Country: United States
Language: English
Source: NLM (National Library of Medicine)
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
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. 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 hear
Atorvastatin calcium tablets USP, 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s. Bottles of 30 NDC 55111-121-30 Bottles of 60 NDC 55111-121-60 Bottles of 90 NDC 55111-121-90 Bottles of 500 NDC 55111-121-05 Bottles of 1000 NDC 55111-121-10 Atorvastatin calcium tablets USP, 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s. Bottles of 30 NDC 55111-122-30 Bottles of 60 NDC 55111-122-60 Bottles of 90 NDC 55111-122-90 Bottles of 500 NDC 55111-122-05 Bottles of 1000 NDC 55111-122-10 Atorvastatin calcium tablets USP, 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s. Bottles of 30 NDC 55111-123-30 Bottles of 60 NDC 55111-123-60 Bottles of 90 NDC 55111-123-90 Bottles of 500 NDC 55111-123-05 Bottles of 1000 NDC 55111-123-10 Storage Store atorvastatin calcium tablets at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ATORVASTATIN CALCIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM TABLETS, FOR ORAL ADMINISTRATION INITIAL U.S. APPROVAL: 1996 RECENT MAJOR CHANGES Dosage and Administration, Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors (2.6) 4/2019 Warnings and Precautions, Skeletal Muscle (5.1) 4/2019 INDICATIONS AND USAGE Atorvastatin calcium tablet is 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). DOSAGE AND ADMINISTRATION Dose range: 10 to 80 mg once daily ( 2.1). Recommended start dose: 10 or 20 mg once daily ( 2.1). Patients requiring large LDL-C reduct Read the complete document