Oxaprozin

Warning

Increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, and gastrointestinal bleeding, ulceration, and perforation

Contraindications

• Known hypersensitivity to oxaprozin or any components of the drug product
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• In the setting of coronary artery bypass graft (CABG) surgery

Adverse Reactions

• Cardiovascular thrombotic events
• Gastrointestinal bleeding, ulceration, and perforation
• Hepatotoxicity
• Hypertension
• Heart failure and edema
• Renal toxicity and hyperkalemia
• Anaphylactic reactions
• Serious skin reactions
• Hematologic toxicity

General Guidance

Dose adjustments may be necessary in patients with renal impairment or low body weight

Pregnancy

• Use of oxaprozin during pregnancy may cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction
• Limit dose and duration of use between 20 and 30 weeks of gestation

Nursing Mothers

• Oxaprozin is expected to be excreted in human milk
• Caution should be exercised when administering oxaprozin to nursing mothers

Pediatric Use

• Safety and effectiveness of oxaprozin in pediatric patients under 6 years have not been established
• Use of oxaprozin in pediatric patients 6 to 16 years of age is supported by evidence from adult rheumatoid arthritis studies

Geriatric Use

• Elderly patients are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions
• Start dosing at the low end of the dosing range and monitor patients for adverse effects