Повышенная индивидуальная чувствительность к компонентам препарата и
другим азолам; беременность (I триместр); период грудного вскармливания;
органические поражения центральной нервной системы (в т.ч. эпилепсия);
порфирия; тяжелые нарушения функции печени; детский возраст до 18 лет; девственницы.
вспомогательные вещества (основа для
суппозиториев):
полусинтетические глицериды (Суппоцир АМ) 1400 мг.
Описание
Белые или белые с желтоватым оттенком суппозитории торпедообразной
формы. На срезе допускается наличие воздушного стержня или воронкообразного
углубления.
Фармакотерапевтическая группа
Противомикробное средство комбинированное (противомикробное и
противопротозойное средство + противогрибковое средство).
Фармакологические свойства
Фармакодинамика. Метронидазол относится к 5-нитроимидазолам и
является препаратом с бактерицидным типом действия, проявляющим тропность
(способность взаимодействия) к дезоксирибонуклеиновой кислоте.
Механизм действия заключается в биохимическом
восстановлении 5-нитрогруппы метронидазола внутриклеточными транспортными
протеинами анаэробных микроорганизмов и простейших. Восстановленная
5-нитрогруппа метронидазола взаимодействует с дезоксирибонуклеиновой кислотой
клетки микроорганизмов, ингибируя синтез их нуклеиновых кислот, что ведет к
гибели бактерий. Активен в отношении простейших: Trichomonas vaginalis,
Entamoeba histolytica, а также облигатных анаэробных бактерий:
грамотрицательных – Bacteroides spp. (в том числе
Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides
thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp.,
Prevotella spp. (Prevotella bivia, Prevotella buccae, Prevotella disiens), грамположительных –
Clostridium spp., Eubacterium spp., Peptococcus spp., Peptostreptococcus
spp., Mobiluncus spp. и факультативного анаэроба – Gardnerella vaginalis.
К метронидазолу нечувствительны аэробные
микроорганизмы, но в присутствии смешанной флоры (аэробы и анаэробы)
метронидазол действует синергично с антибиотиками, эффективными против обычных
аэробов.
Миконазол является противогрибковым средством, производным азола. При
интравагинальном применении активен в основном в отношении Candida
albicans. Фунгицидный и
фунгистатический эффект миконазола обусловлен ингибированием биосинтеза
эргостерола оболочки и плазматических мембран грибов, изменением липидного
состава и проницаемости клеточной стенки, вызывая гибель клетки гриба.
Фармакокинетика. По сравнению с приемом внутрь биодоступность
метронидазола при интравагинальном введении составляет 20 %. Метронидазол
метаболизируется в печени. Гидроксильные метаболиты активны. Период
полувыведения метронидазола составляет 6 - 11 ч. Около 20 % дозы выводится в
неизменном виде с мочой.
При интравагинальном введении миконазол всасывается незначительно и в
плазме не определяется.
Повышенная индивидуальная чувствительность к компонентам препарата и
другим азолам; беременность (I триместр); период грудного вскармливания;
органические поражения центральной нервной системы (в т.ч. эпилепсия);
порфирия; тяжелые нарушения функции печени; детский возраст до 18 лет; девственницы.
Применение при беременности и в период грудного вскармливания
Назначение препарата противопоказано в I триместре беременности.
Применение во II и III триместрах беременности возможно только в том случае,
если потенциальная польза для матери превышает возможный риск для плода.
При необходимости назначения препарата в период лактации грудное
вскармливание должно быть прекращено, так как метронидазол проникает в грудное
молоко. Грудное вскармливание можно возобновить через 24 - 48 ч после окончания
лечения.
Способ применения и дозы
Интравагинально.
Предварительно освободив суппозиторий от контурной упаковки при помощи
ножниц (разрезать пленку по контуру суппозитория), ввести его глубоко во
влагалище.
По 1 суппозиторию утром и на ночь в течение 7 дней. При рецидивирующих
вагинитах или вагинитах резистентных к другим видам лечения, применять в
течение 14 дней.
