действующие вещества: метилпред-низолона ацепонат (метилпреднизолона ацепонат микронизированный) в пересчете на 100 % вещество - 0,1 г, мочевина в пересчете на 100 % вещество - 2 г; вспомогательные вещества: парафин жидкий (вазелиновое масло), пропиленгликоль, полисорбат-80, карбомер интерполимер (тип А), трометамол, метилпарагидроксибензоат, вода очищенная.
Описание
Воспалительные заболевания кожи, чувствительные к терапии топическими глюкокортикостероидами и сопровождающиеся нарушением кератинизации: атопический дерматит, нейродермит; истинная экзема; микробная экзема; простой контактный дерматит; аллергический (контактный) дерматит; дисгидротическая экзема.
Фармакотерапевтическая группа
глюкокортикостероид для местного применения+кератолитическое средство
Фармакологические свойства
Комфодерм® М2 - комбинированный препарат, действие которого обусловлено входящими в его состав компонентами.Метилпреднизолона ацепонат - представляет собой негалогенизированный синтетический стероид. При наружном применении метилпреднизолона ацепонат подавляет воспалительные и аллергические кожные реакции, также как и реакции, связанные с усиленной пролиферацией, что приводит к уменьшению объективных симптомов воспаления (эритема, отек, мокнутие) и субъективных ощущений (зуд, раздражение, боль и т.д.).При применении метилпреднизолона ацепоната наружно в рекомендуемой дозе системное действие минимально как у человека, так и у животных. После многократного нанесения метилпреднизолона ацепоната на большие поверхности (40-60 % поверхности кожи), а также при применении под окклюзионную повязку не отмечается нарушений функций надпочечников: уровень кортизола в плазме и его циркадный ритм остаются в пределах нормы, снижения концентрации кортизола в суточной моче не происходит.Метилпреднизолона ацепонат (особенно его основной метаболит - 6 альфа -метилпреднизолон-17-пропионат) связывается с внутриклеточными глюкокортикоидными рецепторами.Стероид-рецепторный комплекс связывается с определенными участками ДНК клеток иммунного ответа, вызывая, таким образом, серию биологических эффектов.В частности, связывание стероид-рецепторного комплекса с ДНК клетками иммунного ответа приводит к индукции синтеза макрокортина.Макрокортин ингибирует высвобождение арахидоновой кислоты и, тем самым, образование медиаторов воспаления типа простагландинов и лейкотриенов.Ингибирование глюкокортикостероидами синтеза вазодилатирующих простагландинов и потенцирование сосудосуживающего действия адреналина приводят к вазоконстрикторному эффекту.Мочевина - обладает кератолитическим и увлажняющим эффектами. Мочевинаспособствует связыванию воды и вследствие этого размягчению рогового слоя кожи. Помимо кератолитического действия, мочевина обладает протеолитической активностью
Фармакокинетика
При местном применении метилпреднизолона ацепонат гидролизуется в эпидермисе и дерме. Главным и наиболее активным метаболитом является 6?-метилпреднизолон-17-пропионат, обладающий значительно более высоким сродством к глюкокортикостероидным рецепторам кожи, что указывает на наличие его "биоактивации" в коже.Степень чрескожной абсорбции зависит от состояния кожи и способа применения (с использованием или без окклюзионной повязки).Чрескожная абсорбция у пациентов с атоническим дерматитом (нейродермитом) и псориазом составляет не более 2,5 %, что лишь незначительно выше таковой у здоровых добровольцев (0,5-1,5 %).После попадания в системный кровоток 6?-метилпреднизолон-17-пропионат быстро конъюгирует с глюкуроновой кислотой и, таким образом, инактивируется.Метаболиты метилпреднизолона ацепоната элиминируются, главным образом, почками с периодом полувыведення около 16 часов. Метилпреднизолона ацепонат и его метаболиты не кумулируют в организмеВ связи с низкой всасываемостью мочевины при местном применении вероятность ее системных эффектов невелика.
