Содержимое металлического баллона с клапаном дозирующего действия - суспензия, находящаяся под давлением и образующая пятно белого цвета при распылении на предметное стекло.
Фармакотерапевтическая группа
Бронходилатирующее средство - бета-2-адреномиметик селективный
Фармакологические свойства
Фармакодинамика:
Сальбутамол является селективным агонистом бета2-адренорецепторов. В терапевтических дозах он действует на бета2-адренорецепторы гладкой мускулатуры бронхов оказывая выраженный бронхолитический эффект предупреждает и купирует бронхоспазм увеличивает жизненную емкость легких. Предотвращает выделение гистамина медленно реагирующей субстанции из тучных клеток и факторов хемотаксиса нейтрофилов. Вызывает незначительный положительный хроно- и инотропный эффект на миокард расширение коронарных артерий практически не снижает артериальное давление. Оказывает токолитическое действие: понижает тонус и сократительную активность миометрия. Действие препарата начинается через 5 минут после ингаляционного введения и продолжается в течение 4-6 часов.Обладает рядом метаболических эффектов: снижает содержание К+ в плазме оказывает гипергликемический (особенно у пациентов с бронхиальной астмой) и липолитический эффект увеличивает риск развития ацидоза.
Фармакокинетика:
После ингаляционного введения от 10 до 20 % дозы попадает в дыхательные пути. Остальная часть задерживается в приборе или оседает в ротоглотке и затем проглатывается. Часть дозы которая остается в дыхательных путях абсорбируется тканями легких не подвергаясь метаболизму в легких и попадает в кровоток. При попадании в системный кровоток она может метаболизироваться в печени и выводится преимущественно с мочой в неизменном виде. Часть дозы поступившей в желудочно-кишечный тракт всасывается и подвергается интенсивному метаболизму во время первого прохождения через печень. Неизменный препарат и конъюгат выводятся преимущественно с мочой. Большая часть дозы сальбутамола выводится в течение 72 часов. Степень связывания сальбутамола с белками плазмы составляет 10 %.Максимальная концентрация в плазме крови - 30 нг/мл. Период полувыведения - 37-5 ч.
Показания к применению
Предупреждение и купирование бронхоспазма при бронхиальной астме хроническая обструктивная болезнь легких (ХОБЛ) хронический бронхит и эмфизема легких.
Противопоказания
Гиперчувствительность к любому компоненту препарата нарушения ритма (пароксизмальная тахикардия политопная желудочковая экстрасистолия) миокардит пороки сердца аортальный стеноз ишемическая болезнь сердца тяжелая сердечная недостаточность декомпенсированный сахарный диабет глаукома эпиприпадки пилородоуденальное сужение почечная или. печеночная недостаточность беременность одновременный прием неселективных бета-адреноблокаторов детский возраст до 2-х лет.
Применение при беременности и в период грудного вскармливания
Противопоказан во время беременности.
В период лактации назначается только в тех случаях когда ожидаемая польза для матери превышает любой возможный риск для ребенка.
Способ применения и дозы
Ингаляционно. Взрослым и детям старше 12 лет:по 100-200 мкг сальбутамола (1-2 ингаляции) для купирования приступов удушья. При отсутствии эффекта через 5 мин возможна повторная ингаляция. Последующая ингаляция может быть проведена не ранее чем через 2 часа. Для контроля за течением астмы легкой степени тяжести - по 1-2 дозы 1-4 раза в сутки и средней степени тяжести заболевания - в той же дозировке в комбинации с другими противоастматическими препаратами. Для профилактики астмы физического усилия - за 20-30 мин до нагрузки 1-2 дозы на прием. Детям от 2 до 12 лет: при развитии приступа бронхиальной астмы а также для предотвращения приступов бронхиальной астмы связанных с воздействием аллергена или вызванных физической нагрузкой рекомендуемая доза составляет 100-200 мкг (1-2 ингаляции).Суточная доза сальбутамола не должна превышать 1200 мкг (12 ингаляций).При применении дозированного аэрозоля необходимо четкое выполнение следующих инструкций:1. Перед применением баллон тщательно встряхнуть.2. Надеть распылитель на баллон снять с распылителя крышку.3. Сделать глубокий выдох.4. Баллон перевернуть вверх дном обхватить мундштук губами сделать сильный вдох и одновременно нажать на дно баллона. При этом происходит сильный выброс аэрозоля. Задержать дыхание на несколько секунд и отведя мундштук ото рта сделать медленный выдох.5. После использования закрыть крышкой мундштук для предохранения от загрязнения. Пациентам (в том числе детям младшего возраста) которым трудно выполнить правильно дыхательный маневр рекомендуется использовать для ингаляций препарата специальное приспособление (спейсер) увеличивающий дыхательный объем и сглаживающий неточности асинхронного вдоха.
