Use lowest effective dose in frail elderly patients or those w/ low body wt. Allergic reactions, including anaphylactic/anaphylactoid reactions, can occur w/o earlier drug exposure. Very rare reports of serious skin reactions (some fatal), including exfoliative dermatitis, SJS & TEN. Discontinue treatment at the 1st appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. May mask signs & symptoms of infection. Increased risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines. Associated w/ increased risk of GI anastomotic leak. Regular monitoring of hepatic function during prolonged treatment. Discontinue treatment if abnormal liver function tests persist or worsen, clinical signs or symptoms consistent w/ liver disease develop, or if other manifestations occur (eosinophilia, rash). Hepatitis may occur w/o prodromal symptoms. Renal papillary necrosis & other renal injury during long-term administration. Renal toxicity in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Not recommended in patients w/ advanced renal disease. Increased risk of aseptic meningitis in patients w/ SLE & mixed connective tissue disorders. Treat patients w/ CHF (NYHA I) or significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking) only after careful consideration. Reports of fluid retention & oedema. Increased risk of serious CV thrombotic events, MI, & stroke. Not recommended in patients w/ pre-existing CV or cerebrovascular disease, or presenting risk factors for CV disease. Blood count monitoring is recommended during prolonged treatment. May reversibly inhibit platelet aggregation. Can precipitate bronchospasm if administered to patients suffering from, or w/ a previous history of bronchial asthma. Avoid use w/ systemic NSAIDs, including COX-2 selective inhibitors. May impair ability to drive or operate machinery. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption; ulcerative colitis or Crohn's disease; hepatic porphyria; asthma, seasonal allergic rhinitis, nasal mucosa swelling, COPD or chronic resp tract infections (especially if linked to allergic rhinitis-like symptoms); mild to moderate renal &/or hepatic impairment. 1st & 2nd trimester of pregnancy; consider ultrasound monitoring of amniotic fluid if treatment extends >48 hr; discontinue treatment in case of oligohydramnios. May impair female fertility. Not recommended in women attempting to conceive. Do not administer during breastfeeding. Not suitable for childn.
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