Ulcerative colitis
Adult: Acute attack: 2.25 g tid (max: 6.75 g/day), 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.
Hypersensitivity to salicylates or any other ingredients of the cap or balsalazide metabolites.
Warnings / Precautions
Renal impairment, pregnancy, lactation; blood disorders can occur.
Adverse Reactions
Diarrhoea, nausea, vomiting, abdominal pain, exacerbation of symptoms of colitis, headache, hypersensitivity reactions (including rash and urticaria). Adverse effects that occur rarely include acute pancreatitis, hepatitis, myocarditis, pericarditis, lung disorders (including eosinophilia and fibrosing alveolitis), peripheral neuropathy, blood disorders (including agranulocytosis, aplastic anaemia, leucopenia, methaemoglobinaemia, neutropenia, and thrombocytopenia), renal dysfunction (interstitial nephritis, nephrotic syndrome), myalgia, arthralgia, skin reactions (including lupus erythematosus-like syndrome, Stevens-Johnson syndrome), alopecia.
Overdose Reactions
Treatment is supportive and electrolyte abnormalities should be corrected.
Mechanism of Actions
Balsalazide is delivered intact to the colon where it is enzymatically cleaved by colonic bacterial azoreductases to release 5-aminosalicylic acid (5-ASA) which is the active component and the inert 4-aminobenzoyl-β-alanine. The mechanism of action of 5-ASA is unknown, but its action appears to be local rather than systemic. It is possible that 5-ASA inhibits the action of cyclooxgenase and leukotriene synthesis, thus diminishing the formation of inflammatory metabolites in the colon via these two pathways.
Absorption: Very little of an oral dose is absorbed in the GI tract. Almost the entire dose reaches the site of action in the colon.
Metabolism: Broken down by colonic bacterial to 5-ASA (active) and 4-aminobenzoylalanine (inert carrier). Approx 25% of released 5-ASA is absorbed and aceylated; a small percentage of 4-aminobenzoylalanine is absorbed and acetylated during the 1st pass effect in the liver.
Excretion: Acetylated metabolites are removed in the urine.
Should be taken with food. (Take w/ or immediately after meals.)
Storage Conditions
Oral: Store at 25°C.
ATC Classification
A07EC04 - balsalazide ; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.
Oral: Store at 25°C.
Available As
  • Balsalazide 750 mg
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