors since coadministration may cause additive effect
leading to renal calculi; avoid in renal and hepatic insufficiency.

Vigabatrin
Brand Name: Sabril
Add-on therapy in epilepsy
Indications: Refractory partial seizures, infantile spasms (infantile
myoclonic seizures, salam seizures, West syndrome), Lennox-
Gastaut syndrome.
Available as: Tablet 500 mg.
Dose: 20 to 40 mg/kg/day (O). This should be increased in
increments to 80 to 100 mg/kg/day q 8 to 12 hr.
ADRs: GI upset, behavioral problems, defects of field of vision. CNS
depression.
Precautions: It is important to conduct baseline ophthalmic
examination at the outset and then half yearly.

Zonisamide
Brand Names: Zonisamide, Zonigran
An anticonvulsant with unclear mechanism of action.
Indication: Absence seizures (atypical), partial seizures, tonic-
clonic seizures.
Dose: 4 to 8 mg/kg/day q 12 hr
ADRs: Susceptibility to hypohidrosis and hyperthermia while on
this agent, skin rash, renal calculi.
Chapter 12: Anticonvulsants 67

Other Agents Employed for Seizure Control

Adrenocorticotropin (ACTH)
Brand Name: Acthar
Indication: Infantile spasms (infantile myoclonic seizures, salaam
seizures, West syndrome).
Available as: Injection 40, 80 IU/mL.
Dose: 20 to 40 IU/day (IM, SC) for 6 weeks. During next 4 to 12
weeks, it may be tapered.
ADRs: Cushing disease, euphoria, psychosis, superadded fungal
infections, tuberculosis, immunosuppression, cataract, acne, skin
and muscle atrophy, adrenal suppression.
Contraindications: Acute psychosis, hypertension, CCF, peptic ulcer.

Prednisolone
Brand Names: Omnacortil, Predone, Wysolone
Indication: Infantile spasms (infantile myoclonic seizures, salam
seizures, West syndrome); several other indications include
asthma, nephritic syndrome, ITP, rheumatic carditis with CCF
Available as:
Tablets 5, 10, 20, 40 mg
Syrup 5, 10, 15 mg/5 mL.
Dose: 2 mg/kg/day q 12 hr 2 to 6 weeks. During the next 4 to 12
weeks, it may be tapered.
ADRs: Edema, Cushing disease, peptic ulcer, euphoria, psychosis,
superadded fungal infections, tuberculosis, immunosuppression,
cataract, acne, skin and muscle atrophy, adrenal suppression.
Contraindications: Acute psychosis, hypertension, CCF, peptic ulcer.

Pyridoxine (Vitamin B6)


Indication: Pyridoxine dependent seizures, drug-induced (INH,
hydralazine) pyridoxine deficiency causing neuritis.
Dose: 50 to 100 mg/dose (IM, IV). Thereafter, same maintenance
dose but orally.
ADRs: Nausea, folic acid deficiency, liver dysfunction.
Precaution: Large IV doses may precipitate seizures; serum
phenobarbital and phenytoin concentration may be reduced.
Chapter

13
Cardiovascular Drugs
(Cardiotonics)

Adrenaline (Epinephrine)
Indications: Anaphylactic shock, allergic reactions, cardiac arrest.
Also bronchial asthma/bronchospasm, hypoglycemia, open-angle
glaucoma.
Available as: Inj (amp) 0.1 mg/mL of 1:10,000 solution.
Dose:
Neonates: IV, intratracheal 0.01 to 0.03 mg/kg (0.10.3 mL/kg)
of 1:10,000 solution q 3 to 5 min
Infants and children SC: 0.01 mg/kg (0.01 mL/kg/dose of
1:10,000 solution or 0.005 mL/kg/dose suspension)
IV: 0.01 mg/kg (0.1 mL/kg of 1:10,000 solution (max 1 mg)
IT: 0.1 mg/kg/dose (0.1 mL/kg of 1:10,000 solution) (max 0.2
mL/kg)
Continuous infusion: 0.1 to 1 mcg/kg/min per response
Nebulization: .25 to 0.5 mL of 2.25% racemic epinephrine
diluted in 3 mL normal saline
Glaucoma: Instill 1 to 2 drops in the eye OD or BD.
ADRs: Tachycardia, hypertension, nervousness, restlessness, irrita
bility, headache, tremors, weakness, nausea, vomiting, acute
urinary retention.

Atropine Sulfate
Indications: Premedication (before surgery) to inhibit secretions
and salivation, heart block (sinus bradycardia), organophosphate
poisoning.
Chapter 13: Cardiovascular Drugs (Cardiotonics) 69

Available as: 0.5 mg/mL


Dose:
Sinus bradycardia 0.02 mg/kg IV
Premedication < 5 kg 0.2 mg/kg 30 min. preoperatively
followed by q 4 to 6 hr
5 kg 0.1 to 0.2 mg/kg/dose with a max of 0.4 mg/dose
Poisoning 0.02 to 0.05 mg/kg q 10 to 20 min until atropine
effect manifested by tachycardia, mydriasis, fever. Follow with
q 1 to 4 hr for at least 24 hr.
ADRs: Tachycardia, palpitations, delirium, ataxia, dry, hot skin,
tremors, impaired vision.
Caution: Avoids in narrow angle glaucoma, intestinal obstruction,
tachycardia and thyrotoxicosis.

Amiodarone HCl
Brand Names: Cordarone X, Eurythmic
Antiarrhythmic agent
Indication: Refractory CCF
Available as:
Tab 200 mg
Inj 50 mg/mL.
Dose: Oral dose: < 1 yr 10 to 20 mg/kg/24 hr in 2 divided doses for
10 days. Follow with 5 to 10 mg/kg/24 hr. After 1 to 4 wk or control
of arrhythmia, cut doses in half.
IV dose: 5 mg/kg over 1 hr. Follow with continuous infusion of
5 to 15 mcg/kg/min.
ADRs: Proarrhythmias (bradyarrhythmias, tachyarrhythmias or
heart block), fatigue, malaise, nightmares, behavioral changes,
hypothyroidism, hyperglycemia, slate blue color of skin, photo
sensitivity, rash, hepatotoxicity, pulmonary toxicity, photophobia,
thrombocytopenia.
Monitoring: Keep an eye on clinical signs and symptoms of
toxicity; liver, lung and thyroid function tests; chest X-ray, ECG; eye
examination.
70 Section 2: General Medications

Amrinone Lactate
Brand Name: Amicor
An inotrope and vasodilator; increases cellular levels of cyclic
adenosine monophosphate
Available as: Inj (20 mL amp) 5 mg/mL.
Indications: Low cardiac output states.
Dose:
Neonates 0.75 mg/kg IV bolus over 2 to 3 min. Follow with
3 to 5 mcg/kg/min continuous infusion IV
Infants and children 0.75 mg/kg IV bolus over 2 to 3 min.
Follow with 5 to 10 mcg/kg/min continuousinfusion IV.
ADRs: Hypertension, arrhythmias, thrombocytopenia.
Caution: Excess diuresis may result from increased cardiac output.

Digoxin
Brand Name: Lanoxin
Digitalis glycoside with positive inotropic and negative chronotropic
effect
Indications: Congestive cardiac failure (CCF) caused by poor
myocardial contractility.
Available as:
Tablet 0.25 mg
Injection 0.25 mg/mL
Elixir 0.05 mg/mL.
Dose: It is outlined in Table 13.1.

Table 13.1: Total digitalizing dose of digoxin


Age group 24 hours dose (mg/kg)
Newborn full-term 0.030.04
Premature 0.020.25
Infants and children 0.040.06
Adolescents 1.01.5 mg in divided doses
Chapter 13: Cardiovascular Drugs (Cardiotonics) 71

The half of the total calculated dose in given stat. Divide the
remaining one-half in two doses, each to be given at 8 hours
intervals. Maintenance dose, will be about one-fourths to one-
third of the total digitalizing dose. This is to be given as a single
administration or in two divided doses daily.
The above description applies to oral administration. Parenteral
dose should be about 2/3 rd of the oral dose.
ADRs: Bradycardia, pulsus bigeminus, extrasystole, sinus
arrhythmia, heart block, visual disturbances, nausea, vomiting,
diarrhea, feeding intolerance anorexia, delirium, gynecomastia.
Caution: Use of digoxin in CCF is now discouraged on the ground
that it merely temporarily improves the contractility of the
exhausted heart muscle.

Dobutamine
Brand Name: Dobutrex
A beta-adrenergic stimulant
Available as: Inj 50, 250 mg vial.
Indication: Hypotension.
Dose:
Newborn 2 to 20 mcg/kg/min (IV) as constant infusion
Children 25 to 40 mcg/kg/min (IV) as constant infusion.
ADRs: Palpitations, tachycardia, ectopics, angina, tachyarrhythmias,
tingling, paresthesia, cramps.
Caution: Never mix with soda bicarbonate.

Dopamine HCI
Brand Name: Dopinga
Indications: Shock syndrome accompanying acute CCF and
imminent renal failure; acute pancreatitis; activation and support
of diuretic therapy; during artificial respiration with PEEP; to
stabilize cardiorespiratory function during epidural anesthesia;
acute intoxication with antiarrhythmic agents, say barbiturates,
that are excreted by the kidneys.
Available as: 200 mg/5 mL ampoule.
72 Section 2: General Medications

Dose: Start with 0.002 to 0.005 mg/kg/minute. If needed, increase


by increments of 0.005 mg/kg/minute up to 0.050 mg/kg/minute.
To prepare a solution containing 0.400 mg/mL, mix 100 mg
dopamine in 250 mL 5 percent distilled water or an electro
lyte solution with pH less than 7.0. Do not use a bicarbonate
solution.
ADRs: Mild nausea and vomiting occasionally.
Contraindications: Pheochromocytoma, manifest left ventricular
hypertrophy.
Caution: Volume deficiencies must be corrected prior to its
administration.
Marked increase in heart rate and repeated arrhythmia indicate
that no further increase in dose need be made.
Abrupt cessation of the infusion must never be done.

Isoproterenol
Brand Name: Isuprel
b-adrenergic agonist
Indications: Atrioventricular block, low cardiac output shock; also
bronchospasm.
Available as:
Tablets (Sublingual) 10, 15 mg.
Injection 0.2/mL
Dose:
5 to 10 mg/dose sublingually 3 to 4 times daily
IV infusion 0.05 to 0.5 mg/kg/min
ADRs: Palpitations, tachycardia, headache, flushing of skin, anginal
pain, cardiac arrhythmias, nausea, tremors, dizziness, weakness,
sweating.
Contraindications: Significant tachycardia, hypertension, aortic
stenosis, hyperthyroidism.

Lignocaine/lidocaine HCl
Brand Name: Xylocard
Available as: Inj 21.33 mg/mL (2% 50 mL vial)
Topical
Chapter 13: Cardiovascular Drugs (Cardiotonics) 73

Indications:
Short-term control of ventricular arrhythmias, e.g. tachycardia,
premature beats, fibrillation
Local anesthesia.
Dose: 1mg/kg/dose, IV bolus q 5 min up to a maximum of 5 mg/
kg (total dose). This should be followed by IV infusion of 10 to 50
mcg/kg/min, not exceeding maximum dose of 5 mg/kg/day.
ADRs: Nausea, vomiting, arrhythmias, heart block, lethargy, coma,
seizures, blurring of vision, paresthesia, diplopia, rash.
Caution: Avoid concurrent use of epinephrine preparation.

Mephentermine Sulfate
Brand Names: Ephentine, Mephentine
Available as:
Tab 10 mg
Inj 15, 30 mg/mL in 10 mL vial.
Indication: Hypotension (secondary to spinal anesthesia or sur
gery); as vasopressor in hypercyanotic spells (Fallots tetralogy).
Dose: 0.4 mg/kg/dose. This may be given as slow IV infusion or as a
bolus.
ADRs: Nausea, vomiting, loss of appetite, hypersalivation, headache,
generalized weakness, anxiety, confusion, irritability, restlessness,
psychosis, dyspnea, urinary retention, cerebral hemorrhage, ventri
cular arrhythmias, pulmonary edema.
Contraindications: Hypovolemic shock, chlorpromazine-induced
shock.
Caution: Avoid concurrent use of tricyclic antidepressants.

Milrinone
Brand Names: Milicor, Primacor
Available as: Inj 10 mg/10 mL ampoule.
Indications: CCF refractory to diuretics, digoxin and vasodilators.
Dose: Loading dose 50 to 75 mcg/kg followed by 0.25 to 1 mcg/kg/
min continuous IV infusion.
ADRs: Vomiting, hypokalemia, hypotension, dysarrhythmia.
Precaution: This is only a short-term therapy.
74 Section 2: General Medications

Norepinephrine
Brand Name: Adrenor
Available as: Inj 2 mg/mL.
Indications: Cardiac arrest (as adjunct), acute hypotension, shock
(both vasodilatory and septic).
Dose: 0.05 to 0.1 mcg/kg/min.
ADRs: Cardiac disturbances, plasma volume depletion.
Contraindications: Hypovolemia, mesenteric or peripheral vadular
thrombosis, cyclopropane and halothane anesthesia, profound
hypoxia/hypercarbia.
Caution: Monitor BP.
Drug interactions: Tricyclic antidepressants, MAO incompatibilities.

Propranolol HCl
Brand Names: Ciplar, Inderal
See Chapter 17 (Antihypertensive Drugs)
Indications: Hypertension, hypercyanotic spells of Fallot tetralogy
(both preventive and therapeutic); infantile tremor syndrome;
coronary heart disease; migraine; hyperthyroidism.
Available as:
10, 40 and 80 mg tablets
Injection 1 mg/1 mL.
Dose:
0.15 to 0.25 mg/kg/dose (IV) for hypercyanotic spells
0.5 to 1 mg/kg/day (O) in divided doses for arrhythmia and
prevention of hypercyanotic spells
2 mg/kg/day (O) q6 hr in hyperthyroidism.
ADRs: Vomiting, diarrhea, fever, hypotension, bradycardia, cardiac
failure, rash, laryngospasm.
Caution: Poor cardiac reserve, CCF, general anesthesia, clonidine
therapy. In IHD, it should not be withdrawn abruptly.
Contraindications: 2nd or 3rd degree heart block, bronchospasm,
acidosis, prolonged fasting, verapamil therapy.
Chapter 13: Cardiovascular Drugs (Cardiotonics) 75

Procainamide
Brand Names: Pronestyl, Pronestyl, Procan
Available as:
Tab 250 mg
Inj (10 mL vial)100 mg/mL.
Indications: Ventricular tachycardia, premature ventricular con
tractions, paroxysmal atrial tachycardia, atrial fibrillation.
Dose: Loading dose 3 to 6 mg/kg/dose (IV) over 5 min with a max
of 100 mg/dose. Repeat q5-1- min if needed with a max of 15 mg/
kg total dose. Follow with a maintenance dose of 15 to 50 mg/
kg/24 hr (O) q 3 to 6 hr; 20 to 30 mg/kg/24 hr with a max of 4 g/24
hr; continuous IV infusion of 20 to 80 mcg/min with a max of 2
g/24 hr.
ADRs:
Hypotension, arrhythmias, AV block, confusion, agranu
locytosis, Coombs-positive hemolytic anemia, SLE-like syn
drome, fever, rash.
Contraindications: Heart block, myasthenia gravis.
Drug interactions: Cimetidine, beta-agonists, anticholinergic agents.
Monitoring: Maintain procainamide concentration 4 to 10 mcg/
mL (therapeutic) and 10 to 30 mcg/mL (sum of procainamide and
NAPA: therapeutic).
Caution: Watch for positive antinuclear antibody reaction and
general cardiodepression.

Quinidine Sulfate
Brand Name: Quinidine
A myocardial depressant
Available as:
Tabs 200 mg
Inj 80 mg/mL.
Indications: Arrhythmias (supraventricular tachycardia, paroxysmal
ventricular tachycardia, premature atrial/ventricular contractions).
76 Section 2: General Medications

Dose:
Test dose 2 mg/kg
Then 30 mg/kg/day (O) q 6 hr.
ADRs: Syncope, hypotension, heart block, fever, abdominal dis
comfort, bone marrow depression, thrombocytopenia, widened
QRS complexes and long Q-T interval.
Drug interactions: Verapamil, cimetidine, phenytoin, phenobarbital,
digoxin, rifampicin.
Contraindications: Hypotension, CCF, heart block.

Vasopressin
Brand Name: Pitressin
Available as: Inj 20 IU/mL.
Indications: Catecholamine refractory septic shock, diabetes insipi
dus, acute gastrointestinal bleeding.
Dose:
Catecholamine refractory vasodilatory septic shock 0.3 to 2 IU/
kg/min
Diabetes insipidus 2.5 to 10 units/dose BD, TDS or QID
GI bleeding 0.002 to 0.01 units/kg/min as continuous IV
infusion.
ADRs: Nausea, vomiting, flatulence, abdominal pain, tremors,
sweating, circumoral pallor, fever water intoxication, hyponatremia,
hypertension, bradycardia, arrhythmia.
Contraindications: Asthma, heart failure, epilepsy.
Chapter

14
Diuretics

Acetazolamide
Brand Name: Diamox
Indications: Diuretic in CCF, in cerebral edema, hydrocephalus,
glaucoma, epilepsy.
Available as:
Tablet 250 mg
Syrup 250 mg/5 mL
Injection 500 mg/mL. As yet, only tablets are available in India.
Dose: 5 mg/kg/day (O, IM) once daily as a diuretic in CCF; 8 to 30
mg/kg/day (O) in three to four divided doses as antiepileptic, in
cerebral edema, hydrocephalus or glaucoma.
ADRs: Drowsiness, confusion, abnormal sensations, paralysis,
convulsions, hepatic dysfunctions, urticarial rash, fever, crystalluria,
glycosuria, melena, hematuria, renal stone, polyuria, acidosis,
blood dyscrasias, transient myopia.
Caution: Potassium supplements may be warranted during
therapy with this agent.
Contraindications: Significant renal or hepatic damage, hyper
chloremic acidosis, sodium and potassium deple tion, adrenal
failure, sulfonamide sensitivity.

Bumetanide
Brand Names: Bumet, Bumex
Loop diuretic and antihypertensive agent, 40-fold more potent than
frusemide.
Indications: Edematous states, fluid overload, especially when
refractory to frusemide.
78 Section 2: General Medications

Available as:
Tablets 0.5, 1 and 2 mg
Injection 0.25 mg/mL.
Dose: 0.015 to 0.1 mg/kg/dose (O) q6-24 hr with a maximum of 10
mg/24 hr.
ADRs: Dehydration with electrolyte (sodium and potassium)
depletion.
Caution: Avoid in pre-existing hypokalemia.
Contraindications: Anuria, hepatic encephalopathy.

Chlorothiazide
Brand Names: Diuril, Chlotride
Indication: Diuretic.
Available as: Tablets 250, 500 mg.
Dose: 20 (740) mg/kg/day (O) in two divided doses.
ADRs: Weakness, dizziness, hepatic dysfunction, blood dyscrasias,
hyperglycemia, glycosuria, paresthesia, glomerulonephritis, pan
creatitis, hypokalemia, thrombocytopenia in newborn.
Contraindication: Anuria.

Ethacrynic Acid
Brand Name: Edecrin
Indication: Urinary tract infection.
Available as:
Tablets 25, 50 mg
Injection 50 mg.
Dose: 25 mg (O), to be given as a single dose. Then increase by
increments of 25 mg, 0.5 to 1 mg/kg/dose (IV) OD or BD.
ADRs: GIT upset, rash, jaundice, hypoglycemia, hypokalemia, hypo
natremia, peripheral circulatory failure, muscle cramps, weakness,
bone marrow depression.

Frusemide or Furosemide
Brand Names: Furoped, Lasix (Aventis)
A sulfonamide loop diuretic and antihypertensive drug, acting
through inhibition of reabsorption of electrolytes in ascending limb of
Chapter 14: Diuretics 79

loop of Henle and inhibiting reabsorption of sodium and chloride and


increasing potassium excretion in distal tubule and a direct effect on
electrolyte transport at proximal tubule and renal vasodilatory effect.
Indications: As diuretic in edema of CCF, nephrotic syndrome,
cirrhosis; hypertension particular accompanied by CCF or renal
disease; hypocalcemia, etc.
Available as:
Tablet 40 mg
Oral solution 10 mg/mL
Injection 10 mg/mL.
Dose: 1 to 3 mg/kg/dose (O), 0.5 to 1.5 mg/kg/dose (IM, IV).
(parenteral dose being half of the oral dose). This dose may be
doubled if required but the maximum of 6 mg/kg/day must not
be exceeded.
ADRs: Fluid and electrolyte imbalance, nausea, weakness, cramps,
anesthesia, dizziness, urinary frequency, sweating, thirst, rash,
bone marrow depression, thrombocytopenia, hyperuricemia;
orthostatic hypotension.
Contraindications: Hypokalemia, hyponatremia, Addisons disease,
lactation.
Caution: Avoid in neonates who may develop ototoxicity
secondary to renal maturity and in premature neonates in first
week because of the increased risk of PDA through prostaglandin
E-mediated process.

Hydrochlorothiazide
Brand Name: Esidrix
Indications: Edema of congestive cardiac failure, hepatic cirrhosis,
and renal disease.
Available as: Tablets 25, 50 mg.
Dose: 2 mg/kg/day (O) in two divided doses.
ADRs: Hyperglycemia, glycosuria, jaundice, blood dyscrasia, par
esthesia, weakness, dizziness, neonatal thrombocytopenia, glom
erulonephritis, pancreatitis, azotemia, electrolyte imbalance.
80 Section 2: General Medications

Spironolactone
Brand Names: Aldactone, Lactone
Indications: For obtaining diuresis.
Available as: Tablet 25 mg.
Dose: 1.5 to 3 mg/kg/day (O) in one to three divided doses. The
agent is usually given along with a thiazide.
ADRs: Hyperkalemia, drowsiness, hirsutism, gynecomastia, minor
GIT upset, skin rash.
Caution: Do not give potassium and do periodic serum electrolytes.
Contraindications: Anuria, hyperkalemia, renal insufficiency and
sensitivity to spiranolactone.

Triamterene
Brand Name: Ditide
A diuretic and antihypertensive agent, competing with aldosterone
for receptor sites in distal renal tubules.
Indication: For obtaining diuresis.
Available as: Tablets 50 mg (in combination with 25 mg of
benzthiazide).
Dose: 2 to 4 mg/kg/day (O) in one to two doses.
Side effects: Nausea, vomiting, headache, constipation, fatigue,
hyperkalemia, hyponatremia, hyperchloremic metabolic acidosis.
Contraindications: Hyperkalemia, renal failure.
Caution: Avoid concurrent administration of potassium.
Chapter

15
Anticoagulants

Acenocoumarol
Brand Name: Acitrom
It acts via inhibition of coagulation by reducing synthesis of
vitamin K dependent coagulation factors.
It behaves like a vitamin K antagonistjust-like warfarin. It is a
derivative of coumarol.
Indications: Prophylaxis and treatment of venous thrombosis and
pulmonary embolism.
Available as: 1 mg, 2 mg, 3 mg, 4 mg.
Dose: 1 to 8 mg/day (O) OD.
ADRs: Bleeding headache, anorexia, skin necrosis, alopecia
(reversible); bleeding; allergy; hepatotoxicity.
Contraindications: Hemorrhagic conditions, impaired hepatic/
renal function, infective endocarditis, pericarditis, pericardial
effusion, pregnancy.

Heparin
Brand Name: Beparine(BE)
Indications: Situations warranting anticoagulant therapy, e.g.
venous thrombosis, thromboembolism, pulmonary embolism,
prophylactically to cut-down risk of postoperative vascular com
plications; disseminated intravascular coagulopathy, purpura
fulminans.
Available as: Injection 1, 5, 7.5 thousand units/mL (1 mg is
equivalent to 120 units).
Dose: 50 units/kg followed by 100 units/kg to be added to IV drip
every 4 hours.
82 Section 2: General Medications

ADRs: Anaphylaxis, rash, fever, flushing, broncho spasm, nasal


congestion, alopecia, osteoporosis, severe itching, burning of feet,
bleeding.
Contraindications: Gastric ulcer, bleeding diathesis.
Drug interaction: Agents that have antithrombotic or antiplatelet
effect (e.g. streptokinase, urokinase, aspirin, dipyridamole, NSAIDs
like ibuprofen and ketorolac.

Phenindione
Brand Name: Dindevan
Available as: Tablets 50 mg.
Indication: Thromboembolism.
Dose: 0.5 to 4 mg/kg/day q 12 hr.
ADRs: Hemorrhage, agranulocytosis, eosinophilia, hepatitis, renal
damage.
Contraindications: Hemorrhagic states, renal or hepatic dysfunc
tion, lactation.
Caution: Renal impairment, hypertension, vitamin K deficiency.

Warfarin
Brand Names: Coumadin, Sofarin, Uniwarfin, Warf
An anticoagulant that antagonizes hepatic vitamin K synthesis,
depleting vitamin K-dependent clotting factors II, VI, VII, IX and X.
Available as:
Tablets 1, 2, 5 mg
Injection 50 mg.
Dose: 0.2 mg/kg (O) followed by 0.1 mg/kg/24 hr. Younger infants
need higher dose (0.3 mg/kg/24 hr). Dose is dependent on patient.
ADRs: Bleeding, hemoptysis, skin necrosis.
Drug interactions: Aspirin, barbiturates, carbamazepine, cimetidine,
omeprazole, phenytoin, rifampicin, vitamin K, ritonavir, delavirdine.
Caution: Avoid foods with high vitamin K content, e.g green leafy
vegetables.
Chapter 15: Anticoagulants 83

Xantinol Nicotinate
Brand Names: Complamina (German Remedies)
Indications: Disordered cerebral function; circulatory cerebral
disturbances; intermittent claudication; endan giitis obliterans;
diabetic angiopathy.
Available as:
Tablets 150 mg
Injection 300 mg/ampoule.
Dose: 150 to 600 mg twice daily after meals. Injection 300 to 900
mg (IM, IV infusion).
ADRs: Flushing, hypotension.
Contraindications: Recent myocardial infarction, decompensated
cardiac insufficiency, acute hemorrhage and after compensation
with cardiac glycosides.
Drugs for Endocrinal Chapter
Disorders/Hormones/
Enzymes 16
Pituitary

Adrenocorticotropic Hormone (ACTH)


Brand Name: Acthar
Indications: Sudden withdrawal of steroids after a prolonged
course; infantile myoclonic seizures/spasms.
Available as: Injection 40 mg and 60 IU/vial.
Dose: 1.8 units/kg/day (SC, IM, IV) once, twice a week, on alternate
days or successive 4 to 5 days.
ADRs: Edema, obesity, electrolyte imbalance, seizures, osteoporosis.

Desmopressin Acetate
Brand Names: D-Void, Desmospray
Indications: A synthetic analog of vasopressin indicated in noctur
nal enuresis and diabetes insipidus (central).
Available as: Nasal spray 0.1 mg/mL, each dose = 10 g
Dose: One intranasal spray in each nostril at bedtime initially; then
2 sprays in each nostril, if necessary.
ADRs: Headache, nausea, flushing, stomach pain, hypotension,
overhydration and hypernatremia.
Contraindications: Habitual psychogenic polydipsia, hypotension,
cardiac insufficiency, concomitant use of diuretics, von Willebrand
disease (type 2B).
Caution: Avoid in nasal infection, rhinorrhea, cardio vascu
lar disease, renal impairment, hypotension, cystic fibrosis and
hemophilia (hemophilia A with factor VIII levels < 5 percent;
hemophilia B); avoid using beyond 28 days at a stretch.
Chapter 16: Drugs for Endocrinal Disorders/Hormones/Enzymes 85

Drug interaction: Chlorpromazine, indomethacin, tri


cyclic anti
depressants, carbamazepine and other pressor agents.

Growth Hormone (Somatropin)


Brand Names: Genotropin, Saizen, Norditropin
Indications: Definitive indication: growth hormone deficiency.
Relative indications: Turners syndrome, chronic renal failure,
renal transplantation, cranial irradiation causing neurosecretory
dysfunction.
Available as: Injection, 4, 10, 12, 16 units/ampoule or vial.
Dose: 0.09 to 0.2 unit/kg/day (SC, IM) OD thrice a week till
attainment of target height or bone fusion occurs.
ADRs: Premature bone fusion, gynecomastia, pseudotumor cerebri
slipped capital femoral epiphysis, worsening of scoliosis.
Caution: Monitor bone fusion.

Vasopressin
Brand Name: Pitressin
Indications: Bleeding esophageal varices (portal hypertension),
central diabetes insipidus (pituitary origin), catecholamine refrac
tory septic shock (vasodilatory).
Available as: Injection 20 units/mL.
Dose:
Bleeding esophageal varices: 0.33 units/kg (IV) over 15 minutes
followed by 0.2 units/minute or 0.33 units/kg/hr
Central diabetes mellitus: 1.5 to 10 units/kg/minute
Catecholamine refractory septic shock (vasodilatory): 0.3 to 2.0
units/kg/minute.
ADRs: Hyponatremia, water intoxication.
Contraindications: CCF, asthma, epilepsy.

Pancreas

Insulin
Indication: Diabetes mellitus.
Available as:
Soluble 40 IU, 80 IU/mL (action about 6 hours)
86 Section 2: General Medications

Zinc suspension lente 40 IU, 80 IU/mL (action about 24 hours)


Isophan (NPH) 40 IU/mL (action about 24 hours)
Protamine zinc 40 IU/mL (action about 24 hours).
Dose:
0.1 unit/kg/hour (soluble, by IV infusion).
0.5 unit/kg/day in 3 divided doses.
ADRs: Hypoglycemic reactions, local or systemic allergic reactions,
local infection, lipodystrophy, fibrous lipromata and transient
myopia.

Pancreatin
Brand Names: Pancreatic enzyme, Pankreon, Serutan
Indications: Dyspepsia, cystic fibrosis.
Available as: Tablets and powder/granules of various strength.
Dose: 300 to 600 mg with each meal.
ADRs: Hypersensitivity reactions, impaction, rash, abdominal
discomfort, constipation, hyperuricemia.
Drug interactions: H2-receptor antagonists, omeprazol, antacids.

Thyroid

Thyroxine
Brand Names: Eltroxin, Thyrox, Thyronorm
Indications: Hypothyroid states, including cretinism (congenital
hypothyroidism).
Available as: Tablets 25, 50, 100, 200 mcg.
Dose:
Start with 50 to 100 mcg. Increase every 3 to 4 weeks by
increments of 25 to 50 mcg to about 200 to 300 mg.
Neonates: 10 to 15 mcg/kg/day(O) OD
Later ages: 5 mcg/kg/day (O) OD.
ADRs: Weight loss, arrhythmias and CCF. Overdose may cause
diarrhea, tachycardia, irritability, flushing, excessive sweating,
headache, cramps and advanced bone age followed by premature
closure of epiphyses.
Caution: Take special precautions in myocardial and adrenal
insufficiency.
Chapter 16: Drugs for Endocrinal Disorders/Hormones/Enzymes 87

Thyroid (Dessicated)
Available as: Tablets 15, 30, 60 mg.
Dose: 4 mg/day (O) as single dose. Initially 15 mg/day for infants
and 30 mg/day in late years. Increase by increments of 15 mg
every 1 to 3 weeks to 60 to 180 mg/day depending on childs age.
ADRs: Diarrhea, restlessness, excitability, sleep lessness, pain
abdomen, vomiting, polyuria and tremors.

Carbimazole
Brand Name: Neomercazole
Indication: Hyperthyroidism.
Available as: Tablets 5 mg.
Dose: 1 to 2 mg/kg/day (O) q 8 hr.
ADRs: Nausea, loss of taste, sore throat, headache, skin problems
like urticaria, alopecia and pigmentation, bone marrow depression
(agranulocytosis), nephrtic syndrome, arthralgia, rarely cholestatic
jaundice.

Adrenals

Beclomethasone
See Chapter 6 Antiasthma drugs.

Betamethasone
Brand Names: Betnesol, Betacortril, Solubet, Celestone, Walacort
Adrenal corticosteroid, anti-inflammatory agent.
Indications: Antenatal use to enhance fetal lung maturity in
preterm labor (labor starting before 34 weeks); congenital adrenal
hyperplasia (CAH); cerebral edema, asthma collagenosis; topical
use to treat inflammatory conditions.
Available as:
Drops 0.5 mg/mL
Tablets 0.5, 1 mg
Injection 4 mg/mL.
88 Section 2: General Medications

Dose:
Antenatal (to mother) 12 mg (IM) q 24 hr for 2 doses
Children 0.10.2 mg 1 kg/day (0).
ADRs: Maternal pulmonary edema, headache, hypertension.

Dexamethasone
Brand names: Decadron, Wymesone
An adrenal corticosteroid
Available as:
Tab 0.5 mg
Injection 4, 20 mg/mL.
Indications: Inflammatory, allergic, autoimmune and neoplastic
disorders; cerebral edema; septic shock; H. influenzae meningitis;
as antiemetic in chemotherapy as diagnostic agent.
Dose:
Airway edema/extubation in neonates: 0.25 mg/kg q 12 hr 3 to 4
doses
Bronchopulmonary dysplasia 0.25 mg/kg/dose q 12 hr for 6
doses; thereafter taper over 1 to 6 weeks
Airway edema/extubation in infants and children: 0.5 to 2 mg/kg/
day divided q 6 hr
As antiemetic (in chemotherapy): 10 mg/m2 first dose followed
by 5 mg/m2/dose q 6 hr (IV)
Anti-inflammatory: 0.08 to 0.3 mg/kg/day divided q 6 to 12 hr
(O, IM, IV)
H. influenzae meningitis: 0.6 mg/kg/day in divided q 6 hr for
days 1 to 4 of antibiotics.
ADRs: Insomnia, nervousness, increased appetite, hypertension,
hyperglycemia, GI hyperacidity and stress ulcers, cataracts, adrenal
suppression, growth retardation.
Caution: Exercise special caution in its use in bronchopulmonay
dysplasia in view of the enhanced risk of cerebral palsy.

Cortisone Acetate
Brand Name: Cortin
Indications: Physiologic replacement; stressful situations, say
inadrenogenital syndrome; nephrotic syndrome, leukemia,
Chapter 16: Drugs for Endocrinal Disorders/Hormones/Enzymes 89

lymphoma, rheumatic carditis, selected cases of tuberculosis,


immunologic reactions; autoimmune disease.
Dose: 2.5 to 10 mg/kg/day (O) in 3 divided doses. Half of this dose
for IM or IV use.
ADRs: Cushingoid facies, hypertension, electrolyte disturbances,
pseudotumor cerebri, acne, gastritis, increased appetite, peptic
ulcer, activation of tuberculosis, poor resistance to infection,
osteoporosis, glaucoma, cataract, growth retardation, myopathy
and adrenocortical atrophy.
Caution: Special precautions are required in using the drug in
peptic ulcer, diabetes, hypertension and infection.
Table 16.1 lists the relative anti-inflammatory potency and sodium-
retaining potency of corticosteroids.

Table 16.1:Relative anti-inflammatory potency and sodium-retaining


potency of different corticosteroids
Corticosteroid Anti-inflammatory Sodium-retaining
potency (mg) potency (mg)
Hydrocortisone 100 100
Cortisone 80 80
Prednisolone/prednisone 20 100
Methylprednisolone 16 0
Triamcinolone 16 0
Dexamethasone 2 0
Desoxycorticosterone 0 2

Hydrocortisone
Brand Names: Efcorlin, Hydrocortone, Hydrocortistab
Indications: Acute severe asthma/status asthmaticus, endotoxic
shock, acute adrenal insufficiency, congenital adrenal hyperplasia
(CAH).
Available as:
Tablets 10, 20 mg
Injection 100 mg/vial.
Dose:
Acute severe asthma/status asthmaticus: 25 to 50 mg/kg/dose
(IV) 4 to 6 hr
90 Section 2: General Medications

Endotoxic shock: 50 mg/kg to begin with followed by 50 to 150


mg/kg/day in 4 divided dose as for 2 to 3 days
Acute adrenal insufficiency 50 mg/m2/day.
Congenital adrenal hyperplasia: 10 to 15 mg/m2/day (1/4th at
noon and half at night. Maintenance dose 0.3 to 0.4 mg/kg/day
(divided).
ADRs: Hypertension, hyperglycemia, hypokalemia, euphoria,
insomnia, headache, Cushing syndrome, peptic ulcer disease,
cataracts, immunosuppression, skin and muscle atrophy, acne,
edema.
Caution: Avoid abrupt withdrawal which may cause acute adrenal
insufficiency.

Prednisolone
Brand Names: Wysolone, Deltacortril, Predone
A glucocorticoid.
Indications: Treatment of inflammatory and allergic disorders,
e.g. nephrotic syndrome, rheumatic carditis with CCF, immune/
idiopathic thrombocytopenic purpura (ITP), certain encephalo
pathies and encephalitis, viral carditis, collagenosis, severe asthma,
allergic skin conditions, rheumatoid arthritis.
Available as: Tablets 5, 10, 20, 40 mg.
Dose: 1 to 2 mg/kg/day (O) in divided doses.
ADRs: Cushingoid facies, hypertension, euphoria, growth retarda
tion, osteoporosis, myopathy, hyperglycemia, lowered resistance to
infection, pseudotumor cerebri, activation of dormant tuberculosis,
growth retardation, edema from increased salt retention.
Precaution: Avoid prolong treatment course; titrate dose to obtain
desired effect.

Methylprednisolone
Brand Names: Medrol, Depo-medrol, Solu-medrol, Unidrol
Antiallergic, anti-inflammatory and immunosuppressant gluco
corticoid.
Indications: Immune/idiopathic thrombocytopenic purpura (ITP),
chronic GBS, allergic, inflammatory and neoplastic (as immuno
suppressant) conditions; pulse therapy; acute spinal cord injury.
Chapter 16: Drugs for Endocrinal Disorders/Hormones/Enzymes 91

Dose:
Routine 0.5 to 2 (average 1) mg/kg/day(IM, IV)
Emergency 30 mg/kg (IV bolus) over 10 to 20 min; repeat after
4 hr if required
Shock 30 mg/kg/dose q 6 hr 2 days
Pulse therapy 30 mg/kg/day 35 days.
ADRs: Hypertension, edema, headache, nervousness, mood swings,
agitation, delirium, euphoria, psychosis, pseudotumor cerebri,
hyperglycemia, hypokalemia, alkalosis, HPA axis suppression,
Cushing syndrome, skin atrophy, bruising, hyperpigmentation,
osteoporosis (bone loss) peptic ulcer disease, growth retardation,
muscle weakness, joint pains, cataract, glaucoma; immuno
suppression.
Caution: Avoid in concurrent administration of live vaccine as also
in presence of fungal or tuberculous infection.

Triamcinolone
Brand Names: Kenacort, Ledercort
A corticosteroid available in oral, topical, inhalation and spray forms.
Indications: Inflammatory and allergic condition.
Available: Tablet as 4 mg.
Dose:
Up to 24 mg/day (O) in divided doses
40 mg (deep IM)
2.5 to 15 mg (Intra-articular).
ADRs: Tissue atrophy about injection site, fatigue, mental
depression, myopathy (proximal), osteoporosis, cataracts, oral
thrush, growth retardation.
Caution: Avoid < 6 years of age.

Anabolic Steroids
Their most common use (rather abuse) is as performance-enhancing
agents by competitive sportspersons and athletes. Increased muscle
mass and strength appear to be related to the myotrophic action at
androgen receptors, competitive antagonism at catabolism-mediating
corticosteroid receptors and erythropoietic and psychologic effects.
92 Section 2: General Medications

Methandienone
Brand Name: Dianabal
Indications: Weight loss, osteoporosis during steroid therapy.
Available as:
Tablets 1, 5 mg
Drops 1 mg/30 drops.
Dose: 0.04 mg/kg/day (O).
ADRs: Nausea, edema, interference with menstruation, hepatic dys
function, premature epiphyseal closure, gynecomastia, virilization.
Caution: Do not use the drug for a period of more than 4 weeks at
a time. However, the course may be resumed after an interruption
of 6 weeks.
Contraindication: Hepatic insufficiency.

Nandrolone
Brand Name: Durabolin
Indications: Weight loss; osteoporosis; during or after prolonged
corticosteroid therapy; uremia.
Available as: Injections 10, 25 mg/mL.
Dose:
Infants: 5 mg once a week or 100 mg once a fortnight
Children: 10 to 12.5 mg once every 10 days.
ADRs: Nausea, edema, menstrual disturbance, hepatic dysfunction,
premature epiphyseal closure, gynecomastia, virilization.
Anorexia, epigastric pain, nausea, vomiting, diarrhea; transient
rise of SGOT, SGPT, serum creatinine, bilirubin; anemia, thrombo
cytopenia, leukopenia, agranulocytosis.
Contraindication: Hypersensitivity to quinolones; epilepsy.
Caution: Avoid in children below 12 years, except in desperate
situations.

Oxymetholone
Brand Name: Adroyed
Indications: Weight loss, osteoporosis, during corticosteroid therapy.
Available as: Tablet 5 mg.
Dose: 0.1 to 0.8 mg/kg/day (O).
Chapter 16: Drugs for Endocrinal Disorders/Hormones/Enzymes 93

ADRs: Nausea, edema, interference with menstruation, heptic dys


function, premature closure of epiphysis, virilization, gynecomastia.

Ethylestrenol
Brand Name: Orabolin
Indications: Weight loss, osteoporosis, during steroid therapy.
Available as:
Tablet 2 mg
Drops 1 mg/15 drops.
Dose: 0.06 mg (1 drop)/kg/day (O).
ADRs: Nausea, edema, interference with menstruation hepatic dys-
function, premature closure of epiphysis, virilization, gynecomastia.
Table 16.2 lists common adverse effects of anabolic steroids.

Table 16.2: Common adverse effects of anabolic steroids


Increasing acneiform lesions
Linear keloids, stria, oily hair and hirsutism
Males
Gynecomastia/breast pain
Testicular atrophy (irreversible)
Azoospermia (irreversible)
Females
Breast atrophy (irreversible)
Clitoral enlargement
Menstrual abnormalities
Serious psychologic effects
Uncontrolled rage
Depression
Mania
Mood fluctuations
Alteration in libido
Fluid retention
Growth retardation from accelerated epiphyseal closure (irreversible)
IV use
HIV
HBV
Liver
Acute hepatitis
Hepatomegaly
Hepatocellular carcinoma (irreversible)
Chapter

17
Antihypertensive
Drugs

Atenolol
Brand Names: Tenolol, Aten
Available as: Tablets 25, 50, 100 mg.
Dose: 0.5 to 2 mg/kg/day (O) OD.
ADRs: Hypotension, bradycardia, headache, wheezing, CCF, angina,
Raynaud's phenomenon, arthralgia, peripheral neuropathy, diabetes.
Contraindications: Asthma, CCF, bradycardia, heart block, peri
pheral arterial disease.

Captopril
Brand Names: Agiepril, Acetein
Indications: Hypertension (especially renovascular) and CCF.
Available as: Tablet 25 mg.
Dose:
0.1 to 0.4 mg/kg/day 1 to 4 times daily
Increase to 2.0 mg/kg/day (maximum).
ADRs: Bradycardia, hypotension, neutropenia, due to hemopoietic
depression, proteinuria, nephrotic syndrome, hyperkalemia, dys
geusia causing feeding difficulties, rash, abdominal pain, nausea
and vomiting.
Caution: Avoid concomitant use of indomethacin, ibuprofen,
potassium and diuretics.

Clonidine HCI
Brand Names: Catapres, Arkamin
Indications: Essential and secondary hypertension.
Chapter 17: Antihypertensive Drugs 95

Available as: Tablet 100 mcg.


Dose: 5 to 10 mcg/kg/day.
ADRs: Dry mouth, drowsiness, constipation, sleep disturbances,
impotence, allergic manifestations and rebound hypertension
with sudden stoppage of therapy.
Caution: (i) Avoid concomitant use of tranquilizers, sedatives, and
alcohol-containing preparation, (ii) Restrict activity involving risk
of accidents, (iii) Initiation and termination of therapy should be
gradual as sudden withdrawal can cause rebound hypertension.
Contraindication: Sick sinus syndrome (SSS).

Diazoxide
Brand Name: Hyperstat
Indications: Hypertensive crisis and refractory hypoglycemia.
Available as:
Tablet 15 mg
Injection 15 mg/mL (300 mg/20 mL ampoule).
Dose:
8 to 15 mg/kg/dose q 8 to 12 hr
4 to 5 mg/kg/dose (IV). If no response, repeat after half an hour.
ADRs: Burning at injection site, transient tachycardia, hypotension,
weight gain, edema, hyperglycemia, hyperuricemia.

Enalapril Maleate
Brand Names: Enalapril, Minipril
Available as: Tablets 2.5, 5, 10, 20 mg.
Dose: 0.1 to 0.5 mg/kg/day (O) q 12 to 24 hr with a maximum of
40 mg/day.
Contraindications: Outflow obstruction, aortic stenosis, renal
artery stenosis (bilateral).

Guanethidine Sulfate
Brand Name: Ismelin
Indication: Hypertension including renal hypertension.
Available as: Tablets 10 and 25 mg.
Dose: 0.2 mg/kg/day in 1 or 2 doses.
96 Section 2: General Medications

ADRs: Hypotension (postural), syncope after excretion, rising BUN,


diarrhea, retrograde ejaculation.
Contraindications: Pheochromocytoma and recent attack of myo
cardial infarction.

Hydralazine
Brand Name: Apresoline
Indications: Hypertension including renal and essential types.
Available as:
Tablets 10, 25, 100 mg
Injection 20 mg/1 mL ampoule.
Dose:
0.75 mg/kg/day (O) in 4 to 6 divided doses
0.15 mg/kg/dose (IM, IV).
ADRs: Tachycardia, anorexia, sweating, palpitations, headache,
nausea, vomiting, dizziness, rheumatoid and lupus like syndromes.
Nasal congestion, flushing, lacrimation, conjunctivitis, paresthesia,
edema, tremors, muscle cramps, rash, fever, polyneuritis, angina,
anemia, and GIT bleeding occur less frequently.
Contraindications: Systemic lupus erythematosis (SLE), porphyria,
mitral valve stenosis/regurgitation (rheumatic).

Labetalol
Brand Names: Normadate, Lobet, Trandate
Indications: Hypertension including hypertensive crisis.
Available as:
Tablets/Capsules 50, 100, 200, 400 mg
Injection 5 mg/mL
Dose:
Hypertension: 5 to 10 mg/kg/day (O) q 12 hr
Hypertensive crisis: 0.25 to 1 mg/kg/dose (IV). After 5 minutes,
the same dose needs to be repeated
0.4 to 3 mg/kg/hr as continuous IV infusion.
ADRs: Urinary retention, hypotension, CHF, atrioventricular con
duction defects.
Caution: Avoid in coexisting asthma, hypoglycemia state and CCF.
Chapter 17: Antihypertensive Drugs 97

Nifedipine
Brand Names: Calcigard, Calcigard Retard, Depin, Depin Retard
Indication: Hypertensive crisis.
Available as:
Capsules 5, 10 mg
Retard (Sustained-release) Tablet 20 mg.
Dose:
0.2 to 0.5 mg/dose (O) every 4 to 6 hr.
3 to 5 mg/kg/dose (SL) for severe hypertension.
ADRs: Headache, dizziness, flushes, tachycardia, edema, rash,
fatigue, increased micturition, fatigue, tremors, paresthesia,
cramps, gingival hyperplasia, visual disturbances, GI upset (nausea,
vomiting), hepatic dysfunction; rarely ischemic pain.
Drug interaction: Antihypertensives, beta-blockers, diltiazem, di
goxin, cimetidine, quinidine, rifampicin, anticonvulsants (pheno
barbital, phenytoin, carbamazepine), antibiotics (erythromycin,
clarithromycin), anti-asthmatics (theophylline, terbutaline, salbut
amol), anticoagulants.
Contraindications: Cardiogenic shock, severe aortic stenosis,
lactation, porphyria.
Caution: Avoid its concomitant use with large dose of beta-
blockers and in diabetes mellitus, CCF.

Methyldopa
Brand Names: Aldomet, Emdopa
Indications: Hypertension
Available as:
Tablets 125, 250, 500 mg
Injection 50 mg/mL.
Dose: 10 mg/kg/day (O) in divided doses, increasing to the
maximum of 65 mg/kg/day, if need be, at 2 days or more intervals.
20 to 40 mg/kg/day (IV) for hypertensive crisis.
ADRs: Hepatotoxicity, dizziness, headache, drowsiness, irritability,
emotional lability, orthostatic hypotension, dark urine (due to
Coombs positive hemolytic anemia), nasal stuffiness, fever, GIT
upset.
98 Section 2: General Medications

Contraindications: Mental depression, when MAO inhibitors are


being administered, liver dysfunction, pheochromocytoma.

Minoxidil
Brand Names: Gromane, Loniten, Minitop
A direct-action peripheral vasodilator
Indications: Severe hypertension that fails to respond to maximum
therapeutic doses of a diuretic and 2 other antihypertensive drugs;
baldness.
Available as:
Tablets 2.5 , 5, 10 mg
Topical solution (2%, 5%).
Dose:
0.2 mg/kg/day as a single dose (O). Followed by stepwise
increase to 0.25 to 1 mg/kg/day
Topical sol is required to be applied generously to the affected
scalp area at bedtime daily for 3 to 6 months for effective
outcome.
ADRs: Hypertrichosis, pericardial effusion.

Propranolol HCl
Brand Names: Ciplar, Inderal
Indications: Hypertension, cyanotic spells of Fallot tetralogy; in
fantile tremor syndrome; coronary heart disease; migraine; hyper
thyroidism.
Available as:
10, 40 and 80 mg tablets
Injection 1 mg/1 mL.
Dose:
0.5 to 1 mg/kg/day in 2 to 4 divided doses for hypertension
0.15 to 0.25 mg/kg/dose (IV) for cyanotic spells
0.5 to 1 mg/kg/day (O) in divided doses for arrhythmia
2 mg/kg/day (O) q 6 hr in hyperthyroidism.
ADRs: Vomiting, diarrhea, fever, hypotension, bradycardia, cardiac
failure, rash, laryngospasm.
Chapter 17: Antihypertensive Drugs 99

Caution: Poor cardiac reserve, CCF, general anesthesia, clonidine


therapy. In ischemic heart disease (IHD), it should not be withdrawn
abruptly.
Contraindications: 2nd or 3rd degree heart block, bronchospasm,
acidosis, prolonged fasting, verapamil therapy.

Reserpine
Brand Name: Serpasil
Dose: 0.07 mg/kg/dose (IM) for acute hypertension as in acute
nephritis; 0.02 mg/kg/day (O) in 3 to 4 divided doses for chronic
hypertension.
ADRs: Nasal stuffiness, flushing, drowsiness, bradycardia, depression,
diarrhea.

Sodium Nitroprusside
Brand Names: Nipride, Sonide
Indication: Hypertensive crisis.
Dose: 0.5 to 8.0 mcg/kg/min. If we dissolve 50 mg in a liter of
5 percent dextrose solution, a concentration of 5 mcg/mL is
obtained.
ADRs: Hypothyroidism, thiocyanate production.

Verapamil
Brand Names: Isoptin, Veramil, Voratril, Voraprin
Indication: Hypertensive crisis.
Dose:
Hypertension: 2 to 4 mg/kg/day(O) q 8 hr.
Hypertensive crisis: 0.15 mg/kg/ (IV) as loading (bolus) dose
followed by 0.005 mg (5 mcg)/kg/min as infusion. If we dissolve
5 mg in 100 mL of 5 percent dextrose, a concentration of 5
mcg/mL is obtained. A continuous EVG monitoring and BP
monitoring is mandatory.
Contraindications: < 2 year of age, cardiogenic shock, CCF
(uncomplicated), AV block.
Caution: Avoid in liver damage and with beta-blockers.
Chapter

18
Immunoglobulins

Globulin, Anti-Rh D Immune Globulin


Brand Names: Imogam, Mastergam P
Indications: Rh negative mother, immediately after delivery,
chronic idiopathic thrombocytopenic purpura (ITP).
Available as: Intramuscular injection 100, 125 and 350 mcg.
Dose: Given to the Rh negative mother 2 hours after delivery or
abortion/MTP or latest 72 hours postpartum:
Without testing: optimal standard dose 350 mcg
With testing (up to 10 mL of fetal blood has entered the
maternal circulation): 250 mcg
For abortion and MTP cases (up to 10 weeks of conception):
100 mcg.
ARDs: Local reaction over the injection site, sensitization due to
repeated injection.
Contraindications:
Rh (D) negative patient who has inadvertently received Rh (D)
positive blood transfusion within three months before delivery
Patient earlier immunized to the Rh (D) blood factor.
Precaution: Protection given at delivery of first baby does not
protect the mother from exposure to antigen received at a later
time. Hence, the agent requires to be given immediately following
each pregnancy.
Chapter 18: Immunoglobulins 101

Human Normal Immunoglobulin


Brand Names: Bharglob, Gamafine, Gammalin, Globunal, Sii Gamma
Globulin
Indications: Prophylaxis/treatment of primary immune deficiency
disorders, viral infections (measles, hepatitis, HIV/AIDS), bacterial
infections, burns, etc.
Available as: 10, 16.5 percent 1 mL vials
Dose: Immunodeficiency disorders: In order to maintain the serum
IgG level > 500 mg/dL, dose needs to be 300 to 400 mg/kg (IM)
every 3 to 4 weeks.
Attenuation of measles in close contacts: 0.3 mL/kg of 10 percent
sol (IM) within 5 to 6 days of exposure
Attenuation of Hep A (Pre-exposure prophylaxis): 0.02 to 0.04
mL/kg of 10 percent sol (IM) within 14 days of likely exposure
(prexposure prophylaxis for travelers from nonendemic areas)
Attenuation of Hep A (postexposure prophylaxis): 0.02 mL/kg of
10 percent sol plus hepatitis A virus (HAV) vaccine.

Human Tetanus Specific Immunoglobulin


Brand Names: Equirab, ERIG, Carig, Tetagam-p, Tetaglobulin, Tetglob,
Tetanus Immunoglobulin, Immunotetan
Indications: Both prophylaxis and treatment of tetanus.
Dose: Prophylaxis: 250 to 500 units/kg (IM), high dose is for heavily
contaminated wounds, presentation of wounded subject after a
lapse of > 24 hr.
Treatment:
30 to 300 units/kg (IV)
250 units (intrathecal).

Human Rabies Specific Immunoglobulin


Brand Names: Berirab, Imogam Rabies, Imorab
Indications: Category 3 bites.
Available as: 300, 750, 1000 unit vials.
102 Section 2: General Medications

Dose:
Human rabies immunoglobulin (HRIG): 20 units/kg to be
infiltrated into the wound and neighborhood. This is the
preferred choice.
Equine rabies immunoglobulin (ERIG): 40 units/kg to be
infiltrated into the wound and neighborhood.
ADRs: Rarely, anaphylaxis with ERIG.
Precautions: Test hypersensitivity before administering the agent.

Varicella Zoster Immunoglobulin (VZIG)


VZIG provided passive immunity against varicella.
Brand Name: Varitect
Indications: All susceptible individuals (Box 18.1)
Prophylaxis of varicella in neonates whose mothers suffer from
varicella 5 days before delivery and up to 2 days following
delivery.
Postexposure prophylaxis in immunocompromised children
and pregnant women.
Available as: Inj 125 units/5 mL ampl.
Dose:
Infants
i. < 10 kg 125 units (IM). For subsequent each 10 kg weight,
dose is enhanced by 125 units.

Box 18.1: Susceptible individuals needing VZIG


1.All unvaccinated children who do not have a clinical history of varicella
in the past
2.All unvaccinated adults who are seronegative for anti-varicella IgG.
Bone marrow transplant recipients are considered susceptible even if
they had disease or received vaccinations prior to transplantation. A
significant contact is defined as any face-to-face contact or stay within
the same room for a period greater than 1 hour with a patient with
infectious varicella (defined as 12 days before the rash till all lesions
have crusted) or disseminated herpes zoster.

Contd...
Chapter 18: Immunoglobulins 103

Contd...

The following groups meeting these two criteria and who are at high-risk of
developing severe disease merit prophylaxis with VZIG.
Neonates born to mothers who develop varicella 5 days before or 2 days
after delivery. The risk of varicella related death in these infants as per
older estimates is likely to be 30% but may be lower. Other full term
healthy newborns are not at increased risk for complications and do not
merit prophylaxis if exposed to varicella.
All neonates born at less than 28 weeks of gestation/with birth weight
less than 1000 gm, exposed in the neonatal period.
All preterm neonates born at more than 28 weeks of gestation and
exposed to varicella only if their mothers are negative for anti-varicella
IgG, exposed to varicella.
Pregnant women exposed to varicella.

All immunocompromised children especially neoplastic disease,
congenital or acquired immunodeficiency or those receiving
immunosuppressive therapies.
Patients who received IVIG @ 400 mg/kg in the past 3 weeks are deemed
protected.

Children
i. 10 to 20 kg 250 units (IM)
ii. 20 to 30 kg 375 units (IM)
iii. 30 to 40 kg 500 units (IM)
iv. 40 kg 625 units (IM)
ADRs: Allergic reactions and anaphylaxis.
Precautions:
Best given within 48 hours and never after 96 hours of
postexposure.
Max of 2.5 mL should be injected at one site
Do not give in mothers actually suffering from herpes zoster.
Special remarks: The cost of VZIG is prohibitive. If non affordable/
not available, other options with uncertain efficacy include IVIG @
200 mg/kg or oral acyclovir @ 80 mg/kg/day beginning from the
7th day of exposure and given for 7 to 10 days.
104 Section 2: General Medications

Human Hepatitis B Specific Globulin/Hepatitis B


Immunoglobulin (HBIG)
Brand Names: Gamma protect Hepatitis, Hepabig, Hepaglob
Indications: Neonates of HbsAg positive mothers; accidental
mucocutaneous exposure to Hep B-infected blood/blood
products or accidental needle exposure.
Available as: 0.5, 1.0, 3.0, 5.0 mL ampoules.
Dose:
Neonates of HbsAg positive mothers: 0.5 to 1.0 mL (100200
units) IM within 72 hr (within 12 hr is the best) of birth along
with first dose of Hep B vaccine IM at a different site for active
immunization.
Accidental exposure: 0.06 to 0.1 mL/kg (40 units/kg) IM within
24 hr (within 6 hr is the best) of exposure along with first dose
of Hep B vaccine IM at a different site for active immunization.
ADRs: Anaphylactic reactions.
Contraindication: Allergy or intolerance to human immuno
globulins.
Precautions: Avoid giving immunoglobulin and vaccine at the
same site.

Respiratory Syncytial Virus Intravenous


Immunoglobulin (RSV-IVIG)
Brand Name: Raspi Gam
Indications: Prevention of serious RSV infection (bronchiolitis,
pneumonia) in high-risk children (prematurity, bronchopulmonary
dysplasia).
Available as: Injection 50 mg/mL
Dose: 750 mg/kg (IV) once a month. The course should begin
a month before and be ongoing during RSV season. For exact
recommendations, (Box 18.2).
ADRs: Anaphylaxis, fever, headache, backache, arthralgia, skin
reactions, hypertension.
Contraindication: Congenital heart disease (right-to-left shunt).
Chapter 18: Immunoglobulins 105

Box 18.2: Recommendation for RSV-IVIG


Starting dose: 1.5 mL/kg/hr for 15 min
Then, increase the rate to 3 mL/kg/hr for 15 min
If well tolerated, increase the rate to a maximum of 6 mL/kg/hr until a total
of 750 mL/kg is administered.

IV Immunoglobulin (IVIG)
Brand Names: Gamma IV, Globomin IV, Isiven IV, Pentaglobulin,
Sandoglubulin, Venimunn, ZY-IVGG
Indications: Immunodeficiency states, chronic ITP, Rh isoimmuni
zation, Kawasaki disease, Guillain-Barr syndrome (GBS),
hemolytic-uremic syndrome (HUS), sepsis.
Available as: 0.5,1.0, 2.5, 5.0 g vials.
Dose:
Immunodeficiency state: 100 to 400 mg/kg/dose (IV) every 2 to
4 wk
Kawasaki disease: 2.0 g/kg IV infusion over 10 to 12 hr as a
single dose.
Or
400 mg/kg/day (IV) for 4 days
ITP: 800 to 1000 mg/kg/dose (IV) for induction of response.
Thereafter 400 to 800 mg/kg/dose (IV) once every 4 to 6 wk
ADRs: Anaphylaxis, hypersensitivity reactions, fever, chills,
hypotension, transient tachycardia.
Contraindication: IgA deficiency.
Precautions: If ADR occurs, discontinue the infusion until the
reaction is controlled. Resume at a slower rate in keeping with
tolerance.
Chapter

19
Hematinics

Iron
Indication: Iron deficiency anemia
Available as:
Oral preparation (Table 19.1)
Injectable: Iron-dextran complex (IM, IV) and iron sorbitral (IM).
Dose: Prophylaxis/maintenance 0.5 to 1 mg/kg/day (O), in terms of
elemental iron, q 12 hr.
Therapeutic: 3 to 6 mg/kg/day (O), in terms of elemental iron,
q 12 hr
Iron dextran complex: Vide infra
Iron sorbitral: Vide infra
Iron sucrose: Vide infra.
ADRs: GIT upset (nausea, vomiting, diarrhea, abdominal pain),
staining of teeth.

