Болевой синдром (сильной и средней интенсивности, в т.ч. воспалительного, травматического, сосудистого происхождения).
Обезболивание при проведении болезненных диагностических или терапевтических мероприятий.
Противопоказания
Гиперчувствительность; отравление алкоголем, снотворными лекарственными средствами, наркотическими анальгетиками и другими психоактивными лекарственными средствами; тяжелая печеночная и/или почечная недостаточность (клиренс креатинина менее 10 мл/мин); беременность и период лактации (применение возможно только по жизненным показаниям и должно быть ограничено ...
Таблетки белого или белого со слабым желтоватым оттенком цвета плоскоцилиндрической формы с фаской и риской.
Фармакологические свойства
Трамадол - опиоидный синтетический анальгетик, обладающий центральным действием и действием на спинной мозг (способствует открытию К - и Са2+ -каналов, вызывает гиперполяризацию мембран и тормозит проведение болевых импульсов), усиливает действие седативных лекарственных средств. Активирует опиатные рецепторы (мю-, дельта-, каппа-) на пре- и постсинаптических мембранах афферентных волокон ноцицептивной системы в головном мозге и желудочно-кишечном тракте.
Анальгетический эффект обусловлен снижением активности ноцицептивной и увеличением антиноцицептивной систем организма.
В терапевтических дозах не влияет значимым образом на гемодинамику и дыхание, не изменяет давление в легочной артерии, незначительно замедляет перистальтику кишечника, не вызывает при этом запоров. Оказывает некоторое противокашлевое и седативное действие. Угнетает дыхательный центр, возбуждает пусковую зону рвотного центра, ядра глазодвигательного нерва.
При продолжительном применении возможно развитие толерантности.
Анальгезирующее действие развивается через 15-30 минут после приема внутрь и продолжается до
6 ч.
Фармакокинетика
Абсорбция - 90%; биодоступность - 68% (увеличивается при многократном применении).
Время достижения максимальной концентрации после приема внутрь - 2 ч. Ml метаболита - 3 ч.
Проникает через гематоэнцефалический барьер и плаценту, 0.1 % выделяется с грудным молоком. Объем распределения - 306 л. Связь с белками плазмы - 20 %.
В печени метаболизируется путем N- и О-диметилирования с последующей конъюгацией с глюкуроновой кислотой. Выявлено 11 метаболитов, из которых моно-О-диметилтрамадол (Ml) обладает фармакологической активностью. Период полувыделения во второй фазе -6ч (трамадол), 7,9 ч (Ml); у пациентов старше 75 лет - 7,4 ч (трамадол); при циррозе печени -13,3 ± 4,9 ч (трамадол), 18,5 ± 9,4 (Ml), в тяжелых случаях - 22,3 и 36 ч соответственно; при хронической почечной недостаточности (клиренс креатини-на менее 5 мл/мин) - 11+/-3,2 ч (трамадол), 16,9 ± 3 ч (Ml), в тяжелых случаях - 19,5 ч и 43,2 ч, соответственно.
Выводится почками (25-35 % в неизменном виде), средний кумулятивный показатель почечного выведения - 94 % .
Около 7 % выводится с помощью гемодиализа.
Показания к применению
Болевой синдром (сильной и средней интенсивности, в т.ч. воспалительного, травматического, сосудистого происхождения).
Обезболивание при проведении болезненных диагностических или терапевтических мероприятий.
Противопоказания
Гиперчувствительность; отравление алкоголем, снотворными лекарственными средствами, наркотическими анальгетиками и другими психоактивными лекарственными средствами; тяжелая печеночная и/или почечная недостаточность (клиренс креатинина менее 10 мл/мин); беременность и период лактации (применение возможно только по жизненным показаниям и должно быть ограничено только разовым приемом); детский возраст (до 14 лет), прием ингибиторов МАО.
С осторожностью
С осторожностью следует принимать препарат лицам с лекарственной зависимостью к опиоидам; больным с нарушенной функцией почек и печени, при черепно-мозговой травме, повышенном внутричерепном давлении, эпилептическом синдроме (церебрального генеза); в состоянии, сопровождающемся угнетением дыхания или выраженным угнетением центральной нервной системы.
