Острый и хронический психоз; невротические, психофункциональные и психоаффективные расстройства, связанные с соматическими заболеваниями.
Противопоказания
Не рекомендуется назначать эглонил при диагностируемой или подозреваемой феохромоцитоме, так как в ходе лечения антидопаминовыми препаратами, включая некоторые бензамиды, были описаны случаи развития тяжелой аг у лиц с феохромоцитомой, а также при пролактинзависимых опухолях (например пролактинома гипофиза и рак молочной железы).
Инструкция
Фармакологические свойства
Нейролептическое средство. сульпирид является избирательным антагонистом допаминовых рецепторов d2/d3. у больных с психозом с негативными симптомами сульпирид эффективен в дозе 150–600 мг/сут; в этой дозе сульпирид практически не оказывает влияния на позитивную симптоматику. в дозе 0,6–1,6 г/сут улучшает состояние больных с острым или хроническим психозом с положительной симптоматикой. только очень высокие дозы сульпирида оказывают седативное действие.
После в/м введения в дозе 100 мг максимальная концентрация препарата в плазме крови (около 2,2 мг/л) достигается через 30 мин. При приеме внутрь сульпирид всасывается в пищеварительном тракте в течение 4,5 ч, максимальная концентрация препарата в плазме крови колеблется в пределах 0,5–1,8 мг/л после приема в дозе 200 мг. Биодоступность пероральных форм — 25–35% с широкими индивидуальными колебаниями; концентрация сульпирида в плазме крови пропорциональна дозе. Сульпирид быстро распределяется в тканях организма, в основном в почках и печени; небольшое количество проникает через ГЭБ. Менее 40% препарата связывается с белками плазмы крови; соотношение распределения эритроцитов и плазмы крови составляет 1. Количество препарата, которое проникает в грудное молоко, составляет 1/1000 часть от суточной дозы. Сульпирид слабо метаболизируется в организме. Период полувыведения составляет 7 ч; объем распределения в равновесном состоянии — 0,94 л/кг (0,6–1,5 л/кг) массы тела. Общий клиренс — 126 мл/мин. Сульпирид выделяется в основном почками путем клубочковой фильтрации.
Показания к применению
Острый и хронический психоз; невротические, психофункциональные и психоаффективные расстройства, связанные с соматическими заболеваниями.
Противопоказания
Не рекомендуется назначать эглонил при диагностируемой или подозреваемой феохромоцитоме, так как в ходе лечения антидопаминовыми препаратами, включая некоторые бензамиды, были описаны случаи развития тяжелой аг у лиц с феохромоцитомой, а также при пролактинзависимых опухолях (например пролактинома гипофиза и рак молочной железы).
Способ применения и дозы
Начальное лечение проводят в/м введением препарата, после чего переходят на прием внутрь. при невротических, психофункциональных и психоаффективных расстройствах, связанных с соматическими состояниями:
Взрослым — 100–200 мг/сут.
Детям в возрасте старше 6 лет: 5 мг/кг массы тела в сутки (при необходимости эта доза может быть повышена до 10 мг/кг).
При остром и хроническом психозе дозу устанавливают в соответствии с преобладающими симптомами: негативными — 200–600 мг/сут, позитивными — 800–1600 мг/сут.
Побочное действие
Седативное действие, сонливость, ранняя дискинезия (спастическая кривошея, окулогирные кризы, тризм, уменьшающиеся при назначении антихолинергических противопаркинсонических препаратов), экстрапирамидные симптомы, выраженность которых частично уменьшается при назначении антихолинергических противопаркинсонических препаратов, поздняя дискинезия, развивающаяся при длительном применении нейролептиков (антихолинергические противопаркинсонические препараты неэффективны и могут ухудшать состояние больного), постуральная гипотензия, импотенция, фригидность, аменорея, галакторея, гинекомастия, гиперпролактинемия, увеличение массы тела.
