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CADUET®Index Section (amlodipine besilate, atorvastatin calcium)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Hypertension

1.2 Coronary Artery Disease (CAD)

1.3 Prevention of Cardiovascular Disease (CVD) in Adults

1.4 Hyperlipidemia

1.5 Limitations of Use

2 DOSAGE AND ADMINISTRATION

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 Increased Angina and Myocardial Infarction

5.5 Hypotension

5.6 Endocrine Function

5.7 CNS Toxicity

5.8 Hemorrhagic Stroke

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Impact of Other Drugs on Amlodipine

7.2 Impact of Amlodipine on Other Drugs

7.3 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin

7.4 Drug Interactions that may Decrease Exposure to Atorvastatin

7.5 Atorvastatin 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 Amlodipine for Hypertension

14.2 Amlodipine for Chronic Stable Angina

14.3 Amlodipine for Vasospastic Angina

14.4 Amlodipine for Coronary Artery Disease

14.5 Amlodipine for Heart Failure

14.6 Atorvastatin for Prevention of Cardiovascular Disease

14.7 Atorvastatin for Hyperlipidemia and Mixed Dyslipidemia

14.8 Atorvastatin for Hypertriglyceridemia

14.9 Atorvastatin for Dysbetalipoproteinemia

14.10 Atorvastatin for Homozygous Familial Hypercholesterolemia

14.11 Atorvastatin for Heterozygous Familial Hypercholesterolemia in Pediatric Patients

14.12 CADUET for Hypertension and Dyslipidemia

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

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