Prednisolone sodium metasulphobenzoate: clinical use

Prescribing considerations

• Confirm that disease distribution is suitable for local rectal treatment.
• Use extreme caution with severe ulcerative colitis and consider whether infection could be masked.
• Systemic absorption and hypothalamic–pituitary–adrenal suppression remain possible.
• Review strong CYP3A inhibitors and relevant excipient sensitivities.

Contraindications and cautions

• Hypersensitivity to the active substance or product excipients
• Peritonitis, fistulae, intestinal obstruction or bowel perforation
• Local conditions where infection could be masked or healing impaired, including relevant anorectal or sinus infection

Monitoring

• Clinical response and evidence of worsening bowel disease or infection
• Systemic corticosteroid effects if use is extensive or prolonged
• Blood pressure and renal function in patients with systemic sclerosis
• New blurred vision or other visual disturbance; consider ophthalmology assessment

Clinical pharmacology

Prednisolone sodium metasulphobenzoate is a synthetic glucocorticoid ester with enhanced topical activity. Its rectal action is predominantly local; absorbed ester is hydrolysed to free prednisolone and m-sulphobenzoic acid or its salts.

Formulation and product differences

• The metered rectal foam is licensed for proctitis and ulcerative colitis and is not recommended for paediatric use.
• The retention rectal solution is licensed for local treatment of ulcerative colitis and is not recommended below 12 years.
• The foam comes in a pressurised, flammable canister with disposable applicators; it must not be refrigerated, pierced, burned or exposed to excessive heat.
• The solution comes as a ready-to-use disposable bag or bottle, with an extension-tube version available; it may be warmed in warm water before administration.

Enema

Route: Rectal

Strengths: 20 mg/100 mL

Rectal foam

Route: Rectal

Strengths: 20 mg/dose