atorvastatin 10 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.
mylan pharmaceuticals inc.
OVAL WHITE 10
10 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
ATORVASTATIN CALCIUM Tablets, USP are available containing
ATORVASTATIN CALCIUM, USP equivalent to 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin. The 10 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 10 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3950-77 bottles of 90 tablets NDC 0378-3950-05 bottles of 500 tablets The 20 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 20 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3951-77 bottles of 90 tablets NDC 0378-3951-05 bottles of 500 tablets The 40 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 40 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3952-77 bottles of 90 tablets NDC 0378-3952-05 bottles of 500 tablets The 80 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with 80 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3953-77 bottles of 90 tablets NDC 0378-3953-05 bottles of 500 tablets 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 using a child-resistant closure.
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