Псориаз волосистой части головы.
Псориаз легкой и средней степени тяжести других частей
тела.
Противопоказания
Гиперчувствительность к бетаметазону, кальципотриолу, к любому вспомогательному веществу препарата.
Препарат Ксамиол® противопоказан к применению при псориатической эритродермии, эксфолиативном и пустулезном псориазе.
В связи с наличием в составе препарата кальципотриола, Ксамиол® противопоказан пациентам с нарушениями кальциевого обмена.
В связи с наличием в составе препарата глюкокортикостероида
бетаметазона,...
Практически прозрачный, от бесцветного до почти белого цвета гель. На поверхности может
наблюдаться тонкая жирная пленка.
Фармакологические свойства
Кальципотриол - синтетический аналог активного метаболита витамина D. Вызывает
торможение пролиферации кератиноцитов и ускоряет их морфологическую дифференциацию.
Бетаметазон – глюкокортикостероид (ГКС) для наружного применения; оказывает местное противовоспалительное, противозудное, вазоконстрикторное и иммуносупрессивное действие,
однако, точные механизмы противовоспалительного действия глюкокортикостероидов для наружного применения до конца не ясны.
Показания к применению
Псориаз волосистой части головы.
Псориаз легкой и средней степени тяжести других частей
тела.
Противопоказания
Гиперчувствительность к бетаметазону, кальципотриолу, к любому вспомогательному веществу препарата.
Препарат Ксамиол® противопоказан к применению при псориатической эритродермии, эксфолиативном и пустулезном псориазе.
В связи с наличием в составе препарата кальципотриола, Ксамиол® противопоказан пациентам с нарушениями кальциевого обмена.
В связи с наличием в составе препарата глюкокортикостероида
бетаметазона, Ксамиол® противопоказан при следующих состояниях: вирусные, грибковые, бактериальные и паразитарные инфекции кожи, кожные проявления туберкулеза, периоральный
дерматит, атрофия кожи, стрии, повышенная ломкость подкожных
вен, ихтиоз, вульгарные угри, розацеа (розовые угри), язвы, раны.
Детский возраст до 18 лет.
Применение при беременности и в период грудного вскармливания
Адекватные и контролируемые исследования у беременных женщин
не проводились. Клинические данные о применении препарата у
беременных ограничены. В экспериментальных исследованиях на
животных было установлено наличие репродуктивной токсичности,
в том числе тератогенного действия. Риск для плода или ребенка
полностью не исключен. Вопрос о целесообразности применения
препарата при беременности должен решаться индивидуально
после консультации врача, если потенциальная польза для матери
превосходит возможный риск для плода.
Способ применения и дозы
Наружно.
Применение у взрослых.
Перед использованием препарата флакон необходимо встряхнуть. Гель наносят тонким слоем на пораженные участки волосистой части головы или на псориатические бляшки других частей тела 1 раз в сутки, предварительно выдавив небольшое количество геля на чистый палец или непосредственно на пораженный псориазом участок.
Покрытые гелем участки не следует закрывать плотно прилегающей тканью, повязками и окклюзией.
После применения геля Ксамиол® руки необходимо помыть, если гель контактировал с пальцами рук. Это предотвратит случайное попадание геля на другие участки тела (в особенности на лицо, области рта и глаз).
Излишки геля, случайно попавшие на здоровую кожу при нанесении на пораженные зоны, удаляют.
Мыть волосы перед нанесением геля Ксамиол® на волосистую часть головы не обязательно.
Для достижения оптимального эффекта не рекомендуется сразу после нанесения геля принимать душ или ванну. Препарат должен оставаться на коже в течение ночи или дня.
Дозы и продолжительность лечения
Если вы используете другие препараты, содержащие кальципотриол, то суммарное количество препаратов не должно превышать 15 г в день и 100 г в неделю. Максимальная дневная доза 15 г в день. 4 г геля соответствует 1 чайной ложке.
Обычно для лечения волосистой части головы достаточно количества 1 г до 4 г геля в сутки.
Рекомендуемая продолжительность курса лечения составляет 4 недели при псориазе волосистой части головы и 8 недель при псориазе других частей тела. В большинстве случаев видимое улучшение наступает спустя 2 недели после начала лечения, хотя к этому времени полного исчезновения псориаза еще не отмечается.
Общая площадь нанесения препарата не должна превышать 30% поверхности тела (включая как волосистую часть головы, так и другие части тела). Для достижения оптимального терапевтического действия препарат должен оставаться на коже в течение всей ночи или всего дня.
Если рекомендованный период лечения оказался недостаточным, проконсультируйтесь с врачом. Продолжение лечения или повторный курс лечения возможны только под наблюдением врача!
