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CELEBREX®Index Section (celecoxib)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

1. INDICATIONS AND USAGE

1.1 Osteoarthritis (OA)

1.2 Rheumatoid Arthritis (RA)

1.3 Juvenile Rheumatoid Arthritis (JRA)

1.4 Ankylosing Spondylitis (AS)

1.5 Acute Pain

1.6 Primary Dysmenorrhea

2. DOSAGE AND ADMINISTRATION

2.1 General Dosing Instructions

2.2 Osteoarthritis

2.3 Rheumatoid Arthritis

2.4 Juvenile Rheumatoid Arthritis

2.5 Ankylosing Spondylitis

2.6 Management of Acute Pain and Treatment of Primary Dysmenorrhea

2.7 Special Populations

3. DOSAGE FORMS AND STRENGTHS

4. CONTRAINDICATIONS

5. WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Thrombotic Events

5.2 Gastrointestinal Bleeding, Ulceration, and Perforation

5.3 Hepatotoxicity

5.4 Hypertension

5.5 Heart Failure and Edema

5.6 Renal Toxicity and Hyperkalemia

5.7 Anaphylactic Reactions

5.8 Exacerbation of Asthma Related to Aspirin Sensitivity

5.9 Serious Skin Reactions

5.10 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

5.11 Fetal Toxicity

5.12 Hematological Toxicity

5.13 Masking of Inflammation and Fever

5.14 Laboratory Monitoring

5.15 Disseminated Intravascular Coagulation (DIC)

6. ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7. DRUG INTERACTIONS

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

8.7 Renal Impairment

8.8 Poor Metabolizers of CYP2C9 Substrates

10. OVERDOSAGE

11. DESCRIPTION

12. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.5 Pharmacogenomics

13. NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology

14. CLINICAL STUDIES

14.1 Osteoarthritis

14.2 Rheumatoid Arthritis

14.3 Juvenile Rheumatoid Arthritis (NCT00652925)

14.4 Ankylosing Spondylitis

14.5 Analgesia, including Primary Dysmenorrhea

14.6 Cardiovascular Outcomes Trial: Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen (PRECISION; NCT00346216)

14.7 Special Studies

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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