Антидепрессант группы селективных ингибиторов обратного захвата серотонина.
Фармакодинамика
Избирательно блокирует обратный нейрональный захват серотонина (5-гидрокситриптамин) 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.
Обладает низким сродством K a1, a2 M В адренергическим, серотониновым, дофаминергическим, Н1-гистаминовым, мускариновым и ГАМКергическим рецепторам.
Способствует улучшению настроения, снижает напряженность, тревожность и чувство страха, устраняет дисфорию, вызывает снижение аппетита. Вызывает редукцию обсессивно—компульсивных расстройств. Не вызывает ортостатической гипотензии, седативного эффекта, не кардиотоксичен.
Стойкий клинический эффект наступает через 1—2 недели лечения.
Фармакокинетика
При приеме внутрь препарат хорошо всасывается из желудочно—кишечного тракта.
Прием пищи не влияет на биодоступность препарата.
Максимальная концентрация в плазме крови достигается через 6—8 часов. Препарат хорошо связывается с белками плазмы — около 95% (включая альбумин и альфа1-киспый гликопротеин), хорошо накапливается в тканях. Объем распределения препарата — высокий, легко проникает через гематоэнцефалический барьер, выделяется c грудным молоком (до 25% от концентрации в плазме). Метаболизируется в печени изоферментом CYP2D6 путем деметилирования до активного метаболита норфлуоксетина. Метаболиты выводятся почками (80%) и кишечником (15%) преимущественно в виде глюкуронидов. Период полувыведения флуоксетина после достижения равновесной концентрации в плазме составляет 4—6 дней, при однократном приеме — 1—4 дней, период полувыведения норфлуоксетина — 4—16 дней, что вызывает значительную кумуляцию активных форм и длительное присутствие в организме (5—6 недель) после отмены препарата. У больных c циррозом печени период полувыведения удлиняется в 3—4 раза.
Показания к применению
Депрессии различного генеза;
обсессивно-компульсивные расстройства;
булимический невроз;
предменструальная дисфория.
Противопоказания
- Повышенная чувствительность к препарату;
- одновременный прием ингибиторов MAO(моноаминоксидазы) и в течение 14 дней после их отмены, тиоридазина, лимозида;
- период лактации;
- беременность;
- тяжелые нарушения функции почек (клиренскреатинина менее 10 мл/мин) и печени;
- атония мочевого пузыря;
- детский возраст до 18 пет (эффективность и безопасность не становлена).
С осторожностью
Сахарный диабет, эпилепсия (в т.ч. в анамнезе), чрезмерное похудание, болезнь Паркинсона, суицидальная настроенность.
Применение при беременности и в период грудного вскармливания
Противопоказан во время беременности и в период лактации.
Способ применения и дозы
Внутрь.
При депрессии начальная доза составляет 20 мг 1 раз в сутки в первой половине дня, независимо от приема пищи. При необходимости доза может быть увеличена до 40—60 мг/сут, разделенных на 2—3 приема. Максимальная суточная доза — 80 мг.
Обсессивно-компульсивные расстройства: рекомендованная доза составляет 20—60 мг в сутки.
При булимическом неврозе и для пожилых пациентов препарат применяется в суточной дозе 60 мг, разделенных на 2—8 приема.
При предменструальных дисфорических расстройствах рекомендованная доза составляет 20 мг/сут.
При заболеваниях печени и в пожилом возрасте лечение следует начинать с 1/2 дозы.
У больных с нарушениями функции почек следует уменьшать дозу и увеличить интервал между приемом препарата.
Курс лечения 3-4 нед.
Побочное действие
Со стороны ЦНС: головокружение, головная боль, нарушения сна, повышенная утомляемость, астения, тремор, ажитация, двигательное возбуждение, усиление суицидальных тенденций, тревожность, мания или гипомания.
Со стороны ЖКТ: снижение аппетита, нарушение вкуса, тошнота, рвота, сухость во рту или гиперсаливация, диарея.
Аллергические реакции в виде кожной сыпи, зуда, крапивницы, миалгии, артралгии, лихорадки.
Со стороны мочеполовой системы: недержание или задержка мочи, дисменорея, вагинит, снижение либидо, нарушение половой функции y мужчин (замедление эякуляции).
Прочие: повышенное потоотделение, тахикардия, нарушение остроты зрения, похудание, системные нарушения со стороны легких, почек или печени, васкулиты.
Передозировка
Симптомы: тошнота, рвота, состояние возбуждения, двигательное беспокойство, судорожные расстройства, нарушение функции сердечно-сосудистой системы.
Лечение: специфические антагонисты K флуоксетину не найдены. Проводится симптоматическая терапия, промывание желудка, назначение активированного угля, при судорогах назначение транквилизаторов, поддержание дыхания, сердечной деятельности.
