Раствор: препарат + растворитель – прозрачная бесцветная или слегка окрашенная жидкость.
Фармакотерапевтическая группа
Отхаркивающее, муколитическое
средство.
Фармакологические свойства
Фармакодинамика
В исследованиях показано,
что амброксол увеличивает секрецию в дыхательных путях. Он усиливает продукцию
легочного сурфактанта и стимулирует цилиарную активность. Эти эффекты приводят
к усилению тока и транспорта слизи (мукоцилиарного клиренса). Усиление
мукоцилиарного клиренса улучшает отхождение мокроты и облегчает кашель.
У пациентов с хронической
обструктивной болезнью легких длительная терапия амброксолом (на протяжении не
менее 2 месяцев) приводила к значительному снижению числа обострений.
Отмечалось достоверное уменьшение длительности обострений и числа дней
антибиотикотерапии.
Фармакокинетика
Для всех лекарственных форм амброксола
немедленного высвобождения характерна быстрая и почти полная абсорбция из желудочно-кишечного
тракта (ЖКТ) с линейной зависимостью от дозы в терапевтическом интервале
концентраций. Максимальная концентрация (Cmax) в плазме крови при пероральном приеме достигается
через 1-2,5 часа. Объем распределения составляет 552 л. В терапевтическом
интервале концентраций связывание с белками плазмы составляет примерно 90 %.
Переход амброксола из крови в
ткани при пероральном применении происходит быстро. Самые высокие концентрации
активного компонента препарата наблюдаются в легких. Примерно 30 % принятой
пероральной дозы подвергается эффекту первичного прохождения через печень. Исследования
на микросомах печени человека показали, что изофермент СУР3А4 является
преобладающей изоформой, ответственной за метаболизм амброксола до дибромантраниловой
кислоты. Оставшаяся часть амброксола метаболизируется в печени, главным образом
путем глюкуронидации и путем частичного расщепления до дибромантраниловой
кислоты (приблизительно 10 % от введенной дозы), а также небольшого количества
дополнительных метаболитов. Терминальный период полувыведения амброксола
составляет 10 часов. Общий клиренс находится в пределах 660 мл/мин, на почечный
клиренс приходится примерно 8 % от общего клиренса. Методом радиоактивной метки
было подсчитано, после приема единоразовой дозы препарата в течение последующих
5 дней с мочой выделяется около 83 % принятой дозы.
Показания к применению
Острые и хронические
заболевания дыхательных путей с выделением вязкой мокроты: острый и хронический
бронхит, пневмония, хроническая обструктивная болезнь легких, бронхиальная
астма с затруднением отхождения мокроты, бронхоэктатическая болезнь.
Противопоказания
Повышенная
чувствительность к амброксолу или другим компонентам препарата, беременность (І
триместр), период грудного вскармливания.
С осторожностью
Нарушение моторной
функции бронхов и повышенное образование мокроты (при синдроме неподвижных
ресничек), язвенная болезнь желудка и 12-перстной кишки в период обострения,
беременность (ІІ-ІІІ триместр).
Пациенты с нарушениями
функции почек или тяжелыми заболеваниями печени должны принимать амброксол с
особой осторожностью, соблюдая большие интервалы между приемами препарата или
принимая препарат в меньшей дозе.
Применение при беременности и в период грудного вскармливания
Препарат
противопоказано применять в течение І триместра беременности. При необходимости
применения амброксола во ІІ-ІІІ триместрах беременности следует оценить
потенциальную пользу для матери и возможный риск для плода.
В период
грудного вскармливания применять препарат противопоказано, поскольку он
выделяется с грудным молоком.
Способ применения и дозы
Муколитический
эффект препарата проявляется при приеме большого количества жидкости. Поэтому
во время лечения рекомендуется обильное питье.
Применение внутрь
Внутрь применяют препарат из тюбик-капельницы / ампулы
А или флакона (1 мл = 20
капель из капельницы флакона) после еды,
добавляя в воду, чай, молоко или фруктовый сок.
Взрослым и детям старше 12 лет:
первые 2-3
дня по 4 мл (80 капель) 3 раза в сутки (что соответствует 90 мг амброксола в
сутки),затем – по 4 мл (80 капель) 2 раза в сутки (что соответствует
60 мг амброксола в сутки).
Детям от 6 до 12 лет:
по 2 мл (40 капель) 2-3 раза в сутки (что соответствует 30 или 45 мг
амброксола в сутки).
