В данной статье можно ознакомиться с инструкцией по применению лекарственного препарата Флагил. Представлены отзывы посетителей сайта — потребителей данного лекарства, а также мнения врачей специалистов по использованию Флагила в своей практике. Большая просьба активнее добавлять свои отзывы о препарате: помогло или не помогло лекарство избавиться от заболевания, какие наблюдались осложнения и побочные эффекты, возможно не заявленные производителем в аннотации. Аналоги антибиотика Флагила при наличии имеющихся структурных аналогов. Использование для лечения трихомониаза, лямблиоза и других инфекций у взрослых, детей, а также при беременности и кормлении грудью. Состав и взаимодействие препарата с алкоголем.
Флагил — относится к нитро-5-имидазолам. Механизм действия метронидазола (действующее вещество препарата Флагил) заключается в биохимическом восстановлении 5-нитрогруппы метронидазола внутриклеточными транспортными протеинами анаэробных микроорганизмов и простейших. Восстановленная 5-нитрогруппа метронидазола взаимодействует с ДНК клетки микроорганизмов, ингибируя синтез их нуклеиновых кислот, что ведет к гибели микроорганизмов. Основной метаболит (2-оксиметронидазол) также оказывает противопротозойное и противомикробное действие.
Метронидазол является эффективным противомикробным и противопротозойным средством широкого спектра действия. Препарат проявляет высокую активность в отношении Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis (лямблия), а также в отношении облигатных анаэробов (споро- и неспорообразующих) — Bacteroides spp . (B.fragilis, B.ovatus, B.distasonis, B.thetaiotaomicron, B.vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Peptococcus spp., чувствительные штаммы Eubacterium.
К метронидазолу не чувствительны аэробные микроорганизмы и факультативные анаэробы.
Состав
Метронидазол + вспомогательные вещества.
Фармакокинетика
При приеме внутрь Флагил быстро и почти полностью всасывается (примерно 80% за 1 ч). Прием пищи не влияет на абсорбцию препарата. Биодоступность составляет примерно 100%. Препарат быстро проникает в ткани (легкие, почки, печень, кожу, желчь, спинномозговую жидкость, слюну, семенную жидкость, вагинальный секрет), в грудное молоко и проходит через плацентарный барьер. Метаболизируется около 30-60% метронидазола путем гидроксилирования, окисления и глюкуронирования. Основной метаболит (2-оксиметронидазол) также оказывает противопротозойное и противомикробное действие. Выведение препарата осуществляется на 40-70% через почки (в неизмененной форме — около 35% от принятой дозы).
Показания
- протозойные инфекции: внекишечный амебиаз, включая амебный абсцесс печени, кишечный амебиаз (амебная дизентерия), трихомониаз, балантидиаз, лямблиоз, кожный лейшманиоз, трихомонадный вагинит, трихомонадный уретрит;
- инфекции, вызываемые Bacteroides spp. (в т.ч. Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus): инфекции костей и суставов, инфекции ЦНС, в т.ч. менингит, абсцесс мозга, бактериальный эндокардит, пневмония, эмпиема и абсцесс легких, сепсис;
- инфекции, вызываемые видами Clostridium spp., Peptococcus и Peptostreptococcus: инфекции брюшной полости (перитонит, абсцесс печени), инфекции органов таза (эндометрит, абсцесс фаллопиевых труб и яичников, инфекции свода влагалища);
- псевдомембранозный колит (связанный с применением антибиотиков);
- гастрит или язва двенадцатиперстной кишки, связанные с Helicobacter pylori (хеликобактер) (комплексная терапия);
- профилактика послеоперационных осложнений (особенно вмешательства на ободочной кишке, параректальной области, аппендэктомия, гинекологические операции).
Формы выпуска
Таблетки, покрытые оболочкой 250 мг.
Свечи вагинальные 500 мг.
Раствор для инфузий 0,5% (уколы в ампулах для инъекций).
