Флуконазол, представитель класса триазольных противогрибковы... Инструкция
Показания к применению
Криптококкоз: криптококковый менингит, криптококковые инфекции легких и кожи, криптококковый сепсис, профилактика рецидивов криптококкоза у больных СПИД, при трансплантации органов или других случаях иммунодефицита, генерализованный кандидоз, кандидемия, диссеминированный кандидоз и другие формы инвазивных кандидозных инфекций (инфекции брюшной полости, ...
Одновременный прием терфенадина (на фоне постоянного приема флуконазола в дозе 400 мг/сут и выше) и цизаприда, т.к. оба препарата удлиняют интервал QT и увеличивают риск развития тяжелых нарушений ритма сердца, одновременное применение астемизола, период лактации (грудного вскармливания), непереносимость лактозы, дефицит лактазы, глюкозо-галактозная ...
Флуконазол, представитель класса триазольных противогрибковых средств, является селективным ингибитором синтеза стеролов в клетке грибов. Флуконазол, являясь высокоизбирательным для цитохрома Р450 грибов, практически не угнетает систему цитохрома Р450 в организме человека (в сравнении с итраконазолом, клотримазолом, эконазолом и кетоконазолом в меньшей степени подавляет зависимые от цитохрома Р450 окислительные процессы в микросомах печени человека). Не обладает андрогенной активностью. Активен в отношении возбудителей микозов, вызванных Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp. Показана также активность флуконазола на моделях эндемичных микозов, включая инфекции, вызванные Blastomyces dermatitidis, Coccidioides immitis и Histoplasma capsulatum.
Показания к применению
Криптококкоз: криптококковый менингит, криптококковые инфекции легких и кожи, криптококковый сепсис, профилактика рецидивов криптококкоза у больных СПИД, при трансплантации органов или других случаях иммунодефицита, генерализованный кандидоз, кандидемия, диссеминированный кандидоз и другие формы инвазивных кандидозных инфекций (инфекции брюшной полости, эндокарда, глаз, дыхательных и мочевыводящих путей), в т.ч. у больных, получающих курс цитостатической или иммунодепрессивной терапии, а также при наличии других факторов, предрасполагающих к развитию кандидоза - лечение и профилактика, кандидоз слизистых оболочек: полости рта, в т.ч. атрофический кандидоз полости рта, связанный с ношением зубных протезов, глотки, пищевода и неинвазивные бронхолегочные инфекции, кандидурия, профилактика рецидива орофарингеального кандидоза у больных СПИД, генитальный кандидоз: вагинальный (острый или хронический рецидивирующий), профилактика грибковых инфекций у больных со злокачественными новообразованиями, которые предрасположены к таким инфекциям в результате химиотерапии цитостатиками или лучевой терапии, микозы кожи, туловища, паховой области, глубокие эндемические микозы, включая кокцидиоидомикоз, паракокцидиоидомикоз и гистоплазмоз у больных с нормальным иммунитетом.
Противопоказания
Одновременный прием терфенадина (на фоне постоянного приема флуконазола в дозе 400 мг/сут и выше) и цизаприда, т.к. оба препарата удлиняют интервал QT и увеличивают риск развития тяжелых нарушений ритма сердца, одновременное применение астемизола, период лактации (грудного вскармливания), непереносимость лактозы, дефицит лактазы, глюкозо-галактозная мальабсорбция, повышенная чувствительность к компонентам препарата или близким по структуре азольным соединениям.
Применение при беременности и в период грудного вскармливания
Применение препарата Микосист® при беременности возможно только в том случае, когда потенциальная польза для матери превосходит риск для плода. Флуконазол определяется в грудном молоке в такой же концентрации, как и в плазме, поэтому его назначение в период лактации противопоказано.
