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Redes Sociais

Saúde v6n3n

Anvisa aumenta controle na prescrição do zolpidem; veja o que muda 5hd46

Qualquer remédio com substância terá de ser prescrito com receita azul

Publicado há

em

Reprodução

Esse tipo de receita exige que o profissional tenha cadastro prévio na vigilância sanitária. A Anvisa decidiu alterar a forma de prescrição após receber aumento de relatos de uso abusivo do medicamento.

“A medida foi adotada a partir do aumento de relatos de uso irregular e abusivo relacionados ao uso do zolpidem. A análise conduzida pela Anvisa demonstrou um crescimento no consumo dessa substância e a constatação do aumento nas ocorrências de eventos adversos relacionados ao seu uso. Foi possível ainda identificar que não há dados científicos que demonstrem que concentrações de até 10 mg do medicamento mereçam um critério regulatório diferenciado”, diz nota.

O que muda

De acordo com a agência reguladora, o zolpidem estava enquadrado na lista de psicotrópicos, que é mais restrita. No entanto, havia uma adendo (de número 4) que permitia a prescrição de medicamentos com até 10 mg de zolpidem pela receita branca em duas vias, mesma regra para os medicamentos da Lista de Substâncias Sujeitas a Controle Especial (C1) e que não exige cadastro do profissional na autoridade sanitária local.

Com as mudanças, o adendo será excluído e a receita azul a a ser obrigatória para todos os medicamentos com zolpidem, independentemente da quantidade presente.

A Anvisa informa que a definição do prazo, para o início da nova norma, levou em conta tempo necessário para que os profissionais façam o cadastro na vigilância sanitária e os pacientes não tenham descontinuidade do tratamento.

Zolpidem 

O remédio é usado para tratar a insônia de curta duração, quando há dificuldade em adormecer ou manter o sono. A utilização não deve ultraar de quatro semanas. A prorrogação só pode ser feita após avaliação médica, em razão do risco de abuso e dependência pelo paciente.

AS MAIS LIDAS 4e2a2n