Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRIL - UNII:69PN84IO1A)
Watson Laboratories Inc.
Enalapril Maleate
TABLET
ORAL
PRESCRIPTION DRUG
Hypertension Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. Heart Failure Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY,Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction <35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure. (See CLINICAL PHARMAC
Enalapril Maleate Tablets USP are supplied as follows: 2.5 mg tablet: White to off-white, round, biconvex tablet, debossed WATSON in a semi- circle over 668 on one side and a score on the other side, in bottles of 100 and 500. 5 mg tablet: White to off-white, round, biconvex tablet, debossed WATSON in a semi-circle over 669 with a score in the center on one side and plain on the other side, in bottles of 100 and 500. 10 mg tablet: White-speckled pink, round, biconvex tablet, debossed WATSON in a semi-circle over 670 on one side and plain on the other side, in bottles of 100 and 500. 20 mg tablet: White-speckled peach, round, biconvex tablet, debossed WATSON in a semi-circle over 671 on one side and plain on the other side, in bottles of 100 and 500. Store below 30°C (86°F) and avoid transient temperatures above 50°C (122°F). Keep container tightly closed. Protect from moisture. Dispense in a tight container. Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45215 USA Revised: November 2007
ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET WATSON LABORATORIES INC. ---------- ENALAPRIL MALEATE TABLETS USP REVISED: NOVEMBER 2007 RX ONLY RX ONLY USE IN PREGNANCY WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is detected, enalapril should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality. DESCRIPTION Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1- (ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its chemical formula is C H N O •C H O , and its structural formula is: Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin converting enzyme inhibitor. Each tablet for oral administration, contains 2.5 mg, 5 mg, 10 mg or 20 mg of enalapril maleate. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, crospovidone, iron oxide red 30 (in 10 mg and 20 mg only), iron oxide yellow 10 (in 20 mg only), magnesium stearate, microcrystalline cellulose and potassium bicarbonate. CLINICAL PHARMACOLOGY _Mechanism of Action_ Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimu-lates 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 Baca dokumen lengkapnya