Флуконазол, представитель класса триазольных противогрибковы... Инструкция
Показания к применению
Криптококкоз, включая криптококковый менингит и другие локализации данной инфекции (в т.ч. в легких, на коже), как у больных с нормальным иммунным ответом, так и с различными формами иммуносупрессии (в т.ч. у больных СПИДом, при трансплантации органов); препарат может использоваться для профилактики криптококковой инфекции у больных СПИДом; генерализованный ...
Повышенная чувствительность к препарату или близким по структуре азольным соединениям; одновременный прием терфенадина или астемизола и других препаратов, удлиняющих интервал QT; детский возраст (до 3 лет).
Флуконазол, представитель класса триазольных противогрибковых средств, является мощным селективным ингибитором синтеза стеролов в клетке грибов.; Препарат эффективен при оппортунистических микозах, в т.ч. вызванных Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp. Показана также активность флуконазола на моделях эндемичных микозов, включая инфекции, вызванные Blastomyces dermatitidis, Coccidiodes immitis и Histoplasma capsulatum.;
Показания к применению
Криптококкоз, включая криптококковый менингит и другие локализации данной инфекции (в т.ч. в легких, на коже), как у больных с нормальным иммунным ответом, так и с различными формами иммуносупрессии (в т.ч. у больных СПИДом, при трансплантации органов); препарат может использоваться для профилактики криптококковой инфекции у больных СПИДом; генерализованный кандидоз, включая кандидемию, диссеминированный кандидоз и другие формы инвазивных кандидозных инфекций (инфекции брюшины, эндокарда, глаз, дыхательных и мочевых путей); кандидурия, . Лечение может проводиться у больных со злокачественными новообразованиями, пациентов отделений интенсивной терапии, больных, проходящих курс цитостатической или иммуносупрессивной терапии, а также при наличии других факторов, предрасполагающих к развитию кандидоза; кандидоз слизистых оболочек, в т.ч. полости рта и глотки (включая атрофический кандидоз полости рта, связанный с ношением зубных протезов), пищевода, неинвазивные бронхолегочные кандидозы; профилактика рецидива орофарингеального кандидоза у больных СПИДом; генитальный кандидоз: вагинальный кандидоз (острый и хронический рецидивирующий), профилактическое применение с целью уменьшения частоты рецидивов вагинального кандидоза (3 и более эпизодов в год); кандидозный баланит; профилактика грибковых инфекций у больных со злокачественными новообразованиями, которые предрасположены к таким инфекциям в результате химиотерапии цитостатиками или лучевой терапии; микозы кожи, включая микозы стоп, тела, паховой области, отрубевидный лишай, онихомикоз; кандидозы кожи; глубокие эндемические микозы, включая кокцидиоидомикоз, паракокцидиоидомикоз, споротрихоз и гистоплазмоз у больных с нормальным иммунитетом
Противопоказания
Повышенная чувствительность к препарату или близким по структуре азольным соединениям; одновременный прием терфенадина или астемизола и других препаратов, удлиняющих интервал QT; детский возраст (до 3 лет).
