Country: United States
Language: English
Source: NLM (National Library of Medicine)
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)
Teva Pharmaceuticals USA, Inc.
ATORVASTATIN CALCIUM TRIHYDRATE
ATORVASTATIN 10 mg
ORAL
PRESCRIPTION DRUG
Atorvastatin calcium tablets are indicated: - To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD - Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD - MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD - Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD
Atorvastatin calcium tablets, USP are available as follows: 10 mg - White to off-white, oval shaped, film-coated tablet, debossed with "TV" on one side and "5056" on the other side of the tablet. Available in bottles of 90 tablets (NDC 0093-5056-98) and 1,000 tablets (NDC 0093-5056-10). 20 mg - White to off-white, oval shaped, film-coated tablet, debossed with "TV" on one side and "5059" on the other side of the tablet. Available in bottles of 90 tablets (NDC 0093-5059-98) and 1,000 tablets (NDC 0093-5059-10). 40 mg - White to off-white, oval shaped, film-coated tablet, debossed with "TV" on one side and "5058" on the other side of the tablet. Available in bottles of 90 tablets (NDC 0093-5058-98) and 1,000 tablets (NDC 0093-5058-10). 80 mg - White to off-white, oval shaped, film-coated tablet, debossed with "TV" on one side and "5057" on the other side of the tablet. Available in bottles of 90 tablets (NDC 0093-5057-98) and 500 tablets (NDC 0093-5057-05). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED TEVA PHARMACEUTICALS USA, 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 USE INITIAL U.S. APPROVAL: 1996 RECENT MAJOR CHANGES Contraindications, Pregnancy and Lactation (4) Removed 12/2022 Warnings and Precautions, CNS Toxicity (5.5) Removed 12/2022 INDICATIONS AND USAGE Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated (1): To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. 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: Adults with primary hyperlipidemia. 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: Primary dysbetaliproteinemia. Hypertriglyceridemia. DOSAGE AND ADMINISTRATION Take orally once daily with or without food (2.1). Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablet, and adjust dosage if necessary (2.1). _Adults (2.2):_ Recommended starting dosage is 10 or 20 mg once daily; dosage range is 10 mg to 80 mg once daily. Patients requiring LDL-C reduction >45% may start at 40 mg once dai Read the complete document