- нарушения нервно-мышечного проведения (миастения gravis).
В анестезиологии и хирургии:
- в качестве антагониста недеполяризующих миорелаксантов;
- для лечения послеоперационных парезов тонкой кишки и мочевого пузыря.
В физиотерапии:
- для ионофореза при неврологических заболеваниях периферической нервной системы.
В токсикологии:
- при отравлении ингибиторами холинэстеразы.
Противопоказания
Повышенная индивидуальная чувствительность бронхиальная астма тяжелая сердечная недостаточность (III-IV группа по NYHA) брадикардия стенокардия атриовентрикулярная блокада артериальная гипертензия хроническая обструктивная болезнь легких эпилепсия гиперкинезы тяжелые нарушения функции печени (более 9 баллов по шкале Чайлд-Пью) механическая кишечная непроходимость почечная недостаточность (клиренс креатинина менее 9 мл/мин) механические нарушения проходимости мочевыводящих путей недавно перенесенное оперативное вмешательство на мочевыводящих путях или предстательной железе возраст до 1 года беременность и период грудного вскармливания.
С осторожностью
Печеночная и почечная недостаточность нарушение мочеиспускания оперативные вмешательства с применением общей анестезии (наркоза).
Применение при беременности и в период грудного вскармливания
Беременность
Нет достаточных клинических данных по безопасности применения галантамина во время беременности поэтому применение препарата противопоказано.
Период грудного вскармливания
Данных о секреции галантамина с грудным молоком нет поэтому применение препарата противопоказано в период кормления грудью.
Влияние на фертильность
Экспериментальные данные у животных не показали прямого или косвенного неблагоприятного действия галантамина на течение беременности эмбриональное фетальное и постнатальное развитие потомства.
Способ применения и дозы
Внутривенно подкожно.
Доза и продолжительность лечения галантамином устанавливаются врачом в зависимости от степени выраженности симптомов заболевания и индивидуальной реакции больного к проводимому лечению.
В неврологии по заявленным показаниям (см. раздел "Показания к применению" подраздел "В неврологии") галантамин в виде раствора для внутривенного и подкожного введения применяется для краткосрочного лечения в случае невозможности приема препарата внутрь. При первой возможности переходят на прием препарата внутрь.
Взрослым галантамин вводят подкожно обычно в дозе 003-028 мг/кг. Лечение начинают с минимальных доз которые постепенно увеличивают. Начальная доза - 25 мг в сутки. При необходимости возможно увеличение суточной дозы каждые 3-4 дня на 25 мг до максимальной суточной дозы 20 мг в 2-3 приема в равных дозах. Максимальная разовая доза для взрослых составляет 10 мг максимальная суточная доза - 20 мг.
Детям галантамин назначают подкожно согласно расчету на кг массы тела в следующих суточных дозах:
от 1 года до 2 лет - 025-10 мг (002-008 мг/кг);
старше 3-летнего возраста галантамин назначают в дозе 003-028 мг/кг или:
от 3 до 5 лет - 05-50 мг;
от 6 до 8 лет - 075-75 мг;
от 9 до 11 лет - 10-100 мг;
от 12 до 15 лет - 125-125 мг;
старше 15 лет - 125-150 мг
В анестезиологии хирургии и токсикологии галантамин назначают:
при передозировке периферическими недеполяризующими миорелаксантами внутривенно в дозе 10-20 мг в сутки;
- при послеоперационных парезах желудочно-кишечного тракта и мочевого пузыря подкожно или внутривенно в дозах согласно возрасту распределенных на 2-3 введения в сутки.
Взрослым лечение начинают с минимальных доз которые постепенно увеличивают. Начальная доза - 25 мг в сутки. При необходимости возможно увеличение суточной дозы каждые 3-4 дня на 25 мг до максимальной суточной дозы 20 мг в 2-3 приема в равных дозах. Максимальная разовая доза для взрослых составляет 10 мг максимальная суточная доза - 20 мг.
