Фармгруппа: Препараты для лечения урологических заболеваний/... Инструкция
Показания к применению
лечение ургентных позывов к мочеиспусканию, учащенного мочеиспускания и/или ургентного недержания мочи у пациентов с синдромом гиперактивного мочевого пузыря (ГМП)
Противопоказания
гиперчувствительность к активному компоненту препарата Бетмига или к вспомогательным веществам - детский и подростковый возраст до 18 лет - беременность и период лактации
Фармгруппа: Препараты для лечения урологических заболеваний/ Фармдействие: Мирабегрон – мощный селективный агонист бета3-адренорецепторов. В исследованиях при воздействии мирабегрона продемонстрировано расслабление гладких мышц мочевого пузыря у крыс и в изолированном препарате человеческих тканей, а также увеличение концентраций цАМФ в тканях мочевого пузыря у крыс. Таким образом, мирабегрон улучшает резервуарную функцию мочевого пузыря за счет стимуляции бета3-адренорецепторов, расположенных в его стенке. В исследованиях продемонстрирована эффективность мирабегрона как у пациентов, ранее получавших M-холиноблокаторы для лечения гиперактивного мочевого пузыря (ГМП), так и у пациентов без анамнеза предыдущей терапии M-холиноблокаторами. Мирабегрон также был эффективен у пациентов с ГМП, которые прекратили лечение M-холиноблокаторами из-за отсутствия эффекта. Уродинамика. В ходе 12-недельного исследования у мужчин с симптомами со стороны нижних мочевых путей (СНМП) и инфравезикальной обструкцией (ИВО) продемонстрирована безопасность и хорошая переносимость мирабегрона в дозах 50 и 100 мг один раз в сутки, а также отсутствие влияния мирабегрона на цистометрические показатели. Влияние на интервал QT. В дозах 50 мг и 100 мг мирабегрон не оказывал влияния на скорректированный по частоте пульса интервал QT (величина QTcI), что зафиксировано при проведении анализа для групп по половому признаку и для всей группы пациентов. Влияние повторного перорального приема мирабегрона в терапевтической дозе (50 мг один раз в сутки) и сверхтерапевтических дозах (100 и 200 мг один раз в сутки) на величину QTcI изучено в отдельном исследовании (исследование TQT) (n = 164 здоровых добровольца мужчин и n = 153 здоровых добровольца женщин ). Как у мужчин, так и у женщин, получавших мирабегрон в дозах 50 и 100 мг, верхний предел одностороннего 95% доверительного интервала для наибольшей согласованной во времени разницы с плацебо по величине QTcI в любой момент времени не превышал 10 мсек. Влияние на частоту пульса и величину артериального давления у пациентов с ГМП. В ходе 12-недельных двойных слепых плацебо-контролируемых исследований 3 фазы у пациентов с ГМП (средний возраст 59 лет), получавших 50 мг мирабегрона один раз в сутки, отмечено увеличение исходных средних значений разницы с плацебо по частоте пульса (на 1 уд/мин) и систолического артериального давления/диастолического артериального давления (САД/ДАД) (примерно на 1 мм рт ст или менее). Изменения частоты пульса и величины артериального давления на фоне лечения являются обратимыми и проходят после отмены препарата. Влияние на внутриглазное давление (ВГД). Через 56 дней после начала приема мирабегрона в дозе 100 мг один раз в сутки у здоровых добровольцев не зафиксировано повышения ВГД. В исследовании I фазы (n = 310) проведена оценка влияния мирабегрона на величину ВГД с помощью аппланационной тонометрии по Гольдману: мирабегрон в дозе 100 мг не отличался от плацебо по величине эффекта в отношении средней величины изменения исходных средних индивидуальных значений ВГД на 56 день.
