Омепразол Капсулы, 30 шт, 20 мг

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Прием пищи не влияет на биодоступность омепразола."}},{"type":"paragraph","data":{"text":"Показатель связываемости омепразола с белками плазмы составляет около 95 % объём распределения составляет 03 л/кг."}},{"type":"paragraph","data":{"text":"Метаболизм"}},{"type":"paragraph","data":{"text":"Омепразол полностью метаболизируется в печени. Основные ферменты участвующие в процессе метаболизма CYP2C19 и CYP3A4. Образующиеся метаболиты - сульфон- сульфид- и гидрокси-омепразол не оказывают значительного влияния на секрецию соляной кислоты."}},{"type":"paragraph","data":{"text":"Общий плазменный клиренс составляет 03-06 л/мин. Биодоступность омепразола увеличивается приблизительно на 50 % при повторном приеме по сравнению с приемом разовой дозы."}},{"type":"paragraph","data":{"text":"Выведение"}},{"type":"paragraph","data":{"text":"Период полувыведения составляет около 40 минут (30-90 минут). Около 80 % выводится в виде метаболитов почками а остальная часть - кишечником."}},{"type":"paragraph","data":{"text":"Особые группы пациентов"}},{"type":"paragraph","data":{"text":"Не отмечено значительных изменений биодоступности омепразола у пожилых пациентов или пациентов с нарушенной функцией почек. У пациентов с нарушенной функцией печени отмечается увеличение биодоступности омепразола и значительное уменьшение плазменного клиренса."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Взрослые"}},{"type":"paragraph","data":{"text":"- язвенная болезнь желудка и двенадцатиперстной кишки (в фазе обострения и противорецидивное лечение) в т.ч. ассоциированная с Helicobacterpylori (в составе комплексной терапии);"}},{"type":"paragraph","data":{"text":"- эрозивно-язвенные поражения желудка и двенадцатиперстной кишки связанные с приемом нестероидных противовоспалительных препаратов (НПВП);"}},{"type":"paragraph","data":{"text":"- рефлюкс-эзофагит;"}},{"type":"paragraph","data":{"text":"- симптоматическая гастроэзофагеальная рефлюксная болезнь;"}},{"type":"paragraph","data":{"text":"- диспепсия связанная с повышенной кислотностью;"}},{"type":"paragraph","data":{"text":"- синдром Золлингера-Эллисона."}},{"type":"paragraph","data":{"text":"Дети и подростки"}},{"type":"paragraph","data":{"text":"Дети старше 2 лет с массой тела не менее 20 кг:"}},{"type":"paragraph","data":{"text":"- рефлюкс-эзофагит;"}},{"type":"paragraph","data":{"text":"- симптоматическая гастроэзофагеальная рефлюксная болезнь."}},{"type":"paragraph","data":{"text":"Дети старше 4 лет и подростки:"}},{"type":"paragraph","data":{"text":"- язва двенадцатиперстной кишки вызванная Helicobacterpylori."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- Дефицит сахарозы/изомальтазы непереносимость фруктозы глюкозо-галактозная мальабсорбция;"}},{"type":"paragraph","data":{"text":"- повышенная чувствительность к омепразолу или другим компонентам препарата;"}},{"type":"paragraph","data":{"text":"- одновременное применение с нелфинавиром эрлотинибом и позаконазолом препаратами зверобоя продырявленного;"}},{"type":"paragraph","data":{"text":"- совместное применение с кларитромицином у пациентов с печеночной недостаточностью;"}},{"type":"paragraph","data":{"text":"- детский возраст до 2 лет;"}},{"type":"paragraph","data":{"text":"- детский возраст старше 2 лет по другим показаниям кроме лечения рефлюкс-эзофагита и симптоматической гастроэзофагеальной рефлюксной болезни;"}},{"type":"paragraph","data":{"text":"- детский возраст старше 4 лет по другим показаниям кроме лечения рефлюкс-эзофагита симптоматической гастроэзофагеальной рефлюксной болезни и язвы двенадцатиперстной кишки вызванной Helicobacterpylori."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"- Почечная и/или печеночная недостаточность;"}},{"type":"paragraph","data":{"text":"- пациентам с остеопорозом;"}},{"type":"paragraph","data":{"text":"- беременность;"}},{"type":"paragraph","data":{"text":"- одновременное применение с атазанавиром (доза омепразола не должна превышать 20 мг в сутки) клопидогрелом итраконазолом варфарином цилостазолом диазепамом фенитоином саквинавиром такролимусом кларитромицином вориконазолом рифампицином;"}},{"type":"paragraph","data":{"text":"- наличие \"тревожных\" симптомов: значительное снижение массы тела повторяющаяся рвота рвота с примесью крови нарушение глотания изменение цвета кала (дегтеобразный стул);"}},{"type":"paragraph","data":{"text":"- дефицит витамина В12 (цианокобаламина)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Препарат разрешен для применения при беременности и в период грудного вскармливания."