Метформин – пероральное гипогликемическое средство из группы... Инструкция
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Метформин – пероральное гипогликемическое средство из группы бигуанидов. У больных сахарным диабетом снижает концентрацию глюкозы в крови путем угнетения глюконеогенеза в печени, уменьшения всасывания глюкозы из желудочно-кишечного тракта (ЖКТ) и повышения ее утилизации в тканях за счет повышения их чувствительности к инсулину (преимущественно поперечно-полосатой мускулатуры, в меньшей степени – жировой ткани). Стимулирует внутриклеточный гликогенез, активируя гликогенсинтазу. В отличие от производных сульфонилмочевины, не стимулирует секрецию инсулина и не оказывает гипогликемического эффекта у здоровых лиц. Оказывает влияние на липидный обмен – снижает концентрацию в сыворотке крови триглицеридов, холестерина и липопротеинов низкой плотности. Стабилизирует или снижает массу тела. Оказывает фибринолитическое действие за счет подавления ингибитора активатора плазминогена тканевого типа. Фармакокинетика После приема внутрь абсорбция метформина из ЖКТ составляет 48-52 %. При одновременном приеме пищи абсорбция метформина снижается и задерживается. Абсолютная биодоступность составляет 50-60 %. Максимальная концентрация в крови (Cmax) – 2 мкг/мл, время достижения максимальной концентрации (TCmax) – 1,81-2,69 ч. Метформин быстро распределяется в ткани. Проникает в эритроциты. Накапливается в слюнных железах, печени и почках. Объем распределения (для дозы 850 мг) составляет 296-1012 л. Связь с белками плазмы – незначительная. Подвергается метаболизму в очень слабой степени. Выводится почками, преимущественно в неизмененном виде. Клиренс метформина у здоровых лиц составляет 400 мл/мин. Период полувыведения (T1/2) – 6,2 ч (начальный T1/2 – от 1,7 до 3 ч, терминальный – от 9 до 17 ч). При почечной недостаточности он возрастает, появляется риск кумуляции препарата. Показания к применению Сахарный диабет 2 типа у взрослых (особенно у пациентов с ожирением) при неэффективности диетотерапии и физических нагрузок, в качестве монотерапии или в комбинации с другими пероральными гипогликемическими средствами или инсулином. Сахарный диабет 2 типа у детей с 10-летнего возраста – как в качестве монотерапии, так и в комбинации с инсулином. Противопоказания - Повышенная чувствительность к метформину или к любому вспомогательному веществу. - Диабетический кетоацидоз, диабетическая прекома, кома. - Почечная недостаточность или нарушение функции почек (клиренс креатинина (КК) менее 60 мл/мин). - Острые состояния, протекающие с риском развития нарушений функции почек: - дегидратация (при диарее, рвоте), лихорадка, тяжелые инфекционные заболевания, - состояния гипоксии (шок, сепсис, инфекции почек, бронхо-легочные заболевания). - Клинически выраженные проявления острых и хронических заболеваний, которые могут приводить к развитию тканевой гипоксии (в том числе, сердечная или дыхательная недостаточность, острый инфаркт миокарда). - Обширные хирургические операции и травмы, когда показано проведение инсулинотерапии (см. раздел «Особые указания»). - Печеночная недостаточность, нарушение функции печени. - Хронический алкоголизм, острое отравление алкоголем. - Лактоацидоз, в том числе, в анамнезе. - Применение в течение не менее 48 ч до и 48 ч после проведения радиоизотопных или рентгенологических исследований с введением йодсодержащего контрастного вещества (см. раздел «Взаимодействие с другими лекарственными средствами»). - Период не менее 48 ч до и 48 ч после хирургических вмешательств под общим наркозом, спинномозговой или перидуральной анестезией. - Соблюдение гипокалорийной диеты (менее 1000 ккал/сут). - Детский возраст до 10 лет. С осторожностью: У лиц в возрасте старше 60 лет, выполняющих тяжелую физическую работу (повышенная опасность развития лактоацидоза). Применение при беременности и в период лактации Препарат противопоказан к применению при беременности и в период грудного вскармливания. При планировании или возникновении беременности Метформин Канон следует отменить и применить инсулинотерапию. Пациентку следует предупредить о необходимости поставить в известность врача в случае возникновения беременности. За матерью и ребенком следует установить наблюдение. Неизвестно, выделяется ли метформин с грудным молоком. При необходимости применения препарата в период лактации, грудное вскармливание следует прекратить.