enalapril maleate- Enalapril Maleate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRIL - UNII:69PN84IO1A)

Available from:

Watson Laboratories Inc.

INN (International Name):

Enalapril Maleate

Pharmaceutical form:

TABLET

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Summary of Product characteristics

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
WATSON LABORATORIES INC.
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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