Муколитическое и сосудосуживающее действие препарата является отражением фармакологических свойств действующих веществ, входящих в его состав.
Ацетилцистеин обладает муколитической активностью за счет наличия свободной сульфгидрильной группы, которая путем разрыва дисульфидных связей гликопротеинов слизи оказывает разжижающее действие на назофарингеальный секрет.
Туаминогептана сульфат – симпатомиметический амин, при местном применении оказывает сосудосуживающее действие без системных воздействий.
Эти два вещества действуют синергически для снижения интраназальной резистентности.
Фармакокинетика
Всасывание
После введения терапевтической дозы (2 нажатия по 50 мкл) препарата Cmax туаминогептана в плазме достигается в интервале 0.25-6 ч.
Распределение
Среднее значение Сmax туаминогептана после 2 нажатий по 50 мкл препарата составляло 0.95 нг/мл, среднее значение Тmax составляло 2 ч.
Метаболизм
Метаболизм туаминогептана сульфата в гепатоцитах человека был изучен in vitro. В условиях in vitro не происходило трансформации в гепатоцитах человека. Основным метаболитом N-ацетилцистеина является неорганический сульфат, который выводится с мочой, другие метаболиты включают таурин, цистеин и N,N-диацетилцистеин.
N-ацетилцистеин быстро деацетилируется до цистеина, который включается в белки. Избыток цистеина поступает в печень, где он либо метаболизируется для выведения, либо дополнительно модифицируется.
Выведение
Средний Т1/2 туаминогептана в плазме крови после 2 нажатий по 50 мкл препарата составляет 9.8 ч. Через 12 ч после приема туаминогептан определялся у всех испытуемых (среднее значение 0.42 нг/мл). Через 24 ч после приема средняя концентрация туаминогептана в плазме крови составляла 0.30 нг/мл, но у большинства испытуемых концентрация была уже ниже предела количественного определения (0.100 нг/мл).
Показания к применению
острый и подострый ринит с густым гнойно-слизистым секретом;
хронический ринит;
вазомоторный ринит;
атрофический ринит;
синусит.
Противопоказания
гиперчувствительность к действующим веществам или любому из вспомогательных веществ;
сердечно-сосудистые заболевания, в т.ч. артериальная гипертензия;
цереброваскулярные заболевания в анамнезе, в т.ч. наличие соответствующих факторов риска (ввиду альфа-симпатомиметической активности);
судороги в анамнезе;
феохромоцитома;
закрытоугольная глаукома;
одновременный прием других симпатомиметических назальных средств, в т.ч. других средств против заложенности носа;
пациенты, которые получают в настоящее время или получали на протяжении 2 недель ингибиторы МАО А (RIMA);
гипофизэктомия или операция с обнажением твердой мозговой оболочки;
дети в возрасте до 6 лет.
С осторожностью
С осторожностью: окклюзионные сосудистые заболевания; сахарный диабет; гипертиреоз; астма; гипертрофия предстательной железы, поскольку она может затруднять мочеиспускание; применение бета-адреноблокаторов; длительное применение может вызвать возобновление симптомов заложенности и лекарственно-индуцированный ринит.
Применение при беременности и в период грудного вскармливания
Данные об ограниченном количестве пациенток, принимавших данное лекарственное средство при беременности, не указывает на неблагоприятное воздействие ацетилцистеина на течение беременности или на здоровье плода/новорожденного ребенка. На сегодняшний день другие соответствующие эпидемиологические данные отсутствуют. Исследования ацетилцистеина на животных не указывают на прямое или косвенное вредное воздействие в части репродуктивной токсичности.
Данные о применении во время беременности или об исследованиях на животных туаминогептана или комбинации ацетилцистеина с туаминогептаном отсутствуют.
Применение данного лекарственного средства во время беременности не рекомендуется.
Хотя информация о выделении ацетилцистеина или туаминогептана в грудное молоко отсутствует, риск для детей, находящихся на грудном вскармливании, не может быть исключен. Применение данного лекарственного средства во время кормления грудью не рекомендуется.
Способ применения и дозы
Препарат вводят в носовую полость в виде спрея с помощью спрей-насадки.
Взрослым: по 2 впрыскивания спрея (2 нажатия на спрей-насадку) в каждый носовой ход 3-4 раза/сут.
Детям старше 6 лет: по 1 впрыскиванию спрея (1 нажатие на спрей-насадку) в каждый носовой ход 3-4 раза/сут.
