Patients most at risk of developing GI complication w/ NSAIDs; those w/ CV disease; concomitantly using glucocorticoids, antiplatelets (eg, aspirin) or other NSAIDs; those w/ prior history of GI disease (eg, ulceration, GI bleeding or inflammatory conditions). Avoid concomitant use w/ non-aspirin NSAID. May increase risk of serious CV thrombotic events, MI & stroke; inform patients about signs & symptoms of serious CV toxicity. Carefully consider patients w/ significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking). Not a substitute for acetylsalicylic acid for CV thromboembolic disease prophylaxis. May result in renal function deterioration & fluid retention in patients w/ history of cardiac failure, left ventricular dysfunction or HTN, preexisting oedema; patients taking diuretics or at risk of hypovolaemia. Closely monitor BP during initiation & throughout the course of therapy. Maintain medically appropriate supervision for possible compromised renal or hepatic function & especially cardiac dysfunction (more likely in the elderly). May cause renal toxicity; carefully monitor those w/ renal impairment, heart failure, liver dysfunction, those taking diuretics, ACE inhibitors, AIIA. Possible severe hepatic reactions including fulminant hepatitis, liver necrosis & hepatic failure. Consider discontinuation of therapy & take appropriate measures in any deterioration of organ system functions during treatment. Dehydrated patients. May reduce dose for individually dose-titrated drugs metabolised by CYP2D6. Possible 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 signs of hypersensitivity. May mask fever & other signs of inflammation. Concurrent therapy w/ warfarin & other oral anticoagulants. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Increased risk of dose-dependent AR in patients who are known, or suspected to be CYP2C9 poor metabolizers or previous history w/ other CYP2C9 substrates. Patients who experience dizziness, vertigo or somnolence should refrain from driving or operating machinery. Not indicated for childn <18 yr. Elderly (particularly w/ body wt <50 kg).
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