Всасывание и распределение Анастрозол после приема внутрь на... Инструкция
Показания к применению
Адъювантная терапия раннего рака молочной железы, с положительными гормональными рецепторами у женщин в постменопаузе, в т.ч. после 2-3 летней адъювантной терапии тамоксифеном; первая линия терапии местно-распространенного или метастатического рака молочной железы, с положительными или неизвестными гормональными рецепторами у женщин в постменопаузе; ...
Противоопухолевый препарат. Высокоселективный нестероидный ингибитор ароматазы - фермента, с помощью которого у женщин в постменопаузе андростендион в периферических тканях превращается в эстрон и далее в эстрадиол. Анастрозол не обладает гестагенной, андрогенной и эстрогенной активностью. У женщин в постменопаузе анастрозол в суточной дозе 1 мг вызывает снижение уровня эстрадиола на 80%. Анастрозол в суточных дозах до 10 мг не оказывает эффекта на секрецию кортизола и альдостерона.
Фармакологические свойства
Всасывание и распределение
Анастрозол после приема внутрь натощак быстро всасывается из ЖКТ. Cmax в плазме достигается в течение 2 ч. Пища незначительно уменьшает скорость всасывания (но не его степень) и не приводит к клинически значимому влиянию на Css препарата в плазме при однократном приеме суточной дозы анастрозола. После 7-дневного приема препарата Css анастрозола в плазме составляет приблизительно 90-95%. Связывание с белками плазмы крови - 40%.
Метаболизм и выведение
Метаболизм анастрозола осуществляется N -деалкилированием, гидроксилированием и глюкуронизацией. Триазол, основной метаболит, определяемый в плазме, не ингибирует ароматазу.
T1/2 из плазмы составляет 40-50 ч. Менее 10% дозы выделяется с мочой в неизмененном виде в течение 72 ч после приема препарата. Метаболиты выводятся преимущественно с мочой.
Клиренс анастрозола после приема внутрь при циррозе печени или нарушении функции почек не изменяется.
Показания к применению
Адъювантная терапия раннего рака молочной железы, с положительными гормональными рецепторами у женщин в постменопаузе, в т.ч. после 2-3 летней адъювантной терапии тамоксифеном; первая линия терапии местно-распространенного или метастатического рака молочной железы, с положительными или неизвестными гормональными рецепторами у женщин в постменопаузе; вторая линия терапии распространенного рака молочной железы, прогрессирующего после лечения тамоксифеном.
умеренная или выраженная печеночная недостаточность (безопасность и эффективность применения препарата не установлена);
сопутствующая терапия тамоксифеном;
пременопауза;
беременность;
период грудного вскармливания;
детский возраст;
повышенная чувствительность к анастрозолу или другим компонентам препарата.
Способ применения и дозы
Взрослым, в т.ч. пожилым пациентам препарат следует принимать внутрь в одно и то же время по 1 мг (проглотить таблетку целиком, запивая водой) 1 раз/сут длительно. При появлении признаков прогрессирования заболевания прием препарата следует прекратить. Коррекция дозы у пациентов с легкими и умеренными нарушениями функции почек не требуется. Коррекция дозы у пациентов с легкой степенью нарушения функции печени не требуется.
Побочное действие
Определение частоты побочных реакций:
очень часто ( > 10%);
часто (1-10%);
редко (0,1-1%);
очень редко ( < 0,1%).
Со стороны репродуктивной системы: часто - сухость влагалища; редко - влагалищные кровотечения (в основном в течение первых недель после отмены или смены предшествующей гормональной терапии на анастрозол).
Со стороны пищеварительной системы: часто - тошнота, диарея; редко - анорексия, рвота, увеличение активности ГГТ и ЩФ.
Со стороны сердечно-сосудистой системы: очень часто - "приливы" жара.
Со стороны ЦНС: часто - головная боль; редко - сонливость.
Co стороны костно-мышечной системы: часто - артралгия.
Дерматологические реакции: часто - истончение волос, кожная сыпь; очень редко - полиморфная эритема (синдром Стивенса-Джонсона).
