Enalapril Maleate 10 MG Hydrochlorothiazide 25 MG Oral Tablet
INDICATIONS AND USAGE Enalapril maleate and hydrochlorothiazide tablets are 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 tablets, 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 tablets, 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 ).
Mylan Pharmaceuticals Inc.
ROUND WHITE M 723
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HOW SUPPLIED Enalapril Maleate and Hydrochlorothiazide Tablets, USP are available containing enalapril maleate, USP 5 mg and hydrochlorothiazide, USP 12.5 mg or enalapril maleate, USP 10 mg and hydrochlorothiazide, USP 25 mg. The 5 mg/12.5 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and 712 on the other side. They are available as follows: NDC 0378-0712-01 bottles of 100 tablets The 10 mg/25 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and 723 on the other side. They are available as follows: NDC 0378-0723-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2020 ENHCT:R10
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