Профилактика атеротромботических осложнений у взрослых пациентов с инфарктом миокарда (давностью от нескольких дней до 35 дней), ишемическим инсультом (давностью от 7 дней до 6 мес) или диагностированной окклюзионной болезнью периферических артерий. Профилактика атеротромботических осложнений у взрослых пациентов с острым коронарным синдромом: Без подъема ...
Дефицит лактазы, непереносимость лактозы, синдром глюкозо-галактозной мальабсорбции. Беременность. Период грудного вскармливания. Дети до 18 лет (безопасность и эффективность не установлены). С осторожностью: умеренные нарушения функции печени с предрасположенностью к кровотечению (ограниченный опыт применения). Нарушение функции почек (ограниченный ...
Клопидогрел (в форме гидросульфата) 75 мг. Вспомогательные вещества: лактоза безводная, целлюлоза микрокристаллическая, крахмал прежелатинизированный, макрогол 6000, масло касторовое гидрогенизированное, гипромеллоза, титана диоксид (Е171), краситель железа оксид красный (Е172), тальк, пропиленгликоль.
Показания к применению
Профилактика атеротромботических осложнений у взрослых пациентов с инфарктом миокарда (давностью от нескольких дней до 35 дней), ишемическим инсультом (давностью от 7 дней до 6 мес) или диагностированной окклюзионной болезнью периферических артерий. Профилактика атеротромботических осложнений у взрослых пациентов с острым коронарным синдромом: Без подъема сегмента st (нестабильная стенокардия или инфаркт миокарда без зубца q), включая пациентов, которым проведено стентирование при чрескожном коронарном вмешательстве, в комбинации с ацетилсалициловой кислотой. С подъемом сегмента st (острый инфаркт миокарда) при медикаментозном лечении и возможности проведения тромболитической терапии, в комбинации с ацетилсалициловой кислотой. Профилактика атеротромботических и тромбоэмболических осложнений, включая инсульт, при фибрилляции предсердий (мерцательной аритмии). Взрослые пациенты с фибрилляцией предсердий (мерцательной аритмией), которые имеют как минимум один фактор риска развития сосудистых осложнений, не могут принимать непрямые антикоагулянты и имеют низкий риск развития кровотечений (в комбинации с ацетилсалициловой кислотой).
Противопоказания
Дефицит лактазы, непереносимость лактозы, синдром глюкозо-галактозной мальабсорбции. Беременность. Период грудного вскармливания. Дети до 18 лет (безопасность и эффективность не установлены). С осторожностью: умеренные нарушения функции печени с предрасположенностью к кровотечению (ограниченный опыт применения). Нарушение функции почек (ограниченный опыт применения). Патологические состояния, повышающие риск развития кровотечения (в т.ч. Травма, хирургические вмешательства) (см. «особые указания»). Заболевания, при которых имеется предрасположенность к развитию кровотечений (особенно желудочно-кишечных и внутриглазных). Одновременное применение с нпвс, включая ингибиторы цог-2. Одновременное применение варфарина, гепарина или ингибиторов гликопротеина iib/iiia. Пациенты с низкой активностью изофермента cyp2c19 (при применении клопидогрела в рекомендуемых дозах образуется меньше активного метаболита клопидогрела и слабее выражено его антиагрегантное действие. Поэтому при применении клопидогрела в рекомендуемых дозах при остром коронарном синдроме или чрескожном вмешательстве на коронарных артериях частота сердечно-сосудистых осложнений может быть выше, чем у пациентов с нормальной активностью изофермента cyp2c19). Гиперчувствительность к другим тиенопиридинам (например тиклопидин, прасугрел) (см. «особые указания»).
