Хирургическая анестезия у взрослых и детей старше 12 лет; инфильтрационная анестезия, когда требуется достижение длительного анестезирующего эффекта, например, при послеоперационной боли; проводниковая анестезия с продолжительным эффектом или эпидуральная анестезия в случаях, при которых добавление эпинефрина противопоказано, и значительное расслабление ...
Гиперчувствительность к бупивакаину или к другим местным анестетикам амидного типа; состояния, при которых противопоказано проведение эпидуральной анестезии: текущие заболевания ЦНС, такие как менингит, полиомиелит, внутричерепное кровоизлияние, а также новообразования ЦНС; туберкулез позвоночника; пернициозная анемия с подострой комбинированной дегенерацией спинного мозга; гнойничковое поражение кожи в месте предполагаемой пункции или граничащее с местом пункции; кардиогенный или гиповолемический шок; нарушение свертываемости крови или сопутствующая антикоагулянтная терапия; детский возраст до 12 лет.
Бупивакаина гидрохлорид (в форме бупивакаина гидрохлорида моногидрата).
Вспомогательные вещества: метилпарагидроксибензоат - 1 мг, натрия хлорид - 8 мг, 0.1 М раствор натрия гидроксида и/или 0.1 М раствор хлористоводородной кислоты - до доведения pH, вода д/и - до 1 мл.
Описание
Местноанастезирующее средство.
Фармакотерапевтическая группа
Местный анестетик длительного действия амидного типа, в 4 раза сильнее лидокаина. Обратимо блокирует проведение импульса по нервному волокну за счет влияния на натриевые каналы. Может оказывать аналогичный эффект в головном мозге и миокарде.
Оказывает гипотензивное действие, замедляет ЧСС. Послеоперационная анальгезия поддерживается в течение 7-14 ч при межреберной блокаде. После однократной эпидуральной инъекции длительность эффекта при использовании концентрации 5 мг/мл составляет от 2 до 5 ч, и до 12 ч – при периферической блокаде нерва.
Использование растворов в концентрации 2,5 мг/мл оказывает меньший эффект на двигательные нервы.
Фармакологические свойства
Системная абсорбция бупивакаина зависит от дозы, метода его введения и васкуляризации области введения.
Анестезирующее действие наступает быстро; по сравнению с другими местноанестезирующими средствами анестезирующее действие бупивакаина значительно длиннее. Отмечено, что после возвращения чувствительности еще некоторое время сохраняется болеутоляющий эффект, что дает возможность уменьшать дозы анальгетиков. Бупивакаин полностью абсорбируется из эпидурального пространства; абсорбция носит двухфазный характер. TCmax в плазме крови при проведении каудальной эпидуральной и проводниковой анестезии – 30-45 мин, с последующим снижением до незначительного уровня в течение 3-6 ч. Общий плазменный клиренс бупивакаина составляет 580 мл/мин, Vd – 73 л. Конечный T1/2 – 2,7 ч.
Бупивакаин подвергается метаболизму в печени, главным образом, путем конъюгации с глюкуроновой кислотой.
Бупивакаин выводится главным образом почками, только 6% выводится в неизмененном виде с мочой.
Бупивакаин проникает через плаценту путем пассивной диффузии. Связь с белками плазмы в организме плода ниже, чем в организме матери, концентрация несвязанной фракции в организме плода и матери одинакова. Секретируется с молоком матери.
Фармакокинетические параметры могут быть значительно изменены факторами, влияющими на уровень pH мочи и почечный кровоток, в зависимости от пути введения бупивакаина и возраста пациента, а также у пациентов с заболеваниями печени и почек.
Показания к применению
Хирургическая анестезия у взрослых и детей старше 12 лет; инфильтрационная анестезия, когда требуется достижение длительного анестезирующего эффекта, например, при послеоперационной боли; проводниковая анестезия с продолжительным эффектом или эпидуральная анестезия в случаях, при которых добавление эпинефрина противопоказано, и значительное расслабление мышц не требуется; анестезия в акушерстве.
Противопоказания
Гиперчувствительность к бупивакаину или к другим местным анестетикам амидного типа; состояния, при которых противопоказано проведение эпидуральной анестезии: текущие заболевания ЦНС, такие как менингит, полиомиелит, внутричерепное кровоизлияние, а также новообразования ЦНС; туберкулез позвоночника; пернициозная анемия с подострой комбинированной дегенерацией спинного мозга; гнойничковое поражение кожи в месте предполагаемой пункции или граничащее с местом пункции; кардиогенный или гиповолемический шок; нарушение свертываемости крови или сопутствующая антикоагулянтная терапия; детский возраст до 12 лет.
Бупивакаин не используется для проведения в/в регионарной анестезии (блокада по Биру).
