карбамазепин могут снижать концентрацию мифепристона в плазме крови. Следует
соблюдать осторожность при совместном применении мифепристона с лекарственными
препаратами, являющимися субстратами CYP3A4, и имеющими узкий терапевтический
диапазон (в том числе, и лекарственными средствами для общей анестезии), в виду
возможного повышения концентрации их в плазме крови и длительности такого
взаимодействия.
Возможно снижение эффективности метода медикаментозного аборта при совместном
приеме мифепристона с нестероидными противовоспалительными препаратами (НПВП), в
том числе с ацетилсалициловой кислотой, из-за их антипростагландинового действия.
Ограниченные данные показывают отсутствие ингибирующего влияния на действие
мифепристона и аналога простагландина и клиническую эффективность медикаментозного
прерывания беременности в случае совместного приема НПВП в день приема аналога
простагландина.
При одновременном применении мифепристона и ГКС необходимо увеличить дозу ГКС.
Особые указания
Для прерывания беременности мифепристон в комбинации с мизопростолом должен
применяться только в медицинских акушерско-гинекологических учреждениях,
относящихся к государственной системе здравоохранения, а также в учреждениях
муниципальной и частной собственности, имеющих лицензии на данный род деятельности
и соответствующим образом подготовленные врачебные кадры и необходимое
оборудование.
При прерывании беременности женщины должны быть проинформированы о
необходимости сочетать прием мифепристона с применением простагландина (на 2-м
визите); повторного посещения (3-й визит) в период от 14 до 21 дня после приема
мифепристона - для подтверждения полного изгнания плодного яйца (проводится
клиническое обследование, УЗИ органов малого таза и/или определение концентрации βХГЧ в плазме крови); о прерывании беременности оперативным путем в случае
неэффективности применения препарата (неполный аборт или пролонгирование
беременности), ввиду риска возникновения врожденных пороков развития у плода;
снижении эффективности метода медикаментозного аборта с увеличением возраста
женщины; возможности длительных кровянистых выделений из влагалища (в среднем
около 12 дней и более после приема мифепристона), вплоть до обильного кровотечения (в
связи с чем, не рекомендуется ездить в дальние поездки до подтверждения полного аборта).
Женщина должна получить четкие указания, куда ей обращаться в случае возникновения
обильного кровотечения или каких-либо других проблем. Продолжающиеся кровянистые
выделения из влагалища могут свидетельствовать о неполном аборте или
недиагностированной эктопической (внематочной) беременности. Для исключения данных
состояний должно быть проведено соответствующее обследование и лечение. В случае
тяжелого кровотечения (в 1,4% случаев) может потребоваться выскабливание полости
матки с гемостатической целью, в связи с чем особое внимание следует уделять женщинам
с нарушениями гемостаза и анемией. Решение о применении препарата в таких случаях
должно приниматься совместно со специалистами, в зависимости от типа нарушения
гемостаза и степени выраженности анемии.
Очень редко были зарегистрированы случаи эндометрита, вызванного Clostridium sordellii
или кишечной палочкой, осложнившегося токсическим шоком с летальным исходом,
протекающего без лихорадки и других клинических проявлений инфекции, после
медикаментозного аборта с применением мифепристона и последующего не разрешенного
интравагинального введения таблеток мизопростола для перорального применения. Врач
акушер-гинеколог должен знать о таком потенциально возможном смертельном
осложнении.
Применение препарата требует проведения профилактики резус-аллоиммунизации и других общих мероприятий, сопутствующих аборту.
В случае беременности, наступившей на фоне ВМК, его необходимо удалить до начала
применения мифепристона.
Пациенткам с искусственными сердечными клапанами или инфекционным эндокардитом
при применении мифепристона следует проводить профилактическое лечение
антибиотиками.
В случае подозрения на развитие острой надпочечниковой недостаточности рекомендуется
введение дексаметазона (из расчета: на 400 мг мифепристона 1 мг дексаметазона). В связи
с антиглюкокортикоидной активностью мифепристона, эффективность долгосрочной
терапии ГКС, в том числе ингаляционными, у пациенток с бронхиальной астмой может
быть снижена в течение 3-4 дней после приема мифепристона. У таких пациенток требуется
коррекция терапии ГКС.