Способ применения и дозы
Внутрь, независимо от приема пищи, 1 раз в сутки. Взрослые и пациенты пожилого возраста с нормальной активностью изофермента CYP2C19 Инфаркт миокарда, ишемический инсульт или диагностированная окклюзионная болезнь периферических артерий. Препарат Зилт принимается в дозе 75 мг (1 табл.) 1 раз в сутки. Острый коронарный синдром без подъема сегмента ST (нестабильная стенокардия или инфаркт миокарда без зубца Q). Лечение препаратом Зилт должно быть начато с однократного приема нагрузочной дозы (300 мг), а затем продолжено приемом дозы 75 мг 1 раз в сутки (в сочетании с ацетилсалициловой кислотой в дозах 75–325 мг/сут). Поскольку применение более высоких доз ацетилсалициловой кислоты связано с большим риском кровотечений, рекомендуемая доза ацетилсалициловой кислоты не должна превышать 100 мг. Максимальный благоприятный эффект наблюдается к 3-му мес лечения. Оптимальная продолжительность лечения при этом показании официально не определена. Результаты клинических исследований подтверждают целесообразность приема клопидогрела до 12 мес после развития острого коронарного синдрома без подъема сегмента ST. Острый коронарный синдром с подъемом сегмента ST (острый инфаркт миокарда) при медикаментозном лечении и возможности проведения тромболитической терапии, в комбинации с ацетилсалициловой кислотой. Препарат Зилт следует принять в дозе 75 мг (1 табл.) 1 раз в сутки, начиная с нагрузочной дозы, в комбинации с ацетилсалициловой кислотой в сочетании или без тромболитиков. Для пациентов старше 75 лет лечение препаратом Зилт должно осуществляться без использования нагрузочной дозы. Комбинированную терапию начинают как можно раньше после появления симптомов и продолжают в течение по крайней мере 4 нед. Эффективность комбинированной терапии клопидогрелом и ацетилсалициловой кислотой длительностью более 4 нед у таких пациентов не изучалась. Фибрилляция предсердий (мерцательная аритмия). Препарат Зилт назначают в дозе 75 мг 1 раз в сутки. В комбинации с клопидогрелом следует начать терапию и затем продолжить прием ацетилсалициловой кислоты в дозе 75–100 мг/сут. Пропуск приема очередной дозы Если прошло менее 12 ч после пропуска приема очередной дозы, то следует немедленно принять пропущенную дозу препарата Зилт, а затем следующую дозу принять в обычное время. Если прошло более 12 ч после пропуска приема очередной дозы, то следует принять следующую дозу в обычное время; при этом не следует удваивать дозу. Взрослые и пациенты пожилого возраста с генетически обусловленной сниженной активностью изофермента CYP2C19 Низкая активность изофермента CYP2C19 ассоциируется с уменьшением антиагрегантного действия клопидогрела. Применение препарата Зилт в более высоких дозах (нагрузочная доза 600 мг, затем 150 мг 1 раз в сутки) у пациентов с низкой активностью изофермента CYP2C19 приводит к усилению антиагрегантного действия клопидогрела (см. «Фармакокинетика»). Однако в клинических исследованиях по изучению клинических исходов не установлен оптимальный режим дозирования клопидогрела у пациентов со сниженным метаболизмом вследствие генетически обусловленной низкой активности изофермента CYP2C19. Особые группы пациентов Пациенты пожилого возраста. У добровольцев пожилого возраста (старше 75 лет) при сравнении с молодыми добровольцами различий по показателям агрегации тромбоцитов и времени кровотечения не выявили. Коррекция дозы у пациентов пожилого возраста не требуется. Нарушение функции почек. После повторного применения клопидогрела в дозе 75 мг/сут у пациентов с тяжелым нарушением функции почек (Cl креатинина 5–15 мл/мин) степень ингибирования АДФ-индуцированной агрегации тромбоцитов ниже на 25%, чем у здоровых добровольцев. Однако степень удлинения времени кровотечения была сходной с таковой у здоровых добровольцев, получавших клопидогрел в дозе 75 мг/сут. Переносимость препарата у всех пациентов была хорошей. Нарушение функции печени. После применения клопидогрела в дозе 75 мг/сут в течение 10 дней у пациентов с тяжелым нарушением функции печени степень ингибирования АДФ-индуцированной агрегации тромбоцитов и средний показатель удлинения времени кровотечения были сопоставимы с таковыми у здоровых добровольцев. Этнические особенности. Распространенность аллелей генов изофермента CYP2C19, ассоциирующихся с промежуточным или сниженным метаболизмом, отличается у представителей различных расовых/этнических групп (см. Фармакогенетика). Имеются ограниченные литературные данные, позволяющие оценить значение влияния генотипирования изофермента CYP2C19 на клинические исходы для пациентов монголоидной расы. Гендерные эффекты. При сравнении фармакодинамических свойств клопидогрела у мужчин и женщин, у женщин наблюдалось меньшее ингибирование АДФ-индуцированной агрегации тромбоцитов, но различий в удлинении времени кровотечения не было. При сравнении клопидогрела с ацетилсалициловой кислотой у пациентов с риском развития ишемических осложнений частота клинических исходов, других побочных действий и отклонений от нормы клинико-лабораторных показателей была одинаковой как у мужчин, так и женщин.
