Сухой кашель любой этиологии (при простудных заболеваниях, гриппе, коклюше и других состояниях). Подавление кашля в предоперационном и послеоперационном периоде, во время проведения хирургических вмешательств, бронхоскопии.
Противопоказания
Повышенная чувствительность к компонентам препарата, детский возраст до 2-х месяцев, беременность (I триместр), период грудного вскармливания, непереносимость фруктозы (препарат содержит сорбитол), одновременное применение с отхаркивающими препаратами.
Прозрачный бесцветный или с желтоватым оттенком раствор, с характерным запахом.
Фармакологические свойства
Бутамират является противокашлевым средством центрального действия. Однако точный механизм действия препарата не известен. Бутамирата цитрат обладает неспецифическими антихолинергическим и бронхоспазмолитическим эффектами. Подавляет кашель, обладая прямым влиянием на кашлевой центр. Оказывает бронходилатирующий эффект (расширяет бронхи). Способствует облегчению дыхания, улучшая показатели спирометрии (снижает сопротивление дыхательных путей) и оксигенации крови (насыщает кровь кислородом). В терапевтических дозах препарат хорошо переносится.
Всасывание
Бутамират быстро и полностью всасывается при приеме внутрь и гидролизуется в 2- фенилмасляную кислоту и диэтиламиноэтоксиэтанол. Влияние одновременного приема пищи на процессы не изучалось. Содержание 2-фенилмасляной кислоты и диэтиламиноэтоксиэтанола в плазме полностью пропорционально в диапазоне доз 22,5 — 90 мг.
Распределение
Бутамират имеет объем распределения между 81 и 112 л (учитывая массу тела в кг), а также высокую степень связывания с белками плазмы. 2-фенилмасляная кислота имеет высокую степень связывания с белками плазмы в диапазоне доз 22,5 — 90 мг, имея среднее значение 89,3 — 91,6 %. Диэтиламиноэтоксиэтанол в некоторой степени связывается с белками плазмы крови, средние значения варьируют от 28,8 % до 45,7 %.
Нет данных о проникновении бутамирата через плацентарный барьер и его выделении с грудным молоком.
Метаболизм
Гидролиз бутамирата происходит быстро, концентрации метаболитов обнаруживаются через 5 мин. На основании данных исследований, считается, что эти метаболиты также обладают противокашлевой активностью, однако нет клинических данных о метаболизме диэтиламиноэтоксиэтанола. 2-фенилмасляная кислота подвергается дальнейшему частичному метаболизму гидроксилированием в параположении.
Выведение
Через 24 часа после приема препарата основные метаболиты (77 %) состоят из конъюгированной 2-фенилмасляной кислоты и парагидрокси-2-фенилмасляной кислоты. Выведение 2-фенилмасляной кислоты, диэтиламиноэтоксиэтанола и п-гидрокси-2-фенилмасляной кислоты осуществляется преимущественно с мочой.
Уровень конъюгата 2-фенилмасляной кислоты в моче значительно превышает его уровень в плазме. Бутамират определяется в моче в течение 48 часов после приема препарата внутрь. Количество бутамирата, выделяющегося в мочу в течение 96 часов, соответствует 0,02 %, 0,02 %, 0,03 % и 0,03 % при дозах препарата 22,5 мг, 45 мг, 67,5 мг и 90 мг. В большем количестве выводятся метаболиты бутамирата. Период полувыведения бутамирата − 1,48 — 1,93 часа, 2-фенилуксусной кислоты — 23,26 — 24,42 часа, диэтиламиноэтоксиэтанола − 2,72 — 2,90 часов.
Особые группы пациентов
Отсутствуют данные об изменении фармакокинетики препарата у пациентов с нарушением функции печени или почек.
Показания к применению
Сухой кашель любой этиологии (при простудных заболеваниях, гриппе, коклюше и других состояниях). Подавление кашля в предоперационном и послеоперационном периоде, во время проведения хирургических вмешательств, бронхоскопии.
Противопоказания
Повышенная чувствительность к компонентам препарата, детский возраст до 2-х месяцев, беременность (I триместр), период грудного вскармливания, непереносимость фруктозы (препарат содержит сорбитол), одновременное применение с отхаркивающими препаратами.
С осторожностью
Беременность (II и III триместры), у пациентов со склонностью развития лекарственной зависимости, т. к. препарат содержит этанол, нарушение функции печени, алкоголизм, эпилепсия, заболевания головного мозга, применение у детей до 2-х лет.
При наличии какого-либо из перечисленных заболеваний / состояний / факторов риска перед приемом препарата необходимо проконсультироваться с врачом.
