Ксилометазолин относится к группе местных сосудосуживающих с... Инструкция
Показания к применению
Острые респираторные заболевания с явлениями ринита (насморка), острый аллергический ринит, поллиноз, синусит, евстахиит, средний отит (для уменьшения отека слизистой носоглотки).
Подготовка больного к диагностическим манипуляциям в носовых ходах.
Противопоказания
Повышенная чувствительность к компонентам препарата, артериальная гипертензия, тахикардия, выраженный атеросклероз, глаукома, атрофический ринит, гипертиреоз, хирургические вмешательства на мозговых оболочках (в анамнезе), беременность, детский возраст до 2 лет (для препарата Ксимелин Эко 35 мкг/доза); детский возраст до 10 лет (для препарата Ксимелин Эко 140 мкг/доза).
Прозрачная бесцветная или слегка окрашенная жидкость
Фармакотерапевтическая группа
Противоконгестивное средство – вазоконстриктор (альфа-адреномиметик)
Фармакологические свойства
Ксилометазолин относится к группе местных сосудосуживающих средств (деконгестантов) с альфа-адреномиметическим действием, вызывает сужение кровеносных сосудов слизистой носа, устраняя, таким образом, отек и гиперемию слизистой оболочки носоглотки. Облегчает носовое дыхание и проходимость при ринитах.
Ксимелин Эко не содержит консервантов. В терапевтических концентрациях не раздражает слизистую, не вызывает гиперемию. Действие наступает через две минуты и продолжается в течение 12 часов.
Исследования in vitro показали, что ксилометазолин подавляет инфекционную активность риновируса человека, вызывающего «простуду».
Фармакокинетика.
При местном применении практически не абсорбируется, концентрации в плазме настолько малы, что их невозможно определить современными аналитическими методами.
Показания к применению
Острые респираторные заболевания с явлениями ринита (насморка), острый аллергический ринит, поллиноз, синусит, евстахиит, средний отит (для уменьшения отека слизистой носоглотки).
Подготовка больного к диагностическим манипуляциям в носовых ходах.
Противопоказания
Повышенная чувствительность к компонентам препарата, артериальная гипертензия, тахикардия, выраженный атеросклероз, глаукома, атрофический ринит, гипертиреоз, хирургические вмешательства на мозговых оболочках (в анамнезе), беременность, детский возраст до 2 лет (для препарата Ксимелин Эко 35 мкг/доза); детский возраст до 10 лет (для препарата Ксимелин Эко 140 мкг/доза).
Не применять препарат при терапии ингибиторами моноаминооксидазы (МАО) или трициклическими антидепрессантами, включая период 14 дней после их отмены.
С осторожностью
Сахарный диабет; феохромоцитома; заболевания сердечно-сосудистой системы, в т.ч. ИБС, стенокардия III — IV функционального класса; порфирия; период грудного вскармливания; гиперплазия предстательной железы; атеросклероз; при повышенной чувствительности к адренергическим препаратам, сопровождающейся бессонницей, головокружением, аритмией, тремором, повышением артериального давления.
Применение при беременности и в период грудного вскармливания
Применение препарата противопоказано при беременности. В период грудного вскармливания препарат должен применяться только после тщательной оценки соотношения риска и пользы для матери и ребенка, под контролем врача. Не допускается превышать рекомендуемую дозу.
Способ применения и дозы
Интраназально.
Препарат Ксимелин Эко, 35 мкг/доза, спрей для детей от 2 до 10 лет: по 1 впрыскиванию в каждый носовой ход; не следует применять более 3-х раз в сутки.
Препарат применяется не более 5 дней, под присмотром взрослых.
Препарат Ксимелин Эко, 140 мкг/доза, спрей для взрослых и детей старше 10 лет: по 1 впрыскиванию в каждый носовой ход (при необходимости можно повторить); не следует применять более 3-х раз в сутки.
Препарат применяется не более 10 дней.
Одно впрыскивание препарата Ксимелин Эко 35 мкг/доза содержит около 35 мкг ксилометазолина гидрохлорида; одно впрыскивание препарата Ксимелин Эко 140 мкг/доза содержит около 140 мкг ксилометазолина гидрохлорида.
