Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
PHARMAPRESS 10 mg TABLET PHARMAPRESS 20 mg TABLET SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): PHARMAPRESS 10 mg TABLET PHARMAPRESS 20 mg TABLET COMPOSITION: Each PHARMAPRESS 10 mg tablet contains 10 mg enalapril maleate. Each PHARMAPRESS 20 mg tablet contains 20 mg enalapril maleate. PHARMACOLOGICAL CLASSIFICATION: A 7.1.3 Vascular medicines - other hypotensives PHARMACOLOGICAL ACTION: PHARMAPRESS (enalapril maleate, MSD) is the maleate salt of enalapril, a derivative of two amino acids, L-alanine and L-proline. Following oral absorption, PHARMAPRESS is hydrolysed to enalaprilat, which is a specific, long-acting, non- sulphydryl angiotensin converting enzyme inhibitor. CLINICAL PHARMACOLOGY Heart Failure Mortality Trials In a multicenter, placebo-controlled clinical trial, 2 569 patients with all degrees of symptomatic heart failure and ejection fraction < 35 percent were randomized to placebo or enalapril and followed for up to 55 months (SOLVD- Treatment). Use of enalapril was associated with an 11% reduction in all-cause mortality and a 30% reduction in hospitalization for heart failure. Diseases that excluded patients from enrollment in the study included severe stable angina (>2 attacks/day), hemodynamically significant valvular or outflow tract obstruction, renal failure (creatinine >2,5 mg/dL), cerebral vascular disease (e.g., significant carotid artery disease), advanced pulmonary disease, malignancies, active myocarditis and contrictive pericarditis. The mortality benefit associated with enalapril does not appear to depend upon digitalis being present. A second multicenter trial used the SOLVD protocol for study of asymtomatic or minimally symptomatic patients. SOLVD-Prevention patients, who had left ventricular ejection fraction < 35% and no history of symptomatic heart Read the complete document