Синтетический противогрибковый препарат широкого спектра дей... Инструкция
Показания к применению
Дерматомикозы
Грибковый кератит
Онихомикозы, вызванные дерматофитами и/или дрожжами и плесневыми грибами
Системные микозы: системный аспергиллез и кандидоз; криптококкоз, включая криптококковый менингит (пациентам с иммунодефицитом и пациентам с криптококкозом ЦНС Румикоз; следует назначать только в случаях, если препараты первой линии лечения не применимы в данном случае или не эффективны); гистоплазмоз; споротрихоз; паракокцидиоидомикоз; бластомикоз; другие системные или тропические микозы
Одновременное с Румикозом применение лекарственных средств, метаболизирующихся с участием изофермента CYP3A4, которые способны увеличивать интервал QT (терфенадин, астемизол, мизоластин, цизаприд, дофетилид, хинидин, пимозид, левометадон, сертиндол); ингибиторов ГМГ-КоА-редуктазы, метаболизирующихся с участием изофермента CYP3A4 (симвастатин, ловастатин); мидазолама и триазолама (для приема внутрь); препаратов алкалоидов спорыньи (дигидроэрготамин, эргометрин, эрготамин и метилэргометрин)
Повышенная чувствительность к компонентам препарата
Синтетический противогрибковый препарат широкого спектра действия, производное триазола. Ингибирует синтез эргостерола клеточной мембраны грибов, что обуславливает противогрибковый эффект препарата.; Итраконазол активен в отношении дерматофитов (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), дрожжеподобных грибов и дрожжей (Cryptococcus neoformans, Pityrosporum spp., Trichosporon spp., Geotrichum spp., Candida spp., включая Candida albicans, Candida glabrata, Candida krusei), Aspergillus spp., Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cladosporium spp., Blastomyces dermatidis, Pseudallescheria boydii, Penicillium marneffei, а также в отношении других дрожжевых и плесневых грибов.
Показания к применению
Дерматомикозы
Грибковый кератит
Онихомикозы, вызванные дерматофитами и/или дрожжами и плесневыми грибами
Системные микозы: системный аспергиллез и кандидоз; криптококкоз, включая криптококковый менингит (пациентам с иммунодефицитом и пациентам с криптококкозом ЦНС Румикоз; следует назначать только в случаях, если препараты первой линии лечения не применимы в данном случае или не эффективны); гистоплазмоз; споротрихоз; паракокцидиоидомикоз; бластомикоз; другие системные или тропические микозы
Кандидоз с поражением кожи или слизистых (в т.ч. вульвовагинальный кандидоз)
Глубокие висцеральные кандидозы
Отрубевидный лишай
Противопоказания
Одновременное с Румикозом применение лекарственных средств, метаболизирующихся с участием изофермента CYP3A4, которые способны увеличивать интервал QT (терфенадин, астемизол, мизоластин, цизаприд, дофетилид, хинидин, пимозид, левометадон, сертиндол); ингибиторов ГМГ-КоА-редуктазы, метаболизирующихся с участием изофермента CYP3A4 (симвастатин, ловастатин); мидазолама и триазолама (для приема внутрь); препаратов алкалоидов спорыньи (дигидроэрготамин, эргометрин, эрготамин и метилэргометрин)
Повышенная чувствительность к компонентам препарата
С осторожностью следует применять препарат у детей, у пациентов с тяжелой сердечной недостаточностью, с заболеваниями печени (в т.ч. сопровождающимися печеночной недостаточностью), при хронической почечной недостаточности.
Применение при беременности и в период грудного вскармливания
При беременности препарат следует назначать только в том случае, когда потенциальная польза терапии для матери превышает потенциальный риск для плода.; При необходимости применения препарата в период лактации следует прекратить грудное вскармливание.; Женщинам детородного возраста, принимающим итраконазол, необходимо использовать адекватные методы контрацепции на протяжении всего курса лечения вплоть до наступления первой менструации после его завершения.
