ГКС для местного применения. Мометазон оказывает противовосп... Инструкция
Показания к применению
Для ингаляционного применения: базисная терапия бронхиальной астмы любой степени тяжести; ХОБЛ. Для интраназального применения: лечение сезонного и круглогодичного аллергического ринита у взрослых, подростков и детей с 2 лет; острый синусит или обострение хронического синусита у взрослых (в т.ч. пожилого возраста) и подростков с 12 лет (в качестве вспомогательного ...
Повышенная чувствительность к мометазону. Для ингаляционного применения: детский возраст до 12 лет. Для интраназального применения: недавнее оперативное вмешательство или травма носа с повреждением слизистой оболочки носовой полости - до заживления раны (в связи с ингибирующим действием ГКС на процессы заживления); детский и подростковый возраст до ...
Действующее вещество: МометазонКонцентрация действующего вещества (мкг): 50 мкг
Фармакологические свойства
ГКС для местного применения. Мометазон оказывает противовоспалительное и противоаллергическое действие. Местное противовоспалительное действие препарата проявляется при его применении в дозах, при которых не возникает системных эффектов. Тормозит высвобождение медиаторов воспаления. Повышает продукцию липомодулина, являющегося ингибитором фосфолипазы А, что обусловливает снижение высвобождения арахидоновой кислоты и, соответственно, угнетение синтеза продуктов метаболизма арахидоновой кислоты - циклических эндопероксидов, простагландинов. Предупреждает краевое скопление нейтрофилов, что уменьшает воспалительный экссудат и продукцию лимфокинов, тормозит миграцию макрофагов, приводит к уменьшению процессов инфильтрации и грануляции. Уменьшает воспаление за счет снижения образования субстанции хемотаксиса (влияние на поздние реакции аллергии), тормозит развитие немедленной аллергической реакции (за счет торможения образования метаболитов арахидоновой кислоты и снижения высвобождения из тучных клеток медиаторов воспаления). В исследованиях с провокационными тестами с нанесением антигенов на слизистую оболочку полости носа была продемонстрирована высокая противовоспалительная активность препарата, как на ранних, так и на поздних стадиях аллергической реакции. При сравнении с плацебо установлено снижение уровня гистамина и активности эозинофилов, а также уменьшение (по сравнению с исходным) количества эозинофилов, нейтрофилов и белков эпителиальных клеток.
Показания к применению
Для ингаляционного применения: базисная терапия бронхиальной астмы любой степени тяжести; ХОБЛ. Для интраназального применения: лечение сезонного и круглогодичного аллергического ринита у взрослых, подростков и детей с 2 лет; острый синусит или обострение хронического синусита у взрослых (в т.ч. пожилого возраста) и подростков с 12 лет (в качестве вспомогательного терапевтического средства при лечении антибиотиками); острый риносинусит с легкими и умеренно выраженными симптомами без признаков тяжелой бактериальной инфекции у пациентов в возрасте 12 лет и старше; профилактика сезонного аллергического ринита среднетяжелого и тяжелого течения у взрослых и подростков с 12 лет; полипоз носа, сопровождающийся нарушением носового дыхания и обоняния у взрослых.
Противопоказания
Повышенная чувствительность к мометазону. Для ингаляционного применения: детский возраст до 12 лет. Для интраназального применения: недавнее оперативное вмешательство или травма носа с повреждением слизистой оболочки носовой полости - до заживления раны (в связи с ингибирующим действием ГКС на процессы заживления); детский и подростковый возраст до 18 лет при полипозе носа; детский возраст до 12 лет при остром синусите или обострении хронического синусита; детский возраст до 2 лет при сезонном и круглогодичном аллергических ринитах.
Применение при беременности и в период грудного вскармливания
Специальных исследований по безопасности применения мометазона при беременности и в период грудного вскармливания не проводилось. Как и при использовании других назальных ГКС, препарат Дезринит следует назначать при беременности и в период лактации только в том случае, если ожидаемая польза для матери превышает потенциальный риск для плода и ребенка. Новорожденных, матери которых при беременности применяли ГКС, необходимо тщательно обследовать для выявления возможной гипофункции надпочечников.
Способ применения и дозы
Режим дозирования устанавливают индивидуально, в зависимости от показаний, возраста пациента, способа введения, применяемой лекарственной формы.
