Препарат, улучшающий метаболизм миокарда. Оказывает антигипоксическое действие.
Триметазидин предотвращает снижение внутриклеточной концентрации АТФ путем сохранения энергетического метаболизма клеток в состоянии гипоксии. Таким образом, препарат 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 фермента 3-кетоацил-КоА-тиолазы (3-КАТ), что приводит к усилению окисления глюкозы, ускорению гликолиза с окислением глюкозы, и обусловливает защиту миокарда от ишемии. Переключение энергетического метаболизма с окисления жирных кислот на окисление глюкозы лежит в основе фармакологических свойств триметазидина.
Экспериментально подтверждено, что триметазидин обладает следующими свойствами: поддерживает энергетический метаболизм сердца и нейросенсорных тканей во время ишемии; уменьшает выраженность внутриклеточного ацидоза и степень изменений в трансмембранном ионного потоке, возникающих при ишемии; понижает уровень миграции и инфильтрации полинуклеарных нейтрофилов в ишемизированных и реперфузионных тканях сердца; уменьшает размер повреждения миокарда; не оказывает прямого воздействия на показатели гемодинамики.
У пациентов со стенокардией триметазидин увеличивает коронарный резерв, тем самым замедляя наступление ишемии, вызванной физической нагрузкой, начиная с 15-го дня терапии; ограничивает колебания АД, вызванные физической нагрузкой, без значительных изменений ЧСС; снижает частоту приступов стенокардии и потребность в приеме нитроглицерина короткого действия; улучшает сократительную функцию левого желудочка у больных с ишемической дисфункцией.
Фармакокинетика
Всасывание
После приема внутрь триметазидин абсорбируется из ЖКТ. Cmax в плазме крови достигается приблизительно через 5 ч. Более 24 ч концентрация в плазме крови остается на уровне, превышающем 75% концентрации, определяемой через 11 ч. Прием пищи не влияет на биодоступность триметазидина.
Распределение
Css достигается через 60 ч. Vd составляет 4.8 л/кг, что свидетельствует о хорошем распределении триметазидина в тканях. Степень связывания с белками плазмы крови достаточно низкая (около 16% in vitro).
Выведение
Триметазидин выводится в основном почками, главным образом, в неизмененном виде. Почечный клиренс триметазидина прямо коррелирует с КК.
Фармакокинетика в особых клинических случаях
Печеночный клиренс снижается с возрастом пациента.
Показания к применению
ИБС: профилактика приступов стабильной стенокардии (в составе комбинированной терапии).
Противопоказания
почечная недостаточность тяжелой степени (КК менее 30 мл/мин);
болезнь Паркинсона, симптомы паркинсонизма, тремор, синдром "беспокойных" ног и другие, связанные с ними двигательные нарушения;
беременность;
период лактации (грудного вскармливания);
возраст до 18 лет (эффективность и безопасность не установлены);
повышенная чувствительность к любому из компонентов препарата.
С осторожностью
С осторожностью следует назначать препарат пациентам с печеночной недостаточностью тяжелой степени (клинические данные ограничены), нарушением функции почек (КК более 30 мл/мин), в возрасте старше 75 лет.
Применение при беременности и в период грудного вскармливания
Данные о применении препарата Депренорм® ОД у беременных женщин отсутствуют. Экспериментальные исследования на животных не выявили наличие прямой или непрямой репродуктивной токсичности. Исследования 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 с грудным молоком отсутствуют. Риск для новорожденного/ребенка не может быть исключен. Не следует применять препарат Депренорм® ОД в период грудного вскармливания.
Продолжительность курса лечения определяется врачом.
Побочное действие
Частота побочных эффектов, отмеченных при приеме триметазидина, приведена в следующей градации: очень часто (>1/10); часто (>1/100, <1/10); нечасто (>1/1000, <1/100); редко (>1/10 000, <1/1000); очень редко (<1/10 000, в т.ч. отдельные сообщения); неуточненной частоты (частота не может быть подсчитана по доступным данным).
Со стороны ЦНС: часто - головокружение, головная боль; неуточненной частоты - нарушения сна (бессонница, сонливость), 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.
