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.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
AHFS DI Essentials. © Copyright 2017, Selected Revisions May 1, 2006. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, 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. [PubMed 9428213]
4. Gross V. Efficacy of different mesalamine-releasing drugs. Gastroenterology. 1998; 115:1306-7. [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. [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. [PubMed 12167685]
12. Hanauer SB. Inflammatory bowel disease. N Engl J Med. 1996; 334:841-8. [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.
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- Drug class: 5-aminosalicylates