Побочное действие
Местные реакции: жжение,
зуд, раздражение слизистой оболочки влагалища и усиление отечности. Из-за
воспаления слизистой оболочки влагалища при вагините раздражение может
усиливаться после введения первого суппозитория или к третьему дню лечения. Эти
осложнения быстро исчезают после прекращения лечения.
Со стороны желудочно-кишечного тракта: боль или спазмы в животе, «металлический»
привкус, сухость во рту, запор, диарея, потеря аппетита, тошнота, рвота.
Со стороны нервной системы: головная боль, двигательные нарушения (атаксия), головокружение,
психоэмоциональные нарушения (тревожность, лабильность настроения, повышенная
утомляемость), судороги.
Со стороны системы кроветворения: лейкопения.
Аллергические реакции: кожные высыпания, в том числе крапивница.
Передозировка
При соблюдении рекомендуемых доз, в связи с низкой абсорбцией препарата,
случаи передозировки не выявлены.
Возможные симптомы: тошнота, рвота, боль в животе, диарея, зуд,
металлический привкус во рту, атаксия, головокружение, парестезии,
периферическая невропатия (при продолжительном применении в высоких дозах),
судороги, лейкопения, темное окрашивание мочи (обусловлено передозировкой
метронидазола).
Симптомы передозировки миконазола не выявлены.
Лечение:
симптоматическая и поддерживающая терапия, при случайном приеме внутрь -
промывание желудка.
Взаимодействие с другими лекарственными средствами
В связи с попаданием
метронидазола в системный кровоток могут отмечать следующие реакции
взаимодействия при одновременном применении с некоторыми веществами:
Пероральные антикоагулянты: усиливается действие
непрямых антикоагулянтов.
Дисульфирам: могут
наблюдаться нарушения со стороны ЦНС (психические реакции); не следует
назначать метронидазол больным, которые принимали дисульфирам в течение
последних 2 недель;
Фенитоин: повышается
концентрация фенитоина в крови; а концентрация метронидазола в крови снижается.
Препараты лития: может
наблюдаться повышение их токсичности.
Фенобарбитал: снижается
концентрация метронидазола в крови.
Циметидин: может
повыситься концентрация метронидазола в крови.
Астемизол и терфенадин: метронидазол и миконазол ингибируют метаболизм этих препаратов и
повышают концентрацию в плазме крови.
Этанол:
взаимодействие метронидазола с этанолом вызывает дисульфирамоподобные реакции.
Особые указания
При применении препарата следует воздерживаться от половых контактов.
С целью избежания повторного инфицирования необходимо одновременное
лечение полового партнера. В случае трихомонадного вагинита целесообразно
одновременное лечение полового партнера метронидазолом для приема внутрь.
Во время лечения и, по крайней мере, в течение 24-48 ч после окончания
курса лечения следует избегать приема этанола (возможна непереносимость
этанола).
Не рекомендуется одновременное применение препарата с контрацептивными
диафрагмами и презервативами из каучука или латекса (возможно взаимодействие с
основой суппозиториев).
При сильном раздражении влагалища лечение препаратом следует прекратить.
Суппозитории следует применять только интравагинально, их нельзя
проглатывать или применять другим способом.
В случае применения препарата совместно с метронидазолом для приема
внутрь, особенно при повторном курсе, необходим контроль картины периферической
крови (опасность лейкопении).
Влияние на способность управлять автомобилем и движущимися механизмами
Применение препарата не влияет на способность
управлять транспортными средствами и заниматься другими потенциально опасными
видами деятельности, требующими повышенной концентрации внимания и быстроты
психомоторных реакций, однако при появлении побочных эффектов со стороны
центральной нервной системы, следует воздержаться от управления транспортными
средствами и занятий другими потенциально опасными видами деятельности,
требующими повышенной концентрации внимания и быстроты психомоторных реакций.