Детям от 2 до 6 лет:
по 1 мл (20 капель) 3 раза в сутки (что соответствует 22,5 мг
амброксола в сутки).
Детям до 2 лет:
по 1 мл (20 капель) 2 раза в сутки (что соответствует 15 мг амброксола в
сутки).
Детям младше
2 лет препарат назначают только под контролем врача.
Максимальная
суточная доза при приеме внутрь: для взрослых – 90 мг, для детей
6-12 лет – 45 мг, для детей 2-6 лет – 22,5 мг, для детей до 2-х лет – 15
мг.
Применение в виде
ингаляций
Препарат можно применять,
используя любое современное оборудование для ингаляций (кроме паровых
ингаляторов).
Перед ингаляцией
количество препарата, соответствующее необходимой дозировке, смешивают с растворителем
(0,9 % раствором натрия хлорида) (для оптимального увлажнения воздуха – в
соотношении 1:1). Перед ингаляцией
рекомендуется подогреть ингаляционный раствор до температуры тела.
Поскольку при
ингаляционной терапии глубокий вдох может спровоцировать кашель, ингаляции
следует проводить в режиме обычного дыхания. Пациентам с бронхиальной астмой
рекомендуется проводить ингаляцию после приема бронхолитических препаратов во
избежание неспецифического раздражения дыхательных путей и их спазма.
Порядок
работы с комплектом (тюбик-капельница / ампула А + тюбик-капельница / ампула Б):
1. Подготовить оборудование для ингаляций согласно инструкции
производителя.
2. Отделить тюбик-капельницу / ампулу А
3. Вскрыть тюбик-капельницу /
ампулу А, убедившись, что раствор находится в нижней части тюбик-капельницы /
ампулы, вращающими движениями повернуть и отделить клапан.
4. Поместить содержимое тюбик-капельницы / ампулы А в резервуар
оборудования для ингаляций в необходимой дозировке.
5. Выполнив аналогичные действия с тюбик-капельницей / ампулой
Б, добавить ее содержимое перед ингаляцией в резервуар оборудования для ингаляций
(для оптимального увлажнения воздуха – в соотношении 1:1).
6. Далее следовать инструкции по эксплуатации оборудования для
ингаляций.
В случае
применения препарата во флаконе для точного отмеривания дозы препарата
прилагается мерный стакан.
Дозировка для ингаляций
Взрослым и детям старше 6 лет:
1-2 ингаляции в сутки по
2-3 мл (40-60 капель) раствора (что соответствует 15-45 мг амброксола в сутки).
Детям до 6 лет:
1-2 ингаляции в сутки по 2
мл (40 капель) раствора (что соответствует 15-30 мг амброксола в сутки).
Прием
препарата более 4-5 дней возможен только по рекомендации врача.
Побочное действие
Частота побочных эффектов
представлена в следующей градации: очень часто (≥ 1/10); часто (≥ 1/100 до <
1/10); нечасто (≥ 1/1000 до < 1/100); редко (≥ 1/10000 до < 1/1000);
очень редко (< 1/10000); неизвестно (не может быть оценена на основе
имеющихся данных).
Нарушения со стороны желудочно-кишечного тракта: часто – тошнота, снижение
чувствительности в полости рта и глотке; нечасто – диспепсия, боль в верхней
части живота, рвота, диарея; редко – изжога, сухость слизистой оболочки полости
рта и глотки, запор.
Нарушения со стороны дыхательной системы, органов грудной клетки и
средостения: редко –
сухость слизистой оболочки дыхательных путей, ринорея.
Расстройства со стороны нервной системы: часто – дисгевзия (нарушение
вкусовых ощущений).
Нарушения со стороны иммунной системы: редко – реакции
гиперчувствительности, кожная сыпь, крапивница, зуд, ангионевротический отек;
очень редко – анафилактические реакции, в том числе анафилактический шок.
Нарушения со стороны кожи и подкожных тканей: очень редко – синдром
Стивенса-Джонсона, синдром Лайелла.
Прочие: редко
– адинамия, лихорадка.
Передозировка
Симптомы:
изжога, диспепсия, диарея, тошнота, рвота, боли в верхней части живота. Имеются
сообщения о появлении кратковременного беспокойства. При выраженной
передозировке возможно значительное снижение артериального давления.
Лечение:
искусственная рвота, промывание желудка в первые 1-2 ч после приема препарата;
прием жиросодержащих продуктов, симптоматическая терапия.
