DIPIRONA-

Información principal

  • Denominación comercial:
  • DIPIRONA-300 mg
  • Dosis:
  • 300 mg
  • formulario farmacéutico:
  • Tableta
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

Documentos

  • para el público en general:
  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.


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Localización

  • Disponible en:
  • DIPIRONA-300 mg
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • m11065n02
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

DIPIRONA-300 mg

Forma farmacéutica:

Tableta

Fortaleza:

300 mg

Presentación:

Estuche por 3 blísteres de PVC ámbar/AL

con 10 tabletas cada uno.

Estuche múltiple por 200 blísteres de PVC ámbar/AL

con 10 tabletas cada uno (Envase hospitalario).

Titular del Registro Sanitario, país:

SHANGHAI KANGNUO INTERNATIONAL TRADE CO., LTD.,

SHANGHAI, CHINA.

Fabricante, país:

HEBEI JIHENG (GROUP) PHARMACEUTICAL CO., LTD.,

HEBEI, CHINA.

Número de Registro Sanitario:

M-11-065-N02

Fecha de Inscripción:

4 de mayo de 2011

Composición:

Cada tableta contiene:

metamizol sódico

300,0 mg

Plazo de validez:

36 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 ºC. Protéjase de la luz y de la humedad.

Indicaciones terapéuticas:

Fiebre, dolor de cabeza, jaquecas, dolores musculares, dolor articular, dismenorrea. Se usa

raramente para enfermedad reumática.

Contraindicaciones:

Este producto no debe usarse en caso de hipersensibilidad a la pirazolonas.

Embarazo: Contraindicado en el 1er y 3er trimestre.

Lactancia: Se evitará la Lactancia materna transcurrida 48 horas de la administración.

Antecedentes de reacciones alérgicas.

Antecedentes de agranulocitosis.

Insuficiencia hepática y renal.

Precauciones:

Déficit de 6GPD.

Porfiria.

Advertencias especiales y precauciones de uso:

Esta medicina tiene acción de alergia mutua con aspirina.

Generalmente este medicamento no se usa como la primera opción, sólo se usa para

enfermedad aguda de fiebre alta y grave, en los que otros antipiréticos no pueden bajar la

fiebre.

Cuando

más

semana,

deben

realizarse

controles

hemáticos

periódicamente. Una vez se descubre agranulocitosis, debe interrumpirse su uso.

Adulto mayor: Tomar con cuidado.

No debe utilizarse por periodos prolongados.

Efectos indeseables:

Aunque este medicamento afecta poco al estómago y a los intestinos, puede causar las

siguientes reacciones adversas:

Hematológica: puede causar agranulocitosis, incidencia aproximada aproximada de 1,1%,

que es enfermedad aguda, en el caso grave, puede causar riesgo vital. También puede

causar anemia perniciosa, cicatriz violeta por causa de reducción de plaquetas en sangre y

anemia aplástica, etc;

Dermatológica: puede causar urticaria, eritema penetrante y otras reacciones alérgicas. En

el caso grave, puede causar dermatitis de piel desconchado, aflojamiento de superficie de

piel, etc.;

En caso particular, puede ocurrir shock anafiláctico, hasta la muerte.

Posología y método de administración:

Adultos: 300 mg 3 veces al día. No más de 3 g al día

Niños: 10-30 mg/kg/, 2 a 3 veces al día. No más de 40mg/kg/día.

Interacción con otros productos medicinales y otras formas de interacción:

En caso de un uso concomitante con Ciclosporina, podría ocurrir un decremento en los

niveles de Ciclosporina, por consiguiente, es necesario controlar regularmente.

La Dipirona y el alcohol pueden antagonizar en sus efectos.

Uso en Embarazo y lactancia:

La Dipirona atraviesa la barrera placentaria por lo que no debe usarse durante el embarazo,

y en el período de lactancia.

Efectos sobre la conducción de vehículos/maquinarias:

No procede.

Sobredosis:

En caso de sobredosis se emplea tratamiento de soporte.

Propiedades farmacodinámicas:

Compuesto químico de aminopirino y sulfito de sodio, que se disuelve fácilmente en agua.

Es más rápido en aliviar la fiebre y el dolor que el aminopirino.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

El compuesto de aminopirina y sulfito de sodio se disuelve fácilmente en agua. Su acción

antipirética y analgésica supera a la de la aminopirina. Puede absorberse rápidamente

cuando se administra por vía oral. La semivida es de 1 a 4 horas.

Instrucciones de uso, manipulación y destrucción del remanente no utilizable del

producto:

No procede.

Fecha de aprobación/ revisión del texto: 31 de agosto de 2016.

  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.

    Solicitar el prospecto de información al público.



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