Breztri Aerosphere Budesonide Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol

1. Indications and Usage
Chronic Obstructive Pulmonary Disease (COPD):
Maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
Important Safety Limitation: Not indicated for the relief of acute bronchospasm (rescue inhaler).
2. Dosage and Administration
Route of Administration:
For Oral Inhalation ONLY.
Recommended Dosage:
Standard Dose: 2 actuations (puffs) twice daily (morning and evening).
Dose Strength: Available in fixed-dose combinations (e.g., 160/7.2/4.8 mcg per actuation).
Critical Administration Instructions:
Prime the Inhaler: Before using for the first time, or if the inhaler has not been used for more than 7 days, shake well and spray into the air 4 times.
Rinse Mouth: Patients must rinse their mouth with water after inhalation to reduce the risk of oral candidiasis (thrush).
3. Mechanism of Action
The drug combines three distinct pharmacological classes to improve lung function and reduce symptoms:
Budesonide (ICS):
A corticosteroid with local anti-inflammatory activity. It inhibits the release of pro-inflammatory mediators and reduces airway inflammation.
Glycopyrronium Bromide (LAMA):
A long-acting muscarinic antagonist. It blocks the action of acetylcholine on M3 receptors in the airways, preventing bronchoconstriction.
Formoterol Fumarate (LABA):
A long-acting selective β2-adrenergic receptor agonist. It relaxes bronchial smooth muscle by increasing intracellular cAMP, providing bronchodilation for up to 12 hours.
4. Safety and Warnings
Increased Risk of Pneumonia in COPD:
The use of ICS (Budesonide) is associated with an increased risk of pneumonia in patients with COPD. Monitor patients for signs of infection (fever, chills).
Paradoxical Bronchospasm:
Inhalation of the drug may cause immediate bronchospasm. Discontinue immediately if it occurs.
Cardiovascular Effects:
LABA components may cause transient cardiovascular effects (e.g., increased heart rate, palpitations, QTc prolongation).
Glaucoma and Urinary Retention:
Anticholinergic components may cause or worsen narrow-angle glaucoma or urinary retention.
Adrenal Insufficiency:
Systemic absorption of high doses of corticosteroids may lead to adrenal suppression.
5.Adverse Reactions
Most Common:
Oral candidiasis (thrush), pharyngitis, headache, hoarseness/dysphonia, cough, and nausea.
6.Drug Interactions
CYP3A4 Inhibitors:
Budesonide is metabolized by CYP3A4. Strong inhibitors (e.g., ketoconazole, ritonavir) may increase systemic exposure to the corticosteroid, increasing the risk of Cushing’s syndrome or adrenal suppression.
Non-Potassium-Sparing Diuretics:
May potentiate the hypokalemic effect of LABAs.
Beta-Blockers:
May block the pulmonary effects of Formoterol; generally contraindicated unless there are compelling reasons for their use.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredients: Budesonide, Glycopyrronium Bromide, Formoterol Fumarate.
Propellant: Hydrofluoroalkane (HFA-134a).
Appearance: Pressurized Metered-Dose Inhaler (pMDI).
Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Do not puncture or incinerate the canister.