Установленная непереносимость препарата пролактин-секретирующая опухоль гипофиза (пролактинома) детский возраст до 5 лет.
Не следует применять Пассажикс когда стимуляция двигательной функции желудка может быть опасной в т.ч. при желудочно-кишечном кровотечении механической непроходимости или перфорации.
Таблетки жевательные, белого или белого с кремоватым оттенком цвета, круглые, плоскоцилиндрические, с риской.
Фармакотерапевтическая группа
Противорвотное средство - дофаминовых рецепторов блокатор центральный
Фармакологические свойства
Фармакодинамика:
Увеличивает продолжительность перистальтических сокращений антрального отдела желудка и двенадцатиперстной кишки ускоряет опорожнение желудка в случае замедления этого процесса повышает тонус нижнего пищеводного сфинктера устраняет развитие тошноты и рвоты.
Домперидон слабо проникает через гематоэнцефалический барьер поэтому применение домперидона редко сопровождается экстрапирамидными побочными эффектами особенно у взрослых но домперидон стимулирует выделение пролактина из гипофиза. Его противорвотное действие возможно обусловлено сочетанием периферического (гастрокинетического) действия и антагонизма к рецепторам дофамина в триггерной зоне хеморецепторов. Домперидон не оказывает действия на желудочную секрецию.
Фармакокинетика:
Всасывание
После приема препарата внутрь домперидон быстро всасывается. Обладает низкой биодоступностью (около 15%). Снижение кислотности желудочного сока уменьшает абсорбцию домперидона. Максимальная концентрация в плазме достигается через 1 ч.
Распределение
Домперидон широко распределяется в различных тканях в тканях мозга его концентрация невелика. Связь с белками плазмы составляет 91-93%.
Метаболизм
Подвергается интенсивному метаболизму в стенке кишечника и печени.
Выведение
Выводится через кишечник (66%) и почками (33%) в неизмененном виде выводится соответственно 10% и 1% от величины дозы. Период полувыведения составляет 7-9 ч при выраженной почечной недостаточности он удлиняется.
Показания к применению
а) Комплекс диспепсических симптомов часто ассоциирующийся с замедленным опорожнением желудка желудочно-пищеводным рефлюксом эзофагитом:
- чувство переполнения в эпигастрии ощущение вздутия живота боль в верхней части живота;
- отрыжка метеоризм;
- изжога с забросом или без заброса содержимого желудка в полость рта.
б) Тошнота и рвота функционального органического инфекционного происхождения вызванные радиотерапией лекарственной терапией или нарушением диеты а также на фоне агонистов дофамина в случае их применения при болезни Паркинсона (такими как L-допа и бромокриптин).
Противопоказания
Установленная непереносимость препарата пролактин-секретирующая опухоль гипофиза (пролактинома) детский возраст до 5 лет.
Не следует применять Пассажикс когда стимуляция двигательной функции желудка может быть опасной в т.ч. при желудочно-кишечном кровотечении механической непроходимости или перфорации.
Применение при беременности и в период грудного вскармливания
При введении животным в дозах до 160 мг/кг/сут домперидон не оказывал тератогенного действия. Однако как и большинство лекарственных препаратов Пассажикс следует назначать во время I триместра беременности только если его применение оправдано ожидаемой терапевтической пользой. К настоящему времени не имеется данных о повышении риска пороков развития у людей.
У женщин концентрации домперидона в грудном молоке в 4 раза ниже чем соответствующие концентрации в плазме. Неизвестно оказывает ли этот уровень отрицательное воздействие на новорожденных. Поэтому если мать принимает Пассажикс кормление грудью не рекомендуется за исключением случаев когда ожидаемая польза оправдывает потенциальный риск.
Способ применения и дозы
1. Хроническая диспепсия.
Взрослые: по 10 мг (1 таблетка) 3 раза в сутки за 15-30 мин до еды и в случае необходимости перед сном.
Дети старше 5 лет: по 25 мг на 10 кг массы тела. 3 раза в сутки до еды и в случае необходимости перед сном.
При необходимости указанную дозировку можно удвоить.
2. Острые и подострые состояния (прежде всего тошнота и рвота).
Взрослые: по 20 мг (2 таблетки) 3-4 раза в сутки до еды и перед сном.
