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
ARTHROTEC is equivalent to diclofenac in OA efficacy
1.
In the ARTHROTEC and diclofenac treatment groups, improvements in OA pain relief and functional capacity were statistically significantly greater than in the placebo group (P.002)
2.
Abdominal pain, diarrhea, and flatulence were more frequent in the active treatment groups compared with placebo
3.
Withdrawal due to adverse events was not statistically significant between active groups
4.
ARTHROTEC provides the built-in gastroprotection of misoprostol which is optimally designed to reduce the risk of NSAID effects in the upper and lower GI tract1
5.
Endoscopically diagnosed gastric and duodenal ulcers were significantly less frequent in patients receiving ARTHROTEC 50 mg (8%), ARTHROTEC 75 mg (7%), and placebo (4%) than in the diclofenac-alone group (17%) (P.002; N=572)
6.
ARTHROTEC is as effective as diclofenac alone in OA treatment, with a significantly lower incidence of endoscopically diagnosed gastric and/or duodenal ulcers
Reference:
Bocanegra TS, Weaver AL, Tindall EA, et al. Diclofenac/misoprostol compared with diclofenac in the treatment of osteoarthritis of the knee or hip: a randomized, placebo-controlled trial. J Rheumatol. 1998;25:1602-1611.
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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