enalapril maleate 20 mg
INDICATIONS AND USAGE Hypertension Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive. Heart Failure Enalapril maleate tablets 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, increase survival, and decrease 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 ā¤35 percent), enalapril maleate tablets 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 tablets 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 do not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis ). In considering use of enalapril maleate tablets, 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 ).
Solco Healthcare US, LLC
ROUND YELLOW S 11
S 11 ROUND YELLOW
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HOW SUPPLIED
ENALAPRIL MALEATE Tablets, USP NDC Number Strength Quantity Description 43547-545-03 2.5 mg Bottles of 30 with child-resistant closure (with desiccant) white, oval shaped scored tablet, debossed with āS 1ā and scored on one side, āSā and ā1ā are separated by the score and plain on the other side. 43547-545-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-545-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-545-50 Bottles of 500 (with desiccant) 43547-545-11 Bottles of 1,000 (with desiccant) 43547-546-03 5 mg Bottles of 30 with child-resistant closure (with desiccant) white, rounded triangle shaped scored tablet debossed with āS 6ā on one side and scored on the other side. 43547-546-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-546-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-546-50 Bottles of 500 (with desiccant) 43547-546-11 Bottles of 1,000 (with desiccant) 43547-547-03 10 mg Bottles of 30 with child-resistant closure (with desiccant) red, rounded triangle shaped scored tablet debossed with āS 7ā on one side and scored on the other side. 43547-547-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-547-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-547-50 Bottles of 500 (with desiccant) 43547-547-11 Bottles of 1,000 (with desiccant) 43547-548-03 20 mg Bottles of 30 with child-resistant closure (with desiccant) yellow, round scored tablet, debossed with āS 11ā and scored on one side, āS 11ā is on one side of the score and plain on the other side. 43547-548-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-548-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-548-50 Bottles of 500 (with desiccant) 43547-548-11 Bottles of 1,000 (with desiccant) Storage Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted to 15Ā° to 30Ā°C (59Ā° to 86Ā°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. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised: 03/2022 203419-01
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