enalapril maleate 5 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 tablets USP 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 USP improves 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 USP decreases the rate of development of overt heart failure and decreases 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 USP 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 USP does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis). In considering use of enalapril maleate tablets USP, 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 ).
Cronus Pharma LLC
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HOW SUPPLIED Enalapril maleate tablets USP, 2.5 mg are available as yellow, oval, convex tablets debossed "704" on one side and bisect on the other side. They are supplied as follows: NDC 69043-035-01 bottles of 100 (with desiccant) NDC 69043-035-99 bottles of 1000 (with desiccant) Enalapril maleate tablets USP, 5 mg are available as white, oval, convex tablets debossed "705" on one side and bisect on the other side. They are supplied as follows: NDC 69043-032-01 bottles of 100 (with desiccant) NDC 69043-032-99 bottles of 1000 (with desiccant) Enalapril maleate tablets USP, 10 mg are available as salmon, oval, convex tablets debossed "706" on one side and plain on the other side. They are supplied as follows: NDC 69043-033-01 bottles of 100 (with desiccant) NDC 69043-033-99 bottles of 1000 (with desiccant) Enalapril maleate tablets USP, 20 mg are available as peach, oval, convex tablets debossed "707" on one side and plain on the other side. They are supplied as follows: NDC 69043-034-01 bottles of 100 (with desiccant) NDC 69043-034-99 bottles of 1000 (with desiccant) Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°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. All brand names listed are the registered trademarks of their respective owners and are not the trademarks of Chronus Pharma LLC. Manufactured for: Cronus Pharma LLC 2 Tower Center Boulevard, Suite 1101A, East Brunswick, NJ, 08816 USA 51UCP0000009US02 Revised: 01/2021 Image
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