ИНСТРУКЦИЯ
по медицинскому применению препарата
Регистрационный номер:
Торговое название: Флагил ® .
Международное непатентованное название:
Лекарственная форма:
Состав
В одной таблетке содержится: Ядро таблетки:
Активное вещество: метронидазол — 250 мг.
Вспомогательные вещества: крахмал пшеничный — 82,15 мг, повидон — 17,5 мг, магния стеарат — 0,35 мг.
Оболочка таблетки: гипромеллоза — 2,1 мг, макрогол 20000 — 0,7 мг.
Описание
Таблетки, покрытые оболочкой, круглой формы, от белого до бледно-желтого цвета, с гравировкой "F 250" на одной стороне. Вид на поперечном разрезе: от белого до светло-желтого цвета
Фармакотерапевтическая группа
Противомикробное и противопротозойное средство
Код ATX: J01XD01.
Фармакологические свойства
Фармакодинамика
Метронидазол является производным 5-нитроимидазола. 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.
Активен в отношении Trichomonas vaginalis, Entamoeba histolytica, а также грамотрицательных анаэробов Bacteroides spp. (в т.ч. В. fragilis, В. ovatus, В. distasonis, В. thetaiotaomicron, В. vulgatus), Fusobacterium spp., и некоторых грамположительных анаэробов (чувствительные штаммы Eubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp.). МПК для этих штаммов составляет 0.125-6.25 мкг/мл. В сочетании с амоксициллином проявляет активность в отношении Helicobacter pylori (амоксициллин подавляет развитие резистентности к метронидазолу).
К метронидазолу нечувствительны аэробные микроорганизмы и факультативные анаэробы, но в присутствии смешанной флоры (аэробы и анаэробы) метронидазол действует синергидно с антибиотиками, эффективными против обычных аэробов.
Фармакокинетика
При приеме внутрь метронидазол быстро и почти полностью всасывается (примерно 80% за 1 час). Прием пищи не влияет на абсорбцию метронидазола. Биодоступность не менее 80%. После приема внутрь 500 мг метронидазола, плазменная концентрация составляет через 1 час — 10 мкг/мл, а через 3 часа — 13,5 мкг/мл. Период полувыведения равен 8-10 часам, связь с белками крови незначительная и не превышает 10-20%). Метронидазол 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 метронидазола осуществляется на 40-70% через почки (в неизмененном виде — около 35% от принятой дозы). У больных с нарушением функции почек при курсовом приеме метронидазола возможно повышение его концентрации в сыворотке крови.
Показания к применению
Метронидазол предназначен для приема внутрь, до или после еды. Запивать достаточным количеством воды.
При кишечном амебиазе Флагил ® применяют в течение 7 дней по 1500 мг в день за три приема. При острой амебной дизентерии — суточная доза составляет 2250 мг, разделенная на три приема. Детям от 10 до 15 лет — по 500 мг в день, разделенная на 2 приема.
При абсцессе печени и других внекишечных формах амебиаза максимальная суточная доза составляет 2500 мг, разделенная на 3 приема в течение 3-5 дней, в комбинации с тетрациклиновыми антибиотиками и другими методами терапии. Детям от 10 до 15 лет — по 500 мг в день, разделенная на 2 приема.
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 таб. (250 мг) 2 раза в день.
При трихомониазе у мужчин (уретрит) Флагил ® назначают однократно в дозе 2 г или в виде курсового лечения в течение 10 дней по 1 таб. (250 мг) 2 раза в день.
Лечение анаэробных инфекций обычно начинают с внутривенных инфузий, с последующим переходом на таблетки. Для взрослых доза препарата Флагил ® составляет 500 мг 3 раза в день. Длительность лечения составляет до 7 дней.
Для лечения псевдомембранозного колита назначают 500 мг препарата Флагил ® (2 табл.) 3-4 раза в сутки. Длительность лечения определяется врачом.
Для эрадикации Helicobacter pylori назначают по 500 мг препарата Флагил ® 3 раза в сутки в составе комбинированной терапии (например, с амоксициллином).
