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Publicaciones sobre Bilastina

Bilastine 10 and 20 mg in paediatric and adult patients: an updated practical approach to treatment decisions

By | Articles about Bilastine, Publicaciones sobre Bilastina

Amalia Leceta, Aintzane García, Ander Sologuren, Cristina Campo

Drugs Context . 2021 Aug 10;10:2021-5-1. doi: 10.7573/dic.2021-5-1. eCollection 2021

Bilastine is a non-drowsy H1-antihistamine for treating allergic conditions such as rhinoconjunctivitis and urticaria in people of all ages. This review aims to update a former article, focusing on recent clinical data on the use of bilastine in children and adults.

Data was collected from recent clinical studies in children and adults from Faes Farma. Most of the new information was updated on paediatric and elderly use. The European Medicines Agency approval took place in 2017 following a Paediatric Investigation Plan from 2009. Faes Farma received questions related to drug interactions involving bilastine and other concomitant medicines and the use of bilastine in special populations or for the treatment of specific conditions. The summarized advice from specialists consisted of interactions involving the cytochrome P450 isozyme system, leading to changes in drug exposure and, therefore, clinical efficacy and safety. Elderly patients are at particular risk of drug-drug interactions due to the number of concurrent medicines and comorbidities. Of importance are also potential drug-drug interactions between bilastine and drugs with a narrow therapeutic index.

In conclusion, although bilastine has a favorable pharmacokinetic profile, decisions on its use should rely on evidence, expert opinions, and the SmPC of bilastine. Nevertheless, further studies are needed to answer specific questions regarding its use.

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Pharmacokinetics and Safety of a Bilastine Once-Daily, Preservative-Free, Ophthalmic Formulation

By | Articles about Bilastine, Publicaciones sobre Bilastina

Dolores Ochoa, Manuel Roman, Carmen Belmonte, Samuel Martin-Vilchez, Gina Mejia-Abril, Francisco Abad-Santos, Gonzalo Hernandez, Paula Arranz, Lorena Elgezabal, Nieves Fernandez

Adv Ther . 2021 Jun 12. doi: 10.1007/s12325-021-01801-y. Online ahead of print.

Bilastine is a second-generation H1 antihistamine for allergic conditions. A new ophthalmic formulation was developed based on the efficacy and safety profiles of the oral formulation. The aim of this study was to assess the safety and pharmacokinetics of ophthalmic bilastine (6 mg/ml) in adults after one and various doses.

This was an open-label, single-centre, phase 1, bioavailability study that included 12 healthy participants (aged 18-55 years old). Participants were administered one drop of the bilastine eye formulation in each eye for five days. Serum levels of bilastine were assessed by HPLC-MS/MS and adverse drug reactions registered during administration and follow-up.

After various admininistrations, bilastine blood levels were 2682,26 ± 1615,88 pg/mL at 2,5 hours. The half-life of bilastine was 7,88 ± 6,72 h. Area under the curve was 19512,51 ± 9248,76 h/pg/mL. Dysgeusia was the main adverse event, which was mild and transient.

The ophthalmic formulation has proved to be absorbed in low amounts to the bloodstream, showing a good safety profile after administration of various doses.

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