Взаимодействие с другими лекарственными средствами
Нельзя применять препарат одновременно с ингибиторами МАО (моноаминооксидазы), так как возможно развитие серотонинового синдрома (гипертермия, озноб, повышенное потоотделение, миокпонус, гиперрефпексин, тремор, диарея, нарушение координации движения, вегетативная лабильность, возбуждение, бред и кома).
Триптофан усиливает серотонинергические свойства препарата (усиление ажитации, двигательного беспокойства, нарушений со стороны желудочно—кишечного тракта).
При применении с препаратами, содержащими зверобой продырявленный (Hypericum perforatum), может возникнуть усиление серотонинергического эффекта, усиление нежелательных эффектов.
Повышает в плазме концентрацию фенитоина, трициклических антидепрессантов, мапротилина, тразодона в два раза (необходимо на 50% снижать дозу данных препаратов при одновременном применении с флуоксетином).
Одновременный прием флуоксетина с алкоголем или с препаратами центрального действия, вызывающими угнетение функции ЦНС, усиливает их эффект и повышает риск развития побочных эффектов.
Лекарственные средства, содержащие литий (Li+) следует применять с осторожностью из—за возможного повышения концентрации лития (Li*) и риска развития токсических эффектов.
На фоне проведения электросудорожной терапии возможно развитие продолжительных судорожных припадков.
При одновременном применении с препаратами, обладающими высокой степенью связывания с белками, особенно c антикоагулянтами и дигитоксином, возможно повышение концентрации в плазме свободных (несвязанных) лекарственных средств и увеличение риска развития неблагоприятных эффектов.
Особые указания
У больных с сопутствующим сахарным диабетом возможно развитие гипогликемии во время терапии флуоксетином и гипергликемии после его отмены. Поэтому доза инсулина и/или любых других гипогликемических средств должна быть скорректирована. До наступления значительного улучшения в лечении сахарного диабета больные должны находиться под наблюдением врача.
При лечении больных с дефицитом массы тела следует учитывать анорексигенные эффекты (возможна прогрессирующая потеря массы тела).
Интервал между окончанием терапии ингибиторами MAO и началом лечения флуоксетином должен составлять как минимум 14 дней; между окончанием лечения флуоксетином и началом терапии ингибиторами MAO — нe менее 5 нед.
При заболеваниях печени и в пожилом возрасте лечение следует начинать с V2 дозы.
У детей, подростков и молодых людей (младше 24 лет) с депрессией, др. психическими нарушениями антидепрессанты, по сравнению с плацебо, повышают риск возникновения суицидальных мыслей и суицидального поведения. Поэтому при назначении флуоксетина или любых антидепрессантов y детей, подростов и молодых людей (младше 24 лет) следует соотнести риск суицида и пользу от их применения.
В краткосрочных исследованиях у людей старше 24 лет риск суицида не повышался, а у людей старше 65 лет несколько снижался. Любое депрессивное расстройство само по себе увеличивает риск суицида. Поэтому во время лечения антидепрессантами за всеми пациентами должно быть установлено наблюдение с цепью раннего выявления нарушений или изменений поведения, а также суицидальных наклонностей.
Во время лечения флуоксетином следует воздержаться от приема алкоголя и занятий потенциально опасными видами деятельности, требующими повышенного внимания и быстроты психических и двигательных реакций.
Влияние на способность управлять автомобилем и движущимися механизмами
Во время лечения флуоксетином следует воздержаться от приема алкоголя и занятий потенциально опасными видами деятельности, требующими повышенного внимания и быстроты психических и двигательных реакций.
Хранить в сухом защищенном от света месте, при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
3 года. Не использовать после истечения срока годности.
Условия отпуска
По рецепту.
Производитель
G.L. PHARMA. Страна производства: Австрия.
