Парциальные припадки со вторичной генерализацией или без таковой у взрослых и детей старше 16 лет при вновь диагностированной эпилепсии. В составе комплексной терапии: парциальные припадки со вторичной генерализацией или без таковой при эпилепсии у взрослых и детей старше 6 лет, миоклонические судороги у взрослых и детей старше 12 лет при ювенильной ...
Таблетки ЭПИТЕРРА покрытые пленочной оболочкой - противосудорожный препарат, производное пирролидона (S-энантиомер α-этил-2-оксо-1-пирролилин-ацетамида), по химической структуре отличается от известных противоэпилептических лекарственных средств. Механизм действия леветирацетама до конца не изучен, но очевидно, что он отличается от механизма действия известных противоэпилептических препаратов. Один из предполагаемых механизмов основан на доказанном связывании с гликопротеином синаптических везикул SV2A. содержащемся в сером веществе головного и спинного мозга. Считается, что таким образом реализуется противосудорожный эффект, который выражен в противодействии гиперсинхронизации нейронной активности. Также леветирацетам воздействует на рецепторы гамма-аминомасляной кислоты (ГАМК) и глициновые рецепторы, модулируя данные рецепторы через различные эндогенные агенты. Не изменяет нормальную синаптическую передачу, однако подавляет эпилептиформные нейроиальные вспышки. индуцированные ГАМК-агонистом бикукуликом, и возбуждение глутаматных рецепторов. Активность леветирацетама подтверждена как при фокальных, так и при генерализованных эпилептических припадках (эпилептиформные проявления, фотопароксизмальная реакция).
Показания к применению
Парциальные припадки со вторичной генерализацией или без таковой у взрослых и детей старше 16 лет при вновь диагностированной эпилепсии. В составе комплексной терапии: парциальные припадки со вторичной генерализацией или без таковой при эпилепсии у взрослых и детей старше 6 лет, миоклонические судороги у взрослых и детей старше 12 лет при ювенильной миоклонической эпилепсии, первично-генерализованные судорожные (тонико-клонические) припадки у взрослых и детей старше 12 лет при идиопатической генерализованной эпилепсии.
Применение при беременности и в период грудного вскармливания
Адекватных и строго контролируемых клинических исследований по безопасности применения леветирацетама у беременных женщин не проводилось, поэтому препарат Эпитерра применяют во время беременности, только если ожидаемая польза для матери превышает потенциальный риск для плода. Следует учитывать, что перерывы в проведении противоэпилептической терапии могут привести к ухудшению течения заболевания, что вредно для матери и для плода. Исследования на лабораторных животных показали возможность развития репродуктивной токсичности, исследований фертильности не проводилось. Леветирацетам выделяется с грудным молоком, поэтому при необходимости применения препарата Эпитерра в период лактации следует прекратить грудное вскармливание.
