ZYDUCO

What it is ZYDUCO is a mesalazine 1.2 g delayed release tablet .

Approved indications

— Treatment of mild to moderate ulcerative colitis . — Treatment of mild to moderate Crohn's disease . — Maintenance of remission in ulcerative colitis and Crohn's disease .

Dosing overview

For ulcerative colitis, adults receive up to 4 g daily given once daily or in divided doses for treatment of active disease, and 2 g once daily or 1.5–2 g daily in divided doses for maintenance treatment. For Crohn's disease, adults receive up to 4 g daily in divided doses for both active disease treatment and maintenance treatment . The tablets should not be crushed or chewed .

Key safety warnings

Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systematic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment . Treatment should be discontinued immediately in cases of acute intolerance reactions such as nausea, exacerbation of diarrhoea, abdominal cramps, acute abdominal pain, fever, severe headache, and/or the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other signs of hypersensitivity . Mesalazine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) and serious blood dyscrasias have been reported rarely . Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat . Patients with inflammatory bowel disease are at risk of developing nephrolithiasis, and cases of nephrolithiasis have been reported with the use of mesalazine including kidney stones composed entirely of mesalazine . It is recommended to ensure adequate fluid intake during treatment . Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in patients receiving mesalazine, and patients should be warned for signs and symptoms including severe or recurrent headache, visual disturbances or tinnitus .

Contraindications

Hypersensitivity to mesalazine or any of the excipients or salicylates . Severe liver or renal impairment .

Regulatory history

ZYDUCO mesalazine 1.2 g delayed release tablets in blister pack and bottle formats were first listed on the ARTG on 14 March 2025 .