Фармакологическое действие — бронходилатирующее, глюкокортик... Инструкция
Показания к применению
Лечение бронхиальной астмы у пациентов, которым показана комбинированная терапия ?2-адреномиметиком длительного действия и ингаляционным ГКС: - пациенты с недостаточным контролем заболевания на фоне постоянной монотерапии ингаляционным ГКС при периодическом использовании ?2-адреномиметика короткого действия . - пациенты с адекватным контролем заболевания ...
Повышенная чувствительность к компонентам препарата .
Инструкция
Состав
В 1 капсуле активные вещества: салметерола ксинафоат 72,5/72,5/72,5 мкг (в пересчете на салметерол — 50/50/50 мкг), флутиказона пропионат 100/250/500 мкг. Вспомогательные вещества: натрия бензоат — 2/2/2 мг . лактозы моногидрат — до 12/12/12 мг
Фармакологические свойства
Фармакологическое действие — бронходилатирующее, глюкокортикоидное, бета-адреномиметическое.
Показания к применению
Лечение бронхиальной астмы у пациентов, которым показана комбинированная терапия ?2-адреномиметиком длительного действия и ингаляционным ГКС: - пациенты с недостаточным контролем заболевания на фоне постоянной монотерапии ингаляционным ГКС при периодическом использовании ?2-адреномиметика короткого действия . - пациенты с адекватным контролем заболевания на фоне терапии ингаляционным ГКС и ?2-адреномиметиком длительного действия . - в качестве стартовой поддерживающей терапии у пациентов с персистирующей бронхиальной астмой (ежедневное возникновение симптомов, ежедневное использование средств для быстрого купирования симптомов) при наличии показаний к назначению ГКС для достижения контроля над заболеванием. поддерживающая терапии при ХОБЛ у пациентов со значением объема форсированного выдоха (ОФВ1) меньше 60% от должных величин (до ингаляции бронходилататора) и повторными обострениями в анамнезе, у которых выраженные симптомы заболевания сохраняются, несмотря на регулярную терапию бронходилататорами.
Противопоказания
Повышенная чувствительность к компонентам препарата .
Применение при беременности и в период грудного вскармливания
При беременности и в период лактации (грудного вскармливания) Салтиказон .-натив можно назначать только в том случае, если предполагаемая польза для матери превышает любой возможный риск для плода или ребенка.
Способ применения и дозы
Ингаляционно. Для получения оптимального эффекта препарат следует применять регулярно, даже при отсутствии клинических симптомов бронхиальной астмы и ХОБЛ. Курс лечения и изменение дозы назначается врачом в индивидуальном порядке. Пациенту следует назначать препарат в такой лекарственной форме, которая содержит дозу флутиказона пропионата, соответствующую тяжести заболевания. Бронхиальная астма. Если пациент не получает соответствующую терапию, принимая только ингаляционные ГКС, то их замена на препарат Салтиказон .-натив в дозе, терапевтически эквивалентной дозе вводимых ГКС, может улучшить контроль течения астмы. У пациентов, у которых можно контролировать течение астмы исключительно с помощью ингаляционных ГКС, их замена на препарат Салтиказон .-натив может позволить снизить дозу ГКС, необходимую для контроля течения астмы. Взрослые (18 лет и старше). 1 ингаляция (50 мкг салметерола и 100 мкг флутиказона пропионата) 2 раза в сутки или 1 ингаляция (50 мкг салметерола и 250 мкг флутиказона пропионата) 2 раза в сутки или 1 ингаляция (50 мкг салметерола и 500 мкг флутиказона пропионата) 2 раза в сутки. У взрослых старше 18 лет при удвоении дозы Салтиказон .