What is the recommended dosage and treatment regimen of budesonide (corticosteroid) for pediatric asthma?

Budesonide Dosage and Treatment Regimen for Pediatric Asthma

For children with asthma, budesonide inhalation suspension is recommended at a dose of 0.25-0.5 mg twice daily for maintenance therapy, with FDA approval for children 1-8 years of age. 1, 2

Recommended Dosing Based on Previous Therapy

• For children previously on bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily 3
• For children previously on inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily 3
• For children previously on oral corticosteroids: 0.5 mg twice daily 3
• In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered 3

Administration Considerations

• Budesonide inhalation suspension should be administered via compressed air-driven jet nebulizers only (not for use with ultrasonic devices) 3
• For children under 4 years, delivery requires a face mask that should fit snugly over the nose and mouth 2, 4
• Budesonide suspension is compatible with albuterol, ipratropium, and levalbuterol nebulizer solutions in the same nebulizer 4

Treatment Approach and Monitoring

• Initiate long-term control therapy in children who had more than three episodes of wheezing in the past year that lasted more than 1 day and affected sleep AND who have risk factors for developing persistent asthma 1
• Once asthma control is established and sustained, attempt a careful step down in therapy 1
• If no clear benefit is observed within 4-6 weeks, consider alternative therapies or diagnoses 1, 4
• Monitor the patient's response on multiple clinical parameters and adjust the dose accordingly 2

Efficacy Evidence

• All doses of budesonide inhalation suspension (0.25 mg, 0.5 mg, and 1.0 mg twice daily) have been shown to be superior to placebo in improving nighttime and daytime asthma symptom scores, reducing use of breakthrough medication, and improving morning peak expiratory flow 5
• Budesonide inhalation suspension significantly reduces the need for emergency interventions in young children with asthma 6
• Once-daily dosing has been shown to be effective in some children with moderate persistent asthma, offering an important option to be considered by the prescribing physician 7

Safety Considerations

• Potential adverse effects include cough, dysphonia, and oral thrush (candidiasis) 2, 3
• In low-to-medium doses, suppression of growth velocity has been observed in children, but this effect may be transient 2
• Studies have shown no significant effect on adrenal function with short-term (12 weeks) or long-term (52 weeks) treatment with nebulized budesonide 8
• The safety and efficacy of inhaled corticosteroids in children under 1 year has not been established 2

Special Considerations for Intermittent Therapy

• For recurrent wheezing triggered by respiratory tract infections with no wheezing between infections, 1 mg twice daily for 7 days at the first sign of respiratory infection symptoms may be considered 2
• This approach is recommended for children who have had three or more episodes of wheezing triggered by respiratory infections in their lifetime or two episodes in the past year 2

Contraindications

• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required 3
• Hypersensitivity to any of the ingredients in budesonide inhalation suspension 3

Budesonide is the only inhaled corticosteroid with FDA-approved labeling for children under 4 years of age, making it a preferred option for treating persistent asthma in young children 2.