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Indications and Dosage
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. |
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Renal Impairment
Moderate to severe: Contraindicated.
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Hepatic Impairment
Severe: Contraindicated.
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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.
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Contraindications
Severe hepatic and moderate to severe renal impairment.
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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.
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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.
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Monitoring Parameters
Monitor renal function, LFT and CBC.
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Overdosage
Symptoms: Nausea, vomiting, diarrhoea. Management: Supportive and symptomatic treatment.
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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.
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Action
Description:
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. 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). |
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Chemical Structure
 Source: National Center for Biotechnology Information. PubChem Database. Balsalazide, CID=54585, https://pubchem.ncbi.nlm.nih.gov/compound/Balsalazide (accessed on Jan. 21, 2020) |
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Storage
Store between 20-25°C.
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ATC Classification
A07EC04 - balsalazide ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
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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.
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