Большие депрессивные эпизоды у взрослых (лечение).
Противопоказания
Гиперчувствительность к активному веществу или какому-либо компоненту препарата. Одновременное применение с неселективными ингибиторами моноаминоксидазы (имао) или селективными имао а (см. «взаимодейтвие»). Детский и подростковый возраст до 18 лет (безопасность и эффективность не установлены). С осторожностью: тяжелая почечная и печеночная недостаточность. ...
Большие депрессивные эпизоды у взрослых (лечение).
Противопоказания
Гиперчувствительность к активному веществу или какому-либо компоненту препарата. Одновременное применение с неселективными ингибиторами моноаминоксидазы (имао) или селективными имао а (см. «взаимодейтвие»). Детский и подростковый возраст до 18 лет (безопасность и эффективность не установлены). С осторожностью: тяжелая почечная и печеночная недостаточность. Мания и гипомания. Фармакологически неконтролируемая эпилепсия, судорожные припадки в анамнезе. Выраженное суицидальное поведение. Цирроз печени. Склонность к кровотечениям. Одновременный прием с ингибиторами мао в (селегилин, разагилин), серотонинергическими лекарственными препаратами, препаратами, снижающими порог судорожной готовности, литием, триптофаном, лекарственными препаратами, содержащими зверобой продырявленный, пероральными антикоагулянтами и лекарственными препаратами, влияющими на тромбоцитарную функцию, препаратами, способными вызвать гипонатриемию, электросудорожная терапия, пожилой возраст.
Способ применения и дозы
Внутрь, вне зависимости от приема пищи. Режим дозирования. Начальная и рекомендуемая доза Бринтелликса у взрослых пациентов младше 65 лет составляет 10 мг однократно в сутки. В зависимости от индивидуальной реакции пациента, суточная доза вортиоксетина может быть увеличена до максимальной дозы - 20 мг 1 раз в сутки или снижена до минимальной дозы 5 мг 1 раз в сутки. После полного разрешения симптомов депрессии рекомендовано продолжать лечение в течение по крайней мере 6 мес для закрепления антидепрессивного эффекта. Прекращение лечения. Пациенты, получающие лечение препаратом Бринтелликс, могут одномоментно прекратить его прием без необходимости постепенного понижения дозы (см. «Фармакодинамика»). Особые группы пациентов Пожилые пациенты. У пациентов ≥ .65 лет в качестве начальной дозы всегда следует использовать минимальную эффективную дозу Бринтелликса 5 мг однократно в сутки. Необходимо соблюдать осторожность при лечении пациентов ≥ .65 лет с применением доз выше 10 мг вортиоксетина однократно в сутки, т.к. данные о применении препарата у этой группы пациентов ограничены (см. «Особые указания»). Ингибиторы цитохрома Р450. В зависимости от индивидуальной реакции пациента, может потребоваться снижение дозы Бринтелликса в случае присоединения терапии сильными ингибиторами изофермента CYP2D6 (например бупропион, хинидин, флуоксетин, пароксетин) (см. «Взаимодействие»). Индукторы цитохрома Р450. В зависимости от индивидуальной реакции пациента, может потребоваться коррекция дозы Бринтелликса в случае присоединения терапии индукторами цитохрома Р450 широкого спектра (например рифампицин, карбамазепин, фенитоин) (см. «Взаимодействие»). Дети и подростки (младше 18 лет). Безопасность и эффективность препарата Бринтелликс у детей и подростков до 18 лет не установлена. Данных по этой группе пациентов нет (см. «Особые указания»).