Применение препарата Ксамиол® в более высоких дозах и/или более длительный период может вызвать повышение уровня кальция в крови, нарушение нормальной работы надпочечников.
Если прием препарата пропущен, нельзя наносить двойную дозу при следующем применении, чтобы компенсировать пропущенную дозу.
Прекращать применение геля Ксамиол® необходимо постепенно, особенно если он применялся длительное время.
Перед прекращением лечения проконсультируйтесь с врачом.
Побочное действие
Классификация побочных реакций по органам и системам с указанием частоты их возникновения: очень часто (≥1/10), часто (≥1/100 < 1/10), нечасто (≥1/1000 < 1/100), редко (≥1/10000 < 1/1000 ), очень редко (< 1/10000 ), в том числе отдельные сообщения, частота неизвестна (частота не может быть оценена на основе имеющихся данных)»
Инфекционные и паразитарные заболевания:
Нечастые: инфекции кожи (включая бактериальные, грибковые, вирусные инфекции кожи), фолликулиты.
Нарушения со стороны иммунной системы:
Редкие: гиперчувствительность.
Нарушения со стороны органа зрения:
Нечастые: раздражение глаз.
Нарушения со стороны кожи и подкожных тканей:
Частые: зуд.
Нечастые: обострение псориаза, дерматит, эритема, сыпь (сообщалось о различных видах сыпи, таких как эритематозная сыпь, пустулезная сыпь), акне, ощущение жжения кожи, раздражение кожи, сухость кожи.
Редкие: кожные стрии, шелушение.
Общие расстройства и нарушения в месте введения:
Нечастые: Боль в месте нанесения (включая ощущение жжения)
Редкие: эффект отмены
Следующие побочные эффекты связывают с применением кальципотриола и бетаметазона, соответственно:
Кальципотриол:
Побочные реакции включают местные реакции, зуд, раздражение кожи, чувство жжения и пощипывания, сухость кожи, эритему, сыпь, дерматит, экзему, обострение псориаза, реакции фото- и гиперчувствительности, включающие очень редкие случаи ангионевротического отека и отека лица.
Системные реакции, связанные с наружным применением кальципотриола очень редкие: гиперкальциемия или гиперкальциурия.
Бетаметазон (дипропионат):
При наружном, в особенности при длительном, применении бетаметазона (дипропионата), возможны местные реакции, включающие атрофию кожи, телеангиоэктазии, стрии, фолликулит, гипертрихоз, периоральный дерматит, аллергический контактный дерматит, депигментацию и коллоидную дегенерацию кожи, а также повышение риска развития генерализованного пустулезного псориаза.
Системные реакции, связанные с наружным применением глюкокортикостероидов у взрослых пациентов: подавление функции коры надпочечников, катаракта, инфекции, гипергликемия, повышение внутриглазного давления, особенно при длительном применении.
Системные реакции возникают более часто при нанесении препарата под окклюзию (полиэтиленовую пленку, в кожаные складки), а так же во время длительного лечения при нанесении на большие участки кожи.
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
Применение препарата в дозах, превышающих рекомендованную, может привести к гиперкальцемии (повышение содержания кальция в крови); при прекращении лечения состояние нормализуется.
Симптомы гиперкальцемии включают полиурию (увеличенное образование мочи), запор, мускульную слабость, спутанность сознания и кому.
Чрезмерно длительное применение ГКС для наружного применения может подавлять функции гипофизарно-надпочечниковой системы с развитием обратимой вторичной надпочечниковой недостаточности. В этих случаях назначается симптоматическое лечение. В случаях хронической токсичности ГКС следует отменять постепенно.
Взаимодействие с другими лекарственными средствами
Исследования по изучению взаимодействия с другими лекарственными средствами не проводились.
Особые указания
Следует избегать нанесения препарата на площадь, превышающую 30% поверхности тела, а также использовать более 15 г препарата в день или 100 г в неделю.
Не рекомендуется наносить препарат под купальную шапочку, накладывать бандаж, повязки, так как это приводит к увеличению абсорбции глюкокортикостероидов.
Не следует применять на больших участках поврежденной кожи, слизистых оболочках, складках кожи (области паха, подмышек, под грудью), так как это приводит к увеличению абсорбции глюкокортикостероидов.
Следует избегать нанесение препарата на коже лица и в области гениталий (половых органов), так как они очень чувствительны к ГКС. При случайном попадании в глаза возможны нежелательные реакции в виде раздражения глаз и кожи лица, конъюнктивит. В случае попадания препарата в глаза их необходимо промыть проточной водой.
В период лечения препаратом Ксамиол® пациенту рекомендуется ограничивать или избегать
чрезмерного облучения естественным или искусственным солнечным светом.
