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Apriso (Mesalamine) - Summary

 
 



APRISO SUMMARY

Each APRISO capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an anti-inflammatory drug.

APRISO capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older.


See all Apriso indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Apriso (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

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.

more studies >>

Clinical Trials Related to Apriso (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.

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.

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.

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.

Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis. [Completed]
The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks. Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.

more trials >>

Reports of Suspected Apriso (Mesalamine) Side Effects

Crohn's Disease (2)Diarrhoea (2)Pancreatitis Acute (1)Weight Decreased (1)Drug Ineffective (1)Small Intestine Ulcer (1)Headache (1)Frequent Bowel Movements (1)Ileitis (1)Myocardial Infarction (1)more >>


Page last updated: 2014-11-30

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