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Вызывает редукцию обсессивно—компульсивных расстройств. Не вызывает ортостатической гипотензии, седативного эффекта, не кардиотоксичен."}},{"type":"paragraph","data":{"text":"Стойкий клинический эффект наступает через 1—2 недели лечения."}},{"type":"paragraph","data":{"text":"Фармакокинетика "}},{"type":"paragraph","data":{"text":"При приеме внутрь препарат хорошо всасывается из желудочно—кишечного тракта."}},{"type":"paragraph","data":{"text":"Прием пищи не влияет на биодоступность препарата."}},{"type":"paragraph","data":{"text":"Максимальная концентрация в плазме крови достигается через 6—8 часов. Препарат хорошо связывается с белками плазмы — около 95% (включая альбумин и альфа1-киспый гликопротеин), хорошо накапливается в тканях. Объем распределения препарата — высокий, легко проникает через гематоэнцефалический барьер, выделяется c грудным молоком (до 25% от концентрации в плазме). 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У больных c циррозом печени период полувыведения удлиняется в 3—4 раза."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Депрессии различного генеза;"}},{"type":"paragraph","data":{"text":"обсессивно-компульсивные расстройства;"}},{"type":"paragraph","data":{"text":"булимический невроз;"}},{"type":"paragraph","data":{"text":"предменструальная дисфория."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":" - Повышенная чувствительность к препарату;"}},{"type":"paragraph","data":{"text":" - одновременный прием ингибиторов MAO(моноаминоксидазы) и в течение 14 дней после их отмены, тиоридазина, лимозида;"}},{"type":"paragraph","data":{"text":"- период лактации;"}},{"type":"paragraph","data":{"text":"- беременность;"}},{"type":"paragraph","data":{"text":"- тяжелые нарушения функции почек (клиренскреатинина менее 10 мл/мин) и печени;"}},{"type":"paragraph","data":{"text":"- атония мочевого пузыря;"}},{"type":"paragraph","data":{"text":"- детский возраст до 18 пет (эффективность и безопасность не становлена)."}}]},{"name":"С осторожностью","slug":"cautions","id":14,"body":[{"type":"paragraph","data":{"text":"Сахарный диабет, эпилепсия (в т.ч. в анамнезе), чрезмерное похудание, болезнь Паркинсона, суицидальная настроенность."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказан во время беременности и в период лактации."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь."}},{"type":"paragraph","data":{"text":"При депрессии начальная доза составляет 20 мг 1 раз в сутки в первой половине дня, независимо от приема пищи. При необходимости доза может быть увеличена до 40—60 мг/сут, разделенных на 2—3 приема. Максимальная суточная доза — 80 мг."}},{"type":"paragraph","data":{"text":"Обсессивно-компульсивные расстройства: рекомендованная доза составляет 20—60 мг в сутки."}},{"type":"paragraph","data":{"text":"При булимическом неврозе и для пожилых пациентов препарат применяется в суточной дозе 60 мг, разделенных на 2—8 приема."}},{"type":"paragraph","data":{"text":"При предменструальных дисфорических расстройствах рекомендованная доза составляет 20 мг/сут."}},{"type":"paragraph","data":{"text":"При заболеваниях печени и в пожилом возрасте лечение следует начинать с 1/2 дозы."}},{"type":"paragraph","data":{"text":"У больных с нарушениями функции почек следует уменьшать дозу и увеличить интервал между приемом препарата."}},{"type":"paragraph","data":{"text":"Курс лечения 3-4 нед."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны ЦНС: головокружение, головная боль, нарушения сна, повышенная утомляемость, астения, тремор, ажитация, двигательное возбуждение, усиление суицидальных тенденций, тревожность, мания или гипомания."}},{"type":"paragraph","data":{"text":"Со стороны ЖКТ: снижение аппетита, нарушение вкуса, тошнота, рвота, сухость во рту или гиперсаливация, диарея."}},{"type":"paragraph","data":{"text":"Аллергические реакции в виде кожной сыпи, зуда, крапивницы, миалгии, артралгии, лихорадки."}},{"type":"paragraph","data":{"text":"Со стороны мочеполовой системы: недержание или задержка мочи, дисменорея, вагинит, снижение либидо, нарушение половой функции y мужчин (замедление эякуляции)."}},{"type":"paragraph","data":{"text":"Прочие: повышенное потоотделение, тахикардия, нарушение остроты зрения, похудание, системные нарушения со стороны легких, почек или печени, васкулиты."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: тошнота, рвота, состояние возбуждения, двигательное беспокойство, судорожные расстройства, нарушение функции сердечно-сосудистой системы."}},{"type":"paragraph","data":{"text":"Лечение: специфические антагонисты K флуоксетину не найдены. Проводится симптоматическая терапия, промывание желудка, назначение активированного угля, при судорогах назначение транквилизаторов, поддержание дыхания, сердечной деятельности."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":" Нельзя применять препарат одновременно с ингибиторами МАО (моноаминооксидазы), так как возможно развитие серотонинового синдрома (гипертермия, озноб, повышенное потоотделение, миокпонус, гиперрефпексин, тремор, диарея, нарушение координации движения, вегетативная лабильность, возбуждение, бред и кома)."}},{"type":"paragraph","data":{"text":"Триптофан усиливает серотонинергические свойства препарата (усиление ажитации, двигательного беспокойства, нарушений со стороны желудочно—кишечного тракта)."