ФармакодинамикаВерсатис содержит лидокаин, производное ацета... Инструкция
Показания к применению
Нейропатическая боль, ассоциированная с ранее перенесенной герпетической инфекцией (herpes zoster), постгерпетическая невралгия.
Противопоказания
повышенная чувствительность аллергического и неаллергического генеза к действующему и вспомогательным веществам препарата;
повышенная чувствительность аллергического и неаллергического генеза к местным анестетикам группы амидов (например, бупивакаину, этидокаину, мепивакаину и прилокаину);
воспаление или нарушение целостности кожных покровов в месте аппликации пластыря (например, высыпания herpes zoster, атопический дерматит или раны).
Размер пластыря: длина от 13,3 до 14,7 см, ширина от 9,5 до 10,5 см.
Описание
От белого до светло желтого цвета полимерный адгезивный (липкий) материал со слабым характерным запахом, равномерно распределенный на одной стороне нетканого материала и закрытый пластиковой пленкой. На нетканом материале выгравирована надпись «Lidocaine 5 %».
Фармакотерапевтическая группа
Местноанестезирующее средство
Фармакологические свойства
Фармакодинамика
Версатис содержит лидокаин, производное ацетамида. Механизм действия связан со стабилизацией мембран нейронов, что, как полагают, является результатом блокады натриевых каналов.
При местном применении на неповрежденную кожу возникает терапевтический эффект достаточный для снятия болевого синдрома.
Фармакокинетика
Всасывание
При однократном или многократном применении пластыря Версатис в максимальной рекомендуемой дозе (одновременная аппликация трех пластырей продолжительностью 12 часов), только 3 ± 2 % лидокаина, содержащегося в пластыре, поступает в системный кровоток. Концентрация в плазме крови после применения максимальной рекомендованной дозы препарата у пациентов без клиники постгерпетической невралгии составила 84 — 125 нг/мл. У пациентов с постгерпетической невралгией — 52 нг/мл.
Распределение
Объем распределения не зависит от возраста и снижен у пациентов с хронической сердечной недостаточностью, увеличивается при печеночной недостаточности.
С белками плазмы крови связывается 70 % лидокаина, проникающего в системный кровоток после накожной аппликации. Проникает через гематоэнцефалический и плацентарный барьеры путём пассивной диффузии.
Метаболизм
Лидокаин быстро метаболизируется в печени с образованием нескольких метаболитов. Основной путь метаболизма N-дезалкилирование с образованием моноэтилглицинксилидида (МЭГК) и глицинксилидида (ГК), метаболиты обладают меньшей фармакологической активностью, чем лидокаин и присутствуют в меньших концентрациях. Метаболиты гидролизуются до 2,6-ксилидина, который конъюгацией преобразуется в 4-гидрокси-2,6-ксилидин.
Не установлено обладает ли 2,6-ксилидин фармакологической активностью, однако, при изучении на биологических моделях 2,6-ксилидин потенциально обладает канцерогенным эффектом. Кинетический анализ выявил, что при ежедневных аппликациях продолжительностью до одного года, максимальная концентрация 2,6-ксилидина в среднем составляет 9 нг/мл. Лидокаин и его метаболиты (моноэтилглицинксилидид, глицинксилидид и 2,6-ксилидин) не накапливаются в организме, равновесная концентрация достигается в течение первых четырех суток применения.
При увеличении количества одновременно применяемых пластырей с одного до трех, концентрация лидокаина в плазме нарастает медленнее пропорционального соотношения.
Выведение
Лидокаин и его метаболиты выводятся с мочой (более 85 % в виде метаболитов, менее 10 % в неизмененном виде). Основной метаболит в моче — конъюгат 4-гидрокси-2,6-ксилидина, составляющий примерно 70 — 80% дозы, выводимой с мочой. Метаболит 2,6-ксилидин выводится с мочой в концентрации менее чем 1% от полученной дозы. Период полувыведения лидокаина после кожной аппликации пластыря составляет 7,6 ч.
При сердечной, почечной или печеночной недостаточности возможно замедление выведения лидокаина и его метаболитов.
Показания к применению
Нейропатическая боль, ассоциированная с ранее перенесенной герпетической инфекцией (herpes zoster), постгерпетическая невралгия.
