Микозы, вызванные чувствительными к тербинафину микроорганизмами: Онихомикоз, вызванный дерматофитами
Микозы волосистой части головы
Грибковые инфекции кожи – лечение дерматомикозов туловища, голеней, стоп, а также дрожжевых инфекций кожи, вызываемых грибами рода Candida (например, С. Albicans) – в тех случаях, когда локализация, выраженность или распространенность ...
повышенная чувствительность к тербинафину или к любому другому компоненту препарата; детский возраст до 3 лет, при массе тела менее 20 кг (нет данных о применении); тяжелое, хроническое или активное заболевание печени; нарушения функции почек (клиренс креатинина менее 50 мл/мин или концентрация креатинина в сыворотке крови более 300 мкмоль/л), т.к. ...
Тербинафин представляет собой аллиламин, который обладает широким спектром действия в отношении грибов, вызывающих заболевания кожи, волос и ногтей, в том числе дерматофитов, таких как Trychophyton (например, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. tonsurans), Microsporum (M. canis), Epidermophyton floccosum, а также дрожжевых грибов рода Candida (например, С. albicans) и Pityrosporum. В низких концентрациях тербинафин оказывает фунгицидное действие в отношении дерматофитов, плесневых и некоторых диморфных грибов. Активность в отношении дрожжевых грибов, в зависимости от их вида, может быть фунгицидной или фунгистатической.; Тербинафин, ингибируя фермент скваленэпоксидазу в клеточной мембране гриба, (не относящуюся к системе цитохрома Р450), специфически подавляет ранний этап синтеза стеролов в клетке гриба, что приводит к дефициту эргостерола, внутриклеточному накоплению сквалена и гибели клетки гриба.; При применении тербинафина внутрь в коже, волосах и ногтях создаются концентрации, обеспечивающие фунгицидное действие.
Показания к применению
Микозы, вызванные чувствительными к тербинафину микроорганизмами: Онихомикоз, вызванный дерматофитами
Микозы волосистой части головы
Грибковые инфекции кожи – лечение дерматомикозов туловища, голеней, стоп, а также дрожжевых инфекций кожи, вызываемых грибами рода Candida (например, С. Albicans) – в тех случаях, когда локализация, выраженность или распространенность инфекции обуславливают целесообразность пероральной терапии.
Противопоказания
повышенная чувствительность к тербинафину или к любому другому компоненту препарата; детский возраст до 3 лет, при массе тела менее 20 кг (нет данных о применении); тяжелое, хроническое или активное заболевание печени; нарушения функции почек (клиренс креатинина менее 50 мл/мин или концентрация креатинина в сыворотке крови более 300 мкмоль/л), т.к. применение препарата у данной категории пациентов недостаточно изучено.
Применение при беременности и в период грудного вскармливания
Данные экспериментальных исследований не дают оснований предполагать нежелательных явлений в отношении фертильности и токсического действия на плод.; Клинический опыт применения тербинафина у беременных женщин ограничен, вследствие чего не следует применять препарат во время беременности, за исключением тех случаев, когда ожидаемая польза для матери от проведения терапии превышает потенциальный риск для плода.; Тербинафин выделяется с грудным молоком, поэтому препарат противопоказан в период грудного вскармливания.; Данных о влиянии препарата на фертильность у людей нет. Исследования у крыс не выявили нежелательного влияния на фертильность и репродуктивную способность.
