Установленная повышенная чувствительность к компонентам препарата. Беременность и период грудного вскармливания. Возраст до 18 лет (эффективность и безопасность не установлены). Гемодинамически значимый двусторонний стеноз почечных артерий или тяжелый стеноз артерии единственной функционирующей почки. Одновременное применение с алискиреном и алискиренсодержащими ...
Действующее вещество: Эпросартан (Eprosartan)Концентрация действующего вещества (мг): 600
Фармакологические свойства
Антигипертензивное средство, синтетический антагонист рецепторов ангиотензина ii, небифениловое производное тетразола.эпросартан избирательно связывается с ат1-рецепторами, расположенными в сосудах, сердце, почках и коре надпочечников, образует с ними прочную связь с последующей медленной диссоциацией.ангиотензин ii связывается с ат1-рецепторами во многих тканях (в т.ч. в гладкой мускулатуре сосудов, надпочечниках, почках, сердце) и вызывает вазоконстрикцию, задержку натрия и высвобождение альдостерона, поражение органов-мишеней - гипертрофию миокарда и сосудов.эпросартан предупреждает развитие или ослабляет эффекты ангиотензина ii. угнетает активность раас. оказывает вазодилатирующее, гипотензивное и опосредованно - диуретическое действие.уменьшает артериальную вазоконстрикцию, опсс, давление в малом круге кровообращения, реабсорбцию жидкости и ионов натрия в проксимальном сегменте почечных канальцев, секрецию альдостерона. при длительном применении подавляет пролиферативное влияние ангиотензина ii на клетки гладких мышц сосудов и миокарда.у пациентов с артериальной гипертензией эпросартан не влияет на концентрации тг, общего холестерина (хс) или хс-лпнп в крови, определяемых натощак. кроме того, эпросартан не влияет на концентрацию глюкозы в крови натощак.увеличивает почечный кровоток и скорость клубочковой фильтрации, уменьшает выведение альбуминов (нефропротекторное действие), при сохранении почечной саморегуляции вне зависимости от степени выраженности почечной недостаточности.прекращение лечения эпросартаном не сопровождается синдромом отмены.эпросартан не угнетает изоферменты cyp1a, 2а6, 2с9/8, 2с19, 2d6, 2е и 3а in vitro.гипотензивное действие после приема однократной дозы сохраняется в течение 24 ч, стойкий терапевтический эффект проявляется при регулярном приеме - через 2-3 недели без изменения чсс.
Показания к применению
Артериальная гипертензия.
Противопоказания
Установленная повышенная чувствительность к компонентам препарата. Беременность и период грудного вскармливания. Возраст до 18 лет (эффективность и безопасность не установлены). Гемодинамически значимый двусторонний стеноз почечных артерий или тяжелый стеноз артерии единственной функционирующей почки. Одновременное применение с алискиреном и алискиренсодержащими препаратами у пациентов с сахарным диабетом или умеренным или тяжелым нарушением функции почек (СКФ менее 60 мл/мин/1,73 м2). Непереносимость галактозы, дефицит лактазы лопарей (саамов) или синдром глюкозо-галактозной мальабсорбции (препарат содержит лактозы моногидрат).
С осторожностью
Тяжелая хроническая сердечная недостаточность (IV функционального класса по классификации NYHA), двусторонний стеноз почечных артерий или стеноз артерии единственной почки; снижение объема циркулирующей крови (ОЦК) и/или избыточное выведение натрия из организма (в том числе в результате рвоты, диареи, приема высоких доз диуретиков); стеноз аортального и митрального клапана; гипертрофическая обструктивная кардиомиопатия; ишемическая болезнь сердца (опыт применения ограничен); печеночная недостаточность (опыт применения ограничен); у пациентов, находящихся на гемодиализе или с КК менее 30 мл/мин; применение у пациентов негроидной расы (см. раздел «Особые указания»). Компания не располагает данными о безопасности применения препарата Теветен у пациентов с недавно выполненной трансплантацией почки.
Применение при беременности и в период грудного вскармливания
Препарат Теветен противопоказан к применению во время беременности. По причине недостаточного количества данных о применении препарата Теветен в период кормления грудью по возможности данный препарат следует заменить другими гипотензивными лекарственными средствами, обладающими установленными профилями безопасности, особенно при вскармливании новорожденного или недоношенного ребенка.