}},{"type":"paragraph","data":{"text":"При применении с препаратами, содержащими зверобой продырявленный (Hypericum perforatum), может возникнуть усиление серотонинергического эффекта, усиление нежелательных эффектов."}},{"type":"paragraph","data":{"text":"Повышает в плазме концентрацию фенитоина, трициклических антидепрессантов, мапротилина, тразодона в два раза (необходимо на 50% снижать дозу данных препаратов при одновременном применении с флуоксетином)."}},{"type":"paragraph","data":{"text":"Усиливает эффекты алпразолама, диазепама, этанола, гипогликемических лекарственных средств."}},{"type":"paragraph","data":{"text":"Одновременный прием флуоксетина с алкоголем или с препаратами центрального действия, вызывающими угнетение функции ЦНС, усиливает их эффект и повышает риск развития побочных эффектов."}},{"type":"paragraph","data":{"text":"Лекарственные средства, содержащие литий (Li+) следует применять с осторожностью из—за возможного повышения концентрации лития (Li*) и риска развития токсических эффектов."}},{"type":"paragraph","data":{"text":"На фоне проведения электросудорожной терапии возможно развитие продолжительных судорожных припадков."}},{"type":"paragraph","data":{"text":"При одновременном применении с препаратами, обладающими высокой степенью связывания с белками, особенно c антикоагулянтами и дигитоксином, возможно повышение концентрации в плазме свободных (несвязанных) лекарственных средств и увеличение риска развития неблагоприятных эффектов."}}]},{"id":9,"name":"Особые указания","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"У больных с сопутствующим сахарным диабетом возможно развитие гипогликемии во время терапии флуоксетином и гипергликемии после его отмены. Поэтому доза инсулина и/или любых других гипогликемических средств должна быть скорректирована. До наступления значительного улучшения в лечении сахарного диабета больные должны находиться под наблюдением врача."}},{"type":"paragraph","data":{"text":"При лечении больных с дефицитом массы тела следует учитывать анорексигенные эффекты (возможна прогрессирующая потеря массы тела)."}},{"type":"paragraph","data":{"text":"Интервал между окончанием терапии ингибиторами MAO и началом лечения флуоксетином должен составлять как минимум 14 дней; между окончанием лечения флуоксетином и началом терапии ингибиторами MAO — нe менее 5 нед."}},{"type":"paragraph","data":{"text":"При заболеваниях печени и в пожилом возрасте лечение следует начинать с V2 дозы."}},{"type":"paragraph","data":{"text":"У детей, подростков и молодых людей (младше 24 лет) с депрессией, др. психическими нарушениями антидепрессанты, по сравнению с плацебо, повышают риск возникновения суицидальных мыслей и суицидального поведения. Поэтому при назначении флуоксетина или любых антидепрессантов y детей, подростов и молодых людей (младше 24 лет) следует соотнести риск суицида и пользу от их применения. "}},{"type":"paragraph","data":{"text":"В краткосрочных исследованиях у людей старше 24 лет риск суицида не повышался, а у людей старше 65 лет несколько снижался. Любое депрессивное расстройство само по себе увеличивает риск суицида. Поэтому во время лечения антидепрессантами за всеми пациентами должно быть установлено наблюдение с цепью раннего выявления нарушений или изменений поведения, а также суицидальных наклонностей."}},{"type":"paragraph","data":{"text":"Во время лечения флуоксетином следует воздержаться от приема алкоголя и занятий потенциально опасными видами деятельности, требующими повышенного внимания и быстроты психических и двигательных реакций."}}],"slug":""},{"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","id":16,"body":[{"type":"paragraph","data":{"text":"Во время лечения флуоксетином следует воздержаться от приема алкоголя и занятий потенциально опасными видами деятельности, требующими повышенного внимания и быстроты психических и двигательных реакций."}}]},{"name":"Форма выпуска","slug":"","id":17,"body":[{"type":"paragraph","data":{"text":"Твердые желатиновые капсулы № 3, корпус: бежевый, непрозрачный, крышечка: светло-зеленая, непрозрачная."}},{"type":"paragraph","data":{"text":"Содержимое капсул: порошок белого цвета."}}]},{"name":"Условия хранения","slug":"storage","id":18,"body":[{"type":"paragraph","data":{"text":"Хранить в сухом защищенном от света месте, при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"name":"Срок годности","slug":"expiry_date","id":19,"body":[{"type":"paragraph","data":{"text":"3 года. Не использовать после истечения срока годности."}}]},{"name":"Условия отпуска","slug":"release_condition","id":20,"body":[{"type":"paragraph","data":{"text":"По рецепту."}}]},{"name":"Производитель","slug":"","id":21,"body":[{"type":"paragraph","data":{"text":"G.L. PHARMA. Страна производства: Австрия."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Антидепрессант группы селективных ингибиторов обратного захвата серотонина. Фармакодинамика Избирательно блокирует обратный нейрональный захват серотонина (5-гидрокситриптамин) 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. Обладает низким сродством K a1, a2 M В адренергическим, серотониновым, дофаминергическим, Н1-гистаминовым, мускариновым и ГАМКергическим рецепторам. 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