Способ применения и дозы
При криптококковых инфекциях обычная доза флуконазола составляет 400 мг 1 раз/сут в первый день лечения, в дальнейшем - по 200-400 мг 1 раз/сут. Продолжительность лечения при криптококковых инфекциях зависит от клинической эффективности, подтвержденной микологическим исследованием, и обычно составляет от 6 до 8 недель. Рекомендуемая продолжительность лечения при терапии криптококкового менингита составляет 10-12 недель после отрицательного результата микробиологического исследования пробы спинномозговой жидкости. Для профилактики рецидива криптококкового менингита у больных СПИД после завершения полного курса первичной терапии флуконазол назначают в дозе не менее 200 мг/сут в течение длительного периода. При кандидемии, диссеминированном кандидозе и других инвазивных кандидозных инфекциях доза флуконазола составляет 400 мг в первые сутки и 200 мг в последующие дни. При необходимости доза препарата может быть увеличена до 400 мг/сут. Продолжительность лечения зависит от клинической эффективности. При тяжелом системном кандидозе возможно увеличение дозы до 800 мг/сут. Длительность терапии зависит от клинической эффективности. Следует продолжать не менее 2 недель после получения отрицательной гемокультуры или после исчезновения симптомов заболевания. При орофарингеальном кандидозе, включая больных с нарушениями иммунитета, обычная доза флуконазола составляет 50-100 мг 1 раз/сут в течение 7-14 дней. Для профилактики рецидивов орофарингеального кандидоза у больных СПИД после завершения полного курса первичной терапии - по 150 мг 1 раз в неделю. В случае необходимости лечение может быть продлено, особенно при тяжелых нарушениях иммунитета. При атрофическом кандидозе полости рта, связанном с ношением зубных протезов, флуконазол обычно назначают по 50 мг 1 раз/сут в течение 14 дней в сочетании с антисептическими средствами для обработки протеза. При других кандидозных инфекциях, например, при эзофагите, неинвазивных бронхолегочных инфекциях, кандидурии, кандидозе кожи и слизистых оболочек суточная доза составляет 50-100 мг в течение 14-30 дней. При тяжелом кандидозе слизистых оболочек - 100-200 мг/сут. Для профилактики грибковых инфекций у больных со злокачественными новообразованиями доза флуконазола составляет 50 мг 1 раз/сут до тех пор, пока больной находится в группе повышенного риска вследствие цитостатической или лучевой терапии. При вагинальном кандидозе - 150 мг однократно. Для снижения частоты рецидивов используют 1 раз в месяц по 150 мг в течение 4-12 месяцев, иногда может потребоваться более частое применение. Для профилактики кандидоза рекомендуемая доза флуконазола составляет 50-400 мг 1 раз/сут в зависимости от степени риска развития грибковой инфекции. При наличии высокого риска генерализованной инфекции, например, у больных с ожидаемой выраженной или длительно сохраняющейся нейтропенией, рекомендуемая доза составляет 400 мг 1 раз/сут. Флуконазол назначают за несколько дней до ожидаемого появления нейтропении, после повышения числа нейтрофилов более 1000/мкл лечение продолжают еще в течение 7 сут. При глубоких эндемических микозах может потребоваться применение препарата в дозе 200-400 мг/сут в течение 2 лет. Длительность терапии определяют индивидуально, она может составлять 11-24 месяца при кокцидиоидомикозе, 2-17 месяцев при паракокцидиоидомикозе и 3-17 месяцев при гистоплазмозе. У детей препарат не следует применять в суточной дозе, превышающей таковую у взрослых. Длительность лечения зависит от клинического и микологического эффекта. При кандидозе слизистых оболочек рекомендуемая доза флуконазола составляет 3 мг/кг/сут. В первый день может быть назначена ударная доза 6 мг/кг с целью более быстрого достижения равновесной концентрации. Для лечения генерализованного кандидоза и криптококковой инфекции рекомендуемая доза составляет 6-12 мг/кг/сут в зависимости от тяжести заболевания. Для профилактики грибковых инфекций у детей со сниженным иммунитетом, у которых риск развития инфекции связан с нейтропенией, развивающейся в результате цитотоксической химиотерапии или лучевой терапии, препарат назначают по 3-12 мг/кг в сутки в зависимости от выраженности и длительности сохранения индуцированной нейтропении. У новорожденных флуконазол выводится медленнее, поэтому в первые 2 недели жизни препарат назначают в той же дозе (в мг/кг), что и у детей старшего возраста, но с интервалом 72 ч. Детям в возрасте 3-4 недель ту же дозу вводят с интервалом 48 ч. У пациентов пожилого возраста при отсутствии нарушений функции почек следует придерживаться обычных рекомендаций по дозированию препарата. Для пациентов с нарушениями функции почек (КК < 50 мл/мин) режим дозирования следует скорректировать. Флуконазол выводится преимущественно почками в неизмененном виде. При однократном применении флуконазола изменений дозы не требуется. При необходимости проведения курса лечения у пациентов (включая детей) с нарушением функции почек следует первоначально ввести ударную дозу от 50 мг до 400 мг. В дальнейшем суточную дозу в зависимости от показаний определяют по следующей таблице.
