ATORVASTATIN CALCIUM- atorvastatin calcium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

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 are indicated to:  - Reduce the risk of myocardial infarction     - Reduce the risk of stroke     - Reduce the risk for revascularization procedures and angina In adult patients with type 2 diabetes, and without clinically evident coronary hear

Product summary:

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 bottles of 30’s, 60’s, 90’s, 500's and 1000’s. Bottles of 30                                                               NDC 55111-121-30 Bottles of 60                                                               NDC 55111-121-60 Bottles of 90                                                               NDC 55111-121-90 Bottles of 500                                                             NDC 55111-121-05 Bottles of 1000                                                           NDC 55111-121-10 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 bottles of 30’s, 60’s, 90’s, 500's and 1000’s. Bottles of 30                                                               NDC 55111-122-30 Bottles of 60                                                               NDC 55111-122-60 Bottles of 90                                                               NDC 55111-122-90 Bottles of 500                                                             NDC 55111-122-05 Bottles of 1000                                                           NDC 55111-122-10 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 bottles of 30’s, 60’s, 90’s, 500's and 1000’s. Bottles of 30                                                               NDC 55111-123-30 Bottles of 60                                                               NDC 55111-123-60 Bottles of 90                                                               NDC 55111-123-90 Bottles of 500                                                             NDC 55111-123-05 Bottles of 1000                                                           NDC 55111-123-10 Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET
REMEDYREPACK 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 tablet is an HMG-CoA inhibitor reductase
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 with HeFH: starting dose: 10 mg once daily; dose
range: 10 to 20 mg/day for patients 10 years to 17
years of age ( 2.2).
DOSAGE FORMS AND STRENGTHS
T