Гипогликемический препарат. Акарбоза является псевдотетрасах... Инструкция
Показания к применению
лечение сахарного диабета типа 2 в комплексе с диетотерапией.
Противопоказания
хронические заболевания ЖКТ, протекающие с выраженными нарушениями пищеварения и всасывания; - состояния, которые могут сопровождаться метеоризмом (синдром Ремхельда, грыжи больших размеров любой локализации, нарушение проходимости кишечника, язвенная болезнь); - почечная недостаточность тяжелой степени (при КК< 25 мл/мин); - беременность; - лактация (грудное вскармливание); - детский и подростковый возраст до 18 лет; - повышенная чувствительность к акарбозе или любому из компонентов препарата.
Гипогликемический препарат. Акарбоза является псевдотетрасахаридом микробного происхождения. Механизм действия акарбозы основан на ингибировании кишечного фермента альфа-глюкозидазы, расщепляющей ди-, олиго- и полисахариды. В результате подавления активности фермента происходит дозозависимое удлинение времени всасывания углеводов, а следовательно, и глюкозы, которая образуется при расщеплении углеводов. Таким образом, акарбоза замедляет поступление глюкозы в кровоток и уменьшает концентрацию глюкозы в крови после приема пищи. Регулируя всасывание глюкозы из кишечника, препарат уменьшает ее суточные колебания в плазме крови и приводит к снижению ее среднего уровня. В случае повышения концентрации гликолизированного гемоглобина акарбоза снижает его уровень. В проспективном рандомизированном плацебо-контролированном двойном слепом исследовании (продолжительность лечения 3-5 лет, в среднем 3.3 года), в котором приняли участие 1429 пациентов с подтвержденным нарушением толерантности к глюкозе, относительный риск развития сахарного диабета типа 2 в группе лечения Глюкобаем снизился на 25%. У этих пациентов также было отмечено достоверное снижение частоты всех сердечно-сосудистых событий на 49%, а инфаркта миокарда (ИМ) – на 91%. Эти результаты были подтверждены мета-анализом 7 плацебо-контролированных исследований акарбозы в лечении сахарного диабета типа 2 (всего 2180 пациентов, из которых 1248 получали акарбозу и 932 – плацебо). У больных, получавших акарбозу, и у которых сахарный диабет типа 2 развился впервые, риск развития ИМ снизился на 68%.
Показания к применению
лечение сахарного диабета типа 2 в комплексе с диетотерапией.
Противопоказания
хронические заболевания ЖКТ, протекающие с выраженными нарушениями пищеварения и всасывания; - состояния, которые могут сопровождаться метеоризмом (синдром Ремхельда, грыжи больших размеров любой локализации, нарушение проходимости кишечника, язвенная болезнь); - почечная недостаточность тяжелой степени (при КК< 25 мл/мин); - беременность; - лактация (грудное вскармливание); - детский и подростковый возраст до 18 лет; - повышенная чувствительность к акарбозе или любому из компонентов препарата.
Применение при беременности и в период грудного вскармливания
Глюкобай не следует применять при беременности, поскольку не существует достоверной информации по применению препарата у беременных женщин. Глюкобай не рекомендуется применять в период лактации. При необходимости назначения препарата в период лактации грудное вскармливание следует прекратить.
Способ применения и дозы
Внутрь таблетку Глюкобая следует принимать целиком, не разжевывая, с небольшим количеством воды, непосредственно перед едой или разжевывая с первой порцией пищи. Оптимальная доза препарата подбирается индивидуально для каждого пациента. Начальная доза составляет 1 таб. по 50 мг или 1/2 таб. по 100 мг 3 раза/сут. Средняя суточная доза Глюкобая составляет 300 мг (2 таб. по 50 мг или 1 таб. по 100 мг 3 раза/сут). При недостаточной эффективности лечения после 4-8 недель терапии доза может быть увеличена до 200 мг 3 раза/сут. Максимальная суточная доза - 600 мг. У пожилых пациентов в возрасте старше 65 лет изменение дозы или режима дозирования не требуется. У пациентов с нарушением функции печени изменения режима дозирования также не требуется.