Дети старше 5 лет: по 5 мг на 10 кг массы тела 3-4 раза в сутки перед едой и перед сном.
Примечания
Рекомендуется пероральное применение Пассажикса до еды. При приеме препарата после еды абсорбция несколько замедляется.
При почечной недостаточности рекомендуется уменьшение частоты приема препарата (см. раздел "Особые указания").
Побочное действие
Побочные эффекты наблюдаются редко отмечались исключительные случаи преходящих спазмов кишечника.
Экстрапирамидные явления наблюдаются у детей и при повышенной проницаемости гематоэнцефалического барьера. Эти явления полностью обратимы и спонтанно исчезают после прекращения лечения.
Так как гипофиз находится вне гематоэнцефалического барьера Пассажикс может индуцировать повышение уровня пролактина в плазме. В редких случаях эта гиперпролактинемия может стимулировать появление галактореи гинекомастии и дисменореи.
Отмечались редкие аллергические реакции такие как сыпь и крапивница.
Передозировка
Симптомами передозировки могут быть сонливость дезориентация и экстрапирамидные реакции особенно у детей.
Лечение: в случае передозировки рекомендуется применение активированного угля и тщательное наблюдение. Антихолинергические средства препараты применяемые для лечения паркинсонизма или антигистаминные препараты могут оказаться эффективными при возникновении экстрапирамидных реакций.
Взаимодействие с другими лекарственными средствами
При одновременном применении антихолинергические препараты могут нейтрализовать действие Пассажикса.
При одновременном применении с Пассажиксом антацидные и антисекреторные препараты снижают его биодоступность. Н
а основании исследований in vitro можно предположить что при одновременном применении с Пассажиксом лекарственных препаратов значительно ингибирующих фермент цитохром CYP3A4 (противогрибковые препарата группы азолов антибиотики из группы макролидов ингибиторы ВИЧ-протеазы антидепрессант нефазодон) может наблюдаться повышение уровня домперидона в плазме.
Препарат не влияет на уровень парацетамола и дигоксина в крови.
Не исключено что Пассажикс может влиять на всасывание применяемых одновременно внутрь препаратов с замедленным высвобождением активного вещества или покрытых кишечнорастворимой оболочкой.
Особые указания
При сочетанном применении Пассажикса с антацидными или антисекреторными препаратами последние следует принимать после еды а не до еды т.е. их не следует принимать одновременно с Пассажиксом.
Применение при заболеваниях печени
Учитывая метаболизм домперидона в печени следует с осторожностью назначать Пассажикс больным с печеночной недостаточностью.
Применение при заболеваниях почек
У больных тяжелой почечной недостаточностью (сывороточный креатинин > 6 мг/100 мл т.е > 06 ммоль/л) период полувыведения домперидона увеличивался с 74 до 208 часов но концентрации препарата в плазме были ниже чем у здоровых добровольцев. Так как очень небольшой процент препарата выводится почками в неизмененном виде то едва ли необходима коррекция разовой дозы у больных с почечной недостаточностью. Однако при повторном назначении частота введения должна быть снижена до 1-2 раз в сутки в зависимости от тяжести недостаточности также может возникнуть необходимость снижений дозы. При длительной терапии больные должны находиться под регулярным наблюдением.
Влияние на способность управлять автомобилем и движущимися механизмами
Домперидон не нарушает быстроту психомоторных реакций.
Форма выпуска
Таблетки жевательные 10 мг.
Условия хранения
В сухом защищенном от света недоступном для детей месте при температуре не выше 25 °С.
Срок годности
2 года.
Не применять по истечении срока указанного на упаковке.