Взаимодействие с другими лекарственными средствами
При применении с противокашлевыми
препаратами возможно затруднение отхождения мокроты в результате подавления
кашлевого рефлекса. При одновременном применении с амоксициллином,
доксициклином, цефуроксимом, эритромицином амброксол увеличивает их
концентрацию в бронхиальном секрете. О клинически значимых нежелательных
взаимодействиях с другими лекарственными средствами не сообщалось.
Особые указания
Бераксол-СОЛОфарм не следует
принимать одновременно с противокашлевыми препаратами, которые могут тормозить
кашлевой рефлекс.
Бераксол-СОЛОфарм следует с
осторожностью применять у пациентов с ослабленным кашлевым рефлексом или
нарушенным мукоцилиарным транспортом из-за возможности скопления мокроты.
Пациентам, принимающим амброксол, не
следует рекомендовать выполнение дыхательной гимнастики; у пациентов с тяжелым
течением заболевания следует выполнять аспирацию разжиженной мокроты.
У пациентов с бронхиальной астмой
амброксол может усиливать кашель.
Не следует принимать
амброксол непосредственно перед сном.
У пациентов с тяжелыми
поражениями кожи – синдром Стивенса-Джонсона или синдром Лайелла – в ранней
фазе могут появляться температура, боль в теле, ринит, кашель и боль в горле.
При симптоматическом лечении возможно ошибочное назначение муколитических
средств, таких как амброксол. Имеются единичные сообщения 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 рекомендуется прекратить лечение и немедленно обратиться за
медицинской помощью.
При нарушении функции
почек амброксол необходимо применять только по рекомендации врача.
Раствор амброксола не рекомендуется
смешивать с кромоглициевой кислотой и щелочными растворами.
Пациентам, соблюдающим
гипонатриевую диету, следует иметь в виду, что в 1 мл раствора амброксола
содержится 10 мг натрия. В максимальной суточной дозе для взрослых и детей
старше 12 лет содержится 120 мг натрия.
Влияние на способность управлять автомобилем и движущимися механизмами
Случаев влияния препарата на
способность управлять транспортными средствами и механизмами до настоящего
момента выявлено не было.
Форма выпуска
Раствор для приема внутрь
и ингаляций 7,5 мг/мл.
По 50 или 100 мл препарата во флаконы
стеклянные, укупоренные пробкой-капельницей и крышкой с контролем первого
вскрытия.
По 1 флакону в комплекте с мерным
стаканом вместе с инструкцией по применению в пачке из картона.
По 1, 2 или 4 мл
препарата в тюбик-капельницы / ампулы А и по 1, 2 или 4 мл растворителя в
тюбик-капельницы / ампулы Б из полиэтилена низкой плотности.
По 10 тюбик-капельниц / ампул А в пакете
из фольгированной пленки и по 10 тюбик-капельниц / ампул Б в пакете из
фольгированной пленки.
По 1 или 2 пакета из
фольгированной пленки с тюбик-капельницами / ампулами А совместно с 1 или 2
пакетами из фольгированной пленки с тюбик-капельницами / ампулами Б (комплект)
или без них вместе с инструкцией по применению в пачке из картона.
Условия хранения
Хранить при температуре не
выше 25 ºС.
Хранить в недоступном для детей
месте.
Срок годности
3 года.
Срок годности препарата
после вскрытия флакона – 6 месяцев.
