SULFACETAMIDA

Información principal

  • Denominación comercial:
  • SULFACETAMIDA 20 %
  • Dosis:
  • 0,2 g/mL
  • formulario farmacéutico:
  • Colirio
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

Documentos

  • para el público en general:
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Localización

  • Disponible en:
  • SULFACETAMIDA 20 %
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • m16021s01
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

SULFACETAMIDA 20 %

Forma farmacéutica:

Colirio

Fortaleza:

0,2 g/mL

Presentación:

Estuche por un frasco gotero de PEBD blanco con 5 mL.

Titular del Registro Sanitario, país:

EMPRESA LABORATORIOS AICA, LA HABANA, CUBA.

Fabricante, país:

EMPRESA LABORATORIOS AICA, UNIDAD EMPRESARIAL

DE BASE (UEB) "LABORATORIOS JULIO TRIGO",

LA HABANA, CUBA.

Número de Registro Sanitario:

M-16-021-S01

Fecha de Inscripción:

18 de febrero de 2016

Composición:

Cada mL contiene:

Sulfacetamida sódica

200,0 mg

Ácido bórico

Borato de sodio

4,77 mg

8,60 mg

Tiosulfato de sodio

Metilparabeno

Propilparabeno

Edetato de sodio dihidratado

Agua para inyección

Plazo de validez:

12 meses

Condiciones de almacenamiento:

Almacenar por debajo de 25°C. Protéjase de la luz.

Indicaciones terapéuticas:

Tratamiento

infecciones

oculares

superficiales

causadas

organismos

sensibles

(tracoma, blefaritis, blefaroconjuntivitis, queratitis, queratoconjuntivitis).

Contraindicaciones:

Hipersensibilidad a las sulfonamidas o a cualquier componente de la fórmula. Porfiria, déficit

de glucosa 6 fosfato deshidrogenasa, anemia hemolítica por déficit de G6PD o piruvato

quinasa.

Precauciones:

Embarazadas: categoría de riesgo C.

LM: no existe información; estudios de seguridad insuficientes (emplear solo cuando sea

esencial).

Riesgo

kernicterus

recién

nacidos.

derivados

sulfas

recomiendan en lactantes con déficit de G6PD.

Niños: seguridad y efectividad no establecida en menores de 2 meses.

Precaución en el tratamiento del síndrome de ojo seco. Su uso implica el sobrecrecimiento de

organismos

susceptibles

incluso

hongos.

Puede

inactivada

extractos

purulentos.

Advertencias especiales y precauciones de uso:

Se debe cumplir estrictamente el ciclo completo del tratamiento. Producto de uso delicado

que debe ser administrado bajo vigilancia médica.

Efectos indeseables:

Frecuentes:

prurito,

enrojecimiento,

edema

irritación

piel,

reacciones

hipersensibilidad.

Ocasionales: cefalea, conjuntivitis específica y alérgica, hiperemia conjuntival e infecciones

secundarias.

Raras: síndrome de Stevens-Johnson o eritema multiforme, necrólisis tóxica epidérmica,

necrosis

hepática

fulminante,

anemia

aplásica,

anemia

déficit

G6PD

agranulocitosis.

Posología y método de administración:

Adultos: tópica, en la conjuntiva 1 o 2 gotas 4-6 veces al día, según la necesidad clínica.

Tratar entre 7 y 10 días. Niños: ver dosis para adultos.

Modo de administración: Ocular

Interacción con otros productos medicinales y otras formas de interacción:

Las sulfonamidas de uso tópico son incompatibles con las sales de plata, no se recomienda

su uso simultáneo con preparaciones que contengan plata, como: nitrato de plata y proteína

argéntica. No se debe administrar junto con sulfato de gentamicina por posible antagonismo.

Uso en Embarazo y lactancia:

Embarazo: categoría de riesgo C.

Lactancia

materna:

información,

estudios

seguridad

insuficientes

(emplear

solo

cuando sea esencial).

Efectos sobre la conducción de vehículos/maquinarias:

No se han reportado.

Sobredosis:

Medidas generales.

Propiedades farmacodinámicas:

Las sulfamidas son antisépticos bacteriostáticos de amplio espectro. Son análogos estructurales

del ácido aminobenzoico (PABA). La acción de las sulfamidas es antagonizada por el PABA y

sus derivados (por ejemplo, procaína, tetracaína) y por la presencia de pus o de detritus

tisulares que proporcionan los componentes necesarios para el crecimiento bacteriano.

Mecanismo de acción: inhibe competitivamente a una enzima bacteriana, la dihidrofólico

sintetasa, que es responsable de la incorporación del PABA al ácido dihidrofólico. Esto bloquea

síntesis

ácido

dihidrofólico

disminuye

cantidad

ácido

tetrahidrofólico

metabólicamente activo, un cofactor en la síntesis de purinas, timidina y ADN. Las bacterias

sensibles son aquellas que han de sintetizar ácido fólico.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

La sulfamida penetra en los tejidos y líquidos oculares.

Absorción: Después de la aplicación tópica de sulfacetamida 20 % se pueden absorber

pequeñas cantidades en la córnea. La sulfacetamida puede absorberse cuando las conjuntivas

están inflamadas.

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

producto:

Mantenga el envase dentro del estuche. Almacénese en el envase original. Desechar al mes

de abierto el envase.

Fecha de aprobación/ revisión del texto: 18 de febrero 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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