Показания к применению
Воспалительные заболевания кожи, чувствительные к терапии топическими глюко-
кортикостероидами и сопровождающиеся нарушением кератинизации:
● атопический дерматит, нейродермит;
● истинная экзема;
● микробная экзема;
● простой контактный дерматит;
● аллергический (контактный) дерматит;
● дисгидротическая экзема
Противопоказания
гиперчувствительность к компонентам препарата;
● туберкулезный или сифилитический процессы в области нанесения препарата;
● вирусные заболевания (например, ветряная оспа, опоясывающий лишай);
● розацеа, периоральный дерматит в области нанесения препарата;
● участки кожи с проявлениями реакции на вакцинацию;
● детский возраст до 18 лет.
Применение при беременности и в период грудного вскармливания
При необходимости применения препарата Комфодерм® М2 во время беременности и
лактации следует тщательно взвешивать потенциальный риск для плода и ожидаемую пользу лечения для матери. В эти периоды не рекомендуется длительное применение
препарата на обширных поверхностях кожи. Кормящим матерям не следует наносить
препарат на молочные железы
Способ применения и дозы
Наружно. Препарат наносят 1 раз в сутки тонким слоем на пораженные участки кожи.
Как правило, длительность непрерывного ежедневного лечения препаратом
Комфодерм® М 2 не должна превышать 12 недель.
При лечении пациентов с поражением кожи лица курс лечения не должен превышать 5 дней
Побочное действие
Очень редко (менее чем в 0,01 % случаев) могут наблюдаться местные реакции, такие как зуд, жжение, эритема, образование везикулезной сыпи. Если препарат применяют более 4-х недель и/или на площади 10 % и более поверхности тела, могут возникнуть следующие реакции: атрофия кожи, телеангиэктазии, стрии, акнеформные изменения кожи, системные эффекты, обусловленные абсорбцией кортикостероида.
В редких случаях (0,01 % - 0,1 %) могут наблюдаться фолликулит, гипертрихоз, периоральный дерматит, депигментация кожи, аллергические реакции на один из компонентов препарата
Передозировка
При изучении острой токсичности метилпреднизолона ацепоната не было выявлено какого-либо риска острой интоксикации при чрезмерном однократном кожном применении (нанесение препарата на большую площадь при условиях, благоприятных для абсорбции) или при непреднамеренном приеме внутрь.
При чрезмерно долгом и/или интенсивном местном применении глюкокортикостероидов могут развиться атрофия кожи (истончение кожи, телеангиэктазии, стрии).
При появлении признаков атрофии кожи препарат необходимо отменить.
При местном применении мочевины передозировка маловероятна
Взаимодействие с другими лекарственными средствами
Взаимодействия препарата с другими лекарственными средствами не выявлено, однако следует учитывать, что одновременное применение препарата Комфодерм® М2 с другими мазями или кремами может привести к усилению резорбции входящих в их состав лекарственных веществ
Особые указания
При наличии бактериальных осложнений и/или дерматомикозов в дополнение к терапии препаратом Комфодерм® М2 необходимо проводить специфическое антибактериальное и/или антимикотическое лечение.
Препарат не предназначен для применения в офтальмологии. Следует избегать попадания в глаза и на слизистые оболочки.
Как и при применении системных глюкокортикостероидов, после наружного применения глюкокортикостероидов может развиться глаукома (например, после использования больших доз, вследствие очень длительного применения окклюзионных повязок или после нанесения на кожу вокруг глаз).
На коже лица чаще, чем на других поверхностях тела, после длительного лечения глюкокортикостероидами местного действия могут появляться атрофические изменения.
Влияние препарата на способность к управлению транспортными средствами и механизмами:
Не выявлено
Для описания товара использована информация от партнера ЗдравСити
Мобильное приложение «Все аптеки»
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Информация предоставляется в справочных целях. Не занимайтесь самолечением. При первых признаках заболевания обратитесь к врачу.
