WIXELA INHUB

Fluticasone/Salmeterol

WIXELA INHUB

ICSLABA DPI

Fluticasone propionate / Salmeterol · Viatris (Mylan)

Clinical Reference

Active Medication & Mechanism

Fluticasone propionate ICS
100 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 LABA
50 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.

100/50 mcg FDA Approved

Pop · 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.

Total · 200/100 mcg
250/50 mcg FDA Approved

Pop · Patients ≥12 years

1 inhalation twice daily

Generic substitution for Advair Diskus 250/50.

Total · 500/100 mcg
500/50 mcg FDA Approved

Pop · Patients ≥12 years

1 inhalation twice daily

Generic substitution for Advair Diskus 500/50.

Total · 1000/100 mcg
Any strength Not Approved

Pop · Acute bronchospasm

—

Total · — 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.

250/50 mcg FDA Approved

Pop · Adults (≥18 years)

1 inhalation twice daily

Maintenance of airflow obstruction in COPD. Only the 250/50 strength is approved for COPD.

Total · 500/100 mcg
100/50 mcg Not Approved

Pop · Adults (≥18 years)

—

Total · — 100/50 is NOT indicated for COPD.
500/50 mcg Not Approved

Pop · Adults (≥18 years)

—

Total · — 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.

Any strength Not Approved

Pop · Acute bronchospasm / rescue

—

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