Обладает ноотропным, церебровазодилатирующим, противогипокси... Инструкция
Показания к применению
Деменция средней и тяжелой степени выраженности при болезни Альцгеймера.
Противопоказания
Повышенная чувствительность к компонентам препарата, тяжелая печеночная недостаточность, непереносимость лактозы, лактазная недостаточность, синдром глюкозо-галактозной мальабсорбции (препарат содержит лактозу), беременность, грудное вскармливание, возраст до 18 лет.
Состав пленочной оболочки: Opadry OY-S-28959 белый (гипромеллоза (гидроксипропилметилцеллюлоза) — 3,1250 мг, титана диоксид — 1,5625 мг, триацетин — 0,3125 мг).
Описание
Двояковыпуклые капсуловидные таблетки, покрытые пленочной оболочкой белого цвета, с риской с обеих сторон. Цвет на разрезе: от белого до почти белого.
Фармакотерапевтическая группа
Деменции средство лечения
Фармакологические свойства
Обладает ноотропным, церебровазодилатирующим, противогипоксическим и психостимулирующим действием.
Производное адамантана, по химической структуре и фармакологическим свойствам близок к амантадину. Блокирует глутаматные N-метил-D-аспартат (NMDA)-рецепторы (в том числе в черном веществе), тем самым снижая чрезмерное стимулирующее влияние кортикальных глутаматных нейронов на неостриатум, развивающееся на фоне недостаточного выделения допамина. Уменьшая поступление ионизированного кальция в нейроны, снижает возможность их деструкции. В большей степени влияет на скованность (ригидность и брадикинезию). Помимо действия на центральную нервную систему мемантин влияет на эфферентную иннервацию. Улучшает ослабленную память, концентрацию внимания, уменьшает утомляемость и симптомы депрессии, повышает повседневную активность.
После приема внутрь быстро и полностью всасывается из желудочно-кишечного тракта. Максимальная концентрация достигается через 3-8 часов. Пища не влияет на всасывание препарата. Суточная доза 20 мг приводит к равновесной плазменной концентрации от 70 до 150 нг/мл. Объем распределения составляет около 10 л/кг. Связь с белками плазмы – 45%. При нормальной функции почек кумуляции мемантина не отмечено. 80% циркулирующего в крови мемантина представлено неизменным веществом. Метаболизм протекает без участия цитохрома P450. Основными метаболитами являются N-3,5-диметилглудантан, изомерная смесь 4- и 6-гидроксимемантина и 1-нитрозо-3,5-диметиладамантан. Ни один из метаболитов не обладает антагонистической активностью по отношению к NMDA-рецепторам. Выводится преимущественно почками. Выведение происходит однофазно, период полувыведения составляет 60-100 ч, клиренс составляет 170 мл/мин/1,73 м2, частично секретируется почечными канальцами. При щелочной реакции мочи выведение препарата замедляется (в среднем на 80% при pH мочи 8).
Показания к применению
Деменция средней и тяжелой степени выраженности при болезни Альцгеймера.
Противопоказания
Повышенная чувствительность к компонентам препарата, тяжелая печеночная недостаточность, непереносимость лактозы, лактазная недостаточность, синдром глюкозо-галактозной мальабсорбции (препарат содержит лактозу), беременность, грудное вскармливание, возраст до 18 лет.
С осторожностью
С осторожностью назначают при тиреотоксикозе, эпилепсии, судорогах (в т.ч. в анамнезе), при одновременном применении антагонистов NMDA-рецепторов (амантадин, кетамин, декстрометорфан), при наличии факторов, повышающих рН мочи (резкая смена диеты, обильный прием щелочных желудочных буферов), тяжелая инфекция мочевыводящих путей, инфаркт миокарда (в анамнезе), сердечная недостаточность III-IV функционального класса (по классификации NYHA), неконтролируемая артериальная гипертензия, почечная недостаточность, печеночная недостаточность.
Применение при беременности и в период грудного вскармливания
Мемантин обладает способностью замедлять развитие плода.
На время лечения мемантином грудное вскармливание следует прервать.
Способ применения и дозы
Препарат принимают внутрь, независимо от приема пищи.