С осторожностью
Пожилой возраст; ослабленные пациенты; AV блокада II и III степени; нарушение функции печени и почек тяжелой степени; беременность; совместное применение с антиаритмическими средствами III класса (например, амиодарон); совместное применение с другими местными анестетиками или препаратами, имеющими структурное сходство с местными анестетиками амидного типа, такими как антиаритмические препараты lb класса (например, лидокаин, мексилетин); парацервикальная блокада.
Применение при беременности и в период грудного вскармливания
Применение при беременности возможно только в тех случаях, когда ожидаемая польза для матери превышает потенциальный риск для плода. Проведение парацервикальной блокады противопоказано.
При необходимости применения бупивакаина в период лактации следует прекратить грудное вскармливание.
Способ применения и дозы
Индивидуально, в зависимости от показаний и возраста.
Бупивакаин должен применяться только врачами, имеющими опыт проведения местной анестезии или под их наблюдением. Следует использовать минимальную дозу, позволяющую достигнуть адекватной анестезии.
Побочное действие
Со стороны ЦНС и периферической нервной системы: онемение языка, головокружение, нечеткость зрения, мышечный тремор, сонливость, судороги, потеря сознания, нейропатия, повреждение периферических нервов, арахноидит, парез, параплегия. В области анестезии возможны парестезии, ослабление тонуса сфинктеров.
Со стороны сердечно-сосудистой системы: уменьшение сердечного выброса, блокады сердца, артериальная гипотензия, брадикардия, желудочковые аритмии, остановка сердца, аритмия.
Со стороны пищеварительной системы: тошнота, рвота.
Со стороны мочевыводящей системы: задержка мочи.
Со стороны дыхательной системы: апноэ.
Со стороны органа зрения: диплопия.
Аллергические реакции: кожные проявления, в тяжелых случаях - анафилактический шок.
Взаимодействие с другими лекарственными средствами
При одновременном применении с антиаритмическими препаратами, обладающими местноанестезирующей активностью, повышается риск аддитивного токсического действия.
При одновременном применении с барбитуратами возможно уменьшение концентрации бупивакаина в крови.
Особые указания
Определенные виды блокад могут быть связаны с серьезными неблагоприятными реакциями.
Эпидуральная анестезия может сопровождаться угнетением сердечно-сосудистой системы, особенно на фоне гиповолемии. Поэтому следует соблюдать осторожность у пациентов с нарушением функции сердечно-сосудистой системы.
В редких случаях при ретробульбарном введении возможно проникновение бупивакаина в краниальное субарахноидальное пространство, при этом возникает временная слепота, сердечно-сосудистый коллапс, апноэ и судороги. Эти симптомы требуют незамедлительного лечения.
При ретробульбарном и перибульбарном введении местных анестетиков существует небольшой риск возникновения стойкого нарушения функции нарушения глазных мышц.
Основными причинами является травма и/или местное токсическое действие введенного бупивакаина на мышцы и/или нервы.
Случайное внутрисосудистое введение местных анестетиков в области головы и шеи даже в низких дозах может вызывать симптомы токсичности со стороны со стороны ЦНС.
Парацервикальная блокада иногда приводит к брадикардии/тахикардии у плода, поэтому следует тщательно мониторировать сердечный ритм у плода.
Следует соблюдать осторожность у пациентов с атриовентрикулярной блокадой II или III стадии, поскольку местные анестетики могут снижать проводимость миокарда. Следует соблюдать осторожность у пациентов с нарушением функции печени или почек тяжелой степени, пожилых или ослабленных пациентов.
Пациенты, получающие антиаритмические препараты III класса (например, амиодарон), должны находиться под тщательным наблюдением с контролем ЭКГ с учетом риска развития осложнений со стороны сердечно-сосудистой системы из-за возможного аддитивного эффекта.
