Beclomethasone Dipropionate / Formoterol Fumarate / Glycopyrronium

What it is and how it works

Beclometasone dipropionate reduces airway inflammation; formoterol, a long-acting beta2-agonist, and glycopyrronium, a long-acting muscarinic antagonist, produce complementary bronchodilatation through adrenergic stimulation and blockade of M3 receptors in airway smooth muscle.

Indications

Maintenance treatment of moderate to severe COPD not adequately controlled by an ICS/LABA or LABA/LAMA combination; maintenance treatment of asthma in adults not adequately controlled on medium- or high-dose ICS/LABA with at least one exacerbation in the previous year (depending on strength).

Dosage and administration (summary)

Inhalation: 2 puffs twice daily (e.g. 87/5/9 micrograms per actuation).

Contraindications

Hypersensitivity to the active substances or any excipient.

Warnings and precautions

Not indicated for relief of acute bronchospasm. Use with caution in cardiac arrhythmias, QT prolongation, severe cardiovascular disease, thyrotoxicosis, diabetes, narrow-angle glaucoma, prostatic hyperplasia or urinary retention and severe renal impairment. Pneumonia risk is increased in COPD; paradoxical bronchospasm may occur; rinse mouth after use.

Pregnancy

Use in pregnancy only if the expected benefit justifies the potential risk.

Storage and supply

Before dispensing store at 2–8 °C; after dispensing store below 25 °C for the in-use period stated by the manufacturer; pressurised canister.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.