Антипсихотический препарат (нейролептик). Проявляет более высокое сродство к серотониновым 5-НТ2-рецепторам, чем к допаминовым D1- и D2-рецепторам головного мозга. Обладает сродством к гистаминовым и 1-адренорецепторам, менее активен по отношению к 2-адренорецепторам. Не обнаружено избирательного сродства к холинергическим мускариновым и бензодиазепиновым рецепторам. Уменьшает активность мезолимбических А10-допаминергических нейронов, в сравнении с А9-нигростриатными нейронами, вовлеченными в двигательные функции. Не вызывает длительного повышения концентрации пролактина. Длительность связи с серотониновым 5-НТ2-рецепторами и допаминовым D2-рецепторам составляет менее 12 ч после приема препарата.
Показания к применению
Острые и хронические психозы, включая шизофрению
Маниакальные эпизоды при биполярном расстройстве
Противопоказания
Период грудного вскармливания
Дети и подростки до 18 лет (эффективность и безопасность не установлены)
Непереносимость лактозы, дефицит лактазы, глюкозо-галактозная мальабсорбция (в лекарственной форме препарата содержится лактоза)
Повышенная чувствительность к кветиапину или другим компонентам препарата
С осторожностью следует назначать препарат при сердечно-сосудистых и цереброваскулярных заболеваниях, артериальной гипотензии, врожденном синдроме удлинения интервала QT или наличии условий, потенциально способных вызвать удлинение интервала QT (одновременное назначение препаратов, удлиняющих интервал QT, застойная сердечная недостаточность, гипокалиемия, гипомагниемия), гипотиреозе, сахарном диабете, печеночной недостаточности, эпилепсии, судорожных припадках в анамнезе, беременности, пациентам пожилого возраста, пациентам с риском развития венозной тромбоэмболии.
Применение при беременности и в период грудного вскармливания
Безопасность и эффективность применения при беременности не установлена. Поэтому при беременности Нантарид; можно применять только, если ожидаемая польза для матери превышает потенциальный риск для плода. Степень выведения кветиапина с женским молоком не известна. При необходимости применения препарата Нантарид; в период лактации грудное вскармливание рекомендуется прекратить.
Способ применения и дозы
Внутрь, 2 раза/сут, независимо от приема пищи.; При лечении острых и хронических психозов, включая шизофрению, суточная доза для первых 4 дней терапии - 50 мг (1 день), 100 мг (2 день), 200 мг (3 день), 300 мг (4 день). Начиная с 4 дня, доза должна подбираться до эффективной в пределах от 300 до 450 мг/сут. В зависимости от клинического эффекта и переносимости препарата доза может варьировать от 150 до 750 мг/сут.; При лечении маниакальных эпизодов при биполярном расстройстве суточная доза для первых 4 дня терапии - 100 мг (1 день), 200 мг (2 день), 300 мг (3 день), 400 мг (4 день). В дальнейшем в течение 6 дней суточную дозу увеличивают до 800 мг, но не более чем на 200 мг/сут. В зависимости от клинического эффекта и переносимости препарата доза может варьировать от 200 до 800 мг/сут. Эффективная доза составляет от 400 до 800 мг/сут.; Плазменный клиренс кветиапина у лиц пожилого возраста снижен на 30-50% по сравнению с молодыми пациентами, поэтому назначать препарат следует с осторожностью, особенно в начале лечения. Стартовая доза составляет 25 мг/сут, с последующим увеличением на 25-50 мг/сут до достижения эффективной дозы.; При почечной и/или печеночной недостаточности следует начинать лечение кветиапином с 25 мг/сут, с последующим ежедневным увеличением на 25-50 мг до достижения эффективной дозы.; Безопасность и эффективность препарата у детей и подростков не исследовалась.
