Для приема внутрь:- 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 Candida albicans)— в тех случаях, когда локализация, выраженность или распространенность инфекции обусловливают ...
Гиперчувствительность.При приеме внутрь: тяжелое, хроническое или активное заболевание печени; нарушение функции почек (Cl креатинина <50 мл/мин или концентрация креатинина в сыворотке крови >300 мкмоль/л), поскольку применение у данной категории больных недостаточно изучено; возраст до 2 лет, при массе тела менее 20 кг (для таблеток), т.к. нет данных ...
Для приема внутрь:- 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 Candida albicans)— в тех случаях, когда локализация, выраженность или распространенность инфекции обусловливают целесообразность пероральной терапии.Для наружного применения (все ЛФ для наружного применения— гель, крем, мазь, спрей— кроме раствора пленкообразующего):- профилактика и лечение грибковых инфекций кожи, в т.ч. микозов стоп (грибок стопы), паховой эпидермофитии (tinea cruris), грибковых поражений гладкой кожи тела (tinea corporis), вызванных такими дерматофитами, как Trichophyton (в т.ч. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis и Epidermophyton floccosum;- дрожжевые инфекции кожи, в основном те, которые вызываются грибками рода Candida (например Candida albicans), в частности опрелость;- разноцветный лишай (Pityriasis versicolor), вызываемый Pityrosporum orbiculare (также известный под названием Malassezia furfur).Для наружного применения (раствор пленкообразующий): лечение микозов стоп (грибок стопы, tinea pedis).
Противопоказания
Гиперчувствительность.При приеме внутрь: тяжелое, хроническое или активное заболевание печени; нарушение функции почек (Cl креатинина <50 мл/мин или концентрация креатинина в сыворотке крови >300 мкмоль/л), поскольку применение у данной категории больных недостаточно изучено; возраст до 2 лет, при массе тела менее 20 кг (для таблеток), т.к. нет данных о применении.При наружном применении: период грудного вскармливания; возраст до 18 лет (гель, спрей), до 15 лет (раствор пленкообразующий) или до 12 лет (крем, мазь) из-за отсутствия достаточного клинического опыта.
Применение при беременности и в период грудного вскармливания
Категория действия на плод по FDA— B.Данные экспериментальных исследований не дают оснований предполагать наличие нежелательных явлений в отношении фертильности и токсического действия на плод. Поскольку клинический опыт применения тербинафина у беременных женщин очень ограничен, не следует его применять во время беременности, за исключением тех случаев, когда ожидаемая польза от проведения терапии для матери превышает потенциальный риск для плода. Тербинафин выделяется с грудным молоком, поэтому на период лечения необходимо прекратить грудное вскармливание.Не следует допускать контакта младенца с поверхностью кожи, обработанной местной формой тербинафина.
Побочное действие
Побочные эффекты обычно слабо или умеренно выражены и носят преходящий характер. Ниже приведены нежелательные явления, которые наблюдались при приеме тербинафина внутрь в ходе клинических исследований или в пострегистрационный период.При оценке частоты встречаемости побочных эффектов использованы следующие градации (ВОЗ): очень часто (≥1/10); часто (от ≥1/100, <1/10); нечасто (≥1/1000, <1/100); редко (≥1/10000, <1/1000); очень редко (<1/10000), включая отдельные сообщения.Со стороны крови и лимфатической системы: нечасто— анемия; очень редко— нейтропения, агранулоцитоз, панцитопения, тромбоцитопения.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.Со стороны нервной системы: очень часто— головная боль; часто— головокружение, нарушение 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 отмечалось истощение; нечасто— парестезия, гипестезия.Со стороны органа зрения: нечасто— нарушение зрения.Со стороны органа слуха и лабиринтные нарушения: нечасто— шум в ушах.Со стороны печени и желчевыводящих путей: редко— гепатобилиарная дисфункция (преимущественно холестатической природы), в т.ч. 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 тербинафина была сомнительной), гепатит, желтуха, холестаз, повышение активности печеночных ферментов.Со стороны пищеварительной системы: очень часто— вздутие живота, снижение аппетита, диспепсия, тошнота, слабо выраженная боль в животе, диарея.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 на коже или обострения псориаза, алопеция.Со стороны скелетно-мышечной системы и соединительной ткани: очень часто— артралгия, миалгия.Общие расстройства: часто— чувство усталости; нечасто— повышение температуры тела.Лабораторные и инструментальные данные: нечасто— снижение массы тела (вторично по отношению к нарушению вкусовых ощущений).На основе спонтанных сообщений, полученных в пострегистрационный период, и литературных данных выявлены следующие нежелательные явления, частота которых вследствие неточного количества пациентов не может быть установлена.Со стороны иммунной системы: анафилактические реакции, синдром, подобный сывороточной болезни.Со стороны органа зрения: затуманивание зрения, снижение остроты зрения.Со стороны кожи и подкожных тканей: лекарственная сыпь с эозинофилией и системными симптомами (сыпь, отеки, лихорадка и увеличение лимфатических узлов).