Способ применения и дозы
Длительность лечения зависит от показания и тяжести течения заболевания.; Препарат принимают внутрь, независимо от приема пищи, запивая небольшим количеством воды. Желательно принимать препарат в одно и то же время. Длительность лечения зависит от показания и тяжести течения заболевания.; Взрослые; 250 мг 1 раз в сутки.; Инфекции кожных покровов; Рекомендуемая продолжительность лечения: дерматомикоз стоп (межпальцевый, подошвенный или по типу носков) - 2-6 недель; дерматомикоз туловища, голеней - 2-4 недели; кандидоз кожи - 2-4 недели. Полное исчезновение проявлений инфекции и жалоб, связанных с ней, может наступить не ранее, чем через несколько недель после микологического излечения.; Инфекции волос и волосистой части головы; Рекомендуемая продолжительность лечения: микоз волосистой части головы – 4 недели. Микозы волосистой части головы наблюдаются преимущественно у детей.; Онихомикоз; Продолжительность лечения составляет у большинства пациентов от 6 до ; 12 недель. При онихомикозе кистей в большинстве случаев достаточно 6-ти недель лечения. При онихомикозе стоп в большинстве случаев достаточно ; 12-ти недель лечения. Некоторым больным, которые имеют сниженную скорость роста ногтей, может потребоваться более длительное лечение. Оптимальный клинический эффект наблюдается спустя несколько месяцев после микологического излечения и прекращения терапии. Это определяется тем периодом времени, который необходим для отрастания здорового ногтя.; Применение у детей; Данные применения препарата у детей в возрасте младше 3 лет (масса тела которых обычно менее 12 кг) отсутствуют. Применение препарата для лечения у детей с массой тела менее 20 кг не рекомендуется в виду невозможности адекватного подбора дозы. Применение у детей от 3 до 12 лет при массе тела более 20 кг целесообразно только в том случае, когда положительный ожидаемый эффект от терапии превышает потенциальный риск развития побочного действия. Длительность лечения и дозы зависят от массы тела ребенка. У детей старше 3-х лет препарат назначают 1 раз в сутки. Разовая доза составляет: для детей с массой тела от 20 до 40 кг - ; 125 мг; более 40 кг - 250 мг.; Применение у пациентов пожилого возраста; Нет оснований предполагать, что для пациентов пожилого возраста требуется изменять режим дозирования препарата или что у них, отмечаются побочные действия, отличающиеся от таковых у пациентов более молодого возраста. В случае применения в этой возрастной группе препарата в таблетках следует учитывать возможность сопутствующего нарушения функции печени или почек.
Побочное действие
Тербинафин в целом переносится хорошо. Побочные эффекты обычно слабо или умеренно выражены и носят преходящий характер. Ниже приведены нежелательные явления, которые наблюдались в ходе клинических исследований или в пострегистрационный период. Частота побочных эффектов оценивалась следующим образом: очень часто (≥1/10); часто (≥1/100, меньше1/10); нечасто (≥1/1000, меньше1/100); редко (≥1/10000, меньше1/1000); очень редко (меньше1/10000, включая отдельные случаи), частота неизвестна (частоту возникновения побочных эффектов невозможно оценить на основании имеющихся данных).; Нарушения со стороны крови и лимфатической системы; нечасто - анемия; очень редко - нейтропения, агранулоцитоз, панцитопения, тромбоцитопения.; Нарушения со стороны иммунной системы; очень редко - анафилактоидные реакции (включая ангионевротический отек), кожная и системная красная волчанка (или их обострение).; Нарушения психики; часто - депрессия; нечасто - тревожность.; Нарушения со стороны нервной системы; очень часто - головная боль; часто - головокружение, нарушения вкусовых ощущений, вплоть до их потери (обычно восстановление происходит в пределах нескольких недель после прекращения лечения. Имеются отдельные сообщения о случаях длительных нарушений вкусовых ощущений). В отдельных случаях на фоне приема препарата отмечалось истощение; нечасто - парестезии, гипестезии.; Нарушения со стороны органа зрения; нечасто - нарушение зрения.; Нарушения со стороны органа слуха и лабиринтные нарушения; нечасто - шум в ушах.; Нарушения со стороны желудочно-кишечного тракта; очень часто - вздутие живота, снижение аппетита, диспепсия, тошнота, слабо выраженные боли в животе, диарея.; Нарушения со стороны печени и желчевыводящих