Фармакологическое действие — средство для лечения деменции. Инструкция
Показания к применению
Деменция альцгеймеровского типа умеренной и тяжелой степени.
Противопоказания
индивидуальная повышенная чувствительность к мемантину или любому из компонентов, входящих в состав препарата;дефицит лактазы, непереносимость лактозы, синдром глюкозо-галактозной мальабсорбции, т.к. в состав препарата Мемантинол® входит лактоза;беременность;период грудного вскармливания;возраст до 18 лет (эффективность и безопасность не установлены).С ...
Продолговатые двояковыпуклые таблетки, покрытые пленочной оболочкой белого цвета, с гравировкой «g» и «Ph» и риской между буквами с каждой стороны.На разломе— таблетки белого или почти белого цвета.
Фармакологические свойства
Фармакологическое действие — средство для лечения деменции.
Показания к применению
Деменция альцгеймеровского типа умеренной и тяжелой степени.
Противопоказания
индивидуальная повышенная чувствительность к мемантину или любому из компонентов, входящих в состав препарата;дефицит лактазы, непереносимость лактозы, синдром глюкозо-галактозной мальабсорбции, т.к. в состав препарата Мемантинол® входит лактоза;беременность;период грудного вскармливания;возраст до 18 лет (эффективность и безопасность не установлены).С осторожностью: тиреотоксикоз, эпилепсия, предрасположенность к развитию судорог (в т.ч. в анамнезе); одновременное применение других антагонистов NMDA-рецепторов (амантадин, кетамин, декстрометорфан), наличие факторов, повышающих рН мочи (резкая смена диеты, например переход на вегетарианство, обильный прием щелочных желудочных буферов); почечный канальцевый ацидоз; тяжелые инфекции мочевыводящих путей, вызванные бактериями рода Proteus; 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
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
Внутрь, 1 раз в сутки и всегда в одно и то же время, независимо от приема пищи.Лечение мемантином следует начинать и проводить под наблюдением врача, имеющего опыт постановки диагноза и лечения деменции при болезни Альцгеймера. Диагноз должен быть установлен в соответствии с действующими рекомендациями. Лечение следует начинать только в том случае, если лицо, осуществляющее постоянный уход за пациентом, будет регулярно контролировать прием препарата. Переносимость и дозировку мемантина необходимо регулярно пересматривать, желательно в течение первых 3 мес от начала терапии. По прошествии этого периода клиническую эффективность мемантина и переносимость пациентом лечения следует регулярно пересматривать в соответствии с действующими клиническими рекомендациями. Поддерживающее лечение можно продолжать неопределенно долго при наличии положительного эффекта проводимой терапии и хорошей переносимости лечения. Прием мемантина следует прекратить при отсутствии положительного терапевтического эффекта или непереносимости пациентом лечения.ВзрослыеТитрация дозы. 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 3 нед: в течение 1-й нед терапии (дни с 1-го по 7-й) пациент должен принимать мемантин в дозе 5 мг/сут (0,5 табл. 10 мг), в течение 2-й нед (дни с 8-го по 14-й)— в дозе 10 мг/сут (1 табл. 10 мг), в течение 3-й нед (дни с 15-го по 21-й)— в дозе 15 мг/сут (1,5 табл. 10 мг). Начиная с 4-й нед пациенту назначают прием мемантина в дозе 20 мг/сут (2 табл. по 10 мг). Рекомендуемая поддерживающая доза— 20 мг/сут.Особые группы пациентовПожилой возраст (старше 65 лет). Коррекция дозы не требуется.Нарушение функции почек. У пациентов с Cl креатинина 50–80 мл/мин, коррекция дозы не требуется. Для больных с умеренной почечной недостаточностью (Cl креатинина 30–49 мл/мин) рекомендуемая суточная доза— 10 мг/сут. При хорошей переносимости этой дозы на протяжении 7 дней ее можно увеличить до 20 мг/сут в соответствии со стандартной схемой титрования. У пациентов с тяжелой почечной недостаточностью (Cl креатинина 5–29 мл/мин) суточная доза не должна превышать 10 мг/сут.Нарушение функции печени. У пациентов с легким и умеренным нарушением функции печени (класс А и класс В по шкале Чайлд-Пью) коррекция дозы не требуется. Данных по применению мемантина у пациентов с тяжелым нарушением функции печени нет, поэтому назначение мемантина таким пациентам не рекомендуется.
