Деменция средней и тяжелой степени при болезни Альцгеймера
Противопоказания
Классификация частоты развития побочных эффектов ВОЗ: очень часто - ≥1/10; часто - от ≥1/100 до <1/10; нечасто - от ≥1/1000 до <1/100; редко - от ≥1/10000 до <1/1000; очень редко - <1/10000; частота неизвестна - не может быть оценена на основе имеющихся данных. В клинических исследованиях общая частота развития побочных реакций не отличалась при приеме ...
Деменция средней и тяжелой степени при болезни Альцгеймера
Противопоказания
Классификация частоты развития побочных эффектов ВОЗ: очень часто - ≥1/10; часто - от ≥1/100 до <1/10; нечасто - от ≥1/1000 до <1/100; редко - от ≥1/10000 до <1/1000; очень редко - <1/10000; частота неизвестна - не может быть оценена на основе имеющихся данных. В клинических исследованиях общая частота развития побочных реакций не отличалась при приеме мемантина и плацебо. Как правило, они были от легкой до умеренной степени тяжести. Наиболее частыми побочными реакциями в группе мемантина по сравнению с 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%). Побочные эффекты представлены по классификации MedDRA. Инфекционные и паразитарные заболевания: редко - грибковые инфекции. Со стороны иммунной системы: часто - гиперчувствительность к компонентам препарата. Нарушения психики: часто - сонливость; нечасто - спутанность сознания, галлюцинации*; частота неизвестна - психотические реакции. Со стороны нервной системы: часто - головокружение, нарушение равновесия; нечасто - нарушение походки; очень редко - судороги. Со стороны сердца: нечасто - сердечная недостаточность. Со стороны сосудов: 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, рвота; частота неизвестна - панкреатит. Со стороны печени и желчевыводящих путей: часто - повышение активности печеночных ферментов; частота неизвестна - гепатит. Общие расстройства и нарушения в месте введения: часто - головная боль; нечасто - утомляемость. * Галлюцинации наблюдались главным образом у пациентов с болезнью Альцгеймера на стадии тяжелой деменции. 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 и аллергические реакции.
Применение при беременности и в период грудного вскармливания
В связи с возможной задержкой внутриутробного развития препарат Марукса не применяется при беременности. Сведений о выделении мемантина с грудным молоком нет. Однако, учитывая липофильность мемантина, выделение возможно. Поэтому на время лечения препаратом Марукса грудное вскармливание необходимо прекратить.
Способ применения и дозы
Внутрь, 1 раз в сутки и всегда в одно и тоже время, независимо от приема пищи. Терапия должна проводиться под контролем врача, имеющего опыт в вопросах диагностики и лечения деменции при болезни Альцгеймера. Терапию следует начинать только в том случае, если лицо, регулярно ухаживающее за пациентом, будет следить за приемом им лекарственного препарата. Диагноз должен быть поставлен в соответствии с действующими рекомендациями. Следует регулярно оценивать переносимость и дозу препарата Марукса, предпочтительно в течение 3 мес. после начала терапии. Затем следует регулярно оценивать клиническую эффективность лекарственного препарата и переносимость терапии в соответствии с действующими клиническими рекомендациями. Поддерживающую терапию можно продолжать неопределенно долго при наличии терапевтического эффекта и хорошей переносимости препарата Марукса. Следует прекратить применение препарата Марукса, если терапевтический эффект более не наблюдается или пациент не переносит терапию. С целью уменьшения риска развития побочных эффектов рекомендуется постепенное увеличение дозы: 5 мг/нед. в течение первых 3 нед. терапии. Рекомендуемая поддерживающая доза составляет 20 мг/сут. Рекомендуется следующий режим дозирования: 1-я нед. (1–7-й день): суточная доза - 5 мг (по 1⁄2 табл. Марукса 10 мг каждый день в течение 7 дней); 2-я нед. (8–14-й день): суточная доза - 10 мг (по 1 табл. Марукса 10 мг каждый день в течение 7 дней); 3-я нед. (15–21-й день): суточная доза - 15 мг (по 11⁄2 табл. Марукса 10 мг каждый день в течение 7 дней); начиная с 4-й нед.: суточная доза - 20 мг (2 табл. Марукса 10 мг каждый день).
