WIXELA INHUB
ICSLABA DPI
Fluticasone propionate / Salmeterol · Viatris (Mylan)
Active Medication & Mechanism
- Fluticasone propionate ICS100 mcg, 250 mcg, or 500 mcg per blister
Synthetic corticosteroid with potent anti-inflammatory activity. Inhibits inflammatory cells and mediators involved in airway inflammation.
- Salmeterol xinafoate LABA50 mcg per blister
Long-acting beta2-adrenergic agonist. Provides prolonged bronchodilation (≥12 hours) via beta2-receptor stimulation.
FDA-Approved Dosing by Indication
// approval varies by strength + age Asthma
3/4 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 100/50 mcg | Patients ≥4 years | 1 inhalation twice daily (~12 hours apart) Generic substitution for Advair Diskus 100/50. For patients not controlled on ICS or whose disease warrants ICS/LABA. | 200/100 mcg | FDA Approved |
| 250/50 mcg | Patients ≥12 years | 1 inhalation twice daily Generic substitution for Advair Diskus 250/50. | 500/100 mcg | FDA Approved |
| 500/50 mcg | Patients ≥12 years | 1 inhalation twice daily Generic substitution for Advair Diskus 500/50. | 1000/100 mcg | FDA Approved |
| Any strength | Acute bronchospasm | — | — | Not Approved Not a rescue inhaler. Use a SABA. |
COPD
1/3 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 250/50 mcg | Adults (≥18 years) | 1 inhalation twice daily Maintenance of airflow obstruction in COPD. Only the 250/50 strength is approved for COPD. | 500/100 mcg | FDA Approved |
| 100/50 mcg | Adults (≥18 years) | — | — | Not Approved 100/50 is NOT indicated for COPD. |
| 500/50 mcg | Adults (≥18 years) | — | — | Not Approved 500/50 is NOT indicated 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 use. Use a SABA. |