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Breztri Aerosphere

Generic Names: Budesonide, glycopyrrolate, and formoterol fumarate.
Dosage Form: Inhalation aerosol, for use in oral inhalation.
Drug Class: Bronchodilator combinations.

Active Ingredients: Micronized budesonide as well as micronized formoterol fumarate.
Inactive Ingredients: Hydrofluoroalkane (HFA 134a) and porous particles (comprised of DSPC [1,2-distearoyl-sn-glycero-3-phosphocholine] and calcium chloride).

What is the Breztri Aerosphere?

Breztri Aerosphere combines three medicines that include one oral corticosteroid (ICS) medication (budesonide) as well as an anticholinergic medication (glycopyrrolate) and an extended-acting beta 2-adrenergic agonist (LABA) medicine (formoterol fumarate) in a single inhaler that is dispensed as a propellant spray.

  • ICS medications like budesonide are effective in reducing inflammation in the lung. Inflammation of the lungs could result in breathing difficulties.
  • Anticholinergic drugs, such as glycopyrrolate, and LABA medications, like formoterol fumarate, help the muscles that surround the airways of your lungs remain relaxed and prevent the occurrence of symptoms such as coughing, wheezing, tightness, and shortness of breath. These symptoms may occur when the muscles surrounding the airways become tighter. This makes it difficult to breathe.
  • Breztri Aerosphere is a prescription medicine prescribed for long-term use in treating patients suffering from chronic obstructive pulmonary disease (COPD). COPD is a lung condition that can be caused by chronic bronchitis, emphysema, or both.
  • Breztri Aerosphere is used as two inhalations, twice throughout the day (2 puffs at the beginning of your day and 2 puffs at night), to help improve the symptoms of COPD, improve breathing, and also decrease the severity of flare-ups (the increase in your COPD symptoms for a few days).
  • Breztri Aerosphere is not intended for treating asthma. It is not established if this medication can be used safely and effectively for those suffering from asthma. Breztri Aerosphere contains fomoterol fumarate. LABA-based medicines like formoterol fumarate, if used in combination, increase the chance of hospitalization as well as death due to asthma issues. Breztri Aerosphere contains an ICS, which is an anticholinergic, as well as an LABA. When ICS and LABA are combined, there is no substantial risk of hospitalizations or deaths due to asthma.
  • Breztri Aerosphere is not to be used to treat acute breathing issues and is not a substitute for the need for a rescue inhaler. Always carry an emergency inhaler (an inhaled short-acting bronchodilator) in your possession to treat acute breathing problems. If you don't own an emergency inhaler, talk to your doctor to get one prescribed to you.
  • The Breztri Aerosphere should not be administered to children. It is unknown whether this drug is safe and effective for youngsters.

Warnings

Don't use Breztri Aerosphere if you are sensitive to budesonide, glycopyrrolate, or formoterol, as well as any other ingredient. Check out what ingredients are present that make up Breztri Aerosphere. at the end of this page to find the complete listing of the ingredients.

Before you take this drug

Before you use Breztri Aerosphere, be sure to inform your physician about all the medical issues you have, especially the following:

  • Heart problems can be a problem for those with them.
  • Have high blood pressure.
  • have seizures.
  • Have thyroid issues.
  • Are diabetics.
  • Have liver issues.
  • Suffer from kidney issues.
  • Suffer from weak bones (osteoporosis).
  • Are suffering from an immune system issue.
  • Suffer from eye issues like cataracts or glaucoma. The Breztri Aerosphere may make your glaucoma condition worse.
  • Suffer from bladder or prostate problems or have problems passing urine. The Breztri Aerosphere may make these issues worse.
  • Have any kind of bacterial, viral, fungal, or parasitic infection.
  • Can be exposed to chickenpox and measles.
  • You are expecting or planning to be pregnant. It isn't known whether Breztri Aerosphere may harm your unborn baby.
  • Are breastfeeding. It isn't known whether the medications contained in Breztri Aerosphere are absorbed into breast milk or whether they could cause harm to the baby. Your healthcare professional and you must decide whether you want to take Breztri Aerosphere while breastfeeding.

