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ARTHROTEC® (misoprostol, diclofenac sodium) Dosage and Administration

2 DOSAGE AND ADMINISTRATION

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.

For the relief of rheumatoid arthritis and osteoarthritis, the dosage is given below.

ARTHROTEC is administered as ARTHROTEC 50 (50 mg diclofenac sodium/200 mcg misoprostol) or as ARTHROTEC 75 (75 mg diclofenac sodium/200 mcg misoprostol).

Note: See Special Dosing Considerations section below.

For osteoarthritis, the dosage 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 are less effective in preventing ulcers. This fixed combination product, ARTHROTEC, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

OA regimen Diclofenac sodium
(mg/day)
Misoprostol
(mcg/day)
ARTHROTEC 50 three times a day 150 600
two times a day 100 400
ARTHROTEC 75 two times a day 150 400

For rheumatoid arthritis, the dosage 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. This fixed combination product, ARTHROTEC, is not recommended for patients who would not receive the appropriate dose of both ingredients. Doses of the components delivered with these regimens are as follows:

RA regimen Diclofenac sodium
(mg/day)
Misoprostol
(mcg/day)
ARTHROTEC 50 four times a day 200 800
three times a day 150 600
two times a day 100 400
ARTHROTEC 75 two times a day 150 400

Special Dosing Considerations:

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), after which the patient may be changed to the appropriate dose of ARTHROTEC. If clinically indicated, misoprostol co-therapy with ARTHROTEC, or use of the individual components to optimize the misoprostol dose and/or frequency of administration, may be appropriate. The total dose of misoprostol should not exceed 800 mcg/day, and no more than 200 mcg of misoprostol should be administered at any one time. Doses of diclofenac higher than 150 mg/day in osteoarthritis or higher than 225 mg/day in rheumatoid arthritis are not recommended.

When concomitant use of CYP2C9 inhibitors is necessary, the total daily dose of diclofenac should not exceed the lowest recommended dose of ARTHROTEC 50 two times a day.

For additional information, it may be helpful to refer to the package inserts for misoprostol and diclofenac.

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