Передозировка
Дискинетические проявления со спастической кривошеей, протрузией языка и тризмом. у некоторых больных иногда развиваются выраженные проявления паркинсонизма и кома. эглонил частично выводится при гемодиализе. лечение симптоматическое: реанимационные мероприятия, интенсивная терапия при постоянном контроле дыхания и сердечной деятельности (при увеличении интервала q–t), который необходимо проводить до полного выздоровления больного. при развитии тяжелых экстрапирамидных симптомов следует применять антихолинергические препараты.
Взаимодействие с другими лекарственными средствами
Алкоголь может потенцировать седативное действие нейролептических средств, поэтому во время лечения сульпиридом больным следует воздерживаться от употребления алкоголя и применения лекарственных препаратов, содержащих этиловый спирт. Леводопа оказывает антагонистическое действие относительно нейролептических препаратов и наоборот. Больным с экстрапирамидными симптомами, обусловленными применением нейролептических препаратов, не следует назначать леводопу. Если нейролептический препарат требуется пациенту, принимающему леводопу в связи с болезнью Паркинсона, рекомендуется выбрать препарат со слабо выраженными экстрапирамидными эффектами, в частности хлорпромазин или левомепромазин. Антигипертензивные препараты могут оказывать аддитивное гипотензивное действие и повышать риск развития постуральной гипотензии. Средства, вызывающие угнетение ЦНС (производные морфина, большинство блокаторов Н1-рецепторов, барбитураты, бензодиазепины, транквилизаторы небензодиазепиновой структуры, клонидин и родственные ему соединения) потенцируют депримирующее действие сульпирида.
Особые указания
При развитии гипертермии сульпирид следует отменить. гипертермия может быть проявлением злокачественного нейролептического синдрома (бледность, гипертермия и вегетативная дисфункция). эта предосторожность особенно важна при применении препарата в высоких дозах. Следует соблюдать осторожность при лечении пациентов пожилого возраста, более восприимчивых к действию препарата. Поскольку сульпирид выделяется почками, у больных с тяжелой почечной недостаточностью препарат следует применять в сниженных дозах и использовать интермиттирующую схему лечения. Больные с эпилепсией требуют более тщательного контроля (клинического и при необходимости — ЭЭГ), так как сульпирид снижает порог судорожной готовности. Пациентам с болезнью Паркинсона сульпирид назначают с осторожностью по строгим показаниям. У больных с агрессивным поведением или возбуждением с импульсивностью сульпирид следует назначать вместе с седативными препаратами. У детей, матери которых принимали в период беременности сульпирид в низкой дозе (примерно 200 мг/сут), не наблюдали повышения частоты врожденных дефектов. Опыта применения препарата в более высоких дозах нет. Нет также данных о потенциальном действии нейролептических средств, принимаемых в период беременности, на развитие мозга плода. Представляется целесообразным по возможности снизить дозу и уменьшить продолжительность лечения препаратом в период беременности. У новорожденных, матери которых проходили длительное лечение нейролептиками в высоких дозах, описано несколько случаев развития экстрапирамидного синдрома. Рекомендуется контролировать неврологический статус детей, рожденных от матерей, получавших препарат, в течение некоторого времени после рождения. Поскольку сульпирид проникает в грудное молоко, кормление грудью во время лечения препаратом следует прекратить. Водители транспортных средств и лица, работающие с потенциально опасными механизмами, должны быть предупреждены о возможности развития сонливости во время приема препарата.
Условия хранения
При температуре 15–30 °с.
Условия отпуска
По рецепту.