Инструкция по применению и дозировка
Внутрь. При амебиазе Флагил применяют внутрь в течение 7 дней по 1.5 г в сутки за 3 приема (взрослые).
Лямблиоз лечат в течение 5 дней: взрослым назначают по 750-1000 мг в сутки, детям 6-10 лет — по 375 мг в сутки (1.5 таблетки) и детям 10-15 лет — по 500 мг в сутки (2 таблетки). Для детей младше 6 лет предпочтительнее использование метронидазола в форме суспензии.
При трихомониазе у женщин (уретрит и вагинит) Флагил назначают однократно в дозе 2 г или в виде курсового лечения в течение 10 дней: по 1 таблетке (250 мг) 2 раза в сутки.
При трихомониазе у мужчин (уретрит) Флагил назначают однократно в дозе 2 г или в виде курсового лечения в течение 10 дней по 1 таблетке (250 мг) 2 раза в сутки.
При неспецифических вагинитах применяют 500 мг Флагила 2 раза в сутки в течение 7 дней.
При лечении анаэробных инфекций взрослым назначают Флагил по 1-1.5 г в сутки.
При выраженных нарушениях функции почек (КК менее 10 мл/мин) рекомендовано уменьшить суточную дозу препарата в 2 раза.
Препарат применяется только у взрослых.
Трихомонадный вагинит: по 1 суппозиторию в сутки во влагалище, в течение 10 дней в сочетании с приемом препарата метронидазол, таблетки внутрь.
Неспецифический вагинит: по 1 суппозиторию 2 раза в сутки в течение 7 дней, при необходимости в сочетании с приемом препарата метронидазол, таблетки внутрь. Обязательно одновременное лечение полового партнера препаратом метронидазол, независимо от того, имеются ли у него проявления заболевания.
Лечение метронидазолом не должно назначаться более чем на 10 дней, и повторяться чаще, чем 2-3 раза в год.
Предварительно освободив суппозиторий от контурной упаковки при помощи ножниц, разрезать пленку по контуру суппозитория и ввести его глубоко во влагалище.
Побочное действие
- тошнота, рвота;
- металлический привкус во рту;
- сухость во рту;
- снижение аппетита;
- глоссит;
- стоматит;
- панкреатит;
- анорексия;
- боли в эпигастрии;
- диарея, запор;
- головная боль;
- головокружение;
- нарушение координации движений;
- спутанность сознания;
- раздражительность;
- депрессии;
- повышенная возбудимость;
- слабость;
- бессонница;
- судороги;
- спутанность сознания;
- галлюцинации;
- периферическая нейропатия (особенно при длительном применении);
- крапивница;
- кожная сыпь;
- гиперемия кожи;
- заложенность носа;
- лихорадка;
- артралгии;
- дизурия;
- полиурия;
- цистит;
- недержание мочи;
- кандидоз;
- возможно окрашивание мочи в коричнево-красноватый цвет;
- нейтропения, лейкопения;
- уплощение зубца Т на ЭКГ.
Противопоказания
- органические поражения ЦНС;
- болезни крови, в т.ч. лейкопения в анамнезе;
- печеночная недостаточность (в случае назначения больших доз);
- беременность;
- грудное вскармливание;
- детский возраст до 6 лет;
- повышенная чувствительность к имидазолам.
Применение при беременности и кормлении грудью
Флагил противопоказан при беременности и лактации (грудном вскармливании).
Применение у детей
Противопоказан детям в возрасте до 6 лет.
Лямблиоз лечат в течение 5 дней: детям 6-10 лет — по 375 мг в сутки (1.5 таблетки) и детям 10-15 лет — по 500 мг в сутки (2 таблетки). Для детей младше 6 лет предпочтительнее использование метронидазола в форме суспензии.
Особые указания
Поскольку одновременный прием препарата с алкоголем может оказывать эффект, аналогичный эффекту дисульфирама (чувство жара, рвота, тахикардия), следует предупредить пациентов о том, что во время лечения Флагилом не следует употреблять алкогольные напитки или лекарства, содержащие алкоголь.