Редкие, но серьезные осложнения со стороны сердечно-сосудистой системы были
зарегистрированы после внутримышечного введения аналога простагландина. В связи с
этим, следует относиться с особой осторожностью к пациенткам с факторами риска
развития или установленными сердечно-сосудистыми заболеваниями. Во время приема и в
течение 3 часов после приема простагландина женщина должна находиться в лечебном
учреждении, для того чтобы не пропустить возможные острые состояния, вызванные
применением простагландина.
Чтобы избежать потенциального негативного воздействия мифепристона на последующую
беременность, рекомендуется исключить возможность беременности во время следующего
менструального цикла. После применения мифепристона следует как можно раньше
начинать применение надежных методов контрацепции.
Влияние на способность управлять автомобилем и движущимися механизмами
Исследований влияния мифепристона на способность управлять транспортными
средствами и механизмами не проводилось. Однако, учитывая профиль возможных
нежелательных реакций (головокружение, артериальная гипотензия, обморок), следует
соблюдать осторожность при управлении транспортными средствами, механизмами и
занятием деятельностью, требующей быстроты психомоторных реакций и концентрации
внимания.
Форма выпуска
Таблетки, 200 мг. По 1, 2 или 3 таблетки в контурную ячейковую упаковку из пленки
поливинилхлоридной и фольги алюминиевой печатной лакированной.
По 1, 2, 3 или 5 контурных ячейковых упаковок с инструкцией по медицинскому применению лекарственного препарата в пачку из картона.
Условия хранения
В сухом, защищенном от света месте, при температуре не выше 30 °С.
Хранить в недоступном для детей месте.
Срок годности
5 лет. Не применять по истечении срока годности.
Условия отпуска
Препарат может поставляться только в медицинские акушерско-гинекологические
учреждения, относящиеся к государственной системе здравоохранения, а также в
учреждения муниципальной и частной собственности, имеющие лицензии на этот род
деятельности.
Производитель
ЗАО «Обнинская химико-фармацевтическая компания», Россия
Все стадии производственного процесса:
Калужская область, г. Обнинск, Киевское шоссе, зд. 103, зд. 107
Организация, принимающая претензии потребителей
АО «Нижфарм», Россия
603950, г. Нижний Новгород, ул. Салганская, д. 7
Тел.: (831) 278-80-88; факс: (831) 430-72-28
E-mail: med@stada.ru
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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группа","slug":"","body":[{"type":"paragraph","data":{"text":" антигестаген."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Фармакодинамика"}},{"type":"paragraph","data":{"text":"Мифепристон - синтетическое стероидное антипрогестагенное средство (блокирует"}},{"type":"paragraph","data":{"text":"действие прогестерона на уровне рецепторов), гестагенной активностью не обладает."}},{"type":"paragraph","data":{"text":"Отмечен антагонизм с глюкокортикостероидами (ГКС) за счет конкуренции на уровне связи"}},{"type":"paragraph","data":{"text":"с рецепторами. Повышает сократительную способность миометрия, стимулируя"}},{"type":"paragraph","data":{"text":"высвобождение интерлейкина-8 в хориодецидуальных клетках, повышая чувствительность"}},{"type":"paragraph","data":{"text":"миометрия к простагландинам (для усиления эффекта применяют в сочетании с"}},{"type":"paragraph","data":{"text":"синтетическим аналогом простагландина). В результате действия препарата происходит"}},{"type":"paragraph","data":{"text":"десквамация децидуальной оболочки и экспульсия плодного яйца."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"Всасывание"}},{"type":"paragraph","data":{"text":"После однократного приема внутрь в дозе 600 мг максимальная концентрация"}},{"type":"paragraph","data":{"text":"мифепристона (1,98 мг/л) достигается через 1,3 часа. Абсолютная биодоступность"}},{"type":"paragraph","data":{"text":"составляет 69 %."}},{"type":"paragraph","data":{"text":"Распределение"}},{"type":"paragraph","data":{"text":"Мифепристон на 98 % связывается с белками плазмы крови - альбумином и кислым альфа1-"}},{"type":"paragraph","data":{"text":"гликопротеином."