Применение при беременности и в период грудного вскармливания
Нет данных о безопасности применения препарата при беременности и прохождении его через плацентарный барьер. Применение препарата в I триместре беременности противопоказано. Во II и III триместрах беременности применение препарата возможно в случае, если ожидаемая польза для матери превосходит потенциальный риск для плода.
Неизвестно, проникает ли активное вещество препарата или его метаболиты в грудное молоко, поэтому применение препарата в период грудного вскармливания не рекомендуется.
Способ применения и дозы
Внутрь, перед едой.
Детям от 2 месяцев до 1 года: по 10 капель 4 раза в день; от 1 года до 3 лет: по 15 капель 4 раза в день; от 3 лет и старше: по 25 капель 4 раза в день.
Если кашель сохраняется более 7 дней, то следует обратиться к врачу.
Перед применением препарата у детей до 2 лет следует проконсультироваться с врачом.
Побочное действие
Классификация частоты развития побочных реакций: 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 случаи.
Со стороны нервной системы: редко — сонливость.
Со стороны желудочно-кишечного тракта: редко — тошнота, диарея.
Со стороны кожи и подкожных тканей: редко — крапивница, возможно развитие аллергических реакций.
Передозировка
Симптомы: сонливость, тошнота, рвота, диарея, головокружение и снижение артериального давления.
Лечение: промывание желудка; прием активированного угля, поддержание жизненно-важных функций организма. Специального антидота нет.
Взаимодействие с другими лекарственными средствами
Какие-либо лекарственные взаимодействия для бутамирата не описаны.
В период лечения препаратом не рекомендуется употреблять алкогольные напитки, а также лекарственные средства, угнетающие центральную нервную систему (снотворные, нейролептики, транквилизаторы и другие препараты).
В связи с тем, что бутамират подавляет кашлевой рефлекс, следует избегать одновременного применения отхаркивающих средств и муколитиков во избежание скопления мокроты в дыхательных путях с риском развития бронхоспазма и инфекции дыхательных путей.
Особые указания
Капли содержат в качестве подсластителей сахаринат и сорбитол, поэтому могут назначаться больным с сахарным диабетом. Препарат содержит небольшое количество спирта этилового 96 % (2,88 мг/мл в пересчете на этанол), менее чем 100 мг на одну дозу. В связи с наличием в составе препарата этилового спирта с осторожностью применять у пациентов со склонностью к развитию лекарственной зависимости, с заболеваниями печени, алкоголизмом, эпилепсией, заболеваниями головного мозга, у беременных и детей. Препарат содержит менее 1 ммоль натрия в дозе.
Влияние на способность управлять автомобилем и движущимися механизмами
В редких случаях препарат может вызывать сонливость. В случае появления сонливости не рекомендуется управлять транспортными средствами и работать с механизмами.
Форма выпуска
Капли для приема внутрь 5 мг/мл.
По 20 мл препарата во флакон темного (янтарного) стекла, снабженный капельницей-дозатором из полиэтилена низкой плотности, укупоренный крышкой из полиэтилена с контролем первого вскрытия.
По 1 флакону вместе с инструкцией по медицинскому применению лекарственного препарата в пачку из картона.
Условия хранения
При температуре не выше 25 °С
Хранить в недоступном для детей месте.
Срок годности
2 года 6 месяцев.
Не применять после истечения срока годности, указанного на упаковке.