Показания к применению
лечение ургентных позывов к мочеиспусканию, учащенного мочеиспускания и/или ургентного недержания мочи у пациентов с синдромом гиперактивного мочевого пузыря (ГМП)
Противопоказания
гиперчувствительность к активному компоненту препарата Бетмига или к вспомогательным веществам - детский и подростковый возраст до 18 лет - беременность и период лактации
Применение при беременности и в период грудного вскармливания
Беременность Имеются ограниченные данные по применению мирабегрона во время беременности. Результаты исследований репродуктивной токсичности на животных не указывают на прямое или косвенное отрицательное воздействие мирабегрона. Для предотвращения возможного негативного влияния на плод следует избегать применения препарата Бетмига у беременных женщин и у женщин, находящихся в детородном возрасте и не использующих средства контрацепции. Период лактации У грызунов мирабегрон выделяется с грудным молоком, следовательно, у человека также существует риск попадания препарата в грудное молоко. Исследования по изучению влияния мирабегрона на продукцию грудного молока, выделения мирабегрона с грудным молоком и воздействия на ребенка отсутствуют. Мирабегрон не следует применять женщинам в период кормления грудью. Фертильность В исследованиях на животных влияния мирабегрона на фертильность в нелетальных дозах не выявлено. Не установлено, влияет ли мирабегрон на фертильность у человека.
Способ применения и дозы
Взрослые (старше 18 лет), в т.ч. пожилые По 50 мг один раз в сутки внутрь, запивая жидкостью, независимо от времени приема пищи. Таблетка должна быть принята целиком, ее нельзя разжевывать, т.к. это может повлиять на пролонгированное высвобождение активного вещества.
Побочное действие
Наиболее частыми побочными реакциями, зафиксированными в ходе 12-недельных двойных слепых, плацебо-контролируемых исследований 3 фазы у пациентов, получающих мирабегрон в дозе 50 мг, являются тахикардия и инфекции мочевых путей. У пациентов, получающих мирабегрон в дозе 50 мг, частота тахикардии достигала 1.2%. У 0.1% пациентов, получающих мирабегрон в дозе 50 мг, развитие тахикардии послужило причиной досрочного прекращения участия в исследовании. У пациентов, получающих мирабегрон в дозе 50 мг, частота развития инфекций мочевых путей достигала 2,9%. Развитие инфекций мочевых путей не послужило причиной досрочного прекращения участия в исследовании ни у одного из пациентов, получающих мирабегрон в дозе 50 мг. Серьезные нежелательные реакции включали в себя мерцание предсердий (0.2%). В ходе долгосрочного (1 год) исследования с активным контролем (препарат контроля -м-холиноблокатор ) были зафиксированы побочные реакции, сходные по виду и частоте с реакциями, зафиксированными во время 12-недельных двойных слепых плацебо-контролируемых исследований 3 фазы. В рамках каждой группы реакции перечислены по мере снижения степени серьезности. Инфекции и инвазии: часто - инфекция мочевыводящих путей, нечасто - вагинальная инфекция, цистит. Нарушения со стороны органа зрения: редко - отек век Нарушения со стороны сердечно-сосудистой системы: часто - тахикардия; нечасто - учащенное сердцебиение, фибрилляция предсердий. Нарушения со стороны желудочно-кишечного тракта: нечасто - диспепсия, гастрит; редко - отек губ. Нарушения со стороны кожи и подкожной клетчатки: нечасто - крапивница, сыпь макулезная, сыпь папулезная, сыпь, зуд; редко - лейкоцитокластический васкулит, пурпура. Нарушения со стороны костно-мышечной системы и соединительной ткани: нечасто - воспаление суставов. Нарушения со стороны репродуктивной системы и молочной железы: нечасто - вульвовагинальный зуд. Отклонения от нормы, выявленные в лабораторных исследованиях: нечасто - повышение артериального давления, повышение активности ГГТ, повышение активности АСТ, повышение активности АЛТ.
