ENALAPRIL MALEATE Enalapril Maleate 2.5 MG Oral Tablet
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 ).
Wockhardt USA LLC.
ROUND WHITE W 923
W 923 ROUND WHITE
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HOW SUPPLIED Enalapril Maleate Tablets, USP NDC number Strength Description Quantity NDC 64679-923-01 2.5 mg white, round flat-faced beveled 90’s bottle NDC 64679-923-02 edged, compressed tablets with W 100’s bottle NDC 64679-923-03 923 on one side and breakline 1000’s bottle NDC 64679-923-07 on the other side. Unit Dose Carton of 100 NDC 64679-924-01 5 mg white, round flat-faced beveled 90’s bottle NDC 64679-924-02 edged, compressed tablets with W 100’s bottle NDC 64679-924-03 924 on one side and breakline 1000’s bottle NDC 64679-924-07 on the other side. Unit Dose Carton of 100 NDC 64679-925-01 10 mg Light salmon, round flat-faced 90’s bottle NDC 64679-925-02 beveled edged, compressed tablets 100’s bottle NDC 64679-925-03 with W 925 on one side, plain on the 1000’s bottle NDC 64679-925-07 other side. Unit Dose Carton of 100 NDC 64679-926-01 20 mg Light beige, round flat-faced 90’s bottle NDC 64679-926-02 beveled edged, compressed tablets 100’s bottle NDC 64679-926-03 with W 926 on one side, plain on the 1000’s bottle NDC 64679-926-07 other side. Unit Dose Carton of 100 Storage Store below 25°C (77°F); excursion permitted to 15-30°C (59-86°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. ----------------------------------------------- # Trademark of Paddock Laboratories, Inc. Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.041018
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