ZYDASA

What it is

ZYDASA contains mesalazine as the active ingredient. ZYDASA is available as a 1.2 g delayed release tablet in blister pack and bottle presentations.

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, treatment of active disease in adults requires individual dosage up to 4 g given once daily or in divided doses. Maintenance treatment is 2 g once daily or individual dosage starting with 1.5–2 g daily in divided doses. For Crohn's disease, both treatment of active disease and maintenance treatment in adults requires individual dosage up to 4 g daily in divided doses. The tablets should not be crushed or chewed; they may be dispersed in 50 mL of cold water, stirred and drunk immediately. Alternatively, sachets may be emptied onto the tongue and washed down with water or juice, or the sachet contents may be taken with yoghurt and consumed immediately.

Key safety warnings

Severe cutaneous adverse reactions including drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported in association with mesalazine treatment. Treatment should be discontinued immediately if acute intolerance reactions occur such as nausea, exacerbation of diarrhoea, abdominal cramps, acute abdominal pain, fever, severe headache, or the first appearance of signs and symptoms of severe skin reactions including skin rash, mucosal lesions, or any other signs of hypersensitivity. Mesalazine-induced cardiac hypersensitivity reactions including myocarditis and pericarditis have been reported rarely, as have serious blood dyscrasias. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat, and treatment should be stopped if there is suspicion or evidence of blood dyscrasia. Cases of nephrolithiasis have been reported with the use of mesalazine including kidney stones composed entirely of mesalazine, and it is recommended to ensure adequate fluid intake during treatment. Idiopathic intracranial hypertension has been reported in patients receiving mesalazine, and patients should be warned of signs and symptoms including severe or recurrent headache, visual disturbances or tinnitus; discontinuation should be considered if it occurs.

Contraindications

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

Regulatory history

ZYDASA mesalazine 1.2 g delayed release tablets were first listed on the ARTG on 14 March 2025, with two variants registered in blister pack and bottle presentations.