Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)
Lake Erie Medical DBA Quality Care Products LLC
ENALAPRIL MALEATE
ENALAPRIL MALEATE 10 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE- ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- USE IN PREGNANCY WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is detected, enalapril maleate and hydrochlorothiazide tablets should be discontinued as soon as possible (see WARNINGS: _Pregnancy, Enalapril Maleate, Fetal/Neonatal Morbidity and Mortality)_. DESCRIPTION Enalapril maleate and hydrochlorothiazide 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 492.52. 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. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C H ClN O S and its structural formula is: It is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Enalapril Maleate and Hydrochlorothiazide is available in two tablet combinations of enalapril maleate with hydrochlorothiazide: Enalapril Maleate and Hydrochlorothiazide Tablets 5/12.5, containing 5 mg enalapril maleate and 12.5 mg hydrochlorothiazide and Enalapril Maleate and Hydrochlorothiazide Tablets 10/25, containing 10 mg enalapril maleate and 25 mg hydrochlorothiazide. Inactive ingredients combines Прочитать полный документ