Побочное действие
По частоте побочные эффекты могут быть разделены на следующие категории: очень частые (> 1/10) частые (> 1/100 и < 1/10) нечастые (> 1/1000 и < 1/100) редкие (> 1/10 000 и <1/100) очень редкие (<1/10 000).
Со стороны иммунной системы: очень редко - реакции гиперчувствительности включая ангионевротический отек крапивницу эритему заложенность носа бронхоспазм.
Со стороны обменных процессов: редко - гипокалиемия а также обратимые метаболические нарушения например увеличение концентрации глюкозы в крови.
Со стороны центральной нервной системы: часто - тремор головная боль; не часто - головокружение; очень редко - повышенная возбудимость тревожность нарушение сна бессонница усталость.
Со стороны сердечно-сосудистой системы: редко - незначительное компенсаторное увеличение частоты сердечных сокращений повышение артериального давления; очень редко - аритмия включая фибрилляцию предсердий наджелудочковую тахикардию и экстрасистолию артериальная гипотензия и коллапс; редко - расширение периферических сосудов (гиперемия кожи лица).
Со стороны дыхательной системы: очень редко - парадоксальный бронхоспазм кашель.
Со стороны пищеварительной системы: не часто - изменение вкусовых ощущений; редко - сухость или раздражение слизистой оболочки полости рта и глотки (фарингит) тошнота рвота.
Со стороны костно-мышечной системы: редко - мышечные судороги.
Передозировка
Симптомы: тошнота рвота повышенная возбудимость галлюцинации тахикардия трепетание желудочков расширение периферических сосудов снижение артериального давления гипоксемия ацидоз гипокалиемия гипергликемия мышечный тремор головная боль.
При подозрении на передозировку следует контролировать уровень калия в сыворотке крови.
Взаимодействие с другими лекарственными средствами
Теофиллин и другие ксантины при одновременном применении с сальбутамолом повышают вероятность развития тахиаритмий; средства для ингаляционной анестезии леводопа - тяжелых желудочковых аритмий.
He рекомендуется одновременно применять сальбутамол и неселективные блокаторы бета-адренорецепторов такие как пропранолол.
Ингибиторы моноаминоксидазы и трициклические антидепрессанты усиливают действие сальбутамола и могут привести к резкому снижению артериального давления.
Сальбутамол усиливает действие стимуляторов центральной нервной системы побочное действие на сердце гормонов щитовидной железы.
Повышает вероятность развития гликозидной интоксикации. Снижает эффектовность гипотензивных препаратов нитратов.
Гипокалиемия может усиливаться в результате одновременного применения производных ксантина глюкокортикостероидов диуретиков.
Одновременное назначение с антихолинергическими средствами (в т.ч. ингаляционными) может способствовать повышению внутриглазного давления.
Особые указания
У пациентов с тяжелым или нестабильным течением бронхиальной астмы применение бронходилататоров не должно быть основным или единственным методом терапии. Если действие обычной дозы сальбутамола становится менее эффективным или менее продолжительным (действие препарата должно сохраняться не менее 3 часов) пациенту следует обратиться к врачу.
Частое применение сальбутамола может привести к усилению бронхоспазма внезапной смерти в связи с чем между приемами очередных доз препарата необходимо делать перерывы в несколько часов.
Повышение потребности в применении ингаляционных агонистов бета2-адренорецепторов с короткой продолжительностью действия для контроля симптомов бронхиальной астмы свидетельствует об обострении заболевания. В таких случаях следует пересмотреть план лечения пациента и решить вопрос о назначении или увеличении дозы ингаляционных или системных глюкокортикостероидов.
