Бифоназол активное вещество крема МИКОСПОР является производным имидазола и обладает широким спектром антимикотического действия.
Бифоназол обладает фунгицидным действием в отношении дерматофитов (в частности в отношении Trichophyton spp.). Полный фунгицидный эффект достигается при концентрации бифоназола 5 мкг/мл и продолжительности воздействия не менее 6 часов. Бифоназол обладает фунгиетатическим действием в отношении дрожжевых и плесневых грибов а также Malassezia furfur. При поражении дрожжевыми грибами например Candida species при концентрации 1-4 мкг/мл отмечается преимущественно фунгистатический эффект бифоназола; для фунгицидного эффекта необходима концентрация бифоназола 20 мкг/мл. Бифоназол также активен в отношении Corynebacterium minutissimum (МПК от 0.5 до 2 мкг/мл) грамположительных кокков за исключением энтерококков (МПК от 4 до 16 мкг/мл). Резистентные штаммы грибов встречаются очень редко. Исследования не подтвердили развитие вторичной устойчивости у первично чувствительных штаммов. Бифоназол подавляет биосинтез эргостерола на двух различных уровнях что отличает его от других противогрибковых препаратов и других производных азола. Такое двойное действие приводит к структурным и функциональным повреждениям цитоплазматической мембраны грибов.
Фармакокинетика:
Бифоназол хорошо проникает в пораженные слои кожи. Через 6 часов после применения концентрации в различных слоях кожи достигают от 1000 мкг/см3 в верхнем слое эпидермиса (в роговом слое) до 5 мкг/см3 в сосочковом слое. Таким образом все полученные концентрации находятся в пределах диапазона противогрибковой активности.
При нанесении на неповреждённую кожу абсорбируется незначительное количество бифоназола (06-08% от дозы препарата); уровень концентрации бифоназола в плазме крови при этом всегда ниже предела обнаружения (т.е. < 1 нг/мл). Незначительная абсорбция выявляется только после нанесения крема бифоназола на воспалённую кожу (2-4% от дозы препарата). Таким образом поскольку в плазме крови создаются весьма низкие концентрации бифоназола при его местном применении (обычно не выше 5 нг/мл) то никаких системных эффектов не наблюдается. Продолжительность нахождения в коже (определенная по защитному действию в отношении грибковой инфекции у морских свинок) - 48-72 ч.
Бифоназол проникает через плацентарный барьер у крыс.
Показания к применению
Грибковые заболевания кожи вызванные дерматофитами дрожжеподобными плесневыми грибами и другими видами грибов:
- микозы стоп (дерматофития кожи стоп и межпальцевая дерматофития стоп);
- микозы кистей рук (дерматофития кожи рук и межпальцевая дерматофития);
- дерматофития гладкой кожи тела;
- дерматофития паховой области;
- поверхностный кандидоз кожи;
- отрубевидный лишай;
- эритразма.
Противопоказания
- Повышенная чувствительность к бифоназолу или любому другому компоненту препарата;
- беременность (I триместр);
- период грудного вскармливания.
С осторожностью
При беременности (II и III триместр) (см. раздел "Применение во время беременности и в период грудного вскармливания").
Детский возраст (см. раздел "Способ применения и дозы").
Применять с осторожностью у пациентов имеющих повышенную чувствительность к другим противогрибковым лекарственным средствам из группы производных имидазола (эконазол клотримазол миконазол).
Применение при беременности и в период грудного вскармливания
Беременность
Абсорбция бифоназола при наружном применении препарата незначительна (см. раздел "Фармакокинетика"). Данные доклинических ифармакокинетических исследований показывают что бифоназол не оказывает какого-либоотрицательного действия на организм матери и плода. Клинические исследования у беременных не проводились. В качестве меры предосторожности следует избегать применения бифоназола в первом триместре беременности.
Во II и III триместре беременности применение препарата возможно если потенциальная польза для матери превосходит возможный риск для плода.
Период грудного вскармливания
Абсорбция бифоназола при наружном применении препарата незначительна (см. раздел "Фармакокинетика") неизвестно проникает ли бифоназол в грудное молоко у женщин.
Данные полученные наэкспериментальных животныхпоказывают что бифоназол выделяется с грудным молоком.
