Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria
Bilastine is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H1 receptors. It shows moderate to high affinity for histamine H1-receptors and no affinity for muscarinic, serotonergic, dopaminergic and noradrenergic receptors.
The recommended dose in children 6 to 11 years of age with a body weight of at least 20 kg is 10 mg bilastine (4 ml of oral solution) once daily for the relief of symptoms of allergic rhinoconjunctivitis and urticaria.
Hypersensitivity to bilastine or to any ingredient in the formulation or component.
Coadministration of bilastine and P-glycoprotein inhibitors should be avoided in patients with moderate or severe renal impairment.
There are no or limited amount of data from the use of bilastine in pregnant women. The excretion of bilastine in milk has not been studied in humans. A decision on whether to discontinue/abstain from bilastine therapy must be made taking into account the benefit of breast-feeding for the child and mother. Efficacy and safety of bilastine in children under 2 years of age have not been established and there is little clinical experience in children aged 2 to 5 years, therefore bilastine should not be used in these age groups.
Concomitant intake of bilastine 20 mg o.d. and ketoconazole 400 mg o.d. or erythromycin 500 mg t.i.d. increased plasma concentration of bilastine
The most commonly reported adverse events are headache, somnolence, dizziness, and fatigue.