About COLAZAL
This information is intended for U.S. Healthcare Professionals only.
Product Description
COLAZAL® (balsalazide disodium) Capsules 750 mg is indicated for the treatment of mildly to moderately active ulcerative colitis.
Each COLAZAL capsule contains 750 mg of balsalazide disodium, an azo-bonded, sulfa-free, prodrug that links 5-aminosalicylic acid (5-ASA) with the INERT carrier molecule 4-aminobenzoyl-ß-alanine (4-ABA). COLAZAL delivers 99% of the 5-ASA directly to the colon, where it is metabolized to 5-ASA and 4-ABA by azoreductase present in many species of intestinal bacteria.
back to top
Mechanism of Action
The mechanism of action of 5-ASA, the active component of COLAZAL, is unknown, but it appears to be topical rather than systemic.1,2
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-aminosalicyclic acid diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.
back to top
Pharmacokinetics
Following oral administration, approximately 99% of the administered COLAZAL dose is delivered to the colon, while undergoing negligible systemic absorption.
Only trace amounts (less than 1%) of the parent compound (COLAZAL), 5-aminosalicyclic acid (5-ASA), or 4-aminobenzoyl-¤-alanine (4-ABA) were found in the urine of healthy subjects following single and multiple doses of COLAZAL, while up to 25% of the dose was recovered as in-acytylated (inactive) metabolites.
In a study that examined the disposition of balsalazide in patients who were taking 3-6 grams of COLAZAL daily for more than one year, and who were in remission from UC, less than 1% of an oral dose was recovered in the urine as intact balsalazide.
back to top
Contraindications
COLAZAL should not be given to persons with a hypersensitivity to salicylates or to any components of COLAZAL capsules or balsalazide metabolites.
back to top
Precautions
General
Patients with pyloric stenosis may have prolonged gastric retention of COLAZAL capsules.
Renal
Caution should be exercised when administering COLAZAL to patients with known renal dysfunction or a history of renal disease.
Drug Interactions
There are no reported studies on drug-drug interactions with COLAZAL. However, oral antibiotics could theoretically interfere with mesalamine release in the colon.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Click here to view the Prescribing Information for COLAZAL.
Pregnant Women or Nursing Mothers
Pregnancy Category B
Caution should be exercised when administering COLAZAL to a nursing woman.
No adequate and well-controlled studies in pregnant women have been preformed. This drug should be used in pregnant women only when clearly needed.
Pediatric Use
A clinical trial of 68 patients ages 5-17 years has been conducted comparing two doses of COLAZAL (6.75 g/day and 2.25 g/day). Based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day. Safety and efficacy of COLAZAL in pediatric patients below the age of 5 years have not been established.
Geriatric Use
No information is available for the geriatric population.
back to top
Adverse Reactions
In four controlled clinical trials, patients receiving COLAZAL (6.75 g/day) most frequently reported the following (reporting frequency ≥ 3%):
- Headache (8%)
- Abdominal pain (6%)
- Diarrhea (5%)
- Nausea (5%)
- Vomiting (4%)
- Respiratory infection (4%)
- Arthralgia (4%)
Withdrawal from therapy due to adverse events was comparable to placebo.
back to top
Dosage and Administration
For the treatment of active ulcerative colitis, the usual adult dose is three 750 mg COLAZAL capsules, to be taken 3 times a day for a total daily dose of 6.75 g for a duration of 8 weeks. Some patients in the clinical trials required treatment for up to 12 weeks.
It is important to note that each daily dose of COLAZAL (6.75 g/day) has equimolar equivalence to 2.4 g mesalamine.
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 use, treatment should be supportive, with particular attention to correction of electrolyte abnormalities.
back to top
For More Information
For additional information on COLAZAL, please call Salix Pharmaceuticals, Inc. at 1-800-669-7597.
back to top
References
COLAZAL® (balsalazide disodium) Capsules 750 mg are indicated for the treatment of mildly to moderately active Ulcerative Colitis in patients 5 years of age and older.
COLAZAL does not relieve symptoms in all patients; your patients' results may vary. In four well-controlled clinical trials, patients receiving a COLAZAL dose of 6.75g/day most frequently reported the following events
(reporting frequency > 3%): headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to
placebo. In the pediatric trial, patients most frequently reported the following adverse events: headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%),
nasopharyngitis (6%) and, pyrexia (6%). COLAZAL is contraindicated in patients with a hypersensitivity to salicylates or the components of COLAZAL capsules or balsalazide metabolites. The safety and effectiveness of
COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
For product information, adverse event reports, and product complaint reports please call:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: