Инфильтрационная (в т.ч. внутрикостная), проводниковая, ретробульбарная (регионарная), эпидуральная анестезия; вагосимпатическая шейная, паранефральная, циркулярная и паравертебральная блокады.
Противопоказания
Повышенная чувствительность к прокаину; детский возраст до 12 лет; выраженные фиброзные изменения в тканях (для анестезии методом ползучего инфильтрата).
Инструкция
Регистрационный номер
Р N001206/01
Лекарственная форма
Р-р д/инъекц.
Состав
Активное вещество:
Прокаина гидрохлорид — 5 мг или 20 мг.
Вспомогательные вещества:
0,1 М раствор хлористоводородной кислоты — до pH 3,8–4,5, вода для инъекций — до 1 мл.
Описание
Прозрачная бесцветная или слегка окрашенная жидкость.
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. 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 введения) и итоговой дозы (количества и концентрации). Прокаин быстро гидролизуется эстеразами плазмы и печени с образованием двух основных фармакологически активных метаболитов: диэтиламиноэтанола (обладает умеренным сосудорасширяющим действием) и п-аминобензойной кислоты (является конкурентным антагонистом сульфаниламидных препаратов и может ослабить их противомикробное действие). T1/2 – 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 т.ч. внутрикостная), проводниковая, ретробульбарная (регионарная), эпидуральная анестезия; вагосимпатическая шейная, паранефральная, циркулярная и паравертебральная блокады.
Противопоказания
Повышенная чувствительность к прокаину; 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 следует применять только после консультации с врачом, в тех случаях, когда предполагаемая польза для матери превышает потенциальный риск для плода или младенца.
Способ применения и дозы
Доза и концентрация раствора новокаина зависят от характера оперативного вмешательства, способа применения, состояния и возраста пациента.
Для инфильтрационной анестезии используют 2,5–5 мг/мл растворы; для анестезии по методу Вишневского (тугая ползучая инфильтрация) – 1,25–2,5 мг/мл растворы; для проводниковой анестезии — 10–20 мг/мл растворы (до 25 мл); для эпидуральной — 20 мг/мл раствор (20–25 мл).
Высшие дозы для инфильтрационной анестезии для взрослых: первая разовая доза в начале операции не выше 0,75 г (150 мл), в дальнейшем на протяжении каждого часа операции — не свыше 2 г (400 мл) раствора.
При паранефральной блокаде (по А. В. Вишневскому) в околопочечную клетчатку вводят 50–80 мл 5 мг/мл раствора или 100–150 мл 2,5 мг/мл раствора.
При циркулярной и паравертебральной блокаде внутрикожно вводят 5–10 мл.
При вагосимпатической блокаде вводят 30–40 мл.
При вагосимпатической блокаде — 15–50 мл 5 мг/мл раствора.
При ретробульбарной (регионарной) анестезии — 5–8 мл 20 мг/мл раствора.
Для уменьшения всасывания и удлинения действия при местной анестезии, дополнительно вводят 0,1% раствор эпинефрина — по 1 кап на 2–5–10 мл раствора новокаина.
Максимальная доза для применения у детей старше 12 лет — 15 мг/кг.
Применение при беременности и кормлении грудью
Применение препарата допустимо, если ожидаемая польза для матери превышает потенциальный риск для плода и ребенка.
Побочное действие
Со стороны нервной системы: головная боль, головокружение, сонливость, стойкая анестезия, слабость, двигательное беспокойство, нервозность, потеря сознания, судороги, тризм, тремор, зрительные и слуховые нарушения, нистагм, синдром конского хвоста (паралич ног, парестезии), паралич дыхательных мышц, блок моторный и чувствительный.
Со стороны сердечно-сосудистой системы: повышение или снижение артериального давления, коллапс, периферическая вазодилатация, брадикардия, аритмия, боль в грудной клетке, изменения процесса распространения возбуждения в сердце, которые проявляются на ЭКГ в виде плоского зубца Т или укорочения сегмента ST.
Со стороны дыхательной системы: спазмы дыхательных путей или затруднение дыхания.
Со стороны пищеварительной системы: тошнота, рвота.
Аллергические реакции: зуд кожи, кожная сыпь, ангионевротический отек, анафилактические реакции (в том числе анафилактический шок), крапивница.
Прочие: непроизвольное мочеиспускание, метгемоглобинемия, гипотермия, дрожь, отек губ, лица, рта, языка и горла.
Передозировка
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.
Лечение: поддержание адекватной легочной вентиляции с ингаляцией кислорода, внутривенное введение короткодействующих лекарственных средств для общей анестезии, в тяжелых случаях — дезинтоксикационная и симптоматическая терапия.
Взаимодействие с другими лекарственными средствами
При одновременном применении прокаин усиливает угнетающее действие на ЦНС средств для общей анестезии, снотворных и седативных препаратов, наркотических анальгетиков и транквилизаторов.
