Действующее вещество:
Содержание
Фармакологическая группа
Состав и форма выпуска
| Сироп | 100 мл |
| лактулоза | 66,7 г |
| вспомогательное вещество: вода очищенная — до 100 мл |
в полиэтиленовых флаконах по 200, 500 или 1000 мл с навинчивающейся крышкой, в комплекте с мерным стаканчиком; в одноразовых пакетиках из полиэтилена и алюминиевой фольги по 15 мл; в коробке картонной 10 пакетов.
Описание лекарственной формы
Прозрачная вязкая жидкость от бесцветной до светло-желтой с коричневым оттенком.
Фармакологическое действие
Фармакодинамика
Оказывает гиперосмотическое слабительное действие, стимулирует перистальтику кишечника, улучшает всасывание фосфатов и солей Ca 2+ , способствует выведению ионов аммония.
Лактулоза расщепляется кишечной флорой толстой кишки на низкомолекулярные органические кислоты, которые приводят к снижению pH , и, за счет повышения осмотического давления, к увеличению объема кишечного содержимого. Указанные эффекты стимулируют перистальтику кишечника и оказывают влияние на консистенцию стула. Запор исчезает, и восстанавливается физиологический ритм опорожнения толстого кишечника.
При печеночной энцефалопатии и печеночной (пре)коме эффект приписывается подавлению протеолитических бактерий посредством увеличения количества ацидофильных бактерий (например лактобактерий); переходу аммиака в ионную форму за счет подкисления содержимого толстой кишки; опорожнению кишечника вследствие снижения pH в толстой кишке и осмотического эффекта; а также уменьшению азотсодержащих токсических веществ путем стимуляции бактерий, утилизирующих аммиак для бактериального белкового синтеза.
Ингибирует рост сальмонелл в кишечнике, сокращает период бактериовыделения.
Фармакокинетика
Абсорбция низкая; не всасываясь, доходит до толстого кишечника, где расщепляется кишечной флорой. Полностью метаболизируется при дозах до 45–70 мл; при более высокой дозировке — частично выводится в неизмененном виде.
Показания препарата Дюфалак ®
запор: регуляция физиологического ритма опорожнения толстой кишки;
размягчение стула в медицинских целях (геморроидальные узлы, операции на толстой кишке и в области анального отверстия);
печеночная энцефалопатия — лечение и профилактика печеночной комы и прекомы;
дисбактериоз кишечника; энтерит, вызванный сальмонеллами, шигеллами, сальмонеллез в стадии бактерионосительства; синдром гнилостной диспепсии (у детей раннего возраста в результате острых пищевых отравлений).
Противопоказания
повышенная чувствительность к активному компоненту или фруктозе, галактозе, лактозе;
Применение при беременности и кормлении грудью
Лактулоза может безопасно применяться у беременных и кормящих матерей.
Побочные действия
В первые дни возможно появление метеоризма (проходит через 2 дня), при передозировке могут наблюдаться боли в области живота, диарея, что требует коррекции дозы. В случае применения повышенных доз в течение длительного времени при лечении печеночной энцефалопатии возможны нарушения электролитного баланса вследствие диареи.
Желудочно-кишечные расстройства: метеоризм, тошнота, рвота. При использовании высоких доз — диарея.
Взаимодействие
Из-за механизма действия лактулозы, заключающегося в снижении pH в толстой кишке, ЛС , высвобождение которых зависит от pH в толстой кишке (такие как препараты 5-аминосалициловой кислоты) могут быть инактивированы.
Способ применения и дозы
Внутрь, во время еды (утром), дозу устанавливают индивидуально.
При лечении запора или для размягчения стула приняты следующие дозировки (см. таблицу).
Дозирование Дюфалака ® при лечении запора или для размягчения стула
| Возраст | Начальная доза, мл | Поддерживающая доза, мл |
| Взрослые | 15–45 | 10–25 |
| Дети 7–14 лет | 15 | 10 |
| Дети 3–6 лет | 5–10 | 5–10 |
| Дети до 3 лет | 5 | 5 |
Как правило, доза может быть снижена после 2 дней приема в зависимости от потребности больного. Клинический эффект наступает через 2 дня. Это свойственно действию лактулозы. Дозу или частоту приема увеличивают в том случае, если в течение 2 дней приема препарата не наблюдается улучшения состояния больного.
При лечении печеночной комы и прекомы: начальная доза — 30–45 мл 3 раза в день. Затем переходят на индивидуально подобранную поддерживающую дозу, чтобы мягкий стул был максимально 2–3 раза в день, а показатель рН стула находился в пределах 5,0–5,5.
