Повышенная чувствительность к препарату. Детский и подростковый возраст до 18 лет. Одновременный прием ингибиторов МАО и период до 14 дней после их отмены. Одновременный прием пимозида. Одновременный прием тиоридазина и период до 5 недель после его отмены
Действующее вещество: Флуоксетин (Fluoxetinum). Концентрация действующего вещества (мг): 20
Фармакологические свойства
Прозак является антидепрессантом, селективным ингибитором обратного захвата серотонина, что определяет его механизм действия. Флуоксетин практически не обладает сродством к другим рецепторам, например к αl-, α2- и β-адренергическим, серотонинергическим, дофаминергическим, гистаминергическим, мускариновым и ГАМК-рецепторам.
Повышенная чувствительность к препарату. Детский и подростковый возраст до 18 лет. Одновременный прием ингибиторов МАО и период до 14 дней после их отмены. Одновременный прием пимозида. Одновременный прием тиоридазина и период до 5 недель после его отмены
Применение при беременности и в период грудного вскармливания
Беременность: известно о 2072 случаях беременности, протекавшей на фоне приема флуоксетина в первом триместре. Имеющиеся данные свидетельствуют об отсутствии нежелательного воздействия на протекание беременности или на развитие плода или новорожденного. Однако следует проявлять осторожность, особенно на поздних сроках беременности, поскольку имеются редкие сообщения о развитии синдрома отмены у новорожденного (кратковременное двигательное беспокойство, трудности при кормлении, учащенное дыхание и раздражимость), если мать принимала препарат незадолго до родов. Флуоксетин может применяться во время беременности при условии, что предполагаемая польза превышает возможный риск. Грудное вскармливание: флуоксетин выводится с грудным молоком, следовательно, следует проявлять осторожность при назначении флуоксетина кормящим матерям. Роды: влияние флуоксетина на процесс родов у человека не известно.
Способ применения и дозы
Депрессия. Начальная рекомендованная доза составляет 20 мг в сутки. Булимия. Рекомендованная доза составляет 60 мг в сутки. Обсессивно-компульсивные расстройства. Рекомендованная доза составляет 20-60 мг в сутки. Предменструальные дисфорические расстройства. Рекомендованная доза составляет 20 мг в сутки. Все показания. Рекомендованная доза может быть снижена или увеличена. Дозы более 80 мгсутки систематически не изучались. Возраст. Не существует данных о необходимости изменения доз в зависимости только от возраста. Прием пиши. Флуоксетин можно принимать в любое время независимо от приема пищи. Сопутствующие заболевания или сопутствующее лечение. У больных с нарушениями функции печени, сопутствующими заболеваниями или принимающих другие лекарства, следует уменьшить дозы и снизить частоту приема.
Побочное действие
Как и в случае применения других препаратов группы Селективных ингибиторов обратного захвата серотонина, на фоне использования флуоксетина отмечаются следующие нежелательные явления. Сердечно-сосудистая система: Часто (≥1% - меньше10%): трепетание предсердий, приливы («приливы» жара). Нечасто (≥0. 1% - меньше1%): гипотензия. Редко (меньше0. 1%): васкулит, вазодилатация. Пищеварительная система: Очень часто (≥10%): диарея, тошнота. Часто (≥1% - меньше10%): сухость во рту, диспепсия, рвота, анорексия (включая потерю веса). Нечасто (≥0. 1% - меньше1%): дисфагия, извращение вкуса. Редко (меньше0. 1%): боли по ходу пищевода. Общее влияние на организм: Очень часто (≥10%): слабость (включая астению). Часто (≥1% - меньше10%): озноб, приступы тревоги, беспокойства, зевота. Редко (≥0. 1% - меньше1%): ощущение жара, ощущение холода, недомогание, дискомфорт. Иммунная система: Очень редко (меньше0. 1%): анафилактические реакции, сывороточная болезнь. Нарушения метаболизма и питания: Часто (≥1% - меньше10%): анорексия (включая потерю веса). Скелетно-мышечная система: Нечасто (≥0. 