Daypro / Oxaprozin by drdoc on-line
  Pharmacia :DayproŽ
Oxaprozin / Daypro is a non-steroidal anti-inflammatory drug (NSAID) that has been shown to have anti-inflammatory, analgesics, and antipyretic properties. Oxaprozin is an inhibitor of several steps along the Arachidonic acid pathway of prostaglandin synthesis at the site of inflammation.
Acute analgesic effects are demonstrable in humans after a single 1 200mg dose of Oxaprozin, but anti-inflammatory effects are not reliably achieved after a single dose. Because of the long half-like of Oxaprozin, it takes several days of dosing to reach steady state.

Oxaprozin demonstrates high oral bioavailability (95%), with peak plasma concentrations occurring between 3 and 5 hours after dosing. Food may reduce the rate of absorption of Oxaprozin, but the extent of absorption is unchanged. Antacids have no effect on the rate or extent of Oxaprozin absorption.

CLINICAL STUDIES


Rheumatoid Arthritis

In a study Daypro was evaluated for managing the signs and symptoms of Rheumatoid Arthritis in placebo and active controlled clinical trials in a total of 646 patients. Daypro was given in single or divided daily doses of 600 to 1 800 mg/day and was found to be comparable to 2 600 to 3 900mg/day of aspirin. At these doses there was a trend (over all trials) for Oxaprozin to be more effective and cause fewer gastrointestinal side effects than Disprin.
Daypro was given as a once-a-day dose of 1 200mg in most of the clinical trials, but larger doses (up to 26mg/kg or 1800mg/day) were used in selected patients. In some patients, Daypro may be better tolerated in divided doses. Due to its long half-life, several days of Daypro therapy were needed for the drug to reach its full effect


Osteoarthritis

Daypro was evaluated for the management of the signs and symptoms of osteoarthritis in a total of 616 patients in active controlled clinical trials against aspirin (N=464), Piroxicam (N=102), and other NSAIDs. Daypro was given both in variable (600 to 1200mg/day) and in fixed (1200mg/day) dosing schedules in either single of divided doses. In these trials, Oxaprozin was found to be comparable to 2600 to 3200 mg/day doses of aspirin or 20mg/day doses of Piroxicam. Oxaprozin was effective both in once-daily and in divided dosing schedules. In controlled clinical trials several days of Oxaprozin therapy were needed for the drug to reach its full effects


INDIVIDUALISATION OF DOSAGE

Daypro, like other NSAIDs, shows considerable interindividual differences in both pharmacokinetics and clinical response (pharmacodynamics). Therefore, the dosage for each patient should be individualised according to the patient’s response to therapy.
The usual starting dose for most normal weight patients with rheumatoid arthritis is 1 200mg, once a day.
The usual starting dose for normal weight patients with mild to moderate osteoarthritis is 600mg, once a day.


INDICATIONS AND USAGE

Daypro is indicated for acute and long-term use in the management of the signs and symptoms of osteoarthritis and rheumatoid arthritis.


CONTRAINDICATIONS

Daypro should not be used in patients with previously demonstrated hypersensitivity to Oxaprozin or any of its components or in individuals with the complete or partial syndrome of nasal polyps, angioedema, and bronchospastic reactivity to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
PRECAUTIONS

Hepatic Effects

As with other non-steroidal anti-inflammatory drugs, borderline elevations of one or more liver tests may occur in up to 15% of patients. These abnormalities may progress, remain essentially unchanged, or resolve with continue therapy.

Renal Effects

Acute interstitial nephritis, hematuria and proteinuria have been reported with Daypro as with other NSAIDs. Long-term administration of some non-steroidal anti-inflammatory drugs to animals has resulted in renal papillary necrosis and other abnormal renal pathology. This was not observed with Oxaprozin, but the clinical significance of the difference is unknown.


DOSAGE AND ADMINISTRATION

Rheumatoid Arthritis

The usual daily dose of Daypro for the management of the signs and symptoms of rheumatoid arthritis is 1200mg (two 600mg caplets) once a day


Osteoarthritis

The usual daily dose of Daypro for the management of the signs and symptoms of moderate to severe osteoarthritis is 1200mg (two 600mg caplets) once a day. For patients of low body weight or with milder disease, an initial dosage of one 600mg caplet once a day may be appropriate.
Regardless of the indication, the dosage should be individualised to the lowest effective dose of Daypro to minimise adverse effects, and the maximum recommend total daily dose is 1800mg (or 26mg/kg) whichever is lower) in divided doses.

 

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