Способ применения и дозы
Внутрь, запивая достаточным количеством жидкости, независимо от приема пищи. Суточную дозу разделяют на 2 равные части для приема 2 раза в сутки.1. Монотерапия парциальных припадков со вторичной генерализацией или без таковой при вновь диагностированной эпилепсии: Взрослые и дети старше 16 лет. Начальная доза - 500 мг, разделенная на 2 приема (по 250 мг 2 раза в сутки). Через 2 недели терапии в зависимости от индивидуального ответа и переносимости суточная доза может быть увеличена до начальной терапевтической дозы - 1 г (по 500 мг 2 раза в сутки). Максимальная суточная доза - 3 г по (1,5 г 2 раза в сутки).2. В составе комплексной терапии парциальных припадков со вторичной генерализацией или без таковой при эпилепсии: Взрослые. Начальная доза - 1 г, разделенная на 2 приема (по 500 мг 2 раза в сутки). В зависимости от клинической реакции и переносимости суточная доза может быть увеличена до максимальной дозы - 3 г (по 1,5 г 2 раза в сутки). Дети старше 6 лет. Начальная доза 20 мг/кг массы тела, разделенная на 2 приема (по 10 мг/кг массы тела 2 раза в сутки). В зависимости от клинической реакции и переносимости изменение дозы на 20 мг/кг массы тела может осуществляться каждые 2 недели до достижения рекомендуемой суточной дозы - 60 мг/кг массы тела (по 30 мг/кг массы тела 2 раза в сутки).3. В составе комплексной терапии миоклонических судорог при ювенильной миоклонической эпилепсии и первично-генерализованных судорожных (тонико-клонических) припадков при идиопатической генерализованной эпилепсии: Взрослые и дети старше 12 лет с массой тела более 50 кг. Начальная доза 1 г, разделенная на 2 приема (по 500 мг 2 раза в сутки). В зависимости от клинической реакции и переносимости суточная доза может быть увеличена до максимальной дозы - 3 г (по 1,5 г 2 раза в сутки). Изменение дозы на 500 мг 2 раза в сутки может осуществляться каждые 2-4 недели. Взрослые и дети старше 12 лет с массой тела менее 50 кг. Следует применять минимальную эффективную дозу. Начальная доза 20 мг/кг массы тела, разделенная на 2 приема (по 10 мг/кг массы тела 2 раза в сутки). В зависимости от клинической реакции и переносимости изменение дозы на 20 мг/кг массы тела может осуществляться каждые 2 недели до достижения рекомендуемой суточной дозы - 60 мг/кг массы тела (по 30 мг/кг массы тела 2 раза в сутки).
Побочное действие
Частота возникновения побочных эффектов классифицирована в соответствии с рекомендациями Всемирной организации здравоохранения: очень часто - не менее 10%, часто - не менее 1%, но менее 10%, нечасто - не менее 0.1%, но менее 1%, редко - не менее 0,01%, но менее 0,1%, очень редко - менее 0.01%, включая единичные случаи. Данных постмаркстинговых исследований недостаточно для оценки частоты возникновения неблагоприятных явлений в популяции. Со стороны крови и лимфатической системы: нечасто - тромбоцитопения, лейкопения: редко - нейтропения, панцитемия. Со стороны обмена веществ и питания: часто - анорексия, нечасто увеличение/снижение массы тела. Со стороны ЦНС: очень часто - сонливость, головная боль, часто - перепады настроения, эмоциональная лабильность, депрессия, агрессивность, бессонница, нервозность, нечасто - расстройство поведения, озлобленность, тревога, галлюцинации, психотические расстройства, нарушение памяти, суицидальная попытка. навязчивые идеи, амнезия, расстройство тактильной чувствительности, головокружение, головная боль, гиперкинезия, тремор, нарушение равновесия, рассеянность, парестезии, редко - расстройство личности, в т.ч.числе нарушение мышления, суицид, гиперкинез, хореоатетоз. Со стороны органа зрения: нечасто - диплопия, затуманивание зрения. Со стороны органа слуха и лабиринтные нарушения: часто - головокружение. Со стороны дыхательной системы, органов грудной клетки и средостения: часто - кашель. Со стороны ЖКТ: часто - тошнота, рвота, диарея, боль в животе, диспепсия, редко -панкреатит. Со стороны печени и желчевыводящих путей: нечасто - отклонения лабораторных показателей функции печени от нормы: редко - гепатит, печеночная недостаточность. Со стороны кожи и подкожных тканей: часто - кожная сыпь, нечасто - экзема, кожный зуд, редко - алопеция (в некоторых случаях проходящая после отмены леветирацетама), токсический эпидермальпый некролиз, многоформная эритема, синдром Стивенса-Джонсона. Со стороны скелетно-мышечной и соединительной ткани: нечасто - миалгия, мышечная слабость. Прочие: часто - общая слабость, утомляемость, нечасто - назофарингит, случайная травматизация. Риск развития анорексии возрастает при одновременном применении леветирацетама и топирамата. В некоторых случаях после отмены леветирацетама алопеция проходила самостоятельно. При развитии панцитопении отмечалась супрессия костного мозга. Наиболее частыми нежелательными реакциями у детей по данным клинических исследований были: рвота, ажитация, перепады настроения, агрессия, эмоциональная лабильность, расстройство поведения, вялость.