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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номер","slug":"","body":[{"type":"paragraph","data":{"text":"ЛП-005918"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Омнитус"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"Капли для приема внутрь"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"\u003cb\u003eСостав на 1 мл:\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eДействующее вещество:\u003c/i\u003e бутамирата цитрат — 5,0 мг; \u003ci\u003eвспомогательные вещества:\u003c/i\u003e сорбитол 70 % (некристаллизирующийся), глицерол, натрия сахаринат, бензойная кислота, ванилин, спирт этиловый 96 %, натрия гидроксид, вода очищенная."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Прозрачный бесцветный или с желтоватым оттенком раствор, с характерным запахом."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Бутамират является противокашлевым средством центрального действия. Однако точный механизм действия препарата не известен. Бутамирата цитрат обладает неспецифическими антихолинергическим и бронхоспазмолитическим эффектами. Подавляет кашель, обладая прямым влиянием на кашлевой центр. Оказывает бронходилатирующий эффект (расширяет бронхи). Способствует облегчению дыхания, улучшая показатели спирометрии (снижает сопротивление дыхательных путей) и оксигенации крови (насыщает кровь кислородом). В терапевтических дозах препарат хорошо переносится."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВсасывание\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Бутамират быстро и полностью всасывается при приеме внутрь и гидролизуется в 2- фенилмасляную кислоту и диэтиламиноэтоксиэтанол. Влияние одновременного приема пищи на процессы не изучалось. Содержание 2-фенилмасляной кислоты и диэтиламиноэтоксиэтанола в плазме полностью пропорционально в диапазоне доз 22,5 — 90 мг."}},{"type":"paragraph","data":{"text":"\u003ci\u003eРаспределение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Бутамират имеет объем распределения между 81 и 112 л (учитывая массу тела в кг), а также высокую степень связывания с белками плазмы. 2-фенилмасляная кислота имеет высокую степень связывания с белками плазмы в диапазоне доз 22,5 — 90 мг, имея среднее значение 89,3 — 91,6 %. Диэтиламиноэтоксиэтанол в некоторой степени связывается с белками плазмы крови, средние значения варьируют от 28,8 % до 45,7 %."}},{"type":"paragraph","data":{"text":"Нет данных о проникновении бутамирата через плацентарный барьер и его выделении с грудным молоком."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМетаболизм\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Гидролиз бутамирата происходит быстро, концентрации метаболитов обнаруживаются через 5 мин. На основании данных исследований, считается, что эти метаболиты также обладают противокашлевой активностью, однако нет клинических данных о метаболизме диэтиламиноэтоксиэтанола. 2-фенилмасляная кислота подвергается дальнейшему частичному метаболизму гидроксилированием в параположении."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВыведение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Через 24 часа после приема препарата основные метаболиты (77 %) состоят из конъюгированной 2-фенилмасляной кислоты и парагидрокси-2-фенилмасляной кислоты. Выведение 2-фенилмасляной кислоты, диэтиламиноэтоксиэтанола и п-гидрокси-2-фенилмасляной кислоты осуществляется преимущественно с мочой."}},{"type":"paragraph","data":{"text":"Уровень конъюгата 2-фенилмасляной кислоты в моче значительно превышает его уровень в плазме. Бутамират определяется в моче в течение 48 часов после приема препарата внутрь. Количество бутамирата, выделяющегося в мочу в течение 96 часов, соответствует 0,02 %, 0,02 %, 0,03 % и 0,03 % при дозах препарата 22,5 мг, 45 мг, 67,5 мг и 90 мг. В большем количестве выводятся метаболиты бутамирата. Период полувыведения бутамирата − 1,48 — 1,93 часа, 2-фенилуксусной кислоты — 23,26 — 24,42 часа, диэтиламиноэтоксиэтанола − 2,72 — 2,90 часов."}},{"type":"paragraph","data":{"text":"\u003ci\u003eОсобые группы пациентов\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Отсутствуют данные об изменении фармакокинетики препарата у пациентов с нарушением функции печени или почек."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Сухой кашель любой этиологии (при простудных заболеваниях, гриппе, коклюше и других состояниях). Подавление кашля в предоперационном и послеоперационном периоде, во время проведения хирургических вмешательств, бронхоскопии."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к компонентам препарата, детский возраст до 2-х месяцев, беременность (I триместр), период грудного вскармливания, непереносимость фруктозы (препарат содержит сорбитол), одновременное применение с отхаркивающими препаратами."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Беременность (II и III триместры), у пациентов со склонностью развития лекарственной зависимости, т. к. препарат содержит этанол, нарушение функции печени, алкоголизм, эпилепсия, заболевания головного мозга, применение у детей до 2-х лет."}},{"type":"paragraph","data":{"text":"При наличии какого-либо из перечисленных заболеваний / состояний / факторов риска перед приемом препарата необходимо проконсультироваться с врачом."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Нет данных о безопасности применения препарата при беременности и прохождении его через плацентарный барьер. Применение препарата в I триместре беременности противопоказано. Во II и III триместрах беременности применение препарата возможно в случае, если ожидаемая польза для матери превосходит потенциальный риск для плода."