Вспомогательные вещества: глицерол (глицерин дистиллированный) - 60 мг; вода для инъекций - до 1 мл.
Описание
Прозрачная бесцветная жидкость.
Фармакотерапевтическая группа
Альфа-адреномиметик
Фармакологические свойства
Фармакодинамика:
Фенилэфрин - альфа1-адреностимулятор незначительно влияющий на бета-адренорецепторы сердца; не является катехоламином поскольку содержит лишь одну гидроксильную группу в ароматическом ядре. Вызывает сужение артериол и повышение артериального давления (АД) (с возможной рефлекторной брадикардией) но действует продолжительнее поскольку меньше склонен к действию катехол-о-метилтрансферазы.
Не вызывает увеличения минутного объема крови.
После внутривенного введения действие препарата развивается сразу и продолжается в течение 5-20 мин. При подкожном и внутримышечном введении действие препарата начинается через 10-15 мин и продолжается в течение 1-2 ч после введения.
Фармакокинетика:
После внутримышечного введения быстро всасывается в системный кровоток. Объем распределения после однократного введения составляет 340 л. Связь с белками плазмы крови низкая. Практически полностью метаболизируется в печени моноаминоксидазой (без участия катехол-о-метилтрансферазы). Конечный период полувыведения составляет около 3 часов. Выводится почками в виде метаболитов.
Показания к применению
- Острая артериальная гипотензия;
- Сосудистая недостаточность при передозировке вазодилататорами;
- Шок (травматический токсический);
- Как вазоконстриктор при проведении местной анестезии.
Противопоказания
- Повышенная чувствительность к любому из компонентов препарата;
- Применение одновременно с ингибиторами моноаминооксидазы (МАО) и в течение 14 дней после прекращения терапии ингибиторами МАО;
- Галотановый или циклопропановый наркоз;
- Беременность и период грудного вскармливания;
- Возраст до 18 лет.
С осторожностью
Ишемическая болезнь сердца (особенно после недавно перенесенного инфаркта миокарда) стенокардия тромбоз коронарный брыжеечных и других висцеральных или периферических сосудов сахарный диабет легочная гипертензия желудочковые аритмии окклюзивные заболевания сосудов: артериальная тромбоэмболия атеросклероз облитерирующий тромбангиит (болезнь Бюргера) болезнь Рейно склонность сосудов к спазмам при отморожении диабетический эндартериит дисфункция щитовидной железы метаболический ацидоз гиперкапния гипоксия пожилой возраст нарушения функции почек и/или печени применение у пациентов с заболеваниями предстательной железы у которых существует повышенный риск задержки мочи.
Применение при беременности и в период грудного вскармливания
Адекватных и строго контролируемых исследований применения препарата во время беременности и в период грудного вскармливания не проводилось.
У животных на поздних сроках беременности фенилэфрин вызывал задержку роста плода и стимулировал ранее начало родов.
Применение препарата Мезатон во время беременности и в период грудного вскармливания противопоказано.
Данные о выделении фенилэфрина в грудное молоко отсутствуют.
При необходимости применения препарата в период лактации грудное вскармливание необходимо прекратить.
Способ применения и дозы
Мезатон вводят внутривенно подкожно или внутримышечно.
При коллапсе разовая доза при внутривенном введении составляет 01 -05 мл 1 % раствора препарата Мезатон.
При внутривенном введении разовую дозу разводят в 20 мл 5 % раствора декстрозы (глюкозы) или 09 % раствора натрия хлорида и вводят струйно медленно. При необходимости (если систолическое АД снижается до 70-80 мм рт.ст.) введение повторяют. Интервал между повторными внутривенными введениями препарата должен составлять не менее 15 минут.
Препарат разрешается вводить внутривенно капельно для чего 1 мл 1 % раствора препарата Мезатон разводят в 250-500 мл 5 % раствора декстрозы (глюкозы). Начальная скорость введения составляет 180 мкг в минуту; в дальнейшем скорость введения уменьшают до 30-60 мкг в минуту.
При внутримышечном и подкожном введении разовая доза составляет 03-10 мл 1 % раствора препарата Мезатон.
При местной анестезии добавляют по 03-05 мл 1 % раствора препарата Мезатон на 10 мл раствора анестетика.
После продолжительной внутривенной инфузии дозу препарата необходимо уменьшать постепенно для предотвращения развития синдрома "отмены" (повторного снижения АД).
Высшие дозы при внутримышечном и подкожном введении: разовая - 10 мг суточная - 50 мг. Высшая доза при внутривенном введении: разовая - 5 мг суточная - 25 мг.
