MESALAZINE ZYDUS

What it is

Mesalazine is available as prolonged release tablets containing either 0.5 g or 1 g mesalazine as the active ingredient. Prolonged release granules in sachets contain either 1 g, 2 g or 4 g mesalazine as the active ingredient.

Approved indications

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

Dosing overview

Tablets and granules must not be crushed or chewed. Tablets may be dispersed in 50 mL of cold water, stirred and drunk immediately. Sachet contents should be emptied onto the tongue and washed down with water or juice, or alternatively taken with yoghurt and consumed immediately.

Key safety warnings

Severe cutaneous adverse reactions including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome and toxic epidermal necrolysis 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 the first appearance of signs and symptoms of severe skin reactions. Mesalazine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported rarely. Serious blood dyscrasias have been reported rarely with mesalazine. 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. Concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine, 6-mercaptopurine or tioguanine. Patients with inflammatory bowel disease are at risk of developing nephrolithiasis, and cases of nephrolithiasis including kidney stones composed entirely of mesalazine have been reported with its use. It is recommended to ensure adequate fluid intake during treatment. Idiopathic intracranial hypertension (pseudotumour 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. Mesalazine is not recommended for use in patients with renal impairment. Renal function should be monitored regularly in all patients, especially during the initial phase of treatment. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment, and mesalazine treatment should be discontinued immediately if renal function deteriorates.

Contraindications

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

PBS listing

Mesalazine 1.2 g prolonged release tablets are listed on the PBS with 2 items under restricted access. The ex-manufacturer price is A$73.13.

Regulatory history

Mesalazine 1.2 g prolonged release tablets were first registered on the ARTG on 7 January 2021 under licence category RE, sponsored by Takeda Pharmaceuticals.