Язвенная болезнь желудка и двенадцатиперстной кишки в стадии обострения; гастроэзофагеальная рефлюксная болезнь (ГЭРБ): эрозивный рефлюкс-эзофагит (лечение), симптоматическое лечение ГЭРБ, в т.ч. длительная поддерживающая терапия; синдром Золлингера-Эллисона; в составе комплексной терапии: эрадикация Helicobacter pylori у пациентов с язвенной болезнью ...
Повышенная чувствительность к активному веществу или вспомогательным компонентам препарата; беременность; период грудного вскармливания; детский возраст (отсутствует опыт применения). С осторожностью: тяжелая почечная недостаточность.
Язвенная болезнь желудка и двенадцатиперстной кишки в стадии обострения; гастроэзофагеальная рефлюксная болезнь (ГЭРБ): эрозивный рефлюкс-эзофагит (лечение), симптоматическое лечение ГЭРБ, в т.ч. длительная поддерживающая терапия; синдром Золлингера-Эллисона; в составе комплексной терапии: эрадикация Helicobacter pylori у пациентов с язвенной болезнью желудка и двенадцатиперстной кишки или хроническим гастритом; лечение и профилактика рецидива язвенной болезни, связанной с Helicobacter pylori.
Противопоказания
Повышенная чувствительность к активному веществу или вспомогательным компонентам препарата; беременность; период грудного вскармливания; детский возраст (отсутствует опыт применения). С осторожностью: тяжелая почечная недостаточность.
Применение при беременности и в период грудного вскармливания
Беременность. Отсутствуют данные о безопасности применения рабепразола во время беременности у человека. Репродуктивные исследования у крыс и кроликов не выявили признаков нарушения фертильности или вредного воздействия рабепразола на плод. Препарат Зульбекс не применяется во время беременности. Лактация. Исследования у женщин в период лактации не проводились. Неизвестно, секретируется ли рабепразол в материнское молоко, но он секретируется в молоко крыс. При необходимости применения препарата Зульбекс в период лактации, грудное вскармливание следует прекратить
Способ применения и дозы
Язвенная болезнь желудка и двенадцатиперстной кишки в стадии обострения. По 20 мг 1 раз в сутки, утром. У большинства пациентов активная язва двенадцатиперстной кишки заживает в течение 4 нед. Однако некоторым пациентам может потребоваться еще 4 нед. для полного заживления язвы. Активная доброкачественная язва желудка у большинства пациентов заживает в течение 6 нед. Однако у небольшого количества пациентов для полного заживления может потребоваться еще 6 нед. Гастроэзофагеальная рефлюксная болезнь (ГЭРБ): эрозивный рефлюкс-эзофагит (лечение), симптоматическое лечение ГЭРБ. По 20 мг 1 раз в сутки на протяжении от 4 до 8 нед. При длительной терапии может применяться поддерживающая доза препарата Зульбекс - 10–20 мг 1 раз в сутки, в зависимости от ответа пациента на лечение. Симптоматическое лечение ГЭРБ: 10 мг 1 раз в сутки у пациентов без эзофагита. Если за 4 нед. не удается добиться контроля симптомов, необходимо провести дополнительное обследование пациента. После улучшения состояния пациента дальнейший контроль симптомов можно осуществлять при приеме 10 мг 1 раз в сутки, по требованию. Синдром Золлингера-Эллисона. Рекомендуемая стартовая доза для взрослых составляет 60 мг 1 раз в сутки. Дозу можно увеличивать до 120 мг в сутки в зависимости от индивидуальных потребностей пациента. Можно назначать суточную дозу до 100 мг 1 раз в день. Доза 120 мг может потребовать кратного приема, по 60 мг 2 раза в сутки. Терапия проводится до тех пор, пока существуют соответствующие клинические показания. Эрадикация Н. pylori у пациентов с язвенной болезнью желудка и двенадцатиперстной кишки или хроническим гастритом: пациенты с Н. pylori, должны пройти эрадикационную терапию. Рекомендуются следующие комбинации препаратов курсом 7 дней: Препарат Зульбекс по 20 мг 2 раза в сутки + кларитромицин по 500 мг 2 раза в сутки и амоксициллин 1 г 2 раза в сутки. Если схемы эрадикации требуют применения препаратов 1 раз в сутки, препарат Зульбекс необходимо принимать утром, перед завтраком; время суток и прием пищи не влияют на активность рабепразола. Нарушения функции почек и/или печени: коррекция дозы препарата Зульбекс не требуется. Детский возраст: в связи с недостаточностью данных по эффективности и безопасности рабепразола препарат Зульбекс не применяется у детей.
