Длительная терапия ИБС: профилактика приступов стенокардии (монотерапия или в составе комбинированной терапии) лечение кохлео-вестибулярных нарушений ишемической природы (в т.ч. головокружение, шум в ушах, нарушения слуха) хориоретинальные сосудистые нарушения с ишемическим компонентом.
Противопоказания
Повышенная чувствительность к любому из компонентов препарата, болезнь Паркинсона, симптомы паркинсонизма, тремор, синдром «беспокойных ног» и другие, связанные с ними двигательные нарушения, тяжелая почечная недостаточность (клиренс креатинина менее 30 мл/мин). Из-за отсутствия достаточного количества клинических данных пациентам до 18 лет назначение ...
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Описание
Таблетки пролонгированного действия, покрытые пленочной оболочкой розового цвета, круглые, двояковыпуклые; на поперечном разрезе - ядро белого или почти белого цвета.
Фармакологические свойства
Средство, нормализующее энергетический метаболизм клеток, подвергшихся гипоксии или ишемии. Предотвращает снижение внутриклеточного содержания АТФ, обеспечивает нормальное функционирование мембранных ионных каналов, трансмембранный перенос ионов калия и натрия и сохранение клеточного гомеостаза. Триметазидин замедляет окисление жирных кислот за счет селективного ингибирования длинноцепочечной 3-кетоацетил-КоА тиолазы, что приводит к повышению окисления глюкозы и к восстановлению сопряжения между гликолизом и окислительным декарбоксилированием и, как было показано, обеспечивает защиту миокарда от ишемии. Переключение окисления жирных кислот на окисление глюкозы лежит в основе антиангинального действия триметазидина.
Показания к применению
Длительная терапия ИБС: профилактика приступов стенокардии (монотерапия или в составе комбинированной терапии) лечение кохлео-вестибулярных нарушений ишемической природы (в т.ч. головокружение, шум в ушах, нарушения слуха) хориоретинальные сосудистые нарушения с ишемическим компонентом.
Противопоказания
Повышенная чувствительность к любому из компонентов препарата, болезнь Паркинсона, симптомы паркинсонизма, тремор, синдром «беспокойных ног» и другие, связанные с ними двигательные нарушения, тяжелая почечная недостаточность (клиренс креатинина менее 30 мл/мин). Из-за отсутствия достаточного количества клинических данных пациентам до 18 лет назначение препарата не рекомендуется. С осторожностью: пациенты с тяжелой печеночной недостаточностью (клинические данные ограничены), пациенты с умеренной почечной недостаточностью.
Применение при беременности и в период грудного вскармливания
Данные о применении препарата Депренорм® МВ у беременных отсутствуют. Исследования на животных не выявили наличие прямой или непрямой репродуктивной токсичности. Исследования репродуктивной токсичности не показали влияния триметазидина на репродуктивную функцию у крыс обоего пола. Препарат противопоказан при беременности из-за отсутствия клинических данных о безопасности его применения. Данные о выделении триметазидина или его метаболитов в грудное молоко отсутствуют. Риск для новорожденного/ребенка не может быть исключен. Не следует применять препарат Депренорм® МВ во время грудного вскармливания.
Способ применения и дозы
Таблетки следует принимать целиком, не разжевывая, запивая водой. Внутрь, по 1 таблетке 2 раза в сутки, утром и вечером, во время еды. Продолжительность лечения определяется врачом.
Побочное действие
Нежелательные реакции, определенные как нежелательные явления, по крайней мере имеющие возможное отношение к лечению триметазидином, приведены в следующей градации: очень часто (?1/10), часто (?1/100, <1/10), нечасто (≥1/1000, <1/100), редко (?1/10000, <1/1000), очень редко (<1/10000), неуточненной частоты (частота не может быть подсчитана по доступным данным). Со стороны пищеварительной системы Часто: боль в животе, диарея, диспепсия, тошнота, рвота. Неуточненной частоты: запор. Общие расстройства Часто: астения. Со стороны центральной нервной системы Часто: головокружение, головная боль. Неуточненной частоты: симптомы паркинсонизма (тремор, акинезия, повышение тонуса), неустойчивость в позе Ромберга и «шаткость» походки, синдром «беспокойных ног», другие связанные с ними двигательные нарушения, обычно обратимые после прекращения терапии. Нарушения сна (бессонница, сонливость). Со стороны кожных покровов и подкожно-жировой клетчатки Часто: кожная сыпь, зуд, крапивница. Неуточненной частоты: острый генерализованный экзантематозный пустулез, отек Квинке. Со стороны сердечно-сосудистой системы Редко: ощущение сердцебиения, экстрасистолия, тахикардия, выраженное снижение АД, ортостатическая гипотензия, которая может сопровождаться общей слабостью, головокружением или потерей равновесия, особенно при одновременном приеме гипотензивных препаратов, «приливы» крови к коже лица. Со стороны кровеносной и лимфатической системы Неуточненной частоты: агранулоцитоз, тромбоцитопения, тромбоцитопеническая пурпура. Со стороны печени и желчевыводящих путей Неуточненной частоты: гепатит.
Особые указания
Триметазидин МВ не предназначен для купирования приступов стенокардии и не показан для начального курса терапии нестабильной стенокардии или инфаркта миокарда на догоспитальном этапе или в первые дни госпитализации. В случае развития приступа стенокардии следует пересмотреть и адаптировать лечение (лекарственную терапию или проведение реваскуляризации). Триметазидин МВ может вызывать или ухудшать симптомы паркинсонизма (тремор, акинезию, повышение тонуса), поэтому следует проводить регулярное наблюдение пациентов, особенно пожилого возраста. В сомнительных случаях пациенты должны быть направлены к неврологу для соответствующего обследования. При появлении двигательных нарушений, таких как симптомы паркинсонизма, синдром «беспокойных ног», тремор, неустойчивость в позе Ромберга и «шаткость» походки, Триметазидин МВ следует окончательно отменить.
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