Colazal
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
COLAZAL is a locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. (1) Safety and effectiveness of COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.
History
There is currently no drug history available for this drug.
Other Information
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: C17H13N3O6Na2•2H2O
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.
Sources
Colazal Manufacturers
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Cardinal Health
![Colazal (Balsalazide Disodium) Capsule [Cardinal Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Colazal | Cardinal Health
2.1 Adult DoseFor 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.
2.2 Pediatric DoseFor treatment of active ulcerative colitis in pediatric patients, aged 5 to 17 years, the usual dose is EITHER:
• three 750 mg COLAZAL capsules 3 times a day (6.75 g per day) for up to 8 weeks;
OR:
• one 750 mg COLAZAL capsule 3 times a day (2.25 g per day) for up to 8 weeks. Use of COLAZAL in the pediatric population for more than 8 weeks has not been evaluated in clinical trials. [See Clinical Studies Section (14)]
2.3 Administration AlternativesCOLAZAL capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on applesauce. The entire drug/applesauce mixture should be swallowed immediately; the contents may be chewed, if necessary, since contents of COLAZAL are NOT coated beads/granules. Patients should be instructed not to store any drug/applesauce mixture for future use.
If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient.
Teeth and/or tongue staining may occur in some patients who use COLAZAL IN SPRINKLE FORM WITH FOOD.
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Salix Pharmaceuticals, Inc.
Colazal | Salix Pharmaceuticals, Inc.
2.1 Adult DoseFor 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.
2.2 Pediatric DoseFor treatment of active ulcerative colitis in pediatric patients, aged 5 to 17 years, the usual dose is EITHER:
• three 750 mg COLAZAL capsules 3 times a day (6.75 g per day) for up to 8 weeks; OR: • one 750 mg COLAZAL capsule 3 times a day (2.25 g per day) for up to 8 weeks.Use of COLAZAL in the pediatric population for more than 8 weeks has not been evaluated in clinical trials. [See Clinical Studies Section (14)]
2.3 Administration AlternativesCOLAZAL capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on applesauce. The entire drug/applesauce mixture should be swallowed immediately; the contents may be chewed, if necessary, since contents of COLAZAL are NOT coated beads/granules. Patients should be instructed not to store any drug/applesauce mixture for future use.
If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient.
Teeth and/or tongue staining may occur in some patients who use COLAZAL in sprinkle form with food.
![Colazal (Balsalazide Disodium) Capsule [Salix Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=22f41e83-b9fb-4c9e-8cc3-f457034191a8&name=colazal-3.jpg)
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