Ультракаин Д-С фортеРаствор, 100 шт, 1.7 мл, 1:100 000, для инъекций, для полости рта, для взрослых, Инфильтрационная и проводниковая анестезия при стоматологических операциях: возможно применение детский возраст +4 лет
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Инфильтрационная и проводниковая анестезия в стоматологии (в том числе у больных с сопутствующими тяжелыми соматическими заболеваниями):
хирургические вмешательства на слизистой оболочке и костях, требующие ишемии;
хирургические вмешательства на пульпе зуба (удаление и экстирпация);
удаление пораженных пародонтозом и разрушенных зубов (остеотомия); длительные хирургические вмешательства, например, операция по Колдуэллу-Люку, чрескожный остеосинтез, удаление кист, вмешательства на слизистой десны, резекция верхушки корня, обработка полостей и обтачивание высокочувствительных зубов перед протезированием.
Противопоказания
Повышенная чувствительность к артикаину, эпинефрину или к любому другому компоненту препарата.
Так как в препарате содержится эпинефрин, он противопоказан в следующих случаях:
при пароксизмальной тахикардии и других нарушениях сердечного ритма,
Ультракаин Д-С форте - местный анестетик для инфильтрационной и проводниковой анестезии в стоматологической практике. Оказывает быстрое действие (латентный период - от 1 до 3 минут). Продолжительность анестезии составляет не менее 75 минут.
Вследствие низкого содержания эпинефрина в препарате его влияние на сердечно-сосудистую систему выражено незначительно: почти не отмечается повышения артериального давления и увеличения частоты сердечных сокращений.
Фармакокинетика
Связывание с белками плазмы артикаина составляет 95%. После инъекции в подслизистую оболочку полости рта период полувыведения составляет в среднем 25 минут. Препарат в минимальной степени проникает через плацентарный барьер, практически не выделяется с грудным молоком.
Артикаин выводится из организма преимущественно через почки.
Показания к применению
Инфильтрационная и проводниковая анестезия в стоматологии (в том числе у больных с сопутствующими тяжелыми соматическими заболеваниями):
хирургические вмешательства на слизистой оболочке и костях, требующие ишемии;
хирургические вмешательства на пульпе зуба (удаление и экстирпация);
удаление пораженных пародонтозом и разрушенных зубов (остеотомия); длительные хирургические вмешательства, например, операция по Колдуэллу-Люку, чрескожный остеосинтез, удаление кист, вмешательства на слизистой десны, резекция верхушки корня, обработка полостей и обтачивание высокочувствительных зубов перед протезированием.
Противопоказания
Повышенная чувствительность к артикаину, эпинефрину или к любому другому компоненту препарата.
Так как в препарате содержится эпинефрин, он противопоказан в следующих случаях:
при пароксизмальной тахикардии и других нарушениях сердечного ритма,
закрытоугольная глаукома.
Не следует применять при анемии (в том числе В-12 дефицитной анемии), метгемоглобинемии, гипоксии.
Нельзя использовать у больных бронхиальной астмой при повышенной чувствительности к сульфитам.
Применение при беременности и в период грудного вскармливания
Для оперативных вмешательств во время беременности местная анастезия считается щадящим методом обезболивания. Артикаин проходит через плацентарный барьер в меньшем количестве, чем другие местные анестетики.
В связи с очень быстрым падением уровня артикаина и быстрым выведением его из организма он поступает в материнское молоко в клинически незначимых количествах. Поэтому прерывать кормление грудью не требуется.
Эффективность и безопасность препарата у детей в возрасте до 4-х лет не изучалась.
Способ применения и дозы
Для взрослых: максимальная доза составляет 4-6 мг/кг массы тела. Общая доза - не более 400 мг.
При инфильтрационной анестезии при отсутствии воспаления обычно вводят 1.7 мл раствора Ультракаин Д-С Форте на зуб или на два смежных зуба.
При проводниковой анестезии нижнего альвеолярного нерва примерно требуется 1- 1.7 мл раствора препарата.
Перед введением препарата, рекомендуется всегда проводить аспирационный тест для того, чтобы избежать непреднамеренного внутрисосудистого введения препарата. Инъекционное давление во время введения препарата следует корректировать в зависимости от тканевой чувствительности.
Введение препарата в воспаленные участки слизистой оболочки не рекомендуется.
Побочное действие
В зависимости от дозировки могут наступить нарушения деятельности центральной нервной системы: помутнение сознания вплоть до его потери, нарушения дыхания до угрожающей для жизни остановки, мышечный тремор и подергивания мышц вплоть до генерализованных судорог, тошнота, рвота. Падение артериального давления и остановка сердца также могут возникать при введении препарата.
