Фармакологическое действие - против язвенное. Инструкция
Показания к применению
Язвенная болезнь желудка и 12-перстной кишки (лечение), гастроэзофагеальная рефлюксная болезнь, синдром Золлингера-Эллисона, в составе комплексной терапии: эрадикация Helicobacter pylori у пациентов с язвенной болезнью желудка и 12-перстной кишки или хроническим гастритом. лечение и профилактика рецидива язвенной болезни, связанной с Helicobacter pylori....
Индивидуальная повышенная чувствительность к действующему веществу препарата или к каким-либо вспомогательным ингредиентам, входящим в его состав. Беременность. лактация. детский возраст до 18 лет (в связи с недостаточностью данных по безопасности применения). С осторожностью: тяжелая почечная недостаточность. тяжелая печеночная недостаточность.
Действующее вещество: Рабепразол натрия. Концентрация действующего вещества (мг): 20
Фармакологические свойства
Фармакологическое действие - против язвенное.
Показания к применению
Язвенная болезнь желудка и 12-перстной кишки (лечение), гастроэзофагеальная рефлюксная болезнь, синдром Золлингера-Эллисона, в составе комплексной терапии: эрадикация Helicobacter pylori у пациентов с язвенной болезнью желудка и 12-перстной кишки или хроническим гастритом. лечение и профилактика рецидива язвенной болезни, связанной с Helicobacter pylori.
Противопоказания
Индивидуальная повышенная чувствительность к действующему веществу препарата или к каким-либо вспомогательным ингредиентам, входящим в его состав. Беременность. лактация. детский возраст до 18 лет (в связи с недостаточностью данных по безопасности применения). С осторожностью: тяжелая почечная недостаточность. тяжелая печеночная недостаточность.
Применение при беременности и в период грудного вскармливания
Данных по безопасности применения рабепразола во время беременности нет. Исследования репродуктивности на крысах и кроликах не выявили признаки нарушения фертильности или дефекты развития плода, обусловленные рабепразолом; однако у крыс в небольших количествах препарат проникает через плацентарный барьер. Нофлюкс не следует применять при беременности за исключением случаев, когда ожидаемый положительный эффект для матери превосходит возможный вред для плода. Неизвестно, выделяется ли рабепразол с грудным молоком. Соответствующие исследования у кормящих женщин не проводились. Вместе с тем рабепразол обнаружен в молоке лактирующих крыс, и поэтому Нофлюкс нельзя назначать кормящим женщинам.
Способ применения и дозы
Внутрь. Таблетки проглатывают целиком, не разжевывая и не измельчая. Язвенная болезнь желудка и двенадцатиперстной кишки, гастроэзофагеальная рефлюксная болезнь. По 20 мг 1 раз в сутки, утром. Курс лечения при язвенной болезни желудка и двенадцатиперстной кишки , 4–6 недели, при необходимости , до 12 недель. при гастроэзофагеальной рефлюксной болезни , 4–8 недель. Синдром Золлингера-Эллисона. Рекомендуемая начальная доза для взрослого составляет 60 мг 1 раз в сутки. Дозу можно увеличить до 120 мгдень, индивидуально для каждого случая. Один раз в сутки могут приниматься дозы до 100 мг. Дозы в 120 мг необходимо разделить на 2 приема, по 60 мг 2 раза в сутки. Лечение должно продолжаться по мере клинической необходимости. У некоторых больных с синдромом Золлингера-Эллисона длительность лечения рабепразолом составляет до 1 года. Эрадикация Helicobacter pylori. В составе комплексной терапии , по 20 мг 2 раза в сутки, длительность лечения , 7 дней.
