1.2. Pediatrics

Short-acting beta2-adrenergic bronchodilators are FDA-approved to manage bronchospasm episodes in pediatric patients with reversible obstructive airway disease1-6. Racemic albuterol nebulized solution is FDA-approved to provide bronchospasm relief in children 2 years of age and older with reversible obstructive airway disease1-5. Levalbuterol nebulized solutions are FDA-approved for use in the management and prevention of acute asthma exacerbations in children 6 years of age and older1,2,6. Ipratropium is FDA-approved for use in children 12 years of age and older for management of bronchospasm associated with COPD1,2,11. Recommended dosages are summarized in Tables 6 and 7. Patient profiles with dosages exceeding these recommendations will be reviewed.

Table 6. Maximum Recommended Nebulized Bronchodilator Pediatric Dosages: Short-Acting Sympathomimetics1-6
Drug Name Dosage Strength Maximum Recommended Dosage 
Racemic albuterol (generics) 0.63 mg/3 ml (0.021%) or 1.25 mg/3 ml (0.042%) 2-12 years of age: 1.25 mg 4 times daily (5 mg/day) + 
Racemic albuterol (generics) 2.5 mg/3 ml (0.083%); 2.5 mg/ 0.5 ml (0.5%) 2-12 years of age: 2.5 mg 4 times daily (10 mg/day) *+
  2.5 mg/ 0.5 ml (0.5%) Greater than 12 years of age: 2.5 mg 4 times daily (10 mg/day)+
Levalbuterol (Xopenex®, generics) 0.31 mg/3 ml; 0.63 mg/3 ml; 1.25 mg/3 ml; 1.25 mg/0.5 ml
  • 6 years to 11 years of age: #  
    • 0.63 mg three times daily (every 6-8 hours)
  • 12 years of age and older: ^ 
    • 1.25 mg three times daily (every 6-8 hours)

Legend:

  • * Children weighing less than15 kg who require less than 2.5 mg/dose should use the 0.5% albuterol inhalation solution instead of the 0.083% albuterol inhalation solution3
  • + Manufacturers state that more frequent administration or higher doses not recommended; however, in patients 12 years or younger with severe asthma exacerbations, the National Asthma Education and Prevention Program Expert Panel (NAEPPEP) recommends racemic albuterol doses of 0.15 mg/kg (minimum dose 2.5 mg) for 3 doses then 0.15-0.3 mg/kg (up to 10 mg) every 1-4 hours as needed, or 0.5 mg/kg/hour by continuous nebulization. In patients greater than 12 years of age the NAEPPEP recommends 2.5-5 mg every 20 minutes for 3 doses, then 2.5-10 mg every 1-4 hours as needed, or 10-15 mg/hour by continuous nebulization12
  • # For acute asthma exacerbations in children 12 years and younger, NAEPPEP recommends levalbuterol doses of 0.075 mg/kg (1.25 mg minimum) every 20 minutes x 3 doses, then 0.075—0.15 mg/kg (5 mg max) every 1—4 hours as needed12
  • ^ For acute asthma exacerbations in children greater than 12 years, NAEPPEP recommends levalbuterol doses of 1.25-2.5 mg every 20 minutes for 3 doses, then 1.25-5 mg every 1-4 hours as needed12
Table 7. Maximum Recommended Nebulized Bronchodilator Pediatric Dosages: Short-Acting Anticholinergics1,2,11
Drug Name Dosage Strength Maximum Recommended Dosage
Ipratropium (various generics) 500 mcg/2.5 ml (0.02%) Greater than or equalt to 12 years of age:
500 mcg 4 times daily, every 6 hours apart

Nebulized long-acting beta2-adrenergic bronchodilators and long-acting anticholinergics as well as combination therapy with ipratropium and racemic albuterol are not indicated for use in pediatric patients as safety and efficacy of these agents in this patient population have not been established1,2,7-10,14.