По 7 суппозиториев в контурную ячейковую упаковку из ПВХ/ПЭ пленки.
По 2 контурные ячейковые упаковки вместе с инструкцией по применению в
пачку картонную.
Условия хранения
В защищенном от света месте при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
3 года.
Не использовать после истечения срока годности.
Условия отпуска
Отпускают по рецепту.
Производитель
ООО «ФАРМАПРИМ»
МD-4829, Республика Молдова, р-он Криулень,
с. Порумбень, ул. Кринилор, д. 5.
Организация, принимающая претензии потребителей
ООО «Авексима Сибирь»
652473, Россия, Кемеровская обл.,
г. Анжеро-Судженск, ул. Герцена, д. 7.
Тел./факс: (38453)
5-23-51.
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"}}]},{"id":9,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"МЕТРОМИКОН-НЕО"}}]},{"id":10,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"суппозитории вагинальные "}}]},{"id":1,"name":"Состав","slug":"ingredients","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Один суппозиторий содержит:"}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eдействующие вещества:\u003c/i\u003e\u003c/b\u003e метронидазол "}},{"type":"paragraph","data":{"text":"500 мг, миконазола нитрат 100 мг;"}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eвспомогательные вещества (основа для\nсуппозиториев):\u003c/i\u003e\u003c/b\u003e\nполусинтетические глицериды (Суппоцир АМ) 1400 мг."}}]},{"id":11,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Белые или белые с желтоватым оттенком суппозитории торпедообразной\nформы. На срезе допускается наличие воздушного стержня или воронкообразного\nуглубления. "}}]},{"id":12,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Противомикробное средство комбинированное (противомикробное и\nпротивопротозойное средство + противогрибковое средство). "}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eФармакодинамика.\u003c/i\u003e\u003c/b\u003e Метронидазол относится к 5-нитроимидазолам и\nявляется препаратом с бактерицидным типом действия, проявляющим тропность\n(способность взаимодействия) к дезоксирибонуклеиновой кислоте. "}},{"type":"paragraph","data":{"text":"Механизм действия заключается в биохимическом\nвосстановлении 5-нитрогруппы метронидазола внутриклеточными транспортными\nпротеинами анаэробных микроорганизмов и простейших. Восстановленная\n5-нитрогруппа метронидазола взаимодействует с дезоксирибонуклеиновой кислотой\nклетки микроорганизмов, ингибируя синтез их нуклеиновых кислот, что ведет к\nгибели бактерий. Активен в отношении простейших: \u003ci\u003eTrichomonas vaginalis,\nEntamoeba histolytica,\u003c/i\u003e а также облигатных анаэробных бактерий:\nграмотрицательных –\u003ci\u003e Bacteroides spp. \u003c/i\u003e(в том числе\u003ci\u003e\nBacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides\nthetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp.,\nPrevotella spp. (Prevotella bivia, Prevotella buccae, Prevotella disiens), \u003c/i\u003eграмположительных –\n\u003ci\u003eClostridium spp., Eubacterium spp., Peptococcus spp., Peptostreptococcus\nspp., Mobiluncus spp. \u003c/i\u003eи факультативного анаэроба \u003ci\u003e– Gardnerella vaginalis.\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"К метронидазолу нечувствительны аэробные\nмикроорганизмы, но в присутствии смешанной флоры (аэробы и анаэробы)\nметронидазол действует синергично с антибиотиками, эффективными против обычных\nаэробов. "}},{"type":"paragraph","data":{"text":"Миконазол является противогрибковым средством, производным азола. При\nинтравагинальном применении активен в основном в отношении \u003ci\u003eCandida\nalbicans. \u003c/i\u003eФунгицидный и\nфунгистатический эффект миконазола обусловлен ингибированием биосинтеза\nэргостерола оболочки и плазматических мембран грибов, изменением липидного\nсостава и проницаемости клеточной стенки, вызывая гибель клетки гриба. "}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eФармакокинетика.