Местноанестезирующее средство с умеренной анестезирующей акт... Инструкция
Показания к применению
Инфильтрационная анестезия; вагосимпатическая шейная, паранефральная, циркулярная и паравертебральная блокады.
Противопоказания
Гиперчувствительность (в т.ч. к парааминобензойной кислоте и другим местным анестетикам).
Детский возраст до 12 лет.
Для анестезии методом ползучего инфильтрата: выраженные фиброзные изменения в тканях.
Инструкция
Регистрационный номер
ЛСР-007720/08
Торговое название препарата
Новокаин-Виал
Лекарственная форма
раствор для инъекций
Состав
1 мл раствора содержит:
активное вещество: прокаина гидрохлорид 5 мг или 20 мг;
вспомогательные вещества: натрия хлорид, вода для инъекций.
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.
При внутривенном введении оказывает анальгезирующее, противошоковое, гипотензивное и антиаритмическое действие (увеличивает эффективный рефрактерный период, снижает возбудимость, автоматизм и проводимость), в больших дозах может нарушать нервно-мышечную проводимость. 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 30-60 мин).
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). Быстро гидролизуется эстеразами плазмы и печени с образованием двух основных фармакологически активных метаболитов: диэтиламиноэтанола (обладает умеренным сосудорасширяющим действием) и парааминобензойной кислоты (является конкурентным антагонистом сульфаниламидных химиотерапевтических 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 - 80%, в неизмененном виде выводится не более 2%.
Показания к применению
Инфильтрационная анестезия; вагосимпатическая шейная, паранефральная, циркулярная и паравертебральная блокады.
Противопоказания
Гиперчувствительность (в т.ч. к парааминобензойной кислоте и другим местным анестетикам).
Детский возраст до 12 лет.
Для анестезии методом ползучего инфильтрата: выраженные фиброзные изменения в тканях.
С осторожностью
Экстренные операции, сопровождающиеся острой кровопотерей; состояния, сопровождающиеся снижением печеночного кровотока (например, при 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 и у пожилых пациентов (старше 65 лет); ослабленные больные; беременность и период родов.
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
Для инфильтрационной анестезии: используют концентрации 2,5 мг/мл, 5 мг/мл; для анестезии по методу Вишневского (тугая ползучая инфильтрация) - 1,25 мг/мл, 2,5 мг/мл. Для уменьшения всасывания и удлинения действия при местной анестезии, дополнительно вводят 0,1% раствор эпинефрина гидрохлорида - по 1 капле на 2-5-10 мл раствора прокаина.
Высшие дозы для инфильтрационной анестезии для взрослых: первая разовая доза в начале операции - не более 500 мл раствора 2,5 мг/мл или 150 мл раствора 5 мг/мл. Максимальная доза для применения у детей старше 12 лет - 15 мг/кг массы тела.
При паранефральной блокаде (по А.В. Вишневскому) в околопочечную клетчатку вводят 50-80 мл раствора 5 мг/мл или 100-150 мл раствора 2,5 мг/мл, а при вагосимпатической блокаде - 30-100 мл раствора 2,5 мг/мл.
Для циркуляционной или паравертебральной блокад внутрикожно вводят раствор в концентрации 2,5-5 мг/мл.
Побочное действие
Головная боль, головокружение, сонливость, слабость, повышение или снижение артериального давления, коллапс, периферическая вазодилатация, брадикардия, аритмия, боль в грудной клетке, метгемоглобинемия, аллергические реакции (вплоть до анафилактического шока).
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, дезинтоксикационная и симптоматическая терапия.
Взаимодействие с другими лекарственными средствами
Усиливает угнетающее действие на центральную нервную систему средств для общей анестезии, снотворных, седативных препаратов, наркотических анальгетиков и транквилизаторов.
Метаболит прокаина (парааминобензойная кислота) является антагонистом сульфаниламидов.
При обработке места инъекций местного анестетика дезинфицирующими растворами, содержащими тяжелые металлы, повышается риск развития местной реакции в виде болезненности и отека.
Использование с ингибиторами МАО (фуразолидон, прокарбазин, селегилин) повышает риск развития гипотонии.
