Рисперидон является антипсихотическим средством, оказывает т... Инструкция
Показания к применению
шизофрения (острая и хроническая) и другие психотические состояния с продуктивной и/или негативной симптоматикой;
злоупотребление ЛС или лекарственная зависимость;
в качестве вспомогательной терапии: при лечении маний при биполярных расстройствах, расстройств поведения у подростков с 15 лет и взрослых пациентов со сниженным интеллектуальным уровнем или ...
Рисперидон является антипсихотическим средством, оказывает также седативное, противорвотное и гипотермическое действие. Рисперидон Органика является селективным антагонистом 5-НТ2-серотониновых и дофаминовых D2-рецепторов, связывается также с альфа1-адренорецепторами и при несколько меньшей афинности с Н1-гистаминовыми и альфа2-адренорецепторами. Не обладает тропностью к холинорецепторам. Антипсихотическое действие обусловлено блокадой дофаминовых D2-рецепторов мезолимбической и мезокортикальной системы. Седативное действие обусловлено блокадой адренорецепторов ретикулярной формации ствола головного мозга; противорвотное действие — блокадой дофаминовых D2-рецепторов триггерной зоны рвотного центра; гипотермическое действие — блокадой дофаминовых рецепторов гипоталамуса. Снижает продуктивную симптоматику шизофрении (бред, галлюцинации), агрессивность, автоматизм. Вызывает меньшее подавление двигательной активности и в меньшей степени индуцирует каталепсию, чем классические нейролептики (антипсихотические ЛС). Сбалансированный центральный антагонизм к серотонину и дофамину может уменьшать риск возникновения экстрапирамидной симптоматики и расширять терапевтическое воздействие препарата с охватом негативных и аффективных симптомов шизофрении. Рисперидон Органика может вызывать дозозависимое увеличение концентрации пролактина в плазме.
Фармакокинетика
При приеме внутрь рисперидон полностью всасывается (независимо от приема пищи) и Cmax в плазме крови достигается через 1–2 ч.Рисперидон подвергается метаболизму изоферментом CYP2D6 с образованием 9-гидроксирисперидона, который обладает аналогичным фармакологическим действием. Рисперидон и 9-гидроксирисперидон представляют собой эффективную антипсихотическую фракцию. Дальнейший метаболизм рисперидона заключается в N-дезалкилировании. При приеме внутрь рисперидон выводится с T1/2 около 3 ч. Установлено, что T1/2 9-гидроксирисперидона и активной антипсихотической фракции составляет 24 ч. У большинства пациентов Css рисперидона наблюдается через 1 день после начала лечения. Равновесное состояние 9-гидроксирисперидона в большинстве случаев достигается через 3–4 дня после начала лечения. Концентрация рисперидона в плазме пропорциональна дозе препарата (в пределах терапевтических доз). Рисперидон быстро распределяется в организме. Vd составляет 1–2 л/кг. В плазме рисперидон связан с альбумином и кислым ?1-гликопротеином.Фракция рисперидона и 9-гидроксирисперидона, которая связана белками плазмы, составляет 88 и 77% соответственно. Выводится почками — 70% (из них 35–45% — в виде фармакологически активной фракции) и 14% — с желчью. Остальное количество составляют неактивные метаболиты.Фармакокинетика в особых клинических случаях. У пожилых пациентов, а также у пациентов с почечной недостаточностью концентрация препарата в плазме увеличивается, а T1/2 возрастает. Концентрация рисперидона в плазме у пациентов с печеночной недостаточностью не изменяется.
Показания к применению
шизофрения (острая и хроническая) и другие психотические состояния с продуктивной и/или негативной симптоматикой;
злоупотребление ЛС или лекарственная зависимость;
в качестве вспомогательной терапии: при лечении маний при биполярных расстройствах, расстройств поведения у подростков с 15 лет и взрослых пациентов со сниженным интеллектуальным уровнем или задержкой умственного развития, в случаях, если деструктивное поведение (агрессивность, импульсивность, аутоагрессия) является ведущим в клинической картине болезни.
Противопоказания
повышенная чувствительность к компонентам препарата;
детский возраст младше 15 лет (из-за отсутствия сведений по использованию для лечения шизофрении у детей младше 15 лет);
период лактации.
Способ применения и дозы
Внутрь.
Шизофрения
Взрослые и дети старше 15 лет. Рисперидон Органика может назначаться 1 или 2 раза в сутки. Начальная доза — 2 мг/сут. На второй день дозу следует увеличить до 4 мг/сут. С этого момента дозу можно либо сохранить на прежнем уровне, либо при необходимости скорректировать индивидуально. Обычно оптимальной дозой является 4–6 мг/сут. В ряде случаев может быть оправдано более медленное повышение дозы и более низкие начальная и поддерживающая дозы. Дозы выше 10 мг/сут не показали более высокой эффективности по сравнению с меньшими дозами, но могут вызвать появление экстрапирамидных симптомов. В связи с тем, что безопасность доз выше 16 мг/сут не изучалась, дозы выше этого уровня применять нельзя.
