CLOXACILLIN 125mg/5ml

Usual Pediatric Dose for Pneumonia

The safety and efficacy of cloxacillin in children < 1 year have not been established.
>= 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.
Maximum dose: 4 g/day.

Usual Pediatric Dose for Upper Respiratory Tract Infection

The safety and efficacy of cloxacillin in children < 1 year have not been established.
>= 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.
Maximum dose: 4 g/day.

Usual Pediatric Dose for Skin and Structure Infection

The safety and efficacy of cloxacillin in children < 1 year have not been established.
>= 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.
Maximum dose: 4 g/day.

Other Comments
Cloxacillin is best absorbed when administered on an empty stomach, preferably 1 to 2
hours before meals.

How should I take cloxacillin?

Take cloxacillin exactly as directed by your doctor. If you do not understand these
instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.

Take cloxacillin on an empty stomach 1 hour before or 2 hours after meals.

Do not drink juice or carbonated beverages (soda) with your dose of cloxacillin. These
beverages will decrease the effectiveness of the drug.
Cloxacillin should be taken at evenly spaced intervals throughout the day and night to
keep the level in your blood high enough to treat the infection.
Do not crush, chew, or open the capsules. Swallow them whole.
Shake the suspension well before measuring a dose. To ensure that you get a correct
dose, measure the liquid form of cloxacillin with a dose-measuring spoon or cup, not a
regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist
where you can get one.
Take all of the cloxacillin that has been prescribed for you even if you begin to feel
better. Your symptoms may start to improve before the infection is completely treated.
Store the capsules at room temperature and store the suspension in the refrigerator for
longer use. The suspension is good for 14 days if it is stored in the refrigerator. Throw
away any unused liquid after this amount of time.

CEFALEXIN
Pediatric Patients:

The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided
doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin
structure infections, the total daily dose may be divided and administered every 12
hours.
Cephalexin Suspension
Weight

125 mg/5 mL

10 kg (22 lb)

1/2 to 1 tsp q.i.d.

20 kg (44 lb)

1 to 2 tsp q.i.d.

40 kg (88 lb)

2 to 4 tsp q.i.d.

Weight

250 mg/5 mL

10 kg (22 lb)

1/4 to 1/2 tsp q.i.d.

20 kg (44 lb)

1/2 to 1 tsp q.i.d.

40 kg (88 lb)

1 to 2 tsp q.i.d.

or
Weight

125 mg/5 mL

10 kg (22 lb)

1 to 2 tsp b.i.d.

20 kg (44 lb)

2 to 4 tsp b.i.d.

40 kg (88 lb)

4 to 8 tsp b.i.d.

Weight

250 mg/5 mL

10 kg (22 lb)

1/2 to 1 tsp b.i.d.

20 kg (44 lb)

1 to 2 tsp b.i.d.

40 kg (88 lb)

2 to 4 tsp b.i.d.

In severe infections, the dosage may be doubled.

In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100
mg/kg/day in 4 divided doses is required.

In the treatment of -hemolytic streptococcal infections, a therapeutic dosage of

Cephalexin for Oral Suspension should be administered for at least 10 days.

Indications and Usage for Cephalexin Suspension

Cephalexin for Oral Suspension, USP is indicated for the treatment of the following
infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus
pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of
streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin for
Oral Suspension, USP is generally effective in the eradication of streptococci from the
nasopharynx; however, substantial data establishing the efficacy of cephalexin in the
subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae,
Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis
Skin and skin structure infections caused by Staphylococcus
aureus and/orStreptococcus pyogenes
Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis
Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli,
Proteus mirabilis, and Klebsiella pneumoniae
Note - Culture and susceptibility tests should be initiated prior to and during therapy.
Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
Cephalexin for Oral Suspension, USP and other antibacterial drugs, Cephalexin for Oral
Suspension, USP should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by susceptible bacteria. When culture and
susceptibility information are available, they should be considered in selecting or
modifying antibacterial therapy. In the absence of such data, local epidemiology and
susceptibility patterns may contribute to the empiric selection of therapy.

