TRELEGY ELLIPTA
ICSLAMALABA DPI
Fluticasone furoate / Umeclidinium / Vilanterol · GlaxoSmithKline
Active Medication & Mechanism
- Fluticasone furoate ICS100 mcg or 200 mcg per blister (strip 1)
Synthetic corticosteroid with enhanced glucocorticoid receptor affinity. Provides potent anti-inflammatory activity with once-daily dosing.
- Umeclidinium bromide LAMA62.5 mcg per blister (strip 2)
Long-acting muscarinic antagonist. Blocks M3 receptors on airway smooth muscle, preventing cholinergic bronchoconstriction.
- Vilanterol trifenatate LABA25 mcg per blister (strip 2)
Long-acting beta2-adrenergic agonist. Provides sustained bronchodilation (≥24 hours) via beta2-receptor stimulation.
FDA-Approved Dosing by Indication
// approval varies by strength + age Asthma
2/3 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 100/62.5/25 mcg | Patients ≥18 years | 1 inhalation once daily Maintenance treatment of asthma in adults not adequately controlled with ICS/LABA. | 100/62.5/25 mcg | FDA Approved |
| 200/62.5/25 mcg | Patients ≥18 years | 1 inhalation once daily For patients requiring higher ICS dose. Not adequately controlled on 100/62.5/25. | 200/62.5/25 mcg | FDA Approved |
| Any strength | Acute bronchospasm | — | — | Not Approved Not a rescue inhaler. Use a SABA for acute symptoms. |
- 100/62.5/25 mcg FDA ApprovedPop · Patients ≥18 years1 inhalation once dailyMaintenance treatment of asthma in adults not adequately controlled with ICS/LABA.Total · 100/62.5/25 mcg
- 200/62.5/25 mcg FDA ApprovedPop · Patients ≥18 years1 inhalation once dailyFor patients requiring higher ICS dose. Not adequately controlled on 100/62.5/25.Total · 200/62.5/25 mcg
- Any strength Not ApprovedPop · Acute bronchospasm—Total · — Not a rescue inhaler. Use a SABA for acute symptoms.
COPD
1/2 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 100/62.5/25 mcg | Adults (≥18 years) | 1 inhalation once daily Maintenance treatment of patients with COPD. First FDA-approved once-daily single-inhaler triple therapy. Reduces exacerbations and improves lung function. | 100/62.5/25 mcg | FDA Approved |
| 200/62.5/25 mcg | Adults (≥18 years) | — | — | Not Approved The 200/62.5/25 strength is NOT indicated for COPD. Only 100/62.5/25 is approved for COPD. |
- 100/62.5/25 mcg FDA ApprovedPop · Adults (≥18 years)1 inhalation once dailyMaintenance treatment of patients with COPD. First FDA-approved once-daily single-inhaler triple therapy. Reduces exacerbations and improves lung function.Total · 100/62.5/25 mcg
- 200/62.5/25 mcg Not ApprovedPop · Adults (≥18 years)—Total · — The 200/62.5/25 strength is NOT indicated for COPD. Only 100/62.5/25 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. |
- Any strength Not ApprovedPop · Acute bronchospasm / rescue—Total · — Not for acute bronchospasm. Use a SABA.