Reports of severe cutaneous adverse reactions eg, SJS & TEN. Discontinue treatment at the 1st appearance of signs & symptoms of severe skin reactions. Reports of renal impairment, including minimal change nephropathy, acute/chronic interstitial nephritis, & renal failure. Evaluate renal function prior to treatment initiation & at least twice a yr while on treatment. Reports of nephrolithiasis, including stones w/ 100% mesalazine content. Ensure adequate fluid intake during treatment. Patients w/ chronic lung function impairment, especially asthma, are at risk of hypersensitivity reactions & should be closely monitored. Discontinue treatment if blood dyscrasia &/or acute intolerance syndrome is suspected. Reports of increased liver enzyme levels. Potential risk of cross sensitivity reactions between sulphasalazine & mesalazine. Organic or functional obstruction in the upper GIT may delay onset of action. Treatment may lead to falsely elevated test results when measuring urinary normetanephrine by liqd chromatography w/ electrochemical detection. Caution in patients w/ confirmed mild to moderate renal impairment; conditions predisposing to development of myo- or pericarditis; hepatic impairment. Use during pregnancy & lactation only when benefits outweigh risks. Do not use in paed patients <10 yr & weighing ≤50 kg.
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