Противопоказания
повышенная чувствительность аллергического и неаллергического генеза к действующему и вспомогательным веществам препарата;
повышенная чувствительность аллергического и неаллергического генеза к местным анестетикам группы амидов (например, бупивакаину, этидокаину, мепивакаину и прилокаину);
воспаление или нарушение целостности кожных покровов в месте аппликации пластыря (например, высыпания herpes zoster, атопический дерматит или раны).
С осторожностью
Применяется с осторожностью при тяжелой сердечной, почечной или печеночной недостаточности (см. «Особые указания»).
Применение при беременности и в период грудного вскармливания
Лидокаин проникает через плаценту. Данные по применению лидокаина у беременных отсутствуют, поэтому во время беременности препарат применяют, если ожидаемая польза для матери превышает потенциальный риск для плода.
Лидокаин выделяется с грудным молоком. Поскольку метаболизм лидокаина происходит относительно быстро и преимущественно в печени, можно ожидать, что крайне незначительные количества лидокаина могут выводиться с грудным молоком. Данных по применению пластыря Версатис у кормящих матерей нет, поэтому во время грудного вскармливания препарат применяют, только если ожидаемая польза для матери превышает потенциальный риск для ребенка.
Способ применения и дозы
Пластырь предназначен для наружного применения. Пластырь приклеивают на кожу в области боли один раз в сутки на период до 12 часов. Одновременно можно применять не более 3 пластырей. При необходимости пластырь можно разрезать на части перед удалением пластиковой защитной пленки. Пластырь должен быть приклеен на неповрежденную, сухую, невоспаленную кожу (после полного заживления герпетических высыпаний) покрывая область боли.
Затем пластырь снимают и делают перерыв не менее 12 часов. Не используйте снятый пластырь повторно.
Пластырь приклеивается к коже сразу после извлечения из саше и удаления пластиковой пленки с липкого слоя. Волосы необходимо состричь ножницами (не сбривать). Эффективность терапии необходимо повторно оценить через 2-4 недели от начала лечения. Если в эти сроки ответ на терапию недостаточен или терапевтический эффект определяется только защитными свойствами пластыря, лечение следует прекратить. Необходимо регулярно оценивать эффективность терапии для определения оптимального количества одновременно применяемых пластырей, необходимых для покрытия области боли, или для увеличения периодов времени между аппликациями пластыря.
Применение пластыря Версатис в возрасте до 18 лет не рекомендуется.
Нет данных по безопасности и эффективности пластыря Версатис у пациентов в возрасте до 18 лет.
После приклеивания пластыря следует избегать контакта рук с глазами, необходимо сразу вымыть руки.
Использованный пластырь содержит действующее вещество. Утилизируйте пластырь сразу после применения.
После удаления с кожи, пластырь должен быть сложен пополам липкой стороной внутрь, так, чтобы поверхность, содержащая действующее вещество, не была видна. Использованные пластыри не должны быть доступны для детей или домашних животных.
Побочное действие
Аллергические реакции: аллергический контактный дерматит (гиперемия в месте нанесения, кожная сыпь, крапивница, зуд), ангионевротический отек.
Прочие: чувство жжения в месте аппликации.
Передозировка
Передозировка лидокаина при применении пластыря Версатис маловероятна. Передозировку нельзя исключить при неправильном применении препарата (например, использование более 3 пластырей одновременно, аппликация пластыря более чем на 12 часов или использование пластыря на участках поврежденной кожи), в таких случаях концентрация лидокаина в плазме крови может повышаться. Симптомами передозировки могут быть: головокружение, рвота, сонливость, судороги, мидриаз, брадикардия, аритмия и шок. При передозировке возможно взаимодействие лидокаина с β-адреноблокаторами, ингибиторами изофермента CYP3A4 (например, производными имидазола, макролидами) и антиаритмическими препаратами. При подозрении на передозировку пластырь должен быть удален с кожи и приняты меры поддержания жизненных функций организма. Антидота к лидокаину нет.
Взаимодействие с другими лекарственными средствами
В накопленном опыте применения препарата не отмечалось клинически значимого взаимодействия с другими препаратами.
Поскольку максимальная концентрация лидокаина в плазме крови низка, возникновение клинически значимого фармакокинетического взаимодействия маловероятно.
Хотя абсорбция лидокаина через кожу обычно низка, следует соблюдать осторожность при применении пластыря, содержащего лидокаин 5%, у пациентов, получающих антиаритмические препараты I класса (например, токаинид, мексилетин) или другие местные анестетики, поскольку не исключен риск развития аддитивного системного эффекта.