Table 19.1: Element iron content of various oral iron salts


Salt Elemental iron (%)
Ferrous sulfate 20
Anhydrous ferrous sulfate 37
Ferrous fumarate 33
Ferrous fructose 25
Ferrous succinate 23
Ferrous lactate 19
Contd...
Chapter 19: Hematinics 107

Contd...
Salt Elemental iron (%)
Ferrous carbonate 16
Ferrous ammonium citrate 15
Ferrous choline citrate 20
Ferrous gluconate 12
Colloidal iron 50
Iron (III) hydroxide polymaltose complex 50 mg/5 mL or tablet

Caution: Accidental swallowing in large doses may cause iron


poisoning with local irritative effects on GIT mucosa, hypoglycemia,
metabolic acidosis, hepatic necrosis, pyloric stenosis, and even
death.

Iron Dextran
Brand Name: Imferon
Indication: Iron deficiency anemia.
Available as: Injection 50 mg/mL of elemental iron.
0.3 Weight (Lbs) Hb deficit (%)
Dose: Requirement (mg) =
50
or
= 4 Weight (kg) Hb deficit (g/dL)
The total requirements may be given intravenously as total
dose infusion (TDI) or intramuscularly (daily 12 mL).
ADRs: Anaphylaxis, hypersensitivity reactions, fever, urticaria, nausea,
vomiting, headache, arthralgia, generalized lymphadenopathy.
Caution: Always do sensitivity test.

Iron Sorbitol
Brand Name: Jectofer
Indication: Iron deficiency anemia.
Available as: Injection 1.5 mL providing 50 mg/mL.
Dose: 1.5 mg (0.33 mL) kg/dose (IM).
108 Section 2: General Medications

ADRs: None observed so far.


Contraindications: Severe liver or kidney damage, acute leukemia,
aplastic or hypoplastic anemia.

Iron Sucrose Complex


Brand Name: Venofer
Indication: Severe anemia in > 2-year-old subjects with chronic
kidney disease (CKD).
Available as: IV injection, 1 mL providing 20 mg elemental iron.
Dose: Slow intravenous injection at a rate of 1 mL undiluted
solution per minute and not exceeding 10 mL (200 mg iron) per
injection.
ADRs: Hypersensitivity reactions including anaphylaxis (shock,
hypotension, circulatory collapse), muscle cramps, nausea,
vomiting and diarrhea, disturbance of taste, peripheral edema.
Contraindications: < 2 years age; iron overload.
Cautions: Monitoring for hypersensitivity reactions at least for 30
min following completion of infusion. Also monitor BP.

Ferrous Sulfate
Brand Name: Fersolate
(20% elemental iron)
Indication: Iron deficiency anemia.
Available as: Tablet 200 mg providing 40 mg of elemental iron.
Dose: 1 mg/kg/day (O) for prophylaxis, 3 to 6 mg/kg (O) for curative
purposes (calculated in terms of elemental iron).
ADRs: GIT upset (both diarrhea and constipation are known to
occur), hemochromatosis in cases of chronic hemolytic anemia.

Folic Acid
Brand Name: Folvite, Folet
Indications: Megaloblastic anemia from folic acid deficiency,
endemic tropical sprue, along with iron in iron-deficiency anemia,
thalassemia, during course of phenytoin therapy; periconceptional
therapy (1 month before and 2 months after conception) to prevent
neural tube defects like meningocele and meningomyelocele.
Chapter 19: Hematinics 109

Available as: Tablets 5, 10 mg.


Dose: 5 to 20 mg/day (O); 1 mg/day (IM) or 0.2 mg/kg/day.
ADRs: Rarely, hypersensitivity reactions, GI upset, sleep disturbances,
rash, bronchospasm.
Drug interaction: Anticonvulsants, pyrimethamine, sulphasalazine,
trimethoprim, oral contraceptives, methotrexate, alcohol,
pyrimethamine.
Contraindication: Pernicious anemia.
Caution: Folate-dependent tumors.
Chapter

20
Vitamins

Vitamin A
Brand Names: Aquasol, Arovit
Indications: Vitamin A deficiency (VAD) states (both prophylactic
and therapeutic); measles, diarrhea; occasionally respiratory
infections and IDA.
Available as:
Oral suspension 50,000 IU/2 mL amp
Tab/cap 25000, 50000 IU.
Dose: Prophylaxis: < 6 months 50,000 IU
6 to 12 months 100,000 IU
1 year 200,000 IU
The dose should be repeated every 6 months for a total of 9 doses
by 5th birthday.
Treatment: Table 20.1

Table 20.1: WHO/UNICEF treatment schedule of xerophthalmia


Children 1 to 6 years and above
Immediately on diagnosis 200,000 IU vitamin A(O)
The following day 200,000 IU vitamin A(O)
Four weeks later 200,000 IU vitamin A(O)
Children under 1 year and under 8 kg weight at any age
Half the doses as indicated for children 1 to 6 years and above
For night blindness or Bitot spot
Treat with a daily dose of 10,000 IU of vitamin A(O) for 2 weeks
Note: If there is a persistent vomiting or profuse diarrhea, an intramuscular injection
of 100,000 IU of water-miscible vitamin A (but not an oil-based preparation) may be
substituted for the first dose
Chapter 20: Vitamins 111

ADRs: Anorexia, growth failure, headache, irritability, painful


swelling of long bones (hyperostosis), pseudotumor cerebri,
neural tube defects.

Vitamin B1
Indications: Beri beri, neuropathy, cardiomyopathy, inborn errors
of metabolism.
Daily requirement: 0.1 to 1.0 mg or 0.5 mg/1000 kcal diet.
Dose:
10 mg OD
Inborn errors of metabolism 100 mg q 8 hr
Collapse from cardiomyopathy 25 mg (IV) slowly.

Vitamin B6
Brand Name: Bevidox
Indications: Pyridoxine dependent seizures and anemia,
sideroblastic anemia, pyridoxine-deficiency neuropathy, INH-
induced neuropathy, penicillamine-induced neuropathy.
Available as: In combination with B1 and B12.
Dose: 0.3 to 3 mg/kg/day (O, IV).
Seizures 100 mg (IV) in 1 min followed by 50 to 100 mg/day
Neuropathy 50 mg (O) TDS
ADRs: Rare. Sedation, respiratory depression.

Vitamin B12
Brand Names: Alkem, Macraberin, Bevidex
Indications: Megaloblastic anemia.
Available as: In combination with B1 and B6.
Daily requirement: 0.3 to 2 mcg.
Dose: 250 to 1000 mcg (IM) on alternate days for 1 to 2 weeks
followed by once a week until blood count returns to normal.
Then, maintenance dose of 1000 mcg every 2 to 4 months.
ADRs: Very rare. Peripheral thrombosis, polycythemia vera, gout,
hypokalemia.
Drug interaction: Alcohol, PAS.
112 Section 2: General Medications

Precaution: Since there is every chance of concurrent depletion of


iron and folate stores as also hypokalemia, supplementation with
these micronutrients is recommended.

Vitamin C (Ascorbic Acid)


Brand Names: Redoxon, Sorvicin, Chewcee, Succee, Limcee
Indications: Vitamin C deficiency states, esp. scurvy; as antioxidant
and hemostatic agent; methemoglobinemia; iron-deficiency
anemia; transient tyrosinemia of newborn; Chdiak-Higashi
syndrome.
Available as:
Tablets 50, 100, 500 mg
Drops 100 mg/20 drops
Injection 500 mg/5 mL.
Dose: 100 to 500 mg/day (O, IV).
ADRs: Vomiting, flushing, diarrhea, hyperoxaluria; gastritis with
overdose.

Vitamin D
Brand Names: Arachitol, Calcirol
Indications: Vitamin D deficiency rickets.
Available as: Injection 3,00,000 and 6,00,000 IU/1 mL ampoule.
Granules 60,000 IU/sachet.
Dose: As per Stross regimen, a massive dose of 6,00,000 IU (IM, O)
to be repeated after 3 to 4 weeks gap, once or twice, if indicated.
In infants, a dose of 3,00,000 IU suffices. Alternatively, 30,000 to
60,000 units/day (O) may be given for 10 days. For prevention of
rickets, the same dose may be given every 6 months.
ADRs: Hyperostosis or Caffeys disease in the form of irritability,
anorexia, hypotonia, constipation, anemia, calciuria, metastatic
calcification, fever and high ESR. Affected bones develop soft
swellings over them. X-ray shows hyperplasia of the subperiosteal
bone. Pseudotumor cerebri and nephrocalcinosis may also occur.
Precaution: Ensure adequate intake of oral calcium (through diet
or supplements).
Antidote: Sodium sulfate, 0.5 percent sol in milk (PO). Increase to
1 to 2 percent until diarrhea shows up.
Chapter 20: Vitamins 113

Vitamin E
Brand Names: Evion, Tocofer
An antioxidant.
Indications: Anemia of prematurity, sickle cell anemia, cystic
fibrosis, beta-thalassemia, retinopathy of prematurity (ROP),
bronchopulmonary dysplasia, Rett syndrome, abetalipo
proteinemia, cholestasis.
Available as:
Drops 50 mg/mL
Pearls 30, 100, 200, 400, 600 mg.
Daily requirement: 25 to 100 IU.
Dose:
60 to 75 mg/day (adolescents)
Neonates 25 to 50 IU/day (O)
Children 1 mg/kg/day
Sickle cell anemia 450 mg/day
Cystic fibrosis 100 to 400 mg/day
Beta-thalassemia 750 mg/day.
ADRs: Rare. Diarrhea, lethargy, cramps, muscles weakness
Contraindication: None recorded so far.
Caution: Avoid giving simultaneously with iron since it reduces
iron absorption.

Vitamin K
Brand Name: Menadione sulfate
Indications: Hemorrhagic disease of the newborn (HDN), liver
disorders causing bleeding tendency, vitamin K-dependent
clotting factor(s) deficiency, cholestasis.
Dose:
Prophylaxis of HDN
Premature neonates 0.5 mg (IM)
Term neonates 1 mg (IM)
Therapy of HDN
5 to 10 mg/dose (IM, SC, IV).
ADRs: Rare. Anaphylaxis (when given rapidly IV), hyperbilirubinemia
when dose > 20 mg, severe hemolytic anemia.
Monitoring: PT, PTT.
Chapter

21
Trace Elements

Potassium Chloride
Brand Names: Potklor, P-Lyte
Indications: Prevention and treatment of potassium depletion
of whatsoever origin. Common ECG changes associated with
hypokalemia include loss of P waves, wide QRS complexes,
decreased rate, and conduction disturbances.
Dose:
1 to 3 mEq/kg (O) q 8 hr
1 to 3 mEq/kg (IV) in hypokalemia
2 to 5 mEq/kg/day (O) in kwashiorkor and marasmus with
diarrhea.
ADRs: Nausea, vomiting, flatulence, abdominal pain/discomfort
and diarrhea, upper and lower gastrointestinal conditions
including obstruction, bleeding, ulceration and perforation; skin
rash; hyperkalemia.
Precaution: Administer after the child has passed urine. Since GI
symptoms are due to irritation of the gastrointestinal tract and
are best managed by taking the dose with meals or reducing the
amount taken at one time.

Calcium Gluconate
Indications: Hypocalcemic states, cardiopulmonary resuscitation.
Available as:
Tablet 0.5 and 1 g
Injection 100 mg/mL (10% solution).
Dose: 0.5 g/kg/day (O) in divided doses; 1 to 2 mL/kg/dose (IV).
Chapter 21: Trace Elements 115

ADRs: Necrosis at the site of IV injection, bradycardia; GI irritation


with oral administration.
Precaution:
Avoid intramuscular administration
Avoid in infants at risk of NEC.

Calcium Chloride
Indications: Hypocalcemic states, cardiopulmonary resuscitation.
Available as: Oral solution of variable strengths. Injection 100 mg/mL.
Dose: 0.3 g/kg/day (O, IV) in divided dose.
ADRs: Necrosis at the site of IV injection, bradycardia, gastric
irritation.

Magnesium Sulfate
Indications: Severe PEM, acute severe asthma refractory to
conventional therapy, resuscitation, arrhythmias.
Available as: Injection (1 mL ampoule) 1, 10, 25, 50 percent solution
(Table 21.1).
Dose: PEM 2 to 3 mEq (0.50.75 mL of 50% solution)/kg/day.
Acute severe asthma (as adjunctive therapy)25 to 75 mg/kg
with a maximum of 2.5 g IV over 20 minutes. Resuscitation and
arrhythmias25 to 50 mg/kg (IV) over 10 to 30 minutes with a
maximum dose of 2 g.
ADRs: Hypotension, flushing, CNS, respiratory and CV depression.
Contraindication: Acute renal failure.
Precaution: Monitoring of serum levels and cardiovascular status.

Table 21.1: Magnesium content in various solutions


50% solution 4 mEq/mL
25% solution 2 mEq/mL
10% solution 0.8 mEq/mL
1% solution 0.08 mEq/mL
116 Section 2: General Medications

Zinc
Brand Names: Zincolak, Zn-20, Zevit, Zidust
Indications: Zinc deficiency states, including diarrhea, acroder
matitis enteropathica, infantile tremor syndrome (ITS) and
adolescent nutritional dwarfing; TPN supplement.
Available as:
Suspension 10, 20 mg/mL
Capsules 220 mg.
Dose: Maintenance/prophylaxis0.01 to 0.04 mg/kg/day (daily
needs)
Therapeutic infants: 0.5 to 1 mg/kg/day
Diarrhea (both acute and chronic): 10 mg/day for < 6 months
and 20 mg/day for > 6 months
Acrodermatitis enteropathica: 6 mg/kg/day
ITS: 6 mg/kg/day
TPN supplement: (Table 21.2).

Table 21.2: Zinc supplements in TPN


Preterm infants 400 mcg/kg/24 hr
Infants < 3 months 250 mcg/kg/24 hr
Infants > 3 months 100 mcg/kg/24 hr
Children 50 mcg/kg/24 hr

ADRs: GIT upset, drowsiness, dizziness, anemia, peripheral neuritis,


paresthesia, malabsorption, copper deficiency.
Precaution: Do not exceed a daily dose of 220 mg. Supplements of
copper required in case of excessive doses of zinc.
Chapter

22
Anticancer Drugs

Melphalan
Brand Name: Alkeran
Indications: Malignancy including multiple myeloma.
Available as:
Tablets 2 and 5 mg
Injection 100 mg/vial.
Dose: 2 to 4 mg/day.
ADRs: Nausea, vomiting, bone marrow depression.
Contraindications: Neutropenia, thrombocytopenia, concurrent
radiotherapy.

Mitomycin-C
Brand Name: Mutamycin
Indications: Malignancy, especially lymphosarcoma, adeno
carcinoma, and seminoma.
Available as: Injection 2 mg/vial.
Dose: 0.05 mg/kg/day (IV) for 5 days.
ADRs: Bone marrow depression, leukopenia, thrombocytopenia,
ulceration of mouth.
Contraindications: Bleeding tendencies, bone marrow depression.
Caution: Local necrosis may occur from leakage.

Mercaptopurine
Brand Names: 6-Mp, Puri-Nethol
Indications: Acute leukemias, chronic granulocytic leukemia.
118 Section 2: General Medications

Available as: Tablets 50 mg.


Dose: 2.5 mg/kg/day.
ADRs: Bone marrow depression, nausea, vomiting, diarrhea,
jaundice, anorexia, oral and GIT ulcers, muscular wasting, lupus
(disseminated).
Caution: The dose should be halved when used along with
allopurinol.

Mustine HCl
Brand Name: Mustargen
A nitrogen mustard.
Indications: Hodgkins lymphoma; certain types of chronic
leukemias; bronchogenic carcinoma.
Available as: Injection 10 mg/vial.
Dose: 0.1 to 0.4 mg/kg/dose (IV) with a maximum of 8 mg for 3 to
4 days.
ADRs: Nausea, vomiting, diarrhea, fever, anorexia, skin rash,
alopecia, local thrombosis and thrombophlebitis, bone marrow
depression.
Contraindications: Anemia, severe leukopenia, thrombocytopenia,
infectious granuloma (both coexisting and suspected).
Caution: Never give IM.

Methotrexate
Brand Names: Biotrexate, Neotrexate
Indications: Acute leukemias (lymphoblastic) including CNS
prophylaxis, osteogenic sarcoma, choriocarcinoma, bronchogenic
carcinoma.
Additional indications: Nephrotic syndrome, severe psoriasis,
acute active rheumatoid arthritis refractory to other drugs
Available as:
Tablets 2.5 mg
Injections 5 mg, 15 mg, 50 mg/vial.
Dose: 0.12 mg/kg/dose (O), 0.25 to 0.5 mg/kg/day (IT), 3 to 5 mg/
kg/(IV) as single dose every other week.
Chapter 22: Anticancer Drugs 119

ADRs: Anorexia, stomatitis, diarrhea, pain abdomen, bone marrow


depression, rash (even Steven-Johnson syndrome), superimposed
infections, alopecia, testicular/ovarian dysfunction, menstrual
disturbances, alveolitis, interstitial pneumonia, osteoporosis, renal
toxicity, hepatic toxicity.
Contraindications: Pre-existing bone marrow depression,
leukopenia, thrombocytopenia, severe renal or hepatic dys
function, immunodeficiency, lactation.
Drug Interactions: Protein-bound drugs, hepatitis A and B vaccines,
folic acid, folate antagonists, anticonvulsants, cotrimoxazole,
probenecid, lipid-lowering agents, penicillins.
Caution: Monitor blood, hepatic, renal and pulmonary status
before, during and after therapy. Ensure alkaline urine.

Busulfan
Brand Name: Myleran
Indication: Chronic myeloid leukemia, polycythemia vera,
myelofibrosis, essential thrombocythemia.
Available as: Tablet 2 mg.
Dose: 0.06 mg/kg/day (O) until TLC falls to 20,000/cmm.
ADRs: Bone marrow depression (especially the myeloid series,
sometimes platelets), skin pigmentation, weakness, nausea,
hypotension, heart block (3rd degree), hyperuricemia.
Caution: Hospitalize the patient during induction therapy.

Chlorambucil
Brand Name: Leukeran
An alkylating agent for myeloid elements (granulocyte precursors,
platelets and RBCs).
Indications: Chronic lymphoblastic leukemia, Hodgkins disease,
non-Hodgkins lymphomas.
Available as: Tablets 2 mg, 5 mg.
Dose: 0.1 to 0.2 mg/kg (O) as single dose or in divided doses.
ADRs: Nausea, vomiting, bone marrow depression, rarely skin
rash, hyperpigmentation, fever, cystitis, hepatotoxicity, peripheral
120 Section 2: General Medications

europathy, seizures; anemia, leukopenia, neutropenia, pancyto


n
penia, thrombocytopenia, hyperuricemia, pulmonary fibrosis.
Drug interactions: Drugs lowering seizure threshold, myelosup
pressives, phenylbutazone.
Contraindications: Neutropenia, thrombocytopenia, within 4
weeks of radiation or chemotherapy.
Caution: Hematologic monitoring.

Vinblastine
Brand Name: Cytoblastin
Indications: Leukemias, Hodgkins disease, other responsive
cancers as such or in combination with other agent(s).
Available as: Dry powder providing 1 mg/mL after reconstruction.
Dose: 0.1 to 0.2 mg/kg/week (IV).
ADRs: Transitory bone marrow depression, usually occurring
within a week of the dose, alopecia, neurologic disturbances,
hypertension, bone pain, malaise, bronchospasm, dyspnea.
Contraindications: Leukopenia, bacterial infection, intrathecal (IT)
administration.
Drug interaction: Mitomycin-C, phenytoin.
Caution: Hematologic monitoring. If the WBC count falls below
4,000/cmm, omit the subsequent dose.

Vincristine
Brand Name: Cytocristine
Indications: Acute leukemias.
Available as: Injection 1 mg/mL.
Dose: 0.05 to 0.15 mg/kg/week until remission or toxicity occurs.
1.5 to 2 mg/m2/week.
ADRs: Muscle weakness, particularly of dorsiflexors of feet, hand
and larynx, loss of reflexes and paresthesia, constipation, intestinal
obstruction, alopecia, bone marrow depression, hypertension/
hypotension, bronchospasm.
Drug interaction: Phenytoin, live vaccines.
Caution: If the WBC count falls below 4000/cmm, omit the
subsequent dose.
Chapter 22: Anticancer Drugs 121

Daunorubicin
Brand Name: Daunobin
Indications: Acute myeloblastic leukemia, alone or in association
with other cytotoxic drugs; acute lympho blastic leukemia
chiefly in those subjects refractory to other antileukemic agents;
AIDS-related Kaposis sarcoma.
Available as: Vial containing 20 mg lympholized daunorubicin.
Dose: A single injection in a dose of 0.5 to 3 mg/kg (IV). This dose is
to be dissolved in 10 to 20 mL of normal saline and then injected
into the tubing of a fast-running intravenous drip infusion of
normal saline solution.
Repeat injections are given at 1 to 2 week intervals.
ADRs: Flushing, fever, chills, rash, alopecia, skin pigmentation,
gastrointestinal upset, abdominal pain, chest tightness, backache,
hyperuricemia, immunosuppression, myelosuppression.
Drug interaction: Myelosuppressants (e.g. cyclophosphamide,
methotrexate, doxorubicin); live viral vaccines; heparin;
dexamethasone.
Contraindications: Marked myelosuppression (as a result of earlier
radiotherapy or cytotoxic therapy; cardiac impairment.
Caution: Hematologic, cardiac and renal monitoring of the subject
on this drug is a must.

Nitrogen Mustard
Brand Name: Mustragen
Indications: Malignancy.
Available as: Injection 10 mg.
Dose: 0.4 mg/kg (IV) as single dose or in 2 divided doses at interval
of 1 to 2 days or 1 to 2 weeks.
ADRs: Bone marrow depression.

Cyclophosphamide
Brand Names: Endoxan-N, Cycloxan
Indications: Malignancy, nephrotic syndrome not responsive to
steroids.
122 Section 2: General Medications

Available as:
Tablet 50 mg
Injection 100, 200, 500 mg.
Dose: 2 to 3 mg/kg/day (O, IV) or a total of 7 days dose (IV) once
in a week. For resistant neoplasm, use 4 to 8 mg/kg/day. For
maintenance, 2 to 5 mg/kg (O) twice weekly.
ADRs: Bone marrow depression, alopecia, GIT upset, fluid retention,
cardiac toxicity, menstrual irregularity, hepatic damage, cystitis,
colitis, pigmentation, thrombocytopenia.
Drug interaction: Barbiturates, digoxin, oral coagulants, myelo
suppressive therapy, chloramphenicol, allopurinol, radiotherapy.
Contraindications: Leukopenia, thromocytopenia, bladder
hemorrhage.
Caution: Renal and hepatic failure.

Doxorubicin
Brand Name: Adriamycin
Indication: Leukemia.
Available as: Injection 10 mg/vial.
Dose: 1.2 to 2.4 mg/kg/dose (IV) every 3 weeks.
ADRs: Cardiotoxicity, alopecia, bone marrow depression.
Caution: Avoid in hepatic or cardiac dysfunction.

L-Asparaginase
Brand Name: Leunase
Indications: Acute leukemia, malignant lymphoma.
Available as: Injection 10, 000 units/vial.
Dose: 50 to 200 units/kg/day by IV infusion.
ADRs: Hepatic dysfunction, pancreatitis, hyperglycemia, CNS
depres sion (somnolence, confusion, disorientation), renal
insufficiency, defect in clotting mechanism, thrombocytopenia,
hypersensitivity, fever, chills, respiratory distress, arthralgia.
Drug interaction: Antitumor agents, vincristine, prednisolone,
methotrexate, thyroid function tests.
Contraindication: Pancreatitis.
Caution: Hypersensitivity.
Chapter 22: Anticancer Drugs 123

Allopurinol
Brand Names: Zyloric, Ciploric
As an adjuvant to chemotherapy of malignant conditions.
Indication: To combat hyperuricemia and urate deposition in
subjects on antimalignant therapy.
Available as: Tablet 100 mg.
Dose: 10 to 20 mg/kg/day in divided doses.
ADRs: Hypersensitivity reactions (including Steven-Johnson
syndrome), toxic epidermal necrosis, acute gout, fever, malaise,
muscle aches, drowsiness leukopenia, leukocytosis, eosinophilia,
bone marrow depression, hepatomegaly, peripheral neuritis and
cataract, bone marrow depression. Such undesirable reactions as
nausea, vomiting, diarrhea, headache, vertigo and gastric irritation
occur occasionally but do not warrant discontinuation of therapy.
Drug interaction: Anticoagulants, azathioprine, chlorpropamide,
mercaptopurine, vidarabine, ampicillin, amoxicillin, salicylates,
cyclophosphamide, iron salts, cyclosporine, thiazide diuretics,
high doses salicylates, theophylline.
Contraindication: Acute gout.
Precaution: Hypertension, cardiac insufficiency, renal or hepatic
dysfunction. Ensure adequate fluid intake. At the time of starting
treatment, give colchicines for one month.
Chapter

23
Antitoxins

Antisnake Venom
Four antivenom sera derived from common krait, cobra, Russel viper
and saw-scaled viper make up the currently available AVS.
Available as: 10 mL vials. This is for IV infusion administration, in
250 mL of 1/5th saline at a rate of 20 mL/kg/hr.
Dose: It is calculated on the basis of severity of manifestations
rather than age, body weight or surface area. Children need to be
given 50 percent (1.5 times) higher dose in order to neutralize the
injected venom which is relatively large enough in terms of the
body weight and size.
Mild envenomation: 50 mL (5 vials)
Moderate envenomation: 50 to 150 mL (515 vials)
Severe envenomation: 150 to 200 mL (1520 vials)
Dose is, however, variable from center to center.
Precaution: Before administering AVs, it is a safe to test for the
horse serum allergy by injecting 0.02 mL of 1:10 diluted AVS and,
in case of presence of hypersensitivity, desensitize the child.
ADRs: Hypersensitivity.

Tetanus Antitoxin (TAT)


Brand Names: Anti-TET, Tetanus antitoxin
Indications: Prophylaxis and treatment of tetanus.
Available as: 750, 1000,1500, 5000, 10000 IU.
Dose: Prophylaxis: 3000 to 5000 IU (SC, IM).
Therapeutic: 10000 IU (IM, IV); 250 IU/day for 3 days (IT).
ADRs: Hypersensitivity, serum sickness.
Chapter 23: Antitoxins 125

Precautions: Important to do test for hypersensitivity before


administering it. In some instances, desensitization may be
needed.

Diphtheria Antitoxin
This is the mainstay of treatment of diphtheria. It neutralizes only free
toxin and, therefore, should be administered as early as possible. Its
efficacy decreseas once the mucocutaneous symptoms of diphtheria
appear.
Indications: Treatment of diphtheria; Schick test-positive contacts.
Available as: Ampoules (10 mL) providing 10,000, 20,000 IU. It is
diluted in 1:20 isotonic NaCl solution. Administration should be
slow (up to 1 mL/min).
Dose: Pharygeal/laryngeal diphtheria of < 48 hours duration20,000
to 40,000 units (IV) as a single administration.
Nasopharyngeal diphtheria40,000 to 60,000 units (IV) as a
single administration
Extensive diphtheria with diffuse neck swelling80,000 to
120,000 units (IV) as a single administration
Schick test-positive contacts500 to 2000 units IM. Simul
taneously, a dose of diphtheria toxoid is given IM in the other
arm. After a gap of 6 weeks, 3 doses of diphtheria toxoid (each
at 4 weeks interval) for active immunization.
ADRs: Hypersensitivity reactions.
Precaution: Dose is based not on childs age but on duration and
extent of illness. Test for hypersensitivity before administering the
antitoxin a must.
Special remarks:
1. In mild cases, IM rather than IV administration suffices.
2. In order to achieve eradication of infection, it is necessary
to also give erythromycin, benzyl penicillin (penicillin G) or
procaine penicillin.
Chapter

24
Miscellaneous

Albumin
Brand Names: Albunal, Albudac, Human
Indications: Hypoproteinemia (severe) such as in nephrotic
syndrome, severe PEM, protein-losing enteropathy, pro longed
dysentery, cirrhosis, hookworm anemia, burns; cerebral edema;
preceding exchange transfusion in pathological neonatal
hyperbilirubinemia.
Available as: 5 percent, 25 percent, 25 percent solution.
Dose: 5 percent, solution, isotonsic to total plasma, is given as
continuous intravenous infusion at rate of 5 to 6 mL/minute in
all cases needing fast rise of blood volume; 25 percent solution
is given by continuous intravenous infusion at the rate of 2 mL/
minute as follows:
10 to 15 mL (IV), 2 to 3 times weekly in premature infants with
hypoalbuminemia
50 mL (IV), 2 to 3 times, 5 to 6 hourly, followed by 100 to 200 mL
in shock, collapses and burns
50 mL daily in hypoalbuminemic edema. 100 to 150 mL every
alternate day in nephrotic syndrome.
ADRs: Hypersensitivity reactions.
Contraindications: CCF, severe anemia.

Allopurinol
Brand Names: Zyloric, Ciploric
Indications: Gout, Duchennes myopathy, Lesch-Nyhan syndrome.
Also to combat hyperuricemia and urate deposition in subjects on
antimalignant therapy.
Chapter 24: Miscellaneous 127

Available as: Tablet 100 mg.


Dose: 10 to 20 mg/kg/day in divided doses.
ADRs: Hypersensitivity reactions, acute gout, dermatosis, fever,
malaise, muscle aches, leukopenia, leukocytosis, eosinophilia,
bone marrow depression, hepatomegaly, peripheral neuritis
and cataract. Such undesirable reactions as nausea, vomiting,
diarrhea, headache, vertigo and gastric irritation occur
occasionally but do not warrant discontinuation of therapy (Also
see chapter 22).

Dimethylpolysiloxane
Brand Name: Dimol
Indications: Flatulence, colic, before infant feeding for facilitating
burping; before X-ray of abdomen. to dispel gas
Available as:
Tablet 40 mg
Drops 40 mg/mL.
Dose: to tablet or liquid added to infants formula or adminis
tered directly for burping
< 6 months: 5 to 10 drops 15 min before feed
> 6 months: 10 to 20 drops 15 min before feed.

Lignocaine
Brand Name: Xylocaine
Indications: For local anesthesia
Available as: Injection 1%, 2%.
Also as topical jelly, ointment and viscous.
Dose: 1 to 3 mg/kg (IV).
ADRs: Hypotension, myocardial depression, paresthesia, drowsiness,
agitation, convulsions.

Mannitol
Indications: Cerebral edema, oliguria, water intoxication,
hyponatremia.
128 Section 2: General Medications

Available as: 200 mg/mL (350 and 500 mL bottles, providing 70


and 100 g mannitol).
Dose: 7 to 10 mL/kg/day by drip.
ADRs: Hypersensitivity, thrombosis or pain from extravasation,
hyperglycemia, glycosuria, headache, nausea and vomiting,
circulatory overload, hyponatremia, convulsions.

Nalorphine
Brand Name: Nubain
A unique opiate agonist.
Indication: Moderate-to-severe pain.
Available as: 10 mg/mL.
Dose: 0.1 to 0.2 mg/kg (IM, IV) q 3 to 4 hr with a maximum of 20 mg
for a single dose. Daily dose must not exceed 160 mg.
ADRs: CNS and respiratory depression; dependence potential.
Caution: Avoid in liver disease and respiratory depression.

Oral Rehydration Salts (ORS)


Brand Names: Electrobion, Punarjal, Walyte
Indications: Prophylaxis of diarrheal dehydration and treatment
of mild-moderate dehydration; continuation therapy following
rehydration with IV fluids in severe dehydration
Available as: Sachets 6 g (for 200 mL water), 30 g (for 1 liter water).
Box 24.1 gives composition of different types of ORS dose.
Administration/Dose:
ADRs: Hypernatremic edema in neonates and infants with the
standard ORS.
Caution: In case of vomiting, do not push ORS. Giving it in sips is
not only safe but also helpful in tiding over the difficult period.
Chapter 24: Miscellaneous 129

Box 24.1: Composition of standard ORS and low osmolarity ORS


Component Standard ORS Low osmolarity ORS
Contents
Sodium chloride 3.5 g 2.6 g
Sodium bicarbonate (citrate) 2.5 g (2.9 g) 2.9 g
Potassium chloride 1.5 g 1.5 g
Glucose 20.0 g 13.5 g
Osmolarity
Sodium 90 mmol 75 mmol
Chloride 80 mmol 65 mmol
Citrate 10 mmol 10 mmol
Potassium 80 mmol 20 mmol
Glucose 111 mmol 75 mmol
Total osmolarity 311 245
Adapted from Gupte S, Anderson RA. In: Gupte S (Ed). The Short Textbook of Pediatrics,
11th edn. New Delhi: Jaypee Brothers Medical Publishers. 2009; pp. 441-80.

Probenecid
Brand Names: Procid, Benecid
Indications:
For cutting down excretion of penicillin in urine in order to
build up very high blood levels
For competitive inhibition of tubular secretion and reabsorp
tion of organic acids, e.g. in gout, hyperuricemia.
Available as: Tablet 500 mg.
Dose:
25 mg/kg as loading dose. Follow with 10 mg/kg 6 to 8 hourly
for first indication
250 mg twice daily for one week followed by 500 mg twice
daily in gout and hyperuricemia.
130 Section 2: General Medications

ADRs: Frequency of micturition, headache, blood dyscrasia, GIT


upset, flushing, hepatic necrosis, hemolysis, nephrosis.
Contraindications: Blood dyscrasias, renal uric acid stones.
Caution: History of peptic ulcer disease, renal impairment.
Drug interaction: Salicylates, pyrazinamide, sulfonylurea, sulfo
namides, B-lactum antibiotics, indomethacin, methotrexate.

Surfactant
A surface tension-reducing agent.
Brand Names: Bovine: Survanta, Synthetic: Exosurf
Indications:
 Rescue therapy in respiratory distress syndrome (RDS) of
moderate-to-severe intensity
Prophylaxis of RDS: When gestational age < 29 weeks
Severe meconium aspiration syndrome (MAS)
Acute/adult respiratory distress syndrome (ARDS).
Available as:
Survanta 4 mL, 8 mL vials
Curosurf 1.5 mL, 3 mL vials
Infasurf 3 mL, 6 mL vials
Exosurf 10 mL vial.
Dose: 100 to 200 mg/kg/dose of phospholipids I intratracheal
Bovine: 4 mL/kg/dose intratracheal (IT). A dose needs to be divided
into 4 parts, each 1 mL/kg and administered in each of the 4
positions. Repeat every 6 hourly if required to a maximum of 4
doses.
Artificial: 5 mL/kg/dose (IT). A dose needs to be divided into
2 parts, each administered in 2 positions. Repeat after 12 hours.
Box 24.2 lists the dose of various brands of surfactant.

Box 24.2: Dose of available surfactant brands


Survanta2.5 mL/kg/dose in 4 aliquots
Curosurf2.5 mL/kg/dose (initially), 1.25 mL/kg (subsequent doses)
Infasurf3 mL/kg/dose
Exosurf5 mL/kg/dose
Chapter 24: Miscellaneous 131

ADRs: Reflux of the administered dose, airway obstruction, apnea,


pulmonary hemorrhage (usually in preterm neonates with PDA),
bradycardia, hypotension/hypertension, hypoxemia.
Monitoring:
During administration: Heart rate, oxygen saturation, ECG,
blood pressure.
Post-therapy: Arterial blood gases (ABG) for hyperoxia and
hypocarbia.

Ursodeoxycholic Acid/Ursodiol
Brand Names: Urso, Ursocal, Udihep
Indications: Neonatal cholestasis (especially TPN-induced), scleros
ing cholangitis, cystic fibrosis with liver disease, gallstone (for
dissolution).
Available as: Tabs/caps 150, 250, 300 mg.
Dose:
Neonates 10 to 18 mg/kg/day in 1 to 3 divided doses.
Infants 30 mg/kg/day divided q 8 to 12 hr
Adolescents 300 mg at bedtime for 5 to 12 months.
ADRs: Diarrhea, dyspepsia, biliary pain, rhinitis, pruritus, headache.
Contraindications: Advanced liver disease/sever liver dysfunction,
complete biliary tract obstruction.

Triple Dye
Indication: As an antiseptic for topical application.
Available as: Acriflavin 1.14 g, gentian violet 2.29 g, brilliant green
2.29 g, spirit/distilled water 1000 mL.
Dose: May be employed to the umbilical stump only in the
beginning.
Caution: The old practice of frequent application to umbilical
stump subsequently is no longer recommended.
Section 3
Drugs for Infections and
Infestations
Chapter

25
Antibacterial Drugs

Aminoglycosides

Amikacin
Brand Names: Amicin (Biochem), Mikicin (Aristo)
First semisynthetic aminoglycoside; derivative of kanamycin A;
effective against gram-positive as well as gram-negative organisms
just like tobramycin.
Indications: Fulminant gram-negative infections (septi cemia,
pneumonia, meningitis, peritonitis, infected burns, postoperative
sepsis), and gram-positive infections resistant to other amino
glycosides, e.g. nosocomial infections as in burns, in ICU, and in
immunocompromised subjects.
Available as: Injections 100, 250, 500 mg/vial.
Dose: 15 to 25 mg/kg/day divided q 8 to 12 h.
ADRs: Nephrotoxicity, ototoxicity (mainly cochlear), neuromuscular
blockade, hypersensitivity reactions like drug fever, rash,
eosinophilia, tremors, nausea, vomiting, headache, overgrowth of
nonsusceptible microorganisms.
Contraindications: Known hypersensitivity to aminoglycosides.
Precaution: Suitable reduction in dose must be made in renal
insufficiency depending on creatinine clearance and blood urea
nitrogen (BUN).

Gentamicin
Brand Names: Garamycin (Fulford), Genticyn (Nicholas-Piramal)
An aminoglycoside, binds to 30S subunit of bacterial ribosome;
induces translation misreading, freezing of initiation complex.
Chapter 25: Antibacterial Drugs 133

Indications: Life-threatening fulminant gram-negative infections,


e.g. septicemia, meningitis, UTI.
Available as: Injection 40, 80 mg/mL.
Dose:
3 to 5 mg/kg/day (IV, IM) in first week of life and up to 7.5
mg/kg/day later in 2 to 3 divided doses in life-threatening
situations.
0.8 to 1.2 mg/kg/day (IV, IM) in 2 to 3 divided doses for urinary
tract infections.
ADRs: Nephrotoxic, hepatotoxic, ototoxic, fever, rash, convulsions,
joint pains, hypotension, purpura, anemia, granulocytopenia.
Drug interactions: Frusemide, ethacrynic acid, vitamin K, nephro-
and ototoxic drugs, cephalosporins, penicillins, anesthetics,
neuromuscular blocking agents.
Contraindications: Myasthenia gravis, previous toxic reaction in the
form of nephro- or ototoxicity.
Precaution: Reduce frequency in renal impairment.

Kanamycin
Brand Name: Kancin (Alembic)
Indications: Neonatal septicemia, urogenital, respiratory, CNS, soft
tissue and GIT infections due to Staphylococcus; a reserve drug for
resistant tuberculosis.
Available as: Injections 0.5 and 1.0 g vials.
Dose: 15 mg/kg/day (IM, IV) in 2 to 3 divided doses. IV administration
should be slow-over 30 minutes to 1 hour.
Tuberculosis (MDR): 15 to 30 mg/kg (IM).
ADRs: Nephrotoxic, ototoxic, rash, fever, headache, paresthesia.
Drug interaction: Frusemide, ethacrynic acid, neuromuscular
blocking agents, anesthetics.
Contraindications: Pregnancy, lactation.
Precaution: Myasthenia gravis, parkinsonism; monitor serum
creatine in renal impairment, as also auditory and vestibular
functions.
Remarks: With the availability of more potent and relatively
safe aminoglycosides, use of kanamycin is considerably dimin
ished.
134 Section 3: Drugs for Infections and Infestations

Neomycin
Brand Names: Mycifradin, Neo-Fradin, Neo-Tab (available outside India
only), Neosporin (GSK), Nebasulf (Omni-Protech)
Indications: Infrequently, in selected cases of enteritis; hepatic
coma and abdominal surgery (for sterilization of the gut); skin and
ophthalmic infections.
Available as: Topical-skin and ophthalmic powder/cream/ointment
in varied combinations with bacitracin, sulfacetamide, polymyxin
B, etc. Capsules/Tablets 350, 500 mg.
Drug interaction: Decreases absorption of digoxin.
Dose:
Infants 50 mg/kg/day (O) in 3 divided doses
Children 50 to 100 mg/kg/day (O) in 3 to 4 divided doses.
ADRs: Nephrotoxicity, ototoxicity, malabsorption, hepatic dys
function, muscle weakness, wheeze, rash, superinfection with
Candida secondary to suppression of normal gut flora.
Contraindications: Impaired renal function.
Precaution: Avoid for routine use as an antidiarrheal antibiotic and
even in hepatic encephalopathy.
Special remarks: Neomycin-containing antidiarrheal formulations
for children stand banned in India. Systemic use of neomycin is
nearly a story of the past. The agent is almost limited to topical use
in combination with other agents.

Netilmicin
Brand Name: Netromycin (Fulford)
Indications: Infections caused by gram-negative bacilli (E. coli,
Pseudomonas, Klebsiella); employed usually in combination with
one of the pencillins or cephalosporins but not through the same
syringe or infusion.
Available as:
Ampoules: 10, 25, 50, 100 mg/mL
Vials: 50, 200, 300 mg/vial, respectively.
Dose: 5 to 7.5 mg/kg/day (IM, IV) q 8 hr. In infants, up to 10 mg/kg/
day may be given.
Chapter 25: Antibacterial Drugs 135

ADRs: Nephrotoxicity (renal tubular dysfunction with loss of


sodium, calcium and magnesium), ototoxicity, neuromuscular
blockade with pancuronium.
Drug interactions: Frusemide, ethacrynic acid, cephalosporins,
citrated blood, neuromuscular blocking drugs, anesthetics.
Contraindications: Renal insufficiency, pregnancy, lactation.
Precaution: Myasthenia gravis, Parkinsonism, dehydration, infant
botulism, hypocalcemia; requires monitoring.

Sisomycin Sulfate
Brand Name: Sisoptin (Themis)
Indications: Serious pyogenic infections, including gram-negative
septicemia.
Available as: Injection 10 mg/mL in 1 mL ampoule and 50 mg/mL
in 1 mL ampoule.
Dose:
Under 2 weeks: 5 mg/kg/day in 2 divided doses
2 to 4 weeks: 6 mg/kg/day in 3 divided doses
4 weeks to 1 year: 4.5 to 6 mg/kg/day in 3 divided doses
Above 1 year: 3 to 4.5 mg/kg/day in 3 divided doses.
ADRs: Nephrotoxicity, neurotoxicity in the form of dizziness,
vertigo, tinnitus, noises in the ear, deafness and muscle weakness.
Drug interaction: Ototoxic, neurotoxic and nephrotoxic agents,
other aminoglycosides, cephalosporins, vancomycin, cisplatin,
amphotericin B, methoxyflurane, diuretics, anesthetics.
Contraindication: Hypersensitivity/toxic reaction to any of the
aminoglycosides.
Precaution: Monitor renal and eighth cranial nerve function during
therapy.
Use particular caution in subjects with neuromuscular disorders like
myasthenia gravis.

Streptomycin Sulfate
Brand Name: Ambistryn-S (Sarabhai Piramal)
Indications: Tuberculosis; occasionally, pathogens susceptible to
this drug only.
136 Section 3: Drugs for Infections and Infestations

Available as:
Injection 1 g vial
Syrup 0.28 g/5 mL
Tablet 0.2 g.
Dose:
20 to 50 mg/kg/day (IM)
1 to 2 mg/kg/day (IT)
100 mg/kg/day (O) in divided doses.
ADRs: Deafness, renal damage, allergic reactions, eosinophilia,
fever, rash, CNS depression, blood dyscrasia.
Drug interaction: Frusemide, ethacrynic acid, mannitol, other
aminoglycosides, polymyxin B, colistin sulfate, cyclosporine,
neuromuscular blocking drugs, anesthetics.
Contraindications: Disease of ear, especially suppurative otitis
media (SOM), labyrinthitis.
Precautions: Impaired liver or kidney function, prematurity,
impaired vestibular and auditory functions, pregnancy, lactation,
myasthenia gravis.

Tobramycin Sulfate
Brand Name: Tobraneg (Elder)
An aminoglycoside closely related to gentamicin, including
antimicrobial spectrum, except that it is 2 to 3 times more active in
vitro against Pseudomonas aeruginosa.
Available as: Injections 20, 60, 80 mg vials. Ophthalmic solution/
ointment.
Indications: Fulminant gram-positive and gram-negative infections
under aerobic conditions, including Pseudomonas aeruginosa in
which this is the aminoglycoside of choice.
Dose:
Neonates under 7 days: 4 mg/kg/day in 2 doses.
Neonates above 7 days: 6 mg/kg/day in 3 doses.
ADRs: Anemia, granulocytopenia, thrombocytopenia, fever, rash,
urticaria, gastrointestinal upset, headache, lethargy liver dys
function.
Drug interactions: Likely to potentiate other nephrotoxic and
ototoxic drugs.
Chapter 25: Antibacterial Drugs 137

Contraindications: Known allergy to aminoglycosides, pregnancy


and lactation.
Precaution: Avoid its administration in conjunction with heparin,
penicillin and cephalosporins; control blood levels and dosage in
renal impairment.

-Lactams
-lactams Group 1: Penicillins
Penicillins is a group of antibiotics derived from Penicillium fungi.
Penicillin antibiotics are historically significant because they were
the first effective medicines against many previously serious diseases
such as syphilis and Staphylococcus infections.

Penicillinase-sensitive penicillins

Procaine Penicillin
Indications: Moderately severe infections with gram-positive
organisms.
Available as: Injection 4 lakh units/vial.
Dose:
Under 4 years 2 lakh (IM) daily or twice a day.
Over 4 years 4 lakh (IM) daily or twice a day.
ADRs: -lactam safety profile (rash, eosinophilia), allergy,
hypersensitive reactions in the form of rash, fever, bronchospasm,
vasculitis, serum sickness, Stevens-Johnson syndrome and
anaphylaxis. The clinical picture of anaphylaxis consists of sudden
hypotension, bronchospasm with asthma, skin eruptions, diarrhea,
nausea and vomiting

Benzyl (Crystalline) Penicillin


Indications: Severe infection with gram-positive organisms.
Dose: 50 thousands to 4 lakh units/kg/day (IM, IV) in 4 divided
doses. Higher limit is for severe infections like pyogenic meningitis
or septicemia. For bacterial endocarditis, as much as 100,00,000
units/day.
ADRs: -lactam safety profile (rash, eosinophilia), allergy.
Hypersensitive reactions in the form of rash, fever, bronchospasm,
138 Section 3: Drugs for Infections and Infestations

vasculitis, serum sickness, Stevens-Johnson syndrome and


anaphylaxis. The clinical picture of anaphylaxis consists of sudden
hypotension, bronchospasm with asthma, skin eruptions, diarrhea,
nausea and vomiting. Excessive dose may cause seizures.

Benzathine Penicillin
Brand Name: Penidure 12 and 24 (Wyeth)
Indications: Rheumatic fever prophylaxis, syphilis, streptococcal
infections, pyoderma, post-traumatic tetanus.
Available as: Vials 12 lakh (1.2 mega) units.
Dose:
> 27 kg weight 1.2 mega units every 3 weeks.
< 27 kg weight 6 lakh units every 3 weeks.
ADRs: -lactam safety profile (rash, eosinophilia), allergy.
Hypersensitive reactions in the form of rash, fever, bronchospasm,
vasculitis, serum sickness, Stevens-Johnson syndrome and
anaphylaxis. The clinical picture of anaphylaxis consists of sudden
hypotension, bronchospasm with asthma, skin eruptions, diarrhea,
nausea and vomiting.
Remarks: Penidure LA-6, which was available earlier, stands
withdrawn now. Only Penidure LA-12 is available currently.

Oral Penicillin
Brand Name: Pentids (Sarabhai Piramal)
This is an acid-resistant penicillin administred orally.
Indications: Mild to moderate gram-positive infections; also some
gram-negative (N. gonorrhoeae, N. meningitidis) infections.
Available as: Tablets 2, 4, 8 lakh units.
Dose: 50 thousand units/kg/day in divided doses.
ADRs: -lactam safety profile (rash, eosinophilia), allergy.
Hypersensitive reactions in the form of rash, fever, bronchospasm,
vasculitis, serum sickness, Stevens-Johnson syndrome and
anaphylaxis. The clinical picture of anaphylaxis consists of sudden
hypotension, bronchospasm with asthma, skin eruptions, diarrhea,
nausea and vomiting. Seizures with overdose.
Chapter 25: Antibacterial Drugs 139

Pencillinase-resistant (Semisynthetic) Penicillins


The noteworthy feature of these semisynthetic penicillins is the
side chains that protect the -lactam ring from the onslaught of
enzyme, pencillinase. These are the drug of choice for pencillinase-
producing Staphylococcus aureus, provided that the pathogens are
not methicillin-resistant. The most important member of this class is
cloxacillin. Others, say oxacillin, nafcillin, dicloxacillin, flucloxacillin,
etc. are not marketed in India.

Cloxacillin
Brand Name: Bioclox (Biochem)
Indications: Staphylococcal infections.
Available as:
Capsules 250, 500 mg.
Suspension 125 mg/measure.
Injections 250, 500 mg/vial.
Dose: 50 to 200 mg/kg/day (O, IV) in 4 divided doses. The higher
limit is in case of staphylococcal meningitis.
ADRs: GIT upset, rash, rise in SGOT, superadded infections with
gram-negative bacteria and fungi.
Contraindications: Hypersensitivity to penicillins, asthma, Hay
fever, urticaria.
Precaution: Oral administration 1 hour before or 2 hour after food.

Extended-spectrum (Modified or Amino) Penicillins

Amoxicillin
Brand Names: Novamox (Cipla), Flemoxin (East India), Wymox (Wyeth)
Indications: Respiratory, genitourinary, gastrointestinal, soft tissue,
ENT, etc. infections caused by pneumococci, streptococci, H. influ
enzae, E. coli, gonorrhea.
Available as:
Capsules 250, 500 mg
Tablets 125, 250 mg
Syrup 125, 250 mg/teaspoonful
Drops 100 mg/mL.
140 Section 3: Drugs for Infections and Infestations

Dose: 20 to 50 mg/kg/day, divided q 8-12 h.


ADRs: Diarrhea, vomiting, maculopapular rash, urticaria, rise in
SGOT.
Drug interaction: Probenecid.

Amoxicillin-clavulanate
Brand Names: Augmentin (GSK), Acuclav (Macleods)
Indications: Beta-lactam (amoxicillin) beta-lactamase inhibitor
(clavulanate or clavulanic acid as potassium salt) for boosting
amoxicillin activity against penicillinase producing bacteria such
as S. aureus, Streptococcus pneumoniae, H. influenzae, M. catarrhalis,
E. coli, Klebsiella, B. fragilis.
Available as:
Tablets 375 mg (amoxicillin 250 mg, clavulanate 125 mg);
625 mg (amoxicillin 500 mg, clavulanate 125 mg); 1000 mg
(amoxicillin 875 mg, clavulanate 125 mg).
Syrup amoxicillin 200 mg, clavulanate 28.5 mg/5 mL.
Injection (IV) 300 mg (amoxicillin 250 mg, clavulanate 50
mg); 600 mg (amoxicillin 500 mg, clavulanate 100 mg); 1.2 g
(amoxicillin 1000 mg, clavulanate 200 mg).
Dose:
20 to 45 mg/kg/day (O) divided q 812 h.
In AOM, give higher dose 8090 mg/kg/day.
30 mg/kg (IV) every 8 hours; may give 6 hours in more serious
infections. (Calculations are based on amoxicillin).
ADRs: Diarrhea, vomiting, maculopapular rash, urticaria, rise in SGOT.
Drug interaction: Probenecid.
Contraindication: Hypersensitivity.
Precaution: Reduce dose and frequency in renal impairment.

Ampicillin
Brand Names: Roscillin (Ranbaxy), Campicillin (Cadila Pharma),
Synthocilin (PCI)
Indications: Respiratory, genitourinary, gastrointestinal, soft tissue,
ENT, etc. infections due to gram-negative as well as gram-positive
organisms.
Chapter 25: Antibacterial Drugs 141

Available as:
Tablets 125, 250 mg
Capsules 250 mg, 500 mg
Syrup 125, 250 mg/teaspoonful
Injection (IM, IV, IT) 250, 500 mg.
Dose: 50 to 400 mg/kg/day in 4 divided doses, the upper limit
being the recommendation for very severe infections such as
pyogenic meningitis and septicemia.
ADRs: Hypersensitivity reactions, rash, GIT upset, convulsions,
eosinophilia, superadded infection with Pseudomonas and
Candida due to change in the normal flora of the GIT, mild hepatic
dysfunction, agranulocytosis.
Contraindication: Hypersensitivity.
Drug interactions: Probenecid, anticoagulants, allopurinol, urine
glucose determinations.
Precaution: Monitor blood, liver and kidney function when
therapy exceeds 10 days. Avoid in infectious mononucleosis, renal
impairment and lymphatic leukemia.

Ampicillin-sulbactam
Brand Name: Sulbacin (Unichem)
Combination of a beta-lactam, ampicillin, and a beta-lactamase
inhibitor, sulbactam.
Indications: Beta-lactam (ampicillin) + beta-lactamase inhibitor
(sulbactam) for boosting ampicillin activity against penicillinase-
producing bacteria such as S. aureus, Streptococcus pneumoniae,
H. influenzae, M. catarrhalis, E. coli, Klebsiella, B. fragilis.
Available as: InjectionAmpicillin 1g, sulbactam 500 mg / vial.
Dose: 100 to 200 mg/kg/day (IM, IV) divided q 4 to 8 hr. Calculations
are based on ampicillin component.
ADRs: Diarrhea, especially pseudomembranous colitis, C. difficile-
associated diarrhea (CDAD), skin, rash, hypersensitivity.
Contraindication: Hypersensitivity.
Drug interaction: Probenecid.
142 Section 3: Drugs for Infections and Infestations

Extended- spectrum Penicillins

Piperacillin
Brand Name: Zosyn (Wyeth)
Indications: Many gram-positive and gram-negative infections,
including infections caused by E. coli, Enterobacter, Serratia,
Pseudomonas, Bacteroides.
Available as: Injection (IV, IM) 1, 2, 4 g. Also, in combination with
beta-lactamase inhibitor, tazobactam.
Dose: Generally, 50 to 300 mg/kg/day (IV, IM) in 3 to 4 divided
doses (upper limit for serious infections).
Neonate: < 7 days 150 mg/kg/day (IV) q 8 to 12 hr, 7 days 200
mg/kg/day q 68 hr
Infants and children: 200 to 300 mg q 4 to 6 hr
Cystic fibrosis: 350 to 500 mg/kg/day (IV).
ADRs: -lactam safety profile (rash, eosinophilia, transient rise in
liver enzymes).
Drug interaction: Probenecid.
Precaution: Renal excretion; inactivated by penicillinase.

Ticarcillin
Brand Name: Ticar (Wolters Kluwer)
Indications: Severe infections caused by E. coli, Enterobacter,
Serratia, Pseudomonas, Bacteroides.
Available as: Injection 3.1 g.
Dose:
Neonates:
i. < 7 days/>2000 g 150 mg/kg/day (IV) q 8 to 12 hr (23
divided doses)
ii. 7 day/> 20000 g 225 mg/kg/day (IV) q 8 hr
iii. 7 days/< 1200 g 150 mg/kg/day (IV)
iv. 7 days 1200 to 2000 g 225 mg/kg/day (IV) q 8 hr.
Infants and children: 200 to 400 mg/kg/day (IV) q 4 to 6 hr
Cystic fibrosis: 400 to 600 mg/kg/day (IV).
ADRs: -lactam safety profile (rash, eosinophilia).
Chapter 25: Antibacterial Drugs 143

Drug interaction: Probenecid.


Precaution: Renal excretion; inactivated by penicillinase. Monitor
LFT.

Ticarcillin with Clavulanic Acid


Brand Name: Timentin (GSK)
Indications: Severe infections caused by E. coli, Enterobacter,
Serratia, Pseudomonas, Bacteroides, Acinetobacter, and H. influenzae,
especially in subjects with impaired/suppressed host defenses.
Available as: Injection 3.1 g (ticarcillin 3 g, clavulanic acid 100 mg).
Dose: To be calculated with respect to ticarcillin.
Neonates:
i. < 7 days/>2000 g 150 mg/kg/day (IV) q 8 to 12 hr (23
divided doses)
ii. 7 day/> 20000 g 225 mg/kg/day (IV) q 8 hr
iii. 7 days/< 1200 g 150 mg/kg/day (IV)
iv. 7 days 1200 to 2000 g 225 mg/kg/day (IV) q 8 hr
Infants and children: 200 to 400 mg/kg/day (IV) q 4 to 6 hr
Cystic fibrosis: 400 to 600 mg/kg/day (IV).
ADRs: Hypersensitivity reactions, GI disturbances, pseudo
membranous colitis, S. difficile-associated diarrhea (CDAD),
bleeding diathesis, hypokalemia, hypernatremia, CNS, hepatic and
renal disturbances, superinfections.
Contraindications: Hypersensitivity, moderate or severe renal
dysfunction, pregnancy, lactation.
Drug interaction: Probenecid, methotrexate, oral contraceptives,
may cause false positive Coombs test.
Precaution: Renal excretion; inactivated by penicillinase. Monitor
LFT.

Antipseudomonas (Carboxy and Ureido) Penicillins

Carbenicillin
Brand Name: Carbelin
Indications: Pseudomonas and indole-positive Proteus infections.
Available as: Injection 1 g vial.
144 Section 3: Drugs for Infections and Infestations

Dose:
Neonates:
i. < 7 days and 2000 g 225 mg/kg/day (IM, IV) in 3 divided
doses.
ii. > 2000 g 300 mg/kg/day (IM, IV) in 4 divided doses.
iii. > 7 days 300 to 400 mg/kg/day (IM, IV) in 4 divided doses.
Children: 400 to 600 mg/kg/day (IM, IV) in 4 to 6 divided doses,
the higher range being for Pseudomonas infections.
ADRs: These are generally on the same lines as in case of injectable
penicillin. Others include local pain, local phlebitis, abnormalities
of coagulation leading to bleeding, hypokalemia.
Contraindication: Known penicillin allergy.
Precaution: The vials should be stored in a cool dry place below 5C
temperature. Do not mix in the same syringe with gentamicin to
prevent inactivation of the latter.

Piperacillin
Brand Name: Zosyn (Wyeth)
It is far more (around 8 times) active than carbenicillin in its pseu-
domonal potency.
Details are available under Extended Spectrum Penicillins.

Ticarcillin
Brand Name: Ticar (Wolters Kluwer)
Its pseudomonal activity is greater than carbenicillin.
Details are available under Extended Spectrum Penicillins.

