Balsalazide


Concise Prescribing Info
Indications/Uses
Ulcerative colitis.
Dosage/Direction for Use
Adult : PO Acute attack: 2.25 g tid, until remission or up to 12 wk. Maintenance: 1.5 g bid, adjust as needed. Max: 6 g/day.
Dosage Details
Oral
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.
Administration
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.
Contraindications
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.
MonitoringParameters
Monitor renal function, LFT and CBC.
Overdosage
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.
Action
Description: 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.
Pharmacokinetics:
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
Balsalazide

Source: National Center for Biotechnology Information. PubChem Database. Balsalazide, CID=54585, https://pubchem.ncbi.nlm.nih.gov/compound/Balsalazide (accessed on Jan. 21, 2020)

Storage
Store between 20-25°C.
ATC Classification
A07EC04 - balsalazide ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
References
Anon. Balsalazide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/08/2016.

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

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

Joint Formulary Committee. Balsalazide sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. 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). https://www.medicinescomplete.com. 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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