Длительность лечения не должна превышать 7 дней.
Не следует превышать рекомендованные дозы и курс лечения без консультации с врачом.
Побочное действие
Частое применение препарата в высокой дозировке может послужить причиной побочных эффектов симпатомиметической природы (таких как повышенная возбудимость, учащенное сердцебиение, тремор и прочие).
Иногда возможна сухость в носу и горле, а также угревидная сыпь. Эти реакции, однако, полностью исчезают при прекращении применения препарата.
Нежелательные реакции, приведенные ниже, могут быть связаны с применением препарата; частота возникновения указанных нежелательных реакций неизвестна (невозможно оценить на основании имеющихся данных).
Передозировка
Симптомы: при передозировке у взрослых пациентов могут наблюдаться следующие симптомы: артериальная гипертензия, светобоязнь, сильная головная боль, стеснение в грудной клетке. При передозировке у детей возможна гипотермия с выраженным седативным эффектом.
Лечение: симптоматическое.
Взаимодействие с другими лекарственными средствами
Несмотря на низкую системную абсорбцию туаминогептана, при его местном нанесении в носовую полость следует принимать во внимание следующее потенциальное взаимодействие:
ингибиторы МАО, включая обратимые ингибиторы МАО: повышение риска возникновения гипертонического криза;
антигипертензивные средства (включая блокаторы адренергических нейронов или бета-адреноблокаторы): может блокировать гипотензивное действие препаратов;
сердечные гликозиды: может повышать риск возникновения сердечной аритмии;
алкалоиды спорыньи: может повышать риск возникновения сердечной аритмии;
препараты для лечения болезни Паркинсона: может повышать риск токсического действия на сердечно-сосудистую систему;
окситоцин: может повышать риск возникновения гипертензии.
Особые указания
У пациентов с сердечно-сосудистыми заболеваниями, особенно больных с артериальной гипертензией, лечение должно проводиться под контролем врача.
Препарат следует применять с осторожностью у больных астмой.
Длительный прием препаратов, сужающих кровеносные сосуды, может нарушать нормальную функцию слизистой оболочки носовой полости и придаточных пазух носа, а также вызывать привыкание к препарату. Таким образом, частое применение в течение длительного времени может иметь неблагоприятное воздействие.
Препарат следует применять с осторожностью у пожилых пациентов с гипертрофией простаты из-за риска задержки мочи.
Применение, особенно длительное, средств местного применения может вызывать сенсибилизацию: в этом случае необходимо прекратить использование препарата и, если требуется, прибегнуть к соответствующему лечению. При отсутствии полного терапевтического ответа в течение нескольких дней следует проконсультироваться с врачом; в любом случае, продолжительность лечения не должна составлять больше 1 недели.
По решению врача применение препарата можно сочетать с соответствующей антибактериальной терапией.
Туаминогептана сульфат может давать положительный результат допинг-теста.
Данный препарат не предназначен для офтальмологического применения.
Использование в педиатрии
Препарат следует применять с осторожностью у детей, принимая во внимание, что препарат противопоказан к применению у детей младше 6 лет.
Влияние на способность к управлению транспортными средствами и механизмами
Не оказывает влияния на способность управлять транспортными средствами и механизмами. Специальных исследований не проводилось, но пациентов следует информировать о том, что в некоторых случаях отмечались галлюцинации.
Условия хранения
Препарат следует хранить в недоступном для детей месте при температуре не выше 25°С; не замораживать.
Для описания товара использована информация от партнера 36.6
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Информация предоставляется в справочных целях. Не занимайтесь самолечением. При первых признаках заболевания обратитесь к врачу.