}},{"type":"paragraph","data":{"text":"Метаболизм"}},{"type":"paragraph","data":{"text":"Метаболизм мифепристона происходит при «первичном» прохождении через печень путем"}},{"type":"paragraph","data":{"text":"N-деметилирования и гидроксилирования 17-пропиниловой цепи с образованием трех"}},{"type":"paragraph","data":{"text":"основных метаболитов."}},{"type":"paragraph","data":{"text":"Выведение"}},{"type":"paragraph","data":{"text":"После фазы распределения выведение сначала происходит медленно, концентрация"}},{"type":"paragraph","data":{"text":"мифепристона в плазме крови уменьшается в 2 раза между 12-72 часами, затем более"}},{"type":"paragraph","data":{"text":"быстро. Период полувыведения мифепристона составляет 18 часов. Мифепристон"}},{"type":"paragraph","data":{"text":"выводится преимущественно через кишечник."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Медикаментозное прерывание маточной беременности на ранних сроках (до 42 дней"}},{"type":"paragraph","data":{"text":"аменореи) при комбинированном применении с аналогом простагландина"}},{"type":"paragraph","data":{"text":"(мизопростолом)."}},{"type":"paragraph","data":{"text":" Подготовка и индукция родов при доношенной беременности"}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Общие противопоказания:"}},{"type":"paragraph","data":{"text":" гиперчувствительность к мифепристону и/или к любому из вспомогательных веществ в"}},{"type":"paragraph","data":{"text":"составе препарата;"}},{"type":"paragraph","data":{"text":" хроническая надпочечниковая недостаточность;"}},{"type":"paragraph","data":{"text":" острая или хроническая почечная и/или печеночная недостаточность;"}},{"type":"paragraph","data":{"text":" наследственная порфирия;"}},{"type":"paragraph","data":{"text":" длительное применение ГКС;"}},{"type":"paragraph","data":{"text":" анемия (содержание гемоглобина менее 100 г/л);"}},{"type":"paragraph","data":{"text":" кахексия;"}},{"type":"paragraph","data":{"text":" бронхиальная астма, тяжелая форма;"}},{"type":"paragraph","data":{"text":" нарушение гемостаза (в том числе предшествующая терапия антикоагулянтами);"}},{"type":"paragraph","data":{"text":" острые воспалительные заболевания половых органов;"}},{"type":"paragraph","data":{"text":" миома матки больших размеров;"}},{"type":"paragraph","data":{"text":" наличие тяжелой экстрагенитальной патологии;"}},{"type":"paragraph","data":{"text":" у курящих женщин старше 35 лет без предварительной консультации врача-терапевта."}},{"type":"paragraph","data":{"text":"Для медикаментозного прерывания беременности на ранних сроках (до 42 дней"}},{"type":"paragraph","data":{"text":"аменореи):"}},{"type":"paragraph","data":{"text":" подозрение на внематочную беременность;"}},{"type":"paragraph","data":{"text":" беременность, не подтвержденная клинико-лабораторными или инструментальными"}},{"type":"paragraph","data":{"text":"методами обследования (УЗИ);"}},{"type":"paragraph","data":{"text":" беременность со сроком аменореи более 42 дней;"}},{"type":"paragraph","data":{"text":" беременность, наступившая на фоне применения внутриматочного контрацептива"}},{"type":"paragraph","data":{"text":"(ВМК) до его удаления или после отмены гормонального контрацептивного средства;"}},{"type":"paragraph","data":{"text":" противопоказания к применению мизопростола."}},{"type":"paragraph","data":{"text":"Для подготовки и индукции родов:"}},{"type":"paragraph","data":{"text":" гестоз тяжелой степени, в том числе, преэклампсия, эклампсия;"}},{"type":"paragraph","data":{"text":" недоношенная или переношенная беременность;"}},{"type":"paragraph","data":{"text":" предлежание или отслойка плаценты;"}},{"type":"paragraph","data":{"text":" несоответствие размеров головки плода и таза женщины;"}},{"type":"paragraph","data":{"text":" аномальное положение плода;"}},{"type":"paragraph","data":{"text":" кровянистые выделения из половых путей неясной этиологии;"}},{"type":"paragraph","data":{"text":" тяжелые формы гемолитической болезни плода"}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"При хронических обструктивных заболеваниях легких, бронхиальной астме, артериальной"}},{"type":"paragraph","data":{"text":"гипертензии, нарушениях ритма сердца, хронической сердечной недостаточности, миоме"}},{"type":"paragraph","data":{"text":"матки."