Country: United States
Language: English
Source: NLM (National Library of Medicine)
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)
Greenstone LLC
ATORVASTATIN CALCIUM TRIHYDRATE
ATORVASTATIN 10 mg
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: 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
10 mg tablets (10 mg of atorvastatin): coded "PD 155" on one side and "10" on the other. NDC 59762-0155-1 bottles of 90 NDC 59762-0155-2 bottles of 1000 20 mg tablets (20 mg of atorvastatin): coded "PD 156" on one side and "20" on the other. NDC 59762-0156-1 bottles of 90 NDC 59762-0156-2 bottles of 1000 40 mg tablets (40 mg of atorvastatin): coded "PD 157" on one side and "40" on the other. NDC 59762-0157-1 bottles of 90 NDC 59762-0157-2 bottles of 500 80 mg tablets (80 mg of atorvastatin): coded "PD 158" on one side and "80" on the other. NDC 59762-0158-1 bottles of 90 NDC 59762-0158-2 bottles of 500 Storage Store at controlled room temperature 20 – 25°C (68 – 77°F) [see USP].
New Drug Application Authorized Generic
ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED GREENSTONE LLC ---------- 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 USE INITIAL U.S. APPROVAL: 1996 RECENT MAJOR CHANGES Warnings and Precautions, Myopathy and Rhabdomyolysis (5.1) 11/2020 Warnings and Precautions, Immune-Mediated Necrotizing Myopathy (5.2) 9/2020 INDICATIONS AND USAGE Atorvastatin calcium 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 reduction (>45%) may start at 40 mg once daily (2.1). Pediatric patients wit Read the complete document