atorvastatin calcium 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.
MSN LABORATORIES PRIVATE LIMITED
OVAL WHITE MA 1
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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 30 69539-093-30 white coloured, oval shaped, biconvex, film-coated tablets with "MA" on one side and "1" on other side. bottles of 90 69539-093-90 bottles of 500 69539-093-05 bottles of 1000 69539-093-99 20 mg of atorvastatin bottles of 30 69539-094-30 20 mg of atorvastatin: white coloured, oval shaped, biconvex, film-coated tablets with "MA" on one side and "2" on other side. bottles of 90 69539-094-90 bottles of 500 69539-094-05 bottles of 1000 69539-094-99 40 mg of atorvastatin bottles of 30 69539-095-30 40 mg of atorvastatin: white coloured, oval shaped, biconvex, film-coated tablets with "MA" on one side and "3" on other side. bottles of 90 69539-095-90 bottles of 500 69539-095-05 bottles of 1000 69539-095-99 80 mg of atorvastatin bottles of 30 69539-096-30 80 mg of atorvastatin: white coloured, oval shaped, biconvex, film-coated tablets with "MA" on one side and "4" on other side. bottles of 90 69539-096-90 bottles of 500 69539-096-05 bottles of 1000 69539-096-99 Storage Store at controlled room temperature 20º to 25ºC (68º to 77ºF).
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