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Беременность"}},{"type":"paragraph","data":{"text":"Мифепристон применяется в период беременности только с целью ее прерывания на ранних"}},{"type":"paragraph","data":{"text":"сроках или для подготовки и индукции родов при доношенной беременности."}},{"type":"paragraph","data":{"text":"Грудное вскармливание"}},{"type":"paragraph","data":{"text":"Мифепристон является липофильным соединением и может проникать в грудное молоко."}},{"type":"paragraph","data":{"text":"При проведении медикаментозного аборта грудное вскармливание следует прекратить на"}},{"type":"paragraph","data":{"text":"7 дней, начиная с даты приема мифепристона. Женщинам в период грудного"}},{"type":"paragraph","data":{"text":"вскармливания рекомендуется назначать мифепристон в дозе 200 мг."}},{"type":"paragraph","data":{"text":"Применение мифепристона для подготовки и индукции родов в последующем не влияет на"}},{"type":"paragraph","data":{"text":"лактацию."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат должен применяться только в медицинских учреждениях, которые имеют"}},{"type":"paragraph","data":{"text":"соответствующим образом подготовленные врачебные кадры и необходимое"}},{"type":"paragraph","data":{"text":"оборудование."}},{"type":"paragraph","data":{"text":"Для медикаментозного прерывания беременности ранних сроков"}},{"type":"paragraph","data":{"text":"600 мг (3 таблетки по 200 мг) мифепристона принимают внутрь однократно в присутствии"}},{"type":"paragraph","data":{"text":"врача, запивая 100 мл воды (через 1-1,5 часа после легкого завтрака). Женщина должна"}},{"type":"paragraph","data":{"text":"находиться под наблюдением медицинского персонала не менее 2-х часов после приема"}},{"type":"paragraph","data":{"text":"мифепристона. Через 36-48 часов после приема мифепристона назначают синтетический"}},{"type":"paragraph","data":{"text":"аналог простагландина - мизопростол, внутрь в дозе 400 мкг. Женщина должна находиться"}},{"type":"paragraph","data":{"text":"под наблюдением медицинского персонала не менее 3-х часов после приема мизопростола."}},{"type":"paragraph","data":{"text":"ИЛИ"}},{"type":"paragraph","data":{"text":"200 мг (1 таблетку) мифепристона принимают внутрь однократно в присутствии врача,"}},{"type":"paragraph","data":{"text":"запивая 100 мл воды (через 1-1,5 часа после легкого завтрака). Женщина должна находиться"}},{"type":"paragraph","data":{"text":"под наблюдением медицинского персонала не менее 2-х часов после приема мифепристона."}},{"type":"paragraph","data":{"text":"Через 36-48 часов после приема мифепристона назначают синтетический аналог"}},{"type":"paragraph","data":{"text":"простагландина - мизопростол, внутрь в дозе 400 мкг. Женщина должна находиться под"}},{"type":"paragraph","data":{"text":"наблюдением медицинского персонала не менее 3-х часов после приема мизопростола."}},{"type":"paragraph","data":{"text":"Через 14-21 день после приема мифепристона необходимо проведение повторного"}},{"type":"paragraph","data":{"text":"обследования для подтверждения полного изгнания плодного яйца (см. раздел «Особые"}},{"type":"paragraph","data":{"text":"указания»)."}},{"type":"paragraph","data":{"text":"Для подготовки и индукции родов при доношенной беременности"}},{"type":"paragraph","data":{"text":"Внутрь, однократно мифепристон в дозе 200 мг (1 таблетка) в присутствии врача. Через"}},{"type":"paragraph","data":{"text":"24 часа повторный прием мифепристона в дозе 200 мг. Через 48-72 часа проводится оценка"}},{"type":"paragraph","data":{"text":"состояния родовых путей и, при необходимости, вводятся простагландины или окситоцин"}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Нежелательные реакции распределены по частоте возникновения в соответствии со"}},{"type":"paragraph","data":{"text":"следующей градацией: очень часто (≥ 1/10), часто (≥ 1/100, < 1/10), нечасто (≥ 1/1000,"}},{"type":"paragraph","data":{"text":"< 1/100), редко (≥ 1/10000, < 1/1000), очень редко (< 1/10000), частота неизвестна (по"}},{"type":"paragraph","data":{"text":"имеющимся данным установить частоту возникновения не представляется возможным)."