Гомогенный порошок белого или почти белого цвета, с фруктовым запахом, без агломератов и посторонних частиц.
Фармакотерапевтическая группа
Антибиотик.
Фармакологические свойства
Антибиотик широкого спектра действия. Оказывает бактерицидное действие. Является структурным аналогом фосфоэнола пирувата и проникает в микробную клетку. Лекарственный препарат необратимо ингибирует фермент N-ацетил-глюкозамино-3о-энолпирувил-трансферазу, необратимо блокирует конденсацию уридиндифосфатN-ацетил-глюкозамина с фосфоэнолпируватом, подавляет синтез УДФ-N-ацетилмурамовой кислоты, ингибируя, таким образом, начальный этап образования пептидогликана клеточной стенки бактерий.
Перекрестная резистентность препарата с другими антибактериальными средствами неизвестна. In vitro, при сочетании с амоксициллином, цефалексином, пипемидиновой кислотой, отмечается выраженный синергизм противомикробного действия. In vitro к фосфомицину чувствительны грамположительные (Staphylococcus saprophytticus, Enterococcus faecalis) и грамотрицательные (Escherichia coli, Klebsiella pneumoniea, Citrobacter spp., Enterobacter spp., Proteus mirabilis) микроорганизмы. In vitro фосфомицин трометамол снижает адгезию ряда бактерий к эпителию мочевыводящих путей.
Фармакокинетика Всасывание:
Фосфомицин умеренно всасывается из желудочно-кишечного тракта при пероральном приеме. В организме диссоциирует на фосфомицин и трометамол.
Биодоступность разовой дозы 3 г при пероральном приеме составляет от 32 % до 54 %. Максимальная концентрация в плазме (С max) наблюдается через 2-3 часа (t max) после перорального приема и составляет около 30 мг/л. Период полувыведения из плаз-
Falz мы крови варьирует от 3 до 4 часов.
Распределение:
Фосфомицин не связывается с белками плазмы, не метаболизируется, преимущественно накапливается в моче. Уже через 2-4 часа после перорального приема разовой дозы 3 г в моче достигается высокая терапевтическая концентрация 2-4 г/л, снижающаяся до 1-2 г/л через 6-12 часов. Средние концентрации через 12 - 24 часа и через 36-48 часов составили 0,762 г/л и 0,147 г/л соответственно.
Минимальная ингибирующая концентрация (0,128 г/л), бактерицидная для большинства обычных возбудителей инфекций мочевыводящих путей, сохраняется в моче на протяжении не менее 48 часов, что обусловливает лечение однократной дозой.
Выведение:
Основная часть выводится почками в неизменном виде. Небольшая часть экскретируется через кишечник.
В случае умеренного снижения почечной функции период полувыведения фосфомицина почками немного удлиняется в зависимости от степени функционального нарушения.
Показания к применению
Бактериальные инфекции мочевыводящих путей различной локализации, вызываемые чувствительными к фосфомицину микроорганизмами: острые неосложненные инфекции мочевыводящих путей; бессимптомная бактериурия; профилактика инфекций мочевыводящих путей после хирургического вмешательства и трансуретральных диагностических исследований.
Противопоказания
- повышенная чувствительность к фосфомицину или другим компонентам препарата;
- дети младше 12 лет, поскольку недостаточно данных по его применению;
- дефицит сахаразы/изомальтазы;
- непереносимость фруктозы;
- глюкозо-галактозная мальабсорбция.
Применение при беременности и в период грудного вскармливания
При беременности применяют только в случае, если предполагаемая польза для матери превышает потенциальный риск для плода.
При назначении препарата в период лактации следует прекратить грудное вскармливание на время лечения.
Способ применения и дозы
Внутрь.
Фосфомицин Эспарма применяют однократно, натощак, за 2-3 ч до или после приема пищи, предпочтительно перед сном, предварительно опорожнив мочевой пузырь: взрослым и детям старше 12 лет в суточной дозе 3 г. Содержимое одного пакета растворяют примерно в 150-200 мл воды и принимают непосредственно после приготовления.
