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Pharmaceutical Facts on Breztri Aerosphere

Category	Details
Brand Name	Breztri Aerosphere
Generic Name	Budesonide/Glycopyrrolate/Formoterol Fumarate
Drug Class	Combination Inhaled Corticosteroid, Long-Acting Muscarinic Antagonist (LAMA), Long-Acting Beta2-Agonist (LABA)
Indication	Maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Dosage Form	Inhalation Aerosol, delivered via a pressurized metered-dose inhaler
Strength	160 mcg Budesonide / 7.2 mcg Glycopyrrolate / 5 mcg Formoterol per actuation
Route of Administration	Inhalation
Dosage Frequency	Twice daily (morning and evening), with one inhalation per dose
Mechanism of Action	Budesonide reduces inflammation in the lungs; Glycopyrrolate helps to relax and open the airways; Formoterol aids in keeping the airways open for a longer period
Intended Use	Long-term maintenance treatment of COPD to reduce symptoms, improve lung function, and decrease the frequency of exacerbations
Onset of Action	Initial improvement may be seen within hours, but maximum benefit is usually achieved after a few weeks of regular use
Duration of Action	Up to 12 hours after each dose
Common Side Effects	Cough, upper respiratory tract infections, headache, back pain, oral thrush, voice changes (dysphonia)
Serious Side Effects	Pneumonia, paradoxical bronchospasm, cardiovascular effects (e.g., arrhythmias, hypertension), decreased bone density, glaucoma, urinary retention
Contraindications	Hypersensitivity to any of the ingredients, acute episodes of bronchospasm, asthma (unless co-administered with a long-term asthma control medication)
Drug Interactions	Use with caution when co-administered with other adrenergic drugs, anticholinergics, or drugs that affect the QT interval (e.g., certain antidepressants)
Storage Instructions	Store at room temperature (68°F to 77°F or 20°C to 25°C); avoid exposure to extreme temperatures and humidity; do not freeze
Handling Instructions	Prime the inhaler before first use or if it hasn’t been used for more than 7 days; shake well before each use
Special Precautions	Not intended for acute bronchospasm or asthma attacks; rinse mouth thoroughly after each use to reduce the risk of oral thrush; monitor for signs of systemic corticosteroid effects
Monitoring	Regular monitoring of lung function, blood pressure, and heart rate is recommended; periodic bone density assessments may be necessary in long-term use
Pregnancy and Lactation	Use only if the potential benefit justifies the potential risk to the fetus; it is not known if Breztri components are excreted in human milk
Pediatric Use	Safety and efficacy in pediatric patients have not been established
Geriatric Use	No overall differences in safety or effectiveness observed between elderly and younger patients; however, greater sensitivity of some older individuals cannot be ruled out
Manufacturer	AstraZeneca
Approval Date	July 2020 (FDA)
Price Comparison	Breztri is typically available at up to 70% lower cost in Canada compared to U.S. prices, offering significant savings to patients