Терапия агонистами бета2-адренорецепторов может приводить к гипокалиемии. Особую осторожность рекомендуется проявлять при лечении тяжелых приступов бронхиальной астмы поскольку в этих случаях гипокалиемия может усиливаться в результате одновременного применения производных ксантина глюкокортикостероидов диуретиков а также вследствие гипоксии. В таких ситуациях необходимо контролировать уровень калия в сыворотке крови.
Влияние на способность управлять автомобилем и движущимися механизмами
Данные о влиянии на способность к управлению автотранспортом и/или другими механизмами отсутствуют.
Форма выпуска
Аэрозоль для ингаляций дозированный 100 мкг/доза.
Условия хранения
При температуре не выше 30 °С.
Беречь от детей. Хранить вдали от отопительной системы и прямых солнечных лучей.
Срок годности
2 года.
Не использовать по истечении срока годности указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Открытое акционерное общество "Московское производственное химико-фармацевтическое объединение им. Н.А. Семашко" (ОАО "Мосхимфармпрепараты" им.Н.А.Семашко"), 107120, г. Москва, ул. Сергия Радонежского, д. 15-17, Россия
Организация, принимающая претензии потребителей
ОАО "Мосхимфармпрепараты" им.Н.А.Семашко"
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В терапевтических дозах он действует на бета2-адренорецепторы гладкой мускулатуры бронхов оказывая выраженный бронхолитический эффект предупреждает и купирует бронхоспазм увеличивает жизненную емкость легких. Предотвращает выделение гистамина медленно реагирующей субстанции из тучных клеток и факторов хемотаксиса нейтрофилов. Вызывает незначительный положительный хроно- и инотропный эффект на миокард расширение коронарных артерий практически не снижает артериальное давление. Оказывает токолитическое действие: понижает тонус и сократительную активность миометрия. Действие препарата начинается через 5 минут после ингаляционного введения и продолжается в течение 4-6 часов.Обладает рядом метаболических эффектов: снижает содержание К+ в плазме оказывает гипергликемический (особенно у пациентов с бронхиальной астмой) и липолитический эффект увеличивает риск развития ацидоза."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"После ингаляционного введения от 10 до 20 % дозы попадает в дыхательные пути. Остальная часть задерживается в приборе или оседает в ротоглотке и затем проглатывается. Часть дозы которая остается в дыхательных путях абсорбируется тканями легких не подвергаясь метаболизму в легких и попадает в кровоток. При попадании в системный кровоток она может метаболизироваться в печени и выводится преимущественно с мочой в неизменном виде. Часть дозы поступившей в желудочно-кишечный тракт всасывается и подвергается интенсивному метаболизму во время первого прохождения через печень. Неизменный препарат и конъюгат выводятся преимущественно с мочой. Большая часть дозы сальбутамола выводится в течение 72 часов. Степень связывания сальбутамола с белками плазмы составляет 10 %.Максимальная концентрация в плазме крови - 30 нг/мл. Период полувыведения - 37-5 ч."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Предупреждение и купирование бронхоспазма при бронхиальной астме хроническая обструктивная болезнь легких (ХОБЛ) хронический бронхит и эмфизема легких."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к любому компоненту препарата нарушения ритма (пароксизмальная тахикардия политопная желудочковая экстрасистолия) миокардит пороки сердца аортальный стеноз ишемическая болезнь сердца тяжелая сердечная недостаточность декомпенсированный сахарный диабет глаукома эпиприпадки пилородоуденальное сужение почечная или. печеночная недостаточность беременность одновременный прием неселективных бета-адреноблокаторов детский возраст до 2-х лет."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Сердечная недостаточность гипертиреоз артериальная гипертензия феохромоцитома."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказан во время беременности."}},{"type":"paragraph","data":{"text":"В период лактации назначается только в тех случаях когда ожидаемая польза для матери превышает любой возможный риск для ребенка."