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LIPITOR®(atorvastatin calcium)

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LIPITOR® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

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...

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2 DOSAGE AND ADMINISTRATION

2.1 Hyperlipidemia and Mixed Dyslipidemia

The recommended starting dose of LIPITOR is 10 or 20 mg once daily. Patients who require a...

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3 DOSAGE FORMS AND STRENGTHS

LIPITOR tablets are white elliptical, film-coated, and are available in four strengths (see

Table 1: LIPITOR Tablet Strengths and Identifying Features...
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4 CONTRAINDICATIONS

  • Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels
  • Hypersensitivity to Any Component of This...
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5 WARNINGS AND PRECAUTIONS

5.1 Myopathy and Rhabdomyolysis

LIPITOR may cause myopathy (muscle pain, tenderness,...

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6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Myopathy and Rhabdomyolysis [see

6.1 Clinical Trials Experience...

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7 DRUG INTERACTIONS

7.1 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with LIPITOR

LIPITOR is a substrate of CYP3A4 and transporters (e....

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

LIPITOR is...

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10 OVERDOSAGE

There is no specific treatment for LIPITOR overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding...

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11 DESCRIPTION

LIPITOR is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

LIPITOR is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year carcinogenicity study in rats at dose levels of 10, 30, and 100 mg/kg/...

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14 CLINICAL STUDIES

14.1 Prevention of Cardiovascular Disease

In the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), the effect of LIPITOR on fatal and non-fatal...

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16 HOW SUPPLIED/STORAGE AND HANDLING

10 mg tablets (10 mg of atorvastatin): coded "PD 155" on one side and "10" on the other.

NDC 0071-0155-23 bottles of 90
NDC 0071-0155-40 10 × 10 unit...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients taking LIPITOR should be advised that cholesterol is a chronic condition and they should...

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Resources

LIPITOR Savings Card
For questions regarding the LIPITOR Savings Card, please call (800) 314-7957
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