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Antismine Syrup

 

Active Ingredient:
Each 5ml contains - Chlorpheniramine Maleate 2mg
Preservatives - Methyl Hydroxybenzoate 0.12 % w/v, Propyl Hydroxybenzoate 0.012 % w/v


Presentation:
Bottle of 60ml.


Product Descriptions:
Clear, greenish yellow coloured syrupy liquid with fruity flavour. Alcohol free.


Pharmacology:
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%.


Indications
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 day.


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.


Contraindications
Contraindicated in patients who are hypersensitive to antihistamines and those that have had Monoamine Oxidase Inhibitor therapy within the previous fourteen days.


Precautions
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 premature neonates.


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.


Undesirable Effects
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.


Storage:
Store below 30 C. Protect from light. Keep cap tightly closed.
Keep out of reach of children.


Shelf Life:
3 years from the date of manufacture.

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