Гиперчувствительность одновременный прием ингибиторов МАО (и в течение 14 дней после их отмены) тиоридазина (и в течение 5 нед после отмены флуоксетина) пимозида тяжелые нарушения функции почек (клиренс креатинина менее 10 мл/мин) и печени беременность период лактации возраст до 18 лет.
Инструкция
Регистрационный номер
ЛСР-001746/09 от 10.03.09
Торговое название препарата
Флуоксетин
Лекарственная форма
капсулы
Состав
Капсулы 10 мг. Каждая
капсула содержит активное вещество флуоксетина гидрохлорид 11,2 мг в пересчете на флуоксетин 10 мг. Вспомогательные вещества: целлюлоза микрокристаллическая - 153,0 мг, крахмал прежелатинизированный - 14,3 мг, магния стеарат - 1,5 мг.
Капсулы 10 мг - корпус капсулы оливково-зеленого цвета, крышечка капсулы - оливковозеленого цвета.
Капсулы 20 мг - корпус капсулы оливково-зеленого цвета, крышечка капсулы - зеленого цвета. Содержимое капсул порошок белого или почти белого цвета.
Фармакотерапевтическая группа
антидепрессант
Фармакологические свойства
Фармакодинамика:
Избирательно блокирует обратный нейрональный захват серотонина (5НТ) в синапсах нейронов центральной нервной системы. Ингибирование обратного захвата серотонина приводит к повышению концентрации этого нейромедиатора в синаптической щели усиливает и пролонгирует его действие на постсинаптические рецепторные участки. В терапевтических дозах флуоксетин блокирует захват серотонина тромбоцитами человека. Является слабым антагонистом мускариновых гистаминовых H1 адренергических а1 и а2 рецепторов мало влияет на обратный захват дофамина. Вызывает редукцию обсессивно- комиульсивных расстройств а также снижение аппетита что может привести к снижению массы тела. Не вызывает седативного эффекта. При приеме в средних терапевтических дозах практически не влияет на функции сердечно-сосудистой и других систем.
Фармакокинетика:
При приеме внутрь препарат хорошо всасывается из желудочно-кишечного тракта (до 95% принятой дозы) применение с пищей незначительно тормозит всасывание флуоксетина. Максимальные концентрации в плазме крови достигаются через 6-8 часов. Биодоступность флуоксетина после приема внутрь составляет более 60 %. Препарат хорошо накапливается в тканях легко проникает через гематоэнцефалический барьер связывание с белками плазмы крови составляет более 90%. Метаболизируется в печени путем деметилироваиия до активного метаболита норфлуоксетина и ряда неидентифицированных метаболитов. Выводится почками величина клиренса флуоксетина составляет 94-704 мл/мин норфлуоксетина 60-336 мл/мин. Около 12 % препарата выделяется через желудочно-кишечный тракт. Период полувыведения флуоксетина составляет около 2-3 суток норфлуоксетина - 7-9 суток. У больных с печеночной недостаточностью период полувыведения флуоксетина и норфлуоксетина удлиняется. Препарат выделяется с грудным молоком (до 25% от концентрации в сыворотке крови).
Показания к применению
-Депрессии различной этиологии.
-Обсессивно-компульсивные расстройства.
-Булимический невроз.
-Предменструальное дисфорическое расстройство.
Противопоказания
Гиперчувствительность одновременный прием ингибиторов МАО (и в течение 14 дней после их отмены) тиоридазина (и в течение 5 нед после отмены флуоксетина) пимозида тяжелые нарушения функции почек (клиренс креатинина менее 10 мл/мин) и печени беременность период лактации возраст до 18 лет.
С осторожностью
Сахарный диабет эпилепсия судорожные расстройства (в т.ч. в анамнезе) суицидальная настроенность.
Способ применения и дозы
Препарат принимают внутрь.
Депрессия. Начальная доза составляет 20 мг 1 раз в сутки в первой половине дня независимо от приема пищи. При необходимости и переносимости доза может быть увеличена до 40-60 мг в сутки (на 20 мг в неделю) разделенных на 2-3 приема. Максимальная суточная доза - 80 мг. Терапевтический эффект препарата устанавливается через 1-4 недели после начала лечения у некоторых пациентов он может достигаться позже.
Обсессивно-компульсивные расстройства - рекомендованная доза составляет 20-60 мг в сутки. При нервной булимии рекомендованная доза составляет 60 мг в сутки разделенных на 2-3 приема.
