Excretion: Sixty-five percent (65%) of the dose is excreted into the urine and 35% in the feces as metabolites. Renal elimination of oxaprozin metabolites is a major pathway of elimination. Biliary excretion of unchanged oxaprozin is a minor pathway. After multiple doses of DAYPRO ALTA (1200mg QD), post-steady state mean elimination half-lives of total oxaprozin and protein unbound oxaprozin were 38.0 and 16.4 hrs, respectively (see Table 1).

Special Populations

Pediatric: DAYPRO ALTA has not been investigated in patients < 16 years of age.

Geriatric: As with any NSAID, caution should be exercised in treating the elderly (65 years and older). No dosage adjustment is necessary in the elderly for pharmacokinetic reasons, although many elderly may need a reduced dose due to low body weight or disorders associated with aging.

Gender: No differences in pharmacokinetic parameters have been observed between male and female subjects in studies of DAYPRO ALTA.

Race: Pharmacokinetic differences due to race have not been identified in studies of DAYPRO ALTA.

Hepatic Insufficiency: Approximately 95% of oxaprozin is metabolized by the liver. However, patients with well-compensated cirrhosis do not require reduced doses of oxaprozin as compared to patients with normal hepatic function. Nevertheless, caution should be observed in patients with severe hepatic dysfunction.

Cardiac Failure: Well-compensated cardiac failure does not affect the plasma protein binding or the pharmacokinetics of oxaprozin.

Renal Insufficiency: The pharmacokinetics of oxaprozin has been investigated in patients with renal insufficiency. Oxaprozin's renal clearance decreased proportionally with creatinine clearance (CrCl). Since only about 5% of oxaprozin dose is excreted unchanged in the urine, the decrease in total body clearance becomes clinically important only in those subjects with highly decreased CrCl. Oxaprozin is not significantly removed from the blood in patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) due to its high protein binding. Oxaprozin plasma protein binding may decrease in patients with severe renal deficiency. Dosage adjustment may be necessary in patients with renal insufficiency (see WARNINGS, Renal Effects).

Drug Interactions

(Also see PRECAUTIONS: DRUG INTERACTIONS)

General: The coadministration of oxaprozin and antacids, acetaminophen, or conjugated estrogens resulted in no statistically significant changes in pharmacokinetic parameters in single- and/or multiple dose studies.

Clinical Studies

Osteoarthritis: DAYPRO ALTA 1200 mg once daily was evaluated for the relief of the signs and symptoms of osteoarthritis in a 6-month placebo-controlled study versus oxaprozin acid in over 300 patients. In this trial, treatment with DAYPRO ALTA resulted in improvement in WOMAC (Western Ontario and McMaster Universities) osteoarthritis index, a composite of pain, stiffness, and functional measures in OA. DAYPRO ALTA demonstrated significant reduction in joint pain compared to placebo and was found to be comparable to 1200 mg once daily of oxaprozin acid.

With respect to GI events, DAYPRO ALTA appeared to be less well tolerated than oxaprozin acid in this study. The rates for symptomatic ulcers (2.2%) and nausea (13%) for DAYPRO ALTA treated patients were higher than the rates observed with oxaprozin acid (0% and 6%, respectively) (see ADVERSE REACTIONS).

Rheumatoid arthritis: Oxaprozin, the active component of DAYPRO ALTA (oxaprozin potassium tablets), was evaluated for the relief of the signs and symptoms of rheumatoid arthritis in placebo and active controlled clinical trials in a total of 646 patients. Oxaprozin was given in single or divided daily doses of 600 to 1800 mg/day and was found to be comparable to 2600 to 3900 mg/day of aspirin.

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