Галантамин, будучи третичным алкалоидом, является селективны... Инструкция
Показания к применению
Реминил; показан для лечения деменции альцгеймеровского типа легкой или умеренной степени, в т.ч. c хроническими нарушениями мозгового кровообращения.
Противопоказания
Гиперчувствительность к галантамина гидробромиду или к любому вспомогательному веществу, входящему в состав этого препарата; пациенты с тяжелым нарушением функции почек (Cl креатинина менее 9 мл/мин) — вследствие отсутствия данных о применении; тяжелые нарушения функции печени.
Инструкция
Состав
Действующее вещество: Галантамин (Galantaminum); Концентрация действующего вещества (мг): 8
Фармакологические свойства
Галантамин, будучи третичным алкалоидом, является селективным конкурентным и обратимым ингибитором ацетилхолинэстеразы. Помимо этого галантамин усиливает присущее ацетилхолину действие на никотиновые рецепторы, по-видимому, вследствие связывания с аллостерическим участком рецептора.; Благодаря повышению активности холинергической системы может улучшаться когнитивная функция у пациентов с деменцией альцгеймеровского типа.
Показания к применению
Реминил; показан для лечения деменции альцгеймеровского типа легкой или умеренной степени, в т.ч. c хроническими нарушениями мозгового кровообращения.
Противопоказания
Гиперчувствительность к галантамина гидробромиду или к любому вспомогательному веществу, входящему в состав этого препарата; пациенты с тяжелым нарушением функции почек (Cl креатинина менее 9 мл/мин) — вследствие отсутствия данных о применении; тяжелые нарушения функции печени.
Применение при беременности и в период грудного вскармливания
Исследований безопасности применения препарата Реминил; при беременности не проводилось. Реминил; можно назначать при беременности только в тех случаях, когда потенциальная польза лечения для матери превосходит возможный риск для плода.; Неизвестно, выводится ли галантамин с грудным молоком у человека. Женщины, получающие препарат Реминил;, должны воздерживаться от грудного вскармливания.
Способ применения и дозы
Внутрь, 1 раз в сутки (утром), желательно во время приема пищи.; Начальная доза. Рекомендуемая начальная доза составляет 8 мг/сут.; Пациенты, уже принимающие Реминил; в других формах с немедленным высвобождением активного вещества (табл.), могут перейти на прием препарата Реминил; в форме капсул пролонгированного действия путем приема последней дозы в форме таблеток вечером и начала приема в форме капсул 1 раз в день на следующее утро.; При переходе с препарата Реминил; в форме таблеток с немедленным высвобождением активного вещества, принимаемых 2 раза в день, на Реминил; в форме капсул пролонгированного действия, принимаемых 1 раз в день, общая суточная доза должна остаться неизменной.; Во время лечения необходимо принимать достаточное количество жидкости.
Побочное действие
В данном разделе представлены побочные действия, которые на основе комплексной оценки имеющейся информации были отнесены к использованию галантамина гидробромида. В отдельных случаях причинно-следственная связь с приемом галантамина гидробромида не может быть достоверно установлена. Кроме того, поскольку клинические исследования проводятся в разных условиях, частоты возникновения неблагоприятных явлений в клинических исследованиях препарата не могут непосредственно сравниваться с частотами в клинических исследованиях другого препарата и могут не отражать частоты возникновения неблагоприятных явлений в клинической практике.; Тошнота и рвота — наиболее частые нежелательные явления при проведении клинических исследований (частота — 20,7 и 10,5% соответственно) — наблюдались при подборе дозы препарата, продолжались в большинстве случаев в течение менее 1 нед и в основном были