Для описания товара использована информация от партнера 36.6
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Методом радиоактивной метки\nбыло подсчитано, после приема единоразовой дозы препарата в течение последующих\n5 дней с мочой выделяется около 83 % принятой дозы."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Острые и хронические\nзаболевания дыхательных путей с выделением вязкой мокроты: острый и хронический\nбронхит, пневмония, хроническая обструктивная болезнь легких, бронхиальная\nастма с затруднением отхождения мокроты, бронхоэктатическая болезнь."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная\nчувствительность к амброксолу или другим компонентам препарата, беременность (І\nтриместр), период грудного вскармливания."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Нарушение моторной\nфункции бронхов и повышенное образование мокроты (при синдроме неподвижных\nресничек), язвенная болезнь желудка и 12-перстной кишки в период обострения,\nбеременность (ІІ-ІІІ триместр)."}},{"type":"paragraph","data":{"text":"Пациенты с нарушениями\nфункции почек или тяжелыми заболеваниями печени должны принимать амброксол с\nособой осторожностью, соблюдая большие интервалы между приемами препарата или\nпринимая препарат в меньшей дозе."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Препарат\nпротивопоказано применять в течение І триместра беременности. При необходимости\nприменения амброксола во ІІ-ІІІ триместрах беременности следует оценить\nпотенциальную пользу для матери и возможный риск для плода. "}},{"type":"paragraph","data":{"text":"В период\nгрудного вскармливания применять препарат противопоказано, поскольку он\nвыделяется с грудным молоком."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Муколитический\nэффект препарата проявляется при приеме большого количества жидкости. Поэтому\nво время лечения рекомендуется обильное питье."}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eПрименение внутрь\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Внутрь применяют препарат из тюбик-капельницы / ампулы\nА или флакона (1 мл = 20\nкапель из капельницы флакона) после еды,\nдобавляя в воду, чай, молоко или фруктовый сок."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВзрослым и детям старше 12 лет:\u003cb\u003e \u003c/b\u003e\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"первые 2-3\nдня по 4 мл (80 капель) 3 раза в сутки (что соответствует 90 мг амброксола в\nсутки),\u003cb\u003e\u003ci\u003e \u003c/i\u003e\u003c/b\u003eзатем – по 4 мл (80 капель) 2 раза в сутки (что соответствует\n60 мг амброксола в сутки).\u003cb\u003e\u003ci\u003e\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eДетям от 6 до 12 лет: \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"по 2 мл (40 капель) 2-3 раза в сутки (что соответствует 30 или 45 мг\nамброксола в сутки)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДетям от 2 до 6 лет: \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"по 1 мл (20 капель) 3 раза в сутки (что соответствует 22,5 мг\nамброксола в сутки)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДетям до 2 лет: \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"по 1 мл (20 капель) 2 раза в сутки (что соответствует 15 мг амброксола в\nсутки)."}},{"type":"paragraph","data":{"text":"Детям младше\n2 лет препарат назначают только под контролем врача."}},{"type":"paragraph","data":{"text":"Максимальная\nсуточная доза при приеме внутрь: для взрослых – 90 мг, для детей"}},{"type":"paragraph","data":{"text":"\n6-12 лет – 45 мг, для детей 2-6 лет – 22,5 мг, для детей до 2-х лет – 15\nмг."}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eПрименение в виде\nингаляций\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Препарат можно применять,\nиспользуя любое современное оборудование для ингаляций (кроме паровых\nингаляторов). "}},{"type":"paragraph","data":{"text":"Перед ингаляцией\nколичество препарата, соответствующее необходимой дозировке, смешивают с растворителем\n(0,9 % раствором натрия хлорида) (для оптимального увлажнения воздуха – в\nсоотношении 1:1). Перед ингаляцией\nрекомендуется подогреть ингаляционный раствор до температуры тела."}},{"type":"paragraph","data":{"text":"Поскольку при\nингаляционной терапии глубокий вдох может спровоцировать кашель, ингаляции\nследует проводить в режиме обычного дыхания. Пациентам с бронхиальной астмой\nрекомендуется проводить ингаляцию после приема бронхолитических препаратов во\nизбежание неспецифического раздражения дыхательных путей и их спазма."}},{"type":"paragraph","data":{"text":"Порядок\nработы с комплектом (тюбик-капельница / ампула А + тюбик-капельница / ампула Б):"}},{"type":"paragraph","data":{"text":"1. Подготовить оборудование для ингаляций согласно инструкции\nпроизводителя."