Гемостатическое средство, оказывает также ангиопротекторное... Инструкция
Показания к применению
Профилактика и остановка кровотечений: паренхиматозные и капиллярные кровотечения (в т.ч. травматическое, в хирургии при операциях на сильно васкуляризированных органах и тканях, при оперативных вмешательствах в стоматологической, урологической, офтальмологической, отоларингологической практике, кишечное, почечное, легочное кровотечения, метро- и меноррагии ...
Повышенная чувствительность к этамзилату, острая порфирия, гемобластоз у детей, тромбоз, тромбоэмболия; беременность, период лактации (грудного вскармливания); детский возраст до 3 лет (для приема внутрь).
Инструкция
Регистрационный номер
ЛП-002436 от 21.04.14
Лекарственная форма
Р-р д/в/в и в/м введения 125 мг/мл
Состав
1 мл раствора содержит:
Активное вещество:
этамзилат 125 мг;
Вспомогательные вещества:
натрия дисульфит 4 мг,
динатрия эдетат 0.1 мг,
вода д/и до 1 мл.
Описание
Раствор для в/в и в/м введения прозрачный, бесцветный или слабо окрашенный.
Гемостатическое средство, оказывает также ангиопротекторное и проагрегантное действие. Стимулирует образование тромбоцитов и их выход из костного мозга. Гемостатическому действию, обусловленому активацией формирования тромбопластина в месте повреждения мелких сосудов и снижением образования в эндотелии сосудов простациклина PgI2, способствует повышению адгезии и агрегации тромбоцитов, что, в конечном счете, приводит к остановке или уменьшению кровоточивости. Увеличивает скорость образования первичного тромба и усиливает его ретракцию, практически не влияет на концентрацию фибриногена и протромбиновое время. Дозы более 2-10 мг/кг не приводят к большей выраженности эффекта. При повторных введениях тромбообразование усиливается. Обладая антигиалуронидазной активностью и стабилизируя аскорбиновую кислоту, препятствует разрушению и способствует образованию в стенке капилляров мукополисахаридов с большой молекулярной массой, повышает резистентность капилляров, снижает их хрупкость, нормализует проницаемость при патологических процессах. Уменьшает выход жидкости и диапедез форменных элементов крови из сосудистого русла, улучшает микроциркуляцию. Не оказывает сосудосуживающего действия. Восстанавливает патологически измененное время кровотечения.
На нормальные параметры системы гемостаза не влияет. Гемостатический эффект при в/в введении этамзилата наступает через 5-15 мин, максимальный эффект проявляется через 1-2 ч. Действие продолжается в течение 4-6 ч, затем в течение 24 ч постепенно ослабевает; при в/м введении эффект наступает через 30-60 мин.
Фармакокинетика
Этамзилат хорошо абсорбируется при в/м введении, слабо связывается с белками плазмы и форменными элементами крови. Cmax в плазме после в/м и в/в введения в дозе 500 мг достигается через 10 мин и составляет 30-50 мкг/мл. Терапевтическая концентрация в крови - 0.05-0.02 мг/мл. Этамзилат равномерно распределяется в различных органах и тканях (зависит от степени их кровоснабжения).
После приема внутрь быстро и почти полностью всасывается. Cmax в плазме после приема в дозе 500 мг достигается через 4 ч и составляет 15 мкг/мл.
Связывание с белками плазмы составляет около 95%.
Практически полностью проникает через плацентарный барьер. Неизвестно, выделяется ли этамзилат с грудным молоком.
Выводится из организма главным образом почками (в неизменном виде), в незначительном количестве с желчью. T1/2 после приема внутрь составляет около 3.7 ч, после в/в введения - 1.9 ч, после в/м введения - 2.1 ч.
Выводится из организма главным образом почками (в неизменном виде), в незначительном количестве с желчью: после приема внутрь - 72% в течение 24 ч; через 5 мин после в/в введения - 20-30% дозы, полностью - через 4 ч.
