Asacol (Mesalamine) - Summary

ASACOL SUMMARY

Each Asacol delayed-release tablet for oral administration contains 400 mg of mesalamine, an anti-inflammatory drug. The Asacol delayed-release tablets are coated with acrylic based resin, Eudragit S (methacrylic acid copolymer B, NF), which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon.

Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

ASACOL NEWS HIGHLIGHTS

Media Articles Related to Asacol (Mesalamine)

Shire Announces Results From An Analysis Of LIALDA And Asacol For The Treatment Of UC
Source: Conferences News From Medical News Today [2008.10.07]

ACG: Once-Daily Mesalamine Maintains Remission in Ulcerative Colitis
Source: MedPage Today Gastroenterology [2008.10.08]

Mesalamine Granules Maintain Remission In Ulcerative Colitis Patients Who Switch From Another 5-ASA
Source: Clinical Trials / Drug Trials News From Medical News Today [2008.10.08]

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Published Studies Related to Asacol (Mesalamine)

Delayed-release oral mesalamine 4.8 g/day (800 mg tablets) compared to 2.4 g/day (400 mg tablets) for the treatment of mildly to moderately active ulcerative colitis: The ASCEND I trial. [2007.12]

Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. [2007.01]

Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. [2005.11]

Efficacy and safety of mesalamine 1 g HS versus 500 mg BID suppositories in mild to moderate ulcerative proctitis: a multicenter randomized study. [2005.07]

Multicentre randomized-controlled clinical trial of Ipocol, a new enteric-coated form of mesalazine, in comparison with Asacol in the treatment of ulcerative colitis. [2005.05.01]

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Clinical Trials Related to Asacol (Mesalamine)

Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) [Completed]

Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis [Terminated]

Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis [Completed]

A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease [Completed]

A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis. [Completed]

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