Анальгезирующее. Действующее вещество Нейродолона является п... Инструкция
Показания к применению
Лечение острой боли легкой и средней тяжести у взрослых.
Противопоказания
Повышенная чувствительность к действующему веществу или любому другому компоненту препарата. Пациенты с риском развития печеночной энцефалопатии и пациенты с холестазом, т.к. может развиться энцефалопатия или усугубиться течение уже имеющейся энцефалопатии или атаксии. Пациенты с миастенией gravis в связи с миорелаксирующим действием флупиртина. Пациенты ...
Анальгезирующее. Действующее вещество Нейродолона является представителем селективных активаторов нейрональных калиевых каналов (Selective Neuronal Potassium Channel Opener - SNEPCO) и относятся к неопиоидным анальгетикам центрального действия. Препарат активирует связанные с G-белком нейрональные К+ каналы внутреннего выпрямления. Выход ионов К+ вызывает стабилизацию потенциала покоя и снижение возбудимости мембран нейронов. В результате наступает непрямое ингибирование рецепторов NMDA (N-метил-D-аспартат), поскольку блокада рецепторов NMDA ионами Mg2+ сохраняется до тех пор, пока не наступит деполяризация клеточной мембраны (непрямое антагонистическое действие на NMDA-рецепторы).
Показания к применению
Лечение острой боли легкой и средней тяжести у взрослых.
Противопоказания
Повышенная чувствительность к действующему веществу или любому другому компоненту препарата. Пациенты с риском развития печеночной энцефалопатии и пациенты с холестазом, т.к. может развиться энцефалопатия или усугубиться течение уже имеющейся энцефалопатии или атаксии. Пациенты с миастенией gravis в связи с миорелаксирующим действием флупиртина. Пациенты с сопутствующими заболеваниями печени или алкоголизмом. Одновременное применение флупиртина с другими лекарственными препаратами, которые могут оказывать гепатотоксическое действие. Пациенты с недавно излеченным или имеющимся звоном в ушах, т.к. данные пациенты имеют высокий риск активности «печеночных» ферментов. Детский возраст до 18 лет.
Применение при беременности и в период грудного вскармливания
Недостаточно данных о применении флупиртина при беременности. В экспериментальных исследованиях на животных флупиртин показал репродуктивную токсичность, но не тератогенность. Потенциальный риск для человека не известен. Препарат Нейродолон нельзя применять при беременности, за исключением тех случаев, когда польза для матери превышает потенциальный риск для плода. Согласно проведенным исследованиям, флупиртин в незначительном количестве проникает в грудное молоко. В связи с этим, Нейродолон нельзя применять в период грудного вскармливания за исключением тех случаев, когда в приеме препарата есть крайняя необходимость. При необходимости применения препарата Нейродолонв период лактации следует прекратить грудное вскармливание.
Способ применения и дозы
Внутрь, не разжевывая капсулу и запивая достаточным количеством жидкости (предпочтительней воды). По возможности препарат принимают, находясь в вертикальном положении. В исключительных случаях капсулу препарата Нейродолон можно вскрыть и принять внутрь / ввести через зонд лишь содержимое капсулы, при приеме внутрь содержимого капсулы рекомендуется нейтрализовать его горький вкус приемом пищи, например, банана. Применяют по 100 мг (1 капсула) 3–4 раза в день с равными интервалами между приемами. При выраженных болях — по 200 мг (2 капсулы) 3 раза в день. Максимальная суточная доза — 600 мг/сут (6 капсул). Дозы подбирают в зависимости от интенсивности боли и индивидуальной переносимости препарата. Следует применять минимально эффективную дозу в течении максимально короткого промежутка времени. Продолжительность лечения не должна превышать 2 недель. Пациенты старше 65 лет: в начале лечения по 100 мг (1 капсуле) 2 раза в день утром и вечером. Доза может быть увеличена до 300 мг в зависимости от интенсивности боли и переносимости препарата. У пациентов с почечной недостаточностью следует контролировать концентрацию креатинина в плазме крови. Максимальная суточная доза не должна превышать 300 мг/сут (3 капсулы). У пациентов с легкой и умеренной почечной недостаточность: коррекция дозы не требуется. У пациентов с тяжелой почечной недостаточностью или с гипоальбуминемией: максимальная суточная доза не должна превышать 300 мг/сут (3 капсулы). При необходимости применения препарата в более высокой дозе пациенты должны находиться под наблюдением врача.