Передозировка
Симптомы: сонливость, беспокойство, агрессия, потеря сознания, угнетение дыхания, кома. Лечение: прием активированного угля и промывание желудка. Специфического антидота для леветирацетама нет. При необходимости проводится симптоматическое лечение (включая поддержание проходимости дыхательных путей) в условиях стационара с использованием гемодиализа (эффективность диализа для леветирацетама - 60%, для первичного метаболита - 74%).
Особые указания
Гиперчувствительность к производным пирролидона, леветирацетаму или другим компонентам препарата, период грудного вскармливания, детский возраст до 16 лет при монотерапии парциальных припадков со вторичной генерализацией или без таковой при вновь диагностированной эпилепсии, детский возраст до 6 лет в составе комплексной терапии парциальных припадков со вторичной генерализацией или без таковой при эпилепсии, детский возраст до 12 лет в составе комплексной терапии миоклонических судорог при ювенильной миоклонической эпилепсии и первично-генерализованных судорожных (тонико-клонических) припадков при идиопатической генерализованной эпилепсии, масса тела менее 25 кг. С осторожностью: беременность, тяжелые нарушения функции печени, тяжелые нарушения функции почек (КК менее 50 мл/мин), возраст старше 65 лет, одновременное применение с сульфаниламидами, пробенецидом, НПВП, метотрексатом, депрессия, суицидальное поведение.
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1000 мг. Вспомогательные вещества: крахмал кукурузный 136 мг, повидон (К-30) 32 мг, кроскармеллоза натрия 148 мг, стеарат магния 12 мг. Состав пленочной оболочки: Опадрай 03F18435 белый 36 мг (гипромеллоза 6 cp 22.04 мг, диоксид титана 6.62 мг, макрогол-3350 7.34 мг)."}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Таблетки ЭПИТЕРРА покрытые пленочной оболочкой - противосудорожный препарат, производное пирролидона (S-энантиомер α-этил-2-оксо-1-пирролилин-ацетамида), по химической структуре отличается от известных противоэпилептических лекарственных средств. Механизм действия леветирацетама до конца не изучен, но очевидно, что он отличается от механизма действия известных противоэпилептических препаратов. Один из предполагаемых механизмов основан на доказанном связывании с гликопротеином синаптических везикул SV2A. содержащемся в сером веществе головного и спинного мозга. Считается, что таким образом реализуется противосудорожный эффект, который выражен в противодействии гиперсинхронизации нейронной активности. Также леветирацетам воздействует на рецепторы гамма-аминомасляной кислоты (ГАМК) и глициновые рецепторы, модулируя данные рецепторы через различные эндогенные агенты. Не изменяет нормальную синаптическую передачу, однако подавляет эпилептиформные нейроиальные вспышки. индуцированные ГАМК-агонистом бикукуликом, и возбуждение глутаматных рецепторов. Активность леветирацетама подтверждена как при фокальных, так и при генерализованных эпилептических припадках (эпилептиформные проявления, фотопароксизмальная реакция)."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Парциальные припадки со вторичной генерализацией или без таковой у взрослых и детей старше 16 лет при вновь диагностированной эпилепсии. В составе комплексной терапии: парциальные припадки со вторичной генерализацией или без таковой при эпилепсии у взрослых и детей старше 6 лет, миоклонические судороги у взрослых и детей старше 12 лет при ювенильной миоклонической эпилепсии, первично-генерализованные судорожные (тонико-клонические) припадки у взрослых и детей старше 12 лет при идиопатической генерализованной эпилепсии."