ATORVASTATIN CALCIUM- atorvastatin calcium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE (UNII: YRZ789OWMI) (ATORVASTATIN - UNII:A0JWA85V8F)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

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 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 calciu

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.  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. NDC: 35356-894-30  Bottles of 30 NDC: 35356-894-60  Bottles of 60 NDC: 35356-894-90  Bottles of 90 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.  NDC: 35356-929-30  Bottles of 30 NDC: 35356-929-60  Bottles of 60 NDC: 35356-929-90  Bottles of 90 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.  Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS 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 ADMINISTRATION
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Dosage and Administration (2.6) 10/2012
Warnings and Precautions (5.1) 10/ 2012
Drug Interactions (7) 02/2012
INDICATIONS AND USAGE
Atorvastatin calcium tablets are an inhibitor of HMG-CoA reductase
(statin) indicated as an adjunct therapy to diet to:
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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).
CONTRAINDICATIONS
Active liver disease, which may include unexplained persistent
elevations in hepatic transaminase levels (4.1).
Women who are pregnant or may become pregnant (4.3).
Nursing mothers (4.4).
Hypersensitivity to any component of this medication (4.2)
WARNINGS AND PRECAUTIONS
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks
increase when higher doses are used concomitantly
with cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin
itraconazole, HIV protease inhibitors). Predisposing
factors include advanced age (> 65), uncontrolled hypothyroidism, and
renal impairment. Rare cases of rhabdomyolysis
with acute renal failure secondary to myoglobinuria have been
reported. Advise patients to promptly report to their
physician unexplained and/or persistent muscle pain, tenderness, or
weakness. Atorvastatin calcium therapy should be
discontinued if myopathy is diagnosed or suspected (5.1, 8.5).
Liver enzyme abn