Несовместимость
Препарат нельзя смешивать с другими лекарственными средствами в одной емкости.
Побочное действие
По данным Всемирной организации здравоохранения нежелательные эффекты классифицированы в соответствии с их частотой развития следующим образом: очень часто (>10% назначений); часто (>1% и <10%); нечасто (>01% и <1%); редко (>001% и <01%); очень редко (<001 %); частота неизвестна (недостаточно данных для оценки частоты развития).
Со стороны сердечно-сосудистой системы: редко - повышение или снижение артериального давления ощущение сердцебиения брадикардия тахикардия желудочковые аритмии (особенно при применении в высоких дозах) стенокардия частота неизвестна - отек легких остановка сердца.
Со стороны центральной нервной системы: очень редко - бессонница нервозность тремор тревога повышенная возбудимость спутанность сознания раздражительность и головная боль головокружение кровоизлияние в мозг парестезия слабость.
Со стороны органа зрения: очень редко - боль в глазах мидриаз.
Со стороны мочевыделительной системы: очень редко - дизурия задержка мочи.
Со стороны пищеварительной системы: часто - тошнота рвота частота неизвестна - повышенное слюноотделение.
Со стороны дыхательной системы: редко - диспноэ.
Аллергические реакции: редко - кожная сыпь крапивница.
Прочие: бледность кожи лица ощущение покалывания и похолодания конечностей повышенное потоотделение гипергликемия.
В отдельных случаях возможны некроз и образование струпа при попадании в ткани или при подкожных инъекциях.
Передозировка
Симптомы: головная боль значительное повышение артериального давления рефлекторная брадикардия желудочковая экстрасистолия короткие пароксизмы желудочковой тахикардии ощущение тяжести в голове и конечностях. При значительной передозировке могут возникать спутанность сознания галлюцинации и судороги.
Лечение: внутривенное введение альфа-адреноблокаторов короткого действия (фентоламин в дозе 5-60 мг внутривенно в течение 10-30 минут) и бета-адреноблокаторов (при нарушениях сердечного ритма).
Взаимодействие с другими лекарственными средствами
Фенилэфрин снижает антигипертензивный эффект диуретиков и гипотензивных средств бета-адреноблокаторов (риск развития артериальной гипертензии и нарушений со стороны сердечно-сосудистой системы).
Нейролептики производные фенотиазида снижают гипертензивный эффект препарата. Ингибиторы МАО окситоцин алкалоиды спорыньи трициклические антидепрессанты метилфенидат адреномиметики усиливают прессорный эффект и аритмогенное действие фенилэфрина.
Бета-адреноблокаторы уменьшают кардиостимулирующую активность препарата. Применение препарата на фоне предшествующего применения резерпина может вызвать развитие гипертонического криза вследствие истощения запасов катехоламинов в адренергических окончаниях и повышение чувствительности к адреномиметикам. Ингаляционные анестетики (в том числе хлороформ энфлуран галотан изофлуран метоксифлуран) увеличивают риск возникновения тяжелых предсердных и желудочковых аритмий (в т.ч. фибрилляции желудочков) поскольку резко повышают чувствительность миокарда к симпатомиметикам. Эргометрин эрготамин метилэргометрин окситоцин доксапрам увеличивают выраженность вазоконстрикторного эффекта.
Фенилэфрин снижает антиангинальный эффект нитратов которые в свою очередь могут снижать прессорный эффект Мезатона и риск возникновения артериальной гипотензии (одновременное применение допускается в зависимости от достижения необходимого терапевтического эффекта).
Тиреоидные гормоны увеличивают (взаимно) эффективность препарата и связанный с ним риск возникновения коронарной недостаточности (особенно при коронарном атеросклерозе).
Прессорный эффект фенилэфрина гидрохлорида повышается у пациентов получающих трициклические антидепрессанты.
Фенилэфрин при одновременном применении с дигоксином или другими сердечными гликозидами повышает риск развития нарушений сердечного ритма и инфаркта миокарда. Применение препарата Мезатон во время родов для коррекции артериальной гипотензии на фоне применения средств стимулирующих родовую деятельность (вазопрессина эрготамина эргометрина метилэргометрина) может стать причиной стойкого повышения АД в послеродовом периоде.
Особые указания
Во время лечения следует контролировать показатели электрокардиограммы АД минутного объема крови кровообращение в конечностях и в месте инъекции.
У пациентов с артериальной гипертензией в случае медикаментозного коллапса достаточно поддерживать систолическое АД на уровне ниже обычного на 30- 40 мм рт.ст. Резкое повышение АД выраженная брадикардия или тахикардия стойкие нарушения ритма сердца требуют прекращения лечения.
