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balsalazide disodium
Overview
What is Colazal?
Each COLAZAL capsule contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an anti-inflammatory drug. Each capsule of COLAZAL (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2-carboxyethyl) amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is:
Molecular Weight: 437.32
Molecular Formula: CHNONa●2HO
Balsalazide disodium is a stable, odorless orange to yellow microcrystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents.
Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. The sodium content of each capsule is approximately 86 mg.
What does Colazal look like?
What are the available doses of Colazal?
Capsules: 750 mg ()
What should I talk to my health care provider before I take Colazal?
Renal impairment: Use COLAZAL with caution in patients with a history of renal disease. ()
How should I use Colazal?
COLAZAL is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and effectiveness of COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.
For treatment of active ulcerative colitis in adult patients, the usual dose is three 750 mg COLAZAL capsules to be taken 3 times a day (6.75 g per day) for up to 8 weeks. Some patients in the adult clinical trials required treatment for up to 12 weeks.
What interacts with Colazal?
Sorry No Records found
What are the warnings of Colazal?
Sorry No Records found
What are the precautions of Colazal?
Sorry No Records found
What are the side effects of Colazal?
Sorry No records found
What should I look out for while using Colazal?
Patients with hypersensitivity to salicylates or to any of the components of COLAZAL capsules or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction.
What might happen if I take too much Colazal?
No case of overdose has occurred with COLAZAL. A 3-year-old boy is reported to have ingested 2 g of another mesalamine product. He was treated with ipecac and activated charcoal with no adverse reactions.
If an overdose occurs with COLAZAL, treatment should be supportive, with particular attention to correction of electrolyte abnormalities.
How should I store and handle Colazal?
Store between 2°C and 25°C (36°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product.COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.NDC 65649-101-02 Bottles of 280 capsules.StorageStore at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F)[see USP Controlled Room Temperature].COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.NDC 65649-101-02 Bottles of 280 capsules.StorageStore at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F)[see USP Controlled Room Temperature].COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.NDC 65649-101-02 Bottles of 280 capsules.StorageStore at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F)[see USP Controlled Room Temperature].COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.NDC 65649-101-02 Bottles of 280 capsules.StorageStore at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F)[see USP Controlled Room Temperature].COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.NDC 65649-101-02 Bottles of 280 capsules.StorageStore at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F)[see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Balsalazide disodium is delivered intact to the colon where it is cleaved by bacterial azoreduction to release equimolar quantities of mesalamine, which is the therapeutically active portion of the molecule, and the 4-aminobenzoyl-ß-alanine carrier moiety. The carrier moiety released when balsalazide disodium is cleaved is only minimally absorbed and is largely inert.
The mechanism of action of 5-ASA is unknown, but appears to be local to the colonic mucosa rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.
Non-Clinical Toxicology
Patients with hypersensitivity to salicylates or to any of the components of COLAZAL capsules or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction.Drug Interactions:
The following precaution should be kept in mind in the treatment of anticholinesterase poisoning although it does not bear directly on the use of atropine and pralidoxime. Since barbiturates are potentiated by the anticholinesterases, they should be used cautiously in the treatment of convulsions.
In the adult clinical trials, 3 out of 259 patients reported exacerbation of the symptoms of ulcerative colitis. In the pediatric clinical trials, 4 out of 68 patients reported exacerbation of the symptoms of ulcerative colitis.
Observe patients closely for worsening of these symptoms while on treatment.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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