Для профилактики послеоперационных осложнений назначают по 750-1500 мг в сутки в 3 приема за 3-4 дня до операции. Через 1-2 дня после операции (когда уже разрешен прием внутрь) — по 750 мг препарата Флагил ® в сутки в течение 7 дней. Возможные побочные действия при применении лекарственного препарата
Нарушения со стороны желудочно-кишечного тракта
Нарушения со стороны иммунной системы
Нарушения со стороны нервной системы
Нарушения психики
Нарушения со стороны органа зрения
Нарушения со стороны крови и лимфатической системы
Нарушения со стороны печени и желчевыводящих путей
Нарушения со стороны кожи и подкожных тканей
Нарушения со стороны почек и мочевыводящих путей
Общие расстройства и нарушения в месте введения
Лабораторные и инструментальные данные
С дисулъфирамом
Сообщалось о развитии психотических реакций у пациентов, получавших одновременно метронидазол и дисульфирам (интервал между назначением этих метронидазолов должен быть не менее 2 недель).
С этанолом
Возможно возникновение дифульфирамоподобных реакций (гиперемия кожных покровов, рвота, тахикардия).
С непрямыми антикоагулянтами (варфарин)
Усиление антикоагулянтного эффекта и повышение геморрагического риска, связанного с замедлением их печеночного метаболизма, что может приводить к повышению протромбинового времени. В случае одновременного применения требуется более частый мониторинг протромбинового времени и при необходимости коррекция доз антикоагулянтов.
С препаратами лития
При одновременном приеме метронидазола с препаратами лития может повышаться концентрация последнего в плазме крови. При одновременном применении следует мониторировать плазменные концентрации лития, креатинина и электролитов.
С циклоспорином
При одновременном приеме метронидазола с циклоспорином может повышаться сывороточная концентрация циклоспорина. В случае необходимости одновременного применения этих двух метронидазолов требуется мониторинг сывороточной концентрации циклоспорина и креатинина.
С циметидином
Циметидин ингибирует метаболизм метронидазола, что может привести к повышению его концентрации в сыворотке крови и увеличению риска развития побочных явлений.
С лекарственными средствами, индуцирующими ферменты микросомального окисления в печени (фенобарбитал, фенитоин)
Одновременное назначение метронидазола с лекарственными средствами, стимулирующими ферменты микросомального окисления в печени (фенобарбитал, фенитоин) может ускорять элиминацию метронидазола, в результате чего снижается его концентрация в плазме.
С фторурацилом
Метронидазол уменьшает клиренс фторурацила, приводя к увеличению его токсичности.
С бусульфаном
Метронидазол повышает концентрацию бусульфана в плазме крови, что может приводить к развитию тяжелого токсического действия бусульфана.
С недеполяризующими миорелаксантами (векурония бромид)
Не рекомендуется сочетать с недеполяризующими миорелаксантами (векурония бромид).
Сульфаниламиды усиливают противомикробное действие метронидазола. Меры предосторожности при применении препарата
Поскольку одновременный прием метронидазола с алкоголем может оказывать эффект, аналогичный эффекту дисульфирама (чувство жара, рвота, тахикардия), следует предупредить пациентов о том, что во время лечения препаратом Флагил ® не следует употреблять алкогольные напитки или лекарства, содержащие алкоголь.
Следует тщательно взвешивать показания для длительного приема препарата и без строгих показаний избегать его длительного применения. Если при наличии строгих показаний препарат применяется более длительно, чём это обычно рекомендуется, то лечение следует проводить под контролем гематологических показателей и побочных реакций, таких как периферическая или центральная нейропатия (парестезии, атаксия, головокружение, судороги), при появлении которых лечение должно быть прекращено.
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.
Необходимо принимать во внимание, что метронидазол может иммобилизовать трепонемы, что приводит к ложноположительному тесту Нельсона. Влияние на способность управлять автомобилем и занятие другими потенциально опасными видами деятельности
Учитывая профиль побочных эффектов (головокружение, нарушения зрения и другие) рекомендуется воздерживаться от управления автомобилем, от занятий другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций. Форма выпуска
Таблетки, покрытые пленочной оболочкой 250 мг.
По 10 таблеток в блистер из ПВХ/алюминиевой фольги.
По 2 блистера вместе с инструкцией по применению в картонную пачку. Условия хранения
Хранить при температуре не выше 25°С.
Хранить в недоступном для детей месте. Срок годности 5 лет.
По истечении срока годности препарат применять нельзя. Условия отпуска из аптек По рецепту. Владелец регистрационного удостоверения:
Санофи-авентис франс, Франция 1-13, бульвар Ромэна Роллана, Париж, Франция
Флагил — противомикробное и антисептическое средство, применяемое в гинекологии.
