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:

Northwind Pharmaceuticals, LLC

INN (International Name):

ATORVASTATIN CALCIUM TRIHYDRATE

Composition:

ATORVASTATIN 10 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: - 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 heart disease

Product summary:

Atorvastatin Calcium Tablets are supplied as white, round, film-coated tablets of atorvastatin calcium containing 10mg atorvastatin. 10 mg tablets: debossed with "1" on one side and plain on the other. 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
NORTHWIND PHARMACEUTICALS, LLC
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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,
Letermovir, or Certain Protease Inhibitors ( 2.6) 11/2019
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 tablets are 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: 1