вспомогательные вещества: лактозы моногидрат, целлюлоза микрокристаллическая, кальция стеарат, опадрай II
состав оболочки: спирт поливиниловый, тальк, макрогол (полиэтиленгликоль), лецитин (соевый), окрашивающий пигмент желтого цвета, для дозировки 20 мг (содержит титана диоксид (E 171), железа оксид желтый (E 172) и алюминиевый лак на основе желтого хинолинового (Е 104)) или окрашивающий пигмент розового цвета для дозировки 40 мг (содержит титана диоксид (E 171), алюминиевый лак на основе кармуазина (Е 122), алюминиевый лак на основе индигокармина (Е 132)).
Описание
Таблетки, покрытые оболочкой желтого цвета, с двояковыпуклой поверхностью На поперечном разрезе видны два слоя (для дозировки 20 мг).
Таблетки, покрытые оболочкой розового цвета, с двояковыпуклой поверхностью. На поперечном разрезе видны два слоя (для дозировки 40 мг).
Фармакотерапевтическая группа
Противоязвенные препараты и препараты для лечения гастроэзофагального рефлюкса (GORD). Блокаторы Н2-гистаминовых рецепторов. Фамотидин.
Фармакологические свойства
Фармакокинетика
При приеме внутрь абсорбция неполная; биодоступность 40-45%, увеличивается при приеме с пищей и снижается на фоне антацидов. Связывание с белками плазмы – 15 – 20 %. Тmax – 1 - 3 ч. Проникает в спинномозговую жидкость, через плацентарный барьер и в грудное молоко.
Т½ – 2,5-3,5 ч; у пациентов с тяжелой почечной недостаточностью (КК - ниже 10 мл/мин) возрастает до 20 ч (требуется коррекция дозы). 30-35% препарата метаболизируется в печени с образованием S-оксида. Выводится почками путем клубочковой фильтрации и канальцевой секреции. 25-30% принятой внутрь дозы обнаруживается в моче в неизмененном виде.
Фармакодинамика
Блокатор H2-гистаминорецепторов III поколения. Подавляет базальную и стимулированную гистамином, гастрином и ацетилхолином продукцию соляной кислоты. Одновременно со снижением продукции соляной кислоты и увеличением pH снижается и активность пепсина.
Повышает резистентность слизистой оболочки желудка за счет увеличения образования желудочной слизи, секреции гидрокарбоната, синтеза гликопротеинов и простагландинов, способствует заживлению ее повреждений (в т.ч. рубцеванию стрессовых язв). Практически не влияет на активность цитохрома P450 в печени.
После приема внутрь действие начинается через 1 ч, достигает максимума в течение 3 ч и продолжается от 12 до 24 ч. Однократная доза (10 и 20 мг) подавляет секрецию на 10-12 ч.
Показания к применению
лечение и профилактика рецидивов язвенной болезни желудка и 12-перстной кишки;
- лечение и профилактика симптоматических язв желудка и 12-перстной кишки (НПВП-гастропатия, стрессовые, послеоперационные язвы);
- эрозивный гастродуоденит;
- функциональная диспепсия, ассоциированная с повышенной секреторной функцией желудка;
- рефлюкс-эзофагит;
- синдром Золлингера-Эллисона;
- предупреждение аспирации желудочного сока при общей анестезии (синдром Мендельсона).
Противопоказания
повышенная чувствительность к фамотидину и другим компонентам препарата
Внутрь, при обострениях язвенной болезни желудка и 12-перстной кишки – по 40 мг 1 раз в сутки перед сном или по 20 мг 2 раза в сутки. При необходимости суточную дозу можно увеличить до 80-160 мг. Продолжительность лечения – 4-8 нед.
Профилактика обострений язвенной болезни - по 20 мг 1 раз в сутки на ночь.
При синдроме Золлингера-Эллисона - в начальной дозе по 20-40 мг 4 раза в сутки; при необходимости суточную дозу можно увеличить до 240-480 мг (при тяжелой форме – до 160 мг каждые 6 ч). Дозу препарата и продолжительность курса лечения устанавливают индивидуально.
При рефлюкс-эзофагите начальная доза – 20 мг 2 раза/сут до 6 нед (при необходимости – 20-40 мг 2 раза в сутки до 12 нед).
Для предупреждения аспирации желудочного содержимого – 40 мг накануне операции или утром в день операции.
Больным с клиренсом креатинина ниже 10 мл/мин - 20 мг перед сном.