Amoxicillin drops are used for:

Treating infections caused by certain bacteria. It is also used with other medicines to
treat Helicobacter pylori infection and ulcers of the small intestines.
Amoxicillin drops are a penicillin antibiotic. It works by killing sensitive bacteria.

Do NOT use amoxicillin drops if:

you are allergic to any ingredient in amoxicillin drops or another penicillin

antibiotic (eg, ampicillin)

you have infectious mononucleosis (mono)

you are taking a tetracycline antibiotic (eg, doxycycline)

How to use amoxicillin drops:

Use amoxicillin drops as directed by your doctor. Check the label on the medicine for
exact dosing instructions.

Take amoxicillin drops by mouth with or without food. If stomach upset occurs,
take with food to reduce stomach irritation.
Shake well before each use.

Use a dropper marked for medicine dosing. Ask your pharmacist for help if you
are unsure of how to measure your dose.

Amoxicillin drops may be mixed with formula, milk, fruit juice, water, ginger ale, or
other cold drinks. If you mix amoxicillin drops, take it at once after mixing. Be sure
that the entire dose is swallowed.

To clear up your infection completely, take amoxicillin drops for the full course of
treatment. Keep taking it even if you feel better in a few days.

If you miss a dose of amoxicillin drops, take it as soon as possible. If it is almost

time for your next dose, skip the missed dose and go back to your regular dosing
schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use amoxicillin
drops.

Important safety information:

Amoxicillin drops may cause dizziness. This effect may be worse if you take it
with alcohol or certain medicines. Use amoxicillin drops with caution. Do not drive or
perform other possibly unsafe tasks until you know how you react to it.

Amoxicillin drops only works against bacteria; it does not treat viral infections (eg,
the common cold).

Be sure to use amoxicillin drops for the full course of treatment. If you do not, the
medicine may not clear up your infection completely. The bacteria could also become
less sensitive to this or other medicines. This could make the infection harder to treat
in the future.

Long-term or repeated use of amoxicillin drops may cause a second infection.

Tell your doctor if signs of a second infection occur. Your medicine may need to be
changed to treat this.

Mild diarrhea is common with antibiotic use. However, a more serious form of
diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you
use the antibiotic or within several months after you stop using it. Contact your doctor
right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not
treat diarrhea without first checking with your doctor.

Do not receive a live vaccine (eg, oral typhoid vaccine) while you are taking
amoxicillin drops. Talk with your doctor before you receive any vaccine.

Hormonal birth control (eg, birth control pills) may not work as well while you are
using amoxicillin drops. To prevent pregnancy, use an extra form of birth control (eg,
condoms).

Brown, yellow, or gray tooth discoloration has occurred rarely in some patients
taking amoxicillin drops. It occurred most often in children. The discoloration was
reduced or removed by brushing or dental cleaning in most cases. Contact your
doctor if you experience this effect.

Diabetes patients - Amoxicillin drops may cause the results of some tests for
urine glucose to be wrong. Ask your doctor before you change your diet or the dose
of your diabetes medicine.

Lab tests, including liver function, kidney function, and complete blood cell
counts, may be performed if you use amoxicillin drops for a long period of time.
These tests may be used to monitor your condition or check for side effects. Be sure
to keep all doctor and lab appointments.

Caution is advised when using amoxicillin drops in CHILDREN younger than 3

months old; they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your

doctor. You will need to discuss the benefits and risks of using amoxicillin drops while
you are pregnant. Amoxicillin drops are found in breast milk. If you are or will be
breast-feeding while you use amoxicillin drops, check with your doctor. Discuss any
possible risks to your baby.

Possible side effects of amoxicillin drops:

All medicines may cause side effects, but many people have no, or minor, side
effects.Check with your doctor if any of these most COMMON side effects persist or
become bothersome:
Diarrhea; nausea; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest;
swelling of the mouth, face, lips, or tongue); behavior changes; bloody stools; confusion;
dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin;
seizures; severe or persistent diarrhea; severe stomach pain or cramps; unusual

bruising or bleeding; unusual tiredness or weakness; vaginal discharge or irritation;

white patches in the mouth or on the tongue; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about
side effects, contact your health care provider. Call your doctor for medical advice about
side effects. To report side effects to the appropriate agency, please read the Guide to
Reporting Problems to FDA.