Кальципотриол (и содержащие его препараты) разрешено применять местно в комбинации с ультрафиолетовым облучением только в тех случаях, когда лечащий врач сочтет оправданным сопряженный с таким лечением риск.
Препарат Ксамиол® содержит бутилгидрокситолуол (Е321), который может вызывать местные кожные реакции (например, контактный дерматит) или раздражение глаз и слизистых оболочек.
Необходима консультация с врачом в случаях:
если вы принимаете другие препараты, содержащие глюкокортикостероиды, ввиду повышения риска развития побочных эффектов;
если вы использовали более 15 г в день или 100 г в неделю;
прекращение лечения псориаза местными препаратами, содержащими глюкокортикостероиды, может быть сопряжено с риском развития генерализованного пустулезного псориаза и эффектом отмены. Поэтому прекращение лечения рекомендуется проводить под наблюдением врача;
если у вас диабет, так как глюкокортикостероиды влияют на уровень сахара (глюкозы) в крови;
при инфицировании кожи, так как может потребоваться антимикробная терапия. В случае усугубления инфекции, лечение препаратом Ксамиол® необходимо прекратить;
при каплевидном псориазе, поскольку опыт лечения каплевидного псориаза препаратом Ксамиол® отсутствует.
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Продолжение лечения или повторный курс лечения возможны только под наблюдением врача!\u003cbr /\u003e\nПрименение препарата Ксамиол® в более высоких дозах и/или более длительный период может вызвать повышение уровня кальция в крови, нарушение нормальной работы надпочечников.\u003cbr /\u003e\nЕсли прием препарата пропущен, нельзя наносить двойную дозу при следующем применении, чтобы компенсировать пропущенную дозу.\u003cbr /\u003e\nПрекращать применение геля Ксамиол® необходимо постепенно, особенно если он применялся длительное время.\u003cbr /\u003e\nПеред прекращением лечения проконсультируйтесь с врачом.\u003cbr /\u003e"}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Классификация побочных реакций по органам и системам с указанием частоты их возникновения: очень часто (≥1/10), часто (≥1/100 \u003c 1/10), нечасто (≥1/1000 \u003c 1/100), редко (≥1/10000 \u003c 1/1000 ), очень редко (\u003c 1/10000 ), в том числе отдельные сообщения, частота неизвестна (частота не может быть оценена на основе имеющихся данных)»\u003cbr /\u003e\nИнфекционные и паразитарные заболевания:\u003cbr /\u003e\nНечастые: инфекции кожи (включая бактериальные, грибковые, вирусные инфекции кожи), фолликулиты.\u003cbr /\u003e\nНарушения со стороны иммунной системы:\u003cbr /\u003e\nРедкие: гиперчувствительность.\u003cbr /\u003e\nНарушения со стороны органа зрения:\u003cbr /\u003e\nНечастые: раздражение глаз.\u003cbr /\u003e\nНарушения со стороны кожи и подкожных тканей:\u003cbr /\u003e\nЧастые: зуд.\u003cbr /\u003e\nНечастые: обострение псориаза, дерматит, эритема, сыпь (сообщалось о различных видах сыпи, таких как эритематозная сыпь, пустулезная сыпь), акне, ощущение жжения кожи, раздражение кожи, сухость кожи.\u003cbr /\u003e\nРедкие: кожные стрии, шелушение.\u003cbr /\u003e\nОбщие расстройства и нарушения в месте введения: \u003cbr /\u003e\nНечастые: Боль в месте нанесения (включая ощущение жжения)\u003cbr /\u003e\nРедкие: эффект отмены\u003cbr /\u003e\nСледующие побочные эффекты связывают с применением кальципотриола и бетаметазона, соответственно: \u003cbr /\u003e\nКальципотриол:\u003cbr /\u003e\nПобочные реакции включают местные реакции, зуд, раздражение кожи, чувство жжения и пощипывания, сухость кожи, эритему, сыпь, дерматит, экзему, обострение псориаза, реакции фото- и гиперчувствительности, включающие очень редкие случаи ангионевротического отека и отека лица.\nСистемные реакции, связанные с наружным применением кальципотриола очень редкие: гиперкальциемия или гиперкальциурия.\u003cbr /\u003e\nБетаметазон (дипропионат):\u003cbr /\u003e\nПри наружном, в особенности при длительном, применении бетаметазона (дипропионата), возможны местные реакции, включающие атрофию кожи, телеангиоэктазии, стрии, фолликулит, гипертрихоз, периоральный дерматит, аллергический контактный дерматит, депигментацию и коллоидную дегенерацию кожи, а также повышение риска развития генерализованного пустулезного псориаза.\u003cbr /\u003e\nСистемные реакции, связанные с наружным применением глюкокортикостероидов у взрослых пациентов: подавление функции коры надпочечников, катаракта, инфекции, гипергликемия, повышение внутриглазного давления, особенно при длительном применении.