Применение при беременности и в период грудного вскармливания
При беременности следует избегать длительного применения трамадола из-за риска развития привыкания у плода и возникновения синдрома отмены в неонатальном периоде.
При необходимости применения в период лактации (грудного вскармливания) необходимо учитывать, что трамадол в незначительном количестве выделяется с грудным молоком.
Способ применения и дозы
Препарат применяется по назначению врача, режим дозирования подбирается индивидуально, в зависимости от выраженности болевого синдрома чувствительности больного. Продолжительность лечения определяется индивидуально, не следует назначать препарат свыше срока, оправданного с терапевтической точки зрения.
При отсутствии иных предписаний препарат следует назначать в следующих дозировках: внутрь для однократного применения взрослым и детям cтарше 14 лет - по 50 мг с небольшим количеством жидкости, через 30-60 минут можно повторить прием в той же дозе, но не более 8 доз в сутки. Максимальная суточная доза составляет 400 мг.
Лицам пожилого возраста (75 лет и старше) и больным с почечной недостаточностью необходима индивидуальная дозировка. При клиренсе креатинина менее 30 мл/мин и у больных с печеночной недостаточностью необходим 12 ч интервал между приемом очередных доз препарата.
Побочное действие
Со стороны нервной системы: повышенное потоотделение, головокружение, головная боль, слабость, повышенная утомляемость, заторможенность, парадоксальная стимуляция центральной нервной системы (нервозность, ажитация, тревожность, тремор, спазмы мышц, эйфория, эмоциональная лабильность, галлюцинации), сонливость, нарушение сна, спутанность сознания, нарушение координации движений, судороги центрального генеза, депрессия, амнезия, нарушение когнитивной функции, парестезии.
Со стороны пищеварительной системы: сухость во рту, тошнота, рвота, метеоризм, боль в животе, запоры или диарея, затруднение при глотании.
Со стороны сердечно-сосудистой системы: проявление вазодилатации - тахикардия, ортостатическая гипотензия, обморок, коллапс.
Лечение: обеспечение проходимости дыхательных путей, поддержание дыхания и деятельности сердечно-сосудистой системы. Опиатоподобные эффекты могут быть купированы налоксоном, судороги - бензодиазепином.
Взаимодействие с другими лекарственными средствами
Усиливает действие лекарственных средств, угнетающих центральную нервную систему, и эталона.
Индукторы микросомального окисления (в т. ч. карбамазепин, барбитураты) уменьшают выраженность анальгезирующего эффекта и длительность действия.
Длительное применение опиоидных анальгетиков или барбитуратов стимулирует развитие перекрестной толерантности.
Анксиолитики повышают выраженность анальгезирующего эффекта; продолжительность анестезии увеличивается при комбинации с барбитуратами.
Налоксон активирует дыхание, устраняя анальгезию после применения опиоидных анальгетиков.
Ингибиторы МАО, фуразолидон, прокарбазин, антипсихотические лекарственные средства (нейролептики) повышают риск развития судорог (снижение судорожного порога).
Хинидин повышает плазменную концентрацию трамадола и снижает Ml метаболита за счет конкурентного ингибирования изофермента CYP2D6.
Особые указания
Не применяют для терапии синдрома "отмены" наркотиков.
Не следует одновременно употреблять этанол.
В случае разового приема нет необходимости прерывать кормление грудью.
В период лечения необходимо соблюдать осторожность при вождении автотранспорта и занятии др. потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Таблетки 100 мг.
Упаковка:
По 10 таблеток в контурную ячейковую упаковку или 20 таблеток в банки светозащитного стекла. 2 контурные ячейковые упаковки или каждую банку вместе с инструкцией по применению помещают в пачку из картона.
Условия хранения
Список сильнодействующих веществ.
В защищенном от света месте при температуре не выше 30 °С. Хранить в недоступном для детей месте.
Срок годности
5 лет. Не использовать препарат по истечении срока годности.
