Эффезел содержит в своем составе два активных вещества с различными, однако взаимодополняющими, механизмами действия. Адапален. Адапален является химически стабильным производным нафтойной кислоты с ретиноидоподобным действием. Адапален дей ствует патогенетически при acne vulgaris: является сильным модулятором процессов клеточной дифференцировки и кератинизации, а также обладает противовоспалительным действием. Механизм действия препарата основан на связывании адапалена со специфическими ядерными рецепторами ретиноевой кислоты. Современные данные позволяют предположить, что при местном применении адапален нормализует процесс дифференцировки эпителиальных клеток фолликулов, снижая таким образом образование микрокомедонов. In vitro адапален угнетает хемотаксический (направленный) и хемокинетический (произвольный) ответы полиморфноядерных лейкоцитов человека, а также угнетает метаболизм арахидоновой кислоты и образование медиаторов воспаления. По данным исследований in vitro адапален угнетает AP-1 факторы, а также экспрессию toll-подобных рецепторов-2. Таким образом, можно сказать, что под влиянием адапалена снижается клеточно-опосредованный воспалительный компонент угревой сыпи. Бензоила пероксид. Бензоила пероксид оказывает противомикробное действие, в частности, в отношении Propionibacterium acnes, присутствующих в сально-волосяном фолликуле при угревой сыпи. Оказывает отшелушивающее и кератолитическое действие. Обладает себостатическим действием, предупреждая чрезмерную выработку кожного сала, сопровождающую угревую сыпь.
Показания к применению
Лечение угревой сыпи с комедонами, папулами и пустулами.
Противопоказания
Повышенная чувствительность к действующим веществам или любому из компонентов препарата
Детский возраст до 9 лет (безопасность и эффективность препарата не установлена).
Применение при беременности и в период грудного вскармливания
Беременность Исследования на животных, в которых адапален принимался внутрь в высоких дозах, показали токсическое действие на репродуктивную систему. Клинический опыт наружного применения комбинации адапалена и бензоила пероксида при беременности носит ограниченный характер, о днако немногоимеющихся данных, собранных у пациенток, получавших препарат на ранних сроках беременности, не свидетельствуют о каком-либо его отрицательном влиянии. В связи с ограниченным характером имеющихся данных, а также вследствие возможности незначительного проникновения адапалена через кожу, Эффезел не следует применять во время беременности. В случае наступления беременности лечение следует прекратить. Период грудного вскармливания Исследований проникновения препарата в молоко животных или человека после накожного нанесения геля Эффезел не проводилось. Поскольку системная экспозиция комбинации адапалена и бензоила пероксида у кормящих грудью женщин незначительна, никакого влияния на находящихся на грудном вскармливании младенцев не ожидается. Эффезел может применятся во время кормления грудью. Следует избегать контакта грудного ребенка с препаратом, нанесения препарата на грудь при использовании в период грудного вскармливания.
Способ применения и дозы
Наружно. Наносить тонким слоем с помощью кончиков пальцев на всю пораженную поверхность один раз в день вечером на чистую и сухую кожу, избегая попадания геля в глаза, на губы, слизистые оболочки и уголки носа. Терапевтический эффект развивается через 1-4 недели лечения. Продолжительность лечения должна устанавливаться врачом на основании клинического состояния пациента. В случае появления признаков раздражения кожи рекомендуется применение некомедоногенных косметических средств с увлажняющим действием, в зависимости от степени раздражения кожи число нанесений может быть сокращено (например, через день), лечение может быть временно приостановлено до исчезновения признаков раздражения или полностью прекращено. Возобновление лечения возможно после консультации с врачом.
Побочное действие
При применении препарата Эффезел, в месте его нанесения могут возникнуть следующие нежелательные реакции, представленные в таблице в соответствии с классификацией по системам органов и частоте встречаемости: очень часто (≥ 1/10), часто (≥ 1/100-< 1/10), нечасто (≥ 1/1000-< 1/100), редко (≥ 1/10000-<1/1000), очень редко (< 1/10000), частота неизвестна (не может быть оценена на основании имеющихся данных): Нарушения со стороны органа зрения Неизвестно Отек век Нарушения со стороны дыхательной системы, органов грудной клетки и средостения Неизвестно Чувство сдавления в горле Нарушения со стороны кожи и подкожных тканей часто (≥ 1/100-< 1/10) Сухость кожи, контактный дерматит, раздражение кожи, ощущение жжения кожи, эритема, шелушение кожи, сыпь нечасто (≥ 1/1000-< 1/100) Зуд, солнечный ожог Неизвестно Аллергический контактный дерматит, припухлость лица, болезненность кожи (ощущение покалывания), волдыри (везикулы) При применении препарата Эффезел, как правило, в течение первой недели лечения возможны такие симптомы, как: раздражение кожи, покраснение, сухость, шелушение, жжение и болезненность кожи (ощущение покалывания), легкой или умеренной степени выраженности, которые проходят самопроизвольно и не требуют отмены препарата. Если любые из указанных в инструкции побочных эффектов усугубляются, или отмечаются любые другие побочные эффекты, не указанные в инструкции, следует немедленно сообщить об этом врачу.
Передозировка
Эффезел следует наносить только один раз в день. При случайном проглатывании следует провести соответствующую симптоматическую терапию.
