INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Orudis and Oruvail and other treatment options before deciding to use Orudis and Oruvail. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Orudis and Oruvail are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Oruvail is not recommended for treatment of acute pain because of its extended-release characteristics (see ²PHARMACOKINETICS under CLINICAL PHARMACOLOGY. Orudis is indicated for the management of pain. Orudis is also indicated for treatment of primary dysmenorrhea. DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of Orudis and Oruvail and other treatment options before deciding to use Orudis and Oruvail. 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 Orudis and Oruvail, the dose and frequency should be adjusted to suit an individual patient’s needs. Concomitant use of Orudis and Oruvail is not recommended. If minor side effects appear, they may disappear at a lower dose which may still have an adequate therapeutic effect. If well tolerated but not optimally effective, the dosage may be increased. Individual patients may show a better response to 300 mg of Orudis daily as compared to 200 mg, although in well-controlled clinical trials patients on 300 mg did not show greater mean effectiveness. They did, however, show an increased frequency of upper- and lower-GI distress and headaches. It is of interest that women also had an increased frequency of these adverse effects compared to men. When treating patients with 300 mg/day, the physician should observe sufficient increased clinical benefit to offset potential increased risk. In patients with mildly impaired renal function, the maximum recommended total daily dose of Orudis or Oruvail is 150 mg. In patients with a more severe renal impairment (GFR less than 25 mL/min/1.73 m2 or end-stage renal impairment), the maximum total daily dose of Orudis or Oruvail should not exceed 100 mg. In elderly patients, renal function may be reduced with apparently normal serum creatinine and/or BUN levels. Therefore, it is recommended that the initial dosage of Orudis or Oruvail should be reduced for patients over 75 years of age (see ²Geriatric Use²). It is recommended that for patients with impaired liver function and serum albumin concentration less than 3.5 g/dL, the maximum initial total daily dose of Orudis or Oruvail should be 100 mg. All patients with metabolic impairment, particularly those with both hypoalbuminemia and reduced renal function, may have increased levels of free (biologically active) ketoprofen and should be closely monitored. The dosage may be increased to the range recommended for the general population, if necessary, only after good individual tolerance has been ascertained. Because hypoalbuminemia and reduced renal function both increase the fraction of free drug (biologically active form), patients who have both conditions may be at greater risk of adverse effects. Therefore, it is recommended that such patients also be started on lower doses of Orudis or Oruvail and closely monitored.