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English to Spanish: Prescribing information General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English 7. DRUG INTERACTIONS
7.11. Effect of X on the Metabolism of Other Drugs
No in vivo clinical trials have investigated the effect of X on the clearance of drugs metabolized by CYYP 3A4 (e.g. cisapride, terfenadine) or by CYP 2D6 (e.g. imipramine). However, in vitro studies show a low rate of binding to these enzymes (mean Ki about 50-130 μM), that, given the therapeutic plasma concentrations of donepezil (164 nM), indicates little likelihood of interference.
Whether X has any potential for enzyme induction is not known. Formal pharmacokinetic studies evaluated the potential of X for interaction with theophylline, cimetidine, warfarin, digoxin and ketoconazole. No effects of X on the pharmacokinetics of these drugs were observed.
7.22. Effect of Other Drugs on the Metabolism of X
Ketoconazole and quinidine, inhibitors of CYP450, 3A44 and 2D6, respectively, inhibit donepezil metabolism in vitro. Whether there is a clinical effect of quinidine is not known. In a 7-day crossover study in 18 healthy volunteers, ketoconazole (2000 mg q.d.) increased mean donepezil (5 mg q.d.) concentrations (AUC0-24 and Cmax) by 36%. The clinical relevance of this increase in concentration is unknown.
A small effect of CYYP2D6 inhibitors was identified in a population pharmacokinetic analysis of plasma donepezil concentrations measured in patients with Alzheimer’s disease. Donepezil clearance was reduced by approximately 17% in patients taking 10 or 23 mg in combination with a known CYP2D6 inhibitor. This result is consistent with the conclusion that CYYP2D6 is a minor metabolic pathway of donepezil.
Inducers of CYP 2DD6 and CYP 3A4 (e.g., phenytoin, carbamazepine, dexamethasone, rifampin, and phenobarbital) could increase the rate of elimination of X. Formal pharmacokinetic studies demonstrated that the metabolism of X is not significantly affected by concurrent administration of digoxin or cimetidine.
Translation - Spanish 7. INTERACCIONES MEDICAMENTOSAS
7.11. Efecto de X sobre el metabolismo de otros fármacos
No se han realizado estudios clínicos «in vivo» para investigar el efecto de X sobre la depuración de fármacos metabolizados por CYP3A4 (p. ej., cisaprida o terfenadina) o por CYP2D6 (p. ej., imipramina). Sin embargo, los estudios «in vitro» muestran un índice bajo de unión a estas enzimas (valor Ki promedio: alrededor de 50 a 130 μM), lo que, dadas las concentraciones plasmáticas terapéuticas de donepezilo (164 nM), indica pocas probabilidades de interferencia.
Se desconoce si X tiene potencial de inducción enzimática. Estudios farmacocinéticos formales evaluaron la capacidad de interacción de X con los fármacos teofilina, cimetidina, warfarina, digoxina y ketoconazol. No se observó ningún efecto de X sobre la farmacocinética de estos fármacos.
7.22. Efecto de otros fármacos sobre el metabolismo de X
El ketoconazol y la quinidina, inhibidores de CYP450, 3A44 y 2D6, respectivamente, inhiben el metabolismo del donepezilo «in vitro». No se sabe si existe un efecto clínico de la quinidina. En un estudio cruzado, con una duración de 7 días, realizado en 18 voluntarios sanos, el ketoconazol (2.000 mg diarios) incrementó las concentraciones promedio del donepezilo (5 mg diarios) (AUC0 24 y Cmáx) en un 36%. No se ha descubierto la relevancia clínica de este incremento de la concentración.
En un análisis farmacocinético poblacional de las concentraciones plasmáticas de donepezilo realizado en pacientes con enfermedad de Alzheimer, se identificó un efecto leve de los inhibidores de CYP2D6. La depuración de donepezilo se redujo en un 17% aproximadamente en pacientes que recibieron 10 o 23 mg en combinación con un inhibidor conocido de CYP2D6. Este resultado coincide con la conclusión de que la enzima CYP2D6 es una vía metabólica de menor importancia del donepezilo.
Los inductores de CYP2D6 y CYP3A4 (p. ej., fenitoína, carbamazepina, dexametasona, rifampicina y fenobarbital) podrían incrementar la velocidad de eliminación de X. Estudios farmacocinéticos formales demostraron que el metabolismo de X no se ve afectado en forma significativa por la administración concomitante de digoxina o cimetidina.
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