Беременность период лактации печеночная недостаточность детский возраст повышенная чувствительность к компонентам препарата. Непереносимость лактозы дефицит лактазы или глюкозо-галактазная мальабсорбция.
Таблетки круглые, двояковыпуклой формы, покрытые пленочной оболочкой желтого цвета (для дозировки 20 мг) или белого цвета (для дозировки 40 мг). На поперечном срезе видны два слоя - ядро и пленочная оболочка.
Фармакотерапевтическая группа
желез желудка секрецию понижающее средство - H2-гистаминовых рецепторов блокатор
Фармакологические свойства
Фармакодинамика:
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 и способствует заживлению связанных с воздействием соляной кислоты ее повреждений (в т. ч. прекращению желудочно-кишечных кровотечений и рубцеванию стрессовых язв) 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 концентрацию 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 ЖКТ. После приема внутрь время достижения максимальной концентрации в плазме крови (ТСmах) 1-35 ч.
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). Элиминация в основном происходит через почки: 27-40% препарата выводится с мочой в неизмененном виде.
Период полувыведения - 25-4 часа у пациентов с клиренсом креатинина ниже 30 мл/мин увеличивается до 10-12 часов. У пациентов с тяжелой почечной недостаточностью (клиренс креатинина ниже 10 мл/мин) он возрастает до 20 часов. Проникает через плацентарный барьер и выделяется с грудным молоком.
Показания к применению
Язвенная болезнь 12-перстной кишки и желудка в фазе обострения профилактика рецидивов.
Лечение и профилактика симптоматических язв желудка и 12-перстной кишки (связанных с приемом нестероидных противовоспалительных препаратов стрессовых послеоперационных язв).
Эрозивный гастродуоденит.
Функциональная диспепсия ассоциированная с повышенной секреторной функцией желудка.
Рефлюкс-эзофагит.
Синдром Золлингера-Эллисона.
Профилактика рецидивов кровотечений из верхних отделов ЖКТ.
Предупреждение аспирации желудочного сока при общей анестезии (синдром Мендельсона).
Противопоказания
Беременность период лактации печеночная недостаточность детский возраст повышенная чувствительность к компонентам препарата. Непереносимость лактозы дефицит лактазы или глюкозо-галактазная мальабсорбция.
С осторожностью
Цирроз печени с портосистемной энцефалопатией в анамнезе почечная недостаточность.
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.
При язвенной болезни желудка и 12-перстной кишки в фазе обострения симптоматических язвах эрозивном гастродуодените обычно назначают 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 назначают по 20 мг 1-2 раза в сутки.
С целью профилактики рецидивов язвенной болезни назначают по 20 мг 1 раз в сутки перед сном.
При рефлюкс-эзофагите - 20-40 мг два раза в сутки в течение 6-12 недель.
При синдроме Золлингера-Эллисона дозу препарата и продолжительность курса лечения устанавливают индивидуально. Начальная доза обычно составляет 20 мг каждые 6 часов и может быть увеличена до 160 мг каждые 6 часов.
Для профилактики аспирации желудочного сока при общей анестезии назначают по 40 мг вечером и/или утром перед операцией. Таблетки Фамотидина следует проглатывать не разжевывая запивая достаточным количеством воды.
При почечной недостаточности если клиренс креатинина составляет менее 30 мл/мин или содержание креатинина в сыворотке крови более 3 мг/100 мл суточную дозу препарата необходимо уменьшить до 20 мг.
Побочное действие
Со стороны пищеварительной системы: сухость во рту тошнота рвота боль в животе запор диарея потеря аппетита повышение активности "печеночных" трансаминаз холестатическая желтуха гепатит острый панкреатит.
Со стороны нервной системы: головная боль головокружение астения сонливость бессонница усталость депрессия возбуждение звон в ушах галлюцинации спутанность сознания нечеткость зрительного восприятия.
Со стороны сердечно-сосудистой системы: снижение артериального давления брадикардия атриовентрикулярная блокада аритмия васкулит.
Взаимодействие с другими лекарственными средствами
Вследствие повышения pH содержимого желудка при одновременном приеме может уменьшиться всасывание кетоконазола.
