enalapril 10 mg
INDICATIONS AND USAGE Hypertension Enalapril maleate tablets, USP are indicated for the treatment of hypertension. Enalapril maleate tablets, USP are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. Heart Failure Enalapril maleate tablets. USP 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%), enalapril maleate tablets, USP 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, 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 does not have a similar risk (see WARNINGS ) In considering use of enalapril maleate, 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 nonblacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks (see WARNINGS, Head and Neck Angioedema ).
sandoz inc
ROUND BROWN ELP 10
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HOW SUPPLIED Enalapril maleate tablets USP, 2.5 mg, are light yellow, round, flat tablets with beveled edges, debossed with ‘ELP 2 ½’ on one side and scored on the other side. They are supplied as follows: NDC 0781-5441-01, bottles of 100 tablets NDC 0781-5441-10, bottles of 1000 tablets Enalapril maleate tablets USP, 5 mg, are pink, mottled, round, flat tablets with beveled edges, debossed with ‘ELP 5’ on one side and scored on the other side. They are supplied as follows: NDC 0781-5442-01, bottles of 100 tablets NDC 0781-5442-10, bottles of 1000 tablets Enalapril maleate tablets USP, 10 mg, are brown-pink, mottled, round, flat tablets with beveled edges, debossed with ‘ELP 10’ on one side and scored on both sides. They are supplied as follows: NDC 0781-5443-01, bottles of 100 tablets NDC 0781-5443-10, bottles of 1000 tablets Enalapril maleate tablets USP, 20 mg, are greyish-violet, mottled, round, flat tablets with beveled edges, debossed with ‘ELP 20’ on one side and scored on both sides. They are supplied as follows: NDC 0781-5444-01, bottles of 100 tablets NDC 0781-5444-10, bottles of 1000 tablets Storage Store at 20°-25°C (68°-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. 1 Registered trademark of Alza Corporation. 2 Trademark of Paddock Laboratories, Inc. Manufactured in Slovenia by Lek Pharmaceuticals d.d. for Sandoz Inc., Princeton, NJ 08540 Product of India. Rev. February 2015
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