Побочное действие
Побочные эффекты, наблюдаемые при применении препарата, классифицированы на категории в зависимости от частоты их возникновения: очень часто (≥ 1/10); часто (≥ 1/100, < 1/10); нечасто (≥ 1/1000, < 1/100); редко (≥ 1/10 000, < 1/1000); очень редко (< 1/10 000, включая отдельные сообщения).; Со стороны системы кроветворения: часто - лейкопения; нечасто - эозинофилия, тромбоцитопения; очень редко - нейтропения.; Со стороны эндокринной системы: часто - увеличение массы тела (преимущественно в первые недели лечения), гипергликемия или декомпенсация сахарного диабета; очень редко - сахарный диабет.; Со стороны нервной системы: очень часто - головокружение, сонливость, головная боль; часто - синкопальные состояния, необычные и кошмарные сновидения, обморок, экстрапирамидные симптомы, анорексия; нечасто - тревожность, враждебность, возбуждение, бессонница, акатизия, тремор, судороги, депрессия, дизартрия, парестезии; редко - злокачественный нейролептический синдром (гипертермия, мышечная ригидность, измененный ментальный статус, лабильность вегетативной нервной системы, повышение активности креатинфосфокиназы); очень редко - поздняя дискинезия.; Со стороны сердечно-сосудистой системы: часто - ортостатическая гипотензия, сердцебиение, тахикардия, повышение АД, удлинение интервала QT на ЭКГ; отдельные сообщения - риск развития венозной тромбоэмболии.; Со стороны пищеварительной системы: очень часто - сухость во рту; часто - тошнота, рвота, диарея или запор, диспепсия, нечасто - дисфагия; редко - боль в животе, желтуха; очень редко - гепатит.; Со стороны дыхательной системы: часто - фарингит, ринит.; Аллергические реакции: нечасто - кожная сыпь, реакции гиперчувствительности; очень редко - ангионевротический отек, синдром Стивенса-Джонсона.; Со стороны половой системы: редко - приапизм (болезненная эрекция).; Со стороны органа зрения: часто - нечеткость зрения.; Со стороны иммунной системы: нечасто - реакции гиперчувствительности; очень редко - ангионевротический отек, синдром Стивенса-Джонсона.; Лабораторные показатели: очень часто - гиперхолестеринемия, гипертриглицеридемия; часто - повышение активности печеночных трансаминаз; нечасто - повышение активности ГГТ, снижение концентрации общего и свободного Т4 (первые 4 недели), а также общего Т3 и реверсивного Т3 (только при приеме высоких доз кветиапина), повышение активности креатинфосфокиназы, не связанное со злокачественным нейролептическим синдромом.; Прочие: очень часто - синдром отмены; часто - периферические отеки, астения, повышенное потоотделение; редко - боль в пояснице, боль в грудной клетке, субфебрилитет, миалгия, сухость кожи, ослабление зрения.
Передозировка
Данные о передозировке препарата ограничены. Описаны случаи приема кветиапина в дозе, превышающей 20 г без фатальных исходов и купированием побочных эффектов без последствий. Крайне редко сообщалось о случаях передозировки кветиапина, приводивших к удлинению интервала QT, коме или смерти.; Симптомы: чрезмерная седация, сонливость, тахикардия, артериальная гипотензия.; Лечение: специфических антидотов к кветиапину нет. При случайной передозировке в течение первого часа после приема необходимо рассмотреть возможность симптоматической терапии и рекомендуется проводить мероприятия, направленные на поддержание функции дыхания, сердечно-сосудистой системы, обеспечение адекватной оксигенации и вентиляции. Медицинский контроль и наблюдение должно быть продолжено до полного выздоровления пациента.
