Описание актуально на 17.09.2016
- Латинское название: Guttasil
- Код АТХ: A06AB08
- Действующее вещество: Натрия пикосульфат (Sodium picosulfate)
- Производитель: Фармак ПАО (Украина)
Состав
Состав 1 мл капель Гуттасил:
- 7,5 мг пикосульфата натрия в виде моногидрата (действующее вещество);
- 460 мг сорбитола;
- 2 мг метилпарагидроксибензоата натрия;
- небольшое количество раствора соляной кислоты – столько, сколько необходимо для достижения нужных значений кислотности (pH=6-7);
- до 1мл воды для инъекций.
Каждая таблетка содержит 7,5 мг пикосульфата натрия.
Форма выпуска
Выпускают в двух фармакологических формах:
- Капли. Внешне это прозрачный бесцветный или желтоватый раствор. Разливают во флаконы с дозаторами и крышками-пломбами по 15 мл и 30 мл. Флаконы продают в картонных пачках.
- Таблетки по 7,5 мг. В блистер помещают 10 таблеток, в картонную пачку 3 блистера.
Фармакологическое действие
Оказывает слабительное действие, усиливает перистальтику кишечника.
Фармакодинамика и фармакокинетика
Фармакодинамика
Относится к триарилметановой группе средств, обладающих контактным механизмом действия. Влияние на организм начинается после того, как в толстом кишечнике действующее вещество будет активировано бактериальными сульфатазами.
Вещество, которое образуется при описанном выше взаимодействии, способно действовать на нервные окончания, расположенные в слизистой кишечника. Благодаря этому усиливается его моторика, но не настолько, чтобы наблюдались тенезмы или спазмы.
Если принимать Гуттасил в течение некоторого времени, усилится рост, активность и ускорятся метаболические процессы в популяциях нормальной микрофлоры.
Фармакокинетика
До того, как лекарство попадает в толстый кишечник, оно практически не абсорбируется.
Эффект начинает проявляться через 6-12 часов. Его выраженность далеко не всегда коррелирует с уровнем активной формы в плазме.
Показания к применению
Гуттасил назначают в таких случаях:
- нарушения стула в виде запоров;
- болезни толстой кишки и заднего прохода, при которых необходимо облегчить процесс дефекации (геморрой, трещины, проктит);
- подготовительный этап перед инвазивными медицинскими мероприятиями (операция, инструментальное или рентгенологическое исследование).
Противопоказания
Запрещено назначать Гуттасил при:
- гиперчувствительности к активному веществу, его метаболитам, дополнительным ингредиентам, входящим в состав лекарства;
- непроходимости кишечника;
- остром воспалении в кишечнике или других органах, находящихся в брюшной полости, например, при остром аппендиците, неспецифическом язвенном колите, перитоните);
- острой боли в животе, особенно если она сопровождается тошнотой и рвотой;
- сильном обезвоживании;
- лактации;
- беременности (в первом триместре).
Очень осторожно следует применять лекарство таким категориям пациентов:
- люди преклонного возраста;
- пациенты с гипокалиемией или повышенным содержанием магния в крови;
- астеники;
- беременные на втором или третье триместре беременности.
Побочные действия
При кратковременном лечении практически ни у кого не наблюдалось каких-либо побочных эффектов. Но при увеличении продолжительности приёма лекарства возрастает риск нежелательных последствий.
Последствия побочного действия Гуттасила на органы и системы человеческого организма:
- Со стороны кожи: высыпание, зуд, крапивница.
- Нарушения обмена электролитов и водного баланса: обезвоживание, чрезмерное выведение натрия и калия.
- Со стороны желудочно-кишечного тракта: расстройства пищеварения, тошнота, рвота, боль в области живота, спазмы, повышенное газообразование в кишечнике, повышение тонуса кишечника, боль в области ануса. Всё это обычно проходит при уменьшении дозы.
- Со стороны иммунитета: симптомы аллергии, развитие ангионевротического отёка.
- Нарушения деятельности центральной нервной системы: головные боли, высокая утомляемость, судорожная готовность,судороги, сонливость.
Гуттасил, инструкция по применению (Способ и дозировка)
Инструкция по применению Гуттасила советует принимать всю дозу за один раз, вечером перед сном. В таком случае высока вероятность того, что утром уже пройдёт запор и появится стул.
- пациентам старше 10 лет – 5-10 мг или 13-27 капель, отмеренных дозатором на флаконе;
- детям 4–10 лет – 2,5-5 мг или 7-13 капель;
- детям младше 4 лет дозу рассчитывают соответственно весу – на 1 кг массы тела необходимо давать 2 капли или 250 мг лекарства.
