Инфильтрационная (в том числе внутрикостная) анестезия; вагосимпатическая шейная, паранефральная, циркулярная и паравертебральная блокады.
Противопоказания
Гиперчувствительность (в том числе к пара-аминобензойной кислоте и другим местным анестетикам);
детский возраст до 12 лет;
выраженные фиброзные изменения в тканях (для анестезии методом ползучего инфильтрата).
Инструкция
Регистрационный номер
ЛП-003521
Торговое название препарата
Новокаин
Лекарственная форма
раствор для инъекций
Состав
Действующие вещества:
Прокаина гидрохлорид (новокаин) -0,25% - 2,5 г 0,5% - 5,0 г
Вспомогательные вещества:
Вода для инъекций до 1,0 л
Хлористоводородной кислоты 0,1 М раствор до pH 3,8 - 4,5
Описание
Прозрачная бесцветная жидкость.
Фармакотерапевтическая группа
Местноанестезирующее средство
Фармакологические свойства
Фармакодинамика:
Местноанестезирующее средство с умеренной анестезирующей активностью и большой широтой терапевтического действия. Являясь слабым основанием, блокирует натриевые каналы, препятствует генерации импульсов в окончаниях чувствительных нервов и проведению импульсов по нервным волокнам. Изменяет потенциал действия в мембранах нервных клеток без выраженного влияния на потенциал покоя. Подавляет проведение не только болевых, но и импульсов другой модальности.
При всасывании и непосредственном сосудистом введении в ток крови снижает возбудимость периферических холинергических систем, уменьшает образование и высвобождение ацетилхолина из преганглионарных окончаний (обладает некоторым ганглиоблокирующим действием), устраняет спазм гладкой мускулатуры, уменьшает возбудимость миокарда и моторных зон коры головного мозга. Устраняет нисходящие тормозные влияния ретикулярной формации ствола мозга. Угнетает полисинаптические рефлексы. В больших дозах может вызывать судороги. Обладает короткой анестезирующей активностью (продолжительность инфильтрационной анестезии составляет 0,5- 1 ч).
Фармакокинетика:
Подвергается полной системной абсорбции. Степень абсорбции зависит от места и пути введения (особенно от васкуляризации и скорости кровотока в области введении) и итоговой дозы (количества и концентрации). Быстро гидролизуется эстеразами плазмы и печени с образованием 2 основных фармакологически активных метаболитов: диэтиламиноэтанола (обладает умеренным сосудорасширяющим действием) и пара-аминобензойной кислоты (является конкурентным антагонистом сульфаниламидных препаратов и может ослабить их противомикробное действие). Период полувыведения (Т1/2) - 30-50 сек, в неонатальном периоде - 54-114 сек. Выводится преимущественно почками в виде метаболитов, в неизмененном виде выводится не более 2%.
Показания к применению
Инфильтрационная (в том числе внутрикостная) анестезия; вагосимпатическая шейная, паранефральная, циркулярная и паравертебральная блокады.
Противопоказания
Гиперчувствительность (в том числе к пара-аминобензойной кислоте и другим местным анестетикам);
детский возраст до 12 лет;
выраженные фиброзные изменения в тканях (для анестезии методом ползучего инфильтрата).
С осторожностью
Экстренные операции, сопровождающиеся острой кровопотерей; состояния, сопровождающиеся снижением печеночного кровотока (например, при хронической сердечной недостаточности, заболеваниях печени); прогрессирование сердечно-сосудистой недостаточности (обычно вследствие развития блокад сердца и шока); воспалительные заболевания или инфицирование места инъекции; дефицит псевдохолинэстеразы; почечная недостаточность; детский возраст (от 12 до 18 лет); пожилые пациенты (старше 65 лет); ослабленные больные.
Применение при беременности и в период грудного вскармливания
При беременности и в период грудного вскармливания безопасность и эффективность препарата не установлена.
Применение препарата при беременности и в период грудного вскармливания возможно только по назначению врача, если предполагаемая польза для матери превышает потенциальный риск для плода или ребенка.
