Cofdex

Dextromethorphan (Cofdex) hydrobromide is a cough suppressant used for the relief of non-productive cough Bromhexine (Cofdex) hydrochloride indicated for cough associated with wheeziness (bronchospasm) and tenacious phlegm (sputum).

Dextromethorphan (Cofdex) should not be given to patients at risk of developing respiratory failure. Caution is needed in patients with a history of asthma and it should not be given during an acute attack. Bromhexine (Cofdex) hydrochloride SYRUP is contra-indicated in patients with known hypersensitivity to sympathomimetic amines or any of the other ingredients; hypertrophic obstructive cardiomyopathy; and tachyarrhythmia.

Sympathomimetics, such as orciprenaline sulphate, may interact with monoamine oxidase inhibitors (MAOI), and therefore Bromhexine (Cofdex) hydrochloride SYRUP should not be given to patients receiving such treatment or within 14 days of MAOI treatment termination.

Safety in pregnancy and lactation has not been established.

Severe and sometimes fatal reactions have been reported after use of Dextromethorphan (Cofdex) in patients receiving MAOIs. Dextromethorphan (Cofdex) is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6; the possibility of interactions with inhibitors of this enzyme, including amiodarone, fluoxetine, haloperidol, paroxetine, propafenone, quinidine, and thioridazine, should be borne in mind. A reduction in dose of cardiac glycosides (e.g. digitalis) and quinidine might become necessary in patients suffering from congestive cardiac failure because of the positive inotropic effect of orciprenaline sulphate.

Bromhexine (Cofdex) hydrochloride SYRUP should not be administered concomitantly with beta-blocking agents, due to orciprenaline’s reversal of anti-hypertensive action.

The concomitant use of other sympathomimetic agents should be carefully controlled to avoid potentiation of effects.

Adverse effects with Dextromethorphan (Cofdex) appear to be rare and may include dizziness and gastrointestinal disturbances. Excitation, confusion, and respiratory depression may occur after overdosage. Dextromethorphan (Cofdex) has been subject to abuse, but there is little evidence of dependence of the morphine type. Bromhexine (Cofdex)’s pharmacological action may lead to gastric irritation. A transient rise in serum aminotransferase values have been reported due to Bromhexine (Cofdex).

Orciprenaline sulphate, as a sympathomimetic agent, may precipitate a wide range of adverse effects. Side-effects include fear; anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur. A rise in blood pressure which may produce cerebral haemorrhage and pulmonary oedema, tachycardia and cardiac arrhythmias, anginal pain, palpitations, and cardiac arrest. Hypotension with dizziness and fainting and flushing may occur. Other effects that may occur include difficulty in micturition and urinary retention; dyspnoea; weakness; headache; disturbances of glucose metabolism; sweating and hypersalivation. Muscle cramps or twitching or unpleasant taste may occur.