BUFOMIX EASYHALER 160/4.5MCG IHALATION 120/DOSES

Indications

Approved Uses

Asthma: maintenance treatment in adults and adolescents (≥12 years); may be used as maintenance-and-reliever therapy (MART/SMART) where locally approved and prescribed. COPD: maintenance treatment in adults.

Off-Label Uses

No well-established off-label indication to recommend; use should be limited to labeled asthma/COPD regimens (including MART where approved).

Dosage & Administration

Dosing by Condition

Asthma (≥12 years): 2 inhalations twice daily (80/4.5 or 160/4.5 based on severity); maximum 2 inhalations of 160/4.5 twice daily. COPD (adults): 2 inhalations of 160/4.5 twice daily.

Initial Dose

Asthma: Two inhalations of 160/4.5 mcg twice daily. COPD: Two inhalations of 160/4.5 mcg twice daily.

Maintenance Dose

2 inhalations (160/4.5 mcg) twice daily

Maximum Dose

Asthma (≥12 years): Two inhalations of 160/4.5 mcg twice daily. COPD: Two inhalations of 160/4.5 mcg twice daily.

Children's Dosage

Not approved for children under 12 years. Adolescents 12-17 years: same as adult dosing

How to Take

Easyhaler (dry powder) technique: open/uncap, hold the device upright, shake vigorously a few times, then prime/load ONE dose by pressing the device once (you should hear/feel a click). Breathe out fully away from the mouthpiece, seal lips around the mouthpiece and inhale forcefully and deeply. Remove inhaler, hold breath ~5-10 seconds, then exhale slowly. If a second inhalation is prescribed, repeat loading and inhalation. Replace cap/close. Rinse mouth with water and spit after use (especially with regular maintenance dosing).

Side Effects

Common Side Effects

Common: oral/oropharyngeal candidiasis (thrush), dysphonia/hoarseness, throat irritation, cough; headache; tremor, palpitations/tachycardia; upper respiratory symptoms (e.g., nasopharyngitis).

Side Effect Frequency

Common (1-10%): oral/oropharyngeal candidiasis, dysphonia/hoarseness, headache, tremor, palpitations, cough/throat irritation; Uncommon (<1%): tachycardia, muscle cramps, sleep disturbances/restlessness, dizziness, nausea, hypokalemia, hyperglycemia, paradoxical bronchospasm, hypersensitivity reactions

Safety & Warnings

Contraindications

Hypersensitivity to budesonide, formoterol, or excipients (including lactose/milk proteins); not for primary treatment of status asthmaticus or acute episodes requiring intensive measures.

Warnings & Precautions

Not a rescue inhaler-ensure a reliever is available; rinse mouth after use to reduce oral candidiasis; monitor for pneumonia in COPD; use caution in cardiovascular disease, diabetes, hypokalemia, hyperthyroidism, and QT-prolongation risk; consider effects on growth in adolescents and on bone/ocular health with long-term use; avoid abrupt discontinuation and avoid duplicate LABA therapy.

Age Restriction

Asthma: approved for adults and adolescents ≥12 years; COPD: adults ≥18 years only.

Special Populations

Children

Not approved for children under 12 years. Adolescents 12-17 years: same as adult dosing

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly without medical advice; step down/taper to the lowest effective dose when clinically stable.

Overdose

Symptoms: beta-agonist effects (tremor, headache, palpitations/tachycardia, hypertension, hypokalemia, hyperglycemia, possible QT prolongation/arrhythmia); with prolonged high exposure, corticosteroid effects (adrenal suppression/Cushingoid features). Management: seek urgent care, supportive treatment, monitor ECG/electrolytes/glucose; consider a cardioselective beta-blocker if severe and clinically appropriate.

Patient Counseling

Use exactly as prescribed (maintenance daily; if on MART, use for both maintenance and symptom relief per plan). Demonstrate correct Easyhaler technique (upright, shake, click/load, inhale forcefully and deeply). Rinse mouth and spit after use to prevent thrush/hoarseness. Do not exceed prescribed maximum daily inhalations; seek care if symptoms worsen or relief is inadequate. Report palpitations/tremor, oral white patches/voice changes, and (in COPD) signs of pneumonia (fever, increased sputum, worsening breathlessness).

Monitoring Requirements

Monitor asthma/COPD control (symptoms, reliever use, exacerbations, spirometry/peak flow as appropriate), inhaler technique and adherence; check for oral candidiasis/hoarseness; monitor heart rate/tremor and serum potassium in at-risk patients (e.g., high doses, diuretics); consider bone density/adrenal suppression with prolonged high-dose ICS; in COPD monitor for pneumonia risk; consider ocular effects (cataract/glaucoma) with long-term use.

Pharmacology

Mechanism of Action

Budesonide (ICS) binds glucocorticoid receptors to suppress airway inflammation and inflammatory mediator production; formoterol (LABA) stimulates beta2-receptors in bronchial smooth muscle to produce bronchodilation; the combination provides anti-inflammatory control plus sustained bronchodilation.

Onset of Action

Bronchodilation begins within minutes (often ~1-3 minutes) due to formoterol; full anti-inflammatory benefit from budesonide typically requires days to weeks of regular use.

Product Information

Available Dosage Forms

Inhalation powder (dry powder inhaler, Easyhaler device).

Composition per Dose

Each delivered dose contains: 160 mcg budesonide and 4.5 mcg formoterol fumarate dihydrate.

OTC Alternatives

No OTC alternative

Symptom Target

Asthma and COPD maintenance treatment; not indicated for allergy or multi-symptom relief

Sedating

No

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