From the Guidelines
Mesalamine is recommended as a first-line treatment for mild-to-moderate ulcerative colitis, with a standard dose of 2-3 grams/day, due to its effectiveness in inducing and maintaining remission, as supported by the AGA clinical practice guidelines 1.
Key Points
- The American Gastroenterological Association (AGA) recommends using standard dose mesalamine (2–3 grams/day) for patients with extensive mild-moderate ulcerative colitis 1.
- Mesalamine is available in various forms, including oral tablets, delayed-release capsules, extended-release capsules, suppositories, and enemas.
- The typical dosage ranges from 800 mg to 4.8 grams daily, depending on the formulation and severity of the condition.
- For maintenance therapy of ulcerative colitis, a common regimen is 1.6-2.4 grams daily in divided doses, while active flares may require higher doses up to 4.8 grams daily.
- Mesalamine works locally in the intestine by reducing inflammation through inhibition of cyclooxygenase and prostaglandin production.
- Common side effects include headache, nausea, abdominal pain, and diarrhea.
- Patients should have periodic kidney function tests as mesalamine can rarely cause kidney problems.
Treatment Considerations
- The AGA suggests adding rectal mesalamine to oral 5-ASA for patients with extensive or left-sided mild-moderate ulcerative colitis 1.
- For patients with mild-moderate ulcerative colitis with suboptimal response to standard-dose mesalamine, the AGA suggests using high-dose mesalamine (>3 grams/day) with rectal mesalamine 1.
- Once-daily dosing of mesalamine is preferred over multiple times per day dosing, as it improves adherence and satisfaction with the treatment regimen 1.
Evidence Summary
- The AGA clinical practice guidelines provide strong recommendations for the use of mesalamine in the treatment of mild-to-moderate ulcerative colitis, based on moderate to high-quality evidence 1.
- The guidelines emphasize the importance of individualizing treatment based on disease severity, extent, and patient preferences.
- The evidence supports the use of mesalamine as a first-line treatment for mild-to-moderate ulcerative colitis, with a focus on standard dosing and once-daily administration.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Mesalamine Uses
- Mesalamine is used in the treatment of ulcerative colitis and Crohn's disease, with a clear role in the maintenance of remission in ulcerative colitis and management of mild to moderately active disease 2.
- The efficacy of topical preparations or combined topical and oral mesalamine is superior to oral alone 2.
- Mesalamine has been shown to be effective in inducing clinical response and remission, and maintaining clinical remission, in patients with mild-to-moderate ulcerative colitis 3.
Mesalamine Dosage
- The optimal dosage of oral mesalamine for the maintenance of remission is unclear, but higher daily dosages may provide additional benefit in patients with active distal disease 4.
- Oral delayed-release mesalamine 2.4 to 4.8 g/day has been shown to be effective in treating mild to moderately active ulcerative colitis 4.
- A dose of 4 g/day mesalamine has been shown to be effective in treating active Crohn's disease of the ileum and colon 5.
Mesalamine Efficacy
- Mesalamine has been demonstrated to be effective in reducing the risk of relapse in high-relapse-risk patients with inactive Crohn's disease 6.
- Mesalamine has been shown to be effective in decreasing weaning failure due to steroid dependence in patients with ulcerative colitis 6.
- Rectal mesalamine 4 g hs has been shown to achieve a remission rate of 78% in patients with active ulcerative colitis 6.