What is the recommended dosage of budesonide for pediatric patients?

Recommended Budesonide Dosing for Pediatric Patients

The recommended dosage of budesonide for pediatric patients varies by age, formulation, and condition being treated, with budesonide inhalation suspension being the only inhaled corticosteroid FDA-approved for children under 4 years of age, administered twice daily at 0.25-0.5 mg for low doses, 0.5-1.0 mg for medium doses, and >1.0-2.0 mg for high doses. 1, 2

Budesonide Inhalation Suspension (Nebulized) for Asthma

Children 0-4 Years

• Low dose: 0.25-0.5 mg total daily dose (0.125-0.25 mg twice daily) 1
• Medium dose: 0.5-1.0 mg total daily dose (0.25-0.5 mg twice daily) 1, 3
• High dose: >1.0-2.0 mg total daily dose (>0.5-1.0 mg twice daily) 1, 3
• Budesonide inhalation suspension is the only inhaled corticosteroid with FDA approval for children under 4 years of age 3, 1

Children 5-11 Years

• Low dose: 0.5 mg total daily dose (0.25 mg twice daily) 3
• Medium dose: 1.0 mg total daily dose (0.5 mg twice daily) 3
• High dose: 2.0 mg total daily dose (1.0 mg twice daily) 3

Administration Technique

• For young children, use a face mask that fits snugly over nose and mouth and avoid nebulizing in the eyes 3
• Wash face after each treatment to prevent local side effects such as oral candidiasis 3, 1
• Use only jet nebulizers as ultrasonic nebulizers are ineffective for suspensions 3, 2
• Budesonide suspension is compatible with albuterol, ipratropium, and levalbuterol nebulizer solutions in the same nebulizer 3

Dosing Frequency

• Although once-daily dosing has shown efficacy in some studies, twice-daily administration is recommended for optimal asthma control 2, 4
• FDA-approved labeling supports twice-daily dosing, though evidence suggests that the same nominal dose can be effective when administered once daily 2
• When all measures are considered together, evidence is stronger for twice-daily dosing 2

Budesonide for Eosinophilic Esophagitis

• For children with eosinophilic esophagitis, suggested starting doses range from 440-880 μg per day for children and 880-1760 μg per day for adolescents/adults 3
• For viscous budesonide in eosinophilic esophagitis: 1 mg/day if child is less than 150 cm or 2 mg/day if greater than 150 cm, either as a single dose or divided in two doses per day 3
• Higher doses of 4 mg/day may be used for older children (>150 cm or >11 years) not responding to standard dosage 3

Clinical Considerations and Pitfalls

• Once asthma control is achieved, the dose should be carefully titrated to the minimum dose required to maintain control 3, 1
• Do not discontinue budesonide inhalation suspension therapy abruptly as it may lead to asthma exacerbation 1
• Monitor for potential adverse effects including cough, dysphonia, and oral thrush 3
• At low-to-medium doses, suppression of growth velocity has been observed in children, but this effect may be transient 3
• In high doses, systemic effects may occur (adrenal suppression, osteoporosis, skin thinning), although studies are not conclusive 3
• For children using a face mask, wash face after each treatment to prevent local side effects 3

Budesonide inhalation suspension has demonstrated efficacy in improving nighttime and daytime asthma symptom scores, reducing use of breakthrough medication, and improving morning peak expiratory flow compared to placebo in multiple clinical trials 5, 4, 6.