Перед началом или во время терапии шока обязательна коррекция гиповолемии гипоксии ацидоза и гиперкапнии.
Препарат применяют с осторожностью при артериальной гипертензии в малом круге кровообращения гиповолемии желудочковой аритмии.
В пожилом возрасте снижается количество адренорецепторов чувствительных к фенилэфрину.
Влияние на способность управлять автомобилем и движущимися механизмами
В период лечения необходимо воздержаться от управления транспортными средствами и занятий потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Раствор для инъекций 10 мг/мл.
Условия хранения
В защищенном от света месте при температуре не выше 25 °С.
Для описания товара использована информация от партнера 36.6
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альфа1-адреностимулятор незначительно влияющий на бета-адренорецепторы сердца; не является катехоламином поскольку содержит лишь одну гидроксильную группу в ароматическом ядре. Вызывает сужение артериол и повышение артериального давления (АД) (с возможной рефлекторной брадикардией) но действует продолжительнее поскольку меньше склонен к действию катехол-о-метилтрансферазы."}},{"type":"paragraph","data":{"text":"Не вызывает увеличения минутного объема крови."}},{"type":"paragraph","data":{"text":"После внутривенного введения действие препарата развивается сразу и продолжается в течение 5-20 мин. При подкожном и внутримышечном введении действие препарата начинается через 10-15 мин и продолжается в течение 1-2 ч после введения."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"После внутримышечного введения быстро всасывается в системный кровоток. Объем распределения после однократного введения составляет 340 л. Связь с белками плазмы крови низкая. Практически полностью метаболизируется в печени моноаминоксидазой (без участия катехол-о-метилтрансферазы). Конечный период полувыведения составляет около 3 часов. Выводится почками в виде метаболитов."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"- Острая артериальная гипотензия;"}},{"type":"paragraph","data":{"text":"- Сосудистая недостаточность при передозировке вазодилататорами;"}},{"type":"paragraph","data":{"text":"- Шок (травматический токсический);"}},{"type":"paragraph","data":{"text":"- Как вазоконстриктор при проведении местной анестезии."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- Повышенная чувствительность к любому из компонентов препарата;"}},{"type":"paragraph","data":{"text":"- Заболевания сопровождающиеся обструкцией выносящего тракта левого желудочка (тяжелый аортальный стеноз гипертрофическая кардиомиопатия);"}},{"type":"paragraph","data":{"text":"- Феохромоцитома;"}},{"type":"paragraph","data":{"text":"- Артериальная гипертензия любой степени тяжести;"}},{"type":"paragraph","data":{"text":"- Фибрилляция желудочков;"}},{"type":"paragraph","data":{"text":"- Дефицит глюкозо-6-фосфатдегидрогеназы;"}},{"type":"paragraph","data":{"text":"- Порфирия;"}},{"type":"paragraph","data":{"text":"- Тиреотоксикоз;"}},{"type":"paragraph","data":{"text":"- Закрытоугольная глаукома;"}},{"type":"paragraph","data":{"text":"- Острый инфаркт миокарда;"}},{"type":"paragraph","data":{"text":"- Применение одновременно с ингибиторами моноаминооксидазы (МАО) и в течение 14 дней после прекращения терапии ингибиторами МАО;"}},{"type":"paragraph","data":{"text":"- Галотановый или циклопропановый наркоз;"}},{"type":"paragraph","data":{"text":"- Беременность и период грудного вскармливания;"}},{"type":"paragraph","data":{"text":"- Возраст до 18 лет."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Ишемическая болезнь сердца (особенно после недавно перенесенного инфаркта миокарда) стенокардия тромбоз коронарный брыжеечных и других висцеральных или периферических сосудов сахарный диабет легочная гипертензия желудочковые аритмии окклюзивные заболевания сосудов: артериальная тромбоэмболия атеросклероз облитерирующий тромбангиит (болезнь Бюргера) болезнь Рейно склонность сосудов к спазмам при отморожении диабетический эндартериит дисфункция щитовидной железы метаболический ацидоз гиперкапния гипоксия пожилой возраст нарушения функции почек и/или печени применение у пациентов с заболеваниями предстательной железы у которых существует повышенный риск задержки мочи."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Адекватных и строго контролируемых исследований применения препарата во время беременности и в период грудного вскармливания не проводилось."}},{"type":"paragraph","data":{"text":"У животных на поздних сроках беременности фенилэфрин вызывал задержку роста плода и стимулировал ранее начало родов."}},{"type":"paragraph","data":{"text":"Применение препарата Мезатон во время беременности и в период грудного вскармливания противопоказано."