Побочное действие
Со стороны дыхательной системы: при ингаляционном применении для лечения бронхиальной астмы возможно развитие бронхоспазма и увеличение количества хрипов в легких сразу после ингаляции; при интраназальном применении возможны носовые кровотечения, фарингит, ощущение жжения в носу, чиханье; раздражение слизистой оболочки полости носа; очень редко при интраназальном применении - случаи перфорации носовой перегородки. Системные эффекты (особенно при применении в высоких дозах и в течение продолжительного времени): при ингаляционном применении - угнетение функции коры надпочечников, задержка роста у детей и подростков, деминерализация костной ткани, глаукома, повышение внутриглазного давления (возникает в отдельных случаях при интраназальном применении), развитие катаракты. Аллергические реакции: при постмаркетинговом применении в единичных случаях - проявления повышенной чувствительности, такие как сыпь, кожный зуд, ангионевротический отек и анафилактическая реакция. Сообщалось об ухудшении течения астмы, которое может проявляться кашлем, одышкой, свистящим дыханием и бронхоспазмомПрочие: при интраназальном применении возможна головная боль.
Передозировка
Препарат обладает низкой (меньше1%) системной биодоступностью, поэтому маловероятно, что при передозировке потребуется принятие каких-либо специальных мер, кроме наблюдения и последующего назначения в рекомендованной дозе. При длительном применении ГКС в высоких дозах или при одновременном применении нескольких ГКС возможно угнетение гипоталамо-гипофизарно-надпочечниковой системы.
Особые указания
При применении мометазона в течение 12 мес признаков атрофии слизистой оболочки носа отмечено не было. При исследовании биоптатов слизистой оболочки носа выявлено, что мометазон проявлял тенденцию к нормализации гистологической картины. При применении препарата в течение длительного времени (как и при всяком долгосрочном лечении) необходим периодический осмотр слизистой оболочки носа врачом-оториноларингологом. При развитии местной грибковой инфекции носа или глотки лечение препаратом рекомендуется прекратить и начать проведение специфической терапии. Сохраняющееся в течение длительного времени раздражение слизистой оболочки полости носа и глотки является показанием к отмене препарата. При длительном применении препарата признаков подавления функции гипоталамо-гипофизарно-надпочечниковой системы не наблюдалось. Пациенты, которые переходят на терапию мометазоном после длительного лечения ГКС системного действия, требуют к себе особого внимания. Отмена ГКС системного действия у таких пациентов может привести к недостаточности функции надпочечников, что может потребовать принятия соответствующих мер. Во время перехода от лечения ГКС системного действия к терапии мометазоном у некоторых пациентов могут возникнуть симптомы отмены ГКС для системного применения (например, боль в суставах и/или мышцах, чувство усталости, депрессия), несмотря на уменьшение выраженности симптомов, связанных с поражением слизистой оболочки носа, таких больных необходимо специально убеждать в целесообразности продолжения лечения препаратом Дезринит. Переход от ГКС системного действия к местным ГКС может также выявить уже существовавшие, но маскировавшиеся терапией ГКС системного действия аллергические заболевания, такие как аллергический конъюнктивит и экзема. Эффективность и безопасность мометазона не изучена при лечении односторонних полипов, полипов, связанных с муковисцидозом и полипов, которые полностью закрывают носовую полость. Односторонние полипы неправильной формы или кровоточащие следует дополнительно обследовать. Пациенты, которым проводится терапия ГКС, обладают сниженной иммунной реактивностью, поэтому их следует предупредить о повышенном риске инфицирования при контакте с больными некоторыми инфекционными заболеваниями (например, ветряной оспой, корью), а также о необходимости врачебной консультации, если такой контакт произошел. При длительном применении назальных ГКС в высоких дозах возможно развитие системных побочных эффектов. Вероятность развития этих эффектов гораздо меньше, чем при применении системных ГКС, и может различаться у отдельных пациентов, а также между разными ГКС. К потенциальным системным эффектам относятся синдром Кушинга, характерные признаки кушингоида, подавление функции надпочечников, задержка роста у детей и подростков, катаракта, глаукома и, реже - ряд психологических или поведенческих эффектов, включая психомоторную гиперактивность, нарушение сна, беспокойство, депрессию или агрессию (особенно у детей). Рекомендуется регулярно контролировать рост детей, получающих длительную терапию мометазоном. При замедлении роста следует пересмотреть проводимую терапию с целью снижения дозы мометазона до минимальной эффективной, позволяющей контролировать симптомы заболевания. Кроме того, следует направить пациента на консультацию к педиатру. Лечение ГКС в дозах, превышающих рекомендуемые, может привести к клинически значимому угнетению функции надпочечников. Если известно, что ГКС применяются в высоких дозах, необходимо рассмотреть возможность дополнительного применения системных ГКС в периоды стресса или планового хирургического вмешательства. Влияние на способность к вождению автотранспорта и управлению механизмамиИсследований по изучению влияния на способность к управлению транспортными средствами и механизмами не проводилось.