-Lactams Group 2: Cephalosporins


Cephalosporins are divided into 5 generations. Higher the generation,
greater the activity against gram-negative pathogens with simul
taneous fall in activity against gram-positive pathogens (Box 25.1).
Adverse drug reactions common to cephalosporins are given in Box
25.2.
Chapter 25: Antibacterial Drugs 145

Box 25.1: Five generations of cephalosporins


First generation: These are active against most gram-positive cocci with the
exception of enterococci and methicillin-resistant S. aureus, some strains of
E. coli, K. pneumoniae and P. mirabilis. These agents do not cross the blood-
brain barrier and, hence, are ineffective in treating CNS infections.
Cefadroxil
Cefazolin
Cephalexin
Cephalothin
Cephapirin
Cephradine
Second generation: These are more active against gram-negative bacteria,
e.g. H. influenzae (type B), N. gonorrhoeae and enteric gram-negative
bacteria. Certain members of this group (cefaclor) cross blood-brain barrier
and are effective in treating bacterial meningitis.
Cefaclor
Cefuroxime
Cefuroxime axetil
Cefpodoxime
Third generation: These are relatively less effective against gram-positive
cocci but more effective against most strains of enteric gram-negative bacilli
with the exception of Clostridium difficile, significantly effective against
P. aeruginosa and very effective against H. influenzae and N. gonorrhoeae.
Ceftriaxone
Cefotaxime
Ceftazidime
Ceftibuten
Cefixime
Cefoperazone
Ceftizoxime
Fourth generation: These have activity against Pseudomonas aeruginosa and
methicillin-susceptible staphylococcal infections
Cefpirome
Cefepime
Cefpodoxime
Fifth generation: These have powerful pseudomonal activity and are less
prone to resistance.
Ceftobiprole
Ceftaroline
146 Section 3: Drugs for Infections and Infestations

Box 25.2: Adverse reactions of cephalosporins in general


Hypersensitivity: Rash, urticaria, serum sickness, anaphylaxis
GIT: Nausea, vomiting, diarrhea
Hepatic: Biliary sludge, transient transaminase elevation
Renal: Interstitial nephritis
CNS: Seizures
Hematologic: Eosinophilia, neutropenia, thrombocytopenia, impaired
platelet aggregation, hemolytic anemia
Miscellaneous: Drug fever, phlebitis, superinfection, disulfiram-like reaction,
false-positive Coombs, glycosuria, and serum creatinine

Cefaclor
Brand Name: Keflor (Ranbaxy)
A semisynthetic broadspectrum second generation cephalosporin;
bactericidal.
Indications: Particularly useful in beta-lactamase producing
organisms like H. influenzae and B. catarrhalis causing upper and
lower respiratory infections.
Otitis media caused by Streptococcus pneumoniae, H. influenzae,
B. catarrhalis, Strep. pyogenes, Staphylococcus aureus.
 URI, including pharyngitis and tonsillitis, caused by Strep.
pyogenes. Other ENT infections like rhino sinusitis, acute
laryngitis, epiglottitis, otitis externa caused by Strep.
pneumoniae, Staph. aureus and Strep. pyogenes.
LRI caused by Strep. pneumoniae, H. influenzae, B. catarrhalis,
Staph. aureus, gram-negative bacilli like E. coli, Klebsiella and
Proteus.
Skin infections caused by Staph. aureus and Strep. pyogenes.
UTI caused by E. coli, Proteus mirabilis, Klebsiella spp, Staph.
aureus.
Gonococcal urethritis.
Available as:
Capsules 250 mg
Suspension 125 g/5 mL
Drops 100 mg/mL.
Dose: 20 to 40 mg/kg/day (maximum 1 g) in 3 divided doses.
Chapter 25: Antibacterial Drugs 147

ADRs: Infrequent and minor.


Hypersensitivity reaction: Morbilliform eruptions, pruritus,
urticaria, serum sickness-like reactions, Stevens-Johnson
syndrome, toxic epidermal necrolysis, anaphylaxis.
CNS: Reversible hyperactivity nervousness, insomnia, con
fusion, hypertonia, dizziness, somnolence.
GIT: Nausea, vomiting and diarrhea, pseudomembranous
colitis, transient hepatitis.
Kidneys: Reversible interstitial nephritis.
Hemopoietic: Transient lymphocytosis, leukopenia, neutro
penia, thrombocytopenia, eosinophilia.
Renal: Raised BUN and serum creatinine.
Liver: Raised SGOT, SGPT and alkaline phosphatase.
Drug interaction: Probenecid.
Contraindication: Known allergy to cephalosporins.
Precaution: Avoid in preterm infants and infants < 1 month of age,
and in penicillin allergy.

Cefadroxil
Brand Names: Lydroxil (Hetero), Odoxil (Lupin)
First generation cephalosporin active against Staphylococcus aureus,
Streptococcus, E. coli. Klebsiella and Proteus.
Indications: Majority of gram-positive and gram-negative,
penicillin-sensitive as well as penicillin-resistant pathogens: UTI,
skin infections. URI, including tonsillitis and pharyngitis.
Available as:
Dry syrup 125, 250 mg/5 mL
Tablets/Capsules 250, 500, 1000 mg.
Dose: 30 mg/kg/day in 2 divided doses.
ADRs: Nausea, vomiting, diarrhea, dysuria, Pseudomembranous
colitis, hypersensitivity reactions, allergies, genital pruritus/
moniliasis, vaginitis, moderate neutropenia (transient).
Drug interactions: Probenecid, false positive Coombs test or
ClinTest.
Contraindications: Known allergy to cephalosporins/penicillin
group of antibiotics.
148 Section 3: Drugs for Infections and Infestations

Precautions: Exercise restraint in penicillin-allergic subjects.


Observe for idiosyncrasy. Use caution in renal impairment; modify
dose according to creatinine clearance.

Cefazolin
Brand Name: Azolin (Biochem)
First generation cephalosporin active against Staphylococcus
aureus, Streptococcus, E. coli, Klebsiella and Proteus; not effective in
Pseudomonas.
Indications: Most serious gram-positive and negative infections,
including penicillin-resistant ones, but excluding Pseudomonas.
Available as: Injection 500 mg, 1 g.
Dose: 25 to 100 mg/kg/day (IM, IV) in 2 to 4 divided doses.
ADRs: Hypersensitivity reactions like drug fever, rash, pruritus,
eosinophilia, and rarely, anaphylaxis and bronchospasm, vomiting,
anorexia, hepatotoxicity with transient rise in SGOT, SGPT and
alkaline phosphatase, nephrotoxicity (transient rise in BUN), pain
over injection site, thrombophlebitis, oral thrush.
Drug interactions: Loop diuretics, probenicid, aminoglycosides.
Contraindication: Known hypersensitivity to cephalosporin.
Precaution: Reduce dose in impaired renal function. In mild,
moderate and severe impairment, the dose should be 60 percent
and 10 percent of the usual dose. Only one dose may be given.
Avoid in premature infants under 1 month.

Cefdinir
Brand Name: Sefdin (Unichem)
Extended-spectrum semisynthetic cephalosporin.
Indications: Community-acquired pneumonia (CAP), acute
exacerbation of chronic bronchitis, acute bacterial sinusitis,
uncomplicated skin infections.
Available as:
Capsule 300 mg
Suspension 125 mg/5 mL.
Dose: 14 mg/kg/day (maximum 600 mg/day) in 1 or two daily
doses.
Chapter 25: Antibacterial Drugs 149

ADRs: Nausea, diarrhea, including C. difficile-associated diarrhea


(CDAD) or constipation, indigestion, anorexia, headache, abdo
minal pain, superinfection, pseudomembranous colitis; dizziness,
drowsiness; weakness, rash, serum sickness-like reactions,
anaphylaxis.
Drug interaction: Probenecid, antacids, iron supplements.
Contraindication: Hypersensitivity to cephalosporins.
Precaution: Avoid under 6 months of age. Reduce dosage in renal
insufficiency, i.e. when creatinine clearance < 60 mL/minute.
Administer at least 2 hours apart consumption of antacids and
iron-containing products which are known to remarkably cut
down its absorption.

Cefepime
Brand Name: Ceficad (Cadila Pharma)
Extended-spectrum fourth generation cephalosporin active against
several gram-positive as well as gram-negative bacteria; even several
multidrug resistant (MRD) pathogens may be responsive to it.
Indications: Most serious gram-positive and negative infections,
including MRD states.
Available as: Injections 500 mg, 1g vials.
Dose: 100 to 150 mg/kg/day (IV, IM) in 2 to 3 divided doses.
ADRs: Nausea, diarrhea, superadded vaginal candidiasis, injection
site reactions, pseudomembranous colitis, headache, fever, rash
encephalopathy.
Drug interaction: Probenecid, nephrotoxic agents (aminoglycosides,
potent diuretics).
Precautions: -lactam safety profile (rash, eosinophilia). Monitor
renal parameters since it is renally eliminated.

Cefixime
Brand Name: Cefinar (Zydus-Alidac)
Third generation cephalosporin active against most bacteria
(including Salmonella typhi), except Staphylococcus and Pseudomonas.
CNS penetration inadequate.
150 Section 3: Drugs for Infections and Infestations

Available as:
Tablets 50, 100, 200 mg
Suspension 50 mg/5 mL.
Indications: Most bacteria (including Salmonella typhi), except
Staphylococcus and Pseudomonas.
Dose: Usually, 8 mg/kg/day in 2 divided doses. In enteric fever,
double the dose is required.
ADRs: GIT upset. Also, see Box 25.2.
Drug interaction: Probenecid.
Contraindication: Known cephalosporin allergy.
Precaution: Avoid in CNS infections and known penicillin allergy.

Cefoperazone
Brand Name: Magnamycin (Pfizer)
Third generation cephalosporin effective against gram-positive
and gram-negative bacteria, inclu ding Pseudomonas (weak anti
pseudomonal activity).
Indications: Serious gram-positive and gram-negative bacterial
infections, including Pseudomonas.
Available as: Injections 250 mg, 500 mg, 1 g, 2 g.
Dose: 100 to 150 mg/kg/day (IM, IV) divided q 8 to 12 h.
ADRs: Gastrointestinal upset, rash, urticaria, fever, reversible
neutropenia.
Drug interaction: Disulfiram-like reaction with alcohol.
Precaution: Avoid in severe biliary obstruction, hepatic disease and
coexisting renal dysfunction.

Cefoperazone-sulbactam
Brand Name: Magnex (Pfizer)
A combination of the third generation cephalosporin (cefoperazone)
and the potent beta-lactamase inhibitor (sulbactam) in 1:1 ratio.
Indications: Most serious infections caused by gram-positive,
gram-negative and anaerobic organisms, including septicemia
and meningitis.
Available as: Injections 1 g, 2 g vial (half cefoperazone and half
sulbactam).
Chapter 25: Antibacterial Drugs 151

Dose: 50 to 80 mg/kg/day with reference to cefoperazone (IM, IV)


in 2 to 4 divided doses. The neonates should receive the lower
limit of dose in 2 divided doses.
ADRs: Gastrointestinal upset, rash, urticaria, fever, reversible
neutropenia, transient abnormality of liver function tests.
Contraindication: Known hypersensitivity to cephalosporins.
Drug interactions: Disulfiram-like reaction with alcohol.
Precaution: Avoid in significant biliary obstruction, hepatic
dysfunction and renal dysfunction.

Cefotaxime
Brand Names: Claforan (Aventis) Omnatax (Nicholas-Piramal)
A third generation cephalosporin, resistant to beta-Iactamase.
Indications: Fulminant and life-threatening infections (gram-
positive and negative, anaerobes), especially where inactivation
by beta-lactamases is suspected.
Available as: Injections 250 mg, 1 g vial.
Dose: 50 to 200 mg/kg/day (IM, IV) in 2 to 4 divided doses. In
preterm infants, do not exceed 50 mg/kg/day.
ADRs: Hypersensitivity reactions like anaphylaxis, bronchospasm,
urticaria, rash, fever, and eosinophilia, adenopathy, pseudomem
branous colitis.
Contraindication: Allergy to penicillin.
Precautions:
Never dissolve the drug in soda bicarbonate solution
Do not store above 25C
In renal impairment (creatinine clearance less than 5), reduce
dose by half.

Cefpodoxime Proxetil
Brand Names: Cepodem (Stancare), Monocef-O (Aresto)
Third generation cephalosporin active against most bacterial infections,
except Pseudomonas.
Available as:
Tablets 100, 200 mg
Suspension 50, 100 mg/5 mL.
152 Section 3: Drugs for Infections and Infestations

Indications: Most bacterial infections, except Pseudomonas.


Dose: 10 mg/kg/day in 2 divided doses.
ADRs: See Box 25.2.
Contraindication: Known cephalosporin allergy.
Drug interaction: Probenecid; antacids and H-2 receptor
antagonists are likely to cut down its absorption.
Precaution: Avoid in CNS infections and known penicillin allergy.

Cefprozil
Brand Name: Refzil-O (Ranbaxy)
Second generation cephalosporin active against Staph. aureus,
Streptococcus, H. influenzae, E. coli, M. catarrhalis, Klebsiella and Proteus.
No effect of food on bioavailability.
Indications: Susceptible bacterial infections (vide infra).
Available as:
Tablets 250, 500 mg
Suspension 125 mg, 250 mg/5 mL.
Dose: 30 mg/kg/day in 2 to 3 divided doses.
ADRs: See Box 25.2.
Caution: -lactam safety profile (rash, eosinophilia). Monitor renal
parameters.

Ceftaroline
Fifth generation IV cephalosporin both for serious gram negative and
gram positive infections with a spectrum that is similar to the other
5th generation cephalosporin, i.e. ceftobiprole.
Brand Names: Teflaro, Zinfore
Available as: IV injection 400, 600 mg/vial.
Indications: Complicated skin and other soft tissue infections and
community acquired pneumonia (CAP) caused by gram-negative
and gram-positive pathogens.
Dose: 10 to 20 mg/kg/day (IV infusion) in 2 divided doses for 5 to 7
days in CAP and up to 14 days in complicated soft tissue infections.
IV infusion should be given over 1 hr.
ADRs: Nausea, vomiting, constipation, diarrhea, dizziness, and
itching; hypokalemia, elevation of transaminases; phlebitis; rarely
hypersensitivity reactions.
Chapter 25: Antibacterial Drugs 153

Contraindication: Hypersensitivity to cephalosporins.


Drug interactions: Probencid.
Precautions: Reduce the dose in renal impairment.

Ceftazidime
Brand Name: Fortum (GSK)
Indications: Serious gram-negative hospital infections and most
gram-positive infections, including Pseudomonas.
Available as: Injections 250, 500, 1000 mg/vial.
Dose:
Under 2 months 25 to 60 mg/kg/day (IM, IV) in 2 divided doses.
Above 2 months 30 to 100 mg/kg/day (IM, IV) in 2 to 3 divided
doses.
ADRs: Pain over injection site, phlebitis/thrombophlebitis, rash,
fever, pruritus, anaphylaxis, thrombocytopenia, slight increase in
hepatic enzymes.
Contraindication: Known hypersensitivity to cephalosporins.
Precaution: Impaired renal failure, when GFR is below 50 mL/min,
reduce dose.

Ceftibuten
Brand Name: Procadex (Ranbaxy)
Indications: A third generation cephalosporin indicated in a
wide range of infections, except Group B Streptococcus (GBS),
Staphylococcus, Enterococcus, Listeria spp. Bacteroides spp. and
Clostridium spp; also effective in enteric fever.
Available as:
Dry powder 90 mg/5 mL
Capsule 400 mg.
Dose: 9 mg/kg once a day.
ADRs: Gastrointestinal disturbances, rash, headache, dizziness,
blood dyscrasias, enzyme abnormalities, colitis, seizures.
Contraindications: Known allergy to cephalosporins.
Precaution: Avoid in infants under 6 months, penicillin hyper
sensitivity, renal impairment and gastrointestinal disease.
154 Section 3: Drugs for Infections and Infestations

Ceftizoxime
Brand Names: Cefizox (GSK), Eldcef (Elders)
Indications: Server infections, including sepsis, CNS infections and
anaerobes; effective in immunocompromised states.
Available as: Injections 250, 500, 1 g vials.
Dose: 100 to 200 mg/kg/day (IM, IV) in 3 to 4 divided doses.
ADRs: Pain at injection site, GI upset, superinfection (candidiasis),
eosinophilia, neutropenia, leukopenia, thrombocytopenia, high
blood urea and liver enzymes, positive Coombs test.
Contraindications: Known hypersensitivity to cephalosporins.
Drug interactions: Aminoglycosides, loop diuretics.
Precaution: Avoid in known penicillin allergy.

Ceftobiprole
Fifth generation cephalosporin that is highly broad-spectrum (covers
a variety of different bacteria) effective against both gram positive
and gram negative pathogens; now successfully completed phase
III clinical trials.
Brand Names: Zeftera/Zevtera
Indications: Activity in the test tube against gram-positive cocci,
including methicillin-resistant Staphylococcus aureus (MRSA)
and methicillin-resistant Staphylococcus epidermidis (MRSE),
penicillin-resistant Streptococcus pneumoniae, Enterococcus
faecalis as well as many gram-negative bacilli including AmpC
producing E. coli and Pseudomonas aeruginosa. Major indications
include complicated soft tissue infections as well as nosocomial
pneumonia caused by resistant strains of MRSA, enterococci, and
S. pneumoniae, especially ventilator-associated pneumonia (VAP)
and community-acquired pneumonia (CAP).
Available as: IV injection for infusion.
Dose: 8 to 16 mg/kg/day in 2 divided doses as IV infusion
administred in 2 hours for 5 to 14 days (longer duration is for soft
tissue infections).
ADRs: Nausea, vomiting, caramel-like taste disturbance, headache,
Clostridium difficile-associated diarrhea; rarely anaphylactic
reactions.
Chapter 25: Antibacterial Drugs 155

Drug interactions: Oral contraceptives, warfarin.


Contraindications: Hypersensitivity to cephalosporins.
Precaution: Monitor the dose in renal impairment.

Ceftriaxone
Brand Name: Monocef IV (Aristo)
A third generation cephalosporin.
Indications: Life-threatening gram-positive and negative infec
tions, including penicillin-resistant Staphylococcus and many
strains of Pseudomonas aeruginosa, and some anaerobic bacteria.
Available as: Injections 250, 500, 1000 mg/vial.
Dose: 20 to 80 mg/kg/day (IM, IV) in 1 or 2 doses.
ADRs: Pain, induration and tenderness at the injection site,
thrombophlebitis at IV site, pruritus, fever chills, eosinophilia,
thrombocytosis, leukopenia, anemia, neutropenia, lymphopenia,
thrombocytopenia, diarrhea, nausea, vomiting, alkaline
phosphatase, bilirubin, SGOT and SGPT rise, BUN rise, creatinine
elevation, casts in urine, headache, dizziness, moniliasis, vaginitis
pseudomembranous colitis.
Contraindication: Known allergy to cephalosporins.
Precautions:
Give cautiously to subjects with known penicillin allergy
Do not mix with other antimicrobial agents
Give cautiously in subjects with GI disease.

Ceftriaxone with Sulbactam


Brand Names: Magnex, Sulbacef, Zocef
Third generation cephalosporin empowered with beta-lactamase
inhibition via sulbactam.
Indications: For providing extended spectrum for beta-lactamase
pathogens.
Available as: Injection 500, 1 g vials (cefriaxone and sulbactam in
1:1 ratio).
Dose: Ceftriaxone, 20 to 40 mg/kg/day (IV, IM) in 2 to 4 divided
doses.
ADRs: Pain, induration and tenderness at injection site,
thrombophlebitis when given IV, fever with chills, pruritus, diarrhea,
156 Section 3: Drugs for Infections and Infestations

nausea, vomiting, headache, dizziness, moniliasis, vaginitis,


pseudomembranous colitis, eosinophillia, thrombocytopenia,
raised alkaline phosphatase, bilirubin, SGOT and SGPT, raised BUN,
raised creatinine, casts in urine.
Contraindication: Known allergy to cephalosporins.
Precaution: Avoid/give cautiously in subjects with known penicillin
allergy and gastrointestinal disease. Do not mix with other
antimicrobial agents.

Cefuroxime
Brand Name: Supacef (GSK)
Second generation cephalosporin, resistant to gram-negative beta-
lactamase.
Indications: Life-threatening gram-positive and gram-negative
infections, including penicillin-resistant Staphylococcus aureus
strains.
Available as: Injections 250, 750 mg/vial.
Dose: 15 to 150 mg/kg/day (IM, IV) in 2 or 3 divided doses.
ADRs: Rash, gastrointestinal upset, anemia, eosinophilia, transient
rise in serum bilirubin in liver disease, pain at IM injection site.
Contraindication: Known allergy to cephalosporins.
Precaution: Take special care in subjects with known anaphylaxis to
penicillin, or when the drug is needed to be given in higher doses
in conjunction with frusemide or some other potent diuretic.

Cefuroxime Axetil
Brand Names: Altacef (Glenmark), Ceftum (Glaxo)
An oral prodrug of Cefuroxime.
Indications: Useful in a wide range of gram-positive and gram-
negative infections, including beta-lactamase producing organisms.
Available as:
Capsules/tablets 125, 250, 500 mg.
Suspension 125 mg/5 mL.
Dose: 25 to 50 mg/kg/day in 2 divided doses.
ADRs: See Cefuroxime.
Contraindications: See Cefuroxime.
Precaution: See Cefuroxime.
Chapter 25: Antibacterial Drugs 157

Cephalexin
Brand Names: Sporidex (Ranbaxy), Sepexin (Hetero)
First generation cephalosporin active against Staph. aureus,
Streptococcus, E. coli, Klebsiella and Proteus.
Indications: Respiratory, genitourinary, skin and soft tissue, ENT
infections, osteomyelitis, septicemia, bacterial endocarditis.
Available as:
Capsules 250, 500 mg
Dry syrup 125 mg/5 mL.
Dose: 50 to 100 mg/kg/day in 2 to 4 divided doses.
ADRs: Nausea, vomiting, diarrhea, allergic skin reactions, eosinophilia,
positive Coombs test, overgrowth of nonsusceptible organisms.
Drug interaction: Probenecid.
Precaution: -lactam safety profile (rash, eosinophilia).

-Lactams Group 3: Nonpenicillin,


Noncephalosporin -lactams

Aztreonam
Brand Name: Azenam (Aristo)
Indications: Gram-negative infections of lower respiratory tract,
including pulmonary infections in cystic fibrosis; septicemia,
meningitis caused by H. influenzae type b (Hib) and N. meningitidis,
pyelonephritis, cystitis, asymptomatic bacteriuria, gonorrhea,
adjunct to surgery in management of infections.
Available as: Injection 500 mg, 1 g, 2 g vial.
Dose: 30 to 50 mg/kg/dose (IM, IV) every 6 to 8 hours
ADRs: Vomiting, diarrhea, skin rash, injection site reactions,
pseudomembranous colitis (PMC), C. difficile-associated diarrhea
(CDAD), superinfection, blood dyscrasias, elevation in liver
enzymes (aminotransferases), serum creatinine.
Drug interactions: Frusemide, probenecid, aminoglycosides,
cefoxitin, imipenem.
Contraindications: Pregnancy, lactation.
Precautions: Monitor renal and hepatic function, particularly in
high-dose or prolonged therapy.
158 Section 3: Drugs for Infections and Infestations

Special remarks: In view of absence of cross-reactivity with, by


and large, all other -lactams (ceftazidime may well be excluded),
it can be employed in subjects with allergy to penicillins or
cephalosporins.

Imipenem-cilastatin
Brand Name: Cilanem-500 (Ranbaxy)
Indications: A broadspectrum beta-lactam antimicrobial for
aerobic as well as anaerobic extended-spectrum beta-lactamase-
producing (ESBL) bacterial infections (both gram-positive and
gram-negative).
Available as: Injection 500 mg each of imipenem and cilastatin.
Dose: 15 mg/kg/dose (IV infusion) every 6 hourly with a maximum
of 2 g/day.
ADRs: Local and allergic reactions, phlebitis, GI upset, rash,
fever, blood dyscrasias, hepatic dysfunction, renal dysfunction,
CNS disturbances, hearing loss, seizures, confusion, dizziness,
somnolence, hypotension, perverted taste, superinfections,
pseudomembranous colitis, C. difficile-associated diarrhea (CDAD).
Drug interaction: Probenecid, valproic acid, gancyclovir, divalproex
sodium, estrogen contraceptives.
Contraindications: < 3 months, lactation
Precautions: Penicillin, cephalosporin or other allergy, colitis, con
comitant use with valproic acid, CNS disorders, renal impairment,
meningitis, brain abscess, granulocytopenia, prolonged use,
pregnancy.

Meropenem
Brand Names: Meronem (Astra Zeneca), Meroza ( Zydus Alidac)
An ultra-broadspectrum parenteral antibiotic of the carbapenem
group.
Indications: Anaerobic, aerobic and facultative gram-positive and
gram-negative microorganisms, e.g. pneumonia, septicemia,
bacterial meningitis, febrile neutropenia; skin and soft tissue,
gastrointestinal and urinary tract and other intra-abdominal
infections; cystic fibrosis with superimposed bacterial infections.
Chapter 25: Antibacterial Drugs 159

Available as: Injections 500 mg, 1 g.


Dose:
Complicated skin infections: 10 mg/kg/dose IV every 8 hourly
Sepsis and intra-abdominal infections: 20 mg/kg/dose IV every
8 hourly
Bacterial meningitis: 40 mg/kg/dose IV every 8 hourly.
ADRs: Injection site inflammation, pain; nausea, vomiting, diarrhea/
constipation, rash, headache; rarely, neuropathy; hepatic and
renal dysfunction; thrombocytosis/thrombocytopenia, anemia,
eosinophilia; C. Difficile-associated diarrhea (CDAD).
Contraindications: Known hypersensitivity
Drug interactions: Probenecid, valproic acid; nephrotoxic agents.
Precautions: Lactating mothers, hepatic/renal impairment; seizure
disorder, pretreatment skin test in penicillin-allergic children. Monitor
hepatic, renal and hemopoietic function during long-term use.

Macrolides
Macrolides are antibiotics with a complex cyclic structure. They exert
bacteriostatic action.
Macrolides are indicated for the treatment of gram-positive
cocci and intracellular pathogens (Mycoplasma, Chlamydia). They are
considered to be less toxic antibiotics.

Azithromycin
Brand Names: Aziwok (Wockhardt), Azithral (Alembic)
A macrolide with very long half-life, thereby imparting it the
uniqueness of once daily dosing.
Indications: Infections with S. aureus, Streptococcus, H. influenzae,
V. cholera, Campylobacter, Mycoplasma, Legionella; Salmonella
typhi, Chlamydia trachomatis; nontuberculous Mycobacterium
disease, [especially M. avium complex (MAC)], in combination with
other antibiotics.
Available as:
Tablets 200, 500 mg
Suspension 100, 200 mg/5 mL.
160 Section 3: Drugs for Infections and Infestations

Dose:
Routine10 mg/kg as a single dose on first day followed by 5
mg/kg OD for next 4 days or 10 mg/kg/day OD for only 3 days,
30 mg/kg as single dose therapy
In case of Group A Streptococcus (GAS) pharyngitis: 12 mg/kg/
day OD for 5 days
In case of cholera, 20 mg/kg as a single dose once only
In case of enteric fever, 20 mg/kg/day for 1 to 2 weeks
 In nontuberculous mycobacterial (NTM) infection such as
MAC, 5 mg/kg/day. The duration of therapy is not yet clearly
specified. But it has got to be a prolonged therapy, usually 1
year. More experience is needed in this respect.
ADRs: Mild GIT upset, reversible rise in liver enzymes, allergic
reactions, pseudomembranous colitis, photosensitivity and other
dermatosis, exacerbation of myasthenia gravis.
Drug interaction: Antacids, digoxin, carbamazepine, phenytoin,
theophylline, fluconazole, cyclosporine, anticoagulants.
Precaution: Renal and hepatic dysfunction.

Clarithromycin
Brand Name: Claribid (Pfizer)
Indications: A macrolide antibiotic indicated in treatment of
upper and lower respiratory infections (mild to moderate) and
skin infections due to susceptible bacteria, say H. influenzae,
M. catarrhalis, M. pneumoniae, S. aureus, S. pneumoniae,
C. trachomatis, Legionella spp; nontuberculous mycobacteria.
Available as:
Tablets 250, 500 mg
Suspension 75 mg/5 mL.
Dose: 15 mg/kg/day in 2 divided doses.
In nontuberculous mycobacterial (NTM) infection such as MAC,
7.5 mg/kg/day. The duration of therapy is not yet clearly specified.
But it has got to be a prolonged therapy, usually 1 year. More
experience is needed in this respect.
ADRs: Gastrointestinal upset, allergic reactions.
Drug interactions: Theophylline, digoxin, rifampicin, carbamazepine,
phenobarbital, phenytoin, midazolam, sodium valproate, oral
Chapter 25: Antibacterial Drugs 161

anticoagulants, cisapride, primazole, ergot derivatives, drugs


metabolized by P450, statins, warfarin, colchicines, quinidine,
cyclosporine, bromocriptine, zidovudine.
Contraindications: Hepatic dysfunction, hypersensitivity to
clarithromycin, erythromycin, azithromycin or clarithromycin.
Precautions: Renal/hepatic impairment, arrhythmias, QT interval
prolongation, pregnancy, lactation.

Erythromycin
Brand Names: Ersafe (USV), Erythrocin (Pfizer), Eltocin (Ipca)
A bacteriostatic antimicrobial most active against gram-positive patho
gens, Corynebacterium diphtheriae and Mycoplasma pneumoniae.
Indications: Respiratory infections, especially pharyngitis,
tonsillitis, sinusitis, pneumonia; M. pneumoniae; soft tissue and
wound infections; pertussis; diphtheria carriers. Also employed
for promoting GI motility and feeding intolerance in preterms;
cholera, Campylobacter jejuni infection.
Available as:
Tablets 100, 250 mg
Suspension 100 mg/5 mL.
Dose: 30 to 50 mg/kg/day (O) in divided doses.
ADRs: GIT upset, abdominal pain, hypersensitivity reactions,
eosinophilia, hepatic dysfunction.
Drug interaction: Astemizole, terfenadine, carbamazepine,
theophylline, cyclosporine, digoxin, tacrolimus; antagonizes
hepatic CYP450,344 activity.
Contraindications: Impaired liver function; concomitant cisapride,
pimozide, porphyria.
Precaution: Renal impairment; cholestatic jaundice: immediate the
drug must be discontinued.

Roxithromycin
Brand Names: Roxeptin (Ipca), Roxid (Alembic)
Indications: Respiratory infections, sinusitis, pharyngitis, tonsillitis,
genital infections.
162 Section 3: Drugs for Infections and Infestations

Available as:
Tablets 50, 150 mg
Syrup 50 mg/5 mL.
Dose: 5 mg/kg/day (O) q 12 hr.
ADRs: Nausea, vomiting, diarrhea, pseudomembranous colitis,
superinfection, rash, transient rise in liver transaminase.
Drug interactions: Theophylline, digoxin, warfarin, ergot alkaloids,
midazolam, cyclosporine, disopyramide.
Contraindications: Severe liver dysfunctions, ergotamine-like
agents.
Precaution: Renal or hepatic insufficiency, pregnancy, lactation.

Spiramycin
Brand Name: Rovamycin (Nicholas Piramal)
Indications: Respiratory infections, urethritis, toxoplasmosis
Available as:
Tablets 1.5 mIU, 3.5 mIU
Syrup 0.375 mIU/5 mL.
Dose:
Congenital toxoplasmosis 0.15 to 0.3 mIU/kg BD
Toxoplasmosis in pregnant women6 to 8 mIU/day in 2 to 4
divided doses for 3 weeks. Repeat 3-week course after 2 week
intervals till parturition
Other infections 1.5 to 2.5 mIU BD.
ADRs: Nausea, vomiting, diarrhea, skin allergy.
Contraindication: Lactation, hypersensitivity.
Precautions: Hypersensitivity, lactation.

Telithromycin
Brand Name: Ketek
A structural derivative of macrolide erythromycin, it is the first ketolide
antibiotic to enter clinical use.
It is a ketolide antibiotic which blocks bacterial protein synthesis.
It is uniquely designed to combat DRSP. Streptococcus pneumoniae,
Haemophilus influenzae, Streptococcus pyogenes, and Moraxella
Chapter 25: Antibacterial Drugs 163

catarrhalis are susceptible to telithromycin. It also is active against some


of the atypical respiratory pathogens such as chlamydia pneumoniae,
Legionella pneumophila, and Mycoplasma pneumoniae. However, it
does not cover MRSA, GRE, or any enteric gram-negative bacteria.
Indications: It is indicated for treating upper and lower respiratory
infections, such as acute sinusitis, chronic bronchitis, and
community-acquired pneumonia.
Available as: Tablets 300, 400 mg.
Dose: 10 to 15 mg/kg with a maximum of 800 mg/day administered
in 2 divided doses for 5 days for chronic bronchitis or sinusitis.
For community-acquired pneumonia, same dose should be
administered daily for 7 to 10 days. Dosage of telithromycin has
not been established for patients with severe renal impairment.
ADRs: Diarrhea, nausea, vomiting, headache, dizziness, and persistent
unpleasant taste. Antibiotic-associated pseudomembranous colitis
(PMC) due to Clostridium overgrowth in the bowel, and prolongation
of QT interval, transient vision disturbances.
Contraindications: Myasthenia gravis, liver and renal dysfunction,
QTc prolongation.
Drug interaction: Phenobarbital, phenytoin, carbamazepine
may cause subtherapeutic levels of telithromycin. Digitalis,
theophylline, metoprolol and oral contraceptive levels may also
be affected by telithromycin.
Precautions: Because telithromycin is metabolized mainly by the
liver, dosage adjustment may be necessary in patients with liver
impairment. Special attention is needed when ketoconazole,
itraconazole, antilipidemic statins, midazolam, and cisapride are
administered concomitantly with telithromycin because these
drugs have direct hepatic effects.

Lincosamides

Lincomycin HCl
Brand Name: Lynx (Wallace)
Indications: Serious infections due to susceptible strains of
Streptococci, Pneumococci and Staphylococci.
164 Section 3: Drugs for Infections and Infestations

Available as:
Capsules 250, 500 mg
Syrup 125 mg/5 mL
Injection 300 mg/mL.
Dose:
30 to 60 mg/kg/day (O) in 3 divided doses
10 to 20 mg/kg/day (IM, IV) in 2 or 3 divided doses. IV dose
need to administered as 10 mg/mL solution over a span of 1 to
4 hours.
ADRs: Vomiting, persistent diarrhea, altered taste or smell,
overgrowth of yeast, urticaria, superadded infection, abdominal
pain, muscle pain, pruritus, hepatotoxicity. C. difficile-associated
diarrhea/colitis (CDAD).
Drug interactions: Neuromuscular blocking drugs.
Contraindications: Hypersensitivity to lincomycin or clindamycin.
Precautions: Asthma, allergy, gastrointestinal disease.

Clindamycin
Brand Names: Dalacin Inj (Pfizer), Dalcap (Unichem)
A semisynthetic derivative of lincomycin, effective in serious
staphylococcal infections involving bones and joints, peritonitis,
endocarditis prophylaxis.
Indications: Gram-positive aerobes and anaerobes; serious
infections caused by MRSA; invasive GAS infections in combination
with a beta-lactam; anaerobic infections; acne (topical preparation)
Available as:
Injection 150 mg/mL
Capsules 75, 150, 300 mg
Suspension 75 mg/5 mL
Topical.
Dose:
Under 7 days and weight under 2000 g10 mg/kg/day in 3
divided doses.
Under 7 days and over 2000 g15 mg/kg/day in 3 divided
doses.
Children 20 to 45 mg/kg/day in 3 to 4 divided doses.
Chapter 25: Antibacterial Drugs 165

ADRs: Nausea, diarrhea, C. difficile-associated diarrhea (CDAD),


pseudomembranous colitis (infrequent in children but common
in adults), rash, liver dysfunction, neutropenia, eosinophilia,
agranulocytosis, thrombocytopenia, abscess at injection site.
Drug interaction: Neuromuscular-blocking agents.
Contraindications: Diarrheal state.
Precautions: Renal or hepatic dysfunction. Discontinue therapy in
case of development of persistent diarrhea or colitis. Administer
slowly IV over 30 to 60 minutes.

Quinolones and Fluoroquinolones

Ciprofloxacin
Brand Names: Cifran (Ranbaxy), Ciplox (Cipla), Ciprobid Zydus-Alidac)
A high-performance quinolone active against Pseudomonas aeruginosa,
Serratia, Enterobacter, Shigella, Salmonella, Campylobacter, Neisseria
gonorrhoeae, H. influenzae, M. catarrhalis, Staph. aureus (selected) and
Streptococcus.
Indications: Infections of the urinary tract, gastrointestinal tract,
respiratory tract, bones and joints, skin; serious life-threatening
infections, e.g. septicemia, resistant enteric fever; hospital-acquired
infections; prevention of sepsis in immunocompromised hosts.
Available as:
Tablets 250, 500 mg
Injections 1,2 mg/mL.
Dose: 15 to 30 mg/kg/day (O) in 2 divided doses, 5 to 10 mg/kg/
day (IV) in 2 divided doses.
ADRs: Tendonitis, gastrointestinal intolerance (nausea, vomiting,
diarrhea), anorexia, abdominal pain, flatulence, pseudomem
branous colitis; dizziness, headache, insomnia, confusion agitation,
tremors, ataxia, seizures, halluci nations, visual disturbances,
migraine, deafness; rash, pruritus, drug fever, anaphylaxis,
Stevens-Johnson syndrome, photo sensitivity, eosinophilia;
hepatitis, raised SGOT, SGPT, alkaline phosphatase, serum
bilirubin; crystalluria, nephritis, transient renal failure, raised blood
urea, creatine, crystalluria, hematuria, anemia, thrombocytopenia,
thrombocytosis; thrombophlebitis, superinfections.
166 Section 3: Drugs for Infections and Infestations

The joint destruction (encountered in juvenile animals) is not


seen in humans.
Drug interactions: Antacids (containing Mg, Ca, Al), carbamazepine,
theophylline, digoxin, oral anticoagulants, terfenadine, cyclo
sporine, tacrolimus, astemizole (same as in case of erythromycin;
operates by antagonizing hepatic CYP450 activity.
Contraindications: Hypersensitivity to quinolones; children and
growing adolescents, except when benefits overweigh risk,
tendon disorders, concurrent use of tizanidine.
Precautions:
Avoid the drug 1 to 2 hours before and 4 hours after the
antacids
Avoid with theophylline and nonsteroidal anti-inflammatory
drugs (NSAIDs)
Avoid in epileptics
Monitor drug dose in case of renal disease, creatinine clearance
under 30 mL/min.

Levofloxacin
Brand Names: Levoflox (Cipla), Leeflox (Centaur), Lomflox (Ipca)
A levo isomer of ofloxacin:
Indications: Gram-positive and gram-negative infections; MDR-TB
Available as:
Tablets 250, 500 mg.
Injection 500 mg/100 mL IV infusion.
Dose: 10 to 15 mg/kg OD or in 2 divided doses.
ADRs: Nausea, diarrhea, dizziness, headache, photosensitivity,
peripheral neuropathy (paresthesia, hypoesthesia, weekness),
rupture of tendons.
Drug interactions: Antacids, sucralfate, probenecid.
Contraindications: < 8 years, hypersensitivity, lactation, pregnancy.
Precaution: Avoid in children < 8 years, severe renal impairment;
avoid exposure to sunlight; discontinue in case of hypersensitivity,
photosensitivity, neuropathy.
Chapter 25: Antibacterial Drugs 167

Nalidixic Acid
Brand Name: Negadix (CFL Pharma)
First generation quinolone effective against gram-negative pathogens
e.g. E. coli, Enterobacter, Klebsiella, Proteus.
Indications: Lower urinary tract infection; dysentery due to gram-
negative organisms.
Available as: Tablets 125, 500 mg.
Dose: 50 mg/kg/day (O) in 4 divided doses.
ADRs: GIT upset, vertigo, dizziness, rash, photosensitivity,
eosinophilia, mental disturbances, convulsions, raised intracranial
tension (pseudotumor cerebri), hepatotoxicity, nephrotoxicity.
Drug interaction: Antacids (liquid).
Contraindications: < 3 months, seizure disorder, porphyria; con
comitant therapy with melphalan or other related cancer
chemotherapeutic alkylating agents.
Precautions: Exercise special care while using it in patients with
liver disease, epilepsy and severly impaired kidney function.
Must not be used in systemic infections.

Norfloxacin
Brand Names: Norflox (Cipla), Normac (Ipca), Norbactin (Solus-Ranbaxy)
Indications: Serious gastrointestinal infections, urinary tract
infection, gonococcal infection.
Available as: Tablets 200, 400, 800 mg.
Dose: 4 to 12 mg/kg/day for 5 days in GI infection and 7 to 21 days
for UTI in single or 2 divided doses; gonorrhea needs a single high
dose.
ADRs: Hypersensitivity reactions, vasculitis, edema face, glottis or
tongue, dyspnea, shock, sleeplessness, headache, hallucinations,
visual, smell and taste disturbances; psychotic reactions; anorexia,
epigastric pain, nausea, vomiting, diarrhea; transient rise of SGOT,
SGPT, serum creatinine, bilirubin; anemia, thrombo cytopenia,
leukopenia, agranulocytosis.
Drug interactions: Antacids, probenecid, nitrofurantoin, anti
coagulants, caffeine.
168 Section 3: Drugs for Infections and Infestations

Contraindication: Hypersensitivity to quinolones; < 3 month age,


epilepsy, porphyria.
Precaution: Avoid in children below 12 years, except in desperate
situations.

Ofloxacin
Brand Name: Tarivid (Aventis)
A new fluorinated quinolone.
Indications: Infections of lower respiratory tract, genitourinary tract,
gastrointestinal tract (especially typhoid fever), skin and soft tissue;
peritonitis, gonorrhea.
Available as: Tablets 200, 400 mg.
Dose: 4 to 16 mg/kg/day as a single dose or in 2 divided doses.
ADRs: Anorexia, epigastric pain, nausea, vomiting, diarrhea;
transient rise of SGOT, SGPT, serum creatinine, bilirubin; anemia,
thrombocytopenia, leukopenia, agranulocytosis.
Drug interactions: Antacids (magnesium and aluminum), iron,
sucralfate, NSAIDs, theophylline, warfarin, insulin, oral hypoglycemic,
drugs metabolized by CYP450, probenecid, cimetidine, furosemide,
methotrexate, anticoagulants, steroids, phenobarbital, anesthetics,
hypotensive drugs.
Contraindications: Hypersensitivity to quinolones; epilepsy.
Hypersensitivity reactions; vasculitis, edema face, glottis or tongue,
dyspnea, shock; sleeplessness, headache, hallucination, visual
disturbances, smell and taste disturbances, psychotic reactions.
Precaution: Avoid in children below 12 years except in desperate
situations.

Pefloxacin
Brand Names: Pefbid (Alembic), Pelox (Wockhardt)
Indications: Severe infections in adolescents caused by sensitive
gram-negative bacteria and staphylococci.
Available as:
Tablets 400 mg.
IV infusion: 400 mg/100 mL.
Dose: 12 mg/kg/day (O) q 12 hr or IV infusion.
Chapter 25: Antibacterial Drugs 169

ADRs: Epigastric discomfort, nausea, vomiting, tendinitis (even


rupture of tendon), muscular pains, articular pains, headache,
vigilance disorders, thrombocytopenia.
Drug interaction: Antacids; enhances risk of theophylline toxicity;
chloride solutions.
Contraindication: Allergy to quinolones.
Precaution: Avoid in respiratory infections, exposure to ultraviolet
light.

Sparfloxacin
Brand Names: Sparx (Wockhardt)
Indications: Gram-positive and gram-negative pathogens
Available as: Tablets 100, 200 mg
Dose: 4 mg/kg/day (O) OD or 2 divided doses
ADRs: Nausea, diarrhea, heartburn, anorexia, rash, tendinitis/
ruture, eosinophilia, thrombocytopenia, fall in hemoglobin, WBC
and RBC.
Drug interactions: Erythromycin, phenothiazines, digoxin, tricyclic
antidepressants, etc.
Contraindications: Hypersensitivity, G6PD deficiency, pregnancy,
lactation.
Precautions: Avoid sunlight exposure; avoid in hypokalemia,
hypomagnesemia, seizure disorder, arrhythmias.

Tetracyclines

Doxycycline
Brand Name: Biodoxi (Biochem), Doxypal (Jagsanpal)
Indications: Several bacterial, protozoal and rickettsial infections;
malaria prophylaxis, treatment of complicated malaria in
conjunction with other antimalarials.
Available as: Tablets 100 mg.
Dose: 2 to 5 mg/kg/day (maximum 200 mg) as a single dose or in 2
divided doses.
ADRs: Nausea, vomiting, abdominal pain, dryness of mouth,
C. difficile-associated diarrhea (CDAD); photosensitivity, pruritus,
170 Section 3: Drugs for Infections and Infestations

Stevens Johnson syndrome; hemolytic anemia; superimposed


infections, e.g. vaginitis; pseudotumor cereberi (on withdrawal);
infrequently, esophagitis; in young children (< 8 years), tooth
discoloration (permanent staining), enamel hypoplasia, and
retarded growth of fibula.
Contraindications: Known hypersensitivity; children < 8 years.
Drug interactions: Antacids, laxatives, oral iron, oral anticoagulants;
carbamazepine, phenytoin, barbiturates reduce its half life.
Caution:
Monitor hepatic and renal parameters
Avoid exposure to sunlight/ultraviolet rays during therapy
Avoid in children < 8 years in the wake of risk of staining of
teeth and growth retardation.

Oxytetracycline
Brand Name: Terramycin (Pfizer)
Indications: Systemic infections (respiratory, genitourinary, ENT,
venereal, soft tissue, etc.). brucellosis, Chlamydia, Mycoplasma,
Rickettsia; acne vulgaris.
Available as:
Capsules 250 mg
Injection 50 mg/mL.
Dose:
25 to 50 mg/kg/day (O) in 4 divided doses
15 to 25 mg/kg/day (IM) in 2 divided doses
10 to 15 mg/kg/day (IV) in 2 divided doses.
ADRs: Dental discoloration and enamel hypoplasia, retardation of
bone growth rate, especially in fibula, photosensitivity, GI upset,
pseudotumor cerebri, allergic reactions, superinfections; rarely
hepatotoxicity and blood dyscrasias.
Drug interactions: Antacids, milk, mineral supplements, oral
contraceptives.
Contraindications: Children < 8 years, hypersensitivity, renal
impairment, pregnancy, lactation.
Precautions: Hepatic impairment, myasthenia gravis, SLE,
porphyria.
Chapter 25: Antibacterial Drugs 171

Tetracycline Hydrochloride
Brand Names: Hostacycline (Aventis), Resteclin (Srabhai Piramal)
Indications: Systemic infections (respiratory, genitourinary, ENT,
venereal, soft tissue, etc.) brucellosis, Chlamydia, Mycoplasma,
Rickettsia; acne vulgarias
Available as:
Tablets/capsules 100 mg
Suspension 25 and 50 mg/5 mL.
Dose: 5 mg/kg/day (O) on divided doses on first day. Then 2.5 mg/
kg/day once daily.
ADRs: Dental discoloration and enamel hypoplasia, retardation
of bone growth rate, especially in fibula, photosensitivity, GI
upset, pseudotumor cerebri, allergic reactions, superinfections,
Cl. difficile-associated diarrhea (CDAD; rarely hepatotoxicity and
blood dyscrasias.
Drug interactions: Antacids, milk, mineral supplements, oral
contraceptives.
Contraindications: Children < 8 years, hypersensitivity, renal
impairment, pregnancy, lactation.
Precautions: Hepatic impairment, myasthenia gravis, SLE, porphyria;
avoid exposure to sunlight/UV rays.

Minocycline
Brand Name: Cynomycin (Wyeth)
Indications: Meningococcal carrier state, exacerbation of chronic
bronchitis, brucellosis, Chlamydia, Mycoplasma and Rickettsia,
pleural effusion secondary to cirrhosis or malignancy; acne
vulgaris.
Available as: Capsules 50, 100 mg.
Dose: Initially 4 mg/kg (O) followed by 4 mg/kg/day in 2 divided
doses.
ADRs: Hypersensitivity reactions, GI upset, vestibular disorders,
impaired hearing, pseudotumor cerebri, superinfections, rise in
BUN, blood dyscrasias, autoimmune hepatitis, buccal mucosal
discoloration, Cl. difficile-associated diarrhea (CDAD); rarely
172 Section 3: Drugs for Infections and Infestations

pericarditis, myocarditis, vasculitis, hepatotoxicity, renal failure,


pancreatitis, interstitial nephritis, SLE, hyperpigmentation.
Drug interactions: Antacids, mineral supplements, penicillins,
ergot alkaloids, digoxin, urinary alkalinizers, methoxyflurane, oral
anticoagulants.
Contraindications: Children < 8 years, lactation, pregnancy, renal
failure.
Precaution:
Renal impairment: Monitor serum creatine and blood urea
levels.
Hepatic impairment: Monitor for hepatitis, SLE or unusual
pigmentation every 3 months in long-term therapy. Continue
therapy for 2 days after symptomatic control.

Tigecycline
Brand Name: Tygacil (Wyeth)
Tigecycline, a broad-spectrum glycycline antibiotic resembling
tetracyclines, has FDA approval for intravenous administration only. It
is a semisynthetic derivative of minocycline.
Antibacterial spectrum includes a broad range of gram-positive,
gram-negative, atypical, anaerobic, and antibiotic-resistant bacteria
including MRSA, VRE, and PRSP. Unlike conventional tetracyclines, it
is bacteriostatic, being effective against tetracycline-resistant gram-
positive and gram-negative microorganisms, including MRSA and
VRE. However, Pseudomonas is not covered by it.
Indications: It is most effective for complicated skin and soft tissue
infections and intra-abdominal infections acquired either in the
hospital or the community.
Available as: Each single-dose vial containing 50 mg of tigecycline
as an orange lyophilized powder for reconstitution.
Dose: 1 to 2 mg/kg with a maximum of 100 mg for the first dose
over 30 to 60 minutes followed by a 0.5 to 1 mg with a maximum of
50 mg dose every 12 hours for 5 to 14 days. No dosage adjustment
is needed in patients with renal or liver impairment.
ADRs: Photosensitivity and gastrointestinal effects, such as nausea,
vomiting, and diarrhea. Use in children will cause permanent
Chapter 25: Antibacterial Drugs 173

discoloration of teeth. Pain and swelling at the injection site can


occur.
Drug interaction: Warfarin, oral contraceptive, amphotericin B,
chlorpromazine, methylprednisolone, voriconazole.
Contraindications: Pregnancy, lactation.
Precautions: Severe live 4 dysfunction, cholestasis, hypersensitivity,
sepsis/shock, intestinal perforation; avoid ultraviolet rays.
Special remarks: Very expensive, a vial costing over ` 3,000.

Glycopeptide Antibiotics

Vancomycin
Brand Name: Vancocin (Astra-Zeneca)
First generation complex glycoprotein antibiotic, the glycopeptide
inhibiting synthesis of cell wall in gram-positive bacteria.
Indication: Life-threatening methicillin-resistant staphylococcal
(MRSA) infections. Oral administration is of value in pseudo
membranous colitis caused by such bacteria as Clostridium difficile
and Staphylococcus aureus.
Available as: Injection 500 mg vial.
Dose: Severe infections
Children 45 to 60 mg/kg/day in 2 to 3 divided doses (IV slow)
Adolescents 0.5 g 6 hourly or 1 g 12 hourly (IV slow)
Neonates
i. < 1200 g < 7 days15 mg/kg/day OD (Slow IV)
ii. > 1200 g < 7 days30 mg/kg/day in 2 divided doses
(IV slow)
iii. < 1200 g > 7 days15 mg/kg/day OD (IV slow)
iv. > 1200 g > 7 days30 to 45 mg/kg/day in 2 to 3 divided
doses.
ADRs: Anaphylactoid reaction, flushing, nephrotoxicity, ototoxicity,
neutropenia, nausea, chills, pyrexia, rash, eosinophilia, phlebitis.
Rapid infusion may lead to sudden, profound fall in blood pressure,
flushing, and itching (the so-called red man syndrome).
Drug interaction: Neurotoxic and nephrotoxic agents and
anesthetics.
Contraindication: Renal and auditory diseases.
174 Section 3: Drugs for Infections and Infestations

Precautions: Avoid combining with aminoglycoside since the


combination is likely to boost the nephrotoxicity of each drug.
Reduce dose in renal insufficiency. Monitor blood levels.

Teicoplanin
Brand Name: Targocid (Sanofi-Aventis)
A newer first generation glycopeptide antibiotic:
Indications: Resistant gram-positive bacteria only but more than
vancomycin against enterococci (enterococcal endocarditis) and
equally active against MRSA. Secondly, it may be effective in some
VRSA.
Available as: Injections 200, 400 mg/vial for reconstitution.
Dose:
Children 2 months:
i. Severe infection or neutropenic: 10 mg/kg IV 12 hrly for 1st 3
dose then 10 mg/kg daily IV/IM.
ii. Moderate infection: 10 mg/kg 12 hrly IV for 1st 3 dose then
6 mg/kg daily IV/IM.
Neonate single loading dose: 16 mg/kg. Maintenance8 mg/
kg IV infusion over 30 minutes daily.
ADRs: Gastrointestinal upset in the form of nausea, vomiting and
diarrhea, anaphylaxis, rashes, urticaria, fever, granulocytopenia;
rarely hearing loss and histaminerelease reactions.
Drug interactions: Nephrotoxic drugs like aminoglycosides,
frusemide, cyclosporine, amphotericin B.
Contraindications: Hypersensitivity, pregnancy, lactation.
Precautions: Renal insufficiency; concurrent administration with
drug having oto- and nephrotoxicity.

Dalbavancin (Daptomycin)
Brand Name: Cubicin
The first generation glycopeptides are vancomycin and teicoplanin
which are prototypes. Now, the second generation glycopeptides
have been synthesized.
Dalbavancin and oritavancin, the two members of the second
generation glycopeptides, have bactericidal activity against methicillin
Chapter 25: Antibacterial Drugs 175

resistant Staphylococcus aureus (MRSA), vancomycin-resistant


Staphylococcus aureus (VRSA), vancomycin-resistant E. coli and
drug-resistant Streptococcus pneumoniae (DRSP), and Streptococcus
pyogenes, i.e. Group A Streptococcus (GAS).
It has a long half-life of 6 to 10 days, allowing for a long-spaced
dosing schedule.
It exerts its antibacterial activity through effect on membrane
permeability and nanoscale lipid membrane organization.
Antibacterial spectrum includes serious gram-positive hospital
infections, particularly MRSA and teicoplanin-resistant strains.
Indications: Skin and soft tissue infections. It has not shown efficacy
in pneumonia. Currently, is undergoing clinical trials for treatment
of bacteremia and endocarditis.
Available as: Single-use vials, each containing 500 mg as a
sterile, lyophilized powder. The contents of the vial should be
reconstituted, using aseptic technique, to 50 mg/mL.
Dose: 4 mg/kg in 0.9 percent sodium chloride over a 30-minute
period once every 24 hours for 7 to 14 days. Due to the drugs long
half-life of 9 to 12 days, a dalbavancin treatment regimen consists
of a once-a-week intravenous dose. The pharmacokinetics of
this drug allows an intermittent dosing schedule which could
be suitable for home intravenous therapy. A once-a-week dose
schedule could obviate the need for continuous intravenous lines
and decrease risk of iatrogenic local or bloodstream infections.
ADRs: Unusual muscle pain, tenderness, weakness; numbness or
tingling; dysuria; diarrhea (watery or bloody); anemia; easy bruising
or bleeding; chest pain or swelling. Minor side-effects include
constipation, nausea, diarrhea, vomiting; redness, discomfort, or
irritation over injection site; cough, sore throat; back pain; anorexia;
headache; anxiety, confusion, insomnia; mild skin rash.
Drug interaction: Dextrose intravenous solutions.
Precaution: Dosage modification is needed in patients with renal
impairment.

Oritavancin
Like dalbavancin, that was developed as a replacement for
vancomycin, this novel lipoglycopeptide (derived from vancomycin
176 Section 3: Drugs for Infections and Infestations

with phospholipid bilayer) too has by and large crossed the clinical
trials stage and holds promise for use in serious gram-positive
bacterial infections.
It has a powerful bactericidal activity against vancomycin-resistant
Staphylococcus aureus and Enterococcus species.
Indications: Complicated skin and soft tissue infections from
susceptible pathogens.
Special remarks: Oritavancin is awaiting FDA approval.

Oxazolidinone antibiotics

Linezolid
Brand Name: Linox (Unichem)
This is the first commercially available oxazolidinone antibiotic. It is
usually reserved for the treatment of serious gram-positive bacterial
infections where older antibiotics have failed due to antibiotic
resistance, i.e. methicillin or penicillin resistance. It is very expensive.
It was approved by Food and Drug Association (FDA) for clinical use
in 2000. Repeated studies have shown that linezolid is superior to
vancomycin in treating methicillin-resistant Staphylococcus aureus
(MRSA) infections. Linezolid has out-performed glycopeptides in both
HA-MRSA and CA-MRSA infections. However, reports of resistance and
treatment failures have appeared.
Its mechanism of action is unique in as much as that it is the first
synthesized antibiotic that acts by inhibiting the initiation of bacterial
protein synthesis.
Antibacterial spectrum, in addition to MRSA, includes other
gram-positive pathogens like E. faecium, S. agalactiae, S. pyogenes
and Streptococcus pneumoniae. It is only bacteriostatic against
most Enterococcus species. Against gram-negative pathogens, it is
ineffective.
Indications: MRSA, VRE, coagulase-negative staphylococci,
penicillin-resistant pneumococci. It is recommended for
pneumonia (both community-acquired and nosocomial) caused
by drug-resistant Streptococcus pneumoniae (DRSP), surgical
site infections, complicated skin and soft tissue infections, and
diabetic foot infections; septicemia, osteomyelitis, endocarditis.
Chapter 25: Antibacterial Drugs 177

Availability:
Tablets 400, 600 mg
Oral suspension powder (after reconstitution 100 mg/5 mL)
Injection in an inactive medium for intravenous injection, 200
mg/100 mL, 400 mg/200 mL, 600 mg/300 mL.
Dose: 10 mg/kg (O, IV) q 12 hr for 10 to 14 days. IV administration
should be through infusion over a period of 30 to 120 minutes.
ADRs: Rash, anorexia, diarrhea, nausea, constipation, headache,
and fever. Occasionally, severe allergic reaction, or tinnitis,
or pseudomembranous colitis (PMC), lactic acidosis; anemia,
thrombocytopenia and myelosuppression may occur.
Drug interaction: Probenecid.
Contraindications: Known hypersensitivity to linezolid, concurrent
administration with phenelzine, isocarboxazid; lactation.
Precaution: Its administration with pseudoephedrine and foodstuffs
containing tyramine should be avoided since it is a monoamine
oxidase inhibitor (MAOI).

Dalfopristin-Quinupristin
Brand Name: Synercid (Rhne-Poulenc Rorer)
This dual drug is a prototype of the group Streptogramins which is
highly useful for resistant gram-positive infections. Quinupristin
and dalfopristin are both streptogramin antibiotics, derived from
pristinamycin. Quinupristin is derived from pristinamycin IA and
dalfopristin from pristinamycin IIA. They are combined in a weight-to-
weight ratio of 30 percent quinupristin to 70 percent dalfopristin.
Indications: MRSA, coagulase-negative Staphylococcus, penicillin-
susceptible and penicillin-resistant Pneumococcus, vancomycin-
resistant E. faecium (not E. faecalis).
Available as: IV Injection 150 mg quinupristin and 350 mg
dalfopristin.
Dose:
VRE 7.5 mg/kg q 8 hr IV, preferably through central catheter to
prevent venous irritation and phlebitis.
Skin infections 7.5 mg/kg q 12 hr IV.
178 Section 3: Drugs for Infections and Infestations

ADRs: Local pain, edema, phlebitis, nausea, diarrhea, arthralgia,


myalgia.
Contraindications: Known hypersensitivity to the two components
or to other streptogramins (e.g. pristinamycin or virginiamycin).
Drug interactions: A potent inhibitor of cytochrome P450 (CYP3A4),
thereby enhancing the effects of terfenadine, astemizole,
indinavir, midazolam, Ca channel blockers, warfarin, cisapride and
cyclosporine.
Precautions: Use in children > 12 years, preferably >16 years, for
which it stands approved. Avoid in CNS infections for which it is
not yet approved.

Sulfonamides

Sulfadiazine
Brand Name: Zad-G (Gufic)
Indications: Urinary tract infection, toxoplasmosis, meningococcal
meningitis; bacterial skin infections; alternative prophylaxis
against acute rheumatic fever.
Available as:
Tablets 500 mg
Injection 250 mg/mL
Cream 2.5 percent, 5 percent.
Dose:
100 to 150 mg/kg/day (O) in divided doses; 100 mg/kg/day (IV)
in divided doses.
500 mg to 1 g daily for alternative prophylaxis (patients allergic
to penicillin) in rheumatic fever.
ADRs: Allergic reactions including Stevens-Johnson syndrome,
crystalluria, cyanosis, jaundice, purpura hemolytic anemia in G6PD
deficiency.
Contraindication: Hypersensitivity.
Precaution: Generous intake of water needed during therapy;
avoid in G6PD deficiency subjects.
Chapter 25: Antibacterial Drugs 179

Sulfamethoxazole with Trimethoprim


Brand Names: Septran (GSK), Bactrim (Piramal Health)
Indications: Respiratory, GIT, urinary tract, ENT, skin/soft tissue
infections; typhoid and paratyphoid fevers; nontuberculous
Mycobacteria; Pneumocystis carinii superinfection in HIV/AIDS.
Available as:
Adult tablet 160 mg trimethoprim, 800 mg
sulfamethoxazole.
80 mg trimethoprim, 400 mg
sulfamethoxazole.
Pediatric tablet 20 mg trimethoprim, 100 mg
sulfamethoxazole.
Suspension 40 mg trimethoprim, 200 mg
sulfamethoxazole/5 mL
Injection (5 mL) 80 mg trimethoprim, 400 mg
sulfamethoxazole.
Dose: 4 to 10 mg/kg/day (O, IV) in terms of trimethoprim.
ADRs: Gastric upset, nausea, vomiting, glossitis, anorexia, malaise,
skin rash, crystalluria, rarely blood dyscrasias.
Drug interactions: SMZ-Protein displacement with warfarin,
phenytoin, methotrexate. TMPPhenytoin, cyclosporine, rifampicin,
warfarin.
Contraindications: Sulfonamide allergy and neonatal period; also
any individual with G6PD deficiency; premature infants for first 3
months.
Precaution: The injectable cotrimoxazole should never be given
directly. The drug should be diluted in normal saline or 5 percent
dextrose in a proportion of its 5 mL (1 ampoule) to 125 mL of
infusion. The rate of infusion should be about 2 to 6 mL/minute.
Infusion solution must be used within 6 hours of preparation.