Побочное действие Со стороны центральной нервной системы: нарушение вкуса («металлический» привкус во рту). Со стороны ЖКТ: тошнота, рвота, диарея, боли в животе и отсутствие аппетита. Возникновение данных побочных эффектов наиболее вероятно в начальный период лечения и в большинстве случаев они спонтанно проходят. Для предотвращения симптомов рекомендуется принимать метформин во время или после приема пищи. Медленное увеличение дозы может улучшить желудочно-кишечную переносимость. Со стороны гепатобилиарной системы: нарушение показателей функции печени, гепатит. После отмены метформина нежелательные явления, как правило, полностью исчезают. Аллергические реакции: очень редко – эритема, кожный зуд, сыпь, крапивница. Со стороны обмена веществ: очень редко – лактоацидоз (требует отмены препарата). Прочие: очень редко – при длительном применении развивается гиповитаминоз B12 (в том числе мегалобластная анемия) и фолиевой кислоты (нарушение всасывания). Опубликованные данные показывают, что в ограниченной детской популяции в возрасте от 10 до 16 лет побочные эффекты по характеру и тяжести схожи с таковыми у взрослых пациентов. Передозировка Симптомы: при применении метформина в дозе 85 г не наблюдалось гипогликемии, однако отмечалось развитие лактоацидоза. Ранними симптомами лактоацидоза являются тошнота, рвота, диарея, снижение температуры тела, боли в животе, боли в мышцах, в дальнейшем может отмечаться учащение дыхания, головокружение, нарушение сознания и развитие комы. Лечение: В случае появления признаков лактоацидоза лечение препаратом необходимо немедленно прекратить, больного срочно госпитализировать и, определив концентрацию лактата, уточнить диагноз. Наиболее эффективным мероприятием по выведению из организма лактата и метформина является гемодиализ. Проводят также симптоматическое лечение. Взаимодействие с другими лекарственными препаратами Противопоказанные комбинации Радиологические исследования с применением йодсодержащих рентгеноконтрастных препаратов может вызвать развитие лактоацидоза у больных сахарным диабетом на фоне функциональной почечной недостаточности. Применение метформина следует отменить за 48 ч до и не возобновлять ранее 48 ч после рентгенологического исследования с использованием рентгеноконтрастных препаратов. Нерекомендуемые комбинации При одновременном применении метформина с алкоголем и этанолсодержащими препаратами, во время острой алкогольной интоксикации, при голодании или соблюдении низкокалорийной диеты, а также при печеночной недостаточности повышается риск развития лактоацидоза. Комбинации, требующие особой осторожности При одновременном применении метформина с даназолом возможно развитие гипергликемического эффекта. При необходимости лечения даназолом и после прекращения его приема требуется коррекция дозы метформина под контролем концентрации глюкозы в крови. Хлорпромазин в высоких дозах (100 мг/сут) уменьшает высвобождение инсулина и повышает концентрацию глюкозы в крови. При одновременном применении с нейролептиками и после прекращения их приема требуется коррекция дозы метформина под контролем концентрации глюкозы в крови. Глюкокортикостероиды (ГКС) при парентеральном и местном применении снижают толерантность к глюкозе и повышают концентрацию глюкозы в крови, в некоторых случаях вызывая кетоз. При необходимости применения такой комбинации и после прекращения приема ГКС требуется коррекция дозы метформина под контролем концентрации глюкозы в крови. При одновременном применении «петлевых» диуретиков и метформина имеется риск развития лактоацидоза из-за возможного появления функциональной почечной недостаточности. Применение в виде инъекций бета2-адреномиметиков снижает гипогликемическое действие метформина вследствие стимуляции бета2-адренорецепторов. В этом случае следует контролировать концентрацию глюкозы в крови и при необходимости применять инсулин. Ингибиторы ангиотензинпревращающего фермента и другие антигипертензи