Со стороны обмена веществ: редко - гиперхолестеринемия; возможно - снижение минеральной плотности костной ткани в связи со снижением уровня циркулирующего эстрадиола (риск возникновения остеопороза, переломов костей).
Прочие: часто - астения; очень редко - аллергические реакции (в т.ч. ангиоэдема, крапивница, анафилактический шок).
Передозировка
Симптомы: однократная доза анастрозола, которая могла бы привести к симптомам, угрожающим жизни, не определена. Лечение: в случае передозировки лечение должно быть симптоматическим. Если пациент находится в сознании, целесообразно вызвать рвоту. Рекомендуется общая поддерживающая терапия, наблюдение за пациентом и контроль функции жизненно важных органов и систем. Может быть проведен диализ. Специфического антидота не существует.
Взаимодействие с другими лекарственными средствами
Исследования по лекарственному взаимодействию с антипирином и циметидином указывают на то, что клинически значимое лекарственное взаимодействие, опосредованное изоферментами системы цитохрома Р450 при совместном применении анастрозола с другими препаратами маловероятно.
Клинически значимое лекарственное взаимодействие при применении анастрозола одновременно с другими часто назначаемыми препаратами отсутствует.
На данный момент нет сведений о применении анастрозола в комбинации с другими противоопухолевыми препаратами.
Препараты, содержащие эстрогены, уменьшают фармакологическое действие анастрозола, в связи с чем, они не должны назначаться одновременно с анастрозолом.
Не следует назначать тамоксифен одновременно с анастрозолом, поскольку он может ослабить фармакологическое действие последнего.
Особые указания
У женщин с рецептороотрицательной опухолью к эстрогенам эффективность анастрозола не была продемонстрирована, кроме тех случаев, когда имелся предшествующий положительный клинический ответ на тамоксифен.
В случае сомнений в гормональном статусе пациентки менопаузу следует подтвердить определением половых гормонов в сыворотке крови.
Нет данных о применении анастрозола у пациентов с тяжелой степенью нарушений функции печени или у пациентов с выраженными нарушениями функции почек (КК < 20 мл/мин).
В случае сохраняющегося маточного кровотечения на фоне приема анастрозола необходима консультация и наблюдение гинеколога.
Препараты, содержащие эстрогены, не следует применять одновременно с анастрозолом, поскольку они будут нивелировать фармакологическое действие последнего.
Снижая уровень циркулирующего эстрадиола, анастрозол может вызывать снижение минеральной плотности костной ткани.
У пациенток с остеопорозом (или имеющих риск развития остеопороза) минеральную плотность костной ткани следует оценивать методом денсиометрии (например, DEXA-сканированием) в начале лечения и в динамике. При необходимости следует начать лечение или проводить профилактику остеопороза под тщательным наблюдением врача.
Нет данных об одновременном применении анастрозола и препаратов-аналогов ЛГРГ.
Неизвестно улучшает ли анастрозол результаты лечения при совместном использовании с химиотерапией.
Использование в педиатрии
Противопоказано применение препарата у пациентов детского возраста.
Влияние на способность управлять транспортными средствами и другими механизмами, требующими повышенной концентрации внимания
Некоторые побочные действия анастрозола, такие как астения и сонливость, могут отрицательно влиять на способность выполнения потенциально опасных видов деятельности, требующих повышенной концентрации внимания и быстроты психомоторных реакций. В этой связи рекомендуется при появлении этих симптомов соблюдать осторожность при управлении транспортными средствами и механизмами.
Форма выпуска
Таблетки.
Условия хранения
Хранить в недоступном для детей, сухом месте при температуре не выше 25°С.
Срок годности
2 года.
Условия отпуска
По рецепту.
Производитель
ЗАО Биокад, Российская Федерация.