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вещество: МометазонКонцентрация действующего вещества (мкг): 50 мкг"}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"ГКС для местного применения. Мометазон оказывает противовоспалительное и противоаллергическое действие. Местное противовоспалительное действие препарата проявляется при его применении в дозах, при которых не возникает системных эффектов. Тормозит высвобождение медиаторов воспаления. Повышает продукцию липомодулина, являющегося ингибитором фосфолипазы А, что обусловливает снижение высвобождения арахидоновой кислоты и, соответственно, угнетение синтеза продуктов метаболизма арахидоновой кислоты - циклических эндопероксидов, простагландинов. Предупреждает краевое скопление нейтрофилов, что уменьшает воспалительный экссудат и продукцию лимфокинов, тормозит миграцию макрофагов, приводит к уменьшению процессов инфильтрации и грануляции. Уменьшает воспаление за счет снижения образования субстанции хемотаксиса (влияние на поздние реакции аллергии), тормозит развитие немедленной аллергической реакции (за счет торможения образования метаболитов арахидоновой кислоты и снижения высвобождения из тучных клеток медиаторов воспаления). В исследованиях с провокационными тестами с нанесением антигенов на слизистую оболочку полости носа была продемонстрирована высокая противовоспалительная активность препарата, как на ранних, так и на поздних стадиях аллергической реакции. При сравнении с плацебо установлено снижение уровня гистамина и активности эозинофилов, а также уменьшение (по сравнению с исходным) количества эозинофилов, нейтрофилов и белков эпителиальных клеток."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Для ингаляционного применения: базисная терапия бронхиальной астмы любой степени тяжести; ХОБЛ. Для интраназального применения: лечение сезонного и круглогодичного аллергического ринита у взрослых, подростков и детей с 2 лет; острый синусит или обострение хронического синусита у взрослых (в т.ч. пожилого возраста) и подростков с 12 лет (в качестве вспомогательного терапевтического средства при лечении антибиотиками); острый риносинусит с легкими и умеренно выраженными симптомами без признаков тяжелой бактериальной инфекции у пациентов в возрасте 12 лет и старше; профилактика сезонного аллергического ринита среднетяжелого и тяжелого течения у взрослых и подростков с 12 лет; полипоз носа, сопровождающийся нарушением носового дыхания и обоняния у взрослых."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к мометазону. Для ингаляционного применения: детский возраст до 12 лет. Для интраназального применения: недавнее оперативное вмешательство или травма носа с повреждением слизистой оболочки носовой полости - до заживления раны (в связи с ингибирующим действием ГКС на процессы заживления); детский и подростковый возраст до 18 лет при полипозе носа; детский возраст до 12 лет при остром синусите или обострении хронического синусита; детский возраст до 2 лет при сезонном и круглогодичном аллергических ринитах."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Специальных исследований по безопасности применения мометазона при беременности и в период грудного вскармливания не проводилось. Как и при использовании других назальных ГКС, препарат Дезринит следует назначать при беременности и в период лактации только в том случае, если ожидаемая польза для матери превышает потенциальный риск для плода и ребенка. Новорожденных, матери которых при беременности применяли ГКС, необходимо тщательно обследовать для выявления возможной гипофункции надпочечников."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Режим дозирования устанавливают индивидуально, в зависимости от показаний, возраста пациента, способа введения, применяемой лекарственной формы."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: при ингаляционном применении для лечения бронхиальной астмы возможно развитие бронхоспазма и увеличение количества хрипов в легких сразу после ингаляции; при интраназальном применении возможны носовые кровотечения, фарингит, ощущение жжения в носу, чиханье; раздражение слизистой оболочки полости носа; очень редко при интраназальном применении - случаи перфорации носовой перегородки. Системные эффекты (особенно при применении в высоких дозах и в течение продолжительного времени): при ингаляционном применении - угнетение функции коры надпочечников, задержка роста у детей и подростков, деминерализация костной ткани, глаукома, повышение внутриглазного давления (возникает в отдельных случаях при интраназальном применении), развитие катаракты. Аллергические реакции: при постмаркетинговом применении в единичных случаях - проявления повышенной чувствительности, такие как сыпь, кожный зуд, ангионевротический отек и анафилактическая реакция. Сообщалось об ухудшении течения астмы, которое может проявляться кашлем, одышкой, свистящим дыханием и бронхоспазмомПрочие: при интраназальном применении возможна головная боль."