Breztri Aerosphere (Budesonide, Glycopyrrolate, and Formoterol Fumarate)

Prescription Required
Brand
Dose Size & Price Qty
160mcg / 9mcg / 4.8mcg (same as 160mcg / 7.2mcg / 5mcg) (120 doses / inhaler)
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Fact Table

Fact Table
Formula Combination product (Budesonide: C25H34O6; Glycopyrrolate: C19H28BrNO4; Formoterol fumarate: C19H24N2O4 · C4H4O4)
License FDA approved (2020); EMA approved (2020)
Bioavailability Low systemic bioavailability (inhaled); Budesonide ~39%, Glycopyrrolate <10%, Formoterol ~61%
Legal status Prescription only (Rx)
Chemical Name Budesonide; Glycopyrronium bromide; (RS)-2-hydroxy-5-[(1RS)-1-hydroxy-2-{[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]amino}ethyl]benzamide fumarate
Elimination half-life Budesonide ~2–3 h; Glycopyrrolate ~33–57 h; Formoterol ~10 h
Dosage (Strength) 160 mcg budesonide / 9 mcg glycopyrrolate / 4.8 mcg formoterol per actuation; 2 inhalations twice daily
Pregnancy Use only if potential benefit justifies potential risk to the fetus
Brands Breztri Aerosphere (AstraZeneca)
Protein binding Budesonide ~85–90%; Glycopyrrolate ~38–41%; Formoterol ~61–64%
PubChem CID Budesonide: 5281004; Glycopyrrolate: 3359; Formoterol: 3033606
MedlinePlus Inhaled triple therapy for COPD (budesonide/formoterol/glycopyrrolate)
ChEBI Budesonide: 31501; Glycopyrrolate: 4511; Formoterol: 5147
ATC code R03AL11
DrugBank Budesonide: DB01222; Glycopyrrolate: DB00986; Formoterol: DB00983
KEGG Budesonide: D00288; Glycopyrrolate: D00669; Formoterol: D07593
Routes of administration Inhalation (pressurized metered-dose inhaler)

Breztri Aerosphere is a triple-therapy combination inhaler used for the long-term treatment of chronic obstructive pulmonary disease (COPD). It combines three medicines that work together to reduce lung inflammation and relax the muscles around the airways. This helps keep the airways open and makes breathing easier for people with COPD.

Directions

Breztri Aerosphere is taken as an oral inhalation. The standard dosage is two inhalations twice daily, typically in the morning and evening. Each actuation delivers budesonide 160 mcg, glycopyrrolate 9 mcg, and formoterol fumarate 4.8 metered mcg.

The inhaler needs to be primed before the first use by releasing four sprays into the air, away from the face. If the inhaler hasn't been used for more than seven days, it'll need to be primed again with two sprays.

This medication is meant for maintenance treatment and shouldn't be used to treat sudden breathing problems or acute episodes of COPD. Keep track of the dose counter on the inhaler and discard it when the counter reads zero or after the expiration date, whichever comes first.

Ingredients

The active ingredients in Breztri Aerosphere are budesonide, glycopyrrolate, and formoterol fumarate.

Cautions

Before using this medication, you may want to consult a healthcare provider about the following:

  • Any existing health conditions
  • Any allergies
  • A list of all medications currently being taken

Breztri is approved to treat COPD and should not be used for asthma.

Breztri should not be started during a sudden worsening of COPD and must not be used as a rescue inhaler for sudden breathing problems.

Using Breztri more often than prescribed or combining it with other long-acting beta-agonist inhalers can increase the risk of serious heart-related side effects and should be avoided.

Breztri can cause a yeast infection in the mouth or throat. Rinsing the mouth with water after each use helps reduce this risk.

Pneumonia has been reported in people with COPD using inhaled corticosteroids like Breztri, and symptoms can overlap with COPD flare-ups, so infections should be watched for closely.

Because Breztri contains a corticosteroid, it may increase the risk of infections, and exposure to illnesses like chickenpox or measles can be more serious in people using this medication.

People switching from oral steroids to Breztri need careful monitoring, since the body may temporarily struggle to produce enough natural steroids during illness, injury, or surgery.

Breztri may cause sudden tightening of the airways after inhalation, which is a medical emergency and requires immediate treatment and stopping the medication.

Breztri may affect the heart by increasing heart rate, blood pressure, or causing irregular heart rhythms, especially in people with existing heart conditions.

Long-term use of inhaled corticosteroids may slightly reduce bone strength, so people with risk factors for osteoporosis may need bone monitoring.

Eye problems such as glaucoma or cataracts can occur with long-term use, and new eye pain, blurred vision, or visual changes should be evaluated promptly.

Breztri may worsen difficulty urinating in people with prostate or bladder problems, and new urinary symptoms should be reported.

Caution is needed in people with conditions such as seizures, thyroid disease, diabetes, or low potassium levels, since Breztri may worsen these problems.

Contraindications

Avoid taking or using this medication if you have a known hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or any other ingredients in the formulation.

Side Effects

Common side effects of Breztri include:

  • Upper respiratory tract infection
  • Cough
  • Thrush in the mouth or throat
  • Back or joint pain
  • Headache
  • Diarrhea
  • Hoarseness

More serious side effects can include pneumonia, sudden breathing problems after inhalation, serious allergic reactions, increased blood pressure, or a fast or irregular heartbeat.

Breztri may also weaken the immune system, affect adrenal function, thin bones over time, or cause eye problems like glaucoma or cataracts.

Urinary retention and changes in blood sugar or potassium levels have also been reported. Contact a healthcare provider if you develop severe breathing problems, chest pain, vision changes, signs of infection, or difficulty urinating.

Frequently Asked Questions about Breztri Aerosphere


What is Breztri Aerosphere used for?

Breztri Aerosphere is a prescription inhaler used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, in adults.


What medications are in Breztri Aerosphere?

Breztri Aerosphere contains three medicines: budesonide, a corticosteroid; glycopyrrolate, a long-acting muscarinic antagonist; and formoterol fumarate, a long-acting beta-agonist.


How does Breztri Aerosphere work?

Breztri Aerosphere reduces airway inflammation, relaxes airway muscles, and helps keep airways open, making breathing easier and reducing COPD flare-ups.


How should Breztri Aerosphere be used?

Breztri Aerosphere is inhaled by mouth twice daily, with two inhalations each time, using the inhaler device as directed.


Is Breztri Aerosphere a rescue inhaler?

Breztri Aerosphere is not a rescue inhaler and should not be used for sudden breathing problems; a fast-acting rescue inhaler is needed for acute symptoms.


What are the most common side effects of Breztri Aerosphere?

Common side effects include cough, upper respiratory tract infections, headache, oral thrush, muscle spasms, and diarrhea.


Can Breztri Aerosphere increase the risk of pneumonia?

Yes, inhaled corticosteroids like budesonide may increase the risk of pneumonia in people with COPD, especially with long-term use.


Should the mouth be rinsed after using Breztri Aerosphere?

Rinsing the mouth with water and spitting it out after each dose helps reduce the risk of oral fungal infections.


Who should not use Breztri Aerosphere?

Breztri Aerosphere should not be used by people with severe allergies to any of its ingredients or for treating asthma.


What should I do if I miss a dose of Breztri Aerosphere?

If a dose is missed, the next dose should be taken at the usual time without using extra inhalations to make up for the missed dose.

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