-натив сохраняется такая же безопасность и переносимость, как при регулярном применении этой комбинации 2 раза в сутки. Дозу можно удваивать в тех случаях, когда пациенты нуждаются в дополнительной краткосрочной (до 14 дней) ингаляционной терапии кортикостероидами, как описано в руководствах по лечению бронхиальной астмы. В настоящее время нет данных о применении препарата Салтиказон .-натив у пациентов в возрасте до 18 лет. Дозу препарата Салтиказон .-натив следует снижать до самой низкой дозы, обеспечивающей эффективный контроль симптомов. Если контроль симптомов обеспечивает прием препарата Салтиказон .-натив 2 раза в сутки, снижение дозы до минимально эффективной может включать однократный прием препарата в сутки. ХОБЛ. Максимальная рекомендуемая доза для взрослых составляет: одна ингаляция (50 мкг салметерола и 500 мкг флутиказона пропионата) 2 раза в сутки. Особые группы пациентов. Нет необходимости снижать дозу препарата Салтиказон .-натив у пожилых пациентов, а также у пациентов с нарушениями функции почек или печени. Инструкция по проведению ингаляций. Ингалятор порошковый «Инхалер CDM .» — пластиковое устройство белого цвета с подвижной верхней частью и с выдвигающимся отсеком для капсулы, высотой около 6 см. Для того чтобы обеспечить правильное применение препарата, применять его следует только с помощью «Инхалера CDM .». Капсулы предназначены только для ингаляционного применения и не предназначены для проглатывания. Вынимать капсулу из ячейковой упаковки следует непосредственно перед применением.
Побочное действие
Поскольку препарат Салтиказон .-натив содержит салметерол и флутиказона пропионат, следует ожидать развития побочных реакций, характерных для каждого компонента в отдельности. Дополнительные побочные эффекты при одновременном применении двух компонентов препарата не отмечены. Определение частоты: очень часто (?1/10) . часто (от 1/100 до 1/10) . нечасто (от 1/1000 до 1/100) . редко (от 1/10000 до 1/1000) . очень редко ( меньше 1/10000). Инфекционные и паразитарные заболевания: часто — кандидоз слизистой оболочки полости рта и глотки, пневмония (у пациентов с ХОБЛ). Со стороны иммунной системы: редко — реакции гиперчувствительности, например экзантема, крапивница, зуд, сыпь, дерматит, ангиоэдема, анафилактическая реакция, бронхоспазм. Со стороны обмена веществ: нечасто — гипергликемия . очень редко — гипокалиемия. Со стороны эндокринной системы: редко — гиперкортицизм . очень редко — симптомы системных эффектов ГКС (включая гипофункцию надпочечников, синдром Кушинга), снижение минеральной плотности костной ткани. Со стороны ЦНС: очень часто — головная боль . нечасто — тошнота, головокружение, психомоторное возбуждение, тревожность, нарушения сна . редко — нарушения поведения . очень редко — депрессия, нарушения вкуса. Со стороны ССС: нечасто — ощущение сердцебиения, тахикардия, фибрилляция предсердий . редко — аритмия, включая желудочковую экстрасистолию, суправентрикулярную тахикардию и экстрасистолию . очень редко — стенокардия, колебания АД, периферические отеки. Со стороны дыхательной системы: часто — кашель, охриплость голоса и/или дисфония, исчезающая после прекращения терапии или снижения дозы препарата . нечасто — раздражение глотки . редко — бронхоспазм, включая парадоксальный. Со стороны кожных покровов: нечасто — кровоподтеки. Со стороны опорно-двигательного аппарата: часто — тремор, мышечные судороги, артралгии . нечасто — миалгии . редко — снижение минеральной плотности костной ткани. Прочие: нечасто — катаракта . редко — глаукома. Для снижения риска возникновения кандидоза после ингаляции Салтиказон .-натив рекомендуется прополоскать рот и горло водой. Системное действие ингаляционных ГКС может наблюдаться при приеме препарата в высоких дозах в течение продолжительного времени.