Sulfasalazine
Brand Name: Salazopyrin
Indications: Inflammatory bowel disease (IBD), i.e. ulcerative colitis
and Crohns disease, rheumatoid arthritis.
Available as: Tablet 500 mg.
180 Section 3: Drugs for Infections and Infestations

Dose:
Starting dose: 50 to 75 mg/kg/day (O) div q 4 to 6 hr with a
maximum of 6 g/day.
Maintenance dose: 25 to 50 mg/kg/day (O) div q 6 to 8 hr with
a maximum of 2 g/day.
ADRs: Drug rash, dizziness, headache, gastrointestinal disturbances,
nephrotoxicity (crystalluria); rarely blood dyscrasias.
Drug interactions: Protein displacement with warfarin, phenytoin,
methotrexate.
Contraindications: Sulfonamide allergy; G6PD deficiency.
Precaution: Avoid < 2 years age. Drink plenty of water.

Sulfisoxazole
Brand Name: Gantrisin (Roche)
Indications: Otitis media, chronic bronchitis, lower urinary tract
infection (UTI) due to susceptible pathogens.
Available as:
Tablets 500 mg
Suspension 500 mg/5 mL.
Dose: 5 to 60 mg/kg/day in 2 divided doses.
ADRs: Nausea, vomiting, crystalluria, rash, Stevens-Johnson
syndrome, renal and hepatic impairment.
Drug interaction: Protein displacement with warfarin, phenytoin
and methotrexate.
Contraindications: Hypersensitivity to sulfonamides or chemically-
related drugs (e.g. sulfonylureas, thiazide and loop diuretics,
carbonic anhydrase inhibitors, sunscreens containing PABA, local
anesthetics); hypersensitivity to salicylates; porphyria; children
younger than 2 months of age; pregnancy at term.
Precaution: Avoid in renal disease.

Miscellaneous antibacterial drugs


Chloramphenicol
Brand Names: Chloromycetin (Parke-Davis), Paraxin (Nicholas)
Originally obtained from Streptomyces venezuelae in 1947, now it is
entirely a synthetic product.
Chapter 25: Antibacterial Drugs 181

Indications: Typhoid fever; H. influenzae and other severe infections.


Available as:
Capsules/dragees/tablets 250, 500 mg
Suspension 125 mg/5 mL
Injection 250 mg/mL.
Dose: 50 to 100 mg/kg/day (O, IM, IV) in divided doses, 25 mg/kg/
day (O, IM, IV) in first 2 weeks of life when it is best avoided on
account of the risk of developing gray baby syndrome.
ADRs: Bone marrow depression (parenteral chloramphenicol is
relatively less dangerous than oral chloramphenicol as regards
bone marrow depression), allergic reaction, GIT upset, peripheral
neuritis, retrobulbar neuritis.
In preterm newborns, it may rarely cause gray baby syndrome which is a
cardiovascular collapse characterized by appearance of symptoms like
vomiting or regurgitation, refusal to suck and abdominal distention.
These occur after 2 to 3 days of continued therapy. In another day or
so the infant develops ashen-gray color, cyanosis, and becomes limp.
Prognosis is extremely poor with very high fatality.
This condition is due to a lack of glucuronidation reactions
occurring in the baby, thus leading to an accumulation of toxic
chloramphenicol metabolites.
The UDP-glucuronyl transferase enzyme system of infants,
especially premature infants, is immature and incapable of
metabolizing the excessive drug load. Insufficient renal excretion of
the unconjugated drug makes its own contribution.
Drug interactions: It inhibits metabolism of tolbutamide,
chlorpropamide, warfarin, cyclophosphamide and phenytoin.
Such drugs as phenobarbital, phenytoin, and rifampicin enhance
its metabolism, thereby contributing to failure of adequate
response.
Contraindications: Hematologic disorders.
Precaution: Monitor blood counts; avoid in minor infections that
can be treated with other antimicrobials.
Special remarks: Having had only limited prescriptions over the
past couple of decades on account of emergence of resistance,
antimicrobial sensitivity to chloramphenicol is now bouncing
back.
182 Section 3: Drugs for Infections and Infestations

Metronidazole
Brand Names: Flagyl (Nicholas Piramal), Metrogyl (Unique)
Indications: Anaerobic infections; also in giardiasis, amebiasis,
trichomoniasis, acute ulcerative gingivitis, pseudomembranous
colitis (PMS) dracunculiasis.
Available as:
Tablets 200, 400, and 600 mg
Suspension 100, 200 mg/5 mL
Injection 2 mg/mL.
Dose:
Newborns
i. < 1200 g 7.5 mg/kg (O, IV) 48 hr
ii. < 7 days 1200 to 2000 g 7.5 mg/kg/24 hr (O, IV) q24 hr
iii. > 2000 g 15 mg/kg/24 hr (O, IV) divide 12 hr
iv. > 7 days 1200 to 2000 g 15 mg/kg/24 (O, IV) hr divided q 12 hr
v. > 2000 g 30 mg/kg/24 hr (O, IV) divided q 12 hr.
Children
i. 30 mg/kg/day (IV) for anaerobic infections
ii. 21 mg/kg/day (IV) severe amebic dysentery
iii. 10 to 20 mg/kg/day (O) for 5 to 7 days in divided doses for
giardiasis
iv. 20 to 50 mg/kg/day (O) for 10 days in divided doses for
amebiasis.
ADRs: Metallic taste lasting for some days, nausea, vomiting,
headache, diarrhea, dizziness, rash, itching, furred tongue,
incoordination, leukopenia, hypotension, poor tolerance with
alcohol.
Drug interactions: Phenobarbital, phenytoin, hepatic enzyme
inducers, alcohol, oral anticoagulants, cimetidine, disulfiram.
Contraindications: Active CNS disease, blood dyscrasias, first
trimester of pregnancy, lactation.
Precaution: Avoid in children weighing < 15 kg.

Rifampicin
Brand Names: R-cin (Lupin), Rifamycin (Biochem), Siticox (Sarabhai)
This drug acts through inhibition of bacterial RNA polymerase.
Chapter 25: Antibacterial Drugs 183

Indications: Second agent (synergistic) for S. aureus infections;


elimination of nasopharyngeal colonization in carriers of
H. influenzae type B and N. meningitidis resistant to penicillin and
sulfas; tuberculosis, leprosy.
Available as:
Capsules 150, 300, 450, 600 mg
Syrup 100 mg/5 mL.
Dose: 10 to 20 mg/kg/day (O) as a single daily dose before food.
ADRs: Nausea, hypersensitivity reactions, hepatic dysfunction,
orange-red staining of saliva, sputum, sweat, urine and stool, GIT
upset, heartburn, rash, drowsiness, headache, confusion, numbness,
cramps, visual disturbances, eosinophilia, thrombocytopenia.
Drug interactions: Phenytoin, steroids, narcotics, alcohol, digoxin,
hypoglycemic, oral contraceptives, disulfiram.
Contraindications: Optic neuritis, jaundice
Precaution: Impaired liver and renal function.
Chapter

26
Antimycobacterial Drugs

Antituberculous drugs
Antituberculous drugs are conventionally categorized in 3 groups
(Box 26.1).

Box 26.1: Categories of antituberculous drugs


Group 1: First line drugs
Isoniazid
Rifampicin
Streptomycin
Pyrazinamide
Ethambutol
Group 2: Second line drugs
Cycloserine
Ethionamide
PAS
Kanamycin
Capreomycin
Group 3: Reserve drugs
Quinolones (Ciprofloxacin)
Amikacin
Ampicillin
Imipenem
Chapter 26: Antimycobacterial Drugs 185

Now tendency to categorize antituberculous drug in terms of efficacy


and experience of use is on the increase (Box 26.2).

Box 26.2: Categories of antituberculous drugs based on efficacy


and experience of use
Group 1: First line drugs
Isoniazid (H)
Rifampicin (R)
Pyrazinamide (Z)
Ethambutol (E)
Streptomycin (S)
Group 2: Second line drugs (Injectable)
Kanamycin (Km)
Amikacin (Am)
Capreomycin (Cm)
Group 3: Fluoroquinolones
Ofloxacin (Ofx)
Levofloxacin (Lfx)
Moxifloxacin (Mfx)
Gatifloxacin (Gfx)
Group 4: Oral second line drugs
Ethionamide (Eto)
Prothionamide (Pto)
Cycloserine (Cs)
Terizidone (Trd)
Para-aminosalicylic acid (PAS)
Group 5: Drugs with unclear efficacy
Clofazimine (Cfz)
Linezolid (Lzd)
Amoxycillin-clavulanic acid (Amx/Clv)
Thiacetazone (Thz)
Imipenem/cilastatin (Ipm/CIn)
High-dose isoniazid (High dose H)
Clarithromycin (CIr)
186 Section 3: Drugs for Infections and Infestations

Isoniazid [Isonicotinic Acid (INH)]


Brand Names: Isokin (Pfizer), Ipcazide (Ipca)
Indication: Tuberculosis.
Available as:
Tablets 50, 100, 300 mg
Liquid 50, 100 mg/5 mL.
Dose: 5 to 10 mg/kg/day (O) as a single dose or in 2 to 3 divided
doses.
ADRs: Weight gain, constipation, euphoria, pellagra-like dermatosis,
peripheral neuritis, convulsions, hepatotoxicity.
Contraindication: Liver disease.
Drug interactions: Alcohol, antacids, carbamazepine, ketoconazole,
phenytoin, rifampicin, valproate.
Precaution: Monitor hepatic and ocular function.

Pyrazinamide
Brand Names: PZA-Ciba (Novartis), P-Zide (Cadila Pharma), Pyzina (Lupin)
Indications: Standard/first line antituberculous drug.
Available as:
Tablets 500 mg, 750 mg, 1 g
Syrup 250 mg/5 mL.
Dose: 20 to 35 mg/kg/day (O) as a single dose; maximum dose 2 g
daily.
ADRs: Nausea, vomiting, hepatotoxicity (especially in diabetics
and alcoholics), hyperuricemia, gout, anorexia nervosa, arthralgia,
myalgia, rash, dysuria, sideroblastic anemia; rarely blood dyscrasias
and photosensitivity.
Drug interactions: Uricosurics, probenecid, sulfinpyrazone.
Contraindications: Gout, hepatic dysfunction; lactation.
Precaution: Monitor with LFT, blood uric acid estimation regularly.

Ethambutol
Brand Name: Combutol (Lupin)
Indication: Tuberculosis.
Chapter 26: Antimycobacterial Drugs 187

Available as:
Tablets 200, 400, 500 and 800 mg.
Dose: 15 to 25 mg/kg/day (O) in a single dose.
ADRs: Drowsiness, GIT upset, rash, headache, dizziness, euphoria,
swelling of tongue, hepatic and renal dysfunction, leukopenia,
bone marrow depression, aggravation of grand mal attacks, visual
disturbances.
Precaution: Avoid in preschoolers in view of difficulty in evaluating
their vision.

Rifampicin
Brand Names: R-cin (Lupin), Rifamycin (Biochem), Siticox (Sarabhai)
Indications: Tuberculosis; leprosy; carriers of N. meningitidis
resistant to penicillin and sulfas.
Available as:
Capsules 150, 300, 450, 600 mg
Syrup 100 mg/5 mL.
Dose: 10 to 20 mg/kg/day (O) as a single daily dose before food.
ADRs: Nausea, hypersensitivity reactions, hepatic dysfunction,
orange-red staining of saliva, sputum, sweat, urine and stool, GIT
upset, heartburn, rash, drowsiness, headache, confusion, numbness,
cramps, visual disturbances, eosinophilia, thrombocytopenia.
Drug interactions: Phenytoin, steroids, narcotics, alcohol, digoxin,
hypoglycemic, oral contraceptives, disulfiram.
Contraindication: Optic neuritis, jaundice.

Streptomycin
Brand Name: Ambistryn-S (Sarabhai-Piramal)
Indication: Tuberculosis.
Available as: Injection 750 mg, 1 g/vial.
Dose: 15 to 20 mg/kg/day (IM) for 3 months.
ADRs: Ototoxicity, nephrotoxicity, anaphylaxis, fever, rash, urticaria,
angioneurotic edema, esosinophilia, hemolytic anemia, blood
dyscrasias, azotemia, muscle weakness, amblyopia.
Drug interactions: Diuretics (especially frusemide), mannitol,
other aminoglycosides, ethacrynic acid, polymyxin B, colistin,
cyclosporine, anesthetics, neuromuscular blocking agents.
188 Section 3: Drugs for Infections and Infestations

Contraindications: Hypersensitivity, vestibular damage, suppurative


otitis media (SOM).
Precautions: Impaired hepatic and kidney function, prematurity,
impaired vestibular/auditory function, myasthenia gravis, pre
gnancy, lactation.

Ethionamide
Brand Name: Ethide (Lupin)
Indication: Tuberculosis when other drugs are ineffective or
contraindicated.
Available as: Tablets 250 mg.
Dose: 10 to 20 mg/kg/day with a maximum of 500 to 750 mg daily
(O) in 2 to 3 divided doses.
ADRs: Nausea, vomiting, diarrhea, anorexia, salivation, abdominal
pain, icterus, rash, acne, alopecia, mental changes, peripheral
neuritis, photosensitivity.
Contraindications: Hepatic damage, pregnancy.
Caution: Monitor LFT periodically.

Cycloserine
Brand Name: Cyclorine (Lupin)
Indication: Second line drug for resistant TB; in combination with
other ATT.
Available as: Capsule 250 mg.
Dose: 10 mg/kg/day in 2 divided doses; may be increased to 15 to
20 mg/kg/day in 2 divided doses after 2 weeks.
ADRs: Headache, dizziness, vertigo, drowsiness, depression,
tremors, seizures, psychosis, rash, liver dysfunction, megaloblastic
anemia.
Drug interaction: Alcohol.
Contraindications: Severe renal impairment, epilepsy, alcohol
dependence, psychotic states, porphyria.
Precaution: Reduce dose in impairment; discontinue in case of
allergic rash or CNS toxicity; monitor blood, renal and liver function
status periodically.
Chapter 26: Antimycobacterial Drugs 189

Kanamycin
Brand Name: Kancin (Alembic)
Indications: Tuberculosis as a second line drug. Also, neonatal
sepsis, urogenital, respiratory, CNS, soft tissue and GIT infections
due to Staphylococcus.
Available as: Injections 0.5 and 1.0 g vials.
Dose: 15 to 39 mg/kg/day (IM) in one or 2 divided doses.
ADRs: Nephrotoxic, ototoxic, rash, fever, headache, paresthesia.
Contraindications: Pregnancy, lactation.
Drug interaction: Frusemide, ethacrynic acid, neuromuscular
blocking agents, anesthetics.
Precaution: Myasthenia gravis, Parkinsonism, monitor in renal
impairment.

Para-aminosalicylic Acid (PAS)


A structural analog of para-aminobenzoic acid (PABA), acting by
competitively inhibiting the synthesis of folic acid as do the sulfonamides.
Indication: Resistant tuberculosis as a second line drug in
combination with other ATT.
Available as: Generic sodium PAS 80 g/100 g granules; 4 g packets.
Dose: 200 to 300 mg/kg/day (O) in 3 to 4 divided doses, essentially
after food. The granules are best mixed with a liquid and swallowed
whole.
ADRs: GI disturbances, weight loss, hepatotoxicity, hypersensitivity;
hypokalemia, hematuria, albuminuria, crystalluria.
Drug interaction: May decrease the absorption of rifampicin; on
the other hand, its adverse effects are potentiated when given
along with ethionamide.
Precaution: Liver insufficiency; monitor for weight loss and liver
and renal function.

Ciprofloxacin
Brand Name: Cifran (Ranbaxy), Ciplox (Cipla)
A high-performance quinolone active against Pseudomonas aeru
ginosa, Serratia, Enterobacter, Shigella, Salmonella, Campylobacter,
190 Section 3: Drugs for Infections and Infestations

Neisseria gonorrhoeae, H. influenzae, M. catarrhalis, Staph. aureus


(selected) and Streptococcus.
Indications: Resistant tuberculosis as a reserve drug in
combination with other ATT. Also, infections of the urinary tract,
gastrointestinal tract, respiratory tract, bones and joints, skin;
serious life-threatening infections, e.g. septicemia, resistant
enteric fever; hospital-acquired infections; prevention of sepsis in
immunocompromised hosts.
Available as:
Tablets 250, 500 mg
Injections 1, 2 mg/mL.
Dose: 15 to 30 mg/kg/day (O) in 2 divided doses, 5 to 10 mg/kg/
day (IV) in 2 divided doses.
ADRs: Tendonitis, gastrointestinal intolerance (nausea, vomiting,
diarrhea), anorexia, abdominal pain, flatulence, pseudo
membranous colitis; dizziness, headache, insomnia, confusion
agitation, tremors, ataxia, seizures, halluci nations, visual
disturbances, migraine, deafness; rash, pruritus, drug fever,
anaphylaxis, Stevens-Johnson syndrome, photo sensitivity,
eosinophilia; hepatitis, raised SGOT, SGPT, alkaline phosphatase,
serum bilirubin; crystalluria, nephritis, transient renal failure, raised
blood urea, creatine, crystalluria, hematuria, anemia, thrombo
cytopenia, thrombocytosis; thrombophlebitis, superinfections.
The joint destruction (encountered in juvenile animals) is not
seen in humans.
Drug interactions: Antacids (containing Mg, Ca, Al), sucraflate,
theophylline, probenecid, warfarin, cyclosporine.
Contraindication: Hypersensitivity to quinolones.
Caution:
Avoid the drug 1 to 2 hours before and 4 hours after the antacids.
Avoid with theophylline and nonsteroidal anti-inflammatory
drugs (NSAIDs).
Avoid in epileptics.

Levofloxacin
Brand Names: Levoflox (Cipla), Leeflox (Centaur), Lomflox (Ipca)
A levo isomer of ofloxacin:
Chapter 26: Antimycobacterial Drugs 191

Indications: Resistant tuberculosis (MDR-TB) as a reserve drug in


combination with other ATT. Gram-positive and gram-negative
infections.
Available as:
Tablets 250, 500 mg
Injection 500 mg/100 mL IV infusion.
Dose: 10 to 15 mg/kg OD or in 2 divided doses.
ADRs: Nausea, diarrhea, dizziness, headache, photosensitivity,
peripheral neuropathy (paresthesia, hypoesthesia, weakness),
rupture of tendons.
Drug interactions: Antacids, sucralfate, probenecid.
Contraindications: < 8 years, hypersensitivity, lactation, pregnancy.
Precaution: Avoid in children < 8 years, severe renal impairment;
avoid exposure to sunlight; discontinue in case of hypersensitivity,
photosensitivity, neuropathy manifestations.

Amikacin
Brand Names: Amicin (Biochem), Mikicin (Aristo)
First semisynthetic aminoglycoside; derivative of kanamycin A;
effective against gram-positive as well as gram-negative organisms
just like tobramycin.
Indications: Tuberculosis (third line, i.e. reserve drug) in
combination with other ATT. Also, fulminant gram-negative
infections (sepsis, pneumonia, meningitis, peritonitis, infected
burns, postoperative sepsis), and gram-positive infections
resistant to other aminoglycosides, e.g. nosocomial infections like
in burns, in ICU, and in immunocompromised subjects.
Available as: Injections 100, 250, 500 mg/vial.
Dose: 15 to 25 mg/kg/day divided q 8 to 12 h.
ADRs: Nephrotoxicity, ototoxicity (mainly cochlear), neuromuscular
blockade, hypersensitivity reactions like drug fever, rash,
eosinophilia, tremors, nausea, vomiting, headache, overgrowth of
nonsusceptible microorganisms.
Contraindications: Known hypersensitivity to aminoglycosides.
Precaution: Suitable reduction in dose must be made in renal
insufficiency depending on creatinine clearance and BUN.
192 Section 3: Drugs for Infections and Infestations

Ampicillin
Brand Name: Cilanem-500 (Ranbaxy)
Indications: Multidrug resistant tuberculosis (MDR TB) as reserve/
third line drug along with other ATT. Being a broad-spectrum
beta-lactam antimicrobial, also employed for aerobic as well as
anaerobic extended-spectrum beta-lactamase-producing (ESBL)
bacterial infections (both gram-positive and gram-negative).
Available as: Injection 500 mg each of imipenem and cilastatin.
Dose: 15 mg/kg/dose (IV infusion) every 6 hourly with a maximum
of 2 g/day.
ADRs: Local and allergic reactions, phlebitis, GI upset, rash,
fever, blood dyscrasias, hepatic dysfunction, renal dysfunction,
CNS disturbances, hearing loss, seizures, confusion, dizziness,
somnolence, hypotension, perverted taste, superinfections,
pseudomembranous colitis, Cl. difficile-associated diarrhea (CDAD).
Drug interaction: Probenecid, valproic acid, ganciclovir, divalproex
sodium, estrogen contraceptives.
Contraindications: < 3 months, lactation.
Precautions: Penicillin, cephalosporin orother allergy, colitis,
concomitant use with valproic acid, CNS disorders, renal
impairment, meningitis, brain abscess, granulocytopenia,
prolonged use, pregnancy.

Anti-nontuberculous Mycobacterial Drugs

Azithromycin
Brand Names: Aziwok (Wockhardt), Azithral (Alembic), Rowezy (Jgsonpal)
A macrolide with very long half-life, thereby imparting it the
uniqueness of once daily dosing.
Indications: Nontuberculous/atypical mycobacteria in combination
with ATT comprising rifampicin and ethambutol; also infections
with S. aureus, Streptococcus, H. influenzae, Mycoplasma, Legionella;
typhoid, Chlamydia trachomastis, etc.
Available as:
Tablets/capsules 250, 500 mg
Suspension 100, 200 mg/5 mL.
Chapter 26: Antimycobacterial Drugs 193

Dose: 5 mg/kg/day (O) OD on empty stomach for about 1 year. This


dose is half of the usual short-term dose in acute infections).
ADRs: Hypersensitivity reactions, mild GIT upset including taste/
smell perversion or loss, elevation of liver enzymes (reversible),
pseudomembranous colitis (PMC), hearing loss (reversible),
arthralgia, photosensitivity, seizures, Stevens-Johnson syndrome;
acute renal failure; neutropenia; prolongation of QT interval.
Drug interactions: Antacids, digoxin, carbamazepine, phenytoin,
theophylline, fluconazole, cyclosporine, anticoagulants.
Contraindications: Severe liver dysfunction, lactation.
Precautions: Renal and hepatic dysfunction; it needs to be taken
on empty stomach (one hour before/two hours after food).

Clarithromycin
Brand Name: Claribid (Pfizer)
A methoxy derivative of erythromycin.
Indications: Prophylaxis and treatment of M. avium complex
disease, M. fortuitum, M. marinum and Mycobacterium abscesses in
combination with ATT comprising rifampicin and ethamutol. Also
for upper and lower respiratory infections (mild to moderate) and
skin infections due to susceptible bacteria, say H. influenzae, M.
catarrhalis, M. pneumoniae, S. aureus, S. pneumoniae, C. trachomatis,
Legionella spp.
Available as:
Tablets 250, 500 mg
Suspension 75 mg/5 mL.
Dose: 7.5 mg/kg/day in 2 divided doses for about 1 year. This dose
is around half of the dose for acute infections.
Drug interactions: Theophylline, digoxin, rifampicin, carbamazepine,
phenobarbital, phenytoin, midazolam, sodium valproate, oral
anticoagulants, cisapride, primazole, ergot derivatives, drugs
metabolized by P450, statins, warfarin, colchicines, quinidine,
cyclosporine, bromocriptine, zidovudine.
Contraindications: Concomitant use of cisapride, pimozide,
hypersensitivity to erythromycin, azithromycin or clarithromycin.
Precautions: Renal or hepatic impairment, arrhythmias, QT interval
prolongation, pregnancy, lactation.
194 Section 3: Drugs for Infections and Infestations

Sulfamethoxazole with Trimethoprim (TMP-SMZ,


Cotrimoxazole)
Brand Names: Septran (GSK), Bactrim (Piramal Health)
A synergistic combination, in the fixed ratio of 1 part of TMP and
5 parts of SMZ. SMZ, a sulfa, inhibits synthesis of dihydrofolic
acid by competitively inhibiting PABA. TMP blocks production of
tetrahydrofolic acid and downstream biosynthesis of nucleic acids
and protein by reversely binding to dihydrofolate reductase.
Indications: Nontuberculous mycobacteria in combination with
ATT; also respiratory, GIT, urinary tract, ENT, skin/soft tissue
infections; typhoid and paratyphoid fevers.
Available as:
Adult tablet 160 mg trimethoprim
800 mg sulfamethoxazole.
80 mg trimethoprim.
400 mg Sulfamethoxazole.
Pediatric tablet 20 mg trimethoprim.
100 mg sulfamethoxazole.
Suspension 40 mg trimethoprim
(5 mL) 200 mg sulfamethoxazole.
Injection (5 mL) 80 mg trimethoprim.
400 mg sulfamethoxazole.
Dose: Usual dose is 4 to 10 mg (up to 20 mg)/kg/day (O, IV), in
terms of trimethoprim, in 2 to 3 divided doses. In NTM, half of the
conventional dose suffices. Duration is usually 1 year.
ADRs: Gastric upset, nausea, vomiting, glossitis, anorexia, malaise,
skin rash, rarely blood dyscrasias.
Contraindications: Sulfonamide allergy and neonatal period; also
any individual with G6PD deficiency; premature infants for first 3
months.
Precautions:
The injectable cotrimoxazole should never be given directly.
The drug should be diluted in normal saline or 5 percent
dextrose in a proportion of its 5 mL (1 ampoule) to 125 mL of
infusion. The rate of infusion should be about 2 to 6 mL/minute.
Infusion solution must be used within 6 hours of preparation.
Chapter 26: Antimycobacterial Drugs 195

G6PD deficiency
Routine laboratory monitoring comprising CBC, periodic
electrolytes and creatine for renal function.

Antileprosy Drugs
Leprosy is caused by the Mycobacterium leprae. Once dubbed as an
incurable disease, leprosy is now very much curable thanks to the
availability of effective antileprosy drugs and favorable changes in
therapeutic approach towards multidrug therapy (MDT) rather than
a solitary drug therapy.

Clofazimine
Brand Name: Hansepran (Sarabhai-Piramal)
A synthetic phendimetrazine tartrate derivative, acting by binding to
mycobacterial DNA at guanine sites.
Indications: As a part of combination therapy for M. leprae.
Available as: Capsules 50, 100 mg.
Dose: 1 mg/kg/day (O) as a single dose with a maximum of 100
mg/day in combination with dapsone and rifampicin for 2 years.
Thereafter, it is continued as a single agent for up to 1 year.
ADRs: Reversible skin and conjunctival discoloration (pink to
tan-brown), dry itchy skin, rash, headache, dizziness, abdominal
pain, diarrhea, vomiting, peripheral neuropathy, elevation of liver
transaminases.
Contraindications: Hypersensitivity, G6PD deficiency, severe
anemia (hemoglobin < 7 g percent).
Precaution: It needs to be taken with food to enhance absorption.
Routine laboratory monitoring for liver function is advisable.

Dapsone [Diaminodiphenyl Sulfone (DDS)]


Available under generic name only
A sulfone antimicrobial resembling sulfonamides with same
mechanism of action, acting as a competitive antagonist of PABA that
is essential for bacterial synthesis of folic acid.
Indication: Leprosy in combination with other antileprosy drugs,
say clofazimine, rifampicin, ethionamide; other uses: certain
196 Section 3: Drugs for Infections and Infestations

skin disorders including acne, chloroquine-resistant malaria (in


combination with pyrimethamine). Topical use in dermatitis
herpetiformis.
Available as: Tablets 5, 10, 25, 50, 100 mg.
Dose: 1 to 2 mg/kg/day (O) as a single dose with a maximum of 100
mg/day for 3 to 10 years.
ADRs: Hemolytic anemia (especially in G6PD deficient subjects),
pancreatitis, acute tubular necrosis, acute renal failure, albuminuria,
increased liver enzymes, psychosis, tinnitus, peripheral neuropathy,
photosensitivity, hypersensitivity syndrome characterized by fever,
rash, malaise and hepatic dysfunction; lepra reaction: a Jarisch-
Herxheimer type of reaction (a sort of Arthus phenomenon) as a
consequence of release of antigens from the killed M. leprae and
consists of enlargement of existing skin lesions that may also
become red, swollen and painful, appearance of new lesions, fever,
malaise and other constitutional symptoms; sulfone syndrome:
it develops 4 to 6 weeks following institution of therapy with
dapsone usually in malnourished subjects, and consists of fever,
desquamation of skin, enlargement of lymph nodes, icterus and
anemia.
Drug interaction: Rifampin lowers dapsone levels 7 to 10-fold by
accelerating plasma clearance; in leprosy. This reduction does
necessitate a change in dosage. Folic acid antagonists such as
pyrimethamine may increase the likelihood of hematologic
reactions. There is a mutual interaction between dapsone and
trimethoprim in which each raises the level of the other about 1.5
times.
Contraindication: Hypersensitivity, G6PD deficiency, severe anemia
(hemoglobin < 7 g%).
Precaution: Exercise caution in subjects with G6PD deficiency and
those on folic acid antagonists therapy; periodic renal and hepatic
function; CBC weekly during first month of therapy, weekly
through 6 months of therapy, then every 6 months.
Special remarks: DDS is the most commonly employed, the best and
the most economical of all the antileprosy drugs. On account of
increasing drug resistance, it is employed as a component of MDT.
Chapter 26: Antimycobacterial Drugs 197

Rifampicin
Brand Names: R-cin (Lupin), Rifamycin (Biochem), Siticox (Sarabhai)
Indications: Leprosy in combination with either dapsone or
clofazimine (2-drug combination) or both (3-drug combination);
tuberculosis; carriers of N. meningitidis resistant to penicillin and
sulfas.
Available as:
Capsules 150, 300, 450, 600 mg
Syrup 100 mg/5 mL.
Dose: 10 to 20 mg/kg/day (O) as a single daily dose before food.
ADRs: Nausea, hypersensitivity reactions, hepatic dysfunction,
orange-red staining of saliva, sputum, sweat, urine and stool, GIT
upset, heartburn, rash, drowsiness, headache, confusion, numbness,
cramps, visual disturbances, eosinophilia, thrombocytopenia.
Contraindications: Optic neuritis, jaundice.
Drug interactions: Phenytoin, steroids, narcotics, alcohol, digoxin,
hypoglycemic, oral contraceptives, disulfiram.
Contraindications: Hypersensitivity, liver dysfunction.
Precaution: Impaired liver and renal function. Alert the attendant
regarding high-colored urine.
Chapter

27
Antiviral Drugs

Antiherpes virus drugs

Acyclovir
Brand Name: Zovirax (GSK)
A synthetic purine nucleoside, acts by inhibiting viral DNA polymerase
against human herpes viruses, including Herpes simplex virus (HSV),
types 1 and 2, Varicella zoster virus (VZV), Epstein-Barr virus (EBV) and
cytomegalovirus (CMV). In the last two, its effect and, hence, utility is
quite limited.
Indication: Herpes simplex virus (HSV) infectionsparticularly
involving genitalia; herpes simplex encephalitis; neonatal herpes
simplex infection; primary HSV gingivostomatitis; long-term
suppressive therapy in HSV infections; varicella zoster virus (VZV)
infections; immunocompromised states.
Available as:
Tablets 200 mg
IV Injection 250 mg/vial.
Dose:
Neonates: 30 mg/kg/day (IV) q 8 hr
Children: 200 mg/m2/day (IV) q 8 hr
Prophylaxis: 200 mg (O) 5 times a day for 5 to 10 days.
ADRs: Usually safe; transient skin rashes; occasionally GI
disturbances (nausea, vomiting, diarrhea, abdominal pain);
reversible neurologic reactions (dizziness, confusional states,
hallucinations, somnolence); hair loss, headache, fatigue; rarely
slight transient rise in serum bilirubin and liver-related enzymes,
rise in blood urea and creatinine, fall in hematologic indices.
Chapter 27: Antiviral Drugs 199

Drug interactions: Probenecid, other drugs affecting renal


physiology could influence its pharmacokinetics.
Contraindication: Hypersensitivity to acyclovir.
Precautions:
Avoid rapid infusion which may cause reversible obstructive
uropathy by crystallization of the drug in renal tubules
Avoid prolonged use which can cause neutropenia
Avoid high doses which can cause neurotoxicity
Anti-influenza virus drugs
Miscellaneous (nonselective) antiviral.

Ganciclovir
Brand Name: Cymevene (Roche)
A nucleoside analog structurally resembling acyclovir; inhibits viral
DNA polymerase; effective against all herpes viruses (H. simplex, H.
zoster, Epstein-Barr virus, cytomegalovirusCMV). Against CMV, it
shows higher activity.
Indications: Congenital CMV pneumonia and acquired CMV
retinitis in HIV/AIDS.
Available as: Oral, ocular implant and injectable formulations (500
mg vial)
Dose: 10 to 15 mg/kg/day q 8 to 12 hr for 14 to 21 days followed
by long-term suppression therapy in a dose of 5 to 10 mg/kg/day
thrice a week for 3 months.
ADRs: Reversible myelosuppression; risk of carcinogenicity,
gonadal toxicity
Precaution: Reduce dose in renal impairment/insufficiency,
monitored according to creatinine clearance reduction.

Antiretroviral drugs

Abacavir
Brand Name: Abamune (Cipla)
Indication: A second line antiretroviral therapy in HIV/AIDS.
Available as:
Tablet 300 mg
Suspension 20 mg/mL.
200 Section 3: Drugs for Infections and Infestations

Dose: 3 months to 12 years 8 mg/kg twice daily with a maximum of


600 mg/day.
ADRs: GI upset, diarrhea, anorexia, lethargy, fever, lipodystrophy,
lactic acidosis, gross enlargement of liver with steatosis, myocardial
infarction, hypersensitivity in the form of influenza-like illness
(manifesting with cough, breathlessness, pharyngitis, fever, rash,
abdominal pain, severe fatigue, myalgia, arthralgia).
Drug interactions: Retinoids (theoretical); may antagonize
methadone; may be potentiated by ethanol.
Contraindications: Hepatic and renal dysfunction.
Precaution: Close monitoring for first every 2 weeks, 2 months for
influenza-like symptoms due to hypersensitivity.

Didanosine
Brand Name: Dinex (Cipla)
Indication: HIV infection, along with other ART.
Available as: Chewable tablet 100 mg.
Dose: > 2 weeks 240 mg/m2 in 1 to 2 doses. Alternatively, 180 mg/
m2 daily in combination with zidovudine.
ADRs: GI upset, abdominal pain, rash, chills, fever, headache;
pancreatitis; elevation of liver enzymes, amylase and lipase; peripheral
neuropathy, optic neuritis, hepatic dysfunction; lipodystrophy.
Drug interactions: Antagonistic for quinolones, tetracyclines.
Potentiated by allopurinol, tenofovir, ganciclovir, ribavirin; drugs
causing pancreatitis.
Contraindications: Pancreatitis; concurrent administration of
allopurinol or ribavirin.
Precaution: Monitor serum amylase, retinal and optic nerve
changes, signs of mitochondrial dysfunction; pregnancy,
lactation.

Efavirenz (EFV)
Brand Name: Efavir (Cipla)
Indication: HIV infection, with other ART.
Available as: Capsules 200, 600 mg.
Chapter 27: Antiviral Drugs 201

Dose: > 3 years


13 kg to 15 kg 200 mg OD
15 to 20 kg 250 mg OD
20 to 25 kg 300 mg OD
25 to 32.5 kg 350 mg OD
32.5 to 40 kg 400 mg OD
> 40 kg/17 years 600 mg OD.
ADRs: GI upset, drowsiness, headache, fatigue, fever, cough,
dyspnea, skin rash, neuropathy, psychiatric reactions, raised liver
enzymes and amylase; lipodystrophy, gynecomastia, Steven-
Johnson syndrome, erythema mutiforme; postural disturbances.
Drug interaction: Cisapride, midazolam, ketoconazole, inducers of
substrates of CYP344; alcohol, grapefruit juice.
Precautions: Monitor liver enzymes, serum amylase, lipids and
blood glucose.
Monitor for psychiatric and CNS symptoms which may be
precipitated by this therapy.

Lamivudine
Brand Names: Ladiwin (Zydus Biogen), Lamnidac 100 (Zydus Alidac)
Indications: Employed as an adjuvant to other antivirals in
progressive HIV disease.
Available as: Tablet 150 mg.
Dose: > 3 months 4 mg/kg BID with a maximum of 300 mg/day.
ADRs: Neutropenia, anemia, thrombocytopenia, pure red cell
aplasia, raised liver enzymes, raised serum amylase; headache,
malaise, fatigue, GI upset, abdominal pain, insomnia, cough, nasal
congestion, rhinorrhea, throat discomfort. Fever, rash, alopecia,
dizziness, depression, breathing problems, muscle pains, hepatitis,
pancreatitis, peripheral neuropathy, lactic acidosis, lipodystrophy,
paresthesia, gross hepatomegaly with steatosis.
Drug interactions: Intravenous ganciclovir, zalcitabine, foscamet,
cotrimoxazole, zidovudine, ciprofloxacin, pentamidine.
Contraindications: Simultaneous use of zalcitabine.
Precaution: Monitor liver and kidney function, and signs of
mitochondrial dysfunction.
202 Section 3: Drugs for Infections and Infestations

Lopinavir
Brand Name: Ritomax-L Forte (Alkem)
A second line drug, acting through protease inhibition:
Indication: HIV, in combination with other ART.
Available as: Capsule 200 mg in combination with ritonavir 50 mg
Dose: 3 to 10 mg/kg/day in 2 divided doses with food to enhance
bioavailability.
ADRs: Hyperglycemia, GI upset, abdominal pain, diarrhea, rash,
insomnia, cough, headache, fat redistribution, pancreatitis,
increased serum cholesterol and other lipids, hepatitis, myasthenia,
extrapyramidal syndrome, skin striae, impotence, QT prolongation.
Drug interactions: Drugs metabolized by CYP3A or CYP2D6,
including midazolam, cisapride, rifampicin; other retrovirals,
warfarin, antiarrhythmics; anticonvulsants; steroids; clarithromycin.
Contraindications: Low neutrophil count < 0.75 109/L, low
hemoglobin level < 7.5 g/dL; lactation.
Precaution: Monitor serum lipids, blood glucose and renal and
hepatic function.

Nelfinavir
Brand Name: Nelvir (Cipla)
Indication: HIV infection in combination with other ART.
Available as: Tablet 250 mg.
Dose: 3 to 13 years 50 to 55 mg/kg BD or 25 to 30 mg/kg TID.
ADRs: GI upset, nausea, diarrhea, flatulence, abdominal pain,
rash; increased creatinine kinase, decreased nutrophils, increased
transaminases, hepatitis, lipodystrophy, insulin resistance, diabetes,
hyperlipidemia.
Drug interaction: Midazolam, triazolam, rifabutin, rifampicin, argot
derivatives, cisapride, carbamazepine, phenytoin, primozide,
phenobarbital, amiodarone, quinidine, calcium antagonists, oral
contraceptives, ritonavir, indinavir, saquinavir, azole, antifungals,
erythromycin, azithromycin, clarithromycin, sildenafil, methadone,
statins, fluticasone, PPIs.
Chapter 27: Antiviral Drugs 203

Contraindications: Concurrent use of cisapride, pimozide, triazolam,


midazolam, ergot derivatives, amiodarone, quinidine, lovastatin,
simvastatin, sildenafil, moderate-to-severe liver disease, lactation.
Precaution: Renal or hepatic impairment, hemophilia, diabetes,
monitoring for hyperglycemia or fat redistribution advisable.

Nevirapine (NVP)
Brand Name: Nevimune (Cipla)
A non-nucleoside reverse transcriptase inhibitor specific for HIV-I
transcriptase or human polymerase.
Indication: HIV with advanced or progressive immunodeficiency in
combination with other ARTs.
Available as: Tablet 200 mg.
Dose: Newborn 2 mg/kg OD in mother-to-child transmitted
(MTCT) HIV. Later 150 to 200 mg/m2/dose in 2 divided doses.
ADRs: Rash, nausea, vomiting, abdominal pain, fatigue, fever,
headache, somnolence, myalgia, hepatitis, fat redistribution,
Steven-Johnson syndrome, toxic epidermal necrolysis, agra
nulocytosis, granulocytopenia, anemia.
Drug interactions: Ketoconazole, protease inhibitors, cimetidine,
macrolides, rifampicin, rifabutin, warfarin, contraceptives,
saquinavir.
Contraindications: Renal failure, moderate to severe hepatic
impairment, lactation.
Precaution: Monitoring of liver and renal function, hematologic
status, and signs of severe dermatologic lesions, oral lesions, fever,
muscle and joint pains.

Stavudine
Brand Name: Stavir (Cipla)
Indications: HIV with progressive or advanced immunodeficiency
in combination with other agents.
Available as: Capsules 30 and 40 mg.
Dose:
>3 months
204 Section 3: Drugs for Infections and Infestations

< 30 kg 1 mg/kg BID


>30 kg 30 mg BID
ADRs: Peripheral neuropathy, pancreatitis, raised serum amylase,
ALT, AST, lactic acidosis, hepatitis, liver failure, headache, pain,
malaise, GI and CNS disturbances, fever, skin irritation; neoplasia,
lipodystrophy, lymphadenopathy, macrocytosis, anorexia, myalgia,
rash, diabetes, gross hepatomegaly with steatosis.
Drug interactions: Zidovudine, trimethoprim, doxorubicin, ribavirin,
anti hepatitis B or C therapy; enhanced risk of toxicity with
neurotoxic, hepatotoxic, pancreatotoxic (hydroxyurea, didanosine)
drugs.
Contraindications: Lactation, < 3 months.
Precaution: Monitor renal/liver function, mitochondrial dys
function, lactic acidosis, serum lipids and blood glucose and
physical signs of lipodystrophy and fat redistribution.

Zidovudine (AZT, ZDV)


Brand Name: Retrovir (GSK)
An antiviral agent that interferes with replication of HIV by inhibiting
HIV RNA-dependent DNA polymerases.
Indications: HIV infection, both symptomatic and asymptomatic
Available as:
Capsules/Tablets 100, 300 mg
Syrup 50 mg/5 mL.
Dose:
> 3 months 180 mg/sqm with a maximum of 200 mg every 6
hourly.
12 mg/kg/day in 4 divided doses (IV), or continuous IV infusion.
ADRs: Headache, seizures, diarrhea, lactic acidosis, cholestasis, bone
marrow suppression, rash, hepatotoxicity with hepatomegaly,
myopathy.
Drug interaction: Rifampicin increases its metabolism whereas
cimetidine, fluconazole, valproic acid decrease it.
Contraindication: Low neutrophil cell count < 0.75 109/liter or
low hemoglobin (<7.5 g/dL); lactation.
Chapter 27: Antiviral Drugs 205

Precaution: Monitor with blood tests at least every 2 weeks during


first 3 months and then every month.

Anti-influenza Virus Drugs

Amantadine
Brand Name: Amantrel (Cipla)
A M2-inhibitor antiviral, a tricyclic amine, acting by blocking M2
protein ion channel. It changes pH of lysozymes.
Indications: Influenza A (both prevention and treatment); also herpes
zoster, parkinsonism, drug-induced extrapyramidal reactions.
Available as: Oral formulation:
Capsules 100 mg
Syrup 50 mg/teaspoonful.
Dose: 4 to 8 mg/kg/day (O) q 8 to 12 hr with a maximum of 150 mg/
day and 200 mg/day before and after 10 years of age, respectively,
for 2 to 7 days.
ADRs: Transient insomnia, nervousness, light headedness,
drowsiness, pedal edema, livedo reticularis due to vadso
constriction.
Contraindication: Gastric ulceration, epilepsy, nursing and
pregnant mothers, hypersensitivity to amantadine.
Precaution: Avoid its use in view of widespread resistant strains as
per recommendations of CDC.

Oseltamivir
Brand Names: Antiflu (Cipla), Fluvir (Hetero), Tamiflu (Roche)
This antiviral agent is a neuraminidase inhibitor. Oseltamivir is not a
substitute for early vaccination on an annual basis.
Indications: Treatment of uncomplicated acute illness due to
influenza infection in patients aged 1 year and beyond who have
been symptomatic for up to 48 hours.
Prophylaxis of influenza in patients older than 1 year.
Available as: Capsules 75 mg. Powder for oral suspension, to be
constituted with water (12 mg/mL; available in glass bottles
containing 25 mL of suspension).
206 Section 3: Drugs for Infections and Infestations

Dosage:
Treatment: Optimal dose for adolescents and adults 75
mg BID for 5 days. Pediatric patients who cannot swallow,
shouldreceive the oral suspension.
i. 1 to 12 years:
a. < 15 kg 30 mg
b. 15 to 23 kg 45 mg
c. 23 to 49 g 60 mg
d. >40 kg 75 mg
All twice daily for 5 days.
It should preferably be administered within 48 hours after the
onset of symptoms; most effective if initiated as soon as possible
(< 24 hours). The drug is generally well-tolerated.
Prophylaxis: Optimal dose for adolescents and adults 75 mg
once daily for 10 days or up to 6 weeks during an epidemic.
Pediatric patients who cannot swallow, should receive the oral
suspension.
i. 1 to 12 years:
a. < 15 kg 30 mg
ii. 15 to 23 years:
a. 45 mg
b. 23 49 kg 60 mg
c. >40 kg 75 mg
All once daily for 10 days or up to 6 weeks during an epidemic.
Special dosage: Patients with a serum creatinine clearance
between 10 and 30 mL/min are treated with 75 mg once
daily for 5 days; the prophylactic dose is 75 mg every other
day or 30 mg oral suspension everyday. No recommended
dosing regimens are available for patients undergoing routine
hemodialysis and continuous peritoneal dialysis treatment
with end-stage renal disease.
ADRs: Nausea and vomiting which are generally mild-to-moderate
in degree and usually occur on the first 2 days of treatment; GI
bleeding, hemorrhagic colitis, respiratory infection, dizziness,
fatigue, headache, insomnia, seizures, vertigo, delirium, confusion,
abnormal behavior, delusions, hallucinations, agitation, anxiety,
nightmares.
Chapter 27: Antiviral Drugs 207

Drug interactions: Chlorpromazine, methotrexate, phenylbutazone;


do not administer live attenuated influenza vaccine (LAIV) within 2
weeks prior or 48 hours after treatment.
Contraindication: Children < 1 year age.
Precaution: Patients should be instructed to begin treatment with
oseltamivir as soon as possible after the first appearance of flu
symptoms. Similarly, prevention should begin as soon as possible
following exposure:
Renal and hepatic impairment, hemodialysis, chronic
cardiorespiratory disease, repeat courses, pregnancy and
lactation.
Transient gastrointestinal disturbance may be reduced by
taking oseltamivir after a light snack.
Coadministration with food has no significant effect on the
peak plasma concentration and the AUC.
Oseltamivir is not a substitute for an influenza vaccine. Patients
should continue receiving an annual/seasonal vaccine
according to the relevant national or local recommendations.

Rimantadine
Brand Name: Flumadine
Action: A M2 inhibitor.
Indications: Prophylaxis of influenza A infection. Treatment must
be initiated within 48 hours after the onset of symptoms.
Dose: 100 mg BID. A dose reduction to 100 mg daily is
recommended in patients with severe hepatic dysfunction, renal
failure (CrCl 10 mL/min) and in elderly nursing home patients.
Children less than 10 years of age should receive 5 mg/kg but
not exceeding 150 mg.
Children 10 years of age or older should receive the adult dose.
Drug interactions: No significant interactions.
ADRs: Gastrointestinal symptoms like nausea, vomiting, diarrhea,
dyspepsia; CNS disturbances like insomnia, dizziness, tinnitus,
ataxia; skin rash.
Precaution: A dose reduction to 100 mg daily is recommended in
patients with severe hepatic dysfunction, renal failure (CrCl 10 mL/
min) and in old age. Avoid its use in view of widespread resistance.
208 Section 3: Drugs for Infections and Infestations

Zanamivir
Brand Name: Relenza
A neuraminidase inhibitor. Neuraminidase glycoprotein is essential
in the infective cycle of influenza viruses. It simulates sialic acid, the
natural substrate of neuraminidase.
Indications: Treatment of uncomplicated influenza (A and B)
symptomatic over up to 2 days.

Dosage
Treatment: 10 mg BID twice daily (2 consecutive days).
Prophylaxis: Not yet approved.
ADRs: A good safety profile and the overall risk for any respiratory
event is low. Adverse events include bronchospasm, especially
in the setting of underlying airways disease, allergic reactions,
including oropharyngeal edema; arrhythmias, syncope, seizures.
Drug interactions: No clinically significant pharmacokinetic drug
interactions are predicted based on data from in vitro studies.
Precaution: Not to be recommended for the treatment of patients
with underlying airways disease (such as asthma or chronic
obstructive pulmonary disease) in which risk of bronchospasm is
significant.

Miscellaneous (Nonselective) Antiviral Drugs

Interferon-alfa-2a
Brand Name: Roferon-A (Piramal Healthcare)
An endogenous immunomodulatory protein (precisely, a low
molecular weight glycoprotein cytokine) exerting antiviral activity
through induction of multiple effector proteins in virus-infected cells.
This particular interferon has emerged as an effective antiviral agent.
Indications: Hepatitis B, hepatitis C and human papilloma virus
(HPV) infection; anogenital warts caused by HPV; laryngeal and
respiratory papillomatosis; chronic myeloid leukemia and multiple
myeloma.
Available as: Injections (SC, IM) 3 million IU/dose.
Chapter 27: Antiviral Drugs 209

Dose: 2.5 to 10 million units/day (SC, IM) 1 week followed by


thrice a week for a total of 1 to 6 months.
ADRs: GIT upset, flu-like symptoms (fever, chills, myalgias, fatigue,
malaise), neuropathy (numbness, tremors, sleepiness, seizures)
bone marrow suppression (neutropenia, thrombocytopenia),
thyroid dysfunction (hypo- as well as hyperthyroidism), alopecia,
hepatic insufficiency, hypotension, arrhythmias (transient).

Ribavirin
Brand Name: Ribavin (Lupin)
Indications: A semisynthetic nucleoside antiviral drug, particularly
useful in respiratory syncytial virus (RSV), hepatitis influenza
virus and herpes simplex virus. In practice, primarily used for
treatment of acute bronchiolitis from RSV, especially when the
infant is critically ill or has underlying high risk condition such
as prematurity, chronic lung disease (cystic fibrosis, asthma) or
congenital heart disease (CHD).
Available as:
Aerosol capsules 100 mg, 200 mg
Syrup 50 mg/5 mL.
Dose: 10 mg/kg/day continuous aerosolization for 12 to 18 hours
daily for 3 to 7 days.
ADRs: Hemolysis, anemia, flu-like symptoms, dizziness, weight
loss, alopecia, rash, diabetes, pancreatitis, hyperuricemia,
thrombotic thrombocytopenic purpura, thyroid disorders, dental
and periodontal disorders, vision disorders, optic disk changes,
including papilledema and retinal detachment; psychiatric
problems, cardiac arrest, hypotension.
Drug interactions: Alcohol, nucleoside reverse transcriptase
inhibitors (NRTIs), stavudine, zidovudine, didanosine, peginterferon
alfa 2a.
Contraindications: Pregnancy since it is a teratogenic drug;
hypersensitivity to ribavirin or any component of the product.
Precaution: Avoid in asthma; closely monitor renal, cardiac,
hematological and biochemical parameters before and at 2 to 4
week intervals during therapy.
Chapter

28
Antifungal Drugs

Polyens

Amphotericin B (AMB)
Brand Name: Fungizone (Sarabhai Piramal)
Indications: Progressive and potentially fatal fungal infections; also
leishmaniasis.
Available as: Injection 50 mg vial.
Dose:
250 mcg/kg/day
Increase gradually to 1 mg/kg/day (IV infusion).
ADRs: Nausea, vomiting, diarrhea, anorexia, epigastric pain,
headache, muscle and joint pains, anemia, impaired renal/hepatic
function, fever, rash, anaphylaxis; arrhythmias; blood dyscrasia,
neuropathy, dyselectrolytemia, dyspnea.
Drug interactions: Steroids, aminoglycosides, cardiac glycosides,
polymyxins, other antifungals, diuretics, vancomycin, cyclosporine,
pentamidine, anticancer drugs, leukocyte transfusions.
Contraindications: Renal and hepatic dysfunction.
Precaution:
Exercise caution in its concomitant use with aminoglycosides,
vancomycin, cyclosporine, and other nephrotoxic drugs which
enhance the renal impairment of AMB
Monitor hepatic and renal functions, blood counts, electrolytes.
Avoid rapid infusion.
Chapter 28: Antifungal Drugs 211

Fluconazole
Brand Name: Forcan (Cipla)
Indications: Mucosal candidiasis, systemic candidiasis, cryptococcosis
(meningitis)prophylaxis against fungal infections after cytotoxic
chemotherapy/radiotherapy and in immunocompromised hosts.
Available as:
Capsules 50 mg, 150 mg, 200 mg
Injection 2 mg/mL, 100 mL infusion bottle.
Dose: 3 to 6 mg/kg/day once a day (O) in children > 1 year age.
ADRs: Nausea, abdominal pain, taste perversion, headache,
dizziness, rash, exfoliative dermatitis, hepatotoxicity.
Drug interaction: Rifampicin, anticoagulants, theophylline,
cyclosporine, cisapride, phenytoin, short-acting benzodiazepines,
zidovudine, cimetidine, thiazide.
Contraindications: Pregnancy, lactation.
Precaution: Impaired renal function.

Azoles

Itraconazole
Brand Name: Candistat (Merck)
A first generation triazole.
Indications: Vulvovaginal, oropharyngeal candidiasis, pityriasis
versicolor, dermatophytosis, onychomycosis, histoplasmosis,
coccidomycosis (including meningeal involvement), paracocci
domycosis, sporotrichosis systemic mycosis; also for prevention of
relapse in subjects with AIDS and disseminated histoplasmosis.
Available as: Capsules 100 mg.
Dose: 3 to 5 mg/kg/day OD.
Fungal infection with chronic granulomatous disease 5 to 10
mg/kg/day once or in two divided doses
Disseminated histoplasmosis 6 to 8 mg/kg/day.
ADRs: Nausea, vomiting, hypokalemia (with excess dose), head
ache, neuropathy, allergic reactions, hair loss, cholestatic jaundice,
hepatitis, CHF.
212 Section 3: Drugs for Infections and Infestations

Drug interactions: Such drugs as H2 blockers and gastric proton


pump inhibitors that cut down the gastric acidity reduce its
blood levels by 50 percent. Rifampicin, isoniazid, phenytoin,
Phenobarbital, carbamazepine and cisapride also decrease its
blood levels to some extent.
Contraindications: Pregnancy, lactation.
Precautions: Avoid prolonged use, and in decreasaed gastric acidity
and hepatic and renal impairments. Monitor liver and renal status.

Ketoconazole
Brand Name: Funazole (Khandelwal)
Indications: Superficial and systemic fungal infections.
Available as: Tablet 200 mg.
Dose: 3.3 to 6.6 mg/kg/day OD.
ADRs: Hepatotoxicity.
Contraindications: Liver dysfunction and children < 2 years.
Precaution: Avoid in liver disease. Monitor LFT during therapy.

Miconazole
Brand Names: Daktarin (Ethnor), Micogel (Cipla)
Indications: Fungal and gram-positive bacterial infections of the
skin, nails and vagina.
Available as: Topical gel and powder.
Dose: Apply to lesions twice daily and continue 10 days beyond the
healing of the lesions. Nail disease needs at least 3 month therapy.
Drug interaction: Warfarin.
Precaution: Avoid contact with eyes and during lactation, preg
nancy and superinfections.

Voriconazole
Brand Name: Vfend (Pfizer)
A second generation triazole with enhanced antifungal spectrum.
Indications: Invasive aspergillosis, candidemia in non-neutropenic
subjects, fluconazole-resistant serious invasive Candida infections.
Available as: Tablets 50 mg, 200 mg.
Chapter 28: Antifungal Drugs 213

Dose: Recommended for > 2 year age


< 25 kg 6 to 10 mg/kg/day in two divided doses
25 to 40 kg 200 mg every 12 hr for 2 doses (loading dose)
followed by 100 mg every 12 hr
40 kg 400 mg every 12 hr for two doses followed by 200 mg
every 12 hr.
ADRs: Elevated LFT, rash, visual disturbances, including transient
photophobia and blurred vision.
Drug interactions: Rifampicin, phenobarbital, carbamazepine lower
its concentrations. It raises the levels of cisapride, cyclosporine,
omeprazole, quinidine, tacrolimus and warfarin.
Contraindications: Pregnancy, lactation.
Precautions: Monitor liver and renal function.

Allylamine

Terbinafine
Brand Name: Exifine (Dr Reddys Lab)
Indications: Dermatophyte infections of skin and nails.
Available as:
Tablets 125 mg, 250 mg
Topical 1 percent cream.
Dose:
125 to 250 mg OD for 4 to 12 weeks, higher dose is for
fingernail infections. In case of big toe-nail infection, 3 to 6
months therapy is recommended
For topical application, 1 percent cream is required to be
massaged into affected area once or twice daily for 1 to 2
weeks, avoiding the eyes and mucous membrane.
ADRs: GI upset, taste disturbance, headache, fatigue, malaise,
hypo- or paraesthesia, rash, arthralgia, myalgia; liver dysfunction;
hematologic dysfunction in the form of pancytopenia,
thrombopenia, agranulocytosis, Stevens-Johnson syndrome,
psoriasis and SLE-like skin lesions.
Drug interactions: Hepatic enzyme inhibitors-like cimetidine,
inducers like rifampicin, drugs affecting cytochrome P450;
antidepressants, beta-blockers, MAOIs type B; cyclosporine.
214 Section 3: Drugs for Infections and Infestations

Contraindications: Liver disease (active or chronic), lactation


Precaution: Monitor LFT.

Miscellaneous Antifungals

Griseofulvin
Brand Names: Grisactin Forte (CFL Pharma), Walavin-250 (Wallace)
Indications: Fungal infections of skin, hair and nails.
Available as: Tablet 250 mg.
Dose: 10 to 20 mg/kg/day (O) in 4 divided doses.
ADRs: GIT upset, drowsiness, headache, GIT upset, urticaria,
photosensitivity, SLE precipitation.
Drug interaction: Alcohol, barbiturates, coumarin anticoagulants,
oral contraceptives.
Contraindications: Porphyria, hepatocellular failure, hypersensitivity,
monilial infection, pregnancy, SLE.
Precaution: Lactation, long-term use.

Nystatin
Brand Name: Mycostatin (Sarabhai)
Indications: Fungal infections, especially Candida albicans affecting
intestines.
Available as:
Tablets 5 lakh units
Suspension 1 lakh units/mL.
Dose:
Newborn: 4 lakh units/day (O) in divided doses
Later period: 1 to 2 million units/day in 4 divided doses.
ADRs: GIT upset in the form of nausea, vomiting and diarrhea,
especially in high doses; hypersensitivity reactions.
Drug interactions: None.
Contraindication: Allergy.
Precaution: Avoid giving feed for sometime after the medication;
continue therapy a few days after the lesions have disappeared.
Chapter

29
Antimalarial Drugs

As a guiding principle, WHO and IAP recommend artemisinin


combination therapy (ACT) in falciparum malaria which shows very
high resistance to chloroquine.

Sulfamethoxypyrazine with Pyrimethamine


Brand Name: Metakelfin
Indications: Malaria, especially falciparum, resistant to chloroquine.
Available as: Tablets containing 500 mg sulfamethopyrazine (SMP)
and 25 mg pyrimethamine.
Dose:
25 mg/kg, with reference to sulfamethopyrazine (SMP), or
1 mg/kg with reference to pyrimethamine as a single dose.
For prophylaxis, same dose at fortnightly intervals.
ADRs: Rash (mild and transient), blood dyscrasia, acute hemolytic
anemia in G6PD deficiency.
Contraindication: Allergy to sulfas.
Precaution: Avoid its use in G6PD deficiency. It is a suppressive
treatment and needs to be followed by primaquine therapy in
positive cases.

