Atorvastatin 80 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: 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 dysbetaliproteinemia. Hypertriglyceridemia.
Mylan Institutional Inc.
OVAL WHITE 80
80 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 51079-208-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 51079-209-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 51079-210-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 51079-211-03 – Unit dose blister packages of 30 (5 cards of 6 tablets each). Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
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