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь запивая небольшим количеством воды (содержимое капсулы нельзя разжевывать). Язвенная болезнь двенадцатиперстной кишки в фазе обострения - по 20мг в сутки в течение 2-4 недель (в резистентных случаях до 40 мг в сутки)."}},{"type":"paragraph","data":{"text":"Язвенная болезнь желудка в фазе обострения и эрозивно-язвенный эзофагит - по 20-40 мг в сутки в течение 4-8 недель."}},{"type":"paragraph","data":{"text":"Эрозивно-язвенные поражения желудочно-кишечного тракта вызванные приемом НПВП"}},{"type":"paragraph","data":{"text":"- по 20 мг в сутки в течение 4-8 недель."}},{"type":"paragraph","data":{"text":"Эрадикация Helicobacter pylori - по 20 мг 2 раза в сутки в течение 7 или 14 дней (в зависимости от применяемой схемы лечения) в сочетании с антибактериальными средствами."}},{"type":"paragraph","data":{"text":"Противорецидивное лечение язвенной болезни желудка и 12-перстной кишки - по 20 мг в сутки."}},{"type":"paragraph","data":{"text":"Противорецидивное лечение рефлюкс-эзофагита - 20 мг в сутки в течение длительного времени (до 6 месяцев). Прием по требованию (симптоматическое лечение)."}},{"type":"paragraph","data":{"text":"Синдром Золлингера-Эллисона - доза подбирается индивидуально в зависимости от исходного уровня желудочной секреции обычно начиная с 60 мг в сутки. При необходимости дозу увеличивают до 80 -120 мг в сутки в этом случае ее делят на 2 приема."}},{"type":"paragraph","data":{"text":"У больных с тяжелой печеночной недостаточностью суточная доза не должна превышать 20 мг."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Побочные эффекты омепразола обычно бывают незначительными и обратимыми. Возможно появление указанных ниже побочных эффектов, которые разделены по системно-органным классам в соответствии с классификацией Медицинского словаря по нормативно-правовой деятельности (MedDRA). Для указания частоты встречаемости побочных эффектов была использована классификация ВОЗ: очень часто (≥10%), часто (≥1% и < 10%), нечасто (≥0.1% и < 1%), редко (≥0.01% и < 0.1%), очень редко (< 0.01%), неизвестная частота (по имеющимся данным определить частоту встречаемости побочного эффекта не представляется возможным)."}},{"type":"paragraph","data":{"text":"Со стороны системы кроветворения: редко - лейкопения, тромбоцитопения; очень редко - агранулоцитоз, панцитопения."}},{"type":"paragraph","data":{"text":"Со стороны иммунной системы: редко - реакции гиперчувствительности (например, лихорадка, ангионевротический отек, анафилактическая реакция/анафилактический шок)."}},{"type":"paragraph","data":{"text":"Со стороны обмена веществ: редко — гипонатриемия; неизвестная частота — гипомагниемия."}},{"type":"paragraph","data":{"text":"Психические нарушения: нечасто - бессонница; редко - возбуждение, спутанность сознания, депрессия; очень редко - агрессия, галлюцинации."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: часто - головная боль; нечасто - головокружение, парестезии, сонливость; редко - нарушение вкуса."}},{"type":"paragraph","data":{"text":"Со стороны органа зрения: редко - нечеткость зрения."}},{"type":"paragraph","data":{"text":"Со стороны органа слуха и лабиринтные нарушения: нечасто - головокружение."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: редко - бронхоспазм."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: часто - диарея, запор, тошнота, рвота, метеоризм, боль в животе; нечасто - повышение активности печеночных ферментов; редко - сухость во рту, стоматит, кандидоз ЖКТ, гепатит (с желтухой или без); очень редко - печеночная недостаточность, энцефалопатия у пациентов с заболеваниями печени."}},{"type":"paragraph","data":{"text":"Со стороны кожи и подкожных тканей: нечасто - дерматит, зуд, сыпь, крапивница; редко - алопеция, фотосенсибилизация; очень редко - многоформная эритема, синдром Стивенса-Джонсона, токсический эпидермальный некролиз."