Побочное действие
Побочные реакции классифицированы по клиническим проявлениям (в соответствии с поражением определенных систем органов) и частоте встречаемости согласно классификации ВОЗ: очень часто (≥1/10); часто (≥1/100 до <1/10); нечасто (≥1/1000 до <1/100); редко (≥1/10000 до <1/1000); очень редко (<1/10000), частота не установлена (не может быть оценена по данным, имеющимся в наличии).В клинических исследованиях при умеренной и тяжелой деменции, включавших 1784 пациента, получавших мемантин, и 1595 пациентов, получавших плацебо, общая частота возникновения нежелательных реакций при приеме мемантина не отличалась от таковой при приеме плацебо. Как правило, наблюдались нежелательные реакции легкой или умеренной степени выраженности. Наиболее частыми нежелательными реакциями в группе мемантина по сравнению с группой плацебо были головокружение (6,3 против 5,6% соответственно), головная боль (5,2 против 3,9%), запор (4,6 против 2,6%), сонливость (3,4 против 2,2%) и артериальная гипертензия (4,1 против 2,8% соответственно).Побочные реакции представлены в виде таблицы.Таблица Системы организма и состояния Степень частоты Нежелательные явления Инфекционные и паразитарные заболевания Нечасто Грибковые инфекции Со стороны иммунной системы Часто Гиперчувствительность к компонентам препарата Нарушения психики Часто Сонливость Нечасто Спутанность сознания, галлюцинации1 Частота не установлена Психотические реакции2 Со стороны нервной системы Часто Головокружение, нарушение равновесия Нечасто Нарушение походки Очень редко Судороги Со стороны ССС Часто Повышение АД Нечасто Венозный тромбоз/тромбоэмболия Со стороны дыхательной системы, органов грудной клетки и средостения Часто Одышка Со стороны ЖКТ Часто Запор Нечасто Тошнота, pвота Частота не установлена Панкреатит Со стороны печени и желчевыводящих путей Часто Повышенные показатели печеночных проб Частота не установлена Гепатит Общие реакции Часто Головная боль Нечасто Утомляемость 1 Галлюцинации наблюдались главным образом у пациентов с болезнью Альцгеймера на стадии тяжелой деменции.2 Отдельные сообщения, полученные в период пострегистрационного опыта применения мемантина.При пострегистрационном применении сообщалось о возникновении следующих нежелательных реакций: головокружение, сонливость, повышенная возбудимость, повышенная утомляемость, беспокойство, повышение ВЧД, тошнота, галлюцинации, головная боль, нарушение сознания, мышечный гипертонус, нарушение походки, депрессия, судороги, психотические реакции, суицидальные мысли, запор, тошнота, панкреатит, кандидоз, повышение АД, рвота, цистит, повышение либидо, венозный тромбоз, тромбоэмболия, аллергические реакции, агранулоцитоз, лейкопения (включая нейтропению), панцитопения, тромбоцитопения, тромбоцитопеническая пурпура, гепатит, острая почечная недостаточность, синдром Стивенса-Джонсона.
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.