Условия отпуска
Без рецепта
Производитель
Акционерное общество "Фармацевтическое предприятие "Оболенское" (АО "ФП "Оболенское"), 142279, Московская обл., Серпуховский район, пос. Оболенск, корп. 7-8, корп. 39, Россия
Организация, принимающая претензии потребителей
АО "ФП "Оболенское"
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свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Увеличивает продолжительность перистальтических сокращений антрального отдела желудка и двенадцатиперстной кишки ускоряет опорожнение желудка в случае замедления этого процесса повышает тонус нижнего пищеводного сфинктера устраняет развитие тошноты и рвоты."}},{"type":"paragraph","data":{"text":"Домперидон слабо проникает через гематоэнцефалический барьер поэтому применение домперидона редко сопровождается экстрапирамидными побочными эффектами особенно у взрослых но домперидон стимулирует выделение пролактина из гипофиза. Его противорвотное действие возможно обусловлено сочетанием периферического (гастрокинетического) действия и антагонизма к рецепторам дофамина в триггерной зоне хеморецепторов. Домперидон не оказывает действия на желудочную секрецию."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Всасывание"}},{"type":"paragraph","data":{"text":"После приема препарата внутрь домперидон быстро всасывается. Обладает низкой биодоступностью (около 15%). Снижение кислотности желудочного сока уменьшает абсорбцию домперидона. Максимальная концентрация в плазме достигается через 1 ч."}},{"type":"paragraph","data":{"text":"Распределение"}},{"type":"paragraph","data":{"text":"Домперидон широко распределяется в различных тканях в тканях мозга его концентрация невелика. Связь с белками плазмы составляет 91-93%."}},{"type":"paragraph","data":{"text":"Метаболизм"}},{"type":"paragraph","data":{"text":"Подвергается интенсивному метаболизму в стенке кишечника и печени."}},{"type":"paragraph","data":{"text":"Выведение"}},{"type":"paragraph","data":{"text":"Выводится через кишечник (66%) и почками (33%) в неизмененном виде выводится соответственно 10% и 1% от величины дозы. Период полувыведения составляет 7-9 ч при выраженной почечной недостаточности он удлиняется."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"а) Комплекс диспепсических симптомов часто ассоциирующийся с замедленным опорожнением желудка желудочно-пищеводным рефлюксом эзофагитом:"}},{"type":"paragraph","data":{"text":"- чувство переполнения в эпигастрии ощущение вздутия живота боль в верхней части живота;"}},{"type":"paragraph","data":{"text":"- отрыжка метеоризм;"}},{"type":"paragraph","data":{"text":"- изжога с забросом или без заброса содержимого желудка в полость рта."}},{"type":"paragraph","data":{"text":"б) Тошнота и рвота функционального органического инфекционного происхождения вызванные радиотерапией лекарственной терапией или нарушением диеты а также на фоне агонистов дофамина в случае их применения при болезни Паркинсона (такими как L-допа и бромокриптин)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Установленная непереносимость препарата пролактин-секретирующая опухоль гипофиза (пролактинома) детский возраст до 5 лет."}},{"type":"paragraph","data":{"text":"Не следует применять Пассажикс когда стимуляция двигательной функции желудка может быть опасной в т.ч. при желудочно-кишечном кровотечении механической непроходимости или перфорации."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"При введении животным в дозах до 160 мг/кг/сут домперидон не оказывал тератогенного действия. Однако как и большинство лекарственных препаратов Пассажикс следует назначать во время I триместра беременности только если его применение оправдано ожидаемой терапевтической пользой. К настоящему времени не имеется данных о повышении риска пороков развития у людей."}},{"type":"paragraph","data":{"text":"У женщин концентрации домперидона в грудном молоке в 4 раза ниже чем соответствующие концентрации в плазме. Неизвестно оказывает ли этот уровень отрицательное воздействие на новорожденных. Поэтому если мать принимает Пассажикс кормление грудью не рекомендуется за исключением случаев когда ожидаемая польза оправдывает потенциальный риск."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"1. Хроническая диспепсия."}},{"type":"paragraph","data":{"text":"Взрослые: по 10 мг (1 таблетка) 3 раза в сутки за 15-30 мин до еды и в случае необходимости перед сном."}},{"type":"paragraph","data":{"text":"Дети старше 5 лет: по 25 мг на 10 кг массы тела. 3 раза в сутки до еды и в случае необходимости перед сном."}},{"type":"paragraph","data":{"text":"При необходимости указанную дозировку можно удвоить."}},{"type":"paragraph","data":{"text":"2. Острые и подострые состояния (прежде всего тошнота и рвота)."}},{"type":"paragraph","data":{"text":"Взрослые: по 20 мг (2 таблетки) 3-4 раза в сутки до еды и перед сном."