LIPITOR- atorvastatin calcium tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

atorvastatin calcium (UNII: 48A5M73Z4Q) (atorvastatin - UNII:A0JWA85V8F)

Disponible des:

Rebel Distributors Corp

Designació comuna internacional (DCI):

atorvastatin calcium

Composición:

atorvastatin 40 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, LIPITOR 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, LIPITOR is 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 disease, but with multiple risk factors for coronary hea

Resumen del producto:

40 mg tablets: coded "PD 157" on one side and "40" on the other. NDC 21695-245-90 bottles of 90 Storage Store at controlled room temperature 20 – 25°C (68 – 77°F) [see USP].

Estat d'Autorització:

New Drug Application

Fitxa tècnica

LIPITOR- ATORVASTATIN CALCIUM TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LIPITOR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LIPITOR.
LIPITOR (ATORVASTATIN CALCIUM) TABLETS FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
LIPITOR 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
LIPITOR has 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).
DOSAGE FORMS AND STRENGTHS
10, 20, 40, and 80 mg tablets (3).
CONTRAINDICATIONS
Active liver disease, which may include unexplained persistent
elevations in hepatic transaminase