\u003cbr /\u003e\nСистемные реакции возникают более часто при нанесении препарата под окклюзию (полиэтиленовую пленку, в кожаные складки), а так же во время длительного лечения при нанесении на большие участки кожи.\u003cbr /\u003e\nЕсли любые из указанных в инструкции побочных эффектов усугубляются, или Вы заметили любые другие побочные эффекты не указанные в инструкции, сообщите об этом врачу."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Применение препарата в дозах, превышающих рекомендованную, может привести к гиперкальцемии (повышение содержания кальция в крови); при прекращении лечения состояние нормализуется.\u003cbr /\u003e\nСимптомы гиперкальцемии включают полиурию (увеличенное образование мочи), запор, мускульную слабость, спутанность сознания и кому.\u003cbr /\u003e\nЧрезмерно длительное применение ГКС для наружного применения может подавлять функции гипофизарно-надпочечниковой системы с развитием обратимой вторичной надпочечниковой недостаточности. В этих случаях назначается симптоматическое лечение. В случаях хронической токсичности ГКС следует отменять постепенно."}}]},{"id":10,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Исследования по изучению взаимодействия с другими лекарственными средствами не проводились."}}]},{"id":11,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Следует избегать нанесения препарата на площадь, превышающую 30% поверхности тела, а также использовать более 15 г препарата в день или 100 г в неделю.\u003cbr /\u003e\nНе рекомендуется наносить препарат под купальную шапочку, накладывать бандаж, повязки, так как это приводит к увеличению абсорбции глюкокортикостероидов.\u003cbr /\u003e\nНе следует применять на больших участках поврежденной кожи, слизистых оболочках, складках кожи (области паха, подмышек, под грудью), так как это приводит к увеличению абсорбции глюкокортикостероидов.\u003cbr /\u003e\nСледует избегать нанесение препарата на коже лица и в области гениталий (половых органов), так как они очень чувствительны к ГКС. При случайном попадании в глаза возможны нежелательные реакции в виде раздражения глаз и кожи лица, конъюнктивит. В случае попадания препарата в глаза их необходимо промыть проточной водой.\u003cbr /\u003e\nВ период лечения препаратом Ксамиол® пациенту рекомендуется ограничивать или избегать\nчрезмерного облучения естественным или искусственным солнечным светом.\u003cbr /\u003e\nКальципотриол (и содержащие его препараты) разрешено применять местно в комбинации с ультрафиолетовым облучением только в тех случаях, когда лечащий врач сочтет оправданным сопряженный с таким лечением риск.\u003cbr /\u003e\nПрепарат Ксамиол® содержит бутилгидрокситолуол (Е321), который может вызывать местные кожные реакции (например, контактный дерматит) или раздражение глаз и слизистых оболочек.\u003cbr /\u003e\nНеобходима консультация с врачом в случаях:\u003cbr /\u003e"}},{"type":"list","data":{"style":"unordered","items":["если вы принимаете другие препараты, содержащие глюкокортикостероиды, ввиду повышения риска развития побочных эффектов;\u003cbr /\u003e","если вы использовали более 15 г в день или 100 г в неделю; \u003cbr /\u003e","прекращение лечения псориаза местными препаратами, содержащими глюкокортикостероиды, может быть сопряжено с риском развития генерализованного пустулезного псориаза и эффектом отмены. Поэтому прекращение лечения рекомендуется проводить под наблюдением врача;\u003cbr /\u003e","если у вас диабет, так как глюкокортикостероиды влияют на уровень сахара (глюкозы) в крови;\u003cbr /\u003e","при инфицировании кожи, так как может потребоваться антимикробная терапия. В случае усугубления инфекции, лечение препаратом Ксамиол® необходимо прекратить; \u003cbr /\u003e","при каплевидном псориазе, поскольку опыт лечения каплевидного псориаза препаратом Ксамиол® отсутствует.\u003cbr /\u003e"]}}]},{"id":12,"name":"Срок годности","slug":"expiry_date","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При температуре не выше 25 °С. Не хранить в холодильнике. Хранить в картонной пачке для защиты от света.\u003cbr /\u003e\nХранить в недоступном для детей месте.\u003cbr /\u003e"}}]},{"id":13,"name":"Условия отпуска","slug":"release_condition","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Отпускают без рецепта."}}]}],"source":null},"description_toggle":false,"short_description":"Кальципотриол - синтетический аналог активного метаболита витамина D. Вызывает торможение пролиферации кератиноцитов и ускоряет их морфологическую дифференциацию. 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