Побочное действие
Классификация ВОЗ частоты развития побочных эффектов: очень часто - ≥1/10 назначений (больше 10 %)часто - от ≥1/100 до меньше 1/10 назначений (больше 1 % и меньше 10 %)нечасто - от ≥1/1000 до меньше 1/100 назначений (больше 0.1 % и меньше 1 %)редко - от ≥1/10000 до меньше 1/1000 назначений (больше 0.01 % и меньше 0.1 %)очень редко - меньше 1/10000 назначений (меньше 0.01 %)частота неизвестна (невозможно оценить на основании имеющихся данных) Нарушения со стороны гепатобилиарной системы: очень часто – повышение активности «печеночных» трансаминаз; частота неизвестна – гепатит, печеночная недостаточность. Со стороны иммунной системы:/нечасто – повышенная чувствительность к препарату, аллергические реакции (в отдельных случаях сопровождающиеся повышенной температурой тела, кожной сыпью, крапивницей, кожным зудом). Со стороны обмена веществ: часто – отсутствие аппетита. Со стороны нервной системы: часто – нарушение сна, депрессия, беспокойство/ нервозность, головокружение, тремор, головная боль; нечасто – спутанное сознание. Со стороны органа зрения: нечасто – нарушение зрения. Со стороны желудочно-кишечного тракта: часто – диспепсия, тошнота, рвота, боль в области желудка, запор, боль в животе, сухость слизистой оболочки полости рта, метеоризм, диарея. Со стороны кожи и подкожных тканей: часто – потливость. Прочие: очень часто – усталость/ слабость (у 15 % больных), особенно в начале лечения. Побочное действия в основном зависят от дозы препарата (за исключением аллергических реакций). Во многих случаях они исчезают сами по себе по мере проведения или после окончания лечения.
Передозировка
Имеются сообщения о единичных случаях передозировки с суицидальными намерениями. При этом прием дозы 5 г флупиртина вызвал следующие симптомы: тошнота, тахикардия, состояние прострации, плаксивость, ступор, спутанность сознания, оглушенность сознания, сухость слизистой оболочки полости рта. После рвоты или применения форсированного диуреза, приема активированного угля и введения электролитов самочувствие восстанавливалось в течение 6-12 часов. Об опасных для жизни состояниях не сообщалось. В случае передозировки или признаках интоксикации следует иметь ввиду возможность возникновения нарушений со стороны центральной нервной системы, а также проявления гепатотоксичности по типу усиления метаболических нарушений в печени. Следует провести симптоматическое лечение. Специфический антидот не известен.
Особые указания
Препарат Нейродолонследует применять в том случае, если лечение другими обезболивающими препаратами (например, нестероидные противовоспалительные препараты (НПВП) или легкие опиоидные препараты) противопоказано. У пациентов со сниженной функцией почек следует контролировать концентрацию креатинина в плазме крови. У пациентов старше 65 лет или с выраженными признаками почечной недостаточности или гипоальбуминемии необходимо проводить коррекцию дозы. Во время лечения препаратом Нейродолон один раз в неделю следует контролировать состояние функции печени, так как при терапии флупиртином возможно повышение активности «печеночных» трансаминаз, развитие гепатита и печеночной недостаточности. Если результаты исследования печени отклоняются от нормы или проявляются клинические симптомы, которые указывают на поражение печени, то следует прекратить применение препарата Нейродолон. Пациентов следует предупредить о том, что во время лечения препаратом Нейродолон необходимо обращать внимание на любые симптомы поражения печени (например, отсутствие аппетита, тошнота, рвота, боль в желудке, усталость, темная моча, желтуха, зуд). При проявлении таких симптомов следует прекратить прием препарата Нейродолон и в срочном порядке обратиться к врачу. При лечении флупиртином возможны ложноположительные реакции теста с диагностическими полосками на билирубин, уробилиноген и белок в моче. Аналогичная реакция возможна при количественном определении концентрации билирубина в плазме крови. При применении препарата в высоких дозах в отдельных случаях может отмечаться окрашивание мочи в зеленый цвет, что не является клиническим признаком какой-либо патологии. Влияние на способность управления транспортными средствами и механизмамиУчитывая, что препарат Нейродолон может ослаблять внимание и замедлять скорость реакции, во время лечения рекомендуется воздерживаться от управления транспортом и занятий потенциально опасными видами деятельности. Особо важно это помнить при одновременном употреблении алкоголя.