При одновременном применении антикоагулянты (ардепарин натрия, далтепарин натрия, данапароид натрия, эноксапарин натрия, гепарин натрия, варфарин) повышают риск развития кровотечений.
При обработке места инъекции местного анестетика дезинфицирующими растворами, содержащими тяжелые металлы, повышается риск развития местной реакции в виде болезненности и отека.
При одновременном применении прокаина с ингибиторами МАО (фуразолидон, прокарбазин, селегилин) повышается риск развития гипотензии.
При одновременном применении прокаин 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.
При одновременном применении вазоконстрикторы (эпинефрин, метоксамин, фенилэфрин) удлиняют местноанестезирующее действие прокаина.
При одновременном применении прокаин снижает антимиастеническое действие лекарственных средств, особенно при применении его в высоких дозах, что требует дополнительной коррекции лечения миастении.
Метаболит прокаина (п-аминобензойная кислота) является антагонистом сульфаниламидов.
При применении местноанестезирующих средств для эпидуральной анестезии с гуанадрелом, с гуанетидином, мекамиламином, триметафана камзилатом повышается риск развития резкого снижения АД 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 2 этапа).
При применении средства требуется контроль функции сердечно-сосудистой и дыхательной систем, ЦНС.
Применение ингибиторов МАО противопоказано по меньшей мере за 10 дней до применения прокаина.
Перед применением прокаина необходимо проведение проб на индивидуальную чувствительность.
Следует учитывать, что при проведении местной анестезии при применении одной и той же общей дозы, токсичность прокаина тем выше, чем более концентрированный раствор применяется.
Не всасывается со слизистых оболочек; не обеспечивает поверхностной анестезии при накожном применении.
Влияние на способность управлять автомобилем и движущимися механизмами
В период применения прокаина пациентам следует соблюдать осторожность при управлении транспортными средствами и механизмами, а также при занятиях другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Раствор для инъекций
Условия хранения
В защищенном от света месте, при температуре не выше 25 °C
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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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. Обладает короткой анестезирующей активностью (продолжительность инфильтрационной анестезии составляет 0.5-1 ч)."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"Подвергается полной системной абсорбции. Степень абсорбции зависит от места и пути введения (особенно от васкуляризации и скорости кровотока в области введения) и итоговой дозы (количества и концентрации). Прокаин быстро гидролизуется эстеразами плазмы и печени с образованием двух основных фармакологически активных метаболитов: диэтиламиноэтанола (обладает умеренным сосудорасширяющим действием) и п-аминобензойной кислоты (является конкурентным антагонистом сульфаниламидных препаратов и может ослабить их противомикробное действие). T\u003csub\u003e1/2\u003c/sub\u003e – 30-50 сек, в неонатальном периоде – 54-114 сек. Выводится преимущественно почками в виде метаболитов, в неизмененном виде выводится не более 2%.\n\n"}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Инфильтрационная (в т.ч. внутрикостная), проводниковая, ретробульбарная (регионарная), эпидуральная анестезия; вагосимпатическая шейная, паранефральная, циркулярная и паравертебральная блокады."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к прокаину; детский возраст до 12 лет; 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 следует применять только после консультации с врачом, в тех случаях, когда предполагаемая польза для матери превышает потенциальный риск для плода или младенца."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Доза и концентрация раствора новокаина зависят от характера оперативного вмешательства, способа применения, состояния и возраста пациента."}},{"type":"paragraph","data":{"text":"Для инфильтрационной анестезии используют 2,5–5 мг/мл растворы; для анестезии по методу Вишневского (тугая ползучая инфильтрация) – 1,25–2,5 мг/мл растворы; для проводниковой анестезии — 10–20 мг/мл растворы (до 25 мл); для эпидуральной — 20 мг/мл раствор (20–25 мл)."}},{"type":"paragraph","data":{"text":"Высшие дозы для инфильтрационной анестезии для взрослых: первая разовая доза в начале операции не выше 0,75 г (150 мл), в дальнейшем на протяжении каждого часа операции — не свыше 2 г (400 мл) раствора."}},{"type":"paragraph","data":{"text":"При паранефральной блокаде (по А. В. Вишневскому) в околопочечную клетчатку вводят 50–80 мл 5 мг/мл раствора или 100–150 мл 2,5 мг/мл раствора."}},{"type":"paragraph","data":{"text":"При циркулярной и паравертебральной блокаде внутрикожно вводят 5–10 мл."}},{"type":"paragraph","data":{"text":"При вагосимпатической блокаде вводят 30–40 мл."}},{"type":"paragraph","data":{"text":"При вагосимпатической блокаде — 15–50 мл 5 мг/мл раствора."}},{"type":"paragraph","data":{"text":"При ретробульбарной (регионарной) анестезии — 5–8 мл 20 мг/мл раствора."}},{"type":"paragraph","data":{"text":"Для уменьшения всасывания и удлинения действия при местной анестезии, дополнительно вводят 0,1% раствор эпинефрина — по 1 кап на 2–5–10 мл раствора новокаина."}},{"type":"paragraph","data":{"text":"Максимальная доза для применения у детей старше 12 лет — 15 мг/кг."