Особые указания
При резкой отмене высоких доз антипсихотических препаратов могут наблюдаться следующие острые реакции (синдром отмены) - тошнота, рвота, редко - бессонница. Сообщалось о случаях обострения психотических симптомов и появлении непроизвольных двигательных расстройств (акатизия, дистония, дискинезия). В этой связи отмену препарата рекомендуется проводить постепенно.; Принимая во внимание, что кветиапин, главным образом, влияет на ЦНС, Нантарид; должен быть использован с осторожностью в комбинации с другими препаратами, обладающими угнетающим действием на ЦНС. Рекомендуется воздерживаться от употребления алкоголя.; При появлении симптомов поздней дискинезии следует уменьшить дозу или прекратить использование кветиапина.; При назначении кветиапина одновременно с препаратами, удлиняющими интервал QT, необходимо соблюдать осторожность, особенно у лиц пожилого возраста, у пациентов с врожденным удлинением интервала QT, застойной сердечной недостаточностью, гипертрофией миокарда, гипокалиемией и гипомагниемией.; Злокачественный нейролептический синдром может быть связан с проводимым антипсихотическим лечением. Клинические проявления синдрома включают: гипертермию, измененный ментальный статус, мышечную ригидность, нестабильность вегетативной нервной системы, повышение активности креатинфосфокиназы. При развитии этого синдрома кветиапин должен быть отменен и проведено соответствующее лечение.; У пациентов при длительном применении кветиапина сообщалось о выявлении катаракты. В этой связи следует проводить офтальмологическое обследование перед началом терапии и 1 раз в 6 месяцев при длительном применении лекарственного средства.; Так же, как и при терапии другими антипсихотическими средствами, рекомендуется соблюдать осторожность при лечении пациентов с наличием судорожных приступов в анамнезе.; Есть отдельные сообщения о риске развития венозной тромбоэмболии при применении антипсихотических препаратов. До и во время лечения кветиапином должны быть выявлены все возможные факторы риска развития венозной тромбоэмболии и предприняты превентивные меры.; Влияние на способность к вождению автотранспорта и управлению механизмами; Нантарид; может вызывать сонливость, поэтому пациентам не рекомендуется работать с механизмами, представляющими опасность, в т.ч. не рекомендуется управление автомобилем и занятия другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
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фумарат 115.13 мг,; что соответствует содержанию кветиапина 100 мг; Вспомогательные вещества: кальция гидрофосфат безводный - 50.27 мг, лактозы моногидрат - 4 мг, целлюлоза микрокристаллическая - 48 мг, карбоксиметилкрахмал натрия - 11 мг, повидон - 8 мг, магния стеарат - 3.6 мг.; Состав пленочной оболочки: опадрай; желтый 03В82923 - 6 мг (гипромеллоза - 3.75 мг, титана диоксид - 1.695 мг, макрогол 400 - 0.375 мг, краситель железа оксид желтый - 0.18 мг)."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Антипсихотический препарат (нейролептик). Проявляет более высокое сродство к серотониновым 5-НТ2-рецепторам, чем к допаминовым D1- и D2-рецепторам головного мозга. Обладает сродством к гистаминовым и 1-адренорецепторам, менее активен по отношению к 2-адренорецепторам. Не обнаружено избирательного сродства к холинергическим мускариновым и бензодиазепиновым рецепторам. Уменьшает активность мезолимбических А10-допаминергических нейронов, в сравнении с А9-нигростриатными нейронами, вовлеченными в двигательные функции. Не вызывает длительного повышения концентрации пролактина. Длительность связи с серотониновым 5-НТ2-рецепторами и допаминовым D2-рецепторам составляет менее 12 ч после приема препарата."