Злоупотребление ЛС или лекарственная зависимость
Рекомендуемая суточная доза препарата — 2–4 мг.
Побочное действие
Инфекции: очень часто — инфекции мочевыводящих путей у пожилых пациентов с деменцией; часто — назофарингит, инфекции верхних дыхательных путей, синусит, инфекции мочевыводящих путей, у пожилых пациентов с деменцией — пневмония, флегмона, ринит, гриппоподобные заболевания; нечасто — инфекции уха, вирусные инфекции, фарингит, тонзиллит, бронхит, инфекции глаз, локализованные инфекции, цистит, онихомикоз, акродерматит, бронхопневмония, инфекции дыхательных путей, трахеобронхит.
Со стороны ЦНС: очень часто — головная боль, бессонница, паркинсонизм, включая экстрапирамидные симптомы (тремор, ригидность, гиперсаливация, брадикинезия, акатизия, острая дистония); часто — головокружение, сонливость, неясность зрения; нечасто — снижение способности к концентрации внимания, повышенная утомляемость; очень редко — мания или гипомания, ажитация, тревожность, инсульт у пожилых больных с предрасполагающими факторами. У больных шизофренией нечасто — гиперволемия (либо из-за полидипсии, либо из-за синдрома неадекватной секреции антидиуретического гормона), поздняя дискинезия (непроизвольные ритмические сокращения преимущественно мышц языка и/или лица); редко — злокачественный нейролептический синдром (гипертермия, мышечная ригидность, нестабильность автономных функций (профузное потоотделение, тахикардия и другие нарушения ритма сердца, колебания АД, бледность кожи, одышка, нарушение мочеиспускания), нарушение сознания и повышение активности КФК)
Взаимодействие с другими лекарственными средствами
С учетом того что Рисперидон Органика оказывает действие в первую очередь на ЦНС, его следует применять с осторожностью в сочетании с другими препаратами центрального действия и сочетать с алкоголем.
Рисперидон Органика уменьшает эффективность леводопы и других агонистов дофаминовых рецепторов.
Клозапин снижает клиренс Рисперидона Органика.
При использовании карбамазепина отмечалось снижение концентрации активной антипсихотической фракции Рисперидона Органика в плазме (аналогичные эффекты могут наблюдаться при применении других индукторов микросомальных ферментов печени).
Производные фенотиазина, трициклические антидепрессанты и некоторые бета-адреноблокаторы могут повышать концентрации Рисперидона Органика в плазме, однако это не влияет на концентрацию активной антипсихотической фракции.
Особые указания
Влияние на способность к вождению автотранспорта и управлению механизмами. Во время лечения необходимо воздержаться от занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций
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препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Рисперидон"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки, покрытые пленочной оболочкой"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"рисперидон 4 мг"}},{"type":"paragraph","data":{"text":"вспомогательные вещества: крахмал кукурузный прежелатинизированный (крахмал 1500) — 86,6 мг; кремния диоксид коллоидный (аэросил) — 1 мг; магния стеарата моногидрат — 0,6 мг; стеариновая кислота — 1,2 мг; МКЦ — 86,6 мг; Opadry II белый (спирт поливиниловый — 4 мг, тальк — 1,48 мг, макрогол (полиэтиленгликоль) — 2,02 мг, титана диоксид — 2,5 мг) — 10 мг"}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Антипсихотическое средство (нейролептик)"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика","level":3}},{"type":"paragraph","data":{"text":"Рисперидон является антипсихотическим средством, оказывает также седативное, противорвотное и гипотермическое действие. Рисперидон Органика является селективным антагонистом 5-НТ2-серотониновых и дофаминовых D2-рецепторов, связывается также с альфа1-адренорецепторами и при несколько меньшей афинности с Н1-гистаминовыми и альфа2-адренорецепторами. Не обладает тропностью к холинорецепторам. Антипсихотическое действие обусловлено блокадой дофаминовых D2-рецепторов мезолимбической и мезокортикальной системы. Седативное действие обусловлено блокадой адренорецепторов ретикулярной формации ствола головного мозга; противорвотное действие — блокадой дофаминовых D2-рецепторов триггерной зоны рвотного центра; гипотермическое действие — блокадой дофаминовых рецепторов гипоталамуса. Снижает продуктивную симптоматику шизофрении (бред, галлюцинации), агрессивность, автоматизм. Вызывает меньшее подавление двигательной активности и в меньшей степени индуцирует каталепсию, чем классические нейролептики (антипсихотические ЛС). Сбалансированный центральный антагонизм к серотонину и дофамину может уменьшать риск возникновения экстрапирамидной симптоматики и расширять терапевтическое воздействие препарата с охватом негативных и аффективных симптомов шизофрении. Рисперидон Органика может вызывать дозозависимое увеличение концентрации пролактина в плазме."}},{"type":"header","data":{"text":"Фармакокинетика","level":3}},{"type":"paragraph","data":{"text":"При приеме внутрь рисперидон полностью всасывается (независимо от приема пищи) и Cmax в плазме крови достигается через 1–2 ч.Рисперидон подвергается метаболизму изоферментом CYP2D6 с образованием 9-гидроксирисперидона, который обладает аналогичным фармакологическим действием. Рисперидон и 9-гидроксирисперидон представляют собой эффективную антипсихотическую фракцию. Дальнейший метаболизм рисперидона заключается в N-дезалкилировании. При приеме внутрь рисперидон выводится с T1/2 около 3 ч. Установлено, что T1/2 9-гидроксирисперидона и активной антипсихотической фракции составляет 24 ч. У большинства пациентов Css рисперидона наблюдается через 1 день после начала лечения. Равновесное состояние 9-гидроксирисперидона в большинстве случаев достигается через 3–4 дня после начала лечения. Концентрация рисперидона в плазме пропорциональна дозе препарата (в пределах терапевтических доз). Рисперидон быстро распределяется в организме. Vd составляет 1–2 л/кг. В плазме рисперидон связан с альбумином и кислым ?1-гликопротеином.Фракция рисперидона и 9-гидроксирисперидона, которая связана белками плазмы, составляет 88 и 77% соответственно. Выводится почками — 70% (из них 35–45% — в виде фармакологически активной фракции) и 14% — с желчью. Остальное количество составляют неактивные метаболиты.Фармакокинетика в особых клинических случаях. У пожилых пациентов, а также у пациентов с почечной недостаточностью концентрация препарата в плазме увеличивается, а T1/2 возрастает. Концентрация рисперидона в плазме у пациентов с печеночной недостаточностью не изменяется."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"шизофрения (острая и хроническая) и другие психотические состояния с продуктивной и/или негативной симптоматикой;"}},{"type":"paragraph","data":{"text":"злоупотребление ЛС или лекарственная зависимость;"}},{"type":"paragraph","data":{"text":"в качестве вспомогательной терапии: при лечении маний при биполярных расстройствах, расстройств поведения у подростков с 15 лет и взрослых пациентов со сниженным интеллектуальным уровнем или задержкой умственного развития, в случаях, если деструктивное поведение (агрессивность, импульсивность, аутоагрессия) является ведущим в клинической картине болезни."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"повышенная чувствительность к компонентам препарата;"}},{"type":"paragraph","data":{"text":"детский возраст младше 15 лет (из-за отсутствия сведений по использованию для лечения шизофрении у детей младше 15 лет);"}},{"type":"paragraph","data":{"text":"период лактации."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь."}},{"type":"paragraph","data":{"text":"Шизофрения"}},{"type":"paragraph","data":{"text":"Взрослые и дети старше 15 лет. Рисперидон Органика может назначаться 1 или 2 раза в сутки. Начальная доза — 2 мг/сут. На второй день дозу следует увеличить до 4 мг/сут. С этого момента дозу можно либо сохранить на прежнем уровне, либо при необходимости скорректировать индивидуально. Обычно оптимальной дозой является 4–6 мг/сут. В ряде случаев может быть оправдано более медленное повышение дозы и более низкие начальная и поддерживающая дозы. Дозы выше 10 мг/сут не показали более высокой эффективности по сравнению с меньшими дозами, но могут вызвать появление экстрапирамидных симптомов. В связи с тем, что безопасность доз выше 16 мг/сут не изучалась, дозы выше этого уровня применять нельзя."}},{"type":"paragraph","data":{"text":"Злоупотребление ЛС или лекарственная зависимость"}},{"type":"paragraph","data":{"text":"Рекомендуемая суточная доза препарата — 2–4 мг."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Инфекции: очень часто — инфекции мочевыводящих путей у пожилых пациентов с деменцией; часто — назофарингит, инфекции верхних дыхательных путей, синусит, инфекции мочевыводящих путей, у пожилых пациентов с деменцией — пневмония, флегмона, ринит, гриппоподобные заболевания; нечасто — инфекции уха, вирусные инфекции, фарингит, тонзиллит, бронхит, инфекции глаз, локализованные инфекции, цистит, онихомикоз, акродерматит, бронхопневмония, инфекции дыхательных путей, трахеобронхит."