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– пероральное гипогликемическое средство из группы бигуанидов. У больных сахарным диабетом снижает концентрацию глюкозы в крови путем угнетения глюконеогенеза в печени, уменьшения всасывания глюкозы из желудочно-кишечного тракта (ЖКТ) и повышения ее утилизации в тканях за счет повышения их чувствительности к инсулину (преимущественно поперечно-полосатой мускулатуры, в меньшей степени – жировой ткани). Стимулирует внутриклеточный гликогенез, активируя гликогенсинтазу. В отличие от производных сульфонилмочевины, не стимулирует секрецию инсулина и не оказывает гипогликемического эффекта у здоровых лиц. Оказывает влияние на липидный обмен – снижает концентрацию в сыворотке крови триглицеридов, холестерина и липопротеинов низкой плотности. Стабилизирует или снижает массу тела. Оказывает фибринолитическое действие за счет подавления ингибитора активатора плазминогена тканевого типа. Фармакокинетика После приема внутрь абсорбция метформина из ЖКТ составляет 48-52 %. При одновременном приеме пищи абсорбция метформина снижается и задерживается. Абсолютная биодоступность составляет 50-60 %. Максимальная концентрация в крови (Cmax) – 2 мкг/мл, время достижения максимальной концентрации (TCmax) – 1,81-2,69 ч. Метформин быстро распределяется в ткани. Проникает в эритроциты. Накапливается в слюнных железах, печени и почках. Объем распределения (для дозы 850 мг) составляет 296-1012 л. Связь с белками плазмы – незначительная. Подвергается метаболизму в очень слабой степени. Выводится почками, преимущественно в неизмененном виде. Клиренс метформина у здоровых лиц составляет 400 мл/мин. Период полувыведения (T1/2) – 6,2 ч (начальный T1/2 – от 1,7 до 3 ч, терминальный – от 9 до 17 ч). При почечной недостаточности он возрастает, появляется риск кумуляции препарата. Показания к применению Сахарный диабет 2 типа у взрослых (особенно у пациентов с ожирением) при неэффективности диетотерапии и физических нагрузок, в качестве монотерапии или в комбинации с другими пероральными гипогликемическими средствами или инсулином. Сахарный диабет 2 типа у детей с 10-летнего возраста – как в качестве монотерапии, так и в комбинации с инсулином. Противопоказания - Повышенная чувствительность к метформину или к любому вспомогательному веществу. - Диабетический кетоацидоз, диабетическая прекома, кома. - Почечная недостаточность или нарушение функции почек (клиренс креатинина (КК) менее 60 мл/мин). - Острые состояния, протекающие с риском развития нарушений функции почек: - дегидратация (при диарее, рвоте), лихорадка, тяжелые инфекционные заболевания, - состояния гипоксии (шок, сепсис, инфекции почек, бронхо-легочные заболевания). - Клинически выраженные проявления острых и хронических заболеваний, которые могут приводить к развитию тканевой гипоксии (в том числе, сердечная или дыхательная недостаточность, острый инфаркт миокарда). - Обширные хирургические операции и травмы, когда показано проведение инсулинотерапии (см. раздел «Особые указания»). - Печеночная недостаточность, нарушение функции печени. - Хронический алкоголизм, острое отравление алкоголем. - Лактоацидоз, в том числе, в анамнезе. - Применение в течение не менее 48 ч до и 48 ч после проведения радиоизотопных или рентгенологических исследований с введением йодсодержащего контрастного вещества (см. раздел «Взаимодействие с другими лекарственными средствами»). - Период не менее 48 ч до и 48 ч после хирургических вмешательств под общим наркозом, спинномозговой или перидуральной анестезией. - Соблюдение гипокалорийной диеты (менее 1000 ккал/сут). - Детский возраст до 10 лет. С осторожностью: У лиц в возрасте старше 60 лет, выполняющих тяжелую физическую работу (повышенная опасность развития лактоацидоза). Применение при беременности и в период лактации Препарат противопоказан к применению при беременности и в период грудного вскармливания. При планировании или возникновении беременности Метформин Канон следует отменить и применить инсулинотерапию. Пациентку следует предупредить о необходимости поставить в известность врача в случае возникновения беременности. За матерью и ребенком следует установить наблюдение. Неизвестно, выделяется ли метформин с грудным молоком. При необходимости применения препарата в период лактации, грудное вскармливание следует прекратить.