Budesonide + Formoterol Fumarate

Budesonide + Formoterol Fumarate is a combination inhaler used for the long-term treatment of asthma and COPD. It contains Budesonide and Formoterol Fumarate Dihydrate.

Budesonide is a glucocorticosteroid which, when inhaled, has a dose-dependent anti-inflammatory action in the airways, resulting in reduced symptoms and fewer asthma exacerbations. Formoterol is a selective β2-adrenoceptor agonist that, when inhaled, results in rapid and long-acting relaxation of bronchial smooth muscle (onset within 1-3 minutes, duration at least 12 hours).

This inhaler is indicated for the treatment of asthma in patients 12 years and older and for the twice-daily maintenance treatment of airflow obstruction in COPD (including chronic bronchitis and emphysema). It is not indicated for the relief of acute bronchospasm.

• Asthma - in patients 12 years and older
• Chronic Obstructive Pulmonary Disease (COPD) - maintenance treatment of airflow obstruction

• Budesonide: Inhibits inflammatory cells and mediators, reducing airway inflammation and decreasing symptoms and asthma exacerbations.
• Formoterol: Activates β2-adrenoceptors, increasing intracellular cAMP, which relaxes bronchial smooth muscle and causes bronchodilation (onset 1-3 minutes, duration ≥12 hours).

Inhaler (Asthma) - 12 years and older:
Maintenance dose: 1 puff twice daily OR 2 puffs once daily. Some patients may require 2 puffs twice daily (160/4.5 mcg/inhalation only).
Reliever dose: 1 additional puff as needed; if symptoms persist after a few minutes, another puff. Maximum 6 puffs on any single occasion.

Inhalation Capsule (Asthma) - 12 years and older:
Maintenance dose: 100 or 200 Inhalation Capsule twice daily.
Reliever dose: 1 additional capsule as needed; maximum 6 capsules on any single occasion, total daily dose normally ≤8 capsules (temporarily up to 12).

Inhalation Capsule (Asthma) - Children 4 years and older:
Maintenance dose: 100 Inhalation Capsule once daily.
Reliever dose: 1 additional capsule as needed; maximum 4 capsules on any single occasion, total daily dose normally ≤4 capsules (temporarily up to 8).

Inhalation Capsule (COPD) - 40 years and older:
200 Capsule: 2 capsules twice daily (max 4 capsules/day).
400 Capsule: 1 capsule twice daily (max 2 capsules/day).

Children (<12 years): Safety and efficacy not established for the inhaler.

Common side effects: Cough, fungal infection of mouth, headache, hoarseness of voice, increased heart rate, musculoskeletal pain, nausea, respiratory tract infection, sore throat, vomiting.

Formoterol-related: Tremor, palpitations, headache; uncommon: cardiac arrhythmias, muscle cramps, hypersensitivity reactions (rash, edema, angioedema).

Budesonide-related: Hoarseness, oropharyngeal candidiasis, throat irritation, cutaneous hypersensitivity reactions, respiratory tract infections, immunosuppression, growth effects in children, glaucoma, cataract.

• Not for relief of acute bronchospasm; use rescue inhaler.
• Do not stop abruptly.
• Rinse mouth with water after each use (prevents oral thrush).
• If paradoxical bronchospasm occurs, discontinue immediately and consult your doctor.
• Caution in diabetes mellitus, thyrotoxicosis, hypokalemia, severe hypertension, ischemic heart disease, tachycardia, severe heart failure, glaucoma, cataract, hypercorticism.
• Regular monitoring of height in children on long-term therapy.
• Caution during pregnancy and lactation.

• Primary treatment of status asthmaticus or other acute asthma episodes
• Hypersensitivity to budesonide, formoterol, or lactose

• Strong CYP3A4 inhibitors (itraconazole, clarithromycin, erythromycin, ritonavir): May inhibit budesonide metabolism, increasing systemic corticosteroid effects; avoid.
• Non-potassium-sparing diuretics: May cause ECG changes and/or hypokalemia.
• MAO inhibitors and tricyclic antidepressants: May potentiate formoterol's vascular effects; extreme caution required.
• Beta-blockers: May block bronchodilatory effects and cause severe bronchospasm; caution required.