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ARTHROTEC®Dosage and Administration (misoprostol, diclofenac sodium)

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage Information

  • Carefully consider the potential benefits and risks of ARTHROTEC and other treatment options before deciding to use ARTHROTEC. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
  • After observing the response to initial therapy with ARTHROTEC, the dose and frequency should be adjusted to suit an individual patient's needs.
  • ARTHORTEC is not recommended for patients who would not receive the appropriate dosage of both active ingredients.
  • ARTHROTEC, a fixed combination product, is administered as
    ARTHROTEC 50 (50 mg diclofenac sodium and 200 mcg misoprostol) or
    ARTHROTEC 75 (75 mg diclofenac sodium and 200 mcg misoprostol).

2.2 Recommended Dosage in Patients with Osteoarthritis

The recommended dosage for the treatment of osteoarthritis for maximal GI mucosal protection is ARTHROTEC 50 three times a day. For patients who experience intolerance, ARTHROTEC 75 two times a day or ARTHROTEC 50 two times a day can be used, but these dosages are less effective in preventing ulcers. A daily dosage of diclofenac sodium greater than 150 mg/day is not recommended. Daily doses of the components delivered with these regimens are as follows:

Osteoarthritis RegimenDiclofenac sodium
(mg/day)
Misoprostol
(mcg/day)
*
For patients who experience intolerance; these dosages are less effective in preventing ulcers
ARTHROTEC 50three times a day150600
two times a day*100400
ARTHROTEC 75two times a day*150400

2.3 Recommended Dosage in Patients with Rheumatoid Arthritis

The recommended dosage for the treatment of rheumatoid arthritis is ARTHROTEC 50 three or four times a day. For patients who experience intolerance, ARTHROTEC 75 two times a day or ARTHROTEC 50 two times a day can be used, but are less effective in preventing ulcers. A daily dosage of diclofenac sodium greater than 200 mg/day is not recommended. Daily doses of the components delivered with these regimens are as follows:

Rheumatoid Arthritis RegimenDiclofenac sodium
(mg/day)
Misoprostol
(mcg/day)
*
For patients who experience intolerance; these dosages are less effective in preventing ulcers
ARTHROTEC 50four times a day200800
three times a day150600
two times a day*100400
ARTHROTEC 75two times a day*150400

2.4 Additional Dosage Recommendations

ARTHROTEC contains misoprostol, which provides protection against gastric and duodenal ulcers [see Clinical Studies (14)]. For gastric ulcer prevention, the 200 mcg four and three times a day regimens are therapeutically equivalent, but more protective than the two times a day regimen. For duodenal ulcer prevention, the four times a day regimen is more protective than the three or two times a day regimens. However, the four times a day regimen is less well tolerated than the three times a day regimen because of usually self-limited diarrhea related to the misoprostol dose [see Adverse Reactions (6.1)], and the two times a day regimen may be better tolerated than three times a day in some patients.

Dosages may be individualized using the separate products (misoprostol and diclofenac sodium), after which the patient may be switched to the appropriate ARTHROTEC dosage. If clinically indicated, misoprostol co-therapy with ARTHROTEC to optimize the misoprostol dose and/or frequency of administration, may be appropriate. Do not exceed a total misoprostol dose of 800 mcg/day and do not administer more than 200 mcg of misoprostol at any one time.

When concomitant use of CYP2C9 inhibitors is necessary, the maximum total daily dose of diclofenac is 100 mg per day. Do not exceed a dosage of ARTHOTEC 50 mg twice daily [see Drug Interactions (7)].

For additional information, refer to the Prescribing Information for the individual products of diclofenac sodium and misoprostol.

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