Противовирусный препарат. После приема внутрь фамцикловир быстро превращается в пенцикловир, обладающий активностью в отношении вирусов герпеса человека, включая вирус Varicella zoster (вирус опоясывающего герпеса) и Herpes simplex типов 1 и 2 (лабиальный и генитальный вирус простого герпеса), а также вируса Эпштейна-Барр и цитомегаловируса. Пенцикловир попадает в инфицированные вирусом клетки, где под действием вирусной тимидинкиназы быстро превращается в монофосфат, который, в свою очередь, при участии клеточных ферментов переходит в трифосфат. Пенцикловира трифосфат находится в инфицированных вирусами клетках более 12 ч, подавляя в них репликацию вирусной ДНК. Концентрация пенцикловира трифосфата в неинфицированных клетках не превышает минимальную определяемую, поэтому в терапевтических концентрациях пенцикловир не оказывает влияния на неинфицированные клетки. Пенцикловир активен в отношении недавно обнаруженных устойчивых к ацикловиру штаммов вируса Herpes simplex с измененной ДНК-полимеразой. Частота возникновения резистентности к фамцикловиру (пенцикловиру) не превышает 0.3%, у пациентов с нарушенным иммунитетом — 0.19%. Резистентность выявлялась в начале лечения и не развивалась в процессе лечения или после окончания терапии. Было показано, что фамцикловир существенно снижает выраженность и длительность постгерпетической невралгии у пациентов с опоясывающим герпесом. Было показано, что у пациентов с нарушенным иммунитетом вследствие ВИЧ-инфицирования фамцикловир в дозе 500 мг 2 раза/сут уменьшает число дней выделения вируса простого герпеса (как с клиническими проявлениями, так и без них).
Показания к применению
Инфекции, вызванные вирусом Varicella zoster (опоясывающий герпес), включая офтальмогерпес и постгерпетическую невралгию;
Инфекции, вызванные вирусом Herpes simplex (тип 1 и 2): первичная инфекция, обострение хронической инфекции, супрессия рецидивирующей инфекции (для профилактики обострений)
Инфекции, вызванные вирусами Varicella zoster и Herpes simplex (тип 1 и 2) у пациентов со сниженным иммунитетом
Противопоказания
Повышенная чувствительность к фамцикловиру или любому из компонентов препарата; — повышенная чувствительность к пенцикловиру
Применение при беременности и в период грудного вскармливания
Поскольку безопасность Фамвира у беременных и кормящих женщин не изучалась, его применение при беременности и в период лактации не рекомендуется, если только возможные преимущества лечения не превышают потенциальный риск
Способ применения и дозы
Препарат принимают внутрь, независимо от приема пищи, не разжевывая, запивая водой. Инфекции, вызванные вирусом Varicella zoster, у пациентов с нормальным иммунитетомРекомендуемая доза составляет 250 мг 3 раза/сут, или 500 мг 2 раза/сут, или 750 мг 1 раз/сут, в течение 7 дней (острая фаза заболевания). При офтальмогерпесе рекомендуемая доза составляет 500 мг 3 раза/сут в течение 7 дней. Для снижения длительности и частоты развития постгерпетической невралгии рекомендуемая доза составляет 250-500 мг 3 раза/сут в течение 7 дней. Инфекции, вызванные вирусом Varicella zoster, у пациентов со сниженным иммунитетомРекомендуемая доза составляет 500 мг 3 раза/сут в течение 10 дней. Инфекции, вызванные вирусом Herpes simplex типа 1 и 2, у пациентов с нормальным иммунитетомПри первичной инфекции рекомендуемая доза составляет 250 мг 3 раза/сут в течение 5 дней. Лечение следует начинать как можно раньше, сразу после появления первых симптомов заболевания. При рецидивах хронической инфекции взрослым назначают по 125 мг 2 раза/сут в течение 5 дней. Лечение следует начинать уже в продромальном периоде или сразу после появления симптомов заболевания. Инфекции, вызванные вирусом Herpes simplex типа 1 и 2, у пациентов со сниженным иммунитетомРекомендуемая доза составляет 500 мг 2 раза/сут в течение 7 дней. Лечение следует начинать как можно раньше, сразу после появления первых симптомов заболевания. В качестве супрессивной терапии рецидивирующей герпетической инфекции назначают 250 мг 2 раза/сут. Длительность терапии зависит от тяжести заболевания. Рекомендуется периодическое прекращение приема препарата раз в 12 мес для оценки возможных изменений течения заболевания. У ВИЧ-инфицированных пациентов эффективная доза составляет 500 мг 2 раза/сут. Больные пожилого возраста. При условии сохранной функции почек режим дозирования фамцикловира не меняется. Больные с нарушением функции почек. У пациентов с нарушением функции почек отмечается уменьшение клиренса пенцикловира. Больные с почечной недостаточностью, находящиеся на гемодиализе. Поскольку после 4 ч гемодиализа концентрация пенцикловира в плазме снижается приблизительно на 75%, препарат следует принимать сразу после процедуры гемодиализа. Рекомендуемая доза составляет 250 мг (для больных с опоясывающим герпесом) и 125 мг (для больных с генитальным герпесом). Больным с нарушениями функции печени коррекции дозы не требуется.