В течение первой недели суточная доза составляет 5 мг (утром). В течение второй недели суточная доза составляет 10 мг (по 5 мг 2 раза/сут). Во время третьей недели суточная доза — 15 мг/сут (10 мг утром и 5 мг вечером). С четвертой недели суточная доза составляет 20 мг/сут. Максимальная суточная доза 20 мг/сут.
Коррекции дозы у пожилых пациентов (старше 65 лет) не требуется.
При умеренной почечной недостаточности (клиренс креатинина 50-80 мл/мин) коррекции дозы обычно не требуется; при клиренсе креатинина 30-49 мл/минсуточная доза первоначально не превышает 10 мг, затем через 7 дней при условии хорошей переносимости доза может быть повышена вплоть до 20 мг. При тяжелой почечной недостаточности (клиренс креатинина 5-29 мл/мин) суточная доза не должна превышать 10 мг.
При легкой и умеренной печеночной недостаточности (класс А и В по классификации Чайлд-Пью) коррекции дозы не требуется.
Побочное действие
Со стороны нервной системы: головокружение, головная боль, сонливость, нарушение походки, спутанность сознания, галлюцинации, судороги, психоз, повышенная возбудимость.
Со стороны желудочно-кишечного тракта: запор, рвота, панкреатит, тошнота.
Инфекции и инвазии: грибковые инфекции.
Со стороны сердечно-сосудистой системы: повышение АД, венозный тромбоз, тромбоэмболия, застойная сердечная недостаточность, одышка.
Со стороны организма в целом: общая слабость, повышенная утомляемость, аллергические реакции.
Со стороны крови и лимфатической системы: агранулоцитоз, лейкопения (включая нейтропению), панцитопения, тромбоцитопения, тромбоцитопеническая пурпура.
Со стороны печени и желчевыводящих путей: гепатит, повышение лабораторных показателей функции печения.
Нарушения психики: суицидальные мысли, психотические реакции.
Со стороны почек и мочевыводящих путей: острая почечная недостаточность.
Со стороны кожных покровов: синдром Стивенса-Джонса.
При болезни Альцгеймера могут возникать депрессия, суицидальные идеи и попытки суицида.
Лечение: промывание желудка, назначение активированного угля; симптоматическая терапия. Специфического антидота нет. Выведение препарата можно ускорить путем закисления мочи.
Взаимодействие с другими лекарственными средствами
При одновременном применении может ослаблять эффект барбитуратов и нейролептиков.
Действие баклофена и дантролена может изменяться под влиянием мемантина, поэтому может потребоваться коррекция их доз.
При одновременном применении мемантина с препаратами леводопы, агонистами допамина, антихолинергическими средствами действие последних может усиливаться.
В связи с тем, что мемантин и амантадин представляют собой антагонисты NMDA-рецепторов, следует избегать одновременного применения в связи с риском развития токсического действия. Потенциально токсичными являются также комбинаций мемантина с кетамином, декстрометорфаном и фенитоином.
Для транспорта амантадина, циметидина, ранитидина, хинидина, прокаинамида, хинина и никотина в организме используется одна и та же почечная катионная система, что может обусловливать взаимодействие этих препаратов с мемантином, приводя к увеличению его концентрации в плазме крови.
При одновременном применении мемантин может вызывать снижение концентрации гидрохлоротиазида в сыворотке крови.
При одновременном применении с варфарином и другими непрямыми антикоагулянтами требуется тщательный контроль протромбинового времени и международного нормализованного отношения.
Особые указания
При щелочной реакции мочи требуется более тщательное наблюдение за пациентами из-за замедления выведения мемантина.
Влияние на способность управлять автомобилем и движущимися механизмами
Следует соблюдать осторожность при управлении автомобилем и выполнении работ, требующих повышенной концентрации внимания.
Форма выпуска
Таблетки, покрытые пленочной оболочкой, 10 мг.
10 таблеток в контурной ячейковой упаковке (блистере) из пленки поливинилхлоридной и фольги алюминиевой. 3, 6 или 9 контурных ячейковых упаковок вместе с инструкцией по применению в пачке из картона.
Условия хранения
В сухом, защищенном от света месте при температуре не выше 25 градусов. Хранить в недоступном для детей месте.
Срок годности
2 года. Не использовать позже даты, указанной на упаковке.