Побочное действие
Безопасность клопидогрела была исследована у пациентов, получавших терапию клопидогрелом в течение 1 года или более. Безопасность применения клопидогрела в дозе 75 мг/сут была сопоставимой с таковой при применении ацетилсалициловой кислоты в дозе 325 мг/сут независимо от возраста, пола и расовой принадлежности. Ниже перечислены нежелательные реакции, наблюдавшиеся в клинических исследованиях. Кроме того, указаны спонтанные сообщения о нежелательных реакциях. В клинических исследованиях и постмаркетинговом наблюдении клопидогрела наиболее часто сообщалось о развитии кровотечений, главным образом в течение 1-го мес терапии. Классификация частоты развития побочных эффектов (ВОЗ): очень часто - ≥1/10. часто - от ≥1/100 до меньше 1/10. нечасто - от ≥1/1000 до меньше 1/100. редко - от ≥1/10000 до меньше 1/1000. очень редко - меньше 1/10000. частота неизвестна - не может быть оценена на основе имеющихся данных. Со стороны крови и лимфатической системы, нечасто - тромбоцитопения, лейкопения, эозинофилия. редко - нейтропения, включая случаи тяжелой нейтропении. очень редко - тромботическая тромбоцитопеническая пурпура (см. «Особые указания»), апластическая анемия, панцитопения, агранулоцитоз, тяжелая тромбоцитопения, гранулоцитопения, анемия. Со стороны иммунной системы: очень редко - сывороточная болезнь, анафилактоидные реакции. частота неизвестна - перекрестно-реактивная гиперчувствительность к тиенопиридинам (например тиклопидин, прасугрел). Нарушения психики, очень редко - спутанность сознания, галлюцинации. Со стороны нервной системы, нечасто - внутричерепное кровоизлияние (было сообщено о нескольких случаях с летальным исходом), головная боль, головокружение и парестезия. очень редко - нарушение вкусового восприятия. Со стороны органа зрения, нечасто - кровоизлияние в глазное яблоко (в конъюнктиву, в ткани и сетчатку глаза). Со стороны органа слуха и лабиринтные нарушения, редко - вертиго. Со стороны сосудов, часто - гематома. очень редко - серьезное кровотечение из операционной раны, васкулит, снижение АД. Со стороны дыхательной системы, органов грудной клетки и средостения часто - носовое кровотечение. очень редко - кровотечение из дыхательных путей (кровохарканье, легочное кровотечение), бронхоспазм, интерстициальный пневмонит. Со стороны ЖКТ часто - желудочно-кишечное кровотечение, диарея, боль в животе, диспепсия. нечасто - язва желудка и двенадцатиперстной кишки, гастрит, рвота, тошнота, запор, вздутие живота. редко - забрюшинное кровоизлияние. очень редко - желудочно-кишечное и забрюшинное кровоизлияние с летальным исходом, панкреатит, колит (в т.ч. язвенный колит или лимфоцитарный колит), стоматит. Со стороны печени и желчевыводящих путей очень редко - гепатит, острая печеночная недостаточность, отклонение от нормы показателей функции печени. Со стороны кожи и подкожных тканей часто - подкожные кровоподтеки. нечасто - кожная сыпь, кожный зуд, пурпура (подкожные кровоизлияния). очень редко - буллезный дерматит (токсический эпидермальный некролиз, синдром Стивенса-Джонсона, мультиформная эритема), ангионевротический отек, эритематозная сыпь, крапивница, экзема и плоский лишай. частота неизвестна - лекарственно-индуцированный синдром гиперчувствительности, лекарственная сыпь с эозинофилией и системными симптомами (DRESS-синдром). Со стороны скелетно-мышечной и соединительной ткани очень редко - кровоизлияния в мышцы и суставы (гемартроз), артралгия, артрит, миалгия. Со стороны почек и мочевыводящих путей нечасто - гематурия. очень редко - гломерулонефрит, увеличение концентрации креатинина в сыворотке крови. Общие расстройства и нарушения в месте введения часто - кровотечение из места пунктирования сосудов. очень редко - лихорадка. Лабораторные и инструментальные данные часто - удлинение времени кровотечения, уменьшение количества нейтрофилов, уменьшение количества тромбоцитов.