Взаимодействие с другими лекарственными средствами
При одновременном применении с препаратами леводопы, агонистами дофаминовых рецепторов, антихолинергическими ЛС действие последних может усиливаться.При одновременном применении с барбитуратами, нейролептиками действие последних может уменьшаться.При одновременном применении с дантроленом или баклофеном, а также со спазмолитиками может изменяться (усилиться или уменьшиться) их действие, поэтому дозы препаратов следует корректировать.Следует избегать одновременного применения мемантина с амантадином в связи с риском развития психоза. Мемантин и амантадин относятся к группе антагонистов NMDA-рецепторов. Риск развития психоза также повышен при одновременном применении с кетамином, декстрометорфаном и фенитоином.При одновременном приеме с циметидином, ранитидином, прокаинамидом, хинидином, хинином и никотином возможно повышение в плазме концентрации мемантина.Возможно снижение уровня гидрохлортиазида при одновременном приеме с мемантином за счет увеличения его выведения из организма.Возможно повышение МНО у пациентов, одновременно принимающих пероральные непрямые антикоагулянты (варфарин). Рекомендуется постоянно контролировать ПВ или МНО.Одновременное применение с антидепрессантами, СИОЗС и ингибиторами МАО требует тщательного наблюдения за пациентами.По данным проведенных фармакокинетических исследований, у молодых здоровых добровольцев при однократном одновременном приеме мемантина с глибуридом/метформином или донепезилом эффекты лекарственного взаимодействия выявлены не были.Проведенные клинические исследования также не выявили влияние мемантина на фармакокинетику галантамина у молодых здоровых добровольцев.В исследованиях in vitro мемантин не ингибировал изоферменты CYP1A2, CYP2A6, CYP2C9, CYP2D6, CYP2E1, CYP3A, монооксигеназу, содержащую флавин, эпоксидгидролазу или сульфатирование.
Условия хранения
В сухом, защищенном от света месте, при температуре не выше 25°C. Хранить в недоступном для детей месте.
Срок годности
3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России
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Данных по применению мемантина у пациентов с тяжелым нарушением функции печени нет, поэтому назначение мемантина таким пациентам не рекомендуется."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Побочные реакции классифицированы по клиническим проявлениям (в соответствии с поражением определенных систем органов) и частоте встречаемости согласно классификации ВОЗ: очень часто (≥1/10); часто (≥1/100 до \u003c1/10); нечасто (≥1/1000 до \u003c1/100); редко (≥1/10000 до \u003c1/1000); очень редко (\u003c1/10000), частота не установлена (не может быть оценена по данным, имеющимся в наличии).В клинических исследованиях при умеренной и тяжелой деменции, включавших 1784 пациента, получавших мемантин, и 1595 пациентов, получавших плацебо, общая частота возникновения нежелательных реакций при приеме мемантина не отличалась от таковой при приеме плацебо. Как правило, наблюдались нежелательные реакции легкой или умеренной степени выраженности. Наиболее частыми нежелательными реакциями в группе мемантина по сравнению с группой плацебо были головокружение (6,3 против 5,6% соответственно), головная боль (5,2 против 3,9%), запор (4,6 против 2,6%), сонливость (3,4 против 2,2%) и артериальная гипертензия (4,1 против 2,8% соответственно).Побочные реакции представлены в виде таблицы.Таблица\t\t\tСистемы организма и состояния\t\tСтепень частоты\t\tНежелательные явления\t\t\t\tИнфекционные и паразитарные заболевания\t\tНечасто\t\tГрибковые инфекции\t\t\t\tСо стороны иммунной системы\t\tЧасто\t\tГиперчувствительность к компонентам препарата\t\t\t\tНарушения психики\t\tЧасто\t\tСонливость\t\t\t\tНечасто\t\tСпутанность сознания, галлюцинации1\t\t\t\tЧастота не установлена\t\tПсихотические реакции2\t\t\t\tСо стороны нервной системы\t\tЧасто\t\tГоловокружение, нарушение равновесия\t\t\t\tНечасто\t\tНарушение походки\t\t\t\tОчень редко\t\tСудороги\t\t\t\tСо стороны ССС\t\tЧасто\t\tПовышение АД\t\t\t\tНечасто\t\tВенозный тромбоз/тромбоэмболия\t\t\t\tСо стороны дыхательной системы, органов грудной клетки и средостения\t\tЧасто\t\tОдышка\t\t\t\tСо стороны ЖКТ\t\tЧасто\t\tЗапор\t\t\t\tНечасто\t\tТошнота, pвота\t\t\t\tЧастота не установлена\t\tПанкреатит\t\t\t\tСо стороны печени и желчевыводящих путей\t\tЧасто\t\tПовышенные показатели печеночных проб\t\t\t\tЧастота не установлена\t\tГепатит\t\t\t\tОбщие реакции\t\tЧасто\t\tГоловная боль\t\t\t\tНечасто\t\tУтомляемость\t1 Галлюцинации наблюдались главным образом у пациентов с болезнью Альцгеймера на стадии тяжелой деменции.2 Отдельные сообщения, полученные в период пострегистрационного опыта применения мемантина.