Побочное действие Со стороны центральной нервной системы: нарушение вкуса («металлический» привкус во рту). Со стороны ЖКТ: тошнота, рвота, диарея, боли в животе и отсутствие аппетита. Возникновение данных побочных эффектов наиболее вероятно в начальный период лечения и в большинстве случаев они спонтанно проходят. Для предотвращения симптомов рекомендуется принимать метформин во время или после приема пищи. Медленное увеличение дозы может улучшить желудочно-кишечную переносимость. Со стороны гепатобилиарной системы: нарушение показателей функции печени, гепатит. После отмены метформина нежелательные явления, как правило, полностью исчезают. Аллергические реакции: очень редко – эритема, кожный зуд, сыпь, крапивница. Со стороны обмена веществ: очень редко – лактоацидоз (требует отмены препарата). Прочие: очень редко – при длительном применении развивается гиповитаминоз B12 (в том числе мегалобластная анемия) и фолиевой кислоты (нарушение всасывания). Опубликованные данные показывают, что в ограниченной детской популяции в возрасте от 10 до 16 лет побочные эффекты по характеру и тяжести схожи с таковыми у взрослых пациентов. Передозировка Симптомы: при применении метформина в дозе 85 г не наблюдалось гипогликемии, однако отмечалось развитие лактоацидоза. Ранними симптомами лактоацидоза являются тошнота, рвота, диарея, снижение температуры тела, боли в животе, боли в мышцах, в дальнейшем может отмечаться учащение дыхания, головокружение, нарушение сознания и развитие комы. Лечение: В случае появления признаков лактоацидоза лечение препаратом необходимо немедленно прекратить, больного срочно госпитализировать и, определив концентрацию лактата, уточнить диагноз. Наиболее эффективным мероприятием по выведению из организма лактата и метформина является гемодиализ. Проводят также симптоматическое лечение. Взаимодействие с другими лекарственными препаратами Противопоказанные комбинации Радиологические исследования с применением йодсодержащих рентгеноконтрастных препаратов может вызвать развитие лактоацидоза у больных сахарным диабетом на фоне функциональной почечной недостаточности. Применение метформина следует отменить за 48 ч до и не возобновлять ранее 48 ч после рентгенологического исследования с использованием рентгеноконтрастных препаратов. Нерекомендуемые комбинации При одновременном применении метформина с алкоголем и этанолсодержащими препаратами, во время острой алкогольной интоксикации, при голодании или соблюдении низкокалорийной диеты, а также при печеночной недостаточности повышается риск развития лактоацидоза. Комбинации, требующие особой осторожности При одновременном применении метформина с даназолом возможно развитие гипергликемического эффекта. При необходимости лечения даназолом и после прекращения его приема требуется коррекция дозы метформина под контролем концентрации глюкозы в крови. Хлорпромазин в высоких дозах (100 мг/сут) уменьшает высвобождение инсулина и повышает концентрацию глюкозы в крови. При одновременном применении с нейролептиками и после прекращения их приема требуется коррекция дозы метформина под контролем концентрации глюкозы в крови. Глюкокортикостероиды (ГКС) при парентеральном и местном применении снижают толерантность к глюкозе и повышают концентрацию глюкозы в крови, в некоторых случаях вызывая кетоз. При необходимости применения такой комбинации и после прекращения приема ГКС требуется коррекция дозы метформина под контролем концентрации глюкозы в крови. При одновременном применении «петлевых» диуретиков и метформина имеется риск развития лактоацидоза из-за возможного появления функциональной почечной недостаточности. Применение в виде инъекций бета2-адреномиметиков снижает гипогликемическое действие метформина вследствие стимуляции бета2-адренорецепторов. В этом случае следует контролировать концентрацию глюкозы в крови и при необходимости применять инсулин. Ингибиторы ангиотензинпревращающего фермента и другие