Особые указания
Поскольку препарат Салтиказон .-натив содержит салметерол и флутиказона пропионат, следует ожидать развития побочных реакций, характерных для каждого компонента в отдельности. Дополнительные побочные эффекты при одновременном применении двух компонентов препарата не отмечены. Определение частоты: очень часто (?1/10) . часто (от 1/100 до 1/10) . нечасто (от 1/1000 до 1/100) . редко (от 1/10000 до 1/1000) . очень редко ( меньше 1/10000). Инфекционные и паразитарные заболевания: часто — кандидоз слизистой оболочки полости рта и глотки, пневмония (у пациентов с ХОБЛ). Со стороны иммунной системы: редко — реакции гиперчувствительности, например экзантема, крапивница, зуд, сыпь, дерматит, ангиоэдема, анафилактическая реакция, бронхоспазм. Со стороны обмена веществ: нечасто — гипергликемия . очень редко — гипокалиемия. Со стороны эндокринной системы: редко — гиперкортицизм . очень редко — симптомы системных эффектов ГКС (включая гипофункцию надпочечников, синдром Кушинга), снижение минеральной плотности костной ткани. Со стороны ЦНС: очень часто — головная боль . нечасто — тошнота, головокружение, психомоторное возбуждение, тревожность, нарушения сна . редко — нарушения поведения . очень редко — депрессия, нарушения вкуса. Со стороны ССС: нечасто — ощущение сердцебиения, тахикардия, фибрилляция предсердий . редко — аритмия, включая желудочковую экстрасистолию, суправентрикулярную тахикардию и экстрасистолию . очень редко — стенокардия, колебания АД, периферические отеки. Со стороны дыхательной системы: часто — кашель, охриплость голоса и/или дисфония, исчезающая после прекращения терапии или снижения дозы препарата . нечасто — раздражение глотки . редко — бронхоспазм, включая парадоксальный. Со стороны кожных покровов: нечасто — кровоподтеки. Со стороны опорно-двигательного аппарата: часто — тремор, мышечные судороги, артралгии . нечасто — миалгии . редко — снижение минеральной плотности костной ткани. Прочие: нечасто — катаракта . редко — глаукома. Для снижения риска возникновения кандидоза после ингаляции Салтиказон .-натив рекомендуется прополоскать рот и горло водой. Системное действие ингаляционных ГКС может наблюдаться при приеме препарата в высоких дозах в течение продолжительного времени.
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1 капсуле активные вещества: салметерола ксинафоат 72,5/72,5/72,5 мкг (в пересчете на салметерол — 50/50/50 мкг), флутиказона пропионат 100/250/500 мкг. Вспомогательные вещества: натрия бензоат — 2/2/2 мг . лактозы моногидрат — до 12/12/12 мг"}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Фармакологическое действие — бронходилатирующее, глюкокортикоидное, бета-адреномиметическое."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение бронхиальной астмы у пациентов, которым показана комбинированная терапия ?2-адреномиметиком длительного действия и ингаляционным ГКС: - пациенты с недостаточным контролем заболевания на фоне постоянной монотерапии ингаляционным ГКС при периодическом использовании ?2-адреномиметика короткого действия . - пациенты с адекватным контролем заболевания на фоне терапии ингаляционным ГКС и ?2-адреномиметиком длительного действия . - в качестве стартовой поддерживающей терапии у пациентов с персистирующей бронхиальной астмой (ежедневное возникновение симптомов, ежедневное использование средств для быстрого купирования симптомов) при наличии показаний к назначению ГКС для достижения контроля над заболеванием. поддерживающая терапии при ХОБЛ у пациентов со значением объема форсированного выдоха (ОФВ1) меньше 60% от должных величин (до ингаляции бронходилататора) и повторными обострениями в анамнезе, у которых выраженные симптомы заболевания сохраняются, несмотря на регулярную терапию бронходилататорами."