Therapeutic indications
Amoxicillin is a broad spectrum antibiotic indicated for the treatment of commonly- occurring bacterial
infections including:
Acute and chronic bronchitis
Pneumonia
Ear, nose and throat infections
Otitis media
Urinary tract infection
Gonorrhoea
Invasive salmonellosis,
Gynaecological infections
Peritonitis
Osteomyelitis
Meningitis
Endocarditis
Typhoid fever
Prophylaxis of endocarditis in patients at risk from such procedures as dental extractions.
In some of these infections initiation of treatment or indeed the whole course of treatment may need to be
by the parenteral route.
In children with urinary tract infection, the need for further clinical investigation should be considered.

ORESOL
What is ORS?
When should
ORS be used?
Where can ORS
be obtained?
How is the ORS
drink prepared?

ORS (oral rehydration salts) is a special combination of dry salts that is mixed with safe
water. It can help replace the fluids lost due to diarrhoea.
When a child has three or more loose stools in a day, begin to give ORS. In addition, for
1014 days, give children over 6 months of age 20 milligrams of zinc per day (tablet or
syrup); give children under 6 months of age 10 milligrams per day (tablet or syrup).
In most countries, ORS packets are available from health centres, pharmacies, markets
and shops.
1.

Put the contents of the ORS packet in a clean container. Check the packet for
directions and add the correct amount of clean water. Too little water could make
the diarrhoea worse.

2.

Add water only. Do not add ORS to milk, soup, fruit juice or soft drinks. Do not

add sugar.
3.

Stir well, and feed it to the child from a clean cup. Do not use a bottle.

Encourage the child to drink as much as possible.

How much ORS

drink to give?

A child under the age of 2 years needs at least 1/4 to 1/2 of a large (250-millilitre) cup
of the ORS drink after each watery stool.

A child aged 2 years or older needs at least 1/2 to 1 whole large (250-millilitre) cup of
the ORS drink after each watery stool.

Give the child a drink made with 6 level teaspoons of sugar and 1/2 level teaspoon of
salt dissolved in 1 litre of clean water.

What if ORS is
not available?

Be very careful to mix the correct amounts. Too much sugar can make the diarrhoea
worse. Too much salt can be extremely harmful to the child.

Making the mixture a little too diluted (with more than 1 litre of clean water) is not
harmful.

Oral Rehydration Solutions

To prevent too much liquid being lost from the child's body, an effective oral rehydration solution can be
made using ingredients found in almost every household. One of these drinks should be given to the child
every time a watery stool is passed.
Ideally these drinks (preferably those that have been boiled) should contain:

starches and/or sugars as a source of glucose and energy,

some sodium and

preferably some potassium.

The following traditional remedies make highly effective oral rehydration solutions and are suitable drinks to
prevent a child from losing too much liquid during diarrhoea:

Breastmilk

Gruels (diluted mixtures of cooked cereals and water)

Carrot Soup

Rice water - Congee

A very suitable and effective simple solution for rehydrating a child can also be made by using salt and
sugar, if these ingredients are available.
If possible, add 1/2 cup orange juice or some mashed banana to improve the taste and provide
some potassium.
Molasses and other forms of raw sugar can be used instead of white sugar, and these contain more
potassium than white sugar.
If none of these drinks is available, other alternatives are:

Fresh fruit juice

Weak tea

Green coconut water

If nothing else is available, give

water from the cleanest possible source

(if possible brought to the boil and then cooled).

The "Simple Solution" - Home made Oral Rehydration Salts (ORS) Recipe
Preparing 1 (one) Litre solution using Salt, Sugar and Water at Home Mix an oral rehydration
solution using the following recipe.Ingredients:

Six (6) level teaspoons of Sugar

Half (1/2) level teaspoon of Salt

One Litre of clean drinking or boiled water and then cooled - 5 cupfuls (each cup about
200 ml.)

Preparation Method:

Stir the mixture till the salt and sugar dissolve.

