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LIPITOR®Index Section (atorvastatin calcium)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Prevention of Cardiovascular Disease in Adults

1.2 Hyperlipidemia

1.3 Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Hyperlipidemia and Mixed Dyslipidemia

2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 Years to 17 Years of Age)

2.3 Homozygous Familial Hypercholesterolemia

2.4 Concomitant Lipid-Lowering Therapy

2.5 Dosage in Patients with Renal Impairment

2.6 Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, Letermovir, or Certain Protease Inhibitors

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Myopathy and Rhabdomyolysis

5.2 Immune-Mediated Necrotizing Myopathy

5.3 Liver Dysfunction

5.4 Endocrine Function

5.5 CNS Toxicity

5.6 Use in Patients with Recent Stroke or TIA

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

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

7.2 Drug Interactions that may Decrease Exposure to LIPITOR

7.3 LIPITOR Effects on Other Drugs

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Prevention of Cardiovascular Disease

14.2 Hyperlipidemia and Mixed Dyslipidemia

14.3 Hypertriglyceridemia

14.4 Dysbetalipoproteinemia

14.5 Homozygous Familial Hypercholesterolemia

14.6 Heterozygous Familial Hypercholesterolemia in Pediatric Patients

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Muscle Pain

17.2 Liver Enzymes

17.3 Embryofetal Toxicity

17.4 Lactation

*
Sections or subsections omitted from the full prescribing information are not listed.
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