Препарат у детей следует применять под присмотром взрослых.
Применяйте препарат только согласно тем показаниям, тому способу применения и в тех дозах, которые указаны в инструкции.
Во время введения препарата флакон следует держать распылителем вверх.
Побочное действие
Классификация частоты возникновения нежелательных реакций: очень часто (≥ 1/10); часто (≥ 1/100, ˂ 1/10); нечасто (≥ 1/1000, ˂ 1/100); редко (≥ 1/10000, ˂ 1/1000); очень редко (˂ 1/10000).
Нарушения со стороны иммунной системы
Очень редко: реакции гиперчувствительности (ангионевротический отек, сыпь, зуд).
Нарушения со стороны нервной системы
Часто: головная боль.
Редко: бессонница, депрессия (при длительном применении в высоких дозах).
Очень редко: беспокойство, усталость, галлюцинации и судороги (преимущественно у детей).
Нарушения со стороны органа зрения
Очень редко: нарушение четкости зрительного восприятия.
Нарушения со стороны сердца
Редко: ощущение сердцебиения, повышение артериального давления.
Очень редко: тахикардия, аритмия.
Нарушения со стороны дыхательной системы, органов грудной клетки и средостения
Нечасто: заложенность носа (реактивная гиперемия) (в особенности при частом и длительном применении), кровотечение из носа.
Нарушения со стороны желудочно-кишечного тракта
Часто: тошнота.
Редко: рвота.
Если любые из указанных в инструкции побочных эффектов усугубляются, или Вы заметили любые другие побочные эффекты, не указанные в инструкции, сообщите об этом врачу.
Передозировка
Ксилометазолин при местном введении чрезмерной дозы или при случайном приеме внутрь может вызывать сильное головокружение, усиленный и неравномерный пульс, повышенное потоотделение, резкое снижение температуры тела, головную боль, сонливость, брадикардию, повышение артериального давления, угнетение дыхания, кому и судороги. Вслед за повышением артериального давления может наблюдаться его резкое снижение. Соответствующие поддерживающие меры должны приниматься при любых подозрениях на передозировку, в некоторых случаях показано незамедлительное симптоматическое лечение под наблюдением врача.
В случае тяжелого отравления с остановкой сердца реанимационные действия должны продолжаться не менее 1 часа.
Взаимодействие с другими лекарственными средствами
Применение ксилометазолина противопоказано пациентам, получающим МАО или трициклические антидепрессанты, включая период 14 дней после их отмены.
Одновременное применение три- или тетрациклических антидепрессантов и симпатомиметических препаратов может привести к увеличению симпатомиметического эффекта ксилометазолина, поэтому такого сочетания рекомендуется избегать.
Особые указания
Недопустимо применение у детей до 2-х лет.
Не рекомендуется применять в непрерывном режиме более 10 дней.
Не следует превышать рекомендованные дозы, особенно у детей и пожилых людей.
Длительное (более 10 дней) или чрезмерное применение препарата может вызвать отек слизистой оболочки или гиперсекрецию, вызванную повышенной чувствительностью клеток («эффект рикошета»).
По 10 мл препарата (125 доз во флаконе для дозировки 35 мкг/доза; 60 доз во флаконе для дозировки 140 мкг/доза) в пластиковом флаконе, снабженном помповым дозирующим устройством с наконечником и защитным колпачком из полиэтилена.
По 1 флакону вместе с инструкцией по применению помещают в картонную пачку.