Побочное действие
Классификация частоты развития побочных эффектов Всемирной организации здравоохранения (ВОЗ): очень часто >1/10 часто от > 1/100 до < 1/10 нечасто от > 1/1000 до < 1/100 редко от >1/10000 до < 1/1000 очень редко от < 1/10000, включая отдельные сообщения. В каждой группе нежелательные явления при приеме Зульбекса перечислены в порядке уменьшения их серьезности. Со стороны системы кроветворения: редко: нейтропения, лейкопения, тромбоцитопения, лейкоцитоз. Со стороны иммунной системы: редко: реакции повышенной чувствительности. Нарушения метаболизма и питания: редко: анорексия, увеличение массы тела; очень редко: гипонатриемия. Со стороны нервной системы: часто: головная боль, головокружение, бессонница; нечасто: сонливость, нервозность; редко: депрессия; очень редко: спутанность сознания. Со стороны органов чувств: редко: расстройство зрения. Со стороны сердечно-сосудистой системы: очень редко: периферические отеки. Со стороны дыхательной системы: часто: кашель, фарингит, ринит; нечасто: бронхит, синусит. Со стороны пищеварительной системы: часто: диарея, рвота, тошнота, боль в животе, запор, метеоризм; нечасто: диспепсия, сухость слизистой оболочки полости рта, отрыжка; редко: гастрит, стоматит, изменение вкуса, гепатит, желтуха, печеночная энцефалопатия. Со стороны кожных покровов: нечасто: сыпь, эритема; редко: зуд, потливость, буллезная сыпь; очень редко: мультиформная эритема, токсический эпидермальный некролиз, синдром Стивенса-Джонсона. Со стороны опорно-двигательного аппарата: часто: неспецифическая боль, боль в спине; нечасто: миалгия, судороги икроножных мышц, артралгия. Со стороны мочевыделительной системы: нечасто: инфекции мочевых путей; редко: интерстициальный нефрит. Со стороны репродуктивной системы: очень редко: гинекомастия. Лабораторные показатели: нечасто: повышение активности ферментов печени. Прочее: часто: астения, гриппоподобное заболевание. Существующий опыт преднамеренной или случайной передозировки рабепразолом ограничен. Максимально установленное принятое количество препарата не превышало 60 мг два раза в сутки или 160 мг один раз в сутки. Эффекты были незначительно выражены, соответствовали известному спектру нежелательных реакций, которые проходили самостоятельно без какого-либо дополнительного медицинского вмешательства. Специфический антидот неизвестен. Диализ неэффективен. Лечение симптоматическое
Передозировка
Существующий опыт преднамеренной или случайной передозировки рабепразола ограничен. Максимально установленное принятое количество препарата не превышало 60 мг два раза в сутки или 160 мг один раз в сутки. Эффекты были незначительно выражены, соответствовали известному спектру нежелательных реакций, проходили самостоятельно без какого-либо дополнительного медицинского вмешательства. Специфический антидот неизвестен. Диализ неэффективен. Лечение: симптоматическое
Особые указания
Уменьшение выраженности симптомов на фоне терапии препаратом Зульбекс не исключает наличия злокачественных новообразований в желудке или пищеводе, поэтому перед началом терапии необходимо провести обследование с целью исключения новообразования ЖКТ. Пациенты, получающие длительную терапию препаратом Зульбекс (особенно более одного года), должны проходить регулярное обследование. Нельзя исключить риск перекрестных реакций с другими ингибиторами протонной помпы или с замещенными бензимидазолами. Пациента необходимо предупредить о том, что таблетки необходимо поглатывать целиком, не разжевывая и не разламывая. Препарат Зульбекс не рекомендуется назначать детям, т.к. опыт применения препарата у этой группы пациентов отсутствует. Имеются сообщения постмаркетингового исследования о развитии дискразий крови (случаи тромбоцитопении и нейтропении) на фоне применения рабепразола. В большинстве случаев, когда не удалось выяснить альтернативные причины этих состояний, они не давали осложнений и проходили после отмены рабепразола. На фоне применения препарата Зульбекс возможно изменение активности ферментов печени, проходящее после отмены препарата. В исследовании у пациентов с легкими или умеренными нарушениями функции печени не было отмечено существенных проблем, связанных с безопасностью применения рабепразола, в сравнении с контрольной группой здоровых пациентов, соответствующих по полу и возрасту. Из-за отсутствия клинических данных о применении рабепразола у пациентов с тяжелыми нарушениями функции печени, рекомендуется соблюдать осторожность при применении препарата Зульбекс у этой группы пациентов. Влияние на способность управлять автотранспортом и другими сложными механизмами: исходя из свойств рабепразола, маловероятно, что препарат Зульбекс может нарушать способность управлять транспортными средствами или влиять на работу с техническими устройствами. В случае развития побочных эффектов (сонливость, головокружение, спутанность сознания) следует отказаться от управления транспортным средством и работы, требующей повышенной концентрации внимания и быстроты психомоторных реакций
