Психотические расстройства, в т.ч. шизофрения. Психомоторное возбуждение. Неврозы с преобладанием тревоги и страха. Симптоматическое лечение тошноты и рвоты.
Противопоказания
Коматозные состояния; заболевания, сопровождающиеся миелодепрессией; выраженные нарушения функции печени; беременность, лактация; повышенная чувствительность к трифлуоперазину.
Инструкция
Состав
Действующее вещество: трифлуоперазин.
Фармакологические свойства
Антипсихотическое средство (нейролептик), пиперазиновое производное фенотиазина. Полагают, что антипсихотическое действие фенотиазинов обусловлено блокированием постсинаптических мезолимбических допаминергических рецепторов в головном мозге. По интенсивности антипсихотического действия превосходит хлорпромазин. Оказывает сильное противорвотное действие, центральный механизм которого связан с угнетением или блокадой допаминовых D2-рецепторов в хеморецепторной триггерной зоне мозжечка, а периферический - с блокадой блуждающего нерва в ЖКТ. Обладает альфа-адреноблокирующей активностью. Оказывает некоторое активирующее действие. Антихолинергическая активность и гипотензивный эффект выражены слабо. Оказывает выраженное экстрапирамидное действие. В отличие от хлорпромазина не оказывает антигистаминного, спазмолитического и противосудорожного действия.
Фармакокинетика
Клинические данные по фармакокинетике трифлуоперазина ограничены.
Фенотиазины обладают высоким связыванием с белками плазмы. Выводятся главным образом почками и частично с желчью.
Показания к применению
Психотические расстройства, в т.ч. шизофрения. Психомоторное возбуждение. Неврозы с преобладанием тревоги и страха. Симптоматическое лечение тошноты и рвоты.
Противопоказания
Коматозные состояния; заболевания, сопровождающиеся миелодепрессией; выраженные нарушения функции печени; беременность, лактация; повышенная чувствительность к трифлуоперазину.
Применение при беременности и в период грудного вскармливания
Трифлуоперазин противопоказан для применения при беременности и в период лактации.
В экспериментальных исследованиях показано, что трифлуоперазин (в дозах, значительно превышающих клинические) может повышать частоту пороков развития и уменьшать массу тела новорожденных животных.
Фенотиазины проникают в грудное молоко и могут вызывать сонливость и повышать риск развития поздней дискинезии у ребенка.
Способ применения и дозы
Индивидуальный. Внутрь взрослым - по 1-5 мг 2 раза/сут; при необходимости в течение 2-3 недель дозу повышают до 15-20 мг/сут, кратность применения - 3 раза/сут. Детям в возрасте 6 лет и старше - по 1 мг 2-3 раза/сут, при необходимости доза может быть увеличена до 5-6 мг/сут.
В/м взрослым - по 1-2 мг каждые 4-6 ч. Детям - по 1 мг 1-2 раза/сут.
Со стороны ЦНС: сонливость, головокружение, сухость во рту, расстройства сна, усталость, нарушения зрения; экстрапирамидные расстройства, поздняя дискинезия.
Со стороны пищеварительной системы: анорексия, холестатическая желтуха.
Со стороны системы кроветворения: тромбоцитопения, анемия, гранулоцитопения, панцитопения.
Со стороны сердечно-сосудистой системы: тахикардия, умеренно выраженная ортостатическая гипотензия, нарушения ритма сердца, изменения на ЭКГ (удлинение интервала QT, сглаживание зубца T).
Аллергические реакции: кожная сыпь, крапивница, ангионевротический отек.
Со стороны эндокринной системы: галакторея, аменорея.
Взаимодействие с другими лекарственными средствами
При одновременном применении лекарственных средств, оказывающих угнетающее влияние на ЦНС, этанола, этанолсодержащих препаратов возможно усиление угнетающего влияния на ЦНС и функцию дыхания.
При одновременном применении с противосудорожными средствами возможно снижение порога судорожной готовности; со средствами, вызывающими экстрапирамидные реакции, возможно увеличение частоты и тяжести экстрапирамидных нарушений.
При одновременном применении с трициклическими антидепрессантами, мапротилином, ингибиторами МАО увеличивается риск развития ЗНС.
При одновременном применении с препаратами, вызывающими артериальную гипотензию, возможна выраженная ортостатическая гипотензия.