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мг"}},{"type":"paragraph","data":{"text":"Ксимелин Эко 35 мкг/доза"}},{"type":"paragraph","data":{"text":"\u003ci\u003eдействующее вещество:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"ксилометазолина гидрохлорид 35 мкг"}},{"type":"paragraph","data":{"text":"\u003ci\u003eвспомогательные вещества:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"натрия гидрофосфат дигидрат 140 мкг"}},{"type":"paragraph","data":{"text":"натрия дигидрофосфат дигидрат 140 мкг"}},{"type":"paragraph","data":{"text":"динатрия эдетат 35 мкг"}},{"type":"paragraph","data":{"text":"натрия хлорид 518 мкг"}},{"type":"paragraph","data":{"text":"вода очищенная 69,6 мг"}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Прозрачная бесцветная или слегка окрашенная жидкость"}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Противоконгестивное средство – вазоконстриктор (альфа-адреномиметик)"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Ксилометазолин относится к группе местных сосудосуживающих средств (деконгестантов) с альфа-адреномиметическим действием, вызывает сужение кровеносных сосудов слизистой носа, устраняя, таким образом, отек и гиперемию слизистой оболочки носоглотки. Облегчает носовое дыхание и проходимость при ринитах."}},{"type":"paragraph","data":{"text":"Ксимелин Эко не содержит консервантов. В терапевтических концентрациях не раздражает слизистую, не вызывает гиперемию. Действие наступает через две минуты и продолжается в течение 12 часов."}},{"type":"paragraph","data":{"text":"Исследования \u003ci\u003ein vitro\u003c/i\u003e показали, что ксилометазолин подавляет инфекционную активность риновируса человека, вызывающего «простуду»."}},{"type":"paragraph","data":{"text":"\u003cb\u003eФармакокинетика.\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"При местном применении практически не абсорбируется, концентрации в плазме настолько малы, что их невозможно определить современными аналитическими методами."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Острые респираторные заболевания с явлениями ринита (насморка), острый аллергический ринит, поллиноз, синусит, евстахиит, средний отит (для уменьшения отека слизистой носоглотки)."}},{"type":"paragraph","data":{"text":"Подготовка больного к диагностическим манипуляциям в носовых ходах."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к компонентам препарата, артериальная гипертензия, тахикардия, выраженный атеросклероз, глаукома, атрофический ринит, гипертиреоз, хирургические вмешательства на мозговых оболочках (в анамнезе), беременность, детский возраст до 2 лет (для препарата Ксимелин Эко 35 мкг/доза); детский возраст до 10 лет (для препарата Ксимелин Эко 140 мкг/доза)."}},{"type":"paragraph","data":{"text":"Не применять препарат при терапии ингибиторами моноаминооксидазы (МАО) или трициклическими антидепрессантами, включая период 14 дней после их отмены."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Сахарный диабет; феохромоцитома; заболевания сердечно-сосудистой системы, в т.ч. ИБС, стенокардия III — IV функционального класса; порфирия; период грудного вскармливания; гиперплазия предстательной железы; атеросклероз; при повышенной чувствительности к адренергическим препаратам, сопровождающейся бессонницей, головокружением, аритмией, тремором, повышением артериального давления."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Применение препарата противопоказано при беременности. В период грудного вскармливания препарат должен применяться только после тщательной оценки соотношения риска и пользы для матери и ребенка, под контролем врача. Не допускается превышать рекомендуемую дозу."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Интраназально."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрепарат Ксимелин Эко, 35 мкг/доза, спрей для детей от 2 до 10 лет:\u003c/i\u003e по 1 впрыскиванию в каждый носовой ход; не следует применять более 3-х раз в сутки."}},{"type":"paragraph","data":{"text":"Препарат применяется не более 5 дней, под присмотром взрослых."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрепарат Ксимелин Эко, 140 мкг/доза, спрей для взрослых и детей старше 10 лет:\u003c/i\u003e по 1 впрыскиванию в каждый носовой ход (при необходимости можно повторить); не следует применять более 3-х раз в сутки."}},{"type":"paragraph","data":{"text":"Препарат применяется не более 10 дней."}},{"type":"paragraph","data":{"text":"Одно впрыскивание препарата Ксимелин Эко 35 мкг/доза содержит около 35 мкг ксилометазолина гидрохлорида; одно впрыскивание препарата Ксимелин Эко 140 мкг/доза содержит около 140 мкг ксилометазолина гидрохлорида."}},{"type":"paragraph","data":{"text":"Препарат у детей следует применять под присмотром взрослых."}},{"type":"paragraph","data":{"text":"Применяйте препарат только согласно тем показаниям, тому способу применения и в тех дозах, которые указаны в инструкции."}},{"type":"paragraph","data":{"text":"Во время введения препарата флакон следует держать распылителем вверх."