ENALAPRIL MALEATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Lake Erie Medical DBA Quality Care Products LLC

INN (International ime):

ENALAPRIL MALEATE

Sastav:

ENALAPRIL MALEATE 5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 limitations of survival tri

Proizvod sažetak:

S to rage 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. 5mg - White, round flat-faced beveled edged, compressed tablets with W 924 on one side and breakline on the other side. NDC: 35356-945-30     Bottles of 30 NDC: 35356-945-60     Bottles of 60 NDC: 35356-945-90     Bottles of 90 10mg - LIGHT SALMON, ROUND FLAT-FACED BEVELED EDGED, COMPRESSED TABLETS WITH W OVER 925 ON ONE SIDE PLAIN ON THE OTHER SIDE. NDC: 35356-869-30     Bottles of 30 NDC: 35356-869-60     Bottles of 60 NDC: 35356-869-90     Bottles of 90 20mg - LIGHT BEIGE, ROUND FLAT-FACED BEVELED EDGED, COMPRESSED TABLETS WITH W OVER 926 ON ONE SIDE PLAIN ON THE OTHER SIDE. NDC: 35356-869-30     Bottles of 30 NDC: 35356-869-60     Bottles of 60 NDC: 35356-869-90     Bottles of 90 ___________________________________________________________________________________________________________________________________ ** 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. Repackaged by: Quality Care Products, LLC Rev.080610

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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Product Information
ENALAPRIL MALEATE TABLETS, USP
Rx only
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE
INHIBITORS CAN CAUSE INJURY AND EVEN DEATH TO THE DEVELOPING FETUS.
When
pregnancy is detected, enalapril maleate should be discontinued as
soon as possible.
See WARNINGS, _Fetal / Neonatal Morbidity and Mortality._
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
L-Proline,1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]- , (S)-,
(Z)-2-
butenedioate (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, 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
decrease