Таблетки белого или белого со слабым желтоватым оттенком цвета.
Фармакотерапевтическая группа
Анальгезирующее средство со смешанным механизмом действия
Фармакологические свойства
Фармакодинамика:
Трамадол является дериватом циклогексанола с опиатагонистическими свойствами. Относится к анальгетикам центрального действия. Обладает слабым аффинитетом к опиатным рецепторам без преимущественной избирательности к отдельным популяциям рецепторов. Обладает обезболивающим противокашлевым и седативным эффектами. Активность трамадола составляет 1/10 - 1/6 часть активности морфина. В отличие от морфина трамадол в терапевтических дозах не угнетает дыхание не подавляет моторику желудочно-кишечного тракта и не влияет на сердечно-сосудистую деятельность.
Фармакокинетика:
При приеме внутрь быстро всасывается терапевтическое действие наступает через 15-30 минут. Терапевтическое действие сохраняется в течение 4-8 часов. Максимальная концентрация в плазме крови после приема внутрь наблюдается через 15-2 часа. Связывание с белками плазмы крови около 20%. Проникает через плацентарный барьер (концентрация в крови пупочной вены составляет 80% от концентрации в крови матери).Биотрансформация осуществляется в печени путем деметилирования и конъюгации с образованием 11 метаболитов (1 из них - активный). Выводится преимущественно почками (90%) и кишечником (около 10%). При нарушении функций печени и почек (клиренс креатинина менее 80 мл/мин) выведение замедляется.
Показания к применению
- Острый и хронический болевой синдром сильной и средней интенсивности различного генеза (злокачественные опухоли травмы тяжелая невралгия и др.);
- болезненные диагностические и терапевтические манипуляции.
Противопоказания
- гиперчуствителыюсть к любому из компонентов препарата;
- острые отравления алкоголем анальгетиками снотворными и психофармакологическими средствами;
- лечение ингибиторами МАО и в течение 14 дней после окончания этого лечения;
- детский возраст до 14 лет.
Трамадол нельзя использовать в качестве заместительной терапии при наркоманиях.
С осторожностью
- опиоидная наркомания (зависимость от опиоидов);
- нарушения сознания неясного генеза;
- нарушения дыхательного центра и дыхательных функций а также при состояниях сопровождающихся повышением внутричерепного давления если больной не находится на искусственном дыхании: заболевания головного мозга: шок:
- эпилепсия или склонность к судорожным припадкам. У больных с эпилепсией или склонных к возникновению судорожных припадков препарат применяют только в исключительных случаях:
- больные с повышенной чувствительностью к опиоидам.
Применение при беременности и в период грудного вскармливания
Трамадол проникает через плацентарный барьер. В незначительных количествах (0.1% от концентрации в плазме крови) поступает в материнское молоко. В связи с этим терапия в период беременности должна быть ограничена отдельными разовыми дозами. Длительного применения в период беременности следует избегать из-за риска развития привыкания у плода и возможности возникновения синдрома отмены в неонатальном периоде. Применение трамадола непосредственно перед или в период родов не влияет па сократительную функцию матки. В этих случаях у новорожденного можно наблюдать изменение частоты дыхательных движений которое незначимо для клинической практики. Применение трамадола в период лактации в виде разовых доз не требует прерывания кормления грудью.
Способ применения и дозы
Внутрь. Применяемые дозировки зависят от степени выраженности болевого синдрома и индивидуальной чувствительности больного. Время приема препарата не зависит от времени приема пищи.
Взрослые и подростки с 14 лет:
Разовая доза составляет 50 мг трамадола. В случае недостаточности или при отсутствии обезболивающего действия через 30-60 минут принимают 50 мг трамадола повторно. При болях сильной интенсивности разовая доза 100 мг трамадола. Обезболивающее действие обычно сохраняется в течение 4-8 часов. Максимальная суточная доза 400 мг.
Больные с нарушением функции почек и/или печени:
У больных с нарушением функции почек и/или печени затруднено выведение трамадола из организма. В случае лечения острых болевых синдромов у таких больных когда необходимо редкое или однократное назначение трамадола. специального изменения дозировок не требуется. Однако в случаях лечения хронических болей необходимо помнить об опасности кумуляции препарата в организме поэтому целесообразно увеличивать интервалы между отдельными его приемами. Препарат следует назначать с осторожностью пациентам с нарушениями функции почек (50-100 мг 2 раза в день) а также лицам с циррозом печени (у этой группы больных Т1/2 трамадола увеличивается почти в 3 раза).
