Generic Medicine Info
Indications and Dosage
Ulcerative colitis
Adult: Acute attack: 2.25 g tid, until remission occurs or up to 12 wk. Maintenance: 1.5 g bid, adjusted according to response. Max: 6 g daily.
Child: 5-17 yr 750 mg tid or 2.25 g tid, treatment may continue for up to 8 wk.
Renal Impairment
Moderate to severe: Contraindicated.
Hepatic Impairment
Severe: Contraindicated.
cap: May be taken with or without food. May be swallowed whole or sprinkle entire contents on applesauce. Take mixt immediately; the contents may be chewed. Do not store for future use.
Severe hepatic and moderate to severe renal impairment.
Special Precautions
Patient w/ pyloric stenosis, asthma, bleeding disorders, active peptic ulcer disease. Mild to moderate hepatic and mild renal impairment or history of renal disease. Pregnancy and lactation.
Adverse Reactions
Blood dyscrasias, aplastic anaemia, luecopenia, neutropenia, agranulocytosis, thrombocytopenia; headache, neuropathy; myocarditis, pericarditis; bronchospasm, allergic alveolitis; abdominal pain, diarrhoea, nausea, vomiting, exacerbation of ulcerative colitis, acute pancreatitis; hepatitis, cholelithiasis, increased liver enzymes; alopecia, rash, angioedema; SLE-like syndrome, arthralgia, myalgia; interstitial nephritis; fatigue; staining of the teeth.
Monitoring Parameters
Monitor renal function, LFT and CBC.
Symptoms: Nausea, vomiting, diarrhoea. Management: Supportive and symptomatic treatment.
Drug Interactions
Increased risk of blood dyscrasias w/ azathioprine and 6-mercaptopurine. Increased nephrotoxicity when used w/ NSAIDs. May decreased serum concentration of cardiac glycosides.
Mechanism of Action: Balsalazide is a prodrug of mesalazine which is linked to 4-aminobenzoyl-β-alanine via an azo bond. W/ the release of mesalazine, it reduces inflammation by inhibiting cyclooxygenase and leukotriene synthesis, thus blocking the formation of arachidonic acid in the colonic mucosa.
Absorption: Time to peak plasma concentration: 1-2 hr (balsalazide); 9-10hr (mesalazine).
Distribution: Plasma protein binding: Approx 99%.
Metabolism: Undergoes bacterial azoreduction in the colon to 5-aminosalicylic acid (mesalazine, active), 4-aminobenzoyl-β-alanine (inert), and N-acetylated metabolites; 4-aminobenzoylalanine undergoes hepatic first-pass metabolism.
Excretion: Mainly via faeces (approx 65%, as mesalazine, 4-aminobenzoyl-β-alanine or N-acetylated metabolites); urine (approx 25%, as N-acetylated metabolites); <1% via urine or faeces (as unchanged drug). Elimination half-life: 6-9 hr (as N-acetylated metabolites); approx. 1 hr (mesalazine).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Balsalazide, CID=54585, (accessed on Jan. 21, 2020)

Store between 20-25°C.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification
A07EC04 - balsalazide ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
Anon. Balsalazide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 03/08/2016.

Balsalazide disodium capsule (Apotex Corp.). DailyMed. Source: U.S. National Library of Medicine. Accessed 03/08/2016.

Buckingham R (ed). Balsalazide sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 03/08/2016.

Joint Formulary Committee. Balsalazide sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. Accessed 03/08/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Balsalazide disodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). Accessed 03/08/2016.

Disclaimer: This information is independently developed by MIMS based on Balsalazide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2023 MIMS. All rights reserved. Powered by
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