Drug Index



Mechanism :

The mechanism of action of 5-ASA is unknown but appears to be local to the colonic mucosa rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.

Indication :

• Mildly to moderately active ulcerative colitis in patients 5 years of age and older.

Contraindications :

Patients with hypersensitivity to salicylates or to any of the components or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction.

Dosing :

<5 years: Safety and efficacy not established.

5 to 17 years: One to three 750 mg capsules thrice daily (2.25-6.75 g/day) for up to 8 weeks.

Adverse Effect :

Nausea, diarrhea, abdominal pain, headache, blood dyscrasias, pancreatitis, hepatitis, allergic lung reactions, lupus erythematous-like reactions and rash, interstitial nephritis and nephritic syndrome, renal failure.

Interaction :

Nephrotoxic agents, including Non-Steroidal Anti-Inflammatory drugs (NSAIDs): May increase the risk of renal reactions.
Azathioprine or 6-Mercaptopurine: Concurrent use can increase the potential for blood disorders.

Renal Dose :

Dose in Renal Impairment GFR (mL/min)
20-50Dose as in normal renal function
10-20Use with caution and only if necessary
<10Start with low doses and monitor closely

Dose in Patients undergoing Renal Replacement Therapies
CAPDUnlikely to be dialysed. Dose as in GFR<10 mL/min
HDUnlikely to be dialysed. Dose as in GFR<10 mL/min
HDF/High fluxUnlikely to be dialysed. Dose as in GFR<10 mL/min
CAV/VVHDUnknown dialysability. Dose as in GFR=10–20 mL/min

Hepatic Dose :

No dosage adjustments are recommended. Use with caution.
06/22/2020 03:48:29 Balsalazide
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