Особые указания
Пластырь не должен применяться на слизистых оболочках. Следует избегать контакта пластыря с областью глаз.
Пластырь содержит пропиленгликоль, который может вызывать раздражение кожи, а также метилпарагидроксибензоат и пропилпарагидроксибензоат, которые могут вызывать аллергические реакции (возможно отсроченные).
Следует соблюдать осторожность при использовании пластыря Версатис у пациентов с тяжелой сердечной, почечной или печеночной недостаточностью.
После первого вскрытия саше, препарат необходимо использовать в течение 14 дней, вскрытое саше необходимо хранить плотно закрытым.
Препарат не следует хранить в холодильнике или замораживать.
Влияние на способность управлять автомобилем и движущимися механизмами
Поскольку системная абсорбция минимальна, нет оснований предполагать наличие влияния на способность управлять автомобилем и возможность работать с механизмами.
Форма выпуска
Пластырь. 5 пластырей в саше. 1, 2 или 6 саше в картонной пачке вместе с инструкцией по применению.
Условия хранения
Хранить при температуре не выше 25 ˚С. Не хранить в холодильнике и не замораживать. После вскрытия хранить саше плотно закрытым.
Хранить в недоступном для детей месте.
Срок годности
3 года. Не использовать после истечения срока годности указанного на упаковке. Пластыри должны быть использованы в течение 14 дней после вскрытия саше.
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номер","slug":"","body":[{"type":"paragraph","data":{"text":"ЛС-001775"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Версатис"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"Пластырь"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"Один пластырь содержит:"}},{"type":"paragraph","data":{"text":"\u003ci\u003eАктивное вещество:\u003c/i\u003e лидокаин 0,700 г/пластырь;"}},{"type":"paragraph","data":{"text":"\u003ci\u003eВспомогательные вещества:\u003c/i\u003e вода очищенная 3,367 г, глицерол 2,520 г, сорбитол 2,800 г, раствор полиакриловой кислоты 20% 1,400 г, полиакрилат натрия 400-600 мПа.с 0,700 г, кармеллоза натрия 90-168 мПа.с 0,700 г, пропиленгликоль 0,700 г, мочевина 0,420 г, каолин 0,210 г, кислота винная (тартаровая) 0,210 г, желатин 0,147 г, поливиниловый спирт (75 000) 0,0588 г, алюминия дигидроксиаминоацетат (алюминия глицинат) 0,0322 г, динатрия эдетат 0,014 г, метилпарагидроксибензоат 0,014 г, пропилпарагидроксибензоат 0,007 г, нетканый материал 1,750 г, пластиковая пленка (полиэтилентерефталат (ПЭТ)) 0,742 г."}},{"type":"paragraph","data":{"text":"Размер пластыря: длина от 13,3 до 14,7 см, ширина от 9,5 до 10,5 см."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"От белого до светло желтого цвета полимерный адгезивный (липкий) материал со слабым характерным запахом, равномерно распределенный на одной стороне нетканого материала и закрытый пластиковой пленкой. На нетканом материале выгравирована надпись «Lidocaine 5 %»."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Местноанестезирующее средство"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"\u003cb\u003eФармакодинамика\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Версатис содержит лидокаин, производное ацетамида. Механизм действия связан со стабилизацией мембран нейронов, что, как полагают, является результатом блокады натриевых каналов."}},{"type":"paragraph","data":{"text":"При местном применении на неповрежденную кожу возникает терапевтический эффект достаточный для снятия болевого синдрома."}},{"type":"paragraph","data":{"text":"\u003cb\u003eФармакокинетика\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eВсасывание\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"При однократном или многократном применении пластыря Версатис в максимальной рекомендуемой дозе (одновременная аппликация трех пластырей продолжительностью 12 часов), только 3 ± 2 % лидокаина, содержащегося в пластыре, поступает в системный кровоток. Концентрация в плазме крови после применения максимальной рекомендованной дозы препарата у пациентов без клиники постгерпетической невралгии составила 84 — 125 нг/мл. У пациентов с постгерпетической невралгией — 52 нг/мл."}},{"type":"paragraph","data":{"text":"\u003ci\u003eРаспределение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Объем распределения не зависит от возраста и снижен у пациентов с хронической сердечной недостаточностью, увеличивается при печеночной недостаточности."}},{"type":"paragraph","data":{"text":"С белками плазмы крови связывается 70 % лидокаина, проникающего в системный кровоток после накожной аппликации. Проникает через гематоэнцефалический и плацентарный барьеры путём пассивной диффузии."