Больные старческого возраста:У больных старческого возраста (старше 75 лет) замедляется выведение трамадола из организма даже когда нет клинических проявлений нарушения функции почек и/или печени. У этих больных также необходимо увеличивать интервалы между отдельными приемами препарата. Рекомендуется не превышать суточную дозу в 300 мг.
Побочное действие
Сердечно-сосудистая система: тахикардия снижение артериального давления (вплоть до ортостатического коллапса) синкопальные состояния.
Нервная система и психическая сфера: тревога нарушение координации эйфория или депрессия миоз расстройства сна повышенная нервная возбудимость нарушения когнитивных функций парестезии тремор амнезия судороги галлюцинации угнетение дыхания седация разной степени выраженности головокружение головная боль повышение мышечного тонуса.
Мочевыделительная система: затрудненное или учащенное мочеиспускание.
Прочие: кожные реакции (экзантема зуд) вплоть до анафилактического шока синдром
Стивена-Джонсона повышенная потливость диспноэ.
При длительном применении - лекарственная зависимость при резкой отмене - синдром "отмены".
С ообщалось об ухудшении течения бронхиальной астмы однако доказательных данных об отрицательном влиянии трамадола на течение астмы получено не было.
Передозировка
Симптомы: миоз или мидриаз рвота тахикардия повышение артериального давления коллапс угнетение сознания вплоть до комы угнетение дыхания (вплоть до апноэ). Лечение: при приеме внутрь в первую очередь необходимо обеспечить освобождение желудка от еще не всосавшегося препарата (искусственная рвота промывание желудка). Основными неотложными мероприятиями в более тяжелых случаях являются обеспечение проходимости дыхательных путей (интубация) поддержание дыхания и сердечно-сосудистой системы.
Антидотом при угнетении дыхательного центра является налоксон который вводят повторными дозами т.к. продолжительность его действия короче чем действие трамадола. Для купирования судорожного синдрома применяются бензодиазепины.
Взаимодействие с другими лекарственными средствами
При одновременном применении трамадола и:
- лекарственных средств угнетающих центральную нервную систему особенно антидепрессантов а также алкоголя усиливаются побочные действия трамадола в отношении центральной нервной системы;
- лекарственных средств способных провоцировать судорожные припадки или усиливать судорожную готовность (например нейролептики и антидепрессанты) в очень редких случаях можно наблюдать эпилептические припадки. Риск возникновения судорожных припадков увеличивается при применении высоких доз трамадола - свыше 400 мг в сутки;
- карбамазепина уменьшается и сокращается анальгезирующий эффект трамадола;
- барбитуратов и транквилизаторов возможно усиление и увеличение продолжительности анальгезирующего и седативного действия трамадола.
Длительное применение опиоидных анальгетиков или барбитуратов стимулирует развитие перекрестной толерантности.
Особые указания
Рекомендуемые дозы являются ориентировочными. На практике необходимо выбирать минимальные анальгетически эффективные дозы.
Продолжительность лечения препаратом определяется индивидуально. Нельзя применять дольше срока оправданного с терапевтической точки зрения. При лечении длительно сохраняющегося болевого синдрома целесообразно делать краткосрочные паузы в применении трамадола с тем чтобы вновь определить необходимую терапевтическую дозу. В период лечения необходимо исключить прием алкоголя и воздерживаться от занятий потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Таблетки 50 мг и 100 мг.
Условия хранения
Относится к списку 1 сильнодействующих веществ.
В сухом защищенном от света месте при температуре не выше 25°С. в местах недоступных для детей.
