ezetimibe and simvastatin tablet
1 INDICATIONS AND USAGE Ezetimibe and simvastatin tablets Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin Simvastatin, when used as a component of ezetimibe and simvastatin tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. Ezetimibe and simvastatin tablets are a combination of ezetimibe, a dietary cholesterol absorption inhibitor, and simvastatin, an HMG-CoA reductase inhibitor (statin) indicated: ( 1 ) As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin Simvastatin, when used as a component of ezetimibe and simvastatin tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
actavis pharma, inc.
ROUND BROWN Logo 512
Logo 512 ROUND BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING
EZETIMIBE AND SIMVASTATIN tablets are supplied as follows: Strength How Supplied NDC Tablet Description 10 mg/10 mg unit of use bottles of 30 45963-565-30 Light tan, slightly speckled, round, unscored, biconvex tablet debossed with 511 on one side and on opposite side. unit of use bottles of 90 45963-565-08 10 mg/20 mg unit of use bottles of 30 45963-566-30 Light tan, slightly speckled, round, unscored, biconvex tablet debossed with 512 on one side and on opposite side. unit of use bottles of 90 45963-566-08 10 mg/40 mg unit of use bottles of 30 45963-567-30 Light tan, slightly speckled, round, unscored, biconvex tablet debossed with 513 on one side and on opposite side. unit of use bottles of 90 45963-567-08 10 mg/80 mg unit of use bottles of 30 45963-568-30 Light tan, slightly speckled, capsule shaped, unscored, biconvex tablet debossed with 515 on one side and on opposite side. unit of use bottles of 90 45963-568-08 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep container tightly closed. Dispense in a tight, light-resistant container as defined in the USP. 1 1 1 1
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