Концентрат Доксорубицин-Эбеве для приготовления раствора для внутрисосудистого и внутрипузырного введения. Лекарственное средство, которое используют для лечения раковых заболеваний различных органов. Доксорубицин-Эбеве используется в качестве, как основного, так и вспомогательного препарата при проведении курса химиотерапии.
Фармакологические свойства
Противоопухолевый антибиотик антрациклинового ряда, выделенный из культуры Streptomyces peucetius var. caesius. Оказывает антимитотическое и антипролиферативное действие. Описано три основных механизма действия доксорубицина: взаимодействие с ДНК, ингибирование топоизомеразы I, ДНК и РНК полимераз, образование свободных радикалов и прямое воздействие на мембраны клеток, что приводит к подавлению репликации ДНК и синтеза нуклеиновых кислот, а также прямому цитотоксическому действию. Клетки чувствительны к препарату в S- и G2-фазах митоза.
Доксорубицин можно применять как в качестве монотерапии, так и в комбинации с другими цитостатиками в различных дозах в зависимости от схемы терапии. При индивидуальном подборе дозы следует руководствоваться данными специальной литературы. Внутривенное введение: в качестве монотерапии рекомендованная доза на цикл составляет 60-75 мг/м2 каждые 3 недели. Обычно препарат вводят однократно в течение цикла, однако цикловую дозу можно разделить на несколько введений (например, вводить в течение первых 3 дней подряд, или в первый и в восьмой день цикла). Циклы повторяются каждые 3-4 недели, для уменьшения токсического действия доксорубицина, особенно кардиотоксичности, применяется еженедельный режим введения препарата по 10-20 мг/м2, в комбинации с другими противоопухолевыми препаратами доксорубицин назначается в цикловой дозе 30-60 мг/м2 каждые 3-4 недели. Нарушение функции печени. У пациентов с гипербилирубинемией доза доксорубицина должна быть уменьшена в соответствии с концентрацией общего билирубина: на 50% при концентрации билирубина в сыворотке крови 1.2-3.0 мг/дл, на 75% при концентрации билирубина в сыворотке крови выше 3.0 мг/дл. Суммарная доза доксорубицина не должна превышать 550 мг/м2. У больных, получавших ранее лучевую терапию на область легких и средостения или лечившихся другими кардиотоксичными препаратами, суммарная доза доксорубицина не должна быть более 400 мг/м2. Внутривенное введение доксорубицина следует проводить с осторожностью. Для уменьшения риска развития тромбозов и экстравазации рекомендуется вводить доксорубицин через трубку системы для в/в введения, во время инфузии 0.9% раствора хлорида натрия или 5% раствора декстрозы, в течение 3-5 минут. Введение в мочевой пузырьВведение в мочевой пузырь применяется для лечения поверхностных опухолей мочевого пузыря, а также профилактики рецидивов после трансуретральной резекции. Введение в мочевой пузырь не применяется для лечения инвазивных опухолей с прорастанием в мышечную стенку мочевого пузыря. Рекомендуемая доза для внутрипузырного введения - 30-50 мг на инстилляцию, с интервалами между введениями от 1 недели до 1 месяца, в зависимости от целей терапии - лечение или профилактика. Рекомендуемая концентрация раствора - 1 мг/1 мл воды для инъекций или 0.9% раствора хлорид натрияа. После завершения инстилляции, для обеспечения равномерного воздействия препарата на слизистую мочевого пузыря, пациенты должны переворачиваться с боку на бок каждые 15 минут. Как правило, препарат должен находиться в мочевом пузыре в течение 1-2 часа. В конце инстилляции пациент должен опорожнить мочевой пузырь. Чтобы не допустить чрезмерного разбавления препарата мочой, пациенты должны быть предупреждены о том, что им следует воздерживаться от приема жидкости в течение 12 часов перед инстилляцией. Системное всасывание доксорубицина при инстилляции в мочевой пузырь является очень низким. При проявлениях местного токсического действия (химический цистит, который может проявляться дизурией, полиурией, никтурией, болезненным мочеиспусканием, гематурией, дискомфортом в области мочевого пузыря, некрозом стенки мочевого пузыря) дозу, предназначенную для инстилляций, следует растворить в 50-100 мл 0.9% раствора хлорид натрияа. Особое внимание следует уделить проблемам, связанным с катетеризацией (например, при обструкции мочеиспускательного канала, обусловленной массивными внутрипузырными опухолями). Внутриартериальное введениеБольным с гепатоцеллюлярным раком для обеспечения интенсивного местного воздействия при одновременном уменьшении общего токсического действия доксорубицин может быть введен внутриартериально в главную печеночную артерию в дозе 30-150 мг/м2 с интервалом от 3 недель до 3 месяцев. Более высокие дозы следует применять только в тех случаях, когда одновременно осуществляется экстракорпоральное выведение препарата. Поскольку этот метод потенциально опасен, и при его использовании может произойти воздушная эмболия и/или артериальный тромбоз, приводящий к распространенному некрозу ткани, внутриартериальное введение могут осуществлять только врачи, в совершенстве владеющие данной методикой.
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При индивидуальном подборе дозы следует руководствоваться данными специальной литературы. Внутривенное введение: в качестве монотерапии рекомендованная доза на цикл составляет 60-75 мг/м2 каждые 3 недели. Обычно препарат вводят однократно в течение цикла, однако цикловую дозу можно разделить на несколько введений (например, вводить в течение первых 3 дней подряд, или в первый и в восьмой день цикла). Циклы повторяются каждые 3-4 недели, для уменьшения токсического действия доксорубицина, особенно кардиотоксичности, применяется еженедельный режим введения препарата по 10-20 мг/м2, в комбинации с другими противоопухолевыми препаратами доксорубицин назначается в цикловой дозе 30-60 мг/м2 каждые 3-4 недели. Нарушение функции печени. 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