Симптоматическое лечение боли, спазмов и дискомфорта в
области живота, ощущения вздутия (метеоризма), моторных расстройств кишечника с
изменением частоты стула (диарея или запор), диспепсии, изжоги, отрыжки,
тошноты, рвоты, связанных с функциональными заболеваниями органов ЖКТ и желчных
путей (неэрозивная...
Белый или
почти белый кристаллический порошок с запахом апельсина. Допускается наличие
единичных вкраплений красного цвета.
Фармакотерапевтическая группа
Спазмолитическое средство.
Фармакологические свойства
Фармакодинамика
Тримебутин, действуя на
энкефалинергическую систему кишечника, является регулятором его перистальтики.
Действуя на периферические δ-, μ- и k- рецепторы, в том числе находящиеся
непосредственно на гладкой мускулатуре на всем протяжении желудоч-
но-кишечного тракта (ЖКТ), он регулирует моторику без влияния на центральную
нервную систему. Таким образом, тримебутин восстанавливает нормальную
физиологическую активность мускулатуры ЖКТ (пищевод, желудок, кишечник,
желчевыводящие пути) при различных заболеваниях ЖКТ, связанных с нарушениями
моторики (оказывает стимулирующее действие при гипокинетических состояниях и
спазмолитическое – при гиперкинетических).
Нормализуя висцеральную
чувствительность, тримебутин обеспечивает анальгетический эффект при
абдоминальном болевом синдроме.
Фармакокинетика
После приема внутрь тримебутин
быстро всасывается из ЖКТ. Максимальная концентрация (Cmax) в плазме
крови достигается через 1-2 ч. Биодоступность составляет 4-6 %. Объем
распределения (Vd) – 88 л. Степень связывания с белками плазмы
низкая – около 5 %. Тримебутин в незначительной степени проникает через
плацентарный барьер. Тримебутин биотрансформируется в печени и выводится с
мочой преимущественно в виде метаболитов (примерно 70 % в течение первых 24 ч).
Активным метаболитом тримебутина является десметилтримебутин. Период
полувыведения (T1/2) – около 12 ч.
Показания к применению
Симптоматическое лечение боли, спазмов и дискомфорта в
области живота, ощущения вздутия (метеоризма), моторных расстройств кишечника с
изменением частоты стула (диарея или запор), диспепсии, изжоги, отрыжки,
тошноты, рвоты, связанных с функциональными заболеваниями органов ЖКТ и желчных
путей (неэрозивная форма гастроэзофагеальной рефлюксной болезни, желчнокаменная
болезнь, дисфункция желчевыводящих путей, синдром раздраженного кишечника,
дисфункция сфинктера Одди, постхолецистэктомический синдром).
Пациентам с сахарным диабетом
следует соблюдать осторожность в связи с наличием сахарозы в составе препарата
(см. раздел «Особые указания»).
Препарат следует применять с осторожностью в период грудного вскармливания, так как отсутствуют данные о его способности проникать в грудное молоко.
Применение при беременности и в период грудного вскармливания
В экспериментальных исследованиях не выявлено данных о
тератогенности и эмбриотоксичности тримебутина. Тем не менее, в связи с
отсутствием необходимых клинических данных применение препарата в период
беременности противопоказано.
Не рекомендуется назначать препарат
в период лактации в связи с отсутствием достоверных клинических данных,
подтверждающих безопасность применения в этот период. При необходимости
применения препарата в период грудного вскармливания следует прекратить грудное вскармливание.
Способ применения и дозы
Внутрь.
Перед использованием порошок для
приготовления суспензии следует разбавить питьевой водой комнатной температуры до
риски на флаконе, тщательно взболтать до получения однородной суспензии, повторно
добавить питьевой воды комнатной температуры до риски. Перед
каждым приемом препарата содержимое флакона необходимо тщательно взбалтывать до
получения однородной суспензии.
Необходимую
дозу отмеряют с помощью мерного стаканчика, вложенного в упаковку, на
котором имеются специальные деления, цена которых соответствует количеству препарата
в миллиграммах (от 25 мг до 100 мг). После использования мерный стаканчик
промывают проточной водой, сушат и хранят вместе с флаконом.
Взрослым и детям с 12 лет по
100-200 мг 3 раза в сутки.