}},{"type":"paragraph","data":{"text":"Инфекционные и паразитарные заболевания"}},{"type":"paragraph","data":{"text":"Часто: постабортные инфекции (эндометрит), обострение воспалительных заболеваний"}},{"type":"paragraph","data":{"text":"матки и придатков."}},{"type":"paragraph","data":{"text":"Очень редко: случаи тяжелого или летального токсического и септического шока"}},{"type":"paragraph","data":{"text":"(вызванного Clostridium sordellii или Escherichia coli), с лихорадкой или без нее, были"}},{"type":"paragraph","data":{"text":"зарегистрированы после медикаментозного аборта с использованием неразрешенного"}},{"type":"paragraph","data":{"text":"вагинального или трансбуккального введения таблеток мизопростола для перорального"}},{"type":"paragraph","data":{"text":"применения."}},{"type":"paragraph","data":{"text":"Нарушения со стороны иммунной системы"}},{"type":"paragraph","data":{"text":"Нечасто: гиперчувствительность."}},{"type":"paragraph","data":{"text":"Редко: крапивница."}},{"type":"paragraph","data":{"text":"Очень редко: ангионевротический отек."}},{"type":"paragraph","data":{"text":"Нарушения со стороны крови и лимфатической системы"}},{"type":"paragraph","data":{"text":"Частота неизвестна: анемия."}},{"type":"paragraph","data":{"text":"Нарушения психики"}},{"type":"paragraph","data":{"text":"Частота неизвестна: беспокойство, бессонница."}},{"type":"paragraph","data":{"text":"Нарушения со стороны нервной системы"}},{"type":"paragraph","data":{"text":"Редко: головная боль, головокружение."}},{"type":"paragraph","data":{"text":"Нарушения со стороны сосудов"}},{"type":"paragraph","data":{"text":"Нечасто: снижение артериального давления, обморок."}},{"type":"paragraph","data":{"text":"Нарушения со стороны желудочно-кишечного тракта"}},{"type":"paragraph","data":{"text":"Очень часто: тошнота, рвота, диарея (чаще всего были связаны с применением"}},{"type":"paragraph","data":{"text":"мизопростола)."}},{"type":"paragraph","data":{"text":"Часто: боли спастического характера в животе легкой или средней степени тяжести."}},{"type":"paragraph","data":{"text":"Нарушения со стороны кожи и подкожных тканей"}},{"type":"paragraph","data":{"text":"Нечасто: кожная сыпь."}},{"type":"paragraph","data":{"text":"Редко: узловатая эритема, эритродермия."}},{"type":"paragraph","data":{"text":"Очень редко: токсический эпидермальный некролиз."}},{"type":"paragraph","data":{"text":"Нарушения со стороны половых органов и молочной железы"}},{"type":"paragraph","data":{"text":"Очень часто: маточные сокращения, спазм мышц матки или боли спастического характера"}},{"type":"paragraph","data":{"text":"внизу живота в течение нескольких часов после приема мизопростола, чувство"}},{"type":"paragraph","data":{"text":"дискомфорта внизу живота."}},{"type":"paragraph","data":{"text":"Часто: кровотечения (в 5 % случаев - тяжелой степени, в 1,4 % случаев потребовался"}},{"type":"paragraph","data":{"text":"гемостатический кюретаж полости матки)."}},{"type":"paragraph","data":{"text":"Редко: во время медикаментозного прерывания беременности во II триместре или индукции"}},{"type":"paragraph","data":{"text":"родов при внутриутробной гибели плода в III триместре были редкие сообщения о разрыве"}},{"type":"paragraph","data":{"text":"матки после приема простагландина (в основном у многорожавших женщин или"}},{"type":"paragraph","data":{"text":"беременных с кесаревым сечением в анамнезе)."}},{"type":"paragraph","data":{"text":"Общие расстройства и нарушения в месте введения"}},{"type":"paragraph","data":{"text":"Редко: судороги, недомогание, вагусные проявления («приливы» жара, головокружение,"}},{"type":"paragraph","data":{"text":"озноб), лихорадка.\n"}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы"}},{"type":"paragraph","data":{"text":"Прием мифепристона в дозе до 2 г не вызывает нежелательных реакций."}},{"type":"paragraph","data":{"text":"В случаях передозировки препарата возможно развитие острой надпочечниковой"}},{"type":"paragraph","data":{"text":"недостаточности."