Препарат Онглиза в составе имеет активное вещество саксаглип... Инструкция
Показания к применению
Сахарный диабет 2 типа в дополнение к диете и физическим упражнениям для улучшения гликемического контроля в качестве: монотерапии. Стартовой комбинированной терапии с метформином. Добавления к монотерапии метформином, тиазолидиндионами, производными сульфониломочевины, при отсутствии адекватного гликемического контроля на данной терапии.
Противопоказания
Повышенная индивидуальная чувствительность к любому компоненту препарата. Сахарный диабет 1 типа (применение не изучено). Применение совместно с инсулином (не изучено). Диабетический кетоацидоз. Врожденные непереносимость галактозы, лактазная недостаточность и глюкозо-галактозная мальабсорбция. Беременность, лактация. Возраст до 18 лет (безопасность ...
Действующее вещество: Саксаглиптин (Saxagliptin). Концентрация действующего вещества (мг): 5
Фармакологические свойства
Препарат Онглиза в составе имеет активное вещество саксаглиптин, которое является очень сильным селективным конкурентным обратимым ингибитором дипептидилпептидазы-4. Если препарат принимают пациенты, которые болеют сахарным диабетом, у них на протяжении 24 часов активность фермента ДПП-4 подавляется.
Показания к применению
Сахарный диабет 2 типа в дополнение к диете и физическим упражнениям для улучшения гликемического контроля в качестве: монотерапии. Стартовой комбинированной терапии с метформином. Добавления к монотерапии метформином, тиазолидиндионами, производными сульфониломочевины, при отсутствии адекватного гликемического контроля на данной терапии.
Противопоказания
Повышенная индивидуальная чувствительность к любому компоненту препарата. Сахарный диабет 1 типа (применение не изучено). Применение совместно с инсулином (не изучено). Диабетический кетоацидоз. Врожденные непереносимость галактозы, лактазная недостаточность и глюкозо-галактозная мальабсорбция. Беременность, лактация. Возраст до 18 лет (безопасность и эффективность не изучены).
Применение при беременности и в период грудного вскармливания
В связи с тем, что применение саксаглиптина при беременности не изучено, не следует назначать препарат в этот период. Неизвестно, проникает ли саксаглиптин в грудное молоко. В связи с тем, что не исключена возможность проникновения саксаглиптина в грудное молоко, следует прекратить грудное вскармливание на период лечения саксаглиптином или отменить терапию, учитывая соотношение риска для ребенка и пользы для матери.
Способ применения и дозы
Внутрь, независимо от приема пищи. Монотерапия: рекомендуемая доза саксаглиптина составляет 5 мг 1 раз в сутки. Комбинированная терапия: рекомендуемая доза саксаглиптина составляет 5 мг I раз в сутки в комбинации с метформином, тиазолидиндионами или производными сульфонилмочевины. При стартовой комбинированой терапии с метформином рекомендуемая доза саксаглиптина составляет 5 мг 1 раз в сутки, начальная доза метформина - 500 мг в сутки. В случае неадекватного ответа доза метформина может быть увеличена. При пропуске приема препарата Онглиза пропущенную таблетку следует принять сразу, как только пациент об этом вспомнит, однако не следует принимать двойную дозу препарата в течение одних суток. Применение у особых групп пациентов. Пациенты с нарушением функции почек . Для пациентов с почечной недостаточностью легкой степени (КК больше50 млмин) коррекция дозы не требуется. Для пациентов с умеренной или тяжелой почечной недостаточностью (ККменьше 50 млмин), а также для пациентов на гемодиализе рекомендуемая доза препарата Онглиза составляет 2, 5 мг 1 раз в сутки. Препарат следует принимать по окончании сеанса гемодиализа. Применение саксаглиптина у пациентов на перитонеальном диализе не изучено. Перед началом терапии саксаглиптином и в процессе лечения рекомендуется проводить оценку функции почек. Пациенты с нарушением функции печени При нарушении функции печени легкой, умеренной и тяжелой степени коррекции дозы не требуется. Пациенты пожилого возраста. Коррекции дозы у пожилых пациентов не требуется. Однако при выборе дозы следует учитывать, что у этой категории пациентов более вероятно снижение функции почек. Дети: Безопасность и эффективность применения препарата у пациентов младше 18 лет не изучалась. Одновременное применение с мощными ингибиторами CYP3A45
