Противогрибковый препарат широкого спектра действия, произво... 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), гистоплазмоз, споротрихоз, паракокцидиоидомикоз, бластомикоз и другие системные или тропические микозы; кандидомикозы с поражением кожи или слизистых, ...
Беременным женщинам Орунит следует назначать только в том случае, если ожидаемая польза для женщины превышает потенциальный риск для плода. Женщинам детородного возраста, принимающим Орунит, необходимо использовать адекватные методы контрацепции на протяжении всего курса лечения вплоть до наступления первой менструации после его завершения. С осторожностью ...
Противогрибковый препарат широкого спектра действия, производное триазола. Механизм действия связан со способностью итраконазола ингибировать синтез эргостерина клеточной мембраны грибов. Активен в отношении дерматофитов (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), дрожжеподобных грибов и дрожжей (Cryptococcus neoformans, Pitysporium spp., Candida spp. /включая Candida albicans, Candida glabrata и Candida krusei/, Aspergillus spp., Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cladosporium spp., Blastomyces dermatitidis.
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), гистоплазмоз, споротрихоз, паракокцидиоидомикоз, бластомикоз и другие системные или тропические микозы; кандидомикозы с поражением кожи или слизистых, в том числе вульвовагинальный кандидоз; глубокие висцеральные кандидозы; отрубевидный лишай.
Противопоказания
Беременным женщинам Орунит следует назначать только в том случае, если ожидаемая польза для женщины превышает потенциальный риск для плода. Женщинам детородного возраста, принимающим Орунит, необходимо использовать адекватные методы контрацепции на протяжении всего курса лечения вплоть до наступления первой менструации после его завершения. С осторожностью - детский возраст, тяжелая сердечная недостаточность, заболевания печени (в том числе сопровождающиеся печеночной недостаточностью). Терфенадин, астемизол, мизоластин, цизаприд, дофетилид, хинидин, пимозид, метаболизирующие с участием фермента CYP3A4 ингибиторы редуктазы ГМГ-КоА такие, как симвастатин и ловастатин, триазолам и мидазолам нельзя принимать одновременно с Орунитом. (см. также раздел «Взаимодействия с другими лекарственными средствами»).
Применение при беременности и в период грудного вскармливания
На основании результатов доклинических исследований и в связи с тем, что исследования по применению итраконазола у беременных женщин не проводились, итраконазол следует назначать беременным женщинам только при угрожающих жизни системных микозах, когда потенциальная польза для женщины оправдывает возможный риск для плода. Так как небольшое количество итраконазола выделяется с материнским молоком, ожидаемую пользу от приема итраконазола необходимо сопоставлять с риском для ребенка при грудном вскармливании. В случае сомнений кормить грудью не следует.
Способ применения и дозы
Внутрь, сразу после еды, капсулы проглатывают целиком. Вульвовагинальный кандидоз - 200 мг 2 раза в течение 1 дня или 200 мг 1 раз в сутки в течение 3 дней. Онихомикоз - 200 мг/сут в течение 3 мес или по 200 мг 2 раза в сутки в течение 1 нед с последующим перерывом 3 нед (при онихомикозе стоп рекомендуется 3 курса, кистей - 2 курса лечения). Отрубевидный лишай - 200 мг 1 раз в сутки в течение 7 дней. Дерматомикозы и кандидоз полости рта - 100 мг 1 раз в сутки в течение 15 дней (при необходимости курс повторяют). Грибковый кератит - 200 мг 1 раз в сутки в течение 21 дня. Системные микозы - 100–200 мг 1–2 раза в сутки в течение 2–12 мес (в зависимости от возбудителя)
Побочное действие
Наиболее часто отмечаемыми побочными реакциями в связи с применением итраконазола были реакции со стороны желудочно-кишечного тракта, такие как: диспепсия, тошнота, боль в животе и запор. Кроме того, отмечались: анорексия головная боль, утомляемость, обратимое повышение активности «печеночных» ферментов, холестатическая желтуха, гепатит, нарушения менструального цикла, головокружение и аллергические реакции (такие как зуд, сыпь, крапивница и ангионевротический отек), периферическая нейропатия, синдром Стивенса-Джонсона, алопеция, гипокалиемия, отеки, застойная сердечная недостаточность и отек легких, окрашивание мочи в темный цвет, гиперкреатининемия. В очень редких случаях при применении Орунита развивалось тяжелое токсическое поражение печени, в том числе случаи острой печеночной недостаточности с летальным исходом.
