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Uses

Consider potential benefits and risks of oxaprozin therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Management of juvenile rheumatoid arthritis in children 6-16 years of age.

Dosage and Administration

General

• Consider potential benefits and risks of oxaprozin therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Oral Administration

Administer orally once daily; divided doses may improve tolerance in some patients.

Dosage

Available as oxaprozin and oxaprozin potassium; dosage expressed in terms of oxaprozin.

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to lowest effective dosage.

Pediatric Patients

Inflammatory Disease

Juvenile Rheumatoid Arthritis

Oral

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Initially, 1.2 g once daily. Reserve long-term use of dosages >1.2 g daily for adults with severe disease who weigh >50 kg, have normal renal and hepatic function, and low risk for GI toxicity.

If rapid onset of action needed, administer one-time loading dose of 1.2–1.8 g (up to 26 mg/kg).

Patients with low body weight: Initially, 600 mg once daily. May increase to 1.2 g daily if needed.

Prescribing Limits

Pediatric Patients

Juvenile Rheumatoid Arthritis

Oral

Doses >1.2 g daily not studied.

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Oxaprozin: Maximum 1.8 g or 26 mg/kg daily (whichever is lower). Maximum loading dose is 26 mg/kg.

When administered as oxaprozin potassium: 1.2 g daily.

Special Populations

Dosage in Renal Impairment

Severe renal impairment and in those undergoing hemodialysis: Initially, 600 mg once daily. May increase to 1.2 g daily if needed. Supplemental doses after hemodialysis not needed.

Dosage in Hepatic Impairment

Dosage adjustment not needed in patients with well-compensated cirrhosis.

Geriatric Patients

Dosage adjustment may be necessary in patients with low body weight, decreased renal function, or age-related concomitant disease.

Cautions

Contraindications

• Known hypersensitivity to oxaprozin or any ingredient in the formulation.
• History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.
• Treatment of perioperative pain in the setting of CABG surgery.

Warnings/Precautions

Warnings

Cardiovascular Effects

Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations. Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events. Current data insufficient to assess risk associated with oxaprozin.

Use NSAIAs with caution, careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary.

Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events. (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events. Use with caution in patients with hypertension; monitor BP. Impaired response to certain diuretics may occur. (See Specific Drugs under Interactions.)

Fluid retention and edema reported. Caution in patients with fluid retention or heart failure.

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol; alternatively, consider concomitant use of proton pump inhibitor (e.g., omeprazole) or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.

Potential for overt renal decompensation. Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.

Sensitivity Reactions

Hypersensitivity

Anaphylactoid reactions (e.g., anaphylaxis, angioedema) reported.

Immediate medical intervention and discontinuance for anaphylaxis.

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning. Discontinue at first appearance of rash or any other signs of hypersensitivity (e.g., blisters, fever, pruritus).

Photosensitivity

Rash on sun-exposed areas of the body reported.

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.

Elevations of serum ALT or AST reported.

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results. Discontinue if signs or symptoms of liver disease or systemic manifestation (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.

Hematologic Effects

Anemia reported rarely. Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.

May inhibit platelet aggregation and prolong bleeding time.

Other Precautions

Do not use multiple oxaprozin-containing preparations concomitantly.

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.

May mask certain signs of infection.

Obtain CBC and chemistry profile periodically during long-term use.

Specific Populations

Pregnancy

Category C. Avoid use in third trimester because of possible premature closure of the ductus arteriosus.

Lactation

Distributed into milk in rats; not known whether distributed into human milk. Discontinue nursing or the drug.

Pediatric Use

Oxaprozin: Safety and efficacy not established in children <6 years of age.

Oxaprozin: Safety and efficacy in pediatric patients 6–16 years of age with juvenile rheumatoid arthritis supported by studies in adults with rheumatoid arthritis and by safety and pharmacokinetic data from trials in children with juvenile rheumatoid arthritis.

Oxaprozin potassium: Safety and efficacy not established in children.

Geriatric Use

No overall differences in efficacy or safety were observed between geriatric and younger adults. Possibility exists of greater sensitivity in some geriatric individuals.

Caution advised. Geriatric adults appear to tolerate NSAIA-induced adverse effects less well than younger individuals.

Select dosage with caution because of age-related decreases in renal function. May be useful to monitor renal function.

Hepatic Impairment

Use with caution in patients with severe hepatic impairment.

Renal Impairment

Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used. Dosage adjustment needed. (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Abdominal pain, anorexia, constipation, diarrhea, flatulence, GI ulcers, GI bleeding/perforation, dyspepsia, heartburn, nausea, vomiting, renal function abnormalities, anemia, confusion, depression, sleep disturbance, dizziness, dysuria or increased frequency, edema, liver function test abnormalities, headache, prolonged bleeding time, pruritus, rash, sedation, somnolence, tinnitus.