Способ применения и дозы
Препарат назначают внутрь после еды.; Таблица 1.; Вульвовагинальный кандидоз 200 мг 2 раза/сут 1 день; 200 мг 1 раз/сут 3 дня; Отрубевидный лишай 200 мг 1 раз/сут 7 дней; Дерматомикозы гладкой кожи 200 мг 1 раз/сут 7 дней; 100 мг 1 раз/сут 15 дней; Поражения высококератинизированных областей кожного покрова, таких как кисти рук и стопы 200 мг 2 раз/сут 7 дней; 100 мг 1 раз/сут 30 дней; Оральный кандидоз 100 мг 1 раз/сут 15 дней; Грибковый кератит 200 мг 1 раз/сут 21 день; Возможна коррекция длительности лечения с учетом положительной динамики клинической картины; Биодоступность итраконазола при пероральном приеме может быть снижена у некоторых пациентов с нарушенным иммунитетом, например, у больных с нейтропенией, больных СПИД или перенесших трансплантацию органов. В подобных случаях может потребоваться двукратное увеличение дозы.; Онихомикозы, вызванные дерматофитами и/или дрожжами, плесневыми грибами; Пульс-терапия; Один курс пульс-терапии заключается в ежедневном приеме Румикоза по 200 мг 2 раза/сут (по 2 капс. 2 раза/сут) в течение 1 недели (таблица 2).; Для лечения грибковых поражений ногтевых пластинок кистей рекомендуется 2 курса.; Для лечения грибковых поражений ногтевых пластинок стоп рекомендуется 3 курса.; Интервал между курсами, в течение которого не нужно принимать препарат, составляет 3 недели. Клинические результаты становятся очевидны после окончания лечения, по мере отрастания ногтей.; Непрерывная терапия; При поражении ногтевых пластинок стоп с поражением или без поражения ногтевых пластинок кистей доза составляет 200 мг/сут, продолжительность лечения - 3 мес.; Выведение Румикоза из кожи и ногтевой ткани осуществляется медленнее, чем из плазмы. Таким образом, оптимальные клинические и микологические эффекты достигаются через 2-4 недели после окончания лечения при поражениях кожи и через 6-9 мес после окончания лечения заболеваний ногтей.;
Побочное действие
Со стороны пищеварительной системы: диспепсия, тошнота, рвота, снижение аппетита, боль в животе, диарея, запор, обратимое повышение активности печеночных ферментов, гепатит; очень редко - тяжелое токсическое поражение печени, в т.ч. случаи острой печеночной недостаточности с летальным исходом.; Со стороны ЦНС и периферической нервной системы: головная боль, головокружение, периферическая невропатия.; Аллергические реакции: кожная сыпь, кожный зуд, крапивница, ангионевротический отек; редко - многоформная экссудативная эритема (синдром Стивенса-Джонсона).; Дерматологические реакции: алопеция, фотосенсибилизация.; Прочие: нарушения менструального цикла, гипокалиемия, отечный синдром, застойная сердечная недостаточность и отек легких, окрашивание мочи в темный цвет, гиперкреатининемия.
Передозировка
Данные о случаях передозировки препарата Румикоз; отсутствуют.; Лечение: при случайной передозировке следует применять поддерживающие меры. В течение первого часа провести промывание желудка и, если это необходимо, назначить активированный уголь. Итраконазол не выводится из организма при гемодиализе. Специфического антидота не существует.
