azelastine hydrochloride + fluticasone propionate: clinical use

Prescribing considerations

• Confirm moderate to severe seasonal or perennial allergic rhinitis inadequately controlled by either intranasal component alone.
• Review total corticosteroid exposure, especially with other inhaled, topical or systemic corticosteroids.
• Use caution in severe hepatic disease because systemic fluticasone exposure may increase.
• Assess risks after recent nasal or oral surgery or trauma, and in tuberculosis or untreated infection. Treat nasal infection appropriately.
• Review new visual disturbance and consider ophthalmic assessment.

Contraindications and cautions

• Hypersensitivity to azelastine, fluticasone or any excipient.

Monitoring

• Monitor adolescent growth during prolonged intranasal corticosteroid treatment.
• Monitor for systemic corticosteroid effects with excessive exposure or unavoidable strong CYP3A4 inhibition.
• Monitor visual changes and patients with a history of raised intraocular pressure, glaucoma or cataract.
• Review persistent irritation, mucosal swelling, ulceration or recurrent nosebleeds.

Clinical pharmacology

Azelastine is a selective H1-receptor antagonist with mast-cell-stabilising and anti-inflammatory effects. Fluticasone is a high-affinity glucocorticoid-receptor agonist with potent local anti-inflammatory activity. Intranasal fluticasone normally has low systemic exposure because of extensive first-pass metabolism and high clearance.

Formulation and product differences

• The white, homogeneous nasal spray suspension contains benzalkonium chloride, which may cause nasal irritation or mucosal swelling with long-term use.
• The bottle requires shaking and pump priming; it should not be refrigerated or frozen.

Nasal preparation

Route: Nasal

Strengths: 137 micrograms + 50 micrograms/actuation