При одновременном применении с антацидными средствами сукральфатом происходит снижение интенсивности абсорбции фамотидина поэтому перерыв между приемом этих препаратов должен составлять не менее 1-2 часов.
Увеличивает всасывание амоксициллина и клавулановой кислоты.
Лекарственные средства угнетающие костный мозг увеличивают риск развития нейтропении.
Особые указания
Перед началом лечения необходимо исключить возможность наличия злокачественного заболевания пищевода желудка или двенадцатиперстной кишки. Фамотидин как и все блокаторы Н2-гистаминовых рецепторов нежелательно резко отменять (синдром "рикошета"). При длительном лечении у ослабленных больных а также в условиях стресса возможны бактериальные поражения желудка с последующим распространением инфекции.
Блокаторы Н2-гистаминовых рецепторов могут противодействовать влиянию пентагастрина и гистамина на кислотообразующую функцию желудка поэтому в течение 24 часов предшествующих тесту применять блокаторы Н2-гистаминовых рецепторов не рекомендуется. Блокаторы Н2-гистаминовых рецепторов могут подавлять кожную реакцию на гистамин приводя таким образом к ложноотрицательным результатам (перед проведением диагностических кожных проб для выявления аллергической кожной реакции немедленного типа применение блокаторов Н2-гистаминовых рецепторов рекомендуется прекратить). Во время лечения следует избегать употребления продуктов питания напитков и других лекарственных средств которые могут вызвать раздражение слизистой оболочки желудка. Эффективность препарата в ингибировании ночной секреции соляной кислоты в желудке может снижаться в результате курения. Больным с сопутствующими ожогами может потребоваться увеличение дозы препарата вследствие повышенного клиренса. В случае пропуска дозы ее необходимо принять как можно скорее; не принимать если наступило время приема следующей дозы; не удваивать дозы.
Влияние на способность управлять автомобилем и движущимися механизмами
В период лечения необходимо воздерживаться от занятий потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Таблетки покрытые пленочной оболочкой 20 мг и 40 мг.
Условия хранения
В сухом защищенном от света месте при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
3 года.
Не использовать после истечения срока годности.
Условия отпуска
По рецепту
Производитель
Общество с ограниченной ответственностью "Озон" (ООО "Озон"), 445351, Самарская обл., г. Жигулёвск, ул. Гидростроителей, д. 6, Россия
Организация, принимающая претензии потребителей
ООО "Озон"
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номер","slug":"","body":[{"type":"paragraph","data":{"text":"ЛС-001456"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Фамотидин"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"таблетки, покрытые пленочной оболочкой"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"1 таблетка 20 мг содержит:"}},{"type":"paragraph","data":{"text":"активное вещество: фамотидин 20 мг;"}},{"type":"paragraph","data":{"text":"вспомогательные вещества (ядро): магния стеарат - 1,90 мг; крахмал картофельный - 16,82 мг, повидон (поливинилпирролидон) - 6,36 мг, целлюлоза микрокристаллическая - 53,92 мг, лактозы моногидрат (сахар молочный) - 100,00 мг;"}},{"type":"paragraph","data":{"text":"вспомогательные вещества (оболочка): гипромеллоза - 7,50 мг, титана диоксид - 2,03 мг, краситель хинолиновый желтый - 0,19 мг; полисорбат-80 - 1,28 мг."}},{"type":"paragraph","data":{"text":"1 таблетка 40 мг содержит:"}},{"type":"paragraph","data":{"text":"активное вещество: фамотидин - 40 мг;"}},{"type":"paragraph","data":{"text":"вспомогательные вещества (ядро): магния стеарат - 2,10 мг; крахмал картофельный - 16,00 мг, повидон (поливинилпирролидон) - 7,00 мг, целлюлоза микрокристаллическая - 53,90 мг, лактозы моногидрат (сахар молочный) - 100,00 мг;"}},{"type":"paragraph","data":{"text":"вспомогательные вещества (оболочка): гипромеллоза - 7,50 мг, титана диоксид - 2,22 мг, полисорбат-80 - 1,28 мг."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Таблетки круглые, двояковыпуклой формы, покрытые пленочной оболочкой желтого цвета (для дозировки 20 мг) или белого цвета (для дозировки 40 мг). На поперечном срезе видны два слоя - ядро и пленочная оболочка."