Передозировка
При однократном назначении мирабегрона здоровым добровольцам использовали дозы вплоть до 400 мг. При использовании такого уровня доз зафиксированы нежелательные явления в виде учащенного сердцебиения (у 1 из 6 добровольцев) и увеличения частоты пульса более 100 уд/мин (у 3 из 6 добровольцев). При многократном (в течение 10 дней) применении препарата в суточных дозах до 300 мг у здоровых добровольцев зафиксировано увеличение частоты пульса и повышение систолического АД. При передозировке показана симптоматическая и поддерживающая терапия. Необходим контроль частоты пульса, АД и ЭКГ.
Особые указания
Влияние на способность управлять транспортными средствами и работу с механизмами Препарат Бетмига не оказывает клинически значимого влияния на способность к управлению транспортными средствами и механизмами.
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50 мг в таблетке. Вспомогательные вещества: макрогол 2 000 000 - 70 мг, макрогол 8000 - 119.6 мг, гипролоза - 7.5 мг, бутилгидрокситолуол - 0.4 мг, магния стеарат - 2.5 мг. Состав пленочной оболочки: опадрай 03F42192 (гипромеллоза 2910 6 мПа·сек - 69.536%, макрогол 8000 - 13.024%, краситель железа оксид желтый - 17.44%) - 7.5 мг."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Фармгруппа: Препараты для лечения урологических заболеваний/ Фармдействие: Мирабегрон – мощный селективный агонист бета3-адренорецепторов. В исследованиях при воздействии мирабегрона продемонстрировано расслабление гладких мышц мочевого пузыря у крыс и в изолированном препарате человеческих тканей, а также увеличение концентраций цАМФ в тканях мочевого пузыря у крыс. Таким образом, мирабегрон улучшает резервуарную функцию мочевого пузыря за счет стимуляции бета3-адренорецепторов, расположенных в его стенке. В исследованиях продемонстрирована эффективность мирабегрона как у пациентов, ранее получавших M-холиноблокаторы для лечения гиперактивного мочевого пузыря (ГМП), так и у пациентов без анамнеза предыдущей терапии M-холиноблокаторами. Мирабегрон также был эффективен у пациентов с ГМП, которые прекратили лечение M-холиноблокаторами из-за отсутствия эффекта. Уродинамика. В ходе 12-недельного исследования у мужчин с симптомами со стороны нижних мочевых путей (СНМП) и инфравезикальной обструкцией (ИВО) продемонстрирована безопасность и хорошая переносимость мирабегрона в дозах 50 и 100 мг один раз в сутки, а также отсутствие влияния мирабегрона на цистометрические показатели. Влияние на интервал QT. В дозах 50 мг и 100 мг мирабегрон не оказывал влияния на скорректированный по частоте пульса интервал QT (величина QTcI), что зафиксировано при проведении анализа для групп по половому признаку и для всей группы пациентов. Влияние повторного перорального приема мирабегрона в терапевтической дозе (50 мг один раз в сутки) и сверхтерапевтических дозах (100 и 200 мг один раз в сутки) на величину QTcI изучено в отдельном исследовании (исследование TQT) (n = 164 здоровых добровольца мужчин и n = 153 здоровых добровольца женщин ). Как у мужчин, так и у женщин, получавших мирабегрон в дозах 50 и 100 мг, верхний предел одностороннего 95% доверительного интервала для наибольшей согласованной во времени разницы с плацебо по величине QTcI в любой момент времени не превышал 10 мсек. Влияние на частоту пульса и величину артериального давления у пациентов с ГМП. В ходе 12-недельных двойных слепых плацебо-контролируемых исследований 3 фазы у пациентов с ГМП (средний возраст 59 лет), получавших 50 мг мирабегрона один раз в сутки, отмечено увеличение исходных средних значений разницы с плацебо по частоте пульса (на 1 уд/мин) и систолического артериального давления/диастолического артериального давления (САД/ДАД) (примерно на 1 мм рт ст или менее). Изменения частоты пульса и величины артериального давления на фоне лечения являются обратимыми и проходят после отмены препарата. Влияние на внутриглазное давление (ВГД). Через 56 дней после начала приема мирабегрона в дозе 100 мг один раз в сутки у здоровых добровольцев не зафиксировано повышения ВГД. В исследовании I фазы (n = 310) проведена оценка влияния мирабегрона на величину ВГД с помощью аппланационной тонометрии по Гольдману: мирабегрон в дозе 100 мг не отличался от плацебо по величине эффекта в отношении средней величины изменения исходных средних индивидуальных значений ВГД на 56 день."