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Carefully consider the potential benefits and risks of DAYPRO (oxaprozin caplets) and other treatment options before deciding to use DAYPRO (oxaprozin caplets) . Use the lowest effec- tive dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). DAYPRO (oxaprozin caplets) is indicated:
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of DAYPRO (oxaprozin caplets) and other treatment options before deciding to use DAYPRO (oxaprozin caplets) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with DAYPRO (oxaprozin caplets) , the dose and frequency should be adjusted to suit an individual patient's needs.
Rheumatoid arthritis: For relief of the signs and symptoms of rheumatoid arthritis, the usual recommended dose is 1200 mg (two 600-mg caplets) given orally once a day (see Individualization of dosage).
Osteoarthritis: For relief of the signs and symptoms of osteoarthritis, the usual recommended dose is 1200 mg (two 600-mg caplets) given orally once a day (see Individualization of dosage).
Juvenile rheumatoid arthritis: For the relief of the signs and symptoms of JRA in patients 6-16 years of age, the recommended dose given orally once per day should be based on body weight of the patient as given in Table 3 (see also Individualization of dosage).
|Body Weight Range (kg)||Dose (mg)|
(see CLINICAL PHARMACOLOGY, Special populations: Pediatric patients)
Individualization of dosage: As with other NSAIDs, the lowest dose should be sought for each patient. Therefore, after observing the response to initial therapy with DAYPRO (oxaprozin caplets) , the dose and frequency should be adjusted to suit an individual patient's needs. In osteoarthritis and rheumatoid arthritis and juvenile rheumatoid arthritis, the dosage should be individualized to the lowest effective dose of DAYPRO (oxaprozin caplets) to minimize adverse effects. The maximum recommended total daily dose of DAYPRO (oxaprozin caplets) in adults is 1800 mg (26 mg/kg, whichever is lower) in divided doses. In children, doses greater than 1200 mg have not been studied.
Patients of low body weight should initiate therapy with 600 mg once daily. Patients with severe renal impairment or on dialysis should also initiate therapy with 600 mg once daily. If there is insufficient relief of symptoms in such patients, the dose may be cautiously increased to 1200 mg, but only with close monitoring (see CLINICAL PHARMACOLOGY, Special populations).
In adults, in cases where a quick onset of action is important, the pharmacokinetics of oxaprozin allows therapy to be started with a one time loading dose of 1200 to 1800 mg (not to exceed 26 mg/kg). Doses larger than 1200 mg/day on a chronic basis should be reserved for patients who weigh more than 50 kg, have normal renal and hepatic function, are at low risk of peptic ulcer, and whose severity of disease justifies maximal therapy. Physicians should ensure that patients are tolerating doses in the 600 to 1200 mg/day range without gastroenterologic, renal, hepatic, or dermatologic adverse effects before advancing to the larger doses. Most patients will tolerate once-a-day dosing with DAYPRO (oxaprozin caplets) , although divided doses may be tried in patients unable to tolerate single doses.
Safety And Handling
DAYPRO (oxaprozin caplets) is supplied as a solid dosage form in closed containers, is not known to produce contact dermatitis, and poses no known risk to healthcare workers. It may be disposed of in accordance with applicable local regulations governing the disposal of pharmaceuticals.
DAYPRO (oxaprozin caplets) 600 mg caplets are white, capsule-shaped, scored, filmcoated, with DAYPRO (oxaprozin caplets) debossed on one side and 1381 on the other side.
|0025-1381-31||bottle of 100|
|0025-1381-51||bottle of 500|
|0025-1381-34||carton of 100 unit dose|
Keep bottles tightly closed. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Protect the unit dose from light.
Distributed by G.D. Searle LLC, Division of Pfizer Inc, N Y, NY 10017. Revised January 2007. FDA Rev date: 6/21/2007
Last reviewed on RxList: 4/17/2008
This monograph has been modified to include the generic and brand name in many instances.
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