эпизодическими. Назначение противорвотных препаратов и обеспечение достаточного потребления жидкости наиболее эффективно в таких случаях.; Побочные эффекты препарата Реминил; в терапевтических дозах приведены с распределением по частоте и системам органов. Частоту побочных эффектов классифицировали следующим образом: очень часто (≥1/10 случаев), часто (≥1/100, <1/10 случаев), нечасто (≥1/1000 и <1/100 случаев), редко (≥1/10000 и <1/1000 случаев) и очень редко (<1/10000 случаев).; Со стороны иммунной системы: нечасто — гиперчувствительность.; Нарушения метаболизма и питания: часто — снижение аппетита; нечасто — обезвоживание.; Психические нарушения: часто — депрессия, галлюцинации; нечасто — зрительные и слуховые галлюцинации.; Со стороны нервной системы: часто — головокружение, головная боль, тремор, обморок, заторможенность, сонливость; нечасто — извращение вкуса, гиперсомния, парестезия, судороги. Судороги являются класс-эффектом, наблюдаемым при применении ингибиторов ацетилхолинэстеразы — средств для лечения деменции, и включающим судороги и припадки.; Офтальмологические нарушения: нечасто — затуманенное зрение.; Со стороны уха и лабиринта: нечасто — шум в ушах.; Со стороны ССС: часто — брадикардия, повышение АД; нечасто — AV блокада I степени, ощущение сердцебиения, синусовая брадикардия, суправентрикулярная экстрасистолия, приливы, снижение АД.; Со стороны ЖКТ: очень часто — тошнота, рвота; часто — диарея, боли в области живота, диспепсия, желудочно-кишечный дискомфорт; нечасто — рвотные позывы.; Гепатобилиарные нарушения: редко — гепатит.; Со стороны кожи и подкожных тканей: нечасто — усиленное потоотделение; очень редко — синдром Стивенса-Джонсона, острый генерализованный экзематозный пустулез, мультиформная эритема.; Со стороны костно-мышечной системы и соединительной ткани: часто — мышечные спазмы; нечасто — мышечная слабость.; Общие нарушения: часто — утомление, слабость, недомогание.; Изменения измерений и лабораторных показателей: часто — уменьшение массы тела; нечасто — увеличение активности печеночных ферментов.; Травмы, интоксикации и осложнения манипуляций: часто — падение, рваные раны.
Передозировка
Симптомы. Предполагается, что объективные и субъективные симптомы выраженной передозировки галантамина будут сходны с аналогичными симптомами при передозировке других холиномиметиков. Наблюдаются в основном токсические эффекты со стороны ЦНС, парасимпатической нервной системы и нервно-мышечных синапсов. Помимо мышечной слабости или фасцикуляции могут наблюдаться некоторые или все симптомы холинергического кризиса: сильная тошнота, рвота, спастические боли в животе, усиленное слюноотделение, слезотечение, недержание мочи и кала, сильная потливость, брадикардия, снижение АД, коллапс и судороги. Выраженная мышечная слабость в сочетании с гиперсекрецией слизистой оболочки трахеи и бронхоспазмом может привести к летальной блокаде дыхательных путей.; В сообщениях, полученных при постмаркетинговом контроле, описано развитие двунаправленно-веретенообразной желудочковой тахикардии, удлинения интервала QT, желудочковой тахикардии с кратковременной потерей сознания при случайном приеме 32 мг Реминила в сутки.; Лечение. Как и при передозировке любого другого препарата, необходимо осуществлять обычные поддерживающие мероприятия. В тяжелых случаях в качестве общего антидота можно использовать такие антихолинергические препараты, как атропин. Вначале рекомендуется ввести 0.5-1 мг в/в, частота и величина последующих доз зависят от динамики клинического состояния пациента.; Стратегии лечения передозировок постоянно совершенствуются, и поэтому следует обращаться в ближайший центр по лечению отравлений для получения новейших рекомендаций, касающихся лечения передозировки галантамина.
