порошок для приготовления суспензии для приема внутрь [клубничный]: клубничный ароматизатор 0,032 г; декстрозы моногидрат 0,721 г; натрия сахаринат 0,007 г.
Описание
Порошок для приготовления суспензии для приема внутрь [клубничный] от серовато-белого до серовато-коричневого или серовато-оранжевого цвета, со слабым запахом клубники.
Смектит диоктаэдрический адсорбирует газы в кишечнике у взрослых.
В клиническом исследовании, проведенном у детей с гастроэнтеритом, показано, что смектит диоктаэдрический обладает способностью восстанавливать нормальную проницаемость слизистой оболочки кишечника.
Благодаря своей листовой структуре и высокой пластичной вязкости смектит диоктаэдрический обладает сильными защитными свойствами в отношении слизистой оболочки ЖКТ.
Смектит диоктаэдрический действует как стабилизатор слизи и цитопротектор слизистой оболочки ЖКТ против агрессивных агентов, таких как соляная кислота, соли желчных кислот и других раздражителей. Обладает высокой адсорбционной способностью в отношении энтеротоксинов, бактерий и вирусов, а также усиливает барьер слизистой оболочки кишечника.
В исследованиях in vitro адсорбция холерного токсина (энтеротоксина) наблюдается через 30 мин инкубации со смектитом диоктаэдрическим, связывание вирионов ротавируса - через 1 ч после инкубации.
Смектит диоктаэдрический восстанавливает дефект эпителиального барьера, вызванный провоспалительным цитокином TNF-α (участвует в различных кишечных расстройствах: инфекционная диарея, воспалительные заболевания кишечника и пищевая аллергия).
Фармакокинетика
При попадании в организм смектит диоктаэдрический локализуется на внутренней стороне эпителия (не всасывается и не метаболизируется). Смектит диоктаэдрический выводится через кишечник в процессе нормального кишечного транзита.
Показания к применению
лечение острой диареи у детей старше 2 лет (в дополнение к пероральной регидратации) и у взрослых;
симптоматическое лечение хронической функциональной диареи у взрослых;
симптоматическое лечение боли, связанной с функциональными заболеваниями кишечника у взрослых.
Противопоказания
повышенная чувствительность к действующему веществу или к любому из вспомогательных веществ;
детский возраст до 2 лет.
С осторожностью
у пациентов с тяжелым хроническим запором в анамнезе.
Не рекомендуется пациентам с редкими наследственными заболеваниями непереносимости фруктозы, синдромом мальабсорбции глюкозы и/или галактозы или дефицитом сахаразы/изомальтазы.
Применение при беременности и в период грудного вскармливания
Беременность
Данные о применении смектита диоктаэдрического у беременных женщин отсутствуют или имеются ограниченные данные (менее 300 беременностей).
Экспериментальные исследования на животных недостаточны, чтобы сделать вывод о токсическом действии на репродуктивную функцию.
Применение смектита диоктаэдрического при беременности не рекомендуется.
Период грудного вскармливания
Существует ограниченное количество данных, полученных при применении смектита диоктаэдрического в период грудного вскармливания.
Применение смектита диоктаэдрического в период грудного вскармливания не рекомендуется.
Способ применения и дозы
Препарат принимают внутрь.
Лечение острой диареи
Взрослым назначают 3 пакетика/сут в течение 7 дней. Суточная доза может быть удвоена в начале лечения.
Детям старше 2 лет - 2 пакетика/сут в течение 7 дней. Суточная доза может быть удвоена в начале лечения.
Применение при других показаниях
У взрослых - 3 пакетика/сут.
Способ применения
Перед применением следует приготовить суспензию.
Для взрослых содержимое пакетика растворяют в 1/2 стакана воды, постепенно всыпая порошок и равномерно его размешивая. Предпочтительно принимать между приемами пищи.
Для детей содержимое пакетика можно растворить в детской бутылочке (50 мл) и распределить на несколько приемов в течение дня или перемешать с каким-либо полужидким продуктом (каша, пюре, компот, детское питание).
Если в период лечения улучшения не наступает или симптомы усугубляются, или появляются новые симптомы, необходимо проконсультироваться с врачом. Рекомендуется применять препарат только согласно тем показаниям, тому способу применения и в тех дозах, которые указаны в инструкции по медицинскому применению.
Побочное действие
Со стороны пищеварительной системы: в клинических исследованиях редко - запор (слабо выражен, проходил после коррекции дозы препарата).
Аллергические реакции: в рутинной практике очень редко - крапивница, сыпь, зуд, отек Квинке.
Передозировка
Передозировка может вызвать выраженный запор или безоар.
Взаимодействие с другими лекарственными средствами
Смектит диоктаэдрический может уменьшать скорость и степень всасывания одновременно принимаемых лекарственных средств. Не рекомендуется принимать смектит диоктаэдрический одновременно с другими лекарственными средствами.