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"желез желудка секрецию понижающее средство - H2-гистаминовых рецепторов блокатор"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Блокатор Н\u003csub\u003e2\u003c/sub\u003e-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 и способствует заживлению связанных с воздействием соляной кислоты ее повреждений (в т. ч. прекращению желудочно-кишечных кровотечений и рубцеванию стрессовых язв) 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 концентрацию 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."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"После приема внутрь быстро абсорбируется из ЖКТ. После приема внутрь время достижения максимальной концентрации в плазме крови (ТС\u003csub\u003emах\u003c/sub\u003e) 1-35 ч."}},{"type":"paragraph","data":{"text":"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). Элиминация в основном происходит через почки: 27-40% препарата выводится с мочой в неизмененном виде."}},{"type":"paragraph","data":{"text":"Период полувыведения - 25-4 часа у пациентов с клиренсом креатинина ниже 30 мл/мин увеличивается до 10-12 часов. У пациентов с тяжелой почечной недостаточностью (клиренс креатинина ниже 10 мл/мин) он возрастает до 20 часов. Проникает через плацентарный барьер и выделяется с грудным молоком."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Язвенная болезнь 12-перстной кишки и желудка в фазе обострения профилактика рецидивов."}},{"type":"paragraph","data":{"text":"Лечение и профилактика симптоматических язв желудка и 12-перстной кишки (связанных с приемом нестероидных противовоспалительных препаратов стрессовых послеоперационных язв)."}},{"type":"paragraph","data":{"text":"Эрозивный гастродуоденит."}},{"type":"paragraph","data":{"text":"Функциональная диспепсия ассоциированная с повышенной секреторной функцией желудка."}},{"type":"paragraph","data":{"text":"Рефлюкс-эзофагит."}},{"type":"paragraph","data":{"text":"Синдром Золлингера-Эллисона."}},{"type":"paragraph","data":{"text":"Профилактика рецидивов кровотечений из верхних отделов ЖКТ."}},{"type":"paragraph","data":{"text":"Предупреждение аспирации желудочного сока при общей анестезии (синдром Мендельсона)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Беременность период лактации печеночная недостаточность детский возраст повышенная чувствительность к компонентам препарата. Непереносимость лактозы дефицит лактазы или глюкозо-галактазная мальабсорбция."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Цирроз печени с портосистемной энцефалопатией в анамнезе почечная недостаточность."}}]},{"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."}},{"type":"paragraph","data":{"text":"При язвенной болезни желудка и 12-перстной кишки в фазе обострения симптоматических язвах эрозивном гастродуодените обычно назначают 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 назначают по 20 мг 1-2 раза в сутки."}},{"type":"paragraph","data":{"text":"С целью профилактики рецидивов язвенной болезни назначают по 20 мг 1 раз в сутки перед сном."}},{"type":"paragraph","data":{"text":"При рефлюкс-эзофагите - 20-40 мг два 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 составляет 20 мг каждые 6 часов и может быть увеличена до 160 мг каждые 6 часов."}},{"type":"paragraph","data":{"text":"Для профилактики аспирации желудочного сока при общей анестезии назначают по 40 мг вечером и/или утром перед операцией. Таблетки Фамотидина следует проглатывать не разжевывая запивая достаточным количеством воды."}},{"type":"paragraph","data":{"text":"При почечной недостаточности если клиренс креатинина составляет менее 30 мл/мин или содержание креатинина в сыворотке крови более 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":"Со стороны пищеварительной системы: сухость во рту тошнота рвота боль в животе запор диарея потеря аппетита повышение активности \"печеночных\" трансаминаз холестатическая желтуха гепатит острый панкреатит."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: головная боль головокружение астения сонливость бессонница усталость депрессия возбуждение звон в ушах галлюцинации спутанность сознания нечеткость зрительного восприятия."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: снижение артериального давления брадикардия атриовентрикулярная блокада аритмия васкулит."}},{"type":"paragraph","data":{"text":"Аллергические реакции: кожная сыпь зуд крапивница бронхоспазм ангионевротический отек синдром Стивенса-Джонсона токсический эпидермальный некролиз анафилактический шок."}},{"type":"paragraph","data":{"text":"Со стороны органов кроветворения: лейкопения тромбоцитопения агранулоцитоз панцитопения гипоплазия аплазия костного мозга."