Особые указания
Применение Реминила при других типах деменции или при других нарушениях памяти; Положительные эффекты применения Реминила у пациентов с другими типами деменции и другими типами нарушения памяти не продемонстрированы. ; Пациенты с болезнью Альцгеймера худеют. Лечение ингибиторами ацетилхолинэстеразы, включая галантамин, сопровождается снижением массы тела таких пациентов, и поэтому во время лечения необходимо следить за изменениями массы тела.; Как и другие холиномиметики, Реминил; следует применять с осторожностью при следующих заболеваниях:; Сердечно-сосудистые заболевания: вследствие своего фармакологического действия холиномиметики могут вызывать ваготонические эффекты со стороны сердца (например, брадикардию). Последствия таких эффектов могут быть наиболее серьезными у пациентов с СССУ и с другими суправентрикулярными нарушениями проводимости, а также у пациентов, которые одновременно получают препараты, снижающие ЧСС, такие как дигоксин или бета-адреноблокаторы. Лечение Реминилом сопровождалось обмороком и редко - выраженной брадикардией. Следует применять с осторожностью при нестабильной стенокардии.; Желудочно-кишечные заболевания: у пациентов с повышенным риском развития язвенной болезни, например имеющих язвенную болезнь в анамнезе или предрасположенных к ней, необходимо проводить мониторинг соответствующих симптомов. Следует отметить, однако, что клинические испытания не выявили у пациентов, получавших Реминил;, увеличения, по сравнению с пациентами, которые получали плацебо, частоты пептических язв и желудочно-кишечных кровотечений. Реминил; не рекомендуется применять у пациентов с обструкцией ЖКТ, а также у пациентов, которым недавно была сделана операция на органах пищеварения.; Неврологические заболевания: считается, что холиномиметики обладают определенной способностью вызывать генерализованные судороги. Следует помнить, однако, что судорожная активность может быть проявлением самой болезни Альцгеймера. В клинических испытаниях не наблюдалось повышения частоты судорог у пациентов, принимавших Реминил;, по сравнению с пациентами, получавшими плацебо.; Легочные заболевания: из-за холиномиметической активности Реминил ; следует применять с осторожностью у пациентов, страдающих тяжелой бронхиальной астмой или обструктивной болезнью легких.; Мочеполовые заболевания: Реминил ; не рекомендуется применять у пациентов с обструкцией мочевых путей, а также у пациентов, которые недавно перенесли операцию на мочевом пузыре.; Безопасность у пациентов со слабым когнитивным нарушением; Реминил; не предназначен для пациентов со слабым когнитивным нарушением, т.е. для пациентов с изолированным нарушением памяти, превышающим ожидаемый уровень для их возраста и образования, но не удовлетворяющим критериям болезни Альцгеймера.; Влияние на способность к вождению автотранспорта и управлению механизмами; Болезнь Альцгеймера может ухудшать способность к вождению автомобиля и работе с механизмами. Кроме того, на фоне применения препарата Реминил;, как и других холиномиметиков, способно вызывать сонливость и головокружение, которые негативно отражаются на вождении автомобиля и работе с механизмами, особенно в первые недели после начала лечения этим препаратом.
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вещество: Галантамин (Galantaminum); Концентрация действующего вещества (мг): 8"}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Галантамин, будучи третичным алкалоидом, является селективным конкурентным и обратимым ингибитором ацетилхолинэстеразы. Помимо этого галантамин усиливает присущее ацетилхолину действие на никотиновые рецепторы, по-видимому, вследствие связывания с аллостерическим участком рецептора.; Благодаря повышению активности холинергической системы может улучшаться когнитивная функция у пациентов с деменцией альцгеймеровского типа."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Реминил; показан для лечения деменции альцгеймеровского типа легкой или умеренной степени, в т.ч. c хроническими нарушениями мозгового кровообращения."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к галантамина гидробромиду или к любому вспомогательному веществу, входящему в состав этого препарата; пациенты с тяжелым нарушением функции почек (Cl креатинина менее 9 мл/мин) — вследствие отсутствия данных о применении; тяжелые нарушения функции печени."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Исследований безопасности применения препарата Реминил; при беременности не проводилось. Реминил; можно назначать при беременности только в тех случаях, когда потенциальная польза лечения для матери превосходит возможный риск для плода.; Неизвестно, выводится ли галантамин с грудным молоком у человека. Женщины, получающие препарат Реминил;, должны воздерживаться от грудного вскармливания."