enalapril maleate 10 mg
INDICATIONS AND USAGE Hypertension Enalapril maleate is indicated for the treatment of hypertension. Enalapril maleate is 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 is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate 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 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 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, Neutropenia/Agranulocytosis ). 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 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 ).
taro pharmaceuticals u.s.a., inc.
ROUND WHITE T 10
T 10 ROUND WHITE
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HOW SUPPLIED
ENALAPRIL MALEATE Tablets USP, 2.5 mg are yellow colored, round, biconvex tablets. One side scored and engraved with "T" above the score and "2" below. The other side plain. They are supplied as follows: NDC 51672-4037-1 unit of use bottles of 100 (with desiccant) NDC 51672-4037-3 unit of use bottles of 1,000 (with desiccant)
ENALAPRIL MALEATE Tablets USP, 5 mg are yellow colored, round, biconvex tablets. One side scored and engraved with "T" above the score and "5" below. The other side plain. They are supplied as follows: NDC 51672-4038-1 unit of use bottles of 100 (with desiccant) NDC 51672-4038-3 unit of use bottles of 1,000 (with desiccant)
ENALAPRIL MALEATE Tablets USP, 10 mg are white colored, round, biconvex tablets. One side scored and engraved with "T" above the score and with "10" under the score. The other side plain. They are supplied as follows: NDC 51672-4245-1 unit of use bottles of 100 (with desiccant) NDC 51672-4245-3 unit of use bottles of 1,000 (with desiccant)
ENALAPRIL MALEATE Tablets USP, 20 mg are peach colored, round, biconvex, slightly speckled tablets. One side scored and engraved with "T" above the score and with "20" under the score. The other side plain. They are supplied as follows: NDC 51672-4040-1 unit of use bottles of 100 (with desiccant) NDC 51672-4040-3 unit of use bottles of 1,000 (with desiccant) Storage Store at 20° to 25°C (68° to 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.
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