Длительное введение препарата желательно проводить под контролем формулы крови. При лейкопении возможность продолжения лечения зависит от риска развития инфекционного процесса.
При лечении трихомонадного вагинита у женщин и трихомонадного уретрита у мужчин необходимо воздерживаться от половой жизни. Обязательно одновременное лечение половых партнеров. Лечение не прекращается во время менструаций. После терапии трихомониаза следует провести контрольные пробы в течение 3 очередных циклов до и после менструации.
После лечения лямблиоза, если симптомы сохраняются, через 3-4 недели провести 3 анализа кала с интервалами в несколько дней (у некоторых успешно лечившихся больных непереносимость лактозы, вызванная инвазией, может сохраняться в течение нескольких недель или месяцев, напоминая симптомы лямблиоза).
Следует прекратить лечение при появлении атаксии, головокружения, развитии галлюцинаций, при ухудшении неврологического статуса больных.
Необходимо принимать во внимание, что метронидазол может иммобилизовать трепонемы, что приводит к ложноположительному тесту Нельсона.
Влияние на способность к вождению автотранспорта и управлению механизмами
В связи с возможностью появления головокружения и других побочных эффектов, связанных с приемом препарата, рекомендуется воздерживаться от управления автомобилем и другими механизмами.
Лекарственное взаимодействие
Аналогично дисульфираму вызывает непереносимость этанола (алкоголя).
Одновременное применение с дисульфирамом может привести к развитию различных неврологических симптомов (интервал между назначением — не менее 2 недель).
Усиливает действие непрямых, антикоагулянтов, что ведет к увеличению времени образования протромбина.
При одновременном приеме с препаратами лития может повышаться концентрация последнего в плазме.
При одновременном приеме с циклоспорином может повышаться концентрация последнего в плазме.
Циметидин подавляет метаболизм метронидазола, что может привести к повышению его концентрации в сыворотке крови и увеличению риска развития побочных явлений.
Одновременное назначение лекарственных средств, стимулирующих ферменты микросомального окисления в печени (фенобарбитал, фенитоин), может ускорять элиминацию метронидазола, в результате чего понижается его концентрация в плазме.
Метронидазол уменьшает клиренс 5-фторурацила, приводя к увеличению его токсичности.
Метронидазол повышает уровень бусульфана в плазме крови, приводя к увеличению его токсичности (тяжелая форма).
Не рекомендуется сочетать с недеполяризующими миорелаксантами (векурония бромид).
Аналоги лекарственного препарата Флагил
Структурные аналоги по действующему веществу:
- Бацимекс;
- Дефламон;
- Клион;
- Метровагин;
- Метрогил;
- Метроксан;
- Метролакэр;
- Метрон;
- Метронидазол;
- Метронидал;
- Метросептол;
- Орвагил;
- Розамет;
- Розекс;
- Сиптрогил;
- Трихо Пин;
- Трихоброл;
- Трихопол;
- Трихосепт;
- Эфлоран.
Владелец регистрационного удостоверения:
Произведено:
Контакты для обращений:
Лекарственная форма
 |
Флагил ® |
Форма выпуска, упаковка и состав Флагил ®
Суппозитории вагинальные от белого до светло-желтого цвета, торпедообразной формы.
| 1 супп. | |
| метронидазол | 500 мг |
Вспомогательные вещества: жир твердый — 1600 мг.
5 шт. — упаковки ячейковые контурные (2) — пачки картонные.
Фармакологическое действие
Метронидазол относится к нитро-5-имидазолам. Механизм действия метронидазола заключается в биохимическом восстановлении 5-нитрогруппы метронидазола внутриклеточными транспортными протеинами анаэробных микроорганизмов и простейших. Восстановленная 5-нитрогруппа метронидазола взаимодействует с ДНК клетки микроорганизмов, ингибируя синтез их нуклеиновых кислот, что ведет к гибели микроорганизмов.
