Enalapril Maleate Enalapril Maleate 20 MG Oral Tablet
INDICATIONS AND USAGE Hypertension Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive. Heart Failure Enalapril maleate tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets improve symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY: Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤ 35 percent), enalapril maleate tablets decrease the rate of development of overt heart failure and decrease the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY: Heart Failure, Mortality Trials for details and limitations of survival trials). In using enalapril maleate 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 maleate tablets do not have a similar risk (see WARNINGS ). In considering use of enalapril maleate tablets, 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 ).
Mylan Pharmaceuticals Inc.
ROUND BLUE M E18
M E18 ROUND BLUE
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HOW SUPPLIED Enalapril Maleate Tablets, USP are available containing 2.5 mg, 5 mg, 10 mg or 20 mg of enalapril maleate, USP. The 2.5 mg tablets are white, round tablets debossed with M over E15 on one side and scored on the other side. They are available as follows: NDC 0378-1051-01 bottles of 100 tablets The 5 mg tablets are white, round tablets debossed with M over E16 on one side and scored on the other side. They are available as follows: NDC 0378-1052-01 bottles of 100 tablets NDC 0378-1052-10 bottles of 1000 tablets The 10 mg tablets are light blue, round, unscored tablets debossed with M over E17 on one side and blank on the other side. They are available as follows: NDC 0378-1053-01 bottles of 100 tablets NDC 0378-1053-10 bottles of 1000 tablets The 20 mg tablets are medium blue, round, unscored tablets debossed with M over E18 on one side and blank on the other side. They are available as follows: NDC 0378-1054-01 bottles of 100 tablets NDC 0378-1054-05 bottles of 500 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. The brands listed are trademarks of their respective owners. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 7/2017 ENAL:R12
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