atorvastatin 10 MG Oral Tablet
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 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.
Sun Pharmaceutical Industries Inc.
OVAL WHITE RX 12
RX 12 OVAL WHITE
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atorvastatin 10 MG Oral Tablet
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16 HOW SUPPLIED/STORAGE AND HANDLING
ATORVASTATIN CALCIUM tablets, USP are supplied as follows: Strength How Supplied NDC Tablet Description 10 mg of atorvastatin bottles of 90 bottles of 500 63304-827-90 63304-827-05 white, elliptical, film-coated tablets, debossed with ‘RX 12’ on one side and plain on the other side 20 mg of atorvastatin bottles of 90 bottles of 500 63304-828-90 63304-828-05 white, elliptical, film-coated tablets, debossed with ‘RX 828’ on one side and plain on the other side 40 mg of atorvastatin bottles of 90 bottles of 500 63304-829-90 63304-829-05 white, elliptical, film-coated tablets, debossed with ‘RX 829’ on one side and plain on the other side 80 mg of atorvastatin bottles of 90 bottles of 500 63304-830-90 63304-830-05 white, elliptical, film-coated tablets, debossed with ‘RX 830’ on one side and plain on the other side Storage Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Dispense in tight containers (USP).
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