Блокатор гистаминовых Н1-рецепторов. Фексофенадин (фармакологически активный метаболит терфенадина) является антигистаминным средством с селективной антагонистической активностью к гистаминовым Н1-рецепторам без антихолинергического и альфа-адреноблокирующего действия. Кроме этого у фексофенадина не наблюдается седативного действия и других эффектов со стороны ЦНС. В исследованиях у человека по оценке вызываемых гистамином волдырей и гиперемии антигистаминное действие фексофенадина, принимаемого внутрь 1 или 2 раза в сут, проявляется через 1 ч, достигает максимума через 6 ч, и продолжается в течение 24 ч после его приема. Даже после 28 дней приема фексофенадина не выявлено развития толерантности к препарату. При однократном приеме фексофенадина внутрь наблюдается дозозависимое увеличение антигистаминного эффекта при увеличении дозы от 10 мг до 130 мг. При использовании той же модели антигистаминного действия было установлено, что для постоянного в течение 24 часов действия была необходима доза не менее 130 мг. Максимальное подавление образования волдырей и гиперемии кожи составляет более 80%. У пациентов с сезонным аллергическим ринитом, получавших до 240 мг фексофенадина 2 раза/сут в течение 2 недель продолжительность интервала QTc (QT скорригированного) не отличалась от таковой при приеме плацебо. Также не наблюдалось изменений QTc при приеме фексофенадина здоровыми добровольцами по 60 мг 2 раза/сут в течение 6 месяцев, по 400 мг 2 раза/сут в течение 6.5 дней и 240 мг/сут в течение 1 года по сравнению с продолжительностью QTc при приеме плацебо. Даже при плазменной концентрации в 32 раза превышающей терапевтические концентрации у человека фексофенадин не оказывал влияния на калиевые каналы задержанного выпрямления в человеческом сердце.
Показания к применению
Сезонный аллергический ринит (для уменьшения симптомов) - таблетки 120 мг
Хроническая идиопатическая крапивница (для уменьшения симптомов) - таблетки 180 мг
Противопоказания
Повышенная чувствительность к любому из компонентов препарата
Беременность
Период лактации
Детский возраст до 12 лет. С осторожностью:
У больных с хронической почечной и печеночной недостаточностью, а также у пациентов пожилого возраста (недостаточность клинического опыта применения у этой категории пациентов)
У пациентов с сердечно-сосудистыми заболеваниями, в т.ч. в анамнезе (антигистаминные препараты могут вызывать сердцебиение и тахикардию)
Применение при беременности и в период грудного вскармливания
Нет достаточного количества данных о применении фексофенадина беременными женщинами. Ограниченные исследования на животных показали отсутствие признаков наличия неблагоприятного влияния на течение беременности, внутриутробное развитие, роды и постнатальное развитие. Фексофенадин не должен использоваться при беременности. Данные по содержанию фексофенадина в грудном молоке при его приеме женщинами в период грудного вскармливания отсутствуют. Однако показано, что терфенадин выделяется с грудным молоком у женщин. Поэтому применение фексофенадина в период грудного вскармливания не рекомендуется.
Способ применения и дозы
Препарат предназначен для приема внутрь. Рекомендуемая доза фексофенадина при сезонном аллергическом рините для взрослых и детей 12 лет и старше составляет 120 мг 1 раз/сут перед едой. Рекомендуемая доза фексофенадина при хронической крапивнице для взрослых и детей 12 лет и старше составляет 180 мг 1 раз/сут перед едой. Исследования в специальных группах риска (пациенты пожилого возраста, пациенты с почечной и печеночной недостаточностью) показали, что у них не требуется коррекции режима дозирования.
Побочное действие
В плацебо-контролируемых клинических исследованиях наиболее часто (≥1% - меньше10%) наблюдались: головная боль (7.3%), сонливость (2.3%), головокружение (1.5%) и тошнота (1.5 %). При приеме фексофенадина частота вышеуказанных неблагоприятных эффектов была подобной таковой при приеме плацебо. В плацебо-контролируемых исследованиях с частотой менее 1% (одинаково при приеме фексофенадина и плацебо) и при постмаркетинговом применении наблюдались: слабость, бессонница, нервозность и нарушения сна или необычные сновидения (паронирия), такие как кошмары; тахикардия, сердцебиение; диарея. В редких случаях (≥0.01% - меньше0.1%): экзантема, крапивница, зуд и другие реакции гиперчувствительности, такие как отек Квинке, затруднение дыхания, одышка, гиперемия кожных покровов, системные анафилактические реакции.