Побочное действие
Общая частота нежелательных явлений при приеме препарата Онглиза 5 мг в режиме монотерапии и в режиме добавления к терапии метформином, тиазолидиндионом или глибенкламидом была сопоставима с таковой в группе плацебо. Шкала частоты побочных реакций: очень часто (≥110). часто (≥1100, меньше110). нечасто (≥11000, меньше1100). редко (≥110 000, меньше11000). очень редко (меньше110 000). В таблице приведены побочные эффекты, выявленные у пациентов с сахарным диабетом 2 типа при приеме препарата Онглиза в дозе 5 мг в ходе клинических исследований. Побочные эффекты представлены по данным объединенного анализа пяти плацебо-контролируемых клинических исследований препарата Онглиза. Инфекции верхних отделов дыхательных путей: Часто. Инфекции мочевыводящих путей: Часто. Гастроэнтерит: Часто. Синусит : Часто. Рвота: Часто. Головная боль: Часто. Частота реакций гиперчувствительности, отмеченных к 24 неделе терапии, составила 1. 5% у пациентов, получавших препарат Онглиза 5 мг, и 0. 4% у пациентов, получавших плацебо. Реакции гиперчувствительности, возникшие у пациентов, принимавших препарат Онглиза, не требовали госпитализации и были расценены лечащими врачами как не представлявшие угрозу жизни.
Передозировка
Симптомы интоксикации не описаны при длительном приеме препарата в дозах, до 80 раз превышающих рекомендованные. Лечение: в случае передозировки следует применять симптоматическую терапию. Саксаглиптин и его основной метаболит выводятся из организма при помощи гемодиализа (скорость выведения: 23% дозы за 4 ч).
Особые указания
Применение препарата Онглиза в комбинации с инсулином, а так же в составе тройной терапии с метформином и тиазолидиндионами или метформином и производными сульфонилмочевины, не изучалось. Пациенты с нарушением функции почек. Рекомендуется коррекция дозы для пациентов с умеренной и тяжелой степенью почечной недостаточностью, а также для пациентов, находящихся на гемодиализе. Перед началом терапии и периодически в процессе лечения препаратом рекомендуется проводить оценку функции почек. Применение в комбинации с препаратами, которые могут вызвать гипогликемию. Производные сульфонилмочевины могут вызвать гипогликемию, поэтому для уменьшения риска гипогликемии при одновременном применении с препаратом Онглиза может потребоваться снижение дозы производных сульфонилмочевины. Реакции гиперчувствительности. Препарат не следует назначать пациентам, у которых были отмечены серьезные реакции гиперчувствительности при применении других ингибиторов ДПП-4. Пациенты пожилого возраста. По данным клинических исследований, показатели эффективности и безопасности у пациентов в возрасте 65 лет и старше не отличались от аналогичных показателей у пациентов более молодого возраста. Однако нельзя исключить повышенную индивидуальную чувствительность к саксаглиптину у некоторых пациентов пожилого возраста. Саксаглиптин и его основной метаболит частично выводятся почками, поэтому необходимо учитывать, что у пациентов пожилого возраста более вероятно снижение функции почек. Препарат Онглиза содержит лактозу. Пациенты с врожденной непереносимостью галактозы, лактазной недостаточностью и глюкозо-галактозной мальабсорбцией не должны принимать этот препарат. Влияние на способность к вождению автотранспорта и управлению механизмамиИсследований по изучению влияния саксаглиптина на способность к вождению автотранспорта и управлению механизмами не проводилось. Следует учитывать, что саксаглиптин может вызывать головокружение.
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