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"лечение ургентных позывов к мочеиспусканию, учащенного мочеиспускания и/или ургентного недержания мочи у пациентов с синдромом гиперактивного мочевого пузыря (ГМП)"}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["гиперчувствительность к активному компоненту препарата Бетмига или к вспомогательным веществам - детский и подростковый возраст до 18 лет - беременность и период лактации"]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Беременность Имеются ограниченные данные по применению мирабегрона во время беременности. Результаты исследований репродуктивной токсичности на животных не указывают на прямое или косвенное отрицательное воздействие мирабегрона. Для предотвращения возможного негативного влияния на плод следует избегать применения препарата Бетмига у беременных женщин и у женщин, находящихся в детородном возрасте и не использующих средства контрацепции. Период лактации У грызунов мирабегрон выделяется с грудным молоком, следовательно, у человека также существует риск попадания препарата в грудное молоко. Исследования по изучению влияния мирабегрона на продукцию грудного молока, выделения мирабегрона с грудным молоком и воздействия на ребенка отсутствуют. Мирабегрон не следует применять женщинам в период кормления грудью. Фертильность В исследованиях на животных влияния мирабегрона на фертильность в нелетальных дозах не выявлено. Не установлено, влияет ли мирабегрон на фертильность у человека."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Взрослые (старше 18 лет), в т.ч. пожилые По 50 мг один раз в сутки внутрь, запивая жидкостью, независимо от времени приема пищи. Таблетка должна быть принята целиком, ее нельзя разжевывать, т.к. это может повлиять на пролонгированное высвобождение активного вещества."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Наиболее частыми побочными реакциями, зафиксированными в ходе 12-недельных двойных слепых, плацебо-контролируемых исследований 3 фазы у пациентов, получающих мирабегрон в дозе 50 мг, являются тахикардия и инфекции мочевых путей. У пациентов, получающих мирабегрон в дозе 50 мг, частота тахикардии достигала 1.2%. У 0.1% пациентов, получающих мирабегрон в дозе 50 мг, развитие тахикардии послужило причиной досрочного прекращения участия в исследовании. У пациентов, получающих мирабегрон в дозе 50 мг, частота развития инфекций мочевых путей достигала 2,9%. Развитие инфекций мочевых путей не послужило причиной досрочного прекращения участия в исследовании ни у одного из пациентов, получающих мирабегрон в дозе 50 мг. Серьезные нежелательные реакции включали в себя мерцание предсердий (0.2%). В ходе долгосрочного (1 год) исследования с активным контролем (препарат контроля -м-холиноблокатор ) были зафиксированы побочные реакции, сходные по виду и частоте с реакциями, зафиксированными во время 12-недельных двойных слепых плацебо-контролируемых исследований 3 фазы. В рамках каждой группы реакции перечислены по мере снижения степени серьезности. Инфекции и инвазии: часто - инфекция мочевыводящих путей, нечасто - вагинальная инфекция, цистит. Нарушения со стороны органа зрения: редко - отек век Нарушения со стороны сердечно-сосудистой системы: часто - тахикардия; нечасто - учащенное сердцебиение, фибрилляция предсердий. Нарушения со стороны желудочно-кишечного тракта: нечасто - диспепсия, гастрит; редко - отек губ. Нарушения со стороны кожи и подкожной клетчатки: нечасто - крапивница, сыпь макулезная, сыпь папулезная, сыпь, зуд; редко - лейкоцитокластический васкулит, пурпура. Нарушения со стороны костно-мышечной системы и соединительной ткани: нечасто - воспаление суставов. Нарушения со стороны репродуктивной системы и молочной железы: нечасто - вульвовагинальный зуд. Отклонения от нормы, выявленные в лабораторных исследованиях: нечасто - повышение артериального давления, повышение активности ГГТ, повышение активности АСТ, повышение активности АЛТ."