Описание
Этопозид-Эбеве (Этопозид) — современный цитостатик растительного происхождения, относящийся к полусинтетическим производным растительного алкалоида подофиллотоксина. Основное действующее вещество препарата — Этопозид, способен оказывать цитотоксическое действие за счет повреждения ДНК, ингибированием топоизомеразы II (что приводит к расщеплению одиночных и двойных цепочек ДНК). Высокие концентрации препарата вызывают лизис клеток в премитотической фазе. Его отличие от других известных производных подофиллотоксина в том, что не накапливается в метафазе, но ингибирует митоз клеток или вызывает гибель (апоптоз) клеток в фазе митоза. Запуск процесса самоуничтожения клеток внутри злокачественных образований приводит к регрессу карциномы и выздоровлению. Обладает относительно незначительной токсичностью, поэтому пациенты редко сталкиваются с алопецией при прохождении терапии.
Состав
Один мл раствора содержит:
- активное вещество: этопозид 20 мг;
- вспомогательные вещества: макрогол 300, полисорбат 80, бензиловый спирт, лимонная кислота безводная, этанол 96,7 %.
Показания препарата Этопозид-Эбеве
- герминогенные опухоли яичка и яичников;
- рак легкого.
Имеются сообщения об эффективности Этопозида-Эбеве при лечении:
- рака мочевого пузыря;
- лимфогранулематоза;
- неходжкинских лимфом;
- острого монобластного и миелобластного лейкоза;
- саркомы Юинга;
- трофобластических опухолей;
- рака желудка;
- саркомы Капоши;
- нейробластомы
- рак коры надпочечников.
Фармакодинамика
Этопозид является полусинтетическим липофильным производным подофиллина, характеризующееся сильным цитотоксическим воздействием и дозозависимым эффектом на патологические клетки. Препарат ингибирует митоз, приводя клетки к гибели в G-фазе и поздней S-фазе митотического цикла. Гибель клеток при этом происходит в зависимости от концентрации и продолжительности действия этопозида.
Этопозид также сдерживает проникновение нуклеотидов через плазматическую мембрану, что блокирует синтез и восстановлению ДНК.
Фармакокинетика
Абсорбция
После в/в введения максимальная концентрация составляет 30 мкг/мл. Препарат обнаруживается в слюне, плевральной жидкости, селезенке, ткани печени, почках, тканях мозга, миометрии. Этопозид проникает через ГЭБ и плацентарный барьер. Значения концентрации этопозида в спинномозговой жидкости варьируют от неопределяемых значений до 5% от концентрации в плазме крови. Данные о выделении препарата с грудным молоком отсутствуют. Связывание с белками плазмы составляет примерно 97%.
При приеме этопозида внутрь абсорбция из ЖКТ изменчива (снижается при увеличении дозы), биодоступность в среднем составляет 50% (в диапазоне от 25% до 75%). После в/в инфузии кинетика этопозида описывается двухфазной моделью с периодом полувыведение в начальной фазе около 1,5 часов и в конечную — 4–11 часов. Общий клиренс составляет 16–36 мл/мин/м2 или 33–48 мл/мин. Общий клиренс и терминальный период полувыведения не зависимы от дозы в диапазоне доз 100–600 мг/м2. Не накапливается в плазме при назначении в течение 4–5 дней в дозе 100 мг/м2.
Распределение
Распределение этопозида происходит быстро. Связывание с белками плазмы составляет около 94 %. Средний объем распределения составляет приблизительно 32 % массы тела. Этопозид относительно в небольшом количестве проникает в спинномозговую жидкость, так концентрации в тканях опухоли мозга и в спинномозговой жидкости ниже, по сравнению с содержанием в плазме.
В равновесном состоянии объем распределения составляет 18–29 литров или 7–17 литров/м2. Связывание с белками плазмы составляет 97%. Имеется прямое соотношение между уровнем сывороточного альбумина и коэффициентом связывания этопозида у больных раком и у здоровых добровольцев. Несвязанная фракция этопозида у лиц с заболеванием в значительной степени коррелировала со значением билирубина.
Метаболизм
Этопозид активно метаболизируется в организме. Главным образом метаболизируется в печени. Выводится почками (44–60%, из них 67% — в неизмененном виде), с фекалиями (до 16% — в неизмененном виде и в виде метаболитов), билиарным путем – 6% и менее.
Выведение
Выделение этопозида при этом осуществляется двухфазным способом. У пациентов с нормальной функцией печени и почек период полувыведения в среднем составляет приблизительно 0.6-2 часа с периодом полувыведения в окончательной фазе в пределах 5.3-10.8 чсов. Этопозид выводится с мочой в виде неизмененного вещества (29%) и метаболитов (около 15%) в течение 48-72 ч. 2-16% выделяется с калом.
Кинетика выведения из плазмы характеризуется как двух этапный процесс с исходным периодом полувыведения примерно 1,5 часа и конечным периодом полувыведения 4-11 часов. Около 45 % введенной дозы выводится с мочой, две трети выводится из организма в течение 72 часа.
Фармацевтические характеристики
Прозрачный раствор светло-желтого цвета.
Упаковка, срок годности, условия хранения
Флаконы из коричневого стекла (класс I) по 2,5 мл, 5 мл, 10 мл, 20 мл.
Размеры упаковки:
- 1 флакон × 50 мг/2,5мл
- 1 флакон × 100 мг/5мл
- 1 флакон × 200 мг/10мл
- 1 флакон × 400 мг/20мл
Хранить: в недоступном для детей месте, в защищенном от света месте, при температуре не выше 25 °C.
Срок годности 3 года. Не использовать по истечении срока годности, указанного на упаковке.
Наша компания работает как на территории Казахстана, так и осуществляет доставку в страны ближнего зарубежья. Обращайтесь к нам за консультациями по контактным телефонам.
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