ARTHROTEC® (diclofenac sodium/misoprostol) Tablets Dosage and Administration

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Prescribing Information

ARTHROTEC^® (diclofenac sodium/misoprostol) Tablets
Dosage and Administration


	Return to the ARTHROTEC Product Center

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 appropriate 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
ARTHROTEC 50	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 appropriate 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 REACTIONS—Gastrointestinal), 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.

PRINTER-FRIENDLY

arthrotec_pi_dosage_and_administration.htm

ARTHROTEC Indication and Important Safety Information

Please scroll to see the Indication below.

CONTRAINDICATIONS AND WARNINGS
ARTHROTEC^® CONTAINS DICLOFENAC SODIUM AND MISOPROSTOL. ADMINISTRATION OF MISOPROSTOL TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (see also PRECAUTIONS). ARTHROTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).

PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. ARTHROTEC should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID (see WARNINGS). In such patients, ARTHROTEC may be prescribed if the patient:

has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
is capable of complying with effective contraceptive measures.
has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
will begin ARTHROTEC only on the second or third day of the next normal menstrual period.

Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
ARTHROTEC is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).

ARTHROTEC is the only FDA-approved NSAID for the treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSIAD-induced gastric and duodenal ulcers and their complications

Important Safety Information

ARTHROTEC is contraindicated in women who are pregnant or who may become pregnant. ARTHROTEC can cause miscarriage, often associated with bleeding, which may result in other serious complications.

Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
ARTHROTEC is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

ARTHROTEC is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins and in patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to diclofenac have been reported.

The most common adverse events in ARTHROTEC-treated patients are abdominal pain (21%), diarrhea (19%), dyspepsia (14%), nausea (11%), and flatulence (9%).

As with all NSAIDs, ARTHROTEC can lead to worsening of pre-existing hypertension or the onset of new hypertension, fluid retention, edema, or heart failure. ARTHROTEC should be used with caution in these patients.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury and may cause a dose dependent reduction in prostaglandin formation. Elevations in ALT and/or AST, and rare cases of severe hepatic reactions have also been reported. Transaminases should be monitored within 4-8 weeks after initiating treatment with ARTHROTEC and should be measured periodically thereafter.

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal.

Indication

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.

Please see full prescribing information.

Arthrotec^® (diclofenac sodium/misoprostol)