путей; редко - гепатобилиарная дисфункция (преимущественно холестатической природы), в том числе печеночная недостаточность, включая очень редкие случаи развития тяжелой печеночной недостаточности (некоторые со смертельным исходом или требующие трансплантации печени; в большинстве случаев, когда развивалась печеночная недостаточность, пациенты имели серьезные сопутствующие системные заболевания и причинно-следственная связь печеночной недостаточности с приемом препарата была сомнительной); гепатит, желтуха, холестаз, повышение активности «печеночных» трансаминаз.; Нарушения со стороны кожи и подкожных тканей; очень часто - сыпь, крапивница; нечасто - реакции фоточувствительности; очень редко - синдром Стивенса-Джонсона, токсический эпидермальный некролиз, острый генерализованный экзантематозный пустулез, многоформная эритема, токсическая кожная сыпь, эксфолиативный дерматит, буллезный дерматит, псориазоподобные высыпания или обострение псориаза, алопеция.; Нарушения со стороны скелетно-мышечной и соединительной ткани; очень часто - артралгия, миалгия.; Общие расстройства; часто - чувство усталости; нечасто - повышение температуры тела.; Лабораторные и инструментальные данные: нечасто - снижение веса (вторично по отношению к нарушению вкусовых ощущений).; На основе спонтанных сообщений, получаемых в пострегистрационный период, и литературных данных выявлены следующие нежелательные явления, частота которых вследствие неточного количества пациентов не может быть установлена: Нарушения со стороны иммунной системы; Анафилактические реакции, синдром, подобный сывороточной болезни.; Нарушения со стороны органа зрения; Затуманивание зрения, снижение остроты зрения.; Нарушения со стороны кожи и подкожных тканей; Лекарственная сыпь с эозинофилией и системными симптомами (сыпь, отеки, лихорадка и увеличение лимфатических узлов).; Нарушения со стороны органа слуха и лабиринтные нарушения; Тугоухость, нарушение слуха.; Нарушения со стороны сосудов; Васкулит.; Нарушения со стороны нервной системы; Потеря обоняния, в том числе на длительный период времени, снижение обоняния.; Нарушения со стороны желудочно-кишечного тракта; Панкреатит.; Нарушения со стороны скелетно-мышечной и соединительной ткани; Рабдомиолиз.; Общие расстройства; Гриппоподобный синдром.; Лабораторные и инструментальные данные; Повышение активности креатинфосфокиназы в сыворотке крови.; 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: головная боль, тошнота, боль в эпигастральной области и головокружение.; Рекомендуемое в случае передозировки лечение включает мероприятия по выведению препарата, в первую очередь путем назначения активированного угля и промывания желудка; при необходимости проводят симптоматическую и поддерживающую терапию.
Особые указания
Нерегулярное применение или досрочное прекращение лечения повышает риск развития рецидива заболевания.; До начала применения тербинафина в таблетках необходимо провести анализ функции печени. Гепатотоксичность может возникнуть как у пациентов с предшествующими заболеваниями печени, так и без них. В течение терапии рекомендовано периодическое исследование функции печени (через 4-6 недель после начала лечения). Лечение немедленно должно быть прекращено в случае повышения активности «печеночных» проб. Пациенты, которым назначают препарат, должны быть предупреждены о том, что необходимо немедленно информировать лечащего врача о возникновении на фоне приема препарата таких симптомов как стойкая тошнота, снижение аппетита, чувство усталости, рвота, боли в правом подреберье, желтуха, темная моча или светлый кал. В случае появления подобных симптомов необходимо немедленно прекратить прием препарата и провести исследование функции печени.; Серьезные кожные реакции (в том числе синдром Стивенса-Джонсона, токсический эпидермальный некролиз, лекарственная сыпь с эозинофилией и системными симптомами) крайне редко отмечались на фоне применения тербинафина.; При применении препарата в таблетках отмечались крайне редкие изменения клеточного состава крови (нейтропепия, агранулоцитоз, тромбоцитопения, панцитопения). В случае развития качественных или количественных изменений со стороны форменных элементов крови следует установить причину нарушений и рассмотреть вопрос о снижении дозы препарата или, при необходимости, о прекращении терапии препаратом.
