A fixed-dose combination inhaler containing a long-acting beta2-adrenergic agonist (LABA), formoterol fumarate dihydrate, and an inhaled corticosteroid (ICS), budesonide. It is a maintenance therapy for asthma and COPD, providing both rapid bronchodilation and anti-inflammatory control. It is not indicated for the relief of acute bronchospasm.
Adult: Asthma: 1 inhalation (6/400 mcg) twice daily (morning and evening). Maximum: 2 inhalations twice daily (12/800 mcg per dose). COPD: 1 inhalation twice daily.
Note: For oral inhalation only using a dry powder inhaler (DPI). Instructions: 1) Open the inhaler. 2) Load the dose as per device instructions (e.g., twist, push lever). 3) Breathe out fully away from the mouthpiece. 4) Place lips tightly around mouthpiece. 5) Inhale deeply and forcefully. 6) Hold breath for about 10 seconds. 7) Exhale slowly. 8) Rinse mouth thoroughly with water and SPIT OUT after each use. Do not swallow the water.
The combination provides complementary mechanisms: Formoterol acts as a functional antagonist of bronchoconstriction by relaxing airway smooth muscle, while Budesonide targets the underlying inflammation, reducing airway hyperresponsiveness, mucosal edema, and inflammatory cell infiltration.
Pregnancy: Pregnancy Category C (US). Formoterol: Animal studies show fetal effects. Budesonide: Data from pregnancy registries do not show a clear increase in major birth defects. Use only if potential benefit justifies potential risk to the fetus. Inhaled budesonide is preferred ICS for asthma management during pregnancy.
Driving: May cause dizziness, tremor, or nervousness. Patients should assess their individual response before driving or operating machinery.
| Beta-blockers (e.g., Propranolol, Atenolol) | Antagonize bronchodilator effect of formoterol; may cause severe bronchospasm in asthmatics. | Major |
| Diuretics (e.g., Furosemide, Hydrochlorothiazide) | Concomitant use can potentiate hypokalemia induced by beta2-agonists. | Major |
| CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin) | Increase systemic exposure to budesonide, raising risk of systemic corticosteroid side effects and adrenal suppression. | Major |
| Other Sympathomimetics (e.g., Salbutamol, Ephedrine) | Additive cardiovascular effects (tachycardia, palpitations). | Moderate |
| Xanthine derivatives (e.g., Theophylline) | Increased risk of hypokalemia and cardiac arrhythmias. | Moderate |
| MAOIs and TCAs (e.g., Phenelzine, Amitriptyline) | Potentiate the cardiovascular effects of formoterol. | Moderate |
| Anticholinergics (e.g., Tiotropium) | Additive bronchodilator effect; commonly used together in COPD. | Minor |
Same composition (Formoterol (6mcg) + Budesonide (400mcg)), different brands: