BUDESONIDE TAB,SA

Clinical Criteria Summary

Hypersensitivity to budesonide or any tablet ingredients (anaphylactic reactions have occurred)
Concomitant therapy with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin)
Acute, severe ulcerative colitis
Glucocorticoid-refractory ulcerative colitis (defined as no meaningful clinical response to induction therapy using prednisone 30 to 60 mg/day for 2 weeks with a 2-week taper, or IV equivalent for 1 to 1.5 weeks)
Stable quiescent ulcerative colitis without evidence of recent exacerbation (not indicated for maintenance of remission)
Untreated or uncontrolled fungal, bacterial, systemic viral, or parasitic infections
Crohn’s disease or microscopic/collagenous colitis

Patient receives VA care/consultation and initial prescription is from a gastroenterologist or other ulcerative colitis treatment expert
Intolerance or relative contraindication to orally administered prednisone, prednisolone, methylprednisolone, or other glucocorticoids with higher systemic bioavailability (e.g., unstable/uncontrolled diabetes mellitus, hypertension, heart failure, osteoporosis)
Requires treatment to induce remission in newly diagnosed or recurrent active mild to moderate ulcerative colitis
OR requires rapid-onset treatment for recurrence of active, mild to moderate ulcerative colitis as an adjunct to 5-ASA maintenance therapy

Initial/subsequent dosage: 9 mg orally once daily in the morning with or without food (excluding grapefruit/juice) for up to 8 weeks
Tablets must not be chewed, crushed, or broken
Avoid grapefruit/grapefruit juice due to hypercorticism risk
Discontinuation: Tapering is not required; only one tablet strength (9 mg) is available
Switching from other systemic glucocorticoids: Taper slowly off the prior glucocorticoid to reduce adrenal insufficiency risk; clinically equivalent doses are uncertain

Increased signs/symptoms of hypercorticism, particularly in patients with moderate/severe liver disease or those taking CYP3A4 inhibitors (consider discontinuation)
Signs/symptoms of adrenal insufficiency or benign intracranial hypertension, particularly when switching from higher systemic effect glucocorticoids or during surgery/stress situations (supplementation recommended)
General glucocorticoid complications: HPA axis suppression, Cushing’s syndrome, hyperglycemia, new infections/exacerbations/reactivation of latent infection/masking of infection signs, increased blood pressure, sodium/water retention, hypokalemia, gastrointestinal perforation (signs may be masked), behavioral/mood disturbances, decreased bone density, cataracts/eye infections/glaucoma, weight gain

FDA indication: Induction of remission in patients with active, mild to moderate ulcerative colitis
Not evaluated for isolated ulcerative proctitis (rectal foam is approved for this)
Pregnancy Category C: Use only if potential benefit justifies potential risk to the fetus
Nursing Mothers: Secreted in human milk; discontinue nursing or drug based on clinical importance
Elderly: Use caution; insufficient data on age-related responses
Gastric acid reducing agents (PPIs, H2-receptor antagonists, antacids) may affect pH-dependent dissolution/coating breakdown at pH ≥7.0; no specific management recommendations
Liver Impairment: Cirrhosis causes 2.5-fold increase in systemic bioavailability; severe dysfunction effects unstudied; mild disease causes minimal effects
Tuberculosis: Active or latent TB requires concomitant anti-TB therapy
Formulation distinction: MMX technology releases drug throughout colon for UC; ENTOCORT (CIR) releases in ileum/ascending colon for Crohn’s, may be used off-label for microscopic/collagenous colitis

Each course of therapy limited to 8 weeks
Inadequate response within 4 weeks indicates steroid-refractory disease requiring alternative therapies

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