- Язвенная болезнь желудка и двенадцатиперстной кишки;
- рефлюкс-эзофагит;
- эрозивно-язвенные поражения желудка и двенадцатиперстной кишки связанные с приемом нестероидных противовоспалительных препаратов (НПВП) стрессовые язвы;
- эрозивно-язвенные поражения желудка и двенадцатиперстной кишки ассоциированные Helicobacter pylori (в составе комплексной ...
Крышечка: хинолиновый желтый (Е104) 0,375 мг, титана диоксид (Е 171) 0,579 мг, вода 3,654 мг, желатин 20,590 мг.
Корпус: хинолиновый желтый (Е 104) 0,563 мг, титана диоксид (Е 171) 0,869 мг, вода 5,481 мг, желатин 30,886 мг.
Описание
Твердые желатиновые капсулы № 2 с желтой непрозрачной крышечкой и желтым непрозрачным корпусом. Содержимое капсул сферические микрогранулы белого или почти белого с желтоватым оттенком цвета.
Фармакотерапевтическая группа
Желез желудка секрецию понижающее средство - протонного насоса ингибитор
Фармакологические свойства
Фармакодинамика:
Омепразол ингибирует фермент Н+/К+ АТФ-азу ("протоновый насос") в париетальных клетках желудка и блокирует тем самым 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. У больных с язвенной болезнью двенадцатиперстной кишки прием 20 мг омепразола поддерживает внутри желудочный pH - 30 в течение 17 ч. После прекращения приема препарата секреторная активность полностью восстанавливается через 3-5 суток.
Фармакокинетика:
Всасывание
Омепразол быстро абсорбируется из желудочно-кишечного тракта пик концентрации в плазме достигается через 05 - 1 час. Биодоступность составляет 30-40%.
Распределение и метаболизм
Связывание с белками плазмы - около 90%. Омепразол практически полностью метаболизируется в печени с участием ферментной системы CYP2C19 с образованием 6 метаболитов (гидроксиомепразол сульфидные и сульфоновые производные и др.) фармакологически неактивных. Является ингибитором изофермента CYP2C19.
Выведение
Период полувыведения - 05-1 час. Выводится в основном почками в виде метаболитов. Выведение почками (70-80%) и с желчью (20-30%).
В особых клинических случаях
При хронической почечной недостаточности выведение снижается пропорционально снижению клиренса креатинина. У пациентов пожилого возраста выведение уменьшается биодоступность повышается. При печеночной недостаточности биодоступность - 100 % период полувыведения - 3 часа.
Показания к применению
- Язвенная болезнь желудка и двенадцатиперстной кишки;
- рефлюкс-эзофагит;
- эрозивно-язвенные поражения желудка и двенадцатиперстной кишки связанные с приемом нестероидных противовоспалительных препаратов (НПВП) стрессовые язвы;
- эрозивно-язвенные поражения желудка и двенадцатиперстной кишки ассоциированные Helicobacter pylori (в составе комплексной терапии);
- синдром Золлингера-Эллисона.
Противопоказания
Повышенная чувствительность к препарату печеночная недостаточность детский возраст беременность период лактации.
Применение при беременности и в период грудного вскармливания
Противопоказано.
Способ применения и дозы
Внутрь запивая небольшим количеством воды (содержимое капсулы нельзя разжевывать).
Язвенная болезнь двенадцатиперстной кишки в фазе обострения - по 1 капсуле (20 мг) в сутки в течение 2-4 недель (в резистентных случаях до 2 капсул в сутки).
Язвенная болезнь желудка в фазе обострения и эрозивно-язвенный эзофагит - по 1-2 капсулы в сутки в течение 4-8 недель.
Эрозивно-язвенные поражения желудочно-кишечного тракта вызванные приемом НПВП - по 1 капсуле в сутки в течение 4-8 недель.
Эрадикация Helicobacter pylori - по 1 капсуле 2 раза в сутки в течение 7 дней в сочетании с антибактериальными средствами.
Противорецидивное лечение язвенной болезни желудка и 12 перстной кишки - по 1 капсуле в сутки.
Противорецидивное лечение рефлюкс-эзофагита - 1 капсула в сутки в течение длительного времени (до 6 месяцев).
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.
Побочное действие
В редких случаях могут возникать следующие обычно обратимые побочные явления:
Со стороны органов пищеварения: диарея или запор тошнота рвота метеоризм боль в животе сухость во рту нарушения вкуса стоматит транзиторное повышение активности "печеночных" ферментов в плазме; у больных с предшествующим тяжелым заболеванием печени - гепатит (в т.ч. с желтухой) нарушение функции печени.
Со стороны нервной системы: у больных с тяжелыми сопутствующими соматическими заболеваниями - головокружение головная боль возбуждение депрессия сонливость парестезии бессонница галлюцинации; у больных с предшествующим тяжелым заболеванием печени - энцефалопатия.
Со стороны опорно-двигательного аппарата: артралгия мышечная слабость миалгия.
Со стороны системы кроветворения: лейкопения тромбоцитопения в отдельных случаях - агранулоцитоз панцитопения.