Передозировка
Симптомы: головокружение, сонливость и сухость во рту. Здоровые добровольцы принимали однократные дозы до 800 мг и курсовые дозы до 690 мг 2 раза/сут в течение 1 месяца или 240 мг 2 раза/сут в течение 1 года без каких-либо существенных нежелательных эффектов по сравнению с плацебо. Максимальная переносимая доза для фексофенадина не установлена. Лечение: в случае передозировки рекомендуется проведение промывания желудка, прием активированного угля, при необходимости симптоматическая и поддерживающая терапия. Гемодиализ неэффективен.
Взаимодействие с другими лекарственными средствами
При совместном применении фексофенадина с эритромицином или кетоконазолом концентрация фексофенадина в плазме увеличивается в 2-3 раза, но это не сопровождается значимым удлинением интервала QTc. Не наблюдалось достоверных различий в частоте возникновения неблагоприятных эффектов при применении этих препаратов в качестве монотерапии и в составе комбинированной терапии. Исследования на животных показали, что вышеупомянутое повышение плазменных концентраций фексофенадина вероятно связано с улучшением абсорбции фексофенадина и снижением его билиарной экскреции или секреции в просвет ЖКТ.
Взаимодействия между фексофенадином и омепразолом не наблюдается.
Не взаимодействует с лекарственными средствами, метаболизирующимися в печени.
Прием содержащих алюминий или магний антацидов за 15 мин до приема фексофенадина приводит к снижению биодоступности последнего в результате, по-видимому, связывания в ЖКТ.
Особые указания
Рекомендуется, чтобы промежуток времени между приемом фексофенадина и антацидов, содержащих гидроокись алюминия или магния, составлял как минимум 2 ч. Использование в педиатрииДля применения у детей от 6 до 11 лет выпускаются таблетки 30 мг. Влияние на способность к вождению автотранспорта и управлению механизмамиПри приеме препарата возможно выполнение работ, требующих высокой концентрации внимания и быстроты психомоторных реакций (за исключением больных, обладающих нестандартной реакцией). Поэтому рекомендуется до занятия такими видами деятельности проверить индивидуальную реакцию на прием фексофенадина.
Форма выпуска
Таблетки.
Условия хранения
Препарат следует хранить в недоступном для детей месте при температуре не выше 25°С.
Срок годности
3 года.
Условия отпуска
Препарат отпускается без рецепта.
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Вспомогательные вещества: кроскармеллоза натрия - 24 мг, крахмал прежелатинизированный - 120 мг, целлюлоза микрокристаллическая - 133 мг, магния стеарат - 3 мг."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Блокатор гистаминовых Н1-рецепторов. Фексофенадин (фармакологически активный метаболит терфенадина) является антигистаминным средством с селективной антагонистической активностью к гистаминовым Н1-рецепторам без антихолинергического и альфа-адреноблокирующего действия. Кроме этого у фексофенадина не наблюдается седативного действия и других эффектов со стороны ЦНС. В исследованиях у человека по оценке вызываемых гистамином волдырей и гиперемии антигистаминное действие фексофенадина, принимаемого внутрь 1 или 2 раза в сут, проявляется через 1 ч, достигает максимума через 6 ч, и продолжается в течение 24 ч после его приема. Даже после 28 дней приема фексофенадина не выявлено развития толерантности к препарату. При однократном приеме фексофенадина внутрь наблюдается дозозависимое увеличение антигистаминного эффекта при увеличении дозы от 10 мг до 130 мг. При использовании той же модели антигистаминного действия было установлено, что для постоянного в течение 24 часов действия была необходима доза не менее 130 мг. Максимальное подавление образования волдырей и гиперемии кожи составляет более 80%. У пациентов с сезонным аллергическим ринитом, получавших до 240 мг фексофенадина 2 раза/сут в течение 2 недель продолжительность интервала QTc (QT скорригированного) не отличалась от таковой при приеме плацебо. Также не наблюдалось изменений QTc при приеме фексофенадина здоровыми добровольцами по 60 мг 2 раза/сут в течение 6 месяцев, по 400 мг 2 раза/сут в течение 6.5 дней и 240 мг/сут в течение 1 года по сравнению с продолжительностью QTc при приеме плацебо. Даже при плазменной концентрации в 32 раза превышающей терапевтические концентрации у человека фексофенадин не оказывал влияния на калиевые каналы задержанного выпрямления в человеческом сердце."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Сезонный аллергический ринит (для уменьшения симптомов) - таблетки 120 мг","Хроническая идиопатическая крапивница (для уменьшения симптомов) - таблетки 180 мг"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Повышенная чувствительность к любому из компонентов препарата","Беременность","Период лактации","Детский возраст до 12 лет. С осторожностью:","У больных с хронической почечной и печеночной недостаточностью, а также у пациентов пожилого возраста (недостаточность клинического опыта применения у этой категории пациентов)","У пациентов с сердечно-сосудистыми заболеваниями, в т.