}},{"type":"paragraph","data":{"text":"Со стороны костно-мышечной системы: нечасто - переломы бедра, костей запястья и позвонков; редко - артралгия, миалгия; очень редко - мышечная слабость."}},{"type":"paragraph","data":{"text":"Со стороны мочевыделительной системы: редко - интерстициальный нефрит."}},{"type":"paragraph","data":{"text":"Со стороны половых органов и молочной железы: очень редко - гинекомастия."}},{"type":"paragraph","data":{"text":"Общие нарушения и нарушения в месте введения: нечасто - недомогание, периферические отеки; редко - повышенная потливость."}},{"type":"paragraph","data":{"text":"Сообщалось о случаях образования желудочных гландулярных кист во время длительного лечения ингибиторами протонового насоса (следствие ингибирования секреции соляной кислоты, носит доброкачественный обратимый характер)."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомами передозировки являются нарушение зрения сонливость возбуждение спутанность сознания головная боль повышение потоотделения сухость во рту тошнота аритмия."}},{"type":"paragraph","data":{"text":"Специфического антидота не существует. Лечение симптоматическое. Гемодиализ - недостаточно эффективен."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Длительное применение омепразола в дозе 20 мг 1 раз в сутки в комбинации с кофеином теофиллином пироксикамом диклофенаком напроксеном метопрололом пропранололом этанолом циклоспорином лидокаином хинидином и эстрадиолом не приводило к изменению их концентрации в плазме."}},{"type":"paragraph","data":{"text":"При одновременном применении с омепразолом может наблюдаться увеличение или снижение абсорбции препаратов биодоступность которых в большей степени определяется кислотностью желудочного сока (в т.ч. эрлотиниб кетоконазол итраконазол позаконазол препараты железа и цианокобаламин)."}},{"type":"paragraph","data":{"text":"При одновременном применении с омепразолом может наблюдаться значительное снижение плазменной концентрации атазанавира и нелфинавира."}},{"type":"paragraph","data":{"text":"При одновременном применении с омепразолом отмечается повышение плазменной концентрации саквинавира/ритонавира до 70 % при этом переносимость лечения пациентами с ВИЧ-инфекцией не ухудшается."}},{"type":"paragraph","data":{"text":"Биодоступность дигоксина при одновременном применении с 20 мг омепразола повышается на 10 %. Следует соблюдать осторожность при одновременном применении этих препаратов у пожилых пациентов."}},{"type":"paragraph","data":{"text":"При одновременном применении с омепразолом возможно повышение плазменной концентрации и увеличение периода полувыведения варфарина (R- варфарин) или других антагонистов витамина К цилостазола диазепама фенитоина а также других препаратов метаболизирующихся в печени посредством изофермента CYP2C19 (может потребоваться снижение доз этих препаратов). Сопутствующее лечение омепразолом в суточной дозе 20 мг приводит к изменению времени коагуляции у пациентов длительно принимающих варфарин поэтому при применении омепразола пациентами получающими варфарин или другие антагонисты витамина К необходимо контролировать Международное нормализованное отношение (МНО); в ряде случаев может понадобиться снижение дозы варфарина или другого антагониста витамина К."}},{"type":"paragraph","data":{"text":"Применение омепразола в дозе 40 мг один раз в сутки приводило к увеличению максимальной плазменной концентрации и AUC цилостазола на 18 % и 26 % соответственно; для одного из активных метаболитов цилостазола увеличение составило 29 % и 69 % соответственно."}},{"type":"paragraph","data":{"text":"Омепразол при одновременном применении повышает плазменную концентрацию такролимуса что может потребовать коррекции дозы. В период комбинированного лечения следует тщательно контролировать концентрацию такролимуса в плазме крови и функцию почек (клиренс креатинина)."}},{"type":"paragraph","data":{"text":"Индукторы изоферментов CYP2C19 и CYP3A4 (например рифампицин препараты зверобоя продырявленного (Hypericum perforatum) при одновременном применении с омепразолом могут увеличить его метаболизм снижая тем самым его концентрацию в плазме."