В качестве монотерапии (препарат первого выбора) при лечении: парциальных припадков с вторичной генерализацией или без таковой у взрослых и подростков старше 16 лет с вновь диагностированной эпилепсией. В составе комплексной терапии при лечении: парциальных припадков с вторичной генерализацией или без таковой у взрослых и детей старше 4 лет, страдающих ...
Действующее вещество: Леветирацетам (Levetiracetam)Концентрация действующего вещества (мг): 250
Фармакологические свойства
Противоэпилептический препарат, производное пирролидона (S-энантиомер α-этил-2-оксо-1-пирролидин-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. Исследования in vitro показали, что леветирацетам влияет на внутринейрональную концентрацию ионов Са2+, частично тормозя ток Са2+ через каналы N-типа и снижая высвобождение кальция из внутринейрональных депо. Кроме того, леветирацетам частично восстанавливает токи через GABA- и глицин-зависимые каналы, сниженные цинком и β-карболинами. 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. Не изменяет нормальную нейротрансмиссию, однако подавляет эпилептиформные нейрональные вспышки, индуцированные GABA-агонистом бикукулином, и возбуждение глютаматных рецепторов. Активность препарата подтверждена в отношении как фокальных, так и генерализованных эпилептических припадков (эпилептиформные проявления/фотопароксизмальная реакция).
Показания к применению
В качестве монотерапии (препарат первого выбора) при лечении: парциальных припадков с вторичной генерализацией или без таковой у взрослых и подростков старше 16 лет с вновь диагностированной эпилепсией. В составе комплексной терапии при лечении: парциальных припадков с вторичной генерализацией или без таковой у взрослых и детей старше 4 лет, страдающих эпилепсией (для таблеток); парциальных припадков с вторичной генерализацией или без таковой у взрослых и детей старше 1 месяца, страдающих эпилепсией (для раствора); миоклонических судорог у взрослых и подростков старше 12 лет с ювенильной миоклонической эпилепсией; первично-генерализованных судорожных (тонико-клонических) припадков у взрослых и подростков старше 12 лет с идиопатической генерализованной эпилепсией.
Противопоказания
Детский возраст до 4 лет (для таблеток) (безопасность и эффективность препарата не установлены)
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 не следует назначать при беременности, за исключением случаев крайней необходимости. Физиологические изменения в организме женщины во время беременности могут влиять на концентрацию в плазме леветирацетама, так же, как и других противоэпилептических препаратов. Во время беременности отмечено снижение концентрации леветирацетама в плазме. Это снижение более выражено в I триместре (до 60% от базовой концентрации в период, предшествующий беременности). Лечение леветирацетамом беременных следует проводить под особым контролем. Следует учитывать, что перерывы в проведении противоэпилептической терапии могут привести к ухудшению течения заболевания, что вредно для как для матери, так и для плода. Леветирацетам выделяется с грудным молоком, поэтому грудное вскармливание при лечении препаратом не рекомендуется. Однако, если лечение леветирацетамом необходимо в период лактации, то следует тщательно взвесить соотношение риск/польза лечения относительно важности грудного вскармливания.
Способ применения и дозы
Таблетки следует принимать внутрь, запивая достаточным количеством жидкости, независимо от приема пищи.
Побочное действие
Астения, утомляемость; сонливость; головная боль, амнезия, атаксия, судороги, гиперкинезия, тремор, нарушение равновесия, спутанность сознания, ухудшение памяти, парестезии; возбуждение, депрессия, эмоциональная нестабильность, изменения настроения, враждебность, агрессивность, бессонница, нервозность, раздражительность, спутанность сознания, галлюцинации, психотические нарушения, самоубийство, попытки самоубийства и суицидальные мысли; боль в животе, диарея, диспепсия, тошнота, рвота; панкреатит; печеночная недостаточность, гепатиты; анорексия; головокружение; диплопия, нарушение четкости зрения; миалгия; инфекционные заболевания, назофарингит; кашель; кожная сыпь; алопеция; тромбоцитопения; лейкопения, нейтропения, панцитопения.