Побочное действие
Классификация частоты развития побочных эффектов Всемирной организации здравоохранения (ВОЗ): очень часто >1/10 часто от > 1/100 до < 1/10 нечасто от > 1/1000 до < 1/100 редко от >1/10000 до <1/1000 очень редко <1/10000 частота неизвестна не может быть оценена на основе имеющихся данных. В клинических исследованиях общая частота развития побочных реакции не отличалась при приеме мемантина и плацебо. Как правило, они были от легкой до умеренной степени тяжести. Наиболее частыми побочными реакциями в группе мемантина по сравнению с 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 %, соответственно) и артериальная гипертензия (4,1 % против 2,8 %, соответственно). Инфекционные и паразитарные заболевания: редко - грибковые инфекции. Нарушения со стороны крови и лимфатической системы: частота неизвестна - агранулоцитоз, лейкопения (включая нейтропению), панцитопения, тромбоцитопения, тромбоцитопеническая пурпура. Нарушения со стороны иммунной системы: часто - гиперчувствительность к компонентам препарата. Нарушения психики: часто - сонливость; нечасто - спутанность сознания, галлюцинации; частота неизвестна - психотические реакции. Нарушения со стороны нервной системы: часто - головокружение, нарушение равновесия; нечасто - нарушение походки; очень редко - судороги. Нарушения со стороны сердца: нечасто - сердечная недостаточность. Нарушения со стороны сосудов: часто - повышение артериального давления; нечасто - венозный тромбоз/тромбоэмболия. Нарушения со стороны дыхательной системы, органов грудной клетки и средостения: часто - одышка. Нарушения со стороны желудочно-кишечного тракта: частота неизвестна - панкреатит. Нарушения со стороны печени и желчевыводящих путей: часто - повышение активности печеночных трансаминаз; частота неизвестна - гепатит. Нарушения со стороны почек и мочевыводящих путей: частота неизвестна - острая почечная недостаточность. Нарушения со стороны кожи и подкожных тканей: частота неизвестна - синдром Стивенса-Джонсона. Общие расстройства и нарушения в месте введения: часто - головная боль; нечасто - утомляемость. Галлюцинации наблюдались, главным образом, у пациентов с болезнью Альцгеймера на стадии тяжелой деменции. При пострегистрационном применении Маруксы сообщалось о возникновении следующих нежелательных реакций: головокружение, сонливость, повышенная возбудимость, повышенная утомляемость, беспокойство, повышение внутричерепного давления, тошнота, галлюцинации, головная боль, нарушение сознания, мышечный гипертонус, нарушение походки, депрессия, судороги, психотические реакции, суицидальные мысли, запор, тошнота, панкреатит, кандидоз, повышение артериального давления, рвота, цистит, повышение либидо, венозный тромбоз, тромбоэмболия и аллергические реакции.
Передозировка
Симптомы: усиление выраженности побочных действий, таких как утомляемость, слабость, диарея, спутанность сознания, сонливость, головокружение, ажитация, галлюцинации, нарушение походки, тошнота. В самом тяжелом случае передозировки (2000 мг мемантина) пациент выжил, при этом наблюдались побочные реакции со стороны нервной системы (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 (400 мг), пациент также выжил и выздоровел. Описаны побочные реакции со стороны ЦНС: беспокойство, психоз, зрительные галлюцинации, судорожная готовность, сонливость, ступор и потеря сознания. Лечение: симптоматическое. Специфический антидот препарата не существует. Необходимо проведение стандартных лечебных мероприятий, направленных на выведение активного вещества из желудка, например промывание желудка, прием активированного угля, подкисление мочи, возможно проведение форсированного диуреза.
