Breztri Aerosphere

Indications

Breztri Aerosphere is a prescription medication used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema.

Breztri Aerosphere is a single-inhaler, fixed-dose combination product that contains three active ingredients: budesonide, glycopyrrolate, and formoterol fumarate.

Budesonide is a corticosteroid that helps to reduce airway inflammation, glycopyrrolate is an antimuscarinic that helps to relax and widen the airways, and formoterol is a long-acting beta-agonist that helps to keep the airways open.

Use and Dosage

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill.

Follow the instructions for priming the inhaler if you are using it for the first time, if you have not used it for a week or more, if you dropped the inhaler, or if you put the canister back into the inhaler after cleaning. When priming the inhaler, make sure to spray away from your face so that you do not get the medication into your eyes.

Shake the inhaler well before using it. Inhale this medication by mouth as directed by your doctor, usually twice daily (in the morning and the evening). Wait at least 1 minute between inhalations.

To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle, rinse your mouth with water and spit out after each use. Do not swallow the rinse water.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor. Your condition will not improve any faster, and your risk of side effects will increase.

If you are using other inhalers at the same time, wait at least 1 minute between the uses of each medication.

If you have been using a quick-relief inhaler (such as albuterol, also called salbutamol in some countries) on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use the quick-relief inhaler as needed for sudden shortness of breath. Consult your doctor for details.

Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have a new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well.

Side Effects

Serious effects include:

• Yeast infections in the throat
• Pneumonia
• Weakened immune system
• Adrenal Insufficiency
• Breathing problems after using an inhaler
• Irregular heartbeat/palpitations
• Chest pain
• High blood pressure
• Tremors
• Narrow-angle glaucoma (eye pain, blurred vision, red eyes, seeing halos)
• Urinary retention

Caution

Before using this product, tell your doctor or pharmacist if you are allergic to budesonide, glycopyrrolate, formoterol; or arformoterol; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), heart problems, high blood pressure, seizures, bone loss (osteoporosis), eye problems, overactive thyroid, diabetes, difficulty urinating, liver disease.

This product may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, and fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation.

This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this product safely.

This medication may temporarily slow down a child’s growth if used for a long time. However, poorly controlled asthma can also slow down growth. See the doctor regularly so your child’s height can be checked.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when needed. Discuss the risks and benefits with your doctor.

Budesonide passes into breast milk. It is unknown if glycopyrrolate or formoterol passes into breast milk. Consult your doctor before breastfeeding.

Form & Strength

Breztri Aerosphere (Budesonide/Formoterol/Glycopyrrolate) is available in the following forms and strengths:

• Breztri Aerosphere Aerosol Inhaler:
  • 160/7.2/5mcg
• Budesonide/Formoterol/Glycopyrrolate
  • 160/9/4.8mcg

FAQ

Who should not use Breztri Aerosphere?

If you are allergic to any of the active ingredients or any non-active ingredient used in the formulation of this medication, then you should avoid using this medication.

Can I travel with my Breztri inhaler?

Yes, you can travel with your Breztri inhaler, but you will need to make sure it is kept in a dry place away from heat and sunlight.

How do I administer Breztri?

For oral inhalation only, use Breztri exactly as your healthcare provider tells you to. Start by priming your inhaler before using it for the first time.

Resources:

1. https://www.webmd.com/drugs/2/drug-179866/breztri-aerosphere-inhalation/details
2. https://www.rxlist.com/breztri-aerosphere-drug.htm#indications
3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212122s000lbl.pdf