Effective homemade remedy for watery diarrhea

An efficient and effective homemade remedy to be used when watery diarrhea strikes and is a good
substitute for oral rehydration salts:
Ingredients:

1/2 to 1 cup precooked baby rice cereal or 1 tablespoons of granulated sugar

2 cups of water

1/2 tsp. salt

Instructions:

Mix well the rice cereal (or sugar), water, and salt together until the mixture thickens but is not too thick
to drink. Give the mixture often by spoon and offer the child as much as he or she will accept (every
minute if the child will take it). Continue giving the mixture with the goal of replacing the fluid lost: one
cup lost, give a cup. Even if the child is vomiting, the mixture can be offered in small amounts (2-1 tsp.)
every few minutes or so.

Banana or other non-sweetened mashed fruit can help provide potassium.

Continue feeding children when they are sick and to continue breastfeeding if the child is being
breastfed.

Questions on Solutions made at Home

Q. How do I measure the Salt and Sugar? Different countries and different communities use various
methods for measuring the salt and sugar.

Finger pinch and hand measuring, and the use of local teaspoons can be taught successfully.

A plastic measuring spoon is available from Teaching Aids at Low Cost (TALC) with proportions to
make up 200 ml of sugar/salt solution.

Whatever method is used, people need to be carefully instructed in how to mix and use the solutions. Do
not use too much salt. If the solution has too much salt the child may refuse to drink it. Also, too much
salt can, in extreme cases, cause convulsions. Too little salt does no harm but is less effective in
preventing dehydration. A rough guide to the amount of salt is that the solution should taste no saltier
than tears.
Q. How much solution do I feed? Feed after every loose motion. Adults and large children should drink
at least 3 quarts or liters of ORS a day until they are well. Each Feeding:

For a child under the age of two

Between a quarter and a half of a large cup

For older children

Between a half and a whole large cup

For Severe Dehydration: Drink sips of the ORS (or give the ORS solution to the conscious dehydrated
person) every 5 minutes until urination becomes normal. (It's normal to urinate four or five times a day.)
Q. How do I feed the solution?

Give it slowly, preferably with a teaspoon.

If the child vomits it, give it again.

The drink should be given from a cup (feeding bottles are difficult to clean properly). Remember to feed
sips of the liquid slowly.
Q. What if the child vomits? If the child vomits, wait for ten minutes and then begin again. Continue to
try to feed the drink to the child slowly, small sips at a time. The body will retain some of the fluids and
salts needed even though there is vomiting.
Q. For how long do I feed the liquids? Extra liquids should be given until the diarrhoea has stopped.
This will usually take between three and five days.
Q. How do I store the ORS solution? Store the liquid in a cool place. Chilling the ORS may help. If the
child still needs ORS after 24 hours, make a fresh solution.

10 Things you should know about Rehydrating a child.

1.

Wash your hands with soap and water before preparing solution.

2.

Prepare a solution, in a clean pot, by mixing - Six (6) level teaspoons of sugar and Half (1/2)
level teaspoon of Salt
or
- 1 packet of Oral Rehydration Salts (ORS) 20.5 grams
mix with
- One litre of clean drinking or boiled water (after cooled) Stir the mixture till all the contents
dissolve.

3.

Wash your hands and the baby's hands with soap and water before feeding solution.

4.

Give the sick child as much of the solution as it needs, in small amounts frequently.

5.

Give child alternately other fluids - such as breast milk and juices.

6.

Continue to give solids if child is four months or older.

7.

If the child still needs ORS after 24 hours, make a fresh solution.

8.

ORS does not stop diarrhoea. It prevents the body from drying up. The diarrhoea will stop by
itself.

9.

If child vomits, wait ten minutes and give it ORS again. Usually vomiting will stop.

10. If diarrhoea increases and /or vomiting persists, take child over to a health clinic.

Footnote: People often refer to home-prepared oral rehydration solutions as "home-brew." This should
be discouraged because the word brew implies:

either fermenting which in fact is an obstacle to some home-prepared solutions especially those
made with rice-powder

or it implies boiling (as in tea) which, especially with sugar and salt or using packets of ORS,
should not be done because it decomposes the sugar, or caramelises.