Аллергические реакции могут проявляться: в виде отека или воспаления в месте инъекции, гиперемии кожи, зуда, конъюнктивита, ринита, отечности лица (отек Квинке) с опуханием верхней и/или нижней губы, отека голосовых связок с чувством кома в горле и затрудненным глотанием, крапивницы, затруднении дыхания вплоть до анафилактического шока. Часто возникает головная боль.
Другие побочные действия, обусловленные эпинефрином - тахикардия, нарушения сердечного ритма, повышение артериального давления - при небольшой концентрации 1:200000 (0,5 мг/100 мл) встречаются редко.
Изредка при случайной внутрисосудистой инъекции могут появиться зоны ишемии вплоть до некроза тканей в месте инъекции.
Из-за содержания натрия дисульфита в отдельных случаях у больных бронхиальной астмой могут появиться реакции повышенной чувствительности, проявляющиеся в виде рвоты, поноса, учащенного дыхания, острого приступа астмы, нарушений сознания или шока.
Передозировка
Симптомы: первые проявления токсического действия - головокружение, моторное возбуждение или ступор. Возможны брадикардия, резкое снижение артериального давления, нарушения дыхания, мышечные подергивания, генерализованные судороги, тяжелые нарушения кровообращения, шок.
Лечение: при первых проявлениях симптомов токсического действия во время введения препарата, следует прекратить его введение и перевести пациента в горизонтальное положение с приподнятыми нижними конечностями. Следует обеспечить проходимость дыхательных путей и мониторировать показатели гемодинамики (частоту сердечных сокращений и артериальное давление). Рекомендуется всегда, даже если симптомы интоксикации кажутся нетяжелыми, ставить в/в катетер для того, чтобы в случае необходимости, иметь возможность немедленно провести в/в введение необходимых лекарственных средств.
При нарушениях дыхания, в зависимости от их тяжести, рекомендуется подача кислорода, а при возникновении показаний к проведению искусственного дыхания - проведение эндотрахеальной интубации и искуственной вентиляции легких. Введение аналептиков центрального действия противопоказано.
Мышечные подергивания и генерализованные судороги могут быть купированы в/в введением барбитуратов короткого или ультракороткого действия. Рекомендовано вводить эти препараты медленно, под постоянным врачебным контролем (риск гемодинамических расстройств и угнетения дыхания) и с одновременной подачей кислорода и мониторированием гемодинамических показателей.
Часто брадикардия или резкое снижение АД могут быть устранены при простом переводе пациента в горизонтальное положение с приподнятыми нижними конечностями.
При тяжелых нарушениях кровообращения и шоке, вне зависимости от их причины, введение препарата следует прекратить и пациент должен быть переведен в горизонтальное положение с приподнятыми нижними конечностями. Необходимо обеспечить подачу кислорода, в/в введение растворов электролитов, глюкокортикостероидов (250 - 1000 мг метилпреднизолона), при необходимости, плазмозаменителей, в том числе альбумина.
При развитии коллапса и усилении брадикардии показано медленное в/в введение раствора эпинефрина (0,0025 - 0,1 мг) под контролем сердечного ритма и АД. При необходимости введения в дозах, превышающих 0,1 мг, эпинефрин следует вводить инфузионно, отрегулировав скорость введения под контролем ЧСС и АД.
Взаимодействие с другими лекарственными средствами
Действие вазоконстрикторов, повышающих артериальное давление, типа адреномиметиков, таких, например, как эпинефрин, может усиливаться трициклическими антидепрессантами или ингибиторами МАО. П
одобные наблюдения были описаны для концентраций норэпинефрина 1:25000 и эпинефрина 1:80000 в качестве вазоконстрикторов. Концентрация эпинефрина в Ультракаине Д-С форте значительно ниже - 1:100000. Однако учитывать возможности такого усиления действия необходимо.
Особые указания
Во избежание внутрисосудистого введения необходимо всегда проводить аспирационный тест.
Для предотвращения занесения инфекций (в том числе, вирусного гепатита) необходимо следить за тем, чтобы при заборе раствора из ампул всегда использовались новые стерильные шприцы и иглы. Открытые картриджи нельзя использовать снова для других пациентов.
Нельзя использовать для инъекций поврежденный картридж. Пациентам требуется наблюдение за состоянием сердечно-сосудистой системы, дыхательной системы, ЦНС.
Принимать пищу можно лишь после прекращения действия местной анестезии (восстановления чувствительности).
Влияние на способность управлять автомобилем и движущимися механизмами
Влияние на способность к вождению автотранспорта и управлению механизмами: решение о том, когда пациент после стоматологического вмешательства сможет вернуться к вождению автотранспорта и занятиям потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций, должен принимать врач.
