Chlorphenamine Maleate 2mg/5ml - Oral Solution - 150ml
1. NAME OF THE MEDICINAL PRODUCT
Chlorphenamine Elixir BP
Pollenase Allergy Syrup
Each 5ml contains Chlorphenamine Maleate BP 2.0mg
3. PHARMACEUTICAL FORM
Sugar free syrup in bottles of 150ml
For the relief of symptoms caused by allergic conditions such as hayfever, allergic rhinitis, perennial rhinitis, vasomotor rhinitis, urticaria and skin rashes, angioneurotic oedema, drug and serum reactions, food allergy, insect bites etc, which are responsive to antihistamines.
Adults and children over 12 years:
2 spoonfuls (10ml) every 4-6 hours. Daily maximum should be 24mg i.e. 60ml.
As for adults. Elderly patients are more likely to experience confusional psychosis and other neurological anticholinergic side effects.
Up to1 year
½ spoonful (2.5ml) twice a day
½ spoonful (2.5ml) every 4 – 6 hours. Daily maximum should be 6mg i.e.15ml.
1 spoonful (5ml) every 4 –6 hours. Daily maximum should be 12mg i.e. 30ml.
Chlorphenamine is contraindicated in patients who are hypersensitive to antihistamines or any other ingredients in the syrup.
Chlorphenamine is contraindicated in patients who have had treatment with Monoamine Oxidase Inhibitors (MAOI's) within the last 14 days as the anticholinergic properties of chlorphenamine are intensified by MAOI's.
Chlorphenamine produces anticholinergic effects such as drowsiness, dizziness, blurred vision and psychomotor impairment. This may cause serious problems when the patient is driving or using machinery.
Due to the anticholinergic effect of the drug caution is advised in patients who have epilepsy, raised intra-ocular pressure including glaucoma, prostatic hypertrophy, severe hypertension or cardiovascular disease, bronchitis, bronchiectasis and asthma, hepatic disease and thyrotoxicosis. The neurological anticholinergic effects are more likely in the elderly and children.
The effects of alcohol are likely to be increased.
Alcoholic drinks and certain other central nervous system depressants such as anxiolytics or hypnotics can potentiate the sedative effects of chlorphenamine.
Phenytoin metabolism is inhibited by chlorphenamine and this can cause phenytoin toxicity.
The anticholinergic effects of chlorphenamine are intensified by the use of other anticholinergic drugs such as atropine, tricyclic antidepressants and MAOI's (see contraindications).
Safety in pregnancy has not been established. The use of chlorphenamine in pregnancy should be assessed and only used when the possible benefits outweigh the possible risks to the foetus. Effects on the neonate have been seen when chlorphenamine is used in the third trimester of pregnancy.
There may be some inhibition of lactation by chlorphenamine and some of the drug may be secreted into the breast milk. Therefore the risk to the mother and child should be assessed against the possible benefits of using chlorphenamine when breast feeding.
As with all antihistamines, dizziness and drowsiness may occur. Extreme caution should be advised when driving or operating machinery.
Undesirable effects include sedation, which varies from slight drowsiness to deep sleep.
There have been occasional reports of the following: lassitude, inability to concentrate, blurred vision, hepatitis including jaundice, urinary retention, headaches, dry mouth, dizziness, palpitations, tachycardia, arrhythmias, hypotension, chest tightness, thickening of the bronchial secretions, haemolytic anaemia and other blood dyscrasias, tinnitus, depression, irritability, nightmares, twitching, muscular weakness and incoordination.
Gastrointestinal disturbances have been reported occasionally including, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain and anorexia.
Allergic reactions have been observed and include exfoliative dermatitis, photosensitivity and urticaria.
Paradoxical excitation in children and confusional psychosis in the elderly can occur.
The estimated lethal dose of Chlorphenamine Maleate is 25-50mg per kg bodyweight. Symptoms of overdose include sedation, paradoxical stimulation of the CNS, toxic psychosis, seizures, apnoea, convulsions, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.
Treatment should include gastric lavage for massive overdosage or induced emesis using syrup of Ipecacuanha. Following this activated charcoal and cathartics may be administered to minimise absorption.
Symptomatic and supportive measures should be given, with particular attention paid to the cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. Hypotension and arrhythmias should be treated vigorously. If convulsions occur sedate with intramuscular paraldehyde, or i.v. diazepam or phenytoin Haemoperfusion may be used in severe cases.