Метронидазол является эффективным противомикробным и противопротозойным средством широкого спектра действия. Препарат проявляет высокую активность в отношении Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis , а также в отношении облигатных анаэробов (споро- и неспорообразующих) — Bacteroides spp. (B.fragilis, B.ovatus, B.distasonis, B.thetaiotaomicron, B.vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Peptococcus spp., чувствительные штаммы Eubacterium.
К метронидазолу не чувствительны аэробные микроорганизмы и факультативные анаэробы.
Фармакокинетика
Примерно 20% применяемой дозы метронидазола (500 мг) подвергается системному всасыванию, в результате чего концентрация препарата в плазме крови составляет примерно 12% таковой после приема внутрь однократной дозы 500 мг.
T 1/2 (выведение установленное при системном применении при нормальной функции печени) составляет 8-10 ч.
Связь с белками плазмы — менее чем 20%.
Показания препарата Флагил ®
- местное лечение трихомонадного и неспецифического вагинитов;
- профилактика возникновения анаэробных инфекций при хирургических вмешательствах на органах брюшной полости и малого таза.
Коды МКБ-10
| Код МКБ-10 | Показание |
| A59 | Трихомоноз |
| N76 | Другие воспалительные болезни влагалища и вульвы |
| Z29.2 | Другой вид профилактической химиотерапии (введение антибиотиков с профилактической целью) |
Режим дозирования
Препарат применяется только у взрослых.
Трихомонадный вагинит: по 1 суппозиторию в сутки во влагалище, в течение 10 дней в сочетании с приемом препарата метронидазол, таблетки внутрь.
Неспецифический вагинит: по 1 суппозиторию 2 раза/сут в течение 7 дней, при необходимости в сочетании с приемом препарата метронидазол, таблетки внутрь. Обязательно одновременное лечение полового партнера препаратом метронидазол, независимо от того, имеются ли у него проявления заболевания.
Лечение метронидазолом не должно назначаться более, чем на 10 дней, и повторяться чаще, чем 2-3 раза в год.
Предварительно освободив суппозиторий от контурной упаковки при помощи ножниц, разрезать пленку по контуру суппозитория и ввести его глубоко во влагалище.
Побочное действие
Со стороны ЖКТ: тошнота, металлический привкус во рту, сухость во рту, снижение аппетита, глоссит, стоматит, панкреатит, анорексия, боли в эпигастрии, рвота, диарея, запор.
Со стороны нервной системы: головная боль, головокружение, нарушение координации движений, атаксия, спутанность сознания, раздражительность, депрессии, повышенная возбудимость, слабость, бессонница, судороги, спутанность сознания, галлюцинации, периферическая невропатия (особенно при длительном применении).
Аллергические реакции: крапивница, кожная сыпь, гиперемия кожи, заложенность носа, лихорадка, артралгии.
Со стороны мочевыделителъной системы: дизурия, полиурия, цистит, недержание мочи, кандидоз, возможно окрашивание мочи в коричнево-красноватый цвет.
Местные реакции: ощущение жжения или раздражение полового члена у полового партнера, ощущение жжения или учащенное мочеиспускание, вульвит (зуд, жгучая боль или гиперемия слизистой оболочки в области наружных половых органов).
Прочие: нейтропения, лейкопения, уплощение зубца Т на ЭКГ.
После отмены препарата возможно развитие кандидоза влагалища.
Противопоказания к применению
- органические поражения ЦНС (в т.ч. эпилепсия);
- нарушения координации движений;
- болезни крови (в т.ч. лейкопения в анамнезе);
- печеночная недостаточность (в случае назначения больших доз);
- беременность;
- грудное вскармливание;
- повышенная чувствительность к имидазолам, а также к производным нитроимидазола.