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Активность в отношении дрожжевых грибов, в зависимости от их вида, может быть фунгицидной или фунгистатической.; Тербинафин, ингибируя фермент скваленэпоксидазу в клеточной мембране гриба, (не относящуюся к системе цитохрома Р450), специфически подавляет ранний этап синтеза стеролов в клетке гриба, что приводит к дефициту эргостерола, внутриклеточному накоплению сквалена и гибели клетки гриба.; При применении тербинафина внутрь в коже, волосах и ногтях создаются концентрации, обеспечивающие фунгицидное действие."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Микозы, вызванные чувствительными к тербинафину микроорганизмами: Онихомикоз, вызванный дерматофитами"}},{"type":"paragraph","data":{"text":"Микозы волосистой части головы"}},{"type":"paragraph","data":{"text":"Грибковые инфекции кожи – лечение дерматомикозов туловища, голеней, стоп, а также дрожжевых инфекций кожи, вызываемых грибами рода Candida (например, С. 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Исследования у крыс не выявили нежелательного влияния на фертильность и репродуктивную способность."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Длительность лечения зависит от показания и тяжести течения заболевания.; Препарат принимают внутрь, независимо от приема пищи, запивая небольшим количеством воды. Желательно принимать препарат в одно и то же время. Длительность лечения зависит от показания и тяжести течения заболевания.; Взрослые; 250 мг 1 раз в сутки.; Инфекции кожных покровов; Рекомендуемая продолжительность лечения: дерматомикоз стоп (межпальцевый, подошвенный или по типу носков) - 2-6 недель; дерматомикоз туловища, голеней - 2-4 недели; кандидоз кожи - 2-4 недели. Полное исчезновение проявлений инфекции и жалоб, связанных с ней, может наступить не ранее, чем через несколько недель после микологического излечения.; Инфекции волос и волосистой части головы; Рекомендуемая продолжительность лечения: микоз волосистой части головы – 4 недели. Микозы волосистой части головы наблюдаются преимущественно у детей.; Онихомикоз; Продолжительность лечения составляет у большинства пациентов от 6 до ; 12 недель. При онихомикозе кистей в большинстве случаев достаточно 6-ти недель лечения. При онихомикозе стоп в большинстве случаев достаточно ; 12-ти недель лечения. Некоторым больным, которые имеют сниженную скорость роста ногтей, может потребоваться более длительное лечение. Оптимальный клинический эффект наблюдается спустя несколько месяцев после микологического излечения и прекращения терапии. Это определяется тем периодом времени, который необходим для отрастания здорового ногтя.; Применение у детей; Данные применения препарата у детей в возрасте младше 3 лет (масса тела которых обычно менее 12 кг) отсутствуют. Применение препарата для лечения у детей с массой тела менее 20 кг не рекомендуется в виду невозможности адекватного подбора дозы. Применение у детей от 3 до 12 лет при массе тела более 20 кг целесообразно только в том случае, когда положительный ожидаемый эффект от терапии превышает потенциальный риск развития побочного действия. Длительность лечения и дозы зависят от массы тела ребенка. У детей старше 3-х лет препарат назначают 1 раз в сутки. Разовая доза составляет: для детей с массой тела от 20 до 40 кг - ; 125 мг; более 40 кг - 250 мг.; Применение у пациентов пожилого возраста; Нет оснований предполагать, что для пациентов пожилого возраста требуется изменять режим дозирования препарата или что у них, отмечаются побочные действия, отличающиеся от таковых у пациентов более молодого возраста. В случае применения в этой возрастной группе препарата в таблетках следует учитывать возможность сопутствующего нарушения функции печени или почек."