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Ингаляционно. Взрослым и детям старше 12 лет:по 100-200 мкг сальбутамола (1-2 ингаляции) для купирования приступов удушья. При отсутствии эффекта через 5 мин возможна повторная ингаляция. Последующая ингаляция может быть проведена не ранее чем через 2 часа. Для контроля за течением астмы легкой степени тяжести - по 1-2 дозы 1-4 раза в сутки и средней степени тяжести заболевания - в той же дозировке в комбинации с другими противоастматическими препаратами. Для профилактики астмы физического усилия - за 20-30 мин до нагрузки 1-2 дозы на прием. Детям от 2 до 12 лет: при развитии приступа бронхиальной астмы а также для предотвращения приступов бронхиальной астмы связанных с воздействием аллергена или вызванных физической нагрузкой рекомендуемая доза составляет 100-200 мкг (1-2 ингаляции).Суточная доза сальбутамола не должна превышать 1200 мкг (12 ингаляций).При применении дозированного аэрозоля необходимо четкое выполнение следующих инструкций:1. Перед применением баллон тщательно встряхнуть.2. Надеть распылитель на баллон снять с распылителя крышку.3. Сделать глубокий выдох.4. Баллон перевернуть вверх дном обхватить мундштук губами сделать сильный вдох и одновременно нажать на дно баллона. При этом происходит сильный выброс аэрозоля. Задержать дыхание на несколько секунд и отведя мундштук ото рта сделать медленный выдох.5. После использования закрыть крышкой мундштук для предохранения от загрязнения. Пациентам (в том числе детям младшего возраста) которым трудно выполнить правильно дыхательный маневр рекомендуется использовать для ингаляций препарата специальное приспособление (спейсер) увеличивающий дыхательный объем и сглаживающий неточности асинхронного вдоха."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"По частоте побочные эффекты могут быть разделены на следующие категории: очень частые (> 1/10) частые (> 1/100 и < 1/10) нечастые (> 1/1000 и < 1/100) редкие (> 1/10 000 и <1/100) очень редкие (<1/10 000)."}},{"type":"paragraph","data":{"text":"Со стороны иммунной системы: очень редко - реакции гиперчувствительности включая ангионевротический отек крапивницу эритему заложенность носа бронхоспазм."}},{"type":"paragraph","data":{"text":"Со стороны обменных процессов: редко - гипокалиемия а также обратимые метаболические нарушения например увеличение концентрации глюкозы в крови."}},{"type":"paragraph","data":{"text":"Со стороны центральной нервной системы: часто - тремор головная боль; не часто - головокружение; очень редко - повышенная возбудимость тревожность нарушение сна бессонница усталость."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: редко - незначительное компенсаторное увеличение частоты сердечных сокращений повышение артериального давления; очень редко - аритмия включая фибрилляцию предсердий наджелудочковую тахикардию и экстрасистолию артериальная гипотензия и коллапс; редко - расширение периферических сосудов (гиперемия кожи лица)."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: очень редко - парадоксальный бронхоспазм кашель."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: не часто - изменение вкусовых ощущений; редко - сухость или раздражение слизистой оболочки полости рта и глотки (фарингит) тошнота рвота."}},{"type":"paragraph","data":{"text":"Со стороны костно-мышечной системы: редко - мышечные судороги."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: тошнота рвота повышенная возбудимость галлюцинации тахикардия трепетание желудочков расширение периферических сосудов снижение артериального давления гипоксемия ацидоз гипокалиемия гипергликемия мышечный тремор головная боль."}},{"type":"paragraph","data":{"text":"Лечение: отмена препарата кардиоселективные бета-адреноблокаторы; симптоматическая терапия."}},{"type":"paragraph","data":{"text":"При подозрении на передозировку следует контролировать уровень калия в сыворотке крови."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Теофиллин и другие ксантины при одновременном применении с сальбутамолом повышают вероятность развития тахиаритмий; средства для ингаляционной анестезии леводопа - тяжелых желудочковых аритмий."}},{"type":"paragraph","data":{"text":"He рекомендуется одновременно применять сальбутамол и неселективные блокаторы бета-адренорецепторов такие как пропранолол."}},{"type":"paragraph","data":{"text":"Ингибиторы моноаминоксидазы и трициклические антидепрессанты усиливают действие сальбутамола и могут привести к резкому снижению артериального давления."}},{"type":"paragraph","data":{"text":"Сальбутамол усиливает действие стимуляторов центральной нервной системы побочное действие на сердце гормонов щитовидной железы."}},{"type":"paragraph","data":{"text":"Повышает вероятность развития гликозидной интоксикации. Снижает эффектовность гипотензивных препаратов нитратов."