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 — Strength × Indication
Strength Regimen AsthmaCOPD
100/5 mcg
2 inhalations twice daily (morning and evening) → 400/20 mcg
FDA Approved
For patients previously on medium-dose ICS.
Not Approved
Dulera is not indicated for COPD.
200/5 mcg
2 inhalations twice daily → 800/20 mcg
FDA Approved
For patients previously on high-dose ICS. Maximum recommended dose.
Not Approved
Dulera is not indicated for COPD.
All regimens shown apply to adults (≥18 years) unless otherwise noted · verify against current labelling
100/5 mcg 2 inhalations twice daily (morning and evening) → 400/20 mcg
Asthma FDA Approved
For patients previously on medium-dose ICS.
COPD Not Approved
Dulera is not indicated for COPD.
200/5 mcg 2 inhalations twice daily → 800/20 mcg
Asthma FDA Approved
For patients previously on high-dose ICS. Maximum recommended dose.
COPD Not Approved
Dulera is not indicated for COPD.
All regimens shown apply to adults (≥18 years) unless otherwise noted · verify against current labelling
Not a rescue inhaler. Not for acute relief. Use a SABA.