Детям 5-12 лет: по 50 мг 3 раза в
сутки.
Детям 3-5 лет: по 25 мг 3 раза в
сутки.
Для предупреждения рецидива
синдрома раздраженного кишечника после проведенного курса лечения (4 недели) в
период ремиссии рекомендуется продолжить прием препарата в дозе 300 мг в сутки
в течение 12 недель.
Побочное действие
Указанные ниже побочные
эффекты представлены в соответствии со следующими градациями частоты их
возникновения: очень часто (≥ 1/10); часто (≥ 1/100, <1/10); нечасто (≥ 1/1000,
< 1/100); редко (≥ 1/10000, < 1/1000); очень редко (< 1/10000) (включая
отдельные сообщения); частота неизвестна (по имеющимся данным определить
частоту встречаемости не представляется возможным).
Со стороны пищеварительной системы: частота неизвестна - сухость во
рту, неприятные вкусовые ощущения, диарея, диспепсия, тошнота, запор.
Аллергические реакции: частота неизвестна - кожная сыпь.
Со стороны нервной системы: частота неизвестна - сонливость,
усталость, головокружение, головная боль, беспокойство.
Со стороны мочеполовой системы: частота неизвестна - нарушения
менструального цикла, задержка мочи.
Прочие: частота неизвестна - болезненное увеличение грудных желез.
Передозировка
Случаев передозировки при применении тримебутина до настоящего времени не
зарегистрировано.
Взаимодействие с другими лекарственными средствами
Лекарственное взаимодействие препарата не описано.
Особые указания
Курс
лечения синдрома раздраженного кишечника в острый период в дозе 600 мг в сутки
в течение 4-х недель и продолжение лечения после проведенного курса в дозе 300
мг в сутки в течение 12 недель позволяет избежать рецидива заболевания.
Пациентам с сахарным диабетом
следует обратить внимание на содержание сахарозы в составе препарата. Одна
разовая доза готовой суспензии, содержащая 25 мг действующего вещества,
содержит 3,1 г сахарозы, что соответствует 0,3 хлебным единицам (ХЕ).
Влияние на способность управлять автомобилем и движущимися механизмами
Препарат не оказывает
седативного действия, не влияет на скорость психомоторной реакции и может
использоваться у лиц различных профессий, в том числе требующих повышенного
внимания и координации движений. Однако, учитывая возможные побочные действия,
которые могут влиять на указанные способности (головокружение и другие),
следует соблюдать осторожность при управлении автотранспортом и занятиях
другими потенциально опасными видами деятельности.
Форма выпуска
Порошок для приготовления
суспензии для приема внутрь 152,5 г.
По 152,5 г порошка во флаконы
коричневого стекла с меткой (250 мл), укупоренные крышками винтовыми из
полиэтилена высокой плотности с контролем первого вскрытия.
По 1 флакону вместе с мерным
стаканчиком и инструкцией по применению помещают в пачку из картона.
Условия хранения
В оригинальной упаковке (флакон
в пачке) при температуре не выше 25 °С.
Приготовленную
суспензию хранить не более 14 дней при температуре не выше 25 °С и не более 28
дней при температуре от 2 до 8 °C.
Хранить в недоступном для детей
месте.
Срок годности
2 года.
Не применять по истечении срока годности, указанного на упаковке.
Условия отпуска
Отпускают без рецепта.
