Orudis

Indications
Dosage
How Supplied

INDICATIONS

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

Orudis (ketoprofen) 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 PHARMACOKINETICS under CLINICAL PHARMACOLOGY.

Orudis (ketoprofen) is indicated for the management of pain. Orudis (ketoprofen) is also indicated for treatment of primary dysmenorrhea.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of Orudis (ketoprofen) and Oruvail and other treatment options before deciding to use Orudis (ketoprofen) 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 (ketoprofen) and Oruvail, the dose and frequency should be adjusted to suit an individual patients needs.

Concomitant use of Orudis (ketoprofen) 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 (ketoprofen) 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 (ketoprofen) 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 (ketoprofen) 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 (ketoprofen) or Oruvail should be reduced for patients over 75 years of age (see Geriatric Use).

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 (ketoprofen) 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 (ketoprofen) or Oruvail and closely monitored.

Rheumatoid Arthritis and Osteoarthritis

The recommended starting dose of ketoprofen in otherwise healthy patients is for Orudis (ketoprofen) 75 mg three times or 50 mg four times a day, or for Oruvail 200 mg administered once a day. Smaller doses of Orudis (ketoprofen) or Oruvail should be utilized initially in small individuals or in debilitated or elderly patients. The recommended maximum daily dose of ketoprofen is 300 mg/day for Orudis (ketoprofen) or 200 mg/day for Oruvail.

Dosages higher than 300 mg/day of Orudis (ketoprofen) or 200 mg/day of Oruvail are not recommended because they have not been studied. Concomitant use of Orudis (ketoprofen) and Oruvail is not recommended. Relatively smaller people may need smaller doses.

As with other nonsteroidal anti-inflammatory drugs, the predominant adverse effects of ketoprofen are gastrointestinal. To attempt to minimize these effects, physicians may wish to prescribe that Orudis (ketoprofen) or Oruvail be taken with antacids, food, or milk. Although food delays the absorption of both formulations (see CLINICAL PHARMACOLOGY), in most of the clinical trials ketoprofen was taken with food or milk.

Physicians may want to make specific recommendations to patients about when they should take Orudis (ketoprofen) or Oruvail in relation to food and/or what patients should do if they experience minor GI symptoms associated with either formulation.

Management of Pain and Dysmenorrhea

The usual dose of Orudis (ketoprofen) recommended for mild-to-moderate pain and dysmenorrhea is 25 to 50 mg every 6 to 8 hours as necessary. A smaller dose should be utilized initially in small individuals, in debilitated or elderly patients, or in patients with renal or liver disease (see PRECAUTIONS). A larger dose may be tried if the patients response to a previous dose was less than satisfactory, but doses above 75 mg have not been shown to give added analgesia. Daily doses above 300 mg are not recommended because they have not been adequately studied. Because of its typical nonsteroidal antiinflammatory drug-side-effect profile, including as its principal adverse effect GI side effects (see WARNINGS and ADVERSE REACTIONS), higher doses of Orudis (ketoprofen) should be used with caution and patients receiving them observed carefully.

Oruvail is not recommended for use in treating acute pain because of its extended-release characteristics.

HOW SUPPLIED

Orudis® (ketoprofen) Capsules are available as follows:

25 mg, NDC 0008-4186, dark-green and red capsule marked WYETH 4186 on one side and ORUDIS (ketoprofen) 25 on the reverse side, in bottles of 100 capsules.

50 mg, NDC 0008-4181, dark-green and light-green capsule marked WYETH 4181 on one side and ORUDIS (ketoprofen) 50 on the reverse side, in bottles of 100 capsules.

75 mg, NDC 0008-4187, dark-green and white capsule marked WYETH 4187 on one side and ORUDIS (ketoprofen) 75 on the reverse side, in bottles of 100 and 500 capsules and in Redipak® cartons of 100 each containing 10 blister strips of 10 capsules.

Oruvail® (ketoprofen) Extended-Release Capsules are available as follows:

100 mg, NDC 0008-0821, opaque pink and dark-green capsule marked with two radial bands and ORUVAIL 100 in bottles of 100 capsules.

150 mg, NDC 0008-0822, opaque pink and light-green capsule marked with two radial bands and ORUVAIL 150 in bottles of 100 capsules.

200 mg, NDC 0008-0690, opaque pink and off-white capsule marked with two radial bands and ORUVAIL 200 in bottles of 100 capsules and in Redipak® cartons each containing 10 blister strips of 10 capsules.

Keep tightly closed.

Store at room temperature, approximately 25° C (77° F).

Dispense in a tight container.

Oruvail capsules should be protected from direct light and excessive heat and humidity.

The appearance of these capsules is a registered trademark of Wyeth Pharmaceuticals.

By arrangement with Rhone-Poulenc Rorer France.
Orudis (ketoprofen) Capsules manufactured and distributed by Wyeth Pharmaceuticals
Oruvail Capsules distributed by Wyeth Pharmaceuticals

Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101
Rev 07/05
FDA rev date: 01/18/06

Last reviewed on RxList: 2/21/2006
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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