Срок годности
3 года. Не использовать по истечении срока годности указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Общество с ограниченной ответственностью "ПРАНАФАРМ" (ООО "ПРАНАФАРМ"), 443068, г. Самара, ул. Ново-Садовая, д. 106, корп. 81, Россия
Организация, принимающая претензии потребителей
ООО "ПРАНАФАРМ"
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Относится к анальгетикам центрального действия. Обладает слабым аффинитетом к опиатным рецепторам без преимущественной избирательности к отдельным популяциям рецепторов. Обладает обезболивающим противокашлевым и седативным эффектами. Активность трамадола составляет 1/10 - 1/6 часть активности морфина. В отличие от морфина трамадол в терапевтических дозах не угнетает дыхание не подавляет моторику желудочно-кишечного тракта и не влияет на сердечно-сосудистую деятельность."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"При приеме внутрь быстро всасывается терапевтическое действие наступает через 15-30 минут. Терапевтическое действие сохраняется в течение 4-8 часов. Максимальная концентрация в плазме крови после приема внутрь наблюдается через 15-2 часа. Связывание с белками плазмы крови около 20%. Проникает через плацентарный барьер (концентрация в крови пупочной вены составляет 80% от концентрации в крови матери).Биотрансформация осуществляется в печени путем деметилирования и конъюгации с образованием 11 метаболитов (1 из них - активный). Выводится преимущественно почками (90%) и кишечником (около 10%). При нарушении функций печени и почек (клиренс креатинина менее 80 мл/мин) выведение замедляется."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"- Острый и хронический болевой синдром сильной и средней интенсивности различного генеза (злокачественные опухоли травмы тяжелая невралгия и др.);"}},{"type":"paragraph","data":{"text":"- болезненные диагностические и терапевтические манипуляции."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- гиперчуствителыюсть к любому из компонентов препарата;"}},{"type":"paragraph","data":{"text":"- острые отравления алкоголем анальгетиками снотворными и психофармакологическими средствами;"}},{"type":"paragraph","data":{"text":"- лечение ингибиторами МАО и в течение 14 дней после окончания этого лечения;"}},{"type":"paragraph","data":{"text":"- детский возраст до 14 лет."}},{"type":"paragraph","data":{"text":"Трамадол нельзя использовать в качестве заместительной терапии при наркоманиях."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"- опиоидная наркомания (зависимость от опиоидов);"}},{"type":"paragraph","data":{"text":"- нарушения сознания неясного генеза;"}},{"type":"paragraph","data":{"text":"- нарушения дыхательного центра и дыхательных функций а также при состояниях сопровождающихся повышением внутричерепного давления если больной не находится на искусственном дыхании: заболевания головного мозга: шок:"}},{"type":"paragraph","data":{"text":"- эпилепсия или склонность к судорожным припадкам. У больных с эпилепсией или склонных к возникновению судорожных припадков препарат применяют только в исключительных случаях:"}},{"type":"paragraph","data":{"text":"- больные с повышенной чувствительностью к опиоидам."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Трамадол проникает через плацентарный барьер. В незначительных количествах (0.1% от концентрации в плазме крови) поступает в материнское молоко. В связи с этим терапия в период беременности должна быть ограничена отдельными разовыми дозами. Длительного применения в период беременности следует избегать из-за риска развития привыкания у плода и возможности возникновения синдрома отмены в неонатальном периоде. Применение трамадола непосредственно перед или в период родов не влияет па сократительную функцию матки. В этих случаях у новорожденного можно наблюдать изменение частоты дыхательных движений которое незначимо для клинической практики. Применение трамадола в период лактации в виде разовых доз не требует прерывания кормления грудью."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь. Применяемые дозировки зависят от степени выраженности болевого синдрома и индивидуальной чувствительности больного. Время приема препарата не зависит от времени приема пищи."}},{"type":"paragraph","data":{"text":"Взрослые и подростки с 14 лет:"}},{"type":"paragraph","data":{"text":"Разовая доза составляет 50 мг трамадола. В случае недостаточности или при отсутствии обезболивающего действия через 30-60 минут принимают 50 мг трамадола повторно. При болях сильной интенсивности разовая доза 100 мг трамадола. Обезболивающее действие обычно сохраняется в течение 4-8 часов. Максимальная суточная доза 400 мг."