Элицея - антидепрессант, селективный ингибитор обратного захвата серотонина (СИОЗС), повышает концентрацию нейромедиатора в синаптической щели за счет ингибирования обратного нейронального захвата серотонина, усиливает и пролонгирует действие серотонина на постсинаптические рецепторы. Эсциталопрам практически не обладает или обладает очень слабым сродством к ряду рецепторов, в т.ч. серотониновым: 5-HT1A, 5-НТ2, допаминовым: D1 и D2 . α .1- и α .2- и β .-адренорецепторам, гистаминовым H1-рецепторам, м-холинорецепторам, бензодиазепиновым и опиоидным рецепторам, что обусловливает отсутствие или слабую выраженность различных антихолинергических, седативных, кардиоваскулярных побочных эффектов. Эсциталопрам также не связывается или обладает очень низким сродством по отношению к различным ионным каналам, включая Na+, К+, Сl-, Са2+-каналы.
Показания к применению
Депрессия
Панические расстройства (в т.ч. с агорафобией)
Противопоказания
Одновременное применение с ингибиторами МАО
Одновременное применение с пимозидом
Возраст до 18 лет (эффективность и безопасность не изучены)
Повышенная чувствительность к эсциталопраму и другим компонентам препарата. С осторожностью следует применять препарат при фармакологически неконтролируемой эпилепсии, мании/гипомании в анамнезе, сахарном диабете, депрессии с суицидальными попытками, циррозе печени, хронической почечной недостаточности (КК менее 30 мл/мин), ИБС, склонности к кровотечениям . одновременном применении с препаратами, способными вызвать гипонатриемию, снижающими порог судорожной готовности, с антикоагулянтами или препаратами, влияющими на агрегацию тромбоцитов, с алкоголем, с литием, зверобоем продырявленным, с триптофаном, лекарственными средствами, метаболизирующимися с участием системы изофермента CYP2C19 . при одновременном применении электросудорожной терапии, а также у пациентов в возрасте 18-24 лет (в связи с риском развития суицидального поведения) и у пациентов пожилого возраста
Применение при беременности и в период грудного вскармливания
Препарат Элицея не применяется при беременности (безопасность не установлена). В связи с тем, что эсциталопрам секретируется в грудное молоко, не рекомендуется применение препарата в период грудного вскармливания. В случае необходимости применения препарата Элицея в период лактации, грудное вскармливание следует прекратить.
Способ применения и дозы
Препарат принимают внутрь 1 раз/сут, независимо от приема пищи. Депрессивные эпизоды Рекомендуемая доза - 10 мг/сут. В зависимости от индивидуальной реакции пациента доза может быть увеличена до максимальной - 20 мг/сут. Антидепрессивный эффект развивается через 2-4 недели после начала лечения. После исчезновения симптомов депрессии необходимо продолжать терапию не менее 6 мес для закрепления полученного эффекта. Для прекращении терапии эсциталопрамом необходимо постепенно уменьшать дозу в течение 1-2 недель в целях снижения риска развития синдрома отмены. Панические расстройства (в т.ч. с агорафобией) Назначают по 5 мг/сут в течение первой недели, затем по 10-20 мг/сут. Максимальная суточная доза - 20 мг. Максимальный терапевтический эффект достигается примерно через 3 месяца после начала лечения. Пожилые пациенты (старше 65 лет) Рекомендуется доза - 5 мг/сут, максимальная суточная доза - 10 мг/сут. Нарушения функции почек При легкой или умеренной степени почечной недостаточности (КК более 30 мл/мин) коррекции дозы не требуется. При тяжелой степени почечной недостаточности (КК менее 30 мл/мин) препарат следует назначать с осторожностью. Нарушение функции печени При нарушении функции печени начальная доза - 5 мг/сут в течение 2 недель. В зависимости от индивидуальной реакции пациента доза может быть увеличена до 10 мг/сут. При тяжелых нарушениях функции печени рекомендуется более медленная титрация доз. Сниженная активность изофермента CYP2C19 Рекомендуемая начальная доза в течение первых 2 недель - 5 мг/сут, в зависимости от индивидуальной реакции пациента доза может быть увеличена до 10 мг/сут.