Для описания товара использована информация от партнера 36.6
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номер","slug":"","body":[{"type":"paragraph","data":{"text":"ЛП-000758"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://vseapteki.ru/external/admin/provider/providerposition/417037/change/?_changelist_filters=q%3D%25D0%25BC%25D0%25B5%25D0%25BC%25D0%25BE%25D1%2580%25D0%25B5%25D0%25BB%25D1%258C%2B10%2B%25D0%25BC%25D0%25B3%2B30\"\u003eМеморель таб.п.п.о. 10мг №30\u003c/a\u003e"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки, покрытые пленочной оболочкой."}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"1 таблетка, покрытая пленочной оболочкой, содержит:"}},{"type":"paragraph","data":{"text":"Активное вещество: мемантина гидрохлорид — 10,00 мг"}},{"type":"paragraph","data":{"text":"Вспомогательные вещества: лактозы моногидрат — 192.5 мг, целлюлоза силиконизированная микрокристаллическая (36,75 мг — целлюлоза микрокристаллическая, кремния диоксид коллоидный — 0.75 мг) — 37,50 мг, тальк — 2,50 мг, магния стеарат — 2.50 мг."}},{"type":"paragraph","data":{"text":"Состав пленочной оболочки: Opadry OY-S-28959 белый (гипромеллоза (гидроксипропилметилцеллюлоза) — 3,1250 мг, титана диоксид — 1,5625 мг, триацетин — 0,3125 мг)."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Двояковыпуклые капсуловидные таблетки, покрытые пленочной оболочкой белого цвета, с риской с обеих сторон. Цвет на разрезе: от белого до почти белого."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Деменции средство лечения"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Обладает ноотропным, церебровазодилатирующим, противогипоксическим и психостимулирующим действием."}},{"type":"paragraph","data":{"text":"Производное адамантана, по химической структуре и фармакологическим свойствам близок к амантадину. Блокирует глутаматные N-метил-D-аспартат (NMDA)-рецепторы (в том числе в черном веществе), тем самым снижая чрезмерное стимулирующее влияние кортикальных глутаматных нейронов на неостриатум, развивающееся на фоне недостаточного выделения допамина. Уменьшая поступление ионизированного кальция в нейроны, снижает возможность их деструкции. В большей степени влияет на скованность (ригидность и брадикинезию). Помимо действия на центральную нервную систему мемантин влияет на эфферентную иннервацию. Улучшает ослабленную память, концентрацию внимания, уменьшает утомляемость и симптомы депрессии, повышает повседневную активность."}},{"type":"paragraph","data":{"text":"После приема внутрь быстро и полностью всасывается из желудочно-кишечного тракта. Максимальная концентрация достигается через 3-8 часов. Пища не влияет на всасывание препарата. Суточная доза 20 мг приводит к равновесной плазменной концентрации от 70 до 150 нг/мл. Объем распределения составляет около 10 л/кг. Связь с белками плазмы – 45%. При нормальной функции почек кумуляции мемантина не отмечено. 80% циркулирующего в крови мемантина представлено неизменным веществом. Метаболизм протекает без участия цитохрома P450. Основными метаболитами являются N-3,5-диметилглудантан, изомерная смесь 4- и 6-гидроксимемантина и 1-нитрозо-3,5-диметиладамантан. Ни один из метаболитов не обладает антагонистической активностью по отношению к NMDA-рецепторам. Выводится преимущественно почками. Выведение происходит однофазно, период полувыведения составляет 60-100 ч, клиренс составляет 170 мл/мин/1,73 м2, частично секретируется почечными канальцами. При щелочной реакции мочи выведение препарата замедляется (в среднем на 80% при pH мочи 8)."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Деменция средней и тяжелой степени выраженности при болезни Альцгеймера."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к компонентам препарата, тяжелая печеночная недостаточность, непереносимость лактозы, лактазная недостаточность, синдром глюкозо-галактозной мальабсорбции (препарат содержит лактозу), беременность, грудное вскармливание, возраст до 18 лет."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"\u003cb\u003eС осторожностью\u003c/b\u003e назначают при тиреотоксикозе, эпилепсии, судорогах (в т.ч. в анамнезе), при одновременном применении антагонистов NMDA-рецепторов (амантадин, кетамин, декстрометорфан), при наличии факторов, повышающих рН мочи (резкая смена диеты, обильный прием щелочных желудочных буферов), тяжелая инфекция мочевыводящих путей, инфаркт миокарда (в анамнезе), сердечная недостаточность III-IV функционального класса (по классификации NYHA), неконтролируемая артериальная гипертензия, почечная недостаточность, печеночная недостаточность. "}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Мемантин обладает способностью замедлять развитие плода."