\u003c/i\u003e\u003c/b\u003e По сравнению с приемом внутрь биодоступность\nметронидазола при интравагинальном введении составляет 20 %. Метронидазол\nметаболизируется в печени. Гидроксильные метаболиты активны. Период\nполувыведения метронидазола составляет 6 - 11 ч. Около 20 % дозы выводится в\nнеизменном виде с мочой. "}},{"type":"paragraph","data":{"text":"При интравагинальном введении миконазол всасывается незначительно и в\nплазме не определяется. "}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Вагинальный кандидоз, бактериальный вагиноз, трихомонадный вагинит,\nвагиниты, вызванные смешанными инфекциями."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная индивидуальная чувствительность к компонентам препарата и\nдругим азолам; беременность (I триместр); период грудного вскармливания;\nорганические поражения центральной нервной системы (в т.ч. эпилепсия);\nпорфирия; тяжелые нарушения функции печени; детский возраст до 18 лет; девственницы."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Назначение препарата противопоказано в I триместре беременности.\nПрименение во II и III триместрах беременности возможно только в том случае,\nесли потенциальная польза для матери превышает возможный риск для плода. "}},{"type":"paragraph","data":{"text":"При необходимости назначения препарата в период лактации грудное\nвскармливание должно быть прекращено, так как метронидазол проникает в грудное\nмолоко. Грудное вскармливание можно возобновить через 24 - 48 ч после окончания\nлечения. "}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Интравагинально."}},{"type":"paragraph","data":{"text":"Предварительно освободив суппозиторий от контурной упаковки при помощи\nножниц (разрезать пленку по контуру суппозитория), ввести его глубоко во\nвлагалище."}},{"type":"paragraph","data":{"text":"По 1 суппозиторию утром и на ночь в течение 7 дней. При рецидивирующих\nвагинитах или вагинитах резистентных к другим видам лечения, применять в\nтечение 14 дней."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"\u003ci\u003eМестные реакции: \u003c/i\u003eжжение,\nзуд, раздражение слизистой оболочки влагалища и усиление отечности. Из-за\nвоспаления слизистой оболочки влагалища при вагините раздражение может\nусиливаться после введения первого суппозитория или к третьему дню лечения. Эти\nосложнения быстро исчезают после прекращения лечения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны желудочно-кишечного тракта: \u003c/i\u003eболь или спазмы в животе, «металлический»\nпривкус, сухость во рту, запор, диарея, потеря аппетита, тошнота, рвота."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы:\u003c/i\u003e головная боль, двигательные нарушения (атаксия), головокружение,\nпсихоэмоциональные нарушения (тревожность, лабильность настроения, повышенная\nутомляемость), судороги."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны системы кроветворения:\u003c/i\u003e лейкопения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e кожные высыпания, в том числе крапивница.\u003cb\u003e\u003c/b\u003e"}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"При соблюдении рекомендуемых доз, в связи с низкой абсорбцией препарата,\nслучаи передозировки не выявлены. "}},{"type":"paragraph","data":{"text":"Возможные \u003ci\u003eсимптомы:\u003c/i\u003e тошнота, рвота, боль в животе, диарея, зуд,\nметаллический привкус во рту, атаксия, головокружение, парестезии,\nпериферическая невропатия (при продолжительном применении в высоких дозах),\nсудороги, лейкопения, темное окрашивание мочи (обусловлено передозировкой\nметронидазола)."}},{"type":"paragraph","data":{"text":"Симптомы передозировки миконазола не выявлены. "}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e\nсимптоматическая и поддерживающая терапия, при случайном приеме внутрь -\nпромывание желудка. "}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"В связи с попаданием\nметронидазола в системный кровоток могут отмечать следующие реакции\nвзаимодействия при одновременном применении с некоторыми веществами: "}},{"type":"paragraph","data":{"text":"\u003ci\u003eПероральные антикоагулянты:\u003c/i\u003e усиливается действие\nнепрямых антикоагулянтов. "}},{"type":"paragraph","data":{"text":"\u003ci\u003eДисульфирам:\u003c/i\u003e могут\nнаблюдаться нарушения со стороны ЦНС (психические реакции); не следует\nназначать метронидазол больным, которые принимали дисульфирам в течение\nпоследних 2 недель; "}},{"type":"paragraph","data":{"text":"\u003ci\u003eФенитоин:\u003c/i\u003e повышается\nконцентрация фенитоина в крови; а концентрация метронидазола в крови снижается.