Способ применения и дозы
Для инфильтрационной анестезии применяют 0,25 % и 0,5 % растворы; для анастезии по методу Вишневского (тугая ползучая инфильтрация) - 0,125 % и 0,25 % растворы. Для уменьшения всасывания и удлинения действия при местной анестезии, дополнительно вводят 0,1 % раствор эпинефрина - по 1 капле на 2-5-10 мл раствора прокаина.
При паранефральной блокаде (по А. В. Вишневскому) в околопочечную клетчатку вводят по 50 - 80 мл 0,5 % раствора или 100 - 150 мл 0,25 %, а при вагосимпатической блокаде - 30-100 мл 0,25 % раствора.
Для циркуляторной и паравертебральной блокад внутрикожно вводят 0,25 % или 0,5% раствор.
Высшие дозы для инфильтрационной анестезии я взрослых: первая разовая доза в начале операции - не более 500 мл 0,25 % раствора и 150 мл 0,5 % раствора.
Максимальная доза для применения у детей старше 12 лет - 15 мг/кг.
Побочное действие
Со стороны центральной и периферической нервной системы: головная боль, головокружение, сонливость, слабость, тризм, тремор, нистагм, стойкая анестезия, двигательное беспокойство, потеря сознания, судороги, зрительные и слуховые нарушения.
Со стороны сердечнососудистой системы: повышение или снижение артериального давления, коллапс, периферическая вазодилатация, брадикардия, аритмия, боль в грудной клетке, изменения распространения возбуждения в сердце, которые появляются на ЭКГ в виде плоского зубца Т или укорочения сегмента SТ.
Со стороны дыхательной системы: спазмы дыхательных путей или затруднение дыхания.
Со стороны мочевыделительной системы: непроизвольное мочеиспускание. Со стороны пищеварительной системы: тошнота, рвота.
Со стороны крови: метгемоглобинемия.
Аллергические реакции: аллергические реакции, вплоть до анафилактического шока.
Прочие: возвращение боли, стойкая анестезия, гипотермия, дрожь, отек губ, лица, рта, языка и горла.
Передозировка
При использовании в высоких дозах возможно избыточное всасывание.
Симптомы: бледность кожных покровов и слизистых оболочек, головокружение, тошнота, рвота, "холодный" пот, учащение дыхания, тахикардия, снижение артериального давления вплоть до коллапса, апноэ, метгемоглобинемия. Действие на центральную нервную систему проявляется чувством страха, галлюцинациями, судорогами, двигательным возбуждением.
Взаимодействие с другими лекарственными средствами
Усиливает угнетающее действие на центральную нервную систему средств для общей анестезии, снотворных и седативных препаратов, наркотических анальгетиков и транквилизаторов.
При обработке места инъекции местного анестетика дезинфицирующими растворами, содержащими тяжелые металлы, повышается риск развития местной реакции в виде болезненности и отека.
Одновременное применение с ингибиторами моноаминоксидазы (фуразолидон, прокарбазин, селегилин) повышает риск развития гипотензии. Усиливает и удлиняет действие миорелаксантов.
При применении прокаина совместно с наркотическими анальгетиками отмечается аддитивный эффект, что используется при проведении спинальной и эпидуральной анестезии, при этом усиливается угнетение дыхания.
Прокаин снижает антимиастеническое действие лекарственных средств, особенно при применении его в высоких дозах, что требует дополнительной коррекции лечения миастении.
Метаболит прокаина (пара-аминобензойная кислота) является антогонистом сульфаниламидов.
При применении местноанестезирующих средств для эпидуральной анестезии с гуанадрелом, с гуанетидином, мекамиламином, триметафана камзилатом повышается риск развития резкого снижения артериального давления и брадикардии.
Особые указания
Анестезия должна проводиться опытными специалистами в соответствующим образом оборудованном помещении при доступности готовых к немедленному использованию оборудования и препаратов, необходимых для проведения кардиомониторинга и реанимационных мероприятий. Для предотвращения случайного внутрисосудистого введения, рекомендуется проводить аспирационную пробу (в два этапа).
Пациентам требуется контроль за функциями сердечно-сосудистой, дыхательной и центральной нервной систем. Применение ингибиторов моноаминоксидазы по меньшей мере за 10 дней до введения местного анестетика противопоказано. Перед применением обязательное проведение проб на индивидуальную чувствительность к препарату.
