June 25, 2016
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Daypro

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Daypro




Indications
Dosage
How Supplied

INDICATIONS

DAYPRO is indicated:

DOSAGE AND ADMINISTRATION

General Dosing Instructions

Carefully consider the potential benefits and risks of DAYPRO and other treatment options before deciding to use DAYPRO. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].

Osteoarthritis

For OA, the dosage is 1200 mg (two 600 mg caplets) given orally once a day [see Individualization of Dosage].

Rheumatoid Arthritis

For RA, the dosage is 1200 mg (two 600 mg caplets) given orally once a day [see Individualization of Dosage].

Juvenile Rheumatoid Arthritis

For JRA, in patients 6-16 years of age, the recommended dosage given orally once per day should be based on body weight of the patient as given in Table 1 [see Individualization of Dosage].

Table 1: Recommended Daily Dose of DAYPRO by Body Weight in Pediatric Patients

Body Weight Range (kg) Dose (mg)
22-31 600
32-54 900
≥ 55 1200

Individualization Of Dosage

After observing the response to initial therapy with DAYPRO, 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 to minimize adverse effects. The maximum recommended total daily dose of DAYPRO 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 with 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].

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, although divided doses may be tried in patients unable to tolerate single doses.

HOW SUPPLIED

Dosage Forms And Strengths

DAYPRO (oxaprozin) caplets: 600 mg caplets, white, capsule-shaped, scored, film-coated, with DAYPRO debossed on one side and 1381 on the other side.

Storage And Handling

DAYPRO (oxaprozin) 600 mg caplets are white, capsule-shaped, scored, film-coated, with DAYPRO debossed on one side and 1381 on the other side, supplied as:

NDC Number Size
0025-1381-31 bottle of 100
0025-1381-51 bottle of 500
0025-1381-34 carton of 100 unit dose

Storage

Keep bottles tightly closed. Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 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.

Manufactured for: Pfizer Inc., 235 East 42nd Street, New York, NY, 10017. Distributed by: G. D. Searle LLC, Division of Pfizer Inc., 235 East 42nd Street, New York, NY, 10017. For more information, go to www.pfizer.com or call 1-800-438-1985. Revised: May 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/7/2016

Indications
Dosage
How Supplied

Daypro - User Reviews

Daypro User Reviews

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