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к компонентам препарата ."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При беременности и в период лактации (грудного вскармливания) Салтиказон .-натив можно назначать только в том случае, если предполагаемая польза для матери превышает любой возможный риск для плода или ребенка."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Ингаляционно. Для получения оптимального эффекта препарат следует применять регулярно, даже при отсутствии клинических симптомов бронхиальной астмы и ХОБЛ. Курс лечения и изменение дозы назначается врачом в индивидуальном порядке. Пациенту следует назначать препарат в такой лекарственной форме, которая содержит дозу флутиказона пропионата, соответствующую тяжести заболевания. Бронхиальная астма. Если пациент не получает соответствующую терапию, принимая только ингаляционные ГКС, то их замена на препарат Салтиказон .-натив в дозе, терапевтически эквивалентной дозе вводимых ГКС, может улучшить контроль течения астмы. У пациентов, у которых можно контролировать течение астмы исключительно с помощью ингаляционных ГКС, их замена на препарат Салтиказон .-натив может позволить снизить дозу ГКС, необходимую для контроля течения астмы. Взрослые (18 лет и старше). 1 ингаляция (50 мкг салметерола и 100 мкг флутиказона пропионата) 2 раза в сутки или 1 ингаляция (50 мкг салметерола и 250 мкг флутиказона пропионата) 2 раза в сутки или 1 ингаляция (50 мкг салметерола и 500 мкг флутиказона пропионата) 2 раза в сутки. У взрослых старше 18 лет при удвоении дозы Салтиказон .-натив сохраняется такая же безопасность и переносимость, как при регулярном применении этой комбинации 2 раза в сутки. Дозу можно удваивать в тех случаях, когда пациенты нуждаются в дополнительной краткосрочной (до 14 дней) ингаляционной терапии кортикостероидами, как описано в руководствах по лечению бронхиальной астмы. В настоящее время нет данных о применении препарата Салтиказон .-натив у пациентов в возрасте до 18 лет. Дозу препарата Салтиказон .-натив следует снижать до самой низкой дозы, обеспечивающей эффективный контроль симптомов. Если контроль симптомов обеспечивает прием препарата Салтиказон .-натив 2 раза в сутки, снижение дозы до минимально эффективной может включать однократный прием препарата в сутки. ХОБЛ. Максимальная рекомендуемая доза для взрослых составляет: одна ингаляция (50 мкг салметерола и 500 мкг флутиказона пропионата) 2 раза в сутки. Особые группы пациентов. Нет необходимости снижать дозу препарата Салтиказон .-натив у пожилых пациентов, а также у пациентов с нарушениями функции почек или печени. Инструкция по проведению ингаляций. Ингалятор порошковый «Инхалер CDM .» — пластиковое устройство белого цвета с подвижной верхней частью и с выдвигающимся отсеком для капсулы, высотой около 6 см. Для того чтобы обеспечить правильное применение препарата, применять его следует только с помощью «Инхалера CDM .». Капсулы предназначены только для ингаляционного применения и не предназначены для проглатывания. Вынимать капсулу из ячейковой упаковки следует непосредственно перед применением."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Поскольку препарат Салтиказон .-натив содержит салметерол и флутиказона пропионат, следует ожидать развития побочных реакций, характерных для каждого компонента в отдельности. Дополнительные побочные эффекты при одновременном применении двух компонентов препарата не отмечены. Определение частоты: очень часто (?1/10) . часто (от 1/100 до 1/10) . нечасто (от 1/1000 до 1/100) . редко (от 1/10000 до 1/1000) . очень редко ( меньше 1/10000). Инфекционные и паразитарные заболевания: часто — кандидоз слизистой оболочки полости рта и глотки, пневмония (у пациентов с ХОБЛ). Со стороны иммунной системы: редко — реакции гиперчувствительности, например