Предменструальные дисфорические расстройства: рекомендованная доза составляет 20 мг в сутки У больных пожилого возраста рекомендуемая начальная суточная доза составляет 20 мг.
У больных с нарушениями функции печени и почек рекомендуется применение более низких доз и удлинение интервала между приемами.
Побочное действие
Со стороны центральной нервной системы: усиление суицидальных тенденций тревога головная боль тремор ажитация повышенная раздражительность нарушение сна головокружение сонливость астенические расстройства уменьшение либидо маниакальные и судорожные расстройства.
Со стороны желудочно-кишечного тракта: снижение аппетита нарушение вкуса тошнота рвота сухость во рту или гиперсаливация диарея.
Со стороны мочеполовой системы: недержание или задержка мочи дисменорея вагинит снижение либидо половая дисфункция у мужчин (замедленная эякуляция).
Редко встречаются аллергические реакции в виде кожной сыпи зуда озноба крапивницы повышения температуры тела боли в мышцах и суставах (возможно применение
антигистаминных и стероидных препаратов) гипонатриемия ортостатическая гипотония тахикардия нарушение остроты зрения.
Прочие: повышенное потоотделение тахикардия системные нарушения со стороны легких почек или печени васкулиты.
Возможно развитие анорексии и уменьшение массы тела.
Указанные побочные эффекты чаще возникают в начале терапии флуоксетином или при повышении дозы препарата.
Передозировка
Симптомы: ажитация маниакальные и судорожные расстройства нарушения сердечного ритма тахикардия тошнота рвота.
Лечение: специфические антагонисты к флуоксетину не найдены. Проводится симптоматическая терапия промывание желудка с назначением активированного угля при судорагах - диазепам поддержание дыхания сердечной деятельности температуры тела.
Взаимодействие с другими лекарственными средствами
Усиливает эффекты алпразолама диазепама этилового спирта и гипогликемических лекарственных средств (ЛС).
Повышает в плазме концентрацию фенитоина трициклических антидепрессантов мапротилина тразодона в 2 раза (необходимо на 50 % снижать дозу трициклических антидепрессантов при одновременном применении).
Возможно повышение концентрации лития - риск развития токсических эффектов лития. Эти ЛС следует применять одновременно с осторожностью рекомендуется частое определение концентрации лития в сыворотке крови.
На фоне проведения электросудорожной терапии возможно развитие продолжительных эпилептических припадков.
Триптофан усиливает серотонинергические свойства флуоксетина (усиление ажитации двигательного беспокойства нарушений со стороны желудочно-кишечного тракта).
Ингибиторы МАО повышают риск развития серотонинового синдрома (гипертермия озноб повышенное потоотделение миоклонус гиперрефлексия тремор диарея нарушения координации движений вегетативная лабильность психомоторное возбуждение бредовые расстройства угнетение сознания вплоть до комы).
ЛС оказывающие угнетающее влияние на центральную нервную систему повышают риск развития побочных эффектов и усиления угнетающего действия на центральную нервную систему.
При одновременном применении с ЛС обладающими высокой степенью связывания с белками особенно с антикоагулянтами и дигитоксином возможно повышение концентрации в плазме свободных (несвязанных) ЛС и увеличение риска развития неблагоприятных эффектов. Флуоксетин усиливает действие гипогликемических препаратов и антикоагулянтов.
Особые указания
При лечении больных с дефицитом массы тела следует учитывать анорексигенные эффекты (возможна прогрессирующая потеря массы тела).
У больных сахарным диабетом назначение флуоксетина повышает риск развития гипогликемии и гипергликемии - при его отмене. В связи с этим доза инсулина и/или любых др. гипогликемических ЛС применяемых внутрь должна быть скорректирована. До наступления значительного улучшения в лечении больные должны находиться под наблюдением врача.
Во время лечения следует воздерживаться от приема алкоголя и занятий потенциально опасными видами деятельности требующими повышенного внимания и быстроты психических и двигательных реакций.
После применения ингибиторов МАО назначение флуоксетина допускается не ранее 14 дней. Не следует применять ингибиторы МАО и/или тиоридазин ранее чем через 5 недель после отмены флуоксетина.
При развитии на фоне приёма флуоксетина судорожных припадков препарат следует отменить. При заболеваниях печени и в пожилом возрасте лечение следует начинать с минимальных доз.
Форма выпуска
Капсулы 10 мг и 20 мг.
Условия хранения
Список Б. Хранить в сухом защищенном от света месте при температуре не выше 25 °С. Хранить в недоступном для детей месте.
