DULERA

Mometasone/Formoterol

DULERA

ICSLABA MDI

Mometasone furoate / Formoterol fumarate dihydrate · Organon

Clinical Reference

Active Medication & Mechanism

Mometasone furoate ICS
100 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 LABA
5 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.

100/5 mcg FDA Approved

Pop · Patients ≥12 years

2 inhalations twice daily (morning and evening)

For patients previously on medium-dose ICS.

Total · 400/20 mcg
200/5 mcg FDA Approved

Pop · Patients ≥12 years

2 inhalations twice daily

For patients previously on high-dose ICS. Maximum recommended dose.

Total · 800/20 mcg
Any strength Not Approved

Pop · Acute bronchospasm

—

Total · — 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.

Any strength Not Approved

Pop · Adults

—

Total · — 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.

Any strength Not Approved

Pop · Acute bronchospasm / rescue

—

Total · — Not for acute relief. Use a SABA.