В большинстве случаев детям назначают только однократный приём лекарства. Нежелательно назначать Гуттасил пациентам детского возраста на срок более 3 дней.
Передозировка
- диарея;
- колики (спазмы в кишечнике);
- нарушения водно-электролитного обмена, что может очень сильно сказываться на общем состоянии (например, мышечная слабость вследствие гипокалиемии);
- снижение кровоснабжения слизистых оболочек кишечника;
- при длительном приёме слишком больших доз поражаются почки (нефролитиаз) и развивается вторичный гиперальдостеронизм.
Лечение передозировки заключается в промывании желудка, приёме энтеросорбентов, например, активированного угля, и проведении симптоматического лечения (спазмолитики, растворы электролитов).
Взаимодействие
Гуттасил может взаимодействовать с другими лекарствами:
- если вследствие лечения развился электролитный дисбаланс, снижается толерантность к препаратам группы сердечных гликозидов;
- при одновременном приёме с диуретиками и глюкокортикостероидами повышается риск развития гипокалиемии;
- приём антибиотиков может уменьшить слабительное действие Гуттасила.
Условия продажи
Условия хранения
В темном месте, при температуре от 15°C до 25°C.
Срок годности
Особые указания
При назначении Гуттасила необходимо помнить об особенностях его действия у некоторых пациентов:
- нужна консультация врача и постоянный контроль состояния пациентов, которым препарат назначен на фоне приёма опиоидов (онкологические больные);
- ни в коем случае нельзя принимать лекарство каждый день на протяжении длительного периода времени;
- нежелательно принимать Гуттасил пациентам с наследственной непереносимостью фруктозы, так как в его составе присутствует сорбит.
Детям
Нельзя назначать продолжительный курс лечения.
При беременности и лактации
Запрещено пить Гуттасил в течение первых 3 месяцев беременности и в период кормления грудью. Если без этого лекарства нельзя обойтись, на время лечения нужно перевести ребёнка на искусственное вскармливание.
Во время второго или третьего триместра беременности препарат может быть назначен, но только в крайних случаях, когда отказ от приёма Гуттасила опасен для здоровья женщины.
Аналоги
Аналогами Гуттасила являются такие препараты:
Отзывы о Гуттасиле
Отзывы о Гуттасиле показывают, что в большинстве случаев эффект очевиден, но действие мягкое и безопасное. Кроме того, лекарство стоит относительно недорого.
Но есть несколько негативных отзывов – у некоторых людей приём капель или таблеток не вызывает заметного слабительного эффекта.
Цена Гуттасила, где купить
Цена Гуттасила в аптеках России – от 176 рублей за таблетки и 135-240 рублей за флакон капель, в зависимости от его объёма. В украинских аптеках препарат стоит до 250 грн.
по медицинскому применению препарата
Регистрационный номер
Торговое название:
Международное непатентованное название:
Лекарственная форма:
Состав:
активное вещество:
натрия пикосульфат в пересчете на 100 % безводное вещество — 7,5 мг;
вспомогательные вещества:
сорбитол — 460 мг, метилпарагидроксибензоат натрия — 2,0 мг, 1 М раствор хлористоводородной кислоты до рН 6,0-7,0, вода для инъекций до 1 мл.
Описание:
прозрачная бесцветная или светло-желтая жидкость.
Фармакотерапевтическая группа:
Код ATX: А06А В08
Фармакологические свойства
Контактное слабительное средство триарилметановой группы, активируется в толстом кишечнике под действием бактериальных сульфатаз; вещество, которое освобождается при этом — стимулирует чувствительные нервные окончания слизистой оболочки кишечника, усиливает его моторику. Применение препарата не сопровождается тенезмами и спазмами кишечника.
При курсовом лечении Гуттасил стимулирует рост и метаболическую активность нормальной микрофлоры кишечника.
Фармакокинетика
После приема внутрь достигает толстого кишечника без существенной абсорбции, где под действием бактериальной флоры расщепляется с образованием активной формы — бис-(п-гидроксифенил)-пиридил-2-метана. Слабительный эффект развивается через 6-12 часов после приема, выраженность слабительного эффекта не коррелирует с уровнем активного бис-(п-гидроксифенил)-пиридил-2-метана в плазме крови. Не подвергается печеночно-кишечной рециркуляции.
Показания к применению
Противопоказания
С осторожностью
Использовать с осторожностью пожилым людям, при гипокалиемии, повышении концентрации магния в крови, пациентам с астенией.
