COLAZAL SUMMARY
Each COLAZAL® capsule contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid), an anti inflammatory drug. Each daily dose of COLAZAL® (6.75 grams) is equivalent to 2.4 grams of mesalamine.
COLAZAL® is indicated for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of COLAZAL® beyond 12 weeks has not been established.
Two double-masked, clinical studies (N=259) have shown COLAZAL® to be effective in the treatment of the signs and symptoms of active ulcerative colitis. In one study, the indicated dose of COLAZAL® showed superior effectiveness to a lower dose of COLAZAL®. The percentage of patients improved in measures of stool blood, stool frequency and sigmoidoscopic score after eight weeks of treatment. A second study, conducted in Europe, confirmed these findings of symptomatic improvement.
The most frequently reported adverse events in clinical trials (N=259) included headache (8%), abdominal pain (6%) and nausea (5%). The overall reporting of adverse events was similar to those reported by patients receiving placebo.
COLAZAL® is contraindicated in patients with hypersensitivity to salicylates or to any components of the
COLAZAL® capsules or balsalazide metabolites. COLAZAL® capsules are sulfa-free and do not contain lactose.
COLAZAL® capsules are available as 750mg gelatin capsules, 280 capsules per bottle. The usual course of therapy is eight to twelve weeks.
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NEWS HIGHLIGHTSMedia Articles Related to Colazal (Balsalazide)
Need For Surgery Almost Halved By Ulcerative Colitis Treatment
Source: Irritable-Bowel Syndrome News From Medical News Today [2009.10.03]
A new study led by Mayo Clinic researchers has found that ulcerative colitis patients had a 41 percent reduction in colectomy after a year when treated with infliximab, according to a study published in the October 2009 issue of Gastroenterology. Ulcerative colitis, an inflammatory bowel disease (IBD) that causes chronic inflammation of the colon, is characterized by abdominal pain and diarrhea.
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.
Ulcerative Colitis
Source: MedicineNet Primary Sclerosing Cholangitis Specialty [2007.08.27]
Title: Ulcerative Colitis
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 8/27/2007
Gene Discovery Gives Clues to Crohn's Disease, Colitis (HealthDay)
Source: Y! Health Digestive Health News [2009.11.04]
HealthDay - WEDNESDAY, Nov. 4 (HealthDay News) -- People with painful,
chronic bowel conditions such as Crohn's disease and ulcerative colitis
could see a glimmer of hope from new research.
Treatment For Inflammatory Bowel Disease Increases The Risk Of Infection-Related Cancers
Source: Irritable-Bowel Syndrome News From Medical News Today [2009.10.20]
Patients with Crohn's disease or ulcerative colitis (collectively referred to as inflammatory bowel disease [IBD]) regularly receive treatment with thiopurine drugs to maintain remission. But an Article published Online First (http://www.thelancet.
Published Studies Related to Colazal (Balsalazide)
Prevention of acute radiation-induced proctosigmoiditis by balsalazide: a randomized, double-blind, placebo controlled trial in prostate cancer patients. [2005.12.01]
CONCLUSIONS: Balsalazide is a new-generation 5-ASA drug that yields a high concentration of active drug to the distal colon. Results of this pilot study suggest that it is able to prevent or reduce symptoms of RIPS in patients undergoing RT for prostate cancer. We feel that these results justify the formation of a cooperative group trial to assess its efficacy in a multi-institutional setting.
Low-dose balsalazide plus a high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis. [2004.11]
CONCLUSIONS: Balsalazide/VSL#3 may be a very good choice in the treatment of active mild-to-moderate active ulcerative colitis instead of balsalazide alone or mesalazine.
Comparative pharmacokinetics of equimolar doses of 5-aminosalicylate administered as oral mesalamine (Asacol) and balsalazide: a randomized, single-dose, crossover study in healthy volunteers. [2004.05.15]
BACKGROUND: Existing pharmacokinetic data are insufficient to determine whether a delayed-release formulation of mesalamine (Asacol) results in greater systemic exposure to 5-aminosalicylic acid and its major metabolite N-acetyl-5-aminosalicylic acid than a prodrug (balsalazide). AIM: To determine the pharmacokinetic parameters of 5-aminosalicylic acid and N-acetyl-5-aminosalicylic acid from equimolar doses of 5-aminosalicylic acid administered as Asacol and balsalazide... CONCLUSIONS: The systemic absorption of 5-aminosalicylic acid and N-acetyl-5-aminosalicylic acid from Asacol and balsalazide are comparable based upon plasma pharmacokinetic parameters and urinary excretion values.
Patient-led variable dosing with balsalazide as long-term therapy for maintenance in ulcerative colitis: a 3-year prospective observational study. [2004.02.15]
BACKGROUND: The patient-centred approach is new to the management of ulcerative colitis. To date, it has only been shown to be successful in a short-term study. AIM: To assess the feasibility, safety and efficacy of patient-led dosing using balsalazide in the long-term treatment of ulcerative colitis... CONCLUSIONS: Long-term, patient-led, maintenance treatment with balsalazide is well tolerated with a good safety profile and is effective for patients with ulcerative colitis.
Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute mild-to-moderate ulcerative colitis. [2002.12]
OBJECTIVE: Balsalazide is a novel azo-bonded 5-aminosalicylic acid treatment for mild-to-moderate ulcerative colitis. The study objective was to compare symptomatic remission rates with balsalazide and mesalamine while controlling for extent of disease and time since diagnosis in patients with active, mild-to-moderate ulcerative colitis... CONCLUSIONS: Balsalazide is an effective and safe treatment for mild-to-moderate ulcerative colitis. Improvement of symptoms occurs considerably earlier with balsalazide than with mesalamine.
Clinical Trials Related to Colazal (Balsalazide)
Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan balsalazide
disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg
(3 x 750 mg) dose administration under fed conditions.
Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan balsalazide
disodium 750 mg capsules and Salix Colazal® 750 mg capsules following a single, oral 2250 mg
(3 x 750 mg) dose administration under fasting conditions.
Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions [Completed]
The objective of this study was to assess bioequivalence of a potential generic 750 mg
balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg
balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting
conditions.
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions [Completed]
The objective of this study was to assess the bioequivalence of a potential generic 750 mg
balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg
balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under
fasting conditions.
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis [Completed]
To establish the efficacy and safety of a new tablet formulation and dosing regimen of
balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with
mildly to moderately active ulcerative colitis after 6 weeks of therapy.
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