Особые указания
При исследовании в/в лекарственной формы итраконазола отмечалось преходящее бессимптомное уменьшение фракции выброса левого желудочка, нормализовавшееся до следующей инфузии препарата.; Обнаружено, что итраконазол обладает отрицательным инотропным эффектом. Сообщалось о случаях развития сердечной недостаточности, связанных с приемом Румикоза. Поэтому препарат не назначают пациентам с хронической сердечной недостаточностью или с наличием этого заболевания в анамнезе, за исключением случаев, когда ожидаемая польза терапии значительно превосходит потенциальный риск.; Блокаторы кальциевых каналов могут оказывать отрицательный инотропный эффект, который может усиливать подобный эффект итраконазола; итраконазол способен замедлять метаболизм блокаторов кальциевых каналов. При одновременном применении итраконазола и блокаторов кальциевых каналов требуется осторожность.; У пациентов с почечной недостаточностью возможно снижение биодоступности итраконазола, в таких случаях может потребоваться коррекция дозы.; При пониженной кислотности желудка абсорбция итраконазола нарушается. Пациентам, получающим антацидные препараты (например, гидроксид алюминия), рекомендуется принимать их не ранее чем через 2 ч после приема Румикоза. Пациентам с ахлоргидрией, а также больным, принимающим блокаторы гистаминовых Н2-рецепторов или ингибиторы протоновой помпы, рекомендуется принимать итраконазол с кислыми напитками.; В очень редких случаях при применении Румикоза развивалось тяжелое токсическое поражение печени, иногда с острой печеночной недостаточностью и летальным исходом. Это наблюдалось у пациентов с уже имеющимися заболеваниями печени, а также у пациентов, получавших другие лекарственные средства, обладающие гепатотоксическим действием. Несколько таких случаев возникли в первый месяц терапии, а некоторые - в первую неделю лечения. В связи с этим рекомендуется регулярно контролировать функцию печени у пациентов, получающих Румикоз;.; Лечение следует прекратить при возникновении невропатии, которая может быть связана с приемом Румикоза.; Нет данных о перекрестной гиперчувствительности к итраконазолу и другим азоловым противогрибковым препаратам. Румикоз; следует с осторожностью назначать пациентам с гиперчувствительностью к другим азоловым противогрибковым средствам.; У пациентов с нарушенным иммунитетом (СПИД, состояние после трансплантации органов, нейтропения) может потребоваться увеличение дозы Румикоза.; Использование в педиатрии; Румикоз; не следует назначать детям, за исключением случаев, когда ожидаемая польза терапии превосходит возможный риск.; Влияние на способность к вождению автотранспорта и управлению механизмами; Влияния на способность к управлению автомобилем и работе с техникой не наблюдалось.
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100 мг; Вспомогательные вещества: гипромеллоза, полоксамер (лутрол), крахмал пшеничный, сахароза.; Состав твердых желатиновых капсул: желатин, титана диоксид, хинолиновый желтый, железа оксид красный, железа оксид черный, желтый закатный, азорубин."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Синтетический противогрибковый препарат широкого спектра действия, производное триазола. Ингибирует синтез эргостерола клеточной мембраны грибов, что обуславливает противогрибковый эффект препарата.; Итраконазол активен в отношении дерматофитов (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), дрожжеподобных грибов и дрожжей (Cryptococcus neoformans, Pityrosporum spp., Trichosporon spp., Geotrichum spp., Candida spp., включая Candida albicans, Candida glabrata, Candida krusei), Aspergillus spp., Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cladosporium spp., Blastomyces dermatidis, Pseudallescheria boydii, Penicillium marneffei, а также в отношении других дрожжевых и плесневых грибов."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Дерматомикозы","Грибковый кератит","Онихомикозы, вызванные дерматофитами и/или дрожжами и плесневыми грибами","Системные микозы: системный аспергиллез и кандидоз; криптококкоз, включая криптококковый менингит (пациентам с иммунодефицитом и пациентам с криптококкозом ЦНС Румикоз; следует назначать только в случаях, если препараты первой линии лечения не применимы в данном случае или не эффективны); гистоплазмоз; споротрихоз; паракокцидиоидомикоз; бластомикоз; другие системные или тропические микозы","Кандидоз с поражением кожи или слизистых (в т.