From the Guidelines
Enterocort oral (budesonide) is not the first-line treatment for mild to moderate ulcerative colitis, but it can be considered for patients who do not respond to or cannot tolerate 5-ASA therapy. According to the British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults 1, the recommended first-line treatment for mild to moderate ulcerative colitis is oral 5-ASA 2–3 g/day. The guidelines suggest that patients who do not respond to 5-ASA therapy can be treated with oral prednisolone or topically-acting oral corticosteroids such as budesonide MMX.
The AGA clinical practice guidelines on the management of mild-to-moderate ulcerative colitis also recommend using standard-dose mesalamine (2–3 grams/d) or diazo-bonded 5-ASA as the first-line treatment, and suggest using high-dose mesalamine (>3gm/d) or oral prednisone or budesonide MMX for patients with suboptimal response to standard-dose mesalamine or diazo-bonded 5-ASA 1.
In terms of dosage, the typical dosage of Enterocort oral is 9 mg once daily for up to 8 weeks for active disease, followed by a gradual taper over 2-4 weeks to prevent relapse.
- Key points to consider when prescribing Enterocort oral include:
- Monitoring for common side effects such as headache, nausea, and respiratory infections
- Informing patients to take the medication in the morning with or without food, and to swallow the capsules whole without crushing or chewing
- Regular follow-up with a healthcare provider to monitor response to treatment and adjust the therapy as needed
- Informing patients to complete the full prescribed course even if symptoms improve
- Considering potential interactions with other medications.
Overall, while Enterocort oral can be an effective treatment for mild to moderate ulcerative colitis, it should be used judiciously and in accordance with established guidelines and patient-specific factors.
From the FDA Drug Label
Budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. The recommended dosage for the induction of remission in adult patients with active, mild to moderate ulcerative colitis is one 9 mg tablet to be taken once daily in the morning with or without food for up to 8 weeks.
Budesonide oral is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. The recommended dosage is 9 mg once daily for up to 8 weeks 2, 2, 2.
From the Research
Enterocort Oral for Colitis
- Enterocort, also known as budesonide, is an oral corticosteroid used to treat colitis, including ulcerative colitis and Crohn's disease 3, 4, 5, 6, 7.
- Budesonide has a high degree of topical activity and low systemic bioavailability, which reduces the risk of side effects and complications associated with traditional oral corticosteroids 4, 7.
- Studies have shown that budesonide is effective in inducing clinical and endoscopic remission in patients with mild to moderate ulcerative colitis and Crohn's disease 3, 4, 5, 6.
- Budesonide has been compared to other treatments, such as prednisolone and mesalamine, and has been found to have similar efficacy and a more favorable tolerability profile 4, 6.
- The safety profile of budesonide is favorable, with most adverse events being mild or moderate in intensity, and serious adverse events being uncommon 5.
- Budesonide may be used as a maintenance therapy to prolong time to clinical relapse in patients with ulcerative colitis, but further studies are needed to confirm this 5.
Efficacy of Budesonide
- Budesonide has been shown to be effective in inducing remission in patients with mild to moderate ulcerative colitis and Crohn's disease, with clinical and endoscopic remission rates ranging from 17.4% to 17.9% 3, 5.
- Budesonide has been compared to placebo and other treatments, such as mesalamine and prednisolone, and has been found to have similar or superior efficacy 4, 6.
- The efficacy of budesonide is thought to be due to its high degree of topical activity and low systemic bioavailability, which allows it to act locally in the gastrointestinal tract with minimal systemic side effects 4, 7.
Safety of Budesonide
- Budesonide has a favorable safety profile, with most adverse events being mild or moderate in intensity, and serious adverse events being uncommon 5.
- The incidence of glucocorticoid-related adverse events is significantly less frequent with budesonide than with prednisolone 4, 6.
- Budesonide does not suppress plasma cortisol levels, which is a common side effect of traditional oral corticosteroids 6.