Serious hypersensitivity reactions (eg, anaphylaxis & angioedema). Discontinue at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity; if signs of hepatic insufficiency, or persistently abnormal LFTs (3x ULN) occur. Consider discontinuation if any organ system function deteriorate during treatment. Not to be used as substitute for ASA for prophylaxis of CV thromboembolic diseases. Patients most at risk of developing GI complications w/ NSAIDs, using any other NSAIDs or ASA, or w/ prior history of GI disease eg, ulceration & GI bleeding; w/ risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking); history of cardiac failure, left ventricular dysfunction, or HTN & pre-existing oedema from any other reason; dehydration. Upper GI complications; fluid retention, oedema & HTN; ALT &/or AST elevation. Increased risk of GI adverse effects in concomitant use w/ ASA (even at low dose); CV effects. May mask fever & other signs of inflammation. Periodically re-evaluate patient's need for symptomatic relief & response to therapy especially those w/ OA. Monitor renal function in patients w/ preexisting significantly impaired renal function, uncompensated heart failure, or cirrhosis; any patient w/ signs &/or symptoms suggesting liver dysfunction or whom abnormal LFTs occurred. Control HTN before treatment & monitor BP w/in 2 wk after initiation & periodically thereafter. Rehydrate patients prior to starting therapy. Concomitant use w/ warfarin or other oral anticoagulants. May affect ability to drive & use machines. Not recommended in women attempting to conceive. Discontinue during pregnancy. Women should not breastfeed during treatment. Elderly.
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