Показания к применению
Профилактика и остановка кровотечений: паренхиматозные и капиллярные кровотечения (в т.ч. травматическое, в хирургии при операциях на сильно васкуляризированных органах и тканях, при оперативных вмешательствах в стоматологической, урологической, офтальмологической, отоларингологической практике, кишечное, почечное, легочное кровотечения, метро- и меноррагии при фибромиоме и другие), вторичные кровотечения на фоне тромбоцитопении и тромбоцитопатии, гипокоагуляция, гематурия, внутричерепное кровоизлияние (в т.ч. у новорожденных и недоношенных детей), носовые кровотечения на фоне артериальной гипертензии, кровотечения, обусловленные приемом лекарственных средств, геморрагический диатез (в т.ч. болезнь Верльгофа, Виллебранда-Юргенса, тромбоцитопатия), диабетическая микроангиопатия (геморрагическая диабетическая ретинопатия, повторное кровоизлияние в сетчатку, гемофтальм).
Противопоказания
Повышенная чувствительность к этамзилату, острая порфирия, гемобластоз у детей, тромбоз, тромбоэмболия; беременность, период лактации (грудного вскармливания); детский возраст до 3 лет (для приема внутрь).
С осторожностью
Тромбоз, тромбоэмболия в анамнезе; кровотечения на фоне передозировки антикоагулянтов; нарушения функции печени и/или почек.
Применение при беременности и в период грудного вскармливания
Противопоказан к применению при беременности и в период грудного вскармливания.
Способ применения и дозы
Применяют внутрь, в/м, в/в, местно, субконъюнктивально, ретробульбарно. Режим дозирования устанавливают индивидуально, в зависимости от показаний, клинической ситуации, возраста пациента, применяемой лекарственной формы.
Побочное действие
Со стороны пищеварительной системы: часто - тошнота, диарея, тяжесть в эпигастральной области.
Со стороны кожи и подкожных тканей: часто - кожная сыпь; частота неизвестна - гиперемия кожи лица.
Со стороны нервной системы: часто - головная боль; частота неизвестна - головокружение, парестезии нижних конечностей.
Со стороны сердечно-сосудистой системы: очень редко - тромбоэмболия, выраженное снижение АД.
Со стороны системы кроветворения: очень редко - агранулоцитоз, нейтропения, тромбоцитопения.
Со стороны костно-мышечной системы: очень редко - артралгия.
Прочие: часто - астения; очень редко - аллергические реакции, лихорадка.
Передозировка
В рекомендованных дозах и способах введения препарат не вызывает интоксикаций и передозировки.
Взаимодействие с другими лекарственными средствами
Введение этамзилата в дозе 10 мг/кг за 1 ч до введения растворов декстринов со средней молекулярной массой 30000-40000, предотвращает антиагрегационное действие последних; введение этамзилата после растворов декстранов не оказывает гемостатического действия.
Возможно сочетание с аминокапроновой кислотой и менадиона натрия бисульфитом.
Этамзилат фармацевтически несовместим (в одном шприце) с другими лекарственными препаратами.
Особые указания
Перед началом лечения следует исключить другие причины кровотечения.
Этамзилат неэффективен у больных со сниженным числом тромбоцитов.
При геморрагических осложнениях, связанных с передозировкой антикоагулянтов, рекомендуется использовать специфические антидоты.
Использование этамзилата у больных с нарушенными показателями свертывающей системы крови возможно, но оно должно быть дополнено введением препаратов, устраняющих выявленный дефицит или дефект факторов свертывающей системы.
Из-за повышенного риска выраженного снижения АД при парентеральном способе применения этамзилата следует соблюдать осторожность у пациентов с нестабильным АД или склонностью к гипотензии.
Форма выпуска
Этамзилат раствор для в/в и в/м введения.
Условия хранения
Хранить в защищенном от света и недоступном для детей месте при температуре не выше 25°С.
