atorvastatin calcium 40 mg
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: 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.
Biocon Pharma Inc.
OVAL WHITE A4
A4 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
ATORVASTATIN CALCIUM tablets 10 mg debossed with “A6” on one side and plain on the other side. HDPE Bottle 90's count with child resistant closure NDC 70377-077-11 HDPE Bottle 500's count NDC 70377-077-12 HDPE Bottle 1000's count NDC 70377-077-13
ATORVASTATIN CALCIUM tablets 20 mg debossed with “A5” on one side and plain on the other side. HDPE Bottle 90's count with child resistant closure NDC 70377-078-11 HDPE Bottle 500's count NDC 70377-078-12 HDPE Bottle 1000's count NDC 70377-078-13
ATORVASTATIN CALCIUM tablets 40 mg debossed with “A4” on one side and plain on the other side. HDPE Bottle 90's count with child resistant closure NDC 70377-079-11 HDPE Bottle 500's count NDC 70377-079-12 HDPE Bottle 1000's count NDC 70377-079-13
ATORVASTATIN CALCIUM tablets 80 mg debossed with “A3” on one side and plain on the other side. HDPE Bottle 90's count with child resistant closure NDC 70377-080-11 HDPE Bottle 500's count NDC 70377-080-12 HDPE Bottle 1000's count NDC 70377-080-13 Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
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