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активное вещество: рабепразол натрия 20 мг (что соответствует рабепразолу 18,85 мг) вспомогательные вещества: маннитол (Е421) - 37 мг; магния оксид легкий - 60 мг; гипролоза - 5,25 мг; гипролоза низкозамещенная - 25,5 мг; магния стеарат - 2,25 мг оболочка (связующий слой): этилцеллюлоза - 1,2 мг; магния оксид легкий - 1,65 мг оболочка (кишечнорастворимая): гипромеллозы фталат - 13,8 мг; моноглицериды, диацетилированные - 1,4 мг; тальк - 1,3 мг; титана диоксид (Е171) - 0,7 мг; краситель железа оксид желтый (E172) - 0,08 мг"}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противоязвенное"}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Язвенная болезнь желудка и двенадцатиперстной кишки в стадии обострения; гастроэзофагеальная рефлюксная болезнь (ГЭРБ): эрозивный рефлюкс-эзофагит (лечение), симптоматическое лечение ГЭРБ, в т.ч. длительная поддерживающая терапия; синдром Золлингера-Эллисона; в составе комплексной терапии: эрадикация Helicobacter pylori у пациентов с язвенной болезнью желудка и двенадцатиперстной 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":"Повышенная чувствительность к активному веществу или вспомогательным компонентам препарата; беременность; период грудного вскармливания; детский возраст (отсутствует опыт применения). С осторожностью: тяжелая почечная недостаточность."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Беременность. Отсутствуют данные о безопасности применения рабепразола во время беременности у человека. Репродуктивные исследования у крыс и кроликов не выявили признаков нарушения фертильности или вредного воздействия рабепразола на плод. Препарат Зульбекс не применяется во время беременности. Лактация. Исследования у женщин в период лактации не проводились. Неизвестно, секретируется ли рабепразол в материнское молоко, но он секретируется в молоко крыс. При необходимости применения препарата Зульбекс в период лактации, грудное вскармливание следует прекратить"}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Язвенная болезнь желудка и двенадцатиперстной кишки в стадии обострения. По 20 мг 1 раз в сутки, утром. У большинства пациентов активная язва двенадцатиперстной кишки заживает в течение 4 нед. Однако некоторым пациентам может потребоваться еще 4 нед. для полного заживления язвы. Активная доброкачественная язва желудка у большинства пациентов заживает в течение 6 нед. Однако у небольшого количества пациентов для полного заживления может потребоваться еще 6 нед. Гастроэзофагеальная рефлюксная болезнь (ГЭРБ): эрозивный рефлюкс-эзофагит (лечение), симптоматическое лечение ГЭРБ. По 20 мг 1 раз в сутки на протяжении от 4 до 8 нед. При длительной терапии может применяться поддерживающая доза препарата Зульбекс - 10–20 мг 1 раз в сутки, в зависимости от ответа пациента на лечение. Симптоматическое лечение ГЭРБ: 10 мг 1 раз в сутки у пациентов без эзофагита. Если за 4 нед. не удается добиться контроля симптомов, необходимо провести дополнительное обследование пациента. После улучшения состояния пациента дальнейший контроль симптомов можно осуществлять при приеме 10 мг 1 раз в сутки, по требованию. Синдром Золлингера-Эллисона. Рекомендуемая стартовая доза для взрослых составляет 60 мг 1 раз в сутки. Дозу можно увеличивать до 120 мг в сутки в зависимости от индивидуальных потребностей пациента. Можно назначать суточную дозу до 100 мг 1 раз в день. Доза 120 мг может потребовать кратного приема, по 60 мг 2 раза в сутки. Терапия проводится до тех пор, пока существуют соответствующие клинические показания. Эрадикация Н. pylori у пациентов с язвенной болезнью желудка и двенадцатиперстной кишки или хроническим гастритом: пациенты с Н. pylori, должны пройти эрадикационную терапию. Рекомендуются следующие комбинации препаратов курсом 7 дней: Препарат Зульбекс по 20 мг 2 раза в сутки + кларитромицин по 500 мг 2 раза в сутки и амоксициллин 1 г 2 раза в сутки. Если схемы эрадикации требуют применения препаратов 1 раз в сутки, препарат Зульбекс необходимо принимать утром, перед завтраком; время суток и прием пищи не влияют на активность рабепразола. Нарушения функции почек и/или печени: коррекция дозы препарата Зульбекс не требуется. Детский возраст: в связи с недостаточностью данных по эффективности и безопасности рабепразола препарат Зульбекс не применяется у детей."