Inform your doctor about the medications that you are taking, including prescription and non-prescription supplements such as vitamins and herbal supplements. Breztri Aerosphere and certain other medications may interact with each other. This could result in serious unwanted side effects.

Be sure to inform your physician that you are taking:

  • Anticholinergics (including Ipratropium, Tiotropium, Umeclidinium, and Aclidinium).
  • Other LABAs (including salmeterol, formoterol fumarate, arformoterol tartrate, vilanterol, and indacaterol).
  • Atropine.
  • Anti-HIV and antifungal medications.

Be aware of the medications you are taking. Make a list to show your healthcare professional and pharmacist every time you receive an updated medication.

How to take the Breztri Aerosphere?

Learn the step-by-step instructions included with the prescription.

  • Before you use Breztri Aerosphere, be sure your physician has taught you the proper use of this inhaler and that you are aware of the best way to utilize it properly.
  • Follow the directions exactly as your physician advises you to. Use it less often than the recommended amount.
  • Utilize two inhalations of Breztri Aerosphere twice throughout the day. (2 puffs at the beginning of your day and 2 puffs at night).
  • Do not exceed two inhalations of Breztri Aerosphere every day.
  • If you miss a dose (2 puffs), the dose should be taken promptly, and the next dose must take place at your regular time. Don't have more than two doses in order to fill in for a missed dose.
  • Cleanse the mouth using clean water and rinse the water off following every dosing (2 puffs). Don't swallow the water. This can decrease the chances of developing an infection with fungus (thrush) inside the throat and mouth.
  • If you are taking too much Breztri Aerosphere, you should contact your physician or visit the nearest hospital emergency room as soon as possible in the event of unusual symptoms like worsening breathing problems, chest pain, a heightened heart rate, or shaking.
  • Avoid spraying Breztri Aerosphere on your eyes. When Breztri Aerosphere gets in your eyes, clean them with water. If you continue to experience redness, consult your doctor.
  • Don't take other medications that contain LABA or an anticholinergic for any reason. Consult your physician or pharmacist for advice if any of your current medications contain LABA or anticholinergic-containing medications.
  • Do not alter or stop taking any medication that is prescribed to treat or control your breathing issues. Your healthcare provider will modify the medications you take as needed.
  • Breztri Aerosphere does not relieve breath problems that occur suddenly and should not be taken in additional doses to ease the symptoms that arise suddenly. Always keep an emergency inhaler on hand to deal with sudden symptoms. If you do not own an emergency inhaler, you can call your doctor to get one prescribed to you.
  • Contact your health care provider or seek medical emergency care immediately if:
    • Your breathing issues get worse.
    • You should use your rescue inhaler more often than normal.
    • Your rescue inhaler doesn't perform as effectively to alleviate your symptoms.

Side effects of Breztri Aerosphere

Breztri Aerosphere can cause serious adverse effects, such as:

  • Fungal infection that can occur in your throat or mouth (thrush). Rinse your mouth and throat with water, but refrain from swallowing following the use of Breztri Aerosphere to reduce the chance of contracting thrush.
  • Patients with COPD have a greater chance of developing pneumonia. Breztri Aerosphere may increase your risk of developing pneumonia. Contact your doctor in the event that you observe any of these symptoms:
    • The increase in production of mucus (sputum).
    • Change in mucus color.
    • The fever.
    • Chills.
    • Increased cough.
    • More frequent breathing issues.
  • Weakens the immune system and increases the chance of contracting infections (immunosuppression).
  • Diminished functions of the adrenals (adrenal dysfunction). Adrenal insufficiency can be described as an illness in which the adrenal glands don't produce sufficient steroid hormones. It can occur when you stop taking corticosteroid oral medicines (such as prednisone) and then begin to take medication that contains an ICS (such as Breztri Aerosphere). In this transitional time in which your body is under strain due to trauma, fever (such as an accident in a vehicle), infection, surgery, or even worse COPD symptoms, adrenal insufficiency could become more severe and could lead to death.
    Signs of adrenal deficiency include:

