balsalazide disodium: clinical use

Prescribing considerations

• Confirm mild-to-moderate active ulcerative colitis or maintenance of remission.
• The selected product is not recommended for children.
• Use caution with asthma, bleeding disorders, active peptic ulceration, mild renal impairment or established hepatic disease.
• Advise prompt reporting of unexplained bruising, bleeding, purpura, sore throat, fever or malaise.

Contraindications and cautions

• Hypersensitivity to balsalazide, mesalazine, its metabolites, product excipients or salicylates.
• Severe hepatic impairment.
• Moderate-to-severe renal impairment.
• Pregnancy or breastfeeding under the selected product licence.

Monitoring

• Assess renal function before treatment, after initiation and periodically thereafter; monitor more frequently with renal impairment.
• Perform blood counts, renal biochemistry and urinalysis during treatment.
• Monitor hepatic function where clinically appropriate.
• Stop and investigate promptly if blood dyscrasia or clinically significant renal toxicity is suspected.

Clinical pharmacology

Colonic bacterial azoreductases cleave balsalazide into active mesalazine and an inactive carrier. Unchanged balsalazide has low systemic absorption; absorbed metabolites undergo acetylation and are substantially cleared through the kidneys.

Formulation and product differences

• The selected product is a beige hard gelatin capsule intended to be swallowed whole.
• Food reduces systemic exposure compared with fasting, so administration with or after food is preferred.

Capsule

Route: Oral

Strengths: 750 mg