Побочное действие
Классификация частоты развития побочных эффектов (ВОЗ): очень часто (>1/10), часто (от >1/100 до меньше 1/10), нечасто (от >1/1000 до меньше 1/100), редко (от >1/10 000 до меньше 1/1000), очень редко (от меньше 1/10 000, включая отдельные сообщения). Со стороны сердечно-сосудистой системы: нечасто - тахикардия . редко - брадикардия . очень редко - ортостатическая гипотензия. Со стороны системы кроветворения: очень редко - тромбоцитопения. Со стороны нервной системы: часто - бессонница, сонливость, головокружение, парестезии, тремор, тревога, беспокойство, кошмарные сновидения . нечасто - нарушения вкуса, нарушения сна, обморок, скрежет зубами, психомоторное возбуждение, акатизия, повышенная раздражительность, панические расстройства, спутанность сознания . редко - серотониновый синдром (ажитация, тремор, миоклонус, гипертермия), агрессивность, деперсонализация, галлюцинации, суицидальные мысли и поведение . очень редко - дискинезия, судорожные и маниакальные расстройства. Со стороны органов дыхания: часто - синусит, зевота . нечасто - носовые кровотечения. Со стороны пищеварительной системы: очень часто - тошнота . часто - повышение или снижение аппетита, диарея, запор, рвота, сухость слизистой оболочки полости рта . нечасто - желудочно-кишечные кровотечения (в т.ч. ректальные) . очень редко - гепатит. Со стороны мочеполовой системы: часто - нарушения эякуляции, импотенция, снижение либидо, аноргазмия (у женщин) . редко - метроррагия, меноррагия . очень редко — задержка мочи, приапизм, галакторея. Со стороны органов чувств: нечасто - мидриаз, расстройства зрения, шум в ушах. Со стороны кожных покровов: часто - повышенная потливость, алопеция . очень редко - экхимозы. Со стороны костно-мышечной системы: часто - артралгия, миалгия. Со стороны эндокринной системы: очень редко - неадекватная секреция антидиуретического гормона, галакторея. Аллергические реакции: часто - крапивница, кожная сыпь, кожный зуд . редко - анафилактические реакции . очень редко - ангионевротический отек (отек Квинке). Прочие: часто - слабость, повышение температуры тела . нечасто - отеки. Со стороны лабораторных показателей: часто - увеличение массы тела . нечасто - снижение массы тела . очень редко - гипонатриемия, изменение лабораторных показателей функции печени. При резкой отмене препарата возможно развитие синдрома отмены.
Особые указания
Классификация частоты развития побочных эффектов (ВОЗ): очень часто (>1/10), часто (от >1/100 до меньше 1/10), нечасто (от >1/1000 до меньше 1/100), редко (от >1/10 000 до меньше 1/1000), очень редко (от меньше 1/10 000, включая отдельные сообщения). Со стороны сердечно-сосудистой системы: нечасто - тахикардия . редко - брадикардия . очень редко - ортостатическая гипотензия. Со стороны системы кроветворения: очень редко - тромбоцитопения. Со стороны нервной системы: часто - бессонница, сонливость, головокружение, парестезии, тремор, тревога, беспокойство, кошмарные сновидения . нечасто - нарушения вкуса, нарушения сна, обморок, скрежет зубами, психомоторное возбуждение, акатизия, повышенная раздражительность, панические расстройства, спутанность сознания . редко - серотониновый синдром (ажитация, тремор, миоклонус, гипертермия), агрессивность, деперсонализация, галлюцинации, суицидальные мысли и поведение . очень редко - дискинезия, судорожные и маниакальные расстройства. Со стороны органов дыхания: часто - синусит, зевота . нечасто - носовые кровотечения. Со стороны пищеварительной системы: очень часто - тошнота . часто - повышение или снижение аппетита, диарея, запор, рвота, сухость слизистой оболочки полости рта . нечасто - желудочно-кишечные кровотечения (в т.ч. ректальные) . очень редко - гепатит. Со стороны мочеполовой системы: часто - нарушения эякуляции, импотенция, снижение либидо, аноргазмия (у женщин) . редко - метроррагия, меноррагия . очень редко — задержка мочи, приапизм, галакторея. Со стороны органов чувств: нечасто - мидриаз, расстройства зрения, шум в ушах. Со стороны кожных покровов: часто - повышенная потливость, алопеция . очень редко - экхимозы. Со стороны костно-мышечной системы: часто - артралгия, миалгия. Со стороны эндокринной системы: очень редко - неадекватная секреция антидиуретического гормона, галакторея. Аллергические реакции: часто - крапивница, кожная сыпь, кожный зуд . редко - анафилактические реакции . очень редко - ангионевротический отек (отек Квинке). Прочие: часто - слабость, повышение температуры тела . нечасто - отеки. Со стороны лабораторных показателей: часто - увеличение массы тела . нечасто - снижение массы тела . очень редко - гипонатриемия, изменение лабораторных показателей функции печени. При резкой отмене препарата возможно развитие синдрома отмены.
