beclometasone dipropionate + formoterol fumarate dihydrate: clinical use

Prescribing considerations

• Confirm the exact product, strength, device and whether it is intended for maintenance-only or maintenance-and-reliever use.
• Do not initiate during an acute exacerbation or significant acute deterioration.
• Check technique, adherence, symptom control and reliever use before escalating treatment.
• Extrafine beclometasone products are not directly interchangeable with non-extrafine formulations; switching requires clinical reassessment.
• Consider pneumonia risk in COPD and systemic corticosteroid effects with prolonged higher exposure.

Contraindications and cautions

• Hypersensitivity to beclometasone dipropionate, formoterol fumarate dihydrate or a formulation excipient.
• Use caution in significant cardiovascular disease, arrhythmia or prolonged QTc; thyrotoxicosis; diabetes; phaeochromocytoma; untreated hypokalaemia; pulmonary tuberculosis; and fungal or viral airway infection.
• NEXThaler contains lactose with small amounts of milk protein and is unsuitable for patients with relevant excipient hypersensitivity or specified rare carbohydrate-metabolism disorders.

Monitoring

• Clinical control, exacerbations, reliever use, adherence, inhaler technique and lung function where appropriate.
• Serum potassium where severe or unstable asthma, hypoxia or interacting medicines create additional risk.
• Blood glucose in diabetes.
• Features of systemic corticosteroid exposure or adrenal suppression when clinically indicated.
• Visual symptoms, with ophthalmic assessment if disturbance develops.
• Possible pneumonia in COPD, recognising overlap with exacerbation symptoms.

Clinical pharmacology

Beclometasone dipropionate is rapidly converted by esterases to an active metabolite producing local pulmonary glucocorticoid activity. Formoterol is a selective beta2 agonist with rapid-onset, prolonged bronchodilator action. Both selected formulations produce an extrafine aerosol intended to co-deposit the components through the airways.

Formulation and product differences

• The selected Fostair pressurised solution requires coordinated slow inhalation and contains a small amount of ethanol. An AeroChamber Plus spacer can be used if coordination is difficult.
• The selected NEXThaler is a breath-operated dry-powder inhaler requiring forceful, deep inhalation. It must be kept dry and contains lactose with small amounts of milk protein.
• The selected pressurised product is licensed for adult asthma as maintenance therapy only. The selected NEXThaler is licensed for adult asthma, including specified maintenance-and-reliever use, and for specified adults with severe COPD.

Inhaled preparation

Route: Inhaled

Strengths: 100 micrograms + 6 micrograms/actuation, 200 micrograms + 6 micrograms/actuation