Антигипертензивное средство. Является специфическим антагони... Инструкция
Показания к применению
Лечение артериальной гипертензии.
Лечение хронической сердечной недостаточности (II-IV функциональный класс по классификации NYHA) у пациентов, получающих традиционную терапию диуретиками, препаратами наперстянки, а также ингибиторами АПФ или бета-адреноблокаторами.
Противопоказания
Беременность, повышенная чувствительность к валсартану.
Состав корпуса капсулы: краситель железа оксид черный - 0.01%, краситель железа оксид красный - 0.01%, краситель железа оксид желтый - 0.1714%, титана диоксид - 3%, желатин - до 100%.
Состав крышечки капсулы: краситель железа оксид черный - 0.01%, краситель железа оксид красный - 0.01%, краситель железа оксид желтый - 0.1714%, титана диоксид - 3%, желатин - до 100%.
Фармакологические свойства
Антигипертензивное средство. Является специфическим антагонистом рецепторов ангиотензина II. Оказывает избирательное антагонистическое действие на AT1-рецепторы, которые ответственны за реализацию эффектов ангиотензина II.
Вследствие блокады AT1-рецепторов повышается плазменная концентрация ангиотензина II, который может стимулировать незаблокированные AT2-рецепторы. Не обладает агонистической активностью в отношении AT1-рецепторов. Сродство валсартана к AT1-рецепторам примерно в 20 000 раз выше, чем к AT2-рецепторам.
Не ингибирует АПФ. Не взаимодействует и не блокирует рецепторы других гормонов или ионные каналы, имеющие важное значение для регуляции функций сердечно-сосудистой системы. Не оказывает влияния на уровень общего холестерина, ТГ, глюкозы и мочевой кислоты в плазме крови.
Начало антигипертензивного действия валсартана после его применения внутрь в однократной дозе наблюдается в течение 2 ч после приема, максимальный эффект достигается в течение 4-6 ч.
Фармакокинетика
После приема внутрь валсартан быстро абсорбируется из ЖКТ, степень всасывания характеризуется индивидуальными различиями. Абсолютная биодоступность в среднем составляет 23%. Фармакокинетическая кривая валсартана имеет мультиэкспоненциальный характер (T1/2 в α-фазе < 1 ч и T1/2 в β-фазе - около 9 ч), кинетика линейная.
При курсовом применении изменений фармакокинетических параметров не отмечалось.
При приеме валсартана с пищей AUC уменьшается на 48%, при этом примерно через 8 ч после приема концентрации валсартана в плазме одинаковы у пациентов, принимавших его с пищей и натощак. Уменьшение AUC не сопровождается клинически значимым уменьшением терапевтического эффекта.
При приеме валсартана 1 раз/сут кумуляция выражена незначительно. Концентрации валсартана в плазме крови у женщин и мужчин были одинаковы.
Связывание с белками плазмы, преимущественно с альбуминами, составляет 94-97%. Vd в равновесном состоянии составляет около 17 л.
Плазменный клиренс валсартана составляет около 2 л/ч. Выводится с калом - 70% и с мочой - 30%, преимущественно в неизмененном виде.
При билиарном циррозе или обструкции желчевыводящих путей AUC валсартана увеличивается приблизительно в 2 раза.
Показания к применению
Лечение артериальной гипертензии.
Лечение хронической сердечной недостаточности (II-IV функциональный класс по классификации NYHA) у пациентов, получающих традиционную терапию диуретиками, препаратами наперстянки, а также ингибиторами АПФ или бета-адреноблокаторами.
Противопоказания
Беременность, повышенная чувствительность к валсартану.
Применение при беременности и в период грудного вскармливания
Валсартан противопоказан к применению при беременности.
Неизвестно, выделяется ли валсартан с грудным молоком у человека. Применение в период лактации (грудного вскармливания) не рекомендуется.
В экспериментальных исследованиях показано, что валсартан выделяется с грудным молоком у крыс.
Способ применения и дозы
Принимают внутрь в дозе 80 мг 1 раз/сут или по 40 мг 2 раза/сут, ежедневно. При отсутствии адекватного эффекта суточная доза может быть постепенно увеличена.
Максимальная суточная доза составляет 320 мг в 2 приема.
Побочное действие
Со стороны сердечно-сосудистой системы: артериальная гипотензия, постуральное головокружение, постуральная гипотензия.
Со стороны ЦНС: головокружение, головная боль.
Со стороны пищеварительной системы: диарея, тошнота, повышение уровня билирубина.
Со стороны мочевыделительной системы: редко - нарушение функции почек, повышение уровня креатинина и азота мочевины (особенно при хронической сердечной недостаточности).
Со стороны обмена веществ: гиперкалиемия.
Со стороны системы кроветворения: нейтропения, уменьшение гемоглобина и гематокрита.
Прочие: утомляемость, общая слабость, кашель, фарингит, повышение риска развития вирусных инфекций.