}},{"type":"header","data":{"text":"Применение при беременности и кормлении грудью","level":3}},{"type":"paragraph","data":{"text":"Применение препарата допустимо, если ожидаемая польза для матери превышает потенциальный риск для плода и ребенка."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы:\u003c/i\u003e головная боль, головокружение, сонливость, стойкая анестезия, слабость, двигательное беспокойство, нервозность, потеря сознания, судороги, тризм, тремор, зрительные и слуховые нарушения, нистагм, синдром конского хвоста (паралич ног, парестезии), паралич дыхательных мышц, блок моторный и чувствительный."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e повышение или снижение артериального давления, коллапс, периферическая вазодилатация, брадикардия, аритмия, боль в грудной клетке, изменения процесса распространения возбуждения в сердце, которые проявляются на ЭКГ в виде плоского зубца Т или укорочения сегмента ST."}},{"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 пищеварительной системы:\u003c/i\u003e тошнота, рвота."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e зуд кожи, кожная сыпь, ангионевротический отек, анафилактические реакции (в том числе анафилактический шок), крапивница."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e непроизвольное мочеиспускание, метгемоглобинемия, гипотермия, дрожь, отек губ, лица, рта, языка и горла."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"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 с ингаляцией кислорода, внутривенное введение короткодействующих лекарственных средств для общей анестезии, в тяжелых случаях — дезинтоксикационная и симптоматическая терапия."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении прокаин усиливает угнетающее действие на ЦНС средств для общей анестезии, снотворных и седативных препаратов, наркотических анальгетиков и транквилизаторов."}},{"type":"paragraph","data":{"text":"При одновременном применении антикоагулянты (ардепарин натрия, далтепарин натрия, данапароид натрия, эноксапарин натрия, гепарин натрия, 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":"При одновременном применении прокаина с ингибиторами МАО (фуразолидон, прокарбазин, селегилин) повышается риск развития гипотензии."}},{"type":"paragraph","data":{"text":"При одновременном применении прокаин 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":"При одновременном применении вазоконстрикторы (эпинефрин, метоксамин, фенилэфрин) удлиняют местноанестезирующее действие прокаина."}},{"type":"paragraph","data":{"text":"При одновременном применении прокаин снижает антимиастеническое действие лекарственных средств, особенно при применении его в высоких дозах, что требует дополнительной коррекции лечения миастении."}},{"type":"paragraph","data":{"text":"При одновременном применении ингибиторы холинэстеразы (антимиастенические лекарственные средства, циклофосфамид, демекария бромид, экотиопата йодид, тиотепа) снижают метаболизм прокаина."}},{"type":"paragraph","data":{"text":"Метаболит прокаина (п-аминобензойная кислота) является антагонистом сульфаниламидов."}},{"type":"paragraph","data":{"text":"При применении местноанестезирующих средств для эпидуральной анестезии с гуанадрелом, с гуанетидином, мекамиламином, триметафана камзилатом повышается риск развития резкого снижения АД 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."}},{"type":"paragraph","data":{"text":"Для предотвращения случайного внутрисосудистого введения, рекомендуется проводить аспирационную пробу (в 2 этапа)."}},{"type":"paragraph","data":{"text":"При применении средства требуется контроль функции сердечно-сосудистой и дыхательной систем, ЦНС."}},{"type":"paragraph","data":{"text":"Применение ингибиторов МАО противопоказано по меньшей мере за 10 дней до применения прокаина."}},{"type":"paragraph","data":{"text":"Перед применением прокаина необходимо проведение проб на индивидуальную чувствительность."}},{"type":"paragraph","data":{"text":"Следует 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":"Не всасывается со слизистых оболочек; не обеспечивает поверхностной анестезии при накожном применении."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В период применения прокаина пациентам следует соблюдать осторожность при управлении транспортными средствами и механизмами, а также при 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":"\u003ci\u003e\u003cb\u003eРаствор для инъекций\u003c/b\u003e\u003c/i\u003e"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от света месте, при температуре не выше 25 °C"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Отпускается по рецепту."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.vidal.ru/drugs/firm/565\"\u003eБИОХИМИК \u003c/a\u003e(Россия) "}}]}],"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. 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 введения) и итоговой дозы (количества и концентрации). Прокаин быстро гидролизуется эстеразами плазмы и печени с образованием двух основных фармакологически активных метаболитов: диэтиламиноэтанола (обладает умеренным сосудорасширяющим действием) и п-аминобензойной кислоты (является конкурентным антагонистом сульфаниламидных препаратов и может ослабить их противомикробное действие). T1/2– 30-50 сек, в неонатальном периоде – 54-114 сек. 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