Class: Anti-inflammatory Agents
VA Class: GA900
Chemical Name: 5-[[4-[[(2-carboxyethyl)amino]carbonyl]-phenyl]azo]-2-hydroxybenzoic acid disodium dihydrate
Molecular Formula: C17H13N3Na2O6•2H2O
CAS Number: 150399-21-6
Uses for Balsalazide Disodium
Balsalazide Disodium Dosage and Administration
Administer orally 3 times daily.1
Available as balsalazide disodium; dosage expressed in terms of the salt.6
Daily dosage of 6.75 g is equivalent to mesalamine 2.4 g.1
2–6 g daily may be used.12
Safety and efficacy not established beyond 12 weeks.1
Cautions for Balsalazide Disodium
Known hypersensitivity to salicylates, balsalazide or its metabolites, or any ingredient in the formulation.1
Exacerbation of preexisting symptoms of ulcerative colitis has been reported rarely.1
Potential for prolonged gastric retention of basalazide capsules in patients with pyloric stenosis.1
Insufficient experience in patients >65 years of age to determine whether geriatric patients respond differently than younger adults.6
Safety and efficacy not established in patients with hepatic impairment.1
Safety and efficacy not established in patients with renal impairment.1 Use with caution in patients with renal impairment or a history of renal disease, since renal toxicity has been reported in patients receiving other mesalamine preparations.1
Common Adverse Effects
Interactions for Balsalazide Disodium
Potential for interference with bacterial metabolism and release of mesalamine in the colon1
Theoretical; no formal interaction studies to date1
Immunosuppressive agents (azathioprine, mercaptopurine)
Balsalazide Disodium Pharmacokinetics
Absolute bioavailability undetermined in healthy individuals; absorption very limited and variable.1
Systemic exposure (based on mean AUC) in ulcerative colitis patients receiving 1.5 g twice daily for 1 year is up to 60 times greater than that in healthy individuals receiving the same dosage.1
Plasma Protein Binding
In ulcerative colitis patients in remission after 1 year of balsalazide therapy, excreted in urine as N-acetylated metabolites (20–25%), mesalamine (<4%), and unchanged drug (<1%); fecal elimination not studied.1
25°C (may be exposed to 15–30°C).1
May reduce inflammation in the colon by inhibiting cyclooxygenase and lipoxygenase, which catalyze the formation of prostaglandin precursors (endoperoxides) and of leukotrienes and hydroxyeicosatetraenoic acids, respectively, from arachidonic acid and/or its metabolites.1 2 6
Advice to Patients
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Balsalazide Disodium 750MG Capsules (MYLAN): 280/$319.98 or 840/$945.97
Colazal 750MG Capsules (SALIX PHARMACEUTICALS): 280/$449.96 or 560/$865.92
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions May 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Salix Pharmaceuticals. Colazal (balsalazide disodium) capsules prescribing information. Raleigh, NC; 2003 Aug.
2. Prakash A, Spencer CM. Balsalazide. Drugs. 1998; 56:83-9. [PubMed 9664201]
3. Green JRB, Lobo AJ, Holdsworth CD et al. Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitis. Gastroenterology. 1998; 114:15-22. [IDIS 399117] [PubMed 9428213]
4. Gross V. Efficacy of different mesalamine-releasing drugs. Gastroenterology. 1998; 115:1306-7. [IDIS 418378] [PubMed 9797396]
5. Lowry PW, Szumlanski CL, Weinshilboum RM et al. Balsalazide and azathioprine or 6-mercaptopurine: evidence for a potentially serious drug interaction. Gastroenterology. 1999; 116:1505-6. [IDIS 430613] [PubMed 10391741]
6. Novartis, East Hanover, NJ: Personal communication.
7. Pruitt R, Hanson J, Safdi M et al. Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute ulcerative colitis. Gastroenterology. 2000; 118(Suppl 2 Part 1): A120-1.
8. Levine DS, Pruitt R, Riff D et al. A multi-center double-blind dose-response trial of Colazide (balsalazide disodium) and Asacol (mesalamine) for mild-moderately active ulcerative colitis. Gastroenterology. 1997; 112(Suppl):A1026.
9. Anon. Oral balsalazide (Colazal) for ulcerative colitis. Med Lett Drugs Ther. 2001; 43:62-3. [PubMed 11468602]
10. Biancone L, Tosti V, Fina D et al. Review article: maintenance treatment of Crohn’s disease. Aliment Pharmacol Ther. 2003; 17(Suppl. 2):31-37. [PubMed 12786610]
11. Podolsky DK. Inflammatory Bowel Disease. N Engl J Med. 2002; 347:417-29. [IDIS 484721] [PubMed 12167685]
12. Hanauer SB. Inflammatory bowel disease. N Engl J Med. 1996; 334:841-8. [IDIS 361805] [PubMed 8596552]
13. Pardi DS, Loftus EV Jr, Camilleri M. Treatment of inflammatory bowel disease in the elderly: an update. Drugs Aging. 2002; 19:355-63. [PubMed 12093322]
14. Salix Pharmaceuticals. Raleigh, NC: Personal communication.
More Balsalazide Disodium resources
- Balsalazide Prescribing Information (FDA)
- balsalazide Concise Consumer Information (Cerner Multum)
- balsalazide Advanced Consumer (Micromedex) - Includes Dosage Information
- balsalazide MedFacts Consumer Leaflet (Wolters Kluwer)
- Colazal Prescribing Information (FDA)
- Giazo MedFacts Consumer Leaflet (Wolters Kluwer)