Применение препарата у пациентов с почечной недостаточностью тяжелой степени (в соответствии с разделом «Особые указания») только под наблюдением врача.
Применение при беременности и в период грудного вскармливания
Клинические данные показывают, что ни активный метаболит бис-(п-гидрокси- фенил)-пиридил-2-метан (БГПМ), ни его глюкурониды не проникают в грудное молоко. Таким образом препарат Гуттасил можно применять в период грудного вскармливания.
Способ применения и дозы
Рекомендован следующий режим приема:
Взрослым и детям старше 10 лет: 13-27 капель (что соответствует 5-10 мг натрия пикосульфата).
Детям от 4 до 10 лет (только по назначению врача): 7-13 капель (что соответствует 2,5- 5 мг натрия пикосульфата).
Применять препарат у детей в возрасте от 4 лет только после консультации врача.
Рекомендуется начинать с наименьшей дозы. Для того, чтобы достичь регулярного стула, доза может повышаться до максимальной рекомендуемой.
Для получения слабительного эффекта в утренние часы препарат Гуттасил необходимо принимать на ночь. После применения препарата Гуттасил опорожнение кишечника происходит через 10-12 часов. Препарат можно применять как с жидкостью, так и без нее.
Препарат Гуттасил не следует принимать ежедневно без консультации врача более 10 дней.
Побочное действие
Лечение: промывание желудка, приём энтеросорбентов (активированный уголь), симптоматическое лечение (проведение коррекции водно-электролитного баланса, применение спазмолитиков).
Взаимодействие с другими лекарственными средствами
Электролитный дисбаланс может привести к снижению толерантности к сердечным гликозидам. Диуретики или глюкокортикостероиды могут усиливать выраженность гипокалиемии, вызванной применением Гуттасила в высоких дозах лечение антибиотиками может снизить слабительный эффект препарата.
Особые указания
Длительное применение слабительных средств может привести к нарушению водного и электролитного баланса и гипокалиемии, а также стать причиной «привыкания» и запоров вследствие эффекта «рикошета». Гуттасил следует принимать под медицинским наблюдением при состояниях, связанных с нарушением водного и электролитного баланса (например при тяжелом нарушении функции почек).
Сообщали о случаях головокружения и/или обморока, которые по времени совпадали с применением натрия пикосульфата. Анализ случаев показал, что эти состояния связаны с обмороком при дефекации (или обмороком, вызванным напряжением при дефекации) или связаны с вазовагальной реакцией на боль в животе, которая может быть обусловлена запором. и не обязательно связана с приемом препарата. Гуттасил эффективен в устранении запоров у онкологических больных, получающих большие дозы опиоидов.
Исследования по оценке влияния на фертильность не проводились.
Препарат содержит сорбитол, поэтому пациентам с редкой наследственной непереносимостью фруктозы принимать его не рекомендуется.
Влияние на способность управлять транспортными средствами и работать с механизмами
Исследования влияния на способность управлять транспортными средствами и работать с другими механизмами не проводилась.
Однако пациентов следует предупредить о воможность развития вследствие вазовагальной реакции (в частности абдоминального спазма) таких побочных реакций как головокружение и/или синкопе.
В случае возникновения абдоминального спазма больному следует избегать таких потенциально опасных видов деятельности как управление транспортными средствами или работа с другими механизмами.
Форма выпуска
Условия хранения
Срок годности
Условия отпуска
Юридическое лицо, на имя которого выдано регистрационное удостоверение
ПАО «Фармак», Украина, 04080, г. Киев, ул. Фрунзе, 63.
Производитель
Организация, принимающая претензии потребителей:
Представительство ПАО «Фармак» в РФ.
Россия, 121357, г. Москва, ул. Верейская, д. 29 с 154, оф. 44.
Гуттасил – это слабительный препарат, использующийся для лечения запоров при патологических состояниях ЖКТ или погрешностях в диете. Способствует восстановлению микрофлоры толстого кишечника.
Контактное слабительное средство триарилметановой группы, активируется в толстом кишечнике под действием бактериальных сульфатаз. Стимулирует чувствительные нервные окончания слизистой оболочки кишечника, усиливает его моторику. Лечение запоров с помощью Гуттасил не сопровождается тенезмами и спазмами кишечника.
При курсовом лечении стимулирует рост и метаболическую активность нормальной микрофлоры кишечника.
После приема внутрь достигает толстого кишечника без существенной абсорбции, где под действием бактериальной флоры расщепляется с образованием активной формы, которая и оказывает терапевтический эффект.
Через сколько начинает действовать? Гуттасил обладает отсроченным действием, слабительный эффект проявляется через 6-10 часов, в зависимости от особенностей организма. Поэтому препарат принимают на ночь.