}}]},{"id":4,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Адекватных и строго контролируемых клинических исследований по безопасности применения леветирацетама у беременных женщин не проводилось, поэтому препарат Эпитерра применяют во время беременности, только если ожидаемая польза для матери превышает потенциальный риск для плода. Следует учитывать, что перерывы в проведении противоэпилептической терапии могут привести к ухудшению течения заболевания, что вредно для матери и для плода. Исследования на лабораторных животных показали возможность развития репродуктивной токсичности, исследований фертильности не проводилось. Леветирацетам выделяется с грудным молоком, поэтому при необходимости применения препарата Эпитерра в период лактации следует прекратить грудное вскармливание."}}]},{"id":5,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, запивая достаточным количеством жидкости, независимо от приема пищи. Суточную дозу разделяют на 2 равные части для приема 2 раза в сутки.1. Монотерапия парциальных припадков со вторичной генерализацией или без таковой при вновь диагностированной эпилепсии: Взрослые и дети старше 16 лет. Начальная доза - 500 мг, разделенная на 2 приема (по 250 мг 2 раза в сутки). Через 2 недели терапии в зависимости от индивидуального ответа и переносимости суточная доза может быть увеличена до начальной терапевтической дозы - 1 г (по 500 мг 2 раза в сутки). Максимальная суточная доза - 3 г по (1,5 г 2 раза в сутки).2. В составе комплексной терапии парциальных припадков со вторичной генерализацией или без таковой при эпилепсии: Взрослые. Начальная доза - 1 г, разделенная на 2 приема (по 500 мг 2 раза в сутки). В зависимости от клинической реакции и переносимости суточная доза может быть увеличена до максимальной дозы - 3 г (по 1,5 г 2 раза в сутки). Дети старше 6 лет. Начальная доза 20 мг/кг массы тела, разделенная на 2 приема (по 10 мг/кг массы тела 2 раза в сутки). В зависимости от клинической реакции и переносимости изменение дозы на 20 мг/кг массы тела может осуществляться каждые 2 недели до достижения рекомендуемой суточной дозы - 60 мг/кг массы тела (по 30 мг/кг массы тела 2 раза в сутки).3. В составе комплексной терапии миоклонических судорог при ювенильной миоклонической эпилепсии и первично-генерализованных судорожных (тонико-клонических) припадков при идиопатической генерализованной эпилепсии: Взрослые и дети старше 12 лет с массой тела более 50 кг. Начальная доза 1 г, разделенная на 2 приема (по 500 мг 2 раза в сутки). В зависимости от клинической реакции и переносимости суточная доза может быть увеличена до максимальной дозы - 3 г (по 1,5 г 2 раза в сутки). Изменение дозы на 500 мг 2 раза в сутки может осуществляться каждые 2-4 недели. Взрослые и дети старше 12 лет с массой тела менее 50 кг. Следует применять минимальную эффективную дозу. Начальная доза 20 мг/кг массы тела, разделенная на 2 приема (по 10 мг/кг массы тела 2 раза в сутки). В зависимости от клинической реакции и переносимости изменение дозы на 20 мг/кг массы тела может осуществляться каждые 2 недели до достижения рекомендуемой суточной дозы - 60 мг/кг массы тела (по 30 мг/кг массы тела 2 раза в сутки)."}}]},{"id":6,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Частота возникновения побочных эффектов классифицирована в соответствии с рекомендациями Всемирной организации здравоохранения: очень часто - не менее 10%, часто - не менее 1%, но менее 10%, нечасто - не менее 0.1%, но менее 1%, редко - не менее 0,01%, но менее 0,1%, очень редко - менее 0.01%, включая единичные случаи. Данных постмаркстинговых исследований недостаточно для оценки частоты возникновения неблагоприятных явлений в популяции. Со стороны крови и лимфатической системы: нечасто - тромбоцитопения, лейкопения: редко - нейтропения, панцитемия. Со стороны обмена веществ и питания: часто - анорексия, нечасто увеличение/снижение массы тела. Со стороны ЦНС: очень часто - сонливость, головная боль, часто - перепады настроения, эмоциональная лабильность, депрессия, агрессивность, бессонница, нервозность, нечасто - расстройство поведения, озлобленность, тревога, галлюцинации, психотические расстройства, нарушение памяти, суицидальная попытка. навязчивые идеи, амнезия, расстройство тактильной чувствительности, головокружение, головная боль, гиперкинезия, тремор, нарушение равновесия, рассеянность, парестезии, редко - расстройство личности, в т.