симптоматическое лечение синдрома деменции (в т. ч. первичная дегенеративная деменция, сосудистая деменция и смешанные формы), сопровождающегося нарушениями памяти, мышления, способности к концентрации внимания, быстрой утомляемостью, недостаточностью побуждений и мотивации, аффективными расстройствами; - первичная дегенеративная деменция, сосудистая деменция и смешанные формы; - симптоматическая терапия хронических нарушений умственной работоспособности; - посттравматическая энцефалопатия; - церебральный атеросклероз; - последствия энцефалита; - задержка психического развития; - цереброастенический синдром у детей; - энцефалопатия у детей.
Противопоказания
Абсолютные противопоказания- повышенная чувствительность к пиритинолу. Относительные противопоказания- заболевания почек в анамнезе; - выраженные нарушения функции печени; - выраженные изменения картины периферической крови; - острые аутоиммунные заболевания (в т. ч. системная красная волчанка); - миастения; - пемфигус.
Действующее вещество: ПиритинолКонцентрация действующего вещества (мг): 80,5 мг
Фармакологические свойства
Ноотропный препарат. Повышает патологически сниженный метаболизм в тканях головного мозга, что обусловлено повышением захвата и утилизации глюкозы, повышает метаболизм нуклеиновых кислот и высвобождение ацетилхолина в синапсах нервных клеток, улучшает холинергическую передачу в нервной ткани. Пиритинол способствует стабилизации структуры клеточных мембран нейронов и их функции за счет ингибирования лизосомальных ферментов, предотвращая этим образование свободных радикалов. Энцефабол улучшает реологические свойства крови, повышает пластичность эритроцитов путем увеличения содержания АТФ в их мембране, что приводит к снижению вязкости крови и улучшению кровотока. Улучшает кровообращение в ишемизированных участках мозга, увеличивает их оксигенацию, интенсифицирует обмен глюкозы в первично ишемизированных участках мозга. В результате улучшаются показатели памяти и восстанавливаются нарушенные обменные процессы в нервной ткани, что способствует полноценному функционированию ее клеток.
Показания к применению
симптоматическое лечение синдрома деменции (в т. ч. первичная дегенеративная деменция, сосудистая деменция и смешанные формы), сопровождающегося нарушениями памяти, мышления, способности к концентрации внимания, быстрой утомляемостью, недостаточностью побуждений и мотивации, аффективными расстройствами; - первичная дегенеративная деменция, сосудистая деменция и смешанные формы; - симптоматическая терапия хронических нарушений умственной работоспособности; - посттравматическая энцефалопатия; - церебральный атеросклероз; - последствия энцефалита; - задержка психического развития; - цереброастенический синдром у детей; - энцефалопатия у детей.
Противопоказания
Абсолютные противопоказания- повышенная чувствительность к пиритинолу. Относительные противопоказания- заболевания почек в анамнезе; - выраженные нарушения функции печени; - выраженные изменения картины периферической крови; - острые аутоиммунные заболевания (в т. ч. системная красная волчанка); - миастения; - пемфигус.
Применение при беременности и в период грудного вскармливания
При необходимости применения Энцефабола при беременности или в период лактации (грудного вскармливания) следует соотнести предполагаемую пользу для матери и потенциальный риск для плода или младенца. Пиритинол проникает через плацентарный барьер, в незначительных количествах выделяется с грудным молоком. В экспериментальных исследованиях не установлено наличия тератогенного или эмбриотоксического действия пиритинола.
Способ применения и дозы
Режим дозирования устанавливают индивидуально, в зависимости от тяжести состояния и эффективности терапии. Для взрослых средняя доза составляет 600 мг/сут (по 2 таб. или по 10 мл суспензии 3 раза/сут). Новорожденным Энцефабол назначают с 3 дня после рождения по 20 мг (1 мл суспензии) в сутки в течение месяца, препарат следует давать утром. Детям в возрасте от 2 месяцев дозу увеличивают на 20 мг (1 мл) каждую неделю до тех пор, пока суточная доза не достигнет 100 мг (5 мл суспензии). Детям в возрасте от 1 года до 7 лет назначают в суточной дозе от 50 мг до 300 мг в зависимости от показаний (по 2. 5-5 мл суспензии 1-3 раза/сут). Для детей старше 7 лет суточная доза составляет от 50 мг до 600 мг (по 2. 5-10 мл суспензии или 1-2 таб. 1-3 раза/сут). Принимать препарат следует во время или после еды. При нарушениях сна последнюю дневную дозу не следует принимать вечером или на ночь. Следует учитывать, что в 1 чайной ложке - 5 мл суспензии. Длительность лечения зависит от клинической картины заболевания. При острых состояниях и назначении препарата в высоких дозах заметный терапевтический эффект достигается уже через несколько часов или суток. При хронических заболеваниях (в т. ч. последствия черепно-мозговой травмы или при деменции) заметный терапевтический успех достигается после 2-4 недель лечения. Оптимальный и устойчивый эффект наступает обычно через 6-12 недель. Длительность лечения при хронических заболеваниях должна составлять не менее 8 недель. У новорожденных с высоким риском развития перинатальной патологии средняя продолжительность лечения составляет 6 месяцев, при этом через 3 месяца следует проверить наличие показаний для дальнейшего лечения.
Побочное действие
Со стороны пищеварительной системы: возможны тошнота, рвота, диарея; редко - потеря аппетита, изменение вкусовой чувствительности, нарушение функции печени (повышение уровня трансаминаз, холестаз). Со стороны ЦНС: возможны нарушения сна; редко - повышенная возбудимость, головная боль, головокружение, утомляемость. Прочие: возможны аллергические реакции различной степени тяжести, проявляющиеся обычно в виде высыпаний на коже или слизистых оболочках, зуд, повышение температуры тела. При применении препарата по показаниям в рекомендуемых дозах развитие побочных эффектов маловероятно.
Передозировка
Симптомы: усиление побочных эффектов. Лечение: промывание желудка, назначение активированного угля. При необходимости проводят симптоматическую терапию.
Особые указания
У пациентов с ревматоидным артритом и другими хроническими заболеваниями суставов имеет место повышенная чувствительность к соединениям, в состав которых входит SH-группа, в т.ч. к пиритинолу. У этих пациентов повышен риск возникновения реакций повышенной чувствительности, иммунопатологических реакций, а также нарушений вкусовой чувствительности и функции печени. При проведении лечения этой категории пациентов необходим систематический контроль общих анализов крови, мочи, функционального состояния печени, иммунологических показателей. Не следует назначать суспензию Энцефабола пациентам с непереносимостью фруктозы, т.к. в состав препарата входит сорбол. Реакции повышенной чувствительности к препарату могут возникнуть у пациентов с гиперчувствительностью к D-пеницилламину, поскольку последний имеет сходство с пиритинолом по химическому строению (тиоловые группы). Влияние на способность к вождению автотранспорта и управлению механизмамиПри использовании Энцефабола по показаниям, как правило, отсутствуют ограничения для тех видов деятельности, которые требуют повышенного внимания, быстрых психомоторных реакций. Однако учитывая вероятность индивидуальных различий реакции отдельных пациентов на препарат, в начале лечения и при повышении дозы следует учитывать возможность нарушения скорости психомоторных реакций.
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