From the Guidelines
Mesalazine is recommended as a first-line treatment for mild-to-moderate ulcerative colitis, with a standard dose of 2-3 grams per day. The American Gastroenterological Association (AGA) recommends using either standard-dose mesalamine or diazo-bonded 5-ASA for induction and maintenance of remission in patients with extensive mild-to-moderate ulcerative colitis 1. Mesalazine works locally in the intestine to reduce inflammation, and its effectiveness has been demonstrated in numerous studies, including a meta-analysis showing that standard-dose mesalamine is superior to placebo for induction of remission (RR 0.84,95% CI 0.78-0.91) 1.
Some key points to consider when using mesalazine include:
- The typical dosage ranges from 1.5 to 4.8 grams daily, depending on the severity of the condition and the specific formulation used.
- Mesalazine comes in various formulations, including oral tablets, capsules, granules, suppositories, and enemas, with different release mechanisms designed to target specific parts of the gastrointestinal tract.
- Common side effects include headache, nausea, abdominal pain, and diarrhea.
- Patients should take the medication as prescribed, even when feeling well, as stopping treatment may lead to disease flare-ups.
- Regular monitoring of kidney function is recommended during long-term use as mesalazine can rarely cause kidney problems.
- Patients should inform their healthcare provider about any other medications they're taking to avoid potential interactions.
In terms of specific recommendations, the AGA suggests:
- Using standard-dose oral mesalamine or diazo-bonded 5-ASA for induction and maintenance of remission in patients with extensive mild-to-moderate ulcerative colitis 1.
- Adding rectal mesalamine to oral 5-ASA therapy for patients with extensive mild-to-moderate ulcerative colitis 1.
- Using mesalamine enemas or suppositories for patients with left-sided mild-to-moderate ulcerative proctosigmoiditis or proctitis 1.
- Considering rectal corticosteroid therapy for patients with inadequate response or intolerance to mesalamine suppositories 1.
Overall, mesalazine is a well-established and effective treatment for mild-to-moderate ulcerative colitis, and its use should be guided by the AGA recommendations and individual patient needs.
From the FDA Drug Label
Mesalamine rectal suspension enema is an aminosalicylate indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. The answer to the question about Mesalazine is that it is indicated for the treatment of:
- Active mild to moderate distal ulcerative colitis
- Proctosigmoiditis
- Proctitis in adults 2.
From the Research
Mesalazine Overview
- Mesalazine, also known as 5-aminosalicylic acid, is a primary treatment for mild-to-moderate ulcerative colitis 3, 4, 5, 6, 7
- It is available in various formulations, including oral delayed-release and sustained-release, topical formulations, and as a prodrug 6
Therapeutic Use
- Mesalazine is effective in inducing and maintaining remission in ulcerative colitis, with a faster onset of action compared to some other treatments 3, 5
- It is also used to prevent relapse in ulcerative colitis, with dosages up to 6 g/day potentially providing additional benefits 3
- In Crohn's disease, the role of mesalazine is less clear, but it may be effective in preventing relapse after surgical resection 6
Safety and Tolerability
- Mesalazine is generally well tolerated, but serious adverse effects such as worsening of colitis, interstitial pneumonitis, and nephritis have been reported 7
- These reactions are mostly reversible with cessation of therapy 7
- Mesalazine has a better tolerability profile compared to standard formulations of sulfasalazine at therapeutically relevant dosages 3