При одновременном применении с препаратами для лечения гипертиреоза повышается риск развития агранулоцитоза.
При одновременном применении с антихолинергическими препаратами усиливаются их антихолинергические эффекты, при этом антипсихотический эффект нейролептика может уменьшаться.
При одновременном применении антацидов, противопаркинсонических средств нарушается абсорбция фенотиазинов.
При одновременном применении ослабляется действие пероральных антикоагулянтов, возможно уменьшение эффективности амфетаминов, леводопы, клонидина, гуанетидина, эпинефрина, эфедрина.
При одновременном применении с солями лития возможны нейротоксическое действие, развитие экстрапирамидных симптомов.
При одновременном применении с метилдопой описан случай развития парадоксальной артериальной гипертензии.
При одновременном применении с флуоксетином возможно развитие экстрапирамидных симптомов и дистонии.
Особые указания
Не следует применять при депрессивных состояниях.
С особой осторожностью применяют у пациентов с глаукомой, с сердечно-сосудистыми заболеваниями, эпилепсией, доброкачественной гиперплазией предстательной железы; при повышенной чувствительности к другим препаратам фенотиазинового ряда. Фенотиазины применяют после сопоставлении риска и пользы лечения у пациентов с патологическими изменениям картины крови, при нарушениях функции печени, алкогольной интоксикации, синдроме Рейе, а также при раке молочной железы, болезни Паркинсона, язвенной болезни желудка и двенадцатиперстной кишки, задержке мочи, хронических заболеваниях органов дыхания (особенно у детей), эпилептических припадках, рвоте.
Необходимо избегать одновременного применения фенотиазинов с адсорбирующими противодиарейными средствами.
Пациентам пожилого возраста требуется коррекция режима дозирования трифлуоперазина. В период лечения следует исключить употребление алкоголя.
Влияние на способность управлять автомобилем и движущимися механизмами
Следует с осторожностью применять у пациентов, деятельность которых требует повышенной концентрации внимания и высокой скорости психомоторных реакций.
Форма выпуска
Раствор.
Условия хранения
Максимальная допустимая температура хранения, 25 °C.
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Полагают, что антипсихотическое действие фенотиазинов обусловлено блокированием постсинаптических мезолимбических допаминергических рецепторов в головном мозге. По интенсивности антипсихотического действия превосходит хлорпромазин. Оказывает сильное противорвотное действие, центральный механизм которого связан с угнетением или блокадой допаминовых D\u003csub\u003e2\u003c/sub\u003e-рецепторов в хеморецепторной триггерной зоне мозжечка, а периферический - с блокадой блуждающего нерва в ЖКТ. Обладает альфа-адреноблокирующей активностью. Оказывает некоторое активирующее действие. Антихолинергическая активность и гипотензивный эффект выражены слабо. Оказывает выраженное экстрапирамидное действие. В отличие от хлорпромазина не оказывает антигистаминного, спазмолитического и противосудорожного действия."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"Клинические данные по фармакокинетике трифлуоперазина ограничены."}},{"type":"paragraph","data":{"text":"Фенотиазины обладают высоким связыванием с белками плазмы. Выводятся главным образом почками и частично с желчью."}}]},{"id":10,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Психотические расстройства, в т.ч. шизофрения. Психомоторное возбуждение. Неврозы с преобладанием тревоги и страха. Симптоматическое лечение тошноты и рвоты."}}]},{"id":11,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Коматозные состояния; заболевания, сопровождающиеся миелодепрессией; выраженные нарушения функции печени; беременность, лактация; повышенная чувствительность к трифлуоперазину."}}]},{"id":13,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Трифлуоперазин противопоказан для применения при беременности и в период лактации."}},{"type":"paragraph","data":{"text":"В \u003ci\u003eэкспериментальных исследованиях\u003c/i\u003e показано, что трифлуоперазин (в дозах, значительно превышающих клинические) может повышать частоту пороков развития и уменьшать массу тела новорожденных животных."}},{"type":"paragraph","data":{"text":"Фенотиазины проникают в грудное молоко и могут вызывать сонливость и повышать риск развития поздней дискинезии у ребенка."