Взаимодействие с другими лекарственными средствами
При одновременном применении диуретиков в высоких дозах возможно развитие артериальной гипотензии.
При одновременном применении калийсберегающих диуретиков, гепарина, биологически активных добавок или заменителей соли, содержащих калий, возможно развитие гиперкалиемии.
При одновременном применении с индометацином возможно уменьшение антигипертензивного действия валсартана.
При одновременном применении с лития карбонатом описан случай развития интоксикации литием.
Особые указания
При гипонатриемии и/или уменьшении ОЦК, а также на фоне терапии высокими дозами диуретиков в редких случаях валсартан может вызвать выраженную артериальную гипотензию. Перед началом лечения следует провести коррекцию нарушений водно-солевого обмена.
У пациентов с реноваскулярной гипертензией, развившейся вторично вследствие стеноза почечной артерии, в период лечения следует регулярно контролировать уровень мочевины и креатинина в сыворотке. Данные о безопасности применения у пациентов с КК менее 10 мл/мин отсутствуют.
С особой осторожностью применяют у пациентов с нарушениями проходимости желчных путей.
Вследствие ингибирования РААС у предрасположенных пациентов возможны изменения функции почек. При применении ингибиторов АПФ и антагонистов ангиотензиновых рецепторов у пациентов с хронической сердечной недостаточностью тяжелого течения наблюдались олигурия и/или нарастание азотемии, редко развивалась острая почечная недостаточность с риском летального исхода. Безопасность и эффективность применения валсартана у детей не установлена.
Влияние на способность управлять автомобилем и движущимися механизмами
При применении валсартана рекомендуется соблюдать осторожность при вождении автомобиля и управлении механизмами.
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Является специфическим антагонистом рецепторов ангиотензина II. Оказывает избирательное антагонистическое действие на AT\u003csub\u003e1\u003c/sub\u003e-рецепторы, которые ответственны за реализацию эффектов ангиотензина II."}},{"type":"paragraph","data":{"text":"Вследствие блокады AT\u003csub\u003e1\u003c/sub\u003e-рецепторов повышается плазменная концентрация ангиотензина II, который может стимулировать незаблокированные AT\u003csub\u003e2\u003c/sub\u003e-рецепторы. Не обладает агонистической активностью в отношении AT\u003csub\u003e1\u003c/sub\u003e-рецепторов. Сродство валсартана к AT\u003csub\u003e1\u003c/sub\u003e-рецепторам примерно в 20 000 раз выше, чем к AT\u003csub\u003e2\u003c/sub\u003e-рецепторам."}},{"type":"paragraph","data":{"text":"Не ингибирует АПФ. Не взаимодействует и не блокирует рецепторы других гормонов или ионные каналы, имеющие важное значение для регуляции функций сердечно-сосудистой системы. Не оказывает влияния на уровень общего холестерина, ТГ, глюкозы и мочевой кислоты в плазме крови."}},{"type":"paragraph","data":{"text":"Начало антигипертензивного действия валсартана после его применения внутрь в однократной дозе наблюдается в течение 2 ч после приема, максимальный эффект достигается в течение 4-6 ч."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"После приема внутрь валсартан быстро абсорбируется из ЖКТ, степень всасывания характеризуется индивидуальными различиями. Абсолютная биодоступность в среднем составляет 23%. Фармакокинетическая кривая валсартана имеет мультиэкспоненциальный характер (T\u003csub\u003e1/2\u003c/sub\u003e в α-фазе < 1 ч и T\u003csub\u003e1/2\u003c/sub\u003e в β-фазе - около 9 ч), кинетика линейная."}},{"type":"paragraph","data":{"text":"При курсовом применении изменений фармакокинетических параметров не отмечалось."}},{"type":"paragraph","data":{"text":"При приеме валсартана с пищей AUC уменьшается на 48%, при этом примерно через 8 ч после приема концентрации валсартана в плазме одинаковы у пациентов, принимавших его с пищей и натощак. Уменьшение AUC не сопровождается клинически значимым уменьшением терапевтического эффекта."}},{"type":"paragraph","data":{"text":"При приеме валсартана 1 раз/сут кумуляция выражена незначительно. Концентрации валсартана в плазме крови у женщин и мужчин были одинаковы."}},{"type":"paragraph","data":{"text":"Связывание с белками плазмы, преимущественно с альбуминами, составляет 94-97%. V\u003csub\u003ed\u003c/sub\u003e в равновесном состоянии составляет около 17 л."}},{"type":"paragraph","data":{"text":"Плазменный клиренс валсартана составляет около 2 л/ч. Выводится с калом - 70% и с мочой - 30%, преимущественно в неизмененном виде."}},{"type":"paragraph","data":{"text":"При билиарном циррозе или обструкции желчевыводящих путей AUC валсартана увеличивается приблизительно в 2 раза."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Лечение артериальной гипертензии."}},{"type":"paragraph","data":{"text":"Лечение хронической сердечной недостаточности (II-IV функциональный класс по классификации NYHA) у пациентов, получающих традиционную терапию диуретиками, препаратами наперстянки, а также ингибиторами АПФ или бета-адреноблокаторами."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Беременность, повышенная чувствительность к валсартану."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Валсартан противопоказан к применению при беременности."