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При однократном назначении мирабегрона здоровым добровольцам использовали дозы вплоть до 400 мг. При использовании такого уровня доз зафиксированы нежелательные явления в виде учащенного сердцебиения (у 1 из 6 добровольцев) и увеличения частоты пульса более 100 уд/мин (у 3 из 6 добровольцев). При многократном (в течение 10 дней) применении препарата в суточных дозах до 300 мг у здоровых добровольцев зафиксировано увеличение частоты пульса и повышение систолического АД. При передозировке показана симптоматическая и поддерживающая терапия. Необходим контроль частоты пульса, АД и ЭКГ."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Влияние на способность управлять транспортными средствами и работу с механизмами Препарат Бетмига не оказывает клинически значимого влияния на способность к управлению транспортными средствами и механизмами."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Фармгруппа: Препараты для лечения урологических заболеваний/ Фармдействие: Мирабегрон – мощный селективный агонист бета3-адренорецепторов. В исследованиях при воздействии мирабегрона продемонстрировано расслабление гладких мышц мочевого пузыря у крыс и в изолированном препарате человеческих тканей, а также увеличение концентраций цАМФ в тканях мочевого пузыря у крыс. Таким образом, мирабегрон улучшает резервуарную функцию мочевого пузыря за счет стимуляции бета3-адренорецепторов, расположенных в его стенке. В исследованиях продемонстрирована эффективность мирабегрона как у пациентов, ранее получавших M-холиноблокаторы для лечения гиперактивного мочевого пузыря (ГМП), так и у пациентов без анамнеза предыдущей терапии M-холиноблокаторами. Мирабегрон также был эффективен у пациентов с ГМП, которые прекратили лечение M-холиноблокаторами из-за отсутствия эффекта. Уродинамика. В ходе 12-недельного исследования у мужчин с симптомами со стороны нижних мочевых путей (СНМП) и инфравезикальной обструкцией (ИВО) продемонстрирована безопасность и хорошая переносимость мирабегрона в дозах 50 и 100 мг один раз в сутки, а также отсутствие влияния мирабегрона на цистометрические показатели. Влияние на интервал QT. В дозах 50 мг и 100 мг мирабегрон не оказывал влияния на скорректированный по частоте пульса интервал QT (величина QTcI), что зафиксировано при проведении анализа для групп по половому признаку и для всей группы пациентов. Влияние повторного перорального приема мирабегрона в терапевтической дозе (50 мг один раз в сутки) и сверхтерапевтических дозах (100 и 200 мг один раз в сутки) на величину QTcI изучено в отдельном исследовании (исследование TQT) (n = 164 здоровых добровольца мужчин и n = 153 здоровых добровольца женщин ). Как у мужчин, так и у женщин, получавших мирабегрон в дозах 50 и 100 мг, верхний предел одностороннего 95% доверительного интервала для наибольшей согласованной во времени разницы с плацебо по величине QTcI в любой момент времени не превышал 10 мсек. Влияние на частоту пульса и величину артериального давления у пациентов с ГМП. В ходе 12-недельных двойных слепых плацебо-контролируемых исследований 3 фазы у пациентов с ГМП (средний возраст 59 лет), получавших 50 мг мирабегрона один раз в сутки, отмечено увеличение исходных средних значений разницы с плацебо по частоте пульса (на 1 уд/мин) и систолического артериального давления/диастолического артериального давления (САД/ДАД) (примерно на 1 мм рт ст или менее). Изменения частоты пульса и величины артериального давления на фоне лечения являются обратимыми и проходят после отмены препарата. Влияние на внутриглазное давление (ВГД). Через 56 дней после начала приема мирабегрона в дозе 100 мг один раз в сутки у здоровых добровольцев не зафиксировано повышения ВГД. 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