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С подъемом сегмента st (острый инфаркт миокарда) при медикаментозном лечении и возможности проведения тромболитической терапии, в комбинации с ацетилсалициловой кислотой. Профилактика атеротромботических и тромбоэмболических осложнений, включая инсульт, при фибрилляции предсердий (мерцательной аритмии). Взрослые пациенты с фибрилляцией предсердий (мерцательной аритмией), которые имеют как минимум один фактор риска развития сосудистых осложнений, не могут принимать непрямые антикоагулянты и имеют низкий риск развития кровотечений (в комбинации с ацетилсалициловой кислотой)."}}]},{"id":3,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Дефицит лактазы, непереносимость лактозы, синдром глюкозо-галактозной мальабсорбции. Беременность. Период грудного вскармливания. Дети до 18 лет (безопасность и эффективность не установлены). С осторожностью: умеренные нарушения функции печени с предрасположенностью к кровотечению (ограниченный опыт применения). Нарушение функции почек (ограниченный опыт применения). Патологические состояния, повышающие риск развития кровотечения (в т.ч. Травма, хирургические вмешательства) (см. «особые указания»). Заболевания, при которых имеется предрасположенность к развитию кровотечений (особенно желудочно-кишечных и внутриглазных). Одновременное применение с нпвс, включая ингибиторы цог-2. Одновременное применение варфарина, гепарина или ингибиторов гликопротеина iib/iiia. Пациенты с низкой активностью изофермента cyp2c19 (при применении клопидогрела в рекомендуемых дозах образуется меньше активного метаболита клопидогрела и слабее выражено его антиагрегантное действие. 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Лечение препаратом Зилт должно быть начато с однократного приема нагрузочной дозы (300 мг), а затем продолжено приемом дозы 75 мг 1 раз в сутки (в сочетании с ацетилсалициловой кислотой в дозах 75–325 мг/сут). Поскольку применение более высоких доз ацетилсалициловой кислоты связано с большим риском кровотечений, рекомендуемая доза ацетилсалициловой кислоты не должна превышать 100 мг. Максимальный благоприятный эффект наблюдается к 3-му мес лечения. Оптимальная продолжительность лечения при этом показании официально не определена. Результаты клинических исследований подтверждают целесообразность приема клопидогрела до 12 мес после развития острого коронарного синдрома без подъема сегмента ST. Острый коронарный синдром с подъемом сегмента ST (острый инфаркт миокарда) при медикаментозном лечении и возможности проведения тромболитической терапии, в комбинации с ацетилсалициловой кислотой. Препарат Зилт следует принять в дозе 75 мг (1 табл.) 1 раз в сутки, начиная с нагрузочной дозы, в комбинации с ацетилсалициловой кислотой в сочетании или без тромболитиков. Для пациентов старше 75 лет лечение препаратом Зилт должно осуществляться без использования нагрузочной дозы. Комбинированную терапию начинают как можно раньше после появления симптомов и продолжают в течение по крайней мере 4 нед. Эффективность комбинированной терапии клопидогрелом и ацетилсалициловой кислотой длительностью более 4 нед у таких пациентов не изучалась. Фибрилляция предсердий (мерцательная аритмия). Препарат Зилт назначают в дозе 75 мг 1 раз в сутки. В комбинации с клопидогрелом следует начать терапию и затем продолжить прием ацетилсалициловой кислоты в дозе 75–100 мг/сут. Пропуск приема очередной дозы Если прошло менее 12 ч после пропуска приема очередной дозы, то следует немедленно принять пропущенную дозу препарата Зилт, а затем следующую дозу принять в обычное время. Если прошло более 12 ч после пропуска приема очередной дозы, то следует принять