1% - меньше1%): мышечные подергивания. Нервная система: Очень часто (≥10%): головная боль. Часто (≥1% - меньше10%): нарушение внимания, головокружение, летаргия, сонливость (в том числе гипер сонливость, седация), тремор. Нечасто (≥0, 1% - меньше1%): психомоторная гиперактивность, атаксия, нарушение координации, бруксизм, дискинезия, миоклонус. Редко (меньше0. 1%): букко-глоссальный синдром, судороги. Психические расстройства: Очень часто (≥10%): бессоница (включая раннее утреннее пробуждение, начальную и среднюю бессонницу). Часто (≥1% - меньше10%): необычные сновидения (в том числе кошмары), нервозность, напряженность, снижение либидо (включая отсутствие либидо), эйфория, расстройство сна. Нечасто (≥0. 1% - меньше1%): деперсонализация, гипертимия, нарушение оргазма (включая аноргазмию), нарушение мышления. Редко (меньше0. 1%): мания, гипомания. Кожа: Часто (≥1% - меньше10%): гипергидроз, кожный зуд, сыпь (в том числе эксфолиативная, гипертермическая, эритематозная, фолликулярная, генерализованная, макулезная, макулезнопапулезная, кореподобная, папулезная, зудящая, везикулезная, эритема с пупковидным вдавлением в центре. эритема), крапивница. Нечасто (≥0. 1% - меньше1%): экхимоз, склонность к появлению синяков, аллопеция, холодный пот. Редко (меньше0. 1%): ангионевротический отек, реакции фоточувствительности. Органы чувств: Часто (≥1% - меньше10%): нечеткость зрения. Нечасто (≥0. 1% - меньше1%): мидриаз. Мочеполовая система: Часто (≥1% - меньше10%): учащенное мочеиспускание (включая поллакиурию), нарушения эякуляции (в том числе отсутствие эякуляции, дисфункциональная эякуляция, ранняя эякуляция, задержка эякуляции, ретроградная эякуляция), эректильная дисфункция, гинекологические кровотечения (в том числе кровотечение из шейки матки, дисфункциональное маточное кровотечение, кровотечение из половых путей, менометроррагия, меноррагия, метроррагия, полименорея, кровотечение в пост-менопаузе, маточное кровотечение, вагинальное кровотечение). Нечасто (≥0. 1% - меньше1%): дизурия. Редко (меньше0. 1%): сексуальная дисфункция. Спонтанные (постмаркетинговые) сообщения Эндокринная система: Недостаточная секреция антидиуретического гормона. Гепатобилиарная система: Редко (меньше0. 1%): Идиосинкразический гепатит. Нервная система: Серотониновый синдром. Мочеполовая система: приапизм.
Передозировка
Известно о 633 случаях передозировки флуоксетина у взрослых пациентов, из которых 378 полностью выздоровели; у 15 сохранялись симптомы нарушения аккомодации, походки, спутанности сознания, недоступности контакту, нервозности, нарушения функции дыхательной системы, вертиго, тремора, повышения артериального давления, нарушения потенции у мужчин, двигательных расстройств и гипомании; у 34 имелся летальный исход; сведения об остальных 206 пациентах не известны. Максимальная известная доза флуоксетина, которая принималась человеком внутрь, составляет 8 г. ; данный случай передозировки завершился полным выздоровлением. Минимальная известная доза флуоксетина, прием которой сопровождался летальным исходом, однако без четко установленной причинно-следственной связи, составляет 520 мг. Основные проявления передозировки включали судороги, сонливость, тошноту, тахикардию и рвоту. Другие серьезные проявления, о которых сообщалось при передозировке флуоксетина (как изолированной, так и в сочетании с другими препаратами), включали кому, делирий, удлинение интервала QT и желудочковую тахиаритмию, в том числе мерцание-трепетание желудочков и остановку сердца, снижение артериального давления, обморок, манию, пирексию, ступор и состояние, подобное злокачественному нейролептическому синдрому. Лечение. Рекомендуется контролировать общее состояние и сердечную деятельность, наряду с проведением общих симптоматических и поддерживающих мероприятий/Специфический антидот неизвестен. Усиление Диуреза, диализ, гемоперфузия и перекрестная трансфузия вряд ли принесут пользу. При лечении передозировки следует учитывать возможность применения нескольких лекарственных препаратов.