Метронидазол относится к нитро-5-имидазола и обладает широким спектром действия. Предельными концентрациями, которые действуют возможность отдифференцировать чувствительны штаммы (S) от штаммов с умеренной чувствительностью, а штаммы с умеренной чувствительностью — от резистентных штаммов (R), являются следующие: S 4 мг / л.
К препарату чувствительны: Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Fusobacterium spp., Porphyromonas, Bilophila, Helicobacter pylori, Prevotella spp., Veilonella . Метронидазол сдерживает развитие простейших: Trichomonas vaginalis, Giardia intestinalis (Lamblia intestinalis), Entamoeba histolytica . К препарату непостоянно чувствительны: Bifidobacterium spp., Eubacterium spp . Нечувствительны штаммы микроорганизмов: Propionibacterium, Actinomyces, Mobiluncus.
Фармакокинетика
После вагинального введения системное проникновение является минимальным.
Период полувыведения составляет 8-10 часов.
Связывание с белками плазмы незначительное (менее 20%).
Быстрая и выраженная диффузия в легкие, почки, печень, желчь, спинномозговую жидкость, кожу, слюну и вагинальный секрет. Через плацентарный барьер и экскретируется в грудное молоко.
Метаболизм происходит главным образом в печени: образуются два неконъюгированного окисленные активные метаболиты (5-30% активности).
Экскреция — преимущественно почками: 35-65% полученной дозы выводится с мочой в виде метронидазола и его окисленных метаболитов.
Показания к применению
Флагил применяется в местном лечении трихомонадного и неспецифического вагинитов.
Способ применения
Препарат разрешается применять для лечения только взрослых пациентов.
Флагил суппозитории вагинальные, как правило, применяются с таблетками Флагил.
Трихомонадный вагинит . Назначать по 1 вагинальному суппозиторию 1 раз в сутки в течение 10 дней. Суппозиторий вводить глубоко во влагалище. Лечение следует проводить с одновременным пероральным приемом таблеток препарата Флагил.
Неспецифические вагиниты. 1 вагинальный суппозиторий вводить глубоко во влагалище 1 раз в сутки в течение 7 дней. В случае необходимости можно назначать таблетки Флагил перорально. Абсолютно необходимо одновременное лечение полового партнера пациентки, даже при отсутствии у него симптомов инфекции.
Максимальная продолжительность лечения Флагил не должна превышать 10 дней, а количество курсов лечения — 2-3 в год.
Препарат противопоказано применять для лечения детей.
Побочные действия
Со стороны ЖКТ: незначительные расстройства желудочно-кишечного тракта (боли в эпигастрии, тошнота, рвота, диарея), глоссит с сухостью во рту, стоматит, нарушения вкуса, анорексия; случаи панкреатита, которые носят обратимый характер;
изменение цвета или изменение внешнего вида языка (микоз).
Со стороны кожи и ее производных: приливы с гиперемией, зуд, сыпь, которые могут сопровождаться лихорадкой; крапивница, ангионевротический отек, анафилактический шок (см.
Со стороны нервной системы: периферическая сенсорная нейропатия; головная боль, головокружение, спутанность сознания, судороги; асептический менингит (см. раздел «Особенности применения»); энцефалопатия, может сопровождаться изменениями на МРТ, как правило обратного характера. Очень редко сообщалось о летальных случаях (см. Раздел «Особенности применения»); подострого мозжечкового синдрома (атаксия, дизартрия, нарушение походки, нистагм, тремор) (см. раздел «Особенности применения»).
Со стороны психики: галлюцинации; психотические реакции с паранойей и / или делирием, которые в отдельных случаях могут сопровождаться мыслями суицидального характера или попытками суицида (см. раздел «Особенности применения»); депрессивное настроение.
Со стороны органов зрения: временные нарушения зрения, например, нарушение четкости зрения, диплопия, миопия, снижение остроты зрения, изменения в восприятии цветов; оптическая нейропатия / неврит.
Гематологические нарушения: агранулоцитоз, нейтропения, тромбоцитопения.
Гепатобилиарной системы: повышение уровня печеночных ферментов (АСТ, АЛТ, ЩФ), очень редко сообщалось о случаях острого холестатического или смешанного гепатита и гепатоцеллюлярного поражения печени, иногда с появлением желтухи. Сообщалось о единичных случаях гепатоцеллюлярной недостаточности, при которой может потребоваться в трансплантации печени.