}},{"type":"paragraph","data":{"text":"Лечение"}},{"type":"paragraph","data":{"text":"Специфического антидота нет, следует проводить симптоматическую терапию, в случае"}},{"type":"paragraph","data":{"text":"острой надпочечниковой недостаточности - введение дексаметазона."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Исследований взаимодействия мифепристона не проводилось. Учитывая, что в"}},{"type":"paragraph","data":{"text":"метаболизме мифепристона принимает участие изофермент CYP3A4, не исключено, что"}},{"type":"paragraph","data":{"text":"кетоконазол, итраконазол, эритромицин и грейпфрутовый сок при совместном применении"}},{"type":"paragraph","data":{"text":"или приеме могут повышать концентрацию мифепристона в плазме крови. Рифампицин,"}},{"type":"paragraph","data":{"text":"дексаметазон, препараты зверобоя продырявленного, фенитоин, фенобарбитал,"}},{"type":"paragraph","data":{"text":"карбамазепин могут снижать концентрацию мифепристона в плазме крови. Следует"}},{"type":"paragraph","data":{"text":"соблюдать осторожность при совместном применении мифепристона с лекарственными"}},{"type":"paragraph","data":{"text":"препаратами, являющимися субстратами CYP3A4, и имеющими узкий терапевтический"}},{"type":"paragraph","data":{"text":"диапазон (в том числе, и лекарственными средствами для общей анестезии), в виду"}},{"type":"paragraph","data":{"text":"возможного повышения концентрации их в плазме крови и длительности такого"}},{"type":"paragraph","data":{"text":"взаимодействия."}},{"type":"paragraph","data":{"text":"Возможно снижение эффективности метода медикаментозного аборта при совместном"}},{"type":"paragraph","data":{"text":"приеме мифепристона с нестероидными противовоспалительными препаратами (НПВП), в"}},{"type":"paragraph","data":{"text":"том числе с ацетилсалициловой кислотой, из-за их антипростагландинового действия."}},{"type":"paragraph","data":{"text":"Ограниченные данные показывают отсутствие ингибирующего влияния на действие"}},{"type":"paragraph","data":{"text":"мифепристона и аналога простагландина и клиническую эффективность медикаментозного"}},{"type":"paragraph","data":{"text":"прерывания беременности в случае совместного приема НПВП в день приема аналога"}},{"type":"paragraph","data":{"text":"простагландина."}},{"type":"paragraph","data":{"text":"При одновременном применении мифепристона и ГКС необходимо увеличить дозу ГКС."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Для прерывания беременности мифепристон в комбинации с мизопростолом должен"}},{"type":"paragraph","data":{"text":"применяться только в медицинских акушерско-гинекологических учреждениях,"}},{"type":"paragraph","data":{"text":"относящихся к государственной системе здравоохранения, а также в учреждениях"}},{"type":"paragraph","data":{"text":"муниципальной и частной собственности, имеющих лицензии на данный род деятельности"}},{"type":"paragraph","data":{"text":"и соответствующим образом подготовленные врачебные кадры и необходимое"}},{"type":"paragraph","data":{"text":"оборудование."}},{"type":"paragraph","data":{"text":"При прерывании беременности женщины должны быть проинформированы о"}},{"type":"paragraph","data":{"text":"необходимости сочетать прием мифепристона с применением простагландина (на 2-м"}},{"type":"paragraph","data":{"text":"визите); повторного посещения (3-й визит) в период от 14 до 21 дня после приема"}},{"type":"paragraph","data":{"text":"мифепристона - для подтверждения полного изгнания плодного яйца (проводится"}},{"type":"paragraph","data":{"text":"клиническое обследование, УЗИ органов малого таза и/или определение концентрации βХГЧ в плазме крови); о прерывании беременности оперативным путем в случае"}},{"type":"paragraph","data":{"text":"неэффективности применения препарата (неполный аборт или пролонгирование"}},{"type":"paragraph","data":{"text":"беременности), ввиду риска возникновения врожденных пороков развития у плода;"}},{"type":"paragraph","data":{"text":"снижении эффективности метода медикаментозного аборта с увеличением возраста"}},{"type":"paragraph","data":{"text":"женщины; возможности длительных кровянистых выделений из влагалища (в среднем"}},{"type":"paragraph","data":{"text":"около 12 дней и более после приема мифепристона), вплоть до обильного кровотечения (в"}},{"type":"paragraph","data":{"text":"связи с чем, не рекомендуется ездить в дальние поездки до подтверждения полного аборта)."