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 ).
Apotex Corp.
ROUND RED Apo 10 25
Apo 10 25 ROUND RED
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HOW SUPPLIED Enalapril maleate and hydrochlorothiazide tablets, USP 5 mg/12.5 mg are available for oral administration as reddish-brown, round, unscored tablets, imprinted “APO” on one side and “5” over “12.5” on the other side. They are supplied as follows: Bottles of 100 (NDC 60505-0208-1) Bottles of 1,000 (NDC 60505-0208-2) Enalapril maleate and hydrochlorothiazide tablets, USP 10 mg/25 mg are available for oral administration as reddish-brown, round, unscored tablets, imprinted “APO” on one side and “10” over “25” on the other side. They are supplied as follows: Bottles of 100 (NDC 60505-0209-1) Bottles of 1,000 (NDC 60505-0209-2) Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 mg/12.5 mg and 10 mg/25 mg Manufactured by Manufactured for Apotex Research Pvt. Ltd. Apotex Corp. Bangalore 560 099, Weston, Florida India 33326 Revised: August 2017 Rev. 9
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