País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)
Northstar RxLLC
ENALAPRIL MALEATE
ENALAPRIL MALEATE 2.5 mg
ORAL
PRESCRIPTION DRUG
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 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 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, Heart Failure, Mortality
Enalapril maleate tablets USP, 2.5 mg, are light yellow, round, flat tablets with beveled edges, debossed with ‘ELP 2 ½’ on one side and scored on the other side. They are supplied as follows: NDC 16714-442-01, bottles of 100 tablets NDC 16714-442-02, bottles of 1000 tablets Enalapril maleate tablets USP, 5 mg, are pink, mottled, round, flat tablets with beveled edges, debossed with ‘ELP 5’ on one side and scored on the other side. They are supplied as follows: NDC 16714-443-01, bottles of 100 tablets NDC 16714-443-02, bottles of 1000 tablets Enalapril maleate tablets USP, 10 mg, are brown-pink, mottled, round, flat tablets with beveled edges, debossed with ‘ELP 10’ on one side and scored on both sides. They are supplied as follows: NDC 16714-444-01, bottles of 100 tablets NDC 16714-444-02, bottles of 1000 tablets Enalapril maleate tablets USP, 20 mg, are greyish-violet, mottled, round, flat tablets with beveled edges, debossed with ‘ELP 20’ on one side and scored on both sides. They are supplied as follows: NDC 16714-445-01, bottles of 100 tablets NDC 16714-445-02, bottles of 1000 tablets Storage 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. Manufactured for: Northstar Rx LLC, Memphis, TN 38141. Finished drug product manufactured by: Lek Pharmaceuticals d.d. S1-1526 Ljubljana, Slovenia. Product of India. Rev. October 2018 46235428
Abbreviated New Drug Application
ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET NORTHSTAR RXLLC ---------- 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 molecular 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: corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium bicarbonate. In addition, the 2.5 mg tablets contain ferric oxide yellow, 5 mg tablets contain ferric oxide red and 10 mg and 20 mg tablets contain ferric oxide red and ferric oxide black. 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 WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRIL MALEATE TABLETS, USP AS SOON AS POS S IBLE. 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 Leer el documento completo