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свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Муколитическое и сосудосуживающее действие препарата является отражением фармакологических свойств действующих веществ, входящих в его состав."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАцетилцистеин\u003c/i\u003e обладает муколитической активностью за счет наличия свободной сульфгидрильной группы, которая путем разрыва дисульфидных связей гликопротеинов слизи оказывает разжижающее действие на назофарингеальный секрет."}},{"type":"paragraph","data":{"text":"\u003ci\u003eТуаминогептана сульфат\u003c/i\u003e – симпатомиметический амин, при местном применении оказывает сосудосуживающее действие без системных воздействий."}},{"type":"paragraph","data":{"text":"Эти два вещества действуют синергически для снижения интраназальной резистентности."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"\u003ci\u003eВсасывание\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"После введения терапевтической дозы (2 нажатия по 50 мкл) препарата C\u003csub\u003emax\u003c/sub\u003e туаминогептана в плазме достигается в интервале 0.25-6 ч."}},{"type":"paragraph","data":{"text":"\u003ci\u003eРаспределение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Среднее значение С\u003csub\u003emax\u003c/sub\u003e туаминогептана после 2 нажатий по 50 мкл препарата составляло 0.95 нг/мл, среднее значение Т\u003csub\u003emax\u003c/sub\u003e составляло 2 ч."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМетаболизм\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Метаболизм туаминогептана сульфата в гепатоцитах человека был изучен in vitro. В условиях in vitro не происходило трансформации в гепатоцитах человека. Основным метаболитом N-ацетилцистеина является неорганический сульфат, который выводится с мочой, другие метаболиты включают таурин, цистеин и N,N-диацетилцистеин."}},{"type":"paragraph","data":{"text":"N-ацетилцистеин быстро деацетилируется до цистеина, который включается в белки. Избыток цистеина поступает в печень, где он либо метаболизируется для выведения, либо дополнительно модифицируется."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВыведение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Средний Т\u003csub\u003e1/2\u003c/sub\u003e туаминогептана в плазме крови после 2 нажатий по 50 мкл препарата составляет 9.8 ч. Через 12 ч после приема туаминогептан определялся у всех испытуемых (среднее значение 0.42 нг/мл). Через 24 ч после приема средняя концентрация туаминогептана в плазме крови составляла 0.30 нг/мл, но у большинства испытуемых концентрация была уже ниже предела количественного определения (0.100 нг/мл)."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["острый и подострый ринит с густым гнойно-слизистым секретом;","хронический ринит;","вазомоторный ринит;","атрофический ринит;","синусит."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["гиперчувствительность к действующим веществам или любому из вспомогательных веществ;","сердечно-сосудистые заболевания, в т.ч. артериальная гипертензия;","цереброваскулярные заболевания в анамнезе, в т.ч. наличие соответствующих факторов риска (ввиду альфа-симпатомиметической активности);","судороги в анамнезе;","феохромоцитома;","закрытоугольная глаукома;","одновременный прием других симпатомиметических назальных средств, в т.ч. других средств против заложенности носа;","пациенты, которые получают в настоящее время или получали на протяжении 2 недель ингибиторы МАО А (RIMA);","гипофизэктомия или операция с обнажением твердой мозговой оболочки;","дети в возрасте до 6 лет."]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eС осторожностью:\u003c/i\u003e окклюзионные сосудистые заболевания; сахарный диабет; гипертиреоз; астма; гипертрофия предстательной железы, поскольку она может затруднять мочеиспускание; применение бета-адреноблокаторов; длительное применение может вызвать возобновление симптомов заложенности и лекарственно-индуцированный ринит. "}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Данные об ограниченном количестве пациенток, принимавших данное лекарственное средство при беременности, не указывает на неблагоприятное воздействие ацетилцистеина на течение беременности или на здоровье плода/новорожденного ребенка. На сегодняшний день другие соответствующие эпидемиологические данные отсутствуют. Исследования ацетилцистеина на животных не указывают на прямое или косвенное вредное воздействие в части репродуктивной токсичности."}},{"type":"paragraph","data":{"text":"Данные о применении во время беременности или об исследованиях на животных туаминогептана или комбинации ацетилцистеина с туаминогептаном отсутствуют."}},{"type":"paragraph","data":{"text":"Применение данного лекарственного средства во время беременности не рекомендуется."}},{"type":"paragraph","data":{"text":"Хотя информация о выделении ацетилцистеина или туаминогептана в грудное молоко отсутствует, риск для детей, находящихся на грудном вскармливании, не может быть исключен. Применение данного лекарственного средства во время кормления грудью не рекомендуется."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат вводят в носовую полость в виде спрея с помощью спрей-насадки."}},{"type":"paragraph","data":{"text":"\u003cb\u003eВзрослым:\u003c/b\u003e по 2 впрыскивания спрея (2 нажатия на спрей-насадку) в каждый носовой ход 3-4 раза/сут."