ezetimibe 10 mg simvastatin 80 mg
1 INDICATIONS AND USAGE Ezetimibe and simvastatin tablets Ezetimibe and simvastatin tablet is 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). Simv a statin 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 tablet is 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.
aurobindo pharma limited
OVAL WHITE TS 4
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16 HOW SUPPLIED/STORAGE AND HANDLING
EZETIMIBE AND SIMVASTATIN Tablets are available containing 10 mg of ezetimibe, USP and 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP, providing for the following combinations: 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg or 10 mg/80 mg. The 10 mg/10 mg tablets are white, oval, biconvex tablets debossed with “TS†on one side of the tablet and “1†on the other side. They are available as follows: Bottles of 30 NDC 59651-835-30 Bottles of 90 NDC 59651-835-90 The 10 mg/20 mg tablets are white, oval, biconvex tablets debossed with “TS†on one side of the tablet and “2†on the other side. They are available as follows: Bottles of 30 NDC 59651-836-30 Bottles of 90 NDC 59651-836-90 The 10 mg/40 mg tablets are white, oval, biconvex tablets debossed with “TS†on one side of the tablet and “3†on the other side. They are available as follows: Bottles of 30 NDC 59651-837-30 Bottles of 90 NDC 59651-837-90 The 10 mg/80 mg tablets are white, oval, biconvex tablets debossed with “TS†on one side of the tablet and “4†on the other side. They are available as follows: Bottles of 30 NDC 59651-838-30 Bottles of 90 NDC 59651-838-90 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed.
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