Побочное действие
Сводная характеристика профиля безопасности. Наиболее частой нежелательной реакцией была тошнота. Нежелательные реакции обычно были слабо или умеренно выраженными и отмечались лишь на протяжении первых 2 нед лечения. Нежелательные реакции обычно носили временный характер и, в общем, не являлись причиной отмены препарата. Нежелательные Побочное реакции со стороны ЖКТ, такие как тошнота, чаще наблюдались у женщин, чем у мужчин. Нежелательные реакции, перечисленные ниже, распределены по частоте следующим образом очень часто (≥ .1/10). часто (от ≥ .1/100 до меньше 1/10). Нечасто (от ≥ .1/1000 до меньше 1/100). редко (от ≥ .1/10000 до меньше 1/1000). Очень редко (меньше 1/10000), частота неизвестна (частота не может быть оценена на основании имеющихся данных). Список нежелательных реакций. Системы организма. Частота. Нежелательная реакция. Нарушения психики, часто необычные сновидения. Со стороны нервной системы Часто Головокружение, частота неизвестна Серотониновый синдром. Со стороны сосудов Нечасто ПриливыСо стороны ЖКТ Очень часто ТошнотаЧасто Диарея, запор, рвота. Со стороны кожи и подкожных тканей Часто Зуд, в т.ч. генерализованныйНечасто Ночной пот. Описание отдельных нежелательных реакций Пожилые пациенты Для доз вортиоксетина 10 мг и выше 1 раз в сутки уровень выбывания из исследований был выше у пациентов в возрасте ≥ .65 лет. Для дозы вортиоксетина 20 мг 1 раз в сутки случаи возникновения тошноты и запоров были выше у пациентов в возрасте ≥ .65 лет (42 и 15% соответственно) по сравнению с пациентами меньше 65 лет (27 и 4% соответственно) (см. «Особые указания»). Сексуальная дисфункция. В клинических исследованиях сексуальная дисфункция оценивалась с использованием ASEX. Дозы от 5 до 15 мг не демонстрировали отличие от плацебо. Однако прием дозы вортиоксетина 20 мг ассоциировался с повышением частоты возникновения (TESD) (см. «Фармакодинамика»). Класс-специфический эффект. Эпидемиологические исследования преимущественно с участием пациентов в возрасте 50 лет и старше показали существование повышенного риска костных переломов у пациентов, принимающих лекарственные препараты, относящиеся к соответствующим фармакологическим классам антидепрессантов (трициклических (ТЦА) и СИОЗС). Механизм, приводящий к этому риску, неизвестен, также как неизвестно, относится ли этот риск к приему вортиоксетина.
Особые указания
Сводная характеристика профиля безопасности. Наиболее частой нежелательной реакцией была тошнота. Нежелательные реакции обычно были слабо или умеренно выраженными и отмечались лишь на протяжении первых 2 нед лечения. Нежелательные реакции обычно носили временный характер и, в общем, не являлись причиной отмены препарата. Нежелательные Побочное реакции со стороны ЖКТ, такие как тошнота, чаще наблюдались у женщин, чем у мужчин. Нежелательные реакции, перечисленные ниже, распределены по частоте следующим образом очень часто (≥ .1/10). часто (от ≥ .1/100 до меньше 1/10). Нечасто (от ≥ .1/1000 до меньше 1/100). редко (от ≥ .1/10000 до меньше 1/1000). Очень редко (меньше 1/10000), частота неизвестна (частота не может быть оценена на основании имеющихся данных). Список нежелательных реакций. Системы организма. Частота. Нежелательная реакция. Нарушения психики, часто необычные сновидения. Со стороны нервной системы Часто Головокружение, частота неизвестна Серотониновый синдром. Со стороны сосудов Нечасто ПриливыСо стороны ЖКТ Очень часто ТошнотаЧасто Диарея, запор, рвота. Со стороны кожи и подкожных тканей Часто Зуд, в т.ч. генерализованныйНечасто Ночной пот. Описание отдельных нежелательных реакций Пожилые пациенты Для доз вортиоксетина 10 мг и выше 1 раз в сутки уровень выбывания из исследований был выше у пациентов в возрасте ≥ .65 лет. Для дозы вортиоксетина 20 мг 1 раз в сутки случаи возникновения тошноты и запоров были выше у пациентов в возрасте ≥ .65 лет (42 и 15% соответственно) по сравнению с пациентами меньше 65 лет (27 и 4% соответственно) (см. «Особые указания»). Сексуальная дисфункция. В клинических исследованиях сексуальная дисфункция оценивалась с использованием ASEX. Дозы от 5 до 15 мг не демонстрировали отличие от плацебо. Однако прием дозы вортиоксетина 20 мг ассоциировался с повышением частоты возникновения (TESD) (см. «Фармакодинамика»). Класс-специфический эффект. Эпидемиологические исследования преимущественно с участием пациентов в возрасте 50 лет и старше показали существование повышенного риска костных переломов у пациентов, принимающих лекарственные препараты, относящиеся к соответствующим фармакологическим классам антидепрессантов (трициклических (ТЦА) и СИОЗС). Механизм, приводящий к этому риску, неизвестен, также как неизвестно, относится ли этот риск к приему вортиоксетина.