}},{"type":"paragraph","data":{"text":"Больные с нарушением функции почек и/или печени:"}},{"type":"paragraph","data":{"text":"У больных с нарушением функции почек и/или печени затруднено выведение трамадола из организма. В случае лечения острых болевых синдромов у таких больных когда необходимо редкое или однократное назначение трамадола. специального изменения дозировок не требуется. Однако в случаях лечения хронических болей необходимо помнить об опасности кумуляции препарата в организме поэтому целесообразно увеличивать интервалы между отдельными его приемами. Препарат следует назначать с осторожностью пациентам с нарушениями функции почек (50-100 мг 2 раза в день) а также лицам с циррозом печени (у этой группы больных Т1/2 трамадола увеличивается почти в 3 раза)."}},{"type":"paragraph","data":{"text":"Больные старческого возраста:У больных старческого возраста (старше 75 лет) замедляется выведение трамадола из организма даже когда нет клинических проявлений нарушения функции почек и/или печени. У этих больных также необходимо увеличивать интервалы между отдельными приемами препарата. Рекомендуется не превышать суточную дозу в 300 мг."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Сердечно-сосудистая система: тахикардия снижение артериального давления (вплоть до ортостатического коллапса) синкопальные состояния."}},{"type":"paragraph","data":{"text":"Желудочно-кишечного тракта: тошнота рвота сухость во рту абдоминальная боль анорексия. метеоризм запор."}},{"type":"paragraph","data":{"text":"Нервная система и психическая сфера: тревога нарушение координации эйфория или депрессия миоз расстройства сна повышенная нервная возбудимость нарушения когнитивных функций парестезии тремор амнезия судороги галлюцинации угнетение дыхания седация разной степени выраженности головокружение головная боль повышение мышечного тонуса."}},{"type":"paragraph","data":{"text":"Мочевыделительная система: затрудненное или учащенное мочеиспускание."}},{"type":"paragraph","data":{"text":"Прочие: кожные реакции (экзантема зуд) вплоть до анафилактического шока синдром"}},{"type":"paragraph","data":{"text":"Стивена-Джонсона повышенная потливость диспноэ."}},{"type":"paragraph","data":{"text":"При длительном применении - лекарственная зависимость при резкой отмене - синдром \"отмены\"."}},{"type":"paragraph","data":{"text":"С ообщалось об ухудшении течения бронхиальной астмы однако доказательных данных об отрицательном влиянии трамадола на течение астмы получено не было."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: миоз или мидриаз рвота тахикардия повышение артериального давления коллапс угнетение сознания вплоть до комы угнетение дыхания (вплоть до апноэ). Лечение: при приеме внутрь в первую очередь необходимо обеспечить освобождение желудка от еще не всосавшегося препарата (искусственная рвота промывание желудка). Основными неотложными мероприятиями в более тяжелых случаях являются обеспечение проходимости дыхательных путей (интубация) поддержание дыхания и сердечно-сосудистой системы."}},{"type":"paragraph","data":{"text":"Антидотом при угнетении дыхательного центра является налоксон который вводят повторными дозами т.к. продолжительность его действия короче чем действие трамадола. Для купирования судорожного синдрома применяются бензодиазепины."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении трамадола и:"}},{"type":"paragraph","data":{"text":"- лекарственных средств угнетающих центральную нервную систему особенно антидепрессантов а также алкоголя усиливаются побочные действия трамадола в отношении центральной нервной системы;"}},{"type":"paragraph","data":{"text":"- лекарственных средств способных провоцировать судорожные припадки или усиливать судорожную готовность (например нейролептики и антидепрессанты) в очень редких случаях можно наблюдать эпилептические припадки. Риск возникновения судорожных припадков увеличивается при применении высоких доз трамадола - свыше 400 мг в сутки;"}},{"type":"paragraph","data":{"text":"- карбамазепина уменьшается и сокращается анальгезирующий эффект трамадола;"}},{"type":"paragraph","data":{"text":"- хинидин повышает плазменную концентрацию трамадола;"}},{"type":"paragraph","data":{"text":"- барбитуратов и транквилизаторов возможно усиление и увеличение продолжительности анальгезирующего и седативного действия трамадола."}},{"type":"paragraph","data":{"text":"Длительное применение опиоидных анальгетиков или барбитуратов стимулирует развитие перекрестной толерантности."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Рекомендуемые дозы являются ориентировочными. На практике необходимо выбирать минимальные анальгетически эффективные дозы."}},{"type":"paragraph","data":{"text":"Продолжительность лечения препаратом определяется индивидуально. 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