ATORVASTATIN CALCIUM tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)

Disponible des:

Greenstone LLC

Designació comuna internacional (DCI):

ATORVASTATIN CALCIUM TRIHYDRATE

Composición:

ATORVASTATIN 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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].

Estat d'Autorització:

New Drug Application Authorized Generic

Fitxa tècnica

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