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вещества: метилпред-низолона ацепонат (метилпреднизолона ацепонат микронизированный) в пересчете на 100 % вещество - 0,1 г, мочевина в пересчете на 100 % вещество - 2 г; вспомогательные вещества: парафин жидкий (вазелиновое масло), пропиленгликоль, полисорбат-80, карбомер интерполимер (тип А), трометамол, метилпарагидроксибензоат, вода очищенная."}}]},{"id":1,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Воспалительные заболевания кожи, чувствительные к терапии топическими глюкокортикостероидами и сопровождающиеся нарушением кератинизации: атопический дерматит, нейродермит; истинная экзема; микробная экзема; простой контактный дерматит; аллергический (контактный) дерматит; дисгидротическая экзема."}}]},{"id":5,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"глюкокортикостероид для местного применения+кератолитическое средство"}}]},{"id":6,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Комфодерм® М2 - комбинированный препарат, действие которого обусловлено входящими в его состав компонентами.Метилпреднизолона ацепонат - представляет собой негалогенизированный синтетический стероид. При наружном применении метилпреднизолона ацепонат подавляет воспалительные и аллергические кожные реакции, также как и реакции, связанные с усиленной пролиферацией, что приводит к уменьшению объективных симптомов воспаления (эритема, отек, мокнутие) и субъективных ощущений (зуд, раздражение, боль и т.д.).При применении метилпреднизолона ацепоната наружно в рекомендуемой дозе системное действие минимально как у человека, так и у животных. После многократного нанесения метилпреднизолона ацепоната на большие поверхности (40-60 % поверхности кожи), а также при применении под окклюзионную повязку не отмечается нарушений функций надпочечников: уровень кортизола в плазме и его циркадный ритм остаются в пределах нормы, снижения концентрации кортизола в суточной моче не происходит.Метилпреднизолона ацепонат (особенно его основной метаболит - 6 альфа -метилпреднизолон-17-пропионат) связывается с внутриклеточными глюкокортикоидными рецепторами.Стероид-рецепторный комплекс связывается с определенными участками ДНК клеток иммунного ответа, вызывая, таким образом, серию биологических эффектов.В частности, связывание стероид-рецепторного комплекса с ДНК клетками иммунного ответа приводит к индукции синтеза макрокортина.Макрокортин ингибирует высвобождение арахидоновой кислоты и, тем самым, образование медиаторов воспаления типа простагландинов и лейкотриенов.Ингибирование глюкокортикостероидами синтеза вазодилатирующих простагландинов и потенцирование сосудосуживающего действия адреналина приводят к вазоконстрикторному эффекту.Мочевина - обладает кератолитическим и увлажняющим эффектами. Мочевинаспособствует связыванию воды и вследствие этого размягчению рогового слоя кожи. Помимо кератолитического действия, мочевина обладает протеолитической активностью"}},{"type":"header","data":{"text":"Фармакокинетика","level":3}},{"type":"paragraph","data":{"text":"При местном применении метилпреднизолона ацепонат гидролизуется в эпидермисе и дерме. Главным и наиболее активным метаболитом является 6?-метилпреднизолон-17-пропионат, обладающий значительно более высоким сродством к глюкокортикостероидным рецепторам кожи, что указывает на наличие его \"биоактивации\" в коже.Степень чрескожной абсорбции зависит от состояния кожи и способа применения (с использованием или без окклюзионной повязки).Чрескожная абсорбция у пациентов с атоническим дерматитом (нейродермитом) и псориазом составляет не более 2,5 %, что лишь незначительно выше таковой у здоровых добровольцев (0,5-1,5 %).После попадания в системный кровоток 6?-метилпреднизолон-17-пропионат быстро конъюгирует с глюкуроновой кислотой и, таким образом, инактивируется.Метаболиты метилпреднизолона ацепоната элиминируются, главным образом, почками с периодом полувыведення около 16 часов. Метилпреднизолона ацепонат и его метаболиты не кумулируют в организмеВ связи с низкой всасываемостью мочевины при местном применении вероятность ее системных эффектов невелика."