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Состав оболочки: опадрай белый (04F58804) - 3 мг(гипромеллоза 2910 - 1.875 мг, титана диоксид - 0.75 мг, макрогол 6000 - 0.875 мг)."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Противоопухолевый препарат. Высокоселективный нестероидный ингибитор ароматазы - фермента, с помощью которого у женщин в постменопаузе андростендион в периферических тканях превращается в эстрон и далее в эстрадиол. Анастрозол не обладает гестагенной, андрогенной и эстрогенной активностью. У женщин в постменопаузе анастрозол в суточной дозе 1 мг вызывает снижение уровня эстрадиола на 80%. Анастрозол в суточных дозах до 10 мг не оказывает эффекта на секрецию кортизола и альдостерона."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Всасывание и распределение"}},{"type":"paragraph","data":{"text":"Анастрозол после приема внутрь натощак быстро всасывается из ЖКТ. Cmax в плазме достигается в течение 2 ч. Пища незначительно уменьшает скорость всасывания (но не его степень) и не приводит к клинически значимому влиянию на Css препарата в плазме при однократном приеме суточной дозы анастрозола. После 7-дневного приема препарата Css анастрозола в плазме составляет приблизительно 90-95%. Связывание с белками плазмы крови - 40%."}},{"type":"paragraph","data":{"text":"Метаболизм и выведение"}},{"type":"paragraph","data":{"text":"Метаболизм анастрозола осуществляется N -деалкилированием, гидроксилированием и глюкуронизацией. Триазол, основной метаболит, определяемый в плазме, не ингибирует ароматазу."}},{"type":"paragraph","data":{"text":"T1/2 из плазмы составляет 40-50 ч. Менее 10% дозы выделяется с мочой в неизмененном виде в течение 72 ч после приема препарата. Метаболиты выводятся преимущественно с мочой."}},{"type":"paragraph","data":{"text":"Клиренс анастрозола после приема внутрь при циррозе печени или нарушении функции почек не изменяется."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Адъювантная терапия раннего рака молочной железы, с положительными гормональными рецепторами у женщин в постменопаузе, в т.ч. после 2-3 летней адъювантной терапии тамоксифеном; первая линия терапии местно-распространенного или метастатического рака молочной железы, с положительными или неизвестными гормональными рецепторами у женщин в постменопаузе; вторая линия терапии распространенного рака молочной железы, прогрессирующего после лечения тамоксифеном."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["Выраженная почечная недостаточность (КК < 20 мл/мин);","умеренная или выраженная печеночная недостаточность (безопасность и эффективность применения препарата не установлена);","сопутствующая терапия тамоксифеном;","пременопауза;","беременность;","период грудного вскармливания;","детский возраст;","повышенная чувствительность к анастрозолу или другим компонентам препарата."]}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Взрослым, в т.ч. пожилым пациентам препарат следует принимать внутрь в одно и то же время по 1 мг (проглотить таблетку целиком, запивая водой) 1 раз/сут длительно. При появлении признаков прогрессирования заболевания прием препарата следует прекратить. Коррекция дозы у пациентов с легкими и умеренными нарушениями функции почек не требуется. Коррекция дозы у пациентов с легкой степенью нарушения функции печени не требуется."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Определение частоты побочных реакций:"}},{"type":"list","data":{"style":"ordered","items":["очень часто ( > 10%);","часто (1-10%);","редко (0,1-1%);","очень редко ( < 0,1%)."]}},{"type":"paragraph","data":{"text":"Со стороны репродуктивной системы: часто - сухость влагалища; редко - влагалищные кровотечения (в основном в течение первых недель после отмены или смены предшествующей гормональной терапии на анастрозол)."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: часто - тошнота, диарея; редко - анорексия, рвота, увеличение активности ГГТ и ЩФ."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: очень часто - \"приливы\" жара."}},{"type":"paragraph","data":{"text":"Со стороны ЦНС: часто - головная боль; редко - сонливость."}},{"type":"paragraph","data":{"text":"Co стороны костно-мышечной системы: часто - артралгия."}},{"type":"paragraph","data":{"text":"Дерматологические реакции: часто - истончение волос, кожная сыпь; очень редко - полиморфная эритема (синдром Стивенса-Джонсона)."}},{"type":"paragraph","data":{"text":"Со стороны обмена веществ: редко - гиперхолестеринемия; возможно - снижение минеральной плотности костной ткани в связи со снижением уровня циркулирующего эстрадиола (риск возникновения остеопороза, переломов костей)."