Повышенная чувствительность к бисопрололу; острая сердечная недостаточность; хроническая сердечная недостаточность в стадии декомпенсации, требующая проведения инотропной терапии; кардиогенный шок; AV-блокада II и III степени без электрокардиостимулятора; синдром слабости синусного узла; синоатриальная блокада; тяжелая брадикардия (ЧСС <60 уд./мин); ...
Повышенная чувствительность к бисопрололу; острая сердечная недостаточность; хроническая сердечная недостаточность в стадии декомпенсации, требующая проведения инотропной терапии; кардиогенный шок; AV-блокада II и III степени без электрокардиостимулятора; синдром слабости синусного узла; синоатриальная блокада; тяжелая брадикардия (ЧСС <60 уд./мин); тяжелая артериальная гипотензия (сАД <100 мм рт.ст.); тяжелые формы бронхиальной астмы или хронической обструктивной болезни легких; выраженные нарушения периферического артериального кровообращения или синдром Рейно; феохромоцитома (без одновременного применения α-адреноблокаторов); метаболический ацидоз; возраст до 18 лет (недостаточно данных по эффективности и безопасности у данной возрастной группы).
Применение при беременности и в период грудного вскармливания
При беременности бисопролол следует рекомендовать к применению только в том случае, если польза для матери превышает риск развития побочных эффектов у плода и/или ребенка.Как правило, β-адреноблокаторы снижают кровоток в плаценте и могут влиять на развитие плода. Следует отслеживать кровоток в плаценте и матке, а также наблюдать за ростом и развитием будущего ребенка и в случае появления нежелательных явлений в отношении беременности и/или плода принимать альтернативные методы терапии с доказанным профилем безопасности применения во время беременности. Следует тщательно обследовать новорожденного: в первые 3 дня жизни могут возникать симптомы брадикардии и гипогликемии.Данных о выделении бисопролола в грудное молоко нет. Поэтому прием этого ЛС не рекомендуется женщинам в период грудного вскармливания. Если его прием в период лактации необходим, грудное вскармливание следует прекратить.Категория действия на плод по FDA— C.
Побочное действие
Частота побочных реакций, приведенных ниже, определялась соответственно следующим критериям, рекомендуемым ВОЗ: очень часто (≥1/10); часто (≥1/100, <1/10); нечасто (≥1/1000, <1/100); редко (≥1/10000, <1/1000); очень редко (<1/10000).Со стороны нервной системы: часто— головокружение1, головная боль1; редко— потеря сознания.Со стороны психики: нечасто— депрессия, бессонница; редко— галлюцинации, ночные кошмары.Со стороны органа зрения: редко— уменьшение слезоотделения (следует учитывать при ношении контактных линз); очень редко— конъюнктивит.Со стороны органа слуха и лабиринтные нарушения: редко— нарушение слуха.Со стороны ССС: очень часто— брадикардия (у пациентов с ХСН); часто— усугубление симптомов течения ХСН (у пациентов с ХСН), ощущение похолодания или онемения в конечностях, выраженное снижение АД, особенно у пациентов с ХСН; нечасто— нарушение AV проводимости, брадикардия (у пациентов с артериальной гипертензией или стенокардией), усугубление симптомов течения ХСН (у пациентов с артериальной гипертензией или стенокардией), ортостатическая гипотензия.Со стороны дыхательной системы, органов грудной клетки и средостения: нечасто— бронхоспазм у пациентов с бронхиальной астмой или обструкцией дыхательных путей в анамнезе; редко— аллергический ринит.Со стороны ЖКТ: часто— тошнота, рвота, диарея, запор.Со стороны печени и желчевыводящих путей: редко— гепатит.Со стороны скелетно-мышечной и соединительной ткани: нечасто— мышечная слабость, судороги мышц.Со стороны кожи и подкожных тканей: редко— реакции повышенной чувствительности, такие как кожный зуд, кожная сыпь, гиперемия кожных покровов; очень редко— алопеция.Способствовать обострению симптомов течения псориаза или вызывать псориазоподобную сыпь могут β-адреноблокаторы.Со стороны половых органов и молочной железы: редко— нарушение потенции.Общие расстройства и нарушения в месте введения: часто— астения (у пациентов с ХСН), повышенная утомляемость1; нечасто— астения (у пациентов с артериальной гипертензией или стенокардией).Лабораторные и инструментальные данные: редко— повышение концентрации триглицеридов и активности ACT и AЛT в плазме крови.1 У пациентов с артериальной гипертензией или стенокардией особенно часто данные симптомы появляются в начале курса лечения. Обычно эти явления носят легкий характер и проходят, как правило, в течение 1–2 нед после начала лечения.
