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What are the differences between different brands of mesalazine tablets?

Publisher: East Anglia Medicines Information Service

Keywords: Mesalazine; modified release formulations; colitis-ulcerative; crohn disease

Date published: 25/01/2012 10:05

Review date: 31/01/2014 00:00

Summary
by: Katie Smith
  • Asacol MR, Ipocol, Mesren MR, Mezavant XL, Octasa, Pentasa and Salofalk are all licensed for treatment of mild to moderate ulcerative colitis and maintenance of remission in ulcerative colitis. Asacol MR, Mesren MR and Octasa are also licensed for maintenance of remission in Crohn’s ileo-colitis.
  • Asacol MR, Ipocol and Mesren MR are all 400mg preparations. Asacol MR is also available as an 800mg tablet. Mezavant XL contains 1200mg, Octasa contains 800mg, Pentasa contains 500mg and Salofalk contains 500mg and 250mg mesalazine.
  • Total daily doses of Asacol, Ipocol, Mesren and Salofalk should be taken in 2 or 3 doses throughout the day. Mezavant is taken once daily for all indications. Total treatment doses of Octasa and Pentasa should be taken as 2 or 3 doses throughout the day, however for maintenance of remission, the total daily dose can be taken once daily.
  • Asacol MR, Ipocol, Mesren MR and Octasa are all similar in terms of formulation, optimal pH for drug release and site of drug release. Mezavant XL, Pentasa and Salofalk have slightly different formulations and optimal pH for drug release. Pentasa has a slightly different site of drug release too.
  • The British National Formulary states that ‘the delivery characteristics of EC mesalazine preparations may vary; these preparations should not be considered interchangeable’.
  • A systematic review examining pharmacokinetic profiles concluded that systemic exposure to 5-aminosalicylate is comparable for Asacol 400mg MR, Pentasa and Salofalk.
  • There is some in vitro evidence of inequivalence between Ipocol and Asacol 400mg MR particularly with regard to the timing of dissolution at neutral pH. Mesren MR has a virtually identical in vitro dissolution profile to Asacol 400mg MR.
  • In a small clinical trial, Ipocol has been shown to be as safe and effective as Asacol 400mg MR. Mesren MR has not been compared to Asacol 400mg MR in a clinical trial.
  • A recent review of aminosalicylates concluded that for mesalazine MR formulations there is very little difference in terms of efficacy between mesalazine preparations so choice should depend on factors that may aid adherence to therapy; for example, less frequent dosing has been shown for some preparations to be as effective as multiple daily dosing.

 

About this library entry
Category: 1.5 Chronic bowel disorders | Inflammatory bowel disease
NeLM area:  Evidence > Medicines Q & A
Mesalazine67.4.doc

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