Chlorpheniramine maleate ............... 4 mg
Excipients q.s ……………………….. 1 tablet
Tablet.
Product description: A lemon-yellow, capsule-shaped tablet, engraved with a sign on one side, plain on the other side, undamaged edges.
Box of 10 blisters x 10 tablets. Box of 1 bottle x 200 tablets.
Pharmacotherapeutic group: 1st generation antihistamine. ATC Code: N02B E51.
Chlorpheniramine is a potent antihistamine (H1-antagonist).
Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine H1-receptor sites on tissues. Chlorpheniramine also has anticholinergic activity.
Antihistamines act to prevent the release of histamine, prostaglandins and leukotrienes and have been shown to prevent the migration of inflammatory mediators. The actions of chlorpheniramine include inhibition of histamine on smooth muscle, capillary permeability and hence reduction of oedema and wheal in hypersensitivity reactions such as allergy and anaphylaxis.
Chlorpheniramine is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours.
Chlorpheniramine is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine.
The anticholinergic properties of chlorpheniramine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients' ability to drive and use machinery.
Pregnancy
There are no adequate data from the use of chlorpheniramine maleate in pregnant women. The potential risk for humans is unknown. Use during the third trimester may result in reactions in the newborn or premature neonates. Not to be used during pregnancy unless considered essentially by a physician.
Lactation
Chlorpheniramine maleate and other antihistamine may inhibit lactation and may be secreted in breast milk. Not to be used during lactation unless considered essential by a physician
Concurrent use of chlorpheniramine and hypnotics or anxiolytics may cause an increase in sedative effects, concurrent use of alcohol may have a similar effect therefore medical advice should be sought before taking chlorpheniramine concurrently with these medicines.
Chlorpheniramine inhibits phenytoin metabolism and can lead to phenytoin toxicity.
The anticholinergic effects of chlorpheniramine are intensified by MAOIs.
The following convention has been utilised for the classification of the frequency of adverse reactions: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).
Adverse reactions identified during post-marketing use with chlorpheniramine are listed below. As these reactions are reported voluntarily from a population of uncertain size, the frequency of some reactions is unknown but likely to be rare or very rare:
Nervous system disorders*
Very common: Sedation, somnolence. Common: Disturbance in attention, abnormal coordination, dizziness headache.
Eye disorders
Common: Blurred vision.
Gastrointestinal disorders
Common: Nausea, dry mouth. Unknown: Vomiting, abdominal pain, diarrhoea, dyspepsia.
Immune system disorders:
Unknown: Allergic reaction, angioedema, anaphylactic reactions.
Metabolism and nutritional disorders
Unknown: Anorexia.
Blood and lymphatic system disorders
Unknown: Haemolytic anaemia, blood dyscrasias.
Musculoskeletal and connective tissue disorders
Unknown: Muscle twitching, muscle weakness.
Psychiatric disorders
Unknown: Confusion*, excitation*, irritability*, nightmares*, depression.
Renal and urinary disorders
Unknown: Urinary retention.
Skin and subcutaneous disorders
Unknown: Exfoliative dermatitis, rash, urticaria, photosensitivity.
Respiratory, thoracic and mediastinal disorders
Unknown: Thickening of bronchial secretions.
Vascular disorders
Unknown: Hypotension.
Hepatobiliary disorders
Unknown: Hepatitis, including jaundice.
Ear and labyrinth disorders
Unknown: Tinnitus.
Cardiac disorders
Unknown: Palpitations, tachycardia, arrhythmias.
General disorders and administration site conditions
Common: Fatigue.
Unknown: Chest tightness.
* Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).
Please inform your doctor of all undesirable effects upon drug administration.
Symptoms and signs
The estimated lethal dose of chlorpheniramine is 25 to 50 mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxic psychosis, convulsions, apnoea, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment
Management should be as clinically indicated or as recommended by the national poison centres where available.
Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently (treatment is most effective if given within an hour of ingestion). Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with i.v. diazepam. Haemoperfusion may be used in severe cases.
Store in dry places, not exceeding 30oC, protect from light.
Chlorpheniramine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis and asthma; hepatic impairment; renal impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness). Avoid use in elderly patients with confusion.
The anticholinergic properties of chlorpheniramine may cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients which may seriously affect ability to drive and use machinery.
Concurrent use with drugs which cause sedation such as anxiolytics and hypnotics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorpheniramine concurrently with these medicines.
The effects of alcohol may be increased and therefore concurrent use should be avoided.
Should not be used with other antihistamine-containing products, including antihistamine-containing cough and cold medicines.
Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine,
Keep out of sight and reach of children.
Excipients
Lactose monohydrate: Patients with problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Chlorpheniramine tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy, drug and serum reactions, insect bites.
Also indicated for the symptomatic relief of itch associated with chickenpox.
Chlorpheniramine tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients.
The anticholinergic properties of chlorpheniramine are intensified by monoamine oxidase inhibitors (MAOIs). Chlorpheniramine is therefore contra-indicated in patients who have been treated with MAOIs within the last fourteen days.
Oral administration only.
Do not exceed the stated dose or frequency of dosing.
Minimum dosing interval: 4 hours.
Do not use continuously for more than two weeks without consulting a doctor.
Adults and children 12 years and over: 1 tablet 4 to 6 hourly. Maximum daily dose: 6 tablets (24 mg) in any 24 hours
Elderly: The elderly are more likely to experience neurological anticholinergic effects. Consideration should be given to using a lower daily dose (e.g. a maximum of 12 mg in any 24 hours).
Children aged 6 - 12 years: ½ tablet 4 to 6 hourly. Maximum daily dose: 3 tablets (12mg) in any 24 hours
Not recommended for children under 6 years
Special populations
Patients with renal or hepatic impairment should seek doctor's advice prior to taking this medicine.
Or as directed by the physician.
Register an account - receive thousands of information
You will be one of the first to receive information, news, recruitment news... from Hau Giang Pharmaceutical as soon as possible. Register today to enjoy thousands of incentives from Hau Giang Pharmaceutical.
