SYMBICORT
ICSLABA MDI
Budesonide / Formoterol fumarate dihydrate · AstraZeneca
Active Medication & Mechanism
- Budesonide ICS80 mcg or 160 mcg per actuation
Corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity. Reduces airway inflammation by inhibiting inflammatory cells and mediators.
- Formoterol fumarate dihydrate LABA4.5 mcg per actuation
Long-acting beta2-adrenergic agonist with rapid onset of action. Relaxes bronchial smooth muscle via beta2-receptor stimulation.
FDA-Approved Dosing by Indication
// approval varies by strength + age Asthma
2/3 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 80/4.5 mcg | Patients ≥6 years | 2 inhalations twice daily (morning and evening) For patients not adequately controlled on long-term asthma control medication or whose disease warrants ICS/LABA. | 320/18 mcg | FDA Approved |
| 160/4.5 mcg | Patients ≥12 years | 2 inhalations twice daily For patients not controlled on medium-dose ICS. Maximum recommended dose. | 640/18 mcg | FDA Approved |
| Any strength | Acute bronchospasm | — | — | Not Approved Not a rescue inhaler. Use a SABA for acute symptoms. |
COPD
1/2 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 160/4.5 mcg | Adults (≥18 years) | 2 inhalations twice daily Maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and emphysema. Reduces exacerbations. | 640/18 mcg | FDA Approved |
| 80/4.5 mcg | Adults (≥18 years) | — | — | Not Approved The 80/4.5 mcg strength is NOT indicated for COPD. Only 160/4.5 is approved 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 bronchospasm. Use a SABA. |