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ампулы, 5 шт, 4 мл, 5 мг/мл, для инъекций, для взрослых","short":"Раствор, 5 шт, 4 мл, 5 мг/мл","package":"5 шт, 4 мл, 5 мг/мл"},"prescription":true,"catalog_section_id":72,"manufacturer":{"id":3370,"title":"Велфарм","slug":"velfarm_3370","logo":{"isTouch":{"retina":null,"default":null},"isFromTablet":{"retina":null,"default":null}}},"is_advert":false,"product_form":"Раствор","slug":"92613-bupivakain","attributes":{"count":"5 шт","dose":"5 мг/мл","volume":"4 мл","spf":"","size":""},"image":{"isTouch":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/60574/phoneMedium_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/60574/phoneMedium_default/"},"isFromTablet":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/60574/tabletLarge_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/60574/tabletLarge_default/"}},"image_thumb":{"isTouch":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/60574/previewTouch_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/60574/previewTouch_default/"},"isFromTablet":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/60574/previewDesktopMedium_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/60574/previewDesktopMedium_default/"}},"available":false,"price":{"min":null,"max":null},"counters":null,"description":{"data":[{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Бупивакаин"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для инъекций. "}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"Бупивакаина гидрохлорид (в форме бупивакаина гидрохлорида моногидрата)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВспомогательные вещества\u003c/i\u003e: метилпарагидроксибензоат - 1 мг, натрия хлорид - 8 мг, 0.1 М раствор натрия гидроксида и/или 0.1 М раствор хлористоводородной кислоты - до доведения pH, вода д/и - до 1 мл."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Местноанастезирующее средство."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nМестный анестетик длительного действия амидного типа, в 4 раза сильнее лидокаина. Обратимо блокирует проведение импульса по нервному волокну за счет влияния на натриевые каналы. Может оказывать аналогичный эффект в головном мозге и миокарде."}},{"type":"paragraph","data":{"text":"Оказывает гипотензивное действие, замедляет ЧСС. Послеоперационная анальгезия поддерживается в течение 7-14 ч при межреберной блокаде. После однократной эпидуральной инъекции длительность эффекта при использовании концентрации 5 мг/мл составляет от 2 до 5 ч, и до 12 ч – при периферической блокаде нерва."}},{"type":"paragraph","data":{"text":"Использование растворов в концентрации 2,5 мг/мл оказывает меньший эффект на двигательные нервы.\n\n"}}]},{"id":7,"name":"Фармакологические свойства","slug":"","body":[{"type":"paragraph","data":{"text":"Системная абсорбция бупивакаина зависит от дозы, метода его введения и васкуляризации области введения."}},{"type":"paragraph","data":{"text":"Анестезирующее действие наступает быстро; по сравнению с другими местноанестезирующими средствами анестезирующее действие бупивакаина значительно длиннее. Отмечено, что после возвращения чувствительности еще некоторое время сохраняется болеутоляющий эффект, что дает возможность уменьшать дозы анальгетиков. Бупивакаин полностью абсорбируется из эпидурального пространства; абсорбция носит двухфазный характер. T\u003csub\u003eCmax\u003c/sub\u003e в плазме крови при проведении каудальной эпидуральной и проводниковой анестезии – 30-45 мин, с последующим снижением до незначительного уровня в течение 3-6 ч. Общий плазменный клиренс бупивакаина составляет 580 мл/мин, V\u003csub\u003ed\u003c/sub\u003e – 73 л. Конечный T\u003csub\u003e1/2\u003c/sub\u003e – 2,7 ч."}},{"type":"paragraph","data":{"text":"Бупивакаин подвергается метаболизму в печени, главным образом, путем конъюгации с глюкуроновой кислотой."}},{"type":"paragraph","data":{"text":"Бупивакаин выводится главным образом почками, только 6% выводится в неизмененном виде с мочой."}},{"type":"paragraph","data":{"text":"Бупивакаин проникает через плаценту путем пассивной диффузии. Связь с белками плазмы в организме плода ниже, чем в организме матери, концентрация несвязанной фракции в организме плода и матери одинакова. Секретируется с молоком матери."}},{"type":"paragraph","data":{"text":"Фармакокинетические параметры могут быть значительно изменены факторами, влияющими на уровень \u003ca href=\"https://yandex.ru/turbo?text=https%3a%2f%2fhealth.yandex.ru%2fprocedures%2fanalysis%2foam%2furina-ph\"\u003epH мочи\u003c/a\u003e и почечный кровоток, в зависимости от пути введения бупивакаина и возраста пациента, а также у пациентов с заболеваниями печени и почек."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Хирургическая анестезия у взрослых и детей старше 12 лет; инфильтрационная анестезия, когда требуется достижение длительного анестезирующего эффекта, например, при послеоперационной боли; проводниковая анестезия с продолжительным эффектом или эпидуральная анестезия в случаях, при которых добавление эпинефрина противопоказано, и значительное расслабление мышц не требуется; анестезия в акушерстве."