Монотерапия: парциальные припадки с вторичной генерализацией или без таковой у взрослых и детей старше 16 лет при вновь диагностированной эпилепсии.
В составе комплексной терапии: парциальные припадки с вторичной генерализацией или без таковой при эпилепсии у взрослых и детей старше 6 лет; миоклонические судороги у взрослых и детей старше 12 лет при ...
гиперчувствительность к производным пирролидона, леветирацетаму или другим компонентам препарата; масса тела менее 25 кг; период грудного вскармливания; детский возраст до 16 лет при монотерапии парциальных припадков с вторичной генерализацией или без таковой при вновь диагностированной эпилепсии; детский возраст до 6 лет в составе комплексной терапии ...
Монотерапия: парциальные припадки с вторичной генерализацией или без таковой у взрослых и детей старше 16 лет при вновь диагностированной эпилепсии.
В составе комплексной терапии: парциальные припадки с 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.
Противопоказания
гиперчувствительность к производным пирролидона, леветирацетаму или другим компонентам препарата; масса тела менее 25 кг; период грудного вскармливания; детский возраст до 16 лет при монотерапии парциальных припадков с вторичной генерализацией или без таковой при вновь диагностированной эпилепсии; детский возраст до 6 лет в составе комплексной терапии парциальных припадков с 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.
С осторожностью: беременность; тяжелые нарушения функции печени; тяжелые нарушения функции почек (Cl креатинина менее 50 мл/мин); возраст старше 65 лет; одновременное применение с сульфаниламидами, пробенецидом, НПВС, метотрексатом; депрессия; суицидальное поведение.
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 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.; 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 нед 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).; В составе комплексной терапии парциальных припадков с 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 может осуществляться каждые 2 нед до достижения рекомендуемой суточной дозы — 60 мг/кг массы тела (по 30 мг/кг массы тела 2 раза в сутки).; 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 нед.; 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 нед до достижения рекомендуемой суточной дозы — 60 мг/кг массы тела (по 30 мг/кг массы тела 2 раза в сутки).; Масса тела, кг Начальная доза 10 мг/кг 2 раза в сутки Максимальная доза 30 мг/кг 2 раза в сутки; 25–50 По 125 мг 2 раза в сутки По 375 мг 2 раза в сутки; больше 50* По 250 мг 2 раза в сутки По 750 мг 2 раза в сутки; * Детям с массой тела больше 50 кг дозирование осуществляется по схеме для взрослых.; Пациентам пожилого возраста и пациентам с почечной недостаточностью дозу следует корректировать в зависимости от клиренса креатинина.; Клиренс креатинина можно рассчитать, исходя из концентрации креатинина в сыворотке, по следующей формуле.; Для мужчин: Cl креатинина, мл/мин = (140-возраст, годы) × масса тела, кг / (72 × концентрация креатинина, мг/дл).; Для женщин: полученное значение умножить на 0,85.; Почечная недостаточность Cl креатинина, мл/мин Доза и кратность приема; Норма больше 80 500–1500 мг 2 раза в сутки; Легкая степень 50–79 500–1000 мг 2 раза в сутки; Средняя степень 30–49 250–750 мг 2 раза в сутки; Тяжелая степень меньше 30 250–500 мг 2 раза в сутки; Терминальная стадия (пациенты, находящиеся на гемодиализе)* — 500–1000 мг 1 раз в сутки**; * В первый день лечения рекомендуется прием насыщающей дозы 750 мг.; ** После диализа рекомендуется прием дополнительной дозы 250–500 мг.; Пациентам с нарушениями функции печени легкой и средней степени тяжести коррекции режима дозирования не требуется. У пациентов с нарушениями функции печени тяжелой степени значение клиренса креатинина может не отражать истинной степени нарушения функции почек, поэтому при Cl креатинина меньше 50 мл/мин рекомендуется уменьшение суточной дозы на 50%.
Побочное действие
Частота возникновения побочных эффектов классифицирована в соответствии с рекомендациями ВОЗ: 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 постмаркетинговых 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. 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 эпидермальный 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 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
В случае необходимости прекращения терапии отмену препарата Эпитерра рекомендуется проводить постепенно, уменьшая разовую дозу на 500 мг каждые 2–4 нед. У взрослых с массой тела менее 50 кг рекомендуется уменьшать дозу на 20 мг/кг каждые 2 нед. У детей с массой тела 25–50 кг рекомендуется уменьшать дозу на 10 мг/кг каждые 2 нед.; Применение препарата Эпитерра пациентами с нарушением функции почек может потребовать коррекцию дозы (см. «Способ применения и дозы»).; Во время приема препарата Эпитерра могут наблюдаться нарушения со стороны ЦНС, включая сонливость, слабость, усталость, психотические и непсихотические изменения поведения, особенно в 1-й мес терапии. Поэтому в начале лечения за пациентами следует установить особо тщательное наблюдение.; Пациентов следует регулярно обследовать на наличие признаков депрессии, суицидальных и навязчивых идей вследствие возрастания риска попыток суицида у пациентов, принимающих противоэпилептические средства, в т.ч. препарат Эпитерра.; При наличии признаков депрессии и попытках суицида пациентам и лицам, осуществляющим уход за ними, следует обратиться к специалисту.; Рекомендуется постепенная отмена сопутствующих противосудорожных ЛС в период перевода пациента на прием препарата Эпитерра.; У пациентов с парциальными судорогами во время лечения препаратом наблюдалось незначительное, но статистически значимое снижение показателей красной крови, что не требует активного клинического вмешательства.; Имеющиеся сведения о применении препарата у детей не свидетельствуют о каком-либо его отрицательном влиянии на развитие и половую зрелость. Однако отдаленные последствия лечения на способность детей к обучению, их интеллектуальное развитие, рост, функции эндокринных желез, половое развитие и фертильность остаются неизвестными.; Влияние на способность управлять транспортными средствами и работать с механизмами. В период лечения препаратом Эпитерра необходимо воздерживаться от вождения автотранспорта и занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций в связи с тем, что могут возникнуть нежелательные реакции, такие как сонливость, головокружение, затуманивание зрения.
