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Pentasa (Mesalamine) - Summary

 
 



PENTASA SUMMARY

PENTASA®
(mesalamine)
Controlled-Release Capsules 250 mg and 500 mg

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)

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.

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.

more studies >>

Clinical Trials Related to Pentasa (Mesalamine)

A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease [Completed]
The primary objective of the clinical trial is the assessment of the acceptability of the new

Pentasa formulation - PentasaR Sachets in comparison with the reference PentasaR tablets 500

mg in children with Crohn's disease. After the screening period (which includes medical history, physical examination, basic haematology, serum chemistry , urine analysis and stool microbiology , PCD Activity Index )patients will receive (visit I) Pentasa sachets 1g or Pentasa tablets 500mg for next 4 weeks according to the randomisation scheme in common dose 2× 1 g of PentasaR Sachets 1 g or PentasaR tablets 500 mg. The formulation of Pentasa will be switched at Visit 2, patients will receive the medication for next 4 weeks. Patients will record the acceptability of the both forms of the medication.

In 6 patients from each group (selected by the randomization), stool and urine will be taken to assess concentrations of mesalazine and N-acetylmesalazine during Visit 2 and Visit 3. Adverse events will be recorded during the whole course of the treatment period.

Canadian Active & Maintenance Modified Pentasa Study [Recruiting]
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 Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) [Completed]

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis [Recruiting]

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.

Sulfamethoxazole Drug Interaction Study With MMX� Mesalazine/Mesalamine [Recruiting]
This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone & in combination with MMX Mesalazine/mesalamine.

more trials >>

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: 2011-12-09

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