При необходимости применения препарата в период грудного вскармливания следует решить вопрос о его прекращении.
Фертильность
Данные по безопасности полученные из доклинических исследований дают основания предположить что применение бифоназола не оказывает какого-либо отрицательного влияния на мужскую и женскую фертильность.
Способ применения и дозы
Наружно крем наносят тонким слоем на пораженные участки кожи 1 раз в день желательно на ночь и осторожно втирают.
Для достижения удовлетворительного результата лечение должно быть непрерывным.
Длительность терапии обычно составляет:
- при микозах стоп(дерматофития кожи стоп и межпальцевая дерматофития стоп): 3 недели;
- при микозах кистей рук (дерматофития кожи рук и межпальцевая дерматофития) кожи тела (дерматофития гладкой кожи) и складок кожи (паховаядерматофития): 2-3 недели;
- при отрубевидном лишаеэритразме: 2 недели;
- при поверхностном кандидозекожи: 2-4 недели.
Для обработки поверхности приблизительно равной площадиладони достаточно небольшоеколичество крема (столбик крема длиной около 1 см).
Отдельных исследований у детей не проводилось. На основании обзора клинических данных не выявлено свидетельств развитиянеблагоприятных побочных эффектов при применении препарата у детей. Однако у детей препарат Микоспор® крем для наружного применения следует применять только под контролем врача.
Если в течение 7 дней улучшение не наблюдается или состояние ухудшилось необходимо обратиться к врачу.
Побочное действие
Общие нарушения и местные реакции: боль в месте нанесения периферические отеки (в месте нанесения).
Нарушения со стороны кожи и подкожных тканей: контактный дерматит аллергический дерматит эритема зуд сыпь крапивница волдыри шелушение и сухость кожи экзема раздражение кожи мацерация чувство жжения кожи.
Побочные эффекты обратимы и исчезают после отмены препарата.
Передозировка
Риск острой интоксикации отсутствует так как передозировка (нанесение на обширные участки кожи при условиях благоприятных для всасывания) после однократного нанесения препарата на кожу или случайном приеме внутрь маловероятна.
Взаимодействие с другими лекарственными средствами
Имеются ограниченные данные о возможном взаимодействии бифоназола для наружного применения и варфарина приводящем к повышению международного нормализованного отношения и возможному кровотечению и синякам. В случае применения бифоназола у пациентов находящихся на терапии варфарином необходимо тщательное наблюдение за такими пациентами.
Особые указания
Применять с осторожностью у пациентов имеющих повышенную чувствительность к другим противогрибковым лекарственным средствам из группы производных имидазола (эконазол клотримазол миконазол).
При усилении/сохранении симптомов после прекращения лечения следует обратиться к врачу.
Избегать попадания крема в глаза.
Не принимать внутрь.
При повышенной чувствительности кцетостеариловому спиртурекомендуется вместо крема применять лекарственные формы бифоназола не содержащие цетостеариловый спирт (например Микоспор раствор для наружного применения 1%).
Применение в педиатрической практике
Отдельных исследований у детей не проводилось. На основании обзора клинических данных не выявлено свидетельств развития неблагоприятных побочных эффектов при применении препарата у детей. Однако у детей младше 1 года Микоспор крем следует использовать только под контролем врача.
Влияние на способность управлять автомобилем и движущимися механизмами
Препарат Микоспор крем для наружного применения не оказывает отрицательного влияния на выполнение потенциально опасных видов деятельности требующих повышенной концентрации внимания и быстроты психомоторных реакций (управление автомобилем работа с движущимися механизмами и др.).
Форма выпуска
Крем для наружного применения 1%.
Условия хранения
Хранить при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
5 лет.
Не использовать по истечении срока годности указанного на упаковке.
