BREO ELLIPTA
ICSLABA DPI
Fluticasone furoate / Vilanterol · GlaxoSmithKline
Active Medication & Mechanism
- Fluticasone furoate ICS50 mcg, 100 mcg, or 200 mcg per blister
Synthetic corticosteroid with enhanced glucocorticoid receptor affinity. Provides potent anti-inflammatory activity with once-daily dosing due to prolonged lung tissue retention.
- Vilanterol trifenatate LABA25 mcg per blister
Long-acting beta2-adrenergic agonist. Provides sustained bronchodilation for ≥24 hours with once-daily dosing.
FDA-Approved Dosing by Indication
// approval varies by strength + age Asthma
2/3 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 100/25 mcg | Adults (≥18 years) | 1 inhalation once daily Maintenance treatment of asthma in adults. | 100/25 mcg | FDA Approved |
| 200/25 mcg | Adults (≥18 years) | 1 inhalation once daily For adults requiring a higher inhaled corticosteroid dose. Maximum recommended adult asthma dose. | 200/25 mcg | FDA Approved |
| Any strength | Acute bronchospasm | — | — | Not Approved Not a rescue inhaler. Use a SABA for acute symptoms. |
COPD
1/2 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 100/25 mcg | Adults (≥18 years) | 1 inhalation once daily Once-daily maintenance treatment of airflow obstruction in COPD. Also reduces COPD exacerbations in patients with a history of exacerbations. | 100/25 mcg | FDA Approved |
| 200/25 mcg | Adults (≥18 years) | — | — | Not Approved The 200/25 mcg strength is NOT indicated for COPD. Only 100/25 mcg is approved for COPD. |
Acute Use
0/1 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| Any strength | Acute bronchospasm / rescue | — | — | Not Approved Not for acute bronchospasm. Use a SABA. |