Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)
Preferred Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
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 Error! Hyperlink reference not valid. 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 Error! Hyperlink reference not valid. for details and limitations of survival trials). In using enalapril maleate consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis ). In considering use of enalapril maleate it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema ). Enalapril maleate is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Do not coadminister aliskiren with enalapril maleate in patients with diabetes (see PRECAUTIONS, Drug Interactions ). Enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS, Head and Neck Angioedema ).
Enalapril Maleate Tablets, USP NDC number Strength Description Quantity NDC 68788-8061-3 20 mg Light Beige, round flat-faced 30 bottle NDC 68788-8061-6 beveled edged, compressed tablets 60 bottle NDC 68788-8061-9 with W 926 on one side, plain on the 90 bottle NDC 68788-8061-1 other side. 100 Bottle Store below 25°C (77°F); excursion permitted to 15-30°C (59-86°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. ----------------------------------------------- # Trademark of Paddock Laboratories, Inc. Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.041018 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
ENALAPRIL MALEATE- ENALAPRIL MALEATE TABLET PREFERRED PHARMACEUTICALS INC. ---------- 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: hypromellose, anhydrous lactose, corn starch, stearic acid and talc. The 10 mg and 20 mg tablets also contain iron oxides. CLINICAL PHARMACOLOGY 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. SEEWARNINGS: FETAL TOXICITY 20 28 2 5 4 4 4 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. Przeczytaj cały dokument