Передозировка
Симптомы: сонливость, тревожность, агрессивность, угнетение сознания, угнетение дыхания, кома. Лечение: в остром периоде - искусственный вызов рвоты и промывание желудка с последующим назначением активированного угля. Специфического антидота для леветирацетама нет. При необходимости проводится симптоматическое лечение в условиях стационара с использованием гемодиализа (эффективность диали
Особые указания
Если требуется прекратить прием препарата, то отмену рекомендуется проводить постепенно, уменьшая разовую дозу на 500 мг каждые 2-4 недели. У детей снижение дозы не должно превышать 10 мг/кг массы тела 2 раза/сут каждые 2 недели. Сопутствующие противоэпилептические лекарственные препараты (в период перевода пациентов на прием леветирацетама) желательно отменять постепенно. Пациентам с заболеваниями почек и декомпенсированными заболеваниями печени рекомендуется исследование функции почек перед началом лечения. При нарушении функции почек может потребоваться коррекция дозы. В связи с имеющимися сообщениями о случаях суицида, суицидальных намерений и попыток суицида при лечении леветирацетамом следует предупреждать пациентов о необходимости немедленно сообщать лечащему врачу о появлении любых симптомов депрессии или суицидальных намерений. Раствор для приема внутрь содержит мальтитол, поэтому пациентам с нарушением толерантности к фруктозе прием препарата Кеппра в соответствующей лекарственной форме противопоказан. Использование в педиатрииИмеющиеся 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 к вождению автотранспорта и управлению механизмамиВлияние препарата Кеппра на способность к вождению автотранспорта и управлению механизмами специально не изучалось. Тем не менее, в силу различной индивидуальной чувствительности к препарату со стороны ЦНС в период лечения необходимо воздерживаться от вождения автотранспорта и занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
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Механизм действия леветирацетама до конца не изучен, но очевидно, что он отличается от механизма действия известных противоэпилептических препаратов. Исследования in vitro показали, что леветирацетам влияет на внутринейрональную концентрацию ионов Са2+, частично тормозя ток Са2+ через каналы N-типа и снижая высвобождение кальция из внутринейрональных депо. Кроме того, леветирацетам частично восстанавливает токи через GABA- и глицин-зависимые каналы, сниженные цинком и β-карболинами. 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. Не изменяет нормальную нейротрансмиссию, однако подавляет эпилептиформные нейрональные вспышки, индуцированные GABA-агонистом бикукулином, и возбуждение глютаматных рецепторов. Активность препарата подтверждена в отношении как фокальных, так и генерализованных эпилептических припадков (эпилептиформные проявления/фотопароксизмальная реакция)."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В качестве монотерапии (препарат первого выбора) при лечении: парциальных припадков с вторичной генерализацией или без таковой у взрослых и подростков старше 16 лет с вновь диагностированной эпилепсией. В составе комплексной терапии при лечении: парциальных припадков с вторичной генерализацией или без таковой у взрослых и детей старше 4 лет, страдающих эпилепсией (для таблеток); парциальных припадков с вторичной генерализацией или без таковой у взрослых и детей старше 1 месяца, страдающих эпилепсией (для раствора); миоклонических судорог у взрослых и подростков старше 12 лет с ювенильной миоклонической эпилепсией; первично-генерализованных судорожных (тонико-клонических) припадков у взрослых и подростков старше 12 лет с идиопатической генерализованной эпилепсией."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Детский возраст до 4 лет (для таблеток) (безопасность и эффективность препарата не установлены)"}}]},{"id":5,"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 не следует назначать при беременности, за исключением случаев крайней необходимости. Физиологические изменения в организме женщины во время беременности могут влиять на концентрацию в плазме леветирацетама, так же, как и других противоэпилептических препаратов. Во время беременности отмечено снижение концентрации леветирацетама в плазме. Это снижение более выражено в I триместре (до 60% от базовой концентрации в период, предшествующий беременности). Лечение леветирацетамом беременных следует проводить под особым контролем. Следует учитывать, что перерывы в проведении противоэпилептической терапии могут привести к ухудшению течения заболевания, что вредно для как для матери, так и для плода. Леветирацетам выделяется с грудным молоком, поэтому грудное вскармливание при лечении препаратом не рекомендуется. Однако, если лечение леветирацетамом необходимо в период лактации, то следует тщательно взвесить соотношение риск/польза лечения относительно важности грудного вскармливания."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Таблетки следует принимать внутрь, запивая достаточным количеством жидкости, независимо от приема пищи."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Астения, утомляемость; сонливость; головная боль, амнезия, атаксия, судороги, гиперкинезия, тремор, нарушение равновесия, спутанность сознания, ухудшение памяти, парестезии; возбуждение, депрессия, эмоциональная нестабильность, изменения настроения, враждебность, агрессивность, бессонница, нервозность, раздражительность, спутанность сознания, галлюцинации, психотические нарушения, самоубийство, попытки самоубийства и суицидальные мысли; боль в животе, диарея, диспепсия, тошнота, рвота; панкреатит; печеночная недостаточность, гепатиты; анорексия; головокружение; диплопия, нарушение четкости зрения; миалгия; инфекционные заболевания, назофарингит; кашель; кожная сыпь; алопеция; тромбоцитопения; лейкопения, нейтропения, панцитопения."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: сонливость, тревожность, агрессивность, угнетение сознания, угнетение дыхания, кома. 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