Детям галантамин назначают подкожно согласно расчету на кг массы тела в следующих суточных дозах: от 1 года до 2 лет - 025-10 мг (003-008 мг/кг);
старше 3-летнего возраста галантамин назначают в дозе 003-028 мг/кг или:
от 3 до 5 лет - 05-50 мг;
от 6 до 8 лет - 075-75 мг;
от 9 до 11 лет - 10-100 мг;
от 12 до 15 лет - 125-125 мг;
старше 15 лет и взрослые - 125-150 мг
В физиотерапии галантамин вводят методом ионофореза в дозе от 25 до 5 мг при величине электрического тока от 1 до 2 мА в течение 10 минут на протяжении 10-15 дней.
Пациенты с нарушением функции печени
У пациентов с умеренным нарушением функции печени (7-9 баллов по шкале Чайлд-Пью) возможно повышение концентрации галантамина в плазме крови поэтому рекомендуется снизить суточную дозу до 15 мг. У пациентов с тяжелым нарушением функции печени (более 9 баллов по шкале Чайлд-Пью) применение препарата противопоказано.
Пациенты с нарушением функции почек
У пациентов с умеренным нарушением функции почек суточная доза препарата не должна превышать 15 мг. У пациентов с тяжелым нарушением функции почек (клиренс креатинина менее 10 мл/мин) применение препарата противопоказано.
Побочное действие
Нежелательные реакции классифицированы по частоте и по системноорганным классам MedDRA: 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 неизвестна (не может быть оценена при помощи доступных данных).
Наиболее распространенные нежелательные реакции связаны с фармакодинамическими эффектами галантамина и опосредованы никотиновыми и мускариновыми эффектами характерными для ингибиторов холинэстеразы.
Часто: боль в животе диарея диспепсия дискомфорт в желудке и кишечнике;
Нечасто: рвота;
Неизвестная частота: усиление перистальтики.
Нарушения со стороны печени и желчевыводящих путей:
Редко: гепатит.
Нарушения со стороны кожи и подкожных тканей:
Часто: повышенная потливость.
Нарушения со стороны скелетно-мышечной и соединительной ткани:
Часто: мышечные спазмы;
Нечасто: мышечная слабость.
Общие расстройства и нарушения в месте введения:
Часто: астения повышенная утомляемость слабость;
Частота неизвестна: боли в месте инъекции возможны местные реакции при парентеральном введении.
Лабораторные и инструментальные данные:
Часто: снижение веса;
Нечасто: повышение активности "печеночных" трансаминаз.
Травмы интоксикации и осложнения манипуляций:
Часто: падения.
Передозировка
Симптомы при передозировке галантамином: тошнота рвота коликообразные боли (спазмы) в животе диарея усиленное слюноотделение слезотечение недержание мочи и кала сильная потливость снижение артериального давления удлинение интервала QT брадикардия бронхоспазм мышечная слабость в более тяжелых случаях - судороги и кома. Выраженная мышечная слабость в сочетании с гиперсекрецией слизистой оболочки трахеи и бронхоспазмом может привести к полной блокаде дыхательных путей.
Лечение: симптоматическая терапия контроль функции дыхательной и сердечно-сосудистой систем. В качестве антидота можно использовать атропин в дозе 05-10 мг внутривенно; дозу можно ввести повторно в зависимости от клинической картины.
Взаимодействие с другими лекарственными средствами
Является слабым антагонистом морфина и его структурных аналогов. Галантамин не только не ослабляет но напротив усиливает действие миорелаксантов деполяризующего типа (суксаметония йодида и др.). Одновременное применение ряда антиаритмиков (хинидин) антидепрессантов (пароксетин флуоксетин амитриптилин) противогрибковых (кетоконазол) противовирусных (зидовудин) антибактериальных (эритромицин) средств которые подавляют изоферменты CYP2D6 и CYP3A4 цитохрома Р450 участвующие в метаболизме галантамина может привести к увеличению его концентрации в сыворотке крови в результате чего может повышаться частота холинергических побочных эффектов (главным образом тошноты и рвоты). AUC галантамина увеличивается на 30-40 % при одновременном применении его с кетоконазолом и пароксетином соответственно. При одновременном применении с эритромицином AUC галантамина возрастает на 10%. Ингибиторы изофермента CYP2D6 (амитриптилин флуоксетин флувоксамин хинидин) снижают клиренс галантамина на 25-33 %. В этом случае в зависимости от переносимости терапии конкретным пациентом может понадобиться снижение поддерживающей дозы галантамина.