}},{"type":"paragraph","data":{"text":"Женщина должна получить четкие указания, куда ей обращаться в случае возникновения"}},{"type":"paragraph","data":{"text":"обильного кровотечения или каких-либо других проблем. Продолжающиеся кровянистые"}},{"type":"paragraph","data":{"text":"выделения из влагалища могут свидетельствовать о неполном аборте или"}},{"type":"paragraph","data":{"text":"недиагностированной эктопической (внематочной) беременности. Для исключения данных"}},{"type":"paragraph","data":{"text":"состояний должно быть проведено соответствующее обследование и лечение. В случае"}},{"type":"paragraph","data":{"text":"тяжелого кровотечения (в 1,4% случаев) может потребоваться выскабливание полости"}},{"type":"paragraph","data":{"text":"матки с гемостатической целью, в связи с чем особое внимание следует уделять женщинам"}},{"type":"paragraph","data":{"text":"с нарушениями гемостаза и анемией. Решение о применении препарата в таких случаях"}},{"type":"paragraph","data":{"text":"должно приниматься совместно со специалистами, в зависимости от типа нарушения"}},{"type":"paragraph","data":{"text":"гемостаза и степени выраженности анемии."}},{"type":"paragraph","data":{"text":"Очень редко были зарегистрированы случаи эндометрита, вызванного Clostridium sordellii"}},{"type":"paragraph","data":{"text":"или кишечной палочкой, осложнившегося токсическим шоком с летальным исходом,"}},{"type":"paragraph","data":{"text":"протекающего без лихорадки и других клинических проявлений инфекции, после"}},{"type":"paragraph","data":{"text":"медикаментозного аборта с применением мифепристона и последующего не разрешенного"}},{"type":"paragraph","data":{"text":"интравагинального введения таблеток мизопростола для перорального применения. Врач"}},{"type":"paragraph","data":{"text":"акушер-гинеколог должен знать о таком потенциально возможном смертельном"}},{"type":"paragraph","data":{"text":"осложнении."}},{"type":"paragraph","data":{"text":"Применение препарата требует проведения профилактики резус-аллоиммунизации и других общих мероприятий, сопутствующих аборту."}},{"type":"paragraph","data":{"text":"В случае беременности, наступившей на фоне ВМК, его необходимо удалить до начала"}},{"type":"paragraph","data":{"text":"применения мифепристона."}},{"type":"paragraph","data":{"text":"Пациенткам с искусственными сердечными клапанами или инфекционным эндокардитом"}},{"type":"paragraph","data":{"text":"при применении мифепристона следует проводить профилактическое лечение"}},{"type":"paragraph","data":{"text":"антибиотиками."}},{"type":"paragraph","data":{"text":"В случае подозрения на развитие острой надпочечниковой недостаточности рекомендуется"}},{"type":"paragraph","data":{"text":"введение дексаметазона (из расчета: на 400 мг мифепристона 1 мг дексаметазона). В связи"}},{"type":"paragraph","data":{"text":"с антиглюкокортикоидной активностью мифепристона, эффективность долгосрочной"}},{"type":"paragraph","data":{"text":"терапии ГКС, в том числе ингаляционными, у пациенток с бронхиальной астмой может"}},{"type":"paragraph","data":{"text":"быть снижена в течение 3-4 дней после приема мифепристона. У таких пациенток требуется"}},{"type":"paragraph","data":{"text":"коррекция терапии ГКС."}},{"type":"paragraph","data":{"text":"Редкие, но серьезные осложнения со стороны сердечно-сосудистой системы были"}},{"type":"paragraph","data":{"text":"зарегистрированы после внутримышечного введения аналога простагландина. В связи с"}},{"type":"paragraph","data":{"text":"этим, следует относиться с особой осторожностью к пациенткам с факторами риска"}},{"type":"paragraph","data":{"text":"развития или установленными сердечно-сосудистыми заболеваниями. Во время приема и в"}},{"type":"paragraph","data":{"text":"течение 3 часов после приема простагландина женщина должна находиться в лечебном"}},{"type":"paragraph","data":{"text":"учреждении, для того чтобы не пропустить возможные острые состояния, вызванные"}},{"type":"paragraph","data":{"text":"применением простагландина."