}},{"type":"paragraph","data":{"text":"Не отмечено взаимодействия с одновременно принимаемыми антацидами. Может снижать абсорбцию эфиров ампициллина солей железа итраконазола и кетоконазола (омепразол повышает pH желудка). Являясь ингибитором цитохрома Р450 может повышать концентрацию и снижать выведение диазепама антикоагулянтов непрямого действия фенитоина (лекарственные средства которые метаболизируются в печени посредством цитохрома CYP2C19) что в некоторых случаях может потребовать уменьшения доз этих лекарственных средств. Усиливает ингибирующее действие на систему кроветворения других лекарственных средств."}},{"type":"paragraph","data":{"text":"При совместном применении метотрексата с ингибиторами протонной помпы у некоторых пациентов наблюдалось незначительное повышение концентрации метотрексата в крови. При лечении высокими дозами метотрексата следует временно прекратить прием омепразола."}},{"type":"paragraph","data":{"text":"При совместном приеме омепразола с кларитромицином или эритромицином концентрация омепразола в плазме крови повышается."}},{"type":"paragraph","data":{"text":"Совместный прием омепразола с амоксициллином или метронидазолом не влияет на концентрацию омепразола в плазме крови."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Перед началом терапии необходимо исключить наличие злокачественного процесса (особенно при язве желудка) т.к. лечение маскируя симптоматику может отсрочить постановку правильного диагноза."}},{"type":"paragraph","data":{"text":"Прием одновременно с пищей не влияет на его эффективность."}},{"type":"paragraph","data":{"text":"При возникновении трудностей с проглатыванием целой капсулы можно проглотить ее содержимое после вскрытия или рассасывания капсулы а также можно смешать содержимое капсулы со слегка подкисленной жидкостью (соком йогуртом) и использовать полученную суспензию в течение 30 мин."}},{"type":"paragraph","data":{"text":"В обычных дозировках препарат не оказывает влияния на скорость психомоторных реакций и концентрацию внимания."}},{"type":"paragraph","data":{"text":"По результатам исследований отмечено фармакокинетическое/фармакодинамическое взаимодействие между клопидогрелом (нагрузочная доза 300 мг и поддерживающая доза 75 мг/сут) и омепразолом (80 мг/сут внутрь) которое приводит к снижению экспозиции к активному метаболиту клопидогрела в среднем на 46 % и снижению максимального ингибирования АДФ-индуцированной агрегации тромбоцитов в среднем на 16 %. Поэтому следует избегать одновременного применения омепразола и клопидогрела."}},{"type":"paragraph","data":{"text":"Вследствие снижения секреции соляной кислоты повышается концентрация хромогранина A(CgA). Повышение концентрации CgA в плазме крови может оказывать влияние на результаты обследований для выявления нейроэндокринных опухолей. Для предотвращения данного влияния необходимо временно прекратить прием омепразола за 5 дней до проведения исследования концентрации CgA."}},{"type":"paragraph","data":{"text":"Препарат следует принимать с осторожностью если присутствует один из следующих симптомов или состояний: наличие \"тревожных\" симптомов - значительное снижение массы тела повторяющаяся рвота рвота с примесью крови нарушение глотания изменение цвета кала (дегтеобразный стул)."}},{"type":"paragraph","data":{"text":"Ингибиторы протонного насоса особенно при применении препарата в высоких дозах и при длительном применении (> 1 года) могут умеренно повышать риск переломов бедра костей запястья и позвонков особенно у пожилых пациентов или при наличии других факторов риска."}},{"type":"paragraph","data":{"text":"В рандомизированных двойных слепых контролируемых клинических исследованиях омепразола и эзомепразола включая два открытых исследования с длительностью терапии более 12 лет не была подтверждена связь переломов на фоне остеопороза с применением ингибиторов протонного насоса."}},{"type":"paragraph","data":{"text":"Хотя причинно-следственная связь применения омепразола/эзомепразола с переломами на фоне остеопороза не установлена пациенты с риском развития остеопороза или переломов на его фоне должны находиться под соответствующим клиническим наблюдением. У пациентов получавших омепразол на протяжении как минимум трех месяцев была зарегистрирована тяжелая гипомагниемия проявляющаяся такими симптомами как: утомляемость бред судороги головокружение и желудочковая аритмия. У большинства пациентов гипомагниемия купировалась после отмены ингибиторов протонного насоса и введением препаратов магния."