Противоаллергическое средство. Левоцетиризин - R-энантиомер цетиризина, который относится к группе конкурентных антагонистов гистамина, блокирует гистаминовые Н1-рецепторы. Оказывает влияние на гистаминзависимую стадию аллергических реакций, уменьшает миграцию эозинофилов, уменьшает сосудистую проницаемость, ограничивает высвобождение медиаторов воспаления. Предупреждает развитие и облегчает течение аллергических реакций, оказывает антиэкссудативное, противозудное действие. Практически не оказывает антихолинергического и антисеротонинергического действия. В терапевтических дозах практически не оказывает седативного действия. Действие препарата начинается через 12 мин после приема однократной дозы у 50% пациентов, через 1 ч - у 95% и продолжается в течение 24 ч.
Показания к применению
Симптоматическое лечение:
Круглогодичного (персистирующего) и сезонного (интермиттирующего) аллергического ринита и конъюнктивита (зуд, чиханье, заложенность носа, ринорея, слезотечение, гиперемия конъюнктивы)
Сенной лихорадки (поллиноз)
Крапивницы, в т.ч. хронической идиопатической крапивницы (для таблеток)
Отека Квинке (для таблеток)
Аллергических дерматозов, сопровождающихся зудом и высыпаниями
Противопоказания
Терминальная стадия почечной недостаточности (КК менее 10 мл/мин)
Детский возраст до 6 лет (для таблеток)
Детский возраст до 2 лет (для капель для приема внутрь - из-за отсутствия клинических данных)
Беременность
Период лактации
Непереносимость лактозы, наследственный дефицит лактазы или синдром мальабсорбции глюкозы-галактозы (для таблеток)
Повышенная чувствительность к активному веществу (в т.ч. производным пиперазина) или любому вспомогательному компоненту препарата. С осторожностью следует назначать при хронической почечной недостаточности (необходима коррекция режима дозирования), пациентам пожилого возраста (возможно снижение клубочковой фильтрации), пациентам с повреждением спинного мозга, гипреплазией предстательной железы, а также при наличии других предрасполагающих факторов к задержке мочи (левоцетиризин может увеличивать риск задержки мочи), при одновременном употреблении с алкоголем
Применение при беременности и в период грудного вскармливания
Доклинические исследования не выявили каких-либо прямых или косвенных неблагоприятных эффектов левоцетиризина на развивающийся плод, а также на развитие в постнатальном периоде; течение беременности и родов также не изменялось. Адекватных и строго контролируемых клинических исследований по безопасности применения препарата при беременности не проводилось. Применение препарата при беременности противопоказано. Левоцетиризин выделяется с грудным молоком, поэтому при необходимости применения препарата в период лактации рекомендуется прекратить грудное вскармливание.
Способ применения и дозы
Препарат следует принимать внутрь во время еды или натощак. Таблетки принимают, не разжевывая, запивая небольшим количеством воды. Для приема препарата в форме капель следует использовать чайную ложку. При необходимости дозу препарата можно разбавить в небольшом количестве воды непосредственно перед употреблением. Рекомендуемая доза взрослым и детям старше 6 лет, пожилым пациентам (при условии нормальной функции почек) составляет 5 мг (1 таб. или 1 мл капель или 20 капель из капельницы)/сут. Максимальная суточная доза - 5 мг. Детям в возрасте от 2 до 6 лет препарат назначают в форме капель для приема внутрь по 1.25 мг (5 капель) 2 раза/сут; суточная доза - 2.5 мг (10 капель). Длительность приема зависит от заболевания. При лечении круглогодичного (персистирующего) аллергического ринита (наличие симптомов более 4 дней в неделю и их общая продолжительность более 4 недель) лечение может продолжаться в течение всего периода воздействия аллергенов. При лечении сезонного (интермиттирующего) аллергического ринита наличие симптомов менее 4 дней в неделю или их общая продолжительность менее 4 недель) длительность лечения зависит от характера заболевания; лечение может быть прекращено при исчезновении симптомов и возобновлено при появлении симптомов. Курс лечения поллиноза в среднем составляет 1-6 недель. При хронических заболеваниях (в т.ч. хроническая идиопатическая крапивница) курс лечения может быть более длительным по согласованию с врачом. Существует клинический опыт непрерывного применения препарата у взрослых пациентов продолжительностью до 6 мес. Поскольку левоцетиризин выводится из организма почками, при назначении препарата пациентам с почечной недостаточностью и пациентам пожилого возраста дозу следует корректировать в зависимости от величины клиренса креатинина (КК). КК для мужчин можно рассчитать, исходя из концентрации сывороточного креатинина, по следующей формуле: КК (мл/мин) = [140 - возраст (годы)] × масса тела (кг) / 72 × КК сыворотки (мг/дл)КК для женщин можно рассчитать, умножив полученное значение на коэффициент 0.85. Пациентам с сочетанной почечной и печеночной недостаточностью дозирование осуществляется по следующей таблице. Почечная недостаточность КК (мл/мин) Режим дозированияНорма >80 5 мг/сутЛегкая 50-79 5 мг/сутСредняя 30-49 5 мг/сут × 1 раз в 2 дняТяжелая <30 5 мг/сут × 1 раз в 3 дняТерминальная стадия - пациенты, находящиеся на диализе <10 Прием препарата противопоказанПациентам с нарушением только функции печени коррекция режима дозирования не требуется.
