Discontinue use at 1st appearance of skin rash, mucosal lesions or other sign of hypersensitivity. Serious skin infections eg, exfoliative dermatitis, SJS & TEN. Anaphylactoid reactions. Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. Increased risk of serious CV thrombotic events, MI & stroke. Risk of GI ulceration, bleeding & perforation. History of serious GI events & other risk factors associated w/ PUD eg, alcoholism, smoking, corticosteroid therapy. Patients w/ risk factors of heart disease, HTN, hyperlipidemia, diabetes, peripheral arterial disease; compromised cardiac function, history of CV disease; preexisting edema, other conditions predisposed to or worsened by fluid retention; hypovolaemia. Patients known or suspected to be CYP2C9 poor metabolizers. Ensure adequate hydration. Closely monitor BP during therapy. Avoid use w/ non-aspirin NSAID. Concomitant use w/ ACE inhibitors, thiazide or loop diuretics; aspirin, glucocorticoids or other NSAIDs; oral corticosteroids; anticoagulants eg, warfarin/coumarin-type & novel oral anticoagulants eg, apixaban, dabigatran, rivaroxaban; SSRIs; CYP2D6-metabolized drugs. Not recommended in severe hepatic impairment. Moderate hepatic impairment (Child-Pugh class B). Advanced renal disease; renal impairment. Avoid use during 3rd trimester of pregnancy. Lactation. Elderly or debilitated patients.
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