Побочное действие
В клинических исследованиях показана хорошая переносимость Фамвира, в т.ч. у пациентов со сниженным иммунитетом. Сообщалось о случаях головной боли и тошноты, однако эти явления были слабо или умеренно выражены и отмечались с такой же частотой у пациентов, получавших плацебо. Ниже приведены нежелательные реакции и частота их возникновения на основе данных о спонтанных сообщениях, а также случаев, описанных в литературе, за весь период, в течение которого Фамвир применяется в клинической практике. Нежелательные явления, о которых сообщалось в ходе клинических исследований у больных со сниженным иммунитетом, совпадали с теми, которые отмечались у пациентов с нормальным иммунитетом. Для оценки частоты развития нежелательных реакций использованы следующие критерии: очень часто (больше 1/10); часто (от больше 1/100, меньше 1/10); иногда (больше 1/1000, меньше 1/100); редко (больше 1/10000, меньше 1/1000); очень редко (меньше 1/10000), включая отдельные сообщения. Со стороны системы кроветворения: очень редко - тромбоцитопения. Со стороны ЦНС: редко - головная боль, спутанность сознания (преимущественно у пожилых пациентов); очень редко - головокружение, сонливость (преимущественно у пожилых пациентов), галлюцинации. Со стороны пищеварительной системы: редко - тошнота; очень редко - рвота, желтуха. Дерматологические реакции: очень редко - сыпь, зуд, тяжелые кожные реакции. Аллергические реакции: очень редко - крапивница, тяжелые кожные реакции (в т.ч. многоформная эритема).
Передозировка
Описанные случаи передозировки (10.5 г) препарата Фамвир не сопровождались клиническими проявлениями. Лечение: проведение симптоматической и поддерживающей терапии. При несоблюдении рекомендаций по уменьшению дозы фамцикловира с учетом функции почек у больных с заболеваниями почек отмечены случаи острой почечной недостаточности. Пенцикловир выводится при гемодиализе. Концентрации пенцикловира в плазме снижаются на 75% после проведения гемодиализа в течение 4 ч.