Побочное действие
Во время проведения клинических исследований у лиц мужского и женского пола в возрасте от 12 лет до 71 года часто (≥1/100, <1/10) встречались следующие нежелательные явления: головная боль, сонливость, сухость во рту, утомляемость; нечасто (≥1/1000, <1/100) - астения и боль в животе. У детей в возрасте от 6 до 12 лет часто (≥1/100, <1/10) встречались головная боль и сонливость. В период пострегистрационного применения препарата наблюдались следующие побочные эффекты, частота которых неизвестна из-за недостаточности данных. Со стороны иммунной системы: реакции гиперчувствительности, включая анафилаксию. Со стороны психики: тревога, агрессия, возбуждение, бессонница, галлюцинации, депрессия, суицидальные мысли. Со стороны нервной системы: судороги, тромбоз синусов твердой мозговой оболочки, парестезия, головокружение, обморок, тремор, дисгевзия. Со стороны слуха: вертиго. Со стороны органа зрения: нарушение зрения, нечеткость зрительного восприятия, воспалительные проявления. Со стороны сердечно-сосудистой системы: ощущение сердцебиения, тахикардия, тромбоз яремной вены. Со стороны дыхательной системы: одышка, усиление симптомов ринита. Со стороны пищеварительной системы: повышение аппетита, тошнота, рвота. Со стороны гепатобилиарной системы: гепатит, изменение функциональных проб печени. Со стороны мочевыделительной системы: дизурия, задержка мочи. Со стороны кожи и мягких тканей: сыпь, зуд, гипотрихоз, трещины. Аллергические реакции: ангионевротический отек, стойкая лекарственная эритема, крапивница, фотосенсибилизация. Со стороны костно-мышечной системы: боль в мышцах. Прочие: периферические отеки, увеличение массы тела, перекрестная реактивность. Если любые указанные в инструкции побочные эффекты усугубляются, или отмечаются другие побочные эффекты, не указанные в инструкции, пациенту следует сообщить об этом врачу.
Передозировка
Симптомы: у взрослых - сонливость, у детей - возбуждение, беспокойство, которые сменяются сонливостью. Лечение: промывание желудка или прием активированного угля, если после приема препарата прошло мало времени. Рекомендуется проведение симптоматической и поддерживающей терапии. Специфического антидота нет. Гемодиализ неэффективен.
Взаимодействие с другими лекарственными средствами
Уменьшение клиренса цетиризина (16%) наблюдалось при многократных введениях теофиллина (400 мг 1 раз/сут); при этом фармакокинетика теофиллина при одновременном введении цетиризина не изменялась.
У восприимчивых пациентов одновременное применение левоцетиризина и этанола или других угнетающих ЦНС средств может приводить к потенцированию угнетающего влияния на ЦНС.