}},{"type":"paragraph","data":{"text":"Прочие: часто - астения; очень редко - аллергические реакции (в т.ч. ангиоэдема, крапивница, анафилактический шок)."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: однократная доза анастрозола, которая могла бы привести к симптомам, угрожающим жизни, не определена. Лечение: в случае передозировки лечение должно быть симптоматическим. Если пациент находится в сознании, целесообразно вызвать рвоту. Рекомендуется общая поддерживающая терапия, наблюдение за пациентом и контроль функции жизненно важных органов и систем. Может быть проведен диализ. Специфического антидота не существует."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Исследования по лекарственному взаимодействию с антипирином и циметидином указывают на то, что клинически значимое лекарственное взаимодействие, опосредованное изоферментами системы цитохрома Р450 при совместном применении анастрозола с другими препаратами маловероятно."}},{"type":"paragraph","data":{"text":"Клинически значимое лекарственное взаимодействие при применении анастрозола одновременно с другими часто назначаемыми препаратами отсутствует."}},{"type":"paragraph","data":{"text":"На данный момент нет сведений о применении анастрозола в комбинации с другими противоопухолевыми препаратами."}},{"type":"paragraph","data":{"text":"Препараты, содержащие эстрогены, уменьшают фармакологическое действие анастрозола, в связи с чем, они не должны назначаться одновременно с анастрозолом."}},{"type":"paragraph","data":{"text":"Не следует назначать тамоксифен одновременно с анастрозолом, поскольку он может ослабить фармакологическое действие последнего."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"У женщин с рецептороотрицательной опухолью к эстрогенам эффективность анастрозола не была продемонстрирована, кроме тех случаев, когда имелся предшествующий положительный клинический ответ на тамоксифен."}},{"type":"paragraph","data":{"text":"В случае сомнений в гормональном статусе пациентки менопаузу следует подтвердить определением половых гормонов в сыворотке крови."}},{"type":"paragraph","data":{"text":"Нет данных о применении анастрозола у пациентов с тяжелой степенью нарушений функции печени или у пациентов с выраженными нарушениями функции почек (КК < 20 мл/мин)."}},{"type":"paragraph","data":{"text":"В случае сохраняющегося маточного кровотечения на фоне приема анастрозола необходима консультация и наблюдение гинеколога."}},{"type":"paragraph","data":{"text":"Препараты, содержащие эстрогены, не следует применять одновременно с анастрозолом, поскольку они будут нивелировать фармакологическое действие последнего."}},{"type":"paragraph","data":{"text":"Снижая уровень циркулирующего эстрадиола, анастрозол может вызывать снижение минеральной плотности костной ткани."}},{"type":"paragraph","data":{"text":"У пациенток с остеопорозом (или имеющих риск развития остеопороза) минеральную плотность костной ткани следует оценивать методом денсиометрии (например, DEXA-сканированием) в начале лечения и в динамике. При необходимости следует начать лечение или проводить профилактику остеопороза под тщательным наблюдением врача."}},{"type":"paragraph","data":{"text":"Нет данных об одновременном применении анастрозола и препаратов-аналогов ЛГРГ."}},{"type":"paragraph","data":{"text":"Неизвестно улучшает ли анастрозол результаты лечения при совместном использовании с химиотерапией."}},{"type":"paragraph","data":{"text":"Использование в педиатрии"}},{"type":"paragraph","data":{"text":"Противопоказано применение препарата у пациентов детского возраста."}},{"type":"paragraph","data":{"text":"Влияние на способность управлять транспортными средствами и другими механизмами, требующими повышенной концентрации внимания"}},{"type":"paragraph","data":{"text":"Некоторые побочные действия анастрозола, такие как астения и сонливость, могут отрицательно влиять на способность выполнения потенциально опасных видов деятельности, требующих повышенной концентрации внимания и быстроты психомоторных реакций. В этой связи рекомендуется при появлении этих симптомов соблюдать осторожность при управлении транспортными средствами и механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить в недоступном для детей, сухом месте при температуре не выше 25°С."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"ЗАО Биокад, Российская Федерация."}}]}],"source":null},"description_toggle":false,"short_description":"Всасывание и распределение Анастрозол после приема внутрь натощак быстро всасывается из ЖКТ. Cmax в плазме достигается в течение 2 ч. 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