Курс лечения составляет 1 день.
Для профилактики инфекций мочевыводящих путей при хирургическом вмешательстве, диагностических процедурах указанная доза принимается 2 раза – за 3 ч до вмешательства и через 24 ч после него.
Не следует принимать Фосфомицин Эспарма пациентам с массой тела ниже 50 кг и детям в возрасте до 12 лет, поскольку дозу нельзя разделить или уменьшить.
Побочное действие
По частоте развития побочные явления находятся в следующих группах:
Очень частые: (≥ 1/10)
Частые: (≥ 1/100 - < 1/10)
Не частые: (≥ 1/1.000 - < 1/100)
Редкие: (≥ 1/10.000 - < 1/1.000)
Очень редкие: (< 1/10.000)
Неизвестно: (частота возникновения побочных явлений на основании существующих данных не определяется).
Со стороны сердечно - сосудистой системы: Редкие: тахикардия
Неизвестно: снижение артериального давления
Со стороны дыхательной системы, органов грудной клетки и средостения:
Неизвестно: бронхиальная астма
Со стороны иммунной системы:
Неизвестно: кожный зуд, анафилактический шок, реакции повышенной чувствительности (ангионевротический отек, кожная сыпь, крапивница)
Со стороны желудочно-кишечного тракта:
Не частые: диарея, тошнота, диспепсия
Редкие: рвота
Неизвестно: псевдомембранозный колит, боль в животе
Со стороны печени и желчевыводящих путей:
Не частые: повышение активности «печеночных» трансаминаз
Со стороны половых органов и молочной железы: Не частые: вульвовагинит
Со стороны крови и лимфатической системы:
Не частые: тромбоцитоз, лейкопения
Если любые из указанных в инструкции побочных эффектов усугубляются или Вы заметили любые другие побочные эффекты не указанные в инструкции, сообщите об этом врачу.
Передозировка
Симптомы передозировки: вестибулярный синдром, нарушение слуха, «металлический» вкус и общие нарушения вкуса, диарея. Специфический антидот не выявлен. При необходимости проводится симптоматическое лечение.
Взаимодействие с другими лекарственными средствами
Одновременный прием с метоклопрамидом, антацидами или препаратами, содержащими соли кальция, может привести к снижению концентрации фосфомицина в сыворотке крови и в моче. По этой причине препараты рекомендуется принимать с интервалом 2-3 часа.
Одновременный прием с другими препаратами, которые усиливают моторику желудочно-кишечного тракта, также может привести к снижению концентрации фосфомицина в сыворотке крови и в моче.
Особые указания
Возникновение острой и упорной диареи во время или после лечения антибиотиками может быть симптомом колита, вызванного приемом антибиотиков. Наиболее серьезная форма – псевдомембранозный колит.
В случае псевдомембранозного колита необходимо незамедлительно принять соответствующие меры. В таком случае, использование препаратов, замедляющих перистальтику, противопоказано.
В составе препарата содержится сахароза. Пациентам с редкими наследственными заболеваниями, непереносимостью фруктозы, нарушением всасывания глюкозы-галактозы или недостаточностью сахаразы-изомальтазы данный препарат принимать не следует.
В одном пакете Фосфомицина Эспарма содержится примерно 2,3 г сахарозы, что эквивалентно примерно 0, 19 хлебных единиц (ХE).
Одновременный прием пищи замедляет всасывание гранул, поэтому рекомендуется прием препарата натощак, за 2-3 часа до или после приема пищи.
Влияние на способность управлять автомобилем и движущимися механизмами
Пациенты должны быть предупреждены о возможности развития головокружения и при появлении головокружения следует воздержаться от выполнения указанных видов деятельности.
Форма выпуска
Порошок для приготовления раствора для приема внутрь 3 г.
По 8 г порошка в пакетах из трехслойного материала (бумага-алюминий-полиэтилен). 1 пакет с инструкцией по применению в пачку картонную.
