MEZAVANT

What it is

MEZAVANT is a mesalazine 1.2 g gastro-resistant, prolonged 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 — Maintenance of remission in Crohn's disease

Dosing overview

For ulcerative colitis, treatment of active disease 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, treatment of active disease and maintenance treatment both require 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 (SCARs), 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. Patients with inflammatory bowel disease are at risk of developing nephrolithiasis. 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 (pseudotumour cerebri) has been reported in patients receiving mesalazine. Patients should be warned for signs and symptoms of idiopathic intracranial hypertension, including severe or recurrent headache, visual disturbances or tinnitus. If idiopathic intracranial hypertension occurs, discontinuation of mesalazine should be considered.

Contraindications

MEZAVANT is contraindicated in patients with hypersensitivity to mesalazine or any of the excipients or salicylates. It is also contraindicated in severe liver or renal impairment.

Regulatory history

MEZAVANT (mesalazine 1.2 g gastro-resistant, prolonged release tablet) was first listed on the ARTG on 25 September 2009.