Cotrimoxazole
Franais

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// Health A-Z / Drugs and Medication

Your child needs to take the medicine called cotrimoxazole (say: coe-try-MOX-a-zole). This information
sheet explains what cotrimoxazole does, how to give it, and what side effects or problems your child
may have when he or she takes this medicine.

What is cotrimoxazole?
Cotrimoxazole is a medicine called an antibiotic. Antibiotics are used to treat or prevent certain types
of infections caused by bacteria.
Cotrimoxazole is made up of 2 medicines, sulfamethoxazole and trimethoprim.
You may hear cotrimoxazole called by its brand names, Septra, Bactrim, Apo-Sulfatrim, or NovoTrimel. Cotrimoxazole comes in tablet and liquid form.

Before giving cotrimoxazole to your child

Tell the doctor if your child has:

an allergy to sulfonamides or sulfa drugs

an allergy to trimethoprim
Talk with the doctor or pharmacist if your child has any of the following conditions.
Precautions may need to be taken with this medicine if your child has:

anemia or other blood problems

glucose-6-phosphate dehydrogenase (G6PD) deficiency
kidney disease
liver disease
porphyria

How should you give your child cotrimoxazole?

Follow these instructions when giving your child cotrimoxazole:

Give your child cotrimoxazole for as long as the doctor or pharmacist tells you, even if your
child seems better. Talk to your childs doctor before you stop giving cotrimoxazole for any reason.
Give your child cotrimoxazole at the same times of the day, exactly as your childs doctor or
pharmacist tells you. Pick a time that is easy for you so that you do not miss doses.
Give your child cotrimoxazole with a full glass of water or other liquid. Get your child to drink
plenty of fluids such as water, juice, or milk while he or she is taking cotrimoxazole.
Your child may take cotrimoxazole with or without food. It may be given with food or milk if it
upsets your childs stomach.
If your child is taking liquid cotrimoxazole, shake the bottle well. Use the special spoon or
syringe that the pharmacist gave you to measure and give the dose.

What should you do if your child misses a dose of cotrimoxazole?

Give the missed dose as soon as you remember.

If it is almost time for the next dose, skip the missed dose. Give the next dose at the regular
time.

Do not give your child two doses to make up for one missed dose.

How long does cotrimoxazole take to work?

Your child may begin to feel better a few days after starting cotrimoxazole.

What are the possible side effects of cotrimoxazole?

Your child may have some of these side effects while he or she takes cotrimoxazole. Check with your
childs doctor if your child continues to have any of these side effects and they do not go away or they
bother your child:

upset stomach
diarrhea (loose, watery stools)
vomiting (throwing up)
loss of appetite
headache
dizziness

Call your childs doctor during office hours if your child has any of these side effects:

increased sensitivity of skin to sun

a pain or burning feeling when your child urinates that is new or does not get better
Most of the following side effects are not common, but they may be a sign of a serious
problem. Call your childs doctor right away or take your child to the Emergency
Department if your child has any of these side effects:

severe skin rash (rash covering large part of body, with fever or blisters)
hives (raised, red itchy areas on the skin)
yellowing of the eyes or skin
unusual bruising or bleeding
swelling of the face, lips, tongue, throat
trouble breathing

What safety measures should you take when your child is using cotrimoxazole?
Before your child has any kind of operation, even on the teeth, or an emergency treatment, tell the
doctor or dentist that your child is taking cotrimoxazole.
Check with your childs doctor or pharmacist before giving your child any other medicines
(prescription, non-prescription, herbal, or natural products).
Cotrimoxazole may make your childs skin more likely to sunburn. To help prevent sunburn:

Avoid direct sunlight for long periods of time.

When outside, cover your child with clothing and a hat.
Apply a sunscreen with an SPF of 15 or higher.
Avoid sunlamps and tanning beds.

What other important information should you know about cotrimoxazole?

