Мемантин является потенциалзависимым неконкурентным ингибито... Инструкция
Показания к применению
Деменция средней и тяжелой степени выраженности при болезни Альцгеймера.
Противопоказания
Индивидуальная повышенная чувствительность к мемантину или любому из компонентов, входящих в состав препарата; беременность и период грудного вскармливания; возраст до 18 лет; дефицит лактазы, непереносимость лактозы, синдром глюкозо-галактозной мальабсорбции.
Один флакон содержит активное вещество – Ретиналамин 5 мг (комплекс водорастворимых полипептидных фракций), вспомогательное вещество – глицин 17 мг (стабилизатор).
Фармакологические свойства
Мемантин является потенциалзависимым неконкурентным ингибитором NMDA-рецепторов с умеренным аффинитетом к ним. Он модулирует действие патологически повышенного тонического содержания глутамата, который может приводить к нейрональной дисфункции.
Показания к применению
Деменция средней и тяжелой степени выраженности при болезни Альцгеймера.
Противопоказания
Индивидуальная повышенная чувствительность к мемантину или любому из компонентов, входящих в состав препарата; беременность и период грудного вскармливания; возраст до 18 лет; дефицит лактазы, непереносимость лактозы, синдром глюкозо-галактозной мальабсорбции.
Применение при беременности и в период грудного вскармливания
Противопоказан при беременности, т.к. клинические данные о влиянии мемантина на течение беременности отсутствуют. Исследования, проведенные на животных, указывают на возможность препарата вызывать задержку внутриутробного развития при уровне воздействия идентичных или несколько превосходящих концентраций мемантина по сравнению с таковыми у человека. Потенциальный риск для человека неизвестен. Неизвестно, происходит ли экскреция мемантина в грудное молоко, поэтому женщинам, принимающим мемантин, следует воздержаться от кормления грудью.
Способ применения и дозы
Препарат следует принимать внутрь один раз в сутки и всегда в одно и то же время, независимо от приема пищи. Взрослые: Титрование. Максимальная суточная доза 20 мг/сут. С целью уменьшения риска возникновения нежелательных реакций доза препарата титруется путем ее последовательного увеличения на 5 мг каждую неделю в течение первых трех недель. Начиная с 4-й недели, пациенту назначают прием мемантина в дозе 20 мг/сут (две таблетки по 10 мг). Рекомендуемая поддерживающая доза 20 мг в сутки.
Побочное действие
В клинических исследованиях при умеренной и тяжелой деменции, общая частота возникновения нежелательных реакций при приеме мемантина не отличалась от таковой при приеме плацебо. Очень редко: Судороги Нечасто: Грибковые инфекции, Спутанность сознания, галлюцинации (у пациентов с болезнью Альцгеймера на стадии тяжелой деменции), нарушение походки, Венозный тромбоз/тромбоэмболия, Тошнота, рвота, Утомляемость; часто - Гиперчувствительность к компонентам препарата, Сонливость, Головокружение, нарушение равновесия, Повышение артериального давления, Одышка, Запор, Повышенные показатели печеночных проб, Головная боль ; частота не установлена - Психотические реакции (в период пострегистрационного опыта применения мемантина), Панкреатит, Гепатит.
Передозировка
Имеются ограниченные данные по передозировке, полученные в ходе клинических исследований и пострегистрационного опыта применения мемантина. Симптомы: при относительно большой передозировке (200 мг однократно или 105 мг/сут в течение 3 дней) отмечалась утомляемость, слабость и/или диарея или симптомы отсутствовали. В случае передозировки в дозе менее 140 мг однократно или приема неизвестной дозы у пациентов наблюдались побочные реакции со стороны ЦНС - спутанность сознания, гиперсомния, сонливость, головокружение, возбуждение, агрессия, галлюцинации, нарушение походки и/или со стороны пищеварительной системы - рвота, диарея. В самом тяжелом случае передозировки пациент выжил после приема дозы 2000 мг мемантина, у него наблюдались побочные реакции со стороны ЦНС (кома в течение 10 дней, затем диплопия и ажитация). Пациент получал симптоматическое лечение и плазмаферез. Пациент выздоровел без последующих осложнений. В другом случае тяжелой передозировки пациент выжил и выздоровел после приема мемантина в дозе 400 мг однократно. У пациента наблюдались побочные реакции со стороны ЦНС - беспокойство, психоз, зрительные галлюцинации, снижение порога судорожной готовности, сонливость, ступор и потеря сознания. Лечение: симптоматическое. Необходимо проведение стандартных лечебных мероприятий, направленных на выведение вещества из желудка, например промывание желудка, назначение активированного угля, подкисление мочи, возможно проведение форсированного диуреза. Специфического антидота нет.
Особые указания
Рекомендуется с осторожностью применять у пациентов с тиреотоксикозом, эпилепсией, судорогами (в т.ч. в анамнезе), а также у пациентов с предрасположенностью к эпилепсии. Одновременное применение антагонистов NMDA-рецепторов (амантадин, кетамин, декстрометорфан) и мемантина следует избегать. Эти соединения воздействуют на ту же систему рецепторов, что и мемантин, в связи с чем побочные реакции (в основном со стороны ЦНС) могут возникать чаще и быть более выраженными. Учитывая замедление выведения мемантина у пациентов в условиях щелочной реакции мочи, в более тщательном наблюдении нуждаются пациенты, имеющие факторы, влияющие на повышение рН мочи (резкая смена диеты, например при переходе от употребления преимущественно мясных продуктов к вегетарианству, интенсивное потребление щелочных желудочных буферов), а также в случаях почечного канальцевого ацидоза или тяжелой инфекции мочевыводящих путей, вызванной бактериями рода Proteus. Данные о приеме мемантина у пациентов с инфарктом миокарда (в анамнезе), с хронической сердечной недостаточностью III–IV функционального класса (по классификации NYHA) и неконтролируемой артериальной гипертензией ограничены, поэтому необходимо тщательное медицинское наблюдение за такими пациентами. Влияние лекарственного препарата для медицинского применения на способность управлять транспортными средствами, механизмами. У пациентов с болезнью Альцгеймера на стадии умеренной и тяжелой деменции обычно нарушена способность к вождению автотранспорта и управлению сложными механизмами. Кроме того, мемантин может вызывать изменение скорости реакции, поэтому пациентам необходимо воздержаться от управления автотранспортом или работы со сложными механизмами.
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