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 per day. This recommendation is based on the American Gastroenterological Association (AGA) clinical practice guidelines, which suggest that mesalamine is effective for both induction and maintenance of remission in patients with mild-to-moderate ulcerative colitis 1. The guidelines also recommend adding rectal mesalamine to oral 5-ASA therapy for patients with extensive mild-moderate ulcerative colitis, as combination therapy has been shown to be more effective for induction of remission and maintenance of remission compared to oral 5-ASA alone 1.
Some key points to consider when using mesalamine include:
- Mesalamine is available in various formulations, including oral tablets, delayed-release capsules, extended-release capsules, suppositories, and enemas, with dosing typically ranging from 800 mg to 4.8 g daily depending on the specific condition and severity.
- For maintenance therapy of ulcerative colitis, a common regimen is 1.6-2.4 g daily in divided doses, while active flares may require higher doses up to 4.8 g daily.
- Patients should take oral formulations with food to minimize stomach upset and complete the full prescribed course even if symptoms improve.
- Regular monitoring by a healthcare provider is important to assess effectiveness and watch for rare but serious side effects such as kidney problems or allergic reactions.
It's also important to note that mesalamine is considered safer than corticosteroids for long-term use, as it has fewer systemic effects and can be used for both induction and maintenance of remission in inflammatory bowel disease 1. However, sulfasalazine, another 5-ASA medication, may be an acceptable alternative in patients who can tolerate it or in patients with prominent arthritic symptoms, although it is often poorly tolerated due to side effects such as headache, nausea, diarrhea, and rash 1.
In terms of specific patient populations, the AGA recommends using mesalamine suppositories in patients with mild-moderate ulcerative proctitis who opt for rectal therapy, as pooled analysis of 4 RCTs showed that mesalamine suppositories are more effective than placebo in inducing remission 1. Additionally, the AGA suggests using rectal corticosteroid therapy in patients with ulcerative proctitis who are refractory to or intolerant of mesalamine suppositories, although the evidence for this recommendation is low quality due to indirectness and imprecision 1.
Overall, mesalamine is a effective and well-tolerated treatment option for mild-to-moderate ulcerative colitis, and its use should be guided by the AGA clinical practice guidelines and individual patient needs and preferences.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Mesalamine Overview
- Mesalamine is a 5-aminosalicylic acid compound used in the treatment of mild to moderate ulcerative colitis and Crohn's disease 2, 3, 4, 5, 6
- It is available in various formulations, including delayed-release, controlled-release, and multi-matrix system, which differ in their means of delivering active mesalamine to the colon 2, 3, 6
Efficacy and Dosage
- Mesalamine has been shown to induce clinical response and remission, and maintain clinical remission, in patients with ulcerative colitis and Crohn's disease 2, 3, 4, 5
- The optimal dose for induction of response is unclear, but high-dose mesalamine (above 2.4 g/d) has been shown to be effective in inducing remission in Crohn's disease 4, 5
- For maintenance therapy, existing data do not support a dose response above 1.5 g 2
Safety and Tolerability
- Mesalamine has few serious adverse effects and is generally well tolerated by patients 3
- Sulfasalazine has more frequent side effects than olsalazine, balsalazide, and mesalamine formulations 2
Chemoprevention
- Mesalamine >/= 1.2 g and sulfasalazine >/= 2 g have been shown to reduce the risk of colorectal cancer in patients with ulcerative colitis 2