В острых случаях Дюфалак ® может назначаться в виде клизм в соотношении 300 мл препарата и 700 мл воды.
При лечении дисбактериоза кишечника: детям до 1 года суточная доза — 1,5–3 мл, 1–3 года — 3 мл, 4–7 лет — 5 мл, старше 7 лет и взрослым — 10 мл.
При лечении сальмонеллеза, шигеллеза: в первые 10–12 дней — по 15 мл 3 раза в день, после недельного перерыва — в той же дозе 5 раз в день.
Передозировка
Симптомы: при использовании больших доз — боль в животе, диарея.
Лечение: прием препарата следует прекратить или уменьшить дозу.
Особые указания
В случае отсутствия терапевтического эффекта в течение 2 дней или при возобновлении запора после лечения следует проконсультироваться с врачом.
Пациентам с непереносимостью лактозы, при применении данного препарата, необходимо учитывать содержание лактозы в препарате (Дюфалак ® содержит до 1,7 г галактозы и до 0,9 г лактозы в 15 мл сиропа).
Доза, обычно используемая при запоре, не должна представлять проблему для пациентов с сахарным диабетом. Доза, используемая при лечении печеночной (пре)комы, обычно намного выше и поэтому должна быть уточнена при назначении пациентам с сахарным диабетом.
При длительном лечении (более 6 мес) повышенными дозами препарата следует регулярно контролировать уровень электролитов в плазме крови.
Препарат не влияет или оказывает незначительное влияние на способность к вождению автомобиля и управлению машинами и механизмами.
Производитель
Солвей Фармасьютикалз Б.В., Нидерланды.
Условия хранения препарата Дюфалак ®
Хранить в недоступном для детей месте.
Срок годности препарата Дюфалак ®
Не применять по истечении срока годности, указанного на упаковке.
Фармакологически Дюфалак («Дюфалак Джуниор») – сильнодействующее, но мягкое слабительное. Его рекомендуют, чтобы нормализовать стул при запорах для детей либо для терапевтического воздействия при патологических состояниях органов пищеварения.
Форма изготовления и составляющие
Главный компонент фармсредства – лактулоза. При эффективном воздействии не происходит его всасывания в стенки желудка и кишечного тракта. Отсутствие взаимодействия со слизистой является одним из достоинств деликатного слабительного. Благодаря этому медикамент показан к применению даже грудным детям. Из дополнительных составляющих – только чистая вода.
В сети аптек лекарственное средство продается безрецептурно в виде сиропа в пластмассовых бутылках по 0,2, 0,5 и 1 л с завинчивающейся крышечкой. Медсредство упаковывается в коробку из картона и комплектуется мерным стаканом.
Фармпрепарат также предлагают упакованным по 15 мл в пластиковые пакеты с алюминиевым напылением – по 10 штучек в коробочке.
Приобретенное медсредство хранят так, чтобы оно было вне досягаемости малышей. Место должно быть сухим и прохладным – не более 25 градусов тепла. Препарат разрешен к употреблению три года с момента производства. Если срок хранения истек, давать лекарство малышам категорически запрещено.
Стоимость «Дюфалака» зависит от числа объема флакона или числа пакетов в упаковке. Цена слабительного может изменяться от 290 до 750 рублей.
Лечебное воздействие
Фармсредство предназначено для стимуляции кишечной перистальтики, улучшения всасывания кальциевых солей и фосфатов. Влияет медпрепарат и на азотистый обмен – идет перенос аммиачных соединений из кровеносной системы в кишечный тракт, где существенно снижается формирование токсинов, и они не попадают обратно в кровь.
Лечебное воздействие основывается на взаимодействии биологически активного составляющего с натуральной микрофлорой кишечного тракта, что способствуют росту числа лактобактерий.
Их деятельность приводит к понижению осмотического давления и увеличению содержимого кишечника, что уменьшает запорные явления и делает стул мягче.
Абсорбция лактулозы в ЖКТ низкая. После приема внутрь медикаментозный препарат почти в неизменном виде направляется в толстую кишку, где идет его расщепление содержащимися там микроорганизмами. Они способны переработать до 70 мл препарата за прием. Если дозировка будет больше, лактулоза выйдет с экскрементами в неизменном виде.