Способ применения и дозы
Внутрь, независимо от приема пищи. Рекомендуемая суточная доза составляет 1 таблетка препарата Теветен 1 раз в день. Максимальная суточная доза препарата Теветен 600 мг. Эпросартан можно применять как в монотерапии, так и в комбинации с другими гипотензивными препаратами.
Побочное действие
Головная боль, головокружение, астения, ринит, аллергические кожные реакции (например, кожная сыпь, зуд), неспецифические жалобы со стороны желудочно-кишечного тракта (например, тошнота, диарея, рвота).
Перечень всех побочных эффектов представлен в инструкции по медицинскому применению.
Передозировка
Данные по передозировке у людей ограничены. Наиболее вероятным проявлением передозировки будет выраженное снижение АД.
Взаимодействие с другими лекарственными средствами
Поскольку в плацебо - контролируемых клинических исследованиях наблюдалось повышение содержания калия в сыворотке крови, а также на основании опыта применения других препаратов, которые оказывают влияние на РААС, одновременное применение калийсберегающих диуретиков, пищевых добавок, содержащих калий, заменителей пищевой соли, содержащих калий, и других препаратов, которые могут повышать содержание калия в крови (например, гепарин) может вызывать повышение содержания калия в сыворотке крови. Данные клинического исследования показали, что двойная блокада РААС посредством совместного применения ингибиторов АПФ, АРА II или алискирена связана с повышенной частотой таких нежелательных явлений, как артериальная гипотензия, гиперкалиемия и снижение функции почек (включая острую почечную недостаточность) по сравнению с применением отдельного средства, действующего на РААС (см. раздел «Особые указания», «Противопоказания»). Антигипертензивное действие препарата Теветен может быть потенцировано другими гипотензивными средствами. Известны случаи обратимого повышения содержания лития в сыворотке крови и развития токсических реакций при одновременном приеме препаратов лития с ингибиторами АПФ. Как и при применении ингибиторов АПФ, совместное применение АРА II и нестероидных противовоспалительных препаратов (НПВП) может привести к повышенному риску ухудшения функции почек, включая возможность развития острой почечной недостаточности, и повышению содержания калия в сыворотке крови, особенно у пациентов с уже имеющимся нарушением функции почек. Такие комбинации следует применять с осторожностью, особенно у пожилых пациентов. Пациентам рекомендовано проводить объем-заместительную терапию и контролировать функцию почек после начала совместной терапии и периодически в процессе лечения. Совместное применение лозартана и НПВП индометацина приводило к снижению эффективности АРА II; нельзя исключить классовый эффект.
Особые указания
У некоторых пациентов, функция почек которых зависит от активности РААС (например, пациенты с тяжелой хронической сердечной недостаточностью IV функционального класса по классификации NYHA, двусторонний стеноз почечных артерий или стеноз почечной артерии единственной почки), во время лечения ингибиторами АПФ может развиться олигурия и/или прогрессирующая азотемия, и, в редких случаях, острая почечная недостаточность. Эти явления наиболее вероятны у пациентов, одновременно принимающих диуретики. В связи с недостаточным опытом применения АРА II у пациентов из упомянутой выше группы риска нельзя исключить нарушения почечной функции на фоне применения препарата Теветен вследствие подавления РААС. При совместном применении с другими лекарственными препаратами, влияющими на РААС, может возникать гиперкалиемия, особенно при наличии почечной недостаточности и/или сердечной недостаточности. Рекомендуется мониторинг содержания калия в сыворотке крови у пациентов в группе риска. Исходя из опыта применения других лекарственных препаратов, влияющих на РААС, совместное применение калийсберегающих диуретиков, пищевых добавок содержащих калий, заменителей пищевой соли, содержащих калий, и других препаратов, которые могут повышать содержание калия в сыворотке крови (например, гепарина), может вызывать повышение содержания калия в сыворотке крови. Совместную терапию следует проводить с осторожностью. Двойная блокада РААС путем комбинированного применения ингибиторов АПФ, АРА II или алискирена не рекомендуется. Пациентам с первичным альдостеронизмом лечение препаратом Теветен не рекомендуется. Как и при применении других вазодилататоров, назначение препарата Теветен пациентам со стенозом аортального и митрального клапана или гипертрофической обструктивной кардиомиопатией необходимо проводить с осторожностью. Отсутствует опыт применения у пациентов с недавно перенесенной трансплантацией почки. Подобно ингибиторам АПФ, Теветен и другие АРА II менее эффективно снижают артериальное давление у пациентов негроидной расы по сравнению с другими расами, возможно, по причине более высокой распространенности состояний, характеризующихся низкой активностью ренина. У пациентов со сниженным ОЦК и/или содержанием солей (в результате терапии диуретиками), при ограничении потребления пищевой соли, при длительной и многократной рвоте прием препарата Теветен может вызывать развитие симптоматической артериальной гипотензии.