Необходимо учитывать, что при проведении местной анестезии при применении одной и той же общей дозы, токсичность прокаина тем выше, чем более концентрированный раствор применяется.
Препарат следует хранить во вторичной упаковке.
Влияние на способность управлять автомобилем и движущимися механизмами
В период лечения необходимо соблюдать осторожность при вождении автотранспорта и занятиях другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Новокаин, раствор для инъекций 0,25% или 0,5%.
Условия хранения
В защищенном от света месте при температуре не выше 25°С.
Хранить в недоступном для детей месте.
Несмачиваемость внутренней поверхности бутылок не является противопоказанием к применению препарата.
В случае изменения окраски препарата или появления взвеси, раствор не пригоден к употреблению.
Срок годности
3 года. Не использовать по истечении срока указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Общество с ограниченной ответственностью "МОСФАРМ" (ООО "МОСФАРМ"), Московская обл., Сергиево-Посадский муниципальный район, городское поселение Богородское, рабочий поселок Богородское, д. 63, Россия
Организация, принимающая претензии потребителей
ООО "МОСФАРМ"
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группа","slug":"","body":[{"type":"paragraph","data":{"text":"Местноанестезирующее средство"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Местноанестезирующее средство с умеренной анестезирующей активностью и большой широтой терапевтического действия. Являясь слабым основанием, блокирует натриевые каналы, препятствует генерации импульсов в окончаниях чувствительных нервов и проведению импульсов по нервным волокнам. Изменяет потенциал действия в мембранах нервных клеток без выраженного влияния на потенциал покоя. Подавляет проведение не только болевых, но и импульсов другой модальности."}},{"type":"paragraph","data":{"text":"При всасывании и непосредственном сосудистом введении в ток крови снижает возбудимость периферических холинергических систем, уменьшает образование и высвобождение ацетилхолина из преганглионарных окончаний (обладает некоторым ганглиоблокирующим действием), устраняет спазм гладкой мускулатуры, уменьшает возбудимость миокарда и моторных зон коры головного мозга. Устраняет нисходящие тормозные влияния ретикулярной формации ствола мозга. Угнетает полисинаптические рефлексы. В больших дозах может вызывать судороги. Обладает короткой анестезирующей активностью (продолжительность инфильтрационной анестезии составляет 0,5- 1 ч)."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Подвергается полной системной абсорбции. Степень абсорбции зависит от места и пути введения (особенно от васкуляризации и скорости кровотока в области введении) и итоговой дозы (количества и концентрации). Быстро гидролизуется эстеразами плазмы и печени с образованием 2 основных фармакологически активных метаболитов: диэтиламиноэтанола (обладает умеренным сосудорасширяющим действием) и пара-аминобензойной кислоты (является конкурентным антагонистом сульфаниламидных препаратов и может ослабить их противомикробное действие). Период полувыведения (Т1/2) - 30-50 сек, в неонатальном периоде - 54-114 сек. Выводится преимущественно почками в виде метаболитов, в неизмененном виде выводится не более 2%."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Инфильтрационная (в том числе внутрикостная) анестезия; вагосимпатическая шейная, паранефральная, циркулярная и паравертебральная блокады."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность (в том числе к пара-аминобензойной кислоте и другим местным анестетикам);"}},{"type":"paragraph","data":{"text":"детский возраст до 12 лет;"}},{"type":"paragraph","data":{"text":"выраженные фиброзные изменения в тканях (для анестезии методом ползучего инфильтрата)."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Экстренные операции, сопровождающиеся острой кровопотерей; состояния, сопровождающиеся снижением печеночного кровотока (например, при хронической сердечной недостаточности, заболеваниях печени); прогрессирование сердечно-сосудистой недостаточности (обычно вследствие развития блокад сердца и шока); воспалительные заболевания или инфицирование места инъекции; дефицит псевдохолинэстеразы; почечная недостаточность; детский возраст (от 12 до 18 лет); пожилые пациенты (старше 65 лет); ослабленные больные."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"При беременности и в период грудного вскармливания безопасность и эффективность препарата не установлена."