Условия отпуска
по рецепту
Производитель
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мг; упаковка контурная ячейковая 10, пачка картонная 2; код EAN: 4206424005751, 4602424005751; № Р N001820/02, 2008-10-22 от Органика ОАО (Россия); переоформлено"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"\n\n1 таблетка содержит активное вещество -трамадола гидрохлорид 100 мг,"}},{"type":"paragraph","data":{"text":"вспомогательные вещества: крахмал картофельный - 100 мг, лактозы моногидрат (сахар молочный) -295 мг, магния стеарат -5 мг\n\n"}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Таблетки белого или белого со слабым желтоватым оттенком цвета плоскоцилиндрической формы с фаской и риской."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Трамадол - опиоидный синтетический анальгетик, обладающий центральным действием и действием на спинной мозг (способствует открытию К - и Са2+ -каналов, вызывает гиперполяризацию мембран и тормозит проведение болевых импульсов), усиливает действие седативных лекарственных средств. Активирует опиатные рецепторы (мю-, дельта-, каппа-) на пре- и постсинаптических мембранах афферентных волокон ноцицептивной системы в головном мозге и желудочно-кишечном тракте."}},{"type":"paragraph","data":{"text":"Анальгетический эффект обусловлен снижением активности ноцицептивной и увеличением антиноцицептивной систем организма."}},{"type":"paragraph","data":{"text":"В терапевтических дозах не влияет значимым образом на гемодинамику и дыхание, не изменяет давление в легочной артерии, незначительно замедляет перистальтику кишечника, не вызывает при этом запоров. Оказывает некоторое противокашлевое и седативное действие. Угнетает дыхательный центр, возбуждает пусковую зону рвотного центра, ядра глазодвигательного нерва."}},{"type":"paragraph","data":{"text":"При продолжительном применении возможно развитие толерантности."}},{"type":"paragraph","data":{"text":"Анальгезирующее действие развивается через 15-30 минут после приема внутрь и продолжается до"}},{"type":"paragraph","data":{"text":"6 ч."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"Абсорбция - 90%; биодоступность - 68% (увеличивается при многократном применении)."}},{"type":"paragraph","data":{"text":"Время достижения максимальной концентрации после приема внутрь - 2 ч. Ml метаболита - 3 ч."}},{"type":"paragraph","data":{"text":"Проникает через гематоэнцефалический барьер и плаценту, 0.1 % выделяется с грудным молоком. Объем распределения - 306 л. Связь с белками плазмы - 20 %."}},{"type":"paragraph","data":{"text":"В печени метаболизируется путем N- и О-диметилирования с последующей конъюгацией с глюкуроновой кислотой. Выявлено 11 метаболитов, из которых моно-О-диметилтрамадол (Ml) обладает фармакологической активностью. Период полувыделения во второй фазе -6ч (трамадол), 7,9 ч (Ml); у пациентов старше 75 лет - 7,4 ч (трамадол); при циррозе печени -13,3 ± 4,9 ч (трамадол), 18,5 ± 9,4 (Ml), в тяжелых случаях - 22,3 и 36 ч соответственно; при хронической почечной недостаточности (клиренс креатини-на менее 5 мл/мин) - 11+/-3,2 ч (трамадол), 16,9 ± 3 ч (Ml), в тяжелых случаях - 19,5 ч и 43,2 ч, соответственно."}},{"type":"paragraph","data":{"text":"Выводится почками (25-35 % в неизменном виде), средний кумулятивный показатель почечного выведения - 94 % ."}},{"type":"paragraph","data":{"text":"Около 7 % выводится с помощью гемодиализа."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"\n\nБолевой синдром (сильной и средней интенсивности, в т.ч. воспалительного, травматического, сосудистого происхождения)."}},{"type":"paragraph","data":{"text":"Обезболивание при проведении болезненных диагностических или терапевтических мероприятий.\n\n"}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность; отравление алкоголем, снотворными лекарственными средствами, наркотическими анальгетиками и другими психоактивными лекарственными средствами; тяжелая печеночная и/или почечная недостаточность (клиренс креатинина менее 10 мл/мин); беременность и период лактации (применение возможно только по жизненным показаниям и должно быть ограничено только разовым приемом); детский возраст (до 14 лет), прием ингибиторов МАО."