Asacol (Mesalamine) - Summary

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.

See all Asacol indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Asacol (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.

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Clinical Trials Related to Asacol (Mesalamine)

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.

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

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 Asacol (Mesalamine) Side Effects

Drug Hypersensitivity (6),  Colitis Ulcerative (4),  Pyrexia (4),  Chest Pain (3),  Dizziness (3),  Diarrhoea (3),  Neutropenia (3),  Headache (2),  Lower Respiratory Tract Infection (2),  Myalgia (2), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Asacol review by 33 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		ulcerative colitis
Dosage & duration:		400mg taken 3 times a day for the period of 1yr
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The treatment benefits included a decrease an abdominal pain, a decrease in diahrea and blood in the stool. There were also benefits in overall comfort when dealing with day to day activities. The decrease in abdominal pain and frequent diahrea allows me to perform my daily activities.
Side effects:		The main side effects was nausea at first but disappeared over time. Headaches occurred frequently at first and have decreased but I still experience them occationally. They usually disappear with tyenol. Other than that the only other issues I experienced was slight symptoms that were not completely taken care of with the medication.
Comments:		My treatment consists of taking 3 pills 3 times a day. Routine colonoscopys are necessary. I also take a multivitamin twice a day. I watch my diet. I drink a minimum amount of milk, eat a minimum amount of fried and unhealthy food, drink more water and fruits and vegetables.

Asacol review by 25 year old male patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Ulcerative Colitis
Dosage & duration:		100mg taken 3 times a day for the period of 6 months
Other conditions:		N/A
Other drugs taken:		N/A
		Reported Results
Benefits:		Flare-ups were less frequent as well and the duration of time they lasted was less. I noticed that it didn't help with the amount of bowl movements I was having but it did help stop the internal bleeding.
Side effects:		Nausea, cramping, abdominal pain were just some of the bigger side effects. Sometimes the stomach pain was so painful it was worse then an actual flare-up.
Comments:		I stopped taking Asacol because of the intense stomach pain it caused me as well as the nausea. I found that while taking Asacol, my falre-ups did decrease but the side effects outweighed the benefits.

Asacol review by care giver of 15 year old male patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Ulcerative Colitis
Dosage & duration:		800 mg taken bid for the period of 2 weeks
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		There were no benefits as he had to stop taking it
Side effects:		Brownish colored urine, nausea and vomiting, stomache ache
Comments:		Patient was to take 800 mg twice daily to treat ulcerative colitis but was found to be intolerant to Asacol and was discontinued. The side effects began about 7-10 days after starting the Asacol. The nausea and vomiting was not immediately associated with Asacol but was attributed to possibly having the flu. It was only until his urine became a brownish purple color that we thought it must be the Asacol and immediately stopped it. Symptoms went away when stopped.