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:

Proficient Rx LP

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate 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 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 survival trials

Produktu pārskats:

Enalapril Maleate Tablets USP, 20 mg are peach colored, round, biconvex, slightly speckled tablets. One side scored and engraved with "T" above the score and with "20" under the score. The other side plain. They are supplied as follows: NDC 63187-977-30 unit of use bottles of 30 (with desiccant) NDC 63187-977-60 unit of use bottles of 60 (with desiccant) NDC 63187-977-90 unit of use bottles of 90 (with desiccant Store at 20° to 25°C (68° to 77°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.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
PROFICIENT RX LP
----------
ENALAPRIL MALEATE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
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 (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, USP, each tablet
contains the following inactive
ingredients: lactose monohydrate, magnesium stearate, pregelatinized
starch and sodium bicarbonate.
The 2.5 mg, 5 mg and 20 mg tablets also contain iron oxide yellow, and
the 10 mg and 20 mg tablets also
contain iron oxide red.
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
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
20
28
2
5
4
4
4
vasoconstrictor substance, angiotensin II. Angiotensin II also
stimulates aldosterone secretion by the
adrenal cortex. The beneficial effects of enalapril in hypertension
and heart failure appea