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:

Preferred Pharmaceuticals Inc.

INN (International Name):

ATORVASTATIN CALCIUM TRIHYDRATE

Composition:

ATORVASTATIN 20 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 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

Product summary:

Atorvastatin calcium tablets are supplied as follows: 20 mg, light yellow, dappled, glossy, round biconvex film-coated tablets, debossed with “HLA 20” on one side. Bottles contain desiccant. NDC 68788-6958-3, bottle of 30 tablets NDC 68788-6958-6, bottle of 60 tablets NDC 68788-6958-9, bottle of 90 tablets NDC 68788-6958-1, bottle of 100 tablets Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
PREFERRED 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 USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Dosage and Administration, Dosage in Patients
Taking Cyclosporine, Clarithromycin, Itraconazole,
INDICATIONS AND USAGE
Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor
indicated as an adjunct therapy to diet to:
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Limitations of Use
Atorvastatin calcium tablets have not been studied in _Fredrickson
_Types I and V dyslipidemias (1.3).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 10, 20, 40, and 80 mg of atorvastatin (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Letermovir or Certain Protease Inhibitors (2.6) 11/2019
Warnings and Precautions, Skeletal Muscle (5.1) 11/2019
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 hypercholes