После приема внутрь рисперидон полностью абсорбируется из ЖКТ, Cmax в плазме достигается в пределах 1-2 ч. Пища не оказывает влияния на абсорбцию рисперидона.Css рисперидона в организме у большинства пациентов достигается в течение 1 дня. Css 9-гидроксирисперидона достигается в течение 4-5 дней. Концентрации рисперидона в плазме пропорциональны дозе (в диапазоне терапевтических доз). Рисперидон быстро распределяется в организме, Vd составляет 1-2 л/кг. В плазме рисперидон связывается с альбумином и альфа1 гликопротеином. Связывание рисперидона с белками плазмы составляет 88%, 9-гидроксирисперидона - на 77%. Рисперидон метаболизируется в печени при участии изофермента CYP2D6 с образованием 9-гидроксирисперидона, который обладает аналогичным рисперидону фармакологическим действием. Антипсихотическое действие обусловлено фармакологической активностью рисперидона и 9-гидроксирисперидона. Другим путем метаболизма рисперидона является N-дезалкилирование. После приема внутрь у больных с психозом T1/2 рисперидона из плазмы составляет 3 ч. T1/2 9-гидроксирисперидона и активной антипсихотической фракции составляет 24 ч. Через 1 неделю приема 70% выводится с мочой, 14% - с калом. В моче суммарное содержание рисперидона и 9-гидроксирисперидона составляет 35-45%. Остальное количество приходится на неактивные метаболиты. У пациентов пожилого возраста и у больных с почечной недостаточностью после однократного приема внутрь наблюдались повышенные концентрации в плазме и замедленное выведение рисперидона.
Показания к применению
Лечение шизофрении (в т.ч. впервые возникший острый психоз, острый приступ шизофрении, хроническая шизофрения) психотические состояния с выраженной продуктивной (галлюцинации, бред, расстройства мышления, враждебность, подозрительность) и/или негативной (притупленный аффект, эмоциональная и социальная отрешенность, скудость речи) симптоматикой для уменьшения аффективной симптоматики (депрессия, чувство вины, тревога) у пациентов с шизофренией профилактика рецидивов (острых психотических состояний) при хроническом течении шизофрении лечение поведенческих расстройств у пациентов с деменцией при проявлении симптомов агрессивности (вспышки гнева, физическое насилие), нарушениях психической деятельности (возбуждение, бред) или психотических симптомах лечение маний при биполярных расстройствах (как стабилизатор настроения в качестве средства вспомогательной терапии).
Противопоказания
Повышенная чувствительность к рисперидону.
Применение при беременности и в период грудного вскармливания
Применение при беременности возможно в случае, если ожидаемая польза терапии для матери превосходит потенциальный риск для плода. При необходимости применения в период лактации грудное вскармливание следует прекратить.
Побочное действие
Со стороны ЦНС: часто - бессонница, ажитация, тревога, головная боль . возможны - сонливость, утомляемость, головокружение, нарушение способности к концентрации внимания, нарушение четкости зрения . редко - экстрапирамидные симптомы, (в т.ч. тремор, ригидность, гиперсаливация, брадикинезия, акатизия, острая дистония). У больных с шизофренией возможны поздняя дискинезия, ЗНС, нарушения терморегуляции и судорожные припадки. Со стороны пищеварительной системы: запор, диспептические явления, тошнота, рвота, абдоминальные боли, повышение активности печеночных ферментов. Со стороны половой системы: приапизм, нарушения эрекции, нарушения эякуляции, нарушения оргазма. Со стороны сердечно-сосудистой системы: редко - ортостатическая гипотензия и рефлекторная тахикардия, артериальная гипертензия. Со стороны эндокринной системы: галакторея, гинекомастия, нарушения менструального цикла, аменорея, увеличение массы тела. Со стороны системы кроветворения: небольшое снижение количества нейтрофилов и/или тромбоцитов. Аллергические реакции: ринит, кожная сыпь, ангионевротический отек. Прочие: недержание мочи.
Особые указания
Со стороны ЦНС: часто - бессонница, ажитация, тревога, головная боль . возможны - сонливость, утомляемость, головокружение, нарушение способности к концентрации внимания, нарушение четкости зрения . редко - экстрапирамидные симптомы, (в т.ч. тремор, ригидность, гиперсаливация, брадикинезия, акатизия, острая дистония). У больных с шизофренией возможны поздняя дискинезия, ЗНС, нарушения терморегуляции и судорожные припадки. Со стороны пищеварительной системы: запор, диспептические явления, тошнота, рвота, абдоминальные боли, повышение активности печеночных ферментов. Со стороны половой системы: приапизм, нарушения эрекции, нарушения эякуляции, нарушения оргазма. Со стороны сердечно-сосудистой системы: редко - ортостатическая гипотензия и рефлекторная тахикардия, артериальная гипертензия. Со стороны эндокринной системы: галакторея, гинекомастия, нарушения менструального цикла, аменорея, увеличение массы тела. Со стороны системы кроветворения: небольшое снижение количества нейтрофилов и/или тромбоцитов. Аллергические реакции: ринит, кожная сыпь, ангионевротический отек. Прочие: недержание мочи.
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