Country: United States
Language: English
Source: NLM (National Library of Medicine)
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)
NCS HealthCare of KY, Inc dba Vangard Labs
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: - Reduce the risk of myocardial infarction - Reduce the risk of stroke - Reduce the risk for revascularization procedures and angina In patients with type 2 diabetes, and without clinically evident coronary heart dise
Atorvastatin calcium tablets of 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 blistercards of 30’s and 15's. Blistercards of 30 NDC 0615-7769-39 Blistercards of 15 NDC 0615-7769-05 Unit-Dose Boxes of 30 NDC 0615-7769-30 Atorvastatin calcium tablets of 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 blistercards of 30’s and 15’s. Blistercards of 30 NDC 0615-7770-39 Blistercards of 15 NDC 0615-7770-05 Unit-Dose Boxes of 30 NDC 0615-7770-30 Atorvastatin calcium tablets of 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 blistercard of 30’s and 15’s. Blistercards of 30 NDC 0615-7771-39 Blistercards of 15 NDC 0615-7771-05 Unit-Dose Boxes of 30 NDC 0615-7771-30 Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ATORVASTATIN CALCIUM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATORVASTATIN CALCIUM. ATORVASTATIN CALCIUM TABLETS FOR ORAL ADMINISTRATION INITIAL U.S. APPROVAL: 1996 RECENT MAJOR CHANGES Dosage and Administration (2.6) 10/2012 Warnings and Precautions (5.1) 10/2012 INDICATIONS AND USAGE Atorvastatin calcium tablet is an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to: Reduce the risk of MI, stroke, revascularization procedures, and angina in patients without CHD, but with multiple risk factors (1.1). Reduce the risk of MI and stroke in 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 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 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 boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia 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. 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 starting dose: 10 mg once daily; maximum recommended dose: 20 mg once daily (2.2). Read the complete document