Država: Južnoafrička Republika
Jezik: engleski
Izvor: South African Health Products Regulatory Authority (SAHPRA)
Cipla
CIPLATEC 5 (Tablets) CIPLATEC 10 (Tablets) SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): CIPLATEC 5 (Tablets) CIPLATEC 10 (Tablets) COMPOSITION: CIPLATEC 5 Each tablet contains Enalapril maleate 5 mg. CIPLATEC 10 Each tablet contains Enalapril maleate 10 mg. PHARMACOLOGICAL CLASSIFICATION: A 7.1.3 Vascular medicines - Other hypotensives. PHARMACOLOGICAL ACTION: Enalapril maleate is an angiotensin converting enzyme (ACE) inhibitor and is hydrolysed by esterases in the liver to produce the parent dicarboxylic acid, enalaprilat, a specific, long acting, nonsulphydryl angiotensin converting enzyme inhibitor. The essential effect of enalaprilat on the renin-angiotensin system is to inhibit the conversion of the inactive angiotensin I to the active angiotensin II. The principal pharmacological and clinical effects of ACE inhibitors arise from the fact that the synthesis of angiotensin II is suppressed. Pharmacokinetics: Enalapril is absorbed from the gastro-intestinal tract, and has an oral bio-availability of approximately 60%. Peak plasma of enalapril occur within an hour and it has a plasma half-life of approximately 1.3 hours, while the active form, enalaprilat, only peaks after 3-4 hours and has a plasma half-life of up to 11 hours. Enalaprilat is 50-60% bound to plasma proteins. Elimination is mainly via the kidneys (60%) as intact enalapril, as well as the active enalaprilat. The remainder is eliminated in the faeces. Clinical pharmacology: SOLVD - TREATMENT TRIAL: In this multicentre, placebo-controlled clinical trial, 2569 patients with all degrees of symptomatic heart failure and ejection fraction of less than 35% were randomised to either enalapril or placebo and followed up for up to 55 months. All-cause mortality was reduced by 11% and hospi Pročitajte cijeli dokument