Срок годности
3 года. Не применять по истечении срока годности.
Условия отпуска
По рецепту
Производитель
Общество с ограниченной ответственностью "Озон" (ООО "Озон"), 445351, Самарская обл., г. Жигулёвск, ул. Гидростроителей, д. 6, Россия
Организация, принимающая претензии потребителей
ООО "Озон"
Для описания товара использована информация от партнера 36.6
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Каждая"}},{"type":"paragraph","data":{"text":"капсула содержит активное вещество флуоксетина гидрохлорид 11,2 мг в пересчете на флуоксетин 10 мг. Вспомогательные вещества: целлюлоза микрокристаллическая - 153,0 мг, крахмал прежелатинизированный - 14,3 мг, магния стеарат - 1,5 мг."}},{"type":"paragraph","data":{"text":"Состав капсулы 10 мг: титана диоксид, индигокармин, краситель железа оксид желтый, желатин."}},{"type":"paragraph","data":{"text":"Капсулы 20 мг. Каждая капсула содержит активное вещество флуоксетина гидрохлорид 22,4 мг в пересчете на флуоксетин 20 мг. Вспомогательные вещества целюлоза микрокристаллическая - 141,8мг, крахмал прежелатинизированный - 14,3 мг, магния стеарат - 1,5 мг."}},{"type":"paragraph","data":{"text":"Состав капсулы 20 мг: титана диоксид, индигокармин, краситель железа оксид желтый, краситель хинолиновый желтый, краситель азорубин, краситель синий патентованный, краситель бриллиантовый черный, желатин."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"твердые желатиновые капсулы № 2."}},{"type":"paragraph","data":{"text":"Капсулы 10 мг - корпус капсулы оливково-зеленого цвета, крышечка капсулы - оливковозеленого цвета."}},{"type":"paragraph","data":{"text":"Капсулы 20 мг - корпус капсулы оливково-зеленого цвета, крышечка капсулы - зеленого цвета. Содержимое капсул порошок белого или почти белого цвета."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"антидепрессант"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Избирательно блокирует обратный нейрональный захват серотонина (5НТ) в синапсах нейронов центральной нервной системы. Ингибирование обратного захвата серотонина приводит к повышению концентрации этого нейромедиатора в синаптической щели усиливает и пролонгирует его действие на постсинаптические рецепторные участки. В терапевтических дозах флуоксетин блокирует захват серотонина тромбоцитами человека. Является слабым антагонистом мускариновых гистаминовых H1 адренергических а1 и а2 рецепторов мало влияет на обратный захват дофамина. Вызывает редукцию обсессивно- комиульсивных расстройств а также снижение аппетита что может привести к снижению массы тела. Не вызывает седативного эффекта. При приеме в средних терапевтических дозах практически не влияет на функции сердечно-сосудистой и других систем."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"При приеме внутрь препарат хорошо всасывается из желудочно-кишечного тракта (до 95% принятой дозы) применение с пищей незначительно тормозит всасывание флуоксетина. Максимальные концентрации в плазме крови достигаются через 6-8 часов. Биодоступность флуоксетина после приема внутрь составляет более 60 %. Препарат хорошо накапливается в тканях легко проникает через гематоэнцефалический барьер связывание с белками плазмы крови составляет более 90%. Метаболизируется в печени путем деметилироваиия до активного метаболита норфлуоксетина и ряда неидентифицированных метаболитов. Выводится почками величина клиренса флуоксетина составляет 94-704 мл/мин норфлуоксетина 60-336 мл/мин. Около 12 % препарата выделяется через желудочно-кишечный тракт. Период полувыведения флуоксетина составляет около 2-3 суток норфлуоксетина - 7-9 суток. У больных с печеночной недостаточностью период полувыведения флуоксетина и норфлуоксетина удлиняется. Препарат выделяется с грудным молоком (до 25% от концентрации в сыворотке крови)."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"-Депрессии различной этиологии."}},{"type":"paragraph","data":{"text":"-Обсессивно-компульсивные расстройства."}},{"type":"paragraph","data":{"text":"-Булимический невроз."}},{"type":"paragraph","data":{"text":"-Предменструальное дисфорическое расстройство."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность одновременный прием ингибиторов МАО (и в течение 14 дней после их отмены) тиоридазина (и в течение 5 нед после отмены флуоксетина) пимозида тяжелые нарушения функции почек (клиренс креатинина менее 10 мл/мин) и печени беременность период лактации возраст до 18 лет."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Сахарный диабет эпилепсия судорожные расстройства (в т.ч. в анамнезе) суицидальная настроенность."