Применение при беременности и кормлении грудью
Применение при нарушениях функции печени
Применение у детей
Особые указания
Поскольку одновременный прием препарата с алкоголем может оказывать эффект, аналогичный эффекту дисульфирама (чувство жара, рвота, тахикардия), следует предупредить пациентов о том, что во время лечения Флагилом не следует употреблять алкогольные напитки или лекарства, содержащие алкоголь.
Длительное введение препарата желательно проводить под контролем формулы крови. При лейкопении возможность продолжения лечения зависит от риска развития инфекционного процесса.
При лечении трихомонадного вагинита у женщин необходимо воздерживаться от половой жизни. Обязательно одновременное лечение половых партнеров. Лечение не прекращается во время менструаций. После терапии трихомониаза следует провести контрольные пробы в течение 3 очередных циклов до и после менструации.
Следует прекратить лечение при появлении атаксии, головокружения, развитии галлюцинаций, при ухудшении неврологического статуса больных.
Необходимо принимать во внимание, что метронидазол может иммобилизовать трепонемы, что приводит к ложноположительному тесту Нельсона.
Влияние на способность управлять автомобилем и другими механизмами
В связи с возможностью появления головокружения и других побочных эффектов, связанных с приемом препарата, рекомендуется воздерживаться от управления автомобилем и другими механизмами.
Лекарственное взаимодействие
Аналогично дисульфираму вызывает непереносимость этанола.
Одновременное применение с дисульфирамом может привести к развитию различных неврологических симптомов (интервал между назначением — не менее 2 нед).
Усиливает действие непрямых, антикоагулянтов, что ведет к увеличению времени образования протромбина.
При одновременном приеме с препаратами лития может повышаться концентрация последнего в плазме.
При одновременном приеме с циклоспорином может повышаться концентрация последнего в плазме.
Циметидин подавляет метаболизм метронидазола, что может привести к повышению его концентрации в сыворотке крови и увеличению риска развития побочных явлений.
Одновременное назначение лекарственных средств, стимулирующих ферменты микросомального окисления в печени (фенобарбитал, фенитоин), может ускорять элиминацию метронидазола, в результате чего понижается его концентрация в плазме.
Метронидазол уменьшает клиренс 5-фторурацила, приводя к увеличению его токсичности.
Метронидазол повышает уровень бусульфана в плазме крови, приводя к увеличению его токсичности (тяжелая форма).
Не рекомендуется сочетать с недеполяризующими миорелаксантами (векурония бромид).
Условия хранения Флагил ®
Список Б. Хранить при температуре не выше 25°С. Хранить в недоступном для детей месте.
Аналоги
- Клион;
- Метронидазол;
- Трихопол.
Средняя цена онлайн * , 999 р. (10 свечей по 500 мг)
Где купить:
Инструкция по применению
Флагил — французский препарат, активным веществом которого является метронидазол. Одна из форм выпуска медикамента — вагинальные свечи или суппозитории. Лекарство оказывает противопротозойное и противомикробное действие.
Показания
Суппозитории прописывают пациенткам, у которых выявлен трихомонадный или неспецифический вагинит. Также их назначают с целью предупреждения появления анаэробных инфекций во время хирургического лечения органов малого таза и абдоминальной полости.
Способ применения и дозы
Суппозитории Флагил прописывают только взрослым пациенткам.
При вагините, спровоцированном трихомонадами, их назначают по 1 свече 1 раз в сутки на протяжении 10 дней. Параллельно прописывают метронидазол в таблетках внутрь.
Если у пациентки наблюдается неспецифический вагинит, то препарат назначают по 1 суппозитории 2 раза в день, на протяжении недели. Одновременно может быть прописан метронидазол внутрь. Независимо от того, наблюдаются ли у полового партнера признаки заболевания, ему также надо принимать внутрь препараты на основе метронидазола.
Продолжительность лечения свечами Флагил не должна превышать 10 суток, в год можно максимум проводить 2 или 3 курса.