}},{"type":"paragraph","data":{"text":"2. Отделить тюбик-капельницу / ампулу А"}},{"type":"paragraph","data":{"text":"3. Вскрыть тюбик-капельницу /\nампулу А, убедившись, что раствор находится в нижней части тюбик-капельницы /\nампулы, вращающими движениями повернуть и отделить клапан."}},{"type":"paragraph","data":{"text":"4. Поместить содержимое тюбик-капельницы / ампулы А в резервуар\nоборудования для ингаляций в необходимой дозировке."}},{"type":"paragraph","data":{"text":"5. Выполнив аналогичные действия с тюбик-капельницей / ампулой\nБ, добавить ее содержимое перед ингаляцией в резервуар оборудования для ингаляций\n(для оптимального увлажнения воздуха – в соотношении 1:1)."}},{"type":"paragraph","data":{"text":"6. Далее следовать инструкции по эксплуатации оборудования для\nингаляций. \u003ci\u003e\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"В случае\nприменения препарата во флаконе для точного отмеривания дозы препарата\nприлагается мерный стакан."}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eДозировка для ингаляций\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eВзрослым и детям старше 6 лет:\u003cb\u003e \u003c/b\u003e\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"1-2 ингаляции в сутки по\n2-3 мл (40-60 капель) раствора (что соответствует 15-45 мг амброксола в сутки)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДетям до 6 лет:\u003c/i\u003e "}},{"type":"paragraph","data":{"text":"1-2 ингаляции в сутки по 2\nмл (40 капель) раствора (что соответствует 15-30 мг амброксола в сутки)."}},{"type":"paragraph","data":{"text":"Прием\nпрепарата более 4-5 дней возможен только по рекомендации врача. "}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Частота побочных эффектов\nпредставлена в следующей градации: очень часто (≥ 1/10); часто (≥ 1/100 до <\n1/10); нечасто (≥ 1/1000 до < 1/100); редко (≥ 1/10000 до < 1/1000);\nочень редко (< 1/10000); неизвестно (не может быть оценена на основе\nимеющихся данных)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны желудочно-кишечного тракта:\u003c/i\u003e часто – тошнота, снижение\nчувствительности в полости рта и глотке; нечасто – диспепсия, боль в верхней\nчасти живота, рвота, диарея; редко – изжога, сухость слизистой оболочки полости\nрта и глотки, запор."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны дыхательной системы, органов грудной клетки и\nсредостения:\u003c/i\u003e редко –\nсухость слизистой оболочки дыхательных путей, ринорея."}},{"type":"paragraph","data":{"text":"\u003ci\u003eРасстройства со стороны нервной системы:\u003c/i\u003e часто – дисгевзия (нарушение\nвкусовых ощущений)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны иммунной системы:\u003c/i\u003e редко – реакции\nгиперчувствительности, кожная сыпь, крапивница, зуд, ангионевротический отек;\nочень редко – анафилактические реакции, в том числе анафилактический шок."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны кожи и подкожных тканей: \u003c/i\u003eочень редко – синдром\nСтивенса-Джонсона, синдром Лайелла."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e редко\n– адинамия, лихорадка."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы:\u003c/i\u003e\nизжога, диспепсия, диарея, тошнота, рвота, боли в верхней части живота. Имеются\nсообщения о появлении кратковременного беспокойства. При выраженной\nпередозировке возможно значительное снижение артериального давления."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e\nискусственная рвота, промывание желудка в первые 1-2 ч после приема препарата;\nприем жиросодержащих продуктов, симптоматическая терапия."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При применении с противокашлевыми\nпрепаратами возможно затруднение отхождения мокроты в результате подавления\nкашлевого рефлекса. При одновременном применении с амоксициллином,\nдоксициклином, цефуроксимом, эритромицином амброксол увеличивает их\nконцентрацию в бронхиальном секрете. О клинически значимых нежелательных\nвзаимодействиях с другими лекарственными средствами не сообщалось."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Бераксол-СОЛОфарм не следует\nпринимать одновременно с противокашлевыми препаратами, которые могут тормозить\nкашлевой рефлекс."}},{"type":"paragraph","data":{"text":"Бераксол-СОЛОфарм следует с\nосторожностью применять у пациентов с ослабленным кашлевым рефлексом или\nнарушенным мукоцилиарным транспортом из-за возможности скопления мокроты."}},{"type":"paragraph","data":{"text":"Пациентам, принимающим амброксол, не\nследует рекомендовать выполнение дыхательной гимнастики; у пациентов с тяжелым\nтечением заболевания следует выполнять аспирацию разжиженной мокроты."}},{"type":"paragraph","data":{"text":"У пациентов с бронхиальной астмой\nамброксол может усиливать кашель."}},{"type":"paragraph","data":{"text":"Не следует принимать\nамброксол непосредственно перед сном."}},{"type":"paragraph","data":{"text":"У пациентов с тяжелыми\nпоражениями кожи – синдром Стивенса-Джонсона или синдром Лайелла – в ранней\nфазе могут появляться температура, боль в теле, ринит, кашель и боль в горле.\nПри симптоматическом лечении возможно ошибочное назначение муколитических\nсредств, таких как амброксол. Имеются единичные сообщения о выявлении синдрома\nСтивенса-Джонсона и синдрома Лайелла, совпавшие по времени с назначением\nпрепарата, однако причинно-следственная связь с приемом препарата отсутствует."}},{"type":"paragraph","data":{"text":"При развитии вышеперечисленных\nсиндромов рекомендуется прекратить лечение и немедленно обратиться за\nмедицинской помощью."}},{"type":"paragraph","data":{"text":"При нарушении функции\nпочек амброксол необходимо применять только по рекомендации врача."}},{"type":"paragraph","data":{"text":"Раствор амброксола не рекомендуется\nсмешивать с кромоглициевой кислотой и щелочными растворами."}},{"type":"paragraph","data":{"text":"Пациентам, соблюдающим\nгипонатриевую диету, следует иметь в виду, что в 1 мл раствора амброксола\nсодержится 10 мг натрия. В максимальной суточной дозе для взрослых и детей\nстарше 12 лет содержится 120 мг натрия."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Случаев влияния препарата на\nспособность управлять транспортными средствами и механизмами до настоящего\nмомента выявлено не было."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для приема внутрь\nи ингаляций 7,5 мг/мл."}},{"type":"paragraph","data":{"text":"По 50 или 100 мл препарата во флаконы\nстеклянные, укупоренные пробкой-капельницей и крышкой с контролем первого\nвскрытия."}},{"type":"paragraph","data":{"text":"По 1 флакону в комплекте с мерным\nстаканом вместе с инструкцией по применению в пачке из картона."}},{"type":"paragraph","data":{"text":"По 1, 2 или 4 мл\nпрепарата в тюбик-капельницы / ампулы А и по 1, 2 или 4 мл растворителя в\nтюбик-капельницы / ампулы Б из полиэтилена низкой плотности."}},{"type":"paragraph","data":{"text":"По 10 тюбик-капельниц / ампул А в пакете\nиз фольгированной пленки и по 10 тюбик-капельниц / ампул Б в пакете из\nфольгированной пленки."}},{"type":"paragraph","data":{"text":"По 1 или 2 пакета из\nфольгированной пленки с тюбик-капельницами / ампулами А совместно с 1 или 2\nпакетами из фольгированной пленки с тюбик-капельницами / ампулами Б (комплект)\nили без них вместе с инструкцией по применению в пачке из картона."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не\nвыше 25 ºС. "}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей\nместе."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}},{"type":"paragraph","data":{"text":"Срок годности препарата\nпосле вскрытия флакона – 6 месяцев."}},{"type":"paragraph","data":{"text":"Не применять\nпосле окончания срока годности!"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Отпускают без\nрецепта."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"ООО «Гротекс»"}},{"type":"paragraph","data":{"text":"Россия, 195279, г. Санкт-Петербург"}},{"type":"paragraph","data":{"text":"Индустриальный проспект, д. 71, корп.\n2, лит. А"}},{"type":"paragraph","data":{"text":"Тел.: +7 812 385 47 87"}},{"type":"paragraph","data":{"text":"Факс: +7 812 385 47 88"}},{"type":"paragraph","data":{"text":"\u003ca href=\"http://www.solopharm.com\"\u003ewww.solopharm.com\u003c/a\u003e"}}]}],"source":null},"description_toggle":false,"short_description":"ФармакодинамикаВ исследованиях показано, что амброксол увеличивает секрецию в дыхательных путях. Он усиливает продукцию легочного сурфактанта и стимулирует цилиарную активность. Эти эффекты приводят к усилению тока и транспорта слизи (мукоцилиарного клиренса). Усиление мукоцилиарного клиренса улучшает отхождение мокроты и облегчает кашель. У пациентов с хронической обструктивной болезнью легких длительная терапия амброксолом (на протяжении не менее 2 месяцев) приводила к значительному снижению числа обострений. Отмечалось достоверное уменьшение длительности обострений и числа дней антибиотикотерапии.ФармакокинетикаДля всех лекарственных форм амброксола немедленного высвобождения характерна быстрая и почти полная абсорбция из желудочно-кишечного тракта (ЖКТ) с линейной зависимостью от дозы в терапевтическом интервале концентраций. Максимальная концентрация (Cmax) в плазме крови при пероральном приеме достигается через 1-2,5 часа. Объем распределения составляет 552 л. В терапевтическом интервале концентраций связывание с белками плазмы составляет примерно 90 %. Переход амброксола из крови в ткани при пероральном применении происходит быстро. Самые высокие концентрации активного компонента препарата наблюдаются в легких. Примерно 30 % принятой пероральной дозы подвергается эффекту первичного прохождения через печень. Исследования на микросомах печени человека показали, что изофермент СУР3А4 является преобладающей изоформой, ответственной за метаболизм амброксола до дибромантраниловой кислоты. 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