раствор для внутривенного и внутримышечного введения
Состав
Состав (1 мл / 1 амп.):
активное вещество:
цитиколин натрия (в пересчете на цитиколин) 125 мг;
вспомогательные вещества:
хлористоводородная кислота 1М или натрия гидроксида раствор 1М - до pH 6.5-7.5, вода д/и - до 4 мл.
Описание
прозрачная бесцветная жидкость.
Фармакотерапевтическая группа
ноотропное средство.
Фармакологические свойства
Фармакодинамика
Цитиколин – природное эндогенное соединение, которое является промежуточным метаболитом в синтезе фосфатидилхолина – одного из основных структурных компонентов клеточной мембраны.
Обладает широким спектром действия – способствует восстановлению поврежденных мембран клеток, ингибирует действие фосфолипаз, препятствует избыточному образованию свободных радикалов, а также предотвращает гибель клеток, воздействуя на механизмы апоптоза. В остром периоде инсульта цитиколин уменьшает объем поражения ткани головного мозга, улучшает холинергическую передачу. При черепно-мозговой травме уменьшает длительность посттравматической комы и выраженность неврологических симптомов, кроме этого, способствует уменьшению продолжительности восстановительного периода.
При хронической гипоксии головного мозга цитиколин эффективен в лечении когнитивных расстройств, таких как ухудшение памяти, безынициативность, затруднения, возникающие при выполнении повседневных действий и самообслуживании. Повышает уровень внимания и сознания, а также уменьшает проявление амнезии.
Фармакокинетика
Метаболизм: после внутривенного введения цитиколин быстро гидролизуется на холин и цитидин и доставляется в различные ткани организма.
Распределение: после введения цитиколин широко распределяется в структурах головного мозга с быстрым включением фракции холина в структурные фосфолипиды и фракции цитидина в цитидиновые нуклеотиды и нуклеиновые кислоты. Достигнув головного мозга, цитиколин встраивается в клеточные, цитоплазматические и митохондриальные мембраны, принимая участие в построении фракции фосфолипидов.
Выведение: только небольшое количество дозы выводится почками и через кишечник (<3%). Около 12% дозы выводится с выдыхаемым СО2. В выведении препарата почками выделяют две фазы: первая фаза – около 36 ч, в которой скорость выведения снижается быстро, и вторая фаза, в которой скорость выведения снижается намного медленнее. Такая же фазность наблюдается при выведении с СО2, скорость выведения выдыхаемого СО2 быстро снижается приблизительно через 15 ч, в дальнейшем она снижается намного медленнее.
Показания к применению
острый период ишемического инсульта (в составе комплексной терапии);
восстановительный период ишемического и геморрагического инсультов;
черепно-мозговая травма, острый (в составе комплексной терапии) и восстановительный период;
когнитивные и поведенческие нарушения при дегенеративных и сосудистых заболеваниях головного мозга.
Противопоказания
повышенная чувствительность к любому из компонентов препарата;
не следует назначать пациентам с выраженной ваготонией (высоким тонусом парасимпатической части вегетативной нервной системы);
в связи с отсутствием достаточных клинических данных, не рекомендуется применять у детей до 18 лет.
Применение при беременности и в период грудного вскармливания
Отсутствуют достаточные данные по применению цитиколина у беременных женщин. Хотя в исследованиях на животных отрицательного влияния не выявлено, в период беременности цитиколин назначают только в тех случаях, когда ожидаемая польза для матери превосходит потенциальный риск для плода.
При применении цитиколина в период лактации женщинам следует прекратить грудное вскармливание, поскольку данные об экскреции цитиколина с грудным молоком отсутствуют.
Способ применения и дозы
Рекомендуемый режим дозирования
Острый период ишемического инсульта и черепно-мозговой травмы (ЧМТ):
по 1000 мг цитиколина каждые 12 ч с первых суток после постановки диагноза, длительность лечения не менее 6-ти недель.
Максимальная суточная доза – 2000 мг.
Восстановительный период ишемического и геморрагического инсультов, восстановительный период ЧМТ, когнитивные и поведенческие нарушения при дегенеративных и сосудистых заболеваниях головного мозга:
Вводят в/в или в/м по 500-2000 мг цитиколина в день. Дозировка и длительность лечения в зависимости от тяжести симптомов заболевания.
Пожилые пациенты
При назначении препарата НЕЙПИЛЕПТ пожилым пациентам коррекции дозы не требуется. Препарат должен быть немедленно использован после вскрытия ампулы.
НЕЙПИЛЕПТ вводится внутримышечно, внутривенно струйно (медленно, в течение 3-5 минут, в зависимости от назначенной дозы) или капельно (скорость инфузии – 40-60 капель в минуту).
