A fixed-dose combination inhaler containing a long-acting beta2-adrenergic agonist (LABA), formoterol fumarate dihydrate, and an inhaled corticosteroid (ICS), fluticasone propionate. It is a maintenance therapy for asthma and COPD, providing bronchodilation and anti-inflammatory action. It is not indicated for the relief of acute bronchospasm.
Adult: Asthma & COPD: 1 inhalation (6mcg/250mcg) twice daily (morning and evening, approximately 12 hours apart). Maximum: 2 inhalations twice daily (only under medical supervision).
Note: For oral inhalation only using a pressurized metered-dose inhaler (pMDI). Shake well before each use. Breathe out fully, place mouthpiece between lips, inhale deeply and slowly while pressing the canister, hold breath for 10 seconds if possible. Wait 30-60 seconds before second inhalation if prescribed. Rinse mouth with water and spit out after each use to prevent oral thrush. Clean inhaler mouthpiece weekly with dry cloth.
The combination provides complementary mechanisms: Formoterol produces relaxation of bronchial smooth muscle via beta2-adrenoceptor stimulation, leading to bronchodilation. Fluticasone propionate exerts potent local anti-inflammatory effects in the lungs, inhibiting multiple inflammatory cells and mediators, reducing airway hyperresponsiveness, and preventing exacerbations.
Pregnancy: Pregnancy Category C (US FDA). Use only if potential benefit justifies potential risk to the fetus. Inhaled drugs are preferred over systemic for asthma control during pregnancy. Uncontrolled asthma poses a greater risk than medication. Monitor neonates for hypoadrenalism if mother received significant doses during pregnancy.
Driving: Unlikely to affect ability to drive or use machines. However, patients should be aware of potential side effects like dizziness, tremor, or palpitations which could impair these abilities.
| 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 |
| Monoamine Oxidase Inhibitors (MAOIs) & Tricyclic Antidepressants (TCAs) | May potentiate the cardiovascular effects of formoterol (tachycardia, hypertension). | Moderate |
| CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin) | Significantly increase systemic exposure to fluticasone, increasing risk of systemic corticosteroid side effects and adrenal suppression. | Major |
| Other Sympathomimetics (e.g., Salbutamol, Ephedrine) | Additive cardiovascular and hypokalemic effects. | Moderate |
| Xanthine derivatives (e.g., Theophylline) | Increased risk of hypokalemia and cardiac arrhythmias. | Moderate |
| Digitalis glycosides | Hypokalemia may increase risk of digitalis-induced arrhythmias. | Moderate |
Same composition (Formoterol (6mcg) + Fluticasone Propionate (250mcg)), different brands: