Однородный порошок белого или почти белого цвета, без агломератов и посторонних частиц, с фруктовым запахом.
Фармакотерапевтическая группа
Отхаркивающее муколитическое средство.
Код АТХ: R05СВ01
Фармакологические свойства
Муколитическое средство, разжижает мокроту, увеличивает ее объем, облегчает отхождение мокроты. Действие связано со способностью свободных сульфгидрильных групп ацетилцистеина разрывать внутри- и межмолекулярные дисульфидные связи мукополисахаридных цепей, что приводит к деполимеризации мукопротеидов и уменьшению вязкости мокроты (в ряде случаев это приводит к значительному увеличению объема мокроты, что требует аспирации содержимого бронхов). Сохраняет активность при гнойной мокроте. Не влияет на иммунитет. Увеличивает секрецию менее вязких сиаломуцинов бокаловидными клетками, снижает адгезию бактерий на эпителиальных клетках слизистой оболочки бронхов. Стимулирует мукозные клетки бронхов, секрет которых лизирует фибрин. Аналогичное действие оказывает на секрет, образующийся при воспалительных заболеваниях ЛОР-органов. Оказывает антиоксидантное действие, обусловленное наличием SH-группы, способной нейтрализовать электрофильные окислительные токсины. Предохраняет альфа-1-антитрипсин (ингибитор эластазы) от инактивирующего воздействия HOCl - окислителя, вырабатываемого миелопероксидазой активных фагоцитов. Обладает также некоторым противовоспалительным действием (за счет подавления образования свободных радикалов и активных кислородсодержащих веществ, ответственных за развитие воспаления в легочной ткани). Приводит к повышенному синтезу глютатиона, чем объясняется детоксикационное действие при отравлении парацетамолом. При профилактическом применении ацетилцистеина отмечается уменьшение частоты и тяжести обострений у пациентов с хроническим бронхитом и муковисцидозом.
Фармакокинетика:
Абсорбция после перорального введения высокая. Биологическая доступность низкая – около 10 % в связи с наличием сильно выраженного эффекта «первого прохождения» через печень с образованием фармакологически активного метаболита – цистеина, а также диацетилцистина, цистина.
Максимальный уровень концентрации (Сmax) в плазме после перорального приема достигается примерно через 1 - 3 ч. Связывание с белками плазмы составляет около 50 %.
Выводится в основном почками в виде неактивных метаболитов (неорганические сульфаты, диацетилцистин), незначительная часть выделяется в неизмененном виде с каловыми массами. Период полувыведения (Т1/2) ацетилцистеина из плазмы составляет около 1 ч. При нарушении функции печени эта величина увеличивается до 8 ч.
Проникает через плацентарный барьер, накапливается в околоплодной жидкости.
Данные о проникновении через гематоэнцефалический барьер отсутствуют.
Показания к применению
Заболевания органов дыхания, сопровождающиеся образованием вязкой трудноотде-
ляемой мокроты:
- острые и хронические бронхиты, обструктивный бронхит;
гипертензия, непереносимость гистамина (следует избегать длительного приема препара-
та, т.к. ацетилцистеин влияет на метаболизм гистамина и может привести к возникновению
признаков непереносимости, таких как головная боль, вазомоторный ринит, зуд).
Применение при беременности и в период грудного вскармливания
Данные по применению ацетилцистеина в периоды беременности и грудного вскармливания ограничены, поэтому применение препарата при беременности противопоказано. В случае необходимости применения препарата в период лактации следует решить вопрос о прекращении грудного вскармливания.
Способ применения и дозы
При отсутствии других назначений следует придерживаться следующих рекомендаций.
Порошок растворяют в 1 стакане горячей воды, принимают внутрь после еды.
ЭСПА-НАЦ® в дозировке 200 мг:
Взрослые и дети старше 14 лет: 2-3 раза в день по 1 пакетику (400-600 мг).
Дети от 6 до 14 лет: 2 раза в день по 1 пакетику (400 мг).
Дети от 2 до 6 лет: 2-3 раза в день по 1/2 пакетика (200-300 мг).
При муковисцидозе:
Дети от 2 до 6 лет: 2 раза в день по 1 пакетику (400 мг).
Дети старше 6 лет: 3 раза в день по 1 пакетику (600 мг).
ЭСПА-НАЦ® в дозировке 600 мг:
Взрослые и дети старше 14 лет: 1 раз в день по 1 пакетику (600 мг).
При муковисцидозе:
Дети старше 6 лет: 1 раз в день по 1 пакетику (600 мг).
Дополнительный прием жидкости усиливает муколитический эффект препарата.
При кратковременных простудных заболеваниях длительность приема составляет
5-7 дней. При хронических бронхитах и муковисцидозе препарат следует принимать
более длительное время для профилактики инфекций. При длительных заболеваниях
длительность терапии определяется лечащим врачом.
Побочное действие
По данным Всемирной организации здравоохранения (ВОЗ) нежелательные эффекты классифицированы в соответствии с их частотой развития следующим образом:
очень часто (≥ 1/10), часто (≥ 1/100, ˂1/10), нечасто (≥ 1/1000, ˂1/100), редко (≥ 1/10000,
˂1/1000) и очень редко (˂ 1/10000); частота неизвестна (частоту возникновения явлений
нельзя определить на основании имеющихся данных).
Со стороны сердечно-сосудистой системы:
редко – снижение артериального давления, увеличение частоты сердечных сокращений
(тахикардия).
Со стороны дыхательной системы:
очень редко - развитие легочного кровотечения, как проявление реакции повышенной чувствительности.
Аллергические реакции:
редко - бронхоспазм (преимущественно у пациентов с гиперреактивной бронхиальной системой при бронхиальной астме), кожная сыпь, зуд и крапивница, экзантема, ангио-невртический отек;
очень редко – анафилактические реакции вплоть до развития анафилактического шока,
редко – стоматит, боли в животе, тошнота, рвота и диарея, изжога, диспепсия.
Со стороны органов чувств:
нечасто - шум в ушах.
Прочие:
редко – головная боль, лихорадка, единичные сообщения о развитии кровотечений в связи с наличием реакций повышенной чувствительности, снижение агрегации тромбоцитов.
Передозировка
При пероральном применении ацетилцистеина в течение трех месяцев в суточной дозе до 11,6 г не было выявлено опасных для жизни побочных явлений. При пероральном приеме ацетилцистеина в дозе до 500 мг/кг веса тела явлений отравления не наблюдалось.
Симптомы: изжога и тошнота, рвота, диарея, боли в желудке.
У новорожденных существует опасность развития гиперсекреции.
Лечение: симптоматическое.
Взаимодействие с другими лекарственными средствами
При одновременном применении ацетилцистеина и противокашлевых средств может возникнуть застой слизи из-за подавления кашлевого рефлекса.
Одновременный прием ацетилцистеина с вазодилятирующими средствами и нитроглицерином может привести к усилению сосудорасширяющего действия последнего.
Фармацевтически несовместим с антибиотиками (пенициллинами, цефалоспоринами, эритромицином, тетрациклином и амфотерицином В) и протеолитическими ферментами. Уменьшает всасывание пенициллинов, цефалоспоринов, тетрациклина (их следует принимать не ранее, чем через 2 часа после приема внутрь ацетилцистеина).
Особые указания
Больным с бронхиальной астмой и обструктивным бронхитом ацетилцистеин следует назначать с осторожностью под систематическим контролем бронхиальной проходимости.
При растворении препарата необходимо пользоваться стеклянной посудой, избегать контакта с металлами, резиной (при контакте образуются сульфиды с характерным запахом), кислородом, легко окисляющимися веществами.
При лечении больных сахарным диабетом необходимо учитывать, что в препарате содержится сахароза (в одном пакетике 200/600 мг содержится 0,23/0,20 ХЕ, соответственно).
У пациентов с тяжелыми поражениями кожи - синдромом Стивенса-Джонсона или синдрома Лайелла - в ранней фазе могут появляться температура, боль в теле, ринит, кашель и воспаление горла. При симптоматическом лечении возможно ошибочное назначение муколитических средств. Имеются единичные сообщения (˂ 1/10000) о выявлении синдрома Стивенса-Джонсона и синдрома Лайелла, совпавшие по времени с назначением препарата; однако причинно-следственная связь с приемом препарата отсутствует. При развитии вышеперечисленных синдромов (внезапное появление сыпи и пятен на лице и туловище, которые позже могут распространиться на другие части тела), рекомендуется прекратить лечение и немедленно обратиться за медицинской помощью.
Влияние на способность управлять автомобилем и движущимися механизмами
В терапевтических дозах не влияет на способность управлять транспортными средствами и механизмами.
Форма выпуска
Порошок для приготовления раствора для приема внутрь, 200 мг, 600 мг. По 3,0 г порошка в пакетик из трехслойного материала (бумага-алюминий-полиэтилен). 20 пакетиков с инструкцией по применению в пачку картонную.
Условия хранения
При температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
4 года.
Не использовать после истечения срока годности.
Условия отпуска
Без рецепта.
Производитель
Линдофарм ГмбХ, Нойштрассе 82, 40721 Хильден, Германия.
Организация, принимающая претензии потребителей
115114, г. Москва, ул. Летниковская, д.16, 6 этаж, комн. 21/1, 23-27
Для описания товара использована информация от партнера 36.6
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муколитическое средство."}},{"type":"paragraph","data":{"text":"Код АТХ: R05СВ01"}}]},{"id":7,"name":"Фармакологические свойства","slug":"","body":[{"type":"paragraph","data":{"text":"Муколитическое средство, разжижает мокроту, увеличивает ее объем, облегчает отхождение мокроты. Действие связано со способностью свободных сульфгидрильных групп ацетилцистеина разрывать внутри- и межмолекулярные дисульфидные связи мукополисахаридных цепей, что приводит к деполимеризации мукопротеидов и уменьшению вязкости мокроты (в ряде случаев это приводит к значительному увеличению объема мокроты, что требует аспирации содержимого бронхов). Сохраняет активность при гнойной мокроте. Не влияет на иммунитет. Увеличивает секрецию менее вязких сиаломуцинов бокаловидными клетками, снижает адгезию бактерий на эпителиальных клетках слизистой оболочки бронхов. Стимулирует мукозные клетки бронхов, секрет которых лизирует фибрин. Аналогичное действие оказывает на секрет, образующийся при воспалительных заболеваниях ЛОР-органов. Оказывает антиоксидантное действие, обусловленное наличием SH-группы, способной нейтрализовать электрофильные окислительные токсины. Предохраняет альфа-1-антитрипсин (ингибитор эластазы) от инактивирующего воздействия HOCl - окислителя, вырабатываемого миелопероксидазой активных фагоцитов. Обладает также некоторым противовоспалительным действием (за счет подавления образования свободных радикалов и активных кислородсодержащих веществ, ответственных за развитие воспаления в легочной ткани). Приводит к повышенному синтезу глютатиона, чем объясняется детоксикационное действие при отравлении парацетамолом. При профилактическом применении ацетилцистеина отмечается уменьшение частоты и тяжести обострений у пациентов с хроническим бронхитом и муковисцидозом."}},{"type":"paragraph","data":{"text":"Фармакокинетика:"}},{"type":"paragraph","data":{"text":"Абсорбция после перорального введения высокая. Биологическая доступность низкая – около 10 % в связи с наличием сильно выраженного эффекта «первого прохождения» через печень с образованием фармакологически активного метаболита – цистеина, а также диацетилцистина, цистина."}},{"type":"paragraph","data":{"text":"Максимальный уровень концентрации (Сmax) в плазме после перорального приема достигается примерно через 1 - 3 ч. Связывание с белками плазмы составляет около 50 %."}},{"type":"paragraph","data":{"text":"Выводится в основном почками в виде неактивных метаболитов (неорганические сульфаты, диацетилцистин), незначительная часть выделяется в неизмененном виде с каловыми массами. Период полувыведения (Т1/2) ацетилцистеина из плазмы составляет около 1 ч. При нарушении функции печени эта величина увеличивается до 8 ч."}},{"type":"paragraph","data":{"text":"Проникает через плацентарный барьер, накапливается в околоплодной жидкости."}},{"type":"paragraph","data":{"text":"Данные о проникновении через гематоэнцефалический барьер отсутствуют."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Заболевания органов дыхания, сопровождающиеся образованием вязкой трудноотде-"}},{"type":"paragraph","data":{"text":"ляемой мокроты:"}},{"type":"paragraph","data":{"text":"- острые и хронические бронхиты, обструктивный бронхит;"}},{"type":"paragraph","data":{"text":"- трахеит, ларинготрахеит;"}},{"type":"paragraph","data":{"text":"- пневмония;"}},{"type":"paragraph","data":{"text":"- бронхоэктатическая болезнь, бронхиальная астма, хроническая обструктивная бо-"}},{"type":"paragraph","data":{"text":"лезнь легких (ХОБЛ), бронхиолиты;"}},{"type":"paragraph","data":{"text":"- муковисцидоз."}},{"type":"paragraph","data":{"text":"Острые и хронические синуситы, воспаление среднего уха (средний отит)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- повышенная чувствительность к ацетилцистеину или другим компонентам препарата;"}},{"type":"paragraph","data":{"text":"- язвенная болезнь желудка и двенадцатиперстной кишки в стадии обострения;"}},{"type":"paragraph","data":{"text":"- кровохарканье, легочное кровотечение;"}},{"type":"paragraph","data":{"text":"- дефицит сахаразы/изомальтазы, непереносимость фруктозы, глюкозо-галактозная"}},{"type":"paragraph","data":{"text":"мальабсорбция (препарат содержит сахарозу);"}},{"type":"paragraph","data":{"text":"- беременность;"}},{"type":"paragraph","data":{"text":"- период лактации;"}},{"type":"paragraph","data":{"text":"- детский возраст до 14 лет (для дозировки 600 мг), детский возраст до 2 лет (для до-"}},{"type":"paragraph","data":{"text":"зировки 200 мг)."}},{"type":"paragraph","data":{"text":"С осторожностью: язвенная болезнь желудка и двенадцатиперстной кишки в анамнезе,"}},{"type":"paragraph","data":{"text":"варикозное расширение вен пищевода, бронхиальная астма, обструктивный бронхит, за-"}},{"type":"paragraph","data":{"text":"болевания надпочечников, печеночная и/или почечная недостаточность, артериальная"}},{"type":"paragraph","data":{"text":"гипертензия, непереносимость гистамина (следует избегать длительного приема препара-"}},{"type":"paragraph","data":{"text":"та, т.к. ацетилцистеин влияет на метаболизм гистамина и может привести к возникновению"}},{"type":"paragraph","data":{"text":"признаков непереносимости, таких как головная боль, вазомоторный ринит, зуд)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Данные по применению ацетилцистеина в периоды беременности и грудного вскармливания ограничены, поэтому применение препарата при беременности противопоказано. В случае необходимости применения препарата в период лактации следует решить вопрос о прекращении грудного вскармливания."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"При отсутствии других назначений следует придерживаться следующих рекомендаций."}},{"type":"paragraph","data":{"text":"Порошок растворяют в 1 стакане горячей воды, принимают внутрь после еды."}},{"type":"paragraph","data":{"text":"ЭСПА-НАЦ® в дозировке 200 мг:"}},{"type":"paragraph","data":{"text":"Взрослые и дети старше 14 лет: 2-3 раза в день по 1 пакетику (400-600 мг)."}},{"type":"paragraph","data":{"text":"Дети от 6 до 14 лет: 2 раза в день по 1 пакетику (400 мг)."}},{"type":"paragraph","data":{"text":"Дети от 2 до 6 лет: 2-3 раза в день по 1/2 пакетика (200-300 мг)."}},{"type":"paragraph","data":{"text":"При муковисцидозе:"}},{"type":"paragraph","data":{"text":"Дети от 2 до 6 лет: 2 раза в день по 1 пакетику (400 мг)."}},{"type":"paragraph","data":{"text":"Дети старше 6 лет: 3 раза в день по 1 пакетику (600 мг)."}},{"type":"paragraph","data":{"text":"ЭСПА-НАЦ® в дозировке 600 мг:"}},{"type":"paragraph","data":{"text":"Взрослые и дети старше 14 лет: 1 раз в день по 1 пакетику (600 мг)."}},{"type":"paragraph","data":{"text":"При муковисцидозе:"}},{"type":"paragraph","data":{"text":"Дети старше 6 лет: 1 раз в день по 1 пакетику (600 мг)."}},{"type":"paragraph","data":{"text":"Дополнительный прием жидкости усиливает муколитический эффект препарата."}},{"type":"paragraph","data":{"text":"При кратковременных простудных заболеваниях длительность приема составляет"}},{"type":"paragraph","data":{"text":"5-7 дней. При хронических бронхитах и муковисцидозе препарат следует принимать"}},{"type":"paragraph","data":{"text":"более длительное время для профилактики инфекций. При длительных заболеваниях"}},{"type":"paragraph","data":{"text":"длительность терапии определяется лечащим врачом."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"По данным Всемирной организации здравоохранения (ВОЗ) нежелательные эффекты классифицированы в соответствии с их частотой развития следующим образом:"}},{"type":"paragraph","data":{"text":"очень часто (≥ 1/10), часто (≥ 1/100, ˂1/10), нечасто (≥ 1/1000, ˂1/100), редко (≥ 1/10000,"}},{"type":"paragraph","data":{"text":"˂1/1000) и очень редко (˂ 1/10000); частота неизвестна (частоту возникновения явлений"}},{"type":"paragraph","data":{"text":"нельзя определить на основании имеющихся данных)."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы:"}},{"type":"paragraph","data":{"text":"редко – снижение артериального давления, увеличение частоты сердечных сокращений"}},{"type":"paragraph","data":{"text":"(тахикардия)."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы:"}},{"type":"paragraph","data":{"text":"очень редко - развитие легочного кровотечения, как проявление реакции повышенной чувствительности."}},{"type":"paragraph","data":{"text":"Аллергические реакции:"}},{"type":"paragraph","data":{"text":"редко - бронхоспазм (преимущественно у пациентов с гиперреактивной бронхиальной системой при бронхиальной астме), кожная сыпь, зуд и крапивница, экзантема, ангио-невртический отек;"}},{"type":"paragraph","data":{"text":"очень редко – анафилактические реакции вплоть до развития анафилактического шока,"}},{"type":"paragraph","data":{"text":"синдром Стивенса-Джонсона, токсический эпидермальный некролиз."}},{"type":"paragraph","data":{"text":"Со стороны желудочно-кишечного тракта:"}},{"type":"paragraph","data":{"text":"редко – стоматит, боли в животе, тошнота, рвота и диарея, изжога, диспепсия."}},{"type":"paragraph","data":{"text":"Со стороны органов чувств:"}},{"type":"paragraph","data":{"text":"нечасто - шум в ушах."}},{"type":"paragraph","data":{"text":"Прочие:"}},{"type":"paragraph","data":{"text":"редко – головная боль, лихорадка, единичные сообщения о развитии кровотечений в связи с наличием реакций повышенной чувствительности, снижение агрегации тромбоцитов."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"При пероральном применении ацетилцистеина в течение трех месяцев в суточной дозе до 11,6 г не было выявлено опасных для жизни побочных явлений. При пероральном приеме ацетилцистеина в дозе до 500 мг/кг веса тела явлений отравления не наблюдалось."}},{"type":"paragraph","data":{"text":"Симптомы: изжога и тошнота, рвота, диарея, боли в желудке."}},{"type":"paragraph","data":{"text":"У новорожденных существует опасность развития гиперсекреции."}},{"type":"paragraph","data":{"text":"Лечение: симптоматическое."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении ацетилцистеина и противокашлевых средств может возникнуть застой слизи из-за подавления кашлевого рефлекса."}},{"type":"paragraph","data":{"text":"Одновременный прием ацетилцистеина с вазодилятирующими средствами и нитроглицерином может привести к усилению сосудорасширяющего действия последнего."}},{"type":"paragraph","data":{"text":"Фармацевтически несовместим с антибиотиками (пенициллинами, цефалоспоринами, эритромицином, тетрациклином и амфотерицином В) и протеолитическими ферментами. Уменьшает всасывание пенициллинов, цефалоспоринов, тетрациклина (их следует принимать не ранее, чем через 2 часа после приема внутрь ацетилцистеина)."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Больным с бронхиальной астмой и обструктивным бронхитом ацетилцистеин следует назначать с осторожностью под систематическим контролем бронхиальной проходимости."}},{"type":"paragraph","data":{"text":"При растворении препарата необходимо пользоваться стеклянной посудой, избегать контакта с металлами, резиной (при контакте образуются сульфиды с характерным запахом), кислородом, легко окисляющимися веществами."}},{"type":"paragraph","data":{"text":"При лечении больных сахарным диабетом необходимо учитывать, что в препарате содержится сахароза (в одном пакетике 200/600 мг содержится 0,23/0,20 ХЕ, соответственно)."}},{"type":"paragraph","data":{"text":"У пациентов с тяжелыми поражениями кожи - синдромом Стивенса-Джонсона или синдрома Лайелла - в ранней фазе могут появляться температура, боль в теле, ринит, кашель и воспаление горла. При симптоматическом лечении возможно ошибочное назначение муколитических средств. Имеются единичные сообщения (˂ 1/10000) о выявлении синдрома Стивенса-Джонсона и синдрома Лайелла, совпавшие по времени с назначением препарата; однако причинно-следственная связь с приемом препарата отсутствует. При развитии вышеперечисленных синдромов (внезапное появление сыпи и пятен на лице и туловище, которые позже могут распространиться на другие части тела), рекомендуется прекратить лечение и немедленно обратиться за медицинской помощью."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В терапевтических дозах не влияет на способность управлять транспортными средствами и механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Порошок для приготовления раствора для приема внутрь, 200 мг, 600 мг. По 3,0 г порошка в пакетик из трехслойного материала (бумага-алюминий-полиэтилен). 20 пакетиков с инструкцией по применению в пачку картонную."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"При температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"4 года."}},{"type":"paragraph","data":{"text":"Не использовать после истечения 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":"Линдофарм ГмбХ, Нойштрассе 82, 40721 Хильден, Германия."}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"115114, г. Москва, ул. 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