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Тербинафин в целом переносится хорошо. Побочные эффекты обычно слабо или умеренно выражены и носят преходящий характер. Ниже приведены нежелательные явления, которые наблюдались в ходе клинических исследований или в пострегистрационный период. Частота побочных эффектов оценивалась следующим образом: очень часто (≥1/10); часто (≥1/100, меньше1/10); нечасто (≥1/1000, меньше1/100); редко (≥1/10000, меньше1/1000); очень редко (меньше1/10000, включая отдельные случаи), частота неизвестна (частоту возникновения побочных эффектов невозможно оценить на основании имеющихся данных).; Нарушения со стороны крови и лимфатической системы; нечасто - анемия; очень редко - нейтропения, агранулоцитоз, панцитопения, тромбоцитопения.; Нарушения со стороны иммунной системы; очень редко - анафилактоидные реакции (включая ангионевротический отек), кожная и системная красная волчанка (или их обострение).; Нарушения психики; часто - депрессия; нечасто - тревожность.; Нарушения со стороны нервной системы; очень часто - головная боль; часто - головокружение, нарушения вкусовых ощущений, вплоть до их потери (обычно восстановление происходит в пределах нескольких недель после прекращения лечения. Имеются отдельные сообщения о случаях длительных нарушений вкусовых ощущений). В отдельных случаях на фоне приема препарата отмечалось истощение; нечасто - парестезии, гипестезии.; Нарушения со стороны органа зрения; нечасто - нарушение зрения.; Нарушения со стороны органа слуха и лабиринтные нарушения; нечасто - шум в ушах.; Нарушения со стороны желудочно-кишечного тракта; очень часто - вздутие живота, снижение аппетита, диспепсия, тошнота, слабо выраженные боли в животе, диарея.; Нарушения со стороны печени и желчевыводящих путей; редко - гепатобилиарная дисфункция (преимущественно холестатической природы), в том числе печеночная недостаточность, включая очень редкие случаи развития тяжелой печеночной недостаточности (некоторые со смертельным исходом или требующие трансплантации печени; в большинстве случаев, когда развивалась печеночная недостаточность, пациенты имели серьезные сопутствующие системные заболевания и причинно-следственная связь печеночной недостаточности с приемом препарата была сомнительной); гепатит, желтуха, холестаз, повышение активности «печеночных» трансаминаз.; Нарушения со стороны кожи и подкожных тканей; очень часто - сыпь, крапивница; нечасто - реакции фоточувствительности; очень редко - синдром Стивенса-Джонсона, токсический эпидермальный некролиз, острый генерализованный экзантематозный пустулез, многоформная эритема, токсическая кожная сыпь, эксфолиативный дерматит, буллезный дерматит, псориазоподобные высыпания или обострение псориаза, алопеция.; Нарушения со стороны скелетно-мышечной и соединительной ткани; очень часто - артралгия, миалгия.; Общие расстройства; часто - чувство усталости; нечасто - повышение температуры тела.; Лабораторные и инструментальные данные: нечасто - снижение веса (вторично по отношению к нарушению вкусовых ощущений).; На основе спонтанных сообщений, получаемых в пострегистрационный период, и литературных данных выявлены следующие нежелательные явления, частота которых вследствие неточного количества пациентов не может быть установлена: Нарушения со стороны иммунной системы; Анафилактические реакции, синдром, подобный сывороточной болезни.; Нарушения со стороны органа зрения; Затуманивание зрения, снижение остроты зрения.; Нарушения со стороны кожи и подкожных тканей; Лекарственная сыпь с эозинофилией и системными симптомами (сыпь, отеки, лихорадка и увеличение лимфатических узлов).; Нарушения со стороны органа слуха и лабиринтные нарушения; Тугоухость, нарушение слуха.; Нарушения со стороны сосудов; Васкулит.; Нарушения со стороны нервной системы; Потеря обоняния, в том числе на длительный период времени, снижение обоняния.; Нарушения со стороны желудочно-кишечного тракта; Панкреатит.; Нарушения со стороны скелетно-мышечной