ENALAPRIL MALEATE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Preferred Pharmaceuticals Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype 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 Trials for details and limitations of survival trials). In using enalapril maleate tablets 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 do not have a similar risk (see Error! Hyperlink reference not valid. ). In considering use of enalapril maleate tablets, 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 Error! Hyperlink reference not valid. ). Enalapril maleate tablets are 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 tablets in patients with diabetes (see PRECAUTIONS, Drug Interactions ). Enalapril maleate tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see Error! Hyperlink reference not valid. ).

Resumen del producto:

Enalapril Maleate Tablets, USP Enalapril Maleate 5mgTablets are yellow, round scored tablet, debossed with “S 11” and scored on one side, “S 11” is on one side of the score and plain on the other side supplied in: Storage Store at 20o to 25o C (68o to 77o 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. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised: 03/2022 203419-01 Repackaged By: Preferred Pharmaceuticals Inc.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
PREFERRED PHARMACEUTICALS INC.
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ENALAPRIL MALEATE TABLETS RX ONLY
WARNING: FETAL TOXICITY
_See full prescribing information for complete boxed warning._
•
•
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 empirical formula is C
H
N O •C H O , and its structural
formula is:
Enalapril maleate, USP, 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, lactose monohydrate,
magnesium
stearate, pregelatinized starch and sodium bicarbonate. The 10 mg
tablets also contain
red ferric oxide, and 20 mg tablets also contain yellow ferric oxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
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 ERROR! HYPERLINK REFERENCE NOT
VALID..)
20
28
2
5
4
4
4
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 an