Побочное действие
Часто
- отсутствие аппетита, сухость во рту, расстройства вкусовых ощущений, тошнота, рвота, вздутие живота, диарея или запор
- головная боль, головокружение, повышенная утомляемость, шум в ушах, преходящие психические нарушения
Взаимодействие с другими лекарственными средствами
Фамотидин не влияет на ферментную систему цитохрома P450, поэтому не влияет на энзиматическую биотранформацию теофилина, кумарина, пропранолола, диазепама, аминопирина и т.п. в печени.
Парасимпатолитики усиливают воздействие обоих групп препаратов на подавление продукции соляной кислоты в желудке.
Уменьшает всасывание одновременное применение фамотидина с кетоконазолом, итраконазолом, препаратами, содержащими железо. В связи с этим данные препараты можно применять не менее чем за 2 ч до приема фамотидина.
Увеличивает всасывание амоксициллина и клавулановой кислоты.
Антациды и сукральфат замедляют абсорбцию.
Лекарственные средства, угнетающие костный мозг, увеличивают риск развития нейтропении.
Особые указания
Симптомы язвенной болезни 12-перстной кишки могут исчезать в течение 1-2 недель, но терапию Фамотидином следует продолжать до тех пор, пока рубцевание не подтверждено данными эндоскопического или рентгеновского исследования. Может маскировать симптомы, связанные с карциномой желудка, поэтому перед началом лечения необходимо исключить наличие злокачественного новообразования. Отмену фамотидина проводят постепенно из-за риска развития синдрома "рикошета".
При длительном лечении у ослабленных больных возможны бактериальные поражения желудка с последующим распространением инфекции.
Блокаторы H2-гистаминорецепторов следует принимать через 2 ч после приема итраконазола или кетоконазола (риск значительного уменьшения их всасывания).
Блокаторы H2-гистаминорецепторов могут нарушать пентагастриновый и гистаминовый тесты кислотообразующей функции желудка (прием прекратить за 24 ч).
Фамотидин может подавлять кожную реакцию на гистамин, вызывая ложноотрицательные результаты кожных проб. При выполнении кожных проб прием фамотидина рекомендуется прекратить.
Во время лечения следует избегать употребления продуктов питания, напитков и лекарственных средств, которые могут вызвать раздражение слизистой оболочки желудка. Курение снижает эффективность фамотидина в отношении ночной секреции соляной кислоты.
Больным с ожогами может потребоваться увеличение дозы вследствие повышения клиренса фамотидина.
В случае пропуска дозы, ее необходимо принять как можно скорее; не удваивать дозу, если наступило время следующего приема.
При отсутствии улучшений необходима консультация врача.
Влияние на способность управлять автомобилем и движущимися механизмами
Особенности влияния лекарственного средства на способность управлять транспортным средством или потенциально опасными механизмами. Следует соблюдать осторожность при управлении транспортом или механизмами, в связи с возможным появлением нарушений со стороны центральной нервной системы.
Форма выпуска
По 10 таблеток в контурной ячейковой упаковке из пленки поливинилхлоридной и фольги алюминиевой.
По 2 контурные ячейковые упаковки вместе с инструкцией по медицинскому применению на государственном и русском языках в пачке из картона.
Условия хранения
Хранить в сухом, защищенном от света месте, при температуре не выше 25 °С.
Беречь от детей!
Срок годности
3 года
Не использовать по истечении срока годности.
Условия отпуска
По рецепту
Производитель
Открытое акционерное общество «Борисовский завод медицинских препаратов», Республика Беларусь, Минская обл., г. Борисов, ул. Чапаева, 64/27,
тел/факс 8-(10375177)744280.