Keep a list of all medications your child is on and show the list to the doctor or pharmacist.
Do not share your childs medicine with others and do not give anyone elses medicine to your child.
Make sure you always have enough cotrimoxazole to last through weekends, holidays, and vacations.
Call your pharmacy at least 2 days before your child runs out of medicine to order refills.
Keep cotrimoxazole tablets and liquid at room temperature in a cool, dry place away from sunlight. Do
not store it in the bathroom or kitchen.
Do not keep any medicines that are out of date. Check with your pharmacist about the best way to
throw away outdated or leftover medicines.
Keep cotrimoxazole out of your childs sight and reach and locked up in a safe place. If your child
takes too much cotrimoxazole, call the Ontario Poison Centre at one of these numbers. These calls are
free.

Therapeutic indications
Salbutamol is indicated in adults, adolescents and children aged 2 to 12 years.
Salbutamol is a selective 2-agonist broncodilator which provides short acting bronchodilation in
reversible airways obstruction. Salbutamol Salbutamol is used to rapidly treat asthma, bronchospasm and
reversible airways obstruction by widening the airways of the lungs. Salbutamol Salbutamol Syrup
2mg/5ml is suitable for children and adults who are unable to use an inhaler device.
4.2 Posology and method of administration
For oral administration. Shake the bottle before use. An oral syringe may be used to measure doses less
than 5ml.
The usual adult dose is (4mg) two 5 ml spoonfuls (10ml), 3 or 4 times per day which may be increased to
a maximum of (8mg) four 5 ml spoonfuls (20ml), 3 or 4 times per day. The minimum starting dose is
(2mg) one 5 ml spoonful (5ml), 3 or 4 times per day.
In elderly patients and patients who are unusually sensitive to this class of medicine treatment may be
initiated with (2mg) one 5 ml spoonful (5ml), 3 or 4 times per day.
Paediatric population
2- 6 years: the minimum starting dose is 1mg as 2.5 ml of syrup three times daily. This may be increased
to 2mg as 5 ml of syrup three or four times daily.
6 12 years: the minimum starting dose is 2 mg as 5 ml of syrup three times daily. This may be increased
to four times daily.
Over 12 years: the minimum starting dose is 2mg three times daily given as 5 ml syrup. This may be
increased to 4 mg as 10 ml syrup three or four times daily.
4.3 Contraindications
Although intravenous salbutamol and occasionally salbutamol syrup are used in the management of
uncomplicated premature labour, salbutamol presentations should not be used for threatened abortion
during the first or second trimester of pregnancy.
Should not be used in patients hypersensitive to any of the product ingredients.
4.4 Special warnings and precautions for use
Patients should be warned that if either the usual relief is diminished or the usual duration of action is
reduced, they should not increase the dose or its frequency of administration, but should seek medical
advice.
Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac
output. Caution should be used in patients suffering from angina, severe tachycardia or thyrotoxicosis.
Caution should be exercised in its use with anaesthetic agents such as chloroform, cyclopropane,
halothane and other halogenated agents.
Salbutamol should not cause difficulty in micturition (urination) because unlike sympathomimetic drugs
such as ephedrine, it does not stimulate -adrenoceptors. However, there have been reports of difficulty
in micturition in patients with prostatic enlargement.
Salbutamol should only be used during pregnancy if considered essential by the physician.
Use with caution in diabetic patients as this product may cause an increase in blood sugar levels. The
development of ketoacidosis has been reported as diabetic patients may be unable to compensate for the
increase in blood glucose. This effect can be exaggerated by concurrent administration of corticosteroids.

Salbutamol does not contain sugars.

