Nausea and Vomiting of Pregnancy and its Management with the Dual-Release Formulation of Doxylamine and Pyridoxine.

Autor: Schleußner E; Klinik für Geburtsmedizin, Universitätsklinikum Jena, Jena, Germany., Jäkel S; Frauenarztpraxis Gera, Gera, Germany., Keck C; Medicover Laborgruppe Deutschland, Berlin, Germany., Kuhlmann K; Frauenarztpraxis Berlin, Berlin, Germany., Mangler M; Klinik für Gynäkologie und Geburtsmedizin, Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany., Paulus WE; Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Ulm, Ulm, Germany., Eiblwieser J; Exeltis Germany GmbH, Ismaning, Germany., Steeb T; Exeltis Germany GmbH, Ismaning, Germany., Regidor PA; Exeltis Healthcare, Ismaning, Germany.
Jazyk: angličtina
Zdroj: Geburtshilfe und Frauenheilkunde [Geburtshilfe Frauenheilkd] 2024 Feb 08; Vol. 84 (2), pp. 144-152. Date of Electronic Publication: 2024 Feb 08 (Print Publication: 2024).
DOI: 10.1055/a-2225-5883
Abstrakt: Nausea and vomiting of pregnancy (NVP) is among the most common conditions that pregnant women encounter in the early stages of pregnancy. It can affect up to 85% of pregnant women, thus representing a significant public health concern. NVP results in substantial negative physical, emotional, and financial consequences. Despite its prevalence, the pathogenesis remains elusive. Few guidelines have been published; however, several interventions exist for the symptomatic treatment of NVP. The aim of this review is to provide an overview of modern treatment strategies of NVP with a special focus on the recently approved dual-release formulation of the doxylamine and pyridoxine combination. This combination was approved by the Food and Drug Administration (FDA) in November 2016 for the treatment of NVP when conservative management fails, and it has been introduced to the American market in April 2018. The maximum plasma concentration (T max ) of doxylamine and pyridoxal-5-phosphate is reached 3.5 h and 15 h, respectively, after administration of one tablet twice daily, or 4.5 h and 0.5 h, respectively, when one tablet is administered just once daily. In addition, the delayed-release combination allows sufficient levels of doxylamine and the active metabolite pyridoxal-5-phosphate in the systemic circulation, providing symptoms relief in the subsequent morning. Hence, the dual-release formulation can improve the quality of life of pregnant women suffering from NVP. Additionally, large epidemiological trials have shown no increased risk of adverse effects to newborns, demonstrating that its use is not teratogenic.
Competing Interests: Conflict of Interest Pedro-Antonio Regidor is an employee of Exeltis Healthcare. Johanna Eiblwieser and Theresa Steeb are employees of Exeltis Germany. The remaining authors have received advisory board honoraria from Exeltis Germany GmbH and state nor further conflict of interest.
(The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
Databáze: MEDLINE
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