icosapent ethyl 1000 MG Oral Capsule Vascepa
1 INDICATIONS AND USAGE VASCEPA ® (icosapent ethyl) is indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels(≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. ( 1 ) as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. ( 1 ) Limitations of Use: The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. ( 1 )
Amarin Pharma Inc.
OVAL YELLOW Vascepa
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16 HOW SUPPLIED/STORAGE AND HANDLING VASCEPA (
ICOSAPENT ETHYL) capsules are supplied as Strength Quantity Description NDC 0.5 gram capsules Bottles of 240 amber-colored soft-gelatin capsules imprinted with V500 52937-003-40 1 gram capsules Bottles of 120 amber-colored soft-gelatin capsules imprinted with VASCEPA 52937-001-20 Store at 20° to 25° C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F) [see USP Controlled Room Temperature].
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