При пострегистрационном применении сообщалось о возникновении следующих нежелательных реакций: головокружение, сонливость, повышенная возбудимость, повышенная утомляемость, беспокойство, повышение ВЧД, тошнота, галлюцинации, головная боль, нарушение сознания, мышечный гипертонус, нарушение походки, депрессия, судороги, психотические реакции, суицидальные мысли, запор, тошнота, панкреатит, кандидоз, повышение АД, рвота, цистит, повышение либидо, венозный тромбоз, тромбоэмболия, аллергические реакции, агранулоцитоз, лейкопения (включая нейтропению), панцитопения, тромбоцитопения, тромбоцитопеническая пурпура, гепатит, острая почечная недостаточность, синдром Стивенса-Джонсона."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"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."}}]},{"id":10,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При одновременном применении с препаратами леводопы, агонистами дофаминовых рецепторов, антихолинергическими ЛС действие последних может усиливаться.При одновременном применении с барбитуратами, нейролептиками действие последних может уменьшаться.При одновременном применении с дантроленом или баклофеном, а также со спазмолитиками может изменяться (усилиться или уменьшиться) их действие, поэтому дозы препаратов следует корректировать.Следует избегать одновременного применения мемантина с амантадином в связи с риском развития психоза. Мемантин и амантадин относятся к группе антагонистов NMDA-рецепторов. Риск развития психоза также повышен при одновременном применении с кетамином, декстрометорфаном и фенитоином.При одновременном приеме с циметидином, ранитидином, прокаинамидом, хинидином, хинином и никотином возможно повышение в плазме концентрации мемантина.Возможно снижение уровня гидрохлортиазида при одновременном приеме с мемантином за счет увеличения его выведения из организма.Возможно повышение МНО у пациентов, одновременно принимающих пероральные непрямые антикоагулянты (варфарин). Рекомендуется постоянно контролировать ПВ или МНО.Одновременное применение с антидепрессантами, СИОЗС и ингибиторами МАО требует тщательного наблюдения за пациентами.По данным проведенных фармакокинетических исследований, у молодых здоровых добровольцев при однократном одновременном приеме мемантина с глибуридом/метформином или донепезилом эффекты лекарственного взаимодействия выявлены не были.Проведенные клинические исследования также не выявили влияние мемантина на фармакокинетику галантамина у молодых здоровых добровольцев.В исследованиях in vitro мемантин не ингибировал изоферменты CYP1A2, CYP2A6, CYP2C9, CYP2D6, CYP2E1, CYP3A, монооксигеназу, содержащую флавин, эпоксидгидролазу или сульфатирование."}}]},{"id":11,"name":"Условия хранения","slug":"storage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В сухом, защищенном от света месте, при температуре не выше 25°C. Хранить в недоступном для детей месте."}}]},{"id":12,"name":"Срок годности","slug":"expiry_date","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России"}}]},{"id":13,"name":"Условия отпуска","slug":"release_condition","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"По рецепту."}}]}],"source":{"title":"ЭркаФарм","url":"https://erkapharm.com"}},"description_toggle":false,"short_description":"Фармакологическое действие — средство для лечения деменции.","substance":[{"id":521,"title":"Мемантин","title_latin":"Memantinum","slug":"memantin_521"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":false,"comments":null,"image_alt":"Мемантин - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/38860/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/38860/share_default/"}},"diseases":[{"id":"467","title":"Деменция при болезни Альцгеймера","slug":"467-dementsiya_pri_bolezni_altsgeymera"},{"id":"548","title":"Болезнь 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