ENALAPRIL MALEATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT Rx USA LLC

INN (International Name):

ENALAPRIL MALEATE

Composition:

ENALAPRIL MALEATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Product summary:

Enalapril Maleate USP - 10 mg are light salmon, round flat-faced beveled edged, compressed tablets with W 925 on one side and plain on the other side. They are available in: Bottles of 30 - NDC # 16590-277-30 Storage Store below 30°C(86°F) and avoid transient temperaturesabove 50°C (122°F).Keep container tightly closed.Protect from moisture. Dispense in a tight container as per USP,if product is subdivided. Manufactured by: Wockhardt Limited , Mumbai, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.080610 Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA 30501

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENALAPRIL MALEATE - ENALAPRIL MALEATE TABLET
STAT RX USA 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
20
28
2
5
4
4
4
decreased plasma angiot