Применяют при острых респираторных заболеваниях с явлениями ринита (насморка), остром аллергическом рините, евстахеите, поллинозе, синуситах, при среднем отите (в составе комбинированной терапии для уменьшения отека слизистой носоглотки), для облегчения проведения риноскопии.
Противопоказания
Повышенная чувствительность к ксилометазолину, артериальная гипертензия, тахикардия, выраженный атеросклероз, глаукома, атрофический ринит, тиреотоксикоз, хирургические вмешательства на мозговых оболочках (в анамнезе), состояния после транссфеноидальной гипофизэктомии, беременность, детский возраст (до 2 лет – для 0,05% раствора, до 6 лет для 0,1 % ...
Действующее вещество: ксилометазолина гидрохлорид – 0,50 мг или 1,00 мг;
Вспомогательные вещества: динатрия эдетата дигидрат – 0,50 мг, натрия хлорид – 9,00 мг, бензалкония хлорид, в пересчете на безводное вещество – 0,15 мг, калия дигидрофосфат – 3,63 мг, натрия гидрофосфат додекагидрат – 7,13 мг, вода очищенная – до 1 мл.
Описание
прозрачная бесцветная или со слегка коричневатым оттенком жидкость.
Фармакотерапевтическая группа
противоконгестивное средство – альфа-адреномиметик
Фармакологические свойства
Фармакодинамика
Ксилометазолин относится к группе местных сосудосуживающих средств (деконгестантов) с альфа-адреномиметической активностью, вызывает сужение кровеносных сосудов слизистой оболочки полости носа, устраняя, таким образом, отек и гиперемию слизистой оболочки носа, восстанавливает проходимость носовых ходов, облегчает носовое дыхание.
Фармакокинетика
При местном применении препарат практически не всасывается, поэтому его концентрация в плазме крови очень низкая (современными аналитическими методами не определяется).
Показания к применению
Применяют при острых респираторных заболеваниях с явлениями ринита (насморка), остром аллергическом рините, евстахеите, поллинозе, синуситах, при среднем отите (в составе комбинированной терапии для уменьшения отека слизистой носоглотки), для облегчения проведения риноскопии.
Противопоказания
Повышенная чувствительность к ксилометазолину, артериальная гипертензия, тахикардия, выраженный атеросклероз, глаукома, атрофический ринит, тиреотоксикоз, хирургические вмешательства на мозговых оболочках (в анамнезе), состояния после транссфеноидальной гипофизэктомии, беременность, детский возраст (до 2 лет – для 0,05% раствора, до 6 лет для 0,1 % раствора).
Не применять при терапии ингибиторами моноаминоксидазы и трициклическими антидепрессантами или тетрациклическими антидепрессантами, включая период 14 дней после их отмены, а также с другими препаратами, повышающими артериальное давление.
Применение при беременности и в период грудного вскармливания
Противопоказано применение препарата при беременности. При необходимости применения препарата в период лактации грудное вскармливание следует прекратить. В период грудного вскармливания, препарат может применяться только в том случае, если предполагаемая польза для матери превышает потенциальный риск для ребенка.
Способ применения и дозы
Взрослым и детям старше 6 лет вводят по 1-2 капли 0,1% раствора ксилометазолина в каждый носовой ход 2-3 раза в сутки.
Детям от 2 до 6 лет применяют 0,05% раствор по 1-2 капли в каждый носовой ход 1-2 раза в сутки.
Не применять препарат без перерыва более 3-5 дней.
Побочное действие
Частота развития побочных явлений оценивается следующим образом:
очень часто: ≥1/10;
часто: ≥1/100 и <1/10;
нечасто: ≥1/1 000 и <1/100;
редко: ≥1/10 000 и <1/1 000;
очень редко: <1/10 000;
При частом и/или длительном применении:
Со стороны иммунной системы: очень редко - реакция гиперчувствительности (ангионевротический отек, сыпь, зуд).
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).
Со стороны органов чувств: очень редко - нарушение четкости зрительного восприятия.
Со стороны сердечно-сосудистой системы: редко - ощущение сердцебиения, повышение артериального давления; очень редко - тахикардия, аритмия.
Со стороны дыхательной системы: часто - раздражение и/или сухость слизистой оболочки носоглотки, жжение, покалывание, чихание, гиперсекреция слизистой оболочки носоглотки; редко - отек слизистой оболочки полости носа, кровотечение из носа.
Со стороны пищеварительной системы: часто - тошнота; редко - рвота.
Местные реакции: часто - жжение в месте применения. Бензалкония хлорид, входящий в состав препарата, может вызвать раздражение слизистой оболочки полости носа.
Передозировка
Усиление побочных эффектов (дозозависимых), снижение температуры тела, спутанность сознания. Клиническая картина передозировки может представлять чередование фаз стимуляции и подавления центральной нервной системы и сердечно сосудистой и дыхательной систем. При случайном приеме внутрь препарат может вызывать: сильное головокружение, повышенное потоотделение, головную боль, брадикардию, повышение артериального давления, угнетение дыхания, кому и судороги; после повышения артериального давления может наблюдаться его резкое снижение.