ч. вульвовагинальный кандидоз)","Глубокие висцеральные кандидозы","Отрубевидный лишай"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Одновременное с Румикозом применение лекарственных средств, метаболизирующихся с участием изофермента CYP3A4, которые способны увеличивать интервал QT (терфенадин, астемизол, мизоластин, цизаприд, дофетилид, хинидин, пимозид, левометадон, сертиндол); ингибиторов ГМГ-КоА-редуктазы, метаболизирующихся с участием изофермента CYP3A4 (симвастатин, ловастатин); мидазолама и триазолама (для приема внутрь); препаратов алкалоидов спорыньи (дигидроэрготамин, эргометрин, эрготамин и метилэргометрин)","Повышенная чувствительность к компонентам препарата"]}},{"type":"paragraph","data":{"text":"С осторожностью следует применять препарат у детей, у пациентов с тяжелой сердечной недостаточностью, с заболеваниями печени (в т.ч. сопровождающимися печеночной недостаточностью), при хронической почечной недостаточности."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При беременности препарат следует назначать только в том случае, когда потенциальная польза терапии для матери превышает потенциальный риск для плода.; При необходимости применения препарата в период лактации следует прекратить грудное вскармливание.; Женщинам детородного возраста, принимающим итраконазол, необходимо использовать адекватные методы контрацепции на протяжении всего курса лечения вплоть до наступления первой менструации после его завершения."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат назначают внутрь после еды.; Таблица 1.; Вульвовагинальный кандидоз 200 мг 2 раза/сут 1 день; 200 мг 1 раз/сут 3 дня; Отрубевидный лишай 200 мг 1 раз/сут 7 дней; Дерматомикозы гладкой кожи 200 мг 1 раз/сут 7 дней; 100 мг 1 раз/сут 15 дней; Поражения высококератинизированных областей кожного покрова, таких как кисти рук и стопы 200 мг 2 раз/сут 7 дней; 100 мг 1 раз/сут 30 дней; Оральный кандидоз 100 мг 1 раз/сут 15 дней; Грибковый кератит 200 мг 1 раз/сут 21 день; Возможна коррекция длительности лечения с учетом положительной динамики клинической картины; Биодоступность итраконазола при пероральном приеме может быть снижена у некоторых пациентов с нарушенным иммунитетом, например, у больных с нейтропенией, больных СПИД или перенесших трансплантацию органов. В подобных случаях может потребоваться двукратное увеличение дозы.; Онихомикозы, вызванные дерматофитами и/или дрожжами, плесневыми грибами; Пульс-терапия; Один курс пульс-терапии заключается в ежедневном приеме Румикоза по 200 мг 2 раза/сут (по 2 капс. 2 раза/сут) в течение 1 недели (таблица 2).; Для лечения грибковых поражений ногтевых пластинок кистей рекомендуется 2 курса.; Для лечения грибковых поражений ногтевых пластинок стоп рекомендуется 3 курса.; Интервал между курсами, в течение которого не нужно принимать препарат, составляет 3 недели. Клинические результаты становятся очевидны после окончания лечения, по мере отрастания ногтей.; Непрерывная терапия; При поражении ногтевых пластинок стоп с поражением или без поражения ногтевых пластинок кистей доза составляет 200 мг/сут, продолжительность лечения - 3 мес.; Выведение Румикоза из кожи и ногтевой ткани осуществляется медленнее, чем из плазмы. Таким образом, оптимальные клинические и микологические эффекты достигаются через 2-4 недели после окончания лечения при поражениях кожи и через 6-9 мес после окончания лечения заболеваний ногтей.;"}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: диспепсия, тошнота, рвота, снижение аппетита, боль в животе, диарея, запор, обратимое повышение активности печеночных ферментов, гепатит; очень редко - тяжелое токсическое поражение печени, в т.