Особые указания
Имеются сообщения о возникновении кожной сыпи, анафилактических реакциях и прогрессирующих системных нарушениях с вовлечением в патологический процесс кожи, легких, печени, почек у пациентов, принимающих флуоксетин. При появлении кожной сыпи или других возможных аллергических реакций, этиология которых не может быть определена, прием Прозака следует отменить. Как и в случае применения других антидепрессантов Прозак следует с осторожностью назначать больным, у которых в анамнезе отмечались эпилептические припадки. При применении флуоксетина отмечались случаи развития гипонатриемии (в отдельных случаях уровень натрия в крови был менее 110 ммоль/л). В основном подобные случаи наблюдались у пожилых пациентов и у больных, получавших диуретики, вследствие уменьшения ОЦК. У больных сахарным диабетом во время лечения Прозаком отмечалась гипогликемия, а после отмены препарата - гипергликемия. В начале и после окончания лечения флуоксетином может потребоваться коррекция доз инсулина и/или гипогликемических препаратов для приема внутрь. Результаты экспериментальных исследований: В исследованиях in vitro и на животных не получено доказательств канцерогенности. Использование в педиатрии: Безопасность и эффективность применения Прозака у детей не установлены. Влияние на способность к вождению автотранспорта и управлению механизмами: Препараты, влияющие на психическую деятельность, могут влиять на способность к принятию решений и на навыки вождения автомобиля. Больным необходимо посоветовать избегать вождения автомобиля или управления опасными механизмами до тех пор, пока не будет установлено отсутствие влияния препарата на способность к этим видам деятельности.
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вещество: Флуоксетин (Fluoxetinum). Концентрация действующего вещества (мг): 20"}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Прозак является антидепрессантом, селективным ингибитором обратного захвата серотонина, что определяет его механизм действия. Флуоксетин практически не обладает сродством к другим рецепторам, например к αl-, α2- и β-адренергическим, серотонинергическим, дофаминергическим, гистаминергическим, мускариновым и ГАМК-рецепторам."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Депрессии различной этиологии, Нервная булимия, Обсессивно-компульсивное расстройство, Предменструальное дисфорическое расстройство."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к препарату. Детский и подростковый возраст до 18 лет. Одновременный прием ингибиторов МАО и период до 14 дней после их отмены. Одновременный прием пимозида. Одновременный прием тиоридазина и период до 5 недель после его отмены"}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Беременность: известно о 2072 случаях беременности, протекавшей на фоне приема флуоксетина в первом триместре. Имеющиеся данные свидетельствуют об отсутствии нежелательного воздействия на протекание беременности или на развитие плода или новорожденного. Однако следует проявлять осторожность, особенно на поздних сроках беременности, поскольку имеются редкие сообщения о развитии синдрома отмены у новорожденного (кратковременное двигательное беспокойство, трудности при кормлении, учащенное дыхание и раздражимость), если мать принимала препарат незадолго до родов. Флуоксетин может применяться во время беременности при условии, что предполагаемая польза превышает возможный риск. Грудное вскармливание: флуоксетин выводится с грудным молоком, следовательно, следует проявлять осторожность при назначении флуоксетина кормящим матерям. Роды: влияние флуоксетина на процесс родов у человека не известно."