Captopril

Hypertension:

The management of mild to moderate hypertension. In severe hypertension it should be used where standard therapy is ineffective or inappropriate.

Congestive Heart Failure:

Captopril is indicated for the treatment of congestive heart failure. The drug should be used together with diuretics, and when appropriate, digitalis and beta-blockers. In patients on doses of over 100 mg daily plus or minus a diuretic, in those with severe renal impairment or those with severe congestive heart failure use of captopril should be under specialist supervision.

Myocardial Infarction: - short-term (4 weeks) treatment:

Captopril is indicated in any clinically stable patient within the first 24 hours of an infarction. - long-term prevention of symptomatic heart failure: Captopril is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction < 40%) following myocardial infarction to improve survival, delay the onset of symptomatic heart failure, reduce hospitalisations for heart failure and reduce recurrent myocardial infarction and coronary revascularisation procedures.

Noyada (captopril) oral solution is indicated: • for the treatment of essential or renovascular hypertension. It is usually administered in association with other drugs, particularly thiazide diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.

In using Noyada, consideration should be given to the risk of neutropenia/agranulocytosis (see 7 WARNINGS AND PRECAUTIONS, Hematologic). In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for patients who have either developed unacceptable side effects on other drugs or have failed to respond satisfactorily to drug combinations (see 7 WARNINGS AND PRECAUTIONS, Renal).

• for the treatment of congestive heart failure as concomitant therapy with a diuretic and other drugs. Noyada therapy must be initiated under close medical supervision. • to improve survival, delay the onset of symptomatic heart failure and reduce hospitalizations for heart failure following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction of ≤ 40%.

INDICATIONS & USAGE

Captopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive. This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components.

When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate.

Treatment may, therefore, be initiated with captopril and hydrochlorothiazide tablets 25 mg/15 mg once daily. Subsequent titration should be with additional doses of the components (captopril, hydrochlorothiazide) as single agents or as captopril and hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25 mg (see DOSAGE AND ADMINISTRATION ).