Со стороны сердечно-сосудистой системы: редко - ортостатическая гипотензия, "приливы" крови к коже лица, ощущение сердцебиения, экстрасистолия, тахикардия, выраженное снижение АД.
Со стороны системы кроветворения: неуточненной частоты - агранулоцитоз, тромбоцитопения, тромбоцитопеническая пурпура.
Со стороны пищеварительной системы: часто - боль в животе, диарея, диспепсия, тошнота, рвота; неуточненной частоты - запор, гепатит.
Аллергические реакции: часто - кожная сыпь, зуд, крапивница; неуточненной частоты - острый генерализованный экзантематозный пустулез, отек Квинке.
Прочие: часто - астения.
Передозировка
Имеется лишь ограниченная информация о передозировке триметазидина.
Лечение: в случае передозировки следует проводить симптоматическую терапию.
Взаимодействие с другими лекарственными средствами
Данных о взаимодействии препарата с другими лекарственными средствами нет.
Особые указания
Депренорм® ОД не предназначен для купирования приступов стенокардии, для начального курса терапии нестабильной стенокардии или инфаркта миокарда, а также при подготовке к госпитализации или в первые ее дни.
В случае развития приступа стенокардии следует пересмотреть и адаптировать лечение (лекарственную терапию или проведение реваскуляризации).
Препарат может вызывать или ухудшать симптомы паркинсонизма (тремор, акинезию, повышение тонуса), поэтому следует проводить регулярное наблюдение пациентов, особенно пожилого возраста.
При появлении двигательных нарушений, таких как симптомы паркинсонизма, синдром "беспокойных" ног, тремор, неустойчивость в позе Ромберга и "шаткость" походки, препарат Депренорм® ОД следует окончательно отменить. Такие случаи редки и симптомы обычно проходят после прекращения терапии, у большинства пациентов в течение 4 мес после отмены препарата. Если симптомы паркинсонизма сохраняются более 4 мес после отмены препарата, пациенту следует проконсультироваться у невролога.
Могут отмечаться случаи падения, связанные с неустойчивостью в позе Ромберга и "шаткостью" походки или артериальной гипотензией, особенно у пациентов, принимающих антигипертензивные препараты.
Влияние на способность к управлению транспортными средствами и механизмами
В связи с возможным развитием головокружения и других побочных эффектов при применении препарата Депренорм® ОД следует соблюдать осторожность при управлении транспортными средствами и занятиями другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Условия хранения
Препарат следует хранить в недоступном для детей, сухом, защищенном от света месте при температуре не выше 25°С.
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вещества\u003c/i\u003e: гипромеллоза (гидроксипропилметилцеллюлоза) - 171 мг, карбомер - 10.97 мг, кремния диоксид коллоидный - 6 мг, магния стеарат - 3 мг, целлюлоза микрокристаллическая - 189.03 мг."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСостав пленочной оболочкой:\u003c/i\u003e Опадрай прозрачный - 2.6 мг (гипромеллоза (гидроксипропилметилцеллюлоза) - 2.08 мг, макрогол 4000 (полиэтиленгликоль 4000) - 0.52 мг); Опадрай II розовый - 12.4 мг (краситель солнечный закат желтый - 0.315 мг, краситель пунцовый (Понсо 4R) - 0.2579 мг, краситель индигокармин - 0.1798 мг, поливиниловый спирт - 4.96 мг, макрогол 4000 (полиэтиленгликоль 4000) - 2.5048 мг, тальк - 1.8352 мг, титана диоксид - 2.3473 мг)."}}]},{"id":6,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Препарат, улучшающий метаболизм миокарда. Оказывает антигипоксическое действие."}},{"type":"paragraph","data":{"text":"Триметазидин предотвращает снижение внутриклеточной концентрации АТФ путем сохранения энергетического метаболизма клеток в состоянии гипоксии. Таким образом, препарат обеспечивает нормальное функционирование мембранных ионных каналов, трансмембранный перенос ионов калия и натрия и сохранение клеточного гомеостаза."}},{"type":"paragraph","data":{"text":"Триметазидин замедляет окисление жирных кислот за счет селективного ингибирования фермента 3-кетоацил-КоА-тиолазы (3-КАТ), что приводит к усилению окисления глюкозы, ускорению гликолиза с окислением глюкозы, и обусловливает защиту миокарда от ишемии. Переключение энергетического метаболизма с окисления жирных кислот на окисление глюкозы лежит в основе фармакологических свойств триметазидина."