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21.04.14"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"Р-р д/в/в и в/м введения 125 мг/мл"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"\u003ci\u003e1 мл раствора содержит: \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eАктивное вещество\u003c/i\u003e:"}},{"type":"paragraph","data":{"text":"этамзилат 125 мг;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eВспомогательные вещества\u003c/i\u003e:"}},{"type":"paragraph","data":{"text":"натрия дисульфит 4 мг,"}},{"type":"paragraph","data":{"text":"динатрия эдетат 0.1 мг,"}},{"type":"paragraph","data":{"text":"вода д/и до 1 мл."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"\u003ci\u003e\u003cb\u003eРаствор для в/в и в/м введения\u003c/b\u003e\u003c/i\u003e прозрачный, бесцветный или слабо окрашенный. "}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.vidal.ru/drugs/pharm-group/181\"\u003eГемостатическое средство\u003c/a\u003e"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Гемостатическое средство, оказывает также ангиопротекторное и проагрегантное действие. Стимулирует образование тромбоцитов и их выход из костного мозга. Гемостатическому действию, обусловленому активацией формирования тромбопластина в месте повреждения мелких сосудов и снижением образования в эндотелии сосудов простациклина PgI2, способствует повышению адгезии и агрегации тромбоцитов, что, в конечном счете, приводит к остановке или уменьшению кровоточивости. Увеличивает скорость образования первичного тромба и усиливает его ретракцию, практически не влияет на концентрацию фибриногена и протромбиновое время. Дозы более 2-10 мг/кг не приводят к большей выраженности эффекта. При повторных введениях тромбообразование усиливается. Обладая антигиалуронидазной активностью и стабилизируя аскорбиновую кислоту, препятствует разрушению и способствует образованию в стенке капилляров мукополисахаридов с большой молекулярной массой, повышает резистентность капилляров, снижает их хрупкость, нормализует проницаемость при патологических процессах. Уменьшает выход жидкости и диапедез форменных элементов крови из сосудистого русла, улучшает микроциркуляцию. Не оказывает сосудосуживающего действия. Восстанавливает патологически измененное время кровотечения."}},{"type":"paragraph","data":{"text":"На нормальные параметры системы гемостаза не влияет. Гемостатический эффект при в/в введении этамзилата наступает через 5-15 мин, максимальный эффект проявляется через 1-2 ч. Действие продолжается в течение 4-6 ч, затем в течение 24 ч постепенно ослабевает; при в/м введении эффект наступает через 30-60 мин."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"Этамзилат хорошо абсорбируется при в/м введении, слабо связывается с белками плазмы и форменными элементами крови. C\u003csub\u003emax \u003c/sub\u003eв плазме после в/м и в/в введения в дозе 500 мг достигается через 10 мин и составляет 30-50 мкг/мл. Терапевтическая концентрация в крови - 0.05-0.02 мг/мл. Этамзилат равномерно распределяется в различных органах и тканях (зависит от степени их кровоснабжения)."}},{"type":"paragraph","data":{"text":"После приема внутрь быстро и почти полностью всасывается. C\u003csub\u003emax \u003c/sub\u003eв плазме после приема в дозе 500 мг достигается через 4 ч и составляет 15 мкг/мл."}},{"type":"paragraph","data":{"text":"Связывание с белками плазмы составляет около 95%."}},{"type":"paragraph","data":{"text":"Практически полностью проникает через плацентарный барьер. Неизвестно, выделяется ли этамзилат с грудным молоком."}},{"type":"paragraph","data":{"text":"Выводится из организма главным образом почками (в неизменном виде), в незначительном количестве с желчью. T\u003csub\u003e1/2\u003c/sub\u003e после приема внутрь составляет около 3.7 ч, после в/в введения - 1.9 ч, после в/м введения - 2.1 ч."}},{"type":"paragraph","data":{"text":"Выводится из организма главным образом почками (в неизменном виде), в незначительном количестве с желчью: после приема внутрь - 72% в течение 24 ч; через 5 мин после в/в введения - 20-30% дозы, полностью - через 4 ч."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Профилактика и остановка кровотечений: паренхиматозные и капиллярные кровотечения (в т.ч. травматическое, в хирургии при операциях на сильно васкуляризированных органах и тканях, при оперативных вмешательствах в стоматологической, урологической, офтальмологической, отоларингологической практике, кишечное, почечное, легочное кровотечения, метро- и меноррагии при фибромиоме и другие), вторичные кровотечения на фоне тромбоцитопении и тромбоцитопатии, гипокоагуляция, гематурия, внутричерепное кровоизлияние (в т.ч. у новорожденных и недоношенных детей), носовые кровотечения на фоне артериальной гипертензии, кровотечения, обусловленные приемом лекарственных средств, геморрагический диатез (в т.