Beclomethasone Dipropionate / Formoterol Fumarate

What it is and how it works

Beclometasone dipropionate is a corticosteroid prodrug that reduces airway inflammation, while formoterol is a rapid-onset long-acting beta2-adrenoceptor agonist that relaxes bronchial smooth muscle. The extrafine aerosol formulation delivers both drugs to large and small airways.

Indications

Regular treatment of asthma where an ICS/LABA combination is appropriate (including maintenance and reliever therapy for some strengths); symptomatic treatment of severe COPD with a history of exacerbations despite bronchodilator therapy.

Dosage and administration (summary)

Inhalation (100/6 micrograms per actuation): asthma, 1–2 puffs twice daily; COPD, 2 puffs twice daily. Dose adjusted to the lowest effective level.

Contraindications

Hypersensitivity to beclometasone, formoterol or any excipient.

Warnings and precautions

Not for initiation of treatment of acute bronchospasm unless licensed for reliever use; do not stop abruptly. Use with caution in cardiac arrhythmias, QT prolongation, thyrotoxicosis, diabetes and severe cardiovascular disease; hypokalaemia may occur. Pneumonia risk is increased in COPD; rinse mouth after use to reduce oral candidiasis; systemic corticosteroid effects are possible at high doses.

Pregnancy

May be used in pregnancy when the benefit outweighs the risk, as uncontrolled asthma poses greater risk to the fetus.

Storage and supply

Before dispensing, store in a refrigerator (2–8 °C); after dispensing, store below 25 °C for the period stated by the manufacturer; pressurised canister — do not puncture or expose to heat.

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