Bilastine Should Not Be Given Twice Daily
Bilastine is approved and should be administered as 20 mg once daily in adults and adolescents aged ≥12 years, not as a twice-daily regimen. 1, 2, 3
Approved Dosing Regimen
- The standard dose of bilastine is 20 mg once daily for adults and adolescents ≥12 years of age 2, 3, 4
- For children aged 6 to <12 years, the approved dose is 10 mg once daily 4
- Bilastine has a 14-hour elimination half-life, which supports once-daily dosing 3
- The drug demonstrates a long duration of action that maintains efficacy throughout a 24-hour period 4
Why Twice-Daily Dosing Is Not Recommended
- No clinical trials have evaluated or established the efficacy or safety of bilastine 20 mg twice daily 2, 3, 5
- The pharmacokinetic profile, with its extended half-life and sustained receptor occupancy, is specifically designed for once-daily administration 3, 4
- All regulatory approvals are based on once-daily dosing studies 2, 3, 4
Critical Dosing Considerations
- Bilastine must be taken at least one hour before or no sooner than two hours after a meal to avoid interference with absorption 2, 3
- Food and fruit juice significantly slow absorption, reducing bioavailability 2
- No dose adjustments are required in patients with renal impairment, hepatic impairment, or in elderly patients 6, 4
When Higher Symptom Control Is Needed
- If standard once-daily dosing provides inadequate symptom control, particularly in chronic urticaria, guidelines support increasing to up to four times the standard dose (80 mg once daily), rather than splitting into twice-daily administration 5
- Bilastine maintains a favorable safety profile even at above-standard doses 4, 5
- The drug shows minimal sedative properties and no cardiotoxic effects even at higher doses 3, 5