1.2. Pediatrics
The safety and efficacy of inhalational salmeterol in children less than 4 years have not been established. Olodaterol is not approved for use in children as safety and efficacy of these agents have not been established in the pediatric population. Similarly, the glycopyrrolate/formoterol, aclidinium/formoterol, fluticasone/vilanterol, and the umeclidinium/vilanterol combination products are not FDA-approved for pediatric use as safety and efficacy have not been determined in this patient population for these inhalation combinations.
To prevent EIB in pediatric patients 4 years of age and older, one salmeterol 50 mcg inhalation is administered at least 30 minutes before exercise on an as-needed basis; doses should not be repeated for at least 12 hours after administration of the previous dose. Patients receiving twice daily LABA doses chronically should not administer additional LABA doses for EIB management.
Pediatric dosages for LABAs used as maintenance asthma therapy are summarized in Tables 3 and 4.
| Drug Name | Dosage Form/Strength | Patient Age/Maximum Recommended Dosage |
|---|---|---|
| salmeterol (Serevent® Diskus®) | inhalation powder: 50 mcg/inhalation | Greater than or equal to 4 years of age: 2 actuations/day (1 actuation twice daily); total dose = 100 mcg/day |
| Drug Name | Dosage Form/Strength | Patient Age/Maximum Recommended Dosage |
|---|---|---|
| budesonide/formoterol (Symbicort®) | inhalation aerosol: 80 mcg/4.5 mcg/ inhalation | 6 to 11 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 320 mcg/18 mcg/day |
| Greater than or equal to 12 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 320 mcg/18 mcg/day | ||
| inhalation aerosol: 160 mcg/4.5 mcg/inhalation | Greater than or equal to 12 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 640 mcg/18 mcg /day | |
| fluticasone propionate/ salmeterol xinafoate (Advair HFA®) | inhalation aerosol: 45 mcg/21 mcg/ inhalation | Greater than or equal to 12 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 180 mcg/84 mcg/day |
| inhalation aerosol: 115 mcg/21 mcg/ inhalation | Greater than or equal to 12 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 460 mcg/84 mcg/day | |
| inhalation aerosol: 230 mcg/21 mcg/inhalation | Greater than or equal to 12 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 920 mcg /84 mcg/day | |
| fluticasone propionate/ salmeterol (Advair Diskus®) | inhalation powder: 100 mcg/50 mcg/ inhalation | 4-11 years of age: 2 actuations/day (1 actuation twice daily); total dose = 200 mcg/100 mcg/day |
| inhalation powder: 100 mcg/50 mcg/inhalation | Greater than or equal to 12 years of age: 2 actuations/day (1 actuation twice daily); total dose = 200 mcg/100 mcg/day | |
| inhalation powder: 250 mcg/50 mcg/inhalation | Greater than or equal to 12 years of age: 2 actuations/day (1 actuation twice daily); total dose = 500 mcg/100 mcg/day | |
| inhalation powder: 500 mcg/50 mcg/ inhalation | Greater than or equal to 12 years of age: 2 actuations/day (1 actuation twice daily); total dose = 1000 mcg/100 mcg/day | |
| fluticasone propionate/salmeterol (AirDuo RespiClick®) | inhalation powder: 55 mcg fluticasone/14 mcg salmeterol/inhalation | Greater than or equal to 12 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 110 mcg/28 mcg/day |
| 113 mcg fluticasone/14 mcg salmeterol/inhalation | Greater than or equal to 12 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 226 mcg/28 mcg/day | |
| 232 mcg fluticasone/14 mcg salmeterol/inhalation | Greater than or equal to 12 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 464 mcg/28 mcg/day | |
| fluticasone propionate/salmeterol (AirDuo Digihaler®) | 55 mcg fluticasone/14 mcg salmeterol/inhalation | Greater than or equal to 12 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 110 mcg/28 mcg/day |
| inhalation powder: 113 mcg fluticasone/14 mcg salmeterol/inhalation | Greater than or equal to 12 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 226 mcg/28 mcg/day | |
| inhalation powder: 232 mcg fluticasone/14 mcg salmeterol/inhalation | Greater than or equal to 12 years of age: 2 actuations/day in divided doses (1 actuation twice daily); total dose = 464 mcg/28 mcg/day | |
| mometasone/ formoterol (Dulera®) | inhalation aerosol: 50 mcg/5 mcg/ inhalation | 5-11 years of age: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 200 mcg/ 20 mcg/ day |
| 100 mcg/5 mcg/inhalation | Greater than or equal to 12 years of age: patients on medium-dose inhaled corticosteroids: 4 actuations/day in divided doses (2 actuations twice daily); total dose = 400 mcg/20 mcg/day | |
| 200 mcg/5 mcg/inhalation |
Legend:
- Number of maximum actuations per day based on dose of salmeterol and formoterol, and independent of inhaled corticosteroid dose.