}},{"type":"paragraph","data":{"text":"Со стороны репродуктивной системы: при длительном приеме больших доз - гиперпролактинемия гинекомастия аменорея снижение либидо снижение потенции."}},{"type":"paragraph","data":{"text":"Прочие: угревая сыпь алопеция лихорадка артралгия миалгия."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: возможно усугубление побочных эффектов."}},{"type":"paragraph","data":{"text":"Лечение: промывание желудка симптоматическая терапия гемодиализ."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Вследствие повышения pH содержимого желудка при одновременном приеме может уменьшиться всасывание кетоконазола."}},{"type":"paragraph","data":{"text":"При одновременном применении с антацидными средствами сукральфатом происходит снижение интенсивности абсорбции фамотидина поэтому перерыв между приемом этих препаратов должен составлять не менее 1-2 часов."}},{"type":"paragraph","data":{"text":"Увеличивает всасывание амоксициллина и клавулановой кислоты."}},{"type":"paragraph","data":{"text":"Лекарственные средства угнетающие костный мозг увеличивают риск развития нейтропении."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Перед началом лечения необходимо исключить возможность наличия злокачественного заболевания пищевода желудка или двенадцатиперстной кишки. Фамотидин как и все блокаторы Н\u003csub\u003e2\u003c/sub\u003e-гистаминовых рецепторов нежелательно резко отменять (синдром \"рикошета\"). При длительном лечении у ослабленных больных а также в условиях стресса возможны бактериальные поражения желудка с последующим распространением инфекции."}},{"type":"paragraph","data":{"text":"Блокаторы Н\u003csub\u003e2\u003c/sub\u003e-гистаминовых рецепторов могут противодействовать влиянию пентагастрина и гистамина на кислотообразующую функцию желудка поэтому в течение 24 часов предшествующих тесту применять блокаторы Н\u003csub\u003e2\u003c/sub\u003e-гистаминовых рецепторов не рекомендуется. Блокаторы Н\u003csub\u003e2\u003c/sub\u003e-гистаминовых рецепторов могут подавлять кожную реакцию на гистамин приводя таким образом к ложноотрицательным результатам (перед проведением диагностических кожных проб для выявления аллергической кожной реакции немедленного типа применение блокаторов Н\u003csub\u003e2\u003c/sub\u003e-гистаминовых рецепторов рекомендуется прекратить). Во время лечения следует избегать употребления продуктов питания напитков и других лекарственных средств которые могут вызвать раздражение слизистой оболочки желудка. Эффективность препарата в ингибировании ночной секреции соляной кислоты в желудке может снижаться в результате курения. Больным с сопутствующими ожогами может потребоваться увеличение дозы препарата вследствие повышенного клиренса. В случае пропуска дозы ее необходимо принять как можно скорее; не принимать если наступило время приема следующей дозы; не удваивать дозы."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В период лечения необходимо воздерживаться от занятий потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки покрытые пленочной оболочкой 20 мг и 40 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом защищенном от света месте при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}},{"type":"paragraph","data":{"text":"Не использовать после истечения срока годности."}}]},{"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":"Общество с ограниченной ответственностью \"Озон\" (ООО \"Озон\"), 445351, Самарская обл., г. Жигулёвск, ул. Гидростроителей, д. 6, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ООО \"Озон\""}}]}],"source":null},"description_toggle":false,"short_description":"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 и способствует заживлению связанных с воздействием соляной кислоты ее повреждений (в т. ч. прекращению желудочно-кишечных кровотечений и рубцеванию стрессовых язв) 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 концентрацию 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. После приема внутрь быстро абсорбируется из ЖКТ. После приема внутрь время достижения максимальной концентрации в плазме крови (ТСmах) 1-35 ч. 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). Элиминация в основном происходит через почки: 27-40% препарата выводится с мочой в неизмененном виде. Период полувыведения - 25-4 часа у пациентов с клиренсом креатинина ниже 30 мл/мин увеличивается до 10-12 часов. У пациентов с тяжелой почечной недостаточностью (клиренс креатинина ниже 10 мл/мин) он возрастает до 20 часов. 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