}},{"type":"paragraph","data":{"text":"Неизвестно, проникает ли активное вещество препарата или его метаболиты в грудное молоко, поэтому применение препарата в период грудного вскармливания не рекомендуется."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь, перед едой."}},{"type":"paragraph","data":{"text":"Детям от 2 месяцев до 1 года: по 10 капель 4 раза в день; от 1 года до 3 лет: по 15 капель 4 раза в день; от 3 лет и старше: по 25 капель 4 раза в день."}},{"type":"paragraph","data":{"text":"Если кашель сохраняется более 7 дней, то следует обратиться к врачу."}},{"type":"paragraph","data":{"text":"Перед применением препарата у детей до 2 лет следует проконсультироваться с врачом."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Классификация частоты развития побочных реакций: 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 случаи."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы:\u003c/i\u003e редко — сонливость."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны желудочно-кишечного тракта:\u003c/i\u003e редко — тошнота, диарея."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны кожи и подкожных тканей:\u003c/i\u003e редко — крапивница, возможно развитие аллергических реакций."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы:\u003c/i\u003e сонливость, тошнота, рвота, диарея, головокружение и снижение артериального давления."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e промывание желудка; прием активированного угля, поддержание жизненно-важных функций организма. Специального антидота нет."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Какие-либо лекарственные взаимодействия для бутамирата не описаны."}},{"type":"paragraph","data":{"text":"В период лечения препаратом не рекомендуется употреблять алкогольные напитки, а также лекарственные средства, угнетающие центральную нервную систему (снотворные, нейролептики, транквилизаторы и другие препараты)."}},{"type":"paragraph","data":{"text":"В связи с тем, что бутамират подавляет кашлевой рефлекс, следует избегать одновременного применения отхаркивающих средств и муколитиков во избежание скопления мокроты в дыхательных путях с риском развития бронхоспазма и инфекции дыхательных путей."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Капли содержат в качестве подсластителей сахаринат и сорбитол, поэтому могут назначаться больным с сахарным диабетом. Препарат содержит небольшое количество спирта этилового 96 % (2,88 мг/мл в пересчете на этанол), менее чем 100 мг на одну дозу. В связи с наличием в составе препарата этилового спирта с осторожностью применять у пациентов со склонностью к развитию лекарственной зависимости, с заболеваниями печени, алкоголизмом, эпилепсией, заболеваниями головного мозга, у беременных и детей. Препарат содержит менее 1 ммоль натрия в дозе."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В редких случаях препарат может вызывать сонливость. В случае появления сонливости не рекомендуется управлять транспортными средствами и работать с механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капли для приема внутрь 5 мг/мл."}},{"type":"paragraph","data":{"text":"По 20 мл препарата во флакон темного (янтарного) стекла, снабженный капельницей-дозатором из полиэтилена низкой плотности, укупоренный крышкой из полиэтилена с контролем первого вскрытия."}},{"type":"paragraph","data":{"text":"По 1 флакону вместе с инструкцией по медицинскому применению лекарственного препарата в пачку из картона."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"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":"2 года 6 месяцев."}},{"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":"Отпускают без рецепта"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nАО «Нижфарм», Россия"}},{"type":"paragraph","data":{"text":"603950, г. Нижний Новгород, ул. Салганская, д. 7"}},{"type":"paragraph","data":{"text":"Тел.: (831) 278-80-88; факс: (831) 430-72-28"}},{"type":"paragraph","data":{"text":"E-mail: \u003ca href=\"mailto:med@stada.ru\"\u003emed@stada.ru\u003c/a\u003e"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"\n\nАО «Нижфарм», Россия"}},{"type":"paragraph","data":{"text":"603950, г. Нижний Новгород, ул. Салганская, д. 7"}},{"type":"paragraph","data":{"text":"Тел.: (831) 278-80-88; факс: (831) 430-72-28"}},{"type":"paragraph","data":{"text":"E-mail: \u003ca href=\"mailto:med@stada.ru\"\u003emed@stada.ru\u003c/a\u003e"}}]}],"source":null},"description_toggle":false,"short_description":"Бутамират является противокашлевым средством центрального действия. Однако точный механизм действия препарата не известен. Бутамирата цитрат обладает неспецифическими антихолинергическим и бронхоспазмолитическим эффектами. Подавляет кашель, обладая прямым влиянием на кашлевой центр. Оказывает бронходилатирующий эффект (расширяет бронхи). Способствует облегчению дыхания, улучшая показатели спирометрии (снижает сопротивление дыхательных путей) и оксигенации крови (насыщает кровь кислородом). В терапевтических дозах препарат хорошо переносится.ВсасываниеБутамират быстро и полностью всасывается при приеме внутрь и гидролизуется в 2- фенилмасляную кислоту и диэтиламиноэтоксиэтанол. Влияние одновременного приема пищи на процессы не изучалось. Содержание 2-фенилмасляной кислоты и диэтиламиноэтоксиэтанола в плазме полностью пропорционально в диапазоне доз 22,5 — 90 мг.РаспределениеБутамират имеет объем распределения между 81 и 112 л (учитывая массу тела в кг), а также высокую степень связывания с белками плазмы. 2-фенилмасляная кислота имеет высокую степень связывания с белками плазмы в диапазоне доз 22,5 — 90 мг, имея среднее значение 89,3 — 91,6 %. 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