\n"}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрепараты лития:\u003c/i\u003e может\nнаблюдаться повышение их токсичности. "}},{"type":"paragraph","data":{"text":"\u003ci\u003eФенобарбитал:\u003c/i\u003e снижается\nконцентрация метронидазола в крови. "}},{"type":"paragraph","data":{"text":"\u003ci\u003eЦиметидин:\u003c/i\u003e может\nповыситься концентрация метронидазола в крови. "}},{"type":"paragraph","data":{"text":"\u003ci\u003eАстемизол и терфенадин\u003c/i\u003e: метронидазол и миконазол ингибируют метаболизм этих препаратов и\nповышают концентрацию в плазме крови. "}},{"type":"paragraph","data":{"text":"\u003ci\u003eЭтанол:\u003c/i\u003e\nвзаимодействие метронидазола с этанолом вызывает дисульфирамоподобные реакции. "}}]},{"id":8,"name":"Особые указания","slug":"","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При применении препарата следует воздерживаться от половых контактов. "}},{"type":"paragraph","data":{"text":"С целью избежания повторного инфицирования необходимо одновременное\nлечение полового партнера. В случае трихомонадного вагинита целесообразно\nодновременное лечение полового партнера метронидазолом для приема внутрь. "}},{"type":"paragraph","data":{"text":"Во время лечения и, по крайней мере, в течение 24-48 ч после окончания\nкурса лечения следует избегать приема этанола (возможна непереносимость\nэтанола)."}},{"type":"paragraph","data":{"text":"Не рекомендуется одновременное применение препарата с контрацептивными\nдиафрагмами и презервативами из каучука или латекса (возможно взаимодействие с\nосновой суппозиториев). "}},{"type":"paragraph","data":{"text":"При сильном раздражении влагалища лечение препаратом следует прекратить.\n"}},{"type":"paragraph","data":{"text":"Суппозитории следует применять только интравагинально, их нельзя\nпроглатывать или применять другим способом. "}},{"type":"paragraph","data":{"text":"В случае применения препарата совместно с метронидазолом для приема\nвнутрь, особенно при повторном курсе, необходим контроль картины периферической\nкрови (опасность лейкопении). "}}]},{"id":16,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Применение препарата не влияет на способность\nуправлять транспортными средствами и заниматься другими потенциально опасными\nвидами деятельности, требующими повышенной концентрации внимания и быстроты\nпсихомоторных реакций, однако при появлении побочных эффектов со стороны\nцентральной нервной системы, следует воздержаться от управления транспортными\nсредствами и занятий другими потенциально опасными видами деятельности,\nтребующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":17,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Суппозитории вагинальные содержащие метронидазол 500 мг и миконазола\nнитрат 100 мг. "}},{"type":"paragraph","data":{"text":"По 7 суппозиториев в контурную ячейковую упаковку из ПВХ/ПЭ пленки. "}},{"type":"paragraph","data":{"text":"По 2 контурные ячейковые упаковки вместе с инструкцией по применению в\nпачку картонную. "}}]},{"id":18,"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":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года. "}},{"type":"paragraph","data":{"text":"Не использовать после истечения срока годности. "}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Отпускают по рецепту. "}}]},{"id":21,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"ООО «ФАРМАПРИМ»"}},{"type":"paragraph","data":{"text":"МD-4829, Республика Молдова, р-он Криулень,"}},{"type":"paragraph","data":{"text":"с. Порумбень, ул. 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