Sulfadoxine with Pyrimethamine


Brand Names: Laridox, Malocide, Croydoxin FM
Indications: Malaria, especially falciparum, resistant to chloroquine.
Available as: Tablets containing 500 mg sulfadoxine (sulfor
methoxine) and 25 mg pyrimethamine.
216 Section 3: Drugs for Infections and Infestations

Dose:
25 mg/kg with reference to sulfadoxine or 1 mg/kg with
reference to pyrimethamine as a single dose
For prophylaxis, same dose should be repeated at fortnightly
intervals.
ADRs: Vomiting, pruritus, leukopenia, rash (mild and transient),
blood dyscrasia and acute hemolytic anemia, especially in G6PD
deficiency). Rarely it may cause Stevens-Johnson syndrome,
hepatitis, psychosis, vertigo and renal complications.
Contraindication: Allergy to sulfas.
Precaution: Avoid its use in individuals with G6PD deficiency. It is
a suppressive treatment and needs to be followed by primaquine
therapy in positive cases.

Amodiaquine Hydrochloride
Brand Name: Camoquin (Pfizer)
Indications: Malaria, both treatment and prophylaxis.
Available as: Tablet 200 mg.
Dose: 10 mg/kg day with a maximum dose of 600 mg (O) as single
dose. If maintenance dose required (as in case of unimmunized
children), give 5 mg/kg/day for 2 more days.
ADRs: Diarrhea, vomiting and vertigo are the ones most commonly
encountered; agranulocytosis, hepatitis, peripheral neuropathy,
corneal deposits, visual disturbances, skin and nail pigmentation
(with frequent use).
Contraindications: Concurrent administration of other antimalarials
Caution: Monitor regularly with blood, liver and ophthalmic tests.
Remarks: Also available as plain amodiaquine (Basoquin-Pfizer)
providing 150 mg base/5 mL.

Artemether
Brand Names: Arte-plus (Zydus Cadila), Lumerax (Ipca)
A derivative of artemisinin, the active principle of Artemisia annua
employed in Chinese traditional medicine, as Qinghaosu. It is lipid
soluble and given either orally or intramuscularly (never intravenously).
Chapter 29: Antimalarial Drugs 217

Indication: Acute falciparum malaria. Oral for uncomplicated


chloroquine/MDR and injectable for complicated malaria.
Available as:
Tablets artemether 20 mg and lumefantrine 120 mg
IM injection 80 mg/mL.
Dose:
5 to 15 kg 1 tablet, 15 to 25 kg 2 tablets, 25 to 35 kg 3 tablets
Adolescents: 4 tablets. This dose is to be administered stat and
then at 8 hour, 24 hours, 36 hour, 48 hour and 60 hour
IM dose: Day 13.2 mg/kg. Then, 1.6 mg/kg OD for 4 days
(total dose 9.6 mg/kg).
ADRs: Headache, dizziness, sleep disorders, GIT upsert, palpitation,
anorexia, pruritus, rash, arthralgia, myalgia, asthma, fatigue, QT
prolongation, paresthesia, gait disturbances, liver dysfunction.
Contraindications: G6PD deficiency, immunocompromised states.
Drug interaction: Inhibitors of CY344, drugs prolonging QT
interval, neuroepileptics, antifungals, antidepressants, macrolides,
quinolones, cisapride, other antimalarials.
Caution: Severe cardiac, renal and hepatic impairment. Monitor
ECG and potassium.

Artesunate
Brand Names: Arnate, Falcigo
A derivative of artemisinin, the active principle of Artemisia annua
employed in Chinese traditional medicine, as Qinghaosu. It is water-
soluble and given orally, intramuscularly or intravenously.
Indication: Acute falciparum malaria. Oral for uncomplicated
chloroquine/MDR and injectable for complicated malaria.
Available as:
Tablets 50 mg
Injection 60 mg/vial.
Dose:
4 mg/kg (O) followed by 2 mg/kg on day 2 and 3 and 1 mg/kg
on day 4 to 7
Injection 2 to 4 mg/kg/dose (IM, IV) stat. Then 1.2 mg/kg/dose
(IM, IV) after 12 to 24 hours
Thereafter 1.2 mg/kg/dose (IM, IV) OD 6 days.
218 Section 3: Drugs for Infections and Infestations

ADRs: Headache, dizziness, sleep disorders, GIT upsert, palpitation,


anorexia, pruritus, rash, arthralgia, myalgia, asthma, fatigue, QT
prolongation, paresthesia, gait disturbances, liver dysfunction.
Contraindications: G6PD deficiency, immunocompromised states.
Drug interaction: Inhibitors of CY344, drugs prolonging QT
interval, neuroepileptics, antifungals, antidepressants, macrolides,
quinolones, cisapride, other antimalarials.
Caution: Severe cardiac, renal and hepatic impairment. Monitor
ECG and potassium.

Chloroquine Sulfate
Brand Names: Nivaquine (Nicholas Piramal), Lariago (Ipca), Resochin
(Bayer)
Indications: Malaria, reactional states in leprosy; at times rheumatoid
arthritis, discoid lupus erythematosus; extraintestinal amebiasis.
Available as:
Tablets 200 mg (150 mg base)
Syrup 50 mg/5 mL (base)
Injection 40 mg/mL (base).
Dose: For P. vivaxIn terms of base, starting dose 10 mg/kg, then
repeat 5 mg/kg at 6, 24 and 48 hours intervals (total of 25 mg/kg).
For P. falciparum10 mg/kg stat followed by 10 mg/kg at 24 hours
and 5 mg/kg at 48 hours. Total dose remains 25 mg/kg.
Prophylactic dose: 5 mg/kg once a week.
i. For cerebral malaria, dose is 5 to 10 mg/kg (maximum of 300
to 400 mg base) which should be given intramuscularly. If
intravenous administration is considered essential, 1/10th
of the calculated dose may be given intravenously and the
remaining intramuscularly. Parenteral overdose may cause
fatal convulsions and cardiovascular collapse.
ii. Parenteral administration may also be indicated in malaria
in an unconscious child or in the presence of persistent
vomiting.
ADRs: Nausea, vomiting, headache, visual disturbances, hepatic
dysfunction, blood dyscrasias, pruritus, rash, neurologic changes,
dystonic reactions, susceptibility to phenothiazine toxicity, rarely
retinopathy may occur with its long-term use.
Chapter 29: Antimalarial Drugs 219

In the event of gross overdosage, vomiting should be induced


or gastric lavage done promptly. This should be followed by
appropriate resuscitative measures. Tracheal intubation with
artificial respiration, use of vasopressor agents and cardiac
massage are indicated. Intravenous molar lactate (1/6) is of
value to counter the quinidine-like action of chloroquine on the
myocardium. To enhance excretion of chloroquin.
Contraindications: Retinal or visual field changes; injectable form
must not be given to children < 5 years.
Drug interactions: Antacids, cimetidine, digoxin, mefloquine,
cyclosporine, rabies vaccine, anticoagulants, neostigmine, phy
sostigmine, amiodarone, hepatotoxic agents, ampicillin.
Caution: Avoid administration during dehydration. Else, dystonic
reaction may occur.

Mefloquine
Brand Name: Meflotas (Intas)
Indications: Resistant malaria; also for prophylaxis.
Available as: Tablet 250 mg.
Dose:
For prophylaxis, once a week
i. 5 to 19 kg tablet
ii. 20 to 30 kg tablet
iii. 31 to 45 kg tablet
iv. Adolescents1 tablet
For treatment: 15 mg/kg/day with a maximum of 1 g in 1 or
2 doses 6 to 8 hourly.
Contraindications: Hypersensitivity to quinine, severe hepatic
impairment, active depression, generalized anxiety disorder,
seizures.
Drug interactions: Quinine, ketoconazole, rifampicin, drugs
affecting cardiac conduction, beta-blockers, calcium channel
blockers, antihistaminics, phenothiazines, anticonvulsants, tricyclic
antidepressants, oral typhoid vaccine.
Caution: Pregnancy, lactation, renal and hepatic impairment,
epilepsy, cardiac conduction disorders, children < 14 years.
220 Section 3: Drugs for Infections and Infestations

Doxycycline
Brand Names: Biodoxi (Biochem), Doxypal (Jagsonpal)
Indications: Malaria prophylaxis, treatment of complicated malaria
in conjunction with other antimalarias. Also several bacterial,
protozoal and Rickettsial infections.
Available as: Tablet 100 mg.
Dose: 2 to 5 mg/kg/day (maximum 200 mg) as a single dose or in 2
divided doses.
ADRs: Nausea, vomiting, abdominal pain, dryness of mouth,
CI. difficile-associated diarrhea (CDAD); photosensitivity, Stevens-
Johnson syndrome; hemolytic anemia; superimposed infections,
e.g. vaginitis; pseudotumor cerebri (on withdrawal); infrequently,
esophagitis; in young children (< 8 years), tooth discoloration
(permanent staining), enamel hypoplasia, and retarded growth of
fibula.
Contraindications: Known hypersensitivity; children < 8 years.
Drug interactions: Antacids, laxatives, oral iron, oral anticoagulants;
carbamazepine, phenytoin, barbiturates reduce its half-life.
Caution:
Monitor hepatic and renal parameters
Avoid exposure to sunlight/ultraviolet rays during therapy
Avoid in children <8 years in the wake of risk of permanent
staining of teeth and growth retardation.

Primaquine Phosphate
Brand Names: Malirid (Ipca), PMQ INGA (Inga)
Indications: Malaria, for obtaining radical cure, especially P. vivax
and P. ovale.
Available as: Tablets 2.5, 5, 7.5, 15 mg.
Dose: To be administered for 14 successive days in the dose
varying with age preferably after excluding significant G6PD
deficiency. In terms of body weight, dose is 0.25 mg/kg/day for 14
days. According to National Anti-malaria Program (NAMP), a 5-day
course is sufficient. In case of falciparum malaria, dose is 0.75 mg/
kg but once only. Beyond 12 years, dose is 15.0 mg.
Chapter 29: Antimalarial Drugs 221

Subjects with borderline G6PD deficiency should receive a dose


of 0.7 mg/kg once only in case of falciparum infection and once a
week for 3 weeks in case of vivax malaria.
ADRs: GIT upset, intravascular hemolysis, anemia, methemo
lobinemia, agranulocytosis.
Primaquine need to be given to subjects with P. falciparum
infection as well for gametocytocidal action. However, it is
sufficient to give it once only but in 2 to 3 times the dose for vivax
malaria. It is to be noted that primaquine therapy should not be
started right from the first day when antimalarial treatment is
initiated. This is likely to precipitate complications and may result
in fatality. Also, remember that primaquine should not be given to
malaria cases unless the hemoglobin level is 7 g% or above.
Contraindications: G6PD deficiency, SLE, rheumatoid arthritis,
bone marrow depression, when hemolysis-producing agents are
being administered.
Drug interactions: Quinacrine.
Caution: Monitoring of CBC; severe anemia with Hb < 7 g/dL,
pregnancy, lactation. Primaquine needs to be given to only MP-
positive cases, preferably after excluding G6PD deficiency if facility
is available.

Quinine Sulfate
Brand Name: Qininga (Inga)
Indications: Malaria resistant to routine antimalarial drugs.
Available as:
Tablets 100, 300 mg
Injection 150, 300 mg/mL.
Dose:
25 mg/kg/day in 3 divided doses (O) for 7 days
20 mg/kg/dose (IV) by slow infusion over 4 hours. Repeat 10
mg/kg at intervals of 8 hours till clinical response occurs and
patient can swallow tablets.
ADRs: Acute hemolytic anemia, vertigo, thrombocytopenia,
tinnitus, headache, dizziness, abdominal pain, nausea, vomiting,
diarrhea, blurring of vision, flushing, confusion; rash lupus-like
222 Section 3: Drugs for Infections and Infestations

syndrome, Stevens-Johnson syndrome; blood dyscrasias, acute


renal failure, hypoglycemia, chest pain, AV block; cinchonism.
Contraindications: Tinnitus, optic neuritis, myasthenia gravis,
hemoglobinuria, prolonged QT interval, G6PD deficiency,
hemolytic uremic syndrome, thrombocytopenia, blackwater fever-
associated previous quinine administration, hypersensitivity.
Drug interactions: Antacids, muscle relaxants, theophylline,
anticoagulants, erythromycin, drugs prolonging QT interval
(quinidine, pracainamide, amiodarone).
Caution: Atrial fibrillation, cinchonism, renal/hepatic impairment,
conduction defects, heart block, cardiac arrhythmias, hypoglycemia,
hypokalemia, bradycardia; pregnancy, lactation. Blood glucose
monitoring needed.
Chapter

30
Antiparasitic (Intestinal)
Drugs

Antiprotozoal Drugs

Albendazole
Brand Names: Albezole (Khandelwal), Emanthal (MM Labs), Nemozole
(Ipca), Zentel (GSK )
A broad-spectrum agent, belonging to the benzimidazole group of
drugs. It acts by synthesis of the parasites microtubules and also by
decreasing glucose uptake.
Indications: Giardiasis. Also employed in nematodes and cestodes,
including hydatid disease.
Available as:
Tablets 400 mg
Syrup 200 mg/5 mL.
Dose: Under 2 years: 200 mg; later 400 mg (O) for 5 successive days.
ADRs: Abdominal discomfort, diarrhea/constipation, dizziness,
rash, fever, reversible alopecia, hematologic and liver enzyme
changes; convulsions and meningism in cerebral disease; acute
renal failure, aplastic anemia, agranulocytosis, rash.
Drug interactions: Theophylline, oral contraceptives, oral
hypoglycemic, anticonvulsants, anticoagulants, potentiated by
dexamethasone, praziquantel, cimetidine, etc.
Contraindications: Pregnancy.
Precaution: Avoid in liver disease, lactation and hyperactive
onchodermatitis; make sure the tablet is properly chewed before
it is swallowed.
224 Section 3: Drugs for Infections and Infestations

Diloxanide Furoate
Brand Name: Amicline (Franco-Indian) Furamide (Knoll)
A purely luminal amebicide.
Indications: Intestinal amebiasisprevention, symptom free cyst
passers, acute/chronic intestinal. It is effective as an intraluminal
amebicidal with no role in hepatic amebiasis.
Available as: Tablet 500 mg.
Dose: 20 mg/kg/day in 3 divided doses for 7 to 10 days.
ADRs: Very safe. Occasionally, nausea, flatulence and abdominal
discomfort; rash, urticaria, pruritus.
Drug interactions: None.
Contraindications: Hypersensitivity to diloxanide furoate.
Precautions: Avoid in lactation and pregnancy.

Furazolidone
Brand Name: Furoxone (GSK)
Indications: Giardiasis, nonspecific diarrhea, bacterial diarrhea,
cholera.
Available as:
Tablet 100 mg
Suspension 25 mg/5 mL.
Dose: 6 to 10 mg/kg/day in 3 to 4 divided doses for 7 to 10 days.
ADRs: High-colored urine, nausea, vomiting, arthralgia, rash,
hemolytic anemia in G6PD deficiency, hypotension, headache
Drug interactions: Alcohol, tyramine-containing foods; MAOIs,
sympathomimetic amines.
Contraindication: G6PD deficiency, neonates.

Metronidazole
Brand Names: Flagyl, Unimezole, Giardyl, Monizole, Metrogyl, Emigyl
Indications: Giardiasis. Also in amebiasis; trichomoniasis; anaerobic
infections; acute ulcerative gingivitis; dracunculiasis.
Available as:
Tablets 200, 400, and 600 mg
Chapter 30: Antiparasitic (Intestinal) Drugs 225

Suspension 100, 200 mg/teaspoonful


Injection 2 mg/mL.
Dose:
10 to 20 mg/kg/day (O) for 5 to 7 days in divided doses for
giardiasis
20 to 50 mg/kg/day (O) for 10 days in divided doses for
amebiasis
21 mg/kg/day (IV) in 3 divided infusions for severe amebiasis
and anerobic infections.
ADRs: Metallic taste lasting for some days, nausea, vomiting,
headache, diarrhea, dizziness, rash, itching, furred tongue,
incoordination, leukopenia, hypotension, poor tolerance with
alcohol.
Drug interactions: Phenobarbital, phenytoin, hepatic enzyme
inducers, alcohol, oral anticoagulants, cimetidine, disulfiram.
Contraindications: Active CNS disease, blood dyscrasias, first
trimester of pregnancy, lactation.
Precaution: Avoid in children weighing < 15 kg.

Nitazoxanide
Brand Names: Nitarid (Cipla), Netazox (Ind-swift)
Indications: Giardiasis, amebiasis, cryptosporidiosis, fascioliasis,
C. parvum. Also in ascariasis, trichuriasis, H. nana, H. pylori.
Available as:
Syrup 100 mg/5 mL
Tablets 200, 500 mg.
Dose:
7 to 10 mg/kg/dose BD 3 days
1 to 4 year 100 mg BD
4 to 11 year 200 mg BD
> 11 year 500 mg BD.
It should be administered with food.
ADRs: GIT upset including abdominal pain, anorexia, headache,
dizziness, eye or urine discoloration, increased creatinine/SGPT.
Drug interaction: Highly protein-bound drugs.
Contraindication: Diabetes mellitus.
226 Section 3: Drugs for Infections and Infestations

Precaution: Avoid giving on empty stomach; avoid in children


< 1 year, in hepatic/biliary impairment, immunocompromised
state, diabetes, pregnancy, lactation.

Ornidazole
Brand Names: Zil (Sarabhai), Ornid erobic infections
Indications: Giardiasis, amebiasis, trichomoniasis, anaerobic
infections.
Available as: Tablet 500 mg.
Dose:
L. giardia: 40 mg/kg/day for 2 days
E. histolytica: 40 mg/kg/day for 3 days
Anaerobes: 40 mg/kg/day in 2 divided doses for 5 to 7 days.
ADRs: GI upset (nausea, vomiting, anorexia), furrowed tongue,
unpleasant taste, urticaria, angioedema, dark urine, leukopenia,
neuropathy and epileptiform seizures on chronic therapy.
Drug interactions: Alcohol, anticoagulants.
Contraindications: First trimester of pregnancy, lactation;
hypersensitivity; neurologic disorders, blood dyscrasias.
Precautions: Avoid in subjects suffering from CNS disorders.

Secnidazole
Brand Name: Secnil forte (Nicholas Piramal)
Indications: E. histolytica, L. giardia, T. vaginalis.
Available as: Tablet 2 g.
Dose: 30 mg/kg with a maximum of 2 g as a single dose once only.
ADRs: Mild GI upset (nausea, vomiting, diarrhea, epigastric pain,
anorexia), fatigue, headache, rash, urticaria, seizures, peripheral
neuropathy; leukopenia.
Drug interaction: Alcohol, disulfiram, warfarin.
Contraindication: Lactation and pregnancy.

Tinidazole
Brand Names: Fasigyn (Pfizer), Tiniba (Zydus ALIDAC)
Indications: Giardiasis, amebiasis. Also urogenital trichomoniasis,
ulcerative gingivitis and anaerobic infections.
Chapter 30: Antiparasitic (Intestinal) Drugs 227

Available as: Tablets 150, 300, 500, 600, 1000 mg.


Dose:
50 to 60 mg/kg as a single dose for giardiasis and trichomoniasis
Or
10 to 15 mg/kg/day for 5 to 7 days
50 to 60 mg/kg/days on 3 successive days for amebiasis. In
severe intestinal amebiasis and/or amebic liver abscess, a
5-day course is preferred.
ADRs: GIT upset, metallic taste, furred tongue, urticaria,
angioedema, neuropathy, dark urine, leukopenia.
Drug interaction: Alcohol.
Contraindications: Neurologic disorders, blood dyscrasias, lactating
mothers, first trimester of pregnancy.
Precautions:
Avoid concomitant use of alcohol
Discontinue in case neurologic adverse reactions
Avoid in liver disease, lactation and hyperactive onchodermatitis.

Anthelmintics

Albendazole
Brand Names: Albezole (Khandelwal), Emanthal (MM Labs), Nemozole
(Ipca), Zentel (GSK)
Indications: Ascariasis, enterobiasis, ancylostomiasis trichuriasis,
strongyloidiasis, teniasis; neurocysticercosis; filariasis (in
combination with ivermectin). Also in giardiasis.
Dose: Most helminths 200 to 400 mg. Neurocysticercosis 15 mg/
kg/day for 28 days.
For details, see page 223.

Ivermectin
Brand Name: Ascapil (Nicholas Piramal)
A broad-spectrum antiparasitic and antimute drug.
Indications: Strongyloidiasis, ascariasis, cutaneous larva migrans;
also scabies, lice, filariasis, onchocerciasis.
Available as: Tablet 6 mg.
228 Section 3: Drugs for Infections and Infestations

Dose:
Ascariasis: 150 to 200 mcg/kg once
Strongyloidiasis: 200 mcg/kg once only
Trichuriasis: 200 mcg/kg OD for 3 days
 Filariasis: 150 mcg/kg once; to be repeated every 6 to 12 month
until the patient becomes symptom-free
Cutaneous larva migrans: 200 mcg/kg OD for 1 to 2 days
Onchocerciasis (River blindness): 150 mcg/kg once only
Loaiasis: 150 mcg/kg once only
Lice: 200 mcg OD 3 dayssay day 1, 2 and 10
Scabies: 200 mcg once.
ADRs: GI upset, worsening of asthma, rash, fever, headache,
dizziness, giddiness, chest pain, pruritus, seizures; abnormal LFT;
rarely ataxia, mydriasis and respiratory paralysis may occur when
given in high doses. Disease-specific ADRs are known.
Drug interaction: Warfarin.
Contraindication: Pregnancy.
Precaution: Avoid < 5 yr age and < 15 kg weight. Do not exceed
12 mg total dose.

Levamisole
Brand Names: Vermisol (Khandelwal), Vizole (MM Labs)
Indications: Ascariasis, ancylostomiasis; also for immuno
potentiation.
Available as:
Tablets 50, 159 mg
Syrup 50 mg/5 mL.
Dose:
Ascariasis: 2.5 mg/kg (O) as a single dose
Ancylostomiasis: 2.5 to 5 mg/kg/dose every 6 hr till 4 doses are
given
 Immunopotentiation: 2 mg/kg/day on alternate days for 4 to 6
weeks
It is advisable to give a repeat course after a month to prevent/
treat reinfestation/recurrence.
ADRs: GI upset, insomnia, altered taste, bodily pains, dermatitis,
flu-like symptoms depression.
Chapter 30: Antiparasitic (Intestinal) Drugs 229

Drug interaction: Warfarin.


Contraindications: Liver and kidney insufficiency.
Precautions: Pregnancy, lactation, rheumatoid arthritis.

Mebendazole
Brand Names: Pantelmin, Mebex (Cipla), Mendazole, Wormin (Cadila)
Indications: Ascariasis, enterobiasis, ancylostomiasis, trichuriasis,
strongyloidiasis, T. solium and T. saginata.
Available as:
Tablet 100 mg
Syrup 100 mg/5 mL
Granules 200 mg/5 g sachet.
Dose:
Threadworm 1 tablet/5 mL (single dose once only)
Roundworm 1 tablet/5 mL (single dose once only)
Hookworm 1 tablet/5 mL (single dose once only)
Trichuris trichiura 1 tablet/5 mL twice daily for 3 successive
days
T. solium 2 tablets/5 mL twice daily for 3 successive days
T. saginata 2 tablets/5 mL twice daily for 3 successive days
Strongyloides stercoralis 2 tablets/5 mL twice daily for 3
successive days.
ADRs: Slight GIT upset, abdomen pain, diarrhea, exanthema,
urticaria, angioedema.
Drug interactions: Cimetidine, metronidazole.
Contraindications: Pregnancy, lactation.

Mepacrine
Brand Names: Quinacrine, Atabrine
Indications: Giardiasis, H. nana infestation.
Available as: Tablets 100 mg.
Dose:
L. giardia: 5 mg/kg/day in 3 divided doses for 5 to 7 days.
 H. nana: 15 mg/kg (maximum 8 g) as a single dose, preferably
through Ryles tube followed by a mild purgative.
ADRs: Very bitter. GI upset, jaundice-like skin and mucous
membrane discoloration, rash, seizures, psychosis.
230 Section 3: Drugs for Infections and Infestations

Drug interaction: None.


Contraindications: Advanced liver disease, psychosis, blood
disorders, hypersensitivity.
Precautions: When a large dose is to be given as in case of
tapeworms, it is advisable to give it through a Ryles tube preceded
by an antiemetic. Secondly, in order to flush out the worms, it is
important to give a mild purgative after the administration of the
drug through the tube.

Pyrantel Pamoate
Brand Name: Nemocid (Mexin)
Indications: Ascariasis, enterobiasis, ancylostomiasis, trichuriasis,
strongyloidiasis
Available as: Tablets 125, 250 mg. Suspension 100, 250 mg/5 mL
Dose: 10 mg/kg with a maximum of 500 mg as a single
administration. A repeat dose may be given after a fortnight.
Whereas as low a dose as 5 mg/kg may suffice for ascariasis, heavy
infestation with hookworm needs either an extended course of
3 days or 20 mg/kg/day dose for 2 days.
ADRs: Rash, pruritus, gI upset, disturbed taste, rise in body
temperature, hepatotoxicity, myasthenia-like symptoms; leuko
penia, thrombocytopenia, albuminuria.
Precaution: Hepatic insufficiency.

Niclosamide
Brand Name: Niclosan (GSK)
Indications: Tapeworm infestations.
Available as: Chewable tablet 500 mg.
Dose: 40 mg/kg (O) as a single dose with a maximum of 2 g for
T. solium, T. saginata and Diphyllobothrium latum (fish tapeworm).
For H. nana, the same dose needs to be given for 5 to 7 successive
days.
ADRs: GIT upset (nausea, vomiting, diarrhea, stomatitis, pain
abdomen), rarely cysticercosis in T. solium infestation, ataxia,
headache, rash, sleep disturbances, paresthesia.
Precaution: Tablets must be chewed thoroughly before being
swallowed or finely ground and mixed with some liquid before
Chapter 30: Antiparasitic (Intestinal) Drugs 231

these are ingested. The child must receive a purgative 1 to 2 hours


after drug administration to clear the bowel of the dead segments
before these are digested. This is important to safeguard against
risk of cysticercosis from the liberated ova.

Nitazoxanide
Brand Name: Nitarid (Cipla), Nitazox (Ind-Swift)
Indications: Ascariasis, trichuriasis, H. nana. Also giardiasis,
amebiasis cryptosporidiosis, fascioliasis, C. parvum, H. pylori.
For details, see page 225.

Paromomycin
Brand Name: Humantin
An aminoglycoside antibiotic.
Indications: Tapeworms, L. giardia, E. histolytica.
Additional: Visceral leishmaniasis, cryptosporidiosis.
Available as: Capsule 250 mg.
Dose:
Tapeworms: 40 to 50 mg/kg/day in 4 divided doses every 15
min (in H. nana, it is given once a day for 7 days)
L. giardia: 30 mg/kg/day in 3 divided doses for 10 days
E. histolytica (eradication of cysts): 30 mg/kg/day in 3 divided
doses.
ADRs: GI upset, rash, pruritus, dizziness, vertrigo, hematuris,
myalgia.
Drug interaction: Atracurium.
Contraindication: Hypersensitivity.
Precaution: Avoid driving during treatment.
Special remarks: Permitted even in pregnancy and lactation.

Piperazine
Brand Name: Antepar
Indications: Ascariasis (first line drug for ascariasis with intestinal or
biliary obstruction), oxyuriasis (enterobiasis).
Available as:
Tablets 500 mg
Syrup 750 mg/5 mL.
232 Section 3: Drugs for Infections and Infestations

Dose:
Ascariasis: 100 to 150 mg/kg as a single administration
Or
50 to 75 mg/kg OD for 2 days
Oxyuriasis (enterobiasis): 50 to 75 mg/mg/kg/day.
ADRs: Rash, vomiting, blurring of vision, muscle weakness, may
precipitate/aggravate seizures.
Contraindications: Seizure disorder.
Precaution: Avoid in epileptic children. It is advantageous to repeat
the course after a month for preventing recurrence/relapse.

Praziquantel (PZQ)
Brand Name; Biltricid (Bayer)
A pyrazinoisoquinoline derivative, readily absorbed from the gut,
metabolized in liver and crosses the blood-brain barrier (BBB).
Indications: Tapeworm infestation; cysticercosis (now second line
choice to albendazole), D. latum, E. granulose, schistosomes liver
flukes.
Available as: Tablet 500 mg.
Dose:
50 to 100 mg/kg/day (O) in 3 divided doses for 7 to 28 days
for neurocysticorcosis in which case dexamethasone therapy
to counter high intracranial tension and inflammatory flare-up
is also indicated
5 to 10 mg/kg (O) single dose once only for tapeworms and
liver fluke. In case of a poor response, 15 to 25 mg/kg single
dose may be given
40 mg/kg as a single dose in schistosomiasis in which it should
be considered the drug of choice.
ADRs: Headache, malaise, dizziness, nausea, vomiting, abdominal
pain; occasionally, urticaria, pruritus and fever low-grade),
localized edematous reaction due to its parasiticidal effect on
cysts in cerebrum.
Precaution: Breastfeeding needs to be interrupted for 3 days after
the dose for nursing mothers.
Chapter

31
Antiparasitic
(Extraintestinal) Drugs

Anti-filaria Drugs

Diethylcarbamazine (DEC)
Brand Names: Banocide (GSK), Hetrazan (Wyeth)
Indications: Filariasis, Loefflers pnemonia, occular larva migrans.
Avaiable as:
Tablets 50, 100 mg
Syrup 50, 100 mg/5 mL.
Dose:
Children with no demonstrable filarial in blood (say, tropical
eosinophilia): 6 mg/kg/day in 3 divided doses for 14 days.
Children with demonstrable filarial in blood:
i. Day 1: 1 mg/kg as a singledose.
ii. Day 2: 1 mg/kg TID.
iii. Day 3: 1 to 2 mg/kg TID.
iv. Day 4 to 14: 6 mg/kg/day in 3 divided doses.
Loefflers pneumonia (A. lumbricoides): 15 mg/kg OD for 4 days
Occular larva migrans: 6 mg/kg/day in 3 divided doses.
ADRs: Dizziness, headache, nausea, arthralgia, conjunctival
congestion; rarely psychosis.
Precautions: Lactation, renal impairment.

Antileishmania Drugs

Amphotericin B
See Chapter 28 Antifungal Drugs.
234 Section 3: Drugs for Infections and Infestations

Pentamidine Isethionate
Brand Names: Pentacarinate, Pentam
Indications: Leishmaniasis (antimony resistance/intolerance),
Pneumocystis carinii (P. jirovecii) pneumoniae.
Dose:
Localized leishmaniasis: 2 to 3 mg/kg/dose (IM) on alternate
days for 4 to 7 injections
Systemic leishmaniasis: 2 to 4 mg/kg/dose (deep IM) on
alternate days for 15 to 24 injections.
i. P. carinii: 4 mg/kg/day (in IV dextrose over 1 hour) for 14
days.
ii. Prophylaxis: 4 mg/kg/dose (IM, IV) every 2 to 4 weeks.
ADRs: Hypotension, hypoglycemia, nephrotoxicity, risk of diabetes.
Precaution: It is important to give IV dose slowly in dextrose over
1 hour period. When administered IM, injection should be deep
enough.

Sodium Stibagluconate
Brand Name: Pentavalent Antimony
Indication: Visceral and localized leishmaniasis.
Available as: Injection 100 mg/mL in 100 mL bottle.
Dose:
Localized cutaneous: 10 mg/kg/day (IV, IM) for 10 days.
Diffuse cutaneous: 20 mg/kg/day for 20 days.
Mucosal and visceral leishmaniasis: 20 mg/kg/day for an
extended period varing from 28 to 40 days.
Relapse: Therapy may be given for 60 days.
ADRs: Nausea, myalgia, arthralgia; fall in hemoglobin, TLC
and platelet counts; raised liver transaminases, ECG changes
(nonspecific flattening/inversion of T wave).
Precaution: Slow IV injection which should be discontinued in case
of substernal pain or cough.

Antimalarial drugs
See Chapter 29.
Chapter 31: Antiparasitic (Extraintestinal) Drugs 235

Anti-schistosomiasis drugs
See Praziquantel (PZQ) in Chapter 30.

Anti-toxoplasmosis Drugs

Pyrimethamine
Brand Name: Daraprim
Indication: Toxoplasmosis
Available as: Tablet 25 mg.
Dose:
 Congenital: 2 mg/kg/day (O) in 2 divided doses for 2 days
followed by 1 mg/kg/day (O) OD for 2 to 6 months. Thereafter,
1 mg/kg/day for 3 alternate days in a week till completion of 12
months of course
 Acquired: 2 mg/kg/day (O) in 2 divided doses for 2 days
followed by 1 mg/kg/day in 2 divided doses for 4 to 6 weeks.
Simultaneous administration of sulfadiazine (vide infra) is an
essential part of therapy of toxoplasmosis.
ADRs: Bone marrow depression; photosensitivity, rash, glossitis,
convulsions.
Precautions: Advisable to coadminister folinic acid (calcium
leucovirin) to safeguard against inhibition of folic acid synthesis
leading to bone marrow depression.

Sulfadiazine
Brand Name: Zad-G (Gufic)
Indications: Toxoplasmosis; urinary tract infection, meningococcal
meningitis; bacterial skin infections; alternative prophylaxis
against acute rheumatic fever.
Available as:
Tablet 500 mg
Injection 250 mg/mL
Cream 2.5 percent, 5 percent.
Dose:
100 to 150 mg/kg/day (O) in divided doses; 100 mg/kg/day (IV)
in divided doses
236 Section 3: Drugs for Infections and Infestations

500 mg to 1 g daily for alternative prophylaxis (patients allergic


to penicillin) in rheumatic fever.
ADRs: Allergic reactions including Stevens-Johnson syndrome,
crystalluria, cyanosis, jaundice, purpura hemolytic anemia in G6PD
deficiency.
Contraindication: Hypersensitivity.
Precaution: Generous intake of water needed during therapy;
avoid in G6PD deficiency subjects.

Antianthropode drugs
See Ivermectin in Chapter 30.
Section 4
Drug Therapy in Neonates

Chapter

32
Emergency Drugs in
Neonates

Box 32.1 lists commonly employed emergency drugs in neonates.

Box 32.1: Emergency drugs in neonates


Drugs
Adrenaline 1:10,000 (0.1 mg/mL)
Dose 0.10.3 mL/kg IV (preferred)
Dose 0.31 mL/kg ETT
For bradycardia:
Repeat q 35 minutes as needed
Never give via artery
Sodium bicarbonate 4.2% (0.5 mEq/mL)
Dose 2 mEq/kg IV
For metabolic acidosis:
Give IV over at least 2 minutes
Assure adequate ventilation before administration
Volume expanders
Dose 10 mL/kg IV
Normal saline (preferred)
Ringers lactate, O negative whole blood
Give IV over 510 minutes
Atropine 1 mg / 10 mL (0.1 mg/mL)
Dose 0.02 mg/kg IV, ETT
May repeat in 5 minutes 1 for bradycardia
Defibrillation
Dose 2 joules/kg
Naloxone (Narcan) 0.4 mg/mL
Dose 0.1 mg/kg IV (preferred) or IM
May repeat dose x3 as needed
For narcotic-induced respiratory depression:
Avoid use if suspected maternal narcotic addiction or methadone use
Contd...
238 Section 4: Drug Therapy in Neonates

Contd...

Drugs
Calcium gluconate (100 mg/mL)
Dose 100 mg/kg IV. Give over 510 minutes
May repeat in 10 minutes if needed
Calcium chloride 10% 1 gram/10 mL (100 mg/mL)
Dose 20 mg/kg IV
Infuse over 1 minute May repeat in 10 minutes if needed
Adenosine 3000 mcg/mL (6 mg/2 mL)
Mix 1 mL of adenosine in 9 mL NS = 300 micrograms/mL
Dose 50 mcg/kg rapid IV push (12 sec) closest to IV insertion site, follow
immediately with rapid saline flush. May repeat q 12 min as needed.
May increase by 50 micrograms/kg/dose to a maximum dose of 300
micrograms/kg for supraventricular tachycardia.
Chapter

33
Drug Dosage in
Neonates

General
Acetaminophen
10 to 15 mg/kg/dose q 4 to 6 hr.

Acetazolamide
25 mg/kg q day to start; increase to bid, tid and qid over 4 to 7 days.

Adenosine
0.05 mg/kg (IV) stat; every 2 minutes increase bolus dose by 0.05 mg/
kg until a clinical response follows or a maximum dose of either 0.25
mg/kg or 12 mg is reached.

Albumin Human
0.5 to 1 g/kg/dose.

Albuterol
0.1 to 0.5 mg/kg/dose pm or q 2 to 6 hr (nebulizer solution).
0.1 to 0.3 mg/kg/dose q 6 to 8 hr (O).

Alprostadil (Prostaglandin)
0.05 to 0.1 g/kg/min as continuous IV infusion; may be slowly
increased to a maximum of 0.4 g/kg/min or wean as low as 0.005 g/
kg/min depending on response.

Aminophylline
6 mg/kg (IV, O) loading dose; maintenance dose 2.5 to 3.0 mg/kg/dose
q 12 hr (IV, O).
240 Section 4: Drug Therapy in Neonates

Amrinone Lactate
0.75 mg/kg IV bolus over 2 to 3 minutes, follow with 3 to 5 mg/kg/
minute.
Continuous IV infusion.

Antihemophilic Factor
Units required = weight (kg)
0.5 desired increase in factor VIII (% of normal).

Atropine Sulfate
0.2 mg/kg 30 minutes preoperative; follow same dose every 4 to 6
hours.

Bumetanide
0.01 to 0.05 mg/kg/dose every 24 to 48 hours.

Caffeine Citrate
10 mg/kg (O, IV) loading dose, then maintenance dose 5 to 10 mg/kg/
day as 1 or 2 doses/day.

Calcitriol (Vitamin D Analog)


0.05 g/kg/day (IV)
1.0 g/day (O).

Calcium Salts
2.4 mEq/kg/day in divided doses.

Captopril
0.01 mg/kg every 8 to 12 hr (premature)
0.05 to 0.1 mg/kg/dose every 8 to 24 hr; titrate upward to response,
maximum dose 0.5 mg/kg/dose every 6 to 24 hr (full-term).

Carnitine
8 to 16 mg/kg/day (IV infusion).
Chapter 33: Drug Dosage in Neonates 241

Chloral Hydrate
25 mg/kg/dose (O).

Chlorothiazide
20 to 40 mg/kg/day divided every 12 hr (O)
2 to 8 mg/kg/day divided every 12 hr (IV).

Cimetidine
5 to 10 mg/kg/day (O, IM, IV) divided every 8 to 12 hr.

Cisapride
0.15 to 0.3 mg/kg/dose 3 to 4 times daily.

Citrate Solutions
2 to 3 mEq/kg/day (O) m 3 to 4 divided doses with water after meals.

Clonidine
1 g/kg every 6 to 8 hr; then up to 2 g/kg/dose every 4 hr.

Dexamethasone
0.25 mg/kg (IV) every 12 hr for 3 to 4 doses in airway edema or
extubation starting over 4 hr before scheduled extubation.
0.25 mg/kg/dose (O, IV) every 12 hr for 6 doses; taper over 1 to 6
weeks in bronchopulmonary dysplasia.

Digoxin
10 to 30 g/kg (IV), then 5 to 10 g/kg/day maintenance dose.

Dihydrotachysterol
0.05 to 0.1 mg/day.

Dobutamine
2 to 20 g/kg/min.
242 Section 4: Drug Therapy in Neonates

Dopamine
1 to 20 g/kg/min (IV) at infusion rate (mL/hr) = 6 weight (kg)
desired dose (g/kg/min)/mg/drug/100 mL IV fluid.

Dornase Alpha (DNA Enzyme)


2.5 mL 1 to 2 times daily nebulized with Pulmo-Aide or Pari-Proneb
compressor in cystic fibrosis.

Doxapram
2.5 to 3.0 mg/kg (IV), then follow with IV infusion of 1 mg/kg/hr with
maximum of 2.5 mg/kg/hr.

Epinephrine (Adrenaline)
0.01 to 0.03 mg/kg (0.10.3 mL/kg of 1:1000 solution) every 3 to 5 min
(IV, 1 Tr).

Erythropoietin (Epoetin)
100 to 500 units/kg/dose every 1 to 2 days for 10 to 21 days.

Folic Acid
25 to 35 g/day.

Glucagon
0.3 mg/kg/dose (IM, SC, IV) with a maximum of 1 mg.

Granulocyte Colony-stimulating Factor (G-CSF)


5 g/kg/dose daily for 3 to 6 doses.

Hydralazine
0.25 to 1.0 mg/kg/dose (O) every 6 to 8 hr.
0.1 to 0.5 mg/kg/dose (IV) every 6 to 8 hr.

Hydrochlorothiazide
2 to 4 mg/kg/day in 2 divided doses.
Chapter 33: Drug Dosage in Neonates 243

Hydrocortisone
Congenital adrenal hyperplasia 0.5 to 0.7 mg/kg/day (IV), follow with
0.3 to 0.4 mg/kg/day ( in morning, at noon and at night).

Adrenal Insufficiency
1 to 2 mg/kg (IV bolus) followed with 25 to 150 mg/day.

Shock
35 to 50 mg/kg (IV) followed with 50 to 150 mg/kg/day divided every
6 hr for 48 to 72 hr.

Indomethacin
0.10 to 0.25 mg/kg/dose every 12 hr for 3 to 6 doses for closure of
patent ductus arteriosus (PDA).

Insulin
Regular insulin 0.01 to 0.10 units/kg/hr continuous IV infusion or 0.1 to
0.2 units/kg every 6 to 12 hr.

Intravenous Immune Globulin (IVIG)


500 to 750 mg/kg (IV) once only.

Levothyroxine
8 to 10 g/kg/day.

Lorazepam
0.05 to 0.20 mg/kg/dose (IV) over 2 to 5 min; may be repeated in 10 to
15 min in status epilepticus.

Magnesium Sulfate
25 to 50 mg/kg/dose (IV) every 8 hr for 2 to 3 doses.

Methadone
0.05 to 0.2 mg/kg/dose every 12 hr; thereafter taper dose according
to abstinence score.
244 Section 4: Drug Therapy in Neonates

Metoclopramide
0.033 to 0.100 mg/kg/dose (O, IM) every 8 hr for GER.
Midazolam
0.15 to 0.50 g/kg/min (IV) continuous infusion; 0.05 to 0.15 mg/kg
(IV) bolus every 2 to 4 hr.
Morphine
0.05 to 0.2 mg/kg/dose (IM, IV, SC) every 2 to 4 hr; 0.025 to 0.05 mg/kg/
hr continuous IV infusion as analgesic.
Naloxone
0.1 mg/kg (IV) with a maximum of 2 mg; may repeat every 2 to 3
minutes until desired effect; continuous IV infusion may also be
employed.
Phenobarbital
10 to 20 mg/kg (O, IV) loading dose followed by 3 to 4 mg/kg/24 hr (O,
IV) q 12 to 24 hours as maintenance dose as an anticonvulsant.
Phenytoin
15 to 20 mg/kg (IV), not exceeding 0.5 mg/kg/min loading dose
followed by 5 mg/kg/24 hr (O, IV) q 12 to 24 hr as maintenance dose
as anticonvulsant.
Primidone
12 to 20 mg/kg/24 hr (O) q 8 to 12 hr.
Propranolol
0.25 gm/kg/dose (O) q 6 to 8 hr. Gradually build up the dose for
desired response to a maximum 5 mg/kg/ 24 hr.
0.01 mg/kg (IV) over 10 to 15 min. Gradually build up the dose for
desired effect to a maximum/mg/kg/24 hr.
Ranitidine
1.5 to 2 mg/kg/24 hr (O, IV) q 12 hr. For continuous 24 hr IV infusion
0.04 mg/kg/hr with a maximum 1 mg/kg/24 hr.
Chapter 33: Drug Dosage in Neonates 245

Spironolactone
1 to 3 mg/kg/day (O) divided q 12 to 24 hr.

Theophylline
6 to 10 mg/kg loading dose then 2 to 4 mg/kg/dose every 12 hr.

Tolazoline
1 to 2 mg/kg (IV) loading dose followed by 1 to 2 mg/kg/hr continuous
IV infusion.

Tromethamine (Tham)
0.3 M solution (mL) = weight (kg) base deficit (mEq/L).

Ursodeoxycholic Acid (Ursodiol)


10 to 15 mg/kg/day (O) qd.

Valproic Acid
20 mg/kg (O) loading dose followed by 10 mg/kg/dose every 12 hr.

Vitamin E
25 to 50 units/day (O).

Chemotherapeutic Drugs/Antibiotics
Amikacin
7 days:
1200 to 2000 g: 7.5 g/kg q 12 to 18 hr
> 2000 g: 10 mg/kg q 12 hr
> 7 days:
> 1200 to 2000 g: 7.5 mg/kg q 8 to 12 hr
> 2000 g: 10 mg/kg q 8 hr
Administer IM or IV over 30 to 60 minutes.
246 Section 4: Drug Therapy in Neonates

Amoxicillin
50 mg/kg/day (O, IM, IV) in divided doses q 12 hr under 1 week, q 8 hr
at 1 to 3 weeks, q 6 hr at > 3 weeks.

Amoxicillin-clavulanate (Coamoxiclav)
30 mg/kg/day (O, IV) divided q 12 hr, increasing to q 8 hr after the
perinatal period.

Ampicillin
7 days:
2000 g 50 mg/kg/day (IM, IV) q 12 hr for septicemia
100 mg/kg/day divided q 8 hr for meningitis.
> 2000 g 75 mg/kg/day divided q 8 hr for septicemia
150 mg/kg/day divided q 8 hr for meningitis.
> 7 days:
< 1200 g 50 mg/kg/day (IM, IV) q 12 hr for septicemia
100 mg/kg/day divided q 12 hr for meningitis.
< 1200 to 2000 g 75 mg/kg/day (IM, IV) divided q 8 hr for septicemia
150 mg/kg/day divided q 8 hr for meningitis.
> 2000 g 100 mg/kg/day (IM, IV) divided q 6 hr for septicemia
200 mg/kg/day divided q 6 hr for meningitis.

Azithromycin
10 mg/kg/day (O) for 3 days
10 mg/kg/(O) on first day, then 5 mg/kg/day for 4 days.

Aztreonam
7 days:
2000 g 60 gm/kg/day (IM, IV) divided q 12 hr.
> 2000 g 90 mg/kg/day divided q 8 hr.
> 7 days:
< 1200 g 90 mg/kg/day divided q 8 hr.
> 2000 g 120 mg/kg/day divided q 6 to 8 hr.
Chapter 33: Drug Dosage in Neonates 247

Carbenicillin
7 days:
2000 g 225 mg/kg/day (IM, IV) divided q 8 hr.
> 2000 g 300 mg/kg/day divided q 6 hr.
> 7 days 300 to 400 mg/kg/day divided q 6 hr.

Cefaclor
20 to 40 mg/kg/day (O) divided q 8 to 12 hr.

Cefadroxil
20 to 30 mg/kg/day (O) divided q 12 hr.

Cefoperazone
100 mg/kg/day (IM ,IV) divided q 12 hr.

Cefotaxime
7 days 100 mg/kg/day (IM, IV) divided q 12 hr.
> 7 days:
< 1200 g 100 mg/kg/day divided q 12 hr.
> 1200 g 150 mg/kg/day divided q 8 hr.

Cefazolin
7 days 40 mg/kg/day (IM, IV) divided q 12 hr.
> 7 days 40 to 60 mg/kg/day divided q 8 hr.
> 2000 g 15 mg/kg/day divided q 8 hr.
> 7 days:
< 1200 g 10 mg/kg/day (IM, IV) divided q 12 hr.
1200 to 2000 g 15 mg/kg/day divided q 8 hr.
> 2000 g 20 mg/kg/day divided q 8 hr.

Ceftazidime
7 days 100 mg/kg/day (IM, IV) divided q 12 hr.
> 7 days:
< 1200 g 100 mg/kg/day divided q 12 hr.
1200 g 150 mg/kg/day divided q 8 hr.
248 Section 4: Drug Therapy in Neonates

Ceftriaxone
50 to 75 mg (IM, IV) q 24 hr.

Cefuroxime
40 to 100 mg/kg/day (IM, IV) divided q 12 hr.

Cephalexin
25 to 100 mg/kg/day (O) divided q 6 to 8 hr.

Chloramphenicol
20 mg/kg (IV) loading dose, then 12 hr later by
7 days 25 mg/kg/day (IV) q 24 hr.
> 7 days:
2000 g 25 mg/kg/day (IV) q 24 hr.
> 2000 g 50 mg/kg/day (IV) divided q 12 hr.

Clindamycin
7 days:
2000 g 10 mg/kg/day (IM, IV) divided q 12 hr.

Erythromycin
7 days 20 mg/kg/day (O) divided q 12 hr.
> 7 days:
< 1200 g 20 mg/kg/day divided q 12 hr.
1200 g 30 mg/kg/day divided q 8 hr.

Gentamicin
7 days:
1200 to 2000 g 2.5 mg/kg/ q 12 to 18 hr.
> 2000 g 2.5 mg/kg/ q 12 hr.
> 7 days:
1200 to 2000 g 2.5 mg/kg q 8 to 12 hr.
> 2000 g 2.5 mg/kg q 8 hr.
Administer IM, IV over 30 to 60 min.
Chapter 33: Drug Dosage in Neonates 249

Imipenem-cilastatin
7 days:
< 1200 g 20 mg/kg (IM, IV) q 18 to 24 hr.
> 1200 g 40 mg/kg divided q 12 hr.
> 7 days:
1200 to 2000 g 40 mg/kg q 12 hr.
> 2000 g 60 mg/kg q 8 hr.

Methicillin
7 days:
1200 to 2000 g 50 mg/kg/day (IV) q 12 hr for sepsis.
100 mg/kg/day divided q 12 hr for meningitis.
> 2000 g 75 mg/kg/day divided q 8 hr for sepsis.
150 mg/kg/day divided q 8 hr for meningitis.
> 7 days:
1200 to 2000 g 
75 mg/kg q 8 hr for sepsis 150 mg/kg/day divided q
8 hr.
> 2000 g 100 mg/kg divided q 6 to 8 hr for sepsis.
200 mg/kg/day divided q 6 hr.

Metronidazole
0 to 4 weeks
< 1200 g 7.5 mg/kg (O, IV) q 48 hr.
< 7 days:
1200 to 2000 g 7.5 mg/kg/day (O, IV) q 24 hr.
> 2000 g 15 mg/kg/day (O, IV) divided q 12 hr.
> 7 days:
1200 to 2000 g 15 mg/kg/day (O, IV) divided q 12 hr.
> 2000 g 30 mg/kg/day (O, IV) divided q 12 hr.

Mezlocillin
7 days 150 mg/kg/day (IV) divided q 12 hr.
> 7 days 225 mg/kg divided q 8 hr.
250 Section 4: Drug Therapy in Neonates

Nafcillin
7 days:
1200 to 2000 g 50 mg/kg/day q 12 hr.
> 2000 g 75 mg/kg/day divided q 8 hr.
> 7 days:
1200 to 2000 g 75 mg/kg q 8 hr.
> 2000 g 100 mg/kg divided q 6 to 8 hr for sepsis.
200 mg/kg/day divided q 6 hr for meningitis.
Oxacillin
7 days:
1200 to 2000 g 50 mg/kg/day q 12 hr.
> 200 g 75 mg/kg/day divided q 8 hr.
< 7 days:
1200 g 50 mg/kg/day divided q 12 hr.
1200 to 2000 g 75 mg/kg/day q 8 hr.
> 2000 g 100 mg/kg/day divided q 6 hr.

Penicillin G
7 days:
1200 to 2000 g 50,000 units/kg/day q 12 hr.
> 2000 g 75,000 units/kg/day divided q 8 hr for sepsis.
150,000 units/kg/day divided q 8 hr for meningitis.
< 7 days:
1200 g 50,000 units/kg/day divided q 12 hr for sepsis.
100,000 units/kg/day divided q 12 hr for meningitis.
1200 to 2000 g 75,000 units/kg/day divided q 8 hr for sepsis.
225,000 units/kg/day divided q 6 hr for meningitis.
> 2000 g 100,000 units/kg/day divided q 6 hr for sepsis.
200,000 units/kg/day divided q 6 hr for meningitis.

Penicillin G, Benzathine
> 1200 g 50,000 units/kg once (IM).

Penicillin G, Procaine
> 1200 g 50,000 units/kg (IM) qd.
Chapter 33: Drug Dosage in Neonates 251

Piperacillin
7 days 150 mg/kg/day (IV) divided q 8 to 12 hr.
> 7 days 200 mg/kg divided q 6 to 8 hr.
Sulfadiazine
100 mg/kg/day (O) divided q 12 hr with pyrimethamine 2 mg/kg/day
(O) qd (with folinic acid) for toxoplasmosis.
Ticarcillin
7 days:
< 2000 g 150 mg/kg/day (IV) divided q 8 to 12 hr.
> 7 days:
> 2000 g 225 mg/kg/day divided q 8 hr.
> 7 days:
< 1200 g 150 mg/kg/day divided q 12 hr.
1200 to 2000 g 225 mg/kg/day divided q 8 hr.
> 2000 g 300 mg/kg/day divided q 6 to 8 hr.
Tobramycin
7 days:
1200 to 2000 g 2.5 mg/kg q 12 to 18 hr.
> 2000 g 2.5 mg/kg q 12 hr.
> 7 days:
1200 to 2000 g 2.5 mg/kg q 8 to 12 hr
> 2000 g 2.5 mg/kg q 8 hr.
Administer IM, IV over 30 to 60 min.
Vancomycin
7 days:
< 1200 g 15 mg/kg/day (IV) divided q 24 hr.
1200 to 2000 g 15 mg/kg/day divided q 12 to 18 hr.
> 2000 g 30 mg/kg/day divided q 12 hr.
> 7 days:
<1200 g 15 mg/kg/day divided q 24 hr.
1200 to 2000 g 15 mg/kg/day divided q 8 to 12 hr.
> 2000 g 45 mg/kg/day divided q 8 hr.
252 Section 4: Drug Therapy in Neonates

Antiviral Drugs
Acyclovir
30 to 45 mg/kg/day (IV) divided q 8 hr for HSV encephalitis.

Vidarabine (Ara-A)
15 to 30 mg/kg/day (IV) infusion over 18 to 24 hr for HSV infection.

Lamivudine
4 mg/kg/day (O) divided q 12 hr used in combination with zidovudine
in HIV.

Nelfinavir
30 mg/kg/day (O) divided q 8 hr.

Nevirapine
5 mg/kg (O) qd for 14 days fallowed by 240 mg/m2/day (O) divided q
12 hr for 14 days and thereafter 400 mg/m2/day divided q 12 hr.

Zidovudine
8 mg/kg/day (O) divided q 6 hr.
6 mg/kg/day (IV) divided q 6 hr.

Antifungal Drugs
Fluconazole
6 mg/kg (O,IV) qd first day qd for 14 to 21 days.

Miconazole
5 to 15 mg/kg/day (IV) divided q 8 to 24 hr.

Nystatin
100,000 units (topical) 4 times a day.
Section 5
Pharmacotherapy in
Emergencies
Chapter

34
Important Emergency
Drugs

Adrenaline
Atropine
Hydrocortisone
Sodium bicarbonate
Naloxone
Dopamine
Dobutamine
Terbutaline sulfate
Potassium chloride
Calcium gluconate
Doxepin
Diazepam
Phenobarbital
Phenytoin
Chapter

35
Pharmacotherapy of
Common Emergencies

Status Epilepticus/Acute Seizures


Pharmacotherapy
Inj diazepam, 0.1 to 0.3 mg/kg (IV) slowly, rate not exceeding 2
mg/min for a maximum of 3 doses
Per rectum diazepam, 0.2 to 0.5 mg/kg
or
Inj lorazepam, 0.05 to 0.1 mg/kg (IV) slowly
Per rectum lorazepam, 0.05 to 0.1mg/kg
Sublingual lorazepam, 0.05 to 0.1 mg/kg
or
Inj midazolam, 0.15 to 0.3 mg/kg (IV)
Buccal or nasal midazolam, 0.5 mg/kg)
Response poor: Phenytoin or fesophenytoin, 15 to 30 mg/kg (IV) at
the rate of 1 mg/kg/min followed 12 to 18 hr later by maintenance
dose of 3 to 9 mg/kg/24 hr in 2 divided doses
or
Phenobarbital, 15 to 20 mg/kg (loading dose) IV followed 12 to 18 hr
later by maintenance dose of 3 to 5 mg/kg/24 hr in 2 divided doses.
Response poor: Diazepam infusion
or
Midazolam infusion, 0.2 mg/kg/hr
or
Propofol infusion, 1 to 2 mg/kg, 2 to 10 mg/kg/hr
or
Valporic acid, 10 to 15 mg/kg (loading dose) IV
or
Paraldehyde (5%), 150 to 200 mg/kg IV slowly for 15 to 20 min
followed by infusion of 20 mg/kg/hr (in glass and not plastic bottle)
Chapter 35: Pharmacotherapy of Common Emergencies 255

Response poor: Barbiturate-induced coma by thiopental, 2 to 4


mg/kg for 24 hr
or
General anesthesia, using halothane or isoflurane by a well-
trained personnel with anesthetic gas scavenging equipment for
prolonged periods.

Supportive Measures
Airway, breathing, circulation (ABC).
Start IV/IO line.
Do blood sugar, serum calcium and magnesium levels.
If blood sugar < 40 mg percent, give IV 10 percent dextrose, 5 mL/
kg.
Seizures controlled: Maintain dextrose drip 8 mg/kg/min.
No response: Give IV 10 percent calcium gluconate 1 mL/kg diluted
1:1 with 5 percent dextrose.
Seizures controlled: Evaluate for the cause and put the child on oral
maintenance calcium 100 mg/kg/day.
No response: Anticonvulsant therapy as outlined in pharma
cotherapy.

Neonatal Seizures
Pharmacotherapy
Phenobarbital (the gold standard), 20 mg/kg (IV) slowly over 10
min followed by, in case of no response, two doses, each 10 mg/
kg, at 5 min interval. Total dose should not exceed 40 mg/kg.
Maintenance dose is 5 mg/kg once a day.
If no response, phenytoin, 20 mg/kg (IV) slowly over 20 min as
loading dose. Maintenance dose is 5 mg/kg once a day.
Intractable seizures: Lorazepam, 0.05 mg/kg/dose (IV) or
midazolam, 0.05 to 0.15 mg/kg (IV) q 2 to 4 hr.
If the cause is not traceable and response to anticonvulsant therapy
and/or correction of biochemical and metabolic abnormalities is
unsatisfactory, it is advisable to give a therapeutic trial with pyridoxine
(vitamin B6), 25 to 50 mg, calcium gluconate, 5 to 10 mL of 10 percent
solution, by slow IV injection, and 1 to 2 mL/kg of 50 percent glucose
diluted with distilled water.
256 Section 5: Pharmacotherapy in Emergencies

Unless there is an indication for a long-term therapy, an


anticonvulsant (say, oral phenobarbital) is continued for only 4 to 12
weeks following control of convulsions and then gradually withdrawn.
Supportive Measures
Stabilization of vitals (ABC)
Stabilization of metabolic/biochemical abnormalities such as
hypoglycemia and hypocalcemia.

Snakebite
Pharmacotherapy
Tetanus prophylaxis
Dopamine drip, 5 to 15 mcg/kg/min if the child is hypotensive.
Antivenom serum (AVS), preferably within 4 hr of the bite. However,
no patient should be deprived of its possible benefit even if he
arrives late and have indication for its use. In our experience of
treating a large number of snakebite cases, it continues to be of
value even after 24 hours of bite.
Mild envenomation (only local swelling without any systemic
manifestations): 20 mL
Moderate envenomation (Local swelling with mild systemic
manifestations): 50 to 90 mL
Severe envenomation (Severe systemic manifestations): 100 to
150 mL and even more.
Inj dexamethasone shield should be employed against
hypersensitivity reactions even if AVS sensitivity testing turns out
to be negative.
AVS sensitivity test should always be done beforehand by instilling
a drop of AVS into eye. Positive test is indicated by conjunctival
congestion. Desensitization is attained in steps (Box 35.1)

Box 35.1: Steps of AVS desensitization


Step 1: Scratch test
Step 2: Intradermal injection
Step 3: Subcutaneous injection
Step 4: IV administration
Chapter 35: Pharmacotherapy of Common Emergencies 257

Any evidence of hypersensitivity reaction is an indication for


adrenaline, 0.1 mL (SC).
Supportive Measures
Immobilization of the affected part which should be kept at a
lower level to reduce travel of the venom to upper body.
Application of a bandage above the bite site so that it occludes the
lymphatics but not the blood flow.
ABC
Oxygen
IV drip
Ventilatory care in case of respiratory failure.

Scorpion Sting
Background Information
Most of the manifestations of scorpion sting are due to autonomic
storm.

Pharmacotherapy
For pain relief, give a NSAID (say paracetamol), local ice packs, 2
percent xylocaine or dehydroemetine locally.
Diazepam to quieten the restless child, allay anxiety and prevent
myocardial stress.
For autonomic storm, Prazosin, 30 mcg/kg/dose. Repeat after 3 hr
and then every 6 hr till improvement.
For pulmonary edema, diuretic.
For hypotension, IV dobutamine, 5 to 15 mcg/kg/min
or
Sodium nitroprusside
or
Nitroglycerine, IV infusion, 0.5 mcg/kg/min.
Supportive Measures
ABC (vitals) monitoring
Application of tourniquet proximal to the location of sting to cut
down absorption of toxin.
258 Section 5: Pharmacotherapy in Emergencies

Oral and IV fluids to prevent development of hypovolemia.