антигипертензи"}}]}],"source":{"title":"('Эркафарм/Столетов',)","url":"https://stoletov.ru/"}},"description_toggle":false,"short_description":"Метформин – пероральное гипогликемическое средство из группы бигуанидов. У больных сахарным диабетом снижает концентрацию глюкозы в крови путем угнетения глюконеогенеза в печени, уменьшения всасывания глюкозы из желудочно-кишечного тракта (ЖКТ) и повышения ее утилизации в тканях за счет повышения их чувствительности к инсулину (преимущественно поперечно-полосатой мускулатуры, в меньшей степени – жировой ткани). Стимулирует внутриклеточный гликогенез, активируя гликогенсинтазу. В отличие от производных сульфонилмочевины, не стимулирует секрецию инсулина и не оказывает гипогликемического эффекта у здоровых лиц. Оказывает влияние на липидный обмен – снижает концентрацию в сыворотке крови триглицеридов, холестерина и липопротеинов низкой плотности. Стабилизирует или снижает массу тела. Оказывает фибринолитическое действие за счет подавления ингибитора активатора плазминогена тканевого типа. Фармакокинетика После приема внутрь абсорбция метформина из ЖКТ составляет 48-52 %. При одновременном приеме пищи абсорбция метформина снижается и задерживается. Абсолютная биодоступность составляет 50-60 %. Максимальная концентрация в крови (Cmax) – 2 мкг/мл, время достижения максимальной концентрации (TCmax) – 1,81-2,69 ч. Метформин быстро распределяется в ткани. Проникает в эритроциты. Накапливается в слюнных железах, печени и почках. Объем распределения (для дозы 850 мг) составляет 296-1012 л. Связь с белками плазмы – незначительная. Подвергается метаболизму в очень слабой степени. Выводится почками, преимущественно в неизмененном виде. Клиренс метформина у здоровых лиц составляет 400 мл/мин. Период полувыведения (T1/2) – 6,2 ч (начальный T1/2 – от 1,7 до 3 ч, терминальный – от 9 до 17 ч). При почечной недостаточности он возрастает, появляется риск кумуляции препарата. Показания к применению Сахарный диабет 2 типа у взрослых (особенно у пациентов с ожирением) при неэффективности диетотерапии и физических нагрузок, в качестве монотерапии или в комбинации с другими пероральными гипогликемическими средствами или инсулином. Сахарный диабет 2 типа у детей с 10-летнего возраста – как в качестве монотерапии, так и в комбинации с инсулином. Противопоказания - Повышенная чувствительность к метформину или к любому вспомогательному веществу. - Диабетический кетоацидоз, диабетическая прекома, кома. - Почечная недостаточность или нарушение функции почек (клиренс креатинина (КК) менее 60 мл/мин). - Острые состояния, протекающие с риском развития нарушений функции почек: - дегидратация (при диарее, рвоте), лихорадка, тяжелые инфекционные заболевания, - состояния гипоксии (шок, сепсис, инфекции почек, бронхо-легочные заболевания). - Клинически выраженные проявления острых и хронических заболеваний, которые могут приводить к развитию тканевой гипоксии (в том числе, сердечная или дыхательная недостаточность, острый инфаркт миокарда). - Обширные хирургические операции и травмы, когда показано проведение инсулинотерапии (см. раздел «Особые указания»). - Печеночная недостаточность, нарушение функции печени. - Хронический алкоголизм, острое отравление алкоголем. - Лактоацидоз, в том числе, в анамнезе. - Применение в течение не менее 48 ч до и 48 ч после проведения радиоизотопных или рентгенологических исследований с введением йодсодержащего контрастного вещества (см. раздел «Взаимодействие с другими лекарственными средствами»). - Период не менее 48 ч до и 48 ч после хирургических вмешательств под общим наркозом, спинномозговой или перидуральной анестезией. - Соблюдение гипокалорийной диеты (менее 1000 ккал/сут). - Детский возраст до 10 лет. С осторожностью: У лиц в возрасте старше 60 лет, выполняющих тяжелую физическую работу (повышенная опасность развития лактоацидоза). Применение при беременности и в период лактации Препарат противопоказан к применению при беременности и в период грудного вскармливания. При планировании или возникновении беременности Метформин Канон следует отменить и применить инсулинотерапию. Пациентку следует предупредить о необходимости поставить в известность врача в случае возникновения беременности. За матерью и ребенком следует установить наблюдение. Неизвестно, выделяется ли метформин с грудным молоком. При необходимости применения препарата в период лактации, грудное вскармливание следует прекратить.