Visa em Debate
Introdução: O paracetamol, também conhecido como N-acetil-p-aminofenol (APAP), tem sido amplamente utilizado como medicamento para o manejo da dor. A toxicidade inadvertida associada ao APAP representa uma preocupação global. Objetivo: Investigar e avaliar a segurança da dose atualmente estabelecida de 4 g/dia para o paracetamol. Calcular os valores de exposição diária permitida (PDE) para o paracetamol. Método: Foi realizada uma revisão de escopo de acordo com as diretrizes do Joanna Briggs Institute (JBI), e o relato seguiu o checklist Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). O cálculo do valor de PDE para o paracetamol foi realizado conforme as diretrizes fornecidas pela Agência Europeia de Medicamentos (EMA) e pelo Conselho Internacional para Harmonização de Requisitos Técnicos para Produtos Farmacêuticos de Uso Humano (ICH). Resultados: O valor de PDE calculado para o paracetamol foi de 51,1 mg/dia. Ser do sexo feminino; com idade superior a 40 anos; histórico de abuso de álcool, desnutrição ou jejum; e uso concomitante de medicamentos contendo fenitoína, isoniazida, inibidores de protease como o ritonavir e a zidovudina foram fatores relatados como potencializadores da toxicidade do APAP. Conclusões: Medicamentos contendo paracetamol são seguros quando utilizados nas doses e posologias recomendadas, limitadas a, no máximo, 4,0 g ao dia. Conforme dados deste estudo, identificaram-se como fatores de risco relevantes para a toxicidade do paracetamol: sexo, alimentação, idade, uso de álcool e interações medicamentosas. O valor de PDE calculado para o APAP, de 51,1 mg/dia, indica que caso um indivíduo seja exposto continuamente a essa dose diária ao longo da vida, é improvável que efeitos adversos sejam observados.
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10.22239/2317-269X.02542
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