Особые указания
Препарат Смекта необходимо применять с мерами особой предосторожности у пациентов с тяжелыми хроническими запорами в анамнезе.
У новорожденных и детей младше 2 лет препарат Смекта применять не следует. Стандартным лечением острой диареи у детей младше 2 лет является раствор для пероральной регидратации.
У детей старше 2 лет применение препарата необходимо осуществлять в сочетании с ранним введением раствора для пероральной регидратационной терапии, чтобы избежать обезвоживания организма. Следует избегать постоянного использования препарата Смекта.
У взрослых комплекс мер по регидратации проводится в случае необходимости.
Количество раствора для пероральной или в/в регидратационной терапии зависит от интенсивности диареи, возраста и состояния пациента.
Рекомендуется соблюдать интервал не менее 2 часов между приемом лекарственного препарата Смекта и других лекарственных средств.
Пациент должен быть предупрежден о потребности:
восполнить потери жидкости, связанные с диареей путем потребления большого количества соленых или сладких жидкостей (среднесуточная потребность в жидкости для взрослого пациента составляет 2 л);
поддерживать рацион питания в период сохранения диареи: исключить некоторые продукты (особенно сырые овощи и фрукты, зеленые овощи, пряные блюда, а также замороженные продукты или напитки); отдать предпочтение мясу, приготовленному на гриле и рису.
Влияние на способность управлять автомобилем и движущимися механизмами
Применение смектита диоктаэдрического не влияет или незначительно влияет на способность управлять транспортными средствами, механизмами.
Форма выпуска
Порошок для приготовления суспензии для приема внутрь
Условия хранения
Препарат следует хранить в недоступном для детей месте при температуре не выше 30°С.
Срок годности
Срок годности - 3 года. Не применять по истечении срока годности, указанного на упаковке.
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Обладает высокой адсорбционной способностью в отношении энтеротоксинов, бактерий и вирусов, а также усиливает барьер слизистой оболочки кишечника."}},{"type":"paragraph","data":{"text":"В исследованиях in vitro адсорбция холерного токсина (энтеротоксина) наблюдается через 30 мин инкубации со смектитом диоктаэдрическим, связывание вирионов ротавируса - через 1 ч после инкубации."}},{"type":"paragraph","data":{"text":"Смектит диоктаэдрический восстанавливает дефект эпителиального барьера, вызванный провоспалительным цитокином TNF-α (участвует в различных кишечных расстройствах: инфекционная диарея, воспалительные заболевания кишечника и пищевая аллергия)."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"При попадании в организм смектит диоктаэдрический локализуется на внутренней стороне эпителия (не всасывается и не метаболизируется). Смектит диоктаэдрический выводится через кишечник в процессе нормального кишечного транзита."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["лечение острой диареи у детей старше 2 лет (в дополнение к пероральной регидратации) и у взрослых;","симптоматическое лечение хронической функциональной диареи у взрослых;","симптоматическое лечение боли, связанной с функциональными заболеваниями кишечника у взрослых."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["повышенная чувствительность к действующему веществу или к любому из вспомогательных веществ;","детский возраст до 2 лет."]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"у пациентов с тяжелым хроническим запором в анамнезе."}},{"type":"paragraph","data":{"text":"Не рекомендуется пациентам с редкими наследственными заболеваниями непереносимости фруктозы, синдромом мальабсорбции глюкозы и/или галактозы или дефицитом сахаразы/изомальтазы."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Беременность"}},{"type":"paragraph","data":{"text":"Данные о применении смектита диоктаэдрического у беременных женщин отсутствуют или имеются ограниченные данные (менее 300 беременностей)."}},{"type":"paragraph","data":{"text":"Экспериментальные исследования на животных недостаточны, чтобы сделать вывод о токсическом действии на репродуктивную функцию."}},{"type":"paragraph","data":{"text":"Применение смектита диоктаэдрического при беременности не рекомендуется."}},{"type":"paragraph","data":{"text":"Период грудного вскармливания"}},{"type":"paragraph","data":{"text":"Существует ограниченное количество данных, полученных при применении смектита диоктаэдрического в период грудного вскармливания."}},{"type":"paragraph","data":{"text":"Применение смектита диоктаэдрического в период грудного вскармливания не рекомендуется."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат принимают внутрь."}},{"type":"paragraph","data":{"text":"Лечение острой диареи"}},{"type":"paragraph","data":{"text":"Взрослым назначают 3 пакетика/сут в течение 7 дней. Суточная доза может быть удвоена в начале лечения."}},{"type":"paragraph","data":{"text":"Детям старше 2 лет - 2 пакетика/сут в течение 7 дней. Суточная доза может быть удвоена в начале лечения."}},{"type":"paragraph","data":{"text":"Применение при других показаниях"}},{"type":"paragraph","data":{"text":"У взрослых - 3 пакетика/сут."}},{"type":"paragraph","data":{"text":"Способ применения"}},{"type":"paragraph","data":{"text":"Перед применением следует приготовить суспензию."