Finished product reference
Budesonide / Formoterol Fumarate / Glycopyrronium Bromide
Inhalant · Respiratory · 160 µg/5 µg/9 µg/1 dose · 120 dose
- List code
- 53177
- Pharmacologic class
- Inhaled corticosteroid / LABA / LAMA (ICS/LABA/LAMA) triple combination
What it is and how it works
Budesonide is an inhaled corticosteroid that reduces airway inflammation. Formoterol (long-acting beta2-agonist) and glycopyrronium (long-acting muscarinic antagonist) produce additive bronchodilatation through complementary mechanisms.
Indications
Maintenance treatment of moderate to severe COPD in adults not adequately treated by an ICS/LABA or LABA/LAMA combination.
Dosage and administration (summary)
Inhalation (pressurised metered-dose inhaler): 2 puffs twice daily (e.g. budesonide 160 micrograms / glycopyrronium 7.2 micrograms / formoterol 5 micrograms per actuation).
Contraindications
Hypersensitivity to the active substances or any excipient.
Warnings and precautions
Not for relief of acute bronchospasm; paradoxical bronchospasm may occur. Use with caution in severe cardiovascular disease, arrhythmias, QT prolongation, thyrotoxicosis, diabetes, narrow-angle glaucoma, urinary retention and severe renal impairment. Increased risk of pneumonia in COPD; rinse mouth after use to reduce oral candidiasis.
Pregnancy
Use in pregnancy only if the expected benefit outweighs the potential risk.
Storage and supply
Store below 30 °C; pressurised canister — do not puncture, protect from heat and direct sunlight; use within the in-use period after removing from the foil pouch.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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