Побочное действие
Со стороны пищеварительной системы: тошнота, рвота, диарея, метеоризм, боль в животе, изменение вкуса, нарушение функции печени (гипербилирубинемия, повышение активности печеночных трансаминаз, ЩФ, желтуха, гепатит, гепатоцеллюлярный некроз, в т.ч. с летальным исходом). Со стороны нервной системы: головная боль, головокружение, судороги. Со стороны органов кроветворения: лейкопения, тромбоцитопения, нейтропения, агранулоцитоз. Аллергические реакции: кожная сыпь, многоформная экссудативная эритема (в т.ч. синдром Стивенса-Джонсона), токсический эпидермальный некролиз (синдром Лайелла), анафилактоидные реакции (в т.ч. ангионевротический отек, отек лица, крапивница, зуд кожи), бронхиальная астма (чаще при непереносимости ацетилсалициловой кислоты). Со стороны сердечно-сосудистой системы: увеличение продолжительности интервала QT на ЭКГ, мерцание/трепетание желудочков. Со стороны обмена веществ: гиперхолестеринемия, гипертриглицеридемия, гипокалиемия. Прочие: нарушение функции почек, алопеция.
Передозировка
Симптомы: тошнота, рвота, диарея, в тяжелых случаях могут отмечаться судороги, галлюцинации, параноидальное поведение. Лечение: промывание желудка, форсированный диурез, гемодиализ, проведение симптоматической терапии. После 3-часового сеанса гемодиализа концентрация флуконазола в плазме крови уменьшается приблизительно на 50%.
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содержит: флуконазол 2 мг. Вспомогательные вещества: хлорид натрия, вода д/и."}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Капсулы Микосист - противогрибкоеове средство."}}]},{"id":3,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Флуконазол, представитель класса триазольных противогрибковых средств, является селективным ингибитором синтеза стеролов в клетке грибов. Флуконазол, являясь высокоизбирательным для цитохрома Р450 грибов, практически не угнетает систему цитохрома Р450 в организме человека (в сравнении с итраконазолом, клотримазолом, эконазолом и кетоконазолом в меньшей степени подавляет зависимые от цитохрома Р450 окислительные процессы в микросомах печени человека). Не обладает андрогенной активностью. Активен в отношении возбудителей микозов, вызванных Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp. Показана также активность флуконазола на моделях эндемичных микозов, включая инфекции, вызванные Blastomyces dermatitidis, Coccidioides immitis и Histoplasma capsulatum."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Криптококкоз: криптококковый менингит, криптококковые инфекции легких и кожи, криптококковый сепсис, профилактика рецидивов криптококкоза у больных СПИД, при трансплантации органов или других случаях иммунодефицита, генерализованный кандидоз, кандидемия, диссеминированный кандидоз и другие формы инвазивных кандидозных инфекций (инфекции брюшной полости, эндокарда, глаз, дыхательных и мочевыводящих путей), в т.ч. у больных, получающих курс цитостатической или иммунодепрессивной терапии, а также при наличии других факторов, предрасполагающих к развитию кандидоза - лечение и профилактика, кандидоз слизистых оболочек: полости рта, в т.ч. атрофический кандидоз полости рта, связанный с ношением зубных протезов, глотки, пищевода и неинвазивные бронхолегочные инфекции, кандидурия, профилактика рецидива орофарингеального кандидоза у больных СПИД, генитальный кандидоз: вагинальный (острый или хронический рецидивирующий), профилактика грибковых инфекций у больных со злокачественными новообразованиями, которые предрасположены к таким инфекциям в результате химиотерапии цитостатиками или лучевой терапии, микозы кожи, туловища, паховой области, глубокие эндемические микозы, включая кокцидиоидомикоз, паракокцидиоидомикоз и гистоплазмоз у больных с нормальным иммунитетом."