Побочное действие
Со стороны органов кроветворения: редко , нейтропения, лейкопения, тромбоцитопения, лейкоцитоз. Аллергические реакции: редко , гиперчувствительность (отек лица, эритема). Со стороны нервной системы: часто , бессонница. нечасто , повышенная возбудимость. редко , головная боль, головокружение, сонливость, слабость, депрессия. частота неизвестна , спутанность сознания. Со стороны дыхательной системы: часто , кашель, фарингит, ринит. нечасто , бронхит, синусит. Со стороны пищеварительной системы: часто , диарея, тошнота, рвота, абдоминальные боли, запоры, метеоризм. нечасто , диспепсия, сухость во рту, отрыжка. редко , анорексия, гастрит, стоматит, расстройства вкуса, гепатит, желтуха. Со стороны мочевыделительной системы: нечасто , инфекции мочевыводящих путей. редко , интерстициальный нефрит. Со стороны кожных покровов: нечасто , сыпь, эритема. редко , кожный зуд, повышенное потоотделение, буллезные реакции. очень редко , полиморфная эритема, токсический эпидермальный некролиз, синдром Стивенса-Джонсона. Прочие: часто , неспецифические боли, боли в спине, астения, гриппоподобный синдром. нечасто , миалгия, артралгия, боль в грудной клетке, судороги икроножных мышц, ознобы, лихорадка, увеличение активности печеночных ферментов. редко , нарушения зрения, увеличение массы тела. частота неизвестна , гипонатриемия, периферические отеки, гинекомастия.
Передозировка
Симптомы: данные о намеренной или случайной передозировке минимальны. Случаи сильной передозировки рабепразола не были отмечены. Лечение: специфический антидот препарата Нофлюкс неизвестен. Рабепразол хорошо связывается с белками плазмы, и поэтому слабо выводится при диализе. Необходимо проводить симптоматическую и поддерживающую терапию.
Особые указания
Ответ пациента на терапию рабепразолом натрия не исключает наличие злокачественных новообразований в желудке. Таблетки препарата Нофлюкс нельзя разжевывать или измельчать. Таблетки следует глотать целиком. Установлено, что ни время суток, ни прием пищи не влияют на активность рабепразола натрия. В специальном исследовании у пациентов с легкими или умеренными нарушениями функции печени не были обнаружены значимые отличия частоты побочных эффектов препарата Нофлюкс от таковой у подобранных по полу и возрасту здоровых лиц, но, несмотря на это, рекомендуется соблюдать осторожность при первом назначении препарата Нофлюкс пациентам с тяжелыми нарушениями функции печени. AUC рабепразола натрия у пациентов с тяжелым нарушением функции печени примерно в 2 раза выше, чем у здоровых пациентов. Пациентам с нарушениями функции почек или печени коррекция дозы препарата Нофлюкс не требуется. Гипомагниемия: При лечении ИПП на протяжении по крайней мере 3 мес в редких случаях были отмечены случаи симптоматической или асимптоматической гипомагниемии. В большинстве эти сообщения поступали через год после проведения терапии. Серьезными побочными явлениями были тетания, аритмия и судороги. Большинству пациентов требовалось лечение гипомагниемии, включающее замещение магния и отмену терапии ИПП. У пациентов, которые будут получать длительное лечение или которые принимают ИПП с препаратами, такими как дигоксин, или препаратами, которые могут вызвать гипомагниемию (например диуретики), медицинские работники должны контролировать уровень магния до начала лечения ИПП и в период лечения. Пациенты не должны принимать одновременно с препаратом Нофлюкс другие средства, снижающие кислотность, например блокаторы Н2-рецепторов или другие ингибиторы протонного насоса. Переломы: Согласно данным наблюдательных исследований, можно предположить, что терапия ИПП может привести к возрастанию риска связанных с остеопорозом переломов бедра, запястья или позвоночника. Риск переломов был увеличен у пациентов, получавших высокие дозы ИПП длительно (год и более). Одновременное применение рабепразола с метотрексатом: Согласно литературным данным, одновременный прием ИПП с метотрексатом (прежде всего в