}},{"type":"paragraph","data":{"text":"Неизвестно, выделяется ли валсартан с грудным молоком у человека. Применение в период лактации (грудного вскармливания) не рекомендуется."}},{"type":"paragraph","data":{"text":"В \u003ci\u003eэкспериментальных исследованиях\u003c/i\u003e показано, что валсартан выделяется с грудным молоком у крыс."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Принимают внутрь в дозе 80 мг 1 раз/сут или по 40 мг 2 раза/сут, ежедневно. При отсутствии адекватного эффекта суточная доза может быть постепенно увеличена."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМаксимальная суточная доза\u003c/i\u003e составляет 320 мг в 2 приема."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e артериальная гипотензия, постуральное головокружение, постуральная гипотензия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны ЦНС:\u003c/i\u003e головокружение, головная боль."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы:\u003c/i\u003e диарея, тошнота, повышение уровня билирубина."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны мочевыделительной системы:\u003c/i\u003e редко - нарушение функции почек, повышение уровня креатинина и азота мочевины (особенно при хронической сердечной недостаточности)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны обмена веществ:\u003c/i\u003e гиперкалиемия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны системы кроветворения:\u003c/i\u003e нейтропения, уменьшение гемоглобина и гематокрита."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e редко - ангионевротический отек, сыпь, зуд, сывороточная болезнь, васкулит."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e утомляемость, общая слабость, кашель, фарингит, повышение риска развития вирусных инфекций."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении диуретиков в высоких дозах возможно развитие артериальной гипотензии."}},{"type":"paragraph","data":{"text":"При одновременном применении калийсберегающих диуретиков, гепарина, биологически активных добавок или заменителей соли, содержащих калий, возможно развитие гиперкалиемии."}},{"type":"paragraph","data":{"text":"При одновременном применении с индометацином возможно уменьшение антигипертензивного действия валсартана."}},{"type":"paragraph","data":{"text":"При одновременном применении с лития карбонатом описан случай развития интоксикации литием."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"При гипонатриемии и/или уменьшении ОЦК, а также на фоне терапии высокими дозами диуретиков в редких случаях валсартан может вызвать выраженную артериальную гипотензию. Перед началом лечения следует провести коррекцию нарушений водно-солевого обмена."}},{"type":"paragraph","data":{"text":"У пациентов с реноваскулярной гипертензией, развившейся вторично вследствие стеноза почечной артерии, в период лечения следует регулярно контролировать уровень мочевины и креатинина в сыворотке. Данные о безопасности применения у пациентов с КК менее 10 мл/мин отсутствуют."}},{"type":"paragraph","data":{"text":"С особой осторожностью применяют у пациентов с нарушениями проходимости желчных путей."}},{"type":"paragraph","data":{"text":"Вследствие ингибирования РААС у предрасположенных пациентов возможны изменения функции почек. При применении ингибиторов АПФ и антагонистов ангиотензиновых рецепторов у пациентов с хронической сердечной недостаточностью тяжелого течения наблюдались олигурия и/или нарастание азотемии, редко развивалась острая почечная недостаточность с риском летального исхода. Безопасность и эффективность применения валсартана у детей не установлена."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"При применении валсартана рекомендуется соблюдать осторожность при вождении автомобиля и управлении механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту."}}]}],"source":null},"description_toggle":false,"short_description":"Антигипертензивное средство. Является специфическим антагонистом рецепторов ангиотензина II. Оказывает избирательное антагонистическое действие на AT1-рецепторы, которые ответственны за реализацию эффектов ангиотензина II. Вследствие блокады AT1-рецепторов повышается плазменная концентрация ангиотензина II, который может стимулировать незаблокированные AT2-рецепторы. 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При курсовом применении изменений фармакокинетических параметров не отмечалось. При приеме валсартана с пищей AUC уменьшается на 48%, при этом примерно через 8 ч после приема концентрации валсартана в плазме одинаковы у пациентов, принимавших его с пищей и натощак. Уменьшение AUC не сопровождается клинически значимым уменьшением терапевтического эффекта. При приеме валсартана 1 раз/сут кумуляция выражена незначительно. Концентрации валсартана в плазме крови у женщин и мужчин были одинаковы. Связывание с белками плазмы, преимущественно с альбуминами, составляет 94-97%. Vdв равновесном состоянии составляет около 17 л. Плазменный клиренс валсартана составляет около 2 л/ч. Выводится с калом - 70% и с мочой - 30%, преимущественно в неизмененном виде. 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