следующую дозу в обычное время; при этом не следует удваивать дозу. Взрослые и пациенты пожилого возраста с генетически обусловленной сниженной активностью изофермента CYP2C19 Низкая активность изофермента CYP2C19 ассоциируется с уменьшением антиагрегантного действия клопидогрела. Применение препарата Зилт в более высоких дозах (нагрузочная доза 600 мг, затем 150 мг 1 раз в сутки) у пациентов с низкой активностью изофермента CYP2C19 приводит к усилению антиагрегантного действия клопидогрела (см. «Фармакокинетика»). Однако в клинических исследованиях по изучению клинических исходов не установлен оптимальный режим дозирования клопидогрела у пациентов со сниженным метаболизмом вследствие генетически обусловленной низкой активности изофермента CYP2C19. Особые группы пациентов Пациенты пожилого возраста. У добровольцев пожилого возраста (старше 75 лет) при сравнении с молодыми добровольцами различий по показателям агрегации тромбоцитов и времени кровотечения не выявили. Коррекция дозы у пациентов пожилого возраста не требуется. Нарушение функции почек. После повторного применения клопидогрела в дозе 75 мг/сут у пациентов с тяжелым нарушением функции почек (Cl креатинина 5–15 мл/мин) степень ингибирования АДФ-индуцированной агрегации тромбоцитов ниже на 25%, чем у здоровых добровольцев. Однако степень удлинения времени кровотечения была сходной с таковой у здоровых добровольцев, получавших клопидогрел в дозе 75 мг/сут. Переносимость препарата у всех пациентов была хорошей. Нарушение функции печени. После применения клопидогрела в дозе 75 мг/сут в течение 10 дней у пациентов с тяжелым нарушением функции печени степень ингибирования АДФ-индуцированной агрегации тромбоцитов и средний показатель удлинения времени кровотечения были сопоставимы с таковыми у здоровых добровольцев. Этнические особенности. Распространенность аллелей генов изофермента CYP2C19, ассоциирующихся с промежуточным или сниженным метаболизмом, отличается у представителей различных расовых/этнических групп (см. Фармакогенетика). Имеются ограниченные литературные данные, позволяющие оценить значение влияния генотипирования изофермента CYP2C19 на клинические исходы для пациентов монголоидной расы. Гендерные эффекты. При сравнении фармакодинамических свойств клопидогрела у мужчин и женщин, у женщин наблюдалось меньшее ингибирование АДФ-индуцированной агрегации тромбоцитов, но различий в удлинении времени кровотечения не было. При сравнении клопидогрела с ацетилсалициловой кислотой у пациентов с риском развития ишемических осложнений частота клинических исходов, других побочных действий и отклонений от нормы клинико-лабораторных показателей была одинаковой как у мужчин, так и женщин."}}]},{"id":5,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Безопасность клопидогрела была исследована у пациентов, получавших терапию клопидогрелом в течение 1 года или более. Безопасность применения клопидогрела в дозе 75 мг/сут была сопоставимой с таковой при применении ацетилсалициловой кислоты в дозе 325 мг/сут независимо от возраста, пола и расовой принадлежности. Ниже перечислены нежелательные реакции, наблюдавшиеся в клинических исследованиях. Кроме того, указаны спонтанные сообщения о нежелательных реакциях. В клинических исследованиях и постмаркетинговом наблюдении клопидогрела наиболее часто сообщалось о развитии кровотечений, главным образом в течение 1-го мес терапии. Классификация частоты развития побочных эффектов (ВОЗ): очень часто - ≥1/10. часто - от ≥1/100 до меньше 1/10. нечасто - от ≥1/1000 до меньше 1/100. редко - от ≥1/10000 до меньше 1/1000. очень редко - меньше 1/10000. частота неизвестна - не может быть оценена на основе имеющихся данных. Со