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:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International ime):

ENALAPRIL MALEATE

Sastav:

ENALAPRIL MALEATE 2.5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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ENALAPRIL MALEATE
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 result