Условия хранения
При температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
2 года.
Не использовать после истечения срока годности, указанного на упаковке.
Условия отпуска
По рецепту.
Производитель
Эспарма ГмбХ,
Билефельдер штрассе 1, 39171 Зюльцеталь, Германия.
Организация, принимающая претензии потребителей
115114, г. Москва, ул. Летниковская, д.16, 6 этаж, комн. 21/1, 23-27 тел.: +7(499) 579 33 70 факс: +7(499) 579 33 71 e-mail: info@esparma-gmbh.ru
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Фосфомицин Эспарма"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"Порошок для приготовления раствора для приема внутрь."}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"1 пакет 8 г содержит:"}},{"type":"paragraph","data":{"text":"Действующее вещество: фосфомицина трометамол - 5,631 г (эквивалентно 3,0 г фосфомицина);"}},{"type":"paragraph","data":{"text":"Вспомогательные вещества: сахароза – 2,244 г; ароматизатор апельсиновый – 0,065 г; ароматизатор мандариновый – 0,050 г; сахарин натрия – 0,010 г."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Гомогенный порошок белого или почти белого цвета, с фруктовым запахом, без агломератов и посторонних частиц."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Антибиотик."}}]},{"id":7,"name":"Фармакологические свойства","slug":"","body":[{"type":"paragraph","data":{"text":"Антибиотик широкого спектра действия. Оказывает бактерицидное действие. Является структурным аналогом фосфоэнола пирувата и проникает в микробную клетку. Лекарственный препарат необратимо ингибирует фермент N-ацетил-глюкозамино-3о-энолпирувил-трансферазу, необратимо блокирует конденсацию уридиндифосфатN-ацетил-глюкозамина с фосфоэнолпируватом, подавляет синтез УДФ-N-ацетилмурамовой кислоты, ингибируя, таким образом, начальный этап образования пептидогликана клеточной стенки бактерий. "}},{"type":"paragraph","data":{"text":"Перекрестная резистентность препарата с другими антибактериальными средствами неизвестна. In vitro, при сочетании с амоксициллином, цефалексином, пипемидиновой кислотой, отмечается выраженный синергизм противомикробного действия. In vitro к фосфомицину чувствительны грамположительные (Staphylococcus saprophytticus, Enterococcus faecalis) и грамотрицательные (Escherichia coli, Klebsiella pneumoniea, Citrobacter spp., Enterobacter spp., Proteus mirabilis) микроорганизмы. In vitro фосфомицин трометамол снижает адгезию ряда бактерий к эпителию мочевыводящих путей."}},{"type":"paragraph","data":{"text":"Фармакокинетика Всасывание:"}},{"type":"paragraph","data":{"text":"Фосфомицин умеренно всасывается из желудочно-кишечного тракта при пероральном приеме. В организме диссоциирует на фосфомицин и трометамол."}},{"type":"paragraph","data":{"text":"Биодоступность разовой дозы 3 г при пероральном приеме составляет от 32 % до 54 %. Максимальная концентрация в плазме (С max) наблюдается через 2-3 часа (t max) после перорального приема и составляет около 30 мг/л. Период полувыведения из плаз-"}},{"type":"paragraph","data":{"text":"Falz мы крови варьирует от 3 до 4 часов."}},{"type":"paragraph","data":{"text":"Распределение:"}},{"type":"paragraph","data":{"text":"Фосфомицин не связывается с белками плазмы, не метаболизируется, преимущественно накапливается в моче. Уже через 2-4 часа после перорального приема разовой дозы 3 г в моче достигается высокая терапевтическая концентрация 2-4 г/л, снижающаяся до 1-2 г/л через 6-12 часов. Средние концентрации через 12 - 24 часа и через 36-48 часов составили 0,762 г/л и 0,147 г/л соответственно."}},{"type":"paragraph","data":{"text":"Минимальная ингибирующая концентрация (0,128 г/л), бактерицидная для большинства обычных возбудителей инфекций мочевыводящих путей, сохраняется в моче на протяжении не менее 48 часов, что обусловливает лечение однократной дозой. "}},{"type":"paragraph","data":{"text":"Выведение:"}},{"type":"paragraph","data":{"text":"Основная часть выводится почками в неизменном виде. Небольшая часть экскретируется через кишечник."