ENALAPRIL MALEATE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRIL - UNII:69PN84IO1A)

Dostupné s:

Physicians Total Care, Inc.

INN (Mezinárodní Name):

ENALAPRIL MALEATE

Složení:

ENALAPRIL MALEATE 2.5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Enalapril maleate is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.

Přehled produktů:

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. ___________________________________________________________________________________________________________________________________ ** 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.221209 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK    74146

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ENALAPRIL MALEATE - ENALAPRIL MALEATE TABLET
PHYSICIANS TOTAL CARE, INC.
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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 ActionEnalapril, 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 angiotens