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(содержит титана диоксид (E 171), алюминиевый лак на основе кармуазина (Е 122), алюминиевый лак на основе индигокармина (Е 132))."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Таблетки, покрытые оболочкой желтого цвета, с двояковыпуклой поверхностью На поперечном разрезе видны два слоя (для дозировки 20 мг)."}},{"type":"paragraph","data":{"text":"Таблетки, покрытые оболочкой розового цвета, с двояковыпуклой поверхностью. На поперечном разрезе видны два слоя (для дозировки 40 мг)."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Противоязвенные препараты и препараты для лечения гастроэзофагального рефлюкса (GORD). Блокаторы Н2-гистаминовых рецепторов. Фамотидин."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"При приеме внутрь абсорбция неполная; биодоступность 40-45%, увеличивается при приеме с пищей и снижается на фоне антацидов. Связывание с белками плазмы – 15 – 20 %. Тmax – 1 - 3 ч. Проникает в спинномозговую жидкость, через плацентарный барьер и в грудное молоко."}},{"type":"paragraph","data":{"text":"Т½ – 2,5-3,5 ч; у пациентов с тяжелой почечной недостаточностью (КК - ниже 10 мл/мин) возрастает до 20 ч (требуется коррекция дозы). 30-35% препарата метаболизируется в печени с образованием S-оксида. Выводится почками путем клубочковой фильтрации и канальцевой секреции. 25-30% принятой внутрь дозы обнаруживается в моче в неизмененном виде."}},{"type":"paragraph","data":{"text":"Фармакодинамика"}},{"type":"paragraph","data":{"text":"Блокатор H2-гистаминорецепторов III поколения. Подавляет базальную и стимулированную гистамином, гастрином и ацетилхолином продукцию соляной кислоты. Одновременно со снижением продукции соляной кислоты и увеличением pH снижается и активность пепсина."}},{"type":"paragraph","data":{"text":"Повышает резистентность слизистой оболочки желудка за счет увеличения образования желудочной слизи, секреции гидрокарбоната, синтеза гликопротеинов и простагландинов, способствует заживлению ее повреждений (в т.ч. рубцеванию стрессовых язв). Практически не влияет на активность цитохрома P450 в печени."}},{"type":"paragraph","data":{"text":"После приема внутрь действие начинается через 1 ч, достигает максимума в течение 3 ч и продолжается от 12 до 24 ч. Однократная доза (10 и 20 мг) подавляет секрецию на 10-12 ч."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"лечение и профилактика рецидивов язвенной болезни желудка и 12-перстной кишки;"}},{"type":"paragraph","data":{"text":"- лечение и профилактика симптоматических язв желудка и 12-перстной кишки (НПВП-гастропатия, стрессовые, послеоперационные язвы);"}},{"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":"- предупреждение аспирации желудочного сока при общей анестезии (синдром Мендельсона)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":" повышенная чувствительность к фамотидину и другим компонентам препарата"}},{"type":"paragraph","data":{"text":"- беременность и период лактации"}},{"type":"paragraph","data":{"text":"- наследственная непереносимость фруктозы, дефицит фермента Lapp-лактазы, мальабсорбция глюкозы-галактозы"}},{"type":"paragraph","data":{"text":"- детский и подростковый возраст до 18 лет"}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь, при обострениях язвенной болезни желудка и 12-перстной кишки – по 40 мг 1 раз в сутки перед сном или по 20 мг 2 раза в сутки. При необходимости суточную дозу можно увеличить до 80-160 мг. Продолжительность лечения – 4-8 нед."}},{"type":"paragraph","data":{"text":"Профилактика обострений язвенной болезни - по 20 мг 1 раз в сутки на ночь."}},{"type":"paragraph","data":{"text":"При синдроме Золлингера-Эллисона - в начальной дозе по 20-40 мг 4 раза в сутки; при необходимости суточную дозу можно увеличить до 240-480 мг (при тяжелой форме – до 160 мг каждые 6 ч). Дозу препарата и продолжительность курса лечения устанавливают индивидуально."}},{"type":"paragraph","data":{"text":"При рефлюкс-эзофагите начальная доза – 20 мг 2 раза/сут до 6 нед (при необходимости – 20-40 мг 2 раза в сутки до 12 нед)."}},{"type":"paragraph","data":{"text":"Для предупреждения аспирации желудочного содержимого – 40 мг накануне операции или утром в день операции."}},{"type":"paragraph","data":{"text":"Больным с клиренсом креатинина ниже 10 мл/мин - 20 мг перед сном."