Особые указания
Лечение следует начинать сразу после установления диагноза. Следует соблюдать осторожность при лечении больных с нарушением функции почек, для которых может потребоваться коррекция режима дозирования. Специальных предосторожностей у пожилых пациентов не требуется. Генитальный герпес – заболевание, передающееся половым путем. Во время рецидивов риск заражения увеличивается. При наличии клинических проявлений заболевания, даже в случае начала противовирусного лечения, пациенты должны избегать половых контактов. Во время поддерживающего лечения противовирусными средствами частота распространения вирусной инфекции значительно уменьшается, однако риск передачи инфекции теоретически существует. Поэтому пациентам следует предпринимать соответствующие защитные меры при половых контактах. В состав таблеток препарата 125 мг, 250 мг и 500 мг входит лактоза (26.9 мг, 53.7 мг и 107.4 мг соответственно). Фамвир не следует применять у пациентов с редкими наследственными нарушениями, связанными, с непереносимостью галактозы, тяжелой лактазной недостаточностью или глюкозо-галактозной мальабсорбцией. Переносимые дозы Фамвира и длительность лечения. Фамвир хорошо переносился при лечении инфекции, вызванной вирусом Varicella zoster, при его применении в дозе 750 мг 3 раза/сут в течение 7 дней; у пациентов с генитальным герпесом при применении препарата в дозе до 750 мг 3 раза/сут в течение 5 дней и в дозе до 500 мг 3 раза/сут в течение 10 дней. Было также показано, что препарат хорошо переносился при приеме 250 мг 3 раза/сут в течение 12 мес для лечения генитального герпеса. Фамвир хорошо переносился у пациентов со сниженным иммунитетом при лечении инфекции, вызванной вирусом Varicella zoster, при приеме 500 мг 3 раза/сут в течение 10 дней, а также инфекций, вызванных вирусами Herpes simplex, при приеме до 500 мг 2 раза/сут в течение 7 дней или 500 мг 2 раза/сут в течение 8 недель. Использование в педиатрииЭффективность и безопасность применения Фамвира у детей не установлена. Таким образом, не рекомендуется применять фамцикловир у детей, за исключением случаев, когда ожидаемая польза лечения оправдывает потенциальный риск, связанный с применением препарата. Влияние на способность к вождению автотранспорта и управлению механизмамиНе ожидается влияния Фамвира на способность пациентов управлять автомобилем и другими механизмами, однако пациентам, у которых на фоне применения препарата Фамвир возникает головокружение, сонливость, спутанность сознания или другие нарушения со стороны ЦНС, следует воздержаться от вождения автомашины или управления механизмами в период применения препарата
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таб. содержит фамцикловир 125 мг. Вспомогательные вещества: натрия крахмала гликолат - 8.26 мг, гидроксипропилцеллюлоза - 3.86 мг, магния стеарат - 1.24 мг, лактоза безводная - 26.85 мг. Состав оболочки (опадрай OY-S-28924): гипромеллоза - 2.42 мг, титана диоксид - 0.99 мг, полиэтиленгликоль 4000 - 0.36 мг, полиэтиленгликоль 6000 - 0.36 мг."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противовирусный препарат. После приема внутрь фамцикловир быстро превращается в пенцикловир, обладающий активностью в отношении вирусов герпеса человека, включая вирус Varicella zoster (вирус опоясывающего герпеса) и Herpes simplex типов 1 и 2 (лабиальный и генитальный вирус простого герпеса), а также вируса Эпштейна-Барр и цитомегаловируса. Пенцикловир попадает в инфицированные вирусом клетки, где под действием вирусной тимидинкиназы быстро превращается в монофосфат, который, в свою очередь, при участии клеточных ферментов переходит в трифосфат. Пенцикловира трифосфат находится в инфицированных вирусами клетках более 12 ч, подавляя в них репликацию вирусной ДНК. Концентрация пенцикловира трифосфата в неинфицированных клетках не превышает минимальную определяемую, поэтому в терапевтических концентрациях пенцикловир не оказывает влияния на неинфицированные клетки. Пенцикловир активен в отношении недавно обнаруженных устойчивых к ацикловиру штаммов вируса Herpes simplex с измененной ДНК-полимеразой. Частота возникновения резистентности к фамцикловиру (пенцикловиру) не превышает 0.3%, у пациентов с нарушенным иммунитетом — 0.19%. Резистентность выявлялась в начале лечения и не развивалась в процессе лечения или после окончания терапии. Было показано, что фамцикловир существенно снижает выраженность и длительность постгерпетической невралгии у пациентов с опоясывающим герпесом. Было показано, что у пациентов с нарушенным иммунитетом вследствие ВИЧ-инфицирования фамцикловир в дозе 500 мг 2 раза/сут уменьшает число дней выделения вируса простого герпеса (как с клиническими проявлениями, так и без них)."