Усиливают и удлиняют действие миорелаксантов.
При назначении 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 использовании его в высоких дозах, что требует дополнительной коррекции лечения миастении.
Перед применением обязательное проведение проб на индивидуальную чувствительность к препарату.
Необходимо учитывать, что при проведении местной анестезии при использовании одной и той же общей дозы, токсичность новокаина тем выше, чем более концентрированный раствор используется.
Необходимо отменить ингибиторы МАО за 10 дней до введения местного анестетика.
Не всасывается со слизистых оболочек; не обеспечивает поверхностной анестезии при накожном применении.
Пациентам требуется контроль за функциями сердечно-сосудистой системы, дыхательной системы и центральной нервной системы.
Влияние на способность управлять автомобилем и движущимися механизмами
В период лечения необходимо воздерживаться от вождения автотранспорта и занятии другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Раствор для инъекций, 5 мг/мл и 20 мг/мл.
Условия хранения
Хранить в защищенном от света месте, при температуре от 5° до 30°С.
Хранить в недоступном для детей месте.
Срок годности
3 года.
Не использовать после истечения срока годности.
Условия отпуска
По рецепту
Производитель
Сишуи Ксирканг Фармасьютикал Ко.Лтд, North of Sihe Road, Sishui County, Shandong, China, Китай
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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."}},{"type":"paragraph","data":{"text":"При внутривенном введении оказывает анальгезирующее, противошоковое, гипотензивное и антиаритмическое действие (увеличивает эффективный рефрактерный период, снижает возбудимость, автоматизм и проводимость), в больших дозах может нарушать нервно-мышечную проводимость. Устраняет нисходящие тормозные влияния ретикулярной формации ствола мозга. Угнетает полисинаптические рефлексы. В больших дозах может вызывать судороги."}},{"type":"paragraph","data":{"text":"Обладает короткой анестезирующей активностью (продолжительность инфильтрационной анестезии составляет 30-60 мин)."}},{"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 введения) и итоговой дозы (количества и концентрации). Быстро гидролизуется эстеразами плазмы и печени с образованием двух основных фармакологически активных метаболитов: диэтиламиноэтанола (обладает умеренным сосудорасширяющим действием) и парааминобензойной кислоты (является конкурентным антагонистом сульфаниламидных химиотерапевтических препаратов и может ослабить их противомикробное действие). Период полувыведения (Т\u003csub\u003e1/2\u003c/sub\u003e) - 30-50 сек, в неонатальном периоде - 54-114 сек."}},{"type":"paragraph","data":{"text":"Выводится преимущественно почками в виде метаболитов - 80%, в неизмененном виде выводится не более 2%."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Инфильтрационная анестезия; вагосимпатическая шейная, паранефральная, циркулярная и паравертебральная блокады."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность (в т.ч. к парааминобензойной кислоте и другим местным анестетикам)."}},{"type":"paragraph","data":{"text":"Детский возраст до 12 лет."}},{"type":"paragraph","data":{"text":"Для анестезии методом ползучего инфильтрата: выраженные фиброзные изменения в тканях."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Экстренные операции, сопровождающиеся острой кровопотерей; состояния, сопровождающиеся снижением печеночного кровотока (например, при 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 и у пожилых пациентов (старше 65 лет); ослабленные больные; беременность и период родов."}}]},{"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":"Для инфильтрационной анестезии: используют концентрации 2,5 мг/мл, 5 мг/мл; для анестезии по методу Вишневского (тугая ползучая инфильтрация) - 1,25 мг/мл, 2,5 мг/мл. Для уменьшения всасывания и удлинения действия при местной анестезии, дополнительно вводят 0,1% раствор эпинефрина гидрохлорида - по 1 капле на 2-5-10 мл раствора прокаина."}},{"type":"paragraph","data":{"text":"Высшие дозы \u003ci\u003eдля инфильтрационной анестезии для взрослых\u003c/i\u003e: первая разовая доза в начале операции - не более 500 мл раствора 2,5 мг/мл или 150 мл раствора 5 мг/мл. Максимальная доза для применения у детей старше 12 лет - 15 мг/кг массы тела."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПри паранефральной блокаде (по А.