Arthrotec

Indications
Dosage
How Supplied

INDICATIONS

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

ARTHROTEC is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. See WARNINGS, Gastrointestinal Effects -Risk of Ulceration, Bleeding, and Perforation for a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications.

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 dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

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 recommended dose 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.

Osteoarthritis

The recommended dosage for maximal GI mucosal protection is ARTHROTEC 50 tid. For patients who experience intolerance, ARTHROTEC 75 bid or ARTHROTEC 50 bid 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 tid 150 600
bid 100 400
ARTHROTEC 75 bid 150 400

Rheumatoid Arthritis: The recommended dosage is ARTHROTEC 50 tid or qid. For patients who experience intolerance, ARTHROTEC 75 bid or ARTHROTEC 50 bid 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 qid 200 800
tid 150 600
bid 100 400
ARTHROTEC 75 bid 150 400

Special Dosing Considerations

ARTHROTEC contains misoprostol, which provides protection against gastric and duodenal ulcers (see Clinical Studies). For gastric ulcer prevention, the 200 mcg qid and tid regimens are therapeutically equivalent, but more protective than the bid regimen. For duodenal ulcer prevention, the qid regimen is more protective than the tid or bid regimens. However, the qid regimen is less well tolerated than the tid regimen because of usually self-limited diarrhea related to the misoprostol dose (see ADVERSE REACTIONSGastrointestinal), and the bid regimen may be better tolerated than tid 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. For additional information, it may be helpful to refer to the package inserts for Cytotec® tablets and Voltaren® tablets.

HOW SUPPLIED

ARTHROTEC (diclofenac sodium/misoprostol) is supplied as a film-coated tablet in dosage strengths of either 50 mg diclofenac sodium/200 mcg misoprostol or 75 mg diclofenac sodium/200 mcg misoprostol. The 50 mg/200 mcg dosage strength is a round, biconvex, white to off-white tablet imprinted with four “A's” encircling a “50” in the middle on one side and “SEARLE” and “1411” on the other. The 75 mg/200 mcg dosage strength is a round, biconvex, white to off-white tablet imprinted with four “A's” encircling a “75” in the middle on one side and “SEARLE” and “1421” on the other.

The dosage strengths are supplied in:

Strength NDC Number Size
50/200 0025-1411-60 bottle of 60
0025-1411-90 bottle of 90
0025-1411-34 carton of 100 unit dose
75/200 0025-1421-60 bottle of 60
0025-1421-34 carton of 100 unit dose

Store at or below 25°C (77°F), in a dry area.

Distributed by: G.D. Searle, Division of Pfizer Inc., NY, NY 10017. Revised September 2014

Last reviewed on RxList: 9/22/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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