Передозировка
Данные отсутствуют. При случайной передозировке следует применять поддерживающие меры. В течение первого часа провести промывание желудка и, если это необходимо, назначить активированный уголь. Итраконазол не выводится при гемодиализе. Какого-либо специфического антидота не существует.
Особые указания
Обнаружено, что итраконазол обладает отрицательным инотропным эффектом. Сообщалось о случаях развития сердечной недостаточности, связанных с приемом Орунита. Орунит не следует принимать пациентам с хронической сердечной недостаточностью или с наличием этого заболевания в анамнезе за исключением случаев, когда возможная польза значительно превосходит потенциальный риск. При индивидуальной оценке соотношения пользы и риска следует принимать во внимание такие факторы как серьезность показаний, режим дозирования и индивидуальные факторы риска возникновения сердечной недостаточности. Факторы риска включают в себя наличие сердечных заболеваний, таких как ишемическая болезнь сердца или поражения клапанов; серьезные заболевания легких, такие как обструктивные поражения легких; почечная недостаточность или другие заболевания, сопровождающиеся отеками. Таких пациентов необходимо проинформировать о признаках и симптомах сердечной недостаточности. Лечение должно проводиться с осторожностью, при этом необходимо наблюдать за больным на предмет выявления симптомов застойной сердечной недостаточности. При их появлении прием Орунит необходимо прекратить. Блокаторы кальциевых каналов могут оказывать отрицательный инотропный эффект, который может усиливать подобный эффект итраконазола; итраконазол может снижать метаболизм блокаторов кальциевых каналов. При одновременном приеме итраконазола и блокаторов кальциевых каналов необходимо соблюдать осторожность. При пониженной кислотности желудка: абсорбция итраконазола нарушается. Пациентам, принимающим антацидные препараты (например, гидроксид алюминия), рекомендуется их использовать не ранее, чем через 2 часа после приема капсул Орунит. Пациентам с ахлоргидрией или применяющим Н2-гистамин блокаторы или ингибиторы протоновой помпы, рекомендуется принимать капсулы Орунит с кислыми напитками. В очень редких случаях при применении Орунита развивалось тяжелое токсическое поражение печени, в том числе случаи острой печеночной недостаточности с летальным исходом. В большинстве случаев это происходило с пациентами, у которых уже имелись заболевания печени, у больных, получавших терапию по системным показаниям, имеющих другие серьезные медицинские состояния, а также у пациентов, получавших другие лекарственные средства, обладающие гепатотоксическим действием. У некоторых пациентов не выявлялись очевидные факторы риска в отношении поражения печени. 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 терапию итраконазолом. Пациентов следует предупредить о необходимости немедленно связаться со своим врачом в случае возникновения симптомов, предполагающих возникновение гепатита, а именно: анорексии, тошноты, рвоты, слабости, боли в животе и потемнения мочи. В случае появления таких симптомов необходимо немедленно прекратить терапию и провести исследование функции печени. Пациентам с повышенной активностью «печеночных» ферментов или заболеванием печени в активной фазе, или при перенесенном токсическом поражении печени при приеме других препаратов не следует назначать лечение Орунит за исключением тех случаев, когда ожидаемая польза оправдывает риск поражения печени. В этих случаях необходимо во время лечения контролировать активность «печеночных» ферментов. Нарушения функции печени: Итраконазол метаболизируется преимущественно в печени. Период полувыведения итраконазола у больных с циррозом несколько увеличен. Биодоступность препарата при пероральном приеме несколько снижена у пациентов с циррозом печени. В этом случае, возможно, будет необходима коррекция дозы. При длительности приема более одного месяца необходим контроль функции печени. Нарушения функции почек: У пациентов с почечной недостаточностью биодоступность итраконазола может быть снижена. В этом случае, возможно, будет необходима коррекция дозы. Лечение следует прекратить при возникновении нейропатии, которая может быть связана с приемом капсул Орунит. Нет данных о перекрестной гиперчувствительности к итраконазолу и другим азоловым противогрибковым препаратам. Орунит в капсулах следует с осторожностью назначать пациентам с гиперчувствительностью к другим азолам. У пациентов с нарушенным иммунитетом (СПИД, после трансплантации органов, нейтропенией) может потребоваться увеличение дозы.
