В качестве слабительного средства в следующих случаях:
- запор, обусловленный атонией и гипотонией толстой кишки (в том числе в пожилом возрасте, у пациентов после операций, после родов и в период грудного вскармливания);
- запор, вызванный приемом лекарственных средств;
- для регулирования стула при геморрое, проктите, анальных трещинах (для размягчения ...
Повышенная чувствительность к натрия пикосульфату или другим компонентам препарата; кишечная непроходимость или обструктивные заболевания кишечника; острые воспалительные заболевания кишечника, острые заболевания органов брюшной полости или сильная боль в животе, которые могут сопровождаться тошнотой, рвотой, повышением температуры тела, включая аппендицит; ...
Круглые, плоскоцилиндрические таблетки белого или почти белого цвета, с риской и фаской.
Фармакотерапевтическая группа
Слабительное средство
Фармакологические свойства
Фармакодинамика:
Действующее вещество - натрия пикосульфат представляет собой слабительное средство триарилметановой группы. Как местное слабительное, натрия пикосульфат после расщепления бактериальными сульфатазами в толстом кишечнике стимулирует чувствительные нервные окончания слизистой оболочки, увеличивая перистальтику, способствует накоплению воды и электролитов в толстом кишечнике. Это приводит к стимуляции акта дефекации, уменьшению времени эвакуации и размягчению стула.
Натрия пикосульфат, действуя на уровне толстой кишки, стимулирует естественный процесс эвакуации содержимого из нижних отделов желудочно-кишечного тракта. Поэтому применение препарата не сопровождается тенезмами и спазмами кишечника, не оказывает влияния на переваривание или всасывание калорийной пищи или незаменимых питательных веществ в тонком кишечнике.
Фармакокинетика:
Абсорбция: незначительная, препарат практически полностью метаболизируется в стенке кишечника и печени до неактивного глюкуронида.
После перорального приема натрия пикосульфат проходит в неизмененном виде через желудок и тонкий кишечник, поступая в толстый кишечник. Абсорбция препарата незначительна, что исключает его энтерогепатическую циркуляцию. В дистальном отделе толстого кишечника происходит расщепление натрия пикосульфата с образованием активного метаболита, бис-(п-гидроксифенил)-пиридил-2-метана. Время развития слабительного эффекта препарата определяется скоростью высвобождения активного метаболита и составляет 6-12 часов.
Взаимосвязь между слабительным эффектом активного метаболита и его концентрацией в плазме крови отсутствует.
После приема 10 мг препарата внутрь около 10,4% от величины общей дозы выводится почками в виде глюкуронида через 48 часов. При применении более высоких доз препарата выведение его почками, в целом, уменьшается.
Показания к применению
В качестве слабительного средства в следующих случаях:
- запор, обусловленный атонией и гипотонией толстой кишки (в том числе в пожилом возрасте, у пациентов после операций, после родов и в период грудного вскармливания);
- запор, вызванный приемом лекарственных средств;
- для регулирования стула при геморрое, проктите, анальных трещинах (для размягчения консистенции кала);
- заболевания желчного пузыря, синдром раздраженной кишки с преобладанием запора;
Повышенная чувствительность к натрия пикосульфату или другим компонентам препарата; кишечная непроходимость или обструктивные заболевания кишечника; острые воспалительные заболевания кишечника, острые заболевания органов брюшной полости или сильная боль в животе, которые могут сопровождаться тошнотой, рвотой, повышением температуры тела, включая аппендицит; тяжелая дегидратация; дефицит лактазы, непереносимость лактозы, глюкозо-галактозная мальабсорбция; детский возраст до 4 лет.
С осторожностью
Пожилой возраст, гипокалиемия.
Применение при беременности и в период грудного вскармливания
В течение длительного опыта применения препарата нежелательных явлений во время беременности выявлено не было. Однако, ввиду отсутствия исследований, применение препарата Гутгасил во время беременности рекомендовано только в случаях, если потенциальная польза для матери превышает возможный риск для плода. В период беременности препарат может быть применен только после консультации со специалистом.
Активный метаболит и его глюкурониды не выделяются с грудным молоком. Таким образом, препарат может быть использован в период грудного вскармливания.
Способ применения и дозы
Назначают внутрь, желательно на ночь.
Препарат необходимо запивать достаточным количеством жидкости.
Взрослым и детям старше 10 лет - по 5-10 мг 1 раз в сутки. Максимально рекомендуемая суточная доза не более 15 мг.
Детям от 4 до 10 лет - 2,5-5 мг 1 раз в сутки.
Не применять препарат детям без консультации врача.
Таблетки по 7,5 мг не применять детям до 10 лет.
Таблетки по 5 мг не применять детям до 4 лет.
