Chlorpheniramine maleate ……..4 mg
Excipients q.s……………………1 tablet
(Quinoline color, lactose, tapioca starch, aerosil, magnesium stearate, talc, gelatin)
DOSAGE FORM: Tablets.
PRESENTATION: Box of 10 blisters x 20 tablets. Box of 1 bottle x 200 tablets.
Chlorpheniramine is an anti-histamine with competitive reversible blockade of histamine H1-receptor site.
Chlorpheniramine maleate is readily absorbed following oral administration and appears in the plasma within 30 – 60 minutes. Peak plasma concentrations achieve in approximately 2.5 – 6 hours. About 70% of the drug in circulation is bound to plasma proteins. Chlorpheniramine is mainly excreted in the urine as unchanged or metabolites. Its secretion depends on pH and urine flow. The plasma half-life is estimated to be 12 – 15 hours.
Allergic rhinitis, runny nose, nasal stuffiness, coryza.
Other symptoms, including urticaria, contact dermatitis, pruritus, food allergies, insect bites, allergic conjunctivitis, Quincke’s edema, etc.
Hypersensitivity to the active substance, to any of the excipients. Closed angle glaucoma. Prostatic hypertrophy. Bladder neck stenosis, stenosing peptic ulcer, pyloroduodental obstruction. Acute asthmatic attacks. Breast-feeding mothers, newborn babies and premature babies. The tablets are contra-indicated in patients who have been treated with MAOIs within the last fourteen days.
Chlorpheniramine can increase the risk of urine retention, particularly in patients with prostatic hypertrophy, urinary obstruction, pyloro-duodenal obstruction and causes exacerbation in myasthenia gravis patients. Sedative effect of chlorpheniramine has been increased by alcohol intake and co-administration with other tranquillisers. Chlorpheniramine should be used with caution in patients with chronic lung disease, apnee or breathing troubles because of risk of respiratory tract complications, respiratory failure, and apnea. A risk of tooth decay occurs in patients getting long-term treatment. Patients with glaucoma should not be recommended. Caution should be exercised in the elderly.
PREGNANCY AND LACTATION:
The drug should be administered to pregnant women if really necessary. The use of chlorpheniramine is contraindicated during the 3rd trimester of pregnancy.
A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
No recommendation to vehicle operators and drivers.
INTERACTIONS: Metabolism of phenytoin may be inhibited by chlorphenamine with the possible development of phenytoin toxicity. Alcoholic drinks and certain other central nervous system depressants such as hypnotics can potentiate the sedative effects of of chlorpheniramine. The anti-acetylcholine effects of antihistamines are enhanced by MAO inhibitors.
ADVERSE EFFECTS: Uncommon: drowsiness, sedation, dryn mouth
Rare: dizziness, nausea
Inform your physician about any adverse effects occur during the treatment.
The estimated lethal dose of chlorpheniramine is 25 – 50 mg/kg body weight
Symptoms and signs include sedation, psychosis, seizures, convulsions, apnoea, anti-acetylcholine effects, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment: Gastric lavage or induced emesis with ipecacuanha syrup is given; then, activated charcoal and cathartic should be applied to reduce absorption. Treat hypotension and arrhythmias vigorously. Convulsions may be treated with i.v diazepam or phenytoin. Haemoperfusion may be used in severe cases.
DOSAGE & ADMINISTRATION: Adults and children aged > 12 years: oral dose of 1 tablet at bedtime. Do not exceed 6 tablets in a day.
Elderly: oral dose of 4 mg in 2 divided doses daily.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.