}},{"type":"paragraph","data":{"text":"Дети старше 5 лет: по 5 мг на 10 кг массы тела 3-4 раза в сутки перед едой и перед сном."}},{"type":"paragraph","data":{"text":"Примечания"}},{"type":"paragraph","data":{"text":"Рекомендуется пероральное применение Пассажикса до еды. При приеме препарата после еды абсорбция несколько замедляется."}},{"type":"paragraph","data":{"text":"При почечной недостаточности рекомендуется уменьшение частоты приема препарата (см. раздел \"Особые указания\")."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Побочные эффекты наблюдаются редко отмечались исключительные случаи преходящих спазмов кишечника."}},{"type":"paragraph","data":{"text":"Экстрапирамидные явления наблюдаются у детей и при повышенной проницаемости гематоэнцефалического барьера. Эти явления полностью обратимы и спонтанно исчезают после прекращения лечения."}},{"type":"paragraph","data":{"text":"Так как гипофиз находится вне гематоэнцефалического барьера Пассажикс может индуцировать повышение уровня пролактина в плазме. В редких случаях эта гиперпролактинемия может стимулировать появление галактореи гинекомастии и дисменореи."}},{"type":"paragraph","data":{"text":"Отмечались редкие аллергические реакции такие как сыпь и крапивница."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомами передозировки могут быть сонливость дезориентация и экстрапирамидные реакции особенно у детей."}},{"type":"paragraph","data":{"text":"Лечение: в случае передозировки рекомендуется применение активированного угля и тщательное наблюдение. Антихолинергические средства препараты применяемые для лечения паркинсонизма или антигистаминные препараты могут оказаться эффективными при возникновении экстрапирамидных реакций."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении антихолинергические препараты могут нейтрализовать действие Пассажикса."}},{"type":"paragraph","data":{"text":"При одновременном применении с Пассажиксом антацидные и антисекреторные препараты снижают его биодоступность. Н"}},{"type":"paragraph","data":{"text":"а основании исследований in vitro можно предположить что при одновременном применении с Пассажиксом лекарственных препаратов значительно ингибирующих фермент цитохром CYP3A4 (противогрибковые препарата группы азолов антибиотики из группы макролидов ингибиторы ВИЧ-протеазы антидепрессант нефазодон) может наблюдаться повышение уровня домперидона в плазме."}},{"type":"paragraph","data":{"text":"Препарат не влияет на уровень парацетамола и дигоксина в крови."}},{"type":"paragraph","data":{"text":"Не исключено что Пассажикс может влиять на всасывание применяемых одновременно внутрь препаратов с замедленным высвобождением активного вещества или покрытых кишечнорастворимой оболочкой."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"При сочетанном применении Пассажикса с антацидными или антисекреторными препаратами последние следует принимать после еды а не до еды т.е. их не следует принимать одновременно с Пассажиксом."}},{"type":"paragraph","data":{"text":"Применение при заболеваниях печени"}},{"type":"paragraph","data":{"text":"Учитывая метаболизм домперидона в печени следует с осторожностью назначать Пассажикс больным с печеночной недостаточностью."}},{"type":"paragraph","data":{"text":"Применение при заболеваниях почек"}},{"type":"paragraph","data":{"text":"У больных тяжелой почечной недостаточностью (сывороточный креатинин > 6 мг/100 мл т.е > 06 ммоль/л) период полувыведения домперидона увеличивался с 74 до 208 часов но концентрации препарата в плазме были ниже чем у здоровых добровольцев. Так как очень небольшой процент препарата выводится почками в неизмененном виде то едва ли необходима коррекция разовой дозы у больных с почечной недостаточностью. Однако при повторном назначении частота введения должна быть снижена до 1-2 раз в сутки в зависимости от тяжести недостаточности также может возникнуть необходимость снижений дозы. При длительной терапии больные должны находиться под регулярным наблюдением."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Домперидон не нарушает быстроту психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки жевательные 10 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом защищенном от света недоступном для детей месте при температуре не выше 25 °С."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года."}},{"type":"paragraph","data":{"text":"Не применять по истечении срока указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Без рецепта"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Акционерное общество \"Фармацевтическое предприятие \"Оболенское\" (АО \"ФП \"Оболенское\"), 142279, Московская обл., Серпуховский район, пос. 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