Bilaxten ODT Drug Interactions

Interaction studies have only been performed in adults and are summarised as follows.
Interaction with food: Food significantly reduces the oral bioavailability of bilastine 20 mg tablets by 30% and that of bilastine 10 mg orodispersible tablets by 20%.
Interaction with grapefruit juice: Concomitant intake of bilastine 20 mg and grapefruit juice decreased bilastine bioavailability by 30%. This effect may also apply to other fruit juices. The degree of bioavailability decrease may vary between producers and fruits. The mechanism for this interaction is an inhibition of OATP1A2, an uptake transporter for which bilastine is a substrate (see Pharmacology: Pharmacokinetics under Actions). Medicinal products that are substrates or inhibitors of OATP1A2, such as ritonavir or rifampicin, may likewise have the potential to decrease plasma concentrations of bilastine.
Interaction with ketoconazole or erythromycin: Concomitant intake of bilastine 20 mg o.d. and ketoconazole 400 mg o.d. or erythromycin 500 mg t.i.d. increased bilastine AUC 2-fold and Cmax 2-3 fold. These changes can be explained by interaction with intestinal efflux transporters, since bilastine is a substrate for P-gp and not metabolized (see Pharmacology: Pharmacokinetics under Actions). These changes do not appear to affect the safety profile of bilastine and ketoconazole or erythromycin, respectively. Other medicinal products that are substrates or inhibitors of P-gp, such as cyclosporine, may likewise have the potential to increase plasma concentrations of bilastine.
Interaction with diltiazem: Concomitant intake of bilastine 20 mg o.d. and diltiazem 60 mg o.d. increased Cmax of bilastine by 50%. This effect can be explained by interaction with intestinal efflux transporters (see Pharmacology: Pharmacokinetics under Actions), and does not appear to affect the safety profile of bilastine.
Interaction with alcohol: The psychomotor performance after concomitant intake of alcohol and 20 mg o.d. bilastine was similar to that observed after intake of alcohol and placebo.
Interaction with lorazepam: Concomitant intake of bilastine 20 mg o.d. and lorazepam 3 mg o.d. for 8 days did not potentiate the depressant CNS effects of lorazepam.
Paediatric population: No interaction studies have been performed in children with bilastine orodispersible tablets. As there is no clinical experience regarding the interaction of bilastine with other medicinal products, food or fruit juices in children, the results obtained in adult interactions studies should be at present taken into consideration when prescribing bilastine to children. There are no clinical data in children to state whether changes to the AUC or Cmax due to interactions affect the safety profile of bilastine.