Производитель
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позитивную симптоматику. в дозе 0,6–1,6 г/сут улучшает состояние больных с острым или хроническим психозом с положительной симптоматикой. только очень высокие дозы сульпирида оказывают седативное действие."}},{"type":"paragraph","data":{"text":"После в/м введения в дозе 100 мг максимальная концентрация препарата в плазме крови (около 2,2 мг/л) достигается через 30 мин. При приеме внутрь сульпирид всасывается в пищеварительном тракте в течение 4,5 ч, максимальная концентрация препарата в плазме крови колеблется в пределах 0,5–1,8 мг/л после приема в дозе 200 мг. Биодоступность пероральных форм — 25–35% с широкими индивидуальными колебаниями; концентрация сульпирида в плазме крови пропорциональна дозе. Сульпирид быстро распределяется в тканях организма, в основном в почках и печени; небольшое количество проникает через ГЭБ. Менее 40% препарата связывается с белками плазмы крови; соотношение распределения эритроцитов и плазмы крови составляет 1. Количество препарата, которое проникает в грудное молоко, составляет \u003csup\u003e1\u003c/sup\u003e/\u003csub\u003e1\u003c/sub\u003e\u003csub\u003e000\u003c/sub\u003e часть от суточной дозы. Сульпирид слабо метаболизируется в организме. Период полувыведения составляет 7 ч; объем распределения в равновесном состоянии — 0,94 л/кг (0,6–1,5 л/кг) массы тела. Общий клиренс — 126 мл/мин. 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Леводопа оказывает антагонистическое действие относительно нейролептических препаратов и наоборот. Больным с экстрапирамидными симптомами, обусловленными применением нейролептических препаратов, не следует назначать леводопу. Если нейролептический препарат требуется пациенту, принимающему леводопу в связи с болезнью Паркинсона, рекомендуется выбрать препарат со слабо выраженными экстрапирамидными эффектами, в частности хлорпромазин или левомепромазин. Антигипертензивные препараты могут оказывать аддитивное гипотензивное действие и повышать риск развития постуральной гипотензии. Средства, вызывающие угнетение ЦНС (производные морфина, большинство блокаторов Н\u003csub\u003e1\u003c/sub\u003e-рецепторов, барбитураты, бензодиазепины, транквилизаторы небензодиазепиновой структуры, клонидин и родственные ему соединения) потенцируют депримирующее действие сульпирида."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"При развитии гипертермии сульпирид следует отменить. гипертермия может быть проявлением злокачественного нейролептического синдрома (бледность, гипертермия и вегетативная дисфункция). эта предосторожность особенно важна при применении препарата в высоких дозах. Следует соблюдать осторожность при лечении пациентов пожилого возраста, более восприимчивых к действию препарата. Поскольку сульпирид выделяется почками, у больных с тяжелой почечной недостаточностью препарат следует применять в сниженных дозах и использовать интермиттирующую схему лечения. Больные с эпилепсией требуют более тщательного контроля (клинического и при необходимости — ЭЭГ), так как сульпирид снижает порог судорожной готовности. Пациентам с болезнью Паркинсона сульпирид назначают с осторожностью по строгим показаниям. У больных с агрессивным поведением или возбуждением с импульсивностью сульпирид следует назначать вместе с седативными препаратами. У детей, матери которых принимали в период беременности сульпирид в низкой дозе (примерно 200 мг/сут), не наблюдали повышения частоты врожденных дефектов. Опыта применения препарата в более высоких дозах нет. Нет также данных о потенциальном действии нейролептических средств, принимаемых в период беременности, на развитие мозга плода. Представляется целесообразным по возможности снизить дозу и уменьшить продолжительность лечения препаратом в период беременности. У новорожденных, матери которых проходили длительное лечение нейролептиками в высоких дозах, описано несколько случаев развития экстрапирамидного синдрома. Рекомендуется контролировать неврологический статус детей, рожденных от матерей, получавших препарат, в течение некоторого времени после рождения. Поскольку сульпирид проникает в грудное молоко, кормление грудью во время лечения препаратом следует прекратить. Водители транспортных средств и лица, работающие с потенциально опасными механизмами, должны быть предупреждены о возможности развития сонливости во время приема препарата."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"При температуре 15–30 °с."}}]},{"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":"САНОФИ ВИНТРОП ИНДАСТРИА"}}]}],"source":null},"description_toggle":false,"short_description":"Нейролептическое средство. сульпирид является избирательным антагонистом допаминовых рецепторов d2/d3. у больных с психозом с негативными симптомами сульпирид эффективен в дозе 150–600 мг/сут; в этой дозе сульпирид практически не оказывает влияния на позитивную симптоматику. в дозе 0,6–1,6 г/сут улучшает состояние больных с острым или хроническим психозом с положительной симптоматикой. только очень высокие дозы сульпирида оказывают седативное действие. 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