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капсула содержит: активное вещество: флупиртина малеат 100 мг; вспомогательные вещества: кальция гидрофосфата дигидрат 132 мг, крахмал кукурузный прежелатинизированный 62 мг, магния стеарат 3 мг, тальк 3 мг; капсула твердая желатиновая No 0 - 96 мг, в том числе: корпус - краситель солнечный закат желтый 0,059 мг, титана диоксид 1,18 мг, желатин 57,761 мг, крышечка - краситель солнечный закат желтый 0,037 мг, титана диоксид 0,74 мг, желатин 36,223 мг."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Анальгезирующее. Действующее вещество Нейродолона является представителем селективных активаторов нейрональных калиевых каналов (Selective Neuronal Potassium Channel Opener - SNEPCO) и относятся к неопиоидным анальгетикам центрального действия. Препарат активирует связанные с G-белком нейрональные К+ каналы внутреннего выпрямления. Выход ионов К+ вызывает стабилизацию потенциала покоя и снижение возбудимости мембран нейронов. В результате наступает непрямое ингибирование рецепторов NMDA (N-метил-D-аспартат), поскольку блокада рецепторов NMDA ионами Mg2+ сохраняется до тех пор, пока не наступит деполяризация клеточной мембраны (непрямое антагонистическое действие на NMDA-рецепторы)."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение острой боли легкой и средней тяжести у взрослых."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к действующему веществу или любому другому компоненту препарата. Пациенты с риском развития печеночной энцефалопатии и пациенты с холестазом, т.к. может развиться энцефалопатия или усугубиться течение уже имеющейся энцефалопатии или атаксии. Пациенты с миастенией gravis в связи с миорелаксирующим действием флупиртина. Пациенты с сопутствующими заболеваниями печени или алкоголизмом. Одновременное применение флупиртина с другими лекарственными препаратами, которые могут оказывать гепатотоксическое действие. Пациенты с недавно излеченным или имеющимся звоном в ушах, т.к. данные пациенты имеют высокий риск активности «печеночных» ферментов. Детский возраст до 18 лет."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Недостаточно данных о применении флупиртина при беременности. В экспериментальных исследованиях на животных флупиртин показал репродуктивную токсичность, но не тератогенность. Потенциальный риск для человека не известен. Препарат Нейродолон нельзя применять при беременности, за исключением тех случаев, когда польза для матери превышает потенциальный риск для плода. Согласно проведенным исследованиям, флупиртин в незначительном количестве проникает в грудное молоко. В связи с этим, Нейродолон нельзя применять в период грудного вскармливания за исключением тех случаев, когда в приеме препарата есть крайняя необходимость. При необходимости применения препарата Нейродолонв период лактации следует прекратить грудное вскармливание."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, не разжевывая капсулу и запивая достаточным количеством жидкости (предпочтительней воды). По возможности препарат принимают, находясь в вертикальном положении. В исключительных случаях капсулу препарата Нейродолон можно вскрыть и принять внутрь / ввести через зонд лишь содержимое капсулы, при приеме внутрь содержимого капсулы рекомендуется нейтрализовать его горький вкус приемом пищи, например, банана. Применяют по 100 мг (1 капсула) 3–4 раза в день с равными интервалами между приемами. При выраженных болях — по 200 мг (2 капсулы) 3 раза в день. Максимальная суточная доза — 600 мг/сут (6 капсул). Дозы подбирают в зависимости от интенсивности боли и индивидуальной переносимости препарата. Следует применять минимально эффективную дозу в течении максимально короткого промежутка времени. Продолжительность лечения не должна превышать 2 недель. Пациенты старше 65 лет: в начале лечения по 100 мг (1 капсуле) 2 раза в день утром и вечером. Доза может быть увеличена до 300 мг в зависимости от интенсивности боли и переносимости препарата. У пациентов с почечной недостаточностью следует контролировать концентрацию креатинина в плазме крови. Максимальная суточная доза не должна превышать 300 мг/сут (3 капсулы). У пациентов с легкой и умеренной почечной недостаточность: коррекция дозы не требуется. У пациентов с тяжелой почечной недостаточностью или с гипоальбуминемией: максимальная суточная доза не должна превышать 300 мг/сут (3 капсулы). При необходимости применения препарата в более высокой дозе пациенты должны находиться под наблюдением врача."