ENALAPRIL MALEATE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Ranbaxy Pharmaceuticals Inc.

INN (Միջազգային անվանումը):

ENALAPRIL MALEATE

Կազմը:

ENALAPRIL MALEATE 2.5 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 Trialsfor 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 Failur

Ապրանքի ամփոփագիր:

Enalapril maleate Tablets, 2.5 mg, are yellow, biconvex round, scored on one side with code RX522 debossed on the other side. They are supplied as follows: NDC 63304-522-01 bottles of 100 (with desiccant) NDC 63304-522-10 bottles of 1000 (with desiccant) Enalapril maleate Tablets, 5 mg, are white, round biconvex, scored on one side with code RX523 debossed on the other side. They are supplied as follows: NDC 63304-523-01 bottles of 100 (with desiccant) NDC 63304-523-10 bottles of 1000 (with desiccant) Enalapril maleate Tablets, 10 mg, are reddish-brown, round biconvex, with code RX524 debossed on one side. They are supplied as follows: NDC 63304-524-01 bottles of 100 (with desiccant) NDC 63304-524-10 bottles of 1000 (with desiccant) Enalapril maleate Tablets, 20 mg, are orange, round biconvex, with code RX525 debossed on one side. They are supplied as follows: NDC 63304-525-01 bottles of 100 (with desiccant) NDC 63304-525-10 bottles of 1000 (with desiccant) Storage Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Keep container tightly closed. Protect from moisture. Dispense in a tight container if product package is subdivided. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32216 USA by: Ohm Laboratories, Inc. North Brunswick, NJ 08902 USA September 2015

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
RANBAXY PHARMACEUTICALS INC.
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ENALAPRIL MALEATE TABLETS USP
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 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.
Each tablet, for oral administration, contains 2.5 mg, 5 mg, 10 mg or
20 mg of enalapril maleate. In
addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, lactose monohydrate, maleic acid,
microcrystalline cellulose and zinc stearate.
Also, the 2.5 mg tablets contain ferric oxide (yellow), the 10 mg
tablets contain ferric oxide (red) and
the 20 mg tablets contain ferric oxide (red & yellow).
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, which leads to decreased vasopressor
activity and to