Budesonide + Glycopyrronium Bromide + Formoterol Fumarate

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

This is a combination of Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Dihydrate. Budesonide is a corticosteroid that reduces the swelling and irritation in the lungs. Formoterol and Glycopyrronium are long-acting bronchodilators that act in different ways to relax muscles in the airways, helping to open the airways wider and allowing to breathe more easily to prevent symptoms, such as wheezing, cough, 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 Cytochrome P450 3A4 inhibitors (Ritonavir) should be used with caution because it may cause systemic corticosteroid effects. Diuretics such as Xanthine derivatives or Steroids may potentiate hypokalemia or ECG changes. Monoamine Oxidase Inhibitors and Tricyclic Antidepressants should be used with extreme caution. It may potentiate the effect of Formoterol Fumarate on the cardiovascular system. Beta blockers should be used with caution because they may block the bronchodilatory effects of beta agonists and produce severe bronchospasm. Anticholinergics may interact additively with concomitantly used anticholinergic medications. Avoid administration of Budesonide, Formoterol and Glycopyrronium with other anticholinergic containing drugs.

It is contraindicated in patients who have demonstrated hypersensitivity to Budesonide, Formoterol Fumarate, Glycopyrronium, or any of the excipients.

The most common side effects include upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasms, urinary tract infection, cough, sinusitis, and diarrhea.

Pregnancy: There is no adequate data on the use of Budesonide, Formoterol and Glycopyrronium in pregnant women. Glucocorticoid agents are known to cause effects in the early gestation phase, while beta-2 sympathomimetic agents like Formoterol have tocolytic effects. Therefore, as a precautionary measure, it is preferable to avoid the use of Budesonide, Formoterol and Glycopyrronium during pregnancy and labor. Budesonide, Formoterol and Glycopyrronium should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. Infants and neonates born to mothers receiving substantial doses of Budesonide, Formoterol and Glycopyrronium should be observed for adrenal suppression.

Lactation: There are no adequate and well-controlled studies on breastfed children or milk production with Budesonide, Formoterol and Glycopyrronium products or with three of its components, Budesonide, Formoterol Fumarate or Glycopyrronium.

This inhaler is not indicated to be used for the relief of acute symptoms (as rescue therapy for the treatment of acute episodes of bronchospasm). The daily dosage should not be increased beyond the recommended dose. Patients should not use another medicine containing a LABA (Salmeterol, Formoterol Fumarate, Arformoterol Tartrate, or Indacaterol) for any reason. Caution should be exercised when considering the co-administration with long-term Ketoconazole, and other known strong CYP3A4 inhibitors (Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nefazodone, Nelvfinavir, Saquinavir, Telithromycin). Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended before initiating this product and periodically thereafter.

Combined bronchodilators, Respiratory corticosteroids

Avoid storage in direct sunlight or heat. Do not store above 30°C temperature. Keep away from light and wet places. Keep out of reach from children. Store the inhaler with the mouthpiece down. Shake well before each use.