Со стороны органа слуха и лабиринтные нарушения: тугоухость, нарушение слуха.Со стороны сосудов: васкулит.Со стороны нервной системы: потеря обоняния, в т.ч. на длительный период времени, снижение обоняния.Со стороны пищеварительной системы: панкреатит.Со стороны скелетно-мышечной системы и соединительной ткани: рабдомиолиз.Общие расстройства: гриппоподобный синдром.Лабораторные и инструментальные данные: повышение активности КФК в сыворотке крови.Побочные эффекты при наружном применении тербинафина (в виде геля, крема, спрея)Со стороны иммунной системы: отдельные сообщения— реакции гиперчувствительности (сыпь).Со стороны органа зрения: редко— раздражение глаз.Со стороны кожных покровов: часто— шелушение кожи, зуд; нечасто— повреждение кожи, образование корки, поражение кожи, нарушение пигментации, эритема, ощущение жжения кожи; редко— ощущение сухости кожи, контактный дерматит, экзема; отдельные сообщения— сыпь.Местные реакции и прочие: нечасто— боль, в т.ч. в месте нанесения, раздражение в месте нанесения; редко— обострение симптомов заболевания. В местах нанесения препарата могут наблюдаться зуд, шелушение кожи, болевые ощущения, раздражение, изменение пигментации кожи, жжение, эритема, корки. Эти незначительные симптомы следует отличать от реакций гиперчувствительности, таких как сыпь, возникающих в редких случаях и требующих отмены терапии. Изредка течение грибковой инфекции может обостряться.
Особые указания
До начала применения тербинафина внутрь 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 нед после начала лечения). Лечение тербинафином должно быть немедленно прекращено в случае повышения значений печеночных проб. Пациенты, которым назначают тербинафин, должны быть предупреждены о том, что необходимо немедленно информировать лечащего врача о возникновении на фоне приема таких симптомов, как стойкая тошнота, снижение аппетита, чувство усталости, рвота, боль в правом подреберье, желтуха, темная моча или светлый кал. В случае появления подобных симптомов необходимо немедленно прекратить прием ЛС и провести исследование функции печени.Серьезные кожные реакции (в т.ч. синдром Стивенса-Джонсона, токсический эпидермальный некролиз, лекарственная сыпь с эозинофилией и системными симптомами) крайне редко отмечались на фоне применения тербинафина.При применении тербинафина внутрь отмечались крайне редкие случаи изменения клеточного состава крови (нейтропения, 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 или при необходимости— о прекращении терапии тербинафином.Было показано, что тербинафин подавляет метаболизм, опосредуемый изоферментом CYP2D6. Поэтому необходимо осуществлять постоянное наблюдение за больными, получающими одновременно с тербинафином лечение ЛС, преимущественно метаболизирующимися с участием этого фермента (такими как трициклические антидепрессанты, бета-адреноблокаторы, СИОЗС, антиаритмические средства IС класса и ингибиторы МАО типаВ), в случае если применяемый одновременно препарат имеет малый диапазон терапевтической концентрации.Дети. Данные о пероральном применении тербинафина у детей в возрасте <3 лет (масса тела которых обычно <12 кг) отсутствуют. Применение для лечения у детей с массой тела <20 кг не рекомендуется ввиду невозможности адекватного подбора дозы. Применение у детей от 3 до 12 лет при массе тела >20 кг целесообразно только в том случае, когда положительный ожидаемый эффект терапии превышает потенциальный риск развития побочного действия. Длительность лечения и дозы зависят от массы тела ребенка.Пациенты пожилого возраста. Нет оснований предполагать, что для пациентов пожилого возраста требуется изменение режима дозирования или у них возможны побочные действия, отличающиеся от таковых у пациентов более молодого возраста. В случае перорального применения тербинафина в этой возрастной группе следует учитывать возможность сопутствующего нарушения функции печени или почек.При местном применении тербинафина уменьшение выраженности клинических проявлений обычно отмечается в первые дни лечения. В случае нерегулярного лечения или преждевременного его прекращения имеется риск рецидива инфекции.Местные формы тербинафина предназначены только для наружного применения. Следует избегать попадания тербинафина в глаза, т.к. он может вызвать раздражение. При случайном попадании в глаза, их следует немедленно промыть проточной водой, а в случае развития стойких явлений раздражения необходимо проконсультироваться с врачом. При развитии аллергических реакций необходимо отменить тербинафин.Тербинафин в виде раствора для наружного применения пленкообразующего не рекомендуется применять в случае хронического подошвенного гиперкератоза, вызванного Tinea pedis (мокасcинового типа/Moccassin type).Следует соблюдать осторожность при нанесении спиртосодержащих местных форм тербинафина на поврежденные участки кожи, т.к. спирт может вызвать раздражение.Влияние на способность управлять автотранспортом и/или работать с механизмами. Влияние тербинафина на способность управлять автотранспортом и работать с механизмами не изучалось. При развитии головокружения на фоне терапии тербинафином пациентам не следует управлять автотранспортом и/или работать с механизмами.
