1.1. Adults

Beta2-adrenergic drugs, used routinely in asthma management, can be identified as long-acting or short-acting agents. Both short- and long-acting compounds can be used to prevent bronchospasm. However, short-acting compounds are the drugs of choice for acute bronchospasm as these agents act within minutes to cause bronchodilation. Drugs in this category include albuterol and levalbuterol. For acute bronchospasm, treatment is initiated with a short-acting beta2-adrenergic agent either as a metered-dose inhaler or a nebulizer solution. Treatment of acute attacks is usually for a finite time period based on the intensity of the attack and/or the need for medical attention either through emergency department management or hospitalization. Usage is individualized based on patient characteristics..

Although not FDA-approved, beta2-selective adrenergic agents such as albuterol are effective in chronic obstructive pulmonary disease (COPD) maintenance therapy to improve lung function and mucociliary clearance. Albuterol has become one of the mainstays of therapy for acute exacerbations of chronic obstructive pulmonary disease COPD due to rapid onset of action as well as efficacy in producing bronchodilation.

For preventive/ maintenance therapy, albuterol is FDA-approved as preventive therapy for exercise-induced asthma. To manage exercise-induced bronchospasm (EIB) in adults, two 90 mcg albuterol inhalations are administered at least 15 to 30 minutes before exercise on an as-needed basis.

Ipratropium/albuterol combination therapy is FDA-approved for use as second-line therapy in adult COPD patients who continue to experience bronchospasm with an aerosol bronchodilator and require a second bronchodilator.

Maximum recommended daily doses for available inhalational beta2-adrenergic agents as monotherapy and combination therapy are summarized in Tables 1 and 2. Prescribed dosages exceeding these criteria will be reviewed.

Table 1: Maximum Adult Daily Dose for Inhalational Beta2-Adrenergic Agents (Short-Acting) - Monotherapy1-7
Drug Name Treatment Indication Dosage Form/Strength Maximum Recommended Dosage
albuterol aerosol solution (Proventil HFA®, Ventolin HFA, generic) asthma, prevention of exercise-induced bronchospasm aerosol (90 mcg albuterol base/actuation) 12 actuations/day (total dose = 1080 mcg albuterol base)
albuterol inhalation powder (ProAir RespiClick®, ProAir Digihaler) asthma, prevention of exercise-induced bronchospasm (90 mcg albuterol base/actuation) 12 actuations/day (total dose = 1080 mcg albuterol base)
levalbuterol (Xopenex HFA, generic) asthma aerosol (45 mcg levalbuterol free base/actuation) 12 actuations/day (total dose = 540 mcg levalbuterol free base)
Table 2: Maximum Adult Daily Dose for Inhalational Beta2-Adrenergic Agents (Short-Acting) – Combination Therapy1,11
Drug Name Treatment Indication Dosage Form/Strength Maximum Recommended Dosage
ipratropium/ albuterol (Combivent Respimat®) chronic obstructive pulmonary disease inhalation spray (20 mcg ipratropium/ 100 mcg albuterol/ actuation) 6 actuations/day (total dose = 120 mcg ipratropium/ 600 mcg albuterol)

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 bronchospasm1-6. Levalbuterol is FDA-approved for use in children 4 years of age and older for prevention/treatment of bronchospasm1, 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) - Monotherapy1-7
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)