DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Oxaprozin (Oxaprozin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Carefully consider the potential benefits and risks of  oxaprozin tablets USP and other treatment options before deciding to use  oxaprozin tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Oxaprozin  tablets USP are indicated:

  • •For relief of the signs and symptoms of osteoarthritis.
  • •For relief of the signs and symptoms of rheumatoid arthritis.
  • •For relief of the signs and symptoms of juvenile rheumatoid arthritis.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of oxaprozin tablets and other treatment options before deciding to use oxaprozin tablets. 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 oxaprozin tablets, 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 of oxaprozin tablets is 1200 mg (two 600 mg tablets) given orally once a day (see Individualization of Dosage ).

Osteoarthritis

For relief of the signs and symptoms of osteoarthritis, the usual recommended dose of oxaprozin tablets is 1200 mg (two 600 mg tablets) 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 to 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 ).

Table 3

Body Weight Range (kg)

Dose (mg)

22-31

600

32-54

900

≥55

1200

(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 oxaprozin tablets, 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 oxaprozin tablets to minimize adverse effects. The maximum recommended total daily dose of oxaprozin tablets 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 mg 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 mg/day 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 oxaprozin, although divided doses may be tried in patients unable to tolerate single doses.

Safety and Handling

Oxaprozin  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.

HOW SUPPLIED

Oxaprozin tablets USP for oral administration are available as:

600 mg : White, capsule-shaped, film-coated, debossed with “E141” on one side and bisected on the other, and supplied as:

NDC 66336-0722-60 bottles of 60

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep bottles tightly closed.

Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017