DOMINAL

Información principal

  • Denominación comercial:
  • DOMINAL
  • formulario farmacéutico:
  • Tableta
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

Documentos

  • para el público en general:
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Localización

  • Disponible en:
  • DOMINAL
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • 058-14d3
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

DOMINAL®

Forma farmacéutica:

Tableta

Fortaleza:

Presentación:

Estuche por 50 tiras de Poliéster-PE-AL

con 2 tabletas cada una.

Titular del Registro Sanitario, país:

Laboratorios López S.A. de C.V., El Salvador.

Fabricante, país:

Laboratorios López S.A. de C.V., El Salvador.

Número de Registro Sanitario:

058-14D3

Fecha de Inscripción:

15 de septiembre de 2014

Composición:

Cada tableta contiene:

Acetaminofen

Cafeína

500,0 mg

25,0 mg

Lactosa monohidratada 84,95 mg

Plazo de validez:

36 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 °C.

Indicaciones terapéuticas:

Indicado en casos de dolor de cabeza, fiebre o calentura, sintomatología del dengue,

influenza, dolor de muelas, oído y todo dolor

Contraindicaciones:

Hipersensibilidad a los componentes de la fórmula y pacientes con insuficiencia hepática.

Precauciones:

exceder

dosis

recomendada.

aconseja

consultar

médico

cuando

tratamiento dure más de 10 días. Tomar con precaución mientras se administren otros

medicamentos o bebidas que contengan cafeína.

Advertencias especiales y precauciones de uso:

En caso de que la fiebre y el dolor persistan por más de 3 días, acudir al médico.

Efectos indeseables:

Las reacciones adversas más frecuentes relativas al acetaminofén son: hepatotoxicidad

en casos de sobredosis, somnolencia.

Las reacciones adversas provocadas por la cafeína afectan principalmente le sistema

nervioso central como insomnio, agitación, excitación.

Posología y método de administración:

Vía de administración: Oral.

Tomar 1 tableta cada 6 horas.

Interacción con otros productos medicinales y otras formas de interacción:

Presenta interacción medicamentosa con barbitúricos que inhiben el metabolismo de la

cafeína como norfloxacina y ciprofloxacina. El efecto anticoagulante de warfarina y otras

cumarinas puede aumentarse por el uso prolongado de paracetamol con el riesgo de

incrementar el sangrado; dosis ocasionales no tienen efecto significativo. El paracetamol

aumenta la toxicidad del cloranfenicol

Uso en Embarazo y lactancia:

Utilizarse durante el embarazo bajo supervisión médica. No se ha establecido la seguridad

de la cafeína en mujeres embarazadas, la administración de dosis elevadas se ha asociado

con un incremento del riesgo de parto prematuro y bajo peso al nacer, por lo que se

recomienda disminuir la dosis de cafeína diaria, y no tomar dosis superiores a 300 mg/día.

Se recomienda consultar con el médico.

Efectos sobre la conducción de vehículos/maquinarias:

No se han descrito.

Sobredosis:

La sintomatología por sobredosis incluyen: Náuseas, vómito, mareos diaforesis, malestar

general; se debe provocar el vómito, ya que dentro de las primeras 24 a 72 horas

postingesta no existe evidencia de daño hepático.

La acetilcisteína es el antídoto universal para la sobredosificación de paracetamol y es más

efectiva si se administra dentro de las primeras 10-12 horas después de la ingesta de la

sobredosis, además de las medidas de soporte necesarias.

Los síntomas que aparecen en caso de sobredosificación de cafeína son a consecuencia de

una sobre estimulación del sistema nervioso central (insomnio, vómitos, inquietud, síntomas

de excitación) y de irritación del sistema gastrointestinal (diarrea, dolor abdominal, vómito,

naúsea).

El tratamiento es principalmente sintomático y de mantenimiento

Propiedades farmacodinámicas:

DOMINAL, contiene Acetaminofén el cual posee propiedades analgésicas debido a la acción

depresora, selectiva sobre el aparato de la percepción del dolor en el SNC situado en el

tálamo

hipotálamo.

Reduce

fiebre

efecto

directo

sobre

centros

termorreguladores del SNC, aumentando la disipación del calor por un incremento de la

circulación sanguínea periférica y de la sudoración o sea una vasodilatación.

Todo lo anterior es reforzado por la acción de una metilxantina como es la Cafeína, que

relaja los músculos lisos, además de los vasculares. La acción más importante es su

capacidad de relajar los músculos lisos de los bronquios, especialmente si éstos han sido

contraidos por histaminas

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

ACETAMINOFEN

Es metabolizado primariamente por acción de las enzimas microsomales hepáticas, se

absorbe rápido y casi totalmente por el tracto gastrointestinal. La concentración plasmática

llega al máximo en 30-60 minutos y la vida media plasmática es de 1-4 horas con dosis

terapéuticas. El acetaminofén tiene una distribución relativamente uniforme en casi todos los

líquidos corporales, su unión a las proteínas plasmáticas es variable, del 20-50% puede

estar ligado en las concentraciones que se encuentran durante la intoxicación aguda.

CAFEINA

Es bien absorbida por el aparato digestivo y se metaboliza un 15% por hora, pasando a la

orina

solo

cierto

neurotropismo.

Atraviesa

barrera

placentaria

hematoencefálica; se liga a las proteínas plasmáticas hasta en un 17 % y se distribuye en el

plasma en aproximadamente 3.5 horas después de ingerida, se elimina a través de la orina

prácticamente metabolizada

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

producto: La eliminación del medicamento no utilizado y de los materiales que hayan

estado en contacto con él, se hará de acuerdo a la normativa local.

Fecha de aprobación/ revisión del texto: 15 de septiembre de 2014.

  • 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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