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Pentasa (Mesalamine) - Summary

 
 



PENTASA SUMMARY

PENTASA (mesalamine) for oral administration is a controlled-release formulation of mesalamine, an aminosalicylate anti-inflammatory agent for gastrointestinal use.

PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.


See all Pentasa indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Pentasa (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.

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Clinical Trials Related to Pentasa (Mesalamine)

Canadian Active & Maintenance Modified Pentasa Study [Completed]
The purpose of this study is to demonstrate that the new modified oral extended-release Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg tablet in active mild to moderate Ulcerative Colitis and also in maintenance of quiescent disease.

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.

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.

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.

An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase [Recruiting]
The purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.

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Reports of Suspected Pentasa (Mesalamine) Side Effects

OFF Label USE (17)Drug Interaction (9)Diarrhoea (9)Abdominal Pain (8)Renal Impairment (8)Erythema (7)Weight Increased (7)Dyspnoea (7)Hypersensitivity (6)Ecchymosis (6)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Pentasa has an overall score of 9. The effectiveness score is 8 and the side effect score is 9.33. The scores are on ten point scale: 10 - best, 1 - worst.
 

Pentasa review by 59 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   crohn's disease
Dosage & duration:   2000mg daily taken 2 times a day for the period of 7 yrs +
Other conditions:   none
Other drugs taken:   nexium imuran
  
Reported Results
Benefits:   It releived symptoms of crohns disease and inflammatory bowel disease. It stopped symptoms of bloating pain cramping and diarrea associated with crohns disease. I did not have any side effects from this medication. After surgery I began taking this medication daily at first I took 16 capsules a day 4 ccapsules 4 timea a day. Then cut it back to 8 daily. About 2 years ago I began taking the 500 mg dosage and take this 2 capsules 2 times a day.
Side effects:   none to me
Comments:   I began talking 250mg 4 capsules 4 times a day along with other medications after surgery for a bowel obstruction. this was the 3rd surgery for bowel obstruction I had over 20 year period. Eventually I weaned down to 8 capsules then began 500 mg and take 4 capsules per day.

 

Pentasa review by 39 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Pentasa
Dosage & duration:   500mg capsules taken 4 capsules/2x day for the period of 8 years
Other conditions:   Crohn's disease, depression
Other drugs taken:   Purinethol, Wellbutrin
  
Reported Results
Benefits:   Pentasa seems to be an effective anti-inflammatory drug, minimizing pain in my intestines/colon. I have been close to remission for a couple of years now, and I attribute it primarily to the Pentasa.
Side effects:   I don't feel as though I have any discernible side-effects with Pentasa, but when paired with Purinethol I do have side effects such as extreme fatigue and headaches, leading me to believe the problem lies with the Purinethol. I do have intermittent constipation, which could be attributable to a number of factors in my life, but is also a side-effect of Pentasa. I also have mild headaches, muscle pain, and anxiety which are listed as possible side-effects with Pentasa, but to the best of my knowledge these symptoms were occuring prior to my starting Pentasa. Perhaps the Pentasa exacerbates the problems, I don't know. I know that I do worry about kidney problems, which is one of the more serious side-effects of this medicine.
Comments:   Twelve years ago I became ill with what was diagnosed two years later (!) as Crohn's disease. I have used a variety of medications, ranging from more serious drugs (Prednisone, Remicade)to less "harmful" drugs (Metronidazole, Ciprofloxacin, Asacol, etc.). I have been on the Pentasa for about 8 years, during which time I was using Purinethol for several years. A year or so ago I weaned myself off of the Purinethol and remained on the highest dose of Pentasa for my weight, and I am doing well (knock on wood). I have constipation issues as opposed to my previous diarrhea problems, which may be attributable to the Pentasa, and is manageable through diet and over-the-counter aids.

 

Pentasa review by 39 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Pentasa
Dosage & duration:   500mg capsules taken 4 capsules/2x day for the period of 8 years
Other conditions:   Crohn's disease, depression
Other drugs taken:   Purinethol, Wellbutrin
  
Reported Results
Benefits:   Pentasa seems to be an effective anti-inflammatory drug, minimizing pain in my intestines/colon. I have been close to remission for a couple of years now, and I attribute it primarily to the Pentasa.
Side effects:   I don't feel as though I have any discernible side-effects with Pentasa, but when paired with Purinethol I do have side effects such as extreme fatigue and headaches, leading me to believe the problem lies with the Purinethol. I do have intermittent constipation, which could be attributable to a number of factors in my life, but is also a side-effect of Pentasa. I also have mild headaches, muscle pain, and anxiety which are listed as possible side-effects with Pentasa, but to the best of my knowledge these symptoms were occuring prior to my starting Pentasa. Perhaps the Pentasa exacerbates the problems, I don't know. I know that I do worry about kidney problems, which is one of the more serious side-effects of this medicine.
Comments:   Twelve years ago I became ill with what was diagnosed two years later (!) as Crohn's disease. I have used a variety of medications, ranging from more serious drugs (Prednisone, Remicade)to less "harmful" drugs (Metronidazole, Ciprofloxacin, Asacol, etc.). I have been on the Pentasa for about 8 years, during which time I was using Purinethol for several years. A year or so ago I weaned myself off of the Purinethol and remained on the highest dose of Pentasa for my weight, and I am doing well (knock on wood). I have constipation issues as opposed to my previous diarrhea problems, which may be attributable to the Pentasa, and is manageable through diet and over-the-counter aids.

See all Pentasa reviews / ratings >>

Page last updated: 2014-11-30

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