What is the recommended dose of Mesalamine (Mesalazine) for an acute mild flare of ulcerative colitis?

From the Guidelines

For an acute mild flare of ulcerative colitis, the recommended mesalamine dose is 2-3 grams per day, as standard dose mesalamine is strongly recommended by the AGA for patients with extensive mild-moderate ulcerative colitis 1.

Key Considerations

• The American Gastroenterological Association (AGA) guidelines suggest using standard dose mesalamine (2–3 grams/d) for extensive mild-moderate ulcerative colitis, which is in line with reducing morbidity and improving quality of life 1.
• The choice of mesalamine dose is based on the strength of recommendation and quality of evidence, with standard dose mesalamine having a strong recommendation and moderate quality of evidence 1.
• High-dose mesalamine (>3gm/d) may be considered for patients with suboptimal response to standard-dose mesalamine or with moderate disease activity, but this has a conditional recommendation and moderate quality of evidence 1.

Treatment Approach

• Treatment should continue until remission is achieved, usually within 2-4 weeks, followed by maintenance therapy at 2-3 grams daily to prevent relapse.
• Topical therapy, such as mesalamine enemas or suppositories, can be added to oral therapy for enhanced effectiveness, especially for distal disease.
• Patients should be monitored for improvement within 2 weeks, and if symptoms don't improve after 2-3 weeks of appropriate dosing, additional therapies or step-up treatment may be necessary.

Rationale

• Mesalamine works through local anti-inflammatory effects in the colon by inhibiting prostaglandin production and blocking inflammatory cytokines.
• The use of standard dose mesalamine is supported by high-quality evidence, including a technical review on the management of mild-to-moderate ulcerative colitis, which found that standard-dose mesalamine compared to placebo reduced the risk of failure to induce remission and failure to maintain remission 1.

From the FDA Drug Label

For induction of remission: 2.4 g to 4.8 g (two to four 1.2-g tablets) once daily. The recommended dose of mesalamine for an acute mild flare of ulcerative colitis is 2.4 g to 4.8 g once daily 2.

• The dose is given as two to four 1.2-g tablets.
• It is essential to evaluate renal function prior to initiation of mesalamine delayed-release tablets and periodically while on therapy.
• Mesalamine delayed-release tablets should be swallowed whole, administered with food, and an adequate amount of fluids should be consumed.

From the Research

Mesalamine Dose for Acute Mild Flare of Ulcerative Colitis

• The dose of mesalamine for acute mild flare of ulcerative colitis is not explicitly stated in the provided studies.
• However, according to the study 3, MMX mesalamine (taken as a once-daily dose of 2.4 or 4.8 g) effectively induced and maintained clinical remission in patients with active mild-to-moderate UC.
• Another study 4 mentions that oral and topical mesalazine is effective in the treatment of mild to moderately active distal ulcerative colitis, but does not specify the exact dose.
• It is worth noting that the study 5 mentions that the choice of treatment depends on disease extent, severity, and the course of the disease, and that topical 5-aminosalicylic acid (5-ASA) drugs are used as the first line agents for proctitis, while oral and topical 5-ASA drugs +/- corticosteroids are used to induce remission in patients with more extensive or severe disease.

Treatment Options for Ulcerative Colitis

• The studies suggest that mesalamine is a first-line therapy for inducing and maintaining clinical remission in patients with mild-to-moderate UC 3, 4.
• Other treatment options for UC include corticosteroids, azathioprine/mercaptopurine, cyclosporine, and infliximab 3, 5, 6.
• The study 6 provides guidance on the management of acute severe ulcerative colitis, including the use of intravenous corticosteroids, cyclosporine, and infliximab as rescue medical therapy.

Maintenance of Remission in Ulcerative Colitis

• The study 7 assesses the effectiveness and safety of azathioprine and 6-mercaptopurine for maintaining remission of ulcerative colitis, and finds that azathioprine is significantly superior to placebo for maintenance of remission.
• The study suggests that azathioprine or 6-mercaptopurine may be effective as maintenance therapy for patients who have failed or cannot tolerate mesalazine or sulfasalazine, and for patients who require repeated courses of steroids 7.