Применение при беременности и в период грудного вскармливания
Применение препарата у беременных нецелесообразно, за исключением тяжелых или угрожающих жизни форм грибковых инфекций, если предполагаемый эффект превышает возможный риск для плода.; Флуконазол находится в грудном молоке в такой же концентрации, как и в плазме, поэтому его назначение в период лактации не рекомендуется;
Способ применения и дозы
Внутрь.; Взрослым при криптококковом менингите и криптококковых инфекциях других локализаций в первый день обычно назначают 400 мг, а затем продолжают лечение в дозе 200–400 мг 1 раз/сут. Продолжительность лечения при криптококковых инфекциях зависит от клинической эффективности, подтвержденной микологическим исследованием; при криптококковом менингите его обычно продолжают по крайней мере 6–8 нед.; Для профилактики рецидива криптококкового менингита у больных СПИДом, после завершения полного курса первичного лечения, флуконазол назначают в дозе 200 мг/сут. в течение длительного периода времени.; При кандидемии, диссеминированном кандидозе и других инвазивных кандидозных инфекциях доза обычно составляет 400 мг в первые сутки, а затем — по 200 мг. При недостаточной клинической эффективности доза препарата может быть увеличена до 400 мг/сут. Длительность терапии зависит от клинической эффективности.; При орофарингеальном кандидозе препарат обычно назначают по 50–100 мг 1 раз/сут.; продолжительность лечения — 7–14 дней. При необходимости, у больных с выраженным снижением иммунитета лечение может быть более длительным.; 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 местными антисептическими средствами для обработки протеза.; При других локализациях кандидоза (за исключением генитального кандидоза), например при эзофагите, неинвазивном бронхолегочном поражении, кандидурии, кандидозе кожи и слизистых оболочек и т.д., эффективная доза обычно составляет 50–100 мг/сут при длительности лечения 14–30 дней. Для профилактики рецидивов орофарингеального кандидоза у больных со СПИДом после завершения полного курса первичной терапии препарат может быть назначен по 150 мг 1 раз в неделю.; При вагинальном кандидозе флуконазол принимают однократно внутрь в дозе 150 мг. Для снижения частоты рецидивов вагинального кандидоза препарат может быть использован в дозе 150 мг 1 раз в мес. Длительность терапии определяют индивидуально; она варьирует от 4 до 12 мес. Некоторым больным может потребоваться более частое применение.; При баланите, вызванном Candida, флуконазол назначают однократно в дозе 150 мг внутрь.; 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/мм3 лечение продолжают еще в течение 7 суток.; При микозах кожи, включая микозы стоп, кожи паховой области, и кандидозах кожи рекомендуемая доза составляет 150 мг 1 раз в неделю или 50 мг 1 раз/сут. Длительность терапии в обычных случаях составляет 2–4 нед, однако при микозах стоп может потребоваться более длительная терапия (до 6 нед.).; При отрубевидном лишае — 300 мг 1 раз в неделю в течение 2 нед., некоторым больным требуется третья доза 300 мг в нед., в то время как в части случаев оказывается достаточным однократный прием 300–400 мг; альтернативной схемой лечения является применение по 50 мг 1 раз в день в течение 2–4 нед.; При онихомикозе рекомендуемая доза составляет 150 мг 1 раз в неделю. Лечение следует продолжать до замещения инфицированного ногтя (вырастания неинфицированного ногтя). Для повторного роста ногтей на пальцах рук и стоп в норме требуется 3–6 и 6–12 мес соответственно.; При глубоких эндемических микозах может потребоваться применение препарата в дозе 200–400 мг/сут. в течение периода до 2 лет. Длительность терапии определяют индивидуально; она может составлять 11–24 мес — при кокцидиоидомикозе; 2–17 мес — при паракокцидиоидомикозе; 1–16 мес — при споротрихозе и 3–17 мес — при гистоплазмозе.; У детей, как и при сходных инфекциях у взрослых, длительность лечения зависит от клинического и микологического эффекта. У детей препарат не следует применять в суточной дозе, которая бы превышала таковую у взрослых. Препарат применяют ежедневно 1 раз/сут.; 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 постоянных равновесных концентраций.; Для лечения генерализованного кандидоза или 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/сут. в зависимости от выраженности и длительности сохранения индуцированной