Not indicated for pain of GI origin. Avoid concomitant use w/ NSAIDs including COX-2 inhibitors. High doses may increase risk of GI bleeding, ulceration or perforation. Patients w/ history of GI toxicity; receiving medications which increased risk of ulceration or bleeding eg, oral corticosteroids, anticoagulants (eg, warfarin), SSRIs or anti-platelet agents (eg, aspirin); w/ history of GI disease (ulcerative colitis, Crohn's disease). Na/fluid retention in CV conditions & peripheral edema; history of HTN &/or heart failure. Arterial thrombotic events (eg, MI or stroke). Serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Discontinue use at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Severe hepatic reactions, including jaundice & hepatitis. Patients taking any other analgesic; w/ coagulation disturbances or taking drugs that influence hemostasis; on intensive diuretic therapy. May impair female fertility. May interfere w/ urinary analyses of 17-ketogenic steroids & 5-hydroxy indoleacetic acid (5 HIAA). May affect ability to drive & use machines. Severe renal, hepatic &/or cardiac impairment. Pregnancy. Avoid use during lactation. Childn <12 yr. Elderly.
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