AIRDUO DIGIHALER

Fluticasone/Salmeterol

AIRDUO DIGIHALER

ICSLABA DPI

Fluticasone propionate / Salmeterol · Teva Pharmaceuticals

Clinical Reference

Active Medication & Mechanism

Fluticasone propionate ICS
55 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 LABA
14 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.

55/14 mcg FDA Approved

Pop · Patients ≥12 years

1 inhalation twice daily (~12 hours apart)

For patients whose asthma is not adequately controlled on a low-dose ICS.

Total · 110/28 mcg
113/14 mcg FDA Approved

Pop · Patients ≥12 years

1 inhalation twice daily

For patients not adequately controlled on medium-dose ICS.

Total · 226/28 mcg
232/14 mcg FDA Approved

Pop · Patients ≥12 years

1 inhalation twice daily

For patients not adequately controlled on high-dose ICS.

Total · 464/28 mcg
Any strength Not Approved

Pop · Acute bronchospasm

—

Total · — 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.

Any strength Not Approved

Pop · Acute bronchospasm / rescue

—

Total · — Not indicated for relief of acute bronchospasm. Use a SABA.