ENALAPRIL MALEATE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Northwind Pharmaceuticals, LLC

INN (nume internaţional):

ENALAPRIL MALEATE

Compoziție:

ENALAPRIL MALEATE 20 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Hypertension Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is 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. Heart Failure Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate 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 decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failu

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
NORTHWIND PHARMACEUTICALS, LLC
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ENALAPRIL MALEATE
BOXED WARNING
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 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, C20H28N2O5●C4H4O4.
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: hypromellose, anhydrous lactose, corn starch, stearic
acid and talc. 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
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
decreased plasma angiotensin II, w