Со стороны кожных покровов: зуд редко в отдельных случаях - фотосенсибилизация мультиформная эритема алопеция.
Прочие: недомогание нарушение зрения периферические отеки усиление потоотделения лихорадка гинекомастия; редко - образование желудочных гландулярных кист во время длительного лечения (следствие ингибирования секреции соляной кислоты носит доброкачественный обратимый характер).
Передозировка
Симптомы: нарушение зрения сонливость возбуждение спутанность сознания головная боль повышение потоотделения сухость во рту тошнота аритмия.
Взаимодействие с другими лекарственными средствами
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 крови.
Не отмечено взаимодействия с одновременно принимаемыми антацидами.
Изменяет биодоступность любого препарата всасывание которого зависит от значения pH (например солей железа).
Являясь ингибитором цитохрома Р450 может повышать концентрацию и снижать выведение диазепама антикоагулянтов непрямого действия фенитоина (ЛС которые метаболизируются в печени посредством цитохрома CYP2C19) что в некоторых случаях может потребовать уменьшения доз этих лекарственных средств. Усиливает ингибирующее действие на систему кроветворения др. ЛС.
Особые указания
Перед началом терапии необходимо исключить наличие злокачественного процесса (особенно при язвенной болезни желудка) т.к. лечение маскируя симптоматику может отсрочить постановку правильного диагноза.
Прием препарата одновременно с пищей не влияет на его эффективность.
У больных с тяжелой печеночной недостаточностью суточная доза не должна превышать 20 мг.
Форма выпуска
Капсулы по 20 мг.
Условия хранения
При температуре не выше 30°С. Хранить в недоступном для детей месте.
Срок годности
3 года.
Не применять по истечении срока годности указанного на упаковке.
Условия отпуска
По рецепту
Производитель
ЗАО "Гедеон Рихтер-РУС", 140132, Московская область, Егорьевский р-н, пос. Шувое, ул. Лесная, д.40, Россия
Организация, принимающая претензии потребителей
Лабораториос Ликонса С.А.
Для описания товара использована информация от партнера 36.6
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мг, желатин 30,886 мг."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Твердые желатиновые капсулы № 2 с желтой непрозрачной крышечкой и желтым непрозрачным корпусом. Содержимое капсул сферические микрогранулы белого или почти белого с желтоватым оттенком цвета."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Желез желудка секрецию понижающее средство - протонного насоса ингибитор"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Омепразол ингибирует фермент Н+/К+ АТФ-азу (\"протоновый насос\") в париетальных клетках желудка и блокирует тем самым 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. У больных с язвенной болезнью двенадцатиперстной кишки прием 20 мг омепразола поддерживает внутри желудочный pH - 30 в течение 17 ч. После прекращения приема препарата секреторная активность полностью восстанавливается через 3-5 суток."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Всасывание"}},{"type":"paragraph","data":{"text":"Омепразол быстро абсорбируется из желудочно-кишечного тракта пик концентрации в плазме достигается через 05 - 1 час. Биодоступность составляет 30-40%."}},{"type":"paragraph","data":{"text":"Распределение и метаболизм"}},{"type":"paragraph","data":{"text":"Связывание с белками плазмы - около 90%. Омепразол практически полностью метаболизируется в печени с участием ферментной системы CYP2C19 с образованием 6 метаболитов (гидроксиомепразол сульфидные и сульфоновые производные и др.) фармакологически неактивных. Является ингибитором изофермента CYP2C19."}},{"type":"paragraph","data":{"text":"Выведение"}},{"type":"paragraph","data":{"text":"Период полувыведения - 05-1 час. Выводится в основном почками в виде метаболитов. Выведение почками (70-80%) и с желчью (20-30%)."}},{"type":"paragraph","data":{"text":"В особых клинических случаях"}},{"type":"paragraph","data":{"text":"При хронической почечной недостаточности выведение снижается пропорционально снижению клиренса креатинина. У пациентов пожилого возраста выведение уменьшается биодоступность повышается. При печеночной недостаточности биодоступность - 100 % период полувыведения - 3 часа."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"- Язвенная болезнь желудка и двенадцатиперстной кишки;"}},{"type":"paragraph","data":{"text":"- рефлюкс-эзофагит;"}},{"type":"paragraph","data":{"text":"- эрозивно-язвенные поражения желудка и двенадцатиперстной кишки связанные с приемом нестероидных противовоспалительных препаратов (НПВП) стрессовые язвы;"}},{"type":"paragraph","data":{"text":"- эрозивно-язвенные поражения желудка и двенадцатиперстной кишки ассоциированные Helicobacter pylori (в составе комплексной терапии);"}},{"type":"paragraph","data":{"text":"- синдром Золлингера-Эллисона."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к препарату печеночная недостаточность детский возраст беременность период лактации."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказано."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь запивая небольшим количеством воды (содержимое капсулы нельзя разжевывать)."}},{"type":"paragraph","data":{"text":"Язвенная болезнь двенадцатиперстной кишки в фазе обострения - по 1 капсуле (20 мг) в сутки в течение 2-4 недель (в резистентных случаях до 2 капсул в сутки)."