Со стороны органов слуха и равновесия: нарушение слуха / потеря слуха (включая нейросенсорная); звон в ушах.
Другие: красно-коричневую окраску мочи, обусловленное водорастворимыми пигментами, которые образуются в ходе метаболизма этого лекарственного средства.
Сообщение о подозреваемых побочные реакции. Сообщение о подозреваемых побочные реакции после регистрации лекарственного средства является важной процедурой. Это позволяет осуществлять мониторинг соотношения польза / риск применения этого лекарственного средства. Медицинских работников просят сообщать обо всех подозреваемых побочные реакции через национальную систему фармаконадзора.
Противопоказания
Противопоказаниями к применению препарата Флагил являются:
— Повышенная чувствительность к метронидазолу или к твердому жира.
— Гиперчувствительность к производным имидазола.
— Это лекарственное средство не рекомендуется применять одновременно с дисульфирамом или алкоголем.
Беременность
Исследования на животных не показали тератогенного эффекта. Поскольку тератогенный эффект не наблюдается у животных, не ожидается возникновения пороков развития у человека. Согласно данным, вещества, приводящие к образованию пороков развития у человека, имеют тератогенный эффект у животных во время адекватно проведенных исследований на двух видах. Многочисленные клинические данные не продемонстрировали никаких специфических тератогенных или фетотоксического эффектов, связанных с назначением метронидазола во время беременности. Однако отсутствие такого риска может быть подтверждена только эпидемиологическими исследованиями. В связи с этим в период беременности метронидазол без необходимости не назначать.
Кормления грудью. Метронидазол выводится в грудное молоко. В связи с этим необходимо избегать применения этого лекарственного средства в период кормления грудью.
Взаимодействие с другими лекарственными средствами
Антабусный эффект. Существует много лекарственных средств, которые запускают антабусный реакцию на алкоголь, и их одновременное применение с алкоголем не рекомендуется.
Комбинации, не рекомендуются .
Алкоголь (в составе напитков или как вспомогательное вещество). Антабусный эффект (приливы, эритема, рвота, тахикардия). Необходимо избегать употребления алкогольных напитков и приема лекарственных средств, содержащих спирт. Следует принимать во внимание время полного выведения препарата из организма, учитывая период его полураспада, до начала употребления алкогольных напитков или приема лекарственных средств, содержащих спирт.
Дисульфирам. Риск развития острых психотических эпизодов или спутанности сознания, которые являются обратимыми после отмены препарата.
Бусульфан. При применении бусульфана в высоких дозах: увеличение вдвое концентраций бусульфана у пациентов, получающих метронидазол.
Комбинации, которые требуют меры предосторожности при применении .
Пероральная терапия антикоагулянтами. Усиление эффектов пероральных антикоагулянтов и повышение риска геморрагических осложнений из-за замедления их метаболизма в печени. Необходимо чаще контролировать уровень протромбина и осуществлять надзор за уровнями МНО (международного нормализованного отношения). Рекомендуется коррекция дозы пероральных антикоагулянтов во время приема метронидазола и в течение 8 дней после его отмены.
Противосудорожные препараты, которые являются индукторами ферментов (карбамазепин, фосфенитоин, фенобарбитал, фенитоин, примидон). Снижение концентраций метронидазола в плазме крови вследствие стимуляции его метаболизма в печени индуктором.
Во время и после лечения индуктором следует осуществлять клинический мониторинг. Может потребоваться коррекция дозы метронидазола.
Рифампицин. Снижение концентраций метронидазола в плазме крови вследствие стимуляции его метаболизма в печени рифампицином.
Во время и после лечения рифампицином следует осуществлять клинический мониторинг. Может потребоваться коррекция дозы метронидазола.
Литий. Повышение концентраций лития в крови, которые могут достигать токсичных уровней с признаками передозировки лития. Нужно тщательный мониторинг концентраций лития в крови и в случае необходимости провести коррекцию дозы препарата лития.
Циклоспорин. Существует риск повышения уровней циклоспорина в сыворотке. Если препараты необходимо принимать одновременно, следует тщательно контролировать уровни циклоспорина и креатинина.
Комбинации, которые требуют особого внимания .
Фторурацил (а также тегафур и капецитацин). Снижение клиренса фторурацила вызывает повышение его токсичности.
