Cofdex Syr

Cofdex Syr hydrochloride SYRUP indicated for cough associated with wheeziness (bronchospasm) and tenacious phlegm (sputum).

Unless otherwise prescribed, the following doses are recommended:

Tablet: Adults and Children >12 years: 8 mg (1 tab) thrice daily; 6-12 years: 4 mg (½ tab) thrice daily; 2-6 years: 4 mg (½ tab) twice daily.

Oral Solution:

Inhalation Solution (with aerosol apparatus): It is generally recommended to warm inhalation solution to body temperature before inhalation. Patients with bronchial asthma may be advised to commencing inhalation after they have taken their regular bronchospasmolytic therapy.

Adults: 4 mL. Children >12 years: 2 mL; 6-12 years: 1 mL; 2-6 years: 10 drops; <2 years: 5 drops. All doses to be taken twice daily.

The solution may be diluted 1:1 in physiological saline solution. In order to avoid precipitation, the solution should be inhaled immediately after mixing. The combined administration of inhalation and oral application intensifies the effect, and is especially suited for the commencement of treatment in cases where the full effect is to be reached quickly.

Syrup: Adults and Children >12 years: 5 ml (1 tsp) thrice daily.

At commencement of treatment, it may be necessary to increase the total daily dose up to 48 mg in adults.

The syrup is sugar-free and therefore suitable for diabetics and small children.

Ampoule: Severe cases, before and after surgical intervention: 1 amp SC, IM or IV (duration of injection: 2-3 min) 2-3 times daily.

Capsule: Adults: 1 cap 3 times daily.

It is recommended for the initial phase of treatment usually lasting not more than a week.

Patients being treated with Cofdex Syr should be notified of an expected increase in the flow of secretions.

Cofdex Syr 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 Cofdex Syr 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.

Cofdex Syr is used to treat breathing difficulties caused by excessive mucus secretions in the air passages associated with respiratory tract infections.

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.

Cofdex Syr 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.

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

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.

Each tablet also contains lactose, maize or potato starch, gelatine and magnesium stearate as excipients.

The oral/inhalation solution also contains tartaric acid and methyl parahydroxybenzoate as excipients.

The syrup also contains tartaric acid, benzoic acid, sodium carboxymethylcellulose, glycerol, sorbitol solution, pharma flavor and ethanol as excipients.

Each capsule also contains lactose, cornstarch and magnesium stearate as excipients.

Cofdex Syr HCl is N-cyclohexyl-N-methyl-(2-amino-3,5-dibromobenzyl)amine hydrochloride.