What is the recommended dosing for Entocort (budesonide) for a colitis flare-up?

Budesonide (Entocort) Dosing for Colitis Flare-Up

For a colitis flare-up, the recommended dosing of Entocort (budesonide) is 9 mg once daily for up to 8 weeks. 1

Dosing Recommendations by Colitis Type

Ulcerative Colitis

• Budesonide MMX 9 mg once daily in the morning with or without food for up to 8 weeks is the FDA-approved dosing for mild to moderate ulcerative colitis 1
• Budesonide should be swallowed whole and not chewed, crushed, or broken 1
• Budesonide MMX is particularly effective for left-sided disease but less effective for extensive colitis 2
• After 8 weeks, treatment should not be extended if inadequate response is observed 2

Microscopic Colitis

• For microscopic colitis (including collagenous and lymphocytic colitis), the standard induction dose is also 9 mg daily for 8 weeks 3
• After achieving remission, budesonide should be tapered over 1-2 weeks rather than abruptly discontinued 3
• In a randomized controlled trial, budesonide (Entocort) 9 mg daily for 6 weeks showed 86.9% clinical remission rate versus 13.6% for placebo in collagenous colitis 4

Monitoring Response to Treatment

• Evaluate patients for symptomatic response to budesonide between 4-8 weeks to determine need for therapy modification 3, 2
• For moderate ulcerative colitis, response should be assessed within the first 2 weeks to determine if therapy modification is needed 5
• If there is inadequate response after 2 weeks, consider escalating to advanced therapies 5

Maintenance Therapy Considerations

• Budesonide should not be used for long-term maintenance therapy in ulcerative colitis as corticosteroids are ineffective for this indication 6, 2
• For patients with microscopic colitis who experience symptom recurrence, maintenance therapy with budesonide may be considered 3
• Maintenance dosing typically starts at 6 mg daily but should be tapered to the lowest effective dose 3
• In a follow-up study of collagenous colitis patients, 61% experienced clinical relapse after successful induction with budesonide, with a median time to relapse of 2 weeks 7

Important Considerations and Cautions

• Avoid concomitant use with CYP3A4 inhibitors (including grapefruit juice) as this may increase signs/symptoms of hypercorticism 1
• Although budesonide has lower systemic bioavailability than conventional corticosteroids, monitor for signs of hypercorticism and adrenal axis suppression 1
• Patients with moderate to severe liver disease require closer monitoring for increased signs of hypercorticism 1
• Budesonide suppresses the immune system and may increase risk of infection 1
• For patients requiring two or more courses of corticosteroids in the past year or who become corticosteroid-dependent, consider treatment escalation with thiopurines, anti-TNF therapy, vedolizumab, or tofacitinib 6

Alternatives to Budesonide

• For moderate to severe ulcerative colitis, oral prednisolone 40 mg daily with tapering over 6-8 weeks is recommended 6, 5
• For mild to moderate ulcerative colitis, 5-ASA therapy (2-3 g/day) is recommended as first-line therapy before considering corticosteroids 6
• If 5-ASA therapy fails, oral prednisolone or budesonide MMX can be considered 6

Budesonide offers the advantage of fewer systemic side effects compared to conventional corticosteroids while maintaining efficacy for induction of remission in colitis 8.