enalapril maleate 20 MG Oral Tablet Vasotec
INDICATIONS AND USAGE Hypertension VASOTEC is indicated for the treatment of hypertension. VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive. Heart Failure VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC 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), VASOTEC 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 VASOTEC 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 VASOTEC does not have a similar risk (see WARNINGS , Neutropenia/Agranulocytosis ). In considering use of VASOTEC, 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 ).
Valeant Pharmaceuticals North America LLC
TRIANGLE PINK VASO 20
VASO 20 TRIANGLE PINK
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HOW SUPPLIED VASOTEC (
ENALAPRIL MALEATE) Tablets NDC Strength Quantity Description 0187-0140-30 2.5 mg Bottles of 30 (with desiccant) white, oval shaped tablet imprinted with “VASO 2.5” and scored on one side and scored on the other. 0187-0140-90 Bottles of 90 (with desiccant) 0187-0141-30 5 mg Bottles of 30 (with desiccant) white, rounded triangle shaped tablet imprinted with “VASO 5” on one side and scored on the other. 0187-0141-90 Bottles of 90 (with desiccant) 0187-0142-30 10 mg Bottles of 30 (with desiccant) Rust red, rounded triangle shaped tablet imprinted with “VASO 10” on one side and scored on the other. 0187-0142-90 Bottles of 90 (with desiccant) 0187-0142-10 Bottles of 1,000 (with desiccant) 0187-0143-30 20 mg Bottles of 30 (with desiccant) peach, rounded triangle shaped tablet imprinted with “VASO 20” on one side and scored on the other. 0187-0143-90 Bottles of 90 (with desiccant) 0187-0143-10 Bottles of 1,000 (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.
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