Специфический ингибитор агрегации тромбоцитов, оказывает кор... Инструкция
Показания к применению
Вторичная профилактика атеротромботических осложнений У взрослых пациентов с инфарктом миокарда (с давностью от нескольких дней до 35 дней) ишемическим инсультом (с давностью от 7 дней до 6 месяцев) или с диагностированной окклюзивной болезнью периферических артерий. У взрослых пациентов с острым коронарным синдромом: - без подъема сегмента ST (нестабильная ...
- повышенная чувствительность к клопидогрелу или любому из вспомогательных веществ препарата; - тяжелая печеночная недостаточность; - острое кровотечение, например, кровотечение из пептической язвы или внутричерепное кровоизлияние; - редкая наследственная непереносимость галактозы, дефицит лактазы и глюкозо-галактозная мальабсорбция; - беременность ...
Действующее вещество: Клопидогрел (Clopidogrel). Концентрация действующего вещества (мг):75
Фармакологические свойства
Специфический ингибитор агрегации тромбоцитов, оказывает коронарорасширяющее действие. Избирательно уменьшает связывание АДФ с рецепторами на тромбоцитах и активацию рецепторов GPIIb/IIIa под действием АДФ, ослабляя, таким образом, агрегацию тромбоцитов.
Показания к применению
Вторичная профилактика атеротромботических осложнений У взрослых пациентов с инфарктом миокарда (с давностью от нескольких дней до 35 дней) ишемическим инсультом (с давностью от 7 дней до 6 месяцев) или с диагностированной окклюзивной болезнью периферических артерий. У взрослых пациентов с острым коронарным синдромом: - без подъема сегмента ST (нестабильная стенокардия или инфаркт миокарда без зубца Q), включая пациентов, которым было проведено стентирование при чрескожном коронарном вмешательстве (в комбинации с ацетилсалициловой кислотой); - с подъемом сегмента ST (острый инфаркт миокарда) при медикаментозном лечении и возможности проведения тромболизиса (в комбинации с ацетилсалициловой кислотой).
Предотвращение атеротромботических и тромбоэмболических осложнений, включая инсульт, при фибрилляции предсердий (мерцательной аритмии). У пациентов 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 кровотечения (в комбинации с ацетилсалициловой кислотой).
Противопоказания
- повышенная чувствительность к клопидогрелу или любому из вспомогательных веществ препарата; - тяжелая печеночная недостаточность; - острое кровотечение, например, кровотечение из пептической язвы или внутричерепное кровоизлияние; - редкая наследственная непереносимость галактозы, дефицит лактазы и глюкозо-галактозная мальабсорбция; - беременность и период грудного вскармливания (см. раздел «Беременность и период грудного вскармливания»); - детский возраст до 18 лет (безопасность и эффективность не установлены).
С осторожностью
Состояния, при которых возможна предрасположенность к кровотечению.
Применение при беременности и в период грудного вскармливания
В качестве меры предосторожности прием клопидогрела противопоказан во время беременности из-за отсутствия клинических данных по его приему беременными женщинами, хотя исследования на животных не выявили ни прямые, ни косвенные неблагоприятные эффекты на течение беременности, эмбриональное развитие, роды и постнатальное развитие. Кормление грудью в случае лечения клопидогрелом следует прекратить, т. к. в исследованиях на крысах было показано, что клопидогрел и/или его метаболиты экскретируются в грудное молоко. Проникает ли клопидогрел в грудное молоко человека неизвестно. Фертильность. В исследованиях на животных не выявлено неблагоприятное влияние клопидогрела на фертильность.
Способ применения и дозы
Клопидогрел следует принимать внутрь, независимо от приема пищи.
Вторичная профилактика атеротромботических осложнений у взрослых пациентов с инфарктом миокарда (с давностью от нескольких дней до 35 дней), ишемическим инсультом (с давностью от 7 дней до 6 месяцев) или с диагностированной окклюзивной болезнью периферических артерий. Препарат следует принимать до 75 мг один раз в сутки.
Вторичная профилактика атеротромботических осложнений у взрослых пациентов с острым коронарным синдромом без подъема сегмента ST (нестабильная стенокардия или инфаркт без зубца Q), включая пациентов, которым было проведено стентирование при чрескожном коронарном вмешательстве (в комбинации с ацетилсалициловой кислотой).
Лечение клопидогрелом должно быть начато с однократного приема нагрузочной дозы, составляющей 300 мг, а затем продолжено приемом поддерживающей дозы 75 мг один раз в сутки (в сочетании с АСК в дозах 75-325 мг в сутки). Поскольку применение более высоких доз АСК связано с увеличением риска кровотечений, рекомендуемая при этом показании доза АСК не должна превышать 100 мг.