высоких дозах) может повысить концентрации метотрексата и/или его метаболита гидроксиметотрексата и увеличить T1/2, что может привести к проявлению токсичности метотрексата. При необходимости применения высоких доз метотрексата может быть рассмотрена возможность временного прекращения терапии ИПП. Терапия ИПП может приводить к возрастанию риска желудочно-кишечных инфекций, например вызванных Clostridium difficile. Пациентам, принимающим препарат Нофлюкс для кратковременного симптоматического лечения проявлений ГЭРБ и НЭРБ (например изжога) без рецепта, следует обратиться к врачу в следующих случаях: применение средств для снятия симптомов изжоги и нарушения пищеварения в течение 4 нед и более, появление новых симптомов или изменение ранее наблюдавшихся симптомов у пациентов в возрасте более 55 лет, случаи ненамеренного уменьшения массы тела, анемии, кровотечений в ЖКТ, дисфагии, боли при глотании, постоянной рвоты или рвоты с кровью и содержимым эпигастрия, случаи язвы желудка или операций на желудке в анамнезе, желтухи и т. д. (в т. ч. нарушение функции печени и почек). Пациенты, длительное время страдающие от повторяющихся симптомов нарушения пищеварения или изжоги, должны регулярно наблюдаться у врача. Пациенты в возрасте более 55 лет, ежедневно принимающие безрецептурные препараты для снятия симптомов изжоги и нарушения пищеварения, должны проинформировать об этом своего лечащего врача. Пациенты не должны принимать одновременно с препаратом Нофлюкс другие средства, снижающие кислотность, например блокаторы Н2-рецепторов или другие ИПП. При применении других препаратов пациентам следует проконсультироваться с фармацевтом или врачом перед началом терапии препаратом Нофлюкс, отпускаемым без рецепта. Пациенты должны сообщить врачу перед началом применения препарата Нофлюкс без рецепта, если им назначено эндоскопическое исследование. Следует избегать приема препарата Нофлюкс перед проведением мочевинного дыхательного теста. Пациенты с тяжелыми нарушениями функции печени должны обратиться к врачу перед началом терапии препаратом Нофлюкс, отпускаемым без рецепта, для кратковременного симптоматического лечения проявлений ГЭРБ и НЭРБ (например изжога). Влияние на способность управлять транспортными средствами и работать с механизмами. Исходя из особенностей фармакодинамики рабепразола и его профиля нежелательных эффектов, маловероятно, что Нофлюкс оказывает влияние на способность водить автомобиль и работать с техникой. Однако в случае появления сонливости следует избегать этих видов деятельности.
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Концентрация действующего вещества (мг): 20"}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Фармакологическое действие - против язвенное."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Язвенная болезнь желудка и 12-перстной кишки (лечение), гастроэзофагеальная рефлюксная болезнь, синдром Золлингера-Эллисона, в составе комплексной терапии: эрадикация Helicobacter pylori у пациентов с язвенной болезнью желудка и 12-перстной кишки или хроническим гастритом. лечение и профилактика рецидива язвенной болезни, связанной с Helicobacter pylori."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Индивидуальная повышенная чувствительность к действующему веществу препарата или к каким-либо вспомогательным ингредиентам, входящим в его состав. Беременность. лактация. детский возраст до 18 лет (в связи с недостаточностью данных по безопасности применения). С осторожностью: тяжелая почечная недостаточность. тяжелая печеночная недостаточность."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Данных по безопасности применения рабепразола во время беременности нет. Исследования репродуктивности на крысах и кроликах не выявили признаки нарушения фертильности или дефекты развития плода, обусловленные рабепразолом; однако у крыс в небольших количествах препарат проникает через плацентарный барьер. Нофлюкс не следует применять при беременности за исключением случаев, когда ожидаемый положительный эффект для матери превосходит возможный вред для плода. Неизвестно, выделяется ли рабепразол с грудным молоком. Соответствующие исследования у кормящих женщин не проводились. Вместе с тем рабепразол обнаружен в молоке лактирующих крыс, и поэтому Нофлюкс нельзя назначать кормящим женщинам."