Условия хранения
В сухом, защищенном от света месте, при температуре не выше 25°C. Не замораживать.Хранить в недоступном для детей месте.
Срок годности
2 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России
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Поскольку клинический опыт применения тербинафина у беременных женщин очень ограничен, не следует его применять во время беременности, за исключением тех случаев, когда ожидаемая польза от проведения терапии для матери превышает потенциальный риск для плода. Тербинафин выделяется с грудным молоком, поэтому на период лечения необходимо прекратить грудное вскармливание.Не следует допускать контакта младенца с поверхностью кожи, обработанной местной формой тербинафина."}}]},{"id":4,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Побочные эффекты обычно слабо или умеренно выражены и носят преходящий характер. Ниже приведены нежелательные явления, которые наблюдались при приеме тербинафина внутрь в ходе клинических исследований или в пострегистрационный период.При оценке частоты встречаемости побочных эффектов использованы следующие градации (ВОЗ): очень часто (≥1/10); часто (от ≥1/100, \u003c1/10); нечасто (≥1/1000, \u003c1/100); редко (≥1/10000, \u003c1/1000); очень редко (\u003c1/10000), включая отдельные сообщения.Со стороны крови и лимфатической системы: нечасто— анемия; очень редко— нейтропения, агранулоцитоз, панцитопения, тромбоцитопения.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.Со стороны нервной системы: очень часто— головная боль; часто— головокружение, нарушение 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 отмечалось истощение; нечасто— парестезия, гипестезия.Со стороны органа зрения: нечасто— нарушение зрения.Со стороны органа слуха и лабиринтные нарушения: нечасто— шум в ушах.Со стороны печени и желчевыводящих путей: редко— гепатобилиарная дисфункция (преимущественно холестатической природы), в т.ч. 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 тербинафина была сомнительной), гепатит, желтуха, холестаз, повышение активности печеночных ферментов.Со стороны пищеварительной системы: очень часто— вздутие живота, снижение аппетита, диспепсия, тошнота, слабо выраженная боль в животе, диарея.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 на коже или обострения псориаза, алопеция.Со стороны скелетно-мышечной системы и соединительной ткани: очень часто— артралгия, миалгия.Общие расстройства: часто— чувство усталости; нечасто— повышение температуры тела.Лабораторные и инструментальные данные: нечасто— снижение массы тела (вторично по отношению к нарушению вкусовых ощущений).На основе спонтанных сообщений, полученных в пострегистрационный период, и литературных данных выявлены следующие нежелательные явления, частота которых вследствие неточного количества пациентов не может быть установлена.Со стороны иммунной системы: анафилактические реакции, синдром, подобный сывороточной болезни.Со стороны органа зрения: затуманивание зрения, снижение остроты зрения.Со стороны кожи и подкожных тканей: лекарственная сыпь с эозинофилией и системными симптомами (сыпь, отеки, лихорадка и увеличение лимфатических узлов).Со стороны органа слуха и лабиринтные нарушения: тугоухость, нарушение слуха.Со стороны сосудов: васкулит.Со стороны нервной системы: потеря обоняния, в т.ч. на длительный период времени, снижение обоняния.Со стороны пищеварительной системы: панкреатит.Со стороны скелетно-мышечной системы и соединительной ткани: рабдомиолиз.Общие расстройства: гриппоподобный синдром.Лабораторные и инструментальные данные: повышение активности КФК в сыворотке крови.Побочные эффекты при наружном применении тербинафина (в виде геля, крема, спрея)Со стороны иммунной системы: отдельные сообщения— реакции гиперчувствительности (сыпь).Со стороны органа зрения: редко— раздражение глаз.Со стороны кожных покровов: часто— шелушение кожи, зуд; нечасто— повреждение кожи, образование корки, поражение кожи, нарушение пигментации, эритема, ощущение жжения кожи; редко— ощущение сухости кожи, контактный дерматит, экзема; отдельные сообщения— сыпь.Местные реакции и прочие: нечасто— боль, в т.ч. в месте нанесения, раздражение в месте нанесения; редко— обострение симптомов заболевания. В местах нанесения препарата могут наблюдаться зуд, шелушение кожи, болевые ощущения, раздражение, изменение пигментации кожи, жжение, эритема, корки. Эти незначительные симптомы следует отличать от реакций гиперчувствительности, таких как сыпь, возникающих в редких случаях и требующих отмены терапии. Изредка течение грибковой инфекции может обостряться."