Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)
Preferred Pharmaceuticals, Inc.
ENALAPRIL MALEATE
ENALAPRIL MALEATE 5 mg
ORAL
PRESCRIPTION DRUG
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. 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). 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 Failure, Mortality Trials for details and limitations of survival trial
Enalapril Maleate Tablets, USP 5mg White, round flat-faced beveled edged, compressed tablets with W/924 on one side and breakline on the other side. Bottle of 30 - 68788-9933-3 Bottle of 60 - 68788-9933-6 Bottle of 90 - 68788-9933-9 Bottle of 100 - 68788-9933-1 Enalapril Maleate Tablets, USP 10mg White, round flat-faced beveled edged, compressed tablets with W/925 on one side and breakline on the other side. Bottle of 30 - 68788-9932-3 Bottle of 60 - 68788-9932-6 Bottle of 90 - 68788-9932-9 Bottle of 100 - 68788-9932-1 Enalapril Maleate Tablets, USP 20mg White, round flat-faced beveled edged, compressed tablets with W/926 on one side and breakline on the other side. Bottle of 30 - 68788-9931-3 Bottle of 60 - 68788-9931-6 Bottle of 90 - 68788-9931-9 Bottle of 100 - 68788-9931-1 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 as per USP, if product package is subdivided. ----------------------------------------------- ** Registered trademark of Alza Corporation *** Trademark of Paddock Laboratories, Inc. Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.080515 Repackaged by Preferred Pharmaceuticals, Inc.
Abbreviated New Drug Application
ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET PREFERRED PHARMACEUTICALS, INC. ---------- ENALAPRIL MALEATE TABLETS, USP RX ONLY WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ 1. 2. 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. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: hypromellose, anhydrous lactose, corn starch, stearic acid and talc. The 10 mg and 20 mg tablets also contain iron oxides. 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 WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRIL MALEATE AS SOON AS POSSIBLE. DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. SEE WARNINGS: Les hele dokumentet