}},{"type":"paragraph","data":{"text":"Данные о выделении фенилэфрина в грудное молоко отсутствуют."}},{"type":"paragraph","data":{"text":"При необходимости применения препарата в период лактации грудное вскармливание необходимо прекратить."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Мезатон вводят внутривенно подкожно или внутримышечно."}},{"type":"paragraph","data":{"text":"При коллапсе разовая доза при внутривенном введении составляет 01 -05 мл 1 % раствора препарата Мезатон."}},{"type":"paragraph","data":{"text":"При внутривенном введении разовую дозу разводят в 20 мл 5 % раствора декстрозы (глюкозы) или 09 % раствора натрия хлорида и вводят струйно медленно. При необходимости (если систолическое АД снижается до 70-80 мм рт.ст.) введение повторяют. Интервал между повторными внутривенными введениями препарата должен составлять не менее 15 минут."}},{"type":"paragraph","data":{"text":"Препарат разрешается вводить внутривенно капельно для чего 1 мл 1 % раствора препарата Мезатон разводят в 250-500 мл 5 % раствора декстрозы (глюкозы). Начальная скорость введения составляет 180 мкг в минуту; в дальнейшем скорость введения уменьшают до 30-60 мкг в минуту."}},{"type":"paragraph","data":{"text":"При внутримышечном и подкожном введении разовая доза составляет 03-10 мл 1 % раствора препарата Мезатон."}},{"type":"paragraph","data":{"text":"При местной анестезии добавляют по 03-05 мл 1 % раствора препарата Мезатон на 10 мл раствора анестетика."}},{"type":"paragraph","data":{"text":"После продолжительной внутривенной инфузии дозу препарата необходимо уменьшать постепенно для предотвращения развития синдрома \"отмены\" (повторного снижения АД)."}},{"type":"paragraph","data":{"text":"Высшие дозы при внутримышечном и подкожном введении: разовая - 10 мг суточная - 50 мг. Высшая доза при внутривенном введении: разовая - 5 мг суточная - 25 мг."}},{"type":"paragraph","data":{"text":"Несовместимость"}},{"type":"paragraph","data":{"text":"Препарат нельзя смешивать с другими лекарственными средствами в одной емкости."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"По данным Всемирной организации здравоохранения нежелательные эффекты классифицированы в соответствии с их частотой развития следующим образом: очень часто (>10% назначений); часто (>1% и <10%); нечасто (>01% и <1%); редко (>001% и <01%); очень редко (<001 %); частота неизвестна (недостаточно данных для оценки частоты развития)."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: редко - повышение или снижение артериального давления ощущение сердцебиения брадикардия тахикардия желудочковые аритмии (особенно при применении в высоких дозах) стенокардия частота неизвестна - отек легких остановка сердца."}},{"type":"paragraph","data":{"text":"Со стороны центральной нервной системы: очень редко - бессонница нервозность тремор тревога повышенная возбудимость спутанность сознания раздражительность и головная боль головокружение кровоизлияние в мозг парестезия слабость."}},{"type":"paragraph","data":{"text":"Со стороны органа зрения: очень редко - боль в глазах мидриаз."}},{"type":"paragraph","data":{"text":"Со стороны мочевыделительной системы: очень редко - дизурия задержка мочи."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: часто - тошнота рвота частота неизвестна - повышенное слюноотделение."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: редко - диспноэ."}},{"type":"paragraph","data":{"text":"Аллергические реакции: редко - кожная сыпь крапивница."}},{"type":"paragraph","data":{"text":"Прочие: бледность кожи лица ощущение покалывания и похолодания конечностей повышенное потоотделение гипергликемия."}},{"type":"paragraph","data":{"text":"В отдельных случаях возможны некроз и образование струпа при попадании в ткани или при подкожных инъекциях."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: головная боль значительное повышение артериального давления рефлекторная брадикардия желудочковая экстрасистолия короткие пароксизмы желудочковой тахикардии ощущение тяжести в голове и конечностях. При значительной передозировке могут возникать спутанность сознания галлюцинации и судороги."}},{"type":"paragraph","data":{"text":"Лечение: внутривенное введение альфа-адреноблокаторов короткого действия (фентоламин в дозе 5-60 мг внутривенно в течение 10-30 минут) и бета-адреноблокаторов (при нарушениях сердечного ритма)."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Фенилэфрин снижает антигипертензивный эффект диуретиков и гипотензивных средств бета-адреноблокаторов (риск развития артериальной гипертензии и нарушений со стороны сердечно-сосудистой системы)."