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Классификация частоты возникновения нежелательных реакций: очень часто (≥ 1/10); часто (≥ 1/100, ˂ 1/10); нечасто (≥ 1/1000, ˂ 1/100); редко (≥ 1/10000, ˂ 1/1000); очень редко (˂ 1/10000)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны иммунной системы\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Очень редко: реакции гиперчувствительности (ангионевротический отек, сыпь, зуд)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны нервной системы\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Часто: головная боль."}},{"type":"paragraph","data":{"text":"Редко: бессонница, депрессия (при длительном применении в высоких дозах)."}},{"type":"paragraph","data":{"text":"Очень редко: беспокойство, усталость, галлюцинации и судороги (преимущественно у детей)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны органа зрения\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Очень редко: нарушение четкости зрительного восприятия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны сердца\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Редко: ощущение сердцебиения, повышение артериального давления."}},{"type":"paragraph","data":{"text":"Очень редко: тахикардия, аритмия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны дыхательной системы, органов грудной клетки и средостения\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Часто: раздражение и/или сухость слизистой оболочки носа, жжение, покалывание, чихание, гиперсекреция слизистой оболочки носоглотки."}},{"type":"paragraph","data":{"text":"Нечасто: заложенность носа (реактивная гиперемия) (в особенности при частом и длительном применении), кровотечение из носа."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны желудочно-кишечного тракта\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Часто: тошнота."}},{"type":"paragraph","data":{"text":"Редко: рвота."}},{"type":"paragraph","data":{"text":"Если любые из указанных в инструкции побочных эффектов усугубляются, или Вы заметили любые другие побочные эффекты, не указанные в инструкции, сообщите об этом врачу."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Ксилометазолин при местном введении чрезмерной дозы или при случайном приеме внутрь может вызывать сильное головокружение, усиленный и неравномерный пульс, повышенное потоотделение, резкое снижение температуры тела, головную боль, сонливость, брадикардию, повышение артериального давления, угнетение дыхания, кому и судороги. Вслед за повышением артериального давления может наблюдаться его резкое снижение. Соответствующие поддерживающие меры должны приниматься при любых подозрениях на передозировку, в некоторых случаях показано незамедлительное симптоматическое лечение под наблюдением врача."}},{"type":"paragraph","data":{"text":"В случае тяжелого отравления с остановкой сердца реанимационные действия должны продолжаться не менее 1 часа."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Применение ксилометазолина противопоказано пациентам, получающим МАО или трициклические антидепрессанты, включая период 14 дней после их отмены."}},{"type":"paragraph","data":{"text":"Одновременное применение три- или тетрациклических антидепрессантов и симпатомиметических препаратов может привести к увеличению симпатомиметического эффекта ксилометазолина, поэтому такого сочетания рекомендуется избегать."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Недопустимо применение у детей до 2-х лет."}},{"type":"paragraph","data":{"text":"Не рекомендуется применять в непрерывном режиме более 10 дней."}},{"type":"paragraph","data":{"text":"Не следует превышать рекомендованные дозы, особенно у детей и пожилых людей."}},{"type":"paragraph","data":{"text":"Длительное (более 10 дней) или чрезмерное применение препарата может вызвать отек слизистой оболочки или гиперсекрецию, вызванную повышенной чувствительностью клеток («эффект рикошета»)."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Спрей назальный дозированный 35 мкг/доза 140 мкг/доза."}},{"type":"paragraph","data":{"text":"По 10 мл препарата (125 доз во флаконе для дозировки 35 мкг/доза; 60 доз во флаконе для дозировки 140 мкг/доза) в пластиковом флаконе, снабженном помповым дозирующим устройством с наконечником и защитным колпачком из полиэтилена."}},{"type":"paragraph","data":{"text":"По 1 флакону вместе с инструкцией по применению помещают в картонную пачку."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 30 °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. Не применять по истечении срока годности."}}]},{"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":"\n\nТакеда ГмбХ, Германия"}},{"type":"paragraph","data":{"text":"Роберт-Бош-Штрассе 8, 78224 Зинген, Германия"}},{"type":"paragraph","data":{"text":"Takeda GmbH, Germany Robert-Bosch-Strasse 8, 78224 Singen, Germany\n\n"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"\n\nООО «Такеда Фармасьютикалс»,"}},{"type":"paragraph","data":{"text":"Москва, 119048, ул. 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