Как и другие слабительные средства, препарат не следует принимать ежедневно длительное время. При необходимости ежедневного приема следует выяснить причину запоров. Длительное применение слабительных средств может привести к электролитному дисбалансу и гипокалиемии, а также стать причиной привыкания и запоров вследствие эффекта рикошета.
Показания к применению
От чего помогает Гуттасил? Согласно инструкции, препарат назначают в следующих случаях:
- нарушения стула в виде запоров;
- болезни толстой кишки и заднего прохода, при которых необходимо облегчить процесс дефекации (геморрой, трещины, проктит);
- подготовительный этап перед инвазивными медицинскими мероприятиями (операция, инструментальное или рентгенологическое исследование).
Инструкция по применению Гуттасил, дозировки
Раствор принимается внутрь в виде капель, которые отмеривают с помощью крышки-капельницы. Их обычно принимают на ночь, для получения слабительного эффекта на следующее утро. Дозировка зависит от возраста:
- взрослым и детям старше 10 лет – от 13 до 27 капель (5-10 мг);
- детям от 4 до 10 лет – от 7 до 13 капель (2,5-5 мг);
- детям моложе 4 лет рекомендуется дозирование 250 мкг/кг массы тела или 2 капли на 3 кг массы тела ребёнка.
Детям препарат можно добавлять в еду. У детей бывает эффективным однократный прием препарата. По необходимости курс лечения у ребенка может быть продлен, но предпочтительно ограничить его 3 днями.
Для взрослых длительность курса определяется нормализацией стула, но не более 5 дней.
Для устранения запоров у онкологических больных, получающих большие дозы опиоидов, применяют по назначению врача.
Побочные эффекты
Инструкция предупреждает о возможности развития следующих побочных эффектов при назначении Гуттасил:
- нарушения нервной системы (судороги, боли в голове, быстрая утомляемость);
- проблемы с кожей (крапивница, ощущение зуда, высыпания);
- расстройства пищеварительной системы (выделение рвотных масс, болевые ощущения в районе кишечника и анального отверстия, рвотные позывы, метеоризм, диарея);
- аллергическая реакция.
В подавляющем большинстве случаев развитие побочных эффектов связано с нарушением дозировки или правил применения препарата.
Противопоказания
Противопоказано назначать Гуттасил в следующих случаях:
- повышенная чувствительность к натрия пикосульфату и другим компонентам препарата;
- кишечная непроходимость;
- острые воспалительные заболевания кишечника и острые заболевания органов брюшной полости (в т.ч. острый аппендицит, неспецифический язвенный колит, перитонит);
- острая абдоминальная боль, сопровождающаяся тошнотой и рвотой, которая может указывать на острые воспалительные заболевания, тяжелая дегидратация;
- беременность (I триместр);
- период лактации.
С осторожностью: пациенты пожилого возраста, гипокалиемия, повышенное содержание магния в крови, пациенты с астенией, II–III триместры беременности.
Передозировка
Передозировка может вызвать жидкие испражнения, спазмы (колики) животе и клинически значимые нарушения водно-электролитного баланса (гипокалиемия, потеря других электролитов и жидкости), ишемию слизистой оболочки толстого . кишечника.
Длительное превышение дозировок приводит к развитию хронической диареи и боли в,животе, гипокалиемии, вторичного гиперальдостеронизма, возможно поражение почек и развитие нефролитиаза, метаболического алкалоза, гипокалиемии и мышечной слабости как результата гипокалиемии.
Лечение заключается в промывании желудка, приёме энтеросорбентов, например, активированного угля, и проведении симптоматического лечения (спазмолитики, растворы электролитов).
Аналоги Гуттасил, цена в аптеках
При необходимости, заменить Гуттасил можно на аналог по активному веществу – это препараты:
Выбирая аналоги важно понимать, что инструкция по применению Гуттасил, цена и отзывы на препараты схожего действия не распространяются. Важно получить консультацию врача и не производить самостоятельную замену препарата.
Цена в аптеках России: капли Гуттасил 15 мл – от 131 до 176 рублей, капли 30мл. – от 238 до 360 рублей, по данным 582 аптек.
Хранить в недоступном для детей месте при температуре до 25 °С. В аптечной сети отпускается без рецепта.
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Не пейте сразу максимальную дозировку, начните с рекомендованных минимальных 13-15 капель, и все будет хорошо! Проверено на себе, так сказать 🙂
Осталась в восторге! Действует очень мягко, никаких болей и мучений, в отличие от Дюфалака.
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