Рекомендуется начинать с наименьшей дозы. Для того чтобы достичь регулярного стула, доза может повышаться до максимально рекомендуемой. Не следует превышать максимально рекомендуемую дозу.
Для детей бывает эффективным однократный прием препарата. При необходимости курс лечения у ребенка может быть продлен, но предпочтительно ограничить его тремя днями.
Длительность лечения устанавливается индивидуально и обычно не должна превышать 10 дней.
Побочное действие
При длительном применении препарата в завышенных дозах возможны появление мышечной слабости, нарушений функций сердца и нарушений водно-электролитного баланса (потери калия и других электролитов, развитие дегидратации).
Со стороны желудочно-кишечного тракта: тошнота, рвота, спазмы и боль в животе, диарея;
Со стороны иммунной системы: реакции гиперчувствительности, включая ангионевротический отек, крапивницу, кожные высыпания, зуд;
Со стороны нервной системы: головокружение и обморок, возникающие после приема препарата и, связанные, по-видимому, с вазовагальной реакцией (например, спазмами в животе или напряжением при дефекации).
Передозировка
Симптомы. Большие дозы препарата Гуттасил могут вызвать диарею, спазмы (колики) в животе и клинически значимые нарушения водно-электролитного баланса (гипокалиемия, потеря других электролитов и жидкости), ишемию слизистой оболочки толстого кишечника, судороги. Длительная передозировка приводит к развитию хронической диареи и боли в животе, гипокалиемии, вторичного гиперальдостеронизма, возможно поражение почек и развитие нефролитиаза, метаболический алкалоз и мышечная слабость как результат гипокалиемии.
Взаимодействие с другими лекарственными средствами
Электролитный дисбаланс может привести к повышению чувствительности к сердечным гликозидам.
Диуретики или глюкокортикостероиды могут усиливать выраженность гипокалиемии, вызванной применением препарата Гуттасил в высоких дозах.
Одновременное лечение антибиотиками может снизить слабительный эффект препарата.
Особые указания
Как и другие слабительные средства, препарат Гуттасил не следует принимать ежедневно или длительное время. Не принимать препарат без консультации врача более 10 дней.
Если есть необходимость в ежедневном приеме слабительных средств, следует выяснить причину запоров. Длительное применение слабительных средств может привести к потере жидкости, электролитному дисбалансу и гипокалиемии, а также стать причиной привыкания и запоров вследствие эффекта "рикошета".
Использовать с осторожностью пожилым людям, при гипокалиемии.
Препарат содержит лактозу, что следует иметь в виду лицам с наследственной непереносимостью лактозы, дефицитом лактазы, глюкозо-галактозной мальабсорбцией.
Влияние на способность управлять автомобилем и движущимися механизмами
Специальные клинические исследования влияния препарата на способность управлять автотранспортом или работать с механизмами не проводились.
Несмотря на это, пациентам следует сообщить, что у них вследствие вазовагальной реакции (т.е. во время спазма кишечника) могут возникнуть головокружение и/или обморок. Если у пациентов возникает спазм кишечника, они должны избегать потенциально опасных видов деятельности, в том числе вождения автотранспорта или управления механизмами.
Форма выпуска
Таблетки, 5 мг и 7,5 мг.
Условия хранения
Хранить в защищенном от света месте, при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
2 года.
Не использовать по истечении срока годности, указанного на упаковке.