Условия отпуска
Без рецепта
Производитель
Байер Фарма АГ, D-51368 Leverkusen, Germany, Германия
Организация, принимающая претензии потребителей
Байер Фарма АГ
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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туба, 15 г, 1 %","short":"Крем, 15 г, 1 %","package":"15 г, 1 %"},"prescription":false,"catalog_section_id":114,"manufacturer":{"id":51,"title":"Байер","slug":"bayer_51","logo":{"isTouch":{"retina":null,"default":null},"isFromTablet":{"retina":null,"default":null}}},"is_advert":false,"product_form":"Крем","slug":"145856-mikospor","attributes":{"count":"15 г","dose":"1 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17.06.08"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Микоспор"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"крем для наружного применения"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"В 100 г крема содержится:"}},{"type":"paragraph","data":{"text":"активный ингредиент: бифоназол микронизированный 1,00 г;"}},{"type":"paragraph","data":{"text":"вспомогательные ингредиенты: спирт бензиловый 2,00 г, спирт цетостеариловый [спирт цетиловый 60%, спирт стеариловый 40%] 10,00 г, цетилпальмитат 3,00 г, октилдодеканол 13,50 г, полисорбат 60 1,50 г, сорбитана стеарат 2,00 г, вода очищенная до 100,0 г."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Однородный крем белого цвета."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Противогрибковое средство"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Бифоназол активное вещество крема МИКОСПОР является производным имидазола и обладает широким спектром антимикотического действия."}},{"type":"paragraph","data":{"text":"Бифоназол обладает фунгицидным действием в отношении дерматофитов (в частности в отношении Trichophyton spp.). Полный фунгицидный эффект достигается при концентрации бифоназола 5 мкг/мл и продолжительности воздействия не менее 6 часов. Бифоназол обладает фунгиетатическим действием в отношении дрожжевых и плесневых грибов а также Malassezia furfur. При поражении дрожжевыми грибами например Candida species при концентрации 1-4 мкг/мл отмечается преимущественно фунгистатический эффект бифоназола; для фунгицидного эффекта необходима концентрация бифоназола 20 мкг/мл. Бифоназол также активен в отношении Corynebacterium minutissimum (МПК от 0.5 до 2 мкг/мл) грамположительных кокков за исключением энтерококков (МПК от 4 до 16 мкг/мл). Резистентные штаммы грибов встречаются очень редко. Исследования не подтвердили развитие вторичной устойчивости у первично чувствительных штаммов. Бифоназол подавляет биосинтез эргостерола на двух различных уровнях что отличает его от других противогрибковых препаратов и других производных азола. Такое двойное действие приводит к структурным и функциональным повреждениям цитоплазматической мембраны грибов."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Бифоназол хорошо проникает в пораженные слои кожи. Через 6 часов после применения концентрации в различных слоях кожи достигают от 1000 мкг/см\u003csup\u003e3\u003c/sup\u003e в верхнем слое эпидермиса (в роговом слое) до 5 мкг/см\u003csup\u003e3\u003c/sup\u003e в сосочковом слое. Таким образом все полученные концентрации находятся в пределах диапазона противогрибковой активности."}},{"type":"paragraph","data":{"text":"При нанесении на неповреждённую кожу абсорбируется незначительное количество бифоназола (06-08% от дозы препарата); уровень концентрации бифоназола в плазме крови при этом всегда ниже предела обнаружения (т.е. < 1 нг/мл). Незначительная абсорбция выявляется только после нанесения крема бифоназола на воспалённую кожу (2-4% от дозы препарата). Таким образом поскольку в плазме крови создаются весьма низкие концентрации бифоназола при его местном применении (обычно не выше 5 нг/мл) то никаких системных эффектов не наблюдается. Продолжительность нахождения в коже (определенная по защитному действию в отношении грибковой инфекции у морских свинок) - 48-72 ч."}},{"type":"paragraph","data":{"text":"Бифоназол проникает через плацентарный барьер у крыс."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Грибковые заболевания кожи вызванные дерматофитами дрожжеподобными плесневыми грибами и другими видами грибов:"}},{"type":"paragraph","data":{"text":"- микозы стоп (дерматофития кожи стоп и межпальцевая дерматофития стоп);"}},{"type":"paragraph","data":{"text":"- микозы кистей рук (дерматофития кожи рук и межпальцевая дерматофития);"}},{"type":"paragraph","data":{"text":"- дерматофития гладкой кожи тела;"}},{"type":"paragraph","data":{"text":"- дерматофития паховой области;"}},{"type":"paragraph","data":{"text":"- поверхностный кандидоз кожи;"}},{"type":"paragraph","data":{"text":"- отрубевидный лишай;"}},{"type":"paragraph","data":{"text":"- эритразма."