ENALAPRIL MALEATE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

St Marys Medical Park Pharmacy

INN (Internationale Bezeichnung):

ENALAPRIL MALEATE

Zusammensetzung:

ENALAPRIL MALEATE 20 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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. 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). 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 Failure, Mortality Trials for details and

Produktbesonderheiten:

Enalapril Maleate 20mg Light Beige, round flat-faced beveled edged, compressed tablets with 926 on one side, plain on the other side. NDC: 60760-0226-30 BOTTLE OF 30 Inactive 08-31-2019 Enalapril Maleate 5mg White, round flat-faced beveled edged, compressed tablets with W 924 on one side and breakline on the other side. NDC: 60760-0227-30 bottle of 30 Store below 30°C (86°F) and avoid transient temperatures above 50°C (122°F). Keep container tightly closed. Protect from moisture. Dispense in a tight container as per USP, if product package is subdivided. ** Registered trademark of Alza Corporation. *** Trademark of Paddock Laboratories, Inc. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.111213

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
ST MARYS MEDICAL PARK PHARMACY
----------
ENALAPRIL MALEATE TABLETS, USP
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 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: 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
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 and heart failure appear to result primarily from
suppression of the
renin-angiotensin-aldosterone system. Inh