Carbamazepina

Suspensión al 2%
Tabletas de liberación retardada
Anticonvulsivante
(Carbamazepina)

Composición Carbamazepina

Cada 100 mL de Suspensión CARBAMAZEPINA MK® al 2% contieneCarbamazepina 2 g; excipientes c.s.
Cada Tableta de libreación retardada de CARBAMAZEPINA MK® contiene Carbamazepina 200 mg; excipientes c.s.
Cada Tableta de liberación retardada de CARBAMAZEPINA MK® contiene Carbamazepina 400 mg; excipientes c.s.

Presentaciones Carbamazepina

CARBAMAZEPINA MK® 200 mg, caja por 30 tabletas retard de 200 mg (Reg. San. No. INVIMA 2009 M-013034-R1).
CARBAMAZEPINA MK® 400 mg, caja por 20 tabletas retard de 400 mg (Reg. San. No. INVIMA 2009 M- 013171-R1).
CARBAMAZEPINA MK® Suspensión al 2%, frasco por 120 ml de suspensión al 2% (Reg. San. 2015 M-014599- R2).

Descripción Carbamazepina

La CARBAMAZEPINA MK® es un anticonvulsivante derivado de la carboxamida, además cuenta con efectos antineurálgicos.

Mecanismo de acción Carbamazepina

Aunque aún no es claro el mecanismo de acción de la Carbamazepina, se presume que puede deprimir la actividad en el nucleus ventralis del tálamo, disminuir la transmisión sináptica o disminuir la sumatoria de la estimulación temporal que lleva a descarga neural, limitando el influjo de iones de sodio a través de la membrana celular u otro mecanismo aún desconocido.

Indicaciones Carbamazepina

Anticonvulsivante, Enfermedad maniaco depresiva, Neuralgia del trigémino.

Farmacocinética Carbamazepina

Absorción: La Carbamazepina se absorbe bien por el tracto gastrointestinal tras su administración oral, el tiempo para obtener la concentración máxima es de 40 horas y de 8,89 mcg/ml.
Distribución: La Carbamazepina se une a proteínas plasmáticas en un 76% y sus concentraciones alcanzan rangos entre 0,5 y 25 mcg/ml, sin una relación aparente con la frecuencia de la dosis administrada; los niveles terapéuticos se alcanzan con concentraciones entre 4 y 12 mcg/ml. La relación de la concentración de Carbamazepina en el líquido cefalorraquídeo y el plasma es de 0,22, similar al porcentaje de Carbamazepina no unida a proteínas (24%) en plasma.
Metabolismo: Debido a que la Carbamazepina induce su propio metabolismo, la vida media es muy variable en el tiempo. Este fenómeno de autoinducción del metabolismo, se completa después de 3-5 semanas de un régimen de dosificación fijo. La Carbamazepina se metaboliza en el hígado, mediante el citocromo P450, isoforma CYP3A4, está es responsable de la conversión del fármaco en Carbamazepina-10 ,11-epóxido.
Eliminación: La vida media inicial de la Carbamazepina (antes de que se instaure el fenómeno de autoinducción), se encuentra en un rango de 25 a 65 horas, disminuyendo a 17,12 horas, luego de llevar un tiempo con dosis repetidas. Tras la administración oral de Carbamazepina marcada con carbono 14, el 72% de la radiactividad administrada se encontró en la orina y el 28% en las heces. Esta estaba compuesta principalmente de metabolitos hidroxilados y conjugados.

Posología Carbamazepina

Se recomienda iniciar con dosis bajas e incrementar gradualmente hasta conseguir el efecto terapéutico. La dosis óptima requiere determinación plasmática.
Niños: Se inicia con 10 a 20 mg/kg/día, procurando llegar a la dosis completa al cabo de 3 a 4 semanas.
Adultos:
− Primera semana: 100 mg cada 12 horas.
− Segunda semana: 200 mg cada 12 horas.
− Tercera semana en adelante: 200 mg cada 8 horas. En algunos pacientes la dosis con la forma retard debe ser incrementada.

