From the Guidelines
Budesonide should be prescribed at a dose of 9 mg once daily for the induction of clinical remission in patients with mild-to-moderate ileocaecal Crohn's disease. This recommendation is based on the findings of a randomised double-blind trial, which demonstrated that ileal-release budesonide 9 mg once daily for 8 weeks was as effective as prednisolone in inducing remission, with significantly fewer side effects 1. The efficacy of budesonide 9 mg/day has also been supported by multiple meta-analyses, which have shown its superiority over placebo in inducing remission 1. Additionally, a once-daily 9 mg dose has been found to be as effective as 3 mg three times daily, making it a convenient and effective treatment option 1. It is essential to note that when remission has been achieved, budesonide should be tapered over 1–2 weeks to prevent adrenal insufficiency 1. In terms of safety, budesonide has been shown to have a better safety profile compared to conventional steroids, with high topical anti-inflammatory activity and low systemic absorption and bioavailability 1. Overall, the available evidence supports the use of budesonide 9 mg once daily as a first-line treatment for mild-to-moderate ileocaecal Crohn's disease, due to its efficacy, safety, and convenience. Some key points to consider when prescribing budesonide include:
- The dose and frequency should be individualized based on the specific condition being treated, its severity, and patient response
- Budesonide works as a corticosteroid that reduces inflammation by suppressing the activity of inflammatory cells and decreasing the production of inflammatory chemicals in the body
- Patients should take budesonide consistently at the prescribed times to maintain therapeutic levels, and oral formulations should be swallowed whole without crushing or chewing
- Tapering may be necessary when discontinuing treatment, especially after prolonged use, to prevent adrenal insufficiency 1.
From the FDA Drug Label
The recommended starting dose and highest recommended dose of budesonide inhalation suspension, based on prior asthma therapy, are listed in the following table. Previous Therapy Recommended Starting Dose Highest Recommended Dose Bronchodilators Alone 0.5 mg total daily dose administered twice daily in divided doses 0.5 mg total daily dose Inhaled Corticosteroids 0. 5 mg total daily dose administered twice daily in divided doses 1 mg total daily dose Oral Corticosteroids 1 mg total daily dose administered as 0.5 mg twice daily 1 mg total daily dose Dosing recommendations based on previous therapy are as follows: Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily Inhaled corticosteroids 0.5 mg once daily or 0. 25 mg twice daily up to 0.5 mg twice daily Oral corticosteroids: 0.5 mg twice daily
The recommended dose of budesonide inhalation suspension varies based on previous therapy:
- Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily, with a highest recommended dose of 0.5 mg total daily dose
- Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily, with a highest recommended dose of 1 mg total daily dose
- Oral corticosteroids: 0.5 mg twice daily, with a highest recommended dose of 1 mg total daily dose 2
From the Research
Budesonide Dose and Frequency
- The optimal dose and frequency of budesonide vary depending on the condition being treated and the individual patient's response to the medication.
- For the induction of remission in Crohn's disease, a dose of 9 mg/day of budesonide was found to be effective, but less effective than conventional steroids 3.
- For maintaining remission in Crohn's disease, a dose of 6 mg/day of budesonide was not found to be effective 3, 4.
- In the treatment of asthma, once-daily administration of budesonide was found to be effective and well-tolerated, with doses ranging from 200 to 400 mcg 5.
- In the treatment of croup, asthma, and chronic obstructive pulmonary disease (COPD), budesonide is often used in monotherapy or in combination with other medications, with the choice of dose and frequency influenced by factors such as safety, efficacy, and personal experience with the medication 6.
Factors Affecting Dose and Frequency
- The choice of budesonide dose and frequency is influenced by factors such as the severity of the condition being treated, the individual patient's response to the medication, and the presence of any concomitant medical conditions.
- Safety and efficacy are key considerations in determining the optimal dose and frequency of budesonide, with the goal of achieving the best possible therapeutic outcome while minimizing the risk of adverse effects 3, 6.
- Personal experience with the medication and recommendations from scientific associations also play a role in determining the choice of budesonide dose and frequency 6.