Особые указания
Рекомендуется применять с осторожностью у пациентов с эпилепсией, судорогами в анамнезе или с предрасположенностью к эпилепсии. Следует избегать одновременного применения мемантина и других антагонистов NMDA-рецепторов, таких как амантадин, кетамин или декстрометорфан. Эти соединения воздействуют на ту же систему рецепторов, что и мемантин, следовательно нежелательные реакции (в основном связанные с ЦНС) могут возникать чаще и быть более выраженными. Наличие у пациента факторов, влияющих на повышение рН мочи (резкие изменения в питании, например переход с рациона, включающего продукты животного происхождения, к вегетарианской диете, или интенсивное потребление щелочных желудочных буферов), а также почечный канальцевый ацидоз или тяжелые инфекции мочевыводящих путей, вызванные Proteus spp., требуют тщательного наблюдения за состоянием пациента. Из большинства клинических исследовании пациенты с инфарктом миокарда в анамнезе, декомпенсированной ХСН (III–IV функциональный класс по классификации NYHA) или неконтролируемой артериальной гипертензией были исключены. Поэтому данные о применении мемантина у таких пациентов ограничены, прием препарата должен осуществляться под тщательным наблюдением врача. Влияние на способность управлять транспортными средствами и работать с 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 вызвать изменение скорости реакции, поэтому пациентам необходимо воздерживаться от управления автотранспортом или работы со сложными механизмами
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В клинических исследованиях общая частота развития побочных реакций не отличалась при приеме мемантина и плацебо. Как правило, они были от легкой до умеренной степени тяжести. Наиболее частыми побочными реакциями в группе мемантина по сравнению с 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%). Побочные эффекты представлены по классификации MedDRA. Инфекционные и паразитарные заболевания: редко - грибковые инфекции. Со стороны иммунной системы: часто - гиперчувствительность к компонентам препарата. Нарушения психики: часто - сонливость; нечасто - спутанность сознания, галлюцинации*; частота неизвестна - психотические реакции. Со стороны нервной системы: часто - головокружение, нарушение равновесия; нечасто - нарушение походки; очень редко - судороги. Со стороны сердца: нечасто - сердечная недостаточность. Со стороны сосудов: 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, рвота; частота неизвестна - панкреатит. Со стороны печени и желчевыводящих путей: часто - повышение активности печеночных ферментов; частота неизвестна - гепатит. Общие расстройства и нарушения в месте введения: часто - головная боль; нечасто - утомляемость. * Галлюцинации наблюдались главным образом у пациентов с болезнью Альцгеймера на стадии тяжелой деменции. 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 и аллергические реакции."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В связи с возможной задержкой внутриутробного развития препарат Марукса не применяется при беременности. Сведений о выделении мемантина с грудным молоком нет. Однако, учитывая липофильность мемантина, выделение возможно. Поэтому на время лечения препаратом Марукса грудное вскармливание необходимо прекратить."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, 1 раз в сутки и всегда в одно и тоже время, независимо от приема пищи. Терапия должна проводиться под контролем врача, имеющего опыт в вопросах диагностики и лечения деменции при болезни Альцгеймера. Терапию следует начинать только в том случае, если лицо, регулярно ухаживающее за пациентом, будет следить за приемом им лекарственного препарата. Диагноз должен быть поставлен в соответствии с действующими рекомендациями. Следует регулярно оценивать переносимость и дозу препарата Марукса, предпочтительно в течение 3 мес. после начала терапии. Затем следует регулярно оценивать клиническую эффективность лекарственного препарата и переносимость терапии в соответствии с действующими клиническими рекомендациями. Поддерживающую терапию можно продолжать неопределенно долго при наличии терапевтического эффекта и хорошей переносимости препарата Марукса. Следует прекратить применение препарата Марукса, если терапевтический эффект более не наблюдается или пациент не переносит терапию. С целью уменьшения риска развития побочных эффектов рекомендуется постепенное увеличение дозы: 5 мг/нед. в течение первых 3 нед. терапии. Рекомендуемая поддерживающая доза составляет 20 мг/сут. Рекомендуется следующий режим дозирования: 1-я нед. (1–7-й день): суточная доза - 5 мг (по 1⁄2 табл. Марукса 10 мг каждый день в течение 7 дней); 2-я нед. (8–14-й день): суточная доза - 10 мг (по 1 табл. Марукса 10 мг каждый день в течение 7 дней); 3-я нед. (15–21-й день): суточная доза - 15 мг (по 11⁄2 табл. Марукса 10 мг каждый день в течение 7 дней); начиная с 4-й нед.: суточная доза - 20 мг (2 табл. 