Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ENALAPRIL MALEATE
PHARMANIAGA MANUFACTURING BERHAD
ENALAPRIL MALEATE
250 Tablets; 100 Tablets; 30 Tablets; 10 Tablets
PHARMANIAGA MANUFACTURING BERHAD
ENALAPRIL _ _ _ _ _ _ COMPOSITION _PHARMANIAGA ENALAPRIL TABLET 5 MG _ Each tablet contains Enalapril maleate 5 mg. _PHARMANIAGA ENALAPRIL TABLET 20 MG _ Each tablet contains Enalapril maleate 20 mg. ACTIONS Enalapril after hydrolysis to enalaprilat, inhibits angiotensin- converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyses the conversion of angiotensin I to the vasoconstrictor substance, angiotensin ll. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin ll, which leads to decreased vasopressor activity and to decreased aldosterone secretion. While the mechanism through which enalapril lowers blood pressure is believed to be primarily suppression of the renin- angiotensin-aldosterone system, enalapril is antihypertensive even in patients with low-renin hypertension. Following oral administration of enalapril maleate peak serum concentrations of enalapril occur within about one hour. Based on urinary recovery, the extent of absorption of enalapril is approximately 60%. Enalapril absorption is not influenced by the presence of food in the gastrointestinal tract. Following absorption, enalapril is hydrolysed to enalaprilat, which is a more potent angiotensin converting enzyme inhibitor than enalapril; enalaprilat is poorly absorbed when administered orally. Peak serum concentrations of enalaprilat occur three to four hours after an oral dose of enalaprilat maleate. Excretion of enalapril maleate is primarily renal. Approximately 94% of the dose is recovered in the urine and faeces as enalaprilat or enalapril. The principal components in urine are enalaprilat, accounting for about 40% of the dose, and intact enalapril. There is no evidence of metabolites of enalapril, other than enalaprilat. Enalaprilat is 50 to 60% bound to plasma p Przeczytaj cały dokument