Information regarding acute overdose of bilastine is retrieved from the experience of clinical trials conducted during the development and the post-marketing surveillance. In clinical trials, after administration of bilastine at doses 10 to 11 times the therapeutic dose (220 mg as single dose or 200 mg/day for 7 days) to healthy volunteers frequency of treatment emergent adverse events was two times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported. The information collected in the post-marketing surveillance is consistent with that reported in clinical trials.
Critical evaluation of Bilastine's multiple dose (100 mg x 4 days) effect on ventricular repolarization by a "thorough QT/QTc cross-over study" involving 30 healthy volunteers did not show significant QTc prolongation.
In the event of overdose symptomatic and supportive treatment is recommended.
There is no known specific antidote to Bilastine.