BREYNA
ICSLABA MDI
Budesonide / Formoterol fumarate dihydrate · Viatris (Mylan)
Active Medication & Mechanism
- Budesonide ICS80 mcg or 160 mcg per actuation
Corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity. Inhibits inflammatory cells and mediators involved in airway inflammation.
- Formoterol fumarate dihydrate LABA4.5 mcg per actuation
Long-acting beta2-adrenergic agonist with rapid onset. Relaxes bronchial smooth muscle by stimulating beta2-receptors.
FDA-Approved Dosing — Strength × Indication
Strength Regimen AsthmaCOPD
80/4.5 mcg
2 inhalations twice daily → 320/18 mcg
FDA Approved
Authorized generic of Symbicort. For patients whose asthma is not adequately controlled on a long-term asthma control medication.
Not Approved
The 80/4.5 mcg strength is NOT indicated for COPD. Only 160/4.5 is approved for COPD.
160/4.5 mcg
2 inhalations twice daily → 640/18 mcg
FDA Approved
Higher strength for patients not controlled on medium-dose ICS.
FDA Approved
Maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and emphysema.
All regimens shown apply to adults (≥18 years) unless otherwise noted · verify against current labelling
80/4.5 mcg 2 inhalations twice daily → 320/18 mcg
Asthma FDA Approved
Authorized generic of Symbicort. For patients whose asthma is not adequately controlled on a long-term asthma control medication.
COPD Not Approved
The 80/4.5 mcg strength is NOT indicated for COPD. Only 160/4.5 is approved for COPD.
160/4.5 mcg 2 inhalations twice daily → 640/18 mcg
Asthma FDA Approved
Higher strength for patients not controlled on medium-dose ICS.
COPD FDA Approved
Maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and emphysema.
All regimens shown apply to adults (≥18 years) unless otherwise noted · verify against current labelling
Not a rescue inhaler. Not for acute bronchospasm. Use a SABA.
Related Inhalers
Same active ingredients (Budesonide/Formoterol)