AIRDUO DIGIHALER
ICSLABA DPI
Fluticasone propionate / Salmeterol · Teva Pharmaceuticals
Active Medication & Mechanism
- Fluticasone propionate ICS55 mcg or 113 mcg or 232 mcg per inhalation
Synthetic corticosteroid with potent anti-inflammatory activity. Reduces airway inflammation by suppressing cytokines, chemokines, and inflammatory cell infiltration.
- Salmeterol xinafoate LABA14 mcg per inhalation
Long-acting beta2-adrenergic agonist producing sustained bronchodilation (≥12 hours) via smooth muscle relaxation.
FDA-Approved Dosing by Indication
// approval varies by strength + age Asthma
3/4 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 55/14 mcg | Patients ≥12 years | 1 inhalation twice daily (~12 hours apart) For patients whose asthma is not adequately controlled on a low-dose ICS. | 110/28 mcg | FDA Approved |
| 113/14 mcg | Patients ≥12 years | 1 inhalation twice daily For patients not adequately controlled on medium-dose ICS. | 226/28 mcg | FDA Approved |
| 232/14 mcg | Patients ≥12 years | 1 inhalation twice daily For patients not adequately controlled on high-dose ICS. | 464/28 mcg | FDA Approved |
| Any strength | Acute bronchospasm | — | — | Not Approved Not a rescue inhaler. Use a SABA for acute symptoms. |
Acute Use
0/1 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| Any strength | Acute bronchospasm / rescue | — | — | Not Approved Not indicated for relief of acute bronchospasm. Use a SABA. |