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат обладает низкой (меньше1%) системной биодоступностью, поэтому маловероятно, что при передозировке потребуется принятие каких-либо специальных мер, кроме наблюдения и последующего назначения в рекомендованной дозе. При длительном применении ГКС в высоких дозах или при одновременном применении нескольких ГКС возможно угнетение гипоталамо-гипофизарно-надпочечниковой системы."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При применении мометазона в течение 12 мес признаков атрофии слизистой оболочки носа отмечено не было. При исследовании биоптатов слизистой оболочки носа выявлено, что мометазон проявлял тенденцию к нормализации гистологической картины. При применении препарата в течение длительного времени (как и при всяком долгосрочном лечении) необходим периодический осмотр слизистой оболочки носа врачом-оториноларингологом. При развитии местной грибковой инфекции носа или глотки лечение препаратом рекомендуется прекратить и начать проведение специфической терапии. Сохраняющееся в течение длительного времени раздражение слизистой оболочки полости носа и глотки является показанием к отмене препарата. При длительном применении препарата признаков подавления функции гипоталамо-гипофизарно-надпочечниковой системы не наблюдалось. Пациенты, которые переходят на терапию мометазоном после длительного лечения ГКС системного действия, требуют к себе особого внимания. Отмена ГКС системного действия у таких пациентов может привести к недостаточности функции надпочечников, что может потребовать принятия соответствующих мер. Во время перехода от лечения ГКС системного действия к терапии мометазоном у некоторых пациентов могут возникнуть симптомы отмены ГКС для системного применения (например, боль в суставах и/или мышцах, чувство усталости, депрессия), несмотря на уменьшение выраженности симптомов, связанных с поражением слизистой оболочки носа, таких больных необходимо специально убеждать в целесообразности продолжения лечения препаратом Дезринит. Переход от ГКС системного действия к местным ГКС может также выявить уже существовавшие, но маскировавшиеся терапией ГКС системного действия аллергические заболевания, такие как аллергический конъюнктивит и экзема. Эффективность и безопасность мометазона не изучена при лечении односторонних полипов, полипов, связанных с муковисцидозом и полипов, которые полностью закрывают носовую полость. Односторонние полипы неправильной формы или кровоточащие следует дополнительно обследовать. Пациенты, которым проводится терапия ГКС, обладают сниженной иммунной реактивностью, поэтому их следует предупредить о повышенном риске инфицирования при контакте с больными некоторыми инфекционными заболеваниями (например, ветряной оспой, корью), а также о необходимости врачебной консультации, если такой контакт произошел. При длительном применении назальных ГКС в высоких дозах возможно развитие системных побочных эффектов. Вероятность развития этих эффектов гораздо меньше, чем при применении системных ГКС, и может различаться у отдельных пациентов, а также между разными ГКС. К потенциальным системным эффектам относятся синдром Кушинга, характерные признаки кушингоида, подавление функции надпочечников, задержка роста у детей и подростков, катаракта, глаукома и, реже - ряд психологических или поведенческих эффектов, включая психомоторную гиперактивность, нарушение сна, беспокойство, депрессию или агрессию (особенно у детей). Рекомендуется регулярно контролировать рост детей, получающих длительную терапию мометазоном. При замедлении роста следует пересмотреть проводимую терапию с целью снижения дозы мометазона до минимальной эффективной, позволяющей контролировать симптомы заболевания. Кроме того, следует направить пациента на консультацию к педиатру. Лечение ГКС в дозах, превышающих рекомендуемые, может привести к клинически значимому угнетению функции надпочечников. Если известно, что ГКС применяются в высоких дозах, необходимо рассмотреть возможность дополнительного применения системных ГКС в периоды стресса или планового хирургического вмешательства. Влияние на способность к вождению автотранспорта и управлению механизмамиИсследований по изучению влияния на способность к управлению транспортными средствами и механизмами не проводилось."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"ГКС для местного применения. Мометазон оказывает противовоспалительное и противоаллергическое действие. Местное противовоспалительное действие препарата проявляется при его применении в дозах, при которых не возникает системных эффектов. Тормозит высвобождение медиаторов воспаления. Повышает продукцию липомодулина, являющегося ингибитором фосфолипазы А, что обусловливает снижение высвобождения арахидоновой кислоты и, соответственно, угнетение синтеза продуктов метаболизма арахидоновой кислоты - циклических эндопероксидов, простагландинов. 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