экзантема, крапивница, зуд, сыпь, дерматит, ангиоэдема, анафилактическая реакция, бронхоспазм. Со стороны обмена веществ: нечасто — гипергликемия . очень редко — гипокалиемия. Со стороны эндокринной системы: редко — гиперкортицизм . очень редко — симптомы системных эффектов ГКС (включая гипофункцию надпочечников, синдром Кушинга), снижение минеральной плотности костной ткани. Со стороны ЦНС: очень часто — головная боль . нечасто — тошнота, головокружение, психомоторное возбуждение, тревожность, нарушения сна . редко — нарушения поведения . очень редко — депрессия, нарушения вкуса. Со стороны ССС: нечасто — ощущение сердцебиения, тахикардия, фибрилляция предсердий . редко — аритмия, включая желудочковую экстрасистолию, суправентрикулярную тахикардию и экстрасистолию . очень редко — стенокардия, колебания АД, периферические отеки. Со стороны дыхательной системы: часто — кашель, охриплость голоса и/или дисфония, исчезающая после прекращения терапии или снижения дозы препарата . нечасто — раздражение глотки . редко — бронхоспазм, включая парадоксальный. Со стороны кожных покровов: нечасто — кровоподтеки. Со стороны опорно-двигательного аппарата: часто — тремор, мышечные судороги, артралгии . нечасто — миалгии . редко — снижение минеральной плотности костной ткани. Прочие: нечасто — катаракта . редко — глаукома. Для снижения риска возникновения кандидоза после ингаляции Салтиказон .-натив рекомендуется прополоскать рот и горло водой. Системное действие ингаляционных ГКС может наблюдаться при приеме препарата в высоких дозах в течение продолжительного времени."}}]},{"id":8,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Поскольку препарат Салтиказон .-натив содержит салметерол и флутиказона пропионат, следует ожидать развития побочных реакций, характерных для каждого компонента в отдельности. Дополнительные побочные эффекты при одновременном применении двух компонентов препарата не отмечены. Определение частоты: очень часто (?1/10) . часто (от 1/100 до 1/10) . нечасто (от 1/1000 до 1/100) . редко (от 1/10000 до 1/1000) . очень редко ( меньше 1/10000). Инфекционные и паразитарные заболевания: часто — кандидоз слизистой оболочки полости рта и глотки, пневмония (у пациентов с ХОБЛ). Со стороны иммунной системы: редко — реакции гиперчувствительности, например экзантема, крапивница, зуд, сыпь, дерматит, ангиоэдема, анафилактическая реакция, бронхоспазм. Со стороны обмена веществ: нечасто — гипергликемия . очень редко — гипокалиемия. Со стороны эндокринной системы: редко — гиперкортицизм . очень редко — симптомы системных эффектов ГКС (включая гипофункцию надпочечников, синдром Кушинга), снижение минеральной плотности костной ткани. Со стороны ЦНС: очень часто — головная боль . нечасто — тошнота, головокружение, психомоторное возбуждение, тревожность, нарушения сна . редко — нарушения поведения . очень редко — депрессия, нарушения вкуса. Со стороны ССС: нечасто — ощущение сердцебиения, тахикардия, фибрилляция предсердий . редко — аритмия, включая желудочковую экстрасистолию, суправентрикулярную тахикардию и экстрасистолию . очень редко — стенокардия, колебания АД, периферические отеки. Со стороны дыхательной системы: часто — кашель, охриплость голоса и/или дисфония, исчезающая после прекращения терапии или снижения дозы препарата . нечасто — раздражение глотки . редко — бронхоспазм, включая парадоксальный. Со стороны кожных покровов: нечасто — кровоподтеки. Со стороны опорно-двигательного аппарата: часто — тремор, мышечные судороги, артралгии . нечасто — миалгии . редко — снижение минеральной плотности костной ткани. Прочие: нечасто — катаракта . редко — глаукома. Для снижения риска возникновения кандидоза после ингаляции Салтиказон .-натив рекомендуется прополоскать рот и горло водой. 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