ASACOL SUMMARY
Asacol®
(mesalamine)
Delayed-Release Tablets
Each Asacol delayed-release tablet for oral administration contains 400 mg of mesalamine, an anti-inflammatory drug. The Asacol delayed-release tablets are coated with acrylic based resin, Eudragit S (methacrylic acid copolymer B, NF), which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon.
Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.
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NEWS HIGHLIGHTSMedia Articles Related to Asacol (Mesalamine)
Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (Mesalamine) Delayed-Release Tablets For Moderately Active Ulcerative Colitis
Source: Irritable-Bowel Syndrome News From Medical News Today [2009.07.09]
Procter & Gamble Pharmaceuticals (P&GP) announced the availability of Asacol HD (mesalamine) delayed-release tablets, which are indicated for the treatment of moderately active ulcerative colitis (UC), a form of inflammatory bowel disease. UC involves inflammation of the lining of the colon and rectum and is typically characterized by flares followed by periods of remission. Moderately active UC is characterized by tougher symptoms than mildly active UC.
Published Studies Related to Asacol (Mesalamine)
Mesalamine once daily is more effective than twice daily in patients with quiescent ulcerative colitis. [2009.07]
BACKGROUND & AIMS: Oral mesalamine (5-aminosalicylate) is the current standard of care for mild-to-moderate ulcerative colitis. We investigated the efficacy and safety of once daily administration of prolonged-release mesalamine granules in maintenance of remission in patients with quiescent ulcerative colitis, compared with the well established twice daily dosing regimen... CONCLUSIONS: Patients with ulcerative colitis given prolonged-release oral mesalamine 2 g once daily had better remission rates, acceptability, and self-reported adherence to therapy compared with patients given oral mesalamine 1 g twice daily.
Comparison of the analgesic effect of ibuprofen with mesalamine after discectomy surgery in patients with lumbar disc herniation: a double-blind randomized controlled trial. [2009.05]
BACKGROUND: Pain management is an important component in the postoperative period following discectomy. AIMS: We hypothesized that mesalamine considering its better safety profile, is likely to be a better choice, if it would be as effective as ibuprofen in controlling post-discectomy pain. SETTINGS AND DESIGN: A double-blind randomized controlled trial was performed on patients who underwent lumbar discectomy surgery... CONCLUSIONS: Since both drugs showed almost equal analgesic effect, considering its safety profile mesalamine, seems to be the preferred choice to alleviate post-discectomy surgery pain.
Mesalamine foam enema versus mesalamine liquid enema in active left-sided ulcerative colitis. [2008.12]
AIM: To determine in a noninferiority study whether mesalamine foam is as effective as mesalamine liquid enema for inducing clinical remission in patients with active left-sided ulcerative colitis (UC)... CONCLUSIONS: A 4-wk treatment of 1 g mesalamine foam induced a clinical remission in 68% patients versus 73% with 1 g mesalamine liquid enema. Although the noninferiority of mesalamine foam could not be strictly demonstrated at W4 in the PP analysis, it was achieved in the ITT population and at W2 in both populations. Mesalamine foam represents a therapeutic alternative to mesalamine liquid enema in patients with mild-to-moderate active proctitis and proctosigmoiditis.
Erythrocyte-mediated delivery of dexamethasone in patients with mild-to-moderate ulcerative colitis, refractory to mesalamine: a randomized, controlled study. [2008.10]
BACKGROUND AND AIM: Nearly 25% of patients with ulcerative colitis (UC) requiring steroids therapy become steroid-dependent after 1 yr, and virtually all develop steroid-related adverse events. We planned a controlled study to investigate the efficacy and safety of dexamethasone 21-P (Dex 21-P) encapsulated into erythrocytes (DEE)... CONCLUSION: Low doses of Dex (mean total dose +/- 20 mg) loaded into autologous erythrocytes were significantly more effective than sham infusions in terms of symptoms relief, endoscopic, and biochemical improvements in UC patients refractory to mesalamine. In addition, in contrast to oral prednisolone (mean total dose +/- 1 g), no steroid-related adverse events were induced.
Delayed-release oral mesalamine 4.8 g/day (800 mg tablets) compared to 2.4 g/day (400 mg tablets) for the treatment of mildly to moderately active ulcerative colitis: The ASCEND I trial. [2007.12]
BACKGROUND: Delayed-release oral mesalamine 2.4 g/day to 4.8 g/day has been shown to be effective in treating mildly to moderately active ulcerative colitis (UC), but it is unknown whether an initial dose of 4.8 g/day is more effective than 2.4 g/day in patients with mildly to moderately active UC and in the subgroup with moderate disease... CONCLUSIONS: Delayed-release oral mesalamine is an effective and well-tolerated initial therapy in patients with mildly to moderately active UC, and a 4.8 g/day dose may enhance treatment success rates in patients with moderate disease compared with mesalamine 2.4 g/day.
Clinical Trials Related to Asacol (Mesalamine)
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) [Completed]
Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis [Terminated]
The purpose of this study is to determine if taking Asacol once a day is as effective as
taking Asacol twice or three times a day in keeping ulcerative colitis inactive, and to
determine which dosing regimen is easiest to follow. Once daily dosing of Asacol is
experimental, and has not been approved by the FDA. Dosing as three times daily is FDA
approved.
This research is being done because the researchers want to learn what the best methods are
for keeping ulcerative colitis inactive, and which way of taking Asacol is most helpful to
subjects in continuing to take a medication to control their ulcerative colitis.
Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis [Completed]
The primary objective of the study was to compare the percentage of subjects in remission
after 8 weeks of treatment with SPD476, 2. 4 g/day once daily vs placebo and SPD476 4. 8 g/day
once daily versus placebo
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
2Ă— 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.
A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis. [Completed]
The purpose of this randomized, open-label, parallel-group study is to determine how the body
absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60
mg/kg/day or 90 mg/kg/day as 400 mg delayed-release tablets given every 12 hours of 28 days
to children and adolescents with active ulcerative colitis.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Asacol has an overall score of 6. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Asacol review by 49 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Crohns Disease |
| Dosage & duration: | | 400mg taken 2 tabs 3 times daily for the period of 5 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Less flair ups of the crohns disease. Less diarhea and cramping. |
| Side effects: | | no side effects evidentent |
| Comments: | | I believe you mean the treatment of the disease. For me it was taking my medication Asacol, and watching my diet. I understand foods have different effects on different individuals. For me, avoiding foods high in fat, avoiding excessive sugars and high fiber foods (popcorn, nuts) made the difference for me. The drug w/o diet would not work.
Should stress be factored, that too, weighed heavily. |
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Page last updated: 2009-10-20
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