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМетаболизм\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Лидокаин быстро метаболизируется в печени с образованием нескольких метаболитов. Основной путь метаболизма N-дезалкилирование с образованием моноэтилглицинксилидида (МЭГК) и глицинксилидида (ГК), метаболиты обладают меньшей фармакологической активностью, чем лидокаин и присутствуют в меньших концентрациях. Метаболиты гидролизуются до 2,6-ксилидина, который конъюгацией преобразуется в 4-гидрокси-2,6-ксилидин."}},{"type":"paragraph","data":{"text":"Не установлено обладает ли 2,6-ксилидин фармакологической активностью, однако, при изучении на биологических моделях 2,6-ксилидин потенциально обладает канцерогенным эффектом. Кинетический анализ выявил, что при ежедневных аппликациях продолжительностью до одного года, максимальная концентрация 2,6-ксилидина в среднем составляет 9 нг/мл. Лидокаин и его метаболиты (моноэтилглицинксилидид, глицинксилидид и 2,6-ксилидин) не накапливаются в организме, равновесная концентрация достигается в течение первых четырех суток применения."}},{"type":"paragraph","data":{"text":"При увеличении количества одновременно применяемых пластырей с одного до трех, концентрация лидокаина в плазме нарастает медленнее пропорционального соотношения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВыведение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Лидокаин и его метаболиты выводятся с мочой (более 85 % в виде метаболитов, менее 10 % в неизмененном виде). Основной метаболит в моче — конъюгат 4-гидрокси-2,6-ксилидина, составляющий примерно 70 — 80% дозы, выводимой с мочой. Метаболит 2,6-ксилидин выводится с мочой в концентрации менее чем 1% от полученной дозы. Период полувыведения лидокаина после кожной аппликации пластыря составляет 7,6 ч."}},{"type":"paragraph","data":{"text":"При сердечной, почечной или печеночной недостаточности возможно замедление выведения лидокаина и его метаболитов."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Нейропатическая боль, ассоциированная с ранее перенесенной герпетической инфекцией (herpes zoster), постгерпетическая невралгия."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["повышенная чувствительность аллергического и неаллергического генеза к действующему и вспомогательным веществам препарата;","повышенная чувствительность аллергического и неаллергического генеза к местным анестетикам группы амидов (например, бупивакаину, этидокаину, мепивакаину и прилокаину);","воспаление или нарушение целостности кожных покровов в месте аппликации пластыря (например, высыпания herpes zoster, атопический дерматит или раны)."]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Применяется с осторожностью при тяжелой сердечной, почечной или печеночной недостаточности (см. «Особые указания»)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Лидокаин проникает через плаценту. Данные по применению лидокаина у беременных отсутствуют, поэтому во время беременности препарат применяют, если ожидаемая польза для матери превышает потенциальный риск для плода."}},{"type":"paragraph","data":{"text":"Лидокаин выделяется с грудным молоком. Поскольку метаболизм лидокаина происходит относительно быстро и преимущественно в печени, можно ожидать, что крайне незначительные количества лидокаина могут выводиться с грудным молоком. Данных по применению пластыря Версатис у кормящих матерей нет, поэтому во время грудного вскармливания препарат применяют, только если ожидаемая польза для матери превышает потенциальный риск для ребенка."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Пластырь предназначен для наружного применения. Пластырь приклеивают на кожу в области боли один раз в сутки на период до 12 часов. Одновременно можно применять не более 3 пластырей. При необходимости пластырь можно разрезать на части перед удалением пластиковой защитной пленки. Пластырь должен быть приклеен на неповрежденную, сухую, невоспаленную кожу (после полного заживления герпетических высыпаний) покрывая область боли."}},{"type":"paragraph","data":{"text":"Затем пластырь снимают и делают перерыв не менее 12 часов. Не используйте снятый пластырь повторно."