}},{"type":"paragraph","data":{"text":"Нейролептики производные фенотиазида снижают гипертензивный эффект препарата. Ингибиторы МАО окситоцин алкалоиды спорыньи трициклические антидепрессанты метилфенидат адреномиметики усиливают прессорный эффект и аритмогенное действие фенилэфрина."}},{"type":"paragraph","data":{"text":"Бета-адреноблокаторы уменьшают кардиостимулирующую активность препарата. Применение препарата на фоне предшествующего применения резерпина может вызвать развитие гипертонического криза вследствие истощения запасов катехоламинов в адренергических окончаниях и повышение чувствительности к адреномиметикам. Ингаляционные анестетики (в том числе хлороформ энфлуран галотан изофлуран метоксифлуран) увеличивают риск возникновения тяжелых предсердных и желудочковых аритмий (в т.ч. фибрилляции желудочков) поскольку резко повышают чувствительность миокарда к симпатомиметикам. Эргометрин эрготамин метилэргометрин окситоцин доксапрам увеличивают выраженность вазоконстрикторного эффекта."}},{"type":"paragraph","data":{"text":"Фенилэфрин снижает антиангинальный эффект нитратов которые в свою очередь могут снижать прессорный эффект Мезатона и риск возникновения артериальной гипотензии (одновременное применение допускается в зависимости от достижения необходимого терапевтического эффекта)."}},{"type":"paragraph","data":{"text":"Тиреоидные гормоны увеличивают (взаимно) эффективность препарата и связанный с ним риск возникновения коронарной недостаточности (особенно при коронарном атеросклерозе)."}},{"type":"paragraph","data":{"text":"Прессорный эффект фенилэфрина гидрохлорида повышается у пациентов получающих трициклические антидепрессанты."}},{"type":"paragraph","data":{"text":"Фенилэфрин при одновременном применении с дигоксином или другими сердечными гликозидами повышает риск развития нарушений сердечного ритма и инфаркта миокарда. Применение препарата Мезатон во время родов для коррекции артериальной гипотензии на фоне применения средств стимулирующих родовую деятельность (вазопрессина эрготамина эргометрина метилэргометрина) может стать причиной стойкого повышения АД в послеродовом периоде."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Во время лечения следует контролировать показатели электрокардиограммы АД минутного объема крови кровообращение в конечностях и в месте инъекции."}},{"type":"paragraph","data":{"text":"У пациентов с артериальной гипертензией в случае медикаментозного коллапса достаточно поддерживать систолическое АД на уровне ниже обычного на 30- 40 мм рт.ст. Резкое повышение АД выраженная брадикардия или тахикардия стойкие нарушения ритма сердца требуют прекращения лечения."}},{"type":"paragraph","data":{"text":"Перед началом или во время терапии шока обязательна коррекция гиповолемии гипоксии ацидоза и гиперкапнии."}},{"type":"paragraph","data":{"text":"Препарат применяют с осторожностью при артериальной гипертензии в малом круге кровообращения гиповолемии желудочковой аритмии."}},{"type":"paragraph","data":{"text":"В пожилом возрасте снижается количество адренорецепторов чувствительных к фенилэфрину."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В период лечения необходимо воздержаться от управления транспортными средствами и занятий потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для инъекций 10 мг/мл."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от света месте 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":"3 года."}},{"type":"paragraph","data":{"text":"Не применять по истечении срока годности."}}]},{"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":"\u003ca href=\"https://www.vidal.ru/drugs/firm/769\"\u003eОПЫТНЫЙ ЗАВОД ГНЦЛС ДП УКРМЕДПРОМ, ГАК\u003c/a\u003e (Украина) "}}]}],"source":null},"description_toggle":false,"short_description":"Фенилэфрин - альфа1-адреностимулятор незначительно влияющий на бета-адренорецепторы сердца; не является катехоламином поскольку содержит лишь одну гидроксильную группу в ароматическом ядре. Вызывает сужение артериол и повышение артериального давления (АД) (с возможной рефлекторной брадикардией) но действует продолжительнее поскольку меньше склонен к действию катехол-о-метилтрансферазы. Не вызывает увеличения минутного объема крови. После внутривенного введения действие препарата развивается сразу и продолжается в течение 5-20 мин. При подкожном и внутримышечном введении действие препарата начинается через 10-15 мин и продолжается в течение 1-2 ч после введения. После внутримышечного введения быстро всасывается в системный кровоток. Объем распределения после однократного введения составляет 340 л. Связь с белками плазмы крови низкая. Практически полностью метаболизируется в печени моноаминоксидазой (без участия катехол-о-метилтрансферазы). Конечный период полувыведения составляет около 3 часов. 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