}}]},{"id":14,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Индивидуальный. Внутрь взрослым - по 1-5 мг 2 раза/сут; при необходимости в течение 2-3 недель дозу повышают до 15-20 мг/сут, кратность применения - 3 раза/сут. Детям в возрасте 6 лет и старше - по 1 мг 2-3 раза/сут, при необходимости доза может быть увеличена до 5-6 мг/сут."}},{"type":"paragraph","data":{"text":"В/м взрослым - по 1-2 мг каждые 4-6 ч. Детям - по 1 мг 1-2 раза/сут."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМаксимальные дозы:\u003c/i\u003e взрослым при приеме внутрь – 40 мг/сут, в/м - 10 мг/сут."}}]},{"id":15,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны ЦНС:\u003c/i\u003e сонливость, головокружение, сухость во рту, расстройства сна, усталость, нарушения зрения; экстрапирамидные расстройства, поздняя дискинезия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы:\u003c/i\u003e анорексия, холестатическая желтуха."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны системы кроветворения:\u003c/i\u003e тромбоцитопения, анемия, гранулоцитопения, панцитопения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e тахикардия, умеренно выраженная ортостатическая гипотензия, нарушения ритма сердца, изменения на ЭКГ (удлинение интервала QT, сглаживание зубца T)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e кожная сыпь, крапивница, ангионевротический отек."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны эндокринной системы:\u003c/i\u003e галакторея, аменорея."}}]},{"id":17,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении лекарственных средств, оказывающих угнетающее влияние на ЦНС, этанола, этанолсодержащих препаратов возможно усиление угнетающего влияния на ЦНС и функцию дыхания."}},{"type":"paragraph","data":{"text":"При одновременном применении с противосудорожными средствами возможно снижение порога судорожной готовности; со средствами, вызывающими экстрапирамидные реакции, возможно увеличение частоты и тяжести экстрапирамидных нарушений."}},{"type":"paragraph","data":{"text":"При одновременном применении с трициклическими антидепрессантами, мапротилином, ингибиторами МАО увеличивается риск развития ЗНС."}},{"type":"paragraph","data":{"text":"При одновременном применении с препаратами, вызывающими артериальную гипотензию, возможна выраженная ортостатическая гипотензия."}},{"type":"paragraph","data":{"text":"При одновременном применении с препаратами для лечения гипертиреоза повышается риск развития агранулоцитоза."}},{"type":"paragraph","data":{"text":"При одновременном применении с антихолинергическими препаратами усиливаются их антихолинергические эффекты, при этом антипсихотический эффект нейролептика может уменьшаться."}},{"type":"paragraph","data":{"text":"При одновременном применении антацидов, противопаркинсонических средств нарушается абсорбция фенотиазинов."}},{"type":"paragraph","data":{"text":"При одновременном применении ослабляется действие пероральных антикоагулянтов, возможно уменьшение эффективности амфетаминов, леводопы, клонидина, гуанетидина, эпинефрина, эфедрина."}},{"type":"paragraph","data":{"text":"При одновременном применении с солями лития возможны нейротоксическое действие, развитие экстрапирамидных симптомов."}},{"type":"paragraph","data":{"text":"При одновременном применении с метилдопой описан случай развития парадоксальной артериальной гипертензии."}},{"type":"paragraph","data":{"text":"При одновременном применении с флуоксетином возможно развитие экстрапирамидных симптомов и дистонии."}}]},{"id":18,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Не следует применять при депрессивных состояниях."}},{"type":"paragraph","data":{"text":"С особой осторожностью применяют у пациентов с глаукомой, с сердечно-сосудистыми заболеваниями, эпилепсией, доброкачественной гиперплазией предстательной железы; при повышенной чувствительности к другим препаратам фенотиазинового ряда. Фенотиазины применяют после сопоставлении риска и пользы лечения у пациентов с патологическими изменениям картины крови, при нарушениях функции печени, алкогольной интоксикации, синдроме Рейе, а также при раке молочной железы, болезни Паркинсона, язвенной болезни желудка и двенадцатиперстной кишки, задержке мочи, хронических заболеваниях органов дыхания (особенно у детей), эпилептических припадках, рвоте."}},{"type":"paragraph","data":{"text":"Необходимо избегать одновременного применения фенотиазинов с адсорбирующими противодиарейными средствами."}},{"type":"paragraph","data":{"text":"Пациентам пожилого возраста требуется коррекция режима дозирования трифлуоперазина. 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