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For prescribing by certain health practitioners Clinical criteria: Treatment criteria: Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
Mild to moderate Crohn disease Clinical criteria: The condition must affect the ileum; OR The condition must affect the ascending colon; OR The condition must affect the ileum and ascending colon. Treatment criteria: Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. The total duration of therapy should be no more than 12 weeks in any single course.
Eosinophilic oesophagitis Clinical criteria: Treatment Phase: Subsequent continuing treatment - Maintenance of remission Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, AND Patient must have documented evidence of having achieved histologic remission while receiving Initial and First continuing PBS-subsidised treatment with this drug for this condition, defined as a peak eosinophil count of less than 5 eosinophils per high power field (hpf), corresponding to less than 16 eosinophils per mm2 hpf on oesophageal biopsy, AND The condition must not have progressed while being treated with this drug. Treatment criteria: Must be treated by a prescriber who is either: (i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis, (iv) a prescriber who is not any of the aforementioned prescriber types, but who has consulted at least one of the aforementioned prescriber types. Histologic assessment should be based on the peak eosinophils count derived, where necessary, from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction). The histologic assessment should, where possible, be performed by, or in consultation with, the same physician or surgeon who confirmed the patient's diagnosis of eosinophilic oesophagitis. This assessment must be conducted within 48 weeks of initiating treatment to determine the patient's eligibility for continuing treatment. The histologic assessment should be conducted no later than 2 weeks prior to the patient completing the PBS-subsidised First continuing treatment course to avoid an interruption of supply for continuing therapy. Where a histologic assessment is not undertaken, the patient will not be eligible for ongoing treatment. The result of the histological assessment must be documented in the patient's medical records. First application for the subsequent continuing treatment of this condition must be received within 12 weeks of the histologic assessment.
“Studies in animals and humans have shown an advantageous ratio between topical anti-inflammatory activity and systemic glucocorticoid effect over a wide dose range. This is explained by the extensive first-pass hepatic degradation of budesonide after systemic absorption, approximately 85-90%, in combination with the low potency of formed metabolites.”
“Excretion of budesonide given as ENTOCORT modified release capsules is rate limited by its absorption, and the terminal half-life averages 4 hours.”
Working under the parallel aged-care framework? Aged-care equivalent →
Severe chronic asthma Clinical criteria: The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient, AND Patient must require long-term steroid therapy, AND Patient must not be able to use other forms of inhaled steroid therapy.
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“The metabolism of budesonide is primarily mediated by CYP3A4, a subfamily of cytochrome P450.”