Показания к использованию
Используют сироп при запорах для детей различной этиологии и для регулирования естественного опорожнения кишечного тракта при многих патологических состояниях:
- Недостаточной выработке некоторых пищеварительных ферментов;
- Синдроме гнилостной диспепсии у детей до года;
- Ухудшении перистальтики кишечника из-за уменьшения двигательной активности;
- Хроническом энтерите либо дисбактериозе, когда разрастается в ЖКТ патологическая микрофлора;
- Заболеваниях печени и токсической энцефалопатии – медикамент понижает токсичность продуктов белкового метаболизма в кишечнике.
Рекомендуется сироп для детей при сальмонеллезе и прочих кишечных инфекциях, а также острых пищевых отравлениях.
Медпрепарат также используется перед некоторыми диагностическими исследованиями толстой кишки, при необходимости расслабления кишечника и его прочистки перед хирургическим вмешательством.
Противопоказания, побочные действия и передозировка
Употребление лекарственного средства в чрезмерных объемах может привести к патологическому состоянию, характеризующегося такими проявлениями, как боли в животе, диарея, нарушение электролитного баланса. В случае возникновения подобных последствий дозировку следует понизить после консультации с педиатром или вовсе прекратить применение медсредства.
Фармпрепарат не следует принимать при:
- Гипервосприимчивости к лактулозе;
- Непроходимости или перфорации стенок кишечника;
- Галактоземии;
- Непереносимости фруктозы и лактозы;
- Лактазной недостаточности;
- Глюкозо-галактозной мальабсорбции.
Если у ребенка нарушена толерантность к глюкозе, фармсредство назначается с осторожностью.
В целом слабительный медикамент хорошо переносят и ребятишки, и взрослые. Иногда реакцией на прием становится вздутие брюшины, метеоризм, подташнивание и рвота, кишечные спазмы. Такие явления возникают в первые дни использования медикаментозного средства. При длительном приеме может понижаться концентрация в крови некоторых минеральных солей. Долговременная терапия предусматривает проведение анализа крови для контроля количества электролитов в плазме.
Инструкция по применению для детей
Дюфалак, как правило, назначается доктором в суточной дозировке. Лекарство можно дать малышу единовременно либо распределить на два приема. Последний вариант подходит для детей до 2 лет. Проведя наблюдение за тем, как кроха реагирует на лекарство, педиатр откорректирует первоначальную дозировку.
Дюфалак – инструкция для детей:
| Возрастные рамки | Суточная доза | |
| Начальное лечение | Поддерживающая терапия | |
| Для детей до 1 года | 5 мл | 5 мл |
| Для детей от 1 года до 6 лет | 5–10 мл | 5–10 мл |
| Для детей от 7 до 14 лет | 15 мл | 10–15 мл |
| Для подростков до 18 лет | 15–45 мл | 15–30 мл |
Регулировка дозировки детям ведется исходя из того, как малыш чувствует себя после принятия фармпрепарата. Лекарство для новорожденных детей растворяют в грудном молоке либо смеси, изредка в воде. Применение медпрепарата позволяет решить проблемы с запором мягко, в течение нескольких часов. В соответствии с руководством по применению новорожденным детям дают медсредство утром, когда малыш проснется или сразу после завтрака. Если кроха сразу срыгнет, предлагают повторную дозу.
Критериями правильно подобранной дозировки сиропа являются:
- Мягкий стул дважды или трижды в сутки;
- Отсутствие болезненных ощущений в животе либо иных неприятных проявлений;
- Кислотность содержимого толстой кишки в диапазоне 5,0–5,5.
При печеночных патологиях терапевтическое воздействие становится заметным спустя 2–5 дней в зависимости от индивидуальной скорости метаболизма.
Если в течение нескольких суток состояние не улучшается, и не происходит разжижение стула, потребуется корректировка дозы либо замена слабительного, но лишь после консультации с доктором. Такие же действия понадобятся, если запор через небольшой промежуток времени повторился снова.
Правила приема лекарства
Слабительный препарат применяется перорально. Медсредство принимают внутрь как разведенным с водой, молоком, молочной 
смесью, так и в чистом виде. Фармпрепарат для детей до 2–3 месяцев дают при помощи шприца без иголки. Карапуз должен проглотить сироп, не держа его во рту. Для малышей постарше можно применить ложку.
Если медпрепарат упакован в пакетик, то, вскрыв его, содержимое выливают в рот и сразу глотают.
Но разрешен такой метод применения для детей 3–4 лет и старше. Дети до 3 лет еще не могут качественно контролировать глотательный рефлекс и способны захлебнуться.