ч. случаи острой печеночной недостаточности с летальным исходом.; Со стороны ЦНС и периферической нервной системы: головная боль, головокружение, периферическая невропатия.; Аллергические реакции: кожная сыпь, кожный зуд, крапивница, ангионевротический отек; редко - многоформная экссудативная эритема (синдром Стивенса-Джонсона).; Дерматологические реакции: алопеция, фотосенсибилизация.; Прочие: нарушения менструального цикла, гипокалиемия, отечный синдром, застойная сердечная недостаточность и отек легких, окрашивание мочи в темный цвет, гиперкреатининемия."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Данные о случаях передозировки препарата Румикоз; отсутствуют.; Лечение: при случайной передозировке следует применять поддерживающие меры. В течение первого часа провести промывание желудка и, если это необходимо, назначить активированный уголь. Итраконазол не выводится из организма при гемодиализе. Специфического антидота не существует."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При исследовании в/в лекарственной формы итраконазола отмечалось преходящее бессимптомное уменьшение фракции выброса левого желудочка, нормализовавшееся до следующей инфузии препарата.; Обнаружено, что итраконазол обладает отрицательным инотропным эффектом. Сообщалось о случаях развития сердечной недостаточности, связанных с приемом Румикоза. Поэтому препарат не назначают пациентам с хронической сердечной недостаточностью или с наличием этого заболевания в анамнезе, за исключением случаев, когда ожидаемая польза терапии значительно превосходит потенциальный риск.; Блокаторы кальциевых каналов могут оказывать отрицательный инотропный эффект, который может усиливать подобный эффект итраконазола; итраконазол способен замедлять метаболизм блокаторов кальциевых каналов. При одновременном применении итраконазола и блокаторов кальциевых каналов требуется осторожность.; У пациентов с почечной недостаточностью возможно снижение биодоступности итраконазола, в таких случаях может потребоваться коррекция дозы.; При пониженной кислотности желудка абсорбция итраконазола нарушается. Пациентам, получающим антацидные препараты (например, гидроксид алюминия), рекомендуется принимать их не ранее чем через 2 ч после приема Румикоза. Пациентам с ахлоргидрией, а также больным, принимающим блокаторы гистаминовых Н2-рецепторов или ингибиторы протоновой помпы, рекомендуется принимать итраконазол с кислыми напитками.; В очень редких случаях при применении Румикоза развивалось тяжелое токсическое поражение печени, иногда с острой печеночной недостаточностью и летальным исходом. Это наблюдалось у пациентов с уже имеющимися заболеваниями печени, а также у пациентов, получавших другие лекарственные средства, обладающие гепатотоксическим действием. Несколько таких случаев возникли в первый месяц терапии, а некоторые - в первую неделю лечения. В связи с этим рекомендуется регулярно контролировать функцию печени у пациентов, получающих Румикоз;.; Лечение следует прекратить при возникновении невропатии, которая может быть связана с приемом Румикоза.; Нет данных о перекрестной гиперчувствительности к итраконазолу и другим азоловым противогрибковым препаратам. Румикоз; следует с осторожностью назначать пациентам с гиперчувствительностью к другим азоловым противогрибковым средствам.; У пациентов с нарушенным иммунитетом (СПИД, состояние после трансплантации органов, нейтропения) может потребоваться увеличение дозы Румикоза.; Использование в педиатрии; Румикоз; не следует назначать детям, за исключением случаев, когда ожидаемая польза терапии превосходит возможный риск.; Влияние на способность к вождению автотранспорта и управлению механизмами; Влияния на способность к управлению автомобилем и работе с техникой не наблюдалось."}}]},{"id":17,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом, защищенном от света месте, при температуре не выше 25 °C."}}]},{"id":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту."}}]},{"id":21,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.eapteka.ru/goods/manufacturer/valenta_farma/\"\u003eВалента Фарм, Россия\u003c/a\u003e."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Синтетический противогрибковый препарат широкого спектра действия, производное триазола. 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