Производитель
АО «Валента Фарм»
Организация, принимающая претензии потребителей
АО «Валента Фарм»
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
Начните сравнивать цены и заказывать лекарства прямо в приложении
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приготовления суспензии для приема внутрь"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eДействующее вещество\u003c/i\u003e: тримебутин – 1,2 г;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eВспомогательные вещества: \u003c/i\u003eсахароза, полоксамер 188\n(микронизированный), полисорбат-80, бетакаротен, ароматизатор апельсиновый.\u003ci\u003e\u003c/i\u003e"}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Белый или\nпочти белый кристаллический порошок с запахом апельсина. Допускается наличие\nединичных вкраплений красного цвета."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Спазмолитическое средство."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eФармакодинамика\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Тримебутин, действуя на\nэнкефалинергическую систему кишечника, является регулятором его перистальтики.\nДействуя на периферические δ-, μ- и k- рецепторы, в том числе находящиеся\nнепосредственно на гладкой мускулатуре на всем протяжении желудоч-"}},{"type":"paragraph","data":{"text":"\nно-кишечного тракта (ЖКТ), он регулирует моторику без влияния на центральную\nнервную систему. Таким образом, тримебутин восстанавливает нормальную\nфизиологическую активность мускулатуры ЖКТ (пищевод, желудок, кишечник,\nжелчевыводящие пути) при различных заболеваниях ЖКТ, связанных с нарушениями\nмоторики (оказывает стимулирующее действие при гипокинетических состояниях и\nспазмолитическое – при гиперкинетических)."}},{"type":"paragraph","data":{"text":"Нормализуя висцеральную\nчувствительность, тримебутин обеспечивает анальгетический эффект при\nабдоминальном болевом синдроме."}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eФармакокинетика\u003c/i\u003e\u003c/b\u003e\u003ci\u003e\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"После приема внутрь тримебутин\nбыстро всасывается из ЖКТ. Максимальная концентрация (C\u003csub\u003emax\u003c/sub\u003e) в плазме\nкрови достигается через 1-2 ч. Биодоступность составляет 4-6 %. Объем\nраспределения (V\u003csub\u003ed\u003c/sub\u003e) – 88 л. Степень связывания с белками плазмы\nнизкая – около 5 %. Тримебутин в незначительной степени проникает через\nплацентарный барьер. Тримебутин биотрансформируется в печени и выводится с\nмочой преимущественно в виде метаболитов (примерно 70 % в течение первых 24 ч).\nАктивным метаболитом тримебутина является десметилтримебутин. Период\nполувыведения (T\u003csub\u003e1/2\u003c/sub\u003e) – около 12 ч."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Симптоматическое лечение боли, спазмов и дискомфорта в\nобласти живота, ощущения вздутия (метеоризма), моторных расстройств кишечника с\nизменением частоты стула (диарея или запор), диспепсии, изжоги, отрыжки,\nтошноты, рвоты, связанных с функциональными заболеваниями органов ЖКТ и желчных\nпутей (неэрозивная форма гастроэзофагеальной рефлюксной болезни, желчнокаменная\nболезнь, дисфункция желчевыводящих путей, синдром раздраженного кишечника,\nдисфункция сфинктера Одди, постхолецистэктомический синдром)."}},{"type":"paragraph","data":{"text":"Послеоперационная\nпаралитическая кишечная непроходимость."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к\nкомпонентам, входящим в состав препарата."}},{"type":"paragraph","data":{"text":"Дефицит сахаразы/изомальтазы,\nнепереносимость фруктозы, глюкозо-галактозная мальабсорбция. "}},{"type":"paragraph","data":{"text":"Детский\nвозраст до 3 лет."}},{"type":"paragraph","data":{"text":"Беременность."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Пациентам с сахарным диабетом\nследует соблюдать осторожность в связи с наличием сахарозы в составе препарата\n(см. раздел «Особые указания»)."}},{"type":"paragraph","data":{"text":"Препарат следует применять с осторожностью в период грудного вскармливания, так как отсутствуют данные о его способности проникать в грудное молоко."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"В экспериментальных исследованиях не выявлено данных о\nтератогенности и эмбриотоксичности тримебутина. Тем не менее, в связи с\nотсутствием необходимых клинических данных применение препарата в период\nбеременности противопоказано."}},{"type":"paragraph","data":{"text":"Не рекомендуется назначать препарат\nв период лактации в связи с отсутствием достоверных клинических данных,\nподтверждающих безопасность применения в этот период. При необходимости\nприменения препарата в период грудного вскармливания следует прекратить грудное вскармливание."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь."}},{"type":"paragraph","data":{"text":"Перед использованием порошок для\nприготовления суспензии следует разбавить питьевой водой комнатной температуры до\nриски на флаконе, тщательно взболтать до получения однородной суспензии, повторно\nдобавить питьевой воды комнатной температуры до риски. Перед\nкаждым приемом препарата содержимое флакона необходимо тщательно взбалтывать до\nполучения однородной суспензии."