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atorvastatin 20 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 dysbetalipoproteinemia. o Hypertriglyceridemia.

Camber Pharmaceuticals, Inc.


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1 month ago OVAL WHITE A54 20 atorvastatin 20 mg

OVAL WHITE A54 20

16 HOW SUPPLIED/STORAGE AND HANDLING

ATORVASTATIN CALCIUM Tablets, USP are supplied as follows: Strength How Supplied NDC Tablet Description 10 mg of atorvastatin bottles of 90 NDC 31722-424-90 white to off-white, oval, biconvex film coated tablets debossed with '10' on one side and 'A 53' on other side bottles of 500 NDC 31722-424-05 bottles of 1000 NDC 31722-424-10 20 mg of atorvastatin bottles of 90 NDC 31722-425-90 white to off-white, oval, biconvex film coated tablets debossed with '20' on one side and 'A 54' on other side bottles of 500 NDC 31722-425-05 bottles of 1000 NDC 31722-425-10 40 mg of atorvastatin bottles of 90 NDC 31722-426-90 white to off-white, oval, biconvex film coated tablets debossed with '40' on one side and 'A 55' on other side bottles of 500 NDC 31722-426-05 bottles of 1000 NDC 31722-426-10 80 mg of atorvastatin bottles of 90 NDC 31722-427-90 white to off-white, oval, biconvex film coated tablets debossed with '80' on one side and 'A 56' on other side bottles of 500 NDC 31722-427-05 bottles of 1000 NDC 31722-427-10 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


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