Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)
Ranbaxy Pharmaceuticals Inc.
ENALAPRIL MALEATE
ENALAPRIL MALEATE 2.5 mg
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 Trialsfor 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 PHARMACOLOGY, Heart Failur
Enalapril maleate Tablets, 2.5 mg, are yellow, biconvex round, scored on one side with code RX522 debossed on the other side. They are supplied as follows: NDC 63304-522-01 bottles of 100 (with desiccant) NDC 63304-522-10 bottles of 1000 (with desiccant) Enalapril maleate Tablets, 5 mg, are white, round biconvex, scored on one side with code RX523 debossed on the other side. They are supplied as follows: NDC 63304-523-01 bottles of 100 (with desiccant) NDC 63304-523-10 bottles of 1000 (with desiccant) Enalapril maleate Tablets, 10 mg, are reddish-brown, round biconvex, with code RX524 debossed on one side. They are supplied as follows: NDC 63304-524-01 bottles of 100 (with desiccant) NDC 63304-524-10 bottles of 1000 (with desiccant) Enalapril maleate Tablets, 20 mg, are orange, round biconvex, with code RX525 debossed on one side. They are supplied as follows: NDC 63304-525-01 bottles of 100 (with desiccant) NDC 63304-525-10 bottles of 1000 (with desiccant) Storage Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Keep container tightly closed. Protect from moisture. Dispense in a tight container if product package is subdivided. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32216 USA by: Ohm Laboratories, Inc. North Brunswick, NJ 08902 USA September 2015
Abbreviated New Drug Application
ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET RANBAXY PHARMACEUTICALS INC. ---------- ENALAPRIL MALEATE TABLETS USP WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • 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 molecular 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 492.53. 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: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, maleic acid, microcrystalline cellulose and zinc stearate. Also, the 2.5 mg tablets contain ferric oxide (yellow), the 10 mg tablets contain ferric oxide (red) and the 20 mg tablets contain ferric oxide (red & yellow). 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 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 II, which leads to decreased vasopressor activity and to Прочитать полный документ