ENALAPRIL MALEATE tablet ENALAPRIL MALEATE tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Hypertension 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 tablets USP and thiazides are approximately additive. Heart Failure 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 USP 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 tablets USP 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 trials). In using enalapril maleate tablets USP consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate tablets USP does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis). In considering use of enalapril maleate tablets USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema ). Enalapril maleate is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Do not coadminister aliskiren with enalapril maleate in patients with diabetes (see PRECAUTIONS, Drug Interactions ). Enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS, Head and Neck Angioedema ).

Резиме производа:

Enalapril maleate tablets USP, 2.5 mg are available as yellow, oval, convex tablets debossed "704" on one side and bisect on the other side. They are supplied as follows:   NDC 23155-704-01 bottles of 100 (with desiccant)   NDC 23155-704-10 bottles of 1000 (with desiccant) Enalapril maleate tablets USP, 5 mg are available as white, oval, convex tablets debossed "705" on one side and bisect on the other side. They are supplied as follows:   NDC 23155-705-01 bottles of 100 (with desiccant)   NDC 23155-705-10 bottles of 1000 (with desiccant) Enalapril maleate tablets USP, 10 mg are available as salmon, oval, convex tablets debossed "706" on one side and bisect on the other side. They are supplied as follows:    NDC 23155-772-01 bottles of 100 (with desiccant)    NDC 23155-772-10 bottles of 1000 (with desiccant) Enalapril maleate tablets USP, 20 mg are available as peach, oval, convex tablets debossed "707" on one side and bisect on the other side. They are supplied as follows:    NDC 23155-773-01         bottles of 100 (with desiccant)    NDC 23155-773-05         bottles of 500 (with desiccant)    NDC 23155-773-10         bottles of 1000 (with desiccant) 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. All brand names listed are the registered trademarks of their respective owners and are not the trademarks of Avet Pharmaceuticals. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000368US02 Revised: 11/2023

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
RX ONLY
DESCRIPTION
Enalapril Maleate Tablets, USP 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 empirical formula is C20H28N2O5•C4H4O4,
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 Tablets, USP are 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, 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 aluminum
lake.
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 res