Monitoring is essential to safeguard from pulmonary edema.
Poor response to supportive and pharmacotherapy: Mechanical
ventilation.

Organophosphate Poisoning
Pharmacotherapy
Inj atropine 0.04 mg/kg every 5 min until signs of atropinization
appear. Do not exceed a total of 10 mg/kg/day.
Pralidoxime chloride (PAM), 25 to 50 mg/kg (IV) in normal
saline with 12 hr of ingestion. PAM reactivates choline-esterase
enzyme and acts by substrate competition mechanism at the
neuromuscular junction.
Anticonvulsant therapy, e.g diazepam 0.3 mg/kg/dose (IV).

Supportive Measures
Shift the patient away from the source and place of the poison.
Wash whole body with soap and water.
Irrigate eyes with distilled water.
ABC. Intubation may be required for the comatose child.
Oxygen.
Gastric lavage with KMnO4.
Milk of magnesia through Ryles tube.
IV drip. Observe extra caution to protect against pulmonary
edema.

Kerosene Oil Poisoning


Pharmacotherapy
Antacid (Mucaine gel, diovol, gelusil) for countering gastric
irritation.
Antibiotics for safeguarding from superimposed bacterial
infection (pneumonia) though of doubtful value.

Supportive Measures
Oxygen/respiratory support.
Chapter 35: Pharmacotherapy of Common Emergencies 259

Decontamination of skin.
Avoidance of gastric lavage and induced vomiting.

Acute Severe Asthma (Status Asthmaticus)


Pharmacotherapy
Warm humidified oxygen.
Nebulization employing salbutamol respiratory solution, 0.5 mL in
2 mL of normal saline, over 5 min. It is first given every 20 min for 4
times followed by every 2 hr.
Inj adrenaline, 1:1,000 sol, 0.01 mL/kg (SC).
IV fluid drip, 150 percent (one and a half time) of normal
maintenance requirement.
Inj hydrocortisone, 10 mg/kg (IV) stat followed by 4 mg/kg every
6 hr. If readily available, methylprednisolone, 2 to 3 mg/kg Q&H,
should be preferred.
Response poor: Nebulization with ipratropium bromide respiratory
sol, 0.5 mL in 2 mL normal saline plus salbutamol. The two are
supposed to provide synergistic effect.
Response still poor: IV aminophylline, 6 mg/kg/bolus in 5 percent
dextrose with equal dilution, over 20 min. Follow with IV
aminophylline infusion, 1 mg/kg/hr.
Response continues to be poor: Magnesium sulfate (50%) infusion,
0.1 to 0.2 mL/kg in 30 mL saline over 30 min.
Last resort: Intubation plus ventilator support.
Supportive Measures
ABC
Oxygen
Hydration
Nutrition.

Acute Diarrhea with Dehydration


Pharmacotherapy
Rehydration
ORS in mild-moderate dehydration
IV fluids in severe dehydration or child not responding to ORS
260 Section 5: Pharmacotherapy in Emergencies

Antibiotic therapy in bacterial diarrhea: Cotrimoxazole (810 mg/


kg/day in terms of trimethoprim, in 2 to 3 divided doses), nalidixic
acid (50 mg/kg/day in 4 divided doses), etc.
Zinc supplements:
< 6 months: 10 mg/day (O) for 2 weeks
> 6 months: 20 mg/day (O) for 2 weeks.
Vitamin A supplements (optional):
< 6 months: 50,000 units/day
6 months to 1 year: 100,000 units/day
> 1 year: 200,000 units/day.
Probiotics (optional): Saccharomyces boulardii, Lactobacillus
acidophilus, Lactobacillus sporogenes, etc.
Antisecretory drug: Racecadotril 1.5 mg/kg/dose thrice daily.
Supportive Measures
1. Maintain good nutrition.
2. Avoid antimotility drugs (e.g. diphenoxylate HCl or loperamide)
especially in under-5s.

Bloody Diarrhea/Acute Bacillary Dysentry (Shigellosis)


Pharmacotherapy
Ampicillin (50100 mg/kg/day in 4 divided doses), cotrimoxazole
(810 mg/kg/day in terms of trimethoprim, in 2 to 3 divided doses),
nalidixic acid (50 mg/kg/day in 4 divided doses), or tetracycline
(only > 8-year-old), etc.
Zinc supplements:
< 6 months: 10 mg/day (O) for 2 weeks
> 6 months: 20 mg/day (O) for 2 weeks.
Vitamin A supplements (optional):
< 6 months: 50,000 units/day
6 months to 1 year: 100,000 units/day
> 1 year: 200,000 units/day.
Probiotics (optional): Saccharomyces boulardii, Lactobacillus
acidophilus, Lactobacillus sporogenes, etc.
Supportive Measures
Correction of dehydration/dyselectrolytemia.
Chapter 35: Pharmacotherapy of Common Emergencies 261

Correction of malnutrition.
Avoidance of antimotility drugs like loperamide and diphenoxylate.

Acute Bronchiolitis
Pharmacotherapy
Humidified oxygen.
Nebulization, employing hypertonic saline, or racemic epinephrine,
2.5 percent, diluted with water, for 5 min. Bronchodilators and
steroids usually not needed.
Antiviral agent, ribavirin aerosol, in case of severe bronchiolitis
causing significant respiratory distress in a child suffering from
immunodeficiency or a lung disease such as asthma, CF, etc.

Supportive Measures
ABC
Fluid and nutrition
Ventilatory care for respiratory failure.

Acute Epiglottitis
Pharmacotherapy
Humidified oxygen
Antibiotic therapy:
Ampicillin: 50 to 100 mg/kg/day in 4 divided doses
Chloramphenicol: 50 mg/kg/day in 4 divided doses
Third generastion cephalosporins.
Antipyretics: Paracitamol (acetaminophen) 15 mg/kg/dose, or
50 mg/kg/day in 3 to 4 divided doses.

Supportive Measures
ABC
IV fluid drip
Severe respiratory disress may warrant
Nasotracheal intubation
Needle cricothyrotomy
Tracheostomy.
262 Section 5: Pharmacotherapy in Emergencies

Pneumonia
Pharmacotherapy (Box 35.2)
Antibiotics based on clinical judgment about the likely organisms.

Box 35.2: Antibiotic therapy in pneumonia


Community acquired
Mild illness
Initiate with cotrimoxazole (810 mg/kg/day q 12 hr) or amoxycillin
(4050 mg/kg/day q 8 hr) orally.
If response unsatisfactory, amoxiclav, cefuroxime axetil or cefpodoxime
Severe illness
Cefuroxime, ceftriaxone or cefotaxime (IV) plus aminoglycoside (IV).
Suspected Staphylococcus aureus: Penicillin, ampicillin or amoxicillin plus
cloxacillin.
Suspected methicillin-resistant Staphylococcus aureus: Vancomycin,
linezolid or telcoplanin.
MDRS: Vancomycin or linezolid.
Klebsiella: Cefotaxime or ceftriaxone (IV).
Nosocomial
Antibiotics to cover E. coli, Klebsiella, Proteus, S. aureus, Pseudomonas and
anaerobes along with metronidazole.

Supportive Measures
Oxygen.
Maintain nutrition and fluid and electrolyte balance.
Tepid hydrotherapy paracetamol, 15 mg/kg/dose (O) for high
fever.

Hematemesis
Variceal Bleed
Pharmacotherapy
Octreotide bolus, 1 mcg/kg bolus, followed by 1 mcg/kg/hour
infusion.
IV antibiotics (say, ampicillin 50 mg/kg/day in divided doses) to
prevent such complication as spontaneous bacterial peritonitis.
Chapter 35: Pharmacotherapy of Common Emergencies 263

Supportive Measures
Initial resuscitation/stabilization of vitals.
Blood transfusion.
Endoscopic variceal band ligation, sclerotherapy and glue
injection.
In case endoscopic therapeutic options fail, transjugular
intrahepatic portosystemic shunt (TIPS).

Nonvariceal Bleed
Pharmacotherapy
Proton pump inhibitor (PPI) such as pantoprozole as an initial IV
bolus followed by continuous infusion (Box 35.3).

Box 35.3: Intravenous dose of pantoprazole in nonvariceal


hematemesis
Under 40 kg weight 0.2 mg/kg followed by 0.2 mg/kg/hour for 72 hours
Over 40 kg weight 80 mg followed by 8 mg/hour

As soon as the subject is stabilized and accepting oral feeds, route of


pantoprazole may be changed over to oral but in a dose that is double
the IV dose.
Treatment for H. pylori if infection is present.
Surgical options in case of rebleeding following endoscopic
therapy.
Supportive Measures
Initial resuscitation/stabilization of vitals.
Endoscopic administration of sclerosant, thermal coagulation or
placement of hemoclips.

Hypertensive Crisis
Background
Aim is to lower high BP promptly (though not suddenly) to prevent
occurrence of endorgan damage. The stepwise phased reduction of
BP should be as follows:
264 Section 5: Pharmacotherapy in Emergencies

1/3rd of the target reduction in 1st 6 hours.


1/3rd of the target reduction in next 24 hours.
Remaining 1/3rd reduction in 48 to 72 hours.

Pharmacotherapy
Sublingual nifedipine 0.25 to 0.5 mg/kg/dose or IV nitroprusside,
0.5 mg/kg/min or labetolol, 0.2 mg/kg (IV) in 2 min, are the current
choice.
After control of severe hypertension in the first 6 to 12 hours, oral
antihypertensive therapy should gradually replace the parenteral
one.
Supportive Therapy
Bed rest.

Diabetic Ketoacidosis
Pharmacotherapy
First hour: Normal saline/Ringers lactate 10 to 20 mL (IV bolus)
plus
Insulin infusion (drip) 0.1 unit/kg/hour.
Second hour and afterward: Saline (0.45%) drip + insulin 0.1 unit/
kg/hour + KCl, 40 mEq/L.
During the next 23 hours, 85 mL/kg deficit + maintenance bolus
is administered.
Once blood sugar has come down to 250 to 300 mg/dL, 0.45
percent saline is replaced by saline in 5 percent dextrose. While
KCl is continued at the rate of 40 mEq/L, insulin may be reduced to
0.05 unit/kg/hour.
In case pH > 7.30, total CO2 > 15 mEq/L, electrolytes are within
normal range, subcutaneous insulin may be initiate. However, it
should be ensured that the insulin infusion continues for one hour
after giving SC insulin injection.
In case, this is a known case of diabetes, old insulin regimen should
be resumed.
In case this is a fresh diabetic child, insulin should be started in the
dose of 0.1 to 0.25 unit/kg divided 6 to 8 hourly subcutaneously.
Chapter 35: Pharmacotherapy of Common Emergencies 265

This establishes the daily insulin requirement of the child. Sub


sequently, child should be put on combination insulin regimen.
Supportive Measures
Close monitoring of potassium status (through ECG), hemodynamic
status, urinary output and evidence of RICP.
Finding out precipitating factor (say, an infection or another stress
factor) and treating it.
Clinical and biochemical monitoring for best outcome.

Hypercyanotic Spell
Pharmacotherapy
After comforting and placing the child in knee-chest position,
administer humidified oxygen by face mask.
Morphine 0.1 to 0.2 mg/kg (IV)
IV fluid replacement and volume expansion; blood transfusion if
child is anemic.
Sodium bicarbonate for combating metabolic acidosis.
Propranolol, 0.1 to 0.2 mg/kg (IV).
Increase systemic vascular resistance by IV vasopressin like
methoxamine or phenylephrine, titrating the dose to increase
systemic systolic blood pressure by 20 percent.
Surgical repair of the defect or systemic-to-pulmonary artery
anastomosis.

Supportive Measures
Place the child in knee-chest position.

Acute Renal Failure (Acute Kidney Injury)


Pharmacotherapy
Normal saline, 20 mL/kg for 1 hour followed by IV mannitol, 0.5 g/
kg.
No response: Repeat normal saline, 20 mL/kg for 1 hour.
No/poor response (urine output < 1 mL/kg/hour) IV frusemide,
1 mg/kg at rate of 4 mg/min.
266 Section 5: Pharmacotherapy in Emergencies

No diuresis after 2 hours: IV frusemide, 10 mg/kg at same rate.


Poor response: Low dose dopamine, 2.5 mcg/kg/min.

Supportive Measures
Salt restriction
Monitoring of BP, electrolytes, input-output, RFT, etc.

Meningoencephalitis
Pharmacotherapy
Antibiotic cover to combat any etiologic or superadded bacterial
infection.
Anticonvulsant such as phenobarbital, phenytoin, lorazepam, etc.
Antipyretic like paracetamol.
Mannitol for reduction of RICP.
Corticosteroids (doubtful value).

Supportive Measures
Maintenance of fluid and electrolyte balance and nutrition.
Tepid sponging for controlling high temperature.
Careful repeated withdrawal of CSF for reduction of RICP.

Bacterial Meningitis
Pharmacotherapy
Antibiotic Therapy
Age birth to 3 months: In view of gram-negative pathogens, start
ampicillin + aminoglycoside/cefataxime. Subsequent therapy depends
on culture and sensitivity report and/or clinical response.
Age 3 months to 12 years: In the wake of H. influenzae, S. pneumoniae
and N. meningitidis being the dominant pathogens, initial therapy
should be ceftriaxone/cefataxime or ampicillin + chloramphenicol.
Subsequent therapy depends on culture and sensitivity report and/
or clinical response.
IV mannitol
Chapter 35: Pharmacotherapy of Common Emergencies 267

Corticosteroids over a brief period


Anticonvulsant therapy.
Supportive Measures
Maintenance of hydration and nutrition.
Good nursing care.

Respiratory Distress Syndrome (RDS)


Pharmacotherapy
Exogenous surfactant (preferably bovine), administered
intratracheally (IT) as preventive as well as rescue therapy. See
Chapter 24 for precise details.
Antibiotic cover.
Indomethacin, ibuprofen or mefenamic acid for accompanying
PDA.
Supportive Measures
Humidified incubator care.
Oxygen: Initially 70 to 90 mm Hg but cut down as soon as possible.
CPAP/assisted ventilation.
IV fluids with sodium bicarbonate.
Exchange transfusion.

Heat Stroke
Pharmacotherapy
Oxygen 100 percent
Rapid cooling
Stripping
Cold sponging
Cool environment
IV fluids: 20 mL/kg normal saline over 20 min. If IV route not
accessible, employ intraosseous (IO) route. After 20 min, if pulse
still not felt, repeat normal saline in same dose.
Dopamine IV infusion, 10 mcg/kg/min if pulse continues to be not
felt and hypotension persists.
268 Section 5: Pharmacotherapy in Emergencies

Anticonvulsant therapy. Inj diazepam, 0.3 mg/kg followed by


phenobarbital or phenytoin.
IV mannitol 20 percent, 7 mL/kg to control cerebral edema causing
RIP.
Attention to DIC manifestations
GI wash with cold fluid
Inj vitamin K
Fresh frozen plasma, 10 mL/kg.

Acute Glomerulonephritis (AGN)


Pharmacotherapy
Inj penicillin (procaine), 4 lakh (IM) OD for 1 week.
Antihypertensive drug(s), say nifedipine.
Anticonvulsant drug other than phenobarbital (say diazepam).
For CCF, frusemide, adequate digitalization or dopamine infusion.

Supportive Measures
During oliguric phase:
Bed rest
Restriction of salt and protein
For renal failure, peritoneal dialysis.

Congestive Cardiac Failure


Pharmacotherapy
Loop diuretic: Furosemide, 1 mg/kg/dose remains the diuretic of
first choice to relieve pulmonary edema. When higher doses are
required, add spironolactonea potassium-sparing weak diuretic.
Diuretic therapy promotes water and sodium excretion via kidneys,
thereby diminishing ventricular preload and pulmonary edema.
Digoxin, employed at its lower dose ranges (Table 35.1), should
be considered the second line agent after furosemide, and is best
restricted to subjects with supraventricular arrhythmias.
Vasodilators for decreasing afterload, especially in CCF associated
with left-right shunt, cardiomyopathy, sever aortic or mitral
insufficiency.
Chapter 35: Pharmacotherapy of Common Emergencies 269

ACE-inhibitors, such as captopril and enalapril, decrease afterload


and to some extent preload, water and sodium retention by
reducing production of aldosterone.
Inotropic agents:
Dopamine
Dobutamine.
Beta-blockers.

Table 35.1: Recommended dosage for digitalization in CCF/


supraventricular arrhythmias
Age Digitalizing Digitalizing Maintenance Maintenance
dose (oral)* dose (IV/IM)* dose (oral)** dose (IV/IM)**
Preterm 30 mcg/kg 25 mcg/kg 810 mcg/kg/ 68 mcg/kg/
day (2 divided day
doses)
Term2 yr 6575 mcg/kg 50 mcg/kg 810 mcg/kg/ 1215 mcg/
day (2 divided kg/day
doses)
210 yr 3040 mcg/kg 25 mcg/kg 810 mcg/kg/ 68 mcg/kg/
day (2 divided day
doses)
>10 yr 11.5 mg 0.51 mg 125250 100400 mcg/
mcg/kg/day day
*Digitalizing dose: Half of the calculated dose is given initially with th the dose given
q 8 h twice.
**Maintenance dose: It is given twice a day in young children and once a day in older
children and adolescents.

Supportive and other Measures


Complete rest.
Cautious treatment of anemia.

Anaphylaxis
Pharmacotherapy
Humidified oxygen.
270 Section 5: Pharmacotherapy in Emergencies

Inj adrenaline (epinephrine) 1:1,000 sol, 0.01 mL/kg IM (preferred


choice) or SC. Repeat every 15 min if required.
Inj hydrocortisone (Efcorlin), 10 mg/kg (IV). Repeat 3 mg/kg every
4 hr if required.
Or
Methylprednisolone, 2 mg/kg/dose IV. Follow with 1 mg/kg/dose
every 6 hr.
Inj diphenhydramine (Benadryl), 1 mg/kg (IV, IM) over 5 min. This
assists to counter the systemic effects of histamine.
Dopamine IV infusion, 5 to 15 mcg/kg/min by continuous IV
infusion in case of presence of peripheral circulatory failure (PCF).
Salbutamol nebulization or IV aminophylline for bronchospasm.
Postreaction: Prednisolone (Wysolone), 1 mg/kg/day q 8 hr plus
antihistaminic (cetrizine or loratadine) for 3 days.
Supportive Measures
ABC: Maintain airway patency, breathing and circulation. At times,
even intubation, tracheostomy or cricothyroidectomy may be
warranted.
Maintain fluid and electrolyte balance.
Maintain appropriate nutrition.
Section 6
Vaccines

Conventional and Chapter


New Vaccines for
Routine Use 36
BCG Vaccine
Brand Name: Tubervac (Serum Institute of India)
Indication: Prophylaxis against severe forms of tuberculosis, e.g.
tuberculous meningitis, miliary tuberculosis (efficacy 5080%;
protective efficacy for pulmonary tuberculosis 50%).
Available as: 10, 20 dose vials/long-necked ampoules plus diluents
0.5 mL and 1 mL, respectively.
Dose: 0.1 mL (0.05 mL if specifically indicated by the manufacturer),
regardless of the age and weight, intradermally with a special
tuberculin syringe and a 26G/27G needle. The best site is top
(convex aspect) of left shoulder at the level of deltoid insertion for
easy visualization of the scar and optimum lymphatic drainage.
Sterile saline (not an antiseptic) should be employed for cleaning
the surface.
Response: Normally, after 2 to 3 weeks, a papule mm develops,
growing up to 5 mm by the end of 5 to 6 weeks. It heals with a
slight ulceration, ending up in a scar after 6 to 12 weeks. Moreover,
slight cervical/axillary lymphadenitis may also develop. It is self-
limiting and resolves spontaneously in a few months.
AEFI: Accelerated reaction, deep ulceration with superimposed
sepsis, significant ipsilateral cervical and/or axillary lymphadenitis
with suppuration (BCGosis) which is managed by antibiotic
therapy, surgical excision, or sometime INH therapy for 3 to 6
months. A chest X-ray should always be done in such cases to
exclude evidence of tuberculosis.
Contraindication: None whatsoever.
272 Section 6: Vaccines

Precautions:
 Avoid in immunocompromised states, especially cellular
immunodeficiency
Keep a gap of 4 weeks between catch-up BCG and measles or
MMR vaccine.
Storage: 2 to 8C (upper shelf of refrigerator); must be used within
4 to 6 hours after reconstitution. Protect from light.
Special Remarks: BCG vaccine was supposed to provide protection
against serious forms of tuberculosis (say miliary and meningeal
tuberculosis) to the magnitude of 50 to 80 percent and pulmonary
tuberculosis around 50 percent. In view of the South Indias
famous Chingelput study observations, protective value of BCG,
considered as the flagship of immunization program, has come
under considerable cloud.

Diphtheria, Tetanus and Pertussis (DTwP, DTaP,


Triple Vaccine)
Brand Names: DTwP (GSK), Triple (SII)
It is a combination of diphtheria toxoid, tetanus toxoid and killed
whole cell pertussis bacilli on adjuvants in the form of insoluble
aluminum salts.
Indication: Combined protection against diphtheria, tetanus and
pertussis (whooping cough).
Available as: 0.5 mL, providing diphtheria toxoid 20 to 30 limit of
floccuation (LF), tetanus toxoid 5 to 25 Lf, pertussis vaccine 20,000
million.
Dose: 0.5 mL (IM), preferably at anterolateral aspect of thigh at 6,
10 and 14 weeks with boosters at 15 to 18 months and 5 years.
Now both National Immunization Schedule (UIP) and IAP schedule
recommend DTP (not DT) as such for the second (5 years) booster
too.
AEFI: Local induration and even abscess at injection site, febrile
reaction, seizures, excessive crying, pseudotumor cerebri;
occasionally, 1 to 3 hours after injection, collapse (pallor, sweating,
slow pulse), allergic skin reactions, encephalitis, provocation/
activation of poliomyelitis during an epidemic of disease.
Chapter 36: Conventional and New Vaccines for Routine Use 273

Contraindications: History of anaphylaxis or development of


encephalopathy within 7 days following previous DTwP/DTaP
vaccination, is the only absolute contraindication. Progressive/
evolving neurological disease is a relative contraindication.
It should be temporarily be deferred in acute febrile illness.
Moreover, DTwP should not be given in children > 7 years.
Precaution: Be prepared to handle anaphylactic reactions. Avoid
administering immunoglobulin concurrently.
Storage: 2 to 8C/35 to 46F (lower shelf of refrigerator).

Diphtheria-Tetanus Toxoid (DT)


Alum-precipitated dual antigen, diphtheria and tetanus, toxoid
Brand Name: Dual (SII), Dual antigen (Haffkine)
Indications: Active protection against diphtheria and tetanus in
infants and children who must not be given pertussis for one or
the other reason until 7 years of age.
Available as: Injection single dose ampoule. Injection multidose
(10 mL) vial.
Dose: 0.5 mL (IM) over anterolateral aspect of thigh (not buttocks).
AEFI: Mild local reaction with painful swelling at the injection site.
Contraindication: Children > 7 years of age. In older children, risk of
AEFIs from high dose of diphtheria toxoid can be high.
Precautions: Avoid administration in buttocks in the wake of risk of
injury to sciatic nerve and poor absorption due to excessive fat.

Diphtheria, Tetanus and Pertussis


(DTaP, Acellular Triple Vaccine)
Brand Names: Infanrix (GSK), Tripacel (Sanofi Pasteur)
It is a combination of diphtheria toxoid, tetanus toxoid and acellular
pertussis bacilli on adjuvants in the form of insoluble aluminum salts.
This may be given after one-to-one discussion with the parents.
Indication: Combined protection against diphtheria, tetanus and
pertussis (whooping cough).
Available as: 0.5 mL providing diphtheria toxoid 20 to 30 Lf, tetanus
toxoid 5 to 25 Lf, pertussis vaccine 20,000 million.
274 Section 6: Vaccines

Dose: 0.5 mL (IM), preferably at anterolateral aspect of thigh at 6, 10


and 14 weeks with boosters at 15 to 18 months and 5 years. Now
both National Immunization Schedule (UIP) and IAP Schedule
recommend DTP (not DT) as such for the second (5 years) booster
too.
AEFIs: Local induration and even abscess at injection site, febrile
reaction, seizures, excessive crying, pseudotumor cerebri;
occasionally, 1 to 3 hours after injection, collapse (pallor, sweating,
slow pulse), allergic skin reactions, encephalitis, provocation/
activation of poliomyelitis during an epidemic of disease.
Contraindications: History of anaphylaxis or development of
encephalopathy within 7 days following previous triple (DTwP/
DTaP) vaccination, is the only absolute contraindication. Progressive/
evolving neurological disease is a relative contraindication. The
vaccine should be temporarily defered in acute febrile illness.
Precaution: Be prepared to handle anaphylactic reactions. Avoid
administering immunoglobulin concurrently.
Storage: 2 to 8 degree C/35 to 46 degree F (lower shelf of
refrigerator).
Special remarks: Only advantage of DTaP (which is expensive) over
DTwP is reduction in the incidence of ADRs. Else, its efficacy is
similar to DTaP.

Tetanus, Diphtheria (Reduced Antigen) and Pertussis


(Acellular) (Tdap)
Brand Names: Boostrix (GSK), Adacel (Sanofi Pasteur)
This is a tetanus, reduced antigen diphtheria, and acellular pertussis
vaccine appropriate for booster effect to DPT - DTwP/DTaPafter the
age of 10 to 11 years.
Indications: As a booster in age group 10 to 64 years. All children
aged 10 to 11 years should receive its single dose. Adults 19 to 64
years should receive its one dose followed by Td every 10 years.
Available as: 0.5 mL vial and prefilled syringe.
Dose: 0.5 mL IM into deltoid of upper arm.
Precautions:
Preparedness to handle anaphylactic reactions.
Avoidance of concurrent administration of immunoglobulins.
Chapter 36: Conventional and New Vaccines for Routine Use 275

Storage: 2 to 8C/35 to 46F (lower shelf of refrigerator)


Special remarks: Tdap, a combined reduced antigen vaccine, must not
be confused with DTaP, acellular vaccine.

Haemophilus influenzae Type B (HIB) Conjugate Vaccine


Brand Names: Hiberix (GSK), ActHiB (SP), Hibpro(SII)
Indications: Active immunization of infants above 2 months
against diseases caused by HIB; all children with hyposplenia
(functional or anatomical).
Available as: Single or in combination with DTP, Hep B, IPV, etc.
Dose: 0.5 mL IM
2 to 6 months: 3 doses at intervals of 1 to 2 months; booster at
18 months
6 to 12 months: 2 doses at intervals of 1 month; 1 dose between
12 to 15 months; booster at 18 months
1 to 5 years: Only one dose.
AEFIs: Mild erythema and tender swelling at the injection site,
pyrexia, excessive crying, irritability, restlessness, anorexia,
vomiting, diarrhea.
Contraindications: Known hypersensitivity, acute severe febrile
illness, age > 6 years.
Caution: Be prepared for an inadequate response in subjects on
immunosuppressive therapy or with immunodeficiency.
Storage: 2 to 8C/35 to 46F (preferably in middle shelf of refrigerator).

Hepatitis A Vaccine
Brand Name: Inactivated: Havrix (GSK), Avaxim (Sanofi Pasteur. Live
attenuated: Biovac (Wockhardt)
IAP recommends it as an additional vaccine that may be given after
one-to-one discussion with parents after 18 months of age (earlier
recommendation was after 12 months of age).
Indication: Active immunization against hepatitis A virus (HAV)
infection, especially in healthy children who are less likely to have
developed natural immunity because of sophisticated lifestyle,
provided that the parents can afford it.
It is also indicated in high-risk groups (Box 36.1)
276 Section 6: Vaccines

Box 36.1: High-risk situations needing hepatitis A vaccine


Chronic liver disease
Hep B and Hep C carriers
Immunodeficiency (both congenital and acquired)
Transplant recipients
Adolescents seronegative for HAV who are leaving home for residential
school.
Travelers to countries with high endemicity for Hep A.

Available as: Though most of the vaccines are inactivated (killed),


a live-attenuate Chinese vaccine (Biovac, Wockhardt) is also
available.
Havrix 720 Junior providing 720 ELISA units/0.5 mL
Havrix 1440 providing 1440 ELISA units/0.5 mL.
Dose: Havrix: 12 months to 18 (inclusive) year 0.5 mL (720 ELISA
units) IM), 19 years and above1 mL (1440 ELISA units) IM.
Avaxim: Cut-off age for 1 mL dose is 15 years.
The recommended site of injection is anterolateral part of thigh
in infants and deltoid muscle in children and adolescents. In
subjects with bleeding diathesis, say thrombocytopenia, it
should be administered subcutaneously.
Two doses at 6 months interval are recommended.
In case of live attenuated vaccine (Biovac), single dose
is considered enough though two doses give yet better
seroconversion and higher antibody titer.
AEFIs: Transient erythema and tender swelling over injection site,
nausea, vomiting, anorexia, malaise, headache, fatigue, pyrexia.
Contraindications: Acute severe febrile illness, known hypersensitivity.
Storage: 2 to 8C/35 to 46F (preferably, middle shelf of refrigerator).

Hepatitis B Vaccine
Brand Names: Engerix B (GSK), Genevac B (Serum Institute), Revac B
(Bharat Biotec), Shanvac B (Shanta Biotec)
Indications: Prophylaxis of HBV infection. This, the first anti-
cancer vaccine, should be considered a universal vaccine as
recommended by the WHO.
Chapter 36: Conventional and New Vaccines for Routine Use 277

Available as: 20 mcg/mL; 0.5 mL, 1 mL, multidose vials.


Dose:
< 18 years 0.5 mL (10 mcg) IM in the deltoid region (children)
and anterolateral aspect of thigh (infants and neonates)
>19 years 1.0 mL (20 mcg) IM in the deltoid region
Indian Academy of Pediatrics (IAP) Recommendation:
At birth (zero dose) and then at 6 and 14 weeks
Or
At 6, 10 and 14 weeks along with the injection DTP and OPV,
Or
0, 1 and 6 months.
Protective efficacy: > 90 percent
AEFIs: Only minor, say soreness, erythema and induration at the
injection site; infrequently fatigue, flu-like symptoms, malaise,
dizziness, headache, paresthesia, abnormal liver function tests,
nausea, vomiting, diarrhea, abdominal pain, arthralgia, myalgia,
rash, pruritus, urticaria, syncope, hypotension, anaphylaxis, serum
sickness.
Contraindications: Hypersensitivity, severe acute febrile illness.
Storage: 2 to 8C/35 to 46F (preferably in lower shelf of
refrigerator); should never be allowed to freeze.
Special remarks: All brands are equally good. Hepatitis B
immunoglobulin (HBIG) must be given along with Hep B vaccine
in case of exposure to hepatitis B (perinatal, sexual, occupational)
in susceptible individuals.

Human Papilloma Virus (HPV) Vaccines


Brand Names: Gardasil (MSD), Cervarix (GSK)
Indication: Protection against cervical cancer, the most important
cause of common cancer-related mortality in Indian women. IAP
recommends this vaccine to all females who can afford it.
Dose: 0.5 mL (IM) in deltoid, preferably at 10 to 12 year of age.
The catchup vaccine is permitted up to the age of 26 years. Three
doses at 0, 2 and 6 months are recommended in case of Gardasil
and at 0, 1 and 6 months in case of Cervarix.
AEFI: Syncope.
278 Section 6: Vaccines

Precautions:
To guard against syncope, the vaccine should be administered
in a sitting/lying down position and the vaccine should be
observed for 15 minutes post-vaccination
Avoid in pregnancy
Efficacy and immunogenicity in immunocompromised
children is relatively low.
Contraindications: History of previous hypersensitivity to any
vaccine component.
Storage: 2 to 8C/35 to 46F.
Special remarks: Following reports of deaths allegedly from this
vaccine, two Indian Council of Medical Research (ICMR) - sponsored
research studies in India were suspended pending outcome of
an enquiry. The vaccine was, however, neither withdrawn nor its
administration suspended.

Measles Vaccine
Brand Name: M-vac (Serum Institute of India)
A live-attenuated vaccine, usually including Schwartz, Edmonston-
Zagreb, Moraten and Edmonston-B strains. The vaccines manufactured
in India are formulated from Edmonston Zagreb strain grown on
human diploid cells or purified chick embryo cells.
Indications: Active immunization against measles.
Available as: Single and multidose vials, providing at least 1000
TCID-50/0.5 mL.
Dose: 0.5 mL (SC, IM) at 9 to 12 months. In high-risk situations, it
may well be administered earlier. In that event, it is best repeated
after an interval of 6 months or so.
ADRs: Febrile reactions for a day or two from 5th to 12th post-
vaccination day, febrile seizures, local erythema and soreness
over the injection site, malaise, headache, slight gastrointestinal
upset, rhinopharyngitis; toxic shock syndrome; very infrequently,
encephalitis and thrombocytopenic purpura.
Contraindications: Acute febrile illness, hypersensitivity to
neomycin, severe immune deficiency (both primary and
secondary), immunosuppressive therapy, recent gamma globulin
Chapter 36: Conventional and New Vaccines for Routine Use 279

administration, active untreated tuberculosis and history of severe


allergic reactions to constituents.
Precaution: Never administer by IV route. Observe special
precaution in subjects with seizure disorder.
Storage: 2 to 8C/35 to 46F.

Measles, Mumps and Rubella (MMR) Vaccine


Brand Names: Tresivac (Serum Institute of India), Priorix (GSK)
Indications: Active combined immunization against measles,
mumps and rubella.
Dose: A single injection (SC, IM) at 12 to 15 months of age (at least
3 months following measles vaccine). It is useful to give second
dose at school entry (4 to 6 years) or at any time 4 to 8 weeks after
the first dose.
Catchup MMR in 2 doses 8 weeks apart should be given to children
not previously vaccinated.
AEFI: Soreness at injection site, rhinopharyngitis, discrete
exanthemata, parotitis, lymphadenitis, hyperthermia, seizures.
There is no causal relationship of MMR vaccine with autism.
Same applies to the preservative for inactivated vaccines,
i.e. thimerosal which had also been incriminated for causing
neurodevelopmental disorders, including autism.
Contraindications: Allergy to egg protein, recent administration of
immunoglobulins, congenital or acquired immune deficiency.
Storage: 2 to 8C/35 to 46F (preferably, top shelf of refrigerator).

Inactivated Polio Vaccine (IPV)


Brand Names: Imovax (SP), Polprotec (CP)
Salk strain type, killed (inactivated) vaccine, providing 95 to 100
protective efficacy.
Indications: Now that eradication of polio is round the corner, over
and above the OPV, the enhanced IPV has been introduced in the
IAP immunization schedule. In addition to routine immunization
againt polio, it is especially indicated in immunocompromised
children and for boosting the eradication endeavors.
Available as: As such and in combination with other vaccines.
280 Section 6: Vaccines

Dosage: 0.5 mL (SC, IM) at 6, 10 and 14 weeks followed by a booster


at 15 to 18 months. This is over and above the routine OPV.
ADRs: No significant side-effects recorded so far.
Contraindication: Severe hypersensitivity.
Storage: 2 to 8C 35 to 46F.

Oral Polio Vaccine (OPV)


Brand Names: Bromide (GSK), Bipolio (BB)
Sabin strain type, live-attenuated vaccine that also indices humoral
immunity, providing per dose efficacy of 30 percent worldwide and
10 to 15 percent in India. A highly heat-sensitive vaccine, having shelf-
life of 6 months at 2 to 8 C. At -20 C, it zooms to 2 years. It is just 1 to
3 days at room temperature.
Indication: Protection against poliomyelitis.
Dose: 2 to 3 drops directly into childs mouth at birth (zero dose),
6 weeks, 10 weeks, 14 weeks. Following these 4 primary doses,
booster doses are administered at 15 to 18 months and 5th year.
Thus, a total 6 doses are recommended (IAP schedule). Pulse polio
doses are in addition to these basic doses.
AEFIs: Practically no side effects are seen; rarely VAPP.
Contraindications: Severe vomiting and diarrhea; immuno
deficiency.
Storage: Vaccine carrier for transport to outreach center: 2 to
8C/35 to 46F.
Clinical level: Freezer (-5 to -15C). State and district levels: -20C.
protected from light.

Pneumococcal Polysaccharide Vaccine (PPV-23)


Brand Names: Pneumo 23 (SP), Pneumovax-23 (MSD)
Unlike PCV-7, PCV-10 and PCV-13, this is an unconjugated vaccine,
containing 23 serotypes that must not be administered < 2 years
of age on account of its immunogenicity. Furthermore, it is T cell
independent, has low immunologic memory, and fails to reduce
nasopharygeal carriage and provide herd immunity.
Indications: Active protection against pneumococcal disease in
children > 2 years of age.
Chapter 36: Conventional and New Vaccines for Routine Use 281

Dose: 0.5 mL (SC, IM) as a single dose. Maximum 2 lifetime doses.


Immunologic hypersensitivity may occur following repeated
doses.
AEFIs: Quite safe except for local injection site reactions, low grade
fever, irritability, drowsiness, relapse of stabilized ITP, purpura;
rarely skin rash, arthralgia, myalgia, headache, fatigue; aponea in
preterm infants; arthus-like reactions on revaccination.
Precautions: Severe cardiopulmonary disease, acute febrile illness;
reduced protection in immunocompromised subjects; monitor
respiratory function, especially in preterm infants.
Storage: 2 to 8C/35 to 46F.
Remarks: Expensive vaccine costing around ` 730.

Pneumococcal Conjugate Vaccine (PCV-7, PCV-13)


Brand Names: Prevenar-7 (Wyeth), Prevenar 13 (Pfizer-Wyeth)
IAP recommends it as an additional vaccine after one-to-one discussion
with parents at > 6 weeks age (unlike the earlier nonconjugate
polysaccharide vaccine which has to be given only > 2 years of age
and which does not produce herd immunity)
The pneumococcal 7-valent conjugate vaccine is a sterile solution
of saccharides of the capsular antigens of Streptococcus pneumoniae
serotypes 4, 6B, 9V, 14, 18C, 19F and 23F individually conjugated
to diphtheria CRP197 protein, thereby covering the commonly
encountered pneumococcal infections like pneumonia, bacteremia,
meningitis and otitis media.
Pneumococcal 13-valent conjugate vaccine contains all seven
serotypes of PCV-7 plus additional 6 serotypes commonly encountered,
thereby rendering the vaccine more broad-based.
Indication: Protection against infection with Streptococcus
pneumoniae in infants and children with high-risk of serious pneu
mococcal infections (nephrotic syndrome, asplenia, splenectomy,
immunocompromised states), sickle cell anemia, chronic renal
failure and cerebrospinal fluid (CSF) rhinorrhea. Box 36.2 lists the
detailed high-risk situations.
Available as: Single dose 0.5 mL pre-filled syringes.
Dose: 0.5 mL (IM, SC) at 6, 10 and 14 weeks followed by a booster
at 15 to 18 months.
282 Section 6: Vaccines

AEFIs: Local painful erythema and induration. Quite safe unlike


earlier nonconjugate vaccine.
Contraindications: Hypersensitivity to any component of the
vaccine.
Storage: 2 to 8C/35 to 46F. It must never be freezed.
Box 36.2: High-risk situations for pneumococcal disease/vaccine
Immunodeficiency (including congenital immunodeficiency)
Immunosuppressive therapy
Splenic: A splenemia, hyposplenemia, autosplenectomy (sickle-cell disease)
Chronic cardiac disease
Chronic pulmonary disease (but not asthma unless on high dose steroids)
Chronic liver disease
Chronic renal disease: Nephrotic syndrome, chronic renal failure (CRF)
Diabetes insipidus
Miscellaneous: Cerebrospinal fistula, CSF rhinorrhea, cochlear implants

Tetanus Toxoid (TT)


Brand Names: Tetanus Toxoid (Serum Institute of India), BETT (Biologic
Evans)
According to current recommendations, its better substitute is
tetanus reduced dose diphtheria toxoid (Td) or tetanus, reduced dose
diphtheria and acellular pertussis vaccine (Tdap) which provide better
and more comprehensive protection.
Indication: Active immunization against tetanus.
Available as: 0.5 mL ampoule, 10, 20 dose vials; 0.5 mL providing
40 Lf units (constituting one dose)
Dose: 0.5 mL (IM) every 10 years if already immunized, having
completed primary and booster vaccination with triple vaccine
(DTwP or DTaP).
Each and every pregnant woman, not previously immunized, must
receive two doses of TT (preferably Td) at an interval of one month,
the second dose at least 2 weeks prior to delivery. For subsequent
pregnancy within next 5 years, a single dose suffices.
AEFIs: Mild local reaction with painful swelling at the injection site.
Contraindications: Acute febrile illness, outbreak of poliomyelitis.
Storage: 2 to 8C/35 to 46F.
Chapter 36: Conventional and New Vaccines for Routine Use 283

Tetanus Toxoid-Reduced Dose Diphtheria Toxoid (Td)


This is a preferable substitute for TT.
Indication: Active immunization against tetanus.
Available as: 0.5 mL ampoule, 10, 20 dose vials; 0.5 mL providing
40 Lf units (constituting one dose)
Dose: 0.5 mL (IM) every 10 years if already immunized, having
completed primary and booster vaccination with triple vaccine
(DTwP or DTaP).
Each and every pregnant woman, not previously immunized, must
receive two doses of TT (preferably Td) at an interval of one month,
the second dose at least 2 weeks prior to delivery. For subsequent
pregnancy within next 5 years, a single does suffices.
AEFIs: Mild local reaction with painful swelling at the injection site.
Contraindications: Acute febrile illness, outbreak of poliomyelitis.
Storage: 2 to 8C/35 to 46F.

Rotavirus Vaccine
Brand Names: Human: Rotarix (GSK), Bovine: RotaTeq (MSD)
Rotavirus has earned the designation democratic virus since it infects
children globally regardless of the socioeconomic status of the country.
Rotavirus vaccine is a live-attenuated vaccine. IAP recommends it after
one-to-one discussion with parents at/or > 6 weeks of age. Two types
are available:
1. A monovalent attenuated human rotavirus vaccine (Rotarix)
2. Human bovine reassortant vaccine (RotaTeq).
Their efficacy and safety profiles are similar.
Indication: Prevention of rotavirus diarrhea.
Available as:
Rotarix: Lympholized vaccine needing reconstitution with
liquid diluents
RotaTeq: Liquid virus mixed with buffer, needing no
reconstitution.
Dose: Starting at > 6 weeks, 2 to 3 doses (O) depending on the
brand (Rota: 2, RotaTeq 3). The gap between two doses should be
about 4 to 8 weeks.
284 Section 6: Vaccines

AEFIs: Minor reactions, including pain and redness at the injection


site.
Special remarks: The vaccine was temporarily withdrawn following
alleged occurrence of intussusception following it.

Rubella Vaccine
Brand Name: R-Vac (Serum Institute)
A live-attenuated vaccine, derived from RA 27/3 strain grown in
human diploid/chick embryo cell cultures. It is usually recommended
as a part of MMR vaccine which also provided measles and mumps
vaccine, thereby providing triple protection.
Indications: Prevention of maternal rubella through active
immunization against rubella (a potential cause of congenital
rubella syndrome) in: (i) girls between 1 year and puberty,
(ii) susceptible females of child-bearing age (seronegative)
provided that they are not already pregnant and conception is
unlikely in the subsequent 2 months.
Available as: Freeze-dried with sterile diluents for reconstitution.
Needs to be used within 6 hours of reconstitution.
Dose: 0.5 mL (deep SC, IM) as a single administration. In 95 percent
cases, it provides lifelong immunity.
AEFIs: Local erythema and soreness at the injection site, mild rubella-
like illness with skin rash, pharyngitis, pyrexia, lymphadenitis,
arthralgia, arthritis; rarely thrombocytopenia, neuropathy and
paresthesia; rarely encephalitis.
Drug interaction: Live vaccines, tuberculin reaction.
Contraindications: Severe immunocompromised states, pregnancy.
Precautions:
Availability of epinephrine injection.
Defer it for at least 3 months after blood transfusion/immune
serum globulin.
Defer for at least 1 month before/after other live virus vaccines
(except OPV, measles and mumps).
Defer pregnancy for 3 months after the rubella vaccine.
Storage: 2 to 8C/35 to 46C (preferably upper shelf of the
refrigerator).
Chapter 36: Conventional and New Vaccines for Routine Use 285

Typhoid vaccines

Vi Capsular Polysaccharide Typhoid Vaccine


Brand Names: Typherix (GSK), Typhim Vi (SP), Typhobar (BT), Biotyph
(Biomed)
Indication: Active immunization from 2 years onwards. It is not
immunogenic < 2 years age.
Dose: 0.5 mL (25 mcg ViCPS antigen) administered as a single IM,
SC dose; to be repeated every 3 years for continuity of protection.
AEFIs: Mild local pain and swelling, pyrexia, headache.
Contraindication: Hypersensitivity, acute severe febrile illness.
Precaution: Availability of facility to handle a severe anaphylactic
reaction, i.e. epinephrine injection 1:1000.
Storage: 2 to 8C/35 to 46F (preferably middle shelf of
refrigerator).

Vi Conjugate Typhoid Vaccine


Brand Name: Peda Typh
In this vaccine conjugation is with protein carrier, tetanus toxoid, to
induce T-cell dependent immune response and immunogenicity.
Indications: Active immunization from 3 months onwards.
Dose: 3 months to 2 years: Two injections of one dose at 4 to 8
weeks interval followed by booster at 2 to 2 years and then every
10 years.
AEFIs: Mild local pain, erythema, induration, mild fever in first 48
hours.
Contraindication: Hypersensitivity to any component.
Precaution: Availability of facility to handle a severe anaphylactic
reaction, i.e. epinephrine injection 1:1000.
Special remarks: Whereas Vi capsular polysaccharide typhoid
vaccine can be given only after 2 years of age, V1 conjugate
typhoid vaccine can be given as early as 3 months.
Storage: 2 to 8C/35 to 46F (preferably middle shelf of
refrigerator).
286 Section 6: Vaccines

Oral Typhoid Vaccine


Brand Name: Typhoral (Hoechst)
This is an oral live attenuated Ty21a vaccine, recommended for
children 6 years of age and above. Now, it is not available in India. A
liquid form of the vaccine is in pipeline.
Indication: Active immunization in subjects over 6 years of age.
Dose: One capsule on day 1, 3 and 5 one hour before meal, given
every 3 years.
AEFIs: Slight gastrointestinal upset, rash, pyrexia.
Contraindication: Acute febrile illness, GIT infection, immuno
deficiency, immunosuppressant drugs, antimitotics, certain
antibiotics and sulfa active against Salmonella.
Storage: 2 to 8C/35 to 46F; protect from light.

Whole-cell Killed (Inactivated) TA and TAB Vaccines


Though very effective against both typhoid and paratyphoid, these
vaccines now stand withdrawn on account of high reactogenicity,
especially high fever.
Indication: Active immunization in the community.
Dose:
2 doses (SC) 6 to 9 months apart; booster every 3 to 5 years
(IAP recommendation)
First dose (SC) at 5 to 6 months; boosters at 10 years and 16
years (National Immunization Schedule).
ADRs: Incidence of side effects (pyrexia, local pain and induration)
high.
Storage: 2 to 8C; protect from light.
Special remarks: At present, only two typhoid vaccine (Vi
polysaccharide and conjugate) are available in India.

Tetanus, Low Dose Diphtheria (Td) Vaccine


Indications:
As a replacement for TT in all situations
As a replacement for DPT/DT >7 years of age when catchup
Chapter 36: Conventional and New Vaccines for Routine Use 287

vaccination is needed. DT/DT must not be employed in


children > 7 years of age on account of reactogenicity to high
dose of diphtheria and pertussis components.
Dose: 0.5 mL (IM).
AEFIs: Local injection site reactions.
Storage: 2 to 8C/35 to 46F.
Remarks: Tdap, though expensive, is a superior replacement for Td
since it provides more comprehensive protection.

Tetanus, Low Dose Diphtheria and Pertussis (Tdap) Vaccine


Brand Name: Bosterix (GSK)
Indications:
Children who have received all 3 primary and 2 booster doses
of DTP, it may be given at 10 to 12 years of age.
Children > 7 years of age who missed the second booster of
DTP
Children > 7 years who failed to complete primary immunization
with DTP
As a better option to TT/TD in wound management > 10 years.
Dose: 0.5 mL (IM).
AEFIs: Local injection site reactions; rarely fever, headache and
fatigue.
Contraindications: Allergic reactions to its component(s), history of
encephalopathy secondary to pertussis vaccine.
Storage: 2 to 8C/35 to 46F.

Varicella Vaccine
Brand Name: Varilrix (GSK), Okavax (Sanofi/Pasteur), Varipox (Ziadus
Biogen)
A lypholized vaccine providing live-attenuated Oka strains of Varicella
zoster virus.
Indian Academy of Pediatrics (IAP) now recommends it as
additional vaccine that may be given after one to one discussion with
parents after 15 months of age (earlier recommendation was after 12
months of age).
288 Section 6: Vaccines

Indications: Active immunization against chickenpox (varicella)


in healthy subjects over 1 year age after one to one discussion
with parents; susceptible healthy contacts of chickenpox patients
within 3 days of exposure; medical and paramedical personnel
who are likely to be in close contact of chickenpox patients; high-
risk groups (Box 36.3).

Box 36.3: High-risk groups needing chickenpox vaccine


Humoral immunodeficiencies
HIV, provided CD4 counts are >15% and > cut-off (age-related)
Leukemia, provided in remission and off chemotherapy for a minimum of
36 months
Long-term salicylate therapy
Long-term steroid therapy
Chronic lung/heart disease
Adolescents who had not suffered from varicella in the past, provided that
they are sero-negative
Adolescents who are sero-negative and are inmates of or working in an
institutional set-up
Postexposure prophylaxis in susceptible healthy nonpregnant contacts,
preferably within 3 days of exposure (efficiency 90%) and potentially up to
5 days of exposure (efficiency 70%; 100% against severe disease).

Available as: Subcutaneous (SC) injection 0.5 mL vial (constituting


one dose). The diluent supplied in a separate ampoule has to be
added to the vial to dissolve the somewhat pink-colored pellet.
The entire contents of the vial constitute a single dose.
Dose:
12 months to 12 years: One dose (SC)
13 years (inclusive) and later: Two doses (SC) at an interval of 4
to 8 weeks
The recommended site is lateral aspect of upper arm.
AEFIs: Infrequently, anaphylaxis, local reactions at the injection
site, headache, GI upset, pyrexia, fatigue and paresthesia.
Drug interactions: Other live vaccines, tuberculin skin test.
Contraindications: Acute severe febrile illness, TLC < 1200/cmm,
lymphocytopenia, blood dyscrasia, active untreated tuberculosis,
lactation. Poor cellular immune response, primary or acquired
immunodeficiency, known systemic hypersensitivity to neomycin,
concurrent administration of pneumococcal vaccine.
Chapter 36: Conventional and New Vaccines for Routine Use 289

Precaution: Make sure that alcohol or any other disinfecting


agent is totally evaporated from the skin before the injection is
actually given; never administer intradermally; do not give within
3 months of blood transfusion or immunoglobulin.
Storage: 2 to 8C/35 to 46F (preferably, in lower shelf of refrigerator;
protect from light.

Vaccines Under Special Circumstances

Cholera Vaccine
Brand Names: Shanchol (Shanta Biotech), Dukoral (Crucell)
Two types of safe and effective oral cholera vaccines are available.
Both are whole-cell killed vaccines, one with a recombinant B-sub
unit, the other without. Both have sustained protection of over 50
percent lasting for two years in endemic settings.
Available as: Dukoral is WHO prequalified and licensed in over
60 countries. Dukoral has been shown to provide short-term
protection of 85 to 90 percent against V. cholerae O1 among all
age groups at 4 to 6 months following immunization.
Shanchol provides relatively long-term protection against
V. cholerae O1 and O139 in children under five years of age. WHO
prequalification is, however, pending for this vaccine.
Dose: Both vaccines are administered in two doses given between
seven days and six weeks apart. The vaccine with the B-subunit
(Dukoral) is given in 150 mL of safe water.
AEFIs: None
Special remarks: According to the WHO recommendations,
immunization with currently available cholera vaccines should
be used in conjunction with the usually recommended control
measures.
In areas where cholera is endemic as well as
In areas at risk of outbreaks.
Vaccines provide a short-term protection. Long-term activities like
improving water and sanitation have got to be put in place.
Vaccination should target vulnerable populations living in
high-risk areas and should not disrupt the provision of other
interventions to control or prevent cholera epidemics. The WHO
290 Section 6: Vaccines

3-step decision making tool aims at guiding health authorities in


deciding whether to use cholera vaccines in complex emergency
settings.

Influenza Virus Vaccines


Trivalent Influenza Vaccine (TIV)
Brand Names: Vaxigrip (Sanofi Pasteur), Influvac (Solvy), Fluarix (GSK),
Agripal (CP)
A killed, split-product vaccine containing 15 mcg each of the WHO-
recommended two influenza A strains and one influenza B strain (the
seasonal vaccine contains novel H1N1 strain (recent pandemic strain)
rather than the old H1N1 strain; provides 80 percent efficacy; licenced
for use > 6 months of age.
Indications: Protection against influenza virus infection, especially
in subjects with underlying chronic cardiac or bronchopulmonary
disease, immunocompromised state, diabetes, chronic renal
insufficiency, or sickle-cell anemia.
Available as: Single dose vial, prefilled syringe or ampoule;
multidose vial.
Dose: This is detailed in Table 36.1.

Table 36.1: Dose of TIV for protection against influenza


Age group Dose No. of doses
635 months 0.25 mL (SC,IM) 1 or 2*
38 years 0.5 mL (SC,IM) 1 or 2*
9 years 0.5 mL (SC,IM) 1
*Second dose after 46 weeks is for subjects who have not received the vaccine earlier

AEFIs: Local pain, erythema and induration at the injection site,


pyrexia, malaise; rarely, anaphylaxis; very rarely Guillain-Barre
syndrome (GBS).
Contraindication: Hypersensitivity to its components.
Caution: Avoid in children with history of GBS and severe egg
allergy.
Storage: 2 to 80C (35 to 46F).
Chapter 36: Conventional and New Vaccines for Routine Use 291

Live Attenuated Influenza Vaccine (LAIV)


Brand Name: FluMist (MedImmune)
Live attenuated reassortants of the 3 WHO-recommended strains (2
influenza A and 1 influenza B; 2010-2011 seasonal vaccine contains
novel H1N1 strain rather than the earlier H1N1 strain), licenced for use
after 2 years of age; superior efficacy than inactivated vaccine (TIV).
Available as: Prefilled, single-use sprayer containing 0.2 mL of
vaccine.
Dose: As a nasal spray. Approximately 0.1 mL (i.e. half of the
total sprayer contents) is sprayed into the first nostril while the
recipient is in the upright position. An attached dose-divider clip
is removed from the sprayer to administer the second half of the
dose into the other nostril.
AEFIs: Mild fever, rhinorrhea, nasal congestion, sore throat,
etc. which, perhaps result from effects of intranasal vaccine
administration or local viral replication.
Contraindications: Children < 2 years of age.
Precautions:
Avoid in children with history of hypersensitivity to egg and
GBS
Vaccine prepared for a previous influenza season should not be
administered to provide protection for any subsequent season.
Storage: 2 to 8C/35 to 46F.

Rabies Vaccine
The earlier nerve tissue vaccine with poor efficacy and serious
adverse (neuroparalytic) reactions are no longer in use. The modern
tissue culture vaccines (MTCVs) include
Purified chick embryo cell vaccine (PCECV): Rabipur (Novartis)
Human diploid cell vaccine (HDCV): Rabivar (SII)
Purified vero cell vaccine (PVRV): Abhyarab (Abhay)
Purified duck embryo vaccine (PDEV): Vaxirab (SP)
As a rule, all cases of rabies exposure belonging to Category III
(transdermal bites, single or multiple, contamination of mucous
membrane with saliva or exposure to a bat) need to be administered
rabies immunoglobulin (RIG):
292 Section 6: Vaccines

Human rabies immunoglobulin (HRIG) which is slightly superior


with least anaphylaxis risk but is expensive.
Or
Equine rabies immunoglobulin (ERIG) which is equally effective,
less expensive but carries some risk of anaphylaxis.

Purified Chick Embryo Cell (PCEC) Vaccine


Brand Name: Rabipur (Hoechst/Novartis)
Indications: Protection against rabies in cases of bite by a
dog suspected of suffering from rabies (post-exposure) and
prophylactic vaccination against rabies before exposure.
Dose: For post-exposure, full course of 6 injections (1 mL each),
one each on zero day (the day of first injection, not necessarily the
day of dog bite), 3rd day, 7th day, 14th day, 30th day and 90th day
(IM, SC). In case antirabies treatment is started immediately with
cleansing of bitten area with soap and water and administration
of antirabies serum. Sixth injection may well be missed.
For prophylaxis, full course of 3 injections (1 mL each) on zero
(first) day, 28th day and 56th day or zero day, 7th day and 21st day
in urgent situations (IM, SC).
AEFIs: Gastrointestinal upset, painful injection site, lympha
denopathy.
Contraindication: Hypersensitivity.

Vero Cell Vaccine


Brand Name: Verorab (Sanofi Pasteur)
See details provided for PCEC vaccine.

Human Diploid Cell (HDC) Vaccine


Brand Name: Rabivac (SII)
Indication: Protection against rabies in cases of bite by a
dog suspected of suffering from rabies (post-exposure) and
prophylactic vaccination against rabies before exposure.
Dose: For post-exposure, full course of 6 injections (1 mL each),
one each on zero day (the day of first injection, not necessarily the
day of dogbite), 3rd day, 7th day, 14th day, 30th day and 90th day.
Chapter 36: Conventional and New Vaccines for Routine Use 293

(IM, SC). In case antirabies treatment is started immediately with


cleansing of bitten area with soap and water and administration
of antirabies serum. Sixth injection may well be missed.
For prophylaxis, full course of 4 injections (1 mL each) on 0, 7th,
21st and 28th day (IM, SC).
AEFIs: Gastrointestinal upset, painful injection site, lympha
denopathy.
Contraindication: Hypersensitivity.
Storage: 2 to 8C.
Special remarks: The active principle, efficacy, safety and dosage of
the three vaccines remains by and large same. Costwise, however,
whereas HDCV is priced around ` 950/dose, PCEC and Verorab are
priced at ` 370/dose.

Japanese Encephalitis Vaccine


Brand Name: JENVAC (Bharat Biotech)
Indication: Single most important control measure against
Japanese encephalitis.
Available as:
Cell culture derived live SA-14-14-2 vaccine (most suitable in
Indian settings)
Cell culture derived inactivated vaccine
Mouse brain-derived inactivated JE vaccine.
Dose:
Live-attenuated vaccine: 0.5 mL (SC) for all ages; 2 doses, 4
week apart.
Formaline-inactivated mouse brain or hamster kidney vaccine:
Two doses, 1 mL each (0.5 mL for < 3 years age) and administered
at an interval of 7 to 14 days (SC). After 6 to 12 months, a third dose
is given. Every 3 to 4 year, a booster is needed.
AEFIs: No serious adverse effects
Contraindications: JE vaccine is contraindicated in high fever,
diabetes mellitus, liver and heart disease and immunodeficiency.
Storage: 2 to 8C/35 to 46F.
Special remark: JENVAC is Indias first fully indigenous vaccine. It is
based on Indian strain.
294 Section 6: Vaccines

Meningococcal Vaccine
Brand Names: MPSV- A+C+Y+W135: Quadrimengo (Biomed), Mencivax
(GSK) A + C: Biomaigo (Biomed)
Though both unconjugated and conjugated vaccines are available,
conjugated vaccines should be preferred. These are either bivalent
(A + C ) or quadrivalent (A, C, Y, W135).
Indication: Active immunization against Neisseria meningitidis (group
A and C) infection which may cause serious illness like meningitis or
septicemia. Precise indications as per IAP are listed in Box 36.4.

Box 36.4: Indications of meningococcal vaccine


During disease outbreaks if caused by serogroups included in the vaccine.
Mass chemoprophylaxis is generally not recommended for control of mass
outbreaks due to cost, implementation problems, adverse reactions and
drug resistance.
Children with terminal complement component deficiencies.
Children with functional/anatomical asplenemia/hyposplenemia. Ideally,
vaccine should be given 2 weeks before splenectomy.
Laboratory personnel and health care workers who are exposed routinely
to N. meningitidis in solutions that may be aerosolized should be
considered for vaccination.
Haj pilgrims to Saudi Arabia. This is a mandatory vaccine for them.
Travelers to African meningitis belt, particularly between December and
June and especially if there is an on going epidemic.
As an adjunct to chemoprophylaxis in close contacts of patients with
meningococcal disease.
Students grouping for study abroad. It is mandatory for most universities
in the United States.

