atorvastatin calcium tablet film coated
1 INDICATIONS AND USAGE Atorvastatin calcium tablets are indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD 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: Adults with primary hyperlipidemia. 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: Primary dysbetalipoproteinemia Hypertriglyceridemia Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. 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: Adults with primary hyperlipidemia. 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: Primary dysbetaliproteinemia. Hypertriglyceridemia.
teva pharmaceuticals usa, inc.
OVAL WHITE TV 5057
TV 5057 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
ATORVASTATIN CALCIUM tablets, USP are available as follows: 10 mg - white to off-white, oval shaped, film-coated tablet, debossed with "TV" on one side and "5056" on the other side of the tablet. Available in bottles of 90 tablets (NDC 0093-5056-98) and 1,000 tablets (NDC 0093-5056-10). 20 mg - white to off-white, oval shaped, film-coated tablet, debossed with "TV" on one side and "5059" on the other side of the tablet. Available in bottles of 90 tablets (NDC 0093-5059-98) and 1,000 tablets (NDC 0093-5059-10). 40 mg - white to off-white, oval shaped, film-coated tablet, debossed with "TV" on one side and "5058" on the other side of the tablet. Available in bottles of 90 tablets (NDC 0093-5058-98) and 1,000 tablets (NDC 0093-5058-10). 80 mg - white to off-white, oval shaped, film-coated tablet, debossed with "TV" on one side and "5057" on the other side of the tablet. Available in bottles of 90 tablets (NDC 0093-5057-98) and 500 tablets (NDC 0093-5057-05). 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, with a child-resistant closure (as required).
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