стороны крови и лимфатической системы, нечасто - тромбоцитопения, лейкопения, эозинофилия. редко - нейтропения, включая случаи тяжелой нейтропении. очень редко - тромботическая тромбоцитопеническая пурпура (см. «Особые указания»), апластическая анемия, панцитопения, агранулоцитоз, тяжелая тромбоцитопения, гранулоцитопения, анемия. Со стороны иммунной системы: очень редко - сывороточная болезнь, анафилактоидные реакции. частота неизвестна - перекрестно-реактивная гиперчувствительность к тиенопиридинам (например тиклопидин, прасугрел). Нарушения психики, очень редко - спутанность сознания, галлюцинации. Со стороны нервной системы, нечасто - внутричерепное кровоизлияние (было сообщено о нескольких случаях с летальным исходом), головная боль, головокружение и парестезия. очень редко - нарушение вкусового восприятия. Со стороны органа зрения, нечасто - кровоизлияние в глазное яблоко (в конъюнктиву, в ткани и сетчатку глаза). Со стороны органа слуха и лабиринтные нарушения, редко - вертиго. Со стороны сосудов, часто - гематома. очень редко - серьезное кровотечение из операционной раны, васкулит, снижение АД. Со стороны дыхательной системы, органов грудной клетки и средостения часто - носовое кровотечение. очень редко - кровотечение из дыхательных путей (кровохарканье, легочное кровотечение), бронхоспазм, интерстициальный пневмонит. Со стороны ЖКТ часто - желудочно-кишечное кровотечение, диарея, боль в животе, диспепсия. нечасто - язва желудка и двенадцатиперстной кишки, гастрит, рвота, тошнота, запор, вздутие живота. редко - забрюшинное кровоизлияние. очень редко - желудочно-кишечное и забрюшинное кровоизлияние с летальным исходом, панкреатит, колит (в т.ч. язвенный колит или лимфоцитарный колит), стоматит. Со стороны печени и желчевыводящих путей очень редко - гепатит, острая печеночная недостаточность, отклонение от нормы показателей функции печени. Со стороны кожи и подкожных тканей часто - подкожные кровоподтеки. нечасто - кожная сыпь, кожный зуд, пурпура (подкожные кровоизлияния). очень редко - буллезный дерматит (токсический эпидермальный некролиз, синдром Стивенса-Джонсона, мультиформная эритема), ангионевротический отек, эритематозная сыпь, крапивница, экзема и плоский лишай. частота неизвестна - лекарственно-индуцированный синдром гиперчувствительности, лекарственная сыпь с эозинофилией и системными симптомами (DRESS-синдром). Со стороны скелетно-мышечной и соединительной ткани очень редко - кровоизлияния в мышцы и суставы (гемартроз), артралгия, артрит, миалгия. Со стороны почек и мочевыводящих путей нечасто - гематурия. очень редко - гломерулонефрит, увеличение концентрации креатинина в сыворотке крови. Общие расстройства и нарушения в месте введения часто - кровотечение из места пунктирования сосудов. очень редко - лихорадка. Лабораторные и инструментальные данные часто - удлинение времени кровотечения, уменьшение количества нейтрофилов, уменьшение количества тромбоцитов."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"","substance":[{"id":407,"title":"Клопидогрел","title_latin":"Clopidogrelum","slug":"klopidogrel_407"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":false,"comments":null,"image_alt":"Зилт - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/16432/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/16432/share_default/"}},"diseases":[{"id":"722","title":"Нестабильная стенокардия","slug":"722-nestabilnaya_stenokardiya"},{"id":"725","title":"Острый инфаркт миокарда","slug":"725-ostryy_infarkt_miokarda"},{"id":"729","title":"Легочная эмболия","slug":"729-legochnaya_emboliya"},{"id":"745","title":"Фибрилляция и трепетание 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