Hypersensitivity; anaphylactoid reactions. Discontinue treatment if erythema multiforme or flu-like symptom; SJS; conjunctivitis occur; at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Increased risk of serious CV thrombotic events, MI & stroke; serious GI inflammation, ulceration, bleeding, & perforation. Patients w/ risk factors for developing CHD eg, HTN, hyperlipidemia, diabetes, smoking, elderly; compromised cardiac function, pre-existing edema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretics or otherwise at risk of hypovolemia. Closely monitor patients w/ pre-existing CHF or HTN. Monitor BP during initiation & throughout the course of therapy. Not recommended in severe hepatic impairment (Child-Pugh class C). Severe renal impairment. Not to be used during 3rd trimester of pregnancy (premature closure of ductus arteriosus). May be associated w/ increased risk of miscarriage. May cause fetal dysfunction during 2nd or 3rd trimester of pregnancy. Closely monitor amniotic fluid vol in pregnant women during treatment. Lactation. 200 mg: Hepatitis, jaundice, liver failure; dyspepsia, diarrhea, abdominal pain, nausea or flatulence. Monitor renal function. Elderly weighing <50 kg. 400 mg: Not to be used as substitute for aspirin for prophylaxis of CV thromboembolic disease. Avoid use in patients w/ advanced renal disease. May diminish utility of diagnostic signs (eg, fever) in detecting infections. Patients w/ dehydration; CV disease, using concomitant glucocorticoids, antiplatelet drugs (eg, aspirin), or other NSAIDs, alcohol, w/ prior history of, or active, GI disease eg, ulceration, GI bleeding or inflammatory conditions. Carefully monitor patients at greater risk for renal toxicity; for evidence of development of more severe hepatic reaction while on therapy. Monitor anticoagulation/INR after treatment initiation or changing dose. Rehydrate patient before initiating therapy. Avoid concomitant use w/ non-aspirin NSAIDs. Concomitant use w/ oral anticoagulants including warfarin/coumarin-type & novel oral anticoagulants (eg, apixaban, dabigatran & rivaroxaban); drugs metabolized by CYP2D6. May affect ability to drive & use machines.
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