DULERA
ICSLABA MDI
Mometasone furoate / Formoterol fumarate dihydrate · Organon
Active Medication & Mechanism
- Mometasone furoate ICS100 mcg or 200 mcg per actuation
Synthetic corticosteroid with potent anti-inflammatory activity. Reduces airway inflammation by inhibiting multiple inflammatory cell types and cytokine release.
- Formoterol fumarate dihydrate LABA5 mcg per actuation
Long-acting beta2-adrenergic agonist with rapid onset. Relaxes airway smooth muscle through beta2-receptor stimulation and increased cAMP.
FDA-Approved Dosing by Indication
// approval varies by strength + age Asthma
2/3 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 100/5 mcg | Patients ≥12 years | 2 inhalations twice daily (morning and evening) For patients previously on medium-dose ICS. | 400/20 mcg | FDA Approved |
| 200/5 mcg | Patients ≥12 years | 2 inhalations twice daily For patients previously on high-dose ICS. Maximum recommended dose. | 800/20 mcg | FDA Approved |
| Any strength | Acute bronchospasm | — | — | Not Approved Not a rescue inhaler. Use a SABA for acute symptoms. |
COPD
0/1 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| Any strength | Adults | — | — | Not Approved Dulera 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 relief. Use a SABA. |