}},{"type":"paragraph","data":{"text":"На время лечения мемантином грудное вскармливание следует прервать."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат принимают внутрь, независимо от приема пищи."}},{"type":"paragraph","data":{"text":"В течение первой недели суточная доза составляет 5 мг (утром). В течение второй недели суточная доза составляет 10 мг (по 5 мг 2 раза/сут). Во время третьей недели суточная доза — 15 мг/сут (10 мг утром и 5 мг вечером). С четвертой недели суточная доза составляет 20 мг/сут. Максимальная суточная доза 20 мг/сут."}},{"type":"paragraph","data":{"text":"Коррекции дозы у пожилых пациентов (старше 65 лет) не требуется."}},{"type":"paragraph","data":{"text":"При умеренной почечной недостаточности (клиренс креатинина 50-80 мл/мин) коррекции дозы обычно не требуется; при клиренсе креатинина 30-49 мл/минсуточная доза первоначально не превышает 10 мг, затем через 7 дней при условии хорошей переносимости доза может быть повышена вплоть до 20 мг. При тяжелой почечной недостаточности (клиренс креатинина 5-29 мл/мин) суточная доза не должна превышать 10 мг."}},{"type":"paragraph","data":{"text":"При легкой и умеренной печеночной недостаточности (класс А и В по классификации Чайлд-Пью) коррекции дозы не требуется."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны нервной системы: головокружение, головная боль, сонливость, нарушение походки, спутанность сознания, галлюцинации, судороги, психоз, повышенная возбудимость."}},{"type":"paragraph","data":{"text":"Со стороны желудочно-кишечного тракта: запор, рвота, панкреатит, тошнота."}},{"type":"paragraph","data":{"text":"Инфекции и инвазии: грибковые инфекции."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: повышение АД, венозный тромбоз, тромбоэмболия, застойная сердечная недостаточность, одышка."}},{"type":"paragraph","data":{"text":"Со стороны организма в целом: общая слабость, повышенная утомляемость, аллергические реакции."}},{"type":"paragraph","data":{"text":"Со стороны крови и лимфатической системы: агранулоцитоз, лейкопения (включая нейтропению), панцитопения, тромбоцитопения, тромбоцитопеническая пурпура."}},{"type":"paragraph","data":{"text":"Со стороны печени и желчевыводящих путей: гепатит, повышение лабораторных показателей функции печения."}},{"type":"paragraph","data":{"text":"Нарушения психики: суицидальные мысли, психотические реакции."}},{"type":"paragraph","data":{"text":"Со стороны почек и мочевыводящих путей: острая почечная недостаточность."}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов: синдром Стивенса-Джонса."}},{"type":"paragraph","data":{"text":"При болезни Альцгеймера могут возникать депрессия, суицидальные идеи и попытки суицида."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: головокружение, тремор, ажитация, сонливость, помрачнение сознания, возбуждение, ступор, судороги, агрессивность, галлюцинации, неустойчивость походки, рвота, диарея."}},{"type":"paragraph","data":{"text":"Лечение: промывание желудка, назначение активированного угля; симптоматическая терапия. Специфического антидота нет. Выведение препарата можно ускорить путем закисления мочи."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении может ослаблять эффект барбитуратов и нейролептиков."}},{"type":"paragraph","data":{"text":"Действие баклофена и дантролена может изменяться под влиянием мемантина, поэтому может потребоваться коррекция их доз."}},{"type":"paragraph","data":{"text":"При одновременном применении мемантина с препаратами леводопы, агонистами допамина, антихолинергическими средствами действие последних может усиливаться."}},{"type":"paragraph","data":{"text":"В связи с тем, что мемантин и амантадин представляют собой антагонисты NMDA-рецепторов, следует избегать одновременного применения в связи с риском развития токсического действия. Потенциально токсичными являются также комбинаций мемантина с кетамином, декстрометорфаном и фенитоином."}},{"type":"paragraph","data":{"text":"Для транспорта амантадина, циметидина, ранитидина, хинидина, прокаинамида, хинина и никотина в организме используется одна и та же почечная катионная система, что может обусловливать взаимодействие этих препаратов с мемантином, приводя к увеличению его концентрации в плазме крови."