}},{"type":"paragraph","data":{"text":"Пластырь приклеивается к коже сразу после извлечения из саше и удаления пластиковой пленки с липкого слоя. Волосы необходимо состричь ножницами (не сбривать). Эффективность терапии необходимо повторно оценить через 2-4 недели от начала лечения. Если в эти сроки ответ на терапию недостаточен или терапевтический эффект определяется только защитными свойствами пластыря, лечение следует прекратить. Необходимо регулярно оценивать эффективность терапии для определения оптимального количества одновременно применяемых пластырей, необходимых для покрытия области боли, или для увеличения периодов времени между аппликациями пластыря."}},{"type":"paragraph","data":{"text":"Применение пластыря Версатис в возрасте до 18 лет не рекомендуется."}},{"type":"paragraph","data":{"text":"Нет данных по безопасности и эффективности пластыря Версатис у пациентов в возрасте до 18 лет."}},{"type":"paragraph","data":{"text":"После приклеивания пластыря следует избегать контакта рук с глазами, необходимо сразу вымыть руки."}},{"type":"paragraph","data":{"text":"Использованный пластырь содержит действующее вещество. Утилизируйте пластырь сразу после применения."}},{"type":"paragraph","data":{"text":"После удаления с кожи, пластырь должен быть сложен пополам липкой стороной внутрь, так, чтобы поверхность, содержащая действующее вещество, не была видна. Использованные пластыри не должны быть доступны для детей или домашних животных."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e аллергический контактный дерматит (гиперемия в месте нанесения, кожная сыпь, крапивница, зуд), ангионевротический отек."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e чувство жжения в месте аппликации."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Передозировка лидокаина при применении пластыря Версатис маловероятна. Передозировку нельзя исключить при неправильном применении препарата (например, использование более 3 пластырей одновременно, аппликация пластыря более чем на 12 часов или использование пластыря на участках поврежденной кожи), в таких случаях концентрация лидокаина в плазме крови может повышаться. Симптомами передозировки могут быть: головокружение, рвота, сонливость, судороги, мидриаз, брадикардия, аритмия и шок. При передозировке возможно взаимодействие лидокаина с β-адреноблокаторами, ингибиторами изофермента CYP3A4 (например, производными имидазола, макролидами) и антиаритмическими препаратами. При подозрении на передозировку пластырь должен быть удален с кожи и приняты меры поддержания жизненных функций организма. Антидота к лидокаину нет."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"В накопленном опыте применения препарата не отмечалось клинически значимого взаимодействия с другими препаратами."}},{"type":"paragraph","data":{"text":"Поскольку максимальная концентрация лидокаина в плазме крови низка, возникновение клинически значимого фармакокинетического взаимодействия маловероятно."}},{"type":"paragraph","data":{"text":"Хотя абсорбция лидокаина через кожу обычно низка, следует соблюдать осторожность при применении пластыря, содержащего лидокаин 5%, у пациентов, получающих антиаритмические препараты I класса (например, токаинид, мексилетин) или другие местные анестетики, поскольку не исключен риск развития аддитивного системного эффекта."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Пластырь не должен применяться на слизистых оболочках. Следует избегать контакта пластыря с областью глаз."}},{"type":"paragraph","data":{"text":"Пластырь содержит пропиленгликоль, который может вызывать раздражение кожи, а также метилпарагидроксибензоат и пропилпарагидроксибензоат, которые могут вызывать аллергические реакции (возможно отсроченные)."}},{"type":"paragraph","data":{"text":"Следует соблюдать осторожность при использовании пластыря Версатис у пациентов с тяжелой сердечной, почечной или печеночной недостаточностью."}},{"type":"paragraph","data":{"text":"После первого вскрытия саше, препарат необходимо использовать в течение 14 дней, вскрытое саше необходимо хранить плотно закрытым."}},{"type":"paragraph","data":{"text":"Препарат не следует хранить в холодильнике или замораживать."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Поскольку системная абсорбция минимальна, нет оснований предполагать наличие влияния на способность управлять автомобилем и возможность работать с механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":" Пластырь. 5 пластырей в саше. \u003ca href=\"https://www.stada.ru/products/versatis.html#\"\u003e1\u003c/a\u003e, 2 или \u003ca href=\"https://www.stada.ru/products/versatis.html#\"\u003e6\u003c/a\u003e саше в картонной пачке вместе с инструкцией по применению. "}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 25 ˚С. Не хранить в холодильнике и не замораживать. После вскрытия хранить саше плотно закрытым."