и соединительной ткани; Рабдомиолиз.; Общие расстройства; Гриппоподобный синдром.; Лабораторные и инструментальные данные; Повышение активности креатинфосфокиназы в сыворотке крови.; 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":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: головная боль, тошнота, боль в эпигастральной области и головокружение.; Рекомендуемое в случае передозировки лечение включает мероприятия по выведению препарата, в первую очередь путем назначения активированного угля и промывания желудка; при необходимости проводят симптоматическую и поддерживающую терапию."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Нерегулярное применение или досрочное прекращение лечения повышает риск развития рецидива заболевания.; До начала применения тербинафина в таблетках необходимо провести анализ функции печени. Гепатотоксичность может возникнуть как у пациентов с предшествующими заболеваниями печени, так и без них. В течение терапии рекомендовано периодическое исследование функции печени (через 4-6 недель после начала лечения). Лечение немедленно должно быть прекращено в случае повышения активности «печеночных» проб. Пациенты, которым назначают препарат, должны быть предупреждены о том, что необходимо немедленно информировать лечащего врача о возникновении на фоне приема препарата таких симптомов как стойкая тошнота, снижение аппетита, чувство усталости, рвота, боли в правом подреберье, желтуха, темная моча или светлый кал. В случае появления подобных симптомов необходимо немедленно прекратить прием препарата и провести исследование функции печени.; Серьезные кожные реакции (в том числе синдром Стивенса-Джонсона, токсический эпидермальный некролиз, лекарственная сыпь с эозинофилией и системными симптомами) крайне редко отмечались на фоне применения тербинафина.; При применении препарата в таблетках отмечались крайне редкие изменения клеточного состава крови (нейтропепия, агранулоцитоз, тромбоцитопения, панцитопения). В случае развития качественных или количественных изменений со стороны форменных элементов крови следует установить причину нарушений и рассмотреть вопрос о снижении дозы препарата или, при необходимости, о прекращении терапии препаратом."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Тербинафин представляет собой аллиламин, который обладает широким спектром действия в отношении грибов, вызывающих заболевания кожи, волос и ногтей, в том числе дерматофитов, таких как Trychophyton (например, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. tonsurans), Microsporum (M. canis), Epidermophyton floccosum, а также дрожжевых грибов рода Candida (например, С. albicans) и Pityrosporum. В низких концентрациях тербинафин оказывает фунгицидное действие в отношении дерматофитов, плесневых и некоторых диморфных грибов. Активность в отношении дрожжевых грибов, в зависимости от их вида, может быть фунгицидной или фунгистатической.; Тербинафин, ингибируя фермент скваленэпоксидазу в клеточной мембране гриба, (не относящуюся к системе цитохрома Р450), специфически подавляет ранний этап синтеза стеролов в клетке гриба, что приводит к дефициту эргостерола, внутриклеточному накоплению сквалена и гибели клетки гриба.; При применении тербинафина внутрь в коже, волосах и ногтях создаются концентрации, обеспечивающие фунгицидное действие.","substance":[{"id":38,"title":"Тербинафин","title_latin":"Terbinafinum","slug":"terbinafin_38"}],"branding":null,"valid_for_quick_buy":false,"is_available_to_delivery":false,"comments":null,"image_alt":"Тербинафин - фото упаковки","image_share":{"isTouch":{"default":null},"isFromTablet":{"default":null}},"diseases":[],"other_packages":[{"id":101920,"title":"Тербинафин","subtitle":{"full":"Таблетки, коробка, 14 шт, 250 мг, для приема внутрь","short":"Таблетки, 14 шт, 250 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