ENALAPRIL MALEATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NuCare Pharmaceuticals, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Enalapril maleate tablets, 2.5 mg, are white, oval shaped tablet with “VASO 2.5” and scored on one side and scored on the other. They are supplied as follows: 68682-710-30 bottles of 30 (with desiccant) 68682-710-90 unit of use bottles of 90 (with desiccant) 68682-710-01 bottles of 100 (with desiccant) 68682-710-10 bottles of 1,000 (with desiccant) Enalapril maleate tablets, 5 mg, are white, rounded triangle shaped tablet with “VASO 5” on one side and scored on the other. They are supplied as follows: 68682-711-30 bottles of 30 (with desiccant) 68682-711-90 unit of use bottles of 90 (with desiccant) 68682-711-01 bottles of 100 (with desiccant) 68682-711-10 bottles of 1,000 (with desiccant) Enalapril maleate tablets, 10 mg, are rust red, rounded triangle shaped tablet with “VASO 10” on one side and scored on the other. They are supplied as follows: 68682-712-30 bottles of 30 (with desiccant) 68682-712-90 unit of use bottles of 90 (with desiccant) 68682-712-01 bottles of 100 (with desiccant) 68682-712-10 bottles of 1,000 (with desiccant) Enalapril maleate tablets, 20 mg, are peach, rounded triangle shaped tablet with “VASO 20” on one side and scored on the other. They are supplied as follows: 68682-713-30 bottles of 30 (with desiccant) 68682-713-90 unit of use bottles of 90 (with desiccant) 68682-713-01 bottles of 100 (with desiccant) 68682-713-10 bottles of 1,000 (with desiccant) Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°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. Vasotec ® is a registered trademark of Valeant Pharmaceuticals North America LLC. Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7, Canada Made in Canada 20000940 Rev. 05/15 9450101

Stato dell'autorizzazione:

New Drug Application Authorized Generic

Scheda tecnica

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
ENALAPRIL MALEATE TABLETS
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 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 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: lactose, magnesium stearate,
sodium1 bicarbonate
and starch. 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
20
28
2
5
4
4
4
renin-angiotensin-aldosterone system. Inhibitio