Нарушение равновесия МЧС (международное нормализованное отношение). У пациентов, получавших антибактериальную терапию, регистрировались многочисленные случаи усиления активности пероральных антикоагулянтов. При этом факторами риска, обусловливающих склонность к такого осложнения, является наличие инфекции или выраженного воспаления, возраст пациента и общее состояние его здоровья. В этих обстоятельствах сложно определить, в какой степени нарушения равновесия МЧС влияет сама инфекция или ее лечение. Однако некоторые классы антибиотиков играют при этом большую роль, в частности: фторхинолоны, макролиды, циклины, тримоксазол и некоторые цефалоспорины.
Результаты лабораторных исследований . Метронидазол способен зафиксировать трепонемы, что приводит к ложно-положительного теста Нельсона.
Одновременное применение метронидазола и алкоголя не рекомендуется (см. Раздел «Взаимодействие с другими лекарственными средствами и другие виды взаимодействий»).
Одновременное применение метронидазола и бусульфана не рекомендуется (см. Раздел «Взаимодействие с другими лекарственными средствами и другие виды взаимодействий»).
Одновременное применение метронидазола и дисульфирама не рекомендуется (см. Раздел «Взаимодействие с другими лекарственными средствами и другие виды взаимодействий»).
Другие виды взаимодействий. Максимальная продолжительность лечения препаратом не должна превышать 10 дней, а количество курсов лечения — 2-3 в год.
Применение суппозиториев при использовании презервативов или диафрагм повышает риск разрыва латекса.
У пациентов с синдромом Кокейна наблюдались случаи быстрого развития острой печеночной недостаточности, в том числе с летальным исходом, при приеме препаратов, содержащих метронидазол, предназначенных для системного применения.
Анализы функции печени должны проводиться непосредственно до начала применения препарата, в течение его применения и после завершения лечения до момента возврата показателей функции печени до нормы или до первоначального состояния. Если во время применения препарата анализы функции печени демонстрируют заметно повышенные показатели, применение препарата следует прекратить.
Пациентам с синдромом Кокейна следует порекомендовать в случае появления каких-либо симптомов возможного нарушения функции печени немедленно сообщить об этом своему врачу и прекратить прием метронидазола.
Передозировка
Зафиксированы случаи однократного приема до 12 г при суицидальных попытках и случайной передозировки. Могут наблюдаться атаксия, рвота, легкая дезориентация. Поскольку специфический антидот метронидазола неизвестен, рекомендуется осуществлять симптоматическую терапию.
Условия хранения
Хранить в недоступном для детей месте. Хранить в оригинальной упаковке при температуре не выше 25 ° С.
Форма выпуска
Флагил — суппозитории вагинальные.
упаковка: 10 (5х2): по 5 суппозиториев в стрипе, по 2 стрипа в картонной коробке.
Состав
1 суппозиторий Флагил содержит метронидазола 500 мг.
Вспомогательные вещества: твердый жир.
Дополнительно
У пациентов с тяжелыми, хроническими или прогрессирующими заболеваниями периферической или центральной нервной системы риск обострения неврологического статуса.
Пациентам, имеющим в анамнезе гематологические нарушения или получающих препарат в высоких дозах и / или в течение длительного срока, необходимо регулярно делать анализ крови, особенно определение содержания лейкоцитов.
В случае длительного лечения необходимо осуществлять надзор за пациенткой о возникновении признаков побочных реакций, таких как центральная или периферическая нейропатия (парестезия, атаксия, головокружение, судороги).
Пациентов следует сообщить, что метронидазол может окрашивать мочу в темный цвет (через активный метаболит).
Применение вагинальных суппозиториев при использовании презервативов или диафрагм повышает риск разрыва латекса.
Гиперчувствительность / расстройства со стороны кожи и ее производных . Могут возникнуть аллергические реакции, в том числе анафилактический шок, которые могут быть опасными для жизни (см. Раздел «Побочные реакции»). В таком случае необходимо отменить лечения препаратом и начать соответствующую терапию.
Если в начале лечения у пациента появляется генерализованная эритема и пустулезные высыпания, сопровождающиеся повышением температуры тела, следует заподозрить острый генерализованный экзантематозный пустулез (см. Раздел «Побочные реакции»); в случае развития такой реакции лечения следует прекратить, и в дальнейшем применение метронидазола как в виде монотерапии, так и в комбинации с другими препаратами противопоказано.