Особые указания
Лечение бисопрололом не следует прерывать внезапно, особенно у пациентов с ИБС. Если прекращение лечения необходимо, то дозу следует снижать постепенно.При одновременном применении клонидина его прием может быть прекращен только через несколько дней после отмены бисопролола.На начальных этапах лечения бисопрололом пациенты нуждаются в постоянном наблюдении.Контроль за состоянием пациентов, принимающих бисопролол, должен включать измерение ЧСС и АД (в начале лечения— ежедневно, затем— 1 раз в 3–4 мес), проведение ЭКГ, определение концентрации глюкозы в крови у пациентов с сахарным диабетом (1 раз в 4–5 мес). У пациентов пожилого возраста рекомендуется следить за функцией почек (1 раз в 4–5 мес).Следует обучить пациента методике подсчета ЧСС и проинструктировать о необходимости консультации врача при ЧСС <60 уд./мин.Бисопролол следует применять с осторожностью в следующих случаях: сахарный диабет со значительными колебаниями концентрации глюкозы в плазме крови— симптомы выраженной гипогликемии, такие как тахикардия, ощущение сердцебиения или повышенное потоотделение, могут маскироваться; строгая диета; проведение десенсибилизирующей терапии; AV-блокада I степени; стенокардия Принцметала; нарушения периферического артериального кровообращения легкой и умеренной степени (в начале терапии может возникнуть усиление симптомов); псориаз (в т. ч. в анамнезе).В случае выявления у пациентов пожилого возраста нарастающей брадикардии (ЧСС <60 уд./мин), выраженного снижения АД (сАД <100 мм рт.ст.), AV-блокады, бронхоспазма, желудочковых аритмий, тяжелых нарушений функции печени и/или почек необходимо уменьшить дозу бисопролола или прекратить лечение.Рекомендуется прекратить терапию при развитии депрессии, вызванной приемом β-адреноблокаторов.Дыхательная системаПеред началом терапии рекомендуется проводить исследование функции внешнего дыхания у пациентов с отягощенным бронхолегочным анамнезом.При бронхиальной астме или ХОБЛ показано одновременное применение бронходилатирующих ЛС. У пациентов с бронхиальной астмой возможно повышение резистентности дыхательных путей, что требует более высокой дозы β2-адреномиметиков. У курильщиков эффективность β-адреноблокаторов ниже.Аллергические реакцииβ-адреноблокаторы, включая бисопролол, могут повышать чувствительность к аллергенам и тяжесть анафилактических реакций из-за ослабления адренергической компенсаторной регуляции под действием β-адреноблокаторов. Терапия эпинефрином не всегда дает ожидаемый терапевтический эффект.Общая анестезияПри проведении общей анестезии, следует учитывать риск возникновения блокады β-адренорецепторов. Если необходимо прекратить терапию бисопрололом перед хирургическим вмешательством, это следует делать постепенно и завершать за 48 ч до проведения общей анестезии.ФеохромоцитомаУ пациентов с опухолью надпочечников (феохромоцитомой) бисопролол может применяться только на фоне одновременного применения α-адреноблокаторов.ГипертиреозПри лечении бисопрололом симптомы гиперфункции щитовидной железы (гипертиреоза) могут маскироваться.Пациенты, пользующиеся контактными линзами, должны быть информированы, что на фоне лечения возможно уменьшение продукции слезной жидкости.Особые группы пациентовНарушение функции почек или печени. При нарушении функции печени или почек легкой или умеренной степени обычно коррекция дозы не требуется.При тяжелом нарушении функции почек (Cl креатинина <20 мл/мин) и у пациентов с тяжелыми заболеваниями печени максимальная суточная доза составляет 10 мг. Увеличение дозы у таких пациентов должно осуществляться с особой осторожностью.Пожилой возраст. Коррекция дозы не требуется.Дети. Так как нет достаточного количества данных по применению бисопролола у детей, не рекомендуется его применять у детей до 18 лет.В настоящее время недостаточно данных относительно применения бисопролола у пациентов с ХСН в сочетании с сахарным диабетом типа 1, тяжелыми нарушениями функции почек и/или печени, рестриктивной кардиомиопатией, врожденными пороками сердца или пороком клапана сердца с выраженными гемодинамическими нарушениями. Также до сих пор не было получено достаточно данных относительно пациентов с ХСН с инфарктом миокарда в течение последних 3 мес.Влияние ни способность выполнения потенциально опасных видов деятельности, требующих особого внимания и быстрых реакций (например управление автотранспортом, работа с движущимися механизмами). Бисопролол не влияет на способность управлять автотранспортом согласно результатам исследования у пациентов с ИБС. Однако вследствие индивидуальных реакций способность управлять автотранспортом или работать с технически сложными механизмами может быть нарушена. На это следует обратить особое внимание в начале лечения, после изменения дозы, а также при одновременном употреблении алкоголя.
Условия хранения
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Срок годности
2 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России
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применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Артериальная гипертензия; ишемическая болезнь сердца: стабильная стенокардия; хроническая сердечная недостаточность."}}]},{"id":2,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к бисопрололу; острая сердечная недостаточность; хроническая сердечная недостаточность в стадии декомпенсации, требующая проведения инотропной терапии; кардиогенный шок; AV-блокада II и III степени без электрокардиостимулятора; синдром слабости синусного узла; синоатриальная блокада; тяжелая брадикардия (ЧСС \u003c60 уд./мин); тяжелая артериальная гипотензия (сАД \u003c100 мм рт.ст.); тяжелые формы бронхиальной астмы или хронической обструктивной болезни легких; выраженные нарушения периферического артериального кровообращения или синдром Рейно; феохромоцитома (без одновременного применения α-адреноблокаторов); метаболический ацидоз; возраст до 18 лет (недостаточно данных по эффективности и безопасности у данной возрастной группы)."}}]},{"id":3,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При беременности бисопролол следует рекомендовать к применению только в том случае, если польза для матери превышает риск развития побочных эффектов у плода и/или ребенка.Как правило, β-адреноблокаторы снижают кровоток в плаценте и могут влиять на развитие плода. Следует отслеживать кровоток в плаценте и матке, а также наблюдать за ростом и развитием будущего ребенка и в случае появления нежелательных явлений в отношении беременности и/или плода принимать альтернативные методы терапии с доказанным профилем безопасности применения во время беременности. Следует тщательно обследовать новорожденного: в первые 3 дня жизни могут возникать симптомы брадикардии и гипогликемии.Данных о выделении бисопролола в грудное молоко нет. Поэтому прием этого ЛС не рекомендуется женщинам в период грудного вскармливания. Если его прием в период лактации необходим, грудное вскармливание следует прекратить.Категория действия на плод по FDA— C."}}]},{"id":4,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Частота побочных реакций, приведенных ниже, определялась соответственно следующим критериям, рекомендуемым ВОЗ: очень часто (≥1/10); часто (≥1/100, \u003c1/10); нечасто (≥1/1000, \u003c1/100); редко (≥1/10000, \u003c1/1000); очень редко (\u003c1/10000).Со стороны нервной системы: часто— головокружение1, головная боль1; редко— потеря сознания.Со стороны психики: нечасто— депрессия, бессонница; редко— галлюцинации, ночные кошмары.Со стороны органа зрения: редко— уменьшение слезоотделения (следует учитывать при ношении контактных линз); очень редко— конъюнктивит.Со стороны органа слуха и лабиринтные нарушения: редко— нарушение слуха.Со стороны ССС: очень часто— брадикардия (у пациентов с ХСН); часто— усугубление симптомов течения ХСН (у пациентов с ХСН), ощущение похолодания или онемения в конечностях, выраженное снижение АД, особенно у пациентов с ХСН; нечасто— нарушение AV проводимости, брадикардия (у пациентов с артериальной гипертензией или стенокардией), усугубление симптомов течения ХСН (у пациентов с артериальной гипертензией или стенокардией), ортостатическая гипотензия.Со стороны дыхательной системы, органов грудной клетки и средостения: нечасто— бронхоспазм у пациентов с бронхиальной астмой или обструкцией дыхательных путей в анамнезе; редко— аллергический ринит.Со стороны ЖКТ: часто— тошнота, рвота, диарея, запор.Со стороны печени и желчевыводящих путей: редко— гепатит.Со стороны скелетно-мышечной и соединительной ткани: нечасто— мышечная слабость, судороги мышц.Со стороны кожи и подкожных тканей: редко— реакции повышенной чувствительности, такие как кожный зуд, кожная сыпь, гиперемия кожных покровов; очень редко— алопеция.Способствовать обострению симптомов течения псориаза или вызывать псориазоподобную сыпь могут β-адреноблокаторы.Со стороны половых органов и молочной железы: редко— нарушение потенции.Общие расстройства и нарушения в месте введения: часто— астения (у пациентов с ХСН), повышенная утомляемость1; нечасто— астения (у пациентов с артериальной гипертензией или стенокардией).Лабораторные и инструментальные данные: редко— повышение концентрации триглицеридов и активности ACT и AЛT в плазме крови.1 У пациентов с артериальной гипертензией или стенокардией особенно часто данные симптомы появляются в начале курса лечения. Обычно эти явления носят легкий характер и проходят, как правило, в течение 1–2 нед после начала лечения."}}]},{"id":5,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение бисопрололом не следует прерывать внезапно, особенно у пациентов с ИБС. Если прекращение лечения необходимо, то дозу следует снижать постепенно.При одновременном применении клонидина его прием может быть прекращен только через несколько дней после отмены бисопролола.На начальных этапах лечения бисопрололом пациенты нуждаются в постоянном наблюдении.Контроль за состоянием пациентов, принимающих бисопролол, должен включать измерение ЧСС и АД (в начале лечения— ежедневно, затем— 1 раз в 3–4 мес), проведение ЭКГ, определение концентрации глюкозы в крови у пациентов с сахарным диабетом (1 раз в 4–5 мес). У пациентов пожилого возраста рекомендуется следить за функцией почек (1 раз в 4–5 мес).Следует обучить пациента методике подсчета ЧСС и проинструктировать о необходимости консультации врача при ЧСС \u003c60 уд./мин.Бисопролол следует применять с осторожностью в следующих случаях: сахарный диабет со значительными колебаниями концентрации глюкозы в плазме крови— симптомы выраженной гипогликемии, такие как тахикардия, ощущение сердцебиения или повышенное потоотделение, могут маскироваться; строгая диета; проведение десенсибилизирующей терапии; AV-блокада I степени; стенокардия Принцметала; нарушения периферического артериального кровообращения легкой и умеренной степени (в начале терапии может возникнуть усиление симптомов); псориаз (в т. ч. в анамнезе).В случае выявления у пациентов пожилого возраста нарастающей брадикардии (ЧСС \u003c60 уд./мин), выраженного снижения АД (сАД \u003c100 мм рт.ст.), AV-блокады, бронхоспазма, желудочковых аритмий, тяжелых нарушений функции печени и/или почек необходимо уменьшить дозу бисопролола или прекратить лечение.Рекомендуется прекратить терапию при развитии депрессии, вызванной приемом β-адреноблокаторов.Дыхательная системаПеред началом терапии рекомендуется проводить исследование функции внешнего дыхания у пациентов с отягощенным бронхолегочным анамнезом.При бронхиальной астме или ХОБЛ показано одновременное применение бронходилатирующих ЛС. У пациентов с бронхиальной астмой возможно повышение резистентности дыхательных путей, что требует более высокой дозы β2-адреномиметиков. У курильщиков эффективность β-адреноблокаторов ниже.Аллергические реакцииβ-адреноблокаторы, включая бисопролол, могут повышать чувствительность к аллергенам и тяжесть анафилактических реакций из-за ослабления адренергической компенсаторной регуляции под действием β-адреноблокаторов. Терапия эпинефрином не всегда дает ожидаемый терапевтический эффект.Общая анестезияПри проведении общей анестезии, следует учитывать риск возникновения блокады β-адренорецепторов. Если необходимо прекратить терапию бисопрололом перед хирургическим вмешательством, это следует делать постепенно и завершать за 48 ч до проведения общей анестезии.ФеохромоцитомаУ пациентов с опухолью надпочечников (феохромоцитомой) бисопролол может применяться только на фоне одновременного применения α-адреноблокаторов.ГипертиреозПри лечении бисопрололом симптомы гиперфункции щитовидной железы (гипертиреоза) могут маскироваться.Пациенты, пользующиеся контактными линзами, должны быть информированы, что на фоне лечения возможно уменьшение продукции слезной жидкости.Особые группы пациентовНарушение функции почек или печени. При нарушении функции печени или почек легкой или умеренной степени обычно коррекция дозы не требуется.При тяжелом нарушении функции почек (Cl креатинина \u003c20 мл/мин) и у пациентов с тяжелыми заболеваниями печени максимальная суточная доза составляет 10 мг. Увеличение дозы у таких пациентов должно осуществляться с особой осторожностью.Пожилой возраст. Коррекция дозы не требуется.Дети. Так как нет достаточного количества данных по применению бисопролола у детей, не рекомендуется его применять у детей до 18 лет.В настоящее время недостаточно данных относительно применения бисопролола у пациентов с ХСН в сочетании с сахарным диабетом типа 1, тяжелыми нарушениями функции почек и/или печени, рестриктивной кардиомиопатией, врожденными пороками сердца или пороком клапана сердца с выраженными гемодинамическими нарушениями. Также до сих пор не было получено достаточно данных относительно пациентов с ХСН с инфарктом миокарда в течение последних 3 мес.Влияние ни способность выполнения потенциально опасных видов деятельности, требующих особого внимания и быстрых реакций (например управление автотранспортом, работа с движущимися механизмами). Бисопролол не влияет на способность управлять автотранспортом согласно результатам исследования у пациентов с ИБС. Однако вследствие индивидуальных реакций способность управлять автотранспортом или работать с технически сложными механизмами может быть нарушена. На это следует обратить особое внимание в начале лечения, после изменения дозы, а также при одновременном употреблении алкоголя."}}]},{"id":6,"name":"Условия хранения","slug":"storage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При температуре не выше 25°C. Хранить в недоступном для детей месте."}}]},{"id":7,"name":"Срок годности","slug":"expiry_date","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"2 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. 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