ENALAPRIL MALEATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Enalapril Maleate (UNII: 9O25354EPJ) (Enalaprilat Anhydrous - UNII:Q508Q118JM)

Available from:

OCEANSIDE PHARMACEUTICALS

INN (International Name):

Enalapril Maleate

Composition:

Enalapril Maleate 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension Enalapril Maleate Tablets are indicated for the treatment of hypertension. Enalapril Maleate Tablets are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of Enalapril Maleate Tablets and thiazides are approximately additive. Heart Failure Enalapril Maleate Tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients Enalapril Maleate Tablets improve 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 Tablets decrease the rate of development of overt heart failure and decreases the incidence of hospitalization for hea

Product summary:

Enalapril Maleate Tablets NDC Strength Quantity Description 68682-710-01 68682-710-10 2.5 mg Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant) White, oval shaped tablet imprinted with “VASO 2.5” and scored on one side and scored on the other. 68682-711-01 68682-711-10 5 mg Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant) White, rounded triangle shaped tablet imprinted with “VASO 5” on one side and scored on the other. 68682-712-01 68682-712-10 10 mg Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant) Rust red, rounded triangle shaped tablet imprinted with “VASO 10” on one side and scored on the other. 68682-713-01 68682-713-10 20 mg Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant) Peach, rounded triangle shaped tablet imprinted with “VASO 20” on one side and scored on the other. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture. Dispense in a tight container as per USP, if product package is subdivided. Distributed by : Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by : Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada © 2020 Bausch Health Companies Inc. or its affiliates 9450104_20003098 Rev. 12/2020

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
OCEANSIDE PHARMACEUTICALS
----------
ENALAPRIL MALEATE TABLETS
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRIL MALEATE TABLETS
AS
SOON AS POSSIBLE.
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING FETUS. (SEE WARNINGS, FETAL
TOXICITY.)
DESCRIPTION
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: lactose, magnesium stearate,
sodium bicarbonate, and
starch. 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
Enalapril Maleate Tablets are 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 empirical formula is C
H
N O •C H O ,
and its structural formula is:
20
28
2
5
4
4
4
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. Inh