С приемом метронидазола ассоциируются острые кожные реакции, включая синдром Стивенса — Джонсона, синдром Лайелла, острый генерализованный экзантематозный пустулез (ГГЕП). Пациентам нужно сообщить о симптомах таких реакций, а также следует проводить тщательный мониторинг кожи.
При появлении у пациента симптомов синдрома Стивенса — Джонсона, синдрома Лайелла (например, постепенное появление высыпаний и кожных волдырей или поражений слизистой оболочки) или генерализованной эритемы с пустулезные высыпания, сопровождающиеся повышением температуры тела, лечения следует прекратить, а в дальнейшем применение метронидазола как в виде монотерапии, так и в комбинации с другими препаратами противопоказано.
Со стороны центральной нервной системы . В случае появления симптомов, характерных для энцефалопатии или мозжечкового синдрома, лечение пациента нужно немедленно пересмотреть, а лечения препаратом прекратить.
О случаях развития энцефалопатии сообщалось в рамках послерегистрационного надзора за препаратом. Кроме этого, наблюдались случаи изменений на МРТ, связанных с энцефалопатией (см. Раздел «Побочные реакции»). Участки поражений чаще всего локализуются в мозжечке (особенно в зубчатом ядре) и в валике мозолистого тела. В большинстве случаев энцефалопатия и изменения на МРТ исчезали после прекращения лечения. Очень редко сообщалось о смертельных случаях.
Следует проводить мониторинг состояния пациентов о возможных признаков энцефалопатии или по обострение симптомов при наличии нарушений со стороны ЦНС.
В случае развития во время лечения асептического менингита повторное назначение метронидазола НЕ рекомендуется, а у пациентов с наличием серьезного инфекционного заболевания нужно провести повторную оценку соотношения польза / риск.
Со стороны периферической нервной системы . Следует проводить мониторинг состояния пациентов о возможных признаков периферической нейропатии, особенно при длительном лечении препаратом или при наличии тяжелой, хронической или прогрессирующей периферической нейропатии.
Со стороны психики . После применения первой дозы препарата у пациентов могут возникнуть психотические реакции, в том числе поведение с нанесением вреда самому себе, особенно при наличии в анамнезе психических расстройств (см. Раздел «Побочные реакции»). В этом случае нужно прекратить лечения препаратом, сообщить врачу и немедленно принять соответствующие лечебные мероприятия.
Гематологические эффекты . У пациентов с наличием в анамнезе нарушений со стороны системы крови и у пациентов, получающих препарат в высоких дозах и / или в течение длительного периода времени, нужно регулярно проводить анализ крови, особенно контроль количества лейкоцитов.
Продолжение лечения пациентов с лейкопенией зависит от того, насколько серьезным является инфекционное заболевание
Способность влиять на скорость реакции при управлении автотранспортом или другими механизмами. Пациентов нужно предупредить о риске возникновения головокружения, спутанности сознания, галлюцинаций, судорог и расстройств зрения. В случае появления таких симптомов пациентам не следует управлять транспортными средствами или работать с другими механизмами.
Аналоги
- Клион;
- Метрон;
- Метронидазол;
- Трихопол.
Средняя цена онлайн * , 123 р. (20 таблеток)
Где купить:
Инструкция по применению
Флагил — антибактериальный и противопротозойный препарат, активным веществом которого является метронидазол.
Показания
Таблетки Флагил прописывают при следующих заболеваниях:
- протозойные инфекции: инфузорная дизентерия, лямблиоз, каучуковая язва, кишечные и внекишечные формы амебиаза, трихомониаз;
- инфекции опорно-двигательного аппарата, нервной системы, сепсис, воспаление эндокардия и легких, вызванные бактероидами;
- заболевания абдоминальной полости и органов таза, вызванные пептококками, пептострептококки, клостридии;
- гастрит и язва 12-ти перстной кишки, ассоциированной с хеликобактерии пилори;
- псевдомембранозный колит, вызванный лечением антибиотиками.
Помимо этого Флагил назначают с целью профилактики бактериальных инфекций после хирургического лечения.
