Dymista^® Nasal Spray

Abbreviated Prescribing Information¹

Product name: Dymista^® Nasal Spray. Composition: 137 μg azelastine hydrochloride/50 μg fluticasone propionate per actuation of Nasal Spray. Indication: Symptomatic treatment of moderate-to-severe allergic rhinitis and rhinoconjunctivitis in adults and children 6 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate. Dosage and administration: Adults, adolescents and children (6 years and older): One spray in each nostril twice daily (morning and evening). Children below 6 years: Not recommended for use as safety and efficacy have not been established in this age group. Contraindications: Known hypersensitive to this drug or to any ingredient in the formulation or component of the container. Special warnings and precautions: Although systemic effects with recommended doses of nasal corticosteroids (fluticasone propionate) have been minimal, potential risk increases with larger doses. Instances of nasal ulceration and nasal septal perforation may occur in patients following the intranasal application of corticosteroids. Dymista^® contains benzalkonium chloride which may cause irritation or swelling inside the nose, especially if used for a long time. Pregnancy and lactation: Pregnancy: No or limited amount of data from the use of azelastine hydrochloride and fluticasone propionate in pregnant women. Therefore, Dymista^® Nasal Spray should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus. Lactation: It is unknown whether nasally administered azelastine hydrochloride/metabolites or fluticasone propionate/metabolites are excreted in human breast milk. Dymista^® Nasal Spray should be used during lactation only if the potential benefit outweighs the potential risk to the newborns/infant. Undesirable effects: Adverse events occurred with similar frequencies in patients treated with Dymista^® compared with either azelastine or fluticasone alone. Commonly, dysgeusia may be experienced after administration (often due to incorrect method of application). Drug interactions: Concomitant use of fluticasone propionate and ritonavir should be avoided. Care is advised when co-administering potent cytochrome P450 3A4 inhibitors (e.g. ketoconazole and cimetidine).

API-DYM-0224

Reference: 1. Dymista^® Malaysia Prescribing Information, Dated February 2024.