В. Вишневскому) \u003c/i\u003eв околопочечную клетчатку вводят 50-80 мл раствора 5 мг/мл или 100-150 мл раствора 2,5 мг/мл, а при вагосимпатической блокаде - 30-100 мл раствора 2,5 мг/мл."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДля циркуляционной или паравертебральной блокад\u003c/i\u003e внутрикожно вводят раствор в концентрации 2,5-5 мг/мл."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Головная боль, головокружение, сонливость, слабость, повышение или снижение артериального давления, коллапс, периферическая вазодилатация, брадикардия, аритмия, боль в грудной клетке, метгемоглобинемия, аллергические реакции (вплоть до анафилактического шока)."}}]},{"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, дезинтоксикационная и 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, седативных препаратов, наркотических анальгетиков и транквилизаторов."}},{"type":"paragraph","data":{"text":"Метаболит прокаина (парааминобензойная кислота) является антагонистом сульфаниламидов."}},{"type":"paragraph","data":{"text":"Антикоагулянты (ардепарин, далтепарин, данапароид, эноксапарин, гепарин, варфарин) повышают риск развития кровотечений."}},{"type":"paragraph","data":{"text":"При обработке места инъекций местного анестетика дезинфицирующими растворами, содержащими тяжелые металлы, повышается риск развития местной реакции в виде болезненности и отека."}},{"type":"paragraph","data":{"text":"Использование с ингибиторами МАО (фуразолидон, прокарбазин, селегилин) повышает риск развития гипотонии."}},{"type":"paragraph","data":{"text":"Усиливают и удлиняют действие миорелаксантов."}},{"type":"paragraph","data":{"text":"При назначении 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 использовании его в высоких дозах, что требует дополнительной коррекции лечения миастении."}},{"type":"paragraph","data":{"text":"Ингибиторы холинэстеразы (антимиастенические лекарственные средства, циклофосфамид, демекарин, экотиофат, тиотепа) снижают метаболизм прокаина."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Перед применением обязательное проведение проб на индивидуальную чувствительность к препарату."}},{"type":"paragraph","data":{"text":"Необходимо учитывать, что при проведении местной анестезии при использовании одной и той же общей дозы, токсичность новокаина тем выше, чем более концентрированный раствор используется."}},{"type":"paragraph","data":{"text":"Необходимо отменить ингибиторы МАО за 10 дней до введения местного анестетика."}},{"type":"paragraph","data":{"text":"Не всасывается со слизистых оболочек; не обеспечивает поверхностной анестезии при накожном применении."}},{"type":"paragraph","data":{"text":"Пациентам требуется контроль за функциями сердечно-сосудистой системы, дыхательной системы и центральной нервной системы."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В период лечения необходимо воздерживаться от вождения автотранспорта и занятии другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для инъекций, 5 мг/мл и 20 мг/мл."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить в защищенном от света месте, при температуре от 5° до 30°С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}},{"type":"paragraph","data":{"text":"Не использовать после истечения срока годности."}}]},{"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":"Сишуи Ксирканг Фармасьютикал Ко.Лтд, North of Sihe Road, Sishui County, Shandong, China, Китай"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ООО \"ВИАЛ\""}}]}],"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. При внутривенном введении оказывает анальгезирующее, противошоковое, гипотензивное и антиаритмическое действие (увеличивает эффективный рефрактерный период, снижает возбудимость, автоматизм и проводимость), в больших дозах может нарушать нервно-мышечную проводимость. 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 30-60 мин). 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). Быстро гидролизуется эстеразами плазмы и печени с образованием двух основных фармакологически активных метаболитов: диэтиламиноэтанола (обладает умеренным сосудорасширяющим действием) и парааминобензойной кислоты (является конкурентным антагонистом сульфаниламидных химиотерапевтических препаратов и может ослабить их противомикробное действие). Период полувыведения (Т1/2) - 30-50 сек, в неонатальном периоде - 54-114 сек. 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