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оксалат 12.78 мг, что соответствует содержанию эсциталопрама 10 мг Вспомогательные вещества: лактозы моногидрат - 107.220 мг, кросповидон - 7.5 мг, повидон К30 - 0.75 мг, целлюлоза микрокристаллическая - 15 мг, крахмал прежелатинизированный - 3.75 мг, магния стеарат - 3 мг. Состав пленочной оболочки: опадрай белый 33G28707 - 3.75 мг (гипромеллоза 6сР - 40%, титана диоксид - 24%, лактозы моногидрат - 22%, макрогол 3000 - 8%, триацетин - 6%)."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Элицея - антидепрессант, селективный ингибитор обратного захвата серотонина (СИОЗС), повышает концентрацию нейромедиатора в синаптической щели за счет ингибирования обратного нейронального захвата серотонина, усиливает и пролонгирует действие серотонина на постсинаптические рецепторы. Эсциталопрам практически не обладает или обладает очень слабым сродством к ряду рецепторов, в т.ч. серотониновым: 5-HT1A, 5-НТ2, допаминовым: D1 и D2 . α .1- и α .2- и β .-адренорецепторам, гистаминовым H1-рецепторам, м-холинорецепторам, бензодиазепиновым и опиоидным рецепторам, что обусловливает отсутствие или слабую выраженность различных антихолинергических, седативных, кардиоваскулярных побочных эффектов. Эсциталопрам также не связывается или обладает очень низким сродством по отношению к различным ионным каналам, включая Na+, К+, Сl-, Са2+-каналы."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Депрессия","Панические расстройства (в т.ч. с агорафобией)"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Одновременное применение с ингибиторами МАО","Одновременное применение с пимозидом","Возраст до 18 лет (эффективность и безопасность не изучены)","Беременность","Период грудного вскармливания","Галактоземия, дефицит лактазы, синдром глюкозо-галактозной мальабсорбции","Повышенная чувствительность к эсциталопраму и другим компонентам препарата. С осторожностью следует применять препарат при фармакологически неконтролируемой эпилепсии, мании/гипомании в анамнезе, сахарном диабете, депрессии с суицидальными попытками, циррозе печени, хронической почечной недостаточности (КК менее 30 мл/мин), ИБС, склонности к кровотечениям . одновременном применении с препаратами, способными вызвать гипонатриемию, снижающими порог судорожной готовности, с антикоагулянтами или препаратами, влияющими на агрегацию тромбоцитов, с алкоголем, с литием, зверобоем продырявленным, с триптофаном, лекарственными средствами, метаболизирующимися с участием системы изофермента CYP2C19 . при одновременном применении электросудорожной терапии, а также у пациентов в возрасте 18-24 лет (в связи с риском развития суицидального поведения) и у пациентов пожилого возраста"]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат Элицея не применяется при беременности (безопасность не установлена). В связи с тем, что эсциталопрам секретируется в грудное молоко, не рекомендуется применение препарата в период грудного вскармливания. В случае необходимости применения препарата Элицея в период лактации, грудное вскармливание следует прекратить."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат принимают внутрь 1 раз/сут, независимо от приема пищи. Депрессивные эпизоды Рекомендуемая доза - 10 мг/сут. В зависимости от индивидуальной реакции пациента доза может быть увеличена до максимальной - 20 мг/сут. Антидепрессивный эффект развивается через 2-4 недели после начала лечения. После исчезновения симптомов депрессии необходимо продолжать терапию не менее 6 мес для закрепления полученного эффекта. Для прекращении терапии эсциталопрамом необходимо постепенно уменьшать дозу в течение 1-2 недель в целях снижения риска развития синдрома отмены. Панические расстройства (в т.ч. с агорафобией) Назначают по 5 мг/сут в течение первой недели, затем по 10-20 мг/сут. Максимальная суточная доза - 20 мг. Максимальный терапевтический эффект достигается примерно через 3 месяца после начала лечения. Пожилые пациенты (старше 65 лет) Рекомендуется доза - 5 мг/сут, максимальная суточная доза - 10 мг/сут. Нарушения функции почек При легкой или умеренной степени почечной недостаточности (КК более 30 мл/мин) коррекции дозы не требуется. При тяжелой степени почечной недостаточности (КК менее 30 мл/мин) препарат следует назначать с осторожностью. Нарушение функции печени При нарушении функции печени начальная доза - 5 мг/сут в течение 2 недель. В зависимости от индивидуальной реакции пациента доза может быть увеличена до 10 мг/сут. При тяжелых нарушениях функции печени рекомендуется более медленная титрация доз. Сниженная активность изофермента CYP2C19 Рекомендуемая начальная доза в течение первых 2 недель - 5 мг/сут, в зависимости от индивидуальной реакции пациента доза может быть увеличена до 10 мг/сут."