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BREZTRI AEROSPHERE (Budesonide/Formoterol/Glycopyr)

BREZTRI AEROSPHERE (Budesonide/Formoterol/Glycopyr)

Regular price $435.00 USD
Regular price Sale price $435.00 USD
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) 182/5.8/8.2mg Inhalation Suspension - 120 dose
What is this medication?

Breztri Aerosphere combines 3 medicines, an inhaled corticosteroid (ICS) medicine (budesonide), an anticholinergic medicine (glycopyrrolate), and a long-acting beta2-adrenergic agonist (LABA) medicine (formoterol fumarate) in 1 inhaler, delivered as a propelled spray.

ICS medicines such as budesonide help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.

Anticholinergic medicines, such as glycopyrrolate and LABA medicines, such as formoterol fumarate help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.

Breztri Aerosphere is a prescription medicine used long term to treat people with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

Breztri Aerosphere should not be used in children. It is not known if this medicine is safe and effective in children.
What are the ingredients in Breztri Aerosphere?

Active ingredients: micronized budesonide, micronized glycopyrrolate, and micronized formoterol fumarate

Inactive ingredients: hydrofluoroalkane (HFA 134a) and porous particles (comprised of DSPC [1,2-Distearoyl-sn-glycero-3-phosphocholine] and calcium chloride)

How should I take this medication?

Read the step-by-step instructions that come with your prescription.

Before using Breztri Aerosphere, make sure your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.

Use this medicine exactly as your healthcare provider tells you to use it. Do not use more often than prescribed.

Use 2 inhalations of Breztri Aerosphere, 2 times each day (2 puffs in the morning and 2 puffs in the evening).

Do not take more than 2 inhalations of Breztri Aerosphere 2 times each day.

If a dose (2 puffs) is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. Do not take more than one dose to make up for a forgotten dose.

Rinse your mouth with water and spit the water out after each dose (2 puffs). Do not swallow the water. This will help to reduce the chance of getting a fungus infection (thrush) in the mouth and throat.

If you take too much Breztri Aerosphere, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.

Do not spray Breztri Aerosphere in your eyes. If Breztri Aerosphere gets in your eyes, rinse them well with water. If redness continues, call your healthcare provider.

Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic containing medicines.

Do not change or stop any medicines used to control or treat your breathing problems. Your healthcare provider will change your medicines as needed.

Breztri Aerosphere does not relieve sudden breathing problems and you should not take extra doses to relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.

Call your healthcare provider or get emergency medical care right away if:

  • your breathing problems get worse.
  • you need to use your rescue inhaler more often than usual.
  • your rescue inhaler does not work as well to relieve your symptoms.
What if I miss a dose?

If a dose (2 puffs) is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. Do not take more than one dose to make up for a forgotten dose.

How should I store this medication?

Store Breztri Aerosphere at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Keep in a dry place away from heat and sunlight.

Store Breztri Aerosphere in the unopened foil pouch and only open when ready for use.

Do not put a hole in the canister.

Do not use or store Breztri Aerosphere near heat or a flame. Temperatures above 120ºF (49ºC) may cause the canister to burst.

Do not throw the canister into a fire or an incinerator.

Throw away Breztri Aerosphere 3 months after you open the foil pouch (for the 120-inhalation canister), or 3 weeks after you open the foil pouch (for the 28-inhalation canister), or when the dose indicator reaches zero “0”, whichever comes first.

Keep Breztri Aerosphere and all medicines out of the reach of children.

What are the possible side effects of using this medication?

Breztri Aerosphere can cause serious side effects, including:

  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using Breztri Aerosphere to help reduce your chance of getting thrush.
  • pneumonia. People with COPD have a higher chance of getting pneumonia. Breztri Aerosphere may increase your chance of getting pneumonia.

    Call your healthcare provider if you notice any of the following symptoms:
  • increase in mucus (sputum) production
  • change in mucus color
  • fever
  • chills
  • increased cough
  • increased breathing problems
  • weakened immune system and increased chance of getting infections (immunosuppression).
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid  hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as Breztri Aerosphere). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.

Symptoms of adrenal insufficiency include:

  • feeling tired
  • lack of energy
  • weakness
  • nausea and vomiting
  • low blood pressure (hypotension)
  • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop taking Breztri Aerosphere and call your healthcare provider right away.
  • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • hives
    • swelling of your face, mouth, and tongue
    • breathing problems

  • effects on your heart.
  • increased blood pressure
  • a fast or irregular heartbeat
  • chest pain
  • effects on your nervous system.
  • tremor
  • nervousness
  • bone thinning or weakness (osteoporosis).
  • new or worsened eye problems including acute narrow-angle glaucoma and cataracts. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
  • eye pain or discomfort
  • nausea or vomiting
  • blurred vision
  • seeing halos or bright colors around lights
  • red eyes
If you have these symptoms, call your healthcare provider right away before taking another dose.
  • urinary retention. People who take Breztri Aerosphere may develop new or worsening urinary retention. Symptoms of urinary retention may include:
  • difficulty urinating
  • urinating frequently
  • painful urination
  • urination in a weak stream or drips
  • If you have these symptoms of urinary retention, stop taking Breztri Aerosphere and call your healthcare provider right away before taking another dose.
  • changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia). Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm.

    Common side effects include:
  • upper respiratory tract infection
  • pneumonia
  • back pain
  • thrush in your mouth and throat. Rinse your mouth with water without swallowing after use to help prevent this.
  • joint pain
  • flu
  • headache
  • high blood sugar levels
  • muscle spasms
  • cough
  • inflammation of the sinuses
  • diarrhea
  • hoarseness
  • painful and frequent urination (signs of a urinary tract infection)
  • nausea
  • difficulty sleeping
  • feeling anxious
  • awareness of your heart beating (palpitations)
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088. You may also report side effects to AstraZeneca at 1-800-236-9933.
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