ч. в анамнезе (антигистаминные препараты могут вызывать сердцебиение и тахикардию)"]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Нет достаточного количества данных о применении фексофенадина беременными женщинами. Ограниченные исследования на животных показали отсутствие признаков наличия неблагоприятного влияния на течение беременности, внутриутробное развитие, роды и постнатальное развитие. Фексофенадин не должен использоваться при беременности. Данные по содержанию фексофенадина в грудном молоке при его приеме женщинами в период грудного вскармливания отсутствуют. Однако показано, что терфенадин выделяется с грудным молоком у женщин. Поэтому применение фексофенадина в период грудного вскармливания не рекомендуется."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат предназначен для приема внутрь. Рекомендуемая доза фексофенадина при сезонном аллергическом рините для взрослых и детей 12 лет и старше составляет 120 мг 1 раз/сут перед едой. Рекомендуемая доза фексофенадина при хронической крапивнице для взрослых и детей 12 лет и старше составляет 180 мг 1 раз/сут перед едой. Исследования в специальных группах риска (пациенты пожилого возраста, пациенты с почечной и печеночной недостаточностью) показали, что у них не требуется коррекции режима дозирования."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В плацебо-контролируемых клинических исследованиях наиболее часто (≥1% - меньше10%) наблюдались: головная боль (7.3%), сонливость (2.3%), головокружение (1.5%) и тошнота (1.5 %). При приеме фексофенадина частота вышеуказанных неблагоприятных эффектов была подобной таковой при приеме плацебо. В плацебо-контролируемых исследованиях с частотой менее 1% (одинаково при приеме фексофенадина и плацебо) и при постмаркетинговом применении наблюдались: слабость, бессонница, нервозность и нарушения сна или необычные сновидения (паронирия), такие как кошмары; тахикардия, сердцебиение; диарея. В редких случаях (≥0.01% - меньше0.1%): экзантема, крапивница, зуд и другие реакции гиперчувствительности, такие как отек Квинке, затруднение дыхания, одышка, гиперемия кожных покровов, системные анафилактические реакции."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: головокружение, сонливость и сухость во рту. Здоровые добровольцы принимали однократные дозы до 800 мг и курсовые дозы до 690 мг 2 раза/сут в течение 1 месяца или 240 мг 2 раза/сут в течение 1 года без каких-либо существенных нежелательных эффектов по сравнению с плацебо. Максимальная переносимая доза для фексофенадина не установлена. Лечение: в случае передозировки рекомендуется проведение промывания желудка, прием активированного угля, при необходимости симптоматическая и поддерживающая терапия. 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Исследования на животных показали, что вышеупомянутое повышение плазменных концентраций фексофенадина вероятно связано с улучшением абсорбции фексофенадина и снижением его билиарной экскреции или секреции в просвет ЖКТ."}},{"type":"paragraph","data":{"text":"Взаимодействия между фексофенадином и омепразолом не наблюдается."}},{"type":"paragraph","data":{"text":"Не взаимодействует с лекарственными средствами, метаболизирующимися в печени."}},{"type":"paragraph","data":{"text":"Прием содержащих алюминий или магний антацидов за 15 мин до приема фексофенадина приводит к снижению биодоступности последнего в результате, по-видимому, связывания в ЖКТ."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Рекомендуется, чтобы промежуток времени между приемом фексофенадина и антацидов, содержащих гидроокись алюминия или магния, составлял как минимум 2 ч. Использование в педиатрииДля применения у детей от 6 до 11 лет выпускаются таблетки 30 мг. Влияние на способность к вождению автотранспорта и управлению механизмамиПри приеме препарата возможно выполнение работ, требующих высокой концентрации внимания и быстроты психомоторных реакций (за исключением больных, обладающих нестандартной реакцией). Поэтому рекомендуется до занятия такими видами деятельности проверить индивидуальную реакцию на прием фексофенадина."}}]},{"id":17,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Препарат следует хранить в недоступном для детей месте при температуре не выше 25°С."}}]},{"id":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Препарат отпускается без рецепта."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Блокатор гистаминовых Н1-рецепторов. 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