}}]},{"id":7,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Воспалительные заболевания кожи, чувствительные к терапии топическими глюко-"}},{"type":"paragraph","data":{"text":"кортикостероидами и сопровождающиеся нарушением кератинизации:"}},{"type":"paragraph","data":{"text":"● атопический дерматит, нейродермит;"}},{"type":"paragraph","data":{"text":"● истинная экзема;"}},{"type":"paragraph","data":{"text":"● микробная экзема;"}},{"type":"paragraph","data":{"text":"● простой контактный дерматит;"}},{"type":"paragraph","data":{"text":"● аллергический (контактный) дерматит;"}},{"type":"paragraph","data":{"text":"● дисгидротическая экзема"}}]},{"id":8,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":" гиперчувствительность к компонентам препарата;"}},{"type":"paragraph","data":{"text":"● туберкулезный или сифилитический процессы в области нанесения препарата;"}},{"type":"paragraph","data":{"text":"● вирусные заболевания (например, ветряная оспа, опоясывающий лишай);"}},{"type":"paragraph","data":{"text":"● розацеа, периоральный дерматит в области нанесения препарата;"}},{"type":"paragraph","data":{"text":"● участки кожи с проявлениями реакции на вакцинацию;"}},{"type":"paragraph","data":{"text":"● детский возраст до 18 лет."}},{"type":"paragraph","data":{"text":"Применение при беременности и в период грудного вскармливания"}},{"type":"paragraph","data":{"text":"При необходимости применения препарата Комфодерм® М2 во время беременности и"}},{"type":"paragraph","data":{"text":"лактации следует тщательно взвешивать потенциальный риск для плода и ожидаемую пользу лечения для матери. В эти периоды не рекомендуется длительное применение"}},{"type":"paragraph","data":{"text":"препарата на обширных поверхностях кожи. Кормящим матерям не следует наносить"}},{"type":"paragraph","data":{"text":"препарат на молочные железы"}}]},{"id":11,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Наружно. Препарат наносят 1 раз в сутки тонким слоем на пораженные участки кожи."}},{"type":"paragraph","data":{"text":"Как правило, длительность непрерывного ежедневного лечения препаратом"}},{"type":"paragraph","data":{"text":"Комфодерм® М 2 не должна превышать 12 недель."}},{"type":"paragraph","data":{"text":"При лечении пациентов с поражением кожи лица курс лечения не должен превышать 5 дней"}}]},{"id":12,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Очень редко (менее чем в 0,01 % случаев) могут наблюдаться местные реакции, такие как зуд, жжение, эритема, образование везикулезной сыпи. Если препарат применяют более 4-х недель и/или на площади 10 % и более поверхности тела, могут возникнуть следующие реакции: атрофия кожи, телеангиэктазии, стрии, акнеформные изменения кожи, системные эффекты, обусловленные абсорбцией кортикостероида."}},{"type":"paragraph","data":{"text":"В редких случаях (0,01 % - 0,1 %) могут наблюдаться фолликулит, гипертрихоз, периоральный дерматит, депигментация кожи, аллергические реакции на один из компонентов препарата"}}]},{"id":13,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"При изучении острой токсичности метилпреднизолона ацепоната не было выявлено какого-либо риска острой интоксикации при чрезмерном однократном кожном применении (нанесение препарата на большую площадь при условиях, благоприятных для абсорбции) или при непреднамеренном приеме внутрь."}},{"type":"paragraph","data":{"text":"При чрезмерно долгом и/или интенсивном местном применении глюкокортикостероидов могут развиться атрофия кожи (истончение кожи, телеангиэктазии, стрии)."}},{"type":"paragraph","data":{"text":"При появлении признаков атрофии кожи препарат необходимо отменить."}},{"type":"paragraph","data":{"text":"При местном применении мочевины передозировка маловероятна"}}]},{"id":14,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Взаимодействия препарата с другими лекарственными средствами не выявлено, однако следует учитывать, что одновременное применение препарата Комфодерм® М2 с другими мазями или кремами может привести к усилению резорбции входящих в их состав лекарственных веществ"}}]},{"id":15,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"При наличии бактериальных осложнений и/или дерматомикозов в дополнение к терапии препаратом Комфодерм® М2 необходимо проводить специфическое антибактериальное и/или антимикотическое лечение."