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Часто"}},{"type":"paragraph","data":{"text":"- отсутствие аппетита, сухость во рту, расстройства вкусовых ощущений, тошнота, рвота, вздутие живота, диарея или запор"}},{"type":"paragraph","data":{"text":"- головная боль, головокружение, повышенная утомляемость, шум в ушах, преходящие психические нарушения"}},{"type":"paragraph","data":{"text":"- возможны мышечные боли, боли в суставах"}},{"type":"paragraph","data":{"text":"- кожный зуд, бронхоспазм, лихорадка, аллопеция, обыкновенные угри, сухость кожи, ангионевротический отек, анафилактический шок, токсический эпидермальный некролиз, отек Квинке, анафилактическая реакция, другие проявления гиперсенсибилизации"}},{"type":"paragraph","data":{"text":"Не часто"}},{"type":"paragraph","data":{"text":"- судороги"}},{"type":"paragraph","data":{"text":"- психические расстройства"}},{"type":"paragraph","data":{"text":"- лейкопения, тромбоцитопения"}},{"type":"paragraph","data":{"text":"- аритмия, атриовентрикулярный блок"}},{"type":"paragraph","data":{"text":"- повышение активности печеночных ферментов, гипербилирубинемия, увеличение уровня мочевины"}},{"type":"paragraph","data":{"text":"Редко"}},{"type":"paragraph","data":{"text":"- развитие холестатической желтухи"}},{"type":"paragraph","data":{"text":"Очень редко"}},{"type":"paragraph","data":{"text":"- агранулоцитоз, панцитопения"}},{"type":"paragraph","data":{"text":"- при длительном приеме – гиперпролактинемия, гинекомастия, аменорея, снижение либидо."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: рвота, двигательное возбуждение, тремор, снижение артериального давления, тахикардия, коллапс."}},{"type":"paragraph","data":{"text":"Лечение: Индукция рвоты или/и промывание желудка. Симптоматическая и поддерживающая терапия: при судорогах – в/в диазепам; брадикардии – атропин; желудочковых аритмиях – лидокаин. Гемодиализ эффективен."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Фамотидин не влияет на ферментную систему цитохрома P450, поэтому не влияет на энзиматическую биотранформацию теофилина, кумарина, пропранолола, диазепама, аминопирина и т.п. в печени."}},{"type":"paragraph","data":{"text":"Парасимпатолитики усиливают воздействие обоих групп препаратов на подавление продукции соляной кислоты в желудке."}},{"type":"paragraph","data":{"text":"Уменьшает всасывание одновременное применение фамотидина с кетоконазолом, итраконазолом, препаратами, содержащими железо. В связи с этим данные препараты можно применять не менее чем за 2 ч до приема фамотидина."}},{"type":"paragraph","data":{"text":"Увеличивает всасывание амоксициллина и клавулановой кислоты."}},{"type":"paragraph","data":{"text":"Антациды и сукральфат замедляют абсорбцию."}},{"type":"paragraph","data":{"text":"Лекарственные средства, угнетающие костный мозг, увеличивают риск развития нейтропении."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Симптомы язвенной болезни 12-перстной кишки могут исчезать в течение 1-2 недель, но терапию Фамотидином следует продолжать до тех пор, пока рубцевание не подтверждено данными эндоскопического или рентгеновского исследования. Может маскировать симптомы, связанные с карциномой желудка, поэтому перед началом лечения необходимо исключить наличие злокачественного новообразования. Отмену фамотидина проводят постепенно из-за риска развития синдрома \"рикошета\"."}},{"type":"paragraph","data":{"text":"При длительном лечении у ослабленных больных возможны бактериальные поражения желудка с последующим распространением инфекции."}},{"type":"paragraph","data":{"text":"Блокаторы H2-гистаминорецепторов следует принимать через 2 ч после приема итраконазола или кетоконазола (риск значительного уменьшения их всасывания)."}},{"type":"paragraph","data":{"text":"Блокаторы H2-гистаминорецепторов могут нарушать пентагастриновый и гистаминовый тесты кислотообразующей функции желудка (прием прекратить за 24 ч)."}},{"type":"paragraph","data":{"text":"Фамотидин может подавлять кожную реакцию на гистамин, вызывая ложноотрицательные результаты кожных проб. При выполнении кожных проб прием фамотидина рекомендуется прекратить."}},{"type":"paragraph","data":{"text":"Во время лечения следует избегать употребления продуктов питания, напитков и лекарственных средств, которые могут вызвать раздражение слизистой оболочки желудка. Курение снижает эффективность фамотидина в отношении ночной секреции соляной кислоты."}},{"type":"paragraph","data":{"text":"Больным с ожогами может потребоваться увеличение дозы вследствие повышения клиренса фамотидина."}},{"type":"paragraph","data":{"text":"В случае пропуска дозы, ее необходимо принять как можно скорее; не удваивать дозу, если наступило время следующего приема."}},{"type":"paragraph","data":{"text":"При отсутствии улучшений необходима консультация врача."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Особенности влияния лекарственного средства на способность управлять транспортным средством или потенциально опасными механизмами. 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