}},{"type":"paragraph","data":{"text":"У пациентов которым планируется длительная терапия или которым назначен омепразол с дигоксином или другими препаратами способными вызвать гипомагниемию (например диуретики) следует оценить содержание магния до начала терапии и периодически контролировать его во время лечения."}},{"type":"paragraph","data":{"text":"Омепразол как и все лекарственные средства снижающие кислотность может приводить к снижению всасывания витамина В12 (цианокобаламина). Об этом необходимо помнить в отношении пациентов со сниженным запасом витамина В12 в организме или с факторами риска нарушения всасывания витамина В12 при длительной терапии."}},{"type":"paragraph","data":{"text":"У пациентов принимающих препараты понижающие секрецию желез желудка в течение длительного времени чаще отмечается образование железистых кист в желудке которые проходят самостоятельно на фоне продолжения терапии. Эти явления обусловлены физиологическими изменениями в результате ингибирования секреции соляной кислоты."}},{"type":"paragraph","data":{"text":"Снижение секреции соляной кислоты в желудке под действием ингибиторов протонной помпы или других кислотоингибирующих агентов приводит к повышению роста нормальной микрофлоры кишечника что в свою очередь может приводить к незначительному увеличению риска развития кишечных инфекций вызванных бактериями рода Salmonellaspp. и Campylobacterspp. а также вероятно бактерий Clostridiumdifficile у госпитализированных пациентов."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"При приеме препарата может возникнуть головокружение сонливость нарушение зрения поэтому следует соблюдать осторожность при управлении транспортными средствами и занятиях потенциально опасными видами деятельности требующих повышенной концентрации внимания и скорости психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы 20 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от света и влаги 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 применять после истечения срока годности указанного на упаковке."}}]},{"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":"ОАО \"АВВА РУС\", 610044, Кировская обл., г. Киров, ул. Луганская, д.53а, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ОАО \"АВВА РУС\""}}]}],"source":null},"description_toggle":false,"short_description":"Ингибирует фермент Н+К+АТФ-азу (\"протонный насос\") в париетальных клетках желудка и тем самым блокирует заключительную стадию синтеза соляной кислоты. Это приводит к снижению уровня базальной и стимулированной секреции независимо от природы раздражителя. После однократного приема препарата внутрь действие омепразола наступает в течение первого часа и продолжается в течение 24 часов максимум эффекта достигается через 2 часа. После прекращения приема препарата секреторная активность полностью восстанавливается через 3-5 суток. Вследствие снижения секреции соляной кислоты повышается концентрация хромогранина A (CgA). Повышение концентрации CgA в плазме крови может оказывать влияние на результаты обследований для выявления нейроэндокринных опухолей. Распределение Омепразол абсорбируется в тонкой кишке обычно в течение 3-6 часов. Биодоступность после приема внутрь составляет приблизительно 60 %. Прием пищи не влияет на биодоступность омепразола. Показатель связываемости омепразола с белками плазмы составляет около 95 % объём распределения составляет 03 л/кг. Метаболизм Омепразол полностью метаболизируется в печени. Основные ферменты участвующие в процессе метаболизма CYP2C19 и CYP3A4. Образующиеся метаболиты - сульфон- сульфид- и гидрокси-омепразол не оказывают значительного влияния на секрецию соляной кислоты. Общий плазменный клиренс составляет 03-06 л/мин. Биодоступность омепразола увеличивается приблизительно на 50 % при повторном приеме по сравнению с приемом разовой дозы. Выведение Период полувыведения составляет около 40 минут (30-90 минут). Около 80 % выводится в виде метаболитов почками а остальная часть - кишечником. 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