}},{"type":"paragraph","data":{"text":"Экспериментально подтверждено, что триметазидин обладает следующими свойствами: поддерживает энергетический метаболизм сердца и нейросенсорных тканей во время ишемии; уменьшает выраженность внутриклеточного ацидоза и степень изменений в трансмембранном ионного потоке, возникающих при ишемии; понижает уровень миграции и инфильтрации полинуклеарных нейтрофилов в ишемизированных и реперфузионных тканях сердца; уменьшает размер повреждения миокарда; не оказывает прямого воздействия на показатели гемодинамики."}},{"type":"paragraph","data":{"text":"У пациентов со стенокардией триметазидин увеличивает коронарный резерв, тем самым замедляя наступление ишемии, вызванной физической нагрузкой, начиная с 15-го дня терапии; ограничивает колебания АД, вызванные физической нагрузкой, без значительных изменений ЧСС; снижает частоту приступов стенокардии и потребность в приеме нитроглицерина короткого действия; улучшает сократительную функцию левого желудочка у больных с ишемической дисфункцией."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"\u003ci\u003eВсасывание\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"После приема внутрь триметазидин абсорбируется из ЖКТ. C\u003csub\u003emax\u003c/sub\u003e в плазме крови достигается приблизительно через 5 ч. Более 24 ч концентрация в плазме крови остается на уровне, превышающем 75% концентрации, определяемой через 11 ч. Прием пищи не влияет на биодоступность триметазидина."}},{"type":"paragraph","data":{"text":"\u003ci\u003eРаспределение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"C\u003csub\u003ess\u003c/sub\u003e достигается через 60 ч. V\u003csub\u003ed\u003c/sub\u003e составляет 4.8 л/кг, что свидетельствует о хорошем распределении триметазидина в тканях. Степень связывания с белками плазмы крови достаточно низкая (около 16% in vitro)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВыведение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Триметазидин выводится в основном почками, главным образом, в неизмененном виде. Почечный клиренс триметазидина прямо коррелирует с КК."}},{"type":"paragraph","data":{"text":"\u003ci\u003eФармакокинетика в особых клинических случаях\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Печеночный клиренс снижается с возрастом пациента."}}]},{"id":7,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["ИБС: профилактика приступов стабильной стенокардии (в составе комбинированной терапии)."]}}]},{"id":8,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["почечная недостаточность тяжелой степени (КК менее 30 мл/мин);","болезнь Паркинсона, симптомы паркинсонизма, тремор, синдром \"беспокойных\" ног и другие, связанные с ними двигательные нарушения;","беременность;","период лактации (грудного вскармливания);","возраст до 18 лет (эффективность и безопасность не установлены);","повышенная чувствительность к любому из компонентов препарата."]}}]},{"id":9,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eС осторожностью \u003c/i\u003eследует назначать препарат пациентам с печеночной недостаточностью тяжелой степени (клинические данные ограничены), нарушением функции почек (КК более 30 мл/мин), в возрасте старше 75 лет."}}]},{"id":10,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Данные о применении препарата Депренорм\u003csup\u003e®\u003c/sup\u003e ОД у беременных женщин отсутствуют. \u003ci\u003eЭкспериментальные исследования\u003c/i\u003e на животных не выявили наличие прямой или непрямой репродуктивной токсичности. Исследования не показали влияния триметазидина на репродуктивную функцию у крыс обоего пола. Препарат противопоказан при беременности из-за отсутствия клинических данных о безопасности его применения."}},{"type":"paragraph","data":{"text":"Данные о выделении триметазидина или его метаболитов с грудным молоком отсутствуют. Риск для новорожденного/ребенка не может быть исключен. Не следует применять препарат Депренорм\u003csup\u003e®\u003c/sup\u003e ОД в период грудного вскармливания."}}]},{"id":11,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат принимают внутрь, во время еды."}},{"type":"paragraph","data":{"text":"Рекомендуемая доза - по 1 таб. (70 мг) 1 раз/сут, предпочтительно утром."}},{"type":"paragraph","data":{"text":"Продолжительность курса лечения определяется врачом."