atorvastatin calcium tablet
1 INDICATIONS AND USAGE Atorvastatin calcium is 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 is an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): To reduce the risk of о Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD о MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD о 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: о Adults with primary hyperlipidemia о 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: о Primary dysbetaliproteinemia о Hypertriglyceridemia
lupin pharmaceuticals, inc.
OVAL WHITE LU A18
LU A18 OVAL WHITE
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atorvastatin calcium 10 mg
lupin pharmaceuticals, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 10 mg tablets (10 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A16" on the other side. NDC 68180-635-06 bottles of 30 NDC 68180-635-09 bottles of 90 NDC 68180-635-02 bottles of 500 20 mg tablets (20 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A17" on the other side. NDC 68180-636-06 bottles of 30 NDC 68180-636-09 bottles of 90 NDC 68180-636-02 bottles of 500 40 mg tablets (40 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A18" on the other side. NDC 68180-637-06 bottles of 30 NDC 68180-637-09 bottles of 90 NDC 68180-637-02 bottles of 500 80 mg tablets (80 mg of atorvastatin): white to off white, elliptical, film coated tablets debossed with "LU" on one side and "A19" on the other side. NDC 68180-638-06 bottles of 30 NDC 68180-638-09 bottles of 90 NDC 68180-638-02 bottles of 500 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]
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