нейтропении.; У детей с нарушениями функции почек суточную дозу препарата следует уменьшить (в той же пропорциональной зависимости, что и у взрослых) в соответствии со степенью выраженности почечной недостаточности.; У больных пожилого возраста при отсутствии нарушений функции почек следует придерживаться обычного режима дозирования препарата. Больным с почечной недостаточностью (Cl креатинина — <50 мл/мин) режим дозирования следует скорректировать, как указано ниже.; Применение препарата у больных с нарушениями функции почек; Флуконазол выводится в основном с мочой в неизмененном виде. При однократном его приеме изменение дозы не требуется. При повторном назначении препарата больным с нарушенной функцией почек следует сначала ввести ударную дозу от 50 до 400 мг. Если Cl креатинина составляет >50 мл/мин, применяется обычная доза препарата (100% рекомендуемой дозы). При Cl креатинина от 11 до 50 мл/мин применяется доза, равная 50% рекомендуемой. Больным, регулярно находящимся на диализе, одна доза препарата применяется после каждого сеанса гемодиализа;
Побочное действие
Со стороны пищеварительной системы: изменения вкуса, рвота, тошнота, диарея, метеоризм, абдоминальные боли, редко — нарушение функции печени (желтуха, гепатит, гепатонекроз, гипербилирубинемия, повышение активности АЛТ, АСТ, ЩФ).; Со стороны нервной системы: головная боль, головокружение, редко — судороги.; Со стороны органов кроветворения: редко — лейкопения, тромбоцитопения, нейтропения, агранулоцитоз.; Аллергические реакции: кожная сыпь, редко — злокачественная экссудативная эритема (синдром Стивенса-Джонсона), токсический эпидермальный некролиз (синдром Лайелла), анафилактоидные реакции.; Прочие: редко — нарушение функции почек, алопеция, гиперхолестеринемия, гипертриглицеридемия, гипокалиемия;
Передозировка
Симптомы: галлюцинации, параноидальное поведение.; Лечение: симптоматическое, промывание желудка, форсированный диурез. Гемодиализ в течение 3 ч снижает концентрацию в плазме приблизительно на 50%.;
Особые указания
В редких случаях применение флуконазола сопровождалось токсическими изменениями печени, в т.ч. с летальным исходом, главным образом у больных с серьезными сопутствующими заболеваниями. В случае гепатотоксических эффектов, связанных с флуконазолом, не отмечено явной зависимости их от общей суточной дозы, длительности терапии, пола и возраста больного. Гепатотоксическое действие флуконазола обычно было обратимым; признаки его исчезали после прекращения терапии. При появлении клинических признаков поражения печени, которые могут быть связаны с флуконазолом, препарат следует отменить.; Больные СПИДом более склонны к развитию тяжелых кожных реакций при применении многих препаратов. В тех случаях, когда у больных с поверхностной грибковой инфекцией развивается сыпь и она расценивается как определенно связанная с флуконазолом, препарат следует отменить. При появлении сыпи у больных с инвазивными/системными грибковыми инфекциями, их следует тщательно наблюдать и отменить флуконазол при появлении буллезных изменений или многоформной эритемы.; Необходимо соблюдать осторожность при одновременном приеме флуконазола с цизапридом, рифабутином или другими препаратами, метаболизирующимися системой цитохрома Р 450;
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Лечение может проводиться у больных со злокачественными новообразованиями, пациентов отделений интенсивной терапии, больных, проходящих курс цитостатической или иммуносупрессивной терапии, а также при наличии других факторов, предрасполагающих к развитию кандидоза; кандидоз слизистых оболочек, в т.ч. полости рта и глотки (включая атрофический кандидоз полости рта, связанный с ношением зубных протезов), пищевода, неинвазивные бронхолегочные кандидозы; профилактика рецидива орофарингеального кандидоза у больных СПИДом; генитальный кандидоз: вагинальный кандидоз (острый и хронический рецидивирующий), профилактическое применение с целью уменьшения частоты рецидивов вагинального кандидоза (3 и более эпизодов в год); кандидозный баланит; профилактика грибковых инфекций у больных со злокачественными новообразованиями, которые предрасположены к таким инфекциям в результате химиотерапии цитостатиками или лучевой терапии; микозы кожи, включая микозы стоп, тела, паховой области, отрубевидный лишай, онихомикоз; кандидозы кожи; глубокие эндемические микозы, включая кокцидиоидомикоз, паракокцидиоидомикоз, споротрихоз и гистоплазмоз у больных с нормальным иммунитетом"}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к препарату или близким по структуре азольным соединениям; одновременный прием терфенадина или астемизола и других препаратов, удлиняющих интервал QT; детский возраст (до 3 лет)."