1.2. Pediatrics

Proventil HFA, Ventolin HFA, ProAir RespiClick, ProAir Digihaler, and generic albuterol HFA are FDA-approved for use in children 4 years of age and older for prevention/treatment of bronchospasm and prevention of exercise-induced bronchospasm^1-6. Levalbuterol is FDA-approved for use in children 4 years of age and older for prevention/treatment of bronchospasm^{1, 7}.;

To prevent EIB in pediatric patients 4 years of age and older, two albuterol 90 mcg inhalations are administered at least 15 to 30 minutes before exercise on an as-needed basis.

Combination therapy with ipratropium and albuterol is not FDA-approved for use in pediatric patients as safety and efficacy in this patient population have not been established.

Pediatric dosages for short-acting beta2-agonists used to manage acute asthma exacerbations are summarized in Table 3. Dosages exceeding these recommendations will be reviewed.

Table 3: Maximum Recommended Pediatric Daily Dose for Inhalational Beta2-Adrenergic Agents (Short-Acting) - Monotherapy^1-7

Drug Name	Treatment Indication	Dosage Form/Strength	Maximum Recommended Dosage
albuterol (Proventil HFA®, Ventolin HFA)	Asthma, prevention of exercise-induced bronchospasm	aerosol solution (90 mcg albuterol base/actuation)	Greater than or equal to 4 years of age: 12 actuations/day (total dose = 1080 mcg albuterol base)
albuterol (ProAir RespiClick®, ProAir Digihaler®)	Asthma, prevention of exercise-induced bronchospasm	inhalation powder (90 mcg albuterol base/actuation)	Greater than or equal to 4 years of age: 12 actuations/day (total dose = 1080 mcg albuterol base)
levalbuterol (Xopenex HFA®)	Asthma	aerosol (45 mcg levalbuterol free base/actuation)	Greater than or equal to 4 years of age: 12 actuations/day (total dose = 540 mcg levalbuterol free base)