Особые указания
Не следует наносить гель Эффезел на поврежденную в результате травм (порезы или ссадины) или экзематозно измененную кожу. Избегать контакта с глазами, ротовой полостью, ноздрями и другими слизистыми оболочками. При попадании препарата в глаза немедленно промыть их теплой водой. Препарат содержит пропиленгликоль (E1520), который может вызвать раздражение кожи. При подозрении на повышенную чувствительность к каким-либо из ингредиентов препарата применение препарата Эффезел следует прекратить. Следует избегать чрезмерного воздействия солнечного света или искусственного ультрафиолетового излучения. Следует избегать контакта с какими-либо окрашенными материалами (включая волосы и окрашенные ткани), поскольку это может привести к изменению их цвета или обесцвечиванию.
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Информация предоставляется в справочных целях. Не занимайтесь самолечением. При первых признаках заболевания обратитесь к врачу.
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Адапален. Адапален является химически стабильным производным нафтойной кислоты с ретиноидоподобным действием. Адапален дей ствует патогенетически при acne vulgaris: является сильным модулятором процессов клеточной дифференцировки и кератинизации, а также обладает противовоспалительным действием. Механизм действия препарата основан на связывании адапалена со специфическими ядерными рецепторами ретиноевой кислоты. Современные данные позволяют предположить, что при местном применении адапален нормализует процесс дифференцировки эпителиальных клеток фолликулов, снижая таким образом образование микрокомедонов. In vitro адапален угнетает хемотаксический (направленный) и хемокинетический (произвольный) ответы полиморфноядерных лейкоцитов человека, а также угнетает метаболизм арахидоновой кислоты и образование медиаторов воспаления. По данным исследований in vitro адапален угнетает AP-1 факторы, а также экспрессию toll-подобных рецепторов-2. Таким образом, можно сказать, что под влиянием адапалена снижается клеточно-опосредованный воспалительный компонент угревой сыпи. Бензоила пероксид. Бензоила пероксид оказывает противомикробное действие, в частности, в отношении Propionibacterium acnes, присутствующих в сально-волосяном фолликуле при угревой сыпи. Оказывает отшелушивающее и кератолитическое действие. Обладает себостатическим действием, предупреждая чрезмерную выработку кожного сала, сопровождающую угревую сыпь."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение угревой сыпи с комедонами, папулами и пустулами."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к действующим веществам или любому из компонентов препарата"}},{"type":"paragraph","data":{"text":"Детский возраст до 9 лет (безопасность и эффективность препарата не установлена)."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Беременность Исследования на животных, в которых адапален принимался внутрь в высоких дозах, показали токсическое действие на репродуктивную систему. Клинический опыт наружного применения комбинации адапалена и бензоила пероксида при беременности носит ограниченный характер, о днако немногоимеющихся данных, собранных у пациенток, получавших препарат на ранних сроках беременности, не свидетельствуют о каком-либо его отрицательном влиянии. В связи с ограниченным характером имеющихся данных, а также вследствие возможности незначительного проникновения адапалена через кожу, Эффезел не следует применять во время беременности. В случае наступления беременности лечение следует прекратить. Период грудного вскармливания Исследований проникновения препарата в молоко животных или человека после накожного нанесения геля Эффезел не проводилось. Поскольку системная экспозиция комбинации адапалена и бензоила пероксида у кормящих грудью женщин незначительна, никакого влияния на находящихся на грудном вскармливании младенцев не ожидается. Эффезел может применятся во время кормления грудью. Следует избегать контакта грудного ребенка с препаратом, нанесения препарата на грудь при использовании в период грудного вскармливания."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Наружно. Наносить тонким слоем с помощью кончиков пальцев на всю пораженную поверхность один раз в день вечером на чистую и сухую кожу, избегая попадания геля в глаза, на губы, слизистые оболочки и уголки носа. Терапевтический эффект развивается через 1-4 недели лечения. Продолжительность лечения должна устанавливаться врачом на основании клинического состояния пациента. В случае появления признаков раздражения кожи рекомендуется применение некомедоногенных косметических средств с увлажняющим действием, в зависимости от степени раздражения кожи число нанесений может быть сокращено (например, через день), лечение может быть временно приостановлено до исчезновения признаков раздражения или полностью прекращено. Возобновление лечения возможно после консультации с врачом."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При применении препарата Эффезел, в месте его нанесения могут возникнуть следующие нежелательные реакции, представленные в таблице в соответствии с классификацией по системам органов и частоте встречаемости: очень часто (≥ 1/10), часто (≥ 1/100-\u003c 1/10), нечасто (≥ 1/1000-\u003c 1/100), редко (≥ 1/10000-\u003c1/1000), очень редко (\u003c 1/10000), частота неизвестна (не может быть оценена на основании имеющихся данных): Нарушения со стороны органа зрения Неизвестно Отек век Нарушения со стороны дыхательной системы, органов грудной клетки и средостения Неизвестно Чувство сдавления в горле Нарушения со стороны кожи и подкожных тканей часто (≥ 1/100-\u003c 1/10) Сухость кожи, контактный дерматит, раздражение кожи, ощущение жжения кожи, эритема, шелушение кожи, сыпь нечасто (≥ 1/1000-\u003c 1/100) Зуд, солнечный ожог Неизвестно Аллергический контактный дерматит, припухлость лица, болезненность кожи (ощущение покалывания), волдыри (везикулы) При применении препарата Эффезел, как правило, в течение первой недели лечения возможны такие симптомы, как: раздражение кожи, покраснение, сухость, шелушение, жжение и болезненность кожи (ощущение покалывания), легкой или умеренной степени выраженности, которые проходят самопроизвольно и не требуют отмены препарата. 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