    • Feeling tired
    • Inability to focus
    • Weaknesses
    • Nausea and vomiting
    • Low blood pressure (hypotension)
  • Sudden breathing problems right after inhaling your medication. If you suddenly have breathing problems after inhaling your medication, take a break from Breztri Aerosphere and contact your doctor immediately.
  • Extremely allergic reactions. Contact your physician or seek emergency medical attention. If you experience any of these symptoms of an allergic reaction that is serious:
    • It is a rash.
    • Hives.
    • Swelling of your mouth, face, and tongue.
    • Breathing issues.
  • The effects on the heart
    • Higher blood pressure.
    • An irregular or rapid heartbeat.
    • Chest pain.
  • Impacts on the nervous system.
    • The tremor.
    • Nervousness.
  • Bone weakness or thinning (osteoporosis).
  • New or aggravated eye issues such as acute narrow-angle glaucoma or cataracts.
    Acute narrow-angle glaucoma may permanently impair vision when treated. The symptoms of acute narrow-angle glaucoma could include:

    • Eye discomfort or pain
    • Nausea or vomiting.
    • Blurred vision
    • Seeing bright colors or halos in the vicinity of lights
    • Eyes with red
      If you are experiencing these symptoms, contact your physician immediately prior to taking another medication.
  • Urinary retention. People who use Breztri Aerosphere may develop new or worsening urinary retention. Signs of urinary retention include:
    • Trouble with urination
    • Utilization frequently
    • Urination is painstakingly painful.
    • Urination that is weak or drips
      If you experience these signs in relation to urinary retention, you should stop using Breztri Aerosphere and consult your healthcare professional immediately before you take another dose.
  • Changes in blood laboratory values, which include blood sugar levels that are high (hyperglycemia) as well as low potassium levels (hypokalemia). Low levels of potassium can result in symptoms of muscle spasms, muscle weakness, or an abnormal heart rhythm.

Common side effects include:

  • Upper respiratory tract infection.
  • Pneumonia.
  • Back in pain.
  • Thrush in your throat and mouth. Rinse your mouth thoroughly with water and do not swallow after each use to avoid this.
  • Joint pain.
  • Flu.
  • Headache.
  • High blood sugar levels.
  • Muscles spasms.
  • Cough.
  • Inflammation of the sinuses.
  • Diarrhea.
  • Hoarseness.
  • Urination that is painful and frequent (signs of an infection of the urinary tract).
  • Nausea.
  • Trouble with insomnia.
  • Feeling anxious.
  • The sensation of your heart beating (palpitations).

Inform your doctor about any side effects that bother you or do not disappear.This is not the only list of possible adverse effects. Talk to your doctor or pharmacist for more details. Contact your doctor to seek medical advice on possible side effects. It is possible to report the side effects to the FDA at 1-800-FDA-1088. You can also report adverse reactions to AstraZeneca at 1-800-236-933.

Storage

  • Keep Breztri Aerosphere at room temperatures ranging from 68 oF to 77 oF (20 oC to 25 oC). Place it in a dry location far from sunlight and heat.
  • Keep Breztri Aerosphere within the sealed foil pouch only to be opened when it is ready to use.
  • Don't make holes inside the canister.
  • Don't store or use the Breztri Aerosphere close to flames or heat. Temperatures that exceed 120 oF (49 oC) could cause the canister to explode.
  • Do not toss the canister into a burning fire or incinerator.
  • Toss away Breztri Aerosphere 3 months after you have opened your foil bag (for the 120-inhalation container) or 3 weeks after opening the pouch in foil (for the 28-inhalation container) or after the dose indicator has reached "0", whichever comes first.
  • Make sure you keep Breztri Aerosphere and all medicines out of the reach of children.

Cautions

Some medicines are prescribed for reasons that are not those stated in the patient information leaflet. Don't use this medication to treat a medical condition for which it is not recommended. Don't offer it to others, even if they suffer from similar conditions to those you do. It could cause harm to them.
You may ask your pharmacist or doctor for the information they have specifically written for healthcare professionals.

 

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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