Влияние на способность управлять автомобилем и движущимися механизмами
В период лечения препаратом Теветен необходимо соблюдать осторожность при вождении автотранспорта и занятии потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций, в связи с возможностью возникновения головокружения и слабости.
Форма выпуска
Таблетки покрытые пленочной оболочкой, 600 мг.
Условия отпуска
По рецепту.
Полная информация по препарату представлена в инструкции по медицинскому применению.
Для описания товара использована информация от партнера 36.6
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мускулатуре сосудов, надпочечниках, почках, сердце) и вызывает вазоконстрикцию, задержку натрия и высвобождение альдостерона, поражение органов-мишеней - гипертрофию миокарда и сосудов.эпросартан предупреждает развитие или ослабляет эффекты ангиотензина ii. угнетает активность раас. оказывает вазодилатирующее, гипотензивное и опосредованно - диуретическое действие.уменьшает артериальную вазоконстрикцию, опсс, давление в малом круге кровообращения, реабсорбцию жидкости и ионов натрия в проксимальном сегменте почечных канальцев, секрецию альдостерона. при длительном применении подавляет пролиферативное влияние ангиотензина ii на клетки гладких мышц сосудов и миокарда.у пациентов с артериальной гипертензией эпросартан не влияет на концентрации тг, общего холестерина (хс) или хс-лпнп в крови, определяемых натощак. кроме того, эпросартан не влияет на концентрацию глюкозы в крови натощак.увеличивает почечный кровоток и скорость клубочковой фильтрации, уменьшает выведение альбуминов (нефропротекторное действие), при сохранении почечной саморегуляции вне зависимости от степени выраженности почечной недостаточности.прекращение лечения эпросартаном не сопровождается синдромом отмены.эпросартан не угнетает изоферменты cyp1a, 2а6, 2с9/8, 2с19, 2d6, 2е и 3а in vitro.гипотензивное действие после приема однократной дозы сохраняется в течение 24 ч, стойкий терапевтический эффект проявляется при регулярном приеме - через 2-3 недели без изменения чсс."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Артериальная гипертензия."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Установленная повышенная чувствительность к компонентам препарата. Беременность и период грудного вскармливания. Возраст до 18 лет (эффективность и безопасность не установлены). Гемодинамически значимый двусторонний стеноз почечных артерий или тяжелый стеноз артерии единственной функционирующей почки. Одновременное применение с алискиреном и алискиренсодержащими препаратами у пациентов с сахарным диабетом или умеренным или тяжелым нарушением функции почек (СКФ менее 60 мл/мин/1,73 м\u003csup\u003e2\u003c/sup\u003e). Непереносимость галактозы, дефицит лактазы лопарей (саамов) или синдром глюкозо-галактозной мальабсорбции (препарат содержит лактозы моногидрат). "}}]},{"name":"С осторожностью","slug":"cautions","id":14,"body":[{"type":"paragraph","data":{"text":"Тяжелая хроническая сердечная недостаточность (IV функционального класса по классификации NYHA), двусторонний стеноз почечных артерий или стеноз артерии единственной почки; снижение объема циркулирующей крови (ОЦК) и/или избыточное выведение натрия из организма (в том числе в результате рвоты, диареи, приема высоких доз диуретиков); стеноз аортального и митрального клапана; гипертрофическая обструктивная кардиомиопатия; ишемическая болезнь сердца (опыт применения ограничен); печеночная недостаточность (опыт применения ограничен); у пациентов, находящихся на гемодиализе или с КК менее 30 мл/мин; применение у пациентов негроидной расы (см. раздел «Особые указания»). Компания не располагает данными о безопасности применения препарата Теветен у пациентов с недавно выполненной трансплантацией почки. "}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат Теветен противопоказан к применению во время беременности. По причине недостаточного количества данных о применении препарата Теветен в период кормления грудью по возможности данный препарат следует заменить другими гипотензивными лекарственными средствами, обладающими установленными профилями безопасности, особенно при вскармливании новорожденного или недоношенного ребенка. "}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, независимо от приема пищи. Рекомендуемая суточная доза составляет 1 таблетка препарата Теветен 1 раз в день. Максимальная суточная доза препарата Теветен 600 мг. Эпросартан можно применять как в монотерапии, так и в комбинации с другими гипотензивными препаратами. 