}},{"type":"paragraph","data":{"text":"Препарат не предназначен для применения в офтальмологии. Следует избегать попадания в глаза и на слизистые оболочки."}},{"type":"paragraph","data":{"text":"Как и при применении системных глюкокортикостероидов, после наружного применения глюкокортикостероидов может развиться глаукома (например, после использования больших доз, вследствие очень длительного применения окклюзионных повязок или после нанесения на кожу вокруг глаз)."}},{"type":"paragraph","data":{"text":"На коже лица чаще, чем на других поверхностях тела, после длительного лечения глюкокортикостероидами местного действия могут появляться атрофические изменения."}},{"type":"paragraph","data":{"text":"Влияние препарата на способность к управлению транспортными средствами и механизмами:"}},{"type":"paragraph","data":{"text":"Не выявлено"}}]}],"source":{"title":"ЗдравСити","url":"https://zdravcity.ru"}},"description_toggle":false,"short_description":"Комфодерм® М2 - комбинированный препарат, действие которого обусловлено входящими в его состав компонентами.Метилпреднизолона ацепонат - представляет собой негалогенизированный синтетический стероид. При наружном применении метилпреднизолона ацепонат подавляет воспалительные и аллергические кожные реакции, также как и реакции, связанные с усиленной пролиферацией, что приводит к уменьшению объективных симптомов воспаления (эритема, отек, мокнутие) и субъективных ощущений (зуд, раздражение, боль и т.д.).При применении метилпреднизолона ацепоната наружно в рекомендуемой дозе системное действие минимально как у человека, так и у животных. После многократного нанесения метилпреднизолона ацепоната на большие поверхности (40-60 % поверхности кожи), а также при применении под окклюзионную повязку не отмечается нарушений функций надпочечников: уровень кортизола в плазме и его циркадный ритм остаются в пределах нормы, снижения концентрации кортизола в суточной моче не происходит.Метилпреднизолона ацепонат (особенно его основной метаболит - 6 альфа -метилпреднизолон-17-пропионат) связывается с внутриклеточными глюкокортикоидными рецепторами.Стероид-рецепторный комплекс связывается с определенными участками ДНК клеток иммунного ответа, вызывая, таким образом, серию биологических эффектов.В частности, связывание стероид-рецепторного комплекса с ДНК клетками иммунного ответа приводит к индукции синтеза макрокортина.Макрокортин ингибирует высвобождение арахидоновой кислоты и, тем самым, образование медиаторов воспаления типа простагландинов и лейкотриенов.Ингибирование глюкокортикостероидами синтеза вазодилатирующих простагландинов и потенцирование сосудосуживающего действия адреналина приводят к вазоконстрикторному эффекту.Мочевина - обладает кератолитическим и увлажняющим эффектами. Мочевинаспособствует связыванию воды и вследствие этого размягчению рогового слоя кожи. Помимо кератолитического действия, мочевина обладает протеолитической активностью При местном применении метилпреднизолона ацепонат гидролизуется в эпидермисе и дерме. Главным и наиболее активным метаболитом является 6?-метилпреднизолон-17-пропионат, обладающий значительно более высоким сродством к глюкокортикостероидным рецепторам кожи, что указывает на наличие его \"биоактивации\" в коже.Степень чрескожной абсорбции зависит от состояния кожи и способа применения (с использованием или без окклюзионной повязки).Чрескожная абсорбция у пациентов с атоническим дерматитом (нейродермитом) и псориазом составляет не более 2,5 %, что лишь незначительно выше таковой у здоровых добровольцев (0,5-1,5 %).После попадания в системный кровоток 6?-метилпреднизолон-17-пропионат быстро конъюгирует с глюкуроновой кислотой и, таким образом, инактивируется.Метаболиты метилпреднизолона ацепоната элиминируются, главным образом, почками с периодом полувыведення около 16 часов. 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