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"С осторожностью следует принимать препарат лицам с лекарственной зависимостью к опиоидам; больным с нарушенной функцией почек и печени, при черепно-мозговой травме, повышенном внутричерепном давлении, эпилептическом синдроме (церебрального генеза); в состоянии, сопровождающемся угнетением дыхания или выраженным угнетением центральной нервной системы."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"\n\nПри беременности следует избегать длительного применения трамадола из-за риска развития привыкания у плода и возникновения синдрома отмены в неонатальном периоде."}},{"type":"paragraph","data":{"text":"При необходимости применения в период лактации (грудного вскармливания) необходимо учитывать, что трамадол в незначительном количестве выделяется с грудным молоком.\n\n"}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"\n\nПрепарат применяется по назначению врача, режим дозирования подбирается индивидуально, в зависимости от выраженности болевого синдрома чувствительности больного. Продолжительность лечения определяется индивидуально, не следует назначать препарат свыше срока, оправданного с терапевтической точки зрения."}},{"type":"paragraph","data":{"text":"При отсутствии иных предписаний препарат следует назначать в следующих дозировках: внутрь для однократного применения взрослым и детям cтарше 14 лет - по 50 мг с небольшим количеством жидкости, через 30-60 минут можно повторить прием в той же дозе, но не более 8 доз в сутки. Максимальная суточная доза составляет 400 мг."}},{"type":"paragraph","data":{"text":"Лицам пожилого возраста (75 лет и старше) и больным с почечной недостаточностью необходима индивидуальная дозировка. При клиренсе креатинина менее 30 мл/мин и у больных с печеночной недостаточностью необходим 12 ч интервал между приемом очередных доз препарата.\n\n"}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\n\nСо стороны нервной системы: повышенное потоотделение, головокружение, головная боль, слабость, повышенная утомляемость, заторможенность, парадоксальная стимуляция центральной нервной системы (нервозность, ажитация, тревожность, тремор, спазмы мышц, эйфория, эмоциональная лабильность, галлюцинации), сонливость, нарушение сна, спутанность сознания, нарушение координации движений, судороги центрального генеза, депрессия, амнезия, нарушение когнитивной функции, парестезии."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: сухость во рту, тошнота, рвота, метеоризм, боль в животе, запоры или диарея, затруднение при глотании."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: проявление вазодилатации - тахикардия, ортостатическая гипотензия, обморок, коллапс."}},{"type":"paragraph","data":{"text":"Аллергические реакции: крапивница, зуд, экзантема, буллезная сыпь."}},{"type":"paragraph","data":{"text":"Со стороны мочевыделительной системы: затруднение мочеиспускания, дизурия, задержка мочи."}},{"type":"paragraph","data":{"text":"Со стороны органов чувств: нарушение зрения, вкуса."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: диспноэ."}},{"type":"paragraph","data":{"text":"Прочие: нарушение менструального цикла. При длительном применении - лекарственная зависимость. При резкой отмене - синдром \"отмены\".\n\n"}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\n\nСимптомы: миоз, рвота, коллапс, кома, судороги, угнетение дыхательного центра, апноэ."}},{"type":"paragraph","data":{"text":"Лечение: обеспечение проходимости дыхательных путей, поддержание дыхания и деятельности сердечно-сосудистой системы. Опиатоподобные эффекты могут быть купированы налоксоном, судороги - бензодиазепином.\n\n"}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"\n\nУсиливает действие лекарственных средств, угнетающих центральную нервную систему, и эталона."}},{"type":"paragraph","data":{"text":"Индукторы микросомального окисления (в т. ч. карбамазепин, барбитураты) уменьшают выраженность анальгезирующего эффекта и длительность действия."}},{"type":"paragraph","data":{"text":"Длительное применение опиоидных анальгетиков или барбитуратов стимулирует развитие перекрестной толерантности."