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Данные клинического исследования показали, что двойная блокада РААС посредством совместного применения ингибиторов АПФ, АРА II или алискирена связана с повышенной частотой таких нежелательных явлений, как артериальная гипотензия, гиперкалиемия и снижение функции почек (включая острую почечную недостаточность) по сравнению с применением отдельного средства, действующего на РААС (см. раздел «Особые указания», «Противопоказания»). Антигипертензивное действие препарата Теветен может быть потенцировано другими гипотензивными средствами. Известны случаи обратимого повышения содержания лития в сыворотке крови и развития токсических реакций при одновременном приеме препаратов лития с ингибиторами АПФ. Как и при применении ингибиторов АПФ, совместное применение АРА II и нестероидных противовоспалительных препаратов (НПВП) может привести к повышенному риску ухудшения функции почек, включая возможность развития острой почечной недостаточности, и повышению содержания калия в сыворотке крови, особенно у пациентов с уже имеющимся нарушением функции почек. Такие комбинации следует применять с осторожностью, особенно у пожилых пациентов. Пациентам рекомендовано проводить объем-заместительную терапию и контролировать функцию почек после начала совместной терапии и периодически в процессе лечения. Совместное применение лозартана и НПВП индометацина приводило к снижению эффективности АРА II; нельзя исключить классовый эффект."}}]},{"id":9,"name":"Особые указания","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"У некоторых пациентов, функция почек которых зависит от активности РААС (например, пациенты с тяжелой хронической сердечной недостаточностью IV функционального класса по классификации NYHA, двусторонний стеноз почечных артерий или стеноз почечной артерии единственной почки), во время лечения ингибиторами АПФ может развиться олигурия и/или прогрессирующая азотемия, и, в редких случаях, острая почечная недостаточность. Эти явления наиболее вероятны у пациентов, одновременно принимающих диуретики. В связи с недостаточным опытом применения АРА II у пациентов из упомянутой выше группы риска нельзя исключить нарушения почечной функции на фоне применения препарата Теветен вследствие подавления РААС. При совместном применении с другими лекарственными препаратами, влияющими на РААС, может возникать гиперкалиемия, особенно при наличии почечной недостаточности и/или сердечной недостаточности. Рекомендуется мониторинг содержания калия в сыворотке крови у пациентов в группе риска. Исходя из опыта применения других лекарственных препаратов, влияющих на РААС, совместное применение калийсберегающих диуретиков, пищевых добавок содержащих калий, заменителей пищевой соли, содержащих калий, и других препаратов, которые могут повышать содержание калия в сыворотке крови (например, гепарина), может вызывать повышение содержания калия в сыворотке крови. Совместную терапию следует проводить с осторожностью. Двойная блокада РААС путем комбинированного применения ингибиторов АПФ, АРА II или алискирена не рекомендуется. Пациентам с первичным альдостеронизмом лечение препаратом Теветен не рекомендуется. Как и при применении других вазодилататоров, назначение препарата Теветен пациентам со стенозом аортального и митрального клапана или гипертрофической обструктивной кардиомиопатией необходимо проводить с осторожностью. Отсутствует опыт применения у пациентов с недавно перенесенной трансплантацией почки. Подобно ингибиторам АПФ, Теветен и другие АРА II менее эффективно снижают артериальное давление у пациентов негроидной расы по сравнению с другими расами, возможно, по причине более высокой распространенности состояний, характеризующихся низкой активностью ренина. У пациентов со сниженным ОЦК и/или содержанием солей (в результате терапии диуретиками), при ограничении потребления пищевой соли, при длительной и многократной рвоте прием препарата Теветен может вызывать развитие симптоматической артериальной гипотензии. 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