This triple combination inhaler is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). It is not intended for the immediate relief of acute bronchospasm.

This formulation combines Budesonide, Glycopyrronium Bromide, and Formoterol Fumarate Dihydrate. Budesonide is a corticosteroid that reduces inflammation, swelling, and irritation in the airways. Formoterol and Glycopyrronium are long-acting bronchodilators that work through different mechanisms to relax airway smooth muscles, helping to widen the airways. Together, these actions improve airflow and ease breathing, while reducing symptoms such as wheezing, coughing, chest tightness, and shortness of breath.

Route of Administration: For oral inhalation only.
Recommended doses: 2 inhalations twice daily in the morning and the evening. The maximum dose is two inhalations twice daily. After inhalation, the patient should rinse the mouth with water without swallowing.

Strong CYP3A4 inhibitors (e.g., ritonavir) should be used cautiously, as they may increase systemic corticosteroid effects. Diuretics (including xanthine derivatives or steroids) may enhance the risk of hypokalemia and ECG changes. Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants should be used with caution as they may potentiate the cardiovascular effects of formoterol. Beta-blockers may reduce the bronchodilatory effect of beta-agonists and may trigger severe bronchospasm. Concurrent use with other anticholinergic drugs may increase anticholinergic effects. Avoid combined use with other anticholinergic-containing medications.

This combination is contraindicated in patients with known hypersensitivity to Budesonide, Formoterol Fumarate, Glycopyrronium, or any excipients in the formulation.

Common adverse effects include upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasms, urinary tract infection, cough, sinusitis, and diarrhea.

Pregnancy: There is insufficient clinical data regarding the use of Budesonide, Formoterol, and Glycopyrronium during pregnancy. Glucocorticoids may affect early fetal development, and beta-2 agonists like formoterol may have tocolytic effects. Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Newborns of mothers receiving high doses should be monitored for adrenal suppression.

Lactation: There is limited information on the excretion of this combination in breast milk or its effects on milk production.

This inhaler is not intended for the relief of acute symptoms or as rescue therapy. Do not exceed the recommended daily dose. Patients should avoid using additional LABA-containing medications. Caution is advised when used with strong CYP3A4 inhibitors. Patients with COPD should be assessed for bone mineral density (BMD) before and during treatment due to potential risk of reduction.

Combined bronchodilators, Respiratory corticosteroids

Store below 30°C, away from direct sunlight, heat, light, and moisture. Keep out of reach of children. Store the inhaler with the mouthpiece facing downward. Shake well before each use.