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ARTHROTEC reduces pain and inflammation, and replenishes prostaglandins produced by the COX-1 enzyme.
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The information contained in this section is intended only for use by healthcare professionals in the United States.
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ARTHROTEC® (diclofenac sodium/misoprostol) 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. When the efficacy of an NSAID is needed with a reduced risk of GI ulcers, consider ARTHROTEC. ARTHROTEC is available in 2
strengths, ARTHROTEC 50 and ARTHROTEC 75.
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For OA: The recommended dosage is ARTHROTEC 50 TID. Although not as effective in preventing ulcers, ARTHROTEC 75 BID or ARTHROTEC 50 BID may be better tolerated and can be used
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For RA: The recommended dosage is ARTHROTEC 50 TID or QID. Although not as effective in preventing ulcers, ARTHROTEC 75 BID or ARTHROTEC 50 BID may be better tolerated and can be used
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For full prescribing information on ARTHROTEC, click on the following link:
View ARTHROTEC Prescribing Information
You will need Adobe® Acrobat® Reader to view and print the Prescribing Information publication. If you don't have it already, download Adobe® Acrobat® Reader.
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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.
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