}},{"type":"paragraph","data":{"text":"Со стороны ЦНС: очень часто — головная боль, бессонница, паркинсонизм, включая экстрапирамидные симптомы (тремор, ригидность, гиперсаливация, брадикинезия, акатизия, острая дистония); часто — головокружение, сонливость, неясность зрения; нечасто — снижение способности к концентрации внимания, повышенная утомляемость; очень редко — мания или гипомания, ажитация, тревожность, инсульт у пожилых больных с предрасполагающими факторами. У больных шизофренией нечасто — гиперволемия (либо из-за полидипсии, либо из-за синдрома неадекватной секреции антидиуретического гормона), поздняя дискинезия (непроизвольные ритмические сокращения преимущественно мышц языка и/или лица); редко — злокачественный нейролептический синдром (гипертермия, мышечная ригидность, нестабильность автономных функций (профузное потоотделение, тахикардия и другие нарушения ритма сердца, колебания АД, бледность кожи, одышка, нарушение мочеиспускания), нарушение сознания и повышение активности КФК)"}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"С учетом того что Рисперидон Органика оказывает действие в первую очередь на ЦНС, его следует применять с осторожностью в сочетании с другими препаратами центрального действия и сочетать с алкоголем."}},{"type":"paragraph","data":{"text":"Рисперидон Органика уменьшает эффективность леводопы и других агонистов дофаминовых рецепторов."}},{"type":"paragraph","data":{"text":"Клозапин снижает клиренс Рисперидона Органика."}},{"type":"paragraph","data":{"text":"При использовании карбамазепина отмечалось снижение концентрации активной антипсихотической фракции Рисперидона Органика в плазме (аналогичные эффекты могут наблюдаться при применении других индукторов микросомальных ферментов печени)."}},{"type":"paragraph","data":{"text":"Производные фенотиазина, трициклические антидепрессанты и некоторые бета-адреноблокаторы могут повышать концентрации Рисперидона Органика в плазме, однако это не влияет на концентрацию активной антипсихотической фракции."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Влияние на способность к вождению автотранспорта и управлению механизмами. Во время лечения необходимо воздержаться от занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций"}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"\u003cb\u003eтаблетки, покрытые пленочной оболочкой\u003c/b\u003e"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"по рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://apteka.ru/vendor/%D0%9E%D1%80%D0%B3%D0%B0%D0%BD%D0%B8%D0%BA%D0%B0,%20%D0%90%D0%9E/\"\u003eОрганика, АО\u003c/a\u003e"}}]}],"source":null},"description_toggle":false,"short_description":"Рисперидон является антипсихотическим средством, оказывает также седативное, противорвотное и гипотермическое действие. Рисперидон Органика является селективным антагонистом 5-НТ2-серотониновых и дофаминовых D2-рецепторов, связывается также с альфа1-адренорецепторами и при несколько меньшей афинности с Н1-гистаминовыми и альфа2-адренорецепторами. Не обладает тропностью к холинорецепторам. Антипсихотическое действие обусловлено блокадой дофаминовых D2-рецепторов мезолимбической и мезокортикальной системы. Седативное действие обусловлено блокадой адренорецепторов ретикулярной формации ствола головного мозга; противорвотное действие — блокадой дофаминовых D2-рецепторов триггерной зоны рвотного центра; гипотермическое действие — блокадой дофаминовых рецепторов гипоталамуса. Снижает продуктивную симптоматику шизофрении (бред, галлюцинации), агрессивность, автоматизм. Вызывает меньшее подавление двигательной активности и в меньшей степени индуцирует каталепсию, чем классические нейролептики (антипсихотические ЛС). Сбалансированный центральный антагонизм к серотонину и дофамину может уменьшать риск возникновения экстрапирамидной симптоматики и расширять терапевтическое воздействие препарата с охватом негативных и аффективных симптомов шизофрении. Рисперидон Органика может вызывать дозозависимое увеличение концентрации пролактина в плазме. При приеме внутрь рисперидон полностью всасывается (независимо от приема пищи) и Cmax в плазме крови достигается через 1–2 ч.Рисперидон подвергается метаболизму изоферментом CYP2D6 с образованием 9-гидроксирисперидона, который обладает аналогичным фармакологическим действием. Рисперидон и 9-гидроксирисперидон представляют собой эффективную антипсихотическую фракцию. Дальнейший метаболизм рисперидона заключается в N-дезалкилировании. При приеме внутрь рисперидон выводится с T1/2 около 3 ч. Установлено, что T1/2 9-гидроксирисперидона и активной антипсихотической фракции составляет 24 ч. 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