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- Повышенная чувствительность к бифоназолу или любому другому компоненту препарата;"}},{"type":"paragraph","data":{"text":"- беременность (I триместр);"}},{"type":"paragraph","data":{"text":"- период грудного вскармливания."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"При беременности (II и III триместр) (см. раздел \"Применение во время беременности и в период грудного вскармливания\")."}},{"type":"paragraph","data":{"text":"Детский возраст (см. раздел \"Способ применения и дозы\")."}},{"type":"paragraph","data":{"text":"Применять с осторожностью у пациентов имеющих повышенную чувствительность к другим противогрибковым лекарственным средствам из группы производных имидазола (эконазол клотримазол миконазол)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Беременность"}},{"type":"paragraph","data":{"text":"Абсорбция бифоназола при наружном применении препарата незначительна (см. раздел \"Фармакокинетика\"). Данные доклинических ифармакокинетических исследований показывают что бифоназол не оказывает какого-либоотрицательного действия на организм матери и плода. Клинические исследования у беременных не проводились. В качестве меры предосторожности следует избегать применения бифоназола в первом триместре беременности."}},{"type":"paragraph","data":{"text":"Во II и III триместре беременности применение препарата возможно если потенциальная польза для матери превосходит возможный риск для плода."}},{"type":"paragraph","data":{"text":"Период грудного вскармливания"}},{"type":"paragraph","data":{"text":"Абсорбция бифоназола при наружном применении препарата незначительна (см. раздел \"Фармакокинетика\") неизвестно проникает ли бифоназол в грудное молоко у женщин."}},{"type":"paragraph","data":{"text":"Данные полученные наэкспериментальных животныхпоказывают что бифоназол выделяется с грудным молоком."}},{"type":"paragraph","data":{"text":"При необходимости применения препарата в период грудного вскармливания следует решить вопрос о его прекращении."}},{"type":"paragraph","data":{"text":"Фертильность"}},{"type":"paragraph","data":{"text":"Данные по безопасности полученные из доклинических исследований дают основания предположить что применение бифоназола не оказывает какого-либо отрицательного влияния на мужскую и женскую фертильность."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Наружно крем наносят тонким слоем на пораженные участки кожи 1 раз в день желательно на ночь и осторожно втирают."}},{"type":"paragraph","data":{"text":"Для достижения удовлетворительного результата лечение должно быть непрерывным."}},{"type":"paragraph","data":{"text":"Длительность терапии обычно составляет:"}},{"type":"paragraph","data":{"text":"- при микозах стоп(дерматофития кожи стоп и межпальцевая дерматофития стоп): 3 недели;"}},{"type":"paragraph","data":{"text":"- при микозах кистей рук (дерматофития кожи рук и межпальцевая дерматофития) кожи тела (дерматофития гладкой кожи) и складок кожи (паховаядерматофития): 2-3 недели;"}},{"type":"paragraph","data":{"text":"- при отрубевидном лишаеэритразме: 2 недели;"}},{"type":"paragraph","data":{"text":"- при поверхностном кандидозекожи: 2-4 недели."}},{"type":"paragraph","data":{"text":"Для обработки поверхности приблизительно равной площадиладони достаточно небольшоеколичество крема (столбик крема длиной около 1 см)."}},{"type":"paragraph","data":{"text":"Отдельных исследований у детей не проводилось. На основании обзора клинических данных не выявлено свидетельств развитиянеблагоприятных побочных эффектов при применении препарата у детей. Однако у детей препарат Микоспор® крем для наружного применения следует применять только под контролем врача."}},{"type":"paragraph","data":{"text":"Если в течение 7 дней улучшение не наблюдается или состояние ухудшилось необходимо обратиться к врачу."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Общие нарушения и местные реакции: боль в месте нанесения периферические отеки (в месте нанесения)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны кожи и подкожных тканей: контактный дерматит аллергический дерматит эритема зуд сыпь крапивница волдыри шелушение и сухость кожи экзема раздражение кожи мацерация чувство жжения кожи."}},{"type":"paragraph","data":{"text":"Побочные эффекты обратимы и исчезают после отмены препарата."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Риск острой интоксикации отсутствует так как передозировка (нанесение на обширные участки кожи при условиях благоприятных для всасывания) после однократного нанесения препарата на кожу или случайном приеме внутрь маловероятна."