CDCs Advisory Committee on Immunization Practices (ACIP) has


provided revised recommendations for conjugate meningococcal
vaccine (Box 36.5), approving two new recommendations, namely
1. Routine vaccination of adolescents, preferably at age 11 or 12
years, with a booster dose at age 16 years.
2. A 2-dose primary series administered 2 months apart for persons
aged 2 through 54 years with persistent complement component
deficiency (e.g. C5C9, properidin, factor H, or factor D) and
Chapter 36: Conventional and New Vaccines for Routine Use 295

functional or anatomic asplenia, and for adolescents with human


immunodeficiency virus (HIV) infection.

Box 36.5: New recommendation of Advisory Committee on


Immunization Practices (ACIP) concerning meningococcal vaccine
Specific recommendations for meningococcal conjugate vaccine by risk
group are as follows:
For persons 11 to 18 years old, the primary series should be 1 dose,
preferably at age 11 or 12 years. The booster dose should be at age 16
years if the primary dose was at age 11 or 12 years, and at ages 16 to 18
years if the primary dose was at ages 13 to 15 years. If the primary dose was
on or after age 16 years, no booster is needed.
For HIV-infected persons 11 to 18 years old, the primary series should be
2 doses, 2 months apart. The booster dose should be at age 16 years if the
primary dose was at age 11 or 12 years, and at ages 16 to 18 years if the
primary dose was at ages 13 to 15 years. If the primary dose was on or after
age 16 years, no booster is needed.
For persons 2 to 55 years old with persistent complement component
deficiency or functional or anatomic asplenia, the primary series should
be 2 doses, 2 months apart, and the booster dose every 5 years. If a 1-dose
primary series was administered, the booster dose should be given at the
earliest opportunity, then at every 5 years.
For persons 2 to 55 years old with a prolonged increased risk for exposure,
the primary series should be 1 dose. The booster dose should be given
after 3 years for persons 2 to 6 years old, and after 5 years for persons 7
years or older, if the person remains at increased risk.

Available as: Single dose (0.5 mL), 10 and 50 dose vials, providing
50 mcg each of N. meningitidis group A and group C/unit (0.5 mL)
Dose: 0.5 mL (SC, IM), to be repeated every 2 to 3 years.
AEFIs: Local redness and swelling, pyrexia.
Contraindication: Acute febrile illness, evolving disease.
Caution: Avoid in children <2 years.
Storage: 2 to 8C (35 to 46F).

Yellow Fever Vaccine


A live-attenuated vaccine derived from 17D strain of the virus grown
in chick embryo cells.
296 Section 6: Vaccines

Brand Name: Stamnil (SP)


Indication: Prophylaxis against yellow fever, influenza-like or severe
hepatitis-like illness, caused by the virus 17D with the vector,
Aedes aegypti, endemic in African countries (both sub-Saharan -
33 and South American - 11). Since this vector is common in India
and travelers from endemic areas keep visiting India, possibility of
its occurrence any time in future cannot be ruled out.
International Health Regulations make it a mandatory vaccine
for travelers to endemic areas.
Available as: Freeze-dried, single or multi-dose vials with sterilize
saline as diluents. In India, it is available at select government-
controlled centers.
Dose: 0.5 mL (SC) every 10 years.
AEFIs: Usually local injection site problems; rarely neuropathy
(encephalitis, GBS), yellow fever-associated visceroptic disease
(YEL-AVD).
Contraindications: Age < 6 months, thymus disease, severely
immunocompromised state (say, HIV with CD4 count < 15% of
age-related cut-off, serious egg allergy.
Precaution: Whereas it is contraindicated < 6 months, it is best
avoided in 6 to 9 months age group.
Storage: 2 to 8C.
Chapter

37
Combination Vaccines

A combination vaccine is defined as a vaccine that aims at providing


protection against a number of infectious diseases through more than
one antigen in a single preparation.
Such a vaccine contains several immunogens in a single shot for
protection against quite a few infectious diseases.
Understandably, its efficacy, immunogenicity, and safety profile is
comparable to the independently administered vaccines.
Usually, the term, combination vaccines, is employed for vaccines
containing multiple pathogens, e.g. DTP (both DTwP and DTaP), MMR,
DTwP + Hib, DTaP + Hib, DTwP + Hep B, etc.
However, many consider single pathogen vaccines like OPV, IPV,
influenza, pneumococcal, etc. also combination vaccines since they
contain various antigens or serotypes of a pathogens.

Benefits
Too many vaccines, predominantly injections, especially with inclusion
of newer vaccines in the schedule, are a burden on the child and also
the family. Too many individual vaccines also mean several visits. Any
medical modality demanding several visits suffers from the malady
of poor compliance and, at times, falls flat. This backdrop has led to
the development of combination vaccines that reduce the number of
pricks and the visits.
The earliest combination vaccine to become available was DPT/
DTP in 1945 followed by MMR in 1971. Various tetravalent and
pentavalent vaccines are built up around DTP.
298 Section 6: Vaccines

Consumer-related Benefits
Reduction in number of pricks.
Reduction in number of visits to the health center.
Reduction in cost of administering and stocking vaccines.
Improved compliance, resulting in fall in incidence of missed
vaccinations.
Facilitation in the introduction of new vaccines in the immunization
schedule.

Health Department/Facility-related Benefits


Reduction in pressure on cold chain.
Reduction in paper work.
Enhanced compliance, contributing to success of immunization
program.
Reduced vaccination visits.
Economic gains.
Advantages of combination vaccines are overwhelming notwith
standing the slight hike in adverse events, justifying their enhanced
use.

Adverse Events
A marginal increase in incidence of minor AEFI may occur following a
combination vaccine.
Adverse effects, if any, are on similar lines as in case of
independently administered vaccines though with somewhat higher
frequency than in case of the latter.
Adverse effects include febrile seizures the risk of seizures being
higher on the day of vaccination.
Compared to an increase in adverse events, advantages of
combination vaccines are overwhelming, overweighing the slight
hike in adverse events, and justifying their enhanced use.

Currently Licensed Combination Vaccines in India


DTwP + Hib
DTwP + Hep B
Chapter 37: Combination Vaccines 299

DTwP + Hep B + Hib


DTaP + Hib
DTaP + Hib + IPV
Hep B + Hep A

Combination Vaccines not yet Licensed in India


DTwP + IPV: This combination vaccine is in use since 1990 in
countries where polio stands eradicated and inactivated (killed)
polio vaccine is being employed. In India, we are still predominantly
using OPV.
DTwP + IPV + Hib
DTaP + IPV
DTaP + Hep B
DTaP + IPV + Hep B
DTaP + Hib + Hep B
DTaP + IPV + Hep B + Hib
Varicella + MMR
Hep A + Typhoid
Hep B + Hib
MMRV.

Recommendations in India
Available combination vaccines are at par with the independently
administered vaccines as far as immunogenicity, efficacy, and safety
profiles are concerned, except for a marginal increase in minor
adverse effects. Vigilance and compliance to instructions with regard
to mixing of different vaccines in the same syringe by the health care
professionals in accordance with the manufacturers instructions are
warranted.

Precautions and Warnings


Never prepare your own combination vaccine by mixing two or
three vaccines. Mixing is permitted only in case of combination
vaccines specifically packed for this purpose. Manufacturers
instructions for mixing need to be strictly followed.
300 Section 6: Vaccines

In the nomenclature, the hyphen (-) is intended to indicate that


the antigens are mixed together by the manufacturer before
the product is sold. The forward slash (/) indicates that the two
products are to be reconstituted by the user in compliance with
the manufacturers instructions.
Appendices
Useful Information Related to
Pediatric Drug Therapy
Appendix
Specific Antidotes
1
Toxic agent Antidote
Amphetamine Chlorpromazine: 1 mg/kg (IM, IV)
Atropine/Belladona/Datura Physiostigmine: 0.5 to 2.0 mg (IM)
Stat; to be repeated every half an hour if
needed.
or
Pilocarpine: 2 to 4 mg (O); 0.25 to 0.5 mg (IM)
Arsenic BAL: 2.5 mg/kg/dose (IM); first day 6 doses,
second day 4 doses and third day 2 doses;
later a single daily dose for the next 10 days
Benzodiazepines IV flumazenil (Romazicone) 0.1, 0.2, 0.3, 0.4,
0.5 mg every alternate minute.
Beta-blocker SC atropine, 0.010.02 mg/kg/dose until atro-
(Propranolol) pinization occurs (dry mouth, tachycardia,
dilated pupils
Carbon monoxide Oxygen (100%) inhalation for half an hour
Cyanide Amyl nitrite: 0.3 mL (inhalation) for 15 to 30
seconds; repeat every minute
Sodium nitrite: 5 mL (3.5% solution), intra-
venously every minute followed by sodium
thiosulfate 2.5 mL (25% solution) every
minute subject to a maximum of 50 mL.
Heparin Protamine sulfate: 2.5 to 5.0 mg/kg (IV); half of
the dose needs to be repeated 4 hourly
INH (Isoniazid) IV vitamin B6 for every 1 mg of INH

Contd...
302 Appendices: Useful Information Related to Pediatric Drug Therapy

Contd...

Toxic agent Antidote


Iron Desferrioxamine: 20 mg/kg/dose (IM) every 4
to 6 hourly until urine color returns to normal,
i.e. 1236 hours.
Alternatively EDTA or BAL may be employed.
Lead BAL: See Arsenic
EDTA: 50 to 75 mg/kg/day (IM, IV) in 4 divided
doses.
Penicillamine: 2040 mg/kg/day (O).
Mercury BAL: See Arsenic
Penicillamine: See Lead
Opium, morphine, etc. Nalorphine (Naloxone): 0.1 mg/kg (IV) stat;
needs to be repeated after 1530 minutes, if
needed.
Organic phosphates Atropine: 0.030.04 mg/kg/(IV); half of this
dose needs to be repeated every 1530
minutes until pupils begin to dilate, mouth
becomes dry and tachycardia results
(atropinzation).
plus
Pyridoxine aldoxime methiodide (PAM): 2550
mg/kg (IV) slowly over 5 minutes period;
repeat after hour; may give maintenance
dose
Paracetamol N-acetylcystein (NAC): 150 mg/kg (IV) as
infusion in 200 mL 5% dextrose in 15 minutes;
then 50 mg/kg in 500 mL 5% dextrose in 4
hours.
Phenothiazine Diphenylhydramine: 12 mg/kg (IV) stat;
repeat half hrly.
Diazepam: 0.30.5 mg/kg IV stat.
Various Solutions Appendix
Used in the Treatment
of Dehydration and
Dyselectrolytemia
2
Solution Ions (mEq/L)
Na+ K+ Ca++ Cl HCO3 Lactate NH4
Isotonic saline 154 154
Strength 77 77
isotonic saline
5% Glucose 154 154
saline (5%)
Hypertonic 855 855
saline (5%)
Hypotonic 77 77
saline (0.45%)
Ringers 147 4 4 155
solution
Ringers lactate 130 4 4 111 28
solution
1/6th Molar 167 167
sodium lactate
Potassium 20 20
(1.5 g)
Chloride (2.2 g) 30 30
Sodium (1.5%) 178 178

Contd...
304 Appendices: Useful Information Related to Pediatric Drug Therapy

Contd...

Solution Ions (mEq/L)


+ + ++
Na K Ca Cl HCO3 Lactate NH4
Ammonium 168 168
chloride (0.9%)
Isotonic
Darrows 122 35 104 53
solution
Plasma 143 5 103
Blood 80 4 32
Drugs Likely to Have Appendix
Adverse Effects on the
Fetus When Consumed
During Pregnancy
3
Drugs Adverse effects (teratogenic)
Diazepam Cleft lip, cleft palate, hypothermia, apnea deafness,
thrombocytopenia, neurologic anomalies
Chloroquine Deafness
(prolonged use)
Sulfas Hyperbilirubinemia
Streptomycin Eighth nerve deafness, renal damage
Tetracyclines Deposition in teeth, staining of teeth, enamel
hypoplasia, retardation of bone growth, congenital
cataracts
Propranolol Growth retardation, thrombocytopenia
Indomethacin LBW, platelet dysfunction
Heroin Intrauterine death, LBW, SIDS
Phenobarbital Cleft lip, cleft palate, CHD, respiratory depression,
withdrawal symptoms
Phenytoin Various malformations in relation to limbs, heart
and face
Valproate Facial anomalies, spina bifida, developmental delay
Smoking LBW, abnormal placentation
Alcoholism IUGR, mental retardation, microcephaly, CHD, flexion
contractures
Diethylstibestrol Genitourinary anomalies in males, adenosis or
carcinoma of vagina in females

Contd...
306 Appendices: Useful Information Related to Pediatric Drug Therapy

Contd...

Drugs Adverse effects (teratogenic)


Progestrogen Masculinization of female fetus
with testosterone
Iodides (in third Congenital goiter, hypothyroidism
trimester)
Cyclophos- Multiple deformities
phamide
Progesterone (in Malformations of external genitalia, postpubertal
third trimester) vaginal adenocarcinoma
Sulfonylurea Neonatal hypoglycemia, brain damage
(third trimester)
Thalidomide (in Limb deformities, defects of CVS, ears and eyes
third trimester)
Radiation Mental retardation, microcephaly
Drugs in Treatment/ Appendix
Prevention of
Fetal Disease 4
Fetal disease Treatment/Prevention
Hypothyroidism Thyroid hormone
Erythroblastosis fetalis Rh (D) immune globulin
Intrauterine blood transfusion
Galactosemia Galactose-free diet. Tocolytic agents
Asphyxia/distress High concentration of oxygen to the
mother
Positioning the uterus to avoid vascular
compression
Operative delivery before severe fetal
trauma occurs
Hyaline membrane Steroids to mother to facilitate
disease fetal lung maturation
Prematurity Tocolytic agents
Adrenogenital syndrome Steroids
Pulmonary immaturity Steroids
Diabetes mellitus Good insulin control
Syphilis Penicillin
Tuberculosis Antituberculous therapy
Toxoplasmosis Spiramycin
Paroxysmal tachycardia Digoxin, quinidine, propranolol
Withdrawal syndrome Methadone
Appendix
Therapeutic Range
of Some Drugs 5
Drugs Serum concentration (mcg)
Antibiotics
INH 210
Chloramphenicol 1025
Gentamicin 410
Amikacin 1525
Kanamycin 1525
Carbenicillin 90110
Tobramycin 410
Antipyretic/analgesic/anti-inflammatory
Paracetamol 50100
Aspirin 50150
(short-term antipyretic therapy)
100300
(long-term antiarthritic therapy)
Anticonvulsants
Phenobarbital 1040
Carbamazepine 412
Diphenylhydantoin 1020
Valproate 50150
Clonazepam 0.020.07
Ethosuximide 40100
Tridione 640
Diazepam 0.150.06

Contd...
Appendix 5: Therapeutic Range of Some Drugs 309

Contd...

Drugs Serum concentration (mcg)


Antiarrhythmic
Digoxin 0.00080.0025
(012 months)
0.00080.0016
(above 1 year)
Quinidine 15
Propranolol 0.020.2
Miscellaneous
Chloral hydrate 510
Chlorpromazine 0.040.3
Imipramine 0.050.16
Theophylline 1020
Appendix
Drugs Excreted into
Breast Milk 6
Vitamins
Practically all.

Tranquilizers
t Chlorpromazine (Largactil)
t Reserpine.

Amphetamines
t Dextroamphetamine (Dexedrine)
t Amphetamine sulfate.

Analgesics
Narcotics
t Morphine
t Codeine
t Heroin.

Non-narcotics
t Aspirin
t Acetaminophen
t Dextropropoxyphene
t Phenacetin.

Antibiotics
t Chloramphenicol
t Erythromycin
Appendix 6: Drugs Excreted into Breast Milk 311

t Isonex
t Neomycin
t PAS
t Streptomycin
t Cycloserine
t Penicillin (benzyl-G)
t Sulfonamides
t Tetracyclines.

Antihistaminics
Diphenhydramine (Benadryl) and most others.

Barbiturates
Phenobarbital (Luminal, Gardenal) and most others.

Laxatives and Cathartics


t Mercurous chloride (Calomel)
t Rhubarb
t Senna
t Cascara.

Metals and Allied Agents


Lead Iodide
Arsenic Phosphate
Mercury Potassium
Magnesium Sodium
Calcium chloride Sulfur

Sedatives
t Chloral hydrate
t Barbiturates
t Bromides.

Miscellaneous
Reserpine Alcohol
Quinine Allergens
312 Appendices: Useful Information Related to Pediatric Drug Therapy

Pseudoephedrine Aminophylline
Diphenylhydantoin Chloroform
Phenylbutazone Ether
Oxyphenylbutazone Caffeine
Nicotine Oral contraceptives
Imipramine HCl DDT
Mandelic acid Ephedrine
Estrogens Bromides
Corticosteroids Cyclophosphamide
Appendix
Drugs that Discolor the
Stools 7
Iron*
Bismuth
Lead
Aspirin
Activated charcoal
Anticoagulants
Aluminium hydroxide
Pyrvinium (Vanquin)
Dithiazinine (Delvex)
Added color or flavor to make a preparation more pleasing
Carmine dye
Phenazopyridine (Pyridium)

*Iron causes discoloration of stools by (a) formation of sulfide or tannate and (b)
production of gastrointestinal bleeding.
Appendix
Drugs that Discolor
the Urine 8
Yellow or Green Discoloration
t Vitamin B-complex
t Vitamin C
t Methylene blue

Rust Yellow or Brownish


t Furazolidone
t Nitrofurantoin
t Chloroquine
t Primaquine
t Mepacrine
t Sulfonamides
t Chloral hydrate
t Alcohol
t Bismuth
t Mercury
t Arsenicals
t Naphthalene

Pink to Red Brown


t Phenothiazine
t Hemolysis-producing drugs
t Hematuria-producing drugs
t Diphenylhydantoin sodium
t Desferrioxamine
Appendix 8: Drugs that Discolor the Urine 315

Magenta to Purple Orange


Phenolphthalein

Green
t Methylene blue
t Resorcinol

Brown to Black Discoloration


t Resorcinol
t Methylene blue
t Quinine
t Furazolidone (Furoxone)
t Nitrofurantoin (Furadantin)
t Naphthalene
t Iron Sorbitol (Jectofer)
t Aniline dyes

Blue Discoloration
Methylene blue
Drugs Likely to Cause Appendix
Hemolysis in G6PD
Deficiency 9
Sulfonamides Antimalarials
t Sulfacetamide t Primaquine
t Sulfamethoxypyridazine t Pamaquine
t Sulfisoxazole t Pentaquine
t Acetylsulfanilamide t Mepacrine
t Salicylazosulfapyridine t Quinine
Nitrofurans Antipyretics/Analgesics
t Nitrofurantoin t Aspirin
t Furazolidone t Phenacetin
t Nitrofurazone t Acetanilid
Sulfones t Phenazone
t Diaminodiphenyl sulfone t Amidopyrine
(DDS) Antibiotics
t Sulfoxone t Chloramphenicol
t Thiazolsulfone t Novobiocin
Vitamins t Gentamicin
t Vitamin K (water-soluble t Kanamycin
analogs) t Cloxacillin
Miscellaneous t PAS
t BAL
t Methylene blue
t Tolbutamide
t Quinidine
t Probenecid
t Fava bean (broad beans)
t Naphthalene (mothballs)
Appendix
Drugs that may Cause
Specific Side Effects 10
Drugs that may cause specific ADRs
t Acetylsalicylic acid (Aspirin): Reyes syndrome (hepatic ence-
phalopathy from aspirin in children suffering from an exanthemata
like varicella oe influenza)
t Anabolic steroids/Glucocorticoids (chronic therapy): Stunting
t Aminoglycosides: Enhanced nephrotoxicity, ototoxicity (especially
tinnitus)
t Chloramphenicol: Gray baby syndrome
t Fluoroquinolones: Arthropathy
t Furosemide/Frusemide: Nephrocalcinosis
t Indomethacin: Intestinal perforation, nephrotoxicity
t Imipramine: Enhanced anticholinergic effects
t Phenobarbital: Paradoxical hyperactivity
t Phenytoin: Coarse facies, thickened skull, atrophied nails
t Phenothiazines: Dystonias (extrapyramidal reactions)
t Sulfas: Kernicterus
t Tetracyclines: Staining of teeth, defective dental enamel, growth
retardation
t Verapamil: Conduction defects
t Propylene glycol*: Hyperosmolarity (in infants)
t Benzyl alcohol*: Metabolic acidosis, gasping, seizures, cardio-
vascular collapse.

*Employed as preservatives in several injectable sb


Appendix
ADRs Specific to
Certain Drugs 11
Photosensitivity

Photophobia
t Atropine eye drops
t Ethosuximide
t PAS
t Trioxidone
t Mercury

Photoallergy
t Sulfonamides
t Tetracyclines
t Antihistaminics
t Neuroleptics
t PABA
t Fluoroquinolones
t Griseofulvin

Phototoxicity
t Sulfonamides
t Tetracyclines
t Nalidixic acid
t Neuroleptics
t Promethazine
t Griseofulvin
t Coal tar derivatives
t Antibacterial soaps
Appendix 11: ADRs Specific to Certain Drugs 319

Pruritus/Urticaria
t Antibiotics
t Sulfas
t Diphenylhydantoin sodium
t Tetracyclines
t Tetanus toxoid
t Piperazine
t Amitriptyline
t Aminophylline
t Antihistaminics
t Antisera
t Aspirin
t Nalidixic acid
t Phenobarbital
t Carbamazepine
t Chloroquine
t Quinine
t Diphenoxylate HCl
t Indomethacin

Eczema
t Kanamycin
t Penicillin
t Neomycin
t Sulfas
t Streptomycin
t Thiazide diuretics
t Amitriptyline
t Antihistaminics
t Iodides
t Phenothiazines
t Salicylates
t Quinine

Bullous or Vesicular Lesions


t Nalidixic acid
320 Appendices: Useful Information Related to Pediatric Drug Therapy

t Penicillamine
t Rifampicin
t Sulfas
t Antimetabolites
t Tricyclic antidepressants
t Thiazide diuretics
t Salicylates
t Acetazolamide
t Phenobarbital
t Bromides
t Chlordiazepoxide
t Clonidine
t Nitrazepam
t Diphenylhydantoin

Erythema Nodosum
t Phenobarbital
t Salicylates
t Sulfas
t Corticosteroids (on discontinuation)
t Bromides
t Iodides
t Penicillin
t Thiouracil

Loss of Scalp Hair


t Ethambutol
t Ethionamide
t PAS
t Gentamicin
t Fenfluramine
t Amphetamines
t Anticoagulants
t Antimetabolites
t Mepacrine
t Nitrofurantoin
t Trimethoprim
Appendix 11: ADRs Specific to Certain Drugs 321

t Troxidone
t Vitamin A excess
t Valproate sodium
t Carbamazepine
t Bismuth
t Carbimazole
t Gold
t Heparin
t Indomethacin
t Primidone
t Diphenylhydantoin
t Propylthiouracil

Hypertrichosis
t Corticosteroids
t Anabolic steroids
t Diphenylhydantoin
t Diazoxide
t Penicillamine
t Streptomycin
t Minoxidil

Excessive Sweating
t Amitriptyline
t Phenothiazines
t Amphetamine
t Haloperidol
t Antihistaminics
t Ephedrine
t Imipramine
t Pethidine
t Thyroxine

Hypothermia
t Phenothiazines
t Chlormethiazole
322 Appendices: Useful Information Related to Pediatric Drug Therapy

Hyperpyrexia
t Dantrolene (used for relief of spasticity)
t Tricyclic antidepressants
t Salicylate poisoning

Mental Depression
t Amphetamine withdrawal
t Propranolol
t Phenothiazines
t Methyldopa
t Physostigmine
t Prednisolone
t Reserpine
t Clonidine
t Codeine
t Morphine
t Dextropropoxyphene
t Antihistaminics

Headache
t Antihistaminics
t Acetazolamide
t Amitriptyline
t Diazepam
t Chlorpromazine
t Ephedrine
t Carbamazepine
t Vincristine
t Ethosuximide
t Ethambutol
t Troxidone
t Trimethoprim
t Tetracyclines
t Thiabendazole
t Griseofulvin
Appendix 11: ADRs Specific to Certain Drugs 323

t Sulfas
t Valproate sodium
t Isoniazid
t Indomethacin
t Niclosamide
t Diphenylhydantoin sodium
t Nalidixic acid
t Nitrofurantoin

Drowsiness
t Nalidixic acid
t Phenothiazines
t Tranquilizers
t Sedatives
t Antiepileptics
t Antihistaminics
t Diphenoxylate HCl
t Fenfluramine
t PAS
t Indomethacin

Dystonia
t Phenothiazines
t Metoclopramide
t Amitriptyline
t Amphetamines
t Antihistaminics
t Chloroquine
t Carbamazepine
t Cephalosporins
t Diazoxide
t Methaqualone
t Carbon monoxide
t Ethosuximide
t Haloperidol
t Imipramine
t Diphenylhydantoin
324 Appendices: Useful Information Related to Pediatric Drug Therapy

Convulsions
t Phenothiazines
t Aminophylline
t Antihistaminics
t Acetazolamide
t Diphenoxylate HCI
t Strychnine
t Propoxyphenes
t Hexachlorophene
t Corticosteroids
t Amitriptyline
t Amphetamine
t Imipramine
t Pyrimethamine
t Chloroquine
t Carbamazepine
t Nalidixic acid
t Isoniazid
t Metoclopramide

Coma
t Barbiturates
t Opiates
t Alcohol
t Carbon monoxide
t Kerosene oil
t Lead
t Haloperidol
t Diphenoxylate HCl
t Aspirin
t Amphetamines
t Antihistaminics
t Phenothiazines
t Organophosphates
t Piperazine
Appendix 11: ADRs Specific to Certain Drugs 325

t Diphenylhydantoin sodium
t Solvent sniffing

Confusion, Delirium or Hallucinations


t Cephalexin
t Cotrimoxazole
t Griseofulvin
t Nitrofurantoin
t Piperazine
t Alcohol
t Amitriptyline
t Diphenylhydantoin sodium
t Antihistaminics
t Amphetamine
t Mepacrine
t Bromides
t Carbamazepine
t Indomethacin
t Digoxin
t Ethionamide
t Chlordiazepoxide
t Ethosuximide
t Fenfluramine
t Cyclopentolate
t Diazepam
t Hyoscine
t Primidone
t Monoamine oxidase inhibitors
t Cannabis
t LSD
t Solvent sniffing

Paresthesia
t Kanamycin
t Nalidixic acid
t Nitrofurantoin
326 Appendices: Useful Information Related to Pediatric Drug Therapy

t Streptomycin
t Polymyxin
t Trimethoprim
t Vincristine
t Thiabendazole
t Acetazolamide
t Amitriptyline
t Ergotamine
t Piperazine
t Niclosamide
t Imipramine
t Chlorothiazide

Hyperactivity
t Phenobarbital
t Diphenylhydantoin sodium
t Primidone
t Chlordiazepoxide
t Tricyclic antidepressants
t Tartrazine (employed as food additive)

Overexcitement
t Phenobarbital
t Diazepam
t Nitrazepam
t Alcohol
t Antihistaminics
t Acetazolamide
t Nortriptyline
t Chlordiazepoxide
t Imipramine
t Mepacrine
t Solvent sniffing

Behavior Problems like Aggressiveness and Temper Tantrums


t Phenobarbital
t Tricyclic antidepressants
Appendix 11: ADRs Specific to Certain Drugs 327

Excessive Irritability
t Phenobarbital
t Primidone
t Acetazolamide
t Thyroxine
t Fenfluramine
t Antihistaminics
t Amidophylline
t Clonazepam
t Hyoscine
t Ethionamide
t Ephedrine
t Cyclopentolate
t Cycloserine
t Imipramine
t Amphetamine

Clumsiness/Ataxia
t Diphenylhydantoin sodium
t Phenobarbital
t Carbamazepine
t Valparin sodium
t Vincristine
t Antihistaminics
t Streptomycin
t Piperazine
t Chlordiazepoxide
t Diphenoxylate HCl
t Niclosamide
t Colistin Sulfate
t Cyclopentolate
t Indomethacin
t Polymyxin
t Virtually all sedatives and tranquilizers
328 Appendices: Useful Information Related to Pediatric Drug Therapy

Insomnia
t Griseofulvin
t Niclosamide
t Vincristine
t Antihistaminics
t Barbiturates
t Amphetamines
t Diphenoxylate HCl
t Ephedrine
t Fenfluramine
t Diazepam
t Imipramine
t Methylphenidate

Trismus
t Tranquillizers
t Metoclopramide
t Antihistaminics
t Strychnine

Floppiness/Hypotonia
t Diazepam
t Tricyclic antidepressants
t Kanamycin
t Colistin sulfate
t Cycloserine
t Ethionamide
t Gentamicin
t Nitrofurantoin
t Neomycin
t Isoniazid
t Cyclophosphamide
t 6-mercaptopurine
t Lead
t Vincristine
Appendix 11: ADRs Specific to Certain Drugs 329

Neutropenia
Antimicrobials
t Chloramphenicol
t Sulfas
t Tetracyclines
t Streptomycin
t Isonex
t PAS
t Chloroquine and other antimalarials

Anticonvulsants
t Trimethadione
t Diphenylhydantoin sodium

Tranquilizers
t Chlorpromazine
t Promethazine

Antihistaminics
t Promethazine
t Chlorpheniramine maleate

Antirheumatic
t Phenylbutazone
t Gold salts

Antithyroids
t Thiouracil
t Carbimazole

Bone Marrow Depression


t Chloramphenicol
t Sulfonamides
t Diphenylhydantoin sodium
330 Appendices: Useful Information Related to Pediatric Drug Therapy

t Anticancer drugs
t Phenylbutazone
t Oxyphenbutazone
t Carbimazole
t Carbamazepine
t Rifampicin
t Pyrimethamine
t Trimethadione
t Ibuprofen
t Amphotericin B
t Analgin
t Griseofulvin
t Penicillin
t Antihistaminics
t Chlorothiazide
t Isonex
t Thiabendazole

Vertigo
t Colistin sulfate
t Gentamicin
t Griseofulvin
t Isoniazid
t Kanamycin
t Minicycline
t Nalidixic acid
t Polymyxin
t Sulfas
t Trimethoprim
t Thiabendazole
t Thiazides
t Aspirin
t Clonidine
t Clonazepam
t Piperazine
t Acetazolamide
t Diphenylhydantoin sodium
Appendix 11: ADRs Specific to Certain Drugs 331

t Phenothiazines
t Amitriptyline
t Antihistaminics
t Meprobamate
t Carbamazepine
t Diazepam
t Ethosuximide
t Dicyclomine
t Fenfluramine
t Imipramine
t Indomethacin
t Pethidine
t Primidone
t Solvent sniffing

Deafness
t Ampicillin
t Colistin sulfate
t Cotrimoxazole
t Gentamicin
t Framycetin
t Kanamycin
t Neomycin
t Streptomycin
t Tobramycin
t Rifampicin
t Vancomycin
t Vincristine
t Chloroquine
t Quinine
t Actinomycin
t Ethacrynic acid
t Frusemide
t Ibuprofen
t Indomethacin
t Propranolol
332 Appendices: Useful Information Related to Pediatric Drug Therapy

t Salicylates
t Medroxyprogesterone
t Nortriptyline

Lacrimation/Epiphora
t Nitrazepam
t Bromides
t Mercury
t Arsenic

Color Vision
t Ethambutol
t Digoxin
t Barbiturates
t Sulfas
t Nalidixic acid
t Thiazide diuretics
t Streptomycin
t Troxidone

Ptosis
t Chloroquine
t Vincristine
t Sulthiame

Diplopia
t Vitamin A excess
t Chloroquine
t Quinine
t Antihistaminics
t Chlorpropamide
t Diazepam
t Carbamazepine
t Vincristine
t Sulfas
Appendix 11: ADRs Specific to Certain Drugs 333

t Nalidixic acid
t Chlorpropramide
t Fenfluramine
t Imipramine
t Indomethacin
t Diphenylhydantoin sodium
t Primidone

Squint
t Tricyclic antidepressants
t Nalidixic acid

Myopia
t Tetracyclines
t Sulfas
t Acetazolamide
t Corticosteroids

Nephrotoxicity
t Gentamicin
t Kanamycin
t Tetracyclines
t Cephaloridine
t Neomycin
t Nalidixic acid
t Penicillamine
t Colistin sulfate
t Rifampicin
t Propranolol
t Griseofulvin
t Amphotericin B
t Cycloserine
t Viomycin
t Mercurials
t Trimethadione
334 Appendices: Useful Information Related to Pediatric Drug Therapy

Frequency of Micturition
t Demeclocycline
t Carbamazepine
t Hypervitaminosis D
t Antihistaminics
t Fenfluramine
t Loperamide

Polydipsia or Polyuria
t Clonazepam
t Vitamin D excess

Hematuria
t Anticoagulants
t Aspirin
t Methicillin
t Thorazine
t Acetazolamide
t Cyclophosphamide
t Sulfas
t Diphenylhydantoin sodium
t Troxidone
t PAS
t Kanamycin
t Cephalosporins
t Bacitracin
t Aminophylline

Hepatotoxicity
t Mepacrine
t Chlorpromazine
t Rifampicin
t Tetracyclines
t Lignocaine
t Isonex
Appendix 11: ADRs Specific to Certain Drugs 335

t Paracetamol
t Nalidixic acid
t Colistin sulfate
t Penicillamine
t Ethambutol
t Erythromycin estolate
t Griseofulvin

Hiccup
t Barbiturates (Short-acting)
t Ethosuximide
t Muscle relaxants (during recovery)
t Diazepam

Excessive Drooling
t Clonazepam
t Nitrazepam
t Chlordiazepoxide
t Dicyclomine
t Ethionamide
t Haloperidol
t Organophosphates
t Anticholinesterase eye drops

Gingivostomatitis
t Diphenylhydantoin sodium
t Sulfas
t Actinomycin D
t Methotrexate
t 6-mercaptopurine
t Vincristine
t Troxidone
t Tetracyclines
t Lincomycin
t Ethosuximide
t Griseofulvin
336 Appendices: Useful Information Related to Pediatric Drug Therapy

t Gold salts
t Niclosamide

Dryness of Mouth
t Isoniazid
t Amitriptyline
t Amphetamine
t Antihistaminics
t Anticholinergics
t Atropine
t Carbamazepine
t Codeine
t Clonidine
t Diazepam
t Fenfluramine
t Niclosamide
t Phenothiazines
t Vitamin A overdose
t Haloperidol
t Hyoscine
t Imipramine

Diarrhea
t Ampicillin
t Iron
t PAS
t Phenothiazines
t Nalidixic acid
t Thiabendazole
t Carbamazepine
t Niclosamide
t Dichlorophen
t Thyroxine

Constipation
t Laxative abuse
t Purgative abuse
Appendix 11: ADRs Specific to Certain Drugs 337

t Isoniazid
t Chlordiazepoxide
t Imipramine
t Amitriptyline
t Vincristine

Gastrointestinal Bleeding
t Aspirin
t Chlortetracycline
t Acetazolamide
t Thiazides
t Indomethacin
t Methotrexate
t Antimetabolites
t Iron

Abdominal Pain
t Tetracyclines
t Erythromycin
t Lincomycin
t Cephalosporins
t Ethionamide
t PAS
t Rifampicin
t Trimethoprim
t Vincristine
t Azathioprine
t Corticosteroids
t Niclosamide
t Dichlorophen
t Amitriptyline
t Carbamazepine
t Chlordiazepoxide
t Ergotamine
t Gentian violet
t Iodides
t Iron
338 Appendices: Useful Information Related to Pediatric Drug Therapy

t Nystatin
t Diphenylhydantoin sodium
t Piperazine
t Primidone
t Troxidone
t Lead salts

Arthritis/Arthralgia
t Corticosteroids
t (on discontinuation after prolonged course)
t Barbiturates
t Penicillin
t Carbamazepine
t Chlordiazepoxide
t Cimetidine
t Ethambutol
t Isoniazid

Lassitude
t Amitriptyline
t Chloroquine
t Nalidixic acid
t Clonazepam
t Corticosteroids
t Diuretics
t Streptomycin
t Ethosuximide
t Beta-blockers

Lymphadenopathy
t Diphenylhydantoin sodium
t Cephaloridine
t Sulfas
t Carbamazepine
t Iron-dextran complex
t PAS
Appendix 11: ADRs Specific to Certain Drugs 339

t Meprobamate
t Phensuximide
t Troxidone
t Phenylbutazone
t BCG

Gynecomastia
t Cytotoxic drugs
t Vincristine
t Tricyclic antidepressants
t Phenothiazines
t Anabolic steroids
t Testosterone
t Amphetamine
t Cannabis
t Cimetidine
t Digitalis
t Gonadotropins
t Imipramine
t Reserpine
t Spironolactone
t Progesterone
t Metoclopramide

Pseudotumor Cerebri
t Tetracyclines
t Vitamin A excess/deficiency
t Corticosteroids
t Nalidixic acid
t Nitrofurantoin
t DPT vaccine
Nomogram for Appendix
Estimation of Surface
Area 12
The surface area is indicated where a straight line connecting the height
and weight levels intersects the surface area column; or if the patient is
roughly of average size, from the weight alone (enclosed area).
Drug Groups with Appendix
Adverse Effects on
Vitamin Status 13
Vitamin Thiamine Ribo- Pyri- Vitamin Folic Ascorbic Vitamin Vitamin Vitamin Vitamin
flavin doxine B12 acid acid A D E K
Analgesics,
antirheumatics
Anorectics
Antacids and
other gastric
agents
Antibiotics
Anti-
cholinergics
Antidiabetics
(Oral)
Anti-
hypertensives
Anti-
convulsants
Contraceptives
(Oral)
Digitalis-based
glycosides
Diuretics
Glucocorticoids
Hypnotics
Laxatives
Lipid-lowering
agents
Psychotropic
agents
Neuroleptics
Sulfonamides
Tuberculostatics
Uricosurics/
uricostatics
Potential Drug Appendix
Interaction with
Chemotherapy 14
Chemothera- Interacting drug Effect of combined action
peutic drug
Amino- t "NQIPUFSJDJO#  t *ODSFBTFEOFQISPUPYJDJUZ
glycosides DZDMPTQPSJOF DJTQMBUJO 
/4"*%TWBODPNZDJO
t 1FOJDJMMJOT JOQBUJFOUT t %FDSFBTFEFDBDZPG
XJUISFOBMGBJMVSF
 QBSFOUFSBMBNJOPHMZDPTJEFT
&UIBDSZOJDBDJE  &OIBODFEQPUFOUJBMGPS
GVSPTFNJEF PUPUPYJDJUZ
"NPYJDJMMJO  t "MMPQVSJOPM t *ODSFBTFEGSFRVFODZPGSBTI
BNQJDJMMJO t 0SBMCFUBCMPDLFST t %FDSFBTFECFUBCMPDLFS
BCTPSQUJPO
$MJOEBNZDJO ,BPMJO %FDSFBTFEBCTPSQUJPOPG
DMJOEBNZDJO
.BDSPMJEFT t $BSCBNB[FQJOF t *ODSFBTFEUPYJDJUZSJTLGPS
FSZUISPNZDJO  DBSCBNB[FQJOF
DMBSJUISPNZDJO
t $PSUJDPTUFSPJET t *ODSFBTFEFFDUTPGTUFSPJET
t 5IFPQIZMMJOF t 5IFPQIZMMJOFJOEVDFE
UPYJDJUZ
t 8BSGBSJOTPEJVN t *ODSFBTFESJTLPGCMFFEJOH
t %JHPYJO t %JHPYJOUPYJDJUZ
t &SHPUBMLBMPJET t &SHPUUPYJDJUZ
t /POTFEBUJOH t 7FOUSJDVMBSBSSIZUINJBT
BOUJIJTUBNJOFT
UFSGFOBEJOF 
BTUFNJ[PMF

Contd...
Appendix 14: Potential Drug Interaction with Chemotherapy 343

Contd...

Chemothera- Interacting drug Effect of combined action


peutic drug
'MVPSPRVJOP $JNFUJEJOF BMVNJ t *ODSFBTFERVJOPMPOFMFWFMT
MPOFT OVN DBMDJVN JSPO t %FDSFBTFEBCTPSQUJPOPG
All NBHOFTJVN [JOD RVJOPMPOFT
BOUBDJET TVDSBMGBUF t %FDSFBTFERVJOPMPOFMFWFMT
&OPYBDJO 'FOCVGFO UIFPQIZMMJOF 4FJ[VSFT JODSFBTFE
UIFPQIZMMJOFMFWFMT
/PSPYBDJO 5IFPQIZMMJOF *ODSFBTFEUIFPQIZMMJOFMFWFMT
$JQSPPYBDJO 5IFPQIZMMJOF *ODSFBTFEUIFPQIZMMJOFMFWFMT
/JUSPGVSBOUPJO .BHOFTJVN %FDSFBTFEOJUSPGVSBOUPJO
BOUBDJET BCTPSQUJPO
.FUSPOJEB[PMF t 8BSGBSJOTPEJVN t *ODSFBTFESJTLPGCMFFEJOH
t "MDPIPM t %JTVMSBNMJLFSFBDUJPO
4VMGPOBNJEFT t 0SBMBOUJDPBHVMBOUT t *ODSFBTFEIZQPQSP
UISPNCJOFNJB
t $ZDMPTQPSJOF t %FDSFBTFEDZDMPTQPSJOF
t .FUIPUSFYBUF MFWFMT
t 1IFOZUPJO t .FUIPUSFYBUFUPYJDJUZ
t 4VMGPOZMVSFBT t 1IFOZUPJOUPYJDJUZ
t *ODSFBTFEIZQPHMZDFNJD
SJTL
5FUSBDZDMJOFT t "MVNJOVN  t %FDSFBTFEUFUSBDZDMJOF
CJTNVUI JSPO BCTPSQUJPO
t #BSCJUVSBUFT  t %FDSFBTFEUFUSBDZDMJOF
DBSCBNB[FQJOF FFDU
t 1IFOZUPJO EJHPYJO t *ODSFBTFEEJHPYJOUPYJDJUZ
5SJNFUIPQSJN t 0SBMBOUJDPBHVMBOUT t *ODSFBTFEBOUJDPBHVMBOU
TVMGBNFUIP t $ZDMPTQPSJOF FFDU
YB[PMF t 1IFOZUPJO t /FQISPUPYJDJUZ
t (MJQJ[JEF t 1IFOZUPJOUPYJDJUZ
t .FUIPUSFYBUF t *ODSFBTFESJTLPG
IZQPHMZDFNJB
t #POFNBSSPXTVQQSFTTJPO
Banned Single Dose Appendix
Drug Combinations
(in India) 15
1. Penicillin with sulfonamides.
2. Tetracyclines with vitamin C.
3. Antitubercular drugs with vitamins [exception is isoniazid with
pyridoxine (vitamin B6)]
4. Vitamins with analgesics/anti-inflammatory drugs.
5. Vitamins with tranquilizers.
6. Atropine in analgesic and antipyretics.
7. Yohimbine and strychnine with testosterone and vitamins.
8. Strychnine and caffeine in tonics.
9. Iron with strychnine, arsenic and yohimbine.
10. Antihistaminics with antidiarrheals.
11. More than one antihistamine in the same preparation.
12. Sedatives/hypnotics/anxiolytics with analgesic-antipyretics.
13. H2-receptor antagonists with antacids (with exception of those
approved by the Drug Controller of India).
14. Anthelmintics (with exception of piperazine) with cathartic/
purgative.
15. Bronchodilators, including salbutamol, with centrally-acting
antitussive and/or antihistamine.
16. Centrally-acting antitussives with antihistamines having high
atropine-like acivity in expectorants.
17. Centrally-acting antitussives and/or antihistamines in prepar-
ations for cough associated with asthma.
18. Laxatives and/or antispasmodics in enzyme preparations.
19. Glycophosphates and/or other phosphates and/or CNS stimulant
in liquid oral tonics.
20. Estrogen and progestin (with exception of oral contraceptives)
containing per tablet estrogen > 50 mcg ethinyl estradiol
Appendix 15: Banned Single Dose Drug Combinations (in India) 345

(or equivalent) and progestin > 3 mg of norethisterone acetate


(or equivalent) and all fixed dose combination injectable
preparations.
21. Ethambutol with isoniazid except in the following daily doses:
Isoniazid 200 mg + Ethambutol 600 mg
or
Isoniazid 300 mg + Ethambutol 800 mg.
22. Pyrazinamide with other antitubercular drugs except those
which provide the following daily doses:
t Rifampicin 450 to 600 mg
t Isoniazid 300 to 400 mg
t Pyrazinamide 1000 to 1500 mg.
23. Essential oils with alcohol having percentage higher than 20 per-
cent proof (with the exception of preparations given in IP).
24. Liquid oral tonic preparations containing alcohol 30 percent.
25. Analgin (Metamizol) with antispasmodics and other drugs.
26. Antidiarrheals containing adsorbents like kaolin, pectin, atta-
pulgite, activated charcoal, etc.
27. Antidiarrheals containing phthalylsulfathiazole, succinyl
sulfathiazole, sulfaguanidine, neomycin, streptomycin, dihydro-
streptomycin.
28. Antidiarrheal formulations for pediatric use containing diphen-
oxylate, lorloperamide, atropine, hyoscyamine, halogenated
hydroxyquinolines.
29. Antidiarrheals with electrolytes.
30. Fixed dose combinations of hemoglobin in any form.
31. Pancreatin or pancrelipase containing amylase, protease and
lipase with any other enzyme.
Banned Fixed Dose Appendix
Drug Combinations with
Other Agents (in India) 16
1. Corticosteroids with any other drug meant for internal use.
2. Chloramphenicol with any other drug for internal use.
3. Sodium bromide/chloral hydrate with other drugs.
4. Ergot with any other drug, except preparations containing
ergotamine, caffeine, analgesics, antihistamines, for treatment of
migraine.
5. Anabolic steroids with other drugs.
6. Metoclopramide with other drugs, except aspirin/paracetamol.
7. Pectin and/or kaolin with any drug that is systemically absorbed
from the gut.
8. Hydroxyquinolones with any other drug, except in preparations
for external use.
9. Oxyphenylbutazone or phenylbutazone with other drug.
10. Dextropropoxyphene with any drug except antispasmodic and/
or NSAIDs.
Appendix
Immunization Schedules
17
Indias National Immunization Schedule
Age Vaccines
t #JSUI #$( 017 GPSJOTUJUVUJPOBMEFMJWFSJFT

t XFFLT %5X1 017 )FQ# )JC$$ #$( JGOPUHJWFOBU


CJSUI

t XFFLT %5X1 017 )FQ# )JC


t XFFLT %5X1 107 )FQ# )JC
t oNPOUIT .FBTMFT
t oNPOUIT %5X1# 017 ..3$
t oZFBST %5X1
t ZFBST 55
t ZFBST 55
t 1SFHOBOUXPNFO 55 FBSMZJOQSFHOBODZ

55 NPOUIMBUFS

55CPPTUFS JGWBDDJOBUFEJOQBTUZFBST

t 7JUBNJO"    BOENPOUIT


..3JTBWBJMBCMFJOTPNFTUBUFTPOMZ
)JCJTCFJOHJOUSPEVDFEJOUXPTUBUFTUPCFHJOXJUI
"TFDPOEEPTFPG%5X1WBDDJOFTIPVMECFHJWFOBUBOJOUFSWBMPGPOFNPOUI JGUIFSF
JTOPDMFBSIJTUPSZPSEPDVNFOUFEFWJEFODFPGQSFWJPVTJNNVOJ[BUJPOXJUI%5X1
"TFDPOEEPTFPG55WBDDJOFTIPVMECFHJWFOBUBOJOUFSWBMPGPOFNPOUI JGUIFSFJT
OPDMFBSIJTUPSZPSEPDVNFOUFEFWJEFODFPGQSFWJPVTJNNVOJ[BUJPOXJUI%5X1 %5PS
55WBDDJOFT
Indian Academy Appendix
of Pediatrics (IAP)
Immunization
Recommendations
18
Table 1: IAP immunization timetable 2012
(IAP recommended vaccines for routine use)
Age Vaccines Comments
t Birth BCG, OPV 0, Hep-B 1 Hepatitis-B: Administer Hep-B
vaccine to all newborns before
hospital discharge.
t 6 weeks DTwP 1/DTaP1, Polio: All doses of IPV may be
IPV 1, Hep-B 2, Hib 1, replaced with OPV if former
Rotavirus, PCV 1 is unaffordable/unavailable;
Additional doses of OPV on all
Supplementary immunization
activities (SIAs); Two doses IPV
instead of 3 for primary series if
started at 8 weeks, and 8 weeks
interval between the doses.
Rotavirus: 2 doses of RV-1
(monovalent) and 3 doses of RV-5
(pentavalent)
t 10 weeks DTwP 2/DTaP 2,
IPV 2, Hib 2,
Rotavirus 2, PCV 2
t 14 weeks DTwP 3/DTaP 3, IPV Rotavirus: Only 2 doses of RV-1
3, Hib 3, Rotavirus 3, are recommended at present.
PCV 3
t 6 months OPV 1, Hep-B 3 Hepatitis B: The final (third or
fourth) dose in the Hep B vaccine
series should be administered no
earlier than age 24 weeks and at
least 16 weeks after the first dose.
Contd
Contd...
Appendix 18: Indian Academy of Pediatrics (IAP) Immunization Recommendations 349

Contd...

Age Vaccines Comments


t 9 months OPV 2, Measles
t 12 months Hep-A 1 Hepatitis A: For both killed and
live hepatitis-A vaccines 2 doses
are recommended.
t 15 months MMR 1, Varicella 1, Varicella: The risk of
PCV booster breakthrough varicella is lower if
given 15 months onwards.
t 16 to 18 DTwP B1/DTaP B1, The first booster (4th dose) may
months IPV B1, Hib B1 be administered as early as age
12 months, provided at least 6
months have elapsed since the
third dose.
t 18 months Hep-A 2 Hepatitis A: For both killed and
live hepatitis-A vaccines, 2 doses
are recommended.
t 2 years Typhoid 1 Typhoid: Typhoid revaccination
every 3 years, if Vi-polysaccharide
vaccine is used
t 45 years DTwP B2/DTaP MMR: The 2nd dose can be given
B2, OPV 3, MMR 2, at anytime 4 to 8 weeks after 1st
Varicella 2, Typhoid 2 dose
Varicella: The 2nd dose can be
given at anytime 3 months after
the 1st dose
t 1012 years Tdap/Td HPV Tdap: Preferred to Td followed by
Td every 10 years.
HPV: Only for females, 3 doses at
0, 1 to 2 (depending on brands)
and 6 months.
Source: Indian Academy of Pediatrics Committee on Immunization (IAPCOI). Consensus
recommendations on immunization and IAP immunization timetable. Indian Pediatric.
2012;49:549-64.
350 Appendices: Useful Information Related to Pediatric Drug Therapy

IAP recommended vaccines for High-risk* children (Vaccines under


special circumstances):
1. Influenza vaccine
2. Meningococcal vaccine
3. Japanese encephalitis vaccine
4. Cholera vaccine
5. Rabies vaccine
6. Yellow fever vaccine
7. Pneumococcal polysaccharide vaccine (PPSV 23).

*High-risk category of children:


t Congenital or acquired immunodeficiency (including HIV infection)
t Chronic cardiac, pulmonary (including asthma if treated with prolonged high-dose oral
corticosteroids), hematologic, renal (including nephrotic syndrome), liver disease and
diabetes mellitus
t Children on long-term steroids, salicylates, immunosuppressive or radiation therapy
t Diabetes mellitus, cerebrospinal fluid lead, cochlear implant, malignancies
t Children with functional/anatomic asplenia/hyposplenia
t During disease outbreaks
t Laboratory personnel and health care workers
t Travelers
Table 2: IAP recommended immunization schedule for children aged 06 years (with range), 2012
Age o Birth 6 10 14 18 6 9 12 15 18 23 46
weeks weeks weeks weeks months months months months months years years
Vaccinep
BCG1 BCG
Hep B2 Hep B1 Hep B2* Hep B3*
Polio3 OPV0 IPV1 IPV2 IPV3* OPV 1 OPV 2 IPV B1* OPV3*
DTP4 DTP 1 DTP 2 DTP 3 DTP B1* DTP B2*
Hib5 Hib 1 Hib 2 Hib 3 Hib-booster*
Pneumococcal6 PCV 1 PCV 2 PCV 3 PCV-booster* PPSV$
Rotavirus7 RV 1 RV 2 RV 3
Measles8 Measles*
MMR9 MMR 1* MMR 2*
Varicella10 Varicella 1* Varicella
2*
Hep A11 Hep A 1* Hep A 2*
Typhoid12 Typhoid*
Influenza13 Influenza (yearly)$
Meningococcal14 Meningococcal$
Cholera15 Cholera 1 and 2
JE16 JE$
*Range of recommended ages for all children; $Ranges of recommended ages for certain high-risk groups
(This schedule includes recommendations in effect as of April 2012. Any dose not administered at the recommended age should be
administered at a subsequent visit, when indicated and feasible. The use of a combination vaccine gnerally is preferred over separate
injections of its equivalent component vaccines).
Source: Indian Academy of Pediatrics Committee on Immunization (IAPCOI). Consensus recommendations immunization and IAP
Appendix 18: Indian Academy of Pediatrics (IAP) Immunization Recommendations

immunization timetable. Indian Pediatr. 2012;49:549-64.


Contd...
351
352
Contd...
1. BCG vaccine
t Should be given at birth or at first contact; t Catch up may be given up to 5 years
2. Hepatitis B (Hep B) vaccine
t Minimum age: Birth; t Administer monovalent Hep B vaccine to all newborns before hospital discharge; t Monovalent Hep B vaccine
should be used for doses administered before age 6 weeks; t Administration of a total of 4 doses of Hep B vaccine is permissible when a
combination vaccine containing Hep B is administered after the birth dose; t Infants who did not receive a birth dose should receive 3 doses
of a Hep B containing vaccine starting as soon as feasible; t The ideal minimum interval between dose 1 and dose 2 is 4 weeks, and between
dose 2 and 3 is 8 weeks; t Ideally, the final (third or fourth) dose in the Hep B vaccine series should be administered no earlier than are 24
weeks and at least 16 weeks after the first dose; t Hep B vaccine may also be given in any of the following schedules: Birth, 1 and 6 months,
Birth, 6 and 14 weeks, 6, 10 and 14 weeks; Birth, 6 weeks, 14 weeks, etc.
3. Poliovirus vaccines
t OPV in place of IPV: If IPV is unaffordable/unavailable, minimum 3 doses; t Additional doses of OPV on all SIAs; t IPV: Minimum age:
6 weeks; t IPV: 2 instead of 3 doses can be also used if primary series started at 8 weeks and the interval between the doses is kept 8
weeks; t IPV: Catch-up schedule: 2 doses at 2 months apart followed by a booster after 6 months
4. Diphtheria and tetanus toxoids and pertussis (DTP) vaccine
t Minimum age: 6 weeks; t The first booster (4th dose) may be administered as early as age 12 months, provided at least 6 months have
elapsed since the third dose; t DTwP/DTaP/Tdap/Td: Catch up below 7 years: DTwP/DTaP at 0, 1 and 6 months; t Catch up above 7 years:
Tdap, Td, Td at 0, 1 and 6 months
5. Haemophilus influenzae type b (Hib) conjugate vaccine
t Minimum age: 6 weeks; t Catch up in 6 to 12 months; 2 doses 1 month apart and 1 booster; 12 to 15 months: 1 primary and 1 booster;
above 15 months single dose.
6. Pneumococcal vaccines
t Minimum age: 6 weeks for pneumococcal conjugate vaccine [PCV]; 2 years for pneumococcal polysaccharide vaccine [PPSV]; t Administer
1 dose of PCV to all healthy children aged 24 through 59 months who are not completely vaccinated for their age; t For children who have
received an age-appropriate series of 7-valent PCV (PCV7), a single supplemental dose of 13-valent PCV (PCV13) is recommended for:
t All children aged 14 through 59 months; t Children aged 60 through 71 months with underlying medial conditions; t Administer PPSV
at least 8 weeks after last dose of PCV to children aged 2 years or older with certain underlying medial conditions (certain high-risk); t PCV:
Catch up in 6 to 12 months: 2 doses 1 month apart and 1 booster; 1223 months: 2 doses 2 months apart; 24 months and above single
Appendices: Useful Information Related to Pediatric Drug Therapy

dose; t PPSV: Revaccination only once after 3 to 5 year only in certain high risk patients.
7. Rotavirus (RV) vaccines
t Minimum age: 6 weeks for both RV-1 [Rotarix] and RV-5 [Rota Teq]); t Only two doses of RV-1 are recommended at present; t The
maximum age for the first dose in the series is 14 weeks, 6 days; and 8 months, 0 days for the final dose in the series; t Vaccination should not
be initiated for infants age 15 weeks, 0 days or older.
Contd...
8. Measles
t Minimum age: At completed months/270 completed days; t Catch up vaccination beyond 12 months should be MMR; t Measles vaccine
can be administered to infants aged 6 through 11 months during outbreaks. These children should be revaccinated with 2 doses of measles
containing vaccines, the first at ages 12 through 15 months and at least 4 weeks after the previous dose, and the second at ages 4 through 6
years.
9. Measles, mumps, and rubella (MMR) vaccine
t Minimum age: 12 months; t The second dose may be administered before age 4 weeks have elapsed since the first dose.
10. Varicella vaccine
t Minimum age: 12 months; t The risk of breakthrough varicella is lower if given 15 months onwards; t The second dose may be
administered before age 4 years, provided at least 3 months have elapsed since the first dose; t For children aged 12 months through 12
years, the recommended minimum interval between doses is 3 months. However, if the second dose was administered at least 4 weeks after
the first dose, it can be accepted as valid.
11. Hepatitis A (Hep A) vaccine
t Minimum age: 12 months; t Two doses of both killed and live HepA vaccines; t Administer the second (final) dose 6 to 18 months after
the first.
12. Typhoid vaccine
t Only Vi-PS (polysaccharide) vaccine is recommended; t Minimum age: 2 years; Revaccination every 3 years; t Vi-PS conjugate vaccine:
data not sufficient to recommend for routine use of currently available vaccine
13. Influenza vaccine
t Minimum age: 6 months for trivalent inactivated influenza vaccine; t First time vaccination: 6 months to below 9 years: two doses 1 month
apart; 9 years and above single dose; Annual revaccination with single dose; t For children age 6 months to below 9 years; For the 2012
season, administer 2 doses (separated by a least 4 weeks) to those who did not receive at least 1 dose of the 2010-2011 vaccine. Those who
received at least 1 dose of the 2010-2011 vaccine require 1 dose for the 2011-2012 season; t Best time to vaccinate: As soon as the new
vaccine is released and available in the market and just before the onset of rainy season.
14. Meningococcal vaccine
t Only meningococcal polysaccharide vaccine (MPSV) is available; t Minimum age: 2 years; t Revaccination only once after 3 years in
those at continued high-risk.
15. Cholera vaccine
t Minimum age: One year [Killed whole cell vibrio cholera (Shanchol)]; t Two doses 2 weeks apart for >1-year-old
16. Japanese encephalitis (JE) vaccine
t Recommended in endemic area only; t Live attenuated, cell culture derived SA-14-14-2 vaccine is preferred; t Minimum age: 8 months;
can be co-administered with measles vaccine at 9 months; single dose; t Catch up vaccination: All susceptible children up to 15 years should
Appendix 18: Indian Academy of Pediatrics (IAP) Immunization Recommendations

be administered during disease outbreak/ahead of anticipated outbreak in campaigns.


353
354 Appendices: Useful Information Related to Pediatric Drug Therapy

Table 3: IAPCOI recommended immunization schedule for persons


aged 7 through 18 years, 2012 (with range)
Age o 710 1112 years 1318
Vaccinep years years
Tdap1 1 Dose 1 dose* 1 dose
(if indicated) (if indicated)
HPV2 See footnote 2 3 doses* Complete
3-doses series
MMR3 Complete 2-dose series
Varicella4 Complete 2-dose series
Hepatitis B5 Complete 3-dose series
Hepatitis A6 Complete 2-dose series
Typhoid7 1 dose every 3 years
Influenza vaccine8 One dose every year$
Japanese encep- Catch-up up to 15 years$
halitis vaccine9
Pneumococcal See footnote 10$
vaccine10
Meningococcal See footnote 11$
vaccine11
Range of recommended ages for all children; *Range of recommended ages for catch-
up immunization; $Range of recommended ages for certain high-risk group.
1. Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine: t Minimum
age: 10 years for Boostrix and 11 years for Adacel; t Persons aged 11
through 18 years who have not received Tdap vaccine should receive a dose
followed by tetanus and diphtheria toxoids (Td) booster doses every 10 years
thereafter; t Tdap vaccine should be substitute for a single dose of Td in the
catch-up series for children age 7 through 10 years; t Tdap vaccine can be
administered regardless of the interval since the last tetanus and diphtheria
toxoid-containing vaccine; t Catch up above 7 years: Tdap, Td, Td at 0, 1 and 6
months; t Tdap can also be administered safely to pregnant women.
2. Human papillomavirus (HPV) vaccines: t HPV4 [Gardasil] and HPV2
[Cervarix]; t Minimum age: 9 years; t Either HPV4 (0, 2, 6 months) or
HPV2 (0, 1, 6 months) is recommended in a 3-dose series for females aged
11 or 12 years; t HPV4 can also be given in a 3-dose series for males aged
11 or 12 years; t The vaccine series can be started beginning at age 9
years; t Administer the second dose 1 to 2 months after the first dose and the
third dose 6 months after the first dose (at least 24 weeks after the first dose).