}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Одновременный прием терфенадина (на фоне постоянного приема флуконазола в дозе 400 мг/сут и выше) и цизаприда, т.к. оба препарата удлиняют интервал QT и увеличивают риск развития тяжелых нарушений ритма сердца, одновременное применение астемизола, период лактации (грудного вскармливания), непереносимость лактозы, дефицит лактазы, глюкозо-галактозная мальабсорбция, повышенная чувствительность к компонентам препарата или близким по структуре азольным соединениям."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Применение препарата Микосист® при беременности возможно только в том случае, когда потенциальная польза для матери превосходит риск для плода. Флуконазол определяется в грудном молоке в такой же концентрации, как и в плазме, поэтому его назначение в период лактации противопоказано."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При криптококковых инфекциях обычная доза флуконазола составляет 400 мг 1 раз/сут в первый день лечения, в дальнейшем - по 200-400 мг 1 раз/сут. Продолжительность лечения при криптококковых инфекциях зависит от клинической эффективности, подтвержденной микологическим исследованием, и обычно составляет от 6 до 8 недель. Рекомендуемая продолжительность лечения при терапии криптококкового менингита составляет 10-12 недель после отрицательного результата микробиологического исследования пробы спинномозговой жидкости. Для профилактики рецидива криптококкового менингита у больных СПИД после завершения полного курса первичной терапии флуконазол назначают в дозе не менее 200 мг/сут в течение длительного периода. При кандидемии, диссеминированном кандидозе и других инвазивных кандидозных инфекциях доза флуконазола составляет 400 мг в первые сутки и 200 мг в последующие дни. При необходимости доза препарата может быть увеличена до 400 мг/сут. Продолжительность лечения зависит от клинической эффективности. При тяжелом системном кандидозе возможно увеличение дозы до 800 мг/сут. Длительность терапии зависит от клинической эффективности. Следует продолжать не менее 2 недель после получения отрицательной гемокультуры или после исчезновения симптомов заболевания. При орофарингеальном кандидозе, включая больных с нарушениями иммунитета, обычная доза флуконазола составляет 50-100 мг 1 раз/сут в течение 7-14 дней. Для профилактики рецидивов орофарингеального кандидоза у больных СПИД после завершения полного курса первичной терапии - по 150 мг 1 раз в неделю. В случае необходимости лечение может быть продлено, особенно при тяжелых нарушениях иммунитета. При атрофическом кандидозе полости рта, связанном с ношением зубных протезов, флуконазол обычно назначают по 50 мг 1 раз/сут в течение 14 дней в сочетании с антисептическими средствами для обработки протеза. При других кандидозных инфекциях, например, при эзофагите, неинвазивных бронхолегочных инфекциях, кандидурии, кандидозе кожи и слизистых оболочек суточная доза составляет 50-100 мг в течение 14-30 дней. При тяжелом кандидозе слизистых оболочек - 100-200 мг/сут. Для профилактики грибковых инфекций у больных со злокачественными новообразованиями доза флуконазола составляет 50 мг 1 раз/сут до тех пор, пока больной находится в группе повышенного риска вследствие цитостатической или лучевой терапии. При