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года. Не использовать после истечения срока годности указанного на упаковке. Пластыри должны быть использованы в течение 14 дней после вскрытия саше."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Тейкоку Сейяку Ко., Лтд., 567 Санбонматсу Хигашикагава, Кагава 769-2695, Япония"}},{"type":"paragraph","data":{"text":"Teikoku Seiyaku Co., Ltd., 567 Sanbonmatsu Higashikagawa, Kagawa 769-2695, Japan"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"\n\nАО «Нижфарм», Россия"}},{"type":"paragraph","data":{"text":"603950, г. Нижний Новгород, ГСП-459, ул. Салганская, д. 7"}},{"type":"paragraph","data":{"text":"Тел.: (831) 278-80-88; факс: (831) 430-72-28"}},{"type":"paragraph","data":{"text":"E-mail: \u003ca href=\"mailto:med@stada.ru\"\u003emed@stada.ru\u003c/a\u003e"}}]}],"source":null},"description_toggle":false,"short_description":"ФармакодинамикаВерсатис содержит лидокаин, производное ацетамида. Механизм действия связан со стабилизацией мембран нейронов, что, как полагают, является результатом блокады натриевых каналов. При местном применении на неповрежденную кожу возникает терапевтический эффект достаточный для снятия болевого синдрома.ФармакокинетикаВсасываниеПри однократном или многократном применении пластыря Версатис в максимальной рекомендуемой дозе (одновременная аппликация трех пластырей продолжительностью 12 часов), только 3 ± 2 % лидокаина, содержащегося в пластыре, поступает в системный кровоток. Концентрация в плазме крови после применения максимальной рекомендованной дозы препарата у пациентов без клиники постгерпетической невралгии составила 84 — 125 нг/мл. У пациентов с постгерпетической невралгией — 52 нг/мл.РаспределениеОбъем распределения не зависит от возраста и снижен у пациентов с хронической сердечной недостаточностью, увеличивается при печеночной недостаточности. С белками плазмы крови связывается 70 % лидокаина, проникающего в системный кровоток после накожной аппликации. Проникает через гематоэнцефалический и плацентарный барьеры путём пассивной диффузии.МетаболизмЛидокаин быстро метаболизируется в печени с образованием нескольких метаболитов. Основной путь метаболизма N-дезалкилирование с образованием моноэтилглицинксилидида (МЭГК) и глицинксилидида (ГК), метаболиты обладают меньшей фармакологической активностью, чем лидокаин и присутствуют в меньших концентрациях. Метаболиты гидролизуются до 2,6-ксилидина, который конъюгацией преобразуется в 4-гидрокси-2,6-ксилидин. Не установлено обладает ли 2,6-ксилидин фармакологической активностью, однако, при изучении на биологических моделях 2,6-ксилидин потенциально обладает канцерогенным эффектом. Кинетический анализ выявил, что при ежедневных аппликациях продолжительностью до одного года, максимальная концентрация 2,6-ксилидина в среднем составляет 9 нг/мл. Лидокаин и его метаболиты (моноэтилглицинксилидид, глицинксилидид и 2,6-ксилидин) не накапливаются в организме, равновесная концентрация достигается в течение первых четырех суток применения. При увеличении количества одновременно применяемых пластырей с одного до трех, концентрация лидокаина в плазме нарастает медленнее пропорционального соотношения.ВыведениеЛидокаин и его метаболиты выводятся с мочой (более 85 % в виде метаболитов, менее 10 % в неизмененном виде). Основной метаболит в моче — конъюгат 4-гидрокси-2,6-ксилидина, составляющий примерно 70 — 80% дозы, выводимой с мочой. Метаболит 2,6-ксилидин выводится с мочой в концентрации менее чем 1% от полученной дозы. Период полувыведения лидокаина после кожной аппликации пластыря составляет 7,6 ч. При сердечной, почечной или печеночной недостаточности возможно замедление выведения лидокаина и его метаболитов.","substance":[{"id":542,"title":"Лидокаин","title_latin":"Lidocainum","slug":"lidokain_542"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":false,"comments":null,"image_alt":"Версатис пластырь - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/4950/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/4950/share_default/"}},"diseases":[{"id":"1038","title":"Дорсалгия","slug":"1038-dorsalgiya"},{"id":"1044","title":"Миозит","slug":"1044-miozit"}],"other_packages":[],"other_product_forms":[],"related_products":{"title":"Аналоги","type":"analogs","products":[{"id":144735,"title":"Версатис трансдермальная терапевтическая система","subtitle":{"full":"Пластырь, коробка, 5 шт, 700 мг","short":"Пластырь, 5 шт, 700 мг","package":"5 шт, 700 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