Условия отпуска
Без рецепта
Производитель
Публичное акционерное общество "Фармак" (ПАО "Фармак"), 04080, г. Киев, ул. Фрунзе, д. 74, Украина
Организация, принимающая претензии потребителей
ПАО "Фармак"
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номер","slug":"","body":[{"type":"paragraph","data":{"text":"ЛП-003355"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Гуттасил"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"таблетки"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eВ одной таблетке 5 мг содержится\u003c/i\u003e:"}},{"type":"paragraph","data":{"text":"\u003ci\u003eдействующее вещество: \u003c/i\u003eнатрия пикосульфат в пересчете на 100% безводное вещество - 5,0 мг;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eвспомогательные вещества\u003c/i\u003e: лактозы моногидрат - 96,8 мг, крахмал кукурузный - 12,0 мг, крахмал прежелатинизированный 1500 - 3,6 мг, кремния диоксид коллоидный - 1,2 мг, магния стеарат - 1,2 мг."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВ одной таблетке 7,5 мг содержится:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eдействующее вещество:\u003c/i\u003e натрия пикосульфат в пересчете на 100% безводное вещество - 7,5 мг;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eвспомогательные вещества\u003c/i\u003e: лактозы моногидрат - 145,2 мг, крахмал кукурузный - 18,0 мг, крахмал прежелатинизированный 1500 - 5,4 мг, кремния диоксид коллоидный - 1,8 мг, магния стеарат - 1,8 мг."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Круглые, плоскоцилиндрические таблетки белого или почти белого цвета, с риской и фаской."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Слабительное средство"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Действующее вещество - натрия пикосульфат представляет собой слабительное средство триарилметановой группы. Как местное слабительное, натрия пикосульфат после расщепления бактериальными сульфатазами в толстом кишечнике стимулирует чувствительные нервные окончания слизистой оболочки, увеличивая перистальтику, способствует накоплению воды и электролитов в толстом кишечнике. Это приводит к стимуляции акта дефекации, уменьшению времени эвакуации и размягчению стула."}},{"type":"paragraph","data":{"text":"Натрия пикосульфат, действуя на уровне толстой кишки, стимулирует естественный процесс эвакуации содержимого из нижних отделов желудочно-кишечного тракта. Поэтому применение препарата не сопровождается тенезмами и спазмами кишечника, не оказывает влияния на переваривание или всасывание калорийной пищи или незаменимых питательных веществ в тонком кишечнике."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"\u003ci\u003eАбсорбция: \u003c/i\u003eнезначительная, препарат практически полностью метаболизируется в стенке кишечника и печени до неактивного глюкуронида."}},{"type":"paragraph","data":{"text":"После перорального приема натрия пикосульфат проходит в неизмененном виде через желудок и тонкий кишечник, поступая в толстый кишечник. Абсорбция препарата незначительна, что исключает его энтерогепатическую циркуляцию. В дистальном отделе толстого кишечника происходит расщепление натрия пикосульфата с образованием активного метаболита, бис-(п-гидроксифенил)-пиридил-2-метана. Время развития слабительного эффекта препарата определяется скоростью высвобождения активного метаболита и составляет 6-12 часов."}},{"type":"paragraph","data":{"text":"Взаимосвязь между слабительным эффектом активного метаболита и его концентрацией в плазме крови отсутствует."}},{"type":"paragraph","data":{"text":"После приема 10 мг препарата внутрь около 10,4% от величины общей дозы выводится почками в виде глюкуронида через 48 часов. При применении более высоких доз препарата выведение его почками, в целом, уменьшается."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"В качестве слабительного средства в следующих случаях:"}},{"type":"paragraph","data":{"text":"- запор, обусловленный атонией и гипотонией толстой кишки (в том числе в пожилом возрасте, у пациентов после операций, после родов и в период грудного вскармливания);"}},{"type":"paragraph","data":{"text":"- запор, вызванный приемом лекарственных средств;"}},{"type":"paragraph","data":{"text":"- для регулирования стула при геморрое, проктите, анальных трещинах (для размягчения консистенции кала);"}},{"type":"paragraph","data":{"text":"- заболевания желчного пузыря, синдром раздраженной кишки с преобладанием запора;"}},{"type":"paragraph","data":{"text":"- запор, обусловленный дисбактериозом кишечника, нарушениями диеты."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к натрия пикосульфату или другим компонентам препарата; кишечная непроходимость или обструктивные заболевания кишечника; острые воспалительные заболевания кишечника, острые заболевания органов брюшной полости или сильная боль в животе, которые могут сопровождаться тошнотой, рвотой, повышением температуры тела, включая аппендицит; тяжелая дегидратация; дефицит лактазы, непереносимость лактозы, глюкозо-галактозная мальабсорбция; детский возраст до 4 лет."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Пожилой возраст, гипокалиемия."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"В течение длительного опыта применения препарата нежелательных явлений во время беременности выявлено не было. Однако, ввиду отсутствия исследований, применение препарата Гутгасил во время беременности рекомендовано только в случаях, если потенциальная польза для матери превышает возможный риск для плода. В период беременности препарат может быть применен только после консультации со специалистом."}},{"type":"paragraph","data":{"text":"Активный метаболит и его глюкурониды не выделяются с грудным молоком. Таким образом, препарат может быть использован в период грудного вскармливания."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Назначают внутрь, желательно на ночь."}},{"type":"paragraph","data":{"text":"Препарат необходимо запивать достаточным количеством жидкости."