Daypro

OXAPROZIN

Manufacturer: Pfizer Laboratories Div Pfizer Inc

Score: 141.0

Quick Summary

Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. It has analgesic, anti-inflammatory, and antipyretic properties. However, it is associated with serious cardiovascular and gastrointestinal risks, and its use should be limited to the lowest effective dose for the shortest duration. The recommended dosage is 1200 mg once daily for osteoarthritis and rheumatoid arthritis, and 600-1200 mg once daily for juvenile rheumatoid arthritis based on body weight.

Key Clinical Findings and Indications

Relief of signs and symptoms of osteoarthritis
Relief of signs and symptoms of rheumatoid arthritis
Relief of signs and symptoms of juvenile rheumatoid arthritis

Important Safety Information

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

Dosing Recommendations

General Guidance

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

Osteoarthritis

Adult Dose

1200 mg once daily

Pediatric Dose

Not recommended for pediatric patients under 6 years

Rheumatoid arthritis

Adult Dose

1200 mg once daily

Pediatric Dose

Not recommended for pediatric patients under 6 years

Juvenile rheumatoid arthritis

Adult Dose

Not applicable

Pediatric Dose

600-1200 mg once daily based on body weight

Special Population Considerations

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