}},{"type":"paragraph","data":{"text":"Анксиолитики повышают выраженность анальгезирующего эффекта; продолжительность анестезии увеличивается при комбинации с барбитуратами."}},{"type":"paragraph","data":{"text":"Налоксон активирует дыхание, устраняя анальгезию после применения опиоидных анальгетиков."}},{"type":"paragraph","data":{"text":"Ингибиторы МАО, фуразолидон, прокарбазин, антипсихотические лекарственные средства (нейролептики) повышают риск развития судорог (снижение судорожного порога)."}},{"type":"paragraph","data":{"text":"Хинидин повышает плазменную концентрацию трамадола и снижает Ml метаболита за счет конкурентного ингибирования изофермента CYP2D6.\n\n"}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nНе применяют для терапии синдрома \"отмены\" наркотиков."}},{"type":"paragraph","data":{"text":"Не следует одновременно употреблять этанол."}},{"type":"paragraph","data":{"text":"В случае разового приема нет необходимости прерывать кормление грудью."}},{"type":"paragraph","data":{"text":"В период лечения необходимо соблюдать осторожность при вождении автотранспорта и занятии др. потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.\n\n"}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nТаблетки 100 мг."}},{"type":"paragraph","data":{"text":"Упаковка:"}},{"type":"paragraph","data":{"text":"По 10 таблеток в контурную ячейковую упаковку или 20 таблеток в банки светозащитного стекла. 2 контурные ячейковые упаковки или каждую банку вместе с инструкцией по применению помещают в пачку из картона.\n\n"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"\n\nСписок сильнодействующих веществ."}},{"type":"paragraph","data":{"text":"В защищенном от света месте при температуре не выше 30 °С. Хранить в недоступном для детей месте.\n\n"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"5 лет. Не использовать препарат по истечении срока годности."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"по рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"ОРГАНИКА АО"}}]}],"source":null},"description_toggle":false,"short_description":"Трамадол - опиоидный синтетический анальгетик, обладающий центральным действием и действием на спинной мозг (способствует открытию К - и Са2+ -каналов, вызывает гиперполяризацию мембран и тормозит проведение болевых импульсов), усиливает действие седативных лекарственных средств. Активирует опиатные рецепторы (мю-, дельта-, каппа-) на пре- и постсинаптических мембранах афферентных волокон ноцицептивной системы в головном мозге и желудочно-кишечном тракте. Анальгетический эффект обусловлен снижением активности ноцицептивной и увеличением антиноцицептивной систем организма. В терапевтических дозах не влияет значимым образом на гемодинамику и дыхание, не изменяет давление в легочной артерии, незначительно замедляет перистальтику кишечника, не вызывает при этом запоров. Оказывает некоторое противокашлевое и седативное действие. Угнетает дыхательный центр, возбуждает пусковую зону рвотного центра, ядра глазодвигательного нерва. При продолжительном применении возможно развитие толерантности. Анальгезирующее действие развивается через 15-30 минут после приема внутрь и продолжается до 6 ч. Абсорбция - 90%; биодоступность - 68% (увеличивается при многократном применении). Время достижения максимальной концентрации после приема внутрь - 2 ч. Ml метаболита - 3 ч. Проникает через гематоэнцефалический барьер и плаценту, 0.1 % выделяется с грудным молоком. Объем распределения - 306 л. Связь с белками плазмы - 20 %. В печени метаболизируется путем N- и О-диметилирования с последующей конъюгацией с глюкуроновой кислотой. Выявлено 11 метаболитов, из которых моно-О-диметилтрамадол (Ml) обладает фармакологической активностью. Период полувыделения во второй фазе -6ч (трамадол), 7,9 ч (Ml); у пациентов старше 75 лет - 7,4 ч (трамадол); при циррозе печени -13,3 ± 4,9 ч (трамадол), 18,5 ± 9,4 (Ml), в тяжелых случаях - 22,3 и 36 ч соответственно; при хронической почечной недостаточности (клиренс креатини-на менее 5 мл/мин) - 11+/-3,2 ч (трамадол), 16,9 ± 3 ч (Ml), в тяжелых случаях - 19,5 ч и 43,2 ч, соответственно. Выводится почками (25-35 % в неизменном виде), средний кумулятивный показатель почечного выведения - 94 % . 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