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Инфекции, вызванные вирусом Varicella zoster (опоясывающий герпес), включая офтальмогерпес и постгерпетическую невралгию;"}},{"type":"list","data":{"style":"unordered","items":["Инфекции, вызванные вирусом Herpes simplex (тип 1 и 2): первичная инфекция, обострение хронической инфекции, супрессия рецидивирующей инфекции (для профилактики обострений)","Инфекции, вызванные вирусами Varicella zoster и Herpes simplex (тип 1 и 2) у пациентов со сниженным иммунитетом"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к фамцикловиру или любому из компонентов препарата; — повышенная чувствительность к пенцикловиру"}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Поскольку безопасность Фамвира у беременных и кормящих женщин не изучалась, его применение при беременности и в период лактации не рекомендуется, если только возможные преимущества лечения не превышают потенциальный риск"}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат принимают внутрь, независимо от приема пищи, не разжевывая, запивая водой. Инфекции, вызванные вирусом Varicella zoster, у пациентов с нормальным иммунитетомРекомендуемая доза составляет 250 мг 3 раза/сут, или 500 мг 2 раза/сут, или 750 мг 1 раз/сут, в течение 7 дней (острая фаза заболевания). При офтальмогерпесе рекомендуемая доза составляет 500 мг 3 раза/сут в течение 7 дней. Для снижения длительности и частоты развития постгерпетической невралгии рекомендуемая доза составляет 250-500 мг 3 раза/сут в течение 7 дней. Инфекции, вызванные вирусом Varicella zoster, у пациентов со сниженным иммунитетомРекомендуемая доза составляет 500 мг 3 раза/сут в течение 10 дней. Инфекции, вызванные вирусом Herpes simplex типа 1 и 2, у пациентов с нормальным иммунитетомПри первичной инфекции рекомендуемая доза составляет 250 мг 3 раза/сут в течение 5 дней. Лечение следует начинать как можно раньше, сразу после появления первых симптомов заболевания. При рецидивах хронической инфекции взрослым назначают по 125 мг 2 раза/сут в течение 5 дней. Лечение следует начинать уже в продромальном периоде или сразу после появления симптомов заболевания. Инфекции, вызванные вирусом Herpes simplex типа 1 и 2, у пациентов со сниженным иммунитетомРекомендуемая доза составляет 500 мг 2 раза/сут в течение 7 дней. Лечение следует начинать как можно раньше, сразу после появления первых симптомов заболевания. В качестве супрессивной терапии рецидивирующей герпетической инфекции назначают 250 мг 2 раза/сут. Длительность терапии зависит от тяжести заболевания. Рекомендуется периодическое прекращение приема препарата раз в 12 мес для оценки возможных изменений течения заболевания. У ВИЧ-инфицированных пациентов эффективная доза составляет 500 мг 2 раза/сут. Больные пожилого возраста. При условии сохранной функции почек режим дозирования фамцикловира не меняется. Больные с нарушением функции почек. У пациентов с нарушением функции почек отмечается уменьшение клиренса пенцикловира. Больные с почечной недостаточностью, находящиеся на гемодиализе. Поскольку после 4 ч гемодиализа концентрация пенцикловира в плазме снижается приблизительно на 75%, препарат следует принимать сразу после процедуры гемодиализа. Рекомендуемая доза составляет 250 мг (для больных с опоясывающим герпесом) и 125 мг (для больных с генитальным герпесом). Больным с нарушениями функции печени коррекции дозы не требуется."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В клинических исследованиях показана хорошая переносимость Фамвира, в т.