ASACOL HD SUMMARY
Each Asacol HD delayed-release tablet for oral administration contains 800 mg of mesalamine, an anti-inflammatory drug. Asacol HD delayed-release tablets have an outer protective coat consisting of a combination of acrylic based resins, Eudragit S (methacrylic acid copolymer B, NF) and Eudragit L (methacrylic acid copolymer A, NF). The inner coat consists of an acrylic based resin, Eudragit S, which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon.
Asacol HD is indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD beyond 6 weeks has not been established.
|
NEWS HIGHLIGHTSMedia Articles Related to Asacol HD (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 HD (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.
N-acetyl-L-cysteine combined with mesalamine in the treatment of ulcerative colitis: Randomized, placebo-controlled pilot study. [2008.05.14]
AIM: To evaluate the effectiveness and safety of oral N-acetyl-L-cysteine (NAC) co-administration with mesalamine in ulcerative colitis (UC) patients... CONCLUSION: In group A (oral NAC combined with mesalamine) contrarily to group B (mesalamine alone), the clinical improvement correlates with a decrease of chemokines such as MCP-1 and IL-8. NAC addition not produced any side effects.
Clinical Trials Related to Asacol HD (Mesalamine)
Canadian Active & Maintenance Modified Pentasa Study [Recruiting]
The purpose of this study is to determine that the new modified oral extended-release
Pentasa® 500mg tablet is of similar efficacy to the currently marketed Pentasa® 500mg tablet
in active mild to moderate Ulcerative Colitis and also in maintenance of quiescent disease.
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis [Recruiting]
The overall objective of this study is to assess the safety and efficacy of high dose and
low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6
weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.
Mechanistic Randomized Controlled Trial (RCT) of Mesalazine in Symptomatic Diverticular Disease [Recruiting]
Diverticulosis (bulges in the bowel wall) affects two third of the elderly population in the
UK. Diverticular disease and its complications are responsible for 68000 hospital admissions
and 2000 deaths per year. It commonly produces recurrent short lived abdominal pain, changes
in bowel habit and incontinence. The causes of symptoms are not known and the treatments
unsatisfactory. Recent studies have found an association between inflammation, alteration of
bowel nerves and symptoms. Mesalazine is an anti-inflammatory drug used in inflammatory
bowel conditions, such as ulcerative colitis and crohn's disease. We plan to perform a
randomized double blind (neither the patients or the doctors known which treatment the
patient is taking) placebo (sham medication) controlled trial of mesalazine in symptomatic
diverticular disease patients. We anticipate a reduction in the amount of inflammation,
bowel nerve changes and symptoms in patients taking mesalazine compare to those taking the
placebo.
Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis. [Recruiting]
The purpose of this study is to demonstrate that mesalazine po 4g 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 UC-DAI score and defined as less than or equal to 1.
Both groups (4g QD and 2gx2) will receive an enema containing 1g of mesalazine at bedtime
during the initial 4 weeks.
A Study With Pentasa in Patients With Active Crohn's Disease [Recruiting]
|