Лечение: симптоматическое.
Взаимодействие с другими лекарственными средствами
Возможно усиление системного действия при одновременном применении ингибиторов моноаминоксидазы и трициклических антидепрессантов или тетрациклических антидепрессантов и адреномиметических препаратов, поэтому не рекомендуется одновременный прием данных лекарственных средств.
Особые указания
Перед применением следует очистить носовые ходы.
Не следует применять в течение длительного времени, например, при хроническом рини-те.
Не следует превышать рекомендованную дозу и увеличивать длительность лечения.
Пациенты с синдромом удлиненного интервала QT, применяющие ксилометазолин, могут быть подвержены повышенному риску развития серьезных желудочковых аритмий.
Влияние на способность управлять автомобилем и движущимися механизмами
При соблюдении режима дозирования ксилометазолин не влияет на концентрацию вни-мания. В дозировках, превышающих рекомендуемые, препарат может влиять на способ-ность управлять транспортными средствами или механизмами.
Форма выпуска
Капли назальные, 0,05% и 0,1%.
По 10 мл или 15 мл во флаконы-капельницы полимерные из полиэтилена высокого давления с винтовой горловиной, пробкой-капельницей и навинчиваемой крышкой с контрольным кольцом первого вскрытия из полиэтилена низкого давления; или во флаконы-капельницы полимерные из полиэтилена высокого давления с винтовой горловиной, насадкой-дозатором из полиэтилена высокого давления и навинчиваемой крышкой с контрольным кольцом первого вскрытия из полипропилена; или во флаконы-капельницы полимерные из полиэтилена высокого давления с винтовой горловиной, насадкой-дозатором из полиэтилена высокого давления и навинчиваемой крышкой с контрольным кольцом первого вскрытия из полиэтилена низкого давления.
1 флакон-капельницу вместе с инструкцией по применению в пачку из картона.
Условия хранения
При температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Хранить в оригинальной упаковке.
Срок годности
3 года. Не использовать препарат по истечении срока годности.
Условия отпуска
Отпускают без рецепта.
Производитель
Закрытое акционерное общество «Фармацевтическая фирма «ЛЕККО» (ЗАО "ЛЕККО"),
Россия, 601125, Владимирская обл., Петушинский район, пос. Вольгинский, ул. Заводская, стр. 277;
601125, Владимирская обл., Петушинский район, пос. Вольгинский, ул. Заводская, стр. 279
Организация, принимающая претензии потребителей
Акционерное общество «Отисифарм» (АО «Отисифарм»), Россия, 1233112, ул. Тестовская, д.10,
эт. 12, пом. II, ком. 29
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Мобильное приложение «Все аптеки»
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средство – альфа-адреномиметик"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Фармакодинамика"}},{"type":"paragraph","data":{"text":"Ксилометазолин относится к группе местных сосудосуживающих средств (деконгестантов) с альфа-адреномиметической активностью, вызывает сужение кровеносных сосудов слизистой оболочки полости носа, устраняя, таким образом, отек и гиперемию слизистой оболочки носа, восстанавливает проходимость носовых ходов, облегчает носовое дыхание."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"При местном применении препарат практически не всасывается, поэтому его концентрация в плазме крови очень низкая (современными аналитическими методами не определяется)."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Применяют при острых респираторных заболеваниях с явлениями ринита (насморка), остром аллергическом рините, евстахеите, поллинозе, синуситах, при среднем отите (в составе комбинированной терапии для уменьшения отека слизистой носоглотки), для облегчения проведения риноскопии."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к ксилометазолину, артериальная гипертензия, тахикардия, выраженный атеросклероз, глаукома, атрофический ринит, тиреотоксикоз, хирургические вмешательства на мозговых оболочках (в анамнезе), состояния после транссфеноидальной гипофизэктомии, беременность, детский возраст (до 2 лет – для 0,05% раствора, до 6 лет для 0,1 % раствора)."}},{"type":"paragraph","data":{"text":"Не применять при терапии ингибиторами моноаминоксидазы и трициклическими антидепрессантами или тетрациклическими антидепрессантами, включая период 14 дней после их отмены, а также с другими препаратами, повышающими артериальное давление."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Сахарный диабет, ишемическая болезнь сердца (стенокардия), гиперплазия предстательной железы, феохромоцитома, порфирия, гипертиреоз, период грудного вскармливания, пациенты с повышенной чувствительностью к адренергическим препаратам, сопровождающейся симптомами 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":"Противопоказано применение препарата при беременности. При необходимости применения препарата в период лактации грудное вскармливание следует прекратить. В период грудного вскармливания, препарат может применяться только в том случае, если предполагаемая польза для матери превышает потенциальный риск для ребенка."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"\n\nВзрослым и детям старше 6 лет вводят по 1-2 капли 0,1% раствора ксилометазолина в каждый носовой ход 2-3 раза в сутки."}},{"type":"paragraph","data":{"text":"Детям от 2 до 6 лет применяют 0,05% раствор по 1-2 капли в каждый носовой ход 1-2 раза в сутки."