ч. болезнь Верльгофа, Виллебранда-Юргенса, тромбоцитопатия), диабетическая микроангиопатия (геморрагическая диабетическая ретинопатия, повторное кровоизлияние в сетчатку, гемофтальм)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к этамзилату, острая порфирия, гемобластоз у детей, тромбоз, тромбоэмболия; беременность, период лактации (грудного вскармливания); детский возраст до 3 лет (для приема внутрь)."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Тромбоз, тромбоэмболия в анамнезе; кровотечения на фоне передозировки антикоагулянтов; нарушения функции печени и/или почек."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказан к применению при беременности и в период грудного вскармливания."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Применяют внутрь, в/м, в/в, местно, субконъюнктивально, ретробульбарно. Режим дозирования устанавливают индивидуально, в зависимости от показаний, клинической ситуации, возраста пациента, применяемой лекарственной формы."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы:\u003c/i\u003e часто - тошнота, диарея, тяжесть в эпигастральной области."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны кожи и подкожных тканей:\u003c/i\u003e часто - кожная сыпь; частота неизвестна - гиперемия кожи лица."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы: \u003c/i\u003eчасто - головная боль; частота неизвестна - головокружение, парестезии нижних конечностей."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e очень редко - тромбоэмболия, выраженное снижение АД."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны системы кроветворения:\u003c/i\u003e очень редко - агранулоцитоз, нейтропения, тромбоцитопения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны костно-мышечной системы: \u003c/i\u003eочень редко - артралгия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e часто - астения; очень редко - аллергические реакции, лихорадка."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"В рекомендованных дозах и способах введения препарат не вызывает интоксикаций и передозировки."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Введение этамзилата в дозе 10 мг/кг за 1 ч до введения растворов декстринов со средней молекулярной массой 30000-40000, предотвращает антиагрегационное действие последних; введение этамзилата после растворов декстранов не оказывает гемостатического действия."}},{"type":"paragraph","data":{"text":"Возможно сочетание с аминокапроновой кислотой и менадиона натрия бисульфитом."}},{"type":"paragraph","data":{"text":"Этамзилат фармацевтически несовместим (в одном шприце) с другими лекарственными препаратами."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Перед началом лечения следует исключить другие причины кровотечения."}},{"type":"paragraph","data":{"text":"Этамзилат неэффективен у больных со сниженным числом тромбоцитов."}},{"type":"paragraph","data":{"text":"При геморрагических осложнениях, связанных с передозировкой антикоагулянтов, рекомендуется использовать специфические антидоты."}},{"type":"paragraph","data":{"text":"Использование этамзилата у больных с нарушенными показателями свертывающей системы крови возможно, но оно должно быть дополнено введением препаратов, устраняющих выявленный дефицит или дефект факторов свертывающей системы."}},{"type":"paragraph","data":{"text":"Из-за повышенного риска выраженного снижения АД при парентеральном способе применения этамзилата следует соблюдать осторожность у пациентов с нестабильным АД или склонностью к гипотензии."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Этамзилат раствор для в/в и в/м введения."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить в защищенном от света и недоступном для детей месте при температуре не выше 25°С."}}]},{"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":"По рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.eapteka.ru/goods/manufacturer/severnaya_kitayskaya_farmatsevticheskaya_korporatsiya_ltd/\"\u003eСеверная Китайская Фармацевтическая Корпорация Лтд, Китай\u003c/a\u003e"}}]}],"source":null},"description_toggle":false,"short_description":"Гемостатическое средство, оказывает также ангиопротекторное и проагрегантное действие. Стимулирует образование тромбоцитов и их выход из костного мозга. Гемостатическому действию, обусловленому активацией формирования тромбопластина в месте повреждения мелких сосудов и снижением образования в эндотелии сосудов простациклина PgI2, способствует повышению адгезии и агрегации тромбоцитов, что, в конечном счете, приводит к остановке или уменьшению кровоточивости. Увеличивает скорость образования первичного тромба и усиливает его ретракцию, практически не влияет на концентрацию фибриногена и протромбиновое время. Дозы более 2-10 мг/кг не приводят к большей выраженности эффекта. При повторных введениях тромбообразование усиливается. Обладая антигиалуронидазной активностью и стабилизируя аскорбиновую кислоту, препятствует разрушению и способствует образованию в стенке капилляров мукополисахаридов с большой молекулярной массой, повышает резистентность капилляров, снижает их хрупкость, нормализует проницаемость при патологических процессах. 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