}},{"type":"paragraph","data":{"text":"Применение препарата при беременности и в период грудного вскармливания возможно только по назначению врача, если предполагаемая польза для матери превышает потенциальный риск для плода или ребенка."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Для инфильтрационной анестезии применяют 0,25 % и 0,5 % растворы; для анастезии по методу Вишневского (тугая ползучая инфильтрация) - 0,125 % и 0,25 % растворы. Для уменьшения всасывания и удлинения действия при местной анестезии, дополнительно вводят 0,1 % раствор эпинефрина - по 1 капле на 2-5-10 мл раствора прокаина."}},{"type":"paragraph","data":{"text":"При паранефральной блокаде (по А. В. Вишневскому) в околопочечную клетчатку вводят по 50 - 80 мл 0,5 % раствора или 100 - 150 мл 0,25 %, а при вагосимпатической блокаде - 30-100 мл 0,25 % раствора."}},{"type":"paragraph","data":{"text":"Для циркуляторной и паравертебральной блокад внутрикожно вводят 0,25 % или 0,5% раствор."}},{"type":"paragraph","data":{"text":"Высшие дозы для инфильтрационной анестезии я взрослых: первая разовая доза в начале операции - не более 500 мл 0,25 % раствора и 150 мл 0,5 % раствора."}},{"type":"paragraph","data":{"text":"Максимальная доза для применения у детей старше 12 лет - 15 мг/кг."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны центральной и периферической нервной системы:\u003c/i\u003e головная боль, головокружение, сонливость, слабость, тризм, тремор, нистагм, стойкая анестезия, двигательное беспокойство, потеря сознания, судороги, зрительные и слуховые нарушения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечнососудистой системы:\u003c/i\u003e повышение или снижение артериального давления, коллапс, периферическая вазодилатация, брадикардия, аритмия, боль в грудной клетке, изменения распространения возбуждения в сердце, которые появляются на ЭКГ в виде плоского зубца Т или укорочения сегмента SТ."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны дыхательной системы:\u003c/i\u003e спазмы дыхательных путей или затруднение дыхания."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны мочевыделительной системы:\u003c/i\u003e непроизвольное мочеиспускание. Со стороны пищеварительной системы: тошнота, рвота."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны крови:\u003c/i\u003e метгемоглобинемия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e аллергические реакции, вплоть до анафилактического шока."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e возвращение боли, стойкая анестезия, гипотермия, дрожь, отек губ, лица, рта, языка и горла."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"При использовании в высоких дозах возможно избыточное всасывание."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы\u003c/i\u003e: бледность кожных покровов и слизистых оболочек, головокружение, тошнота, рвота, \"холодный\" пот, учащение дыхания, тахикардия, снижение артериального давления вплоть до коллапса, апноэ, метгемоглобинемия. Действие на центральную нервную систему проявляется чувством страха, галлюцинациями, судорогами, двигательным возбуждением."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e поддержание адекватной легочной вентиляции, дезинтоксикационная симптоматическая терапия."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Усиливает угнетающее действие на центральную нервную систему средств для общей анестезии, снотворных и седативных препаратов, наркотических анальгетиков и транквилизаторов."}},{"type":"paragraph","data":{"text":"Антикоагулянты (ардепарин натрия, далтепарин натрия, данапароид натрия, эноксапарин натрия, гепарин, варфарин) повышают риск развития кровотечений."}},{"type":"paragraph","data":{"text":"При обработке места инъекции местного анестетика дезинфицирующими растворами, содержащими тяжелые металлы, повышается риск развития местной реакции в виде болезненности и отека."}},{"type":"paragraph","data":{"text":"Одновременное применение с ингибиторами моноаминоксидазы (фуразолидон, прокарбазин, селегилин) повышает риск развития гипотензии. Усиливает и удлиняет действие миорелаксантов."}},{"type":"paragraph","data":{"text":"При применении прокаина совместно с наркотическими анальгетиками отмечается аддитивный эффект, что используется при проведении спинальной и эпидуральной анестезии, при этом усиливается угнетение дыхания."}},{"type":"paragraph","data":{"text":"Вазоконстрикторы (эпинефрин, метоксамин, фенилэфрин) удлиняют местноанестезирующее действие."}},{"type":"paragraph","data":{"text":"Прокаин снижает антимиастеническое действие лекарственных средств, особенно при применении его в высоких дозах, что требует дополнительной коррекции лечения миастении."