}},{"type":"paragraph","data":{"text":"При одновременном применении мемантин может вызывать снижение концентрации гидрохлоротиазида в сыворотке крови."}},{"type":"paragraph","data":{"text":"При одновременном применении с варфарином и другими непрямыми антикоагулянтами требуется тщательный контроль протромбинового времени и международного нормализованного отношения."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"При щелочной реакции мочи требуется более тщательное наблюдение за пациентами из-за замедления выведения мемантина."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Следует соблюдать осторожность при управлении автомобилем и выполнении работ, требующих повышенной концентрации внимания."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки, покрытые пленочной оболочкой, 10 мг."}},{"type":"paragraph","data":{"text":"10 таблеток в контурной ячейковой упаковке (блистере) из пленки поливинилхлоридной и фольги алюминиевой. \u003ca href=\"https://www.stada.ru/products/memorel.html#\"\u003e3\u003c/a\u003e, 6 или \u003ca href=\"https://www.stada.ru/products/memorel.html#\"\u003e9\u003c/a\u003e контурных ячейковых упаковок вместе с инструкцией по применению в пачке из картона."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом, защищенном от света месте при температуре не выше 25 градусов. Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года. Не использовать позже даты, указанной на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту врача."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Билим Иланч Санайии ве Тиджарет А.Ш., Турция"}},{"type":"paragraph","data":{"text":"Адрес места производства"}},{"type":"paragraph","data":{"text":"Коджаэли, Гебзе Организе Санайи, Бельгеси 1900 сокак, № 1904, Турция."}},{"type":"paragraph","data":{"text":"\u003cb\u003eУпаковщик\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"ООО «Скопинский фармацевтический завод»,"}},{"type":"paragraph","data":{"text":"Адрес места производства"}},{"type":"paragraph","data":{"text":"ООО Хемофарм, Россия"}},{"type":"paragraph","data":{"text":"249030, Калужская обл., г.Обнинск, Киевское шоссе, д.62"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"\n\nАО «НИЖФАРМ»,"}},{"type":"paragraph","data":{"text":"Россия, 603950, г. Нижний Новгород, ГСП-459, ул. Салганская, 7"}},{"type":"paragraph","data":{"text":"тел.: (831) 278-80-88,"}},{"type":"paragraph","data":{"text":"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":"Обладает ноотропным, церебровазодилатирующим, противогипоксическим и психостимулирующим действием. Производное адамантана, по химической структуре и фармакологическим свойствам близок к амантадину. Блокирует глутаматные N-метил-D-аспартат (NMDA)-рецепторы (в том числе в черном веществе), тем самым снижая чрезмерное стимулирующее влияние кортикальных глутаматных нейронов на неостриатум, развивающееся на фоне недостаточного выделения допамина. Уменьшая поступление ионизированного кальция в нейроны, снижает возможность их деструкции. В большей степени влияет на скованность (ригидность и брадикинезию). Помимо действия на центральную нервную систему мемантин влияет на эфферентную иннервацию. Улучшает ослабленную память, концентрацию внимания, уменьшает утомляемость и симптомы депрессии, повышает повседневную активность. После приема внутрь быстро и полностью всасывается из желудочно-кишечного тракта. Максимальная концентрация достигается через 3-8 часов. Пища не влияет на всасывание препарата. Суточная доза 20 мг приводит к равновесной плазменной концентрации от 70 до 150 нг/мл. Объем распределения составляет около 10 л/кг. Связь с белками плазмы – 45%. При нормальной функции почек кумуляции мемантина не отмечено. 80% циркулирующего в крови мемантина представлено неизменным веществом. Метаболизм протекает без участия цитохрома P450. Основными метаболитами являются N-3,5-диметилглудантан, изомерная смесь 4- и 6-гидроксимемантина и 1-нитрозо-3,5-диметиладамантан. Ни один из метаболитов не обладает антагонистической активностью по отношению к NMDA-рецепторам. Выводится преимущественно почками. Выведение происходит однофазно, период полувыведения составляет 60-100 ч, клиренс составляет 170 мл/мин/1,73 м2, частично секретируется почечными канальцами. 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