Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ZAPTO-25 TABLETS ZAPTO-50 TABLETS SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): ZAPTO-25 TABLETS ZAPTO-50 TABLETS COMPOSITION: Each tablet contains 25 mg or 50 mg captopril . PHARMACOLOGICAL CLASSIFICATION: A 7.1 Vasodilators, hypotensive medicine. PHARMACOLOGICAL ACTION: The effects of ZAPTO result primarily from suppression of the renin-angiotensin-aldosterone system. Captopril prevents the conversion of angiotensin I to angiotensin II by inhibition of angiotensin-converting enzyme. This leads to a decrease in the pressor substance, angiotensin II, and an increase in plasma renin activity. Reduced concentrations of aldosterone are also found in the blood and urine. The Survival and Ventricular Enlargement (SAVE) study was a multicentre randomised, double-blind, placebo-controlled trial conducted in 2231 patients (age 21 - 79 years) who survived the acute phase of a myocardial infarction and did not have active ischaemia. Patients had left ventricular dysfunction (LVD), defined as a resting left ventricular ejection fraction ˜40%, but at the time of randomisation were not sufficiently symptomatic to require ACE inhibitor therapy for heart failure. About half the patients had had symptoms of heart failure in the past. Patients were given a test dose of 6,25 mg oral Captopril and were randomised within 3-16 days post-infarction to receive either Captopril or placebo in addition to conventional therapy. Captopril was initiated at 6,25 mg or 12,5 mg three times a day and after two weeks titrated to a target maintenance dose of 50 mg three times a day. About 80% of patients were receiving the target dose at the end of the study. Patients were followed for a minimum of two years for up to five years, with an average follow-up of up to 3,5 years. Baseline blood Les hele dokumentet