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат принимают внутрь."}},{"type":"paragraph","data":{"text":"Депрессия. Начальная доза составляет 20 мг 1 раз в сутки в первой половине дня независимо от приема пищи. При необходимости и переносимости доза может быть увеличена до 40-60 мг в сутки (на 20 мг в неделю) разделенных на 2-3 приема. Максимальная суточная доза - 80 мг. Терапевтический эффект препарата устанавливается через 1-4 недели после начала лечения у некоторых пациентов он может достигаться позже."}},{"type":"paragraph","data":{"text":"Обсессивно-компульсивные расстройства - рекомендованная доза составляет 20-60 мг в сутки. При нервной булимии рекомендованная доза составляет 60 мг в сутки разделенных на 2-3 приема."}},{"type":"paragraph","data":{"text":"Предменструальные дисфорические расстройства: рекомендованная доза составляет 20 мг в сутки У больных пожилого возраста рекомендуемая начальная суточная доза составляет 20 мг."}},{"type":"paragraph","data":{"text":"У больных с нарушениями функции печени и почек рекомендуется применение более низких доз и удлинение интервала между приемами."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны центральной нервной системы: усиление суицидальных тенденций тревога головная боль тремор ажитация повышенная раздражительность нарушение сна головокружение сонливость астенические расстройства уменьшение либидо маниакальные и судорожные расстройства."}},{"type":"paragraph","data":{"text":"Со стороны желудочно-кишечного тракта: снижение аппетита нарушение вкуса тошнота рвота сухость во рту или гиперсаливация диарея."}},{"type":"paragraph","data":{"text":"Со стороны мочеполовой системы: недержание или задержка мочи дисменорея вагинит снижение либидо половая дисфункция у мужчин (замедленная эякуляция)."}},{"type":"paragraph","data":{"text":"Редко встречаются аллергические реакции в виде кожной сыпи зуда озноба крапивницы повышения температуры тела боли в мышцах и суставах (возможно применение"}},{"type":"paragraph","data":{"text":"антигистаминных и стероидных препаратов) гипонатриемия ортостатическая гипотония тахикардия нарушение остроты зрения."}},{"type":"paragraph","data":{"text":"Прочие: повышенное потоотделение тахикардия системные нарушения со стороны легких почек или печени васкулиты."}},{"type":"paragraph","data":{"text":"Возможно развитие анорексии и уменьшение массы тела."}},{"type":"paragraph","data":{"text":"Указанные побочные эффекты чаще возникают в начале терапии флуоксетином или при повышении дозы препарата."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: ажитация маниакальные и судорожные расстройства нарушения сердечного ритма тахикардия тошнота рвота."}},{"type":"paragraph","data":{"text":"Лечение: специфические антагонисты к флуоксетину не найдены. Проводится симптоматическая терапия промывание желудка с назначением активированного угля при судорагах - диазепам поддержание дыхания сердечной деятельности температуры тела."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Усиливает эффекты алпразолама диазепама этилового спирта и гипогликемических лекарственных средств (ЛС)."}},{"type":"paragraph","data":{"text":"Повышает в плазме концентрацию фенитоина трициклических антидепрессантов мапротилина тразодона в 2 раза (необходимо на 50 % снижать дозу трициклических антидепрессантов при одновременном применении)."}},{"type":"paragraph","data":{"text":"Возможно повышение концентрации лития - риск развития токсических эффектов лития. Эти ЛС следует применять одновременно с осторожностью рекомендуется частое определение концентрации лития в сыворотке крови."}},{"type":"paragraph","data":{"text":"На фоне проведения электросудорожной терапии возможно развитие продолжительных эпилептических припадков."}},{"type":"paragraph","data":{"text":"Триптофан усиливает серотонинергические свойства флуоксетина (усиление ажитации двигательного беспокойства нарушений со стороны желудочно-кишечного тракта)."}},{"type":"paragraph","data":{"text":"Ингибиторы МАО повышают риск развития серотонинового синдрома (гипертермия озноб повышенное потоотделение миоклонус гиперрефлексия тремор диарея нарушения координации движений вегетативная лабильность психомоторное возбуждение бредовые расстройства угнетение сознания вплоть до комы)."}},{"type":"paragraph","data":{"text":"ЛС оказывающие угнетающее влияние на центральную нервную систему повышают риск развития побочных эффектов и усиления угнетающего действия на центральную нервную систему."