| Drug Name: | Arthrotec |
| Manufacturer: | G.D. Searle, LLC |
| Other Info: | Rx only LAB-0061-11.0September 2008 |
| Clinical Trials: | |
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).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.
See WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding and Perforation for a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications.See boxed CONTRAINDICATIONS AND WARNINGS related to misoprostol.
ARTHROTEC should not be taken by pregnant women.ARTHROTEC is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins.
ARTHROTEC should not be given to 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 in such patients (see WARNINGS- Anaphylactoid Reactions, and PRECAUTIONS- Preexisting Asthma).ARTHROTEC is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see boxed CONTRAINDICATIONS AND WARNINGS).