Exploring the Role of Bilastine Alone and in Combination with Montelukast in Pediatric Populations with Allergic Rhinitis

Pediatric allergic rhinitis (AR), characterized by inflammatory responses, poses significant challenges in management due to its impact on the quality of life and potential long-term consequences. Bilastine, a second-generation H1-antihistamine, has shown efficacy in alleviating AR symptoms, has high specificity, shows rapid action, and reduces the need for frequent dosing with a favorable safety profile. The pediatric formulation of bilastine 10 mg and bilastine 10 mg with montelukast 4 mg is approved by the Drugs Controller General of India for children above 6 years of age. Bilastine is also recommended by the Indian Academy of Pediatrics in 2022 for the management of AR. Montelukast is a leukotriene receptor antagonist (LTRA), which has demonstrated synergistic effects in controlling AR symptoms. Montelukast is the only LTRA licensed for administration in children <12. While there has been considerable research on combination therapy (LTRA + antihistamines) for AR in adults, there is, indeed, a scarcity of clinical trial data on pediatric usage of this combination therapy for AR, thus necessitating more clinical trials. This review summarizes the existing pediatric AR diagnosis and clinical evidence supporting the use of bilastine alone and in combination with montelukast in the management of pediatric AR.