Форма выпуска
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Условия хранения
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Срок годности
30 месяцев.
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инъекций содержится:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eдействующие вещества:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"артикаина гидрохлорид - 40 мг и эпинефрина гидрохлорид - 0,012 мг;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eвспомогательные вещества:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"натрия метабисульфит - 0,5 мг,"}},{"type":"paragraph","data":{"text":"натрия хлорид — 1 мг,"}},{"type":"paragraph","data":{"text":"вода для инъекций."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"\u003cb\u003eФармакодинамика\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Ультракаин Д-С форте - местный анестетик для инфильтрационной и проводниковой анестезии в стоматологической практике. Оказывает быстрое действие (латентный период - от 1 до 3 минут). Продолжительность анестезии составляет не менее 75 минут."}},{"type":"paragraph","data":{"text":"Вследствие низкого содержания эпинефрина в препарате его влияние на сердечно-сосудистую систему выражено незначительно: почти не отмечается повышения артериального давления и увеличения частоты сердечных сокращений."}},{"type":"paragraph","data":{"text":"\u003cb\u003eФармакокинетика\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Связывание с белками плазмы артикаина составляет 95%. После инъекции в подслизистую оболочку полости рта период полувыведения составляет в среднем 25 минут. Препарат в минимальной степени проникает через плацентарный барьер, практически не выделяется с грудным молоком."}},{"type":"paragraph","data":{"text":"Артикаин выводится из организма преимущественно через почки."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Инфильтрационная и проводниковая анестезия в стоматологии (в том числе у больных с сопутствующими тяжелыми соматическими заболеваниями):"}},{"type":"list","data":{"style":"ordered","items":["хирургические вмешательства на слизистой оболочке и костях, требующие ишемии;","хирургические вмешательства на пульпе зуба (удаление и экстирпация);","удаление пораженных пародонтозом и разрушенных зубов (остеотомия); длительные хирургические вмешательства, например, операция по Колдуэллу-Люку, чрескожный остеосинтез, удаление кист, вмешательства на слизистой десны, резекция верхушки корня, обработка полостей и обтачивание высокочувствительных зубов перед протезированием."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к артикаину, эпинефрину или к любому другому компоненту препарата. "}},{"type":"paragraph","data":{"text":"Так как в препарате содержится эпинефрин, он противопоказан в следующих случаях:"}},{"type":"list","data":{"style":"ordered","items":["при пароксизмальной тахикардии и других нарушениях сердечного ритма,","закрытоугольная глаукома. "]}},{"type":"paragraph","data":{"text":"Не следует применять при анемии (в том числе В-12 дефицитной анемии), метгемоглобинемии, гипоксии. "}},{"type":"paragraph","data":{"text":"Нельзя использовать у больных бронхиальной астмой при повышенной чувствительности к сульфитам. "}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Для оперативных вмешательств во время беременности местная анастезия считается щадящим методом обезболивания. Артикаин проходит через плацентарный барьер в меньшем количестве, чем другие местные анестетики."}},{"type":"paragraph","data":{"text":"В связи с очень быстрым падением уровня артикаина и быстрым выведением его из организма он поступает в материнское молоко в клинически незначимых количествах. Поэтому прерывать кормление грудью не требуется."}},{"type":"paragraph","data":{"text":"Эффективность и безопасность препарата у детей в возрасте до 4-х лет не изучалась."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Для взрослых: максимальная доза составляет 4-6 мг/кг массы тела. Общая доза - не более 400 мг."}},{"type":"paragraph","data":{"text":"При инфильтрационной анестезии при отсутствии воспаления обычно вводят 1.7 мл раствора Ультракаин Д-С Форте на зуб или на два смежных зуба. "}},{"type":"paragraph","data":{"text":"При проводниковой анестезии нижнего альвеолярного нерва примерно требуется 1- 1.7 мл раствора препарата. "}},{"type":"paragraph","data":{"text":"Перед введением препарата, рекомендуется всегда проводить аспирационный тест для того, чтобы избежать непреднамеренного внутрисосудистого введения препарата. Инъекционное давление во время введения препарата следует корректировать в зависимости от тканевой чувствительности. "}},{"type":"paragraph","data":{"text":"Введение препарата в воспаленные участки слизистой оболочки не рекомендуется."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"В зависимости от дозировки могут наступить нарушения деятельности центральной нервной системы: помутнение сознания вплоть до его потери, нарушения дыхания до угрожающей для жизни остановки, мышечный тремор и подергивания мышц вплоть до генерализованных судорог, тошнота, рвота. Падение артериального давления и остановка сердца также могут возникать при введении препарата."