Indications
- Used to control and prevent symptoms of ongoing lung disease (COPD) such as wheezing and shortness of breath.
- Contains three medications: budesonide, glycopyrrolate, and formoterol.
- Budesonide (corticosteroid) reduces airway irritation and swelling.
- Glycopyrrolate (anticholinergic) and formoterol (long-acting beta agonist) relax muscles around airways, facilitating easier breathing.
- Regular use is necessary for effectiveness; not for sudden breathing problems.
- Should not be used for immediate relief; use a quick-relief inhaler as prescribed for sudden shortness of breath.
- Not approved for asthma treatment.
Dosage and administration
- Read Patient Information Leaflet and Instructions for Use before using; consult doctor or pharmacist for questions.
- Prime inhaler if first use, not used for a week or more, dropped, or canister reinserted after cleaning.
- When priming, spray away from the face to avoid eye exposure.
- Shake inhaler well before use; inhale by mouth twice daily, with at least 1 minute between inhalations.
- Gargle, rinse mouth, and spit after each use to prevent dry mouth, hoarseness, and oral yeast infections.
- Use regularly at the same times each day for maximum benefit.
- Do not increase, use more often, or stop without consulting the doctor.
- If using other inhalers, wait at least 1 minute between each.
- If using another oral corticosteroid, do not stop suddenly; consult a doctor for tapering instructions.
- If regularly using a quick-relief inhaler, follow doctor’s instructions for usage changes.
- Learn which inhalers to use daily and for sudden breathing issues; consult a doctor if symptoms worsen.
- Inform the doctor if the condition does not improve or worsens.
Side effects
- Possible side effects: dry/irritated throat, hoarseness, coughing; inform doctor/pharmacist if persistent or worsens.
- Medication prescribed due to doctor’s judgment on benefits outweighing risks; many users don’t experience serious side effects.
- Regularly check blood pressure, inform the doctor if results are high.
- Rarely, may cause sudden severe wheezing/breathing issues; use a quick-relief inhaler and seek immediate medical help if it occurs.
- Report serious side effects to the doctor: white patches in mouth, signs of infection, difficult/painful urination, muscle cramps/weakness, increased thirst/urination, bone pain, nervousness, shaking (tremors).
- Seek medical help for very serious side effects: chest pain, fast/irregular heartbeat, severe dizziness, fainting, eye pain/swelling/redness, vision changes.
- Very serious allergic reaction is rare; seek immediate medical help for symptoms like rash, itching/swelling (especially face/tongue/throat), severe dizziness, trouble breathing.
- Not a complete list of possible side effects; contact doctor/pharmacist for other observed effects.
Precautions
- Inform doctor/pharmacist of allergies to budesonide, glycopyrrolate, formoterol, arformoterol, or any other allergies.
- Discuss medical history, especially infections, heart problems, high blood pressure, seizures, bone loss, eye problems, overactive thyroid, diabetes, difficulty urinating, and liver disease.
- This product may cause QT prolongation, leading to serious heart rhythm issues. Risk increases with certain medical conditions or drugs; inform doctors of all medications and relevant conditions.
- Low potassium/magnesium levels may further increase QT prolongation risk; discuss safety with a doctor, especially if using diuretics or experiencing severe sweating, diarrhea, or vomiting.
- Medication may mask signs of infection, making you more susceptible; avoid contact with those carrying infections like chickenpox, COVID-19, measles, and flu. Inform doctor if exposed to infection.
- If switched from oral corticosteroid to inhaler within the past 12 months or used higher doses, the body may respond differently to physical stress. Inform healthcare professionals before surgery or emergency treatment. Report unusual tiredness or weight loss promptly. Carry a warning card or medical ID indicating corticosteroid use.
- Inform the surgeon/dentist of all products used before surgery.
- Prolonged use in children may temporarily slow down growth; monitor regularly.
- Older adults may be more sensitive to side effects, especially QT prolongation.
- Use during pregnancy only if necessary; discuss risks and benefits with the doctor.
- Budesonide passes into breast milk; unknown for glycopyrrolate and formoterol. Consult doctor before breastfeeding.