Этамзилат является гемостатическим лекарственным препаратом. Инструкция
Показания к применению
Капиллярные кровотечения различной этиологии особенно если кровотечение вызвано повреждением эндотелия:
- профилактика и остановка кровотечений во время и после хирургических операций на хорошо васкуляризованных тканях в отоларингологии гинекологии акушерстве урологии стоматологии офтальмологии и пластической хирургии;
Острая порфирия гемобластоз у детей повышенная чувствительность к любому ингредиенту препарата тромбоз тромбоэмболия.
Инструкция
Регистрационный номер
ЛС-001847 от 27.12.11
Торговое название препарата
Этамзилат
Лекарственная форма
раствор для внутривенного и внутримышечного введения
Состав
1 л препарата содержит:
этамзилата 125,0 г, натрия сернистокислого пиро (натрия дисульфит) 2,5 г, натрия сернистокислого безводного (натрия сульфит) 1,0 г, динатриевой соли этилендиамина тетрауксусной кислоты (Трилона Б) (эдетат динатрия) 0,5 г, воды для инъекций до 1 л.
Описание
Прозрачная бесцветная или слегка окрашенная жидкость.
Фармакотерапевтическая группа
гемостатическое средство
Фармакологические свойства
Фармакодинамика:
Этамзилат является гемостатическим лекарственным препаратом.
Кровоостанавливающее действие основано на усилении взаимодействия между эндотелием и тромбоцитами.
Повышает адгезию тромбоцитов стабилизирует стенки капилляров снижая таким образом их проницаемость тормозит синтез простагландинов вызывающих дезагрегацию тромбоцитов вазодилатацию и увеличение проницаемости капилляров что сокращает время кровотечения и уменьшает кровопотери.
Увеличивает скорость образования первичного тромба и усиливает его ретракцию практически не влияет на уровень фибриногена и протромбиновое время.
Восстанавливает патологически измененное время кровотечения. На нормальные параметры системы гемостаза не влияет.
Гемостатический эффект при внутривенном введении раствора Этамзилата наступает через 5-15 минут максимальный эффект - через 1-2 часа действие продолжается в течение 4-6 часов. При внутримышечном введении гемостатический эффект наступает через 30-60 минут.
Фармакокинетика:
Препарат хорошо абсорбируется при внутримышечном введении слабо связывается с белками плазмы и форменными элементами крови. Этамзилат равномерно распределяется в различных органах и тканях (зависит от степени их кровоснабжения).
Период полувыведения препарата после внутривенного введения составляет 19 часа после внутримышечного введения - 21 часа. Через 5 минут после внутривенного введения почками выделяется 20-30% введенного препарата полностью - через 4 часа. Эффективная концентрация в крови - 005-002 мг/мл. Препарат выводится из организма главным образом с мочой в незначительном количестве с желчью.
Показания к применению
Капиллярные кровотечения различной этиологии особенно если кровотечение вызвано повреждением эндотелия:
- профилактика и остановка кровотечений во время и после хирургических операций на хорошо васкуляризованных тканях в отоларингологии гинекологии акушерстве урологии стоматологии офтальмологии и пластической хирургии;
- профилактика и лечение капиллярных кровотечений различной этиологии и локализации: гематурии метроррагии первичной меноррагии меноррагии у женщин с внутриматочными контрацептивами носовых кровотечений кровоточивости десен.
Противопоказания
Острая порфирия гемобластоз у детей повышенная чувствительность к любому ингредиенту препарата тромбоз тромбоэмболия.
С осторожностью
При кровотечениях на фоне передозировки антикоагулянтов беременность.
Применение при беременности и в период грудного вскармливания
Безопасность применения этамзилата при беременности не установлена. Этамзилат следует применять во время беременности только в тех случаях если потенциальная польза для матери превышает возможный риск для плода. Следует прекратить грудное вскармливание во время лечения матери препаратом Этамзилат.
Способ применения и дозы
Этамзилат вводят внутривенно внутримышечно в офтальмологии субконъюнктивально и ретробульбарно. Этамзилат можно вводить внутривенно капельно в 5% растворе глюкозы или в изотоническом растворе натрия хлорида.
Взрослым: с профилактической целью при оперативных вмешательствах препарат вводят внутривенно или внутримышечно за 1 час до операции в дозе 025-05 г (2-4 мл 125% раствора) при необходимости во время операции - в дозе 025-05 г (2-4 мл 125% раствора) при опасности послеоперационного кровотечения - 05-075 г (4-6 мл 125% раствора) в течение суток.
Детям: при необходимости интраоперационно Этамзилат вводят внутривенно из расчета 8-10 мг/кг массы тела.
Для остановки кровотечения Этамзилат вводят внутривенно или внутримышечно 025-05 г (2-4 мл 125% раствора) после чего каждые 4-6 часов по 025 г (2 мл 125% раствора) в течение 5-10 дней.
При лечении метро-меноррагий Этамзилат назначают в разовой дозе 025 г (2 мл 125% раствора) внутривенно или внутримышечно каждые 6-8 часов в течение 5-10 дней.
При диабетической микроангиопатии Этамзилат вводят внутримышечно в течение 10-14 дней в разовой дозе 025-05 г три раза в сутки
В офтальмологии Этамзилат вводят субконъюнктивально или ретробульбарно - в дозе 0125 г (1 мл 125% раствора).