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Механизм действия связан со способностью итраконазола ингибировать синтез эргостерина клеточной мембраны грибов. Активен в отношении дерматофитов (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), дрожжеподобных грибов и дрожжей (Cryptococcus neoformans, Pitysporium spp., Candida spp. /включая Candida albicans, Candida glabrata и Candida krusei/, Aspergillus spp., Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cladosporium spp., Blastomyces dermatitidis."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Дерматомикозы; грибковый кератит; онихомикозы, вызванные дерматофитами и/или дрожжами и плесневыми грибами; системные микозы: системный аспергиллез и кандидоз, криптококкоз (включая криптококковый менингит), гистоплазмоз, споротрихоз, паракокцидиоидомикоз, бластомикоз и другие системные или тропические микозы; кандидомикозы с поражением кожи или слизистых, в том числе вульвовагинальный кандидоз; глубокие висцеральные кандидозы; отрубевидный лишай."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Беременным женщинам Орунит следует назначать только в том случае, если ожидаемая польза для женщины превышает потенциальный риск для плода. Женщинам детородного возраста, принимающим Орунит, необходимо использовать адекватные методы контрацепции на протяжении всего курса лечения вплоть до наступления первой менструации после его завершения. С осторожностью - детский возраст, тяжелая сердечная недостаточность, заболевания печени (в том числе сопровождающиеся печеночной недостаточностью). Терфенадин, астемизол, мизоластин, цизаприд, дофетилид, хинидин, пимозид, метаболизирующие с участием фермента CYP3A4 ингибиторы редуктазы ГМГ-КоА такие, как симвастатин и ловастатин, триазолам и мидазолам нельзя принимать одновременно с Орунитом. (см. также раздел «Взаимодействия с другими лекарственными средствами»)."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"На основании результатов доклинических исследований и в связи с тем, что исследования по применению итраконазола у беременных женщин не проводились, итраконазол следует назначать беременным женщинам только при угрожающих жизни системных микозах, когда потенциальная польза для женщины оправдывает возможный риск для плода. Так как небольшое количество итраконазола выделяется с материнским молоком, ожидаемую пользу от приема итраконазола необходимо сопоставлять с риском для ребенка при грудном вскармливании. В случае сомнений кормить грудью не следует."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, сразу после еды, капсулы проглатывают целиком. Вульвовагинальный кандидоз - 200 мг 2 раза в течение 1 дня или 200 мг 1 раз в сутки в течение 3 дней. Онихомикоз - 200 мг/сут в течение 3 мес или по 200 мг 2 раза в сутки в течение 1 нед с последующим перерывом 3 нед (при онихомикозе стоп рекомендуется 3 курса, кистей - 2 курса лечения). Отрубевидный лишай - 200 мг 1 раз в сутки в течение 7 дней. Дерматомикозы и кандидоз полости рта - 100 мг 1 раз в сутки в течение 15 дней (при необходимости курс повторяют). Грибковый кератит - 200 мг 1 раз в сутки в течение 21 дня. Системные микозы - 100–200 мг 1–2 раза в сутки в течение 2–12 мес (в зависимости от возбудителя)"}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Наиболее часто отмечаемыми побочными реакциями в связи с применением итраконазола были реакции со стороны желудочно-кишечного тракта, такие как: диспепсия, тошнота, боль в животе и запор. Кроме того, отмечались: анорексия головная боль, утомляемость, обратимое повышение активности «печеночных» ферментов, холестатическая желтуха, гепатит, нарушения менструального цикла, головокружение и аллергические реакции (такие как зуд, сыпь, крапивница и ангионевротический отек), периферическая нейропатия, синдром Стивенса-Джонсона, алопеция, гипокалиемия, отеки, застойная сердечная недостаточность и отек легких, окрашивание мочи в темный цвет, гиперкреатининемия. В очень редких случаях при применении Орунита развивалось тяжелое токсическое поражение печени, в том числе случаи острой печеночной недостаточности с летальным исходом."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Данные отсутствуют. При случайной передозировке следует применять поддерживающие меры. В течение первого часа провести промывание желудка и, если это необходимо, назначить активированный уголь. Итраконазол не выводится при гемодиализе. Какого-либо специфического антидота не существует."