}},{"type":"paragraph","data":{"text":"С осторожностью: печеночная и/или почечная недостаточность, одновременный прием потенциально гепатотоксичных ЛС, алкоголизм"}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Применение препарата у беременных нецелесообразно, за исключением тяжелых или угрожающих жизни форм грибковых инфекций, если предполагаемый эффект превышает возможный риск для плода.; Флуконазол находится в грудном молоке в такой же концентрации, как и в плазме, поэтому его назначение в период лактации не рекомендуется;"}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь.; Взрослым при криптококковом менингите и криптококковых инфекциях других локализаций в первый день обычно назначают 400 мг, а затем продолжают лечение в дозе 200–400 мг 1 раз/сут. Продолжительность лечения при криптококковых инфекциях зависит от клинической эффективности, подтвержденной микологическим исследованием; при криптококковом менингите его обычно продолжают по крайней мере 6–8 нед.; Для профилактики рецидива криптококкового менингита у больных СПИДом, после завершения полного курса первичного лечения, флуконазол назначают в дозе 200 мг/сут. в течение длительного периода времени.; При кандидемии, диссеминированном кандидозе и других инвазивных кандидозных инфекциях доза обычно составляет 400 мг в первые сутки, а затем — по 200 мг. При недостаточной клинической эффективности доза препарата может быть увеличена до 400 мг/сут. Длительность терапии зависит от клинической эффективности.; При орофарингеальном кандидозе препарат обычно назначают по 50–100 мг 1 раз/сут.; продолжительность лечения — 7–14 дней. При необходимости, у больных с выраженным снижением иммунитета лечение может быть более длительным.; 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 местными антисептическими средствами для обработки протеза.; При других локализациях кандидоза (за исключением генитального кандидоза), например при эзофагите, неинвазивном бронхолегочном поражении, кандидурии, кандидозе кожи и слизистых оболочек и т.д., эффективная доза обычно составляет 50–100 мг/сут при длительности лечения 14–30 дней. Для профилактики рецидивов орофарингеального кандидоза у больных со СПИДом после завершения полного курса первичной терапии препарат может быть назначен по 150 мг 1 раз в неделю.; При вагинальном кандидозе флуконазол принимают однократно внутрь в дозе 150 мг. Для снижения частоты рецидивов вагинального кандидоза препарат может быть использован в дозе 150 мг 1 раз в мес. Длительность терапии определяют индивидуально; она варьирует от 4 до 12 мес. Некоторым больным может потребоваться более частое применение.; При баланите, вызванном Candida, флуконазол назначают однократно в дозе 150 мг внутрь.; 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/мм3 лечение продолжают еще в течение 7 суток.; При микозах кожи, включая микозы стоп, кожи паховой области, и кандидозах кожи рекомендуемая доза составляет 150 мг 1 раз в неделю или 50 мг 1 раз/сут. Длительность терапии в обычных случаях составляет 2–4 нед, однако при микозах стоп может потребоваться более длительная терапия (до 6 нед.).; При отрубевидном лишае — 300 мг 1 раз в неделю в течение 2 нед., некоторым больным требуется третья доза 300 мг в нед., в то время как в части случаев оказывается достаточным однократный прием 300–400 мг; альтернативной схемой лечения является применение по 50 мг 1 раз в день в течение 2–4 нед.; При онихомикозе рекомендуемая доза составляет 150 мг 1 раз в неделю. Лечение следует продолжать до замещения инфицированного ногтя (вырастания неинфицированного ногтя). Для повторного роста ногтей на пальцах рук и стоп в норме требуется 3–6 и 6–12 мес соответственно.; При глубоких эндемических микозах может потребоваться применение препарата в дозе 200–400 мг/сут. в течение периода до 2 лет. Длительность терапии определяют индивидуально; она может составлять 11–24 мес — при кокцидиоидомикозе; 2–17 мес — при паракокцидиоидомикозе; 1–16 мес — при споротрихозе и 3–17 мес — при гистоплазмозе.; У детей, как и при