Внутривенный (в/в) путь введения предпочтительнее, чем внутримышечный (в/м). При в/м введении следует избегать повторного введения препарата в одно и то же место. НЕЙПИЛЕПТ совместим со всеми видами внутривенных изотонических растворов и растворов декстрозы.
Побочное действие
Побочные действия сгруппированы по частоте появления: очень часто (>1/10), часто (≥1/100 до <1/10), нечасто (≥1/1000 до <1/100), редко (≥1/10000 до <1/1000), очень редко (<1/10000), частота не установлена.
Очень редко (включая индивидуальные случаи): аллергические реакции (сыпь, кожный зуд, анафилактический шок), головная боль, головокружение, чувство жара, тремор, тошнота, рвота, диарея, галлюцинации, отеки, одышка, бессонница, возбуждение, снижение аппетита, онемение в парализованных конечностях, изменение активности печеночных ферментов. В некоторых случаях цитиколин может стимулировать парасимпатическую систему, а также оказывать кратковременное изменение артериального давления.
Если любые из указанных в инструкции побочных эффектов усугубляются или Вы заметили любые другие побочные эффекты не указанные в инструкции, сообщите врачу.
Передозировка
С учетом низкой токсичности препарата случаи передозировки не описаны.
Взаимодействие с другими лекарственными средствами
Цитиколин усиливает эффекты леводопы.
Особые указания
Внутривенно струйно НЕЙПИЛЕПТ вводится медленно (3-5 минут в зависимости от дозы).
При внутривенном капельном введении скорость инфузии должна быть 40-60 капель в минуту. При персистирующем внутричерепном кровоизлиянии рекомендуется не превышать дозу препарата НЕЙПИЛЕПТ 1000 мг в сутки, препарат вводят внутривенно капельно со скоростью 30 капель в минуту.
Влияние на способность управлять автомобилем и движущимися механизмами
Во время применения препарата следует соблюдать осторожность при управлении транспортом и при занятиях другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Раствор для внутривенного и внутримышечного введения, 125 мг/мл и 250 мг/мл.
По 4 мл в ампулы бесцветного стекла с цветным кольцом разлома или с цветной точкой и насечкой. На ампулы дополнительно наносят одно, два или три цветных кольца и/или двухмерный штрих-код, и/или буквенно-цифровую кодировку или без дополнительных цветных колец, двухмерного штрих-кода, буквенно-цифровой кодировки.
По 3 или 5 ампул в контурной ячейковой упаковке из пленки поливинилхлоридной и фольги алюминиевой или пленки полимерной или без фольги и без пленки.
1 контурная ячейковая упаковка по 3 или 5 ампул вместе с инструкцией по применению в пачке из картона.
2 контурные ячейковые упаковки по 5 ампул вместе с инструкцией по применению в пачке из картона.
Условия хранения
При температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
2 года. Не использовать по истечении срока годности, указанного на упаковке.
Для описания товара использована информация от партнера 36.6
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ампулы, 5 шт, 4 мл, 125 мг / мл, для внутривенного и внутримышечного введения, для взрослых","short":"Раствор, 5 шт, 4 мл, 125 мг / мл","package":"5 шт, 4 мл, 125 мг / мл"},"prescription":true,"catalog_section_id":100274,"manufacturer":{"id":2404,"title":"Сотекс","slug":"soteks_2404","logo":{"isTouch":{"retina":null,"default":null},"isFromTablet":{"retina":null,"default":null}}},"is_advert":false,"product_form":"Раствор","slug":"109858-neypilept","attributes":{"count":"5 шт","dose":"125 мг / мл","volume":"4 мл","spf":"","size":""},"image":{"isTouch":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/17654/phoneMedium_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/17654/phoneMedium_default/"},"isFromTablet":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/17654/tabletLarge_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/17654/tabletLarge_default/"}},"image_thumb":{"isTouch":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/17654/previewTouch_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/17654/previewTouch_default/"},"isFromTablet":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/17654/previewDesktopMedium_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/17654/previewDesktopMedium_default/"}},"available":true,"price":{"min":"252","max":"321"},"counters":null,"description":{"data":[{"id":1,"name":"Регистрационный номер","slug":"","body":[{"type":"paragraph","data":{"text":"ЛП-003116"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"НЕЙПИЛЕПТ"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"раствор для внутривенного и внутримышечного введения"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"Состав (1 мл / 1 амп.):"}},{"type":"list","data":{"style":"ordered","items":["активное вещество:","цитиколин натрия (в пересчете на цитиколин) 125 мг;","вспомогательные вещества:"," хлористоводородная кислота 1М или натрия гидроксида раствор 1М - до pH 6.5-7.5, вода д/и - до 4 мл."]}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"прозрачная бесцветная жидкость."