}},{"type":"paragraph","data":{"text":"Чтобы избежать потенциального негативного воздействия мифепристона на последующую"}},{"type":"paragraph","data":{"text":"беременность, рекомендуется исключить возможность беременности во время следующего"}},{"type":"paragraph","data":{"text":"менструального цикла. После применения мифепристона следует как можно раньше"}},{"type":"paragraph","data":{"text":"начинать применение надежных методов контрацепции."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Исследований влияния мифепристона на способность управлять транспортными"}},{"type":"paragraph","data":{"text":"средствами и механизмами не проводилось. Однако, учитывая профиль возможных"}},{"type":"paragraph","data":{"text":"нежелательных реакций (головокружение, артериальная гипотензия, обморок), следует"}},{"type":"paragraph","data":{"text":"соблюдать осторожность при управлении транспортными средствами, механизмами и"}},{"type":"paragraph","data":{"text":"занятием деятельностью, требующей быстроты психомоторных реакций и концентрации"}},{"type":"paragraph","data":{"text":"внимания.\n"}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки, 200 мг. По 1, 2 или 3 таблетки в контурную ячейковую упаковку из пленки"}},{"type":"paragraph","data":{"text":"поливинилхлоридной и фольги алюминиевой печатной лакированной."}},{"type":"paragraph","data":{"text":"По 1, 2, 3 или 5 контурных ячейковых упаковок с инструкцией по медицинскому применению лекарственного препарата в пачку из картона."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом, защищенном от света месте, при температуре не выше 30 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"5 лет. Не применять по истечении срока годности."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Препарат может поставляться только в медицинские акушерско-гинекологические"}},{"type":"paragraph","data":{"text":"учреждения, относящиеся к государственной системе здравоохранения, а также в"}},{"type":"paragraph","data":{"text":"учреждения муниципальной и частной собственности, имеющие лицензии на этот род"}},{"type":"paragraph","data":{"text":"деятельности.\n"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"ЗАО «Обнинская химико-фармацевтическая компания», Россия"}},{"type":"paragraph","data":{"text":"Все стадии производственного процесса:"}},{"type":"paragraph","data":{"text":"Калужская область, г. Обнинск, Киевское шоссе, зд. 103, зд. 107"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"АО «Нижфарм», Россия"}},{"type":"paragraph","data":{"text":"603950, г. Нижний Новгород, ул. Салганская, д. 7"}},{"type":"paragraph","data":{"text":"Тел.: (831) 278-80-88; факс: (831) 430-72-28"}},{"type":"paragraph","data":{"text":"E-mail: med@stada.ru"}}]}],"source":null},"description_toggle":false,"short_description":"Фармакодинамика Мифепристон - синтетическое стероидное антипрогестагенное средство (блокирует действие прогестерона на уровне рецепторов), гестагенной активностью не обладает. Отмечен антагонизм с глюкокортикостероидами (ГКС) за счет конкуренции на уровне связи с рецепторами. Повышает сократительную способность миометрия, стимулируя высвобождение интерлейкина-8 в хориодецидуальных клетках, повышая чувствительность миометрия к простагландинам (для усиления эффекта применяют в сочетании с синтетическим аналогом простагландина). В результате действия препарата происходит десквамация децидуальной оболочки и экспульсия плодного яйца. Фармакокинетика Всасывание После однократного приема внутрь в дозе 600 мг максимальная концентрация мифепристона (1,98 мг/л) достигается через 1,3 часа. Абсолютная биодоступность составляет 69 %. Распределение Мифепристон на 98 % связывается с белками плазмы крови - альбумином и кислым альфа1- гликопротеином. Метаболизм Метаболизм мифепристона происходит при «первичном» прохождении через печень путем N-деметилирования и гидроксилирования 17-пропиниловой цепи с образованием трех основных метаболитов. Выведение После фазы распределения выведение сначала происходит медленно, концентрация мифепристона в плазме крови уменьшается в 2 раза между 12-72 часами, затем более быстро. Период полувыведения мифепристона составляет 18 часов. 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