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): o In adults with primary hyperlipidemia. o 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): o In adults with primary hyperlipidemia. o 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.
glenmark pharmaceuticals inc., usa
OVAL WHITE G 321
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16 HOW SUPPLIED/STORAGE AND HANDLING
EZETIMIBE AND SIMVASTATIN Tablets 10 mg/10 mg are white to off-white, capsule shaped, uncoated tablets debossed with ‘G’ on one side and ‘321’ on the other side. They are supplied as follows: Bottles of 30 NDC 68462-321-30 Bottles of 90 NDC 68462-321-90 Bottles of 1000 NDC 68462-321-10
EZETIMIBE AND SIMVASTATIN Tablets 10 mg/20 mg are white to off-white, capsule shaped, uncoated tablets debossed with ‘G’ on one side and ‘322’ on the other side. They are supplied as follows: Bottles of 30 NDC 68462-322-30 Bottles of 90 NDC 68462-322-90 Bottles of 1000 NDC 68462-322-10
EZETIMIBE AND SIMVASTATIN Tablets 10 mg/40 mg are white to off-white, capsule shaped, uncoated tablets debossed with ‘G’ on one side and ‘323’ on the other side. They are supplied as follows: Bottles of 30 NDC 68462-323-30 Bottles of 90 NDC 68462-323-90 Bottles of 500 NDC 68462-323-05
EZETIMIBE AND SIMVASTATIN Tablets 10 mg/80 mg are white to off-white, capsule shaped, uncoated tablets debossed with ‘G’ on one side and ‘324’ on the other side. They are supplied as follows: Bottles of 30 NDC 68462-324-30 Bottles of 90 NDC 68462-324-90 Bottles of 500 NDC 68462-324-05 Storage Store at 68°F to 77°F (20°C to 25°C) [see USP Controlled Room Temperature]. Keep container tightly closed.
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