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ARTHROTEC®Index Section (misoprostol, diclofenac sodium)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage Information

2.2 Recommended Dosage in Patients with Osteoarthritis

2.3 Recommended Dosage in Patients with Rheumatoid Arthritis

2.4 Additional Dosage Recommendations

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Uterine Rupture, Abortion, Premature Birth, or Birth Defects with Misoprostol and Embryo-Fetal Toxicity with NSAIDs

5.2 Cardiovascular Thrombotic Events

5.3 Gastrointestinal Bleeding, Ulceration, and Perforation

5.4 Hepatotoxicity

5.5 Hypertension

5.6 Heart Failure and Edema

5.7 Renal Toxicity and Hyperkalemia

5.8 Anaphylactic Reactions

5.9 Exacerbation of Asthma Related to Aspirin Sensitivity

5.10 Serious Skin Reactions

5.11 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

5.12 Hematologic Toxicity

5.13 Masking of Inflammation and Fever

5.14 Laboratory Monitoring

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 Renal Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology

14 CLINICAL 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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