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:

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 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 calci

Product summary:

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 68788-6331-3 Bottles of 60                                                               NDC 68788-6331-6 Bottles of 90                                                               NDC 68788-6331-9 Bottles of 100                                                             NDC 68788-6331-1 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
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 ADMINISTRATION
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Atorvastatin calcium tablet is an inhibitor of HMG-CoA reductase
(statin) indicated as an adjunct therapy to diet to:
8.
9.
10.
11.
12.
13.
14.
Limitations of Use
Atorvastatin calcium tablets have not been studied in _Fredrickson_
Types I and V dyslipidemias.
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 and 40 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 abnormalities: Persistent elevations in hepatic
trans