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь. Таблетки проглатывают целиком, не разжевывая и не измельчая. Язвенная болезнь желудка и двенадцатиперстной кишки, гастроэзофагеальная рефлюксная болезнь. По 20 мг 1 раз в сутки, утром. Курс лечения при язвенной болезни желудка и двенадцатиперстной кишки , 4–6 недели, при необходимости , до 12 недель. при гастроэзофагеальной рефлюксной болезни , 4–8 недель. Синдром Золлингера-Эллисона. Рекомендуемая начальная доза для взрослого составляет 60 мг 1 раз в сутки. Дозу можно увеличить до 120 мгдень, индивидуально для каждого случая. Один раз в сутки могут приниматься дозы до 100 мг. Дозы в 120 мг необходимо разделить на 2 приема, по 60 мг 2 раза в сутки. Лечение должно продолжаться по мере клинической необходимости. У некоторых больных с синдромом Золлингера-Эллисона длительность лечения рабепразолом составляет до 1 года. Эрадикация Helicobacter pylori. В составе комплексной терапии , по 20 мг 2 раза в сутки, длительность лечения , 7 дней."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны органов кроветворения: редко , нейтропения, лейкопения, тромбоцитопения, лейкоцитоз. Аллергические реакции: редко , гиперчувствительность (отек лица, эритема). Со стороны нервной системы: часто , бессонница. нечасто , повышенная возбудимость. редко , головная боль, головокружение, сонливость, слабость, депрессия. частота неизвестна , спутанность сознания. Со стороны дыхательной системы: часто , кашель, фарингит, ринит. нечасто , бронхит, синусит. Со стороны пищеварительной системы: часто , диарея, тошнота, рвота, абдоминальные боли, запоры, метеоризм. нечасто , диспепсия, сухость во рту, отрыжка. редко , анорексия, гастрит, стоматит, расстройства вкуса, гепатит, желтуха. Со стороны мочевыделительной системы: нечасто , инфекции мочевыводящих путей. редко , интерстициальный нефрит. Со стороны кожных покровов: нечасто , сыпь, эритема. редко , кожный зуд, повышенное потоотделение, буллезные реакции. очень редко , полиморфная эритема, токсический эпидермальный некролиз, синдром Стивенса-Джонсона. Прочие: часто , неспецифические боли, боли в спине, астения, гриппоподобный синдром. нечасто , миалгия, артралгия, боль в грудной клетке, судороги икроножных мышц, ознобы, лихорадка, увеличение активности печеночных ферментов. редко , нарушения зрения, увеличение массы тела. частота неизвестна , гипонатриемия, периферические отеки, гинекомастия."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: данные о намеренной или случайной передозировке минимальны. Случаи сильной передозировки рабепразола не были отмечены. Лечение: специфический антидот препарата Нофлюкс неизвестен. Рабепразол хорошо связывается с белками плазмы, и поэтому слабо выводится при диализе. Необходимо проводить симптоматическую и поддерживающую терапию."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Ответ пациента на терапию рабепразолом натрия не исключает наличие злокачественных новообразований в желудке. Таблетки препарата Нофлюкс нельзя разжевывать или измельчать. Таблетки следует глотать целиком. Установлено, что ни время суток, ни прием пищи не влияют на активность рабепразола натрия. В специальном исследовании у пациентов с легкими или умеренными нарушениями функции печени не были обнаружены значимые отличия частоты побочных эффектов препарата Нофлюкс от таковой у подобранных по полу и возрасту здоровых лиц, но, несмотря на это, рекомендуется соблюдать осторожность при первом назначении препарата Нофлюкс пациентам с тяжелыми нарушениями функции печени. AUC рабепразола натрия у пациентов с тяжелым нарушением функции печени примерно в 