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atorvastatin 10 MG Oral Tablet

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 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.

Sun Pharmaceutical Industries Inc.


2 years ago OVAL WHITE RX 12 atorvastatin 10 MG Oral Tablet

OVAL WHITE RX 12

2 years ago OVAL WHITE RX 12 atorvastatin 10 MG Oral Tablet

RX 12 OVAL WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

ATORVASTATIN CALCIUM tablets, USP 10 mg are white, elliptical, film-coated tablets, debossed with ‘ RX 12 ’ on one side and plain on the other side. These are supplied as follows: NDC 63304-827-90 Bottles of 90 NDC 63304-827-05 Bottles of 500

ATORVASTATIN CALCIUM tablets, USP 20 mg are white, elliptical, film-coated tablets, debossed with ‘ RX 828 ’ on one side and plain on the other side. These are supplied as follows: NDC 63304-828-90 Bottles of 90 NDC 63304-828-05 Bottles of 500

ATORVASTATIN CALCIUM tablets, USP 40 mg are white, elliptical, film-coated tablets, debossed with ‘ RX 829 ’ on one side and plain on the other side. These are supplied as follows: NDC 63304-829-90 Bottles of 90 NDC 63304-829-05 Bottles of 500

ATORVASTATIN CALCIUM tablets, USP 80 mg are white, elliptical, film-coated tablets, debossed with ‘ RX 830 ’ on one side and plain on the other side. These are supplied as follows: NDC 63304-830-90 Bottles of 90 NDC 63304-830-05 Bottles of 500 Storage Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Dispense in tight containers (USP).


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