Способ применения и дозы
Таблетки назначают внутрь в зависимости от заболевания в следующих дозировках:
| Заболевания | Схемы терапии |
| Амебиаз | Препарат прописывают взрослым по 500 мг 3 раза в сутки на протяжении недели. |
| Трихомониаз | Лекарство назначают или 1 раз в дозировке 2 г или по 250 мг утром и вечером в течение 10 дней. Принимать медикамент надо обоим половым партнерам (особенности лечения у мужчин и женщин), на время лечения стоит отказаться от интимной близости. |
| Неспецифический вагинит | Медикамент выписывают в дозе 500 мг 2 раза в день на протяжении 7 суток. |
| Анаэробные инфекции | Взрослым прописывают в суточной дозировке 1 —1,5 г. |
| Лямблиоз | Взрослым Флагил выписывают в суточной дозировке 0,75—1 г, детям в возрасте от 6 до 10 лет — в суточной дозировке 375 мг, пациентам в возрасте от 10 до 15 лет — в дневной дозировке 500 мг. Курс 5 дней. |
При тяжелых патологиях почек дневную дозировку нужно снизить в 2 раза.
Больной должен быть извещен о том, что во время приема таблеток Флагил нельзя употреблять алкоголь, так как в этом случае будут наблюдаться дисульфирамоподобные явления: покраснение лица, страх, паника, учащение сердцебиения.
При длительном приеме препарата обязательно контролировать картину крови.
Если на фоне терапии наблюдаются галлюцинации, атаксия или головокружение, то прием медикамента надо прекратить.
Противопоказания
Лекарственное средство не прописывают, если наблюдается:
- гиперчувствительность к имидазолам;
- органические поражения нервной системы;
- заболевания крови, включая пониженный уровень лейкоцитов в анамнезе;
- возраст младше 6 лет.
В высоких дозировках препарат не прописывают пациентам, страдающим печеночной недостаточностью.
Назначение медикамента в период вынашивания ребенка и лактации
Таблетки Флагил не применяются для лечения беременных женщин.
Нельзя назначать препарат во время лактации.
Передозировка
При передозировке лекарственным средством наблюдается тошнота, рвота, нарушение координации движения, судороги.
Противоядия нет, лечение направлено на устранение симптомов интоксикации.
Побочные эффекты
При лечении таблетками Флагил могут появиться следующие нежелательные реакции:
- сухость и вкус металла во рту, ослабление аппетита вплоть до полного отказа от еды, боли в эпигастрии, стоматит, тошнота, рвота, запор, жидкий стул, воспаления поджелудочной железы и языка;
- изменение зубца Т на ЭКГ;
- аллергия, может наблюдаться крапивница, повышение температуры, суставная боль, сыпь, заложенность носа, покраснение кожных покровов;
- увеличение количества урины, ее недержание, окрашивание в коричнево-красноватый цвет, воспаление мочевого пузыря;
- головокружение, цефалгия, судороги, расстройство сна и координации движения, бессилие, атаксия, галлюцинации, депрессивное состояние, периферическая невропатия, спутанность сознания, возбудимость, раздражительность;
- молочница.
Состав
Лекарственное средство Флагил выпускается в таблетках, покрытых пленочной оболочкой. Каждая таблетка содержит 250 мг метронидазола.
В качестве дополнительных компонентов применяют:
- стеарат магния;
- повидон;
- пшеничный крахмал.
В состав оболочки входят макрогол и гипромеллоза.
Фармакология и фармакокинетика
В молекуле метронидазола содержится 5-нитрогруппа, которая восстанавливается внутриклеточными транспортными протеинами простейших и анаэробов. Затем она вступает в реакцию с ДНК возбудителя, блокирует выработку в них нуклеиновых кислот, в результате микроорганизмы погибают.
Лекарственное средство проявляет активность в отношении простейших:
К препарату чувствительны также облигатные споро- и неспорообразующие анаэробы:
- бактероиды;
- клостридии;
- пептококки;
- пептострептококки;
- эубактерии;
- фузобактерии.
При приеме внутрь активное вещество в течение часа всасывается на 80% и быстро мигрирует в ткани, в материнское молоко и через планценту. Степень абсорбции не зависит от приема пищи.
Биодоступность достигает практически 100%. До 20% активного вещества связывается с белками крови. Период полувыведения варьирует от 8 до 10 часов.
В организме активное вещество подвергается метаболизму с образованием 2-оскиметронидазола, который также оказывает антибактериальное и противопротозойное действие. Выводится препарат с мочой, у пациентов с патологией почек возможна его кумуляция.
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