Между галантамином и м-холиноблокаторами (атропин гоматропин) ганглиоблокаторами (гексаметония бензолсульфонат азаметония бромид пахикарпина гидройодид) недеполяризующими миорелаксантами (тубокурарина хлорид и др.) хинином и прокаинамидом возможен антагонизм. Аминогликозидные антибиотики (гентамицин амикацин) могут снижать терапевтический эффект галантамина.
При комбинации галантамина с лекарственными средствами снижающими частоту сердечных сокращений (β-адреноблокаторы дигоксин) возрастает риск усугубления брадикардии.
Циметидин может повышать биодоступность галантамина.
Галантамин усиливает угнетающее действие на центральную нервную систему этанола и седативных средств.
При одновременном применении галантамина с другими холиномиметиками (такими как донепизил неостигмин пиридостигмин пилокарпин) может наблюдаться усиление холиномиметического действия поэтому не рекомендуется их одновременное применение. Галантамин не оказывает влияния на фармакокинетику варфарина.
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мл."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Бесцветная прозрачная жидкость"}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"В неврологии:"}},{"type":"paragraph","data":{"text":"- заболевания периферической нервной системы (неврит полиневрит полиневропатия);"}},{"type":"paragraph","data":{"text":"- состояния связанные с повреждениями передних рогов спинного мозга (после полиомиелита миелита спинальной мышечной атрофии);"}},{"type":"paragraph","data":{"text":"- церебральный паралич (остаточные явления перенесенного инсульта детский церебральный паралич (спастические формы));"}},{"type":"paragraph","data":{"text":"- нарушения нервно-мышечного проведения (миастения gravis)."}},{"type":"paragraph","data":{"text":"В анестезиологии и хирургии:"}},{"type":"paragraph","data":{"text":"- в качестве антагониста недеполяризующих миорелаксантов;"}},{"type":"paragraph","data":{"text":"- для лечения послеоперационных парезов тонкой кишки и мочевого пузыря."}},{"type":"paragraph","data":{"text":"В физиотерапии:"}},{"type":"paragraph","data":{"text":"- для ионофореза при неврологических заболеваниях периферической нервной системы."}},{"type":"paragraph","data":{"text":"В токсикологии:"}},{"type":"paragraph","data":{"text":"- при отравлении ингибиторами холинэстеразы."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная индивидуальная чувствительность бронхиальная астма тяжелая сердечная недостаточность (III-IV группа по NYHA) брадикардия стенокардия атриовентрикулярная блокада артериальная гипертензия хроническая обструктивная болезнь легких эпилепсия гиперкинезы тяжелые нарушения функции печени (более 9 баллов по шкале Чайлд-Пью) механическая кишечная непроходимость почечная недостаточность (клиренс креатинина менее 9 мл/мин) механические нарушения проходимости мочевыводящих путей недавно перенесенное оперативное вмешательство на мочевыводящих путях или предстательной железе возраст до 1 года беременность и период грудного вскармливания."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Печеночная и почечная недостаточность нарушение мочеиспускания оперативные вмешательства с применением общей анестезии (наркоза)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Беременность"}},{"type":"paragraph","data":{"text":"Нет достаточных клинических данных по безопасности применения галантамина во время беременности поэтому применение препарата противопоказано."}},{"type":"paragraph","data":{"text":"Период грудного вскармливания"}},{"type":"paragraph","data":{"text":"Данных о секреции галантамина с грудным молоком нет поэтому применение препарата противопоказано в период кормления грудью."