SYMBICORT

Budesonide/Formoterol

SYMBICORT

ICSLABA MDI

Budesonide / Formoterol fumarate dihydrate · AstraZeneca

Clinical Reference

Active Medication & Mechanism

Budesonide ICS
80 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 LABA
4.5 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.

80/4.5 mcg FDA Approved

Pop · 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.

Total · 320/18 mcg
160/4.5 mcg FDA Approved

Pop · Patients ≥12 years

2 inhalations twice daily

For patients not controlled on medium-dose ICS. Maximum recommended dose.

Total · 640/18 mcg
Any strength Not Approved

Pop · Acute bronchospasm

—

Total · — 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.

160/4.5 mcg FDA Approved

Pop · Adults (≥18 years)

2 inhalations twice daily

Maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and emphysema. Reduces exacerbations.

Total · 640/18 mcg
80/4.5 mcg Not Approved

Pop · Adults (≥18 years)

—

Total · — 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.

Any strength Not Approved

Pop · Acute bronchospasm / rescue

—

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