LIALDA SUMMARY
Each LIALDA delayed release tablet for oral administration contains 1.2g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent.
LIALDA tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of LIALDA beyond 8 weeks has not been established.
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NEWS HIGHLIGHTS
Published Studies Related to Lialda (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. [2013]
categorised by the extent of lesions... CONCLUSIONS: The effectiveness of mesalazine suppositories in all types of UC
Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. [2010.04]
BACKGROUND & AIMS: The practice of dosing mesalamines in divided doses for the treatment of ulcerative colitis (UC) began with sulfasalazine and was driven by sulfapyridine toxicity. This convention and the assumption that dosing multiple times a day is necessary to treat UC had not been challenged until recently. This study was conducted to determine the efficacy and safety of once-daily dosing of delayed-release mesalamine (Asacol 400-mg tablets) compared with twice-daily dosing for maintaining remission in UC patients... CONCLUSIONS: Once-daily dosing of delayed-release mesalamine at doses of 1.6-2.4 g/day was shown to be as effective as twice-daily dosing for maintenance of clinical remission in patients with UC. 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
Survival of the probiotic Escherichia coli Nissle 1917 (EcN) in the gastrointestinal tract given in combination with oral mesalamine to healthy volunteers. [2010.02]
BACKGROUND: Mesalamine and the probiotic E. coli Nissle 1917 (EcN) are both effective agents for the treatment of ulcerative colitis. A combined therapy may have more than additive efficacy. However, mesalamine may have antimicrobial effects on EcN... CONCLUSIONS: The combination of EcN and mesalamine has no significant effect on the survival of EcN in healthy volunteers.
Direct comparison of two different mesalamine formulations for the induction of
remission in patients with ulcerative colitis: a double-blind, randomized study. [2010]
formulations for the induction of remission in patients with UC... CONCLUSIONS: Higher dose of the pH-dependent release formulation was more
Delayed-release oral mesalamine 4.8 g/day (800-mg tablet) is effective for patients with moderately active ulcerative colitis. [2009.12]
BACKGROUND AND AIMS: It is not clear what induction dose of mesalamine is optimal for treating patients with mildly and moderately active ulcerative colitis (UC). This study was conducted to determine the efficacy and safety of mesalamine 4.8 g/day compared with 2.4 g/day for the treatment of moderately active UC... CONCLUSIONS: Delayed-release mesalamine 4.8 g/day (800-mg tablet) is efficacious and well-tolerated in patients with moderately active UC.
Clinical Trials Related to Lialda (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.
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.
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.
Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS) [Completed]
The purpose of this study is to find whether treating patients with diarrhea predominant
Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help
improve their symptoms of diarrhea, bloating and abdominal pain.
Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine [Completed]
This study aims to compare azathioprine versus mesalazine tablets for the prevention of
clinical relapse in postoperative Crohn's disease (CD) patients with moderate or severe
endoscopic recurrence.
Reports of Suspected Lialda (Mesalamine) Side Effects
Inappropriate Schedule of Drug Administration (12),
Diarrhoea (12),
Colitis Ulcerative (11),
OFF Label USE (9),
Abdominal Pain (6),
Drug Ineffective (6),
Condition Aggravated (6),
Colitis (6),
Weight Decreased (5),
Pyrexia (5), more >>
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