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к бупивакаину или к другим местным анестетикам амидного типа; состояния, при которых противопоказано проведение эпидуральной анестезии: текущие заболевания ЦНС, такие как \u003ca href=\"https://yandex.ru/turbo?text=https%3a%2f%2fhealth.yandex.ru%2fdiseases%2fnerves%2fmeningitis\"\u003eменингит\u003c/a\u003e, \u003ca href=\"https://yandex.ru/turbo?text=https%3a%2f%2fhealth.yandex.ru%2fdiseases%2finfec%2fpoliomielit\"\u003eполиомиелит\u003c/a\u003e, внутричерепное кровоизлияние, а также новообразования ЦНС; туберкулез позвоночника; пернициозная \u003ca href=\"https://yandex.ru/turbo?text=https%3a%2f%2fhealth.yandex.ru%2fdiseases%2fblood%2fanemia\"\u003eанемия\u003c/a\u003e с подострой комбинированной дегенерацией спинного мозга; гнойничковое поражение кожи в месте предполагаемой пункции или граничащее с местом пункции; кардиогенный или гиповолемический шок; нарушение свертываемости крови или сопутствующая антикоагулянтная терапия; детский возраст до 12 лет."}},{"type":"paragraph","data":{"text":"Бупивакаин не используется для проведения в/в регионарной анестезии (блокада по Биру)."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Пожилой возраст; ослабленные пациенты; AV блокада II и III степени; нарушение функции печени и почек тяжелой степени; беременность; совместное применение с антиаритмическими средствами III класса (например, амиодарон); совместное применение с другими местными анестетиками или препаратами, имеющими структурное сходство с местными анестетиками амидного типа, такими как антиаритмические препараты lb класса (например, лидокаин, мексилетин); парацервикальная блокада."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Применение при беременности возможно только в тех случаях, когда ожидаемая польза для матери превышает потенциальный риск для плода. Проведение парацервикальной блокады противопоказано."}},{"type":"paragraph","data":{"text":"При необходимости применения бупивакаина в период лактации следует прекратить грудное вскармливание."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Индивидуально, в зависимости от показаний и возраста."}},{"type":"paragraph","data":{"text":"Бупивакаин должен применяться только врачами, имеющими опыт проведения местной анестезии или под их наблюдением. Следует использовать минимальную дозу, позволяющую достигнуть адекватной анестезии."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны ЦНС и периферической нервной системы:\u003c/i\u003e онемение языка, головокружение, нечеткость зрения, мышечный тремор, сонливость, судороги, потеря сознания, нейропатия, повреждение периферических нервов, арахноидит, парез, параплегия. В области анестезии возможны парестезии, ослабление тонуса сфинктеров."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e уменьшение сердечного выброса, блокады сердца, артериальная гипотензия, брадикардия, желудочковые \u003ca href=\"https://yandex.ru/turbo?text=https%3a%2f%2fhealth.yandex.ru%2fdiseases%2fvasorum%2faritmia\"\u003eаритмии\u003c/a\u003e, остановка сердца, \u003ca href=\"https://yandex.ru/turbo?text=https%3a%2f%2fhealth.yandex.ru%2fdiseases%2fvasorum%2faritmia\"\u003eаритмия\u003c/a\u003e."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы:\u003c/i\u003e тошнота, рвота."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны мочевыводящей системы: \u003c/i\u003eзадержка мочи."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны дыхательной системы:\u003c/i\u003e апноэ."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны органа зрения: \u003c/i\u003eдиплопия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e кожные проявления, в тяжелых случаях - \u003ca href=\"https://yandex.ru/turbo?text=https%3a%2f%2fhealth.yandex.ru%2fdiseases%2fcutis%2fanaf-shock\"\u003eанафилактический шок\u003c/a\u003e."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении с антиаритмическими препаратами, обладающими местноанестезирующей активностью, повышается риск аддитивного токсического действия."}},{"type":"paragraph","data":{"text":"При одновременном применении с барбитуратами возможно уменьшение концентрации бупивакаина в крови."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Определенные виды блокад могут быть связаны с серьезными неблагоприятными реакциями."}},{"type":"paragraph","data":{"text":"Эпидуральная анестезия может сопровождаться угнетением сердечно-сосудистой системы, особенно на фоне гиповолемии. Поэтому следует соблюдать осторожность у пациентов с нарушением функции сердечно-сосудистой системы."}},{"type":"paragraph","data":{"text":"В редких случаях при ретробульбарном введении возможно проникновение бупивакаина в краниальное субарахноидальное пространство, при этом возникает временная слепота, сердечно-сосудистый коллапс, апноэ и судороги. Эти симптомы требуют незамедлительного лечения."}},{"type":"paragraph","data":{"text":"При ретробульбарном и перибульбарном введении местных анестетиков существует небольшой риск возникновения стойкого нарушения функции нарушения глазных мышц."}},{"type":"paragraph","data":{"text":"Основными причинами является травма и/или местное токсическое действие введенного бупивакаина на мышцы и/или нервы."}},{"type":"paragraph","data":{"text":"Случайное внутрисосудистое введение местных анестетиков в области головы и шеи даже в низких дозах может вызывать симптомы токсичности со стороны со стороны ЦНС."}},{"type":"paragraph","data":{"text":"Парацервикальная блокада иногда приводит к брадикардии/тахикардии у плода, поэтому следует тщательно мониторировать сердечный ритм у плода."}},{"type":"paragraph","data":{"text":"Следует соблюдать осторожность у пациентов с атриовентрикулярной блокадой II или III стадии, поскольку местные анестетики могут снижать проводимость миокарда. 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