ARTHROTEC reduces pain and inflammation, and replenishes prostaglandins produced by the COX-1 enzyme.
The information contained in this section is intended only for use by healthcare professionals in the United States.
Features and Benefits
GI Protection of Misoprostol
Serious gastrointestinal complications associated with NSAID therapy are significantly reduced by the introduction of misoprostol into the treatment regimen.1
Clinical studies demonstrate that misoprostol:
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Reduced the risk of serious ulcer complications by approximately 52% (n=8843, P=.021)1
•
Was effective at a range of doses including 400, 600, and 800 mcg/day2
References:
Silverstein FE, Graham DY, Senior JR, et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs: a randomized, double blind, placebo-controlled trial. Ann Intern Med. 1995;123:241-249.
Raskin JB, White RH, Jackson JE, et al. Misoprostol dosage in the prevention of nonsteroidal anti-inflammatory drug-induced gastric and duodenal ulcers: a comparison of three regimens. Ann Intern Med. 1995;123:344-350.
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.
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 its risk factors may be at greater risk.
ARTHROTEC is contraindicated for treatment of peri-operative pain in coronary artery bypass graft surgery.
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 sodium have been reported.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Administration of NSAIDs 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 diclofenac and should be measured periodically in patients receiving long-term therapy.
NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis which can be fatal.
The most common adverse events in ARTHROTEC-treated patients are abdominal pain (21%), diarrhea (19%), dyspepsia (14%), nausea (11%), and flatulence (9%), which can occur more frequently than with diclofenac alone.