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Депрессия. Начальная рекомендованная доза составляет 20 мг в сутки. Булимия. Рекомендованная доза составляет 60 мг в сутки. Обсессивно-компульсивные расстройства. Рекомендованная доза составляет 20-60 мг в сутки. Предменструальные дисфорические расстройства. Рекомендованная доза составляет 20 мг в сутки. Все показания. Рекомендованная доза может быть снижена или увеличена. Дозы более 80 мгсутки систематически не изучались. Возраст. Не существует данных о необходимости изменения доз в зависимости только от возраста. Прием пиши. Флуоксетин можно принимать в любое время независимо от приема пищи. Сопутствующие заболевания или сопутствующее лечение. У больных с нарушениями функции печени, сопутствующими заболеваниями или принимающих другие лекарства, следует уменьшить дозы и снизить частоту приема."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Как и в случае применения других препаратов группы Селективных ингибиторов обратного захвата серотонина, на фоне использования флуоксетина отмечаются следующие нежелательные явления. Сердечно-сосудистая система: Часто (≥1% - меньше10%): трепетание предсердий, приливы («приливы» жара). Нечасто (≥0. 1% - меньше1%): гипотензия. Редко (меньше0. 1%): васкулит, вазодилатация. Пищеварительная система: Очень часто (≥10%): диарея, тошнота. Часто (≥1% - меньше10%): сухость во рту, диспепсия, рвота, анорексия (включая потерю веса). Нечасто (≥0. 1% - меньше1%): дисфагия, извращение вкуса. Редко (меньше0. 1%): боли по ходу пищевода. Общее влияние на организм: Очень часто (≥10%): слабость (включая астению). Часто (≥1% - меньше10%): озноб, приступы тревоги, беспокойства, зевота. Редко (≥0. 1% - меньше1%): ощущение жара, ощущение холода, недомогание, дискомфорт. Иммунная система: Очень редко (меньше0. 1%): анафилактические реакции, сывороточная болезнь. Нарушения метаболизма и питания: Часто (≥1% - меньше10%): анорексия (включая потерю веса). Скелетно-мышечная система: Нечасто (≥0. 1% - меньше1%): мышечные подергивания. Нервная система: Очень часто (≥10%): головная боль. Часто (≥1% - меньше10%): нарушение внимания, головокружение, летаргия, сонливость (в том числе гипер сонливость, седация), тремор. Нечасто (≥0, 1% - меньше1%): психомоторная гиперактивность, атаксия, нарушение координации, бруксизм, дискинезия, миоклонус. Редко (меньше0. 1%): букко-глоссальный синдром, судороги. Психические расстройства: Очень часто (≥10%): бессоница (включая раннее утреннее пробуждение, начальную и среднюю бессонницу). Часто (≥1% - меньше10%): необычные сновидения (в том числе кошмары), нервозность, напряженность, снижение либидо (включая отсутствие либидо), эйфория, расстройство сна. Нечасто (≥0. 1% - меньше1%): деперсонализация, гипертимия, нарушение оргазма (включая аноргазмию), нарушение мышления. Редко (меньше0. 1%): мания, гипомания. Кожа: Часто (≥1% - меньше10%): гипергидроз, кожный зуд, сыпь (в том числе эксфолиативная, гипертермическая, эритематозная, фолликулярная, генерализованная, макулезная, макулезнопапулезная, кореподобная, папулезная, зудящая, везикулезная, эритема с пупковидным вдавлением в центре. эритема), крапивница. Нечасто (≥0. 1% - меньше1%): экхимоз, склонность к появлению синяков, аллопеция, холодный пот. Редко (меньше0. 1%): ангионевротический отек, реакции фоточувствительности. Органы чувств: Часто (≥1% - меньше10%): нечеткость зрения. Нечасто (≥0. 1% - меньше1%): мидриаз. Мочеполовая система: Часто (≥1% - меньше10%): учащенное мочеиспускание (включая поллакиурию), нарушения эякуляции (в том числе отсутствие эякуляции, дисфункциональная эякуляция, ранняя эякуляция, задержка эякуляции, ретроградная эякуляция), эректильная дисфункция, гинекологические кровотечения (в том числе кровотечение из шейки матки, дисфункциональное маточное кровотечение, кровотечение из половых путей, менометроррагия, меноррагия, метроррагия, полименорея, кровотечение в пост-менопаузе, маточное кровотечение, вагинальное кровотечение). Нечасто (≥0. 1% - меньше1%): дизурия. Редко (меньше0. 1%): сексуальная дисфункция. Спонтанные (постмаркетинговые) сообщения Эндокринная система: Недостаточная секреция антидиуретического гормона. Гепатобилиарная система: Редко (меньше0. 