}}]},{"id":12,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Частота побочных эффектов, отмеченных при приеме триметазидина, приведена в следующей градации: очень часто (>1/10); часто (>1/100, <1/10); нечасто (>1/1000, <1/100); редко (>1/10 000, <1/1000); очень редко (<1/10 000, в т.ч. отдельные сообщения); неуточненной частоты (частота не может быть подсчитана по доступным данным)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны ЦНС:\u003c/i\u003e часто - головокружение, головная боль; неуточненной частоты - нарушения сна (бессонница, сонливость), 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."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e редко - ортостатическая гипотензия, \"приливы\" крови к коже лица, ощущение сердцебиения, экстрасистолия, тахикардия, выраженное снижение АД."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны системы кроветворения:\u003c/i\u003e неуточненной частоты - агранулоцитоз, тромбоцитопения, тромбоцитопеническая пурпура."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы:\u003c/i\u003e часто - боль в животе, диарея, диспепсия, тошнота, рвота; неуточненной частоты - запор, гепатит."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e часто - кожная сыпь, зуд, крапивница; неуточненной частоты - острый генерализованный экзантематозный пустулез, отек Квинке."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e часто - астения."}}]},{"id":13,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Имеется лишь ограниченная информация о передозировке триметазидина."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e в случае передозировки следует проводить симптоматическую терапию."}}]},{"id":14,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Данных о взаимодействии препарата с другими лекарственными средствами нет."}}]},{"id":15,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Депренорм\u003csup\u003e®\u003c/sup\u003e ОД не предназначен для купирования приступов стенокардии, для начального курса терапии нестабильной стенокардии или инфаркта миокарда, а также при подготовке к госпитализации или в первые ее дни."}},{"type":"paragraph","data":{"text":"В случае развития приступа стенокардии следует пересмотреть и адаптировать лечение (лекарственную терапию или проведение реваскуляризации)."}},{"type":"paragraph","data":{"text":"Препарат может вызывать или ухудшать симптомы паркинсонизма (тремор, акинезию, повышение тонуса), поэтому следует проводить регулярное наблюдение пациентов, особенно пожилого возраста."}},{"type":"paragraph","data":{"text":"При появлении двигательных нарушений, таких как симптомы паркинсонизма, синдром \"беспокойных\" ног, тремор, неустойчивость в позе Ромберга и \"шаткость\" походки, препарат Депренорм\u003csup\u003e®\u003c/sup\u003e ОД следует окончательно отменить. Такие случаи редки и симптомы обычно проходят после прекращения терапии, у большинства пациентов в течение 4 мес после отмены препарата. Если симптомы паркинсонизма сохраняются более 4 мес после отмены препарата, пациенту следует проконсультироваться у невролога."}},{"type":"paragraph","data":{"text":"Могут отмечаться случаи падения, связанные с неустойчивостью в позе Ромберга и \"шаткостью\" походки или артериальной гипотензией, особенно у пациентов, принимающих антигипертензивные препараты."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние на способность к управлению транспортными средствами и механизмами\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"В связи с возможным развитием головокружения и других побочных эффектов при применении препарата Депренорм\u003csup\u003e®\u003c/sup\u003e ОД следует соблюдать осторожность при управлении транспортными средствами и занятиями другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Препарат следует хранить в недоступном для детей, сухом, защищенном от света месте при температуре не выше 25°С."}}]},{"id":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"Срок годности - 2 года."}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Препарат отпускается по рецепту."}}]},{"id":21,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.vidal.ru/drugs/company/185\"\u003eКАНОНФАРМА ПРОДАКШН ЗАО\u003c/a\u003e (Россия). 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