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ezetimibe and simvastatin tablet

1 INDICATIONS AND USAGE Ezetimibe and Simvastatin Tablets Ezetimibe and Simvastatin Tablets are a combination of simvastatin and ezetimibe indicated: ā€¢ 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). ā€¢ 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 ) ā€¢ 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). ā€¢ 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


4 years ago OVAL WHITE G 321 ezetimibe and simvastatin tablet

OVAL WHITE G 321

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 ā€˜Gā€™ on one side and ā€˜321ā€™ 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 ā€˜Gā€™ on one side and ā€˜322ā€™ 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 ā€˜Gā€™ on one side and ā€˜323ā€™ 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 ā€˜Gā€™ on one side and ā€˜324ā€™ 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 68Ā°F to 77Ā°F (20Ā°C to 25Ā°C) [see USP Controlled Room Temperature]. Keep container tightly closed.


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