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Обнаружено, что итраконазол обладает отрицательным инотропным эффектом. Сообщалось о случаях развития сердечной недостаточности, связанных с приемом Орунита. Орунит не следует принимать пациентам с хронической сердечной недостаточностью или с наличием этого заболевания в анамнезе за исключением случаев, когда возможная польза значительно превосходит потенциальный риск. При индивидуальной оценке соотношения пользы и риска следует принимать во внимание такие факторы как серьезность показаний, режим дозирования и индивидуальные факторы риска возникновения сердечной недостаточности. Факторы риска включают в себя наличие сердечных заболеваний, таких как ишемическая болезнь сердца или поражения клапанов; серьезные заболевания легких, такие как обструктивные поражения легких; почечная недостаточность или другие заболевания, сопровождающиеся отеками. Таких пациентов необходимо проинформировать о признаках и симптомах сердечной недостаточности. Лечение должно проводиться с осторожностью, при этом необходимо наблюдать за больным на предмет выявления симптомов застойной сердечной недостаточности. При их появлении прием Орунит необходимо прекратить. Блокаторы кальциевых каналов могут оказывать отрицательный инотропный эффект, который может усиливать подобный эффект итраконазола; итраконазол может снижать метаболизм блокаторов кальциевых каналов. При одновременном приеме итраконазола и блокаторов кальциевых каналов необходимо соблюдать осторожность. При пониженной кислотности желудка: абсорбция итраконазола нарушается. Пациентам, принимающим антацидные препараты (например, гидроксид алюминия), рекомендуется их использовать не ранее, чем через 2 часа после приема капсул Орунит. Пациентам с ахлоргидрией или применяющим Н2-гистамин блокаторы или ингибиторы протоновой помпы, рекомендуется принимать капсулы Орунит с кислыми напитками. В очень редких случаях при применении Орунита развивалось тяжелое токсическое поражение печени, в том числе случаи острой печеночной недостаточности с летальным исходом. В большинстве случаев это происходило с пациентами, у которых уже имелись заболевания печени, у больных, получавших терапию по системным показаниям, имеющих другие серьезные медицинские состояния, а также у пациентов, получавших другие лекарственные средства, обладающие гепатотоксическим действием. У некоторых пациентов не выявлялись очевидные факторы риска в отношении поражения печени. 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 терапию итраконазолом. Пациентов следует предупредить о необходимости немедленно связаться со своим врачом в случае возникновения симптомов, предполагающих возникновение гепатита, а именно: анорексии, тошноты, рвоты, слабости, боли в животе и потемнения мочи. В случае появления таких симптомов необходимо немедленно прекратить терапию и провести исследование функции печени. Пациентам с повышенной активностью «печеночных» ферментов или заболеванием печени в активной фазе, или при перенесенном токсическом поражении печени при приеме других препаратов не следует назначать лечение Орунит за исключением тех случаев, когда ожидаемая польза оправдывает риск поражения печени. В этих случаях необходимо во время лечения контролировать активность «печеночных» ферментов. Нарушения функции печени: Итраконазол метаболизируется преимущественно в печени. Период полувыведения итраконазола у больных с циррозом несколько увеличен. Биодоступность препарата при пероральном приеме несколько снижена у пациентов с циррозом печени. В этом случае, возможно, будет необходима коррекция дозы. При длительности приема более одного месяца необходим контроль функции печени. Нарушения функции почек: У пациентов с почечной недостаточностью биодоступность итраконазола может быть снижена. В этом случае, возможно, будет необходима коррекция дозы. Лечение следует прекратить при возникновении нейропатии, которая может быть связана с приемом капсул Орунит. Нет данных о перекрестной гиперчувствительности к итраконазолу и другим азоловым противогрибковым препаратам. Орунит в капсулах следует с осторожностью назначать пациентам с гиперчувствительностью к другим азолам. 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