What is Pulmicort Used For?
Pulmicort (budesonide inhalation suspension) is FDA-approved for maintenance treatment of asthma and prophylactic therapy in children 12 months to 8 years of age, and is not indicated for relief of acute bronchospasm. 1
Primary Indication: Asthma Management
Pulmicort is an inhaled corticosteroid designed specifically for nebulized delivery in young children with persistent asthma. 1, 2 The medication works by decreasing airway hyperresponsiveness and reducing inflammatory cells and mediators in the airways. 2
Age-Specific Use in Asthma
Infants and young children (6 months to 8 years): Budesonide inhalation suspension significantly reduces day- and night-time asthma symptoms, decreases beta2-agonist bronchodilator requirements, and reduces asthma exacerbations compared to placebo. 3
Preschool children with severe persistent asthma: At 2 mg/day, budesonide significantly reduces the number of asthma exacerbations and requirements for systemic corticosteroids. 3
Once-daily dosing is effective: Clinical efficacy is comparable between once-daily and twice-daily regimens in patients with mild-to-moderate asthma, which may improve compliance. 4
Dosing Range
The typical dosing range is 0.25 to 2 mg/day, with dose selection based on asthma severity. 3, 5 Once-daily administration is effective in both children <4 years and ≥4 years of age. 5
Additional Pediatric Respiratory Uses
Croup (Laryngotracheobronchitis)
Single doses of 2 or 4 mg budesonide inhalation suspension are significantly more effective than placebo and as effective as oral dexamethasone 0.6 mg/kg in alleviating croup symptoms and reducing hospitalization duration. 3
Chronic Lung Disease Prevention in Preterm Infants
Early initiation of budesonide inhalation suspension 1 mg/day appears to reduce the need for mechanical ventilation and decrease overall corticosteroid usage in preterm very low birthweight infants at risk for chronic lung disease. 3
Adult Uses
Persistent Asthma in Adults
Budesonide inhalation suspension at doses ≤8 mg/day has been studied in adults with persistent asthma, producing improvements in asthma control. 3 However, other formulations (dry powder inhaler) are more commonly used in adults.
Acute Asthma Exacerbations
Small studies suggest budesonide inhalation suspension may be as effective as oral corticosteroids during acute exacerbations of asthma, though this is not the primary indication. 3
Important Limitations
Pulmicort is NOT indicated for:
- Relief of acute bronchospasm 1
- Chronic cough without confirmed asthma (when bronchial hyperresponsiveness and eosinophilia testing are negative) 6
- Unexplained chronic cough in adults with negative BHR and eosinophil testing 6
Safety Profile
Growth in children: Long-term treatment (52 weeks) with 0.5-1 mg/day generally does not affect growth velocity, though a small decrease was detected in children not previously using inhaled corticosteroids. 3
HPA axis function: Not affected by short-term (12 weeks) or long-term (52 weeks) treatment with nebulized budesonide at therapeutic doses. 3, 7
Adverse events: Frequency of adverse events is similar between budesonide 0.25-2 mg/day and placebo in 12-week studies. 3
Pharmacologic Advantages
Budesonide has a high ratio of topical anti-inflammatory to systemic activity, allowing for potent local effects with limited systemic exposure. 2 After nebulization in children 3-6 years, total systemic availability is approximately 6% of the labeled dose, with rapid absorption and a terminal elimination half-life of 2.3 hours. 2