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, 1 раз в сутки (утром), желательно во время приема пищи.; Начальная доза. Рекомендуемая начальная доза составляет 8 мг/сут.; Пациенты, уже принимающие Реминил; в других формах с немедленным высвобождением активного вещества (табл.), могут перейти на прием препарата Реминил; в форме капсул пролонгированного действия путем приема последней дозы в форме таблеток вечером и начала приема в форме капсул 1 раз в день на следующее утро.; При переходе с препарата Реминил; в форме таблеток с немедленным высвобождением активного вещества, принимаемых 2 раза в день, на Реминил; в форме капсул пролонгированного действия, принимаемых 1 раз в день, общая суточная доза должна остаться неизменной.; Во время лечения необходимо принимать достаточное количество жидкости."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В данном разделе представлены побочные действия, которые на основе комплексной оценки имеющейся информации были отнесены к использованию галантамина гидробромида. В отдельных случаях причинно-следственная связь с приемом галантамина гидробромида не может быть достоверно установлена. Кроме того, поскольку клинические исследования проводятся в разных условиях, частоты возникновения неблагоприятных явлений в клинических исследованиях препарата не могут непосредственно сравниваться с частотами в клинических исследованиях другого препарата и могут не отражать частоты возникновения неблагоприятных явлений в клинической практике.; Тошнота и рвота — наиболее частые нежелательные явления при проведении клинических исследований (частота — 20,7 и 10,5% соответственно) — наблюдались при подборе дозы препарата, продолжались в большинстве случаев в течение менее 1 нед и в основном были эпизодическими. Назначение противорвотных препаратов и обеспечение достаточного потребления жидкости наиболее эффективно в таких случаях.; Побочные эффекты препарата Реминил; в терапевтических дозах приведены с распределением по частоте и системам органов. Частоту побочных эффектов классифицировали следующим образом: очень часто (≥1/10 случаев), часто (≥1/100, \u003c1/10 случаев), нечасто (≥1/1000 и \u003c1/100 случаев), редко (≥1/10000 и \u003c1/1000 случаев) и очень редко (\u003c1/10000 случаев).; Со стороны иммунной системы: нечасто — гиперчувствительность.; Нарушения метаболизма и питания: часто — снижение аппетита; нечасто — обезвоживание.; Психические нарушения: часто — депрессия, галлюцинации; нечасто — зрительные и слуховые галлюцинации.; Со стороны нервной системы: часто — головокружение, головная боль, тремор, обморок, заторможенность, сонливость; нечасто — извращение вкуса, гиперсомния, парестезия, судороги. Судороги являются класс-эффектом, наблюдаемым при применении ингибиторов ацетилхолинэстеразы — средств для лечения деменции, и включающим судороги и припадки.; Офтальмологические нарушения: нечасто — затуманенное зрение.; Со стороны уха и лабиринта: нечасто — шум в ушах.; Со стороны ССС: часто — брадикардия, повышение АД; нечасто — AV блокада I степени, ощущение сердцебиения, синусовая брадикардия, суправентрикулярная экстрасистолия, приливы, снижение АД.; Со стороны ЖКТ: очень часто — тошнота, рвота; часто — диарея, боли в области живота, диспепсия, желудочно-кишечный дискомфорт; нечасто — рвотные позывы.; Гепатобилиарные нарушения: редко — гепатит.; Со стороны кожи и подкожных тканей: нечасто — усиленное потоотделение; очень редко — синдром Стивенса-Джонсона, острый генерализованный экзематозный пустулез, мультиформная эритема.; Со стороны костно-мышечной системы и соединительной ткани: часто — мышечные спазмы; нечасто — мышечная слабость.; Общие нарушения: часто — утомление, слабость, недомогание.; Изменения измерений и лабораторных показателей: часто — уменьшение массы тела; нечасто — увеличение активности печеночных ферментов.; Травмы, интоксикации и осложнения манипуляций: часто — падение, рваные раны."