1%): Идиосинкразический гепатит. Нервная система: Серотониновый синдром. Мочеполовая система: приапизм."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Известно о 633 случаях передозировки флуоксетина у взрослых пациентов, из которых 378 полностью выздоровели; у 15 сохранялись симптомы нарушения аккомодации, походки, спутанности сознания, недоступности контакту, нервозности, нарушения функции дыхательной системы, вертиго, тремора, повышения артериального давления, нарушения потенции у мужчин, двигательных расстройств и гипомании; у 34 имелся летальный исход; сведения об остальных 206 пациентах не известны. Максимальная известная доза флуоксетина, которая принималась человеком внутрь, составляет 8 г. ; данный случай передозировки завершился полным выздоровлением. Минимальная известная доза флуоксетина, прием которой сопровождался летальным исходом, однако без четко установленной причинно-следственной связи, составляет 520 мг. Основные проявления передозировки включали судороги, сонливость, тошноту, тахикардию и рвоту. Другие серьезные проявления, о которых сообщалось при передозировке флуоксетина (как изолированной, так и в сочетании с другими препаратами), включали кому, делирий, удлинение интервала QT и желудочковую тахиаритмию, в том числе мерцание-трепетание желудочков и остановку сердца, снижение артериального давления, обморок, манию, пирексию, ступор и состояние, подобное злокачественному нейролептическому синдрому. Лечение. Рекомендуется контролировать общее состояние и сердечную деятельность, наряду с проведением общих симптоматических и поддерживающих мероприятий/Специфический антидот неизвестен. Усиление Диуреза, диализ, гемоперфузия и перекрестная трансфузия вряд ли принесут пользу. При лечении передозировки следует учитывать возможность применения нескольких лекарственных препаратов."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Имеются сообщения о возникновении кожной сыпи, анафилактических реакциях и прогрессирующих системных нарушениях с вовлечением в патологический процесс кожи, легких, печени, почек у пациентов, принимающих флуоксетин. При появлении кожной сыпи или других возможных аллергических реакций, этиология которых не может быть определена, прием Прозака следует отменить. Как и в случае применения других антидепрессантов Прозак следует с осторожностью назначать больным, у которых в анамнезе отмечались эпилептические припадки. При применении флуоксетина отмечались случаи развития гипонатриемии (в отдельных случаях уровень натрия в крови был менее 110 ммоль/л). В основном подобные случаи наблюдались у пожилых пациентов и у больных, получавших диуретики, вследствие уменьшения ОЦК. У больных сахарным диабетом во время лечения Прозаком отмечалась гипогликемия, а после отмены препарата - гипергликемия. В начале и после окончания лечения флуоксетином может потребоваться коррекция доз инсулина и/или гипогликемических препаратов для приема внутрь. Результаты экспериментальных исследований: В исследованиях in vitro и на животных не получено доказательств канцерогенности. Использование в педиатрии: Безопасность и эффективность применения Прозака у детей не установлены. Влияние на способность к вождению автотранспорта и управлению механизмами: Препараты, влияющие на психическую деятельность, могут влиять на способность к принятию решений и на навыки вождения автомобиля. Больным необходимо посоветовать избегать вождения автомобиля или управления опасными механизмами до тех пор, пока не будет установлено отсутствие влияния препарата на способность к этим видам деятельности."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Прозак является антидепрессантом, селективным ингибитором обратного захвата серотонина, что определяет его механизм действия. 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