ENALAPRIL MALEATE- enalapril maleate tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)

可用日期:

Preferred Pharmaceuticals, Inc.

INN（国际名称）:

ENALAPRIL MALEATE

组成:

ENALAPRIL MALEATE 5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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.

授权状态:

Abbreviated New Drug Application

产品特点

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: