Селективный антагонист кальция из группы дигидропиридинов. С... Инструкция
Показания к применению
Артериальная гипертензия (монотерапия или в комбинации с другими антигипертензивными средствами), стенокардия напряжения, вазоспастическая стенокардия.
Противопоказания
Повышенная чувствительность к амлодипину и другим производным дигидропиридина;
Селективный антагонист кальция из группы дигидропиридинов. Связываясь с дигидропиридиновыми рецепторами, блокирует кальциевые каналы, снижает трансмембранный переход ионов кальция в клетку (в большей степени в гладкомышечные клетки сосудов, чем в кардиомиоциты). Под его действием снижается тонус гладкой мускулатуры сосудов (артериол), уменьшается периферическое сосудистое сопротивление, что приводит к снижению артериального давления (АД). Гипотензивное действие обусловлено прямым расслабляющим влиянием на гладкую мышцу сосудов. При стенокардии уменьшает выраженность ишемии миокарда (за счёт расширения периферических артериол и снижения ОПСС на фоне мало изменяющегося ЧСС). Уменьшение нагрузки на сердце приводит к снижению потребности миокарда в кислороде; с другой стороны, за счёт расширения главных коронарных артерий и коронарных артериол как в неизменных, так и в ишемизированных зонах миокарда увеличивается поступление кислорода в миокард (особенно при вазоспастической стенокардии). Предотвращает развитие констрикции коронарных артерий (в том числе вызванной курением). При артериальной гипертензии разовая суточная доза обеспечивает клинически значимое снижение АД на протяжении 24 ч (как в положении лёжа, так и стоя). Благодаря медленному началу действия не вызывает резкого снижения АД, снижения толерантности к физической нагрузке, фракции выброса левого желудочка. У больных стенокардией разовая суточная доза увеличивает время выполнения физической нагрузки, замедляет скорость развития приступа стенокардии и «ишемической» депрессии сегмента ST, снижает частоту приступов стенокардии и потребления нитроглицерина. Не оказывает неблагоприятных влияний на обмен веществ и липиды плазмы крови. Время наступления клинического эффекта — 2–4 ч, длительность — 24 ч.
Фармакокинетика
Медленно и почти полностью всасывается из желудочно-кишечного тракта (абсорбция — 90 %). Приём пищи не влияет на всасываемость препарата. Максимальная концентрация препарата в плазме наблюдается через 6–9 ч после применения. Биодоступность составляет 60-80 %, связь с белками плазмы — 90–97 %.
Амлодипин подвергается медленному, но экстенсивному метаболизму (90 %) в печени с образованием неактивных метаболитов, имеет эффект “первого прохождения” через печень. Метаболиты не обладают значимой фармакологической активностью.
После однократного перорального приёма период полувыведения (T½) варьирует от 31 до 48 часов, при повторном назначении T½ составляет приблизительно 45 часов. Около 60 % принятой внутрь дозы экскретируется почками преимущественно в виде метаболитов, 10 % в неизменённом виде, а 20–25 % через кишечник, а также с грудным молоком.
Препарат проникает через гематоэнцефалический барьер. При гемодиализе не удаляется.
Показания к применению
Артериальная гипертензия (монотерапия или в комбинации с другими антигипертензивными средствами), стенокардия напряжения, вазоспастическая стенокардия.
Противопоказания
Повышенная чувствительность к амлодипину и другим производным дигидропиридина;
артериальная гипотензия;
коллапс, сосудистый и кардиогенный шок;
нестабильная стенокардия;
беременность и период лактации;
возраст до 18 лет (эффективность и безопасность не установлены).
С осторожностью
Печёночная и/или почечная недостаточность, синдром слабости синусового узла (выраженная брадикардия, тахикардия), хроническая сердечная недостаточность в стадии декомпенсации, аортальный стеноз, митральный стеноз, гипертрофическая обструктивная кардиомиопатия, острый инфаркт миокарда (и в течение 1 месяца после), сахарный диабет, нарушений липидного профиля, пожилой возраст.
Применение при беременности и в период грудного вскармливания
Противопоказан
Способ применения и дозы
Внутрь, начальная доза для лечения артериальной гипертензии и стенокардии составляет 5 мг препарата 1 раз в сутки. Доза максимально может быть увеличена до 10 мг однократно в сутки. При артериальной гипертензии поддерживающая доза может быть 5 мг в сутки.
При стенокардии напряжения и вазоспастической стенокардии — 5–10 мг в сутки, однократно. Худым пациентам, пациентам невысокого роста, пожилым больным, больным с нарушением функции печени в качестве гипотензивного средства назначают в начальной дозе 2,5 мг; в качестве антиангинального средства — 5 мг.
Не требуется изменения дозы при одновременном назначении с тиазидными диуретиками, бета-адреноблокаторами и ингибиторами ангиотензинпревращающего фермента (АПФ). Не требуется изменения дозы у пациентов с почечной недостаточностью.
Побочное действие
Со стороны сердечно-сосудистой системы: сердцебиение, одышка, выраженное снижение артериального давления, обморок, васкулит, отеки (отёчность лодыжек и стоп), «приливы» крови к лицу, редко — нарушения ритма (брадикардия, желудочковая тахикардия, трепетание предсердий), боль в грудной клетке, ортостатическая гипотензия, очень редко — развитие или усугубление сердечной недостаточности, экстрасистолия, мигрень.
Со стороны центральной нервной системы: головная боль, головокружение, утомляемость, сонливость, изменение настроения, судороги, редко — потеря сознания, гипестезия, нервозность, парестезии, тремор, вертиго, астения, недомогание, бессонница, депрессия, необычные сновидения, очень редко — атаксия, апатия, ажитация, амнезия.
Со стороны пищеварительной системы: тошнота, рвота, боли в эпигастрии, редко — повышение уровня «печёночных» трансаминаз и желтуха (обусловленные холестазом), панкреатит, сухость во рту, метеоризм, гиперплазия дёсен, запор или диареа, очень редко — гастрит, повышение аппетита, анорексия, гипербилирубинемия.
Со стороны мочеполовой системы: редко — поллакиурия, болезненные позывы на мочеиспускание, никтурия, нарушение сексуальной функции (в том числе снижение потенции); очень редко — дизурия, полиурия.
Со стороны кожных покровов: очень редко — ксеродермия, алопеция, дерматит, пурпура, изменение цвета кожи.
Аллергические реакции: кожный зуд, сыпь (в том числе эритематозная, макулопапулёзная сыпь, крапивница), ангионевротический отёк.
Со стороны опорно-двигательного аппарата: редко — артралгия, артроз, миалгия (при длительном применении); очень редко — миастения.
Прочие: редко — гинекомастия, полиурикемия, увеличение/снижение массы тела, тромбоцитопения, лейкопения, гипергликемия, нарушение зрения, диплопия, конъюнктивит, боль в глазах, звон в ушах, боль в спине, диспноэ, носовое кровотечение, повышенное потоотделение, жажда; очень редко — холодный липкий пот, кашель, ринит, паросмия, нарушение вкусовых ощущений, нарушение аккомодации, ксерофтальмия.
Передозировка
Симптомы — чрезмерная периферическая вазодилатация, выраженное и длительное снижение АД, тахикардия.
Лечение — промывание желудка, поддержание функции сердечно-сосудистой системы, мониторирование показателей работы сердца и лёгких, возвышенное положение конечностей, контроль за объёмом циркулирующей крови и диурезом, в/в введение глюконата кальция и допамина. Гемодиализ не эффективен.
Взаимодействие с другими лекарственными средствами
Ингибиторы микросомального окисления повышают концентрацию амлодипина в плазме крови, потенцируя риск развития побочных эффектов, а индукторы микросомальных ферментов печени — уменьшают.
Гипотензивный эффект ослабляют нестероидные противовоспалительные препараты (НПВП), особенно индометацин и эстрогены. Средства для ингаляционного наркоза, амиодарон, хинидин и др. антагонисты кальция могут усиливать гипотензивное действие.
Тиазидные и «петлевые» диуретики, бета-адреноблокаторы, ингибиторы АПФ, нитратами, усиливают антиангинальный и гипотензивный эффекты.
Не оказывает влияния на фармакокинетические параметры дигоксина и варфарина.
Циметидин не влияет на фармакокинетику амлодипина.
При совместном применении с препаратами лития возможно усиление проявлений их нейротоксичности (тошнота, рвота, диарея, атаксия, тремор, шум в ушах).
Препараты кальция могут уменьшить эффект блокаторов «медленных» кальциевых каналов.
Прокаинамид, хинидин и другие лекарственные средства, вызывающие удлинение интервала QT, усиливают отрицательный инотропный эффект и могут повышать риск значительного удлинения интервала QT.
Грейпфрутовый сок может снижать концентрацию амлодипина в плазме крови, однако это снижение настолько мало, что значимо не изменяет действие амлодипина
Особые указания
В период лечения необходим контроль за массой тела и потреблением натрия, назначение соответствующей диеты.
Необходимо поддержание гигиены зубов и частое посещение стоматолога (для предотвращения болезненности, кровоточивости и гиперплазии дёсен).
Режим дозирования для пожилых такой же, как и для пациентов других возрастных групп. При увеличении дозы необходимо тщательное наблюдение за пожилыми пациентами.
Несмотря на отсутствие у блокаторов “медленных” кальциевых каналов синдрома «отмены», перед прекращением лечения рекомендуется постепенное уменьшение доз.
Амлодипин не влияет на плазменные концентрации K+, глюкозы, триглицеридов, общего холестерина, ЛПНП, мочевой кислоты, креатинина и азота мочевой кислоты.
Условия хранения
В сухом, защищённом от света месте, при температуре не выше 25 °C.
Срок годности
2 года.
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Связываясь с дигидропиридиновыми рецепторами, блокирует кальциевые каналы, снижает трансмембранный переход ионов кальция в клетку (в большей степени в гладкомышечные клетки сосудов, чем в кардиомиоциты). Под его действием снижается тонус гладкой мускулатуры сосудов (артериол), уменьшается периферическое сосудистое сопротивление, что приводит к снижению артериального давления (АД). Гипотензивное действие обусловлено прямым расслабляющим влиянием на гладкую мышцу сосудов. При стенокардии уменьшает выраженность ишемии миокарда (за счёт расширения периферических артериол и снижения ОПСС на фоне мало изменяющегося ЧСС). Уменьшение нагрузки на сердце приводит к снижению потребности миокарда в кислороде; с другой стороны, за счёт расширения главных коронарных артерий и коронарных артериол как в неизменных, так и в ишемизированных зонах миокарда увеличивается поступление кислорода в миокард (особенно при вазоспастической стенокардии). Предотвращает развитие констрикции коронарных артерий (в том числе вызванной курением). При артериальной гипертензии разовая суточная доза обеспечивает клинически значимое снижение АД на протяжении 24 ч (как в положении лёжа, так и стоя). Благодаря медленному началу действия не вызывает резкого снижения АД, снижения толерантности к физической нагрузке, фракции выброса левого желудочка. У больных стенокардией разовая суточная доза увеличивает время выполнения физической нагрузки, замедляет скорость развития приступа стенокардии и «ишемической» депрессии сегмента ST, снижает частоту приступов стенокардии и потребления нитроглицерина. Не оказывает неблагоприятных влияний на обмен веществ и липиды плазмы крови. Время наступления клинического эффекта — 2–4 ч, длительность — 24 ч."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"Медленно и почти полностью всасывается из желудочно-кишечного тракта (абсорбция — 90 %). Приём пищи не влияет на всасываемость препарата. Максимальная концентрация препарата в плазме наблюдается через 6–9 ч после применения. Биодоступность составляет 60-80 %, связь с белками плазмы — 90–97 %."}},{"type":"paragraph","data":{"text":"Амлодипин подвергается медленному, но экстенсивному метаболизму (90 %) в печени с образованием неактивных метаболитов, имеет эффект “первого прохождения” через печень. Метаболиты не обладают значимой фармакологической активностью."}},{"type":"paragraph","data":{"text":"После однократного перорального приёма период полувыведения (T½) варьирует от 31 до 48 часов, при повторном назначении T½ составляет приблизительно 45 часов. Около 60 % принятой внутрь дозы экскретируется почками преимущественно в виде метаболитов, 10 % в неизменённом виде, а 20–25 % через кишечник, а также с грудным молоком."}},{"type":"paragraph","data":{"text":"Препарат проникает через гематоэнцефалический барьер. При гемодиализе не удаляется."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Артериальная гипертензия (монотерапия или в комбинации с другими антигипертензивными средствами), стенокардия напряжения, вазоспастическая стенокардия."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к амлодипину и другим производным дигидропиридина;"}},{"type":"paragraph","data":{"text":"артериальная гипотензия;"}},{"type":"paragraph","data":{"text":"коллапс, сосудистый и кардиогенный шок;"}},{"type":"paragraph","data":{"text":"нестабильная стенокардия;"}},{"type":"paragraph","data":{"text":"беременность и период лактации;"}},{"type":"paragraph","data":{"text":"возраст до 18 лет (эффективность и безопасность не установлены)."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Печёночная и/или почечная недостаточность, синдром слабости синусового узла (выраженная брадикардия, тахикардия), хроническая сердечная недостаточность в стадии декомпенсации, аортальный стеноз, митральный стеноз, гипертрофическая обструктивная кардиомиопатия, острый инфаркт миокарда (и в течение 1 месяца после), сахарный диабет, нарушений липидного профиля, пожилой возраст."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказан"}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь, начальная доза для лечения артериальной гипертензии и стенокардии составляет 5 мг препарата 1 раз в сутки. Доза максимально может быть увеличена до 10 мг однократно в сутки. При артериальной гипертензии поддерживающая доза может быть 5 мг в сутки."}},{"type":"paragraph","data":{"text":"При стенокардии напряжения и вазоспастической стенокардии — 5–10 мг в сутки, однократно. Худым пациентам, пациентам невысокого роста, пожилым больным, больным с нарушением функции печени в качестве гипотензивного средства назначают в начальной дозе 2,5 мг; в качестве антиангинального средства — 5 мг."}},{"type":"paragraph","data":{"text":"Не требуется изменения дозы при одновременном назначении с тиазидными диуретиками, бета-адреноблокаторами и ингибиторами ангиотензинпревращающего фермента (АПФ). Не требуется изменения дозы у пациентов с почечной недостаточностью."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: сердцебиение, одышка, выраженное снижение артериального давления, обморок, васкулит, отеки (отёчность лодыжек и стоп), «приливы» крови к лицу, редко — нарушения ритма (брадикардия, желудочковая тахикардия, трепетание предсердий), боль в грудной клетке, ортостатическая гипотензия, очень редко — развитие или усугубление сердечной недостаточности, экстрасистолия, мигрень."}},{"type":"paragraph","data":{"text":"Со стороны центральной нервной системы: головная боль, головокружение, утомляемость, сонливость, изменение настроения, судороги, редко — потеря сознания, гипестезия, нервозность, парестезии, тремор, вертиго, астения, недомогание, бессонница, депрессия, необычные сновидения, очень редко — атаксия, апатия, ажитация, амнезия."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: тошнота, рвота, боли в эпигастрии, редко — повышение уровня «печёночных» трансаминаз и желтуха (обусловленные холестазом), панкреатит, сухость во рту, метеоризм, гиперплазия дёсен, запор или диареа, очень редко — гастрит, повышение аппетита, анорексия, гипербилирубинемия."}},{"type":"paragraph","data":{"text":"Со стороны мочеполовой системы: редко — поллакиурия, болезненные позывы на мочеиспускание, никтурия, нарушение сексуальной функции (в том числе снижение потенции); очень редко — дизурия, полиурия."}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов: очень редко — ксеродермия, алопеция, дерматит, пурпура, изменение цвета кожи."}},{"type":"paragraph","data":{"text":"Аллергические реакции: кожный зуд, сыпь (в том числе эритематозная, макулопапулёзная сыпь, крапивница), ангионевротический отёк."}},{"type":"paragraph","data":{"text":"Со стороны опорно-двигательного аппарата: редко — артралгия, артроз, миалгия (при длительном применении); очень редко — миастения."}},{"type":"paragraph","data":{"text":"Прочие: редко — гинекомастия, полиурикемия, увеличение/снижение массы тела, тромбоцитопения, лейкопения, гипергликемия, нарушение зрения, диплопия, конъюнктивит, боль в глазах, звон в ушах, боль в спине, диспноэ, носовое кровотечение, повышенное потоотделение, жажда; очень редко — холодный липкий пот, кашель, ринит, паросмия, нарушение вкусовых ощущений, нарушение аккомодации, ксерофтальмия."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы — чрезмерная периферическая вазодилатация, выраженное и длительное снижение АД, тахикардия."}},{"type":"paragraph","data":{"text":"Лечение — промывание желудка, поддержание функции сердечно-сосудистой системы, мониторирование показателей работы сердца и лёгких, возвышенное положение конечностей, контроль за объёмом циркулирующей крови и диурезом, в/в введение глюконата кальция и допамина. Гемодиализ не эффективен."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Ингибиторы микросомального окисления повышают концентрацию амлодипина в плазме крови, потенцируя риск развития побочных эффектов, а индукторы микросомальных ферментов печени — уменьшают."}},{"type":"paragraph","data":{"text":"Гипотензивный эффект ослабляют нестероидные противовоспалительные препараты (НПВП), особенно индометацин и эстрогены. Средства для ингаляционного наркоза, амиодарон, хинидин и др. антагонисты кальция могут усиливать гипотензивное действие."}},{"type":"paragraph","data":{"text":"Тиазидные и «петлевые» диуретики, бета-адреноблокаторы, ингибиторы АПФ, нитратами, усиливают антиангинальный и гипотензивный эффекты."}},{"type":"paragraph","data":{"text":"Не оказывает влияния на фармакокинетические параметры дигоксина и варфарина."}},{"type":"paragraph","data":{"text":"Циметидин не влияет на фармакокинетику амлодипина."}},{"type":"paragraph","data":{"text":"При совместном применении с препаратами лития возможно усиление проявлений их нейротоксичности (тошнота, рвота, диарея, атаксия, тремор, шум в ушах)."}},{"type":"paragraph","data":{"text":"Препараты кальция могут уменьшить эффект блокаторов «медленных» кальциевых каналов."}},{"type":"paragraph","data":{"text":"Прокаинамид, хинидин и другие лекарственные средства, вызывающие удлинение интервала QT, усиливают отрицательный инотропный эффект и могут повышать риск значительного удлинения интервала QT."}},{"type":"paragraph","data":{"text":"Грейпфрутовый сок может снижать концентрацию амлодипина в плазме крови, однако это снижение настолько мало, что значимо не изменяет действие амлодипина"}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"В период лечения необходим контроль за массой тела и потреблением натрия, назначение соответствующей диеты."}},{"type":"paragraph","data":{"text":"Необходимо поддержание гигиены зубов и частое посещение стоматолога (для предотвращения болезненности, кровоточивости и гиперплазии дёсен)."}},{"type":"paragraph","data":{"text":"Режим дозирования для пожилых такой же, как и для пациентов других возрастных групп. При увеличении дозы необходимо тщательное наблюдение за пожилыми пациентами."}},{"type":"paragraph","data":{"text":"Несмотря на отсутствие у блокаторов “медленных” кальциевых каналов синдрома «отмены», перед прекращением лечения рекомендуется постепенное уменьшение доз."}},{"type":"paragraph","data":{"text":"Амлодипин не влияет на плазменные концентрации K+, глюкозы, триглицеридов, общего холестерина, ЛПНП, мочевой кислоты, креатинина и азота мочевой кислоты."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом, защищённом от света месте, при температуре не выше 25 °C."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года."}}]}],"source":null},"description_toggle":false,"short_description":"Селективный антагонист кальция из группы дигидропиридинов. Связываясь с дигидропиридиновыми рецепторами, блокирует кальциевые каналы, снижает трансмембранный переход ионов кальция в клетку (в большей степени в гладкомышечные клетки сосудов, чем в кардиомиоциты). Под его действием снижается тонус гладкой мускулатуры сосудов (артериол), уменьшается периферическое сосудистое сопротивление, что приводит к снижению артериального давления (АД). Гипотензивное действие обусловлено прямым расслабляющим влиянием на гладкую мышцу сосудов. При стенокардии уменьшает выраженность ишемии миокарда (за счёт расширения периферических артериол и снижения ОПСС на фоне мало изменяющегося ЧСС). Уменьшение нагрузки на сердце приводит к снижению потребности миокарда в кислороде; с другой стороны, за счёт расширения главных коронарных артерий и коронарных артериол как в неизменных, так и в ишемизированных зонах миокарда увеличивается поступление кислорода в миокард (особенно при вазоспастической стенокардии). Предотвращает развитие констрикции коронарных артерий (в том числе вызванной курением). При артериальной гипертензии разовая суточная доза обеспечивает клинически значимое снижение АД на протяжении 24 ч (как в положении лёжа, так и стоя). Благодаря медленному началу действия не вызывает резкого снижения АД, снижения толерантности к физической нагрузке, фракции выброса левого желудочка. У больных стенокардией разовая суточная доза увеличивает время выполнения физической нагрузки, замедляет скорость развития приступа стенокардии и «ишемической» депрессии сегмента ST, снижает частоту приступов стенокардии и потребления нитроглицерина. Не оказывает неблагоприятных влияний на обмен веществ и липиды плазмы крови. Время наступления клинического эффекта — 2–4 ч, длительность — 24 ч. Фармакокинетика Медленно и почти полностью всасывается из желудочно-кишечного тракта (абсорбция — 90 %). Приём пищи не влияет на всасываемость препарата. Максимальная концентрация препарата в плазме наблюдается через 6–9 ч после применения. Биодоступность составляет 60-80 %, связь с белками плазмы — 90–97 %. Амлодипин подвергается медленному, но экстенсивному метаболизму (90 %) в печени с образованием неактивных метаболитов, имеет эффект “первого прохождения” через печень. Метаболиты не обладают значимой фармакологической активностью. После однократного перорального приёма период полувыведения (T½) варьирует от 31 до 48 часов, при повторном назначении T½ составляет приблизительно 45 часов. Около 60 % принятой внутрь дозы экскретируется почками преимущественно в виде метаболитов, 10 % в неизменённом виде, а 20–25 % через кишечник, а также с грудным молоком. Препарат проникает через гематоэнцефалический барьер. 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