Each 5ml contains - Chlorpheniramine Maleate 2mg
Preservatives - Methyl Hydroxybenzoate 0.12 % w/v, Propyl Hydroxybenzoate
0.012 % w/v
Bottle of 60ml.
Clear, greenish yellow coloured syrupy liquid with fruity flavour. Alcohol
Chlorpheniramine Maleate is a member of the alkylamine group of
antihistamine (H, receptor antagonist). It does not block the release of
histamine but acts by competitively antagonizing the effects of histamine at
H, receptor site. If the histamine concentration at the receptor site
exceeds the drug concentration, histamine effects predominate. Histamine
release causes allergic reactions; therefore Chlofpheniramine Maleate is
used therapeutically for palliative treatment in allergic reactions.
Although antihistamine action is the dominant effects, it is structurally
similar to other pharmacological classes of drugs (anticholinergic, local
anaesthetic, ganglion-blocking and adrenergic-blocking drugs) and can exert
combinations and degrees of side effects. In some cases the side effects
have been used to achieve a therapeutic goal (e.g. CNS depression for
insomnia, local anaesthetic effect for pruritus), but others (e.g.
drowsiness) may be bothersome and potentially dangerous.
After oral administration, Chlorpheniramine Maleate is readily and almost
completely absorbed and its effects are apparent within 15 to 30 minutes,
are maximal within 1 hour and persist for 4 to 6 hours. Metabolised in the
liver to polar and non-polar metabolites; bioavailability about 35%. The
major metabolites are monodesmethyl- and didesmethylchlorpheniramine. About
35% of a single dose is excreted in the urine in 48 hours, the 24 hours
excretion of unchanged drug accounts for about 3 to 10% of the dose but this
is increased by acidification of the urine and increased urinary flow and
decreased when the urine is alkaline. More non-polar metabolites appear to
be excreted after IV then after oral administration. After daily oral
administration, about 20% of a dose is excreted in the urine as unchanged
drug within 24 hours; 20% as monodesmethylchlorpheniramine and 5% as
didesmethylchorpheniramine. Less than 1% of a dose is eliminated in the
faeces. Plasma half-life: 18 to 40 hours; decreased in children. Volume of
distribution: About 3L/kg. Clearance: Plasma clearance about 1.5ml/min/kg.
Protein binding: In plasma about 70%.
To be used therapeutically for palliative treatment in allergic reactions
including hay fever, vasomotor rhinitis, urticaria, itching skin conditions
including pruritus of drug rashes, contact dermatitis and insect bites.
Dosage and Administration
Adults and Children above 12 years
Give 10ml (4mg) 3 to 4 times a day. Do not exceed 60ml or 24mg in a day.
Children 6 to 12 years
Give 5ml (2mg) 3 to 4 times a day. Do not exceed 30ml or 12mg in a day.
Children 1 to 5 years
Give 2.5ml (1 mg) to 5ml (2mg) 3 times a day. Do not exceed 15ml or 6mg in a
Children up to 1 year
Give 2.5ml (1 mg) 2 times a day. Do not exceed 5ml or 2mg in a day.
Symptoms and Treatments of Overdose
Symptoms and signs include sedation, paradoxical stimulation of CNS,
toxic-psychosis, seizures, apnoea, convulsions, anticholinergic effects,
dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment includes gastric lavage
or emesis using syrup of lpecacuanha. Following these measures activated
charcoal and cathartics may be administered to minimize absorption.
If overdosage is by oral route, other symptomatic and supportive measures
should be provided with special attention to cardiac, respiratory, renal and
hepatic functions and fluid and electrolyte balance. Treat hypotention and
arrhythmias vigorously. CNS convulsion may be treated with IV diazepam or
phenytoin. Haemoperfusion may be used in severe cases.
Contraindicated in patients who are hypersensitive to antihistamines and
those that have had Monoamine Oxidase Inhibitor therapy within the previous
Caution should be taken when given to patients with epilepsy, severe
cardiovascular disorders, liver disorders, glaucoma, urinary retention,
prostatic enlargement, pyloroduodenal obstruction, asthma, bronchitis,
bronchiectasis, thyrotoxicosis and severe hypertension.
Special care should be taken when using Chlorpheniramine Maleate in children
and the elderly as they are more prone to developing CNS effects.
If symptoms persist for more than 5 days, please consult a doctor.
This medicine may cause drowsiness. If affected, do not drive or
operate machinery. Avoid alcoholic drinks.
Use in Pregnancy and Lactation
Safety for the use of Chlorpheniramine during pregnancy has not been
established. It should only be used during pregnancy when clearly needed and
when potential benefit outweighs the potential unknown risks to the fetus.
Use during the third trimester may result in reactions in the newborn or
Small amounts of antihistamines are excreted in breast milk. Use by nursing
mothers is not recommended because the risk of adverse effects in the
infant. Antihistamines may inhibit lactation.
Interactions with Other Medicaments
May enhance the sedative effect of central nervous system depression,
including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives
and tranquilisers. Chlorpheniramine inhibits phenytoin metabolism and can
lead to phenytoin toxicity.
More common side effects are drowsiness, diminished alertness and
ability to concentrate. Other common side effects include gastrointestinal
upset such as nausea, vomiting, diarrhoea or constipation, and epigastric
pain, lassitude, urinary retention, dizziness, palpitation, tachycarda,
arrhythmias, hypotension, anorexia, hepatitis including jaundice, hemolytic
anaemia and blood dyscrasias, depression, allergic reactions including
exfoliative dermatitis, photosensitivity and skin reactions.
Store below 30 C. Protect from light. Keep cap tightly closed.
Keep out of reach of children.
3 years from the date of manufacture.