На фоне лечения нельзя принимать любые спиртосодержащие жидкости, так как возможно развитие дисульфирамоподобных реакций (ощущение жара, учащение сердцебиения, рвота).
При длительном использовании препарата обязательно контролировать показатели крови.
Свечи надо вставлять глубоко во влагалище. На время лечения стоит воздержаться от половых контактов. Во время менструации суппозитории вставляются по прописанной врачом схеме.
При лечении трихомониаза после окончания терапии обязательно сдавать анализы на наличие трихомонады в течение 3-х циклов, до и после месячных кровотечений.
Из-за появления головокружения и других нежелательных реакций со стороны ЦНС надо проявлять осторожность при управлении транспортным средством.
Противопоказания
Суппозитории не назначают, если у пациента диагностированы следующие патологии:
- органические поражения нервной системы, к примеру, эпилепсия;
- заболевания крови, такие как снижение уровня лейкоцитов в анамнезе;
- расстройство координации движения;
- нарушение функции печени (при лечении большими дозировками).
Также препарат нельзя использовать при индивидуальной непереносимости имидазола и производных нитроимидазола.
Применение свечей Флагил во время беременности и кормления грудью
Суппозитории нельзя прописывать женщинам, ожидающим ребенка.
Лекарственное средство несовместимо с грудным вскармливанием, поэтому на время терапии младенца стоит перевести на смесь.
Передозировка
При интравагинальном использовании суппозиториев из-за низкой абсорбции передозировка маловероятна.
Побочные эффекты
Во время терапии могут развиться следующие нежелательные реакции:
- воспаление языка, поджелудочной железы, стоматит, рвота, жидкий стул, запор, тошнота, боли в эпигастральной области, отсутствие аппетита, вплоть до анорексии, сухость и металлический привкус во рту;
- аллергия, которая может проявляться заложенностью носа, жаром, болью в суставах, крапивницей, покраснением кожи, сыпью;
- расстройство мочеиспускания, увеличение объема мочи, ее недержание, воспаление мочевого пузыря, молочница, окрашивание урины в красно-коричневый цвет, жжение при опорожнении мочевого пузыря;
- вульвит;
- снижение уровня лейкоцитов, нейтропения;
- утолщение зубца Т на электрокардиограмме;
- головные боли, вертиго, проблемы с координацией.
Также на фоне использования суппозиториев могут появиться нежелательные реакции со стороны ЦНС, которые требуют прекращения терапии:
- чрезмерная возбудимость;
- депрессивное состояние;
- нарушение сознания;
- галлюцинации;
- проблемы со сном;
- судороги;
- раздражительность;
- атаксия;
- бессилие;
- периферическая невропатия, которая чаще возникает при продолжительном лечении.
Состав
Препарат выпускается в виде вагинальных свечей белого или светло-желтого цвета, которые имеют форму торпеды.
Каждая суппозитория содержит 500 мг метронидазола. В качестве вспомогательного вещества в них используется твердый жир.
Фармакология и фармакокинетика
Метронидазол представляет собой производное нитро-5-имидазола. Внутриклеточные транспортные протеины анаэробов и простейших восстанавливают 5-нитрогруппу метронидазола, которая взаимодействует с ДНК микробов, в результате они погибают.
Активное вещество обладает широким антибактериальным и противопротозойным действием.
Оно эффективно в отношении следующих микроорганизмов:
- трихомонады;
- бактероиды;
- лямблии;
- фузобактерии;
- эубактерии;
- клостридии;
- пептококки;
- дизентерийная амеба;
- пептострептококки.
При интравагинальном введении около 20% активного вещества всасывается в системный кровоток. Период полувыведения при нормальной функции печени может варьировать от 8 до 10 часов.
Условия продажи и хранения
Суппозитории Флагил отпускаются по рецепту доктора, хранить их надо при температуре максимум 25 градусов, в месте, где свечи не достанут дети.
Срок годности лекарственного средства составляет 4 года, по истечении которого медикамент подлежит утилизации.
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