2 раза выше, чем у здоровых пациентов. Пациентам с нарушениями функции почек или печени коррекция дозы препарата Нофлюкс не требуется. Гипомагниемия: При лечении ИПП на протяжении по крайней мере 3 мес в редких случаях были отмечены случаи симптоматической или асимптоматической гипомагниемии. В большинстве эти сообщения поступали через год после проведения терапии. Серьезными побочными явлениями были тетания, аритмия и судороги. Большинству пациентов требовалось лечение гипомагниемии, включающее замещение магния и отмену терапии ИПП. У пациентов, которые будут получать длительное лечение или которые принимают ИПП с препаратами, такими как дигоксин, или препаратами, которые могут вызвать гипомагниемию (например диуретики), медицинские работники должны контролировать уровень магния до начала лечения ИПП и в период лечения. Пациенты не должны принимать одновременно с препаратом Нофлюкс другие средства, снижающие кислотность, например блокаторы Н2-рецепторов или другие ингибиторы протонного насоса. Переломы: Согласно данным наблюдательных исследований, можно предположить, что терапия ИПП может привести к возрастанию риска связанных с остеопорозом переломов бедра, запястья или позвоночника. Риск переломов был увеличен у пациентов, получавших высокие дозы ИПП длительно (год и более). Одновременное применение рабепразола с метотрексатом: Согласно литературным данным, одновременный прием ИПП с метотрексатом (прежде всего в высоких дозах) может повысить концентрации метотрексата и/или его метаболита гидроксиметотрексата и увеличить T1/2, что может привести к проявлению токсичности метотрексата. При необходимости применения высоких доз метотрексата может быть рассмотрена возможность временного прекращения терапии ИПП. Терапия ИПП может приводить к возрастанию риска желудочно-кишечных инфекций, например вызванных Clostridium difficile. Пациентам, принимающим препарат Нофлюкс для кратковременного симптоматического лечения проявлений ГЭРБ и НЭРБ (например изжога) без рецепта, следует обратиться к врачу в следующих случаях: применение средств для снятия симптомов изжоги и нарушения пищеварения в течение 4 нед и более, появление новых симптомов или изменение ранее наблюдавшихся симптомов у пациентов в возрасте более 55 лет, случаи ненамеренного уменьшения массы тела, анемии, кровотечений в ЖКТ, дисфагии, боли при глотании, постоянной рвоты или рвоты с кровью и содержимым эпигастрия, случаи язвы желудка или операций на желудке в анамнезе, желтухи и т. д. (в т. ч. нарушение функции печени и почек). Пациенты, длительное время страдающие от повторяющихся симптомов нарушения пищеварения или изжоги, должны регулярно наблюдаться у врача. Пациенты в возрасте более 55 лет, ежедневно принимающие безрецептурные препараты для снятия симптомов изжоги и нарушения пищеварения, должны проинформировать об этом своего лечащего врача. Пациенты не должны принимать одновременно с препаратом Нофлюкс другие средства, снижающие кислотность, например блокаторы Н2-рецепторов или другие ИПП. При применении других препаратов пациентам следует проконсультироваться с фармацевтом или врачом перед началом терапии препаратом Нофлюкс, отпускаемым без рецепта. Пациенты должны сообщить врачу перед началом применения препарата Нофлюкс без рецепта, если им назначено эндоскопическое исследование. Следует избегать приема препарата Нофлюкс перед проведением мочевинного дыхательного теста. Пациенты с тяжелыми нарушениями функции печени должны обратиться к врачу перед началом терапии препаратом Нофлюкс, отпускаемым без рецепта, для кратковременного симптоматического лечения проявлений ГЭРБ и НЭРБ (например изжога). Влияние на способность управлять транспортными средствами и работать с механизмами. Исходя из особенностей фармакодинамики рабепразола и его профиля нежелательных эффектов, маловероятно, что Нофлюкс оказывает влияние на способность водить автомобиль и работать с техникой. 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