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Острые и хронические психозы, включая шизофрению","Маниакальные эпизоды при биполярном расстройстве"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Период грудного вскармливания","Дети и подростки до 18 лет (эффективность и безопасность не установлены)","Непереносимость лактозы, дефицит лактазы, глюкозо-галактозная мальабсорбция (в лекарственной форме препарата содержится лактоза)","Повышенная чувствительность к кветиапину или другим компонентам препарата"]}},{"type":"paragraph","data":{"text":"С осторожностью следует назначать препарат при сердечно-сосудистых и цереброваскулярных заболеваниях, артериальной гипотензии, врожденном синдроме удлинения интервала QT или наличии условий, потенциально способных вызвать удлинение интервала QT (одновременное назначение препаратов, удлиняющих интервал QT, застойная сердечная недостаточность, гипокалиемия, гипомагниемия), гипотиреозе, сахарном диабете, печеночной недостаточности, эпилепсии, судорожных припадках в анамнезе, беременности, пациентам пожилого возраста, пациентам с риском развития венозной тромбоэмболии."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Безопасность и эффективность применения при беременности не установлена. Поэтому при беременности Нантарид; можно применять только, если ожидаемая польза для матери превышает потенциальный риск для плода. Степень выведения кветиапина с женским молоком не известна. При необходимости применения препарата Нантарид; в период лактации грудное вскармливание рекомендуется прекратить."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, 2 раза/сут, независимо от приема пищи.; При лечении острых и хронических психозов, включая шизофрению, суточная доза для первых 4 дней терапии - 50 мг (1 день), 100 мг (2 день), 200 мг (3 день), 300 мг (4 день). Начиная с 4 дня, доза должна подбираться до эффективной в пределах от 300 до 450 мг/сут. В зависимости от клинического эффекта и переносимости препарата доза может варьировать от 150 до 750 мг/сут.; При лечении маниакальных эпизодов при биполярном расстройстве суточная доза для первых 4 дня терапии - 100 мг (1 день), 200 мг (2 день), 300 мг (3 день), 400 мг (4 день). В дальнейшем в течение 6 дней суточную дозу увеличивают до 800 мг, но не более чем на 200 мг/сут. В зависимости от клинического эффекта и переносимости препарата доза может варьировать от 200 до 800 мг/сут. Эффективная доза составляет от 400 до 800 мг/сут.; Плазменный клиренс кветиапина у лиц пожилого возраста снижен на 30-50% по сравнению с молодыми пациентами, поэтому назначать препарат следует с осторожностью, особенно в начале лечения. Стартовая доза составляет 25 мг/сут, с последующим увеличением на 25-50 мг/сут до достижения эффективной дозы.; При почечной и/или печеночной недостаточности следует начинать лечение кветиапином с 25 мг/сут, с последующим ежедневным увеличением на 25-50 мг до достижения эффективной дозы.; Безопасность и эффективность препарата у детей и подростков не исследовалась."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Побочные эффекты, наблюдаемые при применении препарата, классифицированы на категории в зависимости от частоты их возникновения: очень часто (≥ 1/10); часто (≥ 1/100, \u003c 1/10); нечасто (≥ 1/1000, \u003c 1/100); редко (≥ 1/10 000, \u003c 1/1000); очень редко (\u003c 1/10 000, включая отдельные сообщения).; Со стороны системы кроветворения: часто - лейкопения; нечасто - эозинофилия, тромбоцитопения; очень редко - нейтропения.; Со стороны эндокринной системы: часто - увеличение массы тела (преимущественно в первые недели лечения), гипергликемия или декомпенсация сахарного диабета; очень редко - сахарный диабет.; Со стороны нервной системы: очень часто - головокружение, сонливость, головная боль; часто - синкопальные состояния, необычные и кошмарные сновидения, обморок, экстрапирамидные симптомы, анорексия; нечасто - тревожность, враждебность, возбуждение, бессонница, акатизия, тремор, судороги, депрессия, дизартрия, парестезии; редко - злокачественный нейролептический синдром (гипертермия, мышечная ригидность, измененный ментальный статус, лабильность вегетативной нервной системы, повышение активности креатинфосфокиназы); очень редко - поздняя дискинезия.; Со стороны сердечно-сосудистой системы: часто - ортостатическая гипотензия, сердцебиение, тахикардия, повышение АД, удлинение интервала QT на ЭКГ; отдельные сообщения - риск развития венозной тромбоэмболии.; Со стороны пищеварительной системы: очень часто - сухость во рту; часто - тошнота, рвота, диарея или запор, диспепсия, нечасто - дисфагия; редко - боль в животе, желтуха; очень редко - гепатит.; Со стороны дыхательной системы: часто - фарингит, ринит.; Аллергические реакции: нечасто - кожная сыпь, реакции гиперчувствительности; очень редко - ангионевротический отек, синдром Стивенса-Джонсона.; Со стороны половой системы: редко - приапизм (болезненная эрекция).; Со стороны органа зрения: часто - нечеткость зрения.; Со стороны иммунной системы: нечасто - реакции гиперчувствительности; очень редко - ангионевротический отек, синдром Стивенса-Джонсона.; Лабораторные показатели: очень часто - гиперхолестеринемия, гипертриглицеридемия; часто - повышение активности печеночных трансаминаз; нечасто - повышение активности ГГТ, снижение концентрации общего и свободного Т4 (первые 4 недели), а также общего Т3 и реверсивного Т3 (только при приеме высоких доз кветиапина), повышение активности креатинфосфокиназы, не связанное со злокачественным нейролептическим синдромом.; Прочие: очень часто - синдром отмены; часто - периферические отеки, астения, повышенное потоотделение; редко - боль в пояснице, боль в грудной клетке, субфебрилитет, миалгия, сухость кожи, ослабление зрения."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Данные о передозировке препарата ограничены. Описаны случаи приема кветиапина в дозе, превышающей 20 г без фатальных исходов и купированием побочных эффектов без последствий. Крайне редко сообщалось о случаях передозировки кветиапина, приводивших к удлинению интервала QT, коме или смерти.; Симптомы: чрезмерная седация, сонливость, тахикардия, артериальная гипотензия.; Лечение: специфических антидотов к кветиапину нет. При случайной передозировке в течение первого часа после приема необходимо рассмотреть возможность симптоматической терапии и рекомендуется проводить мероприятия, направленные на поддержание функции дыхания, сердечно-сосудистой системы, обеспечение адекватной оксигенации и вентиляции. Медицинский контроль и наблюдение должно быть продолжено до полного выздоровления пациента."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При резкой отмене высоких доз антипсихотических препаратов могут наблюдаться следующие острые реакции (синдром отмены) - тошнота, рвота, редко - бессонница. Сообщалось о случаях обострения психотических симптомов и появлении непроизвольных двигательных расстройств (акатизия, дистония, дискинезия). В этой связи отмену препарата рекомендуется проводить постепенно.; Принимая во внимание, что кветиапин, главным образом, влияет на ЦНС, Нантарид; должен быть использован с осторожностью в комбинации с другими препаратами, обладающими угнетающим действием на ЦНС. Рекомендуется воздерживаться от употребления алкоголя.; При появлении симптомов поздней дискинезии следует уменьшить дозу или прекратить использование кветиапина.; При назначении кветиапина одновременно с препаратами, удлиняющими интервал QT, необходимо соблюдать осторожность, особенно у лиц пожилого возраста, у пациентов с врожденным удлинением интервала QT, застойной сердечной недостаточностью, гипертрофией миокарда, гипокалиемией и гипомагниемией.; Злокачественный нейролептический синдром может быть связан с проводимым антипсихотическим лечением. Клинические проявления синдрома включают: гипертермию, измененный ментальный статус, мышечную ригидность, нестабильность вегетативной нервной системы, повышение активности креатинфосфокиназы. При развитии этого синдрома кветиапин должен быть отменен и проведено соответствующее лечение.; У пациентов при длительном применении кветиапина сообщалось о выявлении катаракты. В этой связи следует проводить офтальмологическое обследование перед началом терапии и 1 раз в 6 месяцев при длительном применении лекарственного средства.; Так же, как и при терапии другими антипсихотическими средствами, рекомендуется соблюдать осторожность при лечении пациентов с наличием судорожных приступов в анамнезе.; Есть отдельные сообщения о риске развития венозной тромбоэмболии при применении антипсихотических препаратов. 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