}},{"type":"paragraph","data":{"text":"Гипокалиемия может усиливаться в результате одновременного применения производных ксантина глюкокортикостероидов диуретиков."}},{"type":"paragraph","data":{"text":"Одновременное назначение с антихолинергическими средствами (в т.ч. ингаляционными) может способствовать повышению внутриглазного давления."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"У пациентов с тяжелым или нестабильным течением бронхиальной астмы применение бронходилататоров не должно быть основным или единственным методом терапии. Если действие обычной дозы сальбутамола становится менее эффективным или менее продолжительным (действие препарата должно сохраняться не менее 3 часов) пациенту следует обратиться к врачу."}},{"type":"paragraph","data":{"text":"Частое применение сальбутамола может привести к усилению бронхоспазма внезапной смерти в связи с чем между приемами очередных доз препарата необходимо делать перерывы в несколько часов."}},{"type":"paragraph","data":{"text":"Повышение потребности в применении ингаляционных агонистов бета2-адренорецепторов с короткой продолжительностью действия для контроля симптомов бронхиальной астмы свидетельствует об обострении заболевания. В таких случаях следует пересмотреть план лечения пациента и решить вопрос о назначении или увеличении дозы ингаляционных или системных глюкокортикостероидов."}},{"type":"paragraph","data":{"text":"Терапия агонистами бета2-адренорецепторов может приводить к гипокалиемии. Особую осторожность рекомендуется проявлять при лечении тяжелых приступов бронхиальной астмы поскольку в этих случаях гипокалиемия может усиливаться в результате одновременного применения производных ксантина глюкокортикостероидов диуретиков а также вследствие гипоксии. В таких ситуациях необходимо контролировать уровень калия в сыворотке крови."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Данные о влиянии на способность к управлению автотранспортом и/или другими механизмами отсутствуют."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Аэрозоль для ингаляций дозированный 100 мкг/доза."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"При температуре не выше 30 °С."}},{"type":"paragraph","data":{"text":"Беречь от детей. Хранить вдали от отопительной системы и прямых солнечных лучей."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года."}},{"type":"paragraph","data":{"text":"Не использовать по истечении срока годности указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Открытое акционерное общество \"Московское производственное химико-фармацевтическое объединение им. Н.А. Семашко\" (ОАО \"Мосхимфармпрепараты\" им.Н.А.Семашко\"), 107120, г. Москва, ул. Сергия Радонежского, д. 15-17, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ОАО \"Мосхимфармпрепараты\" им.Н.А.Семашко\""}}]}],"source":null},"description_toggle":false,"short_description":"Сальбутамол является селективным агонистом бета2-адренорецепторов. В терапевтических дозах он действует на бета2-адренорецепторы гладкой мускулатуры бронхов оказывая выраженный бронхолитический эффект предупреждает и купирует бронхоспазм увеличивает жизненную емкость легких. Предотвращает выделение гистамина медленно реагирующей субстанции из тучных клеток и факторов хемотаксиса нейтрофилов. Вызывает незначительный положительный хроно- и инотропный эффект на миокард расширение коронарных артерий практически не снижает артериальное давление. Оказывает токолитическое действие: понижает тонус и сократительную активность миометрия. Действие препарата начинается через 5 минут после ингаляционного введения и продолжается в течение 4-6 часов.Обладает рядом метаболических эффектов: снижает содержание К+ в плазме оказывает гипергликемический (особенно у пациентов с бронхиальной астмой) и липолитический эффект увеличивает риск развития ацидоза. После ингаляционного введения от 10 до 20 % дозы попадает в дыхательные пути. Остальная часть задерживается в приборе или оседает в ротоглотке и затем проглатывается. Часть дозы которая остается в дыхательных путях абсорбируется тканями легких не подвергаясь метаболизму в легких и попадает в кровоток. При попадании в системный кровоток она может метаболизироваться в печени и выводится преимущественно с мочой в неизменном виде. Часть дозы поступившей в желудочно-кишечный тракт всасывается и подвергается интенсивному метаболизму во время первого прохождения через печень. Неизменный препарат и конъюгат выводятся преимущественно с мочой. 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