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы. Предполагается, что объективные и субъективные симптомы выраженной передозировки галантамина будут сходны с аналогичными симптомами при передозировке других холиномиметиков. Наблюдаются в основном токсические эффекты со стороны ЦНС, парасимпатической нервной системы и нервно-мышечных синапсов. Помимо мышечной слабости или фасцикуляции могут наблюдаться некоторые или все симптомы холинергического кризиса: сильная тошнота, рвота, спастические боли в животе, усиленное слюноотделение, слезотечение, недержание мочи и кала, сильная потливость, брадикардия, снижение АД, коллапс и судороги. Выраженная мышечная слабость в сочетании с гиперсекрецией слизистой оболочки трахеи и бронхоспазмом может привести к летальной блокаде дыхательных путей.; В сообщениях, полученных при постмаркетинговом контроле, описано развитие двунаправленно-веретенообразной желудочковой тахикардии, удлинения интервала QT, желудочковой тахикардии с кратковременной потерей сознания при случайном приеме 32 мг Реминила в сутки.; Лечение. Как и при передозировке любого другого препарата, необходимо осуществлять обычные поддерживающие мероприятия. В тяжелых случаях в качестве общего антидота можно использовать такие антихолинергические препараты, как атропин. Вначале рекомендуется ввести 0.5-1 мг в/в, частота и величина последующих доз зависят от динамики клинического состояния пациента.; Стратегии лечения передозировок постоянно совершенствуются, и поэтому следует обращаться в ближайший центр по лечению отравлений для получения новейших рекомендаций, касающихся лечения передозировки галантамина."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Применение Реминила при других типах деменции или при других нарушениях памяти; Положительные эффекты применения Реминила у пациентов с другими типами деменции и другими типами нарушения памяти не продемонстрированы. ; Пациенты с болезнью Альцгеймера худеют. Лечение ингибиторами ацетилхолинэстеразы, включая галантамин, сопровождается снижением массы тела таких пациентов, и поэтому во время лечения необходимо следить за изменениями массы тела.; Как и другие холиномиметики, Реминил; следует применять с осторожностью при следующих заболеваниях:; Сердечно-сосудистые заболевания: вследствие своего фармакологического действия холиномиметики могут вызывать ваготонические эффекты со стороны сердца (например, брадикардию). Последствия таких эффектов могут быть наиболее серьезными у пациентов с СССУ и с другими суправентрикулярными нарушениями проводимости, а также у пациентов, которые одновременно получают препараты, снижающие ЧСС, такие как дигоксин или бета-адреноблокаторы. Лечение Реминилом сопровождалось обмороком и редко - выраженной брадикардией. Следует применять с осторожностью при нестабильной стенокардии.; Желудочно-кишечные заболевания: у пациентов с повышенным риском развития язвенной болезни, например имеющих язвенную болезнь в анамнезе или предрасположенных к ней, необходимо проводить мониторинг соответствующих симптомов. Следует отметить, однако, что клинические испытания не выявили у пациентов, получавших Реминил;, увеличения, по сравнению с пациентами, которые получали плацебо, частоты пептических язв и желудочно-кишечных кровотечений. Реминил; не рекомендуется применять у пациентов с обструкцией ЖКТ, а также у пациентов, которым недавно была сделана операция на органах пищеварения.; Неврологические заболевания: считается, что холиномиметики обладают определенной способностью вызывать генерализованные судороги. Следует помнить, однако, что судорожная активность может быть проявлением самой болезни Альцгеймера. В клинических испытаниях не наблюдалось повышения частоты судорог у пациентов, принимавших Реминил;, по сравнению с пациентами, получавшими плацебо.; Легочные заболевания: из-за холиномиметической активности Реминил ; следует применять с осторожностью у пациентов, страдающих тяжелой бронхиальной астмой или обструктивной болезнью легких.; Мочеполовые заболевания: Реминил ; не рекомендуется применять у пациентов с обструкцией мочевых путей, а также у пациентов, которые недавно перенесли операцию на мочевом пузыре.; Безопасность у пациентов со слабым когнитивным нарушением; Реминил; не предназначен для пациентов со слабым когнитивным нарушением, т.е. для пациентов с изолированным нарушением памяти, превышающим ожидаемый уровень для их возраста и образования, но не удовлетворяющим критериям болезни Альцгеймера.; Влияние на способность к вождению автотранспорта и управлению механизмами; Болезнь Альцгеймера может ухудшать способность к вождению автомобиля и работе с механизмами. Кроме того, на фоне применения препарата Реминил;, как и других холиномиметиков, способно вызывать сонливость и головокружение, которые негативно отражаются на вождении автомобиля и работе с механизмами, особенно в первые недели после начала лечения этим препаратом."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Галантамин, будучи третичным алкалоидом, является селективным конкурентным и обратимым ингибитором ацетилхолинэстеразы. 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