Выраженные нарушения функции дыхания;. фиброз легочной ткани;. выраженные нарушения функции почек (КК менее 35 мл/мин) и/или печени;. заболевания сердечно-сосудистой системы тяжелого течения;. беременность;. повышенная чувствительность к блеомицину.
Инструкция
Торговое название препарата
Блеоцин лиофилизат
Лекарственная форма
Лиофилизат для приготовления раствора для инъекций, 15 мг, - флаконы (1) - пачки картонные
Состав
Блеомицин (в форме гидрохлорида) - 15 мг.
Фармакотерапевтическая группа
Противоопухолевое средство. Представляет собой A2-фракцию, изолированную из культуры Streptomyces verticillus, содержащую собственно противоопухолевый антибиотик. Механизм действия связан со способностью вызывать фрагментацию молекул ДНК. Обладает слабо выраженной миелодепрессивной и иммунодепрессивной активностью.
Фармакологические свойства
Связывание с белками 1%. Подвергается метаболизму, пути которого точно не установлены. T1/2 при КК более 35 мл/мин составляет 115 мин. Выводится почками, 60-70% преимущественно в неизмененном виде.
Показания к применению
Рак кожи, пищевода, легкого, шейки матки, щитовидной железы, почки;. злокачественные опухоли головы и шеи;. саркомы мягких тканей, остеогенная саркома;. лимфогранулематоз, неходжкинские лимфомы, герминогенные опухоли яичка и яичников.. лечение и профилактика экссудативного плеврита и лечение экссудативного перитонита при злокачественных опухолях (внутриполостное введение).
Противопоказания
Выраженные нарушения функции дыхания;. фиброз легочной ткани;. выраженные нарушения функции почек (КК менее 35 мл/мин) и/или печени;. заболевания сердечно-сосудистой системы тяжелого течения;. беременность;. повышенная чувствительность к блеомицину.
Применение при беременности и в период грудного вскармливания
Блеомицин противопоказан при беременности. В случае необходимости применения в период лактации грудное вскармливание следует прекратить. Женщины детородного возраста, получающие терапию блеомицином, должны применять надежные методы контрацепции. В экспериментальных исследованиях установлено тератогенное и эмбриотоксическое действие блеомицина.
Способ применения и дозы
В каждом индивидуальном случае при выборе дозы и режима введения Блеоцина следует пользоваться данными специальной литературы. Блеоцин можно вводить внутримышечно, внутривенно, подкожно или внутриплеврально.
Рекомендуемые дозы: внутримышечно (в 1-5 мл воды для инъекций, чередуя места инъекций) или внутривенно струйно (в 5-10 мл 0,9% раствора хлорида натрия или воды для инъекций в течение 5-10 минут) в дозе 10-15 мг/м² один или два раза в неделю интраплеврально (в 50-100 мл 0,9% раствора хлорида натрия после эвакуации максимально возможного количества экссудата) 60 мг однократно.
Из-за повышенного риска развития анафилактической реакции у больных злокачественными лимфомами начальная доза может быть снижена (например до 2-3 мг/м²). В случае отсутствия острой реакции на введение препарата, дальнейшая терапия может быть продолжена в обычной дозе.
Общая суммарная доза Блеоцина не должна превышать 400 мг и дальнейшее продолжение введения препарата можно осуществлять только после оценки функции легких.
У пожилых пациентов доза препарата определяется следующим образом:Возраст (годы )Общая дозаЕженедельная доза80 и старше100 мг15 мг70-79150-200 мг30 мг60-69200-300 мг30-60 мгМеньше 60400 мг30-60 мг
Введение Блеоцина детям может проводиться только в особых случаях, определение дозы препарата должно осуществляться из расчета поверхности тела.
При проведении лучевой терапии доза Блеоцина должна быть уменьшена, поскольку облученные ткани в большей степени чувствительны к препарату. Корректировка дозы препарата должна осуществляться и в том случае, если Блеоцин используется в сочетании с другими химиопрепаратами.
У больных с нарушением функции почек доза Блеоцина изменяется следующим образом - при уровне креатинина в сыворотке 130-180 мкмоль/л доза препарата должна быть снижена на 50 % при уровне креатинина в сыворотке более 180 мкмоль/л введение препарата откладывается до нормализации показателей уровня креатинина.
