ARTHROTEC® (diclofenac sodium/misoprostol) Tablets Clinical Studies

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Prescribing Information

ARTHROTEC^® (diclofenac sodium/misoprostol) Tablets
Clinical Studies


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Osteoarthritis

Diclofenac sodium, as a single ingredient or in combination with misoprostol, has been shown to be effective in the management of the signs and symptoms of osteoarthritis.

Rheumatoid arthritis

Diclofenac sodium, as a single ingredient or in combination with misoprostol, has been shown to be effective in the management of the signs and symptoms of rheumatoid arthritis.

Upper gastrointestinal safety

Diclofenac, and other NSAIDs, have caused serious gastrointestinal toxicity, such as bleeding, ulceration and perforation of the stomach, small intestine or large intestine. Misoprostol has been shown to reduce the incidence of endoscopically diagnosed NSAID-induced gastric and duodenal ulcers. In a 12-week, randomized, double-blind, dose-response study, misoprostol 200 mcg administered qid, tid or bid, was significantly more effective than placebo in reducing the incidence of gastric ulcer in OA and RA patients using a variety of NSAIDs. The tid regimen was therapeutically equivalent to misoprostol 200 mcg qid with respect to the prevention of gastric ulcers. Misoprostol 200 mcg given bid was less effective than 200 mcg given tid or qid. The incidence of NSAID-induced duodenal ulcer was also significantly reduced with all three regimens of misoprostol compared to placebo (see Table 2).

Table 2. Misoprostol 200 mcg Dosage Regimen

Results of a study in 572 patients with osteoarthritis demonstrate that patients receiving ARTHROTEC have a lower incidence of endoscopically defined gastric ulcers compared to patients receiving diclofenac sodium (see Table 3).

Table 3. Osteoarthritis patients with history of ulcer or erosive disease (N=572), 6 weeks

PRINTER-FRIENDLY

ARTHROTEC Safety Information

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.

Please see full prescribing information.

Arthrotec^® (diclofenac sodium/misoprostol)