COHANA

What it is

COHANA is a mesalazine prolonged release tablet . Each COHANA tablet contains 1.2 g of mesalazine . The tablet contains a core of mesalazine formulated in a multi-matrix system coated with methacrylic acid copolymers designed to dissolve at approximately pH 7 . The matrix facilitates extended delivery of effective concentrations of mesalazine through the entire colon with limited systemic absorption .

Approved indications

— Induction of remission in patients with mild to moderate, active ulcerative colitis . — Maintenance of remission in patients with mild to moderate ulcerative colitis .

Dosing overview

COHANA is intended for once daily, oral administration . For induction of remission in adults, including the elderly over 65 years, 2.4 to 4.8 g (two to four tablets) should be taken once daily . For maintenance of remission, 2.4 g (two tablets) should be taken once daily . COHANA tablets must not be crushed or chewed and should be swallowed whole with or without food . When using the highest dose of 4.8 g per day, the effect of treatment should be evaluated at 8 weeks .

Key safety warnings

Serious blood dyscrasias have been reported rarely following mesalazine treatment. If the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat, haematological investigations should be performed, and if blood dyscrasia is suspected, treatment should be terminated . Mesalazine has been associated with an acute intolerance syndrome occurring in 3% of patients in controlled clinical trials, with symptoms including cramping, acute abdominal pain and bloody diarrhoea, sometimes fever, headache and rash. If acute intolerance syndrome is suspected, prompt withdrawal is required and products containing mesalazine must not be reintroduced . Severe cutaneous adverse reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with mesalazine treatment. Discontinue mesalazine at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity . Reports of renal impairment, including minimal change nephropathy, acute or chronic interstitial nephritis and renal failure have been associated with mesalazine preparations. All patients should have an evaluation of renal function prior to initiation of therapy and periodically whilst on treatment . Cases of nephrolithiasis have been reported with mesalazine use, including stones with mesalazine content, and adequate fluid intake should be ensured during treatment .

Contraindications

COHANA is contraindicated in patients with a history of hypersensitivity to salicylates (including mesalazine) or any of the excipients of COHANA .

Regulatory history

COHANA mesalazine 1.2 g delayed release tablets were first listed on the ARTG on 14 March 2025, with two registered variants (bottle and blister pack) sponsored by KSJ Pharmatech .