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atorvastatin 20 MG Oral Tablet

1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet. Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors ( 1.1 ). Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors ( 1.1 ). Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adult patients with CHD ( 1.1 ). Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( 1.2 ). Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia ( 1.2 ). Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) ( 1.2 ). Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy ( 1.2 ). Limitations of Use: Atorvastatin calcium tablets have not been studied in Fredrickson Types I and V dyslipidemias ( 1.3 ). 1.1 Prevention of Cardiovascular Disease in Adults In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: Reduce the risk of myocardial infarction Reduce the risk of stroke Reduce the risk for revascularization procedures and angina In adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to: Reduce the risk of myocardial infarction Reduce the risk of stroke In adult patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to: Reduce the risk of non-fatal myocardial infarction Reduce the risk of fatal and non-fatal stroke Reduce the risk for revascularization procedures Reduce the risk of hospitalization for CHF Reduce the risk of angina 1.2 Hyperlipidemia Atorvastatin calcium tablets are indicated: As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( Fredrickson Types IIa and IIb); As an adjunct to diet for the treatment of adult patients with elevated serum TG levels ( Fredrickson Type IV); For the treatment of adult patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet; To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable; As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients,10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following findings are present: LDL-C remains ≥ 190 mg/dL or LDL-C remains ≥ 160 mg/dL and: there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the pediatric patient 1.3 Limitations of Use Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons ( Fredrickson Types I and V).

biocon pharma inc.,


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9 months ago OVAL WHITE 114 atorvastatin 20 MG Oral Tablet

OVAL WHITE 114

9 months ago OVAL WHITE 114 atorvastatin 20 MG Oral Tablet

114 OVAL WHITE

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 shaped tablet plain on one side and debossed with '11' on other side. They are available as follows: Bottles of 90 tablets with child-resistant closure, NDC 70377-027-11 Bottles of 500 tablets, NDC 70377-027-12 Bottles of 1,000 tablets, NDC 70377-027-13 The 20 mg tablets are white to off-white, film-coated, oval shaped tablet plain on one side and debossed with '114' on other side. They are available as follows: Bottles of 90 tablets with child-resistant closure, NDC 70377-028-11 Bottles of 500 tablets, NDC 70377-028-12 Bottles of 1,000 tablets, NDC 70377-028-13 The 40 mg tablets are white to off-white, film-coated, oval shaped tablet plain on one side and debossed with '115'on other side. They are available as follows: Bottles of 90 tablets with child-resistant closure, NDC 70377-029-11 Bottles of 500 tablets, NDC 70377-029-12 Bottles of 1,000 tablets, NDC 70377-029-13 The 80 mg tablets are white to off-white, film-coated, oval shaped tablet plain on one side and debossed with '116'on other side. They are available as follows: Bottles of 30 tablets with child-resistant closure, NDC 70377-030-11 Bottles of 90 tablets with child-resistant closure, NDC 70377-030-12 Bottles of 500 tablets, NDC 70377-030-13 Bottles of 1,000 tablets, NDC 70377-030-14 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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