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В зависимости от клинической реакции и переносимости изменение дозы на 20 мг/кг массы тела может осуществляться каждые 2 нед до достижения рекомендуемой суточной дозы — 60 мг/кг массы тела (по 30 мг/кг массы тела 2 раза в сутки).; Масса тела, кг Начальная доза 10 мг/кг 2 раза в сутки Максимальная доза 30 мг/кг 2 раза в сутки; 25–50 По 125 мг 2 раза в сутки По 375 мг 2 раза в сутки; больше 50* По 250 мг 2 раза в сутки По 750 мг 2 раза в сутки; * Детям с массой тела больше 50 кг дозирование осуществляется по схеме для взрослых.; Пациентам пожилого возраста и пациентам с почечной недостаточностью дозу следует корректировать в зависимости от клиренса креатинина.; Клиренс креатинина можно рассчитать, исходя из концентрации креатинина в сыворотке, по следующей формуле.; Для мужчин: Cl креатинина, мл/мин = (140-возраст, годы) × масса тела, кг / (72 × концентрация креатинина, мг/дл).; Для женщин: полученное значение умножить на 0,85.; Почечная недостаточность Cl креатинина, мл/мин Доза и кратность приема; Норма больше 80 500–1500 мг 2 раза в сутки; Легкая степень 50–79 500–1000 мг 2 раза в сутки; Средняя степень 30–49 250–750 мг 2 раза в сутки; Тяжелая степень меньше 30 250–500 мг 2 раза в сутки; Терминальная стадия (пациенты, находящиеся на гемодиализе)* — 500–1000 мг 1 раз в сутки**; * В первый день лечения рекомендуется прием насыщающей дозы 750 мг.; ** После диализа рекомендуется прием дополнительной дозы 250–500 мг.; Пациентам с нарушениями функции печени легкой и средней степени тяжести коррекции режима дозирования не требуется. У пациентов с нарушениями функции печени тяжелой степени значение клиренса креатинина может не отражать истинной степени нарушения функции почек, поэтому при Cl креатинина меньше 50 мл/мин рекомендуется уменьшение суточной дозы на 50%."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Частота возникновения побочных эффектов классифицирована в соответствии с рекомендациями ВОЗ: 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 постмаркетинговых 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. 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 эпидермальный 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":8,"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 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":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В случае необходимости прекращения терапии отмену препарата Эпитерра рекомендуется проводить постепенно, уменьшая разовую дозу на 500 мг каждые 2–4 нед. У взрослых с массой тела менее 50 кг рекомендуется уменьшать дозу на 20 мг/кг каждые 2 нед. У детей с массой тела 25–50 кг рекомендуется уменьшать дозу на 10 мг/кг каждые 2 нед.; Применение препарата Эпитерра пациентами с нарушением функции почек может потребовать коррекцию дозы (см. «Способ применения и дозы»).; Во время приема препарата Эпитерра могут наблюдаться нарушения со стороны ЦНС, включая сонливость, слабость, усталость, психотические и непсихотические изменения поведения, особенно в 1-й мес терапии. Поэтому в начале лечения за пациентами следует установить особо тщательное наблюдение.; Пациентов следует регулярно обследовать на наличие признаков депрессии, суицидальных и навязчивых идей вследствие возрастания риска попыток суицида у пациентов, принимающих противоэпилептические средства, в т.ч. препарат Эпитерра.; При наличии признаков депрессии и попытках суицида пациентам и лицам, осуществляющим уход за ними, следует обратиться к специалисту.; Рекомендуется постепенная отмена сопутствующих противосудорожных ЛС в период перевода пациента на прием препарата Эпитерра.; У пациентов с парциальными судорогами во время лечения препаратом наблюдалось незначительное, но статистически значимое снижение показателей красной крови, что не требует активного клинического вмешательства.; Имеющиеся сведения о применении препарата у детей не свидетельствуют о каком-либо его отрицательном влиянии на развитие и половую зрелость. Однако отдаленные последствия лечения на способность детей к обучению, их интеллектуальное развитие, рост, функции эндокринных желез, половое развитие и фертильность остаются неизвестными.; Влияние на способность управлять транспортными средствами и работать с механизмами. В период лечения препаратом Эпитерра необходимо воздерживаться от вождения автотранспорта и занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций в связи с тем, что могут возникнуть нежелательные реакции, такие как сонливость, головокружение, затуманивание зрения."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"противоэпилептическое","substance":[{"id":433,"title":"Леветирацетам","title_latin":"Levetiracetamum","slug":"levetiratsetam_433"}],"branding":null,"valid_for_quick_buy":false,"is_available_to_delivery":false,"comments":null,"image_alt":"Эпитерра - фото 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