Colazal 1 Indications And Usage

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.

Colazal 4 Contraindications

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.

Colazal Side Effects

5.1 Exacerbations Of Ulcerative Colitis

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.

5.2 Pyloric Stenosis

Patients with pyloric stenosis may have prolonged gastric retention of COLAZAL capsules.

5.3 Renal

Renal toxicity has been observed in animals and patients given other mesalamine products. Therefore, caution should be exercised when administering COLAZAL to patients with known renal dysfunction or a history of renal disease. [See Nonclinical Toxicology 13.2)]

Colazal 10 Overdosage

No case of overdose has occurred with COLAZAL . A 3-year-old boy is reported to have ingested 2 grams 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.

Colazal 11 Description

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: C17 H13 N3 O6 Na2 ?2H2 O

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.

Colazal 17.1 Important Precautions Regarding Colazal

• Instruct patients not to take COLAZAL if they have a hypersensitivity to salicylates (e.g., aspirin). Patients should be instructed to contact their health care provider under the following circumstances: If they experience a worsening of their ulcerative colitis symptoms. If they are diagnosed with pyloric stenosis, because COLAZAL capsules may be slow to pass through their digestive tract. If they are diagnosed with renal dysfunction. Damage to the kidney has been observed in people given medications similar to COLAZAL.