Monitorização do uso clínico de formulação extemporânea de captopril preparada com o veículo "Gute".

Abstract

ABSTRACT In Brazil, as in other countries, hospitalized children receive medications that have no t been studied in this population and neither developed in age - appropriate formulations.This situation leads to off - label use of medicines and the use of extemporaneous preparations , more frequent in cardiovascular therapy.Liquid formulations of captopril are not currently marketed in the country , so tablets developed for adults must be transformed into extemporaneous formulations for administration to pediatric patients. Generally, w ater is used as the vehicle, with the risk of loss of stability and therap eutic ineffectiveness.A suitable vehicle should respect the physical and chemical characteristics of the actives and should not contain potentially harmful excipients for the child, ensuring a stable, safe and effective formulation . In this study we assesse d the safety and efficacy of extemporaneous formulation of captopril incorporated in Gute , a vehicle developed by the research group MeMeCri ( MelhoresMedicamentos para Crianças ), from UFC, intended for pediatric use . We compared the change in Mean Arterial Pressure (MAP) after administration of captopril extemporaneous formulation prepared with Gute and water in hospitalized children to which the drug was prescribedin c ardiologyintensive care unit.For convenience and ethical issues, the captopril in water co ntrol group was identified retrospectively through medical records, while the experimental group, captopril in Gute, was evaluated prospectively. Were also recorded and compared indicators of adverse events in both groups. R eduction in MAP with captopril wa s statistically significant i n both groups, but Gute group in a larger number of children required dose adjustment.A probable explanation may be the best control of procedures and increased data reliability of Gute group versus Water group, given the prosp ective nature of the first.Hypotensive episodes were identified in both groups, with 6/43 in the water group and 4/43 in Gute group. Some episodes of diarrhea (4/43) were detected inGute group. Considering the limitations of the work, it is assumed that th e results are not sufficient to ensure the sa fe and effective use of Gute in critical patients, making it necessary to investigate the stability of the obtained formulations and better standardize the use conditions of the vehicle.