VASOTEC- enalapril maleate tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

Enalapril Maleate (UNII: 9O25354EPJ) (Enalaprilat Anhydrous - UNII:Q508Q118JM)

Fáanlegur frá:

Bausch Health US LLC

INN (Alþjóðlegt nafn):

Enalapril Maleate

Samsetning:

Enalapril Maleate 2.5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Hypertension VASOTEC is indicated for the treatment of hypertension. VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive. Heart Failure VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), VASOTEC decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of surv

Vörulýsing:

VASOTEC (enalapril maleate) Tablets NDC Strength Quantity Description 0187-0140-30 2.5 mg Bottles of 30 (with desiccant) White, oval shaped tablet imprinted with “VASO 2.5” and scored on one side and scored on the other. 0187-0140-90 Bottles of 90 (with desiccant) 0187-0141-30 5 mg Bottles of 30 (with desiccant) White, rounded triangle shaped tablet imprinted with “VASO 5” on one side and scored on the other. 0187-0141-90 Bottles of 90 (with desiccant) 0187-0142-30 10 mg Bottles of 30 (with desiccant) Rust red, rounded triangle shaped tablet imprinted with “VASO 10” on one side and scored on the other. 0187-0142-90 Bottles of 90 (with desiccant) 0187-0142-10 Bottles of 1,000 (with desiccant) 0187-0143-30 20 mg Bottles of 30 (with desiccant) Peach, rounded triangle shaped tablet imprinted with “VASO 20” on one side and scored on the other. 0187-0143-90 Bottles of 90 (with desiccant) 0187-0143-10 Bottles of 1,000 (with desiccant) Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture. Dispense in a tight container as per USP, if product package is subdivided.

Leyfisstaða:

New Drug Application

Vara einkenni

VASOTEC- ENALAPRIL MALEATE TABLET
BAUSCH HEALTH US LLC
----------
VASOTEC
(ENALAPRIL MALEATE) TABLETS
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
DESCRIPTION
VASOTEC (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 empirical 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 to the active ingredient enalapril
maleate, each tablet contains
the following inactive ingredients: lactose, magnesium stearate,
sodium bicarbonate, and
starch. 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
®
WHEN PREGNANCY IS DETECTED, DISCONTINUE VASOTEC AS SOON AS
POSSIBLE.
®
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THEDEVELOPING FETUS. (SEEWARNINGS, FETAL
TOXICITY.)
®
20
28
2
5
4
4
4
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