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:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

ENALAPRIL MALEATE

Composition:

ENALAPRIL MALEATE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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, increase survival, and decrease 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 tablets decrease the rate of development of overt heart failure and decrease the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY , Heart Failure, Mortality Tria

Product summary:

Enalapril maleate tablets USP, 2.5 mg are available as yellow, oval, convex tablets debossed “93” bisect “26” on one side, plain on the other side. They are supplied as follows: NDC 0093-0026-01 bottles of 100 (with desiccant) NDC 0093-0026-10 bottles of 1000 (with desiccant) Enalapril maleate tablets USP, 5 mg are available as white, oval, convex tablets debossed “93” bisect “27” on one side, plain on the other side. They are supplied as follows: NDC 0093-0027-01 bottles of 100 (with desiccant) NDC 0093-0027-50 bottles of 5000 (with desiccant) Enalapril maleate tablets USP, 10 mg are available as salmon, oval, convex tablets debossed “93 28” on one side, plain on the other side. They are supplied as follows: NDC 0093-0028-01 bottles of 100 (with desiccant) NDC 0093-0028-10 bottles of 1000 (with desiccant) NDC 0093-0028-50 bottles of 5000 (with desiccant) Enalapril maleate tablets USP, 20 mg are available as peach, oval, convex tablets debossed “93 29” on one side, plain on the other side. They are supplied as follows: NDC 0093-0029-01 bottles of 100 (with desiccant) NDC 0093-0029-10 bottles of 1000 (with desiccant) NDC 0093-0029-50 bottles of 5000 (with desiccant) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc. Distributed by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. S 7/2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
ENALAPRIL MALEATE TABLETS USP 2.5 MG, 5 MG, 10 MG AND 20 MG
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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, FETAL TOXICITY).
DESCRIPTION
Enalapril maleate, USP is the maleate salt of enalapril, the ethyl
ester of a long-acting angiotensin
converting enzyme inhibitor, enalaprilat. Enalapril maleate, USP is
chemically described as (_S_)-1-[_N_- [1-
(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline,
(_Z_)-2-butenedioate salt (1:1), and its structural
formula is:
C
H N O ·C H O M.W. 492.53
Enalapril maleate, USP is an off-white, crystalline powder. 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 tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, and
20 mg tablets for oral
administration. In addition, each tablet contains the following
inactive ingredients: corn starch, lactose
monohydrate, magnesium stearate, pregelatinized starch, and sodium
bicarbonate. Each 2.5 mg tablet
contains D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C
blue #1 aluminum lake,
FD&C red #40 aluminum lake, and FD&C yellow #6 aluminum lake. Each 10
mg tablet contains FD&C
blue #2 aluminum lake, FD&C red #40 aluminum lake and FD&C yellow #6
aluminum lake. Each 20 mg
tablet contains FD&C Yellow #6.
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,