Contraindicaciones y advertencias Carbamazepina

Suspensión al 2%: Hipersensibilidad conocida a la Carbamazepina, a fármacos estructuralmente relacionados con esta (como los antidepresivos tricíclicos) o a cualquier otro componente de la formulación. Pacientes con bloqueo auriculoventricular. Pacientes con antecedentes de depresión de la médula ósea. Pacientes con antecedentes de porfirias hepáticas (p. ej.: porfiria intermitente aguda, porfiria mixta, porfiria cutánea tardía). El uso con inhibidores de la monoaminoxidasa (imao) está contraindicada. Advertencias y precauciones: debe administrarse únicamente bajo supervisión médica. En los individuos con antecedentes de alteraciones cardíacas, hepáticas o renales, reacciones hematológicas adversas a otros medicamentos o interrupción del tratamiento. Sólo se prescribirá tras una estimación crítica de los riesgos y beneficios esperados, y ello bajo estrecha vigilancia médica. Ideas de autolesión o suicidio. Riesgo de trastornos de la densidad mineral ósea con el uso a largo plazo, que puede conducir al desarrollo de osteopenia, osteoporosis y fracturas. Durante el tratamiento a largo plazo se recomienda monitorear la densidad mineral ósea del paciente.
Tabletas 200 mg y 400 mg: Insuficiencia renal o hepática; embarazo a menos que sea absolutamente necesario, lactancia; no administrar concomitantemente con inhibidores de la MAO ni con alcohol. Adminístrese con precaución en pacientes con glaucoma, enfermedad cardiovascular y en pacientes con trastornos sanguíneos. Precauciones: Aumenta el riesgo de presentar ideas de autolesión y conductas suicidas. Riesgo de trastornos de la densidad mineral ósea con el uso a largo plazo, que puede conducir al desarrollo de osteopenia, osteoporosis y fracturas. Durante el tratamiento a largo plazo se recomienda monitorear la densidad mineral ósea del paciente.

Precauciones Carbamazepina

Adminístrese con precaución en pacientes con enfermedad hepática. Se han reportado alteraciones hematológicas potencialmente fatales, por lo que se recomienda estar atento a signos tempranos, incluyendo fiebre, dolor de garganta, úlceras en la boca, infecciones, producción de hematomas, petequias y hemorragias. La Carbamazepina no es efectiva en convulsiones mioclónicas o akinéticas, ni crisis de ausencias. En niños con desórdenes convulsivos mixtos, se han observado exacerbaciones de ciertas convulsiones después de iniciar Carbamazepina; los adultos mayores en tratamiento con Carbamazepina, tienen mayor riesgo de un síndrome de secreción inadecuada de aldosterona. Aumenta el riesgo de presentar ideas de autolesión y conductas suicidas. Se deben realizar controles periódicos de cuadro hemático y función hepática.

Eventos adversos Carbamazepina

Arritmias, bloqueo auriculoventricular, bradicardia, edema, híper e hipotensión, insuficiencia cardiaca congestiva, linfadenopatía, síncope, tromboembolismo, tromboflebitis, ataxia, cefalea, confusión, fatiga, disartria, mareo, meningitis aséptica, neuritis periférica, sedación, alteraciones de la pigmentación de la piel, alopecia, fotosensibilidad, púrpura, erupción, síndrome de Stevenss-Johnson (en especial si es asociado al ácido valproico), urticaria, anorexia, estreñimiento, malestar estomacal, náusea, pancreatitis, vómito, falla renal, impotencia, polaquiuria, retención urinaria, anemia aplástica, agranulocitosis, depresión de la médula ósea, eosinofilia, leucopenia, leucocitosis, pancitopenia, porfiria intermitente aguda, trombocitopenia, falla hepática, hepatitis, ictericia, conjuntivitis, nistagmus, opacidades del cristalino, visión borrosa, tos, diaforesis, reacciones de hipersensibilidad, vasculitis y trastornos similares a linfoma.

Interacciones farmacológicas Carbamazepina

Los inhibidores de la monoaminoxidasa, se deben suspender mínimo 14 días antes de iniciar la terapia con Carbamazepina.
Aumento del efecto/tóxico: Los niveles plasmáticos (y por tanto la toxicidad) de la Carbamazepina, pueden ser aumentados por amprenavir, cimetidina, claritromicina, danazol, diltiazem, eritromicina, felbamato, fluoxetina, fluvoxamina, isoniacida, lamotrigina, metronidazol, propoxifeno, verapamilo, fluconazol, itraconazol y ketoconazol. La Carbamazepina puede aumentar el potencial tóxico del acetaminofén. El uso concomitante con litio puede resultar en neurotoxicidad.
Disminución del efecto: La Carbamazepina puede disminuir el efecto de las benzodiacepinas, el citalopram, la clozapina, los corticoides, la ciclosporina, la doxiciclina, la etosuximida, el felbamato, el felodipino, el haloperidol, el mebendazol, la metadona, los anticonceptivos orales, la fenitoína, el tacrolimus, la teofilina, las hormonas tiroideas, los antidepresivos tricíclicos, el ácido valproico y la warfarina. La dosis de la presentación en suspensión de Carbamazepina debe ser programada por lo menos con una a dos horas de diferencia, con cualquier otra medicina líquida. La mefloquina puede disminuir la concentración sérica de Carbamazepina.
Consideraciones dietarias: Evite el alcohol (pues aumenta la depresión del sistema nervioso central). Los niveles séricos pueden aumentar al tomarse con comida o jugo de toronja. Evitar uso conjunto con valeriana, hierba de San Juan, kava kava, kola (pueden aumentar la depresión del sistema nervioso central).

Embarazo y lactancia Carbamazepina

Categoría D: Existe evidencia de riesgo para el feto basada en datos de investigación, datos post-comercialización, registros de reacciones adversas o estudios en humanos, aunque los beneficios potenciales de su uso en mujeres embarazadas pueden ser aceptables a pesar de los riesgos probables en algunas situaciones.

