ASACOL HD SUMMARY
Each Asacol HD delayed-release tablet for oral administration contains 800 mg of mesalamine, an aminosalicylate. Asacol HD delayed-release tablets have an outer protective coat consisting of a combination of acrylic based resins, Eudragit S (methacrylic acid copolymer B, NF) and Eudragit L (methacrylic acid copolymer A, NF). The inner coat consists of an acrylic based resin, Eudragit S, which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon.
AsacolÂ® HD is indicated for the treatment of moderately active ulcerative colitis in adults. Safety and effectiveness of Asacol HD beyond 6 weeks have not been established.
Media Articles Related to Asacol HD (Mesalamine)
Mesalamine Enemas May Be Helpful in Pediatric Ulcerative Colitis
Source: Medscape General Surgery Headlines [2017.04.20]
Following failure of high-dose oral mesalamine (5-aminosalicylic acid), topical enemas containing the agent may be effective in many children with mild to moderate ulcerative colitis (UC), according to Israeli and Finnish researchers.
Reuters Health Information
Published Studies Related to Asacol HD (Mesalamine)
Randomised clinical trial: evaluation of the efficacy of mesalazine (mesalamine)
suppositories in patients with ulcerative colitis and active rectal inflammation
-- a placebo-controlled study. 
categorised by the extent of lesions... CONCLUSIONS: The effectiveness of mesalazine suppositories in all types of UC
Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease. [2011.02]
BACKGROUND & AIMS: Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD... CONCLUSIONS: Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-L-coated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
A multicenter, randomized study to evaluate the efficacy and safety of mesalamine suppositories 1 g at bedtime and 500 mg Twice daily in patients with active mild-to-moderate ulcerative proctitis. [2011.02]
BACKGROUND: Ulcerative proctitis (UP) is a prevalent condition associated with increased morbidity and mortality. Topical mesalamine (5-aminosalicylic acid [5-ASA]) inhibits inflammatory processes in UP... CONCLUSIONS: Mesalamine 500-mg BID and 1-g QHS suppositories are safe and effective for patients with UP. Most patients reported significant improvement within 3 weeks and UP remission and reduced disease extension after 6 weeks of treatment. Validity of QHS administration was confirmed.
Clinical trial: a novel high-dose 1 g mesalamine suppository (Salofalk) once daily is as efficacious as a 500-mg suppository thrice daily in active ulcerative proctitis. [2010.11]
BACKGROUND: Mesalamine suppositories are first-line therapy in active ulcerative proctitis; the standard regime still recommends multiple doses per day. The primary objective of this study was to show the noninferiority of once-daily administration of a novel 1 g mesalamine suppository versus thrice-daily administration of the 0.5 g mesalamine suppository... CONCLUSIONS: In active ulcerative proctitis the once-daily administration of a 1 g mesalamine suppository is as effective and safe, yet considerably more convenient, than the standard thrice-daily administration of a 0.5 g mesalamine suppository.
Clinical trial: once-daily mesalamine granules for maintenance of remission of ulcerative colitis - a 6-month placebo-controlled trial. [2010.10]
BACKGROUND: Ulcerative colitis (UC) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder. AIM: To evaluate once-daily mesalamine (mesalazine) granules (MG) for maintenance of remission of UC... CONCLUSIONS: Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months. (c) 2010 Salix Pharmaceuticals.
Clinical Trials Related to Asacol HD (Mesalamine)
Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis [Completed]
The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine
following administration in children and adolescents with ulcerative colitis.
Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers [Completed]
This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3
regimens of oral mesalamine 2. 4 g/day (Lialda 2. 4 g/day 2 x 1. 2 g every 24 hours, Asacol® 6
x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA
area under the plasma concentration versus time curve from zero to 24 hours (AUC24) and
total 5-ASA percent of dose excreted (A'e [%]) over the 24-hour period on Day 7.
The Colitis Once Daily Asacol Study [Completed]
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis [Terminated]
The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and
high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg
delayed-release tablets given twice daily for 26 weeks to children and adolescents for the
maintenance of remission of ulcerative colitis.
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study [Recruiting]
The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in
patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will
evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma
cytokines before and after treatment with Lialda.