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Классификация частоты развития побочных эффектов (ВОЗ): очень часто (\u003e1/10), часто (от \u003e1/100 до меньше 1/10), нечасто (от \u003e1/1000 до меньше 1/100), редко (от \u003e1/10 000 до меньше 1/1000), очень редко (от меньше 1/10 000, включая отдельные сообщения). Со стороны сердечно-сосудистой системы: нечасто - тахикардия . редко - брадикардия . очень редко - ортостатическая гипотензия. Со стороны системы кроветворения: очень редко - тромбоцитопения. Со стороны нервной системы: часто - бессонница, сонливость, головокружение, парестезии, тремор, тревога, беспокойство, кошмарные сновидения . нечасто - нарушения вкуса, нарушения сна, обморок, скрежет зубами, психомоторное возбуждение, акатизия, повышенная раздражительность, панические расстройства, спутанность сознания . редко - серотониновый синдром (ажитация, тремор, миоклонус, гипертермия), агрессивность, деперсонализация, галлюцинации, суицидальные мысли и поведение . очень редко - дискинезия, судорожные и маниакальные расстройства. Со стороны органов дыхания: часто - синусит, зевота . нечасто - носовые кровотечения. Со стороны пищеварительной системы: очень часто - тошнота . часто - повышение или снижение аппетита, диарея, запор, рвота, сухость слизистой оболочки полости рта . нечасто - желудочно-кишечные кровотечения (в т.ч. ректальные) . очень редко - гепатит. Со стороны мочеполовой системы: часто - нарушения эякуляции, импотенция, снижение либидо, аноргазмия (у женщин) . редко - метроррагия, меноррагия . очень редко — задержка мочи, приапизм, галакторея. Со стороны органов чувств: нечасто - мидриаз, расстройства зрения, шум в ушах. Со стороны кожных покровов: часто - повышенная потливость, алопеция . очень редко - экхимозы. Со стороны костно-мышечной системы: часто - артралгия, миалгия. Со стороны эндокринной системы: очень редко - неадекватная секреция антидиуретического гормона, галакторея. Аллергические реакции: часто - крапивница, кожная сыпь, кожный зуд . редко - анафилактические реакции . очень редко - ангионевротический отек (отек Квинке). Прочие: часто - слабость, повышение температуры тела . нечасто - отеки. Со стороны лабораторных показателей: часто - увеличение массы тела . нечасто - снижение массы тела . очень редко - гипонатриемия, изменение лабораторных показателей функции печени. При резкой отмене препарата возможно развитие синдрома отмены."}}]},{"id":8,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Классификация частоты развития побочных эффектов (ВОЗ): очень часто (\u003e1/10), часто (от \u003e1/100 до меньше 1/10), нечасто (от \u003e1/1000 до меньше 1/100), редко (от \u003e1/10 000 до меньше 1/1000), очень редко (от меньше 1/10 000, включая отдельные сообщения). Со стороны сердечно-сосудистой системы: нечасто - тахикардия . редко - брадикардия . очень редко - ортостатическая гипотензия. Со стороны системы кроветворения: очень редко - тромбоцитопения. Со стороны нервной системы: часто - бессонница, сонливость, головокружение, парестезии, тремор, тревога, беспокойство, кошмарные сновидения . нечасто - нарушения вкуса, нарушения сна, обморок, скрежет зубами, психомоторное возбуждение, акатизия, повышенная раздражительность, панические расстройства, спутанность сознания . редко - серотониновый синдром (ажитация, тремор, миоклонус, гипертермия), агрессивность, деперсонализация, галлюцинации, суицидальные мысли и поведение . очень редко - дискинезия, судорожные и маниакальные расстройства. Со стороны органов дыхания: часто - синусит, зевота . нечасто - носовые кровотечения. Со стороны пищеварительной системы: очень часто - тошнота . часто - повышение или снижение аппетита, диарея, запор, рвота, сухость слизистой оболочки полости рта . нечасто - желудочно-кишечные кровотечения (в т.ч. ректальные) . очень редко - гепатит. Со стороны мочеполовой системы: часто - нарушения эякуляции, импотенция, снижение либидо, аноргазмия (у женщин) . редко - метроррагия, меноррагия . очень редко — задержка мочи, приапизм, галакторея. Со стороны органов чувств: нечасто - мидриаз, расстройства зрения, шум в ушах. Со стороны кожных покровов: часто - повышенная потливость, алопеция . очень редко - экхимозы. Со стороны костно-мышечной системы: часто - артралгия, миалгия. Со стороны эндокринной системы: очень редко - неадекватная секреция антидиуретического гормона, галакторея. Аллергические реакции: часто - крапивница, кожная сыпь, кожный зуд . редко - анафилактические реакции . очень редко - ангионевротический отек (отек Квинке). Прочие: часто - слабость, повышение температуры тела . нечасто - отеки. Со стороны лабораторных показателей: часто - увеличение массы тела . нечасто - снижение массы тела . очень редко - гипонатриемия, изменение лабораторных показателей функции печени. 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