Breztri Aerosphere FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 27, 2021.
FDA Approved: Yes (First approved July 23, 2020)
Brand name: Breztri Aerosphere
Generic name: budesonide/glycopyrrolate/formoterol fumarate
Dosage form: Metered Dose Inhalation
Treatment for: COPD
Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is a fixed dose triple-combination of the inhaled corticosteroid budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta2-agonist (LABA) formoterol fumarate, delivered in a pressurized metered-dose inhaler for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
- Breztri Aerosphere is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
- Breztri Aerosphere is administered by oral inhalation twice daily (2 puffs in the morning and 2 puffs in the evening). Patients should always rinse their mouth with water after each dose to reduce the risk of Candida albicans infection (oral thrush).
- Breztri Aerosphere is not meant to relieve acute symptoms of COPD. Patients should always have available a rescue inhaler (an inhaled, short-acting bronchodilator) to treat sudden breathing problems.
- Common adverse reactions include upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasm, urinary tract infection, cough, sinusitis and diarrhea.
Development Timeline for Breztri Aerosphere
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