}},{"type":"paragraph","data":{"text":"Ингибиторы холинэстеразы (антимиастенические лекарственные средства, циклофосфамид, демекария бромид, экотиопата йодид, тиотепа) снижают метаболизм прокаина."}},{"type":"paragraph","data":{"text":"Метаболит прокаина (пара-аминобензойная кислота) является антогонистом сульфаниламидов."}},{"type":"paragraph","data":{"text":"При применении местноанестезирующих средств для эпидуральной анестезии с гуанадрелом, с гуанетидином, мекамиламином, триметафана камзилатом повышается риск развития резкого снижения артериального давления и брадикардии."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Анестезия должна проводиться опытными специалистами в соответствующим образом оборудованном помещении при доступности готовых к немедленному использованию оборудования и препаратов, необходимых для проведения кардиомониторинга и реанимационных мероприятий. Для предотвращения случайного внутрисосудистого введения, рекомендуется проводить аспирационную пробу (в два этапа)."}},{"type":"paragraph","data":{"text":"Пациентам требуется контроль за функциями сердечно-сосудистой, дыхательной и центральной нервной систем. Применение ингибиторов моноаминоксидазы по меньшей мере за 10 дней до введения местного анестетика противопоказано. Перед применением обязательное проведение проб на индивидуальную чувствительность к препарату."}},{"type":"paragraph","data":{"text":"Необходимо учитывать, что при проведении местной анестезии при применении одной и той же общей дозы, токсичность прокаина тем выше, чем более концентрированный раствор применяется."}},{"type":"paragraph","data":{"text":"Препарат следует хранить во вторичной упаковке."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В период лечения необходимо соблюдать осторожность при вождении автотранспорта и 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":"Новокаин, раствор для инъекций 0,25% или 0,5%."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от света месте при температуре не выше 25°С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}},{"type":"paragraph","data":{"text":"Несмачиваемость внутренней поверхности бутылок не является противопоказанием к применению препарата."}},{"type":"paragraph","data":{"text":"В случае изменения окраски препарата или появления взвеси, раствор не пригоден к употреблению."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года. Не использовать по истечении срока указанного на упаковке."}}]},{"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":"Общество с ограниченной ответственностью \"МОСФАРМ\" (ООО \"МОСФАРМ\"), Московская обл., Сергиево-Посадский муниципальный район, городское поселение Богородское, рабочий поселок Богородское, д. 63, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ООО \"МОСФАРМ\""}}]}],"source":null},"description_toggle":false,"short_description":"Местноанестезирующее средство с умеренной анестезирующей активностью и большой широтой терапевтического действия. Являясь слабым основанием, блокирует натриевые каналы, препятствует генерации импульсов в окончаниях чувствительных нервов и проведению импульсов по нервным волокнам. Изменяет потенциал действия в мембранах нервных клеток без выраженного влияния на потенциал покоя. Подавляет проведение не только болевых, но и импульсов другой модальности. При всасывании и непосредственном сосудистом введении в ток крови снижает возбудимость периферических холинергических систем, уменьшает образование и высвобождение ацетилхолина из преганглионарных окончаний (обладает некоторым ганглиоблокирующим действием), устраняет спазм гладкой мускулатуры, уменьшает возбудимость миокарда и моторных зон коры головного мозга. Устраняет нисходящие тормозные влияния ретикулярной формации ствола мозга. Угнетает полисинаптические рефлексы. В больших дозах может вызывать судороги. Обладает короткой анестезирующей активностью (продолжительность инфильтрационной анестезии составляет 0,5- 1 ч). Подвергается полной системной абсорбции. Степень абсорбции зависит от места и пути введения (особенно от васкуляризации и скорости кровотока в области введении) и итоговой дозы (количества и концентрации). Быстро гидролизуется эстеразами плазмы и печени с образованием 2 основных фармакологически активных метаболитов: диэтиламиноэтанола (обладает умеренным сосудорасширяющим действием) и пара-аминобензойной кислоты (является конкурентным антагонистом сульфаниламидных препаратов и может ослабить их противомикробное действие). Период полувыведения (Т1/2) - 30-50 сек, в неонатальном периоде - 54-114 сек. 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