Bilastine Pediatric Dosage
The recommended dose of bilastine for children aged 2 to <12 years is 10 mg once daily, administered as an orodispersible tablet, while adolescents ≥12 years should receive the adult dose of 20 mg once daily. 1, 2, 3
Age-Specific Dosing
Children 2 to <12 Years
- Administer 10 mg once daily using orodispersible tablets 1, 2, 3
- This dose achieves comparable systemic exposure (AUC and Cmax) to the therapeutic 20 mg adult dose, with median pediatric/adult ratios of 0.93 and 0.91 respectively 2
- No dose adjustments are needed based on age or weight within this pediatric range, as pharmacokinetic modeling demonstrated no relationship between bilastine exposure and these variables 1, 3
Adolescents and Children ≥12 Years
- Use the adult dose of 20 mg once daily 4, 5
- This is the standard approved dose for allergic rhinoconjunctivitis and chronic urticaria in this age group 5
Children <2 Years
- Bilastine is not recommended for children under 2 years of age, as safety and efficacy data are lacking in this population 4, 1
Critical Administration Requirements
Bilastine must be taken on an empty stomach to ensure proper absorption 4, 5:
- Administer at least 1 hour before meals 4
- Wait at least 2 hours after meals before administration 4
- Avoid concurrent intake with food or fruit juice, as these significantly slow absorption and reduce bioavailability 4, 5
Safety Profile
The safety profile of bilastine 10 mg in children aged 2-11 years is comparable to placebo 2, 3:
- Treatment-emergent adverse events occurred in only 21.6% of children aged 2-5 years, with none being severe 3
- No significant difference in adverse event incidence between bilastine and placebo in children aged 6-11 years 2
- Headache is the most commonly reported adverse effect across all age groups 5
- No cardiotoxic effects or sedation at therapeutic doses 5
Pharmacokinetic Considerations
- Peak plasma concentrations occur approximately 1 hour after administration (Cmax ~635 ng/mL in young children) 3
- Elimination half-life is 14 hours, supporting once-daily dosing 5
- Bilastine is minimally metabolized and eliminated primarily through kidneys and feces 5
- No interaction with cytochrome P450 enzymes 5
Common Pitfalls to Avoid
- Do not administer with meals or fruit juice, as this is the most critical error that compromises drug absorption and therapeutic efficacy 4, 5
- Do not use in children under 2 years, as there are insufficient data to support safety and appropriate dosing in this age group 4, 1
- Do not adjust dose based on weight or age within the 2 to <12 year range, as population pharmacokinetic modeling confirmed age-independent kinetics 1, 3