Особые указания
С осторожностью следует применять препарат у пациентов с повреждением спинного мозга, гиперплазией предстательной железы, а так же при наличии других предрасполагающих факторов к задержке мочи, поскольку левоцетиризин может увеличивать риск задержки мочи. Таблетки Супрастинекс; содержат лактозу, поэтому не следует назначать данную лекарственную форму пациентам с непереносимостью лактозы, наследственным дефицитом лактазы или синдромом мальабсорбции глюкозы-галактозы. Капли Супрастинекс; могут вызвать аллергические реакции (иногда поздние), т.к. содержат метилпарагидроксибензоат и пропилпарагидроксибензоат. Препарат Супрастинекс; в каплях противопоказан детям в возрасте до 2 лет из-за отсутствия клинических данных. Препарат следует назначать с осторожностью при хронической почечной недостаточности, лицам пожилого возраста, при одновременном применении этанола. Влияние на способность к вождению автотранспорта и управлению механизмамиЛевоцетиризин может привести к повышенной сонливости, и, следовательно, может оказывать влияние на способность управлять автомобилем или работать с техникой. В период лечения необходимо воздерживаться от занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Таблетки.
Условия хранения
При температуре не выше 30 °C.
Срок годности
5 лет.
Условия отпуска
Без рецепта.
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дигидрохлорид 5 мг, что соответствует содержанию левоцетиризина 4.21 мг. Вспомогательные вещества: целлюлоза кремниевая микрокристаллическая (Prosolv; HD90) - 40.4 мг (целлюлоза микрокристаллическая (98%), кремния диоксид коллоидный безводный (2%)), лактозы моногидрат - 37.9 мг, гипролоза низкозамещенная (L-HPC11) - 10 мг, магния стеарат - 1.7 мг. Состав оболочки: опадрай II 33G28523 белый - 5 мг (гипромеллоза 2910 (40%), титана диоксид (25%), лактозы моногидрат (21%) - 1.05 мг, макрогол 3350 (8%), триацетин (6%))."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противоаллергическое средство. Левоцетиризин - R-энантиомер цетиризина, который относится к группе конкурентных антагонистов гистамина, блокирует гистаминовые Н1-рецепторы. Оказывает влияние на гистаминзависимую стадию аллергических реакций, уменьшает миграцию эозинофилов, уменьшает сосудистую проницаемость, ограничивает высвобождение медиаторов воспаления. Предупреждает развитие и облегчает течение аллергических реакций, оказывает антиэкссудативное, противозудное действие. Практически не оказывает антихолинергического и антисеротонинергического действия. В терапевтических дозах практически не оказывает седативного действия. Действие препарата начинается через 12 мин после приема однократной дозы у 50% пациентов, через 1 ч - у 95% и продолжается в течение 24 ч."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптоматическое лечение:"}},{"type":"list","data":{"style":"unordered","items":["Круглогодичного (персистирующего) и сезонного (интермиттирующего) аллергического ринита и конъюнктивита (зуд, чиханье, заложенность носа, ринорея, слезотечение, гиперемия конъюнктивы)","Сенной лихорадки (поллиноз)","Крапивницы, в т.ч. хронической идиопатической крапивницы (для таблеток)","Отека Квинке (для таблеток)","Аллергических дерматозов, сопровождающихся зудом и высыпаниями"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Терминальная стадия почечной недостаточности (КК менее 10 мл/мин)","Детский возраст до 6 лет (для таблеток)","Детский возраст до 2 лет (для капель для приема внутрь - из-за отсутствия клинических данных)","Беременность","Период лактации","Непереносимость лактозы, наследственный дефицит лактазы или синдром мальабсорбции глюкозы-галактозы (для таблеток)","Повышенная чувствительность к активному веществу (в т.ч. производным пиперазина) или любому вспомогательному компоненту препарата. С осторожностью следует назначать при хронической почечной недостаточности (необходима коррекция режима дозирования), пациентам пожилого возраста (возможно снижение клубочковой фильтрации), пациентам с повреждением спинного мозга, гипреплазией предстательной железы, а также при наличии других предрасполагающих факторов к задержке мочи (левоцетиризин может увеличивать риск задержки мочи), при одновременном употреблении с алкоголем"]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Доклинические исследования не выявили каких-либо прямых или косвенных неблагоприятных эффектов левоцетиризина на развивающийся плод, