Potential risk of cross-sensitivity reactions between sulphasalazine & mesalazine. Reports of renal impairment, including minimal change nephropathy, acute/chronic interstitial nephritis & renal failure. Caution in patients w/ confirmed mild to moderate renal impairment. Evaluate renal function prior to treatment initiation & at least twice yrly while on treatment. Patients w/ chronic lung function impairment, especially asthma, are at risk of hypersensitivity reactions & should be closely monitored. Rare reports of serious blood dyscrasias following treatment. Terminate treatment if blood dyscrasia is suspected. Rare reports of mesalazine-induced cardiac hypersensitivity reactions. Caution in patients w/ conditions predisposing to development of myo/pericarditis. Reports of severe cutaneous adverse reactions, including DRESS, SJS & TEN. Discontinue treatment at the 1st appearance of signs & symptoms of severe skin reactions. Associated w/ an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Promptly w/draw treatment if acute intolerance syndrome is suspected. Reports of increased liver enzyme levels. Caution in patients w/ hepatic impairment. Organic or functional obstruction in the upper GIT may delay onset of action. Reports of nephrolithiasis, including stones w/ 100% mesalazine content. Ensure adequate fluid intake during treatment. May lead to falsely elevated test results when measuring urinary normetanephrine by liqd chromatography w/ electrochemical detection. May produce red-brown urine discoloration after contact w/ Na hypochlorite bleach. Should be used during pregnancy & breastfeeding only when benefits outweigh risks. Should not be used in paed patients <10 yr & weighing ≤50 kg.
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