}},{"type":"paragraph","data":{"text":"В случае умеренного снижения почечной функции период полувыведения фосфомицина почками немного удлиняется в зависимости от степени функционального нарушения."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Бактериальные инфекции мочевыводящих путей различной локализации, вызываемые чувствительными к фосфомицину микроорганизмами: острые неосложненные инфекции мочевыводящих путей; бессимптомная бактериурия; профилактика инфекций мочевыводящих путей после хирургического вмешательства и трансуретральных диагностических исследований. "}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"-\tповышенная чувствительность к фосфомицину или другим компонентам препарата;"}},{"type":"paragraph","data":{"text":"-\tтяжелая почечная недостаточность (клиренс креатинина < 20 мл/мин);"}},{"type":"paragraph","data":{"text":"-\tдети младше 12 лет, поскольку недостаточно данных по его применению;"}},{"type":"paragraph","data":{"text":"-\tдефицит сахаразы/изомальтазы; "}},{"type":"paragraph","data":{"text":"-\tнепереносимость фруктозы;"}},{"type":"paragraph","data":{"text":"-\tглюкозо-галактозная мальабсорбция. "}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"При беременности применяют только в случае, если предполагаемая польза для матери превышает потенциальный риск для плода."}},{"type":"paragraph","data":{"text":"При назначении препарата в период лактации следует прекратить грудное вскармливание на время лечения."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь."}},{"type":"paragraph","data":{"text":"Фосфомицин Эспарма применяют однократно, натощак, за 2-3 ч до или после приема пищи, предпочтительно перед сном, предварительно опорожнив мочевой пузырь: взрослым и детям старше 12 лет в суточной дозе 3 г. Содержимое одного пакета растворяют примерно в 150-200 мл воды и принимают непосредственно после приготовления. "}},{"type":"paragraph","data":{"text":"Курс лечения составляет 1 день."}},{"type":"paragraph","data":{"text":"Для профилактики инфекций мочевыводящих путей при хирургическом вмешательстве, диагностических процедурах указанная доза принимается 2 раза – за 3 ч до вмешательства и через 24 ч после него."}},{"type":"paragraph","data":{"text":"Не следует принимать Фосфомицин Эспарма пациентам с массой тела ниже 50 кг и детям в возрасте до 12 лет, поскольку дозу нельзя разделить или уменьшить. "}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"По частоте развития побочные явления находятся в следующих группах:"}},{"type":"paragraph","data":{"text":"Очень частые: (≥ 1/10)"}},{"type":"paragraph","data":{"text":"Частые: (≥ 1/100 - < 1/10)"}},{"type":"paragraph","data":{"text":"Не частые: (≥ 1/1.000 - < 1/100)"}},{"type":"paragraph","data":{"text":"Редкие: (≥ 1/10.000 - < 1/1.000)"}},{"type":"paragraph","data":{"text":"Очень редкие: (< 1/10.000)"}},{"type":"paragraph","data":{"text":"Неизвестно: (частота возникновения побочных явлений на основании существующих данных не определяется)."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы:"}},{"type":"paragraph","data":{"text":"Частые: головная боль, головокружение, астения"}},{"type":"paragraph","data":{"text":"Не частые: ощущение онемения кожи, \"ползания мурашек\", парестезия Неизвестно: неврит зрительного нерва"}},{"type":"paragraph","data":{"text":"Со стороны сердечно - сосудистой системы: Редкие: тахикардия"}},{"type":"paragraph","data":{"text":"Неизвестно: снижение артериального давления"}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы, органов грудной клетки и средостения:"}},{"type":"paragraph","data":{"text":"Неизвестно: бронхиальная астма"}},{"type":"paragraph","data":{"text":"Со стороны иммунной системы:"}},{"type":"paragraph","data":{"text":"Неизвестно: кожный зуд, анафилактический шок, реакции повышенной чувствительности (ангионевротический отек, кожная сыпь, крапивница)"}},{"type":"paragraph","data":{"text":"Со стороны желудочно-кишечного тракта:"}},{"type":"paragraph","data":{"text":"Не частые: диарея, тошнота, диспепсия"}},{"type":"paragraph","data":{"text":"Редкие: рвота"}},{"type":"paragraph","data":{"text":"Неизвестно: псевдомембранозный колит, боль в животе"}},{"type":"paragraph","data":{"text":"Со стороны печени и желчевыводящих путей:"}},{"type":"paragraph","data":{"text":"Не частые: повышение активности «печеночных» трансаминаз"}},{"type":"paragraph","data":{"text":"Со стороны половых органов и молочной железы: Не частые: вульвовагинит"}},{"type":"paragraph","data":{"text":"Со стороны крови и лимфатической системы:"}},{"type":"paragraph","data":{"text":"Не частые: тромбоцитоз, лейкопения"}},{"type":"paragraph","data":{"text":"Если любые из указанных в инструкции побочных эффектов усугубляются или Вы заметили любые другие побочные эффекты не указанные в инструкции, сообщите об этом врачу."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы передозировки: вестибулярный синдром, нарушение слуха, «металлический» вкус и общие нарушения вкуса, диарея. Специфический антидот не выявлен. При необходимости проводится симптоматическое лечение. "}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Одновременный прием с метоклопрамидом, антацидами или препаратами, содержащими соли кальция, может привести к снижению концентрации фосфомицина в сыворотке крови и в моче. По этой причине препараты рекомендуется принимать с интервалом 2-3 часа."}},{"type":"paragraph","data":{"text":"Одновременный прием с другими препаратами, которые усиливают моторику желудочно-кишечного тракта, также может привести к снижению концентрации фосфомицина в сыворотке крови и в моче."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Возникновение острой и упорной диареи во время или после лечения антибиотиками может быть симптомом колита, вызванного приемом антибиотиков. Наиболее серьезная форма – псевдомембранозный колит. "}},{"type":"paragraph","data":{"text":"В случае псевдомембранозного колита необходимо незамедлительно принять соответствующие меры. В таком случае, использование препаратов, замедляющих перистальтику, противопоказано. "}},{"type":"paragraph","data":{"text":"В составе препарата содержится сахароза. Пациентам с редкими наследственными заболеваниями, непереносимостью фруктозы, нарушением всасывания глюкозы-галактозы или недостаточностью сахаразы-изомальтазы данный препарат принимать не следует."}},{"type":"paragraph","data":{"text":"В одном пакете Фосфомицина Эспарма содержится примерно 2,3 г сахарозы, что эквивалентно примерно 0, 19 хлебных единиц (ХE). "}},{"type":"paragraph","data":{"text":"Одновременный прием пищи замедляет всасывание гранул, поэтому рекомендуется прием препарата натощак, за 2-3 часа до или после приема пищи."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Пациенты должны быть предупреждены о возможности развития головокружения и при появлении головокружения следует воздержаться от выполнения указанных видов деятельности. "}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Порошок для приготовления раствора для приема внутрь 3 г. "}},{"type":"paragraph","data":{"text":"По 8 г порошка в пакетах из трехслойного материала (бумага-алюминий-полиэтилен). 1 пакет с инструкцией по применению в пачку картонную."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"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":"2 года."}},{"type":"paragraph","data":{"text":"Не использовать после истечения срока годности, указанного на упаковке. "}}]},{"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":"Эспарма ГмбХ, "}},{"type":"paragraph","data":{"text":"Билефельдер штрассе 1, 39171 Зюльцеталь, Германия."}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"115114, г. Москва, ул. 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