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Имеются ограниченные данные о возможном взаимодействии бифоназола для наружного применения и варфарина приводящем к повышению международного нормализованного отношения и возможному кровотечению и синякам. В случае применения бифоназола у пациентов находящихся на терапии варфарином необходимо тщательное наблюдение за такими пациентами."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Применять с осторожностью у пациентов имеющих повышенную чувствительность к другим противогрибковым лекарственным средствам из группы производных имидазола (эконазол клотримазол миконазол)."}},{"type":"paragraph","data":{"text":"При усилении/сохранении симптомов после прекращения лечения следует обратиться к врачу."}},{"type":"paragraph","data":{"text":"Избегать попадания крема в глаза."}},{"type":"paragraph","data":{"text":"Не принимать внутрь."}},{"type":"paragraph","data":{"text":"При повышенной чувствительности кцетостеариловому спиртурекомендуется вместо крема применять лекарственные формы бифоназола не содержащие цетостеариловый спирт (например Микоспор раствор для наружного применения 1%)."}},{"type":"paragraph","data":{"text":"Применение в педиатрической практике"}},{"type":"paragraph","data":{"text":"Отдельных исследований у детей не проводилось. На основании обзора клинических данных не выявлено свидетельств развития неблагоприятных побочных эффектов при применении препарата у детей. Однако у детей младше 1 года Микоспор крем следует использовать только под контролем врача."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Препарат Микоспор крем для наружного применения не оказывает отрицательного влияния на выполнение потенциально опасных видов деятельности требующих повышенной концентрации внимания и быстроты психомоторных реакций (управление автомобилем работа с движущимися механизмами и др.)."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Крем для наружного применения 1%."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"5 лет."}},{"type":"paragraph","data":{"text":"Не использовать по истечении срока годности указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Без рецепта"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Байер Фарма АГ, D-51368 Leverkusen, Germany, Германия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"Байер Фарма АГ"}}]}],"source":null},"description_toggle":false,"short_description":"Бифоназол активное вещество крема МИКОСПОР является производным имидазола и обладает широким спектром антимикотического действия. Бифоназол обладает фунгицидным действием в отношении дерматофитов (в частности в отношении Trichophyton spp.). Полный фунгицидный эффект достигается при концентрации бифоназола 5 мкг/мл и продолжительности воздействия не менее 6 часов. Бифоназол обладает фунгиетатическим действием в отношении дрожжевых и плесневых грибов а также Malassezia furfur. При поражении дрожжевыми грибами например Candida species при концентрации 1-4 мкг/мл отмечается преимущественно фунгистатический эффект бифоназола; для фунгицидного эффекта необходима концентрация бифоназола 20 мкг/мл. Бифоназол также активен в отношении Corynebacterium minutissimum (МПК от 0.5 до 2 мкг/мл) грамположительных кокков за исключением энтерококков (МПК от 4 до 16 мкг/мл). Резистентные штаммы грибов встречаются очень редко. Исследования не подтвердили развитие вторичной устойчивости у первично чувствительных штаммов. Бифоназол подавляет биосинтез эргостерола на двух различных уровнях что отличает его от других противогрибковых препаратов и других производных азола. Такое двойное действие приводит к структурным и функциональным повреждениям цитоплазматической мембраны грибов. Бифоназол хорошо проникает в пораженные слои кожи. Через 6 часов после применения концентрации в различных слоях кожи достигают от 1000 мкг/см3в верхнем слое эпидермиса (в роговом слое) до 5 мкг/см3в сосочковом слое. Таким образом все полученные концентрации находятся в пределах диапазона противогрибковой активности. При нанесении на неповреждённую кожу абсорбируется незначительное количество бифоназола (06-08% от дозы препарата); уровень концентрации бифоназола в плазме крови при этом всегда ниже предела обнаружения (т.е.\u003c1 нг/мл). Незначительная абсорбция выявляется только после нанесения крема бифоназола на воспалённую кожу (2-4% от дозы препарата). Таким образом поскольку в плазме крови создаются весьма низкие концентрации бифоназола при его местном применении (обычно не выше 5 нг/мл) то никаких системных эффектов не наблюдается. Продолжительность нахождения в коже (определенная по защитному действию в отношении грибковой инфекции у морских свинок) - 48-72 ч. 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