Таблетки покрытые пленочной оболочкой 40 мг: круглые, двояковыпуклые таблетки, покрытые пленочной оболочкой, бледно-коричневого со слегка розоватым оттенком цвета, на изломе белого цвета.
Фармакотерапевтическая группа
H2-гистаминовых рецепторов блокатор
Фармакологические свойства
Фамотидин оказывает противоязвенное действие. Блокатор Н2-гистаминовых рецепторов III поколения. Подавляет базальную и стимулированную гистамином, гастрином и ацетилхолином продукцию соляной кислоты.
Уменьшает активность пепсина. Усиливает защитные механизмы слизистой оболочки желудка, способствует заживлению связанных с воздействием соляной кислоты ее повреждений (в т. ч. рубцеванию стрессовых язв) и прекращению желудочно-кишечных кровотечений путем увеличения образования желудочной слизи, содержания в ней гликопротеидов, стимуляции секреции гидрокарбоната слизистой оболочкой желудка, эндогенного синтеза в ней простагландинов и скорости регенерации. Существенно не изменяет уровень гастрина в плазме. Слабо ингибирует оксидазную систему цитохрома Р450 в печени.
После приема внутрь действие начинается через 1 час, достигает максимума в течение 3 часов. Продолжительность действия препарата при однократном приеме зависит от дозы и составляет от 12 до 24 часов.
Фармакокинетика
После приема внутрь быстро абсорбируется из желудочно-кишечного тракта, максимальная концентрация в плазме крови достигается в течение 1-3,5 часов. Биодоступность – 40-45%, увеличивается при приеме с пищей и снижается на фоне приема антацидов. Связь с белками плазмы – 15-20%.
30-35% фамотидина метаболизируется в печени (с образованием S-оксида). Проникает в спинномозговую жидкость, через плацентарный барьер, выделяется с грудным молоком.
Элиминация, в основном, происходит через почки: 27-40% препарата выводится с мочой в неизмененном виде.
Период полувыведения – 2,5-4 часа, у пациентов с клиренсом креатинина ниже 30 мл в минуту увеличивается до 10-12 часов. У пациентов с тяжелой почечной недостаточностью (клиренс креатинина ниже 10 мл/мин) период полувыведения возрастает до 20 часов.
Показания к применению
Язвенная болезнь желудка и двенадцатиперстной кишки (в т.ч. профилактика обострений);
симптоматические язвы, эрозивный и рефлюкс-эзофагит;
синдром Золлингера-Эллисона.
Противопоказания
Беременность, период лактации, повышенная чувствительность к фамотидину.
С осторожностью
С осторожностью: печеночная и/или почечная недостаточность, цирроз печени с портосистемной энцефалопатией (в анамнезе), иммунодефицит, детский возраст.
Применение при беременности и в период грудного вскармливания
Противопоказан к применению при беременности и в период лактации.
Фамотидин выделяется с грудным молоком.
Способ применения и дозы
Внутрь, проглатывая целиком (не разжевывая), запивая достаточным количеством воды. При язвенной болезни желудка и двенадцатиперстной кишки в фазе обострения, симптоматических язвах, эрозивном гастродуодените — обычно по 20 мг 2 раза в сутки или по 40 мг 1 раз в сутки на ночь. При необходимости суточная доза может быть увеличена до 80–160 мг. Курс лечения — 4–8 недель.
При диспепсии, связанной с повышенной секреторной функцией желудка, — по 20 мг 1–2 раза в сутки.
С целью профилактики рецидивов язвенной болезни — по 20 мг 1 раз в сутки перед сном.
При рефлюкс-эзофагите — по 20–40 мг 2 раза в сутки в течение 6–12 недель.
При синдроме Золлингера-Эллисона дозу препарата и продолжительность курса лечения устанавливают индивидуально. Начальная доза — обычно 20 мг каждые 6 ч и возможно ее увеличение до 160 мг каждые 6 ч.
Для профилактики аспирации желудочного сока при общей анестезии — по 40 мг вечером и/или утром перед операцией.
При почечной недостаточности (при Cl креатинина <30 мл/мин или содержании креатинина в сыворотке крови >3 мг/100 мл) суточную дозу препарата необходимо уменьшить до 20 мг.
Побочное действие
Редко — головная боль, головокружение, усталость, сухость во рту, отсутствие аппетита, диарея или запор, кожная сыпь.
