MESALZ

What it is

MESALZ is a prolonged release tablet containing mesalazine as the active ingredient.

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, active disease is treated with individual dosage up to 4 g given once daily or in divided doses, while maintenance treatment involves 2 g once daily or individual dosage starting with 1.5–2 g daily in divided doses. For Crohn's disease, both active disease treatment and maintenance treatment involve individual dosage up to 4 g daily in divided doses. The tablets should not be crushed or chewed.

Key safety warnings

Severe cutaneous adverse reactions including drug reaction with eosinophilia and systemic 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 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) 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. 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.

PBS listing

MESALZ 1.2 g prolonged release tablet is listed on the PBS with 2 items, restriction type is restricted, and the ex-manufacturer price is A$146.26.

Regulatory history

MESALZ mesalazine 1.2 g gastro-resistant prolonged release tablet was first listed on the ARTG on 5 January 2023.