}},{"type":"paragraph","data":{"text":"Влияние на фертильность"}},{"type":"paragraph","data":{"text":"Экспериментальные данные у животных не показали прямого или косвенного неблагоприятного действия галантамина на течение беременности эмбриональное фетальное и постнатальное развитие потомства."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутривенно подкожно."}},{"type":"paragraph","data":{"text":"Доза и продолжительность лечения галантамином устанавливаются врачом в зависимости от степени выраженности симптомов заболевания и индивидуальной реакции больного к проводимому лечению."}},{"type":"paragraph","data":{"text":"В неврологии по заявленным показаниям (см. раздел \"Показания к применению\" подраздел \"В неврологии\") галантамин в виде раствора для внутривенного и подкожного введения применяется для краткосрочного лечения в случае невозможности приема препарата внутрь. При первой возможности переходят на прием препарата внутрь."}},{"type":"paragraph","data":{"text":"Взрослым галантамин вводят подкожно обычно в дозе 003-028 мг/кг. Лечение начинают с минимальных доз которые постепенно увеличивают. Начальная доза - 25 мг в сутки. При необходимости возможно увеличение суточной дозы каждые 3-4 дня на 25 мг до максимальной суточной дозы 20 мг в 2-3 приема в равных дозах. Максимальная разовая доза для взрослых составляет 10 мг максимальная суточная доза - 20 мг."}},{"type":"paragraph","data":{"text":"Детям галантамин назначают подкожно согласно расчету на кг массы тела в следующих суточных дозах:"}},{"type":"paragraph","data":{"text":"от 1 года до 2 лет - 025-10 мг (002-008 мг/кг);"}},{"type":"paragraph","data":{"text":"старше 3-летнего возраста галантамин назначают в дозе 003-028 мг/кг или:"}},{"type":"paragraph","data":{"text":"от 3 до 5 лет - 05-50 мг;"}},{"type":"paragraph","data":{"text":"от 6 до 8 лет - 075-75 мг;"}},{"type":"paragraph","data":{"text":"от 9 до 11 лет - 10-100 мг;"}},{"type":"paragraph","data":{"text":"от 12 до 15 лет - 125-125 мг;"}},{"type":"paragraph","data":{"text":"старше 15 лет - 125-150 мг"}},{"type":"paragraph","data":{"text":"В анестезиологии хирургии и токсикологии галантамин назначают:"}},{"type":"paragraph","data":{"text":"при передозировке периферическими недеполяризующими миорелаксантами внутривенно в дозе 10-20 мг в сутки;"}},{"type":"paragraph","data":{"text":"- при послеоперационных парезах желудочно-кишечного тракта и мочевого пузыря подкожно или внутривенно в дозах согласно возрасту распределенных на 2-3 введения в сутки."}},{"type":"paragraph","data":{"text":"Взрослым лечение начинают с минимальных доз которые постепенно увеличивают. Начальная доза - 25 мг в сутки. При необходимости возможно увеличение суточной дозы каждые 3-4 дня на 25 мг до максимальной суточной дозы 20 мг в 2-3 приема в равных дозах. Максимальная разовая доза для взрослых составляет 10 мг максимальная суточная доза - 20 мг."}},{"type":"paragraph","data":{"text":"Детям галантамин назначают подкожно согласно расчету на кг массы тела в следующих суточных дозах: от 1 года до 2 лет - 025-10 мг (003-008 мг/кг);"}},{"type":"paragraph","data":{"text":"старше 3-летнего возраста галантамин назначают в дозе 003-028 мг/кг или:"}},{"type":"paragraph","data":{"text":"от 3 до 5 лет - 05-50 мг;"}},{"type":"paragraph","data":{"text":"от 6 до 8 лет - 075-75 мг;"}},{"type":"paragraph","data":{"text":"от 9 до 11 лет - 10-100 мг;"}},{"type":"paragraph","data":{"text":"от 12 до 15 лет - 125-125 мг;"}},{"type":"paragraph","data":{"text":"старше 15 лет и взрослые - 125-150 мг"}},{"type":"paragraph","data":{"text":"В физиотерапии галантамин вводят методом ионофореза в дозе от 25 до 5 мг при величине электрического тока от 1 до 2 мА в течение 10 минут на протяжении 10-15 дней."