ATORVASTATIN CALCIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

INN (International Name):

ATORVASTATIN CALCIUM

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. 1.1 Prevention of Cardiovascular Disease in Adults 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

Product summary:

Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin. 10 mg tablets Atorvastatin calcium tablets, 10 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “A10” on the other side. Bottles of 30 (NDC 60505-2578-3) Bottles of 90 (NDC 60505-2578-9) Bottles of 500 (NDC 60505-2578-5) Bottles of 1,000 (NDC 60505-2578-8) Bottles of 5,000 (NDC60505-2578-7) Blister of 100 (NDC 60505-2578-0) 20 mg tablets Atorvastatin calcium tablets, 20 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV20” on the other side. Bottles of 30 (NDC 60505-2579-3) Bottles of 90 (NDC 60505-2579-9) Bottles of 500 (NDC 60505-2579-5) Bottles of 1,000 (NDC 60505-2579-8) Bottles of 5,000 (NDC 60505-2579-7) Blister of 100 (NDC 60505-2579-0) 40 mg tablets Atorvastatin calcium tablets, 40 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV40” on the other side. Bottles of 30 (NDC 60505-2580-3) Bottles of 90 (NDC 60505-2580-9) Bottles of 500 (NDC 60505-2580-5) Bottles of 1,000 (NDC 60505-2580-8) Bottles of 4,000 (NDC 60505-2580-7) Blister of 100 (NDC 60505-2580-0) 80 mg tablets Atorvastatin calcium tablets, 80 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV80” on the other side. Bottles of 30 (NDC 60505-2671-3) Bottles of 90 (NDC 60505-2671-9) Bottles of 500 (NDC60505-2671-5) Bottles of 1,000 (NDC 60505-2671-8) Bottles of 2,500 (NDC 60505-2671-7) Blister of 100 (NDC 60505-2672-0) Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
REDPHARM DRUG, INC.
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ATORVAS TATIN
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
INDICATIONS AND USAGE
Atorvastatin calcium tablets are a 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 has 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
Table