}},{"type":"paragraph","data":{"text":"Не применять препарат без перерыва более 3-5 дней.\n\n"}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Частота развития побочных явлений оценивается следующим образом:"}},{"type":"paragraph","data":{"text":"очень часто: ≥1/10;"}},{"type":"paragraph","data":{"text":"часто: ≥1/100 и <1/10;"}},{"type":"paragraph","data":{"text":"нечасто: ≥1/1 000 и <1/100;"}},{"type":"paragraph","data":{"text":"редко: ≥1/10 000 и <1/1 000;"}},{"type":"paragraph","data":{"text":"очень редко: <1/10 000;"}},{"type":"paragraph","data":{"text":"При частом и/или длительном применении:"}},{"type":"paragraph","data":{"text":"Со стороны иммунной системы: очень редко - реакция гиперчувствительности (ангионевротический отек, сыпь, зуд)."}},{"type":"paragraph","data":{"text":"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)."}},{"type":"paragraph","data":{"text":"Со стороны органов чувств: очень редко - нарушение четкости зрительного восприятия."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: редко - ощущение сердцебиения, повышение артериального давления; очень редко - тахикардия, аритмия."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: часто - раздражение и/или сухость слизистой оболочки носоглотки, жжение, покалывание, чихание, гиперсекреция слизистой оболочки носоглотки; редко - отек слизистой оболочки полости носа, кровотечение из носа."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: часто - тошнота; редко - рвота."}},{"type":"paragraph","data":{"text":"Местные реакции: часто - жжение в месте применения. Бензалкония хлорид, входящий в состав препарата, может вызвать раздражение слизистой оболочки полости носа."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\n\nУсиление побочных эффектов (дозозависимых), снижение температуры тела, спутанность сознания. Клиническая картина передозировки может представлять чередование фаз стимуляции и подавления центральной нервной системы и сердечно сосудистой и дыхательной систем. При случайном приеме внутрь препарат может вызывать: сильное головокружение, повышенное потоотделение, головную боль, брадикардию, повышение артериального давления, угнетение дыхания, кому и судороги; после повышения артериального давления может наблюдаться его резкое снижение."}},{"type":"paragraph","data":{"text":"Лечение: симптоматическое.\n\n"}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Возможно усиление системного действия при одновременном применении ингибиторов моноаминоксидазы и трициклических антидепрессантов или тетрациклических антидепрессантов и адреномиметических препаратов, поэтому не рекомендуется одновременный прием данных лекарственных средств."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nПеред применением следует очистить носовые ходы."}},{"type":"paragraph","data":{"text":"Не следует применять в течение длительного времени, например, при хроническом рини-те."}},{"type":"paragraph","data":{"text":"Не следует превышать рекомендованную дозу и увеличивать длительность лечения."}},{"type":"paragraph","data":{"text":"Пациенты с синдромом удлиненного интервала QT, применяющие ксилометазолин, могут быть подвержены повышенному риску развития серьезных желудочковых аритмий.\n\n"}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"При соблюдении режима дозирования ксилометазолин не влияет на концентрацию вни-мания. В дозировках, превышающих рекомендуемые, препарат может влиять на способ-ность управлять транспортными средствами или механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nКапли назальные, 0,05% и 0,1%."}},{"type":"paragraph","data":{"text":"По 10 мл или 15 мл во флаконы-капельницы полимерные из полиэтилена высокого давления с винтовой горловиной, пробкой-капельницей и навинчиваемой крышкой с контрольным кольцом первого вскрытия из полиэтилена низкого давления; или во флаконы-капельницы полимерные из полиэтилена высокого давления с винтовой горловиной, насадкой-дозатором из полиэтилена высокого давления и навинчиваемой крышкой с контрольным кольцом первого вскрытия из полипропилена; или во флаконы-капельницы полимерные из полиэтилена высокого давления с винтовой горловиной, насадкой-дозатором из полиэтилена высокого давления и навинчиваемой крышкой с контрольным кольцом первого вскрытия из полиэтилена низкого давления."}},{"type":"paragraph","data":{"text":"1 флакон-капельницу вместе с инструкцией по применению в пачку из картона.\n\n"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"\n\nПри температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}},{"type":"paragraph","data":{"text":"Хранить в оригинальной упаковке.\n\n"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года. Не использовать препарат по истечении срока годности."}}]},{"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\nЗакрытое акционерное общество «Фармацевтическая фирма «ЛЕККО» (ЗАО \"ЛЕККО\"),"}},{"type":"paragraph","data":{"text":"Россия, 601125, Владимирская обл., Петушинский район, пос. Вольгинский, ул. Заводская, стр. 277;"}},{"type":"paragraph","data":{"text":"601125, Владимирская обл., Петушинский район, пос. Вольгинский, ул. Заводская, стр. 279\n\n"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"\n\nАкционерное общество «Отисифарм» (АО «Отисифарм»), Россия, 1233112, ул. Тестовская, д.10,"}},{"type":"paragraph","data":{"text":"эт. 12, пом. 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