País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)
Solco Healthcare US, LLC
ORAL
PRESCRIPTION DRUG
Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive. Enalapril maleate tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets improve symptoms, increase survival, and decrease 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 decrease the rate of development of overt heart failure and decrease the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials f
Enalapril Maleate Tablets, USP NDC Number Strength Quantity Description 43547-545-03 2.5 mg Bottles of 30 with child-resistant closure (with desiccant) White, oval shaped scored tablet, debossed with “S 1” and scored on one side, “S” and “1” are separated by the score and plain on the other side. 43547-545-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-545-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-545-50 Bottles of 500 (with desiccant) 43547-545-11 Bottles of 1,000 (with desiccant) 43547-546-03 5 mg Bottles of 30 with child-resistant closure (with desiccant) White, rounded triangle shaped scored tablet debossed with “S 6” on one side and scored on the other side. 43547-546-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-546-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-546-50 Bottles of 500 (with desiccant) 43547-546-11 Bottles of 1,000 (with desiccant) 43547-547-03 10 mg Bottles of 30 with child-resistant closure (with desiccant) Red, rounded triangle shaped scored tablet debossed with “S 7” on one side and scored on the other side. 43547-547-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-547-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-547-50 Bottles of 500 (with desiccant) 43547-547-11 Bottles of 1,000 (with desiccant) 43547-548-03 20 mg Bottles of 30 with child-resistant closure (with desiccant) Yellow, round scored tablet, debossed with “S 11” and scored on one side, “S 11” is on one side of the score and plain on the other side. 43547-548-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-548-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-548-50 Bottles of 500 (with desiccant) 43547-548-11 Bottles of 1,000 (with desiccant) Storage Store at 20o to 25o C (68o to 77o 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 by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised: 03/2022 203419-01
Abbreviated New Drug Application
ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET SOLCO HEALTHCARE US, LLC ---------- ENALAPRIL MALEATE TABLETS 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, USP, 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, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The 10 mg tablets also contain red ferric oxide, and 20 mg tablets also contain yellow ferric oxide. CLINICAL PHARMACOLOGY MECHANISM OF ACTION 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.) 20 28 2 5 4 4 4 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 app Leer el documento completo