Contd...
Appendix 18: Indian Academy of Pediatrics (IAP) Immunization Recommendations 355

Contd...
3. Measles, mumps, and rubella (MMR) vaccine: t The minimum interval between
the 2 dose of MMR vaccine is 4 weeks; t One dose if previously vaccinated with
one dose.
4. Varicella (VAR) vaccine: t For persons without evidence of immunity, administer
2 doses if not previously vaccinated or the second dose if only 1 dose has been
administered; t For persons aged 7 through 12 years, the recommended
minimum interval between doses is 3 months. However, if the second dose
was administered at least 4 weeks after the first dose, it can be accepted as
vaild; t For persons aged 13 years and older, the minimum interval between
doses is 4 weeks.
5. Hepatitis B (Hep B) vaccine: t Administer the 3-dose series to those not previously
vaccinated; t For those with incomplete vaccination, the recommended
minimum interval between dose 1 and dose 2 is 4 weeks, and between dose 2
and 3 is 8 weeks. The final (third or fourth) dose in the Hep B vaccine series should
be administered at least 16 weeks after the first dose.
6. Hepatitis A (Hep A) vaccine: t Administer 2 doses at least 6 months apart to
unvaccinated persons; t For catch up vaccination, pre vaccination screening
for Hepatitis A antibody is recommended in children older than 10 years as at this
age the estimated sero-positive rates exceed 50%; t Combination of Hep B and
Hep A may be used in 0, 1, 6 schedule.
7. Typhoid vaccine: t Only Vi-PS (polysaccharide) vaccine is recommended; t Vi-
PS conjugate vaccine: data not sufficient to recommend for routine use of
currently available vaccine; t A minimum interval of 3 years should be
observed between 2 doses of typhoid vaccine.
8. Influenza vaccine: t Administer 1 dose to persons aged 9 years and older; t For
children aged 6 months through 8 years; t For the 2012 season administer
2 doses (separated by at least 4 weeks) to those who did not receive at least 1
dose of the 2010-2011 vaccine. Those who received at least 1 dose of the 2010-11
vaccine require 1 dose for the 2011-2012 season; t Annual revaccination with
single dose; t Best time to vaccinate: as soon as the new vaccination is released
and available in the market and just before the onset of rainy season.
9. Japanese encephalitis (JE) vaccine: t Only in endemic area as catch
up; t Currently no type of JE vaccine available in private Indian
market; t Living attenuated, cell culture derived SA-14-14-2 JE vaccine should
be preferred; t Dose: 0.5 mL, SC, single dose up to 15 years.
10. Pneumococcal vaccines: t Pneumococcal conjugate vaccine (PCV) and
pneumococcal polysaccharide vaccine (PPSV) both are used in certain high risk
group of children; t A single dose of PCV may be administered to children
aged 6 through 18 years who have anatomic/functional asplenia, HIV infection
or other immunocompromising condition, cochlear implant, or cerebral spinal
fluid leak; t Administer PPSV at least 8 weeks after the last dose of PCV to
children aged 2 years or older with certain underlying medical conditions,
including a cochlear implant t A single re-vaccination (with PPSV) should be
administered after 5 years to children with anatomic/functional asplenia or an
immunocompromising condition.

Contd...
356 Appendices: Useful Information Related to Pediatric Drug Therapy

Contd...
11. Meningococcal vaccine: t Recommended only for certain high risk group
of children, during outbreaks, travelers to endemic areas, and student going
for study abroad; t Only meningococcal polysaccharide vaccine (MPSV) is
available; t Minimum age: 2 years; t Dose schedule: a single dose 0.5 mL SC/IM
is recommended; t Revaccination only once after 3 years in those at continued
high risk.
Source: Indian Academy of Pediatric Committee on Immunization (IAPCOI). Consensus
recommendations on immunization and IAP immunization timetable. Indian Pediatric.
2012;49:549-64.
Appendix
Adverse Events
Following Immunization 19
S. Adverse Vaccine Symptoms Management
no. event
1. Anaphylaxis Any Within minutes t "ESFOBMJOF
vaccine t "DVUF t $BSEJPQVMNPOBSZ
decompensation resuscitation
of circulatory t *7WPMVNF
system expanders or
t )ZQPWPMFNJD hydrocortisone
shock t %PQBNJOF%PCV-
t -BSZOHPTQBTN tamine
edema
t "DVUFSFTQJSBUPSZ
distress
Within 12 hours
2. )ZQPUFOTJWF %15 t "DVUFQBMFOFTT t *7VJET
hyporespon- t 5SBOTJFOUEF- t %
 FYBNFUIBTPOF
sive episode creased level or t 0YZHFO
loss of conscious-
ness
t %FDSFBTFPSMPTT
of muscle tone
3. *ODFTTBOUDSZ %15 t 8JUIJOo t 4FEBUJPOXJUI
IPVSTBGUFS%15 5SJDMPGPTNH
immunization LHISTBOE
t &YDFTTJWFJODPO- HJWFQBSBDFUBNPM
TPMBCMFDSZJOH oNHLHQFS
dose)
t 'FFEJOHBEWJDF

Contd...
 Appendices: Useful Information Related to Pediatric Drug Therapy

Contd...

S. Adverse Vaccine Symptoms Management


no. event
 5PYJDTIPDL $POUBNJ- 8JUIJONJOVUFT t *7VJET
syndrome nation of UPGFXIPVST t "OUJNJDSPCJBMT
measles t .PVOUJOHGFWFS t $MPYBDJMMJOo
vaccine t 7PNJUJOH NHLHIST
CZ t %JBSSIFB t 4UFSPJET
S. aureus t 4FQUJDTIPDL t "OUJQZSFUJDT
t 4VQQPSUJWF
therapy
 -ZNQIB #$( 8JUIJOoNPOUIT t MGSN OP
denitis t 'JSNUPTPGU treatment
axillary lymphad- t *GTPGUBOE
enitis VDUVBOU)3 
oDNTJ[F Aspiration (if
XJUIPSXJUIPVU OFFECF

sinus t *GTJOVTQSFTFOU
steroid therapy
 Bacterial Any 8JUIJOIPVST t "OUJCJPUJDT
BCTDFTT vaccine VDUVBOUPSSN t "OUJQZSFUJDT
"CTDFTTXJUIPS t %SBJOBHF
XJUIPVUGFWFS JGOFFECF

 4UFSJMFBC- %15  #ZIPVST t %SBJOBHF


scess %5 55  t .JOJNVN JGOFFECF

typhoid JOBNNBUJPO
BOE)# t /PGFWFS
 .PEFSBUFUP Any /POVDUVBOU t 1BSBDFUBNPM
severe local vaccine TXFMMJOHSFEOFTT
reaction DNUPDNJO
size at the
injection site
9. 4FJ[VSFT %15 "MXBZTHFOFSBMJ[FE t "OUJDPOWVMTBOUT
XJUIGFWFS .FBTMFT 4JNQMFPSDPNQMFY t "  OUJQZSFUJDT
(rare) t *7VJET
JGOFFECF

Source:(VQUF4*OTUSVDUJWF$BTF4UVEJFTJO1FEJBUSJDT UIFEO/FX%FMIJ+BZQFF#SPUIFST
.FEJDBM1VCMJTIFST 
Glossary of Abbreviations

ABC Airway, breathing, circulation


ABG Arterial blood gases
ACTH Adrenocorticotropic hormone
ADE Adverse drug events
ADR Adverse drug reaction
AED Antiepileptic drug
AEFI Adverse events following immunization
ATT Antituberculous therapy
BD Twice a day
BMI Body mass index
BP Blood pressure
BUN Blood urea nitrogen
BW Body weight
CCF Congestive cardiac failure
Cap Capsule
CSF Cerebrospinal fluid
DIC Disseminated intravascular coagulopathy
Div Divided
ET Endotracheal
Hib Haemophilus influenzae b
HIV Human immunodeficiency virus
Hr Hour
IgG Immunoglobulin G
IO Intraoral
IM Intramuscular
IT Intratracheal
IV Intravenous
360 Pediatric Drug Directory

IVH Intraventricular hemorrhage


IVIG Intravenous immunoglobulins
MDR strains Multidrugs resistant strains
Min Minute
MMR Measles, mumps and rubella
MRSA Methicillin resistant Staphylococcus aureus
NG Nasogastric
PEM Protein-energy malnutrition
O Orally
PDA Patent ductus arteriosus
PO Per os (by mouth)
PR Per rectum
q Every
ROP Retinopathy of prematurity
SAM Severe acute malnutrition
SC Subcutaneous
Sec Seconds
Susp Suspension
Syr Syrup
Tabs Tablets
TDS Thrice a day
VRSA Vancomycin resistant Staphylococcus aureus
Wk Week
Wt Weight
Yr Year
Index

A glomerulonephritis 268
Abacavir 199 gout 123, 127
Abdominal hemolytic anemia 215, 221
cramps 49 hepatitis 93
discomfort 76, 223 kidney injury 265
pain 38, 76, 106, 121, 161, 195, leukemia 108, 117, 118, 120, 122
200, 202, 203, 211, 221, 337 lymphoblastic leukemia 121
Abetalipoproteinemia 113 myeloblastic leukemia 121
Abhayrab 291 narrow angle glaucoma 62, 65
Absence seizures 63, 65 pulmonary insufficiency 62
Absorption 6, 7 renal failure 22, 223, 265
Accidental exposure 104 seizures 58, 254
Acellular triple vaccine 273 severe asthma 89, 259
Acetaminophen 18, 239 ulcerative gingivitis 182
Acetazolamide 77, 239 urinary retention 68
Acetylsalicylic acid 18 Acyclovir 198, 252
Acidosis 77 Adacel 274
Acitrom 81 Addisons disease 79
Acne 67, 89 Adenosine 238, 239
Acrodermatitis enteropathica 116 Adolescent nutritional dwarfing 116
Acthar 67 Adrenal
Activation of corticosteroid 87
dormant tuberculosis 90 insufficiency 243
tuberculosis 89 suppression 88
Acuclav 140 Adrenaline 25, 68, 237, 253
Acute Adrenocorticotropic hormone 84
adrenal insufficiency 89, 90 Adrenocorticotropin 67
bacillary Adrenor 74
dysentry 260 Adriamycin 122
diarrhea 48 Adult respiratory distress
sinusitis 148 syndrome 130
bronchiolitis 261 Advanced liver
diarrhea with dehydration 259 disease 62, 131
epiglottitis 261 dysfunction 63
exacerbation of chronic Agiepril 94
bronchitis 148 Agranulocytosis 36, 37, 43, 75, 82,
febrile illness 282, 286 216, 203, 221, 223
362 Pediatric Drug Directory

Airway Amiodarone 15, 202,222


disease 208 Amitriptyline 15, 53
obstruction 131 Amodiaquine hydrochloride 216
Albendazole 223, 227 Amoxicillin 123, 139, 246
Albezole 223227 clavulanate 140, 246
Albumin 126, 239 clavulanic acid 185
Albuminuria 55, 189 Amphetamines 310
Albuterol 239 Amphotericin B 210, 233
Alcohol 182, 187, 197, 227 Ampicillin 123, 140, 184, 192, 246
Aldomet 97 sulbactam 141
Aleep disorder 64 Amrinone lactate 70, 240
Alkem 111 Anabolic steroids 91
Alkeran 117 Analgesics 18, 310
Allergic Anaphylactic
bronchial asthma 35 reactions 104
conjunctivitis 35 shock 36, 68
dermatitis 36 Anaphylactoid reactions 34
dermatoses 33 Anaphylaxis 82, 104, 105, 107, 269
rash 188 Ancylostomiasis 228-230
reactions 27, 42, 68, 136, 160, 170, trichuriasis 227
178, 208, 236 Anemia 112, 116, 118, 136, 155, 156,
rhinitis 29, 34, 35 177, 203, 209, 221
states 33 Angina 94
Allergies 147 Anginal pain 72
Allopurinol 122, 123, 126, 141 Angioedema 38
Allylamine 213 Anhidrosis 47
Alprostadil 239 Anhydrous ferrous sulfate 106
Altacef 156 Anogenital warts 208
Aludrox 50 Anorexia 59, 81, 92, 111, 112, 118,
Aluminum hydroxide 50 119, 168, 177, 217, 218
Alveolitis 119 Antacids 50, 160, 167, 222
Amantadine 205 Antianthropode drugs 236
Amantrel 205 Antiasthma drugs 25
Ambistryn-S 135, 187 Antibacterial drugs 132
Amebiasis 182, 225 Antibiotic 310
cryptosporidiosis 231 therapy 266
Amicin 132, 191 Anticancer drugs 117
Amicline 224 Anticholinergic effects 36
Amicor 70 Anticholinergics 66
Amikacin 15, 132, 184, 185, 191, 245 Anticoagulants 141, 21
Aminoglycosides 15, 132 Anticonvulsants 119, 219
Aminophylline 25, 239 Antifilaria drugs 233
Index 363

Antifungal drugs 210, 252 Arthralgia 48, 94, 104, 107, 122, 213,
Antiherpes virus drugs 198 217, 218, 338
Antihistamines 31 Arthritis 338
Antihistaminics 219, 311, 329 Articular pains 169
Antihypertensive drugs 94 Ascapil 227
Anti-influenza virus drugs 205 Ascariasis 227-231
Antileishmania drugs 233 Ascorbic acid 112
Antileprosy drugs 195 Aspirin 82
Antimalarial drugs 215, 234 Astemizole 31
Antimycobacterial drugs 184 Asthenia 43
Anti-nontuberculous mycobacterial Asthma 33, 56, 76, 94, 139,
drugs 192 217, 218
Antiparasitic drugs 223, 233 Ataxia 54, 59, 65
Antiprotozoal drugs 223 Atenolol 94
Antipseudomonas penicillins 143 Atonic generalized seizures 63
Antiretroviral drugs 199 Atracurium 231
Antischistosomiasis drugs 235 Atrial fibrillation 222
Antisnake venom 124 Atropine 49, 237, 253
Antithyroids 329 sulfate 46, 68, 240
Antitoxins 124 Attack of myocardial
Antitoxoplasmosis drugs 235 infarction 96
Antituberculous drugs 184 Augmentin 140
Antiulcers 50 Azathioprine 123
Antivenom serum 256 Azenam 157
Antiviral drugs 198, 252 Azithral 159, 192
Antrenyl 45 Azithromycin 159, 192, 246
Anuria 54, 78 Aziwok 159, 192
Anxiety 54, 73 Azoles 211
Aplastic anemia 108, 223 Azolin 148
Apnea 131 Azoospermia 93
of prematurity 28 Azotemia 79
Apresoline 96 Aztreonam 157, 246
Aquasol 110
Arachitol 112 B
Arnate 217 Backache 34, 104, 121
Arrhythmias 70, 73, 75, 76, 208 Bacterial
Artemether 216 infection 101, 120
Artemisinin combination meningitis 158, 266
therapy 215 Bactrim 179
Arte-plus 216 Banocide 233
Arterial blood gases 131 Barbiturates 82, 122, 311
Artesunate 217 BCG vaccine 271
364 Pediatric Drug Directory

Beclomethasone 87 Bone marrow


dipropionate 29 depression 43, 58, 76, 78, 79, 117-
Behavior problems 64 119, 121-123, 127, 187, 235,
Benzathine 250 329
penicillin 138 suppression 204
Benzodiazepine hypersensitivity 65 Bradyarrhythmias 69
Benzyl penicillin 137 Bradycardia 71, 74, 76, 94, 222
Beparine 81 Breast
Berirab 101 atrophy 93
Beta-blockers 219 pain 93
Beta-lactamase inhibitor 140, 141 Broadspectrum antibiotic therapy
Betamethasone 87 51
Bevidox 111 Bromide 280
Biliary Bronchial asthma 25, 27, 28
excretion 5 Bronchitis 37
function 7 Bronchodilators 25
pain 131 Bronchogenic carcinoma 118
Biltricid 232 Bronchopulmonary dysplasia 88,
Bioclox 139 104, 113
Biodoxi 169, 220 Bronchospasm 28, 82
Biotrexate 118 Budesonide 30
Bipolio 280 Bumetanide 77, 240
B-lactum antibiotics 130 Buscopan 46
Bladder Busulfan 119
hemorrhage 122
neck obstruction 32 C
Bleeding Caffeine citrate 240
diathesis 82, 143 Caffeys disease 112
esophageal varices 85 Calcigard 97
headache 81 Calcitriol 240
tendencies 117 Calcium
Blood antagonists 202
dyscrasia 33, 37, 54, 57, 58, channel blockers 219
77, 79, 130, 136, 153, 215, chloride 115, 238
222 gluconate 114, 238, 253
glucose monitoring 222 salts 240
pressure 131 Calciuria 112
transfusion 263 Calmpose 59
urea nitrogen 132 Camoquin 216
Bloody diarrhea 260 Campicillin 140
Blurring of vision 45, 64, Campylobacter 165
73, 221 Candida albicans 214
Index 365

Candistat 211 Cefotaxime 145, 151, 247


Capreomycin 184, 185 Cefpirome 145
Capsular polysaccharide typhoid Cefpodoxime 145
vaccine 285 proxetil 151
Captopril 94, 240 Cefprozil 152
Carbamazepine 15, 57, 66, 82, 85, Ceftaroline 152
160, 186, 202 Ceftazidime 145, 153, 247
lower concentrations 213 Ceftibuten 145, 153
Carbelin 143 Ceftizoxime 145, 154
Carbenicillin 143, 247 Ceftobiprole 154
Carbimazole 87 Ceftriaxone 145, 155, 248
Carbonic anhydrase inhibitors 66 Ceftum 156
Cardiac Cefuroxime 145, 156, 248
arrhythmias 72, 222 axetil 145, 156
conduction disorders 219 Central
failure 74 diabetes
insufficiency 84, 123 insipidus 85
toxicity 122 mellitus 85
Cardiogenic shock 97 nervous system 19, 53
Cardiopulmonary resuscitation 114, Cephalexin 145, 157, 248
115 Cephalosporins 133, 135, 144
Cardiovascular Cephalothin 145
collapse 58 Cephapirin 145
disease 33, 38, 84 Cephradine 145
drugs 68 Cepodem 151
Carnitine 240 Cerebral
Catapres 94 disease 223
Cataract 67, 88-90 edema 77, 87, 127
Catecholamine refractory septic hemorrhage 73
shock 85 Cerebrospinal
Cautious treatment of anemia 269 fistula 282
Cefaclor 145, 146, 247 fluid 281
Cefadroxil 145, 147, 247 Cervarix 277
Cefazolin 145, 148, 247 Cetirizine dihydrochloride 31
Cefdinir 148 Chest
Cefepime 145, 149 pain 222, 228
Ceficad 149 tightness 121
Cefinar 149 Chills 121, 122, 200
Cefixime 145, 149 Chlamydia pneumoniae 163
Cefizox 154 Chloral hydrate 53, 241
Cefoperazone 145, 150, 247 Chlorambucil 119
sulbactam 150 Chloramphenicol 17, 122, 180, 248
366 Pediatric Drug Directory

Chlordiazepoxide 54 Claribid 160, 193


Chloromycetin 180 Clarithromycin 160, 185, 193
Chloroquine sulfate 218 Clarks rule 9
Chlorothiazide 78, 241 Clavulanic acid 140, 143
Chlorpheniramine maleate 32 Clemastine fumarate 32
Chlorpromazine 85 Clindamycin 164, 248
hydrochloride 53 Clitoral enlargement 93
induced shock 73 Clobazam 62
Chlorpropamide 123 Clofazimine 185, 195
Cholera vaccine 289 Clonazepam 15, 62
Cholestasis 204 Clonidine 94, 241
Choriocarcinoma 118 therapy in ischemic heart disease
Chronic 99
cardiac disease 282 Clostridium difficile 145, 173
granulocytic leukemia 117 Clotrin 62
heart disease 288 Cloxacillin 139
hemolytic anemia 108 Clozam 62
kidney disease 108 CNS
liver disease 276, 282 depression 34, 35, 37, 64, 66, 122,
lung disease 288 136
lymphoblastic leukemia 119 stimulants depressants 62
myeloid leukemia 119, 208 stimulation 38
pulmonary disease 282 toxicity 188
renal Cochlear implants 282
disease 282 Codeine 19
failure 85, 282 Colimex 45
urticaria 35 Colistin sulfate 48, 136
Cifran 165, 189 Colitis 122
Cilanem-500 158, 192 Colloidal iron 107
Cilastatin 185 Colonic motility disorders 46
Cimetidine 51, 62, 75, 82, 182, 203, Color vision 332
225, 241 Coma 36, 43, 73, 324
Ciplar 74, 98 Combination vaccines 297, 299
Ciplox 165 Combutol 186
Ciprofloxacin 165, 184, 189 Common cold 36
Circumoral Community acquired pneumonia
pallor 76 148
paresthesia 148 Complete biliary tract obstruction
Cisapride 201, 202, 211, 241 131
Citrate 129 Concomitant high dose
solutions 241 antidepressants 36
Claforan 151 Confusion 42, 54, 73, 75, 77, 325
Index 367

Congenital Cyclophosphamide 121, 123


adrenal hyperplasia 87, 89, 90 Cyclorine 188
heart disease 104 Cycloserine 184, 185, 188
hypothyroidism 86 Cyclosporine 123, 136, 160, 211, 213
immunodeficiency 282 Cymevene 199
toxoplasmosis 162 Cynomycin 171
Congestion of upper respiratory Cyproheptadine HCl 32
mucosa 40 Cystic fibrosis 86, 113, 142, 157
Congestive cardiac failure 70, 268 Cystitis 122, 157
Conjugate typhoid vaccine 285 Cytoblastin 120
Constipation 32, 43, 44, 47, 49, 50, Cytocristine 120
95, 112, 177, 223, 336
Convulsions 167, 324 D
Coombs-positive hemolytic anemia Daktarin 212
75 Dalacin inj 164
Copper deficiency 116 Dalbavancin 174
Cordarone X 69 Dalcap 164
Corneal deposits 216 Dalfopristin 177
Coronary heart disease 74, 98 Dapsone 195
Cortisone 89 Daptomycin 174
acetate 88 Daraprim 235
Corynebacterium diphtheriae 161 Daunobin 121
Cotrimoxazole 119 Daunorubicin 121
Cough 201, 202 Deafness 331
Coumadin 82 Defibrillation 237
Cramps 97, 113 Dehydration 36
Cranial irradiation causing Delirium 325
neurosecretory dysfunction Dental
85 and periodontal disorders 209
Crohns disease 179 discoloration 170, 171
Cromoglycate disodium 26 Depression 19, 53, 93, 188
Cryptosporidiosis 225 Depsonil 54
Crystalluria 77, 178, 189, 236 Dermatophytosis 211
CSF rhinorrhea 282 Dermatoses 34, 127
Cubicin 174 Desmopressin acetate 84
Cushing Desoxycorticosterone 89
disease 67 Dexamethasone 88, 89, 241
syndrome 90, 91 Dextromethorphan hydrochloride
Cushingoid facies 89, 90 41
Cutaneous larva migrans 228 Dextropropoxyphene HCl 19
Cyanosis 178, 236 Dextrose intravenous solutions 175
Cyanotic spells of Fallot tetralogy 98 Diabetes insipidus 282
368 Pediatric Drug Directory

Diabetic Dizziness 26, 29, 32-38, 42, 48, 49,


ketoacidosis 264 65, 72, 97, 153, 163, 166,
neuropathy 63 167, 188, 191, 217, 218, 221,
Diaminodiphenyl sulfone 195 223, 228
Diarrhea 27, 34, 43, 71, 74, 87, 106, Dobutamine 71, 241, 253
113, 116, 118, 119, 131, 140, Dobutrex 71
141, 146, 155, 163, 166, 169, Domperidone 44
177, 191, 195, 202, 204, 207, Domperon 44
216, 221, 223, 336 Dopamine 71, 242, 253
Diazepam 10, 59, 253 Dopinga 71
Diazoxide 95 Dornase alpha 242
Diclofenac sodium 19 Doxapram 242
Dicyclomine 45 Doxepin 253
Didanosine 200 Doxorubicin 122
Diethylcarbamazine 233 Doxycycline 169, 220
Digoxin 16, 70, 122, 160, 187, Doxypal 220
197, 241 Drotaverine HCl 46
Dihydrotachysterol 241 Drotin 46
Dilantin 58 Drowsiness 32-37, 47, 49, 54, 56,
Diloxanide furoate 224 77, 80, 95, 97, 182, 187, 188,
Dimethindene maleate 33 201, 323
Dimethylpolysiloxane 127 leukopenia 123
Dindevan 82 Drug
Dinex 200 affecting cardiac conduction
Diphenhydramine HCl 33 219
Diphenoxylate hydrochloride 49 induced pyridoxine deficiency
Diphenylhydantoin sodium causing neuritis 67
10, 58 interactions 74
Diphtheria resistant Streptococcus
antitoxin 125 pneumoniae 176
carriers 161 Dryness of
tetanus mouth 32, 37, 45, 49, 64, 336
and pertussis 272, 273 skin 47
toxoid 273 Duchennes myopathy 126
toxoid 283 Dukoral 289
Diphyllobothrium latum 230 Duodenal ulcer 50
Diplopia 73, 332 Dysarrhythmia 73
Disaccharidase deficiency 48 Dyspepsia 26, 29, 38, 86,
Discoid lupus erythematosus 218 131, 207
Disease of ear 136 rash 20
Disopyramide 15 Dyspnea 34, 73, 201
Disulfiram 62 Dystonia 42, 323
Index 369

E Epinephrine 25, 68, 242, 270


Easy fatigability 65 Epiphora 332
Econorm 51 Equine rabies immunoglobulin
Eczema 319 102, 292
Edema 67, 91, 92, 97 Equirab 101
Efavir 200 Ersafe 161
Efavirenz 200 Erythema
Electrolyte disturbances 89 multiforme 201
Elevation of liver nodosum 320
enzymes 200 Erythromycin 161, 169, 222, 248
transaminases 195 Erythropoietin 242
Eltocin 161 Ethacrynic acid 78, 133, 135,
Emanthal 227 136, 189
Emergency Ethambutol 184-186
allergic disorders 36 Ethide 188
drugs in neonates 237 Ethionamide 184, 185, 188
Emeset 44 Ethosuximide 15, 57
Emigyl 224 Ethylestrenol 93
Enalapril 95 Euphoria 67, 90
maleate 95 Exacerbation of myasthenia
Enamel hypoplasia 170, 171 gravis 160
Encephabol 55 Excessive
Endemic tropical sprue 108 drooling 335
Endoscopic variceal band ligation irritability 327
263 sweating 64, 321
Endotoxic shock 89 Exifine 213
Endoxan-N 121 Extensive diphtheria 125
Engerix B 276 Extraintestinal amebiasis 218
ENT infection 179 Extrapyramidal
Enterobacter 13, 165 manifestations 43
Enterobiasis 227, 229, 230 syndrome 43, 202
Enterococcal endocarditis 174
F
Enuff 49
Eosinophilia 57, 82, 123, 136, 156, Faintness 43
161, 167 Fasigyn 226
Ephentine 73 Fat redistribution 202, 203
Epidosin 50 Fatigue 26, 29, 34, 69, 97, 201, 209,
Epigastric 213, 217, 218
discomfort 169 Febrile
pain 92, 168 neutropenia 158
Epilepsy 33, 37, 43, 56, 58, 76, 77, seizure 278
205, 219 Femoral epiphysis 85
370 Pediatric Drug Directory

Fentanyl citrate 20 Fosolin 58


Ferrous Fosphen 58
ammonium citrate 107 Frequency of micturition 130
carbonate 107 Frusemide 22, 78, 133, 135, 136,
choline citrate 107 157, 189
fructose 106 Fulminant gram-negative
fumarate 106 infections 132
gluconate 107 Funazole 212
lactate 106 Fungizone 210
succinate 106 Furazolidone 48, 224
sulfate 106, 108 Furosemide 78
Fetal disease 307 Furoxone 48, 224
Fever 73, 76-78, 82, 104, 105, 107,
112, 121-123, 127, 136, G
150, 151, 174, 200, 201, Gabapentin 63
223, 228 Gabapin 63
Fexofenadine 34 Gait disturbances 217, 218
Filariasis 233 Galactosemia 48
Fine tremors 54 Gamma protect hepatitis 104
Finger tremors 27 Ganciclovir 199
First order pharmacokinetics 2 Gantrisin 180
Flagyl 182, 224 Garamycin 132
Flatulence 76 Gardasil 277
Flecainide 15 Gardenal 56
Flemoxin 139 Gastric
Floppiness 328 acid secretion 7
Fluarix 290 distention 49
Fluconazole 160, 211, 252 emptying time 7
Fluid ulcer 50, 82
and electrolyte imbalance 79 Gastritis 33, 45, 57, 89
retention 93, 122 Gastroesophageal reflux 45
Flumadine 207 Gastrointestinal
Flumist 291 and urinary tract 158
Fluoroquinolones 165 bleeding 21, 337
Flushing 44, 115 disturbances 153
of skin 72 intolerance 20
Fluvir 205 motility 7
Folate antagonists 119 tract 168, 190
Folic acid 108, 119, 242 drugs 42
deficiency 108 upset 136, 150, 151,
Forcan 211 156, 160
Fortum 153 Gatifloxacin 185
Index 371

General anesthesia 99 H
Genevac B 276 Habitual psychogenic
Genital polydipsia 84
infection 161 Haemophilus influenzae 12, 162,
pruritus 147 165, 275
Genitourinary 139 Hallucinations 325
tract 168 Haloperidol 54
Gentamicin 15, 132, 248 Hansepran 195
Genticyn 132 Hay fever 32, 139
Giardia lamblia 52 Headache 26, 27, 29, 32, 34, 38, 42,
Giardiasis 182, 225 44, 49, 65, 72, 73, 84, 88, 90,
Giardyl 224 91, 94, 97, 104, 107, 111, 130,
Giddiness 228 131, 136, 153, 163, 169, 177,
Gingival hyperplasia 97 188, 200-202, 204, 213, 217,
Gingivostomatitis 335 218, 221, 228, 322
GIT infection 179 Heart
Glaucoma 33, 37, 39, 40, 47, block 54, 68, 69, 71, 73, 75, 76,
77, 89 94, 222
Glomerulonephritis 79 burn 169
Glucagon 242 disease 38
Glycopeptide antibiotics 173 failure 76
Glycosuria 77, 79, 128 rate 131
Golden rules in pediatric drug Heat stroke 267
therapy 17 Helicobacter pylori gastritis 51
Gonadal toxicity 199 Hematemesis 262
Gout 126 Hematologic
Granulocyte colony-stimulating disorders 181
factor 242 dysfunction 213
Granulocytopenia 136, 174, 203 monitoring 120
Gray baby syndrome 181 Hematuria 57, 77, 189, 334
Grisactin forte 214 Hemolytic anemia 48, 97,
Griseofulvin 214 146, 196
Gromane 98 Hemopoietic depression 94
Growth Hemorrhage 82
failure 111 Hemorrhagic
hormone 85 colitis 206
deficiency 85 disease of newborn 113
retardation 88-90 Heparin 81
Guanethidine sulfate 95 Hepatic
Guillain-Barr syndrome 290 and renal dysfunction
Gynecomastia 10, 43, 80, 85, 892, 93, 57, 200
201, 339 damage 122
372 Pediatric Drug Directory

dysfunction 43, 54, 77, 92, 97, papilloma virus


119, 122, 161, 165, 200, 210 infection 208
enzyme 182, 225 vaccines 277
failure 122 rabies
impairment 170 immunoglobulin 102, 292
insufficiency 56, 162 specific immunoglobulin 101
necrosis 130, 138 tetanus specific immunoglobulin
Hepatitis 82, 101, 202-204, 216 101
A Humantin 231
vaccine 275 Hydralazine 67, 96, 242
virus 275 Hydrocephalus 77
and B vaccines 119 Hydrochlorothiazide 79, 242
B 208 Hydrocortisone 89, 243, 253
immunoglobulin 277 Hydroxyzine HCl 34
vaccine 276 Hyoscine butyl bromide 46
C 208 Hypercyanotic spells of Fallot
influenza virus 209 tetralogy 74f
Hepatocellular carcinoma 93 Hyperglycemia 69, 79, 90-92, 95,
Hepatotoxicity 55, 69, 97 122, 128, 202
Herpes simplex Hyperkalemia 54, 80, 94
encephalitis 198 Hypermagnesemia 27
virus 209 Hypernatremia 84, 143
infections 198 Hypernatremic edema in neonates
Hetrazan 233 and infants 128
Hiberix 275 Hyperostosis 112
Hiccup 335 Hyperplasia of gums 58
High Hyperpyrexia 322
dose isoniazid 185 Hypersensitivity 44, 48, 122, 124,
intraocular tension 33 128, 139, 140, 141, 143, 146,
Hirsutism 80 155, 162, 169, 174, 188, 197,
HIV infection 204 231
Hoarseness 29 reactions 105, 107, 108, 123, 125,
Hodgkins 127, 143, 147, 161
disease 119, 120 Hyperstat 95
lymphoma 118 Hypertension 33, 68, 70, 76, 82, 88-
Hookworm anemia 126 92, 98, 104, 123
Hostacycline 171 Hypertensive crisis 37, 95, 97, 99,
Human 263
diploid cell vaccine 291, 292 Hyperthyroidism 33, 74, 98
immunodeficiency virus Hypertrichosis 98, 321
infection 295 Hyperuricemia 95, 121, 209
normal immunoglobulin 101 Hypnotic in insomnia 64
Index 373

Hypocalcemic states 114, 115 Influenza A 205


Hypoglycemia 78, 138, 222 virus vaccines 290
Hypoglycemic 187, 197 Influvac 290
reactions 86 Inhalation therapy 29
Hypokalemia 73, 78, 79, 90, 91, 143, Insect bite 36
189, 222 Insomnia 90, 202, 328
Hyponatremia 65, 76, 78, 79, 127 Insulin 85, 243
Hypoplastic anemia 108 Interstitial
Hypoproteinemia 126 nephritis 146, 192
Hypotension 27, 29, 33, 48, 54, 58, pneumonia 119
71, 73-75, 76, 84, 94-96, Intestinal obstruction 48
105, 115 Intra-abdominal infections 158
Hypothermia 321 Intradermal injection 256
Hypothyroidism 10, 69, 99 Intrauterine growth retardation 1
Hypotonia 10, 112, 328 Intravascular hemolysis 221
Hypovolemic shock 73 Intravenous immune globulin 243
Ipcazide 186
I Ipratropium bromide 30
Ibuprofen 20 Iron 106
Idiosyncrasy 56 deficiency anemia 106,
Imipenem 184, 185 107, 108
cilastatin 158, 259 dextran 107
Imipramine 15, 54 salts 123
Immunosuppressive therapy 282 sorbitol 107
Imodium 48 sucrose complex 108
Imogam 100 Irritability 10, 64
Imovax 279 Irritable bowel syndrome 51
Important emergency drugs 253 Ischemic pain 97
Inactivated polio vaccine 279 Ismelin 95
Indinavir 202 Isokin 186
Indole-positive proteus infections 143 Isoniazid 184-186
Indomethacin 21, 85, 130, 243 Isonicotinic acid 186
Infantile Isoproterenol 72
myoclonic seizures 65-69 Isoptin 99
spasms 64, 66, 67 Isuprel 72
tremor syndrome 74, 98, 116 Itraconazole 211
Infections of Ivermectin 227
lower respiratory tract 168
urinary tract 190 J
Infectious granuloma 118 Japanese encephalitis vaccine 293
Infective endocarditis 81 Jaundice 36, 37, 49, 54, 78, 79, 118,
Inflammatory bowel disease 51, 179 178, 236
374 Pediatric Drug Directory

Jenvac 293 Leukeran 119


Juvenile rheumatoid arthritis 24 Leukocytosis 123, 127
Leukopenia 54, 117, 119, 120, 122,
K 127, 155, 187
Kanamycin 133, 184, 185, 189 Leunase 122
Kancin 133, 189 Levamisole 228
Kaposis sarcoma 121 Levels of
Keflor 146 cisapride 213
Kepra 63 telithromycin Digitalis 163
Kerosene oil poisoning 258 Levetiracetam 63
Ketek 162 Levocetirizine 35
Ketoconazole 186, 203, 212, 219 Levodopa 36
Ketotifen 35 Levoflox 166, 190
Kidney damage 108 Levofloxacin 166, 185, 190
Klebsiella pneumonia 13 Levothyroxine 243
Librium 54
L Lidocaine HCl 72
Labetalol 96 Lignocaine 15, 72, 127
Lactation 33-36, 162 Lincomycin HCl 163
Lactic acidosis 177, 204 Lincosamides 163
Lactobacillus Linezolid 176, 185
acidophilus 51 Linox 176
sporogenes 51 Lipid-lowering agents 119
Lactorrhea 43 Lipodystrophy 201, 204
Lactulose 47 Live
Lametec 63 attenuated influenza vaccine 291
Lamivudine 201, 252 vaccines 120, 284
Lamnidac 100, 201 Liver
Lamotrigine 63 damage 58
Lanoxin 70 disease 38, 214
Largactil 53 disorders 113
Lariago 218 dysfunction 44, 98, 188, 197, 213,
Laridox 215 217, 218
L-asparaginase 122 failure 204
Lastuss 41 function status periodically 188
Leeflox 166, 190 insufficiency 189
Legionella pneumophila 163 Loefflers pneumonia 233
Lennox-Gestaut syndrome 62, 65, 66 Lomflox 166, 190
Lesch-Nyhan syndrome 126 Lomotil 49
Lethargy 73, 113 Loose motions 10
liver dysfunction 136 Lopamide 48
Leukemia 120, 122 Loperamide HCl 48
Index 375

Lopinavir 202 Menstrual


Loratadine 35 abnormalities 93
Lorazepam 64, 243 disturbance 92, 119
Lorpose 64 irregularity 122
Loss of Mental
appetite 73 depression 98, 322
scalp hair 320 disturbances 167
Lumerax 216 dullness 57
Lydroxil 147 Mepacrine 229
Lymphadenopathy 204, 338 Mephentermine sulfate 73
Lymphopenia 155 Mercaptopurine 117, 123
Lynx 163 Meronem 158
Meropenem 158
M Meroza 158
Macrocytosis 204 Metabolic acidosis 138
Macrolides 159, 203 Metakelfin 215
Maculopapular rash 140 Metastatic calcification 112
Magnamycin 150 Methadone 243
Magnesium sulfate 27, 115, 243 Methandienone 92
Magnex 150, 155 Methdilazine HCl 36
Malaise 69, 123, 127, 204, 209, 213, Methemoglobinemia 10, 221
218 Methicillin 249
Malignant lymphoma 122 resistant
Malirid 220 staphylococcal infections 173
Mania 93 Staphylococcus aureus
Manocalm 43 176, 262
Maternal pulmonary edema 88 Methotrexate 118, 130, 143, 180
Measles 101 Methyldopa 97
mumps and rubella vaccine 279 Methylprednisolone 89, 90, 270
vaccine 278 Metoclopramide 244
Mebendazole 229 HCl 43
Mefenamic acid 21 Metoprolol 163
Mefloquine 219 Metrogyl 182, 224
Meflotas 219 Metronidazole 182, 224, 249
Megaloblastic anemia 108, Mexiletine 15
111, 188 Mezlocillin 249
Melena 77 Mezolam 64
Melphalan 117 Michaelis-Menten kinetics 2
Menadione sulfate 113 Micogel 212
Meningitis 132 Miconazole 212, 252
Meningococcal vaccine 294 Microbial flora 7
Meningoencephalitis 266 Micturition 334
376 Pediatric Drug Directory

Midazolam 64, 201, 202, 244 Mycifradin 134


Migraine 74, 98 Mycobacterium leprae 195
Mikicin 132, 191 Mycoplasma pneumoniae 13,
Mild 161, 163
abdominal cramps 44 Mycostatin 214
fever 291 Myelosuppressive therapy 122
Milicor 73 Myleran 119
Milrinone 73 Myocardial depressant 75, 127
Minipril 95 Myocarditis 172
Minocycline 171 Myoclonic seizures 63
Minoxidil 98 Myopathy 90
Mitochondrial dysfunction 204 Myopia 333
Mitomycin-C 117, 120 Mysoline 56
Moderate neutropenia 147
Moniliasis 147 N
Monitor Nafcillin 250
blood 188 Nalidixic acid 167
bone fusion 85 Nalorphine 128
Monizole 224 Naloxone 237, 244, 253
Monoamine oxidase inhibitor 177 Nandrolone 92
Mood Naproxen 23
fluctuations 93 Narcotic 10, 187, 197, 310
swings 91 analgesia 20
Morbilliform eruptions 147 Narrow angle glaucoma 32, 33, 64
Morphine 244 Nasal
sulfate 22 congestion 39, 82, 291
Moxifloxacin 185 decongestants 39
Mucosal candidiasis 211 infection 84
Multidrug resistant tuberculosis 192 polyposis 29
Multiple myeloma 117, 208 stuffiness 43, 99
Muscle Nasopharyngeal diphtheria 125
aches 123, 127 Nasotracheal intubation 261
cramps 38, 78 National Immunization
relaxants 222 Schedule 274
weakness 36, 113, 120 Nausea 33, 34, 48, 59, 71-73, 76, 79,
Muscular pains 169 84, 92, 97, 106, 107, 118, 146,
Mustine HCl 118 155, 163, 166, 168, 169, 177,
Mutamycin 117 202, 211, 221
Myalgia 203, 209, 213, 217, 218 sleep disturbances 27
Myasthenia 202 Nebasulf 134
gravis 33, 47, 62, 65, 133, 135, 136, Necrotizing enterocolitis 51
163, 170 Negadix 167
Index 377

Neisseria gonorrhoeae 165 Non-Hodgkins lymphomas 119


Nelfinavir 202, 252 Nonpenicillin 157
Nelvir 202 Nonsteroidal anti-inflammatory
Nemocid 230 drug 18, 22
Nemozole 227 Nontuberculous mycobacteria 179
Neomycin 134 Nonvariceal bleed 263
Neonatal Norbactin 167
apnea 25 Norepinephrine 74
herpes simplex infection 198 Norflox 167
hyperbilirubinemia 126 Norfloxacin 167
seizures 255 Nosocomial infections 132
thrombocytopenia 79 Novamox 139
Neoplasia 204 Novartis 291
Neosporin 134 Numbness 148
Neotrexate 118 Nyasthenia gravis 75
Nephrotic syndrome 57, 94, 121, Nystagmus 43
126, 282 Nystatin 214, 252
Nephrotoxicity 333
Netilmicin 134 O
Netromycin 134 Obstructive urinary tract 33
Neural tube defects 111 Occular larva migrans 233
Neurocysticercosis 227 Oculogyric crisis 43
Neuromuscular blocking drugs 135 Odoxil 147
Neurontin 63 Ofloxacin 168
Neuropathy 201 Okavax 287
Neutropenia 94, 155, 329 Oliguria 127
Nevimune 203 Omeprazole 82, 213
Nevirapine 203, 252 Omnacortil 67
Niclosamide 230 Omnatax 151
Niclosan 230 Ondansetron HCl 44
Nifedipine 97 Onychomycosis 211
Nightmares 69 Open angle glaucoma 68
Nimesulide 22 Optic neuritis 200
Nitarid 99, 225, 231 Oral
Nitazoxanide 225, 231 anticoagulants 182, 225
Nitravan 64 coagulants 122
Nitrazepam 64 contraceptive 143, 173, 197, 202
Nitrofurantoin 167 penicillin 138
Nitrogen mustard 121 polio vaccine 280
Nitroxazepine HCl 55 rehydration salts 128
Nivaquine 218 route 6
Nocturnal enuresis 53 typhoid vaccine 219, 286
378 Pediatric Drug Directory

Orciprenaline sulfate 27 Paromomycin 231


Organophosphate poisoning 68, 258 Paroxysmal ventricular
Oritavancin 175 tachycardia 75
Ornidazole 226 Partial
Oropharyngeal epilepsy 63, 64
candidiasis 211 seizures 56, 63
edema 208 Pefloxacin 168
Orthostatic hypotension 43, 79, 97 Pelox 168
Oseltamivir 205 Pencillinase-resistant penicillins 139
Osteogenic sarcoma 118 Penicillamine-induced neuropathy
Osteoporosis 89, 90 111
Ovarian dysfunction 119 Penicillin 10, 119, 137
Overhydration 84 antibiotics 137
Oxacillin 250 G 250
Oxazolidinone antibiotics 176 resistant pneumococci 176
Oxcarbazepine 65 Penicillium fungi 137
Oxycarb 65 Pentacarinate 234
Oxygen saturation 131 Pentamidine isethionate 234
Oxymetazoline HCl 39 Pentazocine HCl 23
Oxymetholone 92 Pentids 138
Oxyphenonium bromide 45 Peptic ulcer 21, 45, 67, 89
Oxytetracycline 170 disease 90, 130
Perennial allergic rhinitis 35
P Perinatal distress 55
Pain 155 Perinorm 43
abdomen 87, 119 Peripheral
Painful swelling of long bones 111 arterial disease 94
Palpitation 34, 27, 43, 72, 217, 218 circulatory failure 78
Pancreas 85 neuritis 116
Pancreatitis 79, 122, 179, 202, neuropathy 94, 191, 195,
204, 209 204, 216
Pantelmin 229 Peritonitis 132
Para-aminosalicylic acid 185, 189 Pernicious anemia 109
Paracetamol 18 Persistent asthma 29, 30
Paracoccidomycosis 211 Pethidine 23
Paradoxical Pharyngitis infection 161
excitement 33 Phenergan 42
hyperactivity 56 Phenindione 82
stimulation 64 Pheniramine maleate 36
Paraldehyde 65 Phenobarbital 10, 163, 182, 202, 213,
Paratyphoid fever 179 244, 253
Paresthesia 73, 97, 116, 325 sodium 56
Index 379

Phenobarbitone 15 Prednisolone 67, 89, 90


Phenothiazines 169, 219 Prednisone 89
Phenylbutazone 120 Pre-existing bone marrow
Phenylpropanolamine 39 depression 119
Phenytoin 15, 58, 66, 82, 120, 160, Pregnancy 57, 135, 219
163, 180, 182, 187, 197, 202, Premature
211, 225, 244, 253 bone fusion 85
Pheochromocytoma 72, 96, 98 epiphyseal closure 92
Phlebitis 146 Prevenar-7 281
Photophobia 69, 318 Prevention and treatment of
Photosensitivity 69, 166, 167, 191, 318 potassium depletion of
Phototoxicity 318 whatsoever origin 114
Pigmentary degeneration of retina 43 Primaquine phosphate 220
Pipenzolate methyl bromide 47 Primary
Piperacillin 142, 144, 251 generalized tonic-clonic seizures
Piperazine 231 65
Piroxicam 24 HSV gingivostomatitis 198
Pitressin 76 Primidone 56, 244
Pityriasis versicolor 211 Primozide 202
Pneumococcal Principle of linear pharmacokinetics
conjugate vaccine 281 2
polysaccharide vaccine 280 Priorix 279
Pneumococci 163 Proarrhythmias 69
Pneumocystis carinii superinfection Pro-banthine 47
in HIV/AIDS 179 Probenecid 119, 129, 140, 142, 143,
Pneumonia 132, 158, 161, 262 167
Poliomyelitis 282 Procadex 153
Polycythemia vera 119 Procainamide 15, 75
Polydipsia 334 Procaine penicillin 137
Polyens 210 Prochlorperazine 42
Polyuria 77, 87, 334 Promethazine hydrochloride 42
Poor cardiac reserve 99 Pronestyl 75
Porphyria 56-58, 65 Propantheline bromide 47
Postencephalitic sequelae 55 Prophylaxis of
Post-traumatic tetanus 138 acute asthmatic attack 26
Potassium 129 diarrheal dehydration and
chloride 114, 129, 253 treatment of mild-moderate
supplements 77 dehydration 128
Potklor 114 febrile seizures, epilepsy 56
Pracainamide 222 Propranolol 244
Pralidoxime chloride 258 HCl 74, 98
Praziquantel 232 Prostaglandin 239
380 Pediatric Drug Directory

Protamine zinc 86 Pyridoxine 67


Protease inhibitors 203 deficiency neuropathy 111
Protein dependent seizures 67
bound drugs 119 and anemia 111
displacement with warfarin 180 Pyrimethamine 215, 235
Proteinuria 94 Pyrithioxine 55
Proteus mirabilis 146 Pyritinol 55
Prothionamide 185
Proton pump inhibitor 263 Q
Protrusion of tongue 43 Quinacrine 229
Pruritus 34, 48, 131, 147, Quinidine 15, 75, 202, 213, 222
217, 218 sulfate 75
Pseudoephedrine 37 Quinine 219
hydrochloride 39 sulfate 221
Pseudomembranous Quinolones 165, 184
colitis 141, 143, 147, 160, 163, Quinupristin 177
177, 182
enterocolitis 49
Pseudomonas 143 R
aeruginosa 13, 136, 145, Rabies vaccine 291
155, 165 Rabivac 292
Pseudotumor cerebri 85, 89-91, 111, Ranitidine 50, 244
167, 170, 171, 339 Ranitin 50
Psychosis 67, 73, 188 Rarely hemolytic anemia 36
Psychosomatic disorders 54 Rash 10, 48, 54, 58, 69, 73, 74, 78, 82,
Ptosis 332 97, 121, 136, 150, 151, 153,
Pulmonary 167, 169, 188, 200, 202, 213,
edema 73 223, 228
excretion 5 Rational drug therapy 11
hemorrhage 131 Raynauds phenomenon 94
toxicity 69 Reactions resembling atropine
Pulsus bigeminus 71 toxicity 54
Purified Reactive anxiety-depression 54
chick embryo cell vaccine Redoxon 112
291, 292 Reduce
duck embryo vaccine 291 dose in
vero cell vaccine 291 impairment 188
Pyelonephritis 157 renal impairment 140
Pyloric stenosis 107 therapeutic effect of levodopa 46
Pyoderma 138 Reflux
Pyrantel pamoate 230 esophagitis 45, 50
Pyrazinamide 130, 184, 185, 186 of administered dose 131
Index 381

Refractory Reversible
hypoglycemia 95 myelosuppression 199
partial seizures 63, 65, 66 neutropenia 150, 151
Refzil-O 152 skin and conjunctival
Relenza 208 discoloration 195
Renal 146 Reye syndrome 19
and hepatic impairment 219 Rheumatic
damage 48, 82, 136 carditis 89
dysfunction 165, 187, 210 chorea 54
excretion 5, 142, 143 fever prophylaxis 138
failure 80, 122, 172, 203 Rheumatoid arthritis 24, 179, 218
function status periodically Rhinitis 131
188 sicca 39, 40
impairment 82 Rhinorrhea 84, 281, 291
insufficiency 56, 80, Ribavirin 209
122, 135 Rickets 10
stone 77 Rifabutin 202
transplantation 85 Rifampicin 82, 182, 184, 185-187,
uric acid stones 130 197, 202, 203, 211, 213, 219
Rescue therapy in respiratory distress Rimantadine 207
syndrome 130 Ringers lactate 264
Reserpine 99 Ritonavir 82, 202
Resistant Rofecoxib 24
enteric fever 190 Roferon-A 208
gram-positive bacteria 174 Roscillin 140
tuberculosis 190, 191 Rotavirus vaccine 283
Resochin 218 Rovamycin 162
Respiratory Roxeptin 161
depression 27, 56, 62, 64 Roxithromycin 161
distress syndrome 267 Rubella vaccine 284
infection 161, 162, 179, 206 Ryles tube 258
syncytial virus 104, 209
tract 190 S
Restlessness 27 Sabril 66
Retardation of bone growth rate Saccharomyces boulardii 16
170, 171 Salaam seizures 64-66
Retention of urine 45, 54 Salazopyrin 179
Retinopathy of prematurity 113 Salbutamol 27
Retrograde ejaculation 96 Salicylates 10, 16, 30, 130
Retrovir 204 Salmeterol 30
RETT syndrome 63, 113 Salmonella 165
Revac B 276 Saquinavir 202
382 Pediatric Drug Directory

Schick test-positive contacts 125 Short-acting benzodiazepines 211


Scorpion sting 257 Sick sinus syndrome 95
Scratch test 256 Sideroblastic anemia 111
Seasonal allergic rhinitis 35 Sintamil 55
Secnidazole 226 Sinus
Secnil forte 226 arrhythmia 71
Secretory diarrhea 49 bradycardia 68, 69
Sedation 59 Sinusitis 161
Sefdin 148 infection 161
Seizures 73, 188, 204, 208 Sisomycin sulfate 135
Sepexin 157 Sisoptin 135
Septicemia 52, 132, 157, 158, 190 Skin 190
Septran 179 atrophy 91
Serenace 54 infection 179
Serpasil 99 irritation 204
Serratia 165 necrosis 81
Serum pigmentation 119, 121
bilirubin in liver disease 156 rash 201
sickness 138 reactions 104
Severe Slate blue color of skin 69
allergic reaction 177 Sleep
anemia 108, 126 apnea 62
angioneurotic edema 36 disorders 217, 218
aortic stenosis 97 disturbances 95
hypertension 98 Slurred speech 148
infection 174 Snakebite 256
with gram-positive organisms Sodium
137 bicarbonate 129, 237, 253
leukopenia 118 chloride 129
liver 108 nitroprusside 99
dysfunctions 162 stibagluconate 234
meconium aspiration syndrome Soft tissue infection 161, 179
130 Solar dermatitis 42
pain; myocardial infarction 22 Somnolence 203
renal dysfunction 51, 119 Sore throat 291
tissue injury 37 Sotalol 15
Shanchol 289 Sparfloxacin 169
Shanvac B 276 Sparx 169
Sheer symptomatic 29 Spiramycin 162
Shigella 165 Spironolactone 80, 245
Shigellosis 260 Sporidex 157
Shock 243 Sporotrichosis systemic mycosis 211
syndrome 71 Squint 333
Index 383

Staining of teeth 106 Sulfonamides 130, 178


Staminol 296 Sulfonylurea 130
Staphylococcal infections 139 Supacef 156
Staphylococcus Superadded fungal infections 67
aureus 139, 146, 148, 173, 176 Suppurative otitis media
infection 137 136, 188
Status Supraventricular tachycardia 75
asthmaticus 89, 259 Susceptible bacterial
epilepticus 58, 64, 254 infections 152
Stavir 203 Sweating 54
Stavudine 203 Swelling of tongue 187
Steroids 187, 197 Symptomatic
Stevens-Johnson syndrome 119, control of diarrhea 49
123, 138, 147, 178, 201, 203, relief of diarrhea 48
213, 222, 236 Syncope 38, 76, 208
Stomach pain 84 Syndrome of drowsiness 62
Stomatitis 119 Synercid 177
Stool softeners 47 Synthocilin 140
Streptococcal infections 138 Syphilis 138
Streptococcus Systemic
pneumoniae 140, 141, 146, 162 candidiasis 211
pyogenes 162 lupus erythematosis 70
venezuelae 180
Streptomycin 184, 185, 187 T
sulfate 135 Tachyarrhythmias 69
Stress ulcer 50, 88 Tachycardia 34, 68, 69, 72, 96, 97
Strongyloides stercoralis 229 Tacrolimus 213
Strongyloidiasis 227-229, 230 Tagamet 51
Subcutaneous Tamiflu 205
injection 256 Targocid 174
route 7 Tarivid 168
Sublingual route 7 Taste disturbance 213
Suicidal ideation 57 Teflaro 152
Sulbacin 141 Tegrital 57
Sulfadiazine 178, 235, 251 Teicoplanin 174
Sulfadoxine 215 Telithromycin 162
Sulfamethopyrazine 215 Tendinitis 169
Sulfamethoxazole with trimethoprim Tenolol 94
179, 194 Terbinafine 30, 213
Sulfamethoxypyrazine 215 Terbutaline sulfate 28, 253
Sulfas 10 Terfenadine 38
Sulfasalazine 179 Terizidone 185
Sulfisoxazole 180 Terramycin 170
384 Pediatric Drug Directory

Testicular atrophy 93 Toxic epidermal


Tetanus necrolysis 203
antitoxin 124 necrosis 123
toxoid 282, 283 Toxoplasmosis 162
Tetracycline 169 Tracheostomy 261
hydrochloride 171 Tranquilizers 310, 329
Theophylline 10, 28, 160, 163, 211, Transient
222, 245 abnormality of liver function
Therapeutic drug monitoring 5, 14 tests 151
Thiazide 211 bronchospasm 26
diuretics 123 myopia 77
Thiocyanate production 99 tachycardia 95, 105
Thrombocytopenia 20, 70, 76, Transjugular intrahepatic
117-119, 122, 136, 155, 169, portosystemic shunt 263
177, 221 Tremors 72, 97, 188
Thrombocytosis 155 Tresivac 279
Thrombotic thrombocytopenic Triamcinolone 89, 91
purpura 209 Triamterene 80
Thromocytopenia 122 Triazolam 202
Thyroid 86, 87 Trichomoniasis 182
disorders 209 Trichuriasis 228-230
dysfunction 209 Tricyclic antidepressants 85, 169, 219
function tests 122 Trifluoperazine 43
Thyroxine 86 Trigeminal neuralgia 57
Ticar 142, 144 Tripacel 273
Ticarcillin 142, 144, 251 Trismus 328
Tigecycline 172 Trivalent influenza vaccine 290
Timentin 143 Tromethamine 245
Tingling sensations 148 Tryptanol 53
Tiniba 226 Tuberculin reaction 284
Tinidazole 226 Tuberculosis 67, 186, 188, 191
Tinnitus 177, 221 Tubervac 271
Tobramycin 15, 251 Turners syndrome 85
sulfate 136 Tygacil 172
Tobraneg 136 Types of
Tolazoline 245 chronic leukemias 118
Tonic-clonic seizures 56, 63 drug-drug interactions 6
Tonsillitis 161 Typherix 285
infection 161 Typhoid
Topamax 65 fever 168, 179
Topiramate 65 vaccines 285
Total osmolarity 129 Typhoral 286
Index 385

U Verapamil 99
Ulcekon 50 Veratril 99
Ulceration of mouth 117 Vermisol 228
Ulcerative colitis 179 Vero cell vaccine 292
Uncomplicated skin infections 148 Verorab 292
Uncontrolled status epilepticus 64 Vertige 56
Unimezole 224 Vertigo 148, 167, 188, 221, 330
Urethritis 162 Vidarabine 123, 252
Urinary Vigabatrin 66
incontinence 64 Vigilance disorders 169
retention 33, 73 Vinblastine 120
tract infection 179 Vincristine 120
Urine glucose determinations 141 Vision disorders 209
Ursodeoxycholic acid 131, 245 Visual disturbances 71
Urticaria 32, 34, 107, 136, 147, 150, Vitamin 110, 310
151, 174, 319 A 110
Urticarial rash 77 supplements 260
B 111
V B1 111
Vaginitis 147 B6 67, 111
Valethamate bromide 50 C 112
Valparin 59 deficiency 112
Valproate 15, 59, 186 D 112
Valproic acid 22, 66, 245 analog 240
Vancocin 173 deficiency rickets 112
Vancomycin 173, 251 E 113, 245
Variceal bleed 262 H 133
Varicella K 82, 113
vaccine 287 deficiency 82
zoster Vomiof 44
immunoglobulin 102 Vomiting 48, 49, 57, 59, 71, 73, 74,
virus infections 198 76, 87, 92, 97, 106, 107,
Varilrix 287 118, 140, 146, 155, 163,
Varipox 287 168, 169, 195, 203,
Varitect 102 207, 221
Vasomotor rhinitis 29 von Willebrand disease 84
Vasopressin 76, 85 Voriconazole 212
Vaxigrip 290
Vaxirab 291 W
Ventricular Walamycin 48
arrhythmias 73 Walavin-250 214
tachyarrhythmia 58 Water intoxication 127
386 Pediatric Drug Directory

West syndrome 65-67 Z


Wheezing 94 Zanamivir 208
Worsening of Zarontin 57
asthma 228 Zeftera 154
scoliosis 85 Zentel 227
Wound infection 161 Zevtera 154
Wymox 139 Zidovudine 204, 211, 252
Zinc 116
X deficiency states 116
Xantinol nicotinate 83 supplements 260
Xylocard 72 suspension lente 86
Xylometazoline HCl 40 Zincolak 116
Zonisamide 66
Y Zosyn 142, 144
Yellow fever vaccine 295 Zovirax 198

You might also like