Sobredosis Carbamazepina

La dosis letal más baja conocida en adultos es de 3,2 g (una mujer de 24 años murió de paro cardiaco y un hombre de 24 años murió de neumonía y encefalopatía hipóxica); para niños es de 4 g (una niña de 14 años murió de paro cardiaco), 1,6 g (una niña de 3 años murió de neumonía por aspiración). Los primeros signos y síntomas aparecen después de 1-3 horas. Los más prominentes son las alteraciones neuromusculares, los desórdenes cardiovasculares generalmente son leves y las complicaciones cardiacas severas se presentan solo cuando se han ingerido dosis muy altas (>60 g). Se ha reportado respiración irregular, depresión respiratoria, taquicardia, hipotensión o hipertensión, shock, desórdenes de conducción, alteraciones de la conciencia que oscilan en severidad hasta el coma profundo, convulsiones, especialmente en niños pequeños, inquietud motora, espasmos musculares, temblor, movimientos atetósicos, opistótonos, ataxia, “modorra”, mareo, midriasis, nistagmus, adiadocoquinesia, balismo, alteraciones psicomotoras, dismetría. Hiperreflexia inicial, seguida de hiporreflexia, náuseas, vómito, anuria u oliguria, retención urinaria. En casos aislados de sobredosis se han encontrado: Leucocitosis y también reducción del recuento de leucocitos, glicosuria y acetonuria. El electrocardiograma puede mostrar disritmias. Cuando se ingieren alcohol, antidepresivos tricíclicos, barbitúricos o hidantoínas al mismo tiempo, los signos y síntomas de intoxicación aguda por Carbamazepina pueden agravarse o modificarse. El pronóstico en casos de toxicidad severa es críticamente dependiente de la eliminación rápida del medicamento, la cual puede lograrse mediante la inducción de vómito, irrigación del estómago y siguiendo los pasos apropiados para disminuir la absorción. Si estas medidas no pueden ser implementadas sin riesgo en el lugar, el paciente debe ser trasladado inmediatamente a un hospital, asegurándose mientras tanto de proteger las funciones vitales. No existe antídoto específico. Incluso aunque hayan pasado más de 4 horas desde la ingesta del medicamento, el estómago debe ser irrigado en forma repetida, especialmente si el paciente también ha consumido alcohol. Se deben implementar medidas para Reducir la absorción, como son el carbón activado y los laxantes osmóticos, otra medida que puede ser empleada consiste en forzar la diuresis. La diálisis está indicada únicamente en la intoxicación severa asociada a falla renal. La transfusión de reemplazo está indicada en la intoxicación severa en niños pequeños. Para el manejo de la depresión respiratoria, se debe mantener despejada la vía aérea, en caso de necesidad utilice el recurso de la intubación endotraqueal, respiración artificial y administración de oxígeno. Si se presenta hipotensión y/o shock mantenga elevadas las piernas del paciente y administre un expansor del volumen plasmático. Si la presión arterial no sube a pesar de las medidas tomadas para aumentar el volumen plasmático, considere la posibilidad de utilizar vasopresores. En caso que el paciente presente convulsiones se debe tener en cuenta que el diazepam o los barbitúricos pueden agravar la depresión respiratoria (especialmente en niños), así como llevar al paciente a hipotensión y coma. No se deben utilizar barbitúricos si el paciente también ha ingerido inhibidores de la monoamino oxidasa, ya sea en sobredosis o como terapia reciente (en la última semana). Después de la fase aguda de la intoxicación se deben controlar continuamente y durante varios días la función respiratoria, la función cardiaca (mediante monitorización de electrocardiograma), la presión arterial, la temperatura corporal, los reflejos pupilares y las funciones renal y vesical.
Si existe evidencia de desarrollo de depresión de la médula ósea, se sugieren las siguientes recomendaciones:
1. Suspenda el medicamento.
2. Tome diariamente un cuadro hemático completo con recuento de plaquetas y de reticulocitos.
3. Tome de forma inmediata un aspirado de médula ósea y biopsia con trépano y repítalos con suficiente frecuencia para monitorizar la recuperación.
Los estudios especiales periódicos que pueden ser útiles incluyen:
1. Anticuerpos contra leucocitos y plaquetas
2. Estudios de 59Fe-ferroquinético.
3. Frotis de sangre periférica con tipificación celular.
4. Estudios citogenéticos de médula y sangre periférica.
5. Estudios de cultivo de médula ósea para unidades formadoras de colonias.
6. Electroforesis de hemoglobina para hemoglobina A2 y F.
7. Niveles séricos de ácido fólico y B12. La anemia aplásica completamente desarrollada requerirá monitorización y terapia intensivas apropiadas, para lo cual se debe considerar una consulta especializada.

Recomendaciones generales Carbamazepina

Almacenar a temperatura inferior a 30 ºC. Manténgase fuera del alcance de los niños. Venta bajo fórmula médica.

Fuente: Carbamazepina MK®

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