Передозировка
Симптомы: рвота, двигательное возбуждение, тремор, снижение АД, тахикардия, коллапс.
Лечение: при пероральном приеме показана индукция рвоты или/и промывание желудка. Симптоматическая и поддерживающая терапия: при судорогах - в/в диазепам; при брадикардии - атропин; при желудочковых аритмиях - лидокаин. Гемодиализ эффективен.
Взаимодействие с другими лекарственными средствами
Антациды нарушают абсорбцию (рекомендуется перерыв между приемом антацидов и фамотидина не менее 1–2 ч).
Особые указания
С осторожностью применяют у пациентов с нарушениями функции почек и печени.
Перед началом лечения необходимо исключить возможность наличия злокачественного заболевания пищевода, желудка или двенадцатиперстной кишки.
Не изменяет активность микросомальных ферментов печени.
Следует соблюдать интервал между приемом антацидов и фамотидина не менее 1-2 ч.
Клинический опыт применения фамотидина у детей ограничен.
Применение при нарушениях функции почек
С осторожностью применяют у пациентов с нарушениями функции почек.
Применение при нарушениях функции печени
С осторожностью применяют у пациентов с нарушениями функции печени.
Применение у детей
Клинический опыт применения фамотидина у детей ограничен.
Форма выпуска
Таблетки, покрытые пленочной оболочкой бледно-коричневого цвета, круглые, двояковыпуклые.
Открытое акционерное общество "Акционерное Курганское общество медицинских препаратов и изделий "Синтез" (ОАО "Синтез"), 640008, Курганская обл., г. Курган, проспект Конституции, д. 7, Россия
Организация, принимающая претензии потребителей
ОАО "Синтез"
23 сентября 2015 г.
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Блокатор Н2-гистаминовых рецепторов III поколения. Подавляет базальную и стимулированную гистамином, гастрином и ацетилхолином продукцию соляной кислоты."}},{"type":"paragraph","data":{"text":"Уменьшает активность пепсина. Усиливает защитные механизмы слизистой оболочки желудка, способствует заживлению связанных с воздействием соляной кислоты ее повреждений (в т. ч. рубцеванию стрессовых язв) и прекращению желудочно-кишечных кровотечений путем увеличения образования желудочной слизи, содержания в ней гликопротеидов, стимуляции секреции гидрокарбоната слизистой оболочкой желудка, эндогенного синтеза в ней простагландинов и скорости регенерации. Существенно не изменяет уровень гастрина в плазме. Слабо ингибирует оксидазную систему цитохрома Р450 в печени."}},{"type":"paragraph","data":{"text":"После приема внутрь действие начинается через 1 час, достигает максимума в течение 3 часов. Продолжительность действия препарата при однократном приеме зависит от дозы и составляет от 12 до 24 часов."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"После приема внутрь быстро абсорбируется из желудочно-кишечного тракта, максимальная концентрация в плазме крови достигается в течение 1-3,5 часов. Биодоступность – 40-45%, увеличивается при приеме с пищей и снижается на фоне приема антацидов. Связь с белками плазмы – 15-20%."}},{"type":"paragraph","data":{"text":"30-35% фамотидина метаболизируется в печени (с образованием S-оксида). Проникает в спинномозговую жидкость, через плацентарный барьер, выделяется с грудным молоком."}},{"type":"paragraph","data":{"text":"Элиминация, в основном, происходит через почки: 27-40% препарата выводится с мочой в неизмененном виде."}},{"type":"paragraph","data":{"text":"Период полувыведения – 2,5-4 часа, у пациентов с клиренсом креатинина ниже 30 мл в минуту увеличивается до 10-12 часов. У пациентов с тяжелой почечной недостаточностью (клиренс креатинина ниже 10 мл/мин) период полувыведения возрастает до 20 часов."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["Язвенная болезнь желудка и двенадцатиперстной кишки (в т.ч. профилактика обострений); ","симптоматические язвы, эрозивный и рефлюкс-эзофагит; ","синдром Золлингера-Эллисона."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Беременность, период лактации, повышенная чувствительность к фамотидину."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"С осторожностью: печеночная и/или почечная недостаточность, цирроз печени с портосистемной энцефалопатией (в анамнезе), иммунодефицит, детский возраст."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказан к применению при беременности и в период лактации."}},{"type":"paragraph","data":{"text":"Фамотидин выделяется с грудным молоком."