ENALAPRIL MALEATE- enalapril maleate tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

REMEDYREPACK INC.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Hypertension Enalapril Maleate Tablets is indicated for the treatment of hypertension. Enalapril Maleate Tablets is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of Enalapril Maleate Tablets and thiazides are approximately additive. Heart Failure Enalapril Maleate Tablets is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients Enalapril Maleate Tablets 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), Enalapril Maleate Tablets decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for hear

Produktu pārskats:

Enalapril Maleate Tablets NDC Number Strength Quantity Description 68682-710-30 68682-710-90 68682-710-01 68682-710-10 2.5 mg Bottles of 30 (with desiccant) Bottles of 90 (with desiccant) Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant) White, oval shaped tablet imprinted with “VASO 2.5” and scored on one side and scored on the other. 68682-711-30 68682-711-90 68682-711-01 68682-711-10 5 mg Bottles of 30 (with desiccant) Bottles of 90 (with desiccant) Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant) White, rounded triangle shaped tablet imprinted with “VASO 5” on one side and scored on the other. 68682-712-30 68682-712-90 68682-712-01 68682-712-10 10 mg Bottles of 30 (with desiccant) Bottles of 90 (with desiccant) Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant) Rust red, rounded triangle shaped tablet imprinted with “VASO 10” on one side and scored on the other. 68682-713-30 68682-713-90 68682-713-01 68682-713-10 20 mg Bottles of 30 (with desiccant) Bottles of 90 (with desiccant) Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant) Peach, rounded triangle shaped tablet imprinted with “VASO 20” on one side and scored on the other. 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. Manufactured for : Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA Manufactured by : Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7 Canada 20002517 9450103 Rev. 11/2018

Autorizācija statuss:

New Drug Application Authorized Generic

Produkta apraksts

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
REMEDYREPACK INC.
----------
ENALAPRIL MALEATE TABLETS
RX ONLY
WARNING: FETAL TOXICITY
_See full prescribing information for complete boxed warning._
• When pregnancy is detected, discontinue Enalapril Maleate Tablets
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 Tablets 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 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 re