ч. у пациентов со сниженным иммунитетом. Сообщалось о случаях головной боли и тошноты, однако эти явления были слабо или умеренно выражены и отмечались с такой же частотой у пациентов, получавших плацебо. Ниже приведены нежелательные реакции и частота их возникновения на основе данных о спонтанных сообщениях, а также случаев, описанных в литературе, за весь период, в течение которого Фамвир применяется в клинической практике. Нежелательные явления, о которых сообщалось в ходе клинических исследований у больных со сниженным иммунитетом, совпадали с теми, которые отмечались у пациентов с нормальным иммунитетом. Для оценки частоты развития нежелательных реакций использованы следующие критерии: очень часто (больше 1/10); часто (от больше 1/100, меньше 1/10); иногда (больше 1/1000, меньше 1/100); редко (больше 1/10000, меньше 1/1000); очень редко (меньше 1/10000), включая отдельные сообщения. Со стороны системы кроветворения: очень редко - тромбоцитопения. Со стороны ЦНС: редко - головная боль, спутанность сознания (преимущественно у пожилых пациентов); очень редко - головокружение, сонливость (преимущественно у пожилых пациентов), галлюцинации. Со стороны пищеварительной системы: редко - тошнота; очень редко - рвота, желтуха. Дерматологические реакции: очень редко - сыпь, зуд, тяжелые кожные реакции. Аллергические реакции: очень редко - крапивница, тяжелые кожные реакции (в т.ч. многоформная эритема)."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Описанные случаи передозировки (10.5 г) препарата Фамвир не сопровождались клиническими проявлениями. Лечение: проведение симптоматической и поддерживающей терапии. При несоблюдении рекомендаций по уменьшению дозы фамцикловира с учетом функции почек у больных с заболеваниями почек отмечены случаи острой почечной недостаточности. Пенцикловир выводится при гемодиализе. Концентрации пенцикловира в плазме снижаются на 75% после проведения гемодиализа в течение 4 ч."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение следует начинать сразу после установления диагноза. Следует соблюдать осторожность при лечении больных с нарушением функции почек, для которых может потребоваться коррекция режима дозирования. Специальных предосторожностей у пожилых пациентов не требуется. Генитальный герпес – заболевание, передающееся половым путем. Во время рецидивов риск заражения увеличивается. При наличии клинических проявлений заболевания, даже в случае начала противовирусного лечения, пациенты должны избегать половых контактов. Во время поддерживающего лечения противовирусными средствами частота распространения вирусной инфекции значительно уменьшается, однако риск передачи инфекции теоретически существует. Поэтому пациентам следует предпринимать соответствующие защитные меры при половых контактах. В состав таблеток препарата 125 мг, 250 мг и 500 мг входит лактоза (26.9 мг, 53.7 мг и 107.4 мг соответственно). Фамвир не следует применять у пациентов с редкими наследственными нарушениями, связанными, с непереносимостью галактозы, тяжелой лактазной недостаточностью или глюкозо-галактозной мальабсорбцией. Переносимые дозы Фамвира и длительность лечения. Фамвир хорошо переносился при лечении инфекции, вызванной вирусом Varicella zoster, при его применении в дозе 750 мг 3 раза/сут в течение 7 дней; у пациентов с генитальным герпесом при применении препарата в дозе до 750 мг 3 раза/сут в течение 5 дней и в дозе до 500 мг 3 раза/сут в течение 10 дней. Было также показано, что препарат хорошо переносился при приеме 250 мг 3 раза/сут в течение 12 мес для лечения генитального герпеса. Фамвир хорошо переносился у пациентов со сниженным иммунитетом при лечении инфекции, вызванной вирусом Varicella zoster, при приеме 500 мг 3 раза/сут в течение 10 дней, а также инфекций, вызванных вирусами Herpes simplex, при приеме до 500 мг 2 раза/сут в течение 7 дней или 500 мг 2 раза/сут в течение 8 недель. Использование в педиатрииЭффективность и безопасность применения Фамвира у детей не установлена. Таким образом, не рекомендуется применять фамцикловир у детей, за исключением случаев, когда ожидаемая польза лечения оправдывает потенциальный риск, связанный с применением препарата. Влияние на способность к вождению автотранспорта и управлению механизмамиНе ожидается влияния Фамвира на способность пациентов управлять автомобилем и другими механизмами, однако пациентам, у которых на фоне применения препарата Фамвир возникает головокружение, сонливость, спутанность сознания или другие нарушения со стороны ЦНС, следует воздержаться от вождения автомашины или управления механизмами в период применения препарата"}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Противовирусный препарат. 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