Prescription Required
Manufacturer
DR.REDDY'S LAB
SKU
55111017001

oxaprozin 600 mg tablet (generic daypro)

Generic
Out of Stock

Uses

Oxaprozin is used for anti-inflammatory and analgesic effects in the symptomatic treatment of osteoarthritis and rheumatoid arthritis in adults. For additional information on the management of osteoarthritis, For additional information on the management of rheumatoid arthritis,

Oxaprozin also is used for the symptomatic management of juvenile rheumatoid arthritis in pediatric patients 6-16 years of age.

The potential benefits and risks of oxaprozin therapy as well as alternative therapies should be considered prior to initiating oxaprozin therapy. The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed.

Patients should be advised that oxaprozin, like other nonsteroidal anti-inflammatory agents (NSAIAs), is not free of potential adverse effects, including some that can cause discomfort, and that more serious effects (e.g., myocardial infarction, stroke, GI bleeding), which may require hospitalization and may even be fatal, also can occur. NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors and prototypical NSAIAs, increase the risk of serious adverse cardiovascular thrombotic events, including myocardial infarction and stroke, in patients with or without cardiovascular disease or risk factors for cardiovascular disease. Available data suggest that the increase in risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use. Use of NSAIAs also is associated with an increased risk of heart failure. The risk of potentially serious adverse GI effects also should be considered in patients receiving oxaprozin, particularly in patients receiving chronic therapy with the drug. NSAIAs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Patients should be advised to read the medication guide for NSAIAs that is provided to the patient each time the drug is dispensed.

Dosage and Administration

Administration

The potential benefits and risks of oxaprozin therapy as well as alternative therapies should be considered prior to initiating oxaprozin therapy.

Oxaprozin is administered orally. The rate but not the extent of GI absorption of the drug may be reduced by concomitant administration with food. The rate and extent of absorption do not appear to be affected when the drug is administered with antacids. Oxaprozin usually is administered once daily. However, administration of the drug in divided doses daily may improve tolerance in some patients.

Dosage

The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed. Dosage of oxaprozin must be carefully adjusted according to individual requirements and response, using the lowest possible effective dosage.

The manufacturer states that safety and efficacy of oxaprozin in children younger than 6 years of age have not been established.

For the symptomatic treatment of rheumatoid arthritis or osteoarthritis, the usual dosage of oxaprozin for normal-weight adults is 1.2 g once daily. The usual dosage for low-weight adults is 600 mg once daily; if an adequate response is not achieved, the dosage may be increased to 1.2 g daily. If rapid onset of action is required in adults, a one-time loading dose of 1.2-1.8 g (not to exceed 26 mg/kg) may be given.

Dosages of oxaprozin exceeding 1.2 g daily may be given, if needed, to adults who weigh more than 50 kg, have normal renal and hepatic functions, are at low risk of peptic ulcer, and have not experienced adverse GI, hepatic, renal, or dermatologic effects while receiving lower dosages. The manufacturer states that the maximum dosage of oxaprozin in adults should not exceed 1.8 g or 26 mg/kg daily, whichever is lower, given in divided doses.

The manufacturer states that clinically important differences in the pharmacokinetic profile of oxaprozin were not observed in studies in healthy geriatric adults. Therefore, dosage adjustment solely on the basis of age generally is not required for healthy, normal-weight geriatric patients. However, the possible need for dosage adjustment in geriatric patients should be considered for those with low body weight, decreased renal function, or other disorders of age. In addition, the possibility that geriatric patients may tolerate oxaprozin less well than younger adults should be considered.

For the symptomatic management of juvenile rheumatoid arthritis in children 6-16 years of age, oxaprozin dosages of 600 mg, 900 mg, or 1.2 g daily for children weighing 22-31, 32-54, or 55 kg or more, respectively, may be used. The manufacturer states that these dosages were based on comparisons of the pharmacokinetics of oxaprozin in adults and pediatric patients and are estimated to result in oxaprozin exposure similar to that reported in 70-kg adults with rheumatoid arthritis receiving an oxaprozin dosage of 1.2 g daily. In an uncontrolled trial in children with juvenile rheumatoid arthritis, oxaprozin was administered at a dosage of 10-20 mg/kg daily; controlled trials of oxaprozin in children with juvenile rheumatoid arthritis have not been conducted. The manufacturer states that dosages exceeding 1.2 g daily have not been studied in children.

Dosage in Renal and Hepatic Impairment

Since pharmacokinetics of oxaprozin are altered in patients with renal impairment and in those undergoing hemodialysis, the manufacturer states that oxaprozin should be initiated at 600 mg daily in adults with severe renal impairment and in those undergoing hemodialysis. If an adequate response is not achieved, dosage may be increased to 1.2 g daily with caution. Supplemental doses for patients undergoing hemodialysis are not necessary because the drug is highly protein bound.

Modification of oxaprozin dosage is not necessary in patients with well-compensated cirrhosis; however, since the drug is metabolized extensively in the liver, the manufacturer states that oxaprozin should be used with caution in patients with severe hepatic impairment.

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