Topril Tablet

Mild-to-moderate hypertension: As an adjunct to thiazide therapy in patients who have not responded effectively to thiazide treatment alone.

Severe hypertension: Where standard therapy has failed.

Congestive heart failure: Topril is indicated for the treatment of congestive heart failure. The drug should be used together with diuretics and where appropriate, digitalis.

Captopril is a sulfhydryl-containing analog of proline with antihypertensive activity. Captopril competitively inhibits angiotensin converting enzyme (ACE), thereby decreasing levels of angiotensin II, increasing plasma renin activity, and decreasing aldosterone secretion. Approxiately 60-75% of an oral dose of captopril is repidly absorbed from the GI tract in fasting healthy individuals or hypertensive patients. More than 95% of a dose is excreted renally, both as unchanged (45-50%) drug and as metabolites.

Adults:
Mild-to-moderate hypertension: The initial dose is 12.5 mg twice daily. The usual maintenance dose is 25mg twice daily which can be increased incrementally, at two to four week intervals, until a satisfactory response is achieved, to a maximum of 50 mg twice daily.

Severe hypertension: In severe hypertension the starting dose is 12.5 mg b.d. The dosage may be increased incrementally to a maximum of 50 mg t.d.s.

Heart failure: A starting dose of 6.25mg or 12.5mg may minimise a transient hypotensive effect. The usual maintenance dose is 25mg three times a day. The usual maximum dose is 150 mg daily.

Captopril must be taken 1 hour before meals to ensure maximum absorption.

Use in Child: Safety and effectiveness in pediatric patients have not been established.

Do not coadminister aliskiren with Topril in patients with diabetes. Monitor renal function periodically.

A history of previous hypersensitivity to captopril. Captopril is contra-indicated in pregnancy and should not be used in women of child-bearing potential unless protected by effective contraception.

Neutropenia, anaemia, proteinuria, hypotension, tachycardia, rashes, usually pruritic may occur. Gastric irritation and abdominal pain may occur.

There are no available data in pregnant women to inform the drug-associated risk. Because of the potential for serious adverse reactions a decision should be made whether to discontinue nursing or to discontinue the drug.

Evaluation of the patient should include assessment of renal function before Topril therapy and at appropriate intervals thereafter. Patients with renal impairment should not normally be treated with Topril. Topril should not be used in patients with aortic stenosis or outflow tract obstruction.

Correction of hypertension would be of primary concern.

Angiotensin-converting enzyme (ACE) inhibitors

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.