сходных инфекциях у взрослых, длительность лечения зависит от клинического и микологического эффекта. У детей препарат не следует применять в суточной дозе, которая бы превышала таковую у взрослых. Препарат применяют ежедневно 1 раз/сут.; 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 постоянных равновесных концентраций.; Для лечения генерализованного кандидоза или 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/сут. в зависимости от выраженности и длительности сохранения индуцированной нейтропении.; У детей с нарушениями функции почек суточную дозу препарата следует уменьшить (в той же пропорциональной зависимости, что и у взрослых) в соответствии со степенью выраженности почечной недостаточности.; У больных пожилого возраста при отсутствии нарушений функции почек следует придерживаться обычного режима дозирования препарата. Больным с почечной недостаточностью (Cl креатинина — \u003c50 мл/мин) режим дозирования следует скорректировать, как указано ниже.; Применение препарата у больных с нарушениями функции почек; Флуконазол выводится в основном с мочой в неизмененном виде. При однократном его приеме изменение дозы не требуется. При повторном назначении препарата больным с нарушенной функцией почек следует сначала ввести ударную дозу от 50 до 400 мг. Если Cl креатинина составляет \u003e50 мл/мин, применяется обычная доза препарата (100% рекомендуемой дозы). При Cl креатинина от 11 до 50 мл/мин применяется доза, равная 50% рекомендуемой. Больным, регулярно находящимся на диализе, одна доза препарата применяется после каждого сеанса гемодиализа;"}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: изменения вкуса, рвота, тошнота, диарея, метеоризм, абдоминальные боли, редко — нарушение функции печени (желтуха, гепатит, гепатонекроз, гипербилирубинемия, повышение активности АЛТ, АСТ, ЩФ).; Со стороны нервной системы: головная боль, головокружение, редко — судороги.; Со стороны органов кроветворения: редко — лейкопения, тромбоцитопения, нейтропения, агранулоцитоз.; Аллергические реакции: кожная сыпь, редко — злокачественная экссудативная эритема (синдром Стивенса-Джонсона), токсический эпидермальный некролиз (синдром Лайелла), анафилактоидные реакции.; Прочие: редко — нарушение функции почек, алопеция, гиперхолестеринемия, гипертриглицеридемия, гипокалиемия;"}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: галлюцинации, параноидальное поведение.; Лечение: симптоматическое, промывание желудка, форсированный диурез. Гемодиализ в течение 3 ч снижает концентрацию в плазме приблизительно на 50%.;"}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В редких случаях применение флуконазола сопровождалось токсическими изменениями печени, в т.ч. с летальным исходом, главным образом у больных с серьезными сопутствующими заболеваниями. В случае гепатотоксических эффектов, связанных с флуконазолом, не отмечено явной зависимости их от общей суточной дозы, длительности терапии, пола и возраста больного. Гепатотоксическое действие флуконазола обычно было обратимым; признаки его исчезали после прекращения терапии. При появлении клинических признаков поражения печени, которые могут быть связаны с флуконазолом, препарат следует отменить.; Больные СПИДом более склонны к развитию тяжелых кожных реакций при применении многих препаратов. В тех случаях, когда у больных с поверхностной грибковой инфекцией развивается сыпь и она расценивается как определенно связанная с флуконазолом, препарат следует отменить. При появлении сыпи у больных с инвазивными/системными грибковыми инфекциями, их следует тщательно наблюдать и отменить флуконазол при появлении буллезных изменений или многоформной эритемы.; Необходимо соблюдать осторожность при одновременном приеме флуконазола с цизапридом, рифабутином или другими препаратами, метаболизирующимися системой цитохрома Р 450;"}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Флуконазол, представитель класса триазольных противогрибковых средств, является мощным селективным ингибитором синтеза стеролов в клетке грибов.; Препарат эффективен при оппортунистических микозах, в т.ч. вызванных Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp. Показана также активность флуконазола на моделях эндемичных микозов, включая инфекции, вызванные Blastomyces dermatitidis, Coccidiodes immitis и Histoplasma 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