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"ноотропное средство."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Фармакодинамика"}},{"type":"paragraph","data":{"text":"Цитиколин – природное эндогенное соединение, которое является промежуточным метаболитом в синтезе фосфатидилхолина – одного из основных структурных компонентов клеточной мембраны."}},{"type":"paragraph","data":{"text":"Обладает широким спектром действия – способствует восстановлению поврежденных мембран клеток, ингибирует действие фосфолипаз, препятствует избыточному образованию свободных радикалов, а также предотвращает гибель клеток, воздействуя на механизмы апоптоза. В остром периоде инсульта цитиколин уменьшает объем поражения ткани головного мозга, улучшает холинергическую передачу. При черепно-мозговой травме уменьшает длительность посттравматической комы и выраженность неврологических симптомов, кроме этого, способствует уменьшению продолжительности восстановительного периода."}},{"type":"paragraph","data":{"text":"При хронической гипоксии головного мозга цитиколин эффективен в лечении когнитивных расстройств, таких как ухудшение памяти, безынициативность, затруднения, возникающие при выполнении повседневных действий и самообслуживании. Повышает уровень внимания и сознания, а также уменьшает проявление амнезии."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"Метаболизм: после внутривенного введения цитиколин быстро гидролизуется на холин и цитидин и доставляется в различные ткани организма."}},{"type":"paragraph","data":{"text":"Распределение: после введения цитиколин широко распределяется в структурах головного мозга с быстрым включением фракции холина в структурные фосфолипиды и фракции цитидина в цитидиновые нуклеотиды и нуклеиновые кислоты. Достигнув головного мозга, цитиколин встраивается в клеточные, цитоплазматические и митохондриальные мембраны, принимая участие в построении фракции фосфолипидов."}},{"type":"paragraph","data":{"text":"Выведение: только небольшое количество дозы выводится почками и через кишечник (<3%). Около 12% дозы выводится с выдыхаемым СО\u003csub\u003e2\u003c/sub\u003e. В выведении препарата почками выделяют две фазы: первая фаза – около 36 ч, в которой скорость выведения снижается быстро, и вторая фаза, в которой скорость выведения снижается намного медленнее. Такая же фазность наблюдается при выведении с СО\u003csub\u003e2\u003c/sub\u003e, скорость выведения выдыхаемого СО\u003csub\u003e2\u003c/sub\u003e быстро снижается приблизительно через 15 ч, в дальнейшем она снижается намного медленнее."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["острый период ишемического инсульта (в составе комплексной терапии);","восстановительный период ишемического и геморрагического инсультов;","черепно-мозговая травма, острый (в составе комплексной терапии) и восстановительный период;","когнитивные и поведенческие нарушения при дегенеративных и сосудистых заболеваниях головного мозга."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["повышенная чувствительность к любому из компонентов препарата;","не следует назначать пациентам с выраженной ваготонией (высоким тонусом парасимпатической части вегетативной нервной системы);","в связи с отсутствием достаточных клинических данных, не рекомендуется применять у детей до 18 лет."]}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"\n\nОтсутствуют достаточные данные по применению цитиколина у беременных женщин. Хотя в исследованиях на животных отрицательного влияния не выявлено, в период беременности цитиколин назначают только в тех случаях, когда ожидаемая польза для матери превосходит потенциальный риск для плода."}},{"type":"paragraph","data":{"text":"При применении цитиколина в период лактации женщинам следует прекратить грудное вскармливание, поскольку данные об экскреции цитиколина с грудным молоком отсутствуют.\n\n"}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"\n\nРекомендуемый режим дозирования"}},{"type":"paragraph","data":{"text":"Острый период ишемического инсульта и черепно-мозговой травмы (ЧМТ):"}},{"type":"paragraph","data":{"text":"по 1000 мг цитиколина каждые 12 ч с первых суток после постановки диагноза, длительность лечения не менее 6-ти недель."}},{"type":"paragraph","data":{"text":"Максимальная суточная доза – 2000 мг."}},{"type":"paragraph","data":{"text":"Восстановительный период ишемического и геморрагического инсультов, восстановительный период ЧМТ, когнитивные и поведенческие нарушения при дегенеративных и сосудистых заболеваниях головного мозга:"}},{"type":"paragraph","data":{"text":"Вводят в/в или в/м по 500-2000 мг цитиколина в день. Дозировка и длительность лечения в зависимости от тяжести симптомов заболевания."}},{"type":"paragraph","data":{"text":"Пожилые пациенты"}},{"type":"paragraph","data":{"text":"При назначении препарата НЕЙПИЛЕПТ пожилым пациентам коррекции дозы не требуется. Препарат должен быть немедленно использован после вскрытия ампулы."