Побочное действие
Со стороны системы пищеварения: часто - метеоризм, диарея, боли в эпигастрии; иногда - тошнота; редко - повышение уровня печеночных ферментов (в 3 раза), исчезающее после отмены препарата, непроходимость кишечника, желтуха и/или гепатит и связанные с ними повреждения печени. В Японии отмечены единичные случаи фульминантного гепатита с летальным исходом, однако связь этих случаев с приемом акарбозы неясна. Аллергические реакции: редко – кожная сыпь, гиперемия, экзантема, крапивница. Со стороны организма в целом: очень редко – отеки.
Передозировка
Симптомы: в случае приема Глюкобая вместе с продуктами и/или напитками, содержащими углеводы (олиго-, ди- и полисахариды), превышение рекомендуемой суточной дозы может привести к развитию симптомов передозировки в виде метеоризма и диареи. При приеме Глюкобая в избыточных дозах независимо от приема пищи не предполагается развитие нежелательных явлений со стороны ЖКТ. Лечение: следует на 4-6 ч исключить из рациона питания продукты и напитки, содержащие углеводы.
Особые указания
При применении Глюкобая обязательно строгое соблюдение диеты. Пациент с сахарным диабетом должен быть предупрежден о невозможности самостоятельной отмены препарата, т.к. это может сопровождаться повышением уровня глюкозы в крови. При несоблюдении рекомендуемой диеты возможно усиление побочных эффектов со стороны ЖКТ. Если несмотря на строгое соблюдение диеты симптомы усиливаются, то дозу препарата можно снизить (на короткий или длительный срок). Глюкобай не вызывает гипогликемию при назначении пациентам только в комбинации с диетой. При присоединении Глюкобая к терапии инсулином или пероральными сахароснижающими средствами развитие гипогликемии возможно вследствие снижения потребности в противодиабетической терапии (в редких случаях вплоть до комы, что может потребовать коррекции назначаемых доз). Следует учитывать, что акарбоза замедляет превращение сахарозы во фруктозу и глюкозу, поэтому при возникновении на фоне применения Глюкобая острой гипогликемии для ее купирования следует применять глюкозу. В амбулаторной карте больного сахарным диабетом должна быть сделана отметка о применении препарата Глюкобай. Влияние на способность к вождению автотранспорта и управлению механизмамиГлюкобай не влияет на способность пациентов заниматься потенциально опасными видами деятельности, требующими повышенного внимания.
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В проспективном рандомизированном плацебо-контролированном двойном слепом исследовании (продолжительность лечения 3-5 лет, в среднем 3.3 года), в котором приняли участие 1429 пациентов с подтвержденным нарушением толерантности к глюкозе, относительный риск развития сахарного диабета типа 2 в группе лечения Глюкобаем снизился на 25%. У этих пациентов также было отмечено достоверное снижение частоты всех сердечно-сосудистых событий на 49%, а инфаркта миокарда (ИМ) – на 91%. Эти результаты были подтверждены мета-анализом 7 плацебо-контролированных исследований акарбозы в лечении сахарного диабета типа 2 (всего 2180 пациентов, из которых 1248 получали акарбозу и 932 – плацебо). 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При несоблюдении рекомендуемой диеты возможно усиление побочных эффектов со стороны ЖКТ. Если несмотря на строгое соблюдение диеты симптомы усиливаются, то дозу препарата можно снизить (на короткий или длительный срок). Глюкобай не вызывает гипогликемию при назначении пациентам только в комбинации с диетой. При присоединении Глюкобая к терапии инсулином или пероральными сахароснижающими средствами развитие гипогликемии возможно вследствие снижения потребности в противодиабетической терапии (в редких случаях вплоть до комы, что может потребовать коррекции назначаемых доз). Следует учитывать, что акарбоза замедляет превращение сахарозы во фруктозу и глюкозу, поэтому при возникновении на фоне применения Глюкобая острой гипогликемии для ее купирования следует применять глюкозу. В амбулаторной карте больного сахарным диабетом должна быть сделана отметка о применении препарата Глюкобай. 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