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Классификация частоты развития побочных эффектов Всемирной организации здравоохранения (ВОЗ): очень часто \u003e1/10 часто от \u003e 1/100 до \u003c 1/10 нечасто от \u003e 1/1000 до \u003c 1/100 редко от \u003e1/10000 до \u003c 1/1000 очень редко от \u003c 1/10000, включая отдельные сообщения. В каждой группе нежелательные явления при приеме Зульбекса перечислены в порядке уменьшения их серьезности. Со стороны системы кроветворения: редко: нейтропения, лейкопения, тромбоцитопения, лейкоцитоз. Со стороны иммунной системы: редко: реакции повышенной чувствительности. Нарушения метаболизма и питания: редко: анорексия, увеличение массы тела; очень редко: гипонатриемия. Со стороны нервной системы: часто: головная боль, головокружение, бессонница; нечасто: сонливость, нервозность; редко: депрессия; очень редко: спутанность сознания. Со стороны органов чувств: редко: расстройство зрения. Со стороны сердечно-сосудистой системы: очень редко: периферические отеки. Со стороны дыхательной системы: часто: кашель, фарингит, ринит; нечасто: бронхит, синусит. Со стороны пищеварительной системы: часто: диарея, рвота, тошнота, боль в животе, запор, метеоризм; нечасто: диспепсия, сухость слизистой оболочки полости рта, отрыжка; редко: гастрит, стоматит, изменение вкуса, гепатит, желтуха, печеночная энцефалопатия. Со стороны кожных покровов: нечасто: сыпь, эритема; редко: зуд, потливость, буллезная сыпь; очень редко: мультиформная эритема, токсический эпидермальный некролиз, синдром Стивенса-Джонсона. Со стороны опорно-двигательного аппарата: часто: неспецифическая боль, боль в спине; нечасто: миалгия, судороги икроножных мышц, артралгия. Со стороны мочевыделительной системы: нечасто: инфекции мочевых путей; редко: интерстициальный нефрит. Со стороны репродуктивной системы: очень редко: гинекомастия. Лабораторные показатели: нечасто: повышение активности ферментов печени. Прочее: часто: астения, гриппоподобное заболевание. Существующий опыт преднамеренной или случайной передозировки рабепразолом ограничен. Максимально установленное принятое количество препарата не превышало 60 мг два раза в сутки или 160 мг один раз в сутки. Эффекты были незначительно выражены, соответствовали известному спектру нежелательных реакций, которые проходили самостоятельно без какого-либо дополнительного медицинского вмешательства. Специфический антидот неизвестен. Диализ неэффективен. Лечение симптоматическое"}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Существующий опыт преднамеренной или случайной передозировки рабепразола ограничен. Максимально установленное принятое количество препарата не превышало 60 мг два раза в сутки или 160 мг один раз в сутки. Эффекты были незначительно выражены, соответствовали известному спектру нежелательных реакций, проходили самостоятельно без какого-либо дополнительного медицинского вмешательства. Специфический антидот неизвестен. Диализ неэффективен. Лечение: симптоматическое"}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Уменьшение выраженности симптомов на фоне терапии препаратом Зульбекс не исключает наличия злокачественных новообразований в желудке или пищеводе, поэтому перед началом терапии необходимо провести обследование с целью исключения новообразования ЖКТ. Пациенты, получающие длительную терапию препаратом Зульбекс (особенно более одного года), должны проходить регулярное обследование. Нельзя исключить риск перекрестных реакций с другими ингибиторами протонной помпы или с замещенными бензимидазолами. Пациента необходимо предупредить о том, что таблетки необходимо поглатывать целиком, не разжевывая и не разламывая. Препарат Зульбекс не рекомендуется назначать детям, т.к. опыт применения препарата у этой группы пациентов отсутствует. 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Влияние на способность управлять автотранспортом и другими сложными механизмами: исходя из свойств рабепразола, маловероятно, что препарат Зульбекс может нарушать способность управлять транспортными средствами или влиять на работу с техническими устройствами. 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