Продолжительность применения «Дюфалака» определяется доктором для каждого ребенка индивидуально. Ввиду того, что фармсредство не накапливается в организме человека, для приведения в норму работы желудочно-кишечного тракта его можно давать столько времени, сколько понадобится. Если лекарственное средство используют в качестве пребиотика, то минимальная продолжительность курса – 30 дней.
Отзывы о фармпрепарате
Большая часть откликов о воздействии мягкого слабительного – положительны. «Дюфалак» не приводит к привыканию: благодаря этому медпрепарат пользуется популярностью у мам, чьи малютки страдают от частых запоров.
При следовании руководству по использованию побочные действия появляются достаточно редко. Мамы пишут, что не стоит в первые дни давать полную дозировку, назначенную на сутки, в особенности, малюткам с чувствительным кишечником. Иначе возможны проявления колик, усиление вздутия живота, газообразования.
Особенно эффективен «Дюфалак», согласно отзывам, при запорах для детей-искусственников.
Им необходимо слабительное, которое разрешено для продолжительного использования, пока желудок и кишечник не окрепнет. «Дюфалак» – один из фармпрепаратов, обладающих эффективным, деликатным воздействием, который не раздражает нежные стенки слизистой.
Взаимодействие с лечебными средствами и аналоги
Совмещенное использование «Дюфалака» с антацидными медпрепаратами и частью антибиотических средств уменьшает его лечебное воздействие.
Сироп считается довольно дорогим, есть более дешевые аналоговые препараты. Заменить лекарство можно одним из препаратов на основе лактулозы: «Порталаком», «Гудлаком», кристаллической «Лактулозой», «Легендалем» либо «Лизалаком».
Дешевле всего стоит российский аналог медикамента «Лактусан» на основе того же активного вещества. Но у фармсредств имеются отличия в показаниях к использованию, поэтому их нельзя считать абсолютно взаимозаменяемыми.
Другим хорошим аналогом считается изготовленный в Италии препарат «Нормазе», имеющий аналогичный механизм воздействия и такие же показания к использованию. Но у него больше побочных действий.
Также рекомендуем прочитать:
Перед выбором для лечения «Дюфалака» или его аналога, обязательно посоветуйтесь с врачом. Только правильный терапевтический курс позволяет сделать пищеварение стабильным и справиться с запором быстро и без вреда для организма.
Инструкция по применению:
Цены в интернет-аптеках:
Дюфалак – фармакологический препарат на основе лактулозы со слабительным эффектом.
Состав и форма выпуска
Дюфалак выпускается в форме сиропа. 100 мл лекарственного средства содержит 66,7 г лактулозы и очищенную воду до объема 100 мл.
Согласно инструкции Дюфалак представляет собой прозрачную вязкую жидкость светло-желтого цвета.
Данный препарат производится в пластиковых флаконах по 200, 500 или 1000 мл (в комплекте – мерный стаканчик). Также существует форма выпуска в одноразовых пакетиках из фольги и полиэтилена по 15 мл (в коробке 10 пакетов).
Фармакологическое действие
Данный препарат оказывает слабительное действие. Дюфалак обладает гиперосмотическим действием, и тем самым стимулирует перистальтику кишечника. Также он улучшает всасывание фосфатов и солей кальция, и благоприятствует выведению ионов аммония. Кишечная микрофлора толстой кишки расщепляет лактулозу до низкомолекулярных органических кислот, способствует увеличению объема содержимого кишечника. Таким образом, Дюфалак стимулирует перистальтику кишечника и влияет на консистенцию стула. Это приводит к восстановлению физиологического ритма опорожнения толстой кишки и устранению запоров.
Применение Дюфалака при печеночной энцефалопатии или прекоме (коме) позволяет уменьшить содержание токсических веществ азотистого обмена в кишечнике, тем самым уменьшая негативное действие этих веществ на головной мозг.
Согласно инструкции Дюфалак является пребиотиком, то есть усиливает рост полезных бактерий (бифидобактерий и лактобактерий) и подавляет рост патогенной флоры (Клостридии, Сальмонеллы) и сокращает период бактериовыделения. Таким образом, данный препарат позволяет обеспечить благоприятное равновесие кишечного микробиоценоза.
Согласно инструкции Дюфалака препарат имеет низкую абсорбцию, после употребления внутрь он доходит до толстой кишки в неизменном виде, и там расщепляется микрофлорой. В дозировке 40-75 мл в сутки данное лекарственное средство полностью метаболизируется. При приеме более высоких доз препарат частично выводится в неизмененном виде.