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Состав пленочной оболочки: Опадрай желтый - 4.5 мг (гипромеллоза - 2.813 мг, титана диоксид (E171) - 1.35 мг, макрогол 400 - 0.281 мг, краситель железа оксид желтый (E172) - 0.056 мг)."}}]},{"id":2,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Большие депрессивные эпизоды у взрослых (лечение)."}}]},{"id":3,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к активному веществу или какому-либо компоненту препарата. Одновременное применение с неселективными ингибиторами моноаминоксидазы (имао) или селективными имао а (см. «взаимодейтвие»). Детский и подростковый возраст до 18 лет (безопасность и эффективность не установлены). С осторожностью: тяжелая почечная и печеночная недостаточность. Мания и гипомания. Фармакологически неконтролируемая эпилепсия, судорожные припадки в анамнезе. Выраженное суицидальное поведение. 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После полного разрешения симптомов депрессии рекомендовано продолжать лечение в течение по крайней мере 6 мес для закрепления антидепрессивного эффекта. Прекращение лечения. Пациенты, получающие лечение препаратом Бринтелликс, могут одномоментно прекратить его прием без необходимости постепенного понижения дозы (см. «Фармакодинамика»). Особые группы пациентов Пожилые пациенты. У пациентов ≥ .65 лет в качестве начальной дозы всегда следует использовать минимальную эффективную дозу Бринтелликса 5 мг однократно в сутки. Необходимо соблюдать осторожность при лечении пациентов ≥ .65 лет с применением доз выше 10 мг вортиоксетина однократно в сутки, т.к. данные о применении препарата у этой группы пациентов ограничены (см. «Особые указания»). Ингибиторы цитохрома Р450. В зависимости от индивидуальной реакции пациента, может потребоваться снижение дозы Бринтелликса в случае присоединения терапии сильными ингибиторами изофермента CYP2D6 (например бупропион, хинидин, флуоксетин, пароксетин) (см. «Взаимодействие»). Индукторы цитохрома Р450. В зависимости от индивидуальной реакции пациента, может потребоваться коррекция дозы Бринтелликса в случае присоединения терапии индукторами цитохрома Р450 широкого спектра (например рифампицин, карбамазепин, фенитоин) (см. «Взаимодействие»). Дети и подростки (младше 18 лет). Безопасность и эффективность препарата Бринтелликс у детей и подростков до 18 лет не установлена. Данных по этой группе пациентов нет (см. «Особые указания»)."}}]},{"id":5,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Сводная характеристика профиля безопасности. Наиболее частой нежелательной реакцией была тошнота. Нежелательные реакции обычно были слабо или умеренно выраженными и отмечались лишь на протяжении первых 2 нед лечения. Нежелательные реакции обычно носили временный характер и, в общем, не являлись причиной отмены препарата. Нежелательные Побочное реакции со стороны ЖКТ, такие как тошнота, чаще наблюдались у женщин, чем у мужчин. Нежелательные реакции, перечисленные ниже, распределены по частоте следующим образом очень часто (≥ .1/10). часто (от ≥ .1/100 до меньше 1/10). Нечасто (от ≥ .1/1000 до меньше 1/100). редко (от ≥ .1/10000 до меньше 1/1000). Очень редко (меньше 1/10000), частота неизвестна (частота не может быть оценена на основании имеющихся данных). Список нежелательных реакций. Системы организма. Частота. Нежелательная реакция. Нарушения психики, часто необычные сновидения. Со стороны нервной системы Часто Головокружение, частота неизвестна Серотониновый синдром. Со стороны сосудов Нечасто ПриливыСо стороны ЖКТ Очень часто ТошнотаЧасто Диарея, запор, рвота. Со стороны кожи и подкожных тканей Часто Зуд, в т.ч. генерализованныйНечасто Ночной пот. Описание отдельных нежелательных реакций Пожилые пациенты Для доз вортиоксетина 10 мг и выше 1 раз в сутки уровень выбывания из исследований был выше у пациентов в возрасте ≥ .65 лет. Для дозы вортиоксетина 20 мг 1 раз в сутки случаи возникновения тошноты и запоров были выше у пациентов в возрасте ≥ .65 лет (42 и 15% соответственно) по сравнению с пациентами меньше 65 лет (27 и 4% соответственно) (см. «Особые указания»). Сексуальная дисфункция. В клинических исследованиях сексуальная дисфункция оценивалась с использованием ASEX. Дозы от 5 до 15 мг не демонстрировали отличие от плацебо. Однако прием дозы вортиоксетина 20 мг ассоциировался с повышением частоты возникновения (TESD) (см. «Фармакодинамика»). Класс-специфический эффект. 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