}},{"type":"paragraph","data":{"text":"Для взрослых содержимое пакетика растворяют в 1/2 стакана воды, постепенно всыпая порошок и равномерно его размешивая. Предпочтительно принимать между приемами пищи."}},{"type":"paragraph","data":{"text":"Для детей содержимое пакетика можно растворить в детской бутылочке (50 мл) и распределить на несколько приемов в течение дня или перемешать с каким-либо полужидким продуктом (каша, пюре, компот, детское питание)."}},{"type":"paragraph","data":{"text":"Если в период лечения улучшения не наступает или симптомы усугубляются, или появляются новые симптомы, необходимо проконсультироваться с врачом. Рекомендуется применять препарат только согласно тем показаниям, тому способу применения и в тех дозах, которые указаны в инструкции по медицинскому применению."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: в клинических исследованиях редко - запор (слабо выражен, проходил после коррекции дозы препарата)."}},{"type":"paragraph","data":{"text":"Аллергические реакции: в рутинной практике очень редко - крапивница, сыпь, зуд, отек Квинке."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Передозировка может вызвать выраженный запор или безоар."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Смектит диоктаэдрический может уменьшать скорость и степень всасывания одновременно принимаемых лекарственных средств. Не рекомендуется принимать смектит диоктаэдрический одновременно с другими лекарственными средствами."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Препарат Смекта необходимо применять с мерами особой предосторожности у пациентов с тяжелыми хроническими запорами в анамнезе."}},{"type":"paragraph","data":{"text":"У новорожденных и детей младше 2 лет препарат Смекта применять не следует. Стандартным лечением острой диареи у детей младше 2 лет является раствор для пероральной регидратации."}},{"type":"paragraph","data":{"text":"У детей старше 2 лет применение препарата необходимо осуществлять в сочетании с ранним введением раствора для пероральной регидратационной терапии, чтобы избежать обезвоживания организма. Следует избегать постоянного использования препарата Смекта."}},{"type":"paragraph","data":{"text":"У взрослых комплекс мер по регидратации проводится в случае необходимости."}},{"type":"paragraph","data":{"text":"Количество раствора для пероральной или в/в регидратационной терапии зависит от интенсивности диареи, возраста и состояния пациента."}},{"type":"paragraph","data":{"text":"Рекомендуется соблюдать интервал не менее 2 часов между приемом лекарственного препарата Смекта и других лекарственных средств."}},{"type":"paragraph","data":{"text":"Пациент должен быть предупрежден о потребности:"}},{"type":"list","data":{"style":"ordered","items":["восполнить потери жидкости, связанные с диареей путем потребления большого количества соленых или сладких жидкостей (среднесуточная потребность в жидкости для взрослого пациента составляет 2 л);","поддерживать рацион питания в период сохранения диареи: исключить некоторые продукты (особенно сырые овощи и фрукты, зеленые овощи, пряные блюда, а также замороженные продукты или напитки); отдать предпочтение мясу, приготовленному на гриле и рису."]}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Применение смектита диоктаэдрического не влияет или незначительно влияет на способность управлять транспортными средствами, механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Порошок для приготовления суспензии для приема внутрь"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Препарат следует хранить в недоступном для детей месте при температуре не выше 30°С."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"Срок годности - 3 года. Не применять по истечении срока годности, указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Препарат отпускают без рецепта."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.vidal.ru/drugs/firm/7326\"\u003eIPSEN CONSUMER HEALTHCARE \u003c/a\u003e(Франция) "}}]}],"source":null},"description_toggle":false,"short_description":"Смектит диоктаэдрический адсорбирует газы в кишечнике у взрослых. В клиническом исследовании, проведенном у детей с гастроэнтеритом, показано, что смектит диоктаэдрический обладает способностью восстанавливать нормальную проницаемость слизистой оболочки кишечника. Благодаря своей листовой структуре и высокой пластичной вязкости смектит диоктаэдрический обладает сильными защитными свойствами в отношении слизистой оболочки ЖКТ. Смектит диоктаэдрический действует как стабилизатор слизи и цитопротектор слизистой оболочки ЖКТ против агрессивных агентов, таких как соляная кислота, соли желчных кислот и других раздражителей. Обладает высокой адсорбционной способностью в отношении энтеротоксинов, бактерий и вирусов, а также усиливает барьер слизистой оболочки кишечника. В исследованиях in vitro адсорбция холерного токсина (энтеротоксина) наблюдается через 30 мин инкубации со смектитом диоктаэдрическим, связывание вирионов ротавируса - через 1 ч после инкубации. Смектит диоктаэдрический восстанавливает дефект эпителиального барьера, вызванный провоспалительным цитокином TNF-α (участвует в различных кишечных расстройствах: инфекционная диарея, воспалительные заболевания кишечника и пищевая аллергия). При попадании в организм смектит диоктаэдрический локализуется на внутренней стороне эпителия (не всасывается и не метаболизируется). 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