Побочное действие
Со стороны дыхательной системы: интерстициальная пневмония, фиброз легочной ткани. Со стороны пищеварительной системы: тошнота, рвота, анорексия, ангулярный стоматит, нарушения функции печени. Со стороны мочевыделительной системы: нарушения функции почек, частое и болезненное мочеиспускание. Со стороны ЦНС: головная боль, головокружение. Со стороны репродуктивной системы: азооспермия, аменорея. Аллергические реакции: эритема, крапивница, анафилактоидные реакции. Дерматологические реакции: очаговые гиперкератозы, гиперпигментация, дерматиты, деформация ногтей, алопеция. Прочие: повышение температуры, лейкопения; редко - токсическое действие на сосуды (в т.ч. церебральный артериит, инсульт, инфаркт миокарда).
Передозировка
Симптомы: непосредственными острыми реакциями в случае передозировки является артериальная гипотензия, лихорадка, учащенный пульс и общие симптомы шока.
Лечение: симптоматическое. При осложнениях со стороны бронхо-легочной системы пациентам должно быть назначено лечение глюкокортикостероидами и антибиотиками широкого спектра.
Взаимодействие с другими лекарственными средствами
Блеомицин повышает риск пневмотоксического действия у пациентов, получающих кислород (например, как часть общей анестезии).
При одновременном применении с препаратами, оказывающими миелотоксическое и пневмотоксическое действие возможно повышение риска развития побочных эффектов.
Возможно замедление клиренса блеомицина и усиление его токсического действия даже при применении в низких дозах вследствие нефротоксического действия цисплатина.
Особые указания
С осторожностью применяют у пациентов с заболеваниями легких (в т.ч. в анамнезе), с нарушениями функции почек, с ИБС, пороками сердца, у лиц пожилого возраста, а также у пациентов, получавших или получающих лучевую терапию.
С осторожностью применяют у больных с ветряной оспой (в т.ч. недавно перенесенной или после контакта с заболевшими), с опоясывающим герпесом и острыми инфекционными заболеваниями.
В процессе лечения необходимы систематический контроль функции органов дыхания, рентгенологическое исследование грудной клетки, контроль функции почек, печени. При появлении кашля или диспноэ лечение следует прекратить и назначить ГКС и антибиотики.
Безопасность применения в педиатрической практике не установлена.
В экспериментальных исследованиях установлено канцерогенное и мутагенное действие блеомицина. В связи с этим при применении блеомицина для лечения других заболеваний (грибовидный микоз, простые бородавки) необходима чрезвычайная осторожность.
Форма выпуска
Лиофилизат для приготовления раствора для инъекций
Условия хранения
В сухом, защищенном от света месте, при температуре не выше 25 °C
Срок годности
2 года
Условия отпуска
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Аллергические реакции: эритема, крапивница, анафилактоидные реакции. Дерматологические реакции: очаговые гиперкератозы, гиперпигментация, дерматиты, деформация ногтей, алопеция. Прочие: повышение температуры, лейкопения; редко - токсическое действие на сосуды (в т.ч. церебральный артериит, инсульт, инфаркт миокарда)."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: непосредственными острыми реакциями в случае передозировки является артериальная гипотензия, лихорадка, учащенный пульс и общие симптомы шока."}},{"type":"paragraph","data":{"text":"Лечение: симптоматическое. При осложнениях со стороны бронхо-легочной системы пациентам должно быть назначено лечение глюкокортикостероидами и антибиотиками широкого спектра."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Блеомицин повышает риск пневмотоксического действия у пациентов, получающих кислород (например, как часть общей анестезии)."}},{"type":"paragraph","data":{"text":"При одновременном применении с препаратами, оказывающими миелотоксическое и пневмотоксическое действие возможно повышение риска развития побочных эффектов."}},{"type":"paragraph","data":{"text":"Возможно замедление клиренса блеомицина и усиление его токсического действия даже при применении в низких дозах вследствие нефротоксического действия цисплатина."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"С осторожностью применяют у пациентов с заболеваниями легких (в т.ч. в анамнезе), с нарушениями функции почек, с ИБС, пороками сердца, у лиц пожилого возраста, а также у пациентов, получавших или получающих лучевую терапию."}},{"type":"paragraph","data":{"text":"С осторожностью применяют у больных с ветряной оспой (в т.ч. недавно перенесенной или после контакта с заболевшими), с опоясывающим герпесом и острыми инфекционными заболеваниями."}},{"type":"paragraph","data":{"text":"В процессе лечения необходимы систематический контроль функции органов дыхания, рентгенологическое исследование грудной клетки, контроль функции почек, печени. При появлении кашля или диспноэ лечение следует прекратить и назначить ГКС и антибиотики."}},{"type":"paragraph","data":{"text":"Безопасность применения в педиатрической практике не установлена."}},{"type":"paragraph","data":{"text":"В экспериментальных исследованиях установлено канцерогенное и мутагенное действие блеомицина. 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