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Indications:

Bromhexine hydrochloride indicated for cough associated with wheeziness (bronchospasm) and tenacious phlegm (sputum).

Contraindications:

Bromhexine hydrochloride 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 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.

Adverse reactions:

Bromhexine’s pharmacological action may lead to gastric irritation. A transient rise in serum aminotransferase values have been reported due to bromhexine. 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.

Interactions:

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 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.

Warnings:

Bromhexine hydrochloride should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics, as it may induce ventricular fibrillation. An increased risk of arrhythmias may also occur if given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants. Hypokalaemia may be induced by higher than recommended doses of beta-agonists, especially in patients receiving digitalis glycosides or diuretics or are prone to cardiac dysrrhythmias. Caution should be exercised in patients suffering from hyperthyroidism due to sympathomimetic effects of orciprenaline sulphate. Caution should be observed in patients with gastric ulcer due to the bromhexine hydrochloride mucolytic action. In addition, care should be observed in patients suffering from cardiovascular diseases i.e. ischaemic heart disease; arrhythmias or tachycardia; occlusive vascular disorders including arteriosclerosis, hypertension or aneurysms. Anginal pain may be precipitated in patients suffering from angina pectoris. Care is also required when Bromhexine hydrochloride SYRUP is given to patients with diabetes mellitus or closed angle glaucoma. Caution is also needed in patients with convulsive disorders.

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