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:

Blenheim Pharmacal, Inc.

INN (International Name):

ENALAPRIL MALEATE

Composition:

ENALAPRIL MALEATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Enalapril Maleate Tablets USP, 2.5 mg are yellow colored, round, biconvex tablets. One side scored and engraved with "T" above the score and "2" below. The other side plain. They are supplied as follows: NDC 51672-4037-1 unit of use bottles of 100 (with desiccant) NDC 51672-4037-3 unit of use bottles of 1,000 (with desiccant) Enalapril Maleate Tablets USP, 5 mg are yellow colored, round, biconvex tablets. One side scored and engraved with "T" above the score and "5" below. The other side plain. They are supplied as follows: NDC 51672-4038-1 unit of use bottles of 100 (with desiccant) NDC 51672-4038-3 unit of use bottles of 1,000 (with desiccant) Enalapril Maleate Tablets USP, 10 mg are pink colored, round, biconvex tablets. One side engraved with "T" at the top and "10" at the bottom. The other side plain. They are supplied as follows: NDC 51672-4039-1 unit of use bottles of 100 (with desiccant) NDC 51672-4039-3 unit of use bottles of 1,000 (with desiccant) Enalapril Maleate Tablets USP, 20 mg are peach colored, round, biconvex, slightly speckled tablets. One side engraved with "T" at the top and "20" at the bottom. The other side plain. They are supplied as follows: NDC 51672-4040-1 unit of use bottles of 100 (with desiccant) NDC 51672-4040-3 unit of use bottles of 1,000 (with desiccant) Store at 20°-25°C (68°-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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET
BLENHEIM PHARMACAL, INC.
----------
ENALAPRIL MALEATE TABLETS, USP
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
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
decreased plasma angiotensin II, which leads to decreased vasopressor
activity and to decreased
aldosterone secretion. Although the latter decrease is small, it
results in small increases of serum
potassium. In hypertensive patients treated with enalapril maleate
alone for up to 48 weeks, mean
increases in serum potassium of approximately 0.2 mEq/L were observed.
In patients treated with
enalapril maleate plus a thiazide diuretic, there was essentially no
change in serum potassium (see
PRECAUTIONS). Removal of angiotensin II negative feedback on renin
secretion leads to increased
plasma renin activity.
ACE is identical to kininase, an enzyme that degrades bradykinin.
Whether increased levels of
bradykinin, a potent vasodepressor peptide, play a role in the
therapeutic effects of enalapril maleate
remains to be elucidated.
While the mechanism through which enalapril maleate lowers blood
pressure is believed to be
primarily suppression of the renin-angiotensin-aldosterone system,
enalapril maleate is antihypertensive
even in patients with low-renin hypertensi