Показания к применению
Дюфалак применяется при запорах функционального происхождения, а также для размягчения стула при геморрое, трещинах анального канала, после операций на кишечнике и области анального канала. Данный препарат показан при печеночной энцефалопатии или коме (прекоме).
Согласно инструкции Дюфалак применяется в комплексном лечении дисбактериоза, энтерита (в стадии бактерионосительства) и синдроме гнилостной диспепсии у детей (в результате острых пищевых отравлений).
Дюфалак применяется также для подготовки толстой кишки к диагностическим исследованиям (ректороманоскопия, ирригоскопия, колоноскопия).
Противопоказания к применению
- Острая кишечная непроходимость;
- Галактоземия;
- гиперчувствительность к составляющим компонентам препарата.
Согласно инструкции Дюфалака его следует использовать с осторожностью у пациентов с непереносимостью лактозы, при кишечных кровотечениях неясной этиологии. Также препарат нужно с осторожностью применять у больных с печеночной энцефалопатией, страдающих сахарным диабетом.
Применение во время беременности и лактации
Согласно инструкции Дюфалак не оказывает никакого воздействия на плод и на течение беременности, он разрешен к применению во время беременности. Препарат не проникает в грудное молоко и может использоваться в период кормления грудью.
Способ применения и дозы
Данный препарат предназначен для приема внутрь. Сироп можно принимать как в неразведенном виде, так и разбавленным водой. Если Дюфалак назначается один раз в сутки, то его нужно пить в одно и то же время (например, утром во время завтрака).
При лечении запоров и для размягчения стула препарат назначается взрослым в начальной дозировке по 15-45 мл ежедневно, а затем переходят на поддерживающую дозу 15-30 мл. Начальная доза подбирается индивидуально, препарат может приниматься однократно, или быть разделенным на 2 части. Поддерживающая доза подбирается в зависимости от реакции на прием данного лекарственного средства. По отзывам Дюфалака терапевтический эффект может появиться через 2-3 дня после начала приема препарата. Во время лечения Дюфалаком необходимо принимать достаточное количество жидкости (1,5-2 литра в сутки).
Детям дозировка препарата подбирается в зависимости от возраста:
- детям 7-14 лет – 10-15 мл в сутки;
- детям 1-6 лет 5-10 мл в сутки;
- детям до года – до 5 мл в сутки.
Дюфалак для новорожденных также используется при лечении запоров и дисбактериоза. Рекомендуется начинать прием с 1 мл, постепенно доводя объем препарата до 4-5 мл (это поможет избежать повышенного газообразования).
При лечении печеночной энцефалопатии доза Дюфалака подбирается индивидуально, обычно начальная дозировка составляет 30-45 мл.
Для подготовки толстой кишки к исследованиям используется 100-150 мл препарата. Обычно дозировка зависит от вида исследования, состояния пациента и подбирается врачом индивидуально. По отзывам Дюфалак для этих целей лучше использовать в сочетании с другими методами очистки кишечника (например, очистительными клизмами).
Побочное действие
В первые дни применения Дюфалака возможно появление повышенного газообразования (метеоризма). Обычно оно исчезает через несколько дней. При приеме высоких доз препарата возникает диарея. Также могут возникать тошнота, рвота и боли в животе. По отзывам Дюфалака сообщения о его побочных действиях недостаточны для точной оценки частоты случаев.
Если препарат используется в повышенных дозах (например, при лечении печеночной энцефалопатии), у пациента может развиться нарушения баланса электролитов из-за диареи.
Передозировка
При приеме высоких доз препарата возможны диарея и боли в животе. Отмена препарата или уменьшение его дозы нивелирует эти проявления. В случае нарушения электролитного баланса требуется коррекция введением электролитных растворов.
Взаимодействие с другими лекарственными средствами
Клинические исследования по взаимодействию Дюфалака с другими фармакологическими препаратами не проводились.
Особые указания
В случае отсутствия эффекта от приема препарата в течение нескольких дней следует проконсультироваться с врачом.
Следует учитывать, что Дюфалак может содержать незначительное количество сахаров (например, лактоза, галактоза, фруктоза). При приеме дозировки для лечения запоров это не представляет проблему для больных с сахарным диабетом. Но при лечении печеночной комы (энцефалопатии) содержание сахаров должно учитываться для этой группы больных.
Пациенты с непереносимостью галактозы, фруктозы не должны использовать данный препарат. Дюфалак для новорожденных может применяться только под наблюдением врача.
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