ENALAPRIL MALEATE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

State of Florida DOH Central Pharmacy

INN (Algemene Internationale Benaming):

ENALAPRIL MALEATE

Samenstelling:

ENALAPRIL MALEATE 2.5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP 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 tablets USP decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY ,

Product samenvatting:

Enalapril maleate tablets USP, 2.5 mg are available as yellow, oval, convex tablets debossed “93” bisect “26” on one side, plain on the other side. Enalapril maleate tablets USP, 5 mg are available as white, oval, convex tablets debossed “93” bisect “27” on one side, plain on the other side. Enalapril maleate tablets USP, 10 mg are available as salmon, oval, convex tablets debossed “93 28” on one side, plain on the other side. Enalapril maleate tablets USP, 20 mg are available as peach, oval, convex tablets debossed “93 29” on one side, plain on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: PROTECT FROM MOISTURE. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. All trademarks are the property of their respective owners. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ENALAPRIL MALEATE - ENALAPRIL MALEATE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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ENALAPRIL MALEATE TABLETS USP 2.5 MG, 5 MG, 10 MG AND 20 MG
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRIL MALEATE AS SOON AS
POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE
DEVELOPING FETUS (SEE WARNINGS, FETAL TOXICITY).
DESCRIPTION
Enalapril maleate, USP is the maleate salt of enalapril, the ethyl
ester of a long-acting angiotensin
converting enzyme inhibitor, enalaprilat. Enalapril maleate, USP is
chemically described as (_S_)-1-[_N_- [1-
(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline,
(_Z_)-2-butenedioate salt (1:1), and its structural
formula is:
C
H N O ·C H O M.W. 492.53
Enalapril maleate, USP is a white to off-white, crystalline powder. 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 tablets USP are 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: corn starch, lactose
monohydrate, magnesium stearate, pregelatinized starch, and sodium
bicarbonate. Each 2.5 mg tablet
contains D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C
blue #1 aluminum lake,
FD&C red #40 aluminum lake, and FD&C yellow #6 aluminum lake. Each 10
mg tablet contains FD&C
blue #2 aluminum lake, FD&C red #40 aluminum lake and FD&C yellow #6
aluminum lake. Each 20 mg
tablet contains FD&C Yellow #6.
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
vasoconstri