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь, проглатывая целиком (не разжевывая), запивая достаточным количеством воды. При язвенной болезни желудка и двенадцатиперстной кишки в фазе обострения, симптоматических язвах, эрозивном гастродуодените — обычно по 20 мг 2 раза в сутки или по 40 мг 1 раз в сутки на ночь. При необходимости суточная доза может быть увеличена до 80–160 мг. Курс лечения — 4–8 недель."}},{"type":"paragraph","data":{"text":"При диспепсии, связанной с повышенной секреторной функцией желудка, — по 20 мг 1–2 раза в сутки."}},{"type":"paragraph","data":{"text":"С целью профилактики рецидивов язвенной болезни — по 20 мг 1 раз в сутки перед сном."}},{"type":"paragraph","data":{"text":"При рефлюкс-эзофагите — по 20–40 мг 2 раза в сутки в течение 6–12 недель."}},{"type":"paragraph","data":{"text":"При синдроме Золлингера-Эллисона дозу препарата и продолжительность курса лечения устанавливают индивидуально. Начальная доза — обычно 20 мг каждые 6 ч и возможно ее увеличение до 160 мг каждые 6 ч."}},{"type":"paragraph","data":{"text":"Для профилактики аспирации желудочного сока при общей анестезии — по 40 мг вечером и/или утром перед операцией."}},{"type":"paragraph","data":{"text":"При почечной недостаточности (при Cl креатинина <30 мл/мин или содержании креатинина в сыворотке крови >3 мг/100 мл) суточную дозу препарата необходимо уменьшить до 20 мг."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Редко — головная боль, головокружение, усталость, сухость во рту, отсутствие аппетита, диарея или запор, кожная сыпь."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\n\nСимптомы: рвота, двигательное возбуждение, тремор, снижение АД, тахикардия, коллапс."}},{"type":"paragraph","data":{"text":"Лечение: при пероральном приеме показана индукция рвоты или/и промывание желудка. Симптоматическая и поддерживающая терапия: при судорогах - в/в диазепам; при брадикардии - атропин; при желудочковых аритмиях - лидокаин. Гемодиализ эффективен.\n\n"}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Антациды нарушают абсорбцию (рекомендуется перерыв между приемом антацидов и фамотидина не менее 1–2 ч)."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"С осторожностью применяют у пациентов с нарушениями функции почек и печени."}},{"type":"paragraph","data":{"text":"Перед началом лечения необходимо исключить возможность наличия злокачественного заболевания пищевода, желудка или двенадцатиперстной кишки."}},{"type":"paragraph","data":{"text":"Не изменяет активность микросомальных ферментов печени."}},{"type":"paragraph","data":{"text":"Следует соблюдать интервал между приемом антацидов и фамотидина не менее 1-2 ч."}},{"type":"paragraph","data":{"text":"Клинический опыт применения фамотидина у детей ограничен."}},{"type":"header","data":{"text":"Применение при нарушениях функции почек","level":4}},{"type":"paragraph","data":{"text":"С осторожностью применяют у пациентов с нарушениями функции почек."}},{"type":"header","data":{"text":"Применение при нарушениях функции печени","level":4}},{"type":"paragraph","data":{"text":"С осторожностью применяют у пациентов с нарушениями функции печени."}},{"type":"header","data":{"text":"Применение у детей","level":4}},{"type":"paragraph","data":{"text":"Клинический опыт применения фамотидина у детей ограничен."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nТаблетки, покрытые пленочной оболочкой бледно-коричневого цвета, круглые, двояковыпуклые."}},{"type":"paragraph","data":{"text":"1 таб. Активное вещество: фамотидин 20 мг;"}},{"type":"paragraph","data":{"text":"Вспомогательные вещества: крахмал кукурузный, целлюлоза микрокристаллическая, кремния диоксид, тальк, магния стеарат, натрия кроскармеллоза."}},{"type":"paragraph","data":{"text":"Состав оболочки: гипромеллоза, макрогол 6000, титана диоксид (Е171), тальк, краситель железа оксид коричневый."}},{"type":"paragraph","data":{"text":"10 шт. - блистеры (2) - пачки картонные."}},{"type":"paragraph","data":{"text":"10 шт. - блистеры (3) - пачки картонные.\n\n"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре от 15 до 25° С."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Открытое акционерное общество \"Акционерное Курганское общество медицинских препаратов и изделий \"Синтез\" (ОАО \"Синтез\"), 640008, Курганская обл., г. 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