}},{"type":"paragraph","data":{"text":"При одновременном применении с ЛС обладающими высокой степенью связывания с белками особенно с антикоагулянтами и дигитоксином возможно повышение концентрации в плазме свободных (несвязанных) ЛС и увеличение риска развития неблагоприятных эффектов. Флуоксетин усиливает действие гипогликемических препаратов и антикоагулянтов."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"При лечении больных с дефицитом массы тела следует учитывать анорексигенные эффекты (возможна прогрессирующая потеря массы тела)."}},{"type":"paragraph","data":{"text":"У больных сахарным диабетом назначение флуоксетина повышает риск развития гипогликемии и гипергликемии - при его отмене. В связи с этим доза инсулина и/или любых др. гипогликемических ЛС применяемых внутрь должна быть скорректирована. До наступления значительного улучшения в лечении больные должны находиться под наблюдением врача."}},{"type":"paragraph","data":{"text":"Во время лечения следует воздерживаться от приема алкоголя и занятий потенциально опасными видами деятельности требующими повышенного внимания и быстроты психических и двигательных реакций."}},{"type":"paragraph","data":{"text":"После применения ингибиторов МАО назначение флуоксетина допускается не ранее 14 дней. Не следует применять ингибиторы МАО и/или тиоридазин ранее чем через 5 недель после отмены флуоксетина."}},{"type":"paragraph","data":{"text":"При развитии на фоне приёма флуоксетина судорожных припадков препарат следует отменить. При заболеваниях печени и в пожилом возрасте лечение следует начинать с минимальных доз."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы 10 мг и 20 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Список Б. Хранить в сухом защищенном от света месте при температуре не выше 25 °С. Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года. Не применять по истечении срока годности."}}]},{"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":"Общество с ограниченной ответственностью \"Озон\" (ООО \"Озон\"), 445351, Самарская обл., г. Жигулёвск, ул. Гидростроителей, д. 6, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ООО \"Озон\""}}]}],"source":null},"description_toggle":false,"short_description":"Избирательно блокирует обратный нейрональный захват серотонина (5НТ) в синапсах нейронов центральной нервной системы. Ингибирование обратного захвата серотонина приводит к повышению концентрации этого нейромедиатора в синаптической щели усиливает и пролонгирует его действие на постсинаптические рецепторные участки. В терапевтических дозах флуоксетин блокирует захват серотонина тромбоцитами человека. Является слабым антагонистом мускариновых гистаминовых H1 адренергических а1 и а2 рецепторов мало влияет на обратный захват дофамина. Вызывает редукцию обсессивно- комиульсивных расстройств а также снижение аппетита что может привести к снижению массы тела. Не вызывает седативного эффекта. При приеме в средних терапевтических дозах практически не влияет на функции сердечно-сосудистой и других систем. При приеме внутрь препарат хорошо всасывается из желудочно-кишечного тракта (до 95% принятой дозы) применение с пищей незначительно тормозит всасывание флуоксетина. Максимальные концентрации в плазме крови достигаются через 6-8 часов. Биодоступность флуоксетина после приема внутрь составляет более 60 %. Препарат хорошо накапливается в тканях легко проникает через гематоэнцефалический барьер связывание с белками плазмы крови составляет более 90%. Метаболизируется в печени путем деметилироваиия до активного метаболита норфлуоксетина и ряда неидентифицированных метаболитов. Выводится почками величина клиренса флуоксетина составляет 94-704 мл/мин норфлуоксетина 60-336 мл/мин. Около 12 % препарата выделяется через желудочно-кишечный тракт. Период полувыведения флуоксетина составляет около 2-3 суток норфлуоксетина - 7-9 суток. У больных с печеночной недостаточностью период полувыведения флуоксетина и норфлуоксетина удлиняется. Препарат выделяется с грудным молоком (до 25% от концентрации в сыворотке крови).","substance":[{"id":1359,"title":"Флуоксетин","title_latin":"Fluoxetinum","slug":"fluoksetin_1359"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":false,"comments":null,"image_alt":"Флуоксетин - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/83164/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/83164/share_default/"}},"diseases":[],"other_packages":[{"id":98379,"title":"Флуоксетин","subtitle":{"full":"Капсулы, 20 шт, 20 мг, для внутреннего применения, для взрослых, антидепрессант","short":"Капсулы, 20 шт, 20 мг","package":"20 шт, 20 мг"},"prescription":true,"catalog_section_id":100271,"manufacturer":{"id":5283,"title":"G.L. 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