atorvastatin 10 mg
1 INDICATIONS AND USAGE Atorvastatin calcium tablets are indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. • As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in: o Adults with primary hyperlipidemia. o 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 and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. • As an adjunct to diet for the treatment of adults with: o Primary dysbetaliproteinemia. o Hypertriglyceridemia.
sandoz inc
ROUND YELLOW HLA 10
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16 HOW SUPPLIED/STORAGE AND HANDLING Atorvastatin calcium tablets are supplied as follows: 10 mg, light yellow, dappled, glossy, round biconvex film-coated tablets, debossed with “HLA 10” on one side. Bottles contain desiccant. NDC 0781-5381-31, bottle of 30 tablets NDC 0781-5381-92, bottle of 90 tablets NDC 0781-5381-01, bottle of 100 tablets NDC 0781-5381-10, bottle of 1000 tablets NDC 0781-5381-34, bottle of 3000 tablets 20 mg, light yellow, dappled, glossy, round biconvex film-coated tablets, debossed with “HLA 20” on one side. Bottles contain desiccant. NDC 0781-5382-31, bottle of 30 tablets NDC 0781-5382-92, bottle of 90 tablets NDC 0781-5382-01, bottle of 100 tablets NDC 0781-5382-10, bottle of 1000 tablets NDC 0781-5382-34, bottle of 3000 tablets 40 mg, light yellow, dappled, glossy, round biconvex film-coated tablets, debossed with “HLA 40” on one side. Bottles contain desiccant. NDC 0781-5384-31, bottle of 30 tablets NDC 0781-5384-92, bottle of 90 tablets NDC 0781-5384-01, bottle of 100 tablets NDC 0781-5384-10, bottle of 1000 tablets NDC 0781-5384-22, bottle of 2000 tablets 80 mg, light yellow, dappled, glossy, oval biconvex film-coated tablets, debossed with “HLA 80” on one side. Bottles contain desiccant. NDC 0781-5388-31, bottle of 30 tablets NDC 0781-5388-92, bottle of 90 tablets NDC 0781-5388-01, bottle of 100 tablets NDC 0781-5388-10, bottle of 1000 tablets Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.
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