Анестезия при хирургических вмешательствах: эпидуральная блокада при хирургических вмешательствах, включая кесарево сечение; блокада крупных нервов и нервных сплетений; блокада отдельных нервов и местная инфильтрационная анестезия.
Купирование острого болевого синдрома: длительная эпидуральная инфузия или периодическое болюсное введение, например, для ...
Детский возраст до 12 лет, повышенная чувствительность к местным анестетикам амидного типа.
Инструкция
Торговое название препарата
Ропивакаин Велфарм
Лекарственная форма
Раствор для инъекций.
Состав
1 мл:
ропивакаина гидрохлорид 7.5 мг.
Вспомогательные вещества: натрия хлорид - 7.5 мг, натрия гидроксида раствор 2 М - для доведения pH 4.0-6.0, хлористоводородной кислоты раствор 2 М - для доведения pH до 4.0-6.0, вода д/и - до 1 мл.
Описание
Местноанестезирующее средство.
Фармакотерапевтическая группа
Местный анестетик амидного типа. Вызывает анестезию и оказывает анальгезирующее действие. В высоких дозах вызывает хирургическую анестезию, в более низких дозах - блокаду чувствительности с ограниченной непрогрессирующей двигательной блокадой.
Механизм действия связан с обратимым уменьшением проницаемости мембраны нервного волокна для ионов натрия. Вследствие этого происходит уменьшение скорости деполяризации и увеличение порога возбудимости, что приводит к местной блокаде нервных импульсов.
При значительно повышенной дозе оказывает угнетающее действие на ЦНС и миокард (снижает возбудимость и автоматизм, ухудшает проводимость). Ропивакаин характеризуется длительным действием. Продолжительность анестезии зависит от дозы и пути введения, но не зависит от присутствия вазоконстриктора.
Фармакологические свойства
После эпидурального введения ропивакаин полностью абсорбируется из эпидурального пространства. Абсорбция носит двухфазный характер. Концентрация ропивакаина в плазме крови зависит от дозы, пути введения и васкуляризации области инъекции.
Фармакокинетика ропивакаина линейная, Cmax в плазме крови пропорциональна дозе.
Vd ропивакаина составляет 47 л. Связывание в плазме крови происходит в основном с α1-кислыми гликопротеинами, несвязанная фракция составляет около 6%.
Длительное эпидуральное введение ропивакаина приводит к повышению общего содержания ропивакаина в плазме крови, что обусловлено послеоперационным увеличением уровня α1-кислых гликопротеинов в крови. При этом концентрация несвязанного, фармакологически активного ропивакаина меняется в гораздо меньшей степени, чем его общая концентрация в плазме крови.
Активно метаболизируется в организме, главным образом путем гидроксилирования. Основной метаболит - 3-гидрокси-ропивакаин.
T1/2 в начальной и терминальной фазах составляет, соответственно, 14 мин и 4 ч. Общий плазменный клиренс - 440 мл/мин. После в/в введения около 86% дозы выводится с мочой, главным образом в виде метаболитов, и только около 1% дозы выводится с мочой в неизмененном виде. Около 37% 3-гидрокси-ропивакаина выводится с мочой в основном в виде конъюгатов.
Показания к применению
Анестезия при хирургических вмешательствах: эпидуральная блокада при хирургических вмешательствах, включая кесарево сечение; блокада крупных нервов и нервных сплетений; блокада отдельных нервов и местная инфильтрационная анестезия.
Купирование острого болевого синдрома: длительная эпидуральная инфузия или периодическое болюсное введение, например, для устранения послеоперационной боли или обезболивания родов; блокада отдельных нервов и местная инфильтрационная анестезия.
Противопоказания
Детский возраст до 12 лет, повышенная чувствительность к местным анестетикам амидного типа.
Применение при беременности и в период грудного вскармливания
Применение при беременности возможно в случаях, когда потенциальная польза терапии матери превышает существующий риск для плода. Имеются данные об отсутствии отрицательных эффектов при применении ропивакаина в акушерстве для анестезии или анальгезии. Ропивакаин хорошо проникает через плацентарный барьер. Связывание с белками плазмы крови у плода ниже, чем у матери.
При необходимости применения в период лактации следует учитывать, что ропивакаин в небольшом количестве выделяется с грудным молоком.
Способ применения и дозы
Дозу устанавливают индивидуально в зависимости от показаний, клинической ситуации, состояния пациента.
Большинство побочных эффектов, возникающих при анестезии, связаны не с воздействием используемого анестетика, а с техникой проведения регионарной анестезии. Наиболее часто (более 1%) отмечались следующие неблагоприятные эффекты, которые были расценены как имеющие клиническое значение вне зависимости от того, была ли установлена причинно-следственная связь с применением анестетика.
Со стороны сердечно-сосудистой системы: артериальная гипертензия, артериальная гипотензия, брадикардия, тахикардия.
Со стороны пищеварительной системы: тошнота, рвота.
Со стороны ЦНС и периферической нервной системы: головная боль, головокружение, парестезии.
Невропатия и нарушения функции спинного мозга (синдром передней спинальной артерии, арахноидит) обычно связаны с техникой проведения регионарной анестезии, а не с действием ропивакаина.
Прочие: повышение температуры тела, озноб, задержка мочеиспускания.
Взаимодействие с другими лекарственными средствами
При одновременном применении ропивакаина с другими местными анестетиками или препаратами, структурно схожими с местными анестетиками амидного типа, возможна суммация эффектов.
Особые указания
Процедуру регионарной анестезии должен проводить опытный специалист при наличии оборудования и лекарственных препаратов для проведения реанимационных мероприятий. До начала выполнения больших блокад должны быть установлены в/в катетеры.