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Инфекционные и паразитарные заболевания: редко - грибковые инфекции. Нарушения со стороны крови и лимфатической системы: частота неизвестна - агранулоцитоз, лейкопения (включая нейтропению), панцитопения, тромбоцитопения, тромбоцитопеническая пурпура. Нарушения со стороны иммунной системы: часто - гиперчувствительность к компонентам препарата. Нарушения психики: часто - сонливость; нечасто - спутанность сознания, галлюцинации; частота неизвестна - психотические реакции. Нарушения со стороны нервной системы: часто - головокружение, нарушение равновесия; нечасто - нарушение походки; очень редко - судороги. Нарушения со стороны сердца: нечасто - сердечная недостаточность. Нарушения со стороны сосудов: часто - повышение артериального давления; нечасто - венозный тромбоз/тромбоэмболия. Нарушения со стороны дыхательной системы, органов грудной клетки и средостения: часто - одышка. Нарушения со стороны желудочно-кишечного тракта: частота неизвестна - панкреатит. Нарушения со стороны печени и желчевыводящих путей: часто - повышение активности печеночных трансаминаз; частота неизвестна - гепатит. Нарушения со стороны почек и мочевыводящих путей: частота неизвестна - острая почечная недостаточность. Нарушения со стороны кожи и подкожных тканей: частота неизвестна - синдром Стивенса-Джонсона. Общие расстройства и нарушения в месте введения: часто - головная боль; нечасто - утомляемость. Галлюцинации наблюдались, главным образом, у пациентов с болезнью Альцгеймера на стадии тяжелой деменции. При пострегистрационном применении Маруксы сообщалось о возникновении следующих нежелательных реакций: головокружение, сонливость, повышенная возбудимость, повышенная утомляемость, беспокойство, повышение внутричерепного давления, тошнота, галлюцинации, головная боль, нарушение сознания, мышечный гипертонус, нарушение походки, депрессия, судороги, психотические реакции, суицидальные мысли, запор, тошнота, панкреатит, кандидоз, повышение артериального давления, рвота, цистит, повышение либидо, венозный тромбоз, тромбоэмболия и аллергические реакции."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: усиление выраженности побочных действий, таких как утомляемость, слабость, диарея, спутанность сознания, сонливость, головокружение, ажитация, галлюцинации, нарушение походки, тошнота. В самом тяжелом случае передозировки (2000 мг мемантина) пациент выжил, при этом наблюдались побочные реакции со стороны нервной системы (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 (400 мг), пациент также выжил и выздоровел. Описаны побочные реакции со стороны ЦНС: беспокойство, психоз, зрительные галлюцинации, судорожная готовность, сонливость, ступор и потеря сознания. Лечение: симптоматическое. Специфический антидот препарата не существует. Необходимо проведение стандартных лечебных мероприятий, направленных на выведение активного вещества из желудка, например промывание желудка, прием активированного угля, подкисление мочи, возможно проведение форсированного диуреза."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Рекомендуется применять с осторожностью у пациентов с эпилепсией, судорогами в анамнезе или с предрасположенностью к эпилепсии. Следует избегать одновременного применения мемантина и других антагонистов NMDA-рецепторов, таких как амантадин, кетамин или декстрометорфан. Эти соединения воздействуют на ту же систему рецепторов, что и мемантин, следовательно нежелательные реакции (в основном связанные с ЦНС) могут возникать чаще и быть более выраженными. Наличие у пациента факторов, влияющих на повышение рН мочи (резкие изменения в питании, например переход с рациона, включающего продукты животного происхождения, к вегетарианской диете, или интенсивное потребление щелочных желудочных буферов), а также почечный канальцевый ацидоз или тяжелые инфекции мочевыводящих путей, вызванные Proteus spp., требуют тщательного наблюдения за состоянием пациента. Из большинства клинических исследовании пациенты с инфарктом миокарда в анамнезе, декомпенсированной ХСН (III–IV функциональный класс по классификации NYHA) или неконтролируемой артериальной гипертензией были исключены. Поэтому данные о применении мемантина у таких пациентов ограничены, прием препарата должен осуществляться под тщательным наблюдением врача. Влияние на способность управлять транспортными средствами и работать с 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 вызвать изменение скорости реакции, поэтому пациентам необходимо воздерживаться от управления автотранспортом или работы со сложными механизмами"}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Ноотропное, нейрометаболическое","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":"Марукса - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/652/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/652/share_default/"}},"diseases":[{"id":"467","title":"Деменция при болезни Альцгеймера","slug":"467-dementsiya_pri_bolezni_altsgeymera"},{"id":"548","title":"Болезнь Альцгеймера","slug":"548-bolezn_altsgeymera"}],"other_packages":[{"id":100474,"title":"Марукса","subtitle":{"full":"Таблетки, 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