Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
NuCare Pharmaceuticals,Inc.
ENALAPRIL MALEATE
ENALAPRIL MALEATE 10 mg
ORAL
PRESCRIPTION DRUG
Enalapril maleate and hydrochlorothiazide is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using enalapril maleate and hydrochlorothiazide, 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 does not have a similar risk (see WARNINGS ). In considering use of enalapril maleate and hydrochlorothiazide, 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 and hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of an
nalapril Maleate and Hydrochlorothiazide Tablets USP, 10/25 mg , are peach colored, capsule shaped, tablets. One side scored and engraved T to the left of the score and 3 to the right of the score. Other side scored. Each tablet contains 10 mg of enalapril maleate and 25 mg of hydrochlorothiazide. They are supplied as follows: NDC 68071-4144-3 Bottles of 30 NDC 68071-4144-6 Bottles of 60 NDC 68071-4144-9 Bottles of 90 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.
Abbreviated New Drug Application
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE- ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET NUCARE PHARMACEUTICALS,INC. ---------- ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP RX ONLY WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE 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 DESCRIPTION Enalapril maleate and hydrochlorothiazide combines an angiotensin converting enzyme inhibitor, enalapril maleate, and a diuretic, 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 492.53. 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. 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: 20 28 2 5 4 4 4 7 8 3 4 2 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 5/12.5 mg, containing 5 mg enalapril maleate and 12.5 mg hydrochlorothiazide and contain t Citiți documentul complet