С осторожностью следует вводить ропивакаин пациентам с тяжелыми сопутствующими заболеваниями (в т.ч. с частичной или полной блокадой сердца, прогрессирующим циррозом печени, значительным нарушением функции почек). Для снижения риска развития тяжелых побочных эффектов необходимо предварительное лечение сопутствующих заболеваний перед проведением больших блокад, а также коррекция используемой дозы анестетика. У больных с тяжелыми заболеваниями печени из-за нарушения элиминации может возникнуть необходимость уменьшения дозы ропивакаина при повторных введениях. Обычно у больных с нарушениями функции почек при однократном введении или при кратковременной инфузии не требуется коррекции доз. Однако при хронической почечной недостаточности часто наблюдаются ацидоз и гипопротеинемия, что повышает риск системного токсического действия ропивакаина. В таких случаях дозы ропивакаина следует уменьшить.
При случайном внутрисосудистом введении ропивакаина возможно развитие симптомов интоксикации, проявляющихся немедленно или в отсроченный период.
Влияние на способность к вождению автотранспорта и управлению механизмами
Применение ропивакаина может приводить к временному нарушению двигательных функций, координации движений и скорости психомоторных реакций.
Период времени, через который можно заниматься потенциально опасными видами деятельности, требующими повышенного внимания, устанавливают индивидуально.
Форма выпуска
Раствор для инъекций прозрачный, бесцветный.
Условия отпуска
По рецепту.
Производитель
Велфарм
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При этом концентрация несвязанного, фармакологически активного ропивакаина меняется в гораздо меньшей степени, чем его общая концентрация в плазме крови."}},{"type":"paragraph","data":{"text":"Активно метаболизируется в организме, главным образом путем гидроксилирования. Основной метаболит - 3-гидрокси-ропивакаин."}},{"type":"paragraph","data":{"text":"T1/2 в начальной и терминальной фазах составляет, соответственно, 14 мин и 4 ч. Общий плазменный клиренс - 440 мл/мин. После в/в введения около 86% дозы выводится с мочой, главным образом в виде метаболитов, и только около 1% дозы выводится с мочой в неизмененном виде. 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Имеются данные об отсутствии отрицательных эффектов при применении ропивакаина в акушерстве для анестезии или анальгезии. Ропивакаин хорошо проникает через плацентарный барьер. Связывание с белками плазмы крови у плода ниже, чем у матери."}},{"type":"paragraph","data":{"text":"При необходимости применения в период лактации следует учитывать, что ропивакаин в небольшом количестве выделяется с грудным молоком."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Дозу устанавливают индивидуально в зависимости от показаний, клинической ситуации, состояния пациента."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Аллергические реакции: кожные проявления, анафилактический шок."}},{"type":"paragraph","data":{"text":"Большинство побочных эффектов, возникающих при анестезии, связаны не с воздействием используемого анестетика, а с техникой проведения регионарной анестезии. Наиболее часто (более 1%) отмечались следующие неблагоприятные эффекты, которые были расценены как имеющие клиническое значение вне зависимости от того, была ли установлена причинно-следственная связь с применением анестетика."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: артериальная гипертензия, артериальная гипотензия, брадикардия, тахикардия."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: тошнота, рвота."}},{"type":"paragraph","data":{"text":"Со стороны ЦНС и периферической нервной системы: головная боль, головокружение, парестезии."}},{"type":"paragraph","data":{"text":"Невропатия и нарушения функции спинного мозга (синдром передней спинальной артерии, арахноидит) обычно связаны с техникой проведения регионарной анестезии, а не с действием ропивакаина."}},{"type":"paragraph","data":{"text":"Прочие: повышение температуры тела, озноб, задержка мочеиспускания."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении ропивакаина с другими местными анестетиками или препаратами, структурно схожими с местными анестетиками амидного типа, возможна суммация эффектов."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Процедуру регионарной анестезии должен проводить опытный специалист при наличии оборудования и лекарственных препаратов для проведения реанимационных мероприятий. До начала выполнения больших блокад должны быть установлены в/в катетеры."}},{"type":"paragraph","data":{"text":"С осторожностью следует вводить ропивакаин пациентам с тяжелыми сопутствующими заболеваниями (в т.ч. с частичной или полной блокадой сердца, прогрессирующим циррозом печени, значительным нарушением функции почек). Для снижения риска развития тяжелых побочных эффектов необходимо предварительное лечение сопутствующих заболеваний перед проведением больших блокад, а также коррекция используемой дозы анестетика. У больных с тяжелыми заболеваниями печени из-за нарушения элиминации может возникнуть необходимость уменьшения дозы ропивакаина при повторных введениях. Обычно у больных с нарушениями функции почек при однократном введении или при кратковременной инфузии не требуется коррекции доз. Однако при хронической почечной недостаточности часто наблюдаются ацидоз и гипопротеинемия, что повышает риск системного токсического действия ропивакаина. В таких случаях дозы ропивакаина следует уменьшить."}},{"type":"paragraph","data":{"text":"При случайном внутрисосудистом введении ропивакаина возможно развитие симптомов интоксикации, проявляющихся немедленно или в отсроченный период."}},{"type":"paragraph","data":{"text":"Влияние на способность к вождению автотранспорта и управлению механизмами"}},{"type":"paragraph","data":{"text":"Применение ропивакаина может приводить к временному нарушению двигательных функций, координации движений и скорости психомоторных реакций."}},{"type":"paragraph","data":{"text":"Период времени, через который можно заниматься потенциально опасными видами деятельности, требующими повышенного внимания, устанавливают индивидуально."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для инъекций прозрачный, бесцветный."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По 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