Indications 

Breztri Aerosphere is an inhaler that combines three medicines, including an inhaled corticosteroid (ICS) medicine (budesonide), an anticholinergic medicine (glycopyrrolate), and a long-acting beta2-adrenergic agonist (LABA) medicine (formoterol fumarate). 

• ICS medicines such as budesonide decrease inflammation in the lungs, which can lead to breathing problems. 
• Anticholinergic medicines like glycopyrrolate and LABA medicines such as formoterol fumarate help keep the muscles around the airways in your lungs relaxed to prevent symptoms like wheezing, cough, chest tightness, and shortness of breath. 
• Breztri Aerosphere is used as a prescription medicine for the long-term treatment of chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis, emphysema, or both. 
• This medicine is administered as two inhalations, twice daily (2 puffs in the morning and 2 puffs in the evening) to improve COPD symptoms, promote better breathing, and reduce the number of flare-ups. 
• The inhaler contains formoterol fumarate, and LABA medicines like formoterol fumarate when used alone increase the risk of hospitalizations and death from asthma problems. 
• When an ICS and LABA are used together, as in Breztri Aerosphere, there is not a significant risk of hospitalizations and deaths from asthma problems. 
• Breztri Aerosphere is not intended to relieve sudden breathing problems and cannot replace a rescue inhaler. Therefore, have a rescue inhaler with you always to treat sudden breathing problems. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you. 

Uses and Dosage 

Prior to using this medication, read the Patient Information Leaflet and Instructions for Use that is available from your pharmacist. In case of any doubts, consult with your doctor or pharmacist. 

When using the inhaler for the first time, if you haven’t used it for a week or longer, if the inhaler was dropped or the canister was put back into the inhaler after cleaning, make sure to follow the priming instructions. Ensure that the inhaler is primed away from your face to prevent the medication from getting into your eyes. 

Before using the inhaler, it should be shaken well. The medication should be inhaled through the mouth as directed by the doctor, usually two times a day – once in the morning and once in the evening. Wait for at least a minute between inhalations. 

To prevent the occurrence of dry mouth, hoarseness, and oral yeast infections, gargle, rinse your mouth with water, and then spit it out after each use. The rinse water should not be swallowed. 

Using this medication regularly is essential for obtaining the maximum benefit from it. To ensure that you do not forget to take it, use it at the same times every day. 

Side Effects 

Severe Side Effects

Breztri Aerosphere is a medication that can cause serious side effects, including the following: 

• Fungal infection in the mouth or throat (thrush). Rinse the mouth with water after using the Breztri Aerosphere to reduce the risk of thrush. 
• Pneumonia. People with COPD have a higher risk of pneumonia, and Breztri Aerosphere may increase that risk. Seek medical attention if you experience increased mucus production, a change in mucus color, fever, chills, increased cough, or breathing problems. 
• Weakened immune system and increased risk of infections (immunosuppression). 
• Reduced adrenal function (adrenal insufficiency). Symptoms of adrenal insufficiency include:
  • Tiredness
  • Lack of energy
  • Weakness
  • Nausea
  • Vomiting
  • Low blood pressure
  • Sudden breathing problems after inhaling the medicine

Allergic Reactions

Seek medical attention immediately if you experience: 

• Rash 
• Hives 
• Swelling of the face, mouth, or tongue 
• Breathing problems 
• Increased blood pressure 
• Fast or irregular heartbeat 
• Chest pain 
• Tremors 
• Nervousness 
• Effects on the heart, including:
  • Increased blood pressure
  • Fast or irregular heartbeat
  • Chest pain
• Effects on the nervous system, including:
  • Tremors
  • Nervousness
• Bone thinning or weakness (osteoporosis)
• New or worsened eye problems, including acute narrow-angle glaucoma and cataracts. Symptoms of acute narrow-angle glaucoma include:
  • Eye pain
  • Nausea or vomiting
  • Blurred vision
  • Seeing halos or bright colors around lights
  • Red eyes
• Urinary retention. Symptoms of urinary retention may include:
  • Difficulty urinating
  • Urinating frequently
  • Painful urination
  • Urination in a weak stream or drips 
• 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
  • Abnormal heart rhythm

Common Side Effects 

• Upper respiratory tract infection 
• Pneumonia 
• Back pain 
• Thrush in the mouth and throat. Rinse the mouth with water after use to 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 heart beating (palpitations) 

Caution 

Prior to using this medication, inform your physician or pharmacist about any known allergies to budesonide, glycopyrrolate, formoterol, or arformoterol, as well as any other allergies that may be present. This product may contain inactive ingredients that can cause allergic reactions or other related issues. For additional information, please consult with your pharmacist. 

In addition, prior to using this medication, disclose your medical history to your doctor or pharmacist, particularly any current or past infections such as tuberculosis or herpes, heart problems including chest pain or irregular heartbeat, high blood pressure, seizures, bone loss or osteoporosis, eye problems including cataracts or glaucoma, overactive thyroid, diabetes, difficulty urinating such as due to an enlarged prostate, and liver disease.