Побочное действие
Головная боль головокружение покраснение лица аллергическая сыпь парестезии нижних конечностей снижение артериального давления.
Взаимодействие с другими лекарственными средствами
Нельзя смешивать Этамзилат с другими лекарственными средствами. Введение препарата в дозе 10 мг/кг массы тела за 1 час до введения растворов декстранов со средней молекулярной массой 50000-40000 Да предотвращает антиагрегационное действие последних: введение этамзилата после растворов декстранов не оказывает гемостатического действия.
Возможно сочетание Этамзилата с аминокапроновой кислотой и менадиона натрия бисульфитом.
Особые указания
Требуется соблюдать осторожность у пациентов у которых когда-либо наблюдался тромбоз или тромбоэмболия.
Препарат 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.
Форма выпуска
Раствор для внутривенного и внутримышечного введения 125 мг/мл.
Условия хранения
В сухом защищенном от света месте при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
4 года.
По истечении срока годности не применять.
Условия отпуска
По рецепту
Производитель
ОАО "Биохимик", 430030, Республика Мордовия, Саранск, Васенко, д. 15а, Россия
Организация, принимающая претензии потребителей
ООО "ПРОМОМЕД РУС"
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На нормальные параметры системы гемостаза не влияет."}},{"type":"paragraph","data":{"text":"Гемостатический эффект при внутривенном введении раствора Этамзилата наступает через 5-15 минут максимальный эффект - через 1-2 часа действие продолжается в течение 4-6 часов. При внутримышечном введении гемостатический эффект наступает через 30-60 минут."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Препарат хорошо абсорбируется при внутримышечном введении слабо связывается с белками плазмы и форменными элементами крови. Этамзилат равномерно распределяется в различных органах и тканях (зависит от степени их кровоснабжения)."}},{"type":"paragraph","data":{"text":"Период полувыведения препарата после внутривенного введения составляет 19 часа после внутримышечного введения - 21 часа. Через 5 минут после внутривенного введения почками выделяется 20-30% введенного препарата полностью - через 4 часа. Эффективная концентрация в крови - 005-002 мг/мл. 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Этамзилат следует применять во время беременности только в тех случаях если потенциальная польза для матери превышает возможный риск для плода. Следует прекратить грудное вскармливание во время лечения матери препаратом Этамзилат."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Этамзилат вводят внутривенно внутримышечно в офтальмологии субконъюнктивально и ретробульбарно. Этамзилат можно вводить внутривенно капельно в 5% растворе глюкозы или в изотоническом растворе натрия хлорида."}},{"type":"paragraph","data":{"text":"Взрослым: с профилактической целью при оперативных вмешательствах препарат вводят внутривенно или внутримышечно за 1 час до операции в дозе 025-05 г (2-4 мл 125% раствора) при необходимости во время операции - в дозе 025-05 г (2-4 мл 125% раствора) при опасности послеоперационного кровотечения - 05-075 г (4-6 мл 125% раствора) в течение суток."}},{"type":"paragraph","data":{"text":"Детям: при необходимости интраоперационно Этамзилат вводят внутривенно из расчета 8-10 мг/кг массы тела."}},{"type":"paragraph","data":{"text":"Для остановки кровотечения Этамзилат вводят внутривенно или внутримышечно 025-05 г (2-4 мл 125% раствора) после чего каждые 4-6 часов по 025 г (2 мл 125% раствора) в течение 5-10 дней."}},{"type":"paragraph","data":{"text":"При лечении метро-меноррагий Этамзилат назначают в разовой дозе 025 г (2 мл 125% раствора) внутривенно или внутримышечно каждые 6-8 часов в течение 5-10 дней."}},{"type":"paragraph","data":{"text":"При диабетической микроангиопатии Этамзилат вводят внутримышечно в течение 10-14 дней в разовой дозе 025-05 г три раза в сутки"}},{"type":"paragraph","data":{"text":"В офтальмологии Этамзилат вводят субконъюнктивально или ретробульбарно - в дозе 0125 г (1 мл 125% раствора)."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Головная боль головокружение покраснение лица аллергическая сыпь парестезии нижних конечностей снижение артериального давления."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Нельзя смешивать Этамзилат с другими лекарственными средствами. Введение препарата в дозе 10 мг/кг массы тела за 1 час до введения растворов декстранов со средней молекулярной массой 50000-40000 Да предотвращает антиагрегационное действие последних: введение этамзилата после растворов декстранов не оказывает гемостатического действия."}},{"type":"paragraph","data":{"text":"Возможно сочетание Этамзилата с аминокапроновой кислотой и менадиона натрия бисульфитом."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Требуется соблюдать осторожность у пациентов у которых когда-либо наблюдался тромбоз или тромбоэмболия."}},{"type":"paragraph","data":{"text":"Препарат 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."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для внутривенного и внутримышечного введения 125 мг/мл."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом защищенном от света месте при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"4 года."}},{"type":"paragraph","data":{"text":"По истечении срока годности не применять."}}]},{"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":"ОАО \"Биохимик\", 430030, Республика Мордовия, Саранск, Васенко, д. 15а, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ООО \"ПРОМОМЕД РУС\""}}]}],"source":null},"description_toggle":false,"short_description":"Этамзилат является гемостатическим лекарственным препаратом. 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