This product should not be diluted.
In patients with severe or unstable asthma, bronchodilators should not be the only or main treatment.
With severe asthma regular medical assessment is necessary, including lung-function testing as patients
are at risk of severe attacks or possibly death. For the treatment of such patients, physicians should
consider using the max recommended dose of inhaled corticosteroids and/or oral corticosteroids.
2-agonist therapy (from parenteral and nebulised administration) may result in potentially serious
hypokalaemia. Special caution is required in acute severe asthma as this effect may be potentiated by
hypoxia and by concomitant treatment with xanthine derivatives, diuretics and steroids. It is important to
monitor serum potassium levels in such situations.
Patients taking Salbutamol may also be using short-acting inhaled bronchodilators to alleviate symptoms.
A decrease in asthma control is indicated by an increase in the use of bronchodilators in particular short
acting inhaled -agonists. In such cases medical advice should be sought. Higher doses of inhaled
corticosteroids or a course of oral corticosteroids may be considered.
Severe exacerbations of asthma must be treated in the usual manner.
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.
4.5 Interaction with other medicinal products and other forms of interaction
Caution should be exercised during use with anaesthetic agents such as chloroform, cyclopropane,
halothane and other halogenated agents.
The effects of this product may be altered by guanethidine, reserpine, methyldopa, tricyclic
antidepressants.
Salbutamol oral preparations and beta-blocking drugs, such as propranolol should not usually be
prescribed together.
Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOI's)
4.6 Pregnancy and lactation
Salbutamol should only be used in pregnancy and lactation if considered essential by the physician.
Salbutamol should only be used during pregnancy/lactation if the expected benefits to the mother are
greater than any potential risks to the foetus/neonate.
As salbutamol is probably secreted in breast milk its use in nursing mothers requires careful
consideration. It is not known whether salbutamol has a harmful effect on the neonate, and so its use
should be restricted to situations where it is felt that the expected benefit to the mother is likely to
outweigh any potential risk to the neonate.
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Undesirable effects
The most common side effect of Salbutamol is fine tremor of the hands, which may interfere with precise
manual work. Tension, restlessness and a rapid heart beat may also occur. There have been very rare
reports of muscle cramps. Hypersensitivity reactions such as angiodema, urticaria, bronchospasm,
hypotension and collapse have rarely been reported. Potentially serious hypokalaemia may result from
2-agonist therapy. Occasional headaches have also been reported. As with other drugs in this class rare
reports of hyperactivity in children have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are
asked to report any suspected adverse reactions via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
4.9 Overdose
The preferred antidote for overdose with salbutamol sulphate is a cardioselective beta-blocking agent,
which should be used with caution in patients with a history of bronchospasm. Salbutamol overdose may
lead to Hypokalaemia (abnormally low potassium concentration in the blood). Serum potassium levels
should therefore be monitored.
5. Pharmacological properties
5.1 Pharmacodynamic properties
As a beta-adrenergic stimulant for relief of bronchospasm such as occurs with asthma, bronchitis,
emphysema. It has a highly selective action on the receptors in bronchial muscle and in therapeutic
dosage, little or no action on the cardiac receptors.

5.2 Pharmacokinetic properties

Salbutamol is readily absorbed from the gastro-intestinal tract and is subject to first pass metabolism in the liver.
Peak plasma concentrations occur within one to four hours after oral administration. After multiple oral doses of
salbutamol 4mg four times a day, steady-state plasma concentrations are obtained after 3 days. About half is
excreted in the urine as an inactive sulphate conjugate following oral administration. The bioavailability of orally
administered salbutamol is about 50%.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that in other sections of
the SmPC.
As with the majority of drugs, there is little published evidence of its safety in the elderly stages of human
pregnancy, but in animal studies there was evidence of some harmful effects on the foetus at very high
dose levels.
6. Pharmaceutical particulars
6.1 List of excipients
Xanthan Gum (E415)
Glycerol (E422)
Sodium Citrate (E331)
Saccharin Sodium (E954)
Sodium Benzoate (E211)
Citric Acid Monohydrate
Raspberry Cola Flavour HSE (containing Ethanol, Propylene Glycol, Polysorbate (E432), Nutmeg Oil,
Safrole and Cinnamic aldehyde)
Purified Water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months - amber glass bottle and HDPE bottle
6.4 Special precautions for storage
Do not store above 25C. Store in the original container.
6.5 Nature and contents of container
100 ml, 150 ml and 200 ml type III amber glass bottle with Pilfer-Proof cap, screw cap or child resistant
closure.
100 ml and 150 ml HDPE bottle with screw cap, tamper evident cap or child resistant closure.
6.6 Special precautions for disposal and other handling
No special instructions.