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:

Sandoz Inc

INN (International Name):

ENALAPRIL MALEATE

Composition:

ENALAPRIL MALEATE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Enalapril maleate tablets, USP are indicated for the treatment of hypertension. Enalapril maleate tablets, USP are 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 tablets. USP 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). In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤ 35%), enalapril maleate tablets, USP decrease the rate of development of overt heart failure and decrease the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY: Heart Failure, Mortality

Product summary:

Enalapril maleate tablets USP, 2.5 mg, are light yellow, round, flat tablets with beveled edges, debossed with ‘ELP 2 ½’ on one side and scored on the other side. They are supplied as follows: NDC 0781-5441-01, bottles of 100 tablets NDC 0781-5441-10, bottles of 1000 tablets Enalapril maleate tablets USP, 5 mg, are pink, mottled, round, flat tablets with beveled edges, debossed with ‘ELP 5’ on one side and scored on the other side. They are supplied as follows: NDC 0781-5442-01, bottles of 100 tablets NDC 0781-5442-10, bottles of 1000 tablets Enalapril maleate tablets USP, 10 mg, are brown-pink, mottled, round, flat tablets with beveled edges, debossed with ‘ELP 10’ on one side and scored on both sides. They are supplied as follows: NDC 0781-5443-01, bottles of 100 tablets NDC 0781-5443-10, bottles of 1000 tablets Enalapril maleate tablets USP, 20 mg, are greyish-violet, mottled, round, flat tablets with beveled edges, debossed with ‘ELP 20’ on one side and scored on both sides. They are supplied as follows: NDC 0781-5444-01, bottles of 100 tablets NDC 0781-5444-10, bottles of 1000 tablets Storage Store at 20°-25°C (68°-77°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. 1 Registered trademark of Alza Corporation. 2 Trademark of Paddock Laboratories, Inc. Manufactured in Slovenia by Lek Pharmaceuticals d.d. for Sandoz Inc., Princeton, NJ 08540 Product of India. Rev. February 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
SANDOZ INC
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ENALAPRIL MALEATE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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•
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: corn starch, croscarmellose sodium, lactose monohydrate,
magnesium stearate,
pregelatinized starch, and sodium bicarbonate. In addition, the 2.5 mg
tablets contain ferric oxide
yellow, 5 mg tablets contain ferric oxide red and 10 mg and 20 mg
tablets contain ferric oxide red and
ferric oxide black.
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 ENALAPR