}},{"type":"paragraph","data":{"text":"Аллергические реакции могут проявляться: в виде отека или воспаления в месте инъекции, гиперемии кожи, зуда, конъюнктивита, ринита, отечности лица (отек Квинке) с опуханием верхней и/или нижней губы, отека голосовых связок с чувством кома в горле и затрудненным глотанием, крапивницы, затруднении дыхания вплоть до анафилактического шока. Часто возникает головная боль."}},{"type":"paragraph","data":{"text":"Другие побочные действия, обусловленные эпинефрином - тахикардия, нарушения сердечного ритма, повышение артериального давления - при небольшой концентрации 1:200000 (0,5 мг/100 мл) встречаются редко. "}},{"type":"paragraph","data":{"text":"Изредка при случайной внутрисосудистой инъекции могут появиться зоны ишемии вплоть до некроза тканей в месте инъекции. "}},{"type":"paragraph","data":{"text":"Из-за содержания натрия дисульфита в отдельных случаях у больных бронхиальной астмой могут появиться реакции повышенной чувствительности, проявляющиеся в виде рвоты, поноса, учащенного дыхания, острого приступа астмы, нарушений сознания или шока."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: первые проявления токсического действия - головокружение, моторное возбуждение или ступор. Возможны брадикардия, резкое снижение артериального давления, нарушения дыхания, мышечные подергивания, генерализованные судороги, тяжелые нарушения кровообращения, шок. "}},{"type":"paragraph","data":{"text":"Лечение: при первых проявлениях симптомов токсического действия во время введения препарата, следует прекратить его введение и перевести пациента в горизонтальное положение с приподнятыми нижними конечностями. Следует обеспечить проходимость дыхательных путей и мониторировать показатели гемодинамики (частоту сердечных сокращений и артериальное давление). Рекомендуется всегда, даже если симптомы интоксикации кажутся нетяжелыми, ставить в/в катетер для того, чтобы в случае необходимости, иметь возможность немедленно провести в/в введение необходимых лекарственных средств. "}},{"type":"paragraph","data":{"text":"При нарушениях дыхания, в зависимости от их тяжести, рекомендуется подача кислорода, а при возникновении показаний к проведению искусственного дыхания - проведение эндотрахеальной интубации и искуственной вентиляции легких. Введение аналептиков центрального действия противопоказано. "}},{"type":"paragraph","data":{"text":"Мышечные подергивания и генерализованные судороги могут быть купированы в/в введением барбитуратов короткого или ультракороткого действия. Рекомендовано вводить эти препараты медленно, под постоянным врачебным контролем (риск гемодинамических расстройств и угнетения дыхания) и с одновременной подачей кислорода и мониторированием гемодинамических показателей."}},{"type":"paragraph","data":{"text":"Часто брадикардия или резкое снижение АД могут быть устранены при простом переводе пациента в горизонтальное положение с приподнятыми нижними конечностями. "}},{"type":"paragraph","data":{"text":"При тяжелых нарушениях кровообращения и шоке, вне зависимости от их причины, введение препарата следует прекратить и пациент должен быть переведен в горизонтальное положение с приподнятыми нижними конечностями. Необходимо обеспечить подачу кислорода, в/в введение растворов электролитов, глюкокортикостероидов (250 - 1000 мг метилпреднизолона), при необходимости, плазмозаменителей, в том числе альбумина. "}},{"type":"paragraph","data":{"text":"При развитии коллапса и усилении брадикардии показано медленное в/в введение раствора эпинефрина (0,0025 - 0,1 мг) под контролем сердечного ритма и АД. При необходимости введения в дозах, превышающих 0,1 мг, эпинефрин следует вводить инфузионно, отрегулировав скорость введения под контролем ЧСС и АД."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Действие вазоконстрикторов, повышающих артериальное давление, типа адреномиметиков, таких, например, как эпинефрин, может усиливаться трициклическими антидепрессантами или ингибиторами МАО. П"}},{"type":"paragraph","data":{"text":"одобные наблюдения были описаны для концентраций норэпинефрина 1:25000 и эпинефрина 1:80000 в качестве вазоконстрикторов. Концентрация эпинефрина в Ультракаине Д-С форте значительно ниже - 1:100000. Однако учитывать возможности такого усиления действия необходимо."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Во избежание внутрисосудистого введения необходимо всегда проводить аспирационный тест."}},{"type":"paragraph","data":{"text":"Для предотвращения занесения инфекций (в том числе, вирусного гепатита) необходимо следить за тем, чтобы при заборе раствора из ампул всегда использовались новые стерильные шприцы и иглы. Открытые картриджи нельзя использовать снова для других пациентов."}},{"type":"paragraph","data":{"text":"Нельзя использовать для инъекций поврежденный картридж. 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