Побочное действие Со стороны центральной нервной системы: нарушение вкуса («металлический» привкус во рту). Со стороны ЖКТ: тошнота, рвота, диарея, боли в животе и отсутствие аппетита. Возникновение данных побочных эффектов наиболее вероятно в начальный период лечения и в большинстве случаев они спонтанно проходят. Для предотвращения симптомов рекомендуется принимать метформин во время или после приема пищи. Медленное увеличение дозы может улучшить желудочно-кишечную переносимость. Со стороны гепатобилиарной системы: нарушение показателей функции печени, гепатит. После отмены метформина нежелательные явления, как правило, полностью исчезают. Аллергические реакции: очень редко – эритема, кожный зуд, сыпь, крапивница. Со стороны обмена веществ: очень редко – лактоацидоз (требует отмены препарата). Прочие: очень редко – при длительном применении развивается гиповитаминоз B12 (в том числе мегалобластная анемия) и фолиевой кислоты (нарушение всасывания). Опубликованные данные показывают, что в ограниченной детской популяции в возрасте от 10 до 16 лет побочные эффекты по характеру и тяжести схожи с таковыми у взрослых пациентов. Передозировка Симптомы: при применении метформина в дозе 85 г не наблюдалось гипогликемии, однако отмечалось развитие лактоацидоза. Ранними симптомами лактоацидоза являются тошнота, рвота, диарея, снижение температуры тела, боли в животе, боли в мышцах, в дальнейшем может отмечаться учащение дыхания, головокружение, нарушение сознания и развитие комы. Лечение: В случае появления признаков лактоацидоза лечение препаратом необходимо немедленно прекратить, больного срочно госпитализировать и, определив концентрацию лактата, уточнить диагноз. Наиболее эффективным мероприятием по выведению из организма лактата и метформина является гемодиализ. Проводят также симптоматическое лечение. Взаимодействие с другими лекарственными препаратами Противопоказанные комбинации Радиологические исследования с применением йодсодержащих рентгеноконтрастных препаратов может вызвать развитие лактоацидоза у больных сахарным диабетом на фоне функциональной почечной недостаточности. Применение метформина следует отменить за 48 ч до и не возобновлять ранее 48 ч после рентгенологического исследования с использованием рентгеноконтрастных препаратов. Нерекомендуемые комбинации При одновременном применении метформина с алкоголем и этанолсодержащими препаратами, во время острой алкогольной интоксикации, при голодании или соблюдении низкокалорийной диеты, а также при печеночной недостаточности повышается риск развития лактоацидоза. Комбинации, требующие особой осторожности При одновременном применении метформина с даназолом возможно развитие гипергликемического эффекта. При необходимости лечения даназолом и после прекращения его приема требуется коррекция дозы метформина под контролем концентрации глюкозы в крови. Хлорпромазин в высоких дозах (100 мг/сут) уменьшает высвобождение инсулина и повышает концентрацию глюкозы в крови. При одновременном применении с нейролептиками и после прекращения их приема требуется коррекция дозы метформина под контролем концентрации глюкозы в крови. Глюкокортикостероиды (ГКС) при парентеральном и местном применении снижают толерантность к глюкозе и повышают концентрацию глюкозы в крови, в некоторых случаях вызывая кетоз. При необходимости применения такой комбинации и после прекращения приема ГКС требуется коррекция дозы метформина под контролем концентрации глюкозы в крови. При одновременном применении «петлевых» диуретиков и метформина имеется риск развития лактоацидоза из-за возможного появления функциональной почечной недостаточности. Применение в виде инъекций бета2-адреномиметиков снижает гипогликемическое действие метформина вследствие стимуляции бета2-адренорецепторов. В этом случае следует контролировать концентрацию глюкозы в крови и при необходимости применять инсулин. 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