MESASAL

What it is

MESASAL contains mesalazine as the active ingredient. It is presented as a 250 mg enteric coated 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, the treatment dose for active disease is up to 4 g daily given once daily or in divided doses, with maintenance treatment at 2 g once daily or starting with 1.5–2 g daily in divided doses. For Crohn's disease, both treatment of active disease and maintenance treatment use 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 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 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, and haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. 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 (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. Mesalazine is not recommended for use in patients with renal impairment, and renal function should be monitored regularly in all patients especially during the initial phase of treatment. Caution is recommended in patients with impaired liver function, and liver function parameters should be assessed prior to and during treatment.

Contraindications

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

PBS listing

MESASAL 250 mg enteric coated tablet is listed on the PBS with 2 items under a restricted authority required restriction, with an ex-manufacturer price of A$29.43.

Regulatory history

MESASAL mesalazine 250 mg enteric coated tablet was first listed on the ARTG on 16 August 2017.