}},{"type":"paragraph","data":{"text":"Пациенты с нарушением функции печени"}},{"type":"paragraph","data":{"text":"У пациентов с умеренным нарушением функции печени (7-9 баллов по шкале Чайлд-Пью) возможно повышение концентрации галантамина в плазме крови поэтому рекомендуется снизить суточную дозу до 15 мг. У пациентов с тяжелым нарушением функции печени (более 9 баллов по шкале Чайлд-Пью) применение препарата противопоказано."}},{"type":"paragraph","data":{"text":"Пациенты с нарушением функции почек"}},{"type":"paragraph","data":{"text":"У пациентов с умеренным нарушением функции почек суточная доза препарата не должна превышать 15 мг. У пациентов с тяжелым нарушением функции почек (клиренс креатинина менее 10 мл/мин) применение препарата противопоказано."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Нежелательные реакции классифицированы по частоте и по системноорганным классам MedDRA: 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 неизвестна (не может быть оценена при помощи доступных данных)."}},{"type":"paragraph","data":{"text":"Наиболее распространенные нежелательные реакции связаны с фармакодинамическими эффектами галантамина и опосредованы никотиновыми и мускариновыми эффектами характерными для ингибиторов холинэстеразы."}},{"type":"paragraph","data":{"text":"Нарушения метаболизма и питания:"}},{"type":"paragraph","data":{"text":"Часто: потеря аппетита анорексия;"}},{"type":"paragraph","data":{"text":"Нечасто: дегидратация."}},{"type":"paragraph","data":{"text":"Психические нарушения:"}},{"type":"paragraph","data":{"text":"Часто: галлюцинации депрессия;"}},{"type":"paragraph","data":{"text":"Нечасто: зрительные и слуховые галлюцинации."}},{"type":"paragraph","data":{"text":"Нарушения со стороны центральной нервной системы:"}},{"type":"paragraph","data":{"text":"Часто: головокружение сонливость обморок тремор головная боль вялость;"}},{"type":"paragraph","data":{"text":"Нечасто: парестезии дисгевзия гиперсомния."}},{"type":"paragraph","data":{"text":"Нарушения со стороны органа зрения:"}},{"type":"paragraph","data":{"text":"Нечасто: нарушение зрения."}},{"type":"paragraph","data":{"text":"Нарушения со стороны уха и лабиринта:"}},{"type":"paragraph","data":{"text":"Нечасто: шум в ушах."}},{"type":"paragraph","data":{"text":"Нарушения со стороны сердца:"}},{"type":"paragraph","data":{"text":"Часто: брадикардия;"}},{"type":"paragraph","data":{"text":"Нечасто: суправентрикулярная экстрасистолия атриовентрикулярная блокада синусовая брадикардия ощущение сердцебиения."}},{"type":"paragraph","data":{"text":"Нарушения со стороны сосудов:"}},{"type":"paragraph","data":{"text":"Часто: повышение артериального давления;"}},{"type":"paragraph","data":{"text":"Нечасто: снижение артериального давления приливы."}},{"type":"paragraph","data":{"text":"Нарушения со стороны желудочно-кишечного тракта:"}},{"type":"paragraph","data":{"text":"Очень часто: тошнота рвота;"}},{"type":"paragraph","data":{"text":"Часто: боль в животе диарея диспепсия дискомфорт в желудке и кишечнике;"}},{"type":"paragraph","data":{"text":"Нечасто: рвота;"}},{"type":"paragraph","data":{"text":"Неизвестная частота: усиление перистальтики."}},{"type":"paragraph","data":{"text":"Нарушения со стороны печени и желчевыводящих путей:"}},{"type":"paragraph","data":{"text":"Редко: гепатит."}},{"type":"paragraph","data":{"text":"Нарушения со стороны кожи и подкожных тканей:"}},{"type":"paragraph","data":{"text":"Часто: повышенная потливость."}},{"type":"paragraph","data":{"text":"Нарушения со стороны скелетно-мышечной и соединительной ткани:"}},{"type":"paragraph","data":{"text":"Часто: мышечные спазмы;"}},{"type":"paragraph","data":{"text":"Нечасто: мышечная слабость."