}},{"type":"paragraph","data":{"text":"\u003cb\u003eДетям старше 6 лет:\u003c/b\u003e по 1 впрыскиванию спрея (1 нажатие на спрей-насадку) в каждый носовой ход 3-4 раза/сут."}},{"type":"paragraph","data":{"text":"Длительность лечения не должна превышать 7 дней."}},{"type":"paragraph","data":{"text":"Не следует превышать рекомендованные дозы и курс лечения без консультации с врачом."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Частое применение препарата в высокой дозировке может послужить причиной побочных эффектов симпатомиметической природы (таких как повышенная возбудимость, учащенное сердцебиение, тремор и прочие)."}},{"type":"paragraph","data":{"text":"Иногда возможна сухость в носу и горле, а также угревидная сыпь. Эти реакции, однако, полностью исчезают при прекращении применения препарата."}},{"type":"paragraph","data":{"text":"Нежелательные реакции, приведенные ниже, могут быть связаны с применением препарата; частота возникновения указанных нежелательных реакций неизвестна (невозможно оценить на основании имеющихся данных)."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы:\u003c/i\u003e при передозировке \u003cb\u003eу взрослых\u003c/b\u003e пациентов могут наблюдаться следующие симптомы: артериальная гипертензия, светобоязнь, сильная головная боль, стеснение в грудной клетке. При передозировке \u003cb\u003eу детей\u003c/b\u003e возможна гипотермия с выраженным седативным эффектом."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e симптоматическое."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Несмотря на низкую системную абсорбцию туаминогептана, при его местном нанесении в носовую полость следует принимать во внимание следующее потенциальное взаимодействие:"}},{"type":"list","data":{"style":"ordered","items":["ингибиторы МАО, включая обратимые ингибиторы МАО: повышение риска возникновения гипертонического криза;","антигипертензивные средства (включая блокаторы адренергических нейронов или бета-адреноблокаторы): может блокировать гипотензивное действие препаратов;","сердечные гликозиды: может повышать риск возникновения сердечной аритмии;","алкалоиды спорыньи: может повышать риск возникновения сердечной аритмии;","препараты для лечения болезни Паркинсона: может повышать риск токсического действия на сердечно-сосудистую систему;","окситоцин: может повышать риск возникновения гипертензии."]}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"У пациентов с сердечно-сосудистыми заболеваниями, особенно больных с артериальной гипертензией, лечение должно проводиться под контролем врача."}},{"type":"paragraph","data":{"text":"Препарат следует применять с осторожностью у больных астмой."}},{"type":"paragraph","data":{"text":"Длительный прием препаратов, сужающих кровеносные сосуды, может нарушать нормальную функцию слизистой оболочки носовой полости и придаточных пазух носа, а также вызывать привыкание к препарату. Таким образом, частое применение в течение длительного времени может иметь неблагоприятное воздействие."}},{"type":"paragraph","data":{"text":"Препарат следует применять с осторожностью у пожилых пациентов с гипертрофией простаты из-за риска задержки мочи."}},{"type":"paragraph","data":{"text":"Применение, особенно длительное, средств местного применения может вызывать сенсибилизацию: в этом случае необходимо прекратить использование препарата и, если требуется, прибегнуть к соответствующему лечению. При отсутствии полного терапевтического ответа в течение нескольких дней следует проконсультироваться с врачом; в любом случае, продолжительность лечения не должна составлять больше 1 недели."}},{"type":"paragraph","data":{"text":"По решению врача применение препарата можно сочетать с соответствующей антибактериальной терапией."}},{"type":"paragraph","data":{"text":"Туаминогептана сульфат может давать положительный результат допинг-теста."}},{"type":"paragraph","data":{"text":"Данный препарат не предназначен для офтальмологического применения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eИспользование в педиатрии\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Препарат следует применять с осторожностью у детей, принимая во внимание, что препарат противопоказан к применению у детей младше 6 лет."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние на способность к управлению транспортными средствами и механизмами\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Не оказывает влияния на способность управлять транспортными средствами и механизмами. Специальных исследований не проводилось, но пациентов следует информировать о том, что в некоторых случаях отмечались галлюцинации."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Препарат следует хранить в недоступном для детей месте при температуре не выше 25°С; не замораживать."}}]}],"source":null},"description_toggle":false,"short_description":"Муколитическое и сосудосуживающее действие препарата является отражением фармакологических свойств действующих веществ, входящих в его состав.Ацетилцистеинобладает муколитической активностью за счет наличия свободной сульфгидрильной группы, которая путем разрыва дисульфидных связей гликопротеинов слизи оказывает разжижающее действие на назофарингеальный секрет.Туаминогептана сульфат– симпатомиметический амин, при местном применении оказывает сосудосуживающее действие без системных воздействий. 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