Оптимальная продолжительность лечения официально не определена. Данные клинических исследований поддерживают прием препарата до 12 месяцев, а максимальный благоприятный эффект наблюдается к третьему месяцу лечения. Вторичная профилактика атеротромботических осложнений у взрослых пациентов с острым коронарным синдромом с подъемом сегмента ST (острый инфаркт миокарда) при медикаментозном лечении и возможности проведения тромболизиса (в комбинации с ацетилсалициловой кислотой). Клопидогрел следует принимать однократно в сутки в дозе 75 мг с первоначальным однократным приемом нагрузочной дозы клопидогрела 300 мг в комбинации с АСК в сочетании с тромболитиками или без сочетания с тромболитиками.
У пациентов старше 75 лет лечение клопидогрелом должно начинаться без приема его нагрузочной дозы. Комбинированную терапию начинают как можно раньше после появления симптомов и продолжают в течение, по крайней мере, четырех недель. Эффективность применения комбинации клопидогрела и АСК при этом показании свыше 4- х недель не изучалась.
Предотвращение атеротромботических и тромбоэмболических осложнений, включая инсульт, при фибрилляции предсердий (мерцательной аритмии) у пациентов 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 кровотечения (в комбинации с ацетилсалициловой кислотой). Клопидогрел следует принимать один раз в сутки в дозе 75 мг. В комбинации с клопидогрелом надо начинать и затем продолжать прием АСК (75- 100 мг/сутки).
Способ применения и дозы в особых группах пациентов см. в инструкции по медицинскому применению.
Побочное действие
Диспепсия, абдоминальные боли, диарея. Перечень всех побочных действий представлен в инструкции по медицинскому применению.
Передозировка
Передозировка клопидогрела может вести к увеличению времени кровотечения с последующими осложнениями в виде развития кровотечений. При появлении кровотечения требуется проведение соответствующих лечебных мероприятий. Антидот клопидогрела не установлен. Если необходима быстрая коррекция удлинившегося времени кровотечения, то рекомендуется проведение переливания тромбоцитарной массы.
Взаимодействие с другими лекарственными средствами
Одновременное с клопидогрелом применение лекарственных препаратов, применение которых ассоциируется с риском развития кровотечения, следует проводить с осторожностью (с варфарином, с блокаторами IIb/IIIa-рецепторов, с ацетилсалициловой кислотой, с гепарином, с тромболитиками, в НПВП, с СИОЗС).
Особые указания
При лечении клопидогрелом, особенно в течение первых недель лечения и/или после инвазивных кардиологических процедур/хирургического вмешательства, необходимо вести тщательное наблюдение за пациентами на предмет исключения признаков кровотечения, в том числе и скрытого.
Влияние на способность управлять автомобилем и движущимися механизмами
Препарат Плагрил не оказывает существенное влияние на способности, необходимые для управления автомобилем или занятия другими потенциально опасными видами деятельности.
Форма выпуска
Таблетки, покрытые пленочной оболочкой, 75 мг.
Условия отпуска
По рецепту.
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Данные клинических исследований поддерживают прием препарата до 12 месяцев, а максимальный благоприятный эффект наблюдается к третьему месяцу лечения. Вторичная профилактика атеротромботических осложнений у взрослых пациентов с острым коронарным синдромом с подъемом сегмента ST (острый инфаркт миокарда) при медикаментозном лечении и возможности проведения тромболизиса (в комбинации с ацетилсалициловой кислотой). Клопидогрел следует принимать однократно в сутки в дозе 75 мг с первоначальным однократным приемом нагрузочной дозы клопидогрела 300 мг в комбинации с АСК в сочетании с тромболитиками или без сочетания с тромболитиками."}},{"type":"paragraph","data":{"text":"У пациентов старше 75 лет лечение клопидогрелом должно начинаться без приема его нагрузочной дозы. Комбинированную терапию начинают как можно раньше после появления симптомов и продолжают в течение, по крайней мере, четырех недель. Эффективность применения комбинации клопидогрела и АСК при этом показании свыше 4- х недель не изучалась."}},{"type":"paragraph","data":{"text":"Предотвращение атеротромботических и тромбоэмболических осложнений, включая инсульт, при фибрилляции предсердий (мерцательной аритмии) у пациентов 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 кровотечения (в комбинации с ацетилсалициловой кислотой). Клопидогрел следует принимать один раз в сутки в дозе 75 мг. 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