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)
Ulcerative Colitis
Source: MedicineNet Abdominal Pain Specialty [2013.05.16]
Title: Ulcerative Colitis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 5/16/2013 12:00:00 AM
Simponi Approved for Ulcerative Colitis
Source: MedicineNet Ulcerative Colitis Specialty [2013.05.16]
Title: Simponi Approved for Ulcerative Colitis
Category: Health News
Created: 5/15/2013 6:36:00 PM
Last Editorial Review: 5/16/2013 12:00:00 AM
Simponi OK'd for Ulcerative Colitis
Source: MedPage Today Gastroenterology [2013.05.15]
(MedPage Today) -- SILVER SPRING, Md. -- The biologic drug golimumab (Simponi) may be used to treat moderate to severe ulcerative colitis, the FDA said Wednesday.
Health Tip: When Ulcerative Colitis Symptoms Flare
Source: MedicineNet Ulcerative Colitis Specialty [2013.04.03]
Title: Health Tip: When Ulcerative Colitis Symptoms Flare
Category: Health News
Created: 4/3/2013 8:35:00 AM
Last Editorial Review: 4/3/2013 12:00:00 AM
Ulcerative Colitis Quiz: Test Your IQ of Digestive Diseases
Source: MedicineNet Ulcerative Colitis Specialty [2012.12.21]
Title: Ulcerative Colitis Quiz: Test Your IQ of Digestive Diseases
Category: MedicineNet Quiz
Created: 12/18/2012 1:08:00 PM
Last Editorial Review: 12/21/2012 12:07:47 PM
Published Studies Related to Colazal (Balsalazide)
Chemoprevention of colonic polyps with balsalazide: an exploratory, double-blind, placebo-controlled study. [2009.11]
BACKGROUD: A number of agents, including aspirin, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, folic acid, calcium, and vitamins, have been evaluated for their potential in chemoprevention of sporadic colorectal adenomas or cancer. Preclinical data suggest that 5-aminosalicylates also may have a chemopreventive effect. AIM: To investigate chemoprevention of colonic polyps with balsalazide, a 5-aminosalicylate prodrug... CONCLUSIONS: Although balsalazide did not have significant chemopreventive effects on established colonic polyps, these results can aid in designing future prospective studies.
Safety, efficacy, and pharmacokinetics of balsalazide in pediatric patients with mild-to-moderate active ulcerative colitis: results of a randomized, double-blind study. [2009.11]
OBJECTIVES:: A multicenter, double-blind study was conducted to evaluate the safety, efficacy, and pharmacokinetics of balsalazide in pediatric patients with mild-to-moderate ulcerative colitis (UC)... CONCLUSIONS:: Balsalazide is well tolerated and improves the signs and symptoms of mild-to-moderate active UC in pediatric patients 5 to 17 years of age.
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.
Clinical Trials Related to Colazal (Balsalazide)
Fed Study of Balsalazide Disodium Capsules 750 mg and ColazalŪ Capsules 750 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan balsalazide
disodium 750 mg capsules to Salix ColazalŪ 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 ColazalŪ Capsules 750 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan balsalazide
disodium 750 mg capsules and Salix ColazalŪ 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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