}},{"type":"paragraph","data":{"text":"НЕЙПИЛЕПТ вводится внутримышечно, внутривенно струйно (медленно, в течение 3-5 минут, в зависимости от назначенной дозы) или капельно (скорость инфузии – 40-60 капель в минуту)."}},{"type":"paragraph","data":{"text":"Внутривенный (в/в) путь введения предпочтительнее, чем внутримышечный (в/м). При в/м введении следует избегать повторного введения препарата в одно и то же место. НЕЙПИЛЕПТ совместим со всеми видами внутривенных изотонических растворов и растворов декстрозы.\n\n"}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\n\nПобочные действия сгруппированы по частоте появления: очень часто (>1/10), часто (≥1/100 до <1/10), нечасто (≥1/1000 до <1/100), редко (≥1/10000 до <1/1000), очень редко (<1/10000), частота не установлена."}},{"type":"paragraph","data":{"text":"Очень редко (включая индивидуальные случаи): аллергические реакции (сыпь, кожный зуд, анафилактический шок), головная боль, головокружение, чувство жара, тремор, тошнота, рвота, диарея, галлюцинации, отеки, одышка, бессонница, возбуждение, снижение аппетита, онемение в парализованных конечностях, изменение активности печеночных ферментов. В некоторых случаях цитиколин может стимулировать парасимпатическую систему, а также оказывать кратковременное изменение артериального давления."}},{"type":"paragraph","data":{"text":"Если любые из указанных в инструкции побочных эффектов усугубляются или Вы заметили любые другие побочные эффекты не указанные в инструкции, сообщите врачу.\n\n"}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"С учетом низкой токсичности препарата случаи передозировки не описаны."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Цитиколин усиливает эффекты леводопы."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nВнутривенно струйно НЕЙПИЛЕПТ вводится медленно (3-5 минут в зависимости от дозы)."}},{"type":"paragraph","data":{"text":"При внутривенном капельном введении скорость инфузии должна быть 40-60 капель в минуту. При персистирующем внутричерепном кровоизлиянии рекомендуется не превышать дозу препарата НЕЙПИЛЕПТ 1000 мг в сутки, препарат вводят внутривенно капельно со скоростью 30 капель в минуту.\n\n"}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Во время применения препарата следует соблюдать осторожность при управлении транспортом и при занятиях другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nРаствор для внутривенного и внутримышечного введения, 125 мг/мл и 250 мг/мл."}},{"type":"paragraph","data":{"text":"По 4 мл в ампулы бесцветного стекла с цветным кольцом разлома или с цветной точкой и насечкой. На ампулы дополнительно наносят одно, два или три цветных кольца и/или двухмерный штрих-код, и/или буквенно-цифровую кодировку или без дополнительных цветных колец, двухмерного штрих-кода, буквенно-цифровой кодировки."}},{"type":"paragraph","data":{"text":"По 3 или 5 ампул в контурной ячейковой упаковке из пленки поливинилхлоридной и фольги алюминиевой или пленки полимерной или без фольги и без пленки."}},{"type":"paragraph","data":{"text":"1 контурная ячейковая упаковка по 3 или 5 ампул вместе с инструкцией по применению в пачке из картона."}},{"type":"paragraph","data":{"text":"2 контурные ячейковые упаковки по 5 ампул вместе с инструкцией по применению в пачке из картона.\n\n"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"\n\nПри температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте.\n\n"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года. Не использовать по истечении срока годности, указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Отпускают по рецепту."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.eapteka.ru/goods/manufacturer/soteks/\"\u003eФармФирма Сотекс, Россия\u003c/a\u003e"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ЗАО «ФармФирма «Сотекс»"}}]}],"source":null},"description_toggle":false,"short_description":"Фармакодинамика Цитиколин – природное эндогенное соединение, которое является промежуточным метаболитом в синтезе фосфатидилхолина – одного из основных структурных компонентов клеточной мембраны. Обладает широким спектром действия – способствует восстановлению поврежденных мембран клеток, ингибирует действие фосфолипаз, препятствует избыточному образованию свободных радикалов, а также предотвращает гибель клеток, воздействуя на механизмы апоптоза. В остром периоде инсульта цитиколин уменьшает объем поражения ткани головного мозга, улучшает холинергическую передачу. При черепно-мозговой травме уменьшает длительность посттравматической комы и выраженность неврологических симптомов, кроме этого, способствует уменьшению продолжительности восстановительного периода. При хронической гипоксии головного мозга цитиколин эффективен в лечении когнитивных расстройств, таких как ухудшение памяти, безынициативность, затруднения, возникающие при выполнении повседневных действий и самообслуживании. Повышает уровень внимания и сознания, а также уменьшает проявление амнезии. 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