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Классификация ВОЗ частоты развития побочных эффектов: очень часто - ≥1/10 назначений (больше 10 %)часто - от ≥1/100 до меньше 1/10 назначений (больше 1 % и меньше 10 %)нечасто - от ≥1/1000 до меньше 1/100 назначений (больше 0.1 % и меньше 1 %)редко - от ≥1/10000 до меньше 1/1000 назначений (больше 0.01 % и меньше 0.1 %)очень редко - меньше 1/10000 назначений (меньше 0.01 %)частота неизвестна (невозможно оценить на основании имеющихся данных) Нарушения со стороны гепатобилиарной системы: очень часто – повышение активности «печеночных» трансаминаз; частота неизвестна – гепатит, печеночная недостаточность. Со стороны иммунной системы:/нечасто – повышенная чувствительность к препарату, аллергические реакции (в отдельных случаях сопровождающиеся повышенной температурой тела, кожной сыпью, крапивницей, кожным зудом). Со стороны обмена веществ: часто – отсутствие аппетита. Со стороны нервной системы: часто – нарушение сна, депрессия, беспокойство/ нервозность, головокружение, тремор, головная боль; нечасто – спутанное сознание. Со стороны органа зрения: нечасто – нарушение зрения. Со стороны желудочно-кишечного тракта: часто – диспепсия, тошнота, рвота, боль в области желудка, запор, боль в животе, сухость слизистой оболочки полости рта, метеоризм, диарея. Со стороны кожи и подкожных тканей: часто – потливость. Прочие: очень часто – усталость/ слабость (у 15 % больных), особенно в начале лечения. Побочное действия в основном зависят от дозы препарата (за исключением аллергических реакций). Во многих случаях они исчезают сами по себе по мере проведения или после окончания лечения."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Имеются сообщения о единичных случаях передозировки с суицидальными намерениями. При этом прием дозы 5 г флупиртина вызвал следующие симптомы: тошнота, тахикардия, состояние прострации, плаксивость, ступор, спутанность сознания, оглушенность сознания, сухость слизистой оболочки полости рта. После рвоты или применения форсированного диуреза, приема активированного угля и введения электролитов самочувствие восстанавливалось в течение 6-12 часов. Об опасных для жизни состояниях не сообщалось. В случае передозировки или признаках интоксикации следует иметь ввиду возможность возникновения нарушений со стороны центральной нервной системы, а также проявления гепатотоксичности по типу усиления метаболических нарушений в печени. Следует провести симптоматическое лечение. Специфический антидот не известен."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат Нейродолонследует применять в том случае, если лечение другими обезболивающими препаратами (например, нестероидные противовоспалительные препараты (НПВП) или легкие опиоидные препараты) противопоказано. У пациентов со сниженной функцией почек следует контролировать концентрацию креатинина в плазме крови. У пациентов старше 65 лет или с выраженными признаками почечной недостаточности или гипоальбуминемии необходимо проводить коррекцию дозы. Во время лечения препаратом Нейродолон один раз в неделю следует контролировать состояние функции печени, так как при терапии флупиртином возможно повышение активности «печеночных» трансаминаз, развитие гепатита и печеночной недостаточности. Если результаты исследования печени отклоняются от нормы или проявляются клинические симптомы, которые указывают на поражение печени, то следует прекратить применение препарата Нейродолон. Пациентов следует предупредить о том, что во время лечения препаратом Нейродолон необходимо обращать внимание на любые симптомы поражения печени (например, отсутствие аппетита, тошнота, рвота, боль в желудке, усталость, темная моча, желтуха, зуд). При проявлении таких симптомов следует прекратить прием препарата Нейродолон и в срочном порядке обратиться к врачу. При лечении флупиртином возможны ложноположительные реакции теста с диагностическими полосками на билирубин, уробилиноген и белок в моче. Аналогичная реакция возможна при количественном определении концентрации билирубина в плазме крови. При применении препарата в высоких дозах в отдельных случаях может отмечаться окрашивание мочи в зеленый цвет, что не является клиническим признаком какой-либо патологии. 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