From the FDA Drug Label
Directions adults and children12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age The dose of bilastine for paediatric patients 12 years and over is 1 tablet every 12 hours, with a maximum of 2 tablets in 24 hours.
- For children under 12 years, bilastine is not recommended 1.
From the Research
Bilastine is safe for pediatric patients aged 2 to 5 years, and the recommended dose is 10 mg once daily. The safety and pharmacokinetics of bilastine in children aged 2 to 5 years were evaluated in a multicenter, open-label clinical trial, which found that oral bilastine 10 mg presented a good safety profile in this age group 2. The study found that the highest plasma concentrations of bilastine were observed 1 hour after administration, and only 8 patients (21.6%) experienced treatment-emergent adverse events, none of which were severe. Key points to consider when administering bilastine to pediatric patients include:
- Bilastine is a second-generation antihistamine with minimal sedative effects and no significant cardiac concerns at therapeutic doses.
- It works by selectively blocking H1 histamine receptors without crossing the blood-brain barrier significantly, which explains its favorable safety profile with minimal central nervous system effects.
- Renal or hepatic dose adjustments are typically not required in pediatric patients with normal organ function.
- If the patient misses a dose, they should take it as soon as remembered, but should not double the dose to make up for a missed one. It is essential to note that the pharmacokinetics of bilastine were linear and consistent with data from a previous trial, suggesting that a 10-mg dose may be used in children aged 2 to <12 years, with no dose adjustments deemed necessary 2.