}},{"type":"paragraph","data":{"text":"Необходимую\nдозу отмеряют с помощью мерного стаканчика, вложенного в упаковку, на\nкотором имеются специальные деления, цена которых соответствует количеству препарата\nв миллиграммах (от 25 мг до 100 мг). После использования мерный стаканчик\nпромывают проточной водой, сушат и хранят вместе с флаконом."}},{"type":"paragraph","data":{"text":"Взрослым и детям с 12 лет по\n100-200 мг 3 раза в сутки."}},{"type":"paragraph","data":{"text":"Детям 5-12 лет: по 50 мг 3 раза в\nсутки."}},{"type":"paragraph","data":{"text":"Детям 3-5 лет: по 25 мг 3 раза в\nсутки. "}},{"type":"paragraph","data":{"text":"Для предупреждения рецидива\nсиндрома раздраженного кишечника после проведенного курса лечения (4 недели) в\nпериод ремиссии рекомендуется продолжить прием препарата в дозе 300 мг в сутки\nв течение 12 недель."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Указанные ниже побочные\nэффекты представлены в соответствии со следующими градациями частоты их\nвозникновения: очень часто (≥ 1/10); часто (≥ 1/100, <1/10); нечасто (≥ 1/1000,\n< 1/100); редко (≥ 1/10000, < 1/1000); очень редко (< 1/10000) (включая\nотдельные сообщения); частота неизвестна (по имеющимся данным определить\nчастоту встречаемости не представляется возможным)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы:\u003c/i\u003e частота неизвестна - сухость во\nрту, неприятные вкусовые ощущения, диарея, диспепсия, тошнота, запор."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e частота неизвестна - кожная сыпь."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы:\u003c/i\u003e частота неизвестна - сонливость,\nусталость, головокружение, головная боль, беспокойство."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны мочеполовой системы:\u003c/i\u003e частота неизвестна - нарушения\nменструального цикла, задержка мочи.\u003ci\u003e\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e частота неизвестна - болезненное увеличение грудных желез."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Случаев передозировки при применении тримебутина до настоящего времени не\nзарегистрировано."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e отмена препарата, промывание желудка, назначение\nактивированного угля,\nсимптоматическая терапия. Специфические антидоты отсутствуют."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Лекарственное взаимодействие препарата не описано."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Курс\nлечения синдрома раздраженного кишечника в острый период в дозе 600 мг в сутки\nв течение 4-х недель и продолжение лечения после проведенного курса в дозе 300\nмг в сутки в течение 12 недель позволяет избежать рецидива заболевания."}},{"type":"paragraph","data":{"text":"Пациентам с сахарным диабетом\nследует обратить внимание на содержание сахарозы в составе препарата. Одна\nразовая доза готовой суспензии, содержащая 25 мг действующего вещества,\nсодержит 3,1 г сахарозы, что соответствует 0,3 хлебным единицам (ХЕ)."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Препарат не оказывает\nседативного действия, не влияет на скорость психомоторной реакции и может\nиспользоваться у лиц различных профессий, в том числе требующих повышенного\nвнимания и координации движений. Однако, учитывая возможные побочные действия,\nкоторые могут влиять на указанные способности (головокружение и другие),\nследует соблюдать осторожность при управлении автотранспортом и занятиях\nдругими потенциально опасными видами деятельности."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Порошок для приготовления\nсуспензии для приема внутрь 152,5 г."}},{"type":"paragraph","data":{"text":"По 152,5 г порошка во флаконы\nкоричневого стекла с меткой (250 мл), укупоренные крышками винтовыми из\nполиэтилена высокой плотности с контролем первого вскрытия."}},{"type":"paragraph","data":{"text":"По 1 флакону вместе с мерным\nстаканчиком и инструкцией по применению помещают в пачку из картона."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В оригинальной упаковке (флакон\nв пачке) при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Приготовленную\nсуспензию хранить не более 14 дней при температуре не выше 25 °С и не более 28\nдней при температуре от 2 до 8 °C."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей\nместе."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 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":"Отпускают без рецепта."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"АО «Валента Фарм»"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"АО «Валента Фарм» "}}]}],"source":null},"description_toggle":false,"short_description":"ФармакодинамикаТримебутин, действуя на энкефалинергическую систему кишечника, является регулятором его перистальтики. 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