}}]},{"id":5,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"До начала применения тербинафина внутрь 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 нед после начала лечения). Лечение тербинафином должно быть немедленно прекращено в случае повышения значений печеночных проб. Пациенты, которым назначают тербинафин, должны быть предупреждены о том, что необходимо немедленно информировать лечащего врача о возникновении на фоне приема таких симптомов, как стойкая тошнота, снижение аппетита, чувство усталости, рвота, боль в правом подреберье, желтуха, темная моча или светлый кал. В случае появления подобных симптомов необходимо немедленно прекратить прием ЛС и провести исследование функции печени.Серьезные кожные реакции (в т.ч. синдром Стивенса-Джонсона, токсический эпидермальный некролиз, лекарственная сыпь с эозинофилией и системными симптомами) крайне редко отмечались на фоне применения тербинафина.При применении тербинафина внутрь отмечались крайне редкие случаи изменения клеточного состава крови (нейтропения, 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 или при необходимости— о прекращении терапии тербинафином.Было показано, что тербинафин подавляет метаболизм, опосредуемый изоферментом CYP2D6. Поэтому необходимо осуществлять постоянное наблюдение за больными, получающими одновременно с тербинафином лечение ЛС, преимущественно метаболизирующимися с участием этого фермента (такими как трициклические антидепрессанты, бета-адреноблокаторы, СИОЗС, антиаритмические средства IС класса и ингибиторы МАО типаВ), в случае если применяемый одновременно препарат имеет малый диапазон терапевтической концентрации.Дети. Данные о пероральном применении тербинафина у детей в возрасте \u003c3 лет (масса тела которых обычно \u003c12 кг) отсутствуют. Применение для лечения у детей с массой тела \u003c20 кг не рекомендуется ввиду невозможности адекватного подбора дозы. Применение у детей от 3 до 12 лет при массе тела \u003e20 кг целесообразно только в том случае, когда положительный ожидаемый эффект терапии превышает потенциальный риск развития побочного действия. Длительность лечения и дозы зависят от массы тела ребенка.Пациенты пожилого возраста. Нет оснований предполагать, что для пациентов пожилого возраста требуется изменение режима дозирования или у них возможны побочные действия, отличающиеся от таковых у пациентов более молодого возраста. В случае перорального применения тербинафина в этой возрастной группе следует учитывать возможность сопутствующего нарушения функции печени или почек.При местном применении тербинафина уменьшение выраженности клинических проявлений обычно отмечается в первые дни лечения. В случае нерегулярного лечения или преждевременного его прекращения имеется риск рецидива инфекции.Местные формы тербинафина предназначены только для наружного применения. Следует избегать попадания тербинафина в глаза, т.к. он может вызвать раздражение. При случайном попадании в глаза, их следует немедленно промыть проточной водой, а в случае развития стойких явлений раздражения необходимо проконсультироваться с врачом. При развитии аллергических реакций необходимо отменить тербинафин.Тербинафин в виде раствора для наружного применения пленкообразующего не рекомендуется применять в случае хронического подошвенного гиперкератоза, вызванного Tinea pedis (мокасcинового типа/Moccassin type).Следует соблюдать осторожность при нанесении спиртосодержащих местных форм тербинафина на поврежденные участки кожи, т.к. спирт может вызвать раздражение.Влияние на способность управлять автотранспортом и/или работать с механизмами. Влияние тербинафина на способность управлять автотранспортом и работать с механизмами не изучалось. При развитии головокружения на фоне терапии тербинафином пациентам не следует управлять автотранспортом и/или работать с механизмами."}}]},{"id":6,"name":"Условия хранения","slug":"storage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В сухом, защищенном от света месте, при температуре не выше 25°C. Не замораживать.Хранить в недоступном для детей месте."}}]},{"id":7,"name":"Срок годности","slug":"expiry_date","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"2 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России"}}]}],"source":{"title":"ЭркаФарм","url":"https://erkapharm.com"}},"description_toggle":false,"short_description":"","substance":[{"id":38,"title":"Тербинафин","title_latin":"Terbinafinum","slug":"terbinafin_38"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":true,"comments":null,"image_alt":"Тербинафин - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/70974/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/70974/share_default/"}},"diseases":[{"id":"131","title":"Микоз бороды и головы","slug":"131-mikoz_borody_i_golovy"},{"id":"133","title":"Микоз кистей","slug":"133-mikoz_kistey"},{"id":"134","title":"Микоз стоп","slug":"134-mikoz_stop"},{"id":"135","title":"Микоз туловища","slug":"135-mikoz_tulovischa"},{"id":"136","title":"Эпидермофития паховая","slug":"136-epidermofitiya_pahovaya"},{"id":"138","title":"Разноцветный 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