вагинальном кандидозе - 150 мг однократно. Для снижения частоты рецидивов используют 1 раз в месяц по 150 мг в течение 4-12 месяцев, иногда может потребоваться более частое применение. Для профилактики кандидоза рекомендуемая доза флуконазола составляет 50-400 мг 1 раз/сут в зависимости от степени риска развития грибковой инфекции. При наличии высокого риска генерализованной инфекции, например, у больных с ожидаемой выраженной или длительно сохраняющейся нейтропенией, рекомендуемая доза составляет 400 мг 1 раз/сут. Флуконазол назначают за несколько дней до ожидаемого появления нейтропении, после повышения числа нейтрофилов более 1000/мкл лечение продолжают еще в течение 7 сут. При глубоких эндемических микозах может потребоваться применение препарата в дозе 200-400 мг/сут в течение 2 лет. Длительность терапии определяют индивидуально, она может составлять 11-24 месяца при кокцидиоидомикозе, 2-17 месяцев при паракокцидиоидомикозе и 3-17 месяцев при гистоплазмозе. У детей препарат не следует применять в суточной дозе, превышающей таковую у взрослых. Длительность лечения зависит от клинического и микологического эффекта. При кандидозе слизистых оболочек рекомендуемая доза флуконазола составляет 3 мг/кг/сут. В первый день может быть назначена ударная доза 6 мг/кг с целью более быстрого достижения равновесной концентрации. Для лечения генерализованного кандидоза и криптококковой инфекции рекомендуемая доза составляет 6-12 мг/кг/сут в зависимости от тяжести заболевания. Для профилактики грибковых инфекций у детей со сниженным иммунитетом, у которых риск развития инфекции связан с нейтропенией, развивающейся в результате цитотоксической химиотерапии или лучевой терапии, препарат назначают по 3-12 мг/кг в сутки в зависимости от выраженности и длительности сохранения индуцированной нейтропении. У новорожденных флуконазол выводится медленнее, поэтому в первые 2 недели жизни препарат назначают в той же дозе (в мг/кг), что и у детей старшего возраста, но с интервалом 72 ч. Детям в возрасте 3-4 недель ту же дозу вводят с интервалом 48 ч. У пациентов пожилого возраста при отсутствии нарушений функции почек следует придерживаться обычных рекомендаций по дозированию препарата. Для пациентов с нарушениями функции почек (КК \u003c 50 мл/мин) режим дозирования следует скорректировать. Флуконазол выводится преимущественно почками в неизмененном виде. При однократном применении флуконазола изменений дозы не требуется. При необходимости проведения курса лечения у пациентов (включая детей) с нарушением функции почек следует первоначально ввести ударную дозу от 50 мг до 400 мг. В дальнейшем суточную дозу в зависимости от показаний определяют по следующей таблице."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: тошнота, рвота, диарея, метеоризм, боль в животе, изменение вкуса, нарушение функции печени (гипербилирубинемия, повышение активности печеночных трансаминаз, ЩФ, желтуха, гепатит, гепатоцеллюлярный некроз, в т.ч. с летальным исходом). Со стороны нервной системы: головная боль, головокружение, судороги. Со стороны органов кроветворения: лейкопения, тромбоцитопения, нейтропения, агранулоцитоз. Аллергические реакции: кожная сыпь, многоформная экссудативная эритема (в т.ч. синдром Стивенса-Джонсона), токсический эпидермальный некролиз (синдром Лайелла), анафилактоидные реакции (в т.ч. ангионевротический отек, отек лица, крапивница, зуд кожи), бронхиальная астма (чаще при непереносимости ацетилсалициловой кислоты). 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