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВзрослым и детям старше 10 лет \u003c/i\u003e- по 5-10 мг 1 раз в сутки. Максимально рекомендуемая суточная доза не более 15 мг."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДетям от 4 до 10 лет\u003c/i\u003e - 2,5-5 мг 1 раз в сутки."}},{"type":"paragraph","data":{"text":"Не применять препарат детям без консультации врача."}},{"type":"paragraph","data":{"text":"Таблетки по 7,5 мг не применять детям до 10 лет."}},{"type":"paragraph","data":{"text":"Таблетки по 5 мг не применять детям до 4 лет."}},{"type":"paragraph","data":{"text":"Рекомендуется начинать с наименьшей дозы. Для того чтобы достичь регулярного стула, доза может повышаться до максимально рекомендуемой. Не следует превышать максимально рекомендуемую дозу."}},{"type":"paragraph","data":{"text":"Для детей бывает эффективным однократный прием препарата. При необходимости курс лечения у ребенка может быть продлен, но предпочтительно ограничить его тремя днями."}},{"type":"paragraph","data":{"text":"Длительность лечения устанавливается индивидуально и обычно не должна превышать 10 дней."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"При длительном применении препарата в завышенных дозах возможны появление мышечной слабости, нарушений функций сердца и нарушений водно-электролитного баланса (потери калия и других электролитов, развитие дегидратации)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны желудочно-кишечного тракта:\u003c/i\u003e тошнота, рвота, спазмы и боль в животе, диарея;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны иммунной системы:\u003c/i\u003e реакции гиперчувствительности, включая ангионевротический отек, крапивницу, кожные высыпания, зуд;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы: \u003c/i\u003eголовокружение и обморок, возникающие после приема препарата и, связанные, по-видимому, с вазовагальной реакцией (например, спазмами в животе или напряжением при дефекации)."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы\u003c/i\u003e. Большие дозы препарата Гуттасил могут вызвать диарею, спазмы (колики) в животе и клинически значимые нарушения водно-электролитного баланса (гипокалиемия, потеря других электролитов и жидкости), ишемию слизистой оболочки толстого кишечника, судороги. Длительная передозировка приводит к развитию хронической диареи и боли в животе, гипокалиемии, вторичного гиперальдостеронизма, возможно поражение почек и развитие нефролитиаза, метаболический алкалоз и мышечная слабость как результат гипокалиемии."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение.\u003c/i\u003e Отмена препарата, вызывание рвоты, промывание желудка, приём энтеросорбентов (активированный уголь), симптоматическое лечение (проведение коррекции водно-электролитного баланса, применение спазмолитиков)."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Электролитный дисбаланс может привести к повышению чувствительности к сердечным гликозидам."}},{"type":"paragraph","data":{"text":"Диуретики или глюкокортикостероиды могут усиливать выраженность гипокалиемии, вызванной применением препарата Гуттасил в высоких дозах."}},{"type":"paragraph","data":{"text":"Одновременное лечение антибиотиками может снизить слабительный эффект препарата."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Как и другие слабительные средства, препарат Гуттасил не следует принимать ежедневно или длительное время. Не принимать препарат без консультации врача более 10 дней."}},{"type":"paragraph","data":{"text":"Если есть необходимость в ежедневном приеме слабительных средств, следует выяснить причину запоров. Длительное применение слабительных средств может привести к потере жидкости, электролитному дисбалансу и гипокалиемии, а также стать причиной привыкания и запоров вследствие эффекта \"рикошета\"."}},{"type":"paragraph","data":{"text":"Использовать с осторожностью пожилым людям, при гипокалиемии."}},{"type":"paragraph","data":{"text":"Препарат содержит лактозу, что следует иметь в виду лицам с наследственной непереносимостью лактозы, дефицитом лактазы, глюкозо-галактозной мальабсорбцией."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Специальные клинические исследования влияния препарата на способность управлять автотранспортом или работать с механизмами не проводились."}},{"type":"paragraph","data":{"text":"Несмотря на это, пациентам следует сообщить, что у них вследствие вазовагальной реакции (т.е. во время спазма кишечника) могут возникнуть головокружение и/или обморок. Если у пациентов возникает спазм кишечника, они должны избегать потенциально опасных видов деятельности, в том числе вождения автотранспорта или управления механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки, 5 мг и 7,5 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить в 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":"2 года."}},{"type":"paragraph","data":{"text":"Не использовать по истечении срока годности, указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Без рецепта"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Публичное акционерное общество \"Фармак\" (ПАО \"Фармак\"), 04080, г. Киев, ул. Фрунзе, д. 74, Украина"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ПАО \"Фармак\""}}]}],"source":null},"description_toggle":false,"short_description":"Действующее вещество - натрия пикосульфат представляет собой слабительное средство триарилметановой группы. Как местное слабительное, натрия пикосульфат после расщепления бактериальными сульфатазами в толстом кишечнике стимулирует чувствительные нервные окончания слизистой оболочки, увеличивая перистальтику, способствует накоплению воды и электролитов в толстом кишечнике. Это приводит к стимуляции акта дефекации, уменьшению времени эвакуации и размягчению стула. Натрия пикосульфат, действуя на уровне толстой кишки, стимулирует естественный процесс эвакуации содержимого из нижних отделов желудочно-кишечного тракта. 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