}},{"type":"paragraph","data":{"text":"Общие расстройства и нарушения в месте введения:"}},{"type":"paragraph","data":{"text":"Часто: астения повышенная утомляемость слабость;"}},{"type":"paragraph","data":{"text":"Частота неизвестна: боли в месте инъекции возможны местные реакции при парентеральном введении."}},{"type":"paragraph","data":{"text":"Лабораторные и инструментальные данные:"}},{"type":"paragraph","data":{"text":"Часто: снижение веса;"}},{"type":"paragraph","data":{"text":"Нечасто: повышение активности \"печеночных\" трансаминаз."}},{"type":"paragraph","data":{"text":"Травмы интоксикации и осложнения манипуляций:"}},{"type":"paragraph","data":{"text":"Часто: падения."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы при передозировке галантамином: тошнота рвота коликообразные боли (спазмы) в животе диарея усиленное слюноотделение слезотечение недержание мочи и кала сильная потливость снижение артериального давления удлинение интервала QT брадикардия бронхоспазм мышечная слабость в более тяжелых случаях - судороги и кома. Выраженная мышечная слабость в сочетании с гиперсекрецией слизистой оболочки трахеи и бронхоспазмом может привести к полной блокаде дыхательных путей."}},{"type":"paragraph","data":{"text":"Лечение: симптоматическая терапия контроль функции дыхательной и сердечно-сосудистой систем. В качестве антидота можно использовать атропин в дозе 05-10 мг внутривенно; дозу можно ввести повторно в зависимости от клинической картины."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Является слабым антагонистом морфина и его структурных аналогов. Галантамин не только не ослабляет но напротив усиливает действие миорелаксантов деполяризующего типа (суксаметония йодида и др.). Одновременное применение ряда антиаритмиков (хинидин) антидепрессантов (пароксетин флуоксетин амитриптилин) противогрибковых (кетоконазол) противовирусных (зидовудин) антибактериальных (эритромицин) средств которые подавляют изоферменты CYP2D6 и CYP3A4 цитохрома Р450 участвующие в метаболизме галантамина может привести к увеличению его концентрации в сыворотке крови в результате чего может повышаться частота холинергических побочных эффектов (главным образом тошноты и рвоты). AUC галантамина увеличивается на 30-40 % при одновременном применении его с кетоконазолом и пароксетином соответственно. При одновременном применении с эритромицином AUC галантамина возрастает на 10%. Ингибиторы изофермента CYP2D6 (амитриптилин флуоксетин флувоксамин хинидин) снижают клиренс галантамина на 25-33 %. В этом случае в зависимости от переносимости терапии конкретным пациентом может понадобиться снижение поддерживающей дозы галантамина."}},{"type":"paragraph","data":{"text":"Между галантамином и м-холиноблокаторами (атропин гоматропин) ганглиоблокаторами (гексаметония бензолсульфонат азаметония бромид пахикарпина гидройодид) недеполяризующими миорелаксантами (тубокурарина хлорид и др.) хинином и прокаинамидом возможен антагонизм. Аминогликозидные антибиотики (гентамицин амикацин) могут снижать терапевтический эффект галантамина."}},{"type":"paragraph","data":{"text":"При комбинации галантамина с лекарственными средствами снижающими частоту сердечных сокращений (β-адреноблокаторы дигоксин) возрастает риск усугубления брадикардии."}},{"type":"paragraph","data":{"text":"Циметидин может повышать биодоступность галантамина."}},{"type":"paragraph","data":{"text":"Галантамин усиливает угнетающее действие на центральную нервную систему этанола и седативных средств."}},{"type":"paragraph","data":{"text":"При одновременном применении галантамина с другими холиномиметиками (такими как донепизил неостигмин пиридостигмин пилокарпин) может наблюдаться усиление холиномиметического действия поэтому не рекомендуется их одновременное применение. 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