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DICLOFENAC Sodium AND MISOPROSTOL Tablets (GREENSTONE LLC) Dosage and Administration

2 DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of diclofenac sodium/misoprostol and other treatment options before deciding to use diclofenac sodium/misoprostol. 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 diclofenac sodium/misoprostol, 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.

Diclofenac sodium/misoprostol is administered as diclofenac sodium/misoprostol 50 (50 mg diclofenac sodium and 200 mcg misoprostol) or as diclofenac sodium/misoprostol 75 (75 mg diclofenac sodium and 200 mcg misoprostol).
Note: See Special Dosing Considerations section below.

For osteoarthritis, the dosage for maximal GI mucosal protection is diclofenac sodium/misoprostol 50 three times a day. For patients who experience intolerance, diclofenac sodium/misoprostol 75 two times a day or diclofenac sodium/misoprostol 50 two times a day can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium/misoprostol, 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:

Osteoarthritis regimenDiclofenac sodium
(mg/day)
Misoprostol
(mcg/day)
Diclofenac sodium/misoprostol 50three times a day
two times a day
150
100
600
400
Diclofenac sodium/misoprostol 75two times a day150400

For rheumatoid arthritis, the dosage is diclofenac sodium/misoprostol 50 three or four times a day. For patients who experience intolerance, diclofenac sodium/misoprostol 75 two times a day or diclofenac sodium/misoprostol 50 two times a day can be used, but are less effective in preventing ulcers. This fixed combination product, diclofenac sodium/misoprostol, 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:

Rheumatoid Arthritis regimenDiclofenac sodium
(mg/day)
Misoprostol
(mcg/day)
Diclofenac sodium/misoprostol 50four times a day
three times a day
two times a day
200
150
100
800
600
400
Diclofenac sodium/misoprostol 75two times a day150400

Special Dosing Considerations:

Diclofenac sodium/misoprostol 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 changed to the appropriate dose of diclofenac sodium/misoprostol. If clinically indicated, misoprostol co-therapy with diclofenac sodium/misoprostol, 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 sodium higher than 150 mg/day in osteoarthritis or higher than 200 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 diclofenac sodium/misoprostol 50 two times a day.

For additional information, it may be helpful to refer to the prescribing information for the individual products of diclofenac sodium and misoprostol.

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