Adult: For mild to moderate active cases: 2.25 g tid until remission occurs or for up to Max of 12 weeks. Maintenance of remission: 1.5 g bid; adjust dose based on individual response. Max: 6 g daily. Child: 5-17 years 0.75 g tid or 2.25 g tid for up to 8 weeks. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
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
Hypersensitivity to balsalazide or its metabolites, aminosalicylates or salicylates. Moderate to severe renal and severe hepatic impairment.
Special Precautions
Patient with active ulcer disease, asthma, bleeding disorders, or pre-existing skin conditions (e.g. atopic dermatitis or eczema). Avoid use in patients at risk of upper gastrointestinal tract obstruction (e.g. pyloric stenosis). Patient taking nephrotoxic medications or with history of renal disease. Mild renal and mild to moderate hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Mesalazine-induced hypersensitivity reactions including internal organ involvement (e.g. hepatitis, myocarditis, pericarditis, nephritis, haematologic abnormalities, and/or pneumonitis); mesalazine-induced acute intolerance syndrome (e.g. acute abdominal pain, cramping, bloody diarrhoea; occasionally, fever, headache, rash); severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalised exanthematous pustulosis); renal impairment (e.g. minimal change disease, acute and chronic interstitial nephritis, renal failure), nephrolithiasis; hepatic failure (particularly in patients with pre-existing hepatic disease); severe photosensitivity reactions (particularly in patients with pre-existing skin conditions); staining of teeth or tongue (when sprinkled on applesauce). Gastrointestinal disorders: Nausea, vomiting, abdominal pain, diarrhoea, flatulence, acute pancreatitis, stomatitis. General disorders and administration site conditions: Fatigue, fever. Hepatobiliary disorders: Cholelithiasis. Musculoskeletal and connective tissue disorders: SLE-like syndrome, arthralgia, myalgia. Nervous system disorders: Headache, neuropathy. Respiratory, thoracic and mediastinal disorders: Cough, bronchospasm, pharyngitis, rhinitis, allergic alveolitis, pneumonia (with and without eosinophilia), pleural effusion, pleurisy; pharyngolaryngeal pain, nasopharyngitis (in children). Skin and subcutaneous tissue disorders: Rash, pruritus, alopecia, angioedema.
Patient Counseling Information
Avoid prolonged exposure to sunlight or UV light and use sunscreen and protective clothing. Maintain adequate fluid intake during treatment.
Monitoring Parameters
Monitor renal function (prior to initiation and periodically during therapy), LFTs, CBC (particularly in elderly). Perform urinalysis during treatment. Assess for signs and symptoms of hypersensitivity reactions and acute intolerance syndrome (e.g. fever, headache, rash, acute abdominal pain, cramping, bloody diarrhoea).
Overdosage
Symptoms: Nausea, vomiting, diarrhoea, abdominal pain, tinnitus, tachypnoea, hyperpnoea, and neurological symptoms (e.g. headache, dizziness, seizures). Severe intoxication may cause electrolyte and blood pH imbalance and possibly damage to other organs (e.g. kidney, liver). Management: Supportive and symptomatic treatment. May perform gastrointestinal tract decontamination to prevent further absorption. Appropriate supportive care includes emesis, cathartics, and activated charcoal. Administer appropriate IV therapy and maintain adequate renal function to correct fluid and electrolyte imbalance.
Drug Interactions
May increase the risk for blood dyscrasias or bone marrow failure with azathioprine and mercaptopurine. May enhance nephrotoxic effect of NSAIDs. May decrease the serum concentration of cardiac glycosides. Oral antibiotics may interfere with the release of mesalazine in the colon.
Lab Interference
May lead to false elevation of urinary normetanephrine levels when measured using liquid chromatography with electrochemical detection.
Action
Description: Mechanism of Action: Balsalazide is a prodrug of mesalazine (5-aminosalicylic acid) which is linked to 4-aminobenzoyl-β-alanine via an azo bond. The exact mechanism of action of mesalazine has not been fully understood; however, it appears to exert its anti-inflammatory effect locally on the colonic mucosa. Mesalazine may reduce inflammation by blocking the mucosal production of arachidonic acid metabolites (through the cyclooxygenase and lipoxygenase pathways) in the colon. Pharmacokinetics: Absorption: Very little portion is absorbed from the upper gastrointestinal tract. Time to peak plasma concentration: 1-2 hours (balsalazide); approx 9-10 hours (mesalazine and N-acetyl-5-aminosalicylic acid). Distribution: Crosses the placenta and enters breast milk (mesalazine). Plasma protein binding: ≥99% (balsalazide); approx 40% (mesalazine); approx 80% (N-acetylated metabolites). Metabolism: Undergoes bacterial azoreduction in the colon into mesalazine (5-aminosalicylic acid, active), 4-aminobenzoyl-β-alanine (inert), and N-acetylated metabolites; small proportion of 4-aminobenzoyl-β-alanine undergoes first-pass metabolism in the liver. Excretion: Mainly via faeces (approx 65% as mesalazine, 4-aminobenzoyl-β-alanine and N-acetylated metabolites; <1% as unchanged drug); urine (<16% as N-acetylated metabolites; <1% as unchanged drug). Elimination half-life: 1.9 hours (balsalazide); 9.5 hours (mesalazine); 10.4 hours (N-acetyl-5-aminosalicylic acid).
Chemical Structure
Balsalazide Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 54585, Balsalazide. https://pubchem.ncbi.nlm.nih.gov/compound/Balsalazide. Accessed Jan. 29, 2024.
A07EC04 - balsalazide ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
References
Anon. Balsalazide. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 31/08/2023.Anon. Balsalazide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 31/08/2023.Balsalazide Disodium Capsule (Apotex Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/08/2023.Buckingham R (ed). Balsalazide Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/08/2023.Colazide 750 mg Hard Capsules (Almirall S.A.). MHRA. https://products.mhra.gov.uk. Accessed 31/08/2023.Joint Formulary Committee. Balsalazide Sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/08/2023.
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