Противоопухолевое средство, ингибитор топоизомеразы I. Топои... Инструкция
Показания к применению
Вторая линия химиотерапии при раке яичников, мелкоклеточном раке легкого.
Противопоказания
Миелодепрессия с количеством нейтрофилов <1.5×109/л или тромбоцитов ≤100×109/л, беременность, лактация (грудное вскармливание), повышенная чувствительность к топотекану.
Инструкция
Состав
Лиофилизат для приготовления раствора для инфузий 1 фл.топотекан (в форме гидрохлорида) - 4 мг
Описание
Противоопухолевое средство, алкалоид
Фармакологические свойства
Противоопухолевое средство, ингибитор топоизомеразы I. Топоизомераза I - фермент, непосредственно участвующий в репликации ДНК. Топотекан связывается с комплексом топоизомераза I-ДНК и предотвращает повторное сшивание нитей ДНК. Полагают, что цитотоксическое действие топотекана обусловлено повреждением удвоенной нити ДНК, образующейся в процессе ее синтеза. При этом ферменты, участвующие в репликации, взаимодействуют с тройным комплексом, сформированным топотеканом, топоизомеразой I и ДНК.
Показания к применению
Вторая линия химиотерапии при раке яичников, мелкоклеточном раке легкого.
Противопоказания
Миелодепрессия с количеством нейтрофилов <1.5×109/л или тромбоцитов ≤100×109/л, беременность, лактация (грудное вскармливание), повышенная чувствительность к топотекану.
Способ применения и дозы
Устанавливают индивидуально, в зависимости от показаний, стадии заболевания, состояния системы кроветворения, схемы противоопухолевой терапии, функции почек.
Побочное действие
Со стороны системы кроветворения: нейтропения, лейкопения, тромбоцитопения, анемия.Со стороны пищеварительной системы: наиболее часто - тошнота, рвота, диарея, запор и стоматит; возможны - боли в животе, анорексия, гипербилирубинемия.Дерматологические реакции: часто - алопеция.Со стороны обмена веществ: редко - отеки.Прочие: возможны утомляемость, астения, недомогание; лихорадка, увеличение частоты инфекционных заболеваний, сепсис (обусловленные преимущественно нейтропенией).
Взаимодействие с другими лекарственными средствами
При одновременном применении топотекана с другими цитотоксическими средствами, вызывающими миелодепрессию, возможно усиление угнетающего действия на костный мозг.
Особые указания
Топотекан следует применять под наблюдением врача, имеющего опыт работы с цитотоксическими средствами.В период лечения следует регулярно контролировать картину периферической крови, включая уровень тромбоцитов.У пациентов с нарушениями функции печени наблюдается небольшое снижение клиренса топотекана.В исследованиях in vitro было показано генотоксическое действие на лимфомные клетки мышей и лимфоциты человека; in vivo - генотоксическое действие на клетки костного мозга мышей.При работе с топотеканом следует принимать следующие меры предосторожности: строго соблюдать правила приготовления растворов; не допускать беременных сотрудниц к работе с топотеканом; при приготовлении растворов следует пользоваться защитной одеждой (в т.ч. маской, защитными очками, защитными перчатками); все предметы, использованные при работе с препаратом, относятся к категории предметов высокого риска, их следует помещать в мешки для высокотемпературной переработки, оставшуюся жидкость можно смыть большим количеством воды; при случайном попадании топотекана на кожу или в глаза необходимо немедленно промыть их обильным количеством воды.Применение топотекана в педиатрии не рекомендуется.Влияние на способность к управлению транспортными средствами и механизмами С осторожностью применять у пациентов, деятельность которых связана с вождением автотранспорта и другой работой, при которой требуется концентрация внимания и высокая скорость психомоторных реакций.
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