Each 5ml spoonful contains
Diphenhydramine Hydrochloride 13.50mg
Codeine Phosphate 10.95mg
Sodium Citrate 54.40mg
Menthol B.P 1.10mg
Diphenhydramine possesses antitussive, antihistaminic and anticholinergic properties. Experiments have shown that the antitussive effect (resulting from an action on the brainstem) is discrete from its antihistaminic effect. The duration of activity is between 4 and 8 hours. Codeine is an opioid analgesic, causes cough suppression by direct central action in the medulla. Menthol has mild local anesthetic and decongestant properties.
Diphenhydramine, codeine and menthol are well absorbed from the gut following oral administration. Diphenhydramine is widely distributed throughout the body, including the Central Nervous System. Codeine is widely distributed throughout the body and is some 25% bond to plasma proteins. Diphenhydramine undergoes extensive first pass metabolism. Little unchanged drug is excreted in the urine. The plasma half-life of codeine has been reported to be between 3 and 4 hours. Metabolism takes place in the liver by O-demethylation to form morphine (approximately 10%), N-demethylation to form norcodeine and conjugation to form glucuronides and sulphates of both unchanged drug and its metabolites. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid. Menthol is conjugated in the liver and excreted both in urine and bile as the glucuronide. Menthol is hydroxylated in the liver by microsomal enzymes to P-methane-3,8diol. This is then conjugated with glucuronide and excreted both in urine and bile as the glucuronide.
Coflax® with Codeine is indicated for the relief of persistent, dry, irritating cough.
This product is contraindicated in patients with known hypersensitivity to the product or any of its constituents. This product is contra-indicated in individuals with hepatic or respiratory failure.
This product contains diphenhydramine and therefore many potentiate the effects of alcohol and other central nervous system depressants. As diphenhydramine possesses some anticholinergic activity, the effects of anticholinergics (e.g some psychotropic drugs and atropine) may be potentiated by this product. This may result in tachycardia, dry mouth, gastrointestinal disturbances (e.g colic), urinary retention and headache. Codeine may interact with monoamine oxidase inhibitors, producing prolongation of the narcotic effects.
WARNINGS AND PRECAUTIONS
It may cause drowsiness. If affected, do not drive or operate machinery. Individual with moderate to severe renal dysfunction should exercise caution when using this product. Diphenhydramine should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy. Codeine is a narcotic analgesic and tolerance, psychological dependence and constipation may occur with high doses.
ADVERSE REACTIONS/SIDE EFFECTS
Side effect associated with the use of Coflax® with Codeine are uncommon.
Diphenhydramine may cause drowsiness, dizziness, gastrointestinal disturbance, dry mouth , nose and throat, difficulty in urination and blurred vision.
Codeine may cause constipation, nausea, dizziness and drowsiness.
Adverse reactions to menthol at the low concentration present in Coflax® with Codeine are not anticipated.
SYMPTOMS OF OVERDOSAGE AND ANTIDOTE
The symptoms include drowsiness, hyperpyrexia, nausea, vomiting, constipation, pulmonary oedema, tachycardia, confusion, dry mouth, sweating and flushing. With massive doses, coma or cardiovascular collapse may follow. Treatment of overdose should be symptomatic and supportive. Measures to promote rapid gastric emptying (with syrup of ipecac – induced emesis or gastric lavage) and, in cases of acute poisoning, the use of activated charcoal may be useful.
PREGNANCY AND LACTATION
Although diphenhydramine and codeine have been in widespread use for many years without ill consequence, both are known to cross the placenta and have been detected in breast milk. Consequently Coflax® with Codeine should only be used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing foetus or suckling infant.
DOSAGE AND ADMINISTRATION
Adult and children over 12 years:
Two 5ml spoonfuls three to four times daily
6 to 12 years – one 5ml spoonful three to four times daily
1 to 5 years– Half 5ml spoonful three to four times daily.
Coflax® with Codeine Cough Syrup is presented in amber bottle with a total content of 100ml.
Store below 300C.