From the Guidelines
Budesonide should be used in pediatric patients with asthma who have had 4 or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep, and who have a positive asthma predictive index, at a dose of 0.25-0.5 mg twice daily for children under 8 years, adjusted to the lowest effective dose for maintenance therapy 1.
Key Considerations
- The decision to start long-term daily therapy with budesonide should be based on the clinician's judgment of the patient's response to therapy, and the dose should be titrated to the minimum dose required to maintain control 1.
- Budesonide is the preferred long-term control medication for initiating therapy in pediatric patients with asthma, due to its targeted anti-inflammatory effects and minimal systemic side effects 1.
- The safety and efficacy of budesonide in children under 1 year of age has not been established, and its use in this age group should be carefully considered 1.
- Intermittent ICS dosing with budesonide may be considered in children aged 0 to 4 years, at a dose of 1 mg twice daily for 7 days at the first sign of respiratory tract infection-associated symptoms, with careful monitoring of length or height due to conflicting data on effects on growth 1.
Monitoring and Adjustments
- The patient's response to therapy should be monitored carefully, and the dose of budesonide should be adjusted as needed to maintain control 1.
- If a clear and beneficial response is not obvious within 4 to 6 weeks, treatment should be stopped and alternative therapies or diagnoses should be considered 1.
- If a clear and beneficial response is sustained for at least 3 months, a step down to evaluate the need for continued daily long-term control therapy should be considered, as children in this age group have high rates of spontaneous remission of symptoms 1.
From the FDA Drug Label
8.4 Pediatric Use Safety and effectiveness of budesonide extended-release tablets in pediatric patients have not been established. Glucocorticosteroids, such as budesonide extended-release tablets, may cause a reduction of growth velocity in pediatric patients.
The proper use of budesonide in pediatric patients has not been established due to potential effects on growth velocity 2.
From the Research
Proper Use of Budesonide in Pediatric Patients
- Budesonide is approved for delivery using a nebulized solution and dry-powder inhaler in pediatric patients with asthma 3.
- The efficacy and safety of budesonide administered by pressurized metered-dose inhaler (pMDI) in children with asthma has been studied, and results show that budesonide treatment significantly improved morning peak expiratory flow (PEF) vs placebo 3.
- Budesonide inhalation suspension is a valuable therapeutic alternative to systemic corticosteroid therapy in infants and young children, improving asthma symptoms and lung function, and decreasing the need for breakthrough bronchodilators 4.
- Guidelines for managing asthma in pediatric patients recommend the use of inhaled corticosteroids, such as budesonide, for the management of persistent asthma in infants and young children 5.
Dosage and Administration
- Budesonide can be administered at a dose of 160 μg twice daily through a pMDI in children 6 to younger than 12 years with asthma 3.
- Budesonide inhalation suspension can be administered at a dose of 0.25-1 mg once- or twice-daily in infants and young children with persistent asthma 5.
Efficacy and Safety
- Budesonide has been shown to be effective in improving lung function, symptoms, rescue medication use, and nighttime awakenings in pediatric patients with asthma 3, 4, 5.
- Budesonide is generally well tolerated, with a low incidence of adverse events, and does not appear to affect growth and hypothalamic-pituitary-adrenal axis function in children 4, 5.
- The use of inhaled budesonide in pediatric patients with acute asthma has been shown to reduce hospitalization rates and the need for systemic corticosteroids 6.