Bilastine Maximum Dose
The maximum recommended dose of bilastine is 20 mg once daily for adults and adolescents aged ≥12 years, and 10 mg once daily for children aged 6 to <12 years. 1, 2
Standard Dosing by Age Group
Adults and adolescents (≥12 years): 20 mg once daily is the standard and maximum approved dose for treatment of allergic rhinoconjunctivitis and chronic urticaria 1, 2, 3
Children (6 to <12 years): 10 mg once daily is the approved pediatric dose, which has been shown to provide similar plasma exposure to the adult 20 mg dose when adjusted for body weight 4
Children under 6 years: Bilastine is not currently approved for use in this age group, as adequate safety and efficacy data are lacking 2, 3
Critical Dosing Considerations
Bilastine should be taken on an empty stomach—at least one hour before or no sooner than two hours after food or fruit juice—as food significantly reduces absorption. 1, 3 This is a crucial administration requirement that distinguishes bilastine from many other antihistamines.
Special Populations Requiring No Dose Adjustment
Renal impairment: Despite increased systemic exposure in patients with renal insufficiency (AUC increased up to 2.3-fold in severe renal impairment), the 20 mg daily dose remains within safety margins and no dose adjustment is required for any degree of renal impairment 2, 5
Hepatic impairment: No dosage adjustments are necessary, as bilastine undergoes minimal hepatic metabolism 2
Elderly patients: No dose reduction is required in older adults 2
Safety Profile at Standard Dosing
Bilastine has been shown to be well-tolerated even when administered at above-standard doses in clinical trials, with no significant sedative, anticholinergic, or cardiotoxic effects observed 2, 3
The drug does not interact with the CYP450 system, minimizing potential drug-drug interactions 2
Headache is the most frequently reported adverse effect at the standard 20 mg dose 1
Common Pitfall to Avoid
Do not exceed the 20 mg once-daily dose in adults or 10 mg once-daily dose in children. While bilastine has demonstrated safety at higher doses in research settings, there is no evidence of additional clinical benefit beyond the standard dose, and the approved maximum doses represent the appropriate therapeutic ceiling for routine clinical practice 1, 2, 3