ч.числе нарушение мышления, суицид, гиперкинез, хореоатетоз. Со стороны органа зрения: нечасто - диплопия, затуманивание зрения. Со стороны органа слуха и лабиринтные нарушения: часто - головокружение. Со стороны дыхательной системы, органов грудной клетки и средостения: часто - кашель. Со стороны ЖКТ: часто - тошнота, рвота, диарея, боль в животе, диспепсия, редко -панкреатит. Со стороны печени и желчевыводящих путей: нечасто - отклонения лабораторных показателей функции печени от нормы: редко - гепатит, печеночная недостаточность. Со стороны кожи и подкожных тканей: часто - кожная сыпь, нечасто - экзема, кожный зуд, редко - алопеция (в некоторых случаях проходящая после отмены леветирацетама), токсический эпидермальпый некролиз, многоформная эритема, синдром Стивенса-Джонсона. Со стороны скелетно-мышечной и соединительной ткани: нечасто - миалгия, мышечная слабость. Прочие: часто - общая слабость, утомляемость, нечасто - назофарингит, случайная травматизация. Риск развития анорексии возрастает при одновременном применении леветирацетама и топирамата. В некоторых случаях после отмены леветирацетама алопеция проходила самостоятельно. При развитии панцитопении отмечалась супрессия костного мозга. Наиболее частыми нежелательными реакциями у детей по данным клинических исследований были: рвота, ажитация, перепады настроения, агрессия, эмоциональная лабильность, расстройство поведения, вялость."}}]},{"id":7,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: сонливость, беспокойство, агрессия, потеря сознания, угнетение дыхания, кома. Лечение: прием активированного угля и промывание желудка. Специфического антидота для леветирацетама нет. При необходимости проводится симптоматическое лечение (включая поддержание проходимости дыхательных путей) в условиях стационара с использованием гемодиализа (эффективность диализа для леветирацетама - 60%, для первичного метаболита - 74%)."}}]},{"id":8,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к производным пирролидона, леветирацетаму или другим компонентам препарата, период грудного вскармливания, детский возраст до 16 лет при монотерапии парциальных припадков со вторичной генерализацией или без таковой при вновь диагностированной эпилепсии, детский возраст до 6 лет в составе комплексной терапии парциальных припадков со вторичной генерализацией или без таковой при эпилепсии, детский возраст до 12 лет в составе комплексной терапии миоклонических судорог при ювенильной миоклонической эпилепсии и первично-генерализованных судорожных (тонико-клонических) припадков при идиопатической генерализованной эпилепсии, масса тела менее 25 кг. С осторожностью: беременность, тяжелые нарушения функции печени, тяжелые нарушения функции почек (КК менее 50 мл/мин), возраст старше 65 лет, одновременное применение с сульфаниламидами, пробенецидом, НПВП, метотрексатом, депрессия, суицидальное поведение."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Таблетки ЭПИТЕРРА покрытые пленочной оболочкой - противосудорожный препарат, производное пирролидона (S-энантиомер α-этил-2-оксо-1-пирролилин-ацетамида), по химической структуре отличается от известных противоэпилептических лекарственных средств. Механизм действия леветирацетама до конца не изучен, но очевидно, что он отличается от механизма действия известных противоэпилептических препаратов. Один из предполагаемых механизмов основан на доказанном связывании с гликопротеином синаптических везикул SV2A. содержащемся в сером веществе головного и спинного мозга. 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