atorvastatin 80 MG Oral Tablet
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 is 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 dysbetalipoproteinemia. Hypertriglyceridemia.
Zydus Pharmaceuticals (USA) Inc.
OVAL WHITE 252
252 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
ATORVASTATIN CALCIUM Tablets, USP 10 mg are white to off-white, oval-shaped, beveled, biconvex, film-coated tablets debossed with '249' on one side and plain on other side and are supplied as follow: NDC 68382-249-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-249-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-249-01 in bottle of 100 tablets NDC 68382-249-05 in bottle of 500 tablets NDC 68382-249-10 in bottle of 1,000 tablets NDC 68382-249-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets
ATORVASTATIN CALCIUM Tablets, USP 20 mg are white to off-white, oval-shaped, beveled, biconvex, film-coated tablets debossed with '250' on one side and plain on other side and are supplied as follow: NDC 68382-250-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-250-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-250-01 in bottle of 100 tablets NDC 68382-250-05 in bottle of 500 tablets NDC 68382-250-10 in bottle of 1,000 tablets NDC 68382-250-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets
ATORVASTATIN CALCIUM Tablets, USP 40 mg are white to off-white, oval-shaped, beveled, biconvex, film-coated tablets debossed with '251' on one side and plain on other side and are supplied as follow: NDC 68382-251-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-251-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-251-01 in bottle of 100 tablets NDC 68382-251-05 in bottle of 500 tablets NDC 68382-251-10 in bottle of 1,000 tablets NDC 68382-251-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets
ATORVASTATIN CALCIUM Tablets, USP 80 mg are white to off-white, oval-shaped, beveled, biconvex, film-coated tablets debossed with '252' on one side and plain on other side and are supplied as follow: NDC 68382-252-06 in bottle of 30 tablets with child-resistant closure. NDC 68382-252-16 in bottle of 90 tablets with child-resistant closure. NDC 68382-252-01 in bottle of 100 tablets NDC 68382-252-05 in bottle of 500 tablets NDC 68382-252-10 in bottle of 1,000 tablets NDC 68382-252-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
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