BREZTRI AEROSPHERE
ICSLAMALABA MDI
Budesonide / Glycopyrrolate / Formoterol fumarate · AstraZeneca
Active Medication & Mechanism
- Budesonide ICS160 mcg per actuation
Corticosteroid with potent anti-inflammatory activity. Reduces airway inflammation through suppression of inflammatory cells and mediators.
- Glycopyrrolate LAMA9 mcg per actuation
Long-acting muscarinic antagonist. Blocks M3 receptors on airway smooth muscle, inhibiting cholinergic bronchoconstriction.
- Formoterol fumarate LABA4.8 mcg per actuation
Long-acting beta2-adrenergic agonist with rapid onset. Produces sustained bronchodilation via beta2-receptor stimulation.
FDA-Approved Dosing by Indication
// approval varies by strength + age COPD
1/1 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 160/9/4.8 mcg | Adults (≥18 years) | 2 inhalations twice daily (morning and evening) Maintenance treatment of COPD. Triple therapy (ICS/LAMA/LABA) in a single inhaler for patients on LAMA/LABA who require additional ICS, or on ICS/LABA who require additional LAMA. | 640/36/19.2 mcg | FDA Approved |
- 160/9/4.8 mcg FDA ApprovedPop · Adults (≥18 years)2 inhalations twice daily (morning and evening)Maintenance treatment of COPD. Triple therapy (ICS/LAMA/LABA) in a single inhaler for patients on LAMA/LABA who require additional ICS, or on ICS/LABA who require additional LAMA.Total · 640/36/19.2 mcg
Asthma
0/1 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| Any strength | All patients | — | — | Not Approved Breztri Aerosphere is NOT indicated for asthma. |
- Any strength Not ApprovedPop · All patients—Total · — Breztri Aerosphere is NOT indicated for asthma.
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 ApprovedPop · Acute bronchospasm / rescue—Total · — Not for acute bronchospasm. Use a SABA.