Generic name: Budesonide, Glycopyrrolate, And Formoterol Fumarate Dosage form: inhalation aerosol, for oral inhalation use Drug class:Bronchodilator combinations
Usage of Breztri Aerosphere
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 is used as 2 inhalations, 2 times each day (2 puffs in the morning and 2 puffs in the evening) to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
Breztri Aerosphere is not for the treatment of asthma. It is not known if this medicine is safe and effective in people with asthma. Breztri Aerosphere contains formoterol fumarate. LABA medicines such as formoterol fumarate when used alone increase the risk of hospitalizations and death from asthma problems. Breztri Aerosphere contains an ICS, an anticholinergic, and a LABA. When an ICS and LABA are used together, there is not a significant risk in hospitalizations and deaths from asthma problems.
Breztri Aerosphere is not to be used to relieve sudden breathing problems and will not replace a rescue inhaler. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden breathing problems. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
Breztri Aerosphere should not be used in children. It is not known if this medicine is safe and effective in children.
Breztri Aerosphere side effects
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.
Before taking Breztri Aerosphere
Do not use Breztri Aerosphere if you are allergic to budesonide, glycopyrrolate, formoterol, or any of the other ingredients. See What are the ingredients in Breztri Aerosphere? at the end of this page for a complete list of ingredients.
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.
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Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
