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EQ 200 / Test E 200 Injectable Steroids

La diferencia observada fue principalmente debida a mas reportes de angina de pecho y estuvo asociada con un subgrupo de pacientes con enfermedad isquemica cardiaca preexistente. PRECAUCIONES EN RELACION CON EFECTOS DE CARCINOGENESIS, MUTAGENESIS, TERATOGENESIS Y SOBRE LA FERTILIDAD: Toxicidad aguda: En estudios con roedores la dosis letal mediana de anastrozol fue mayor de 100 mg/kg por via oral y mayor de 50 mg/kg por via intraperitoneal. En un estudio de toxicidad aguda en perros por via oral, la mediana de la dosis letal fue mayor de 45 mg/kg. Toxicidad cronica: Se realizaron multiples estudios de toxicidad en ratas y perros y no se establecieron niveles sin efecto en estos estudios de toxicidad con anastrozol, pero aquellos efectos observados a dosis baja (1 mg/kg/dia) y dosis media (perro 3 mg/kg/dia; rata 5 mg/kg/dia) estuvieron relacionados con las propiedades ya sea farmacologicas o bien inductoras de enzimas de anastrozol y no estuvieron acompanados de cambios toxicos o degenerativos significativos. Mutagenicidad: Los estudios de toxicologia genetica con anastrozol muestran que no es mutagenico ni clastogenico. Toxicologia reproductiva: La administracion oral de anastrozol en ratas y conejas prenadas no produjo efectos teratogenicos con dosis de hasta 1. Efectos observados (aumento del tamano de la placenta en ratas y embarazos mal logrados en conejas) estuvieron asociados con la farmacologia del producto. La administracion oral de anastrozol en ratas hembra produjo una alta incidencia de infertilidad con 1 mg/kg/dia asi como un incremento en la perdida de preimplantacion con 0. Estos efectos estuvieron relacionados con la farmacologia del compuesto y fueron revertidos completamente despues de un periodo de suspension del producto de cinco semanas. La supervivencia de las camadas de ratas a las que se les administro anastrozol 0, eq 200 / test e 200 injectable steroids . Estos efectos se relacionaron con los efectos farmacologicos del compuesto durante el parto. No hubo efectos adversos en el comportamiento o en la funcion reproductiva de la primera generacion de crios atribuible al tratamiento materno con anastrozol. Carcinogenicidad: Resultados de dos anos de estudios sobre oncogenicidad en ratas mostraron un aumento en la incidencia de tumores hepaticos, polipos uterinos en hembras y adenomas tiroideos en machos solamente a dosis elevadas (25 mg/kg/dia). Estos cambios ocurrieron con dosis que representan 100 veces las dosis terapeuticas en humanos y no son considerados clinicamente significativos en pacientes tratados con anastrozol. Resultados de dos anos de estudios sobre oncogenicidad en ratones tuvieron como resultado la induccion de tumores benignos ovaricos y variaciones en la incidencia de tumores linforreticulares (menos sarcomas histiociticos en hembras y mas muertes como resultado de linfomas). Estos estudios estan considerados como efectos especificos en ratones por la inhibicion de aromatasa y no son clinicamente significativos en pacientes tratados con anastrozol. INTERACCIONES MEDICAMENTOSAS Y DE OTRO GENERO: Los estudios clinicos de interaccion con antipirina y cimetidina indican que es poco probable que la coadministracion de ARIMIDEX ‘ con otros medicamentos produzca interacciones medicamentosas mediadas por el citocromo P-450 que sean clinicamente significativas. La revision de los aspectos de seguridad en la base de datos clinicos no revelo evidencia de interacciones clinicas significativas en pacientes tratadas con ARIMIDEX ‘ quienes tambien recibieron otros medicamentos comunmente prescritos. No hubo interacciones clinicamente significativas con bifosfonatos (vease Farmacocinetica y farmacodinamia). Medicamentos como tamoxifeno y otros tratamientos que contengan estrogenos no deben ser coadministrados con ARIMIDEX ‘ debido a que disminuyen su accion farmacologica. ALTERACIONES EN LOS RESULTADOS DE PRUEBAS DE LABORATORIO: Con poca frecuencia ( ? 0. ARIMIDEX ‘ no ha sido investigado en pacientes con insuficiencia hepatica o renal severa. El potencial riesgo/beneficio para tales pacientes debe ser cuidadosamente considerado antes de la administracion de ARIMIDEX ‘. Como ARIMIDEX ‘ disminuye los niveles de estrogenos circulantes, puede ocasionar una reduccion en la densidad mineral osea teniendo como probable consecuencia un incremento en el riesgo de fracturas. Este posible incremento de riesgo debe manejarse de acuerdo a las guias de tratamiento para la salud osea en mujeres postmenopausicas.
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