ATORVASTATIN CALCIUM- atorvastatin calcium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

ATORVASTATIN CALCIUM TRIHYDRATE

Composition:

ATORVASTATIN 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 w

Product summary:

Atorvastatin Calcium Tablets are supplied as white, round, film-coated tablets of atorvastatin calcium containing 40 mg atorvastatin. 40 mg tablets: debossed with "40" on one side and plain on the other. NDC 68071-3047-3 bottles of 30 NDC 68071-3047-6 bottles of 60 Storage Store at controlled room temperature 20 - 25°C (68 - 77°F) [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
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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 ADMINISTRATION
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Atorvastatin Calcium Tablets 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 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).
CONTRAINDIC