}},{"type":"paragraph","data":{"text":"Язвенная болезнь желудка в фазе обострения и эрозивно-язвенный эзофагит - по 1-2 капсулы в сутки в течение 4-8 недель."}},{"type":"paragraph","data":{"text":"Эрозивно-язвенные поражения желудочно-кишечного тракта вызванные приемом НПВП - по 1 капсуле в сутки в течение 4-8 недель."}},{"type":"paragraph","data":{"text":"Эрадикация Helicobacter pylori - по 1 капсуле 2 раза в сутки в течение 7 дней в сочетании с антибактериальными средствами."}},{"type":"paragraph","data":{"text":"Противорецидивное лечение язвенной болезни желудка и 12 перстной кишки - по 1 капсуле в сутки."}},{"type":"paragraph","data":{"text":"Противорецидивное лечение рефлюкс-эзофагита - 1 капсула в сутки в течение длительного времени (до 6 месяцев)."}},{"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."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"В редких случаях могут возникать следующие обычно обратимые побочные явления:"}},{"type":"paragraph","data":{"text":"Со стороны органов пищеварения: диарея или запор тошнота рвота метеоризм боль в животе сухость во рту нарушения вкуса стоматит транзиторное повышение активности \"печеночных\" ферментов в плазме; у больных с предшествующим тяжелым заболеванием печени - гепатит (в т.ч. с желтухой) нарушение функции печени."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: у больных с тяжелыми сопутствующими соматическими заболеваниями - головокружение головная боль возбуждение депрессия сонливость парестезии бессонница галлюцинации; у больных с предшествующим тяжелым заболеванием печени - энцефалопатия."}},{"type":"paragraph","data":{"text":"Со стороны опорно-двигательного аппарата: артралгия мышечная слабость миалгия."}},{"type":"paragraph","data":{"text":"Со стороны системы кроветворения: лейкопения тромбоцитопения в отдельных случаях - агранулоцитоз панцитопения."}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов: зуд редко в отдельных случаях - фотосенсибилизация мультиформная эритема алопеция."}},{"type":"paragraph","data":{"text":"Аллергические реакции: крапивница ангионевротический отек бронхоспазм интерстициальный нефрит и анафилактический шок."}},{"type":"paragraph","data":{"text":"Прочие: недомогание нарушение зрения периферические отеки усиление потоотделения лихорадка гинекомастия; редко - образование желудочных гландулярных кист во время длительного лечения (следствие ингибирования секреции соляной кислоты носит доброкачественный обратимый характер)."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: нарушение зрения сонливость возбуждение спутанность сознания головная боль повышение потоотделения сухость во рту тошнота аритмия."}},{"type":"paragraph","data":{"text":"Лечение:проведение симптоматической терапии гемодиализ - недостаточно эффективен. Специфический антидот не известен."}}]},{"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 крови."}},{"type":"paragraph","data":{"text":"Не отмечено взаимодействия с одновременно принимаемыми антацидами."}},{"type":"paragraph","data":{"text":"Изменяет биодоступность любого препарата всасывание которого зависит от значения pH (например солей железа)."}},{"type":"paragraph","data":{"text":"Являясь ингибитором цитохрома Р450 может повышать концентрацию и снижать выведение диазепама антикоагулянтов непрямого действия фенитоина (ЛС которые метаболизируются в печени посредством цитохрома CYP2C19) что в некоторых случаях может потребовать уменьшения доз этих лекарственных средств. Усиливает ингибирующее действие на систему кроветворения др. ЛС."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Перед началом терапии необходимо исключить наличие злокачественного процесса (особенно при язвенной болезни желудка) т.к. лечение маскируя симптоматику может отсрочить постановку правильного диагноза."}},{"type":"paragraph","data":{"text":"Прием препарата одновременно с пищей не влияет на его эффективность."}},{"type":"paragraph","data":{"text":"У больных с тяжелой печеночной недостаточностью суточная доза не должна превышать 20 мг."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы по 20 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"При температуре не выше 30°С. 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 по истечении 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":"ЗАО \"Гедеон Рихтер-РУС\", 140132, Московская область, Егорьевский р-н, пос. Шувое, ул. Лесная, д.40, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"Лабораториос Ликонса С.А."}}]}],"source":null},"description_toggle":false,"short_description":"Омепразол ингибирует фермент Н+/К+ АТФ-азу (\"протоновый насос\") в париетальных клетках желудка и блокирует тем самым 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. У больных с язвенной болезнью двенадцатиперстной кишки прием 20 мг омепразола поддерживает внутри желудочный pH - 30 в течение 17 ч. После прекращения приема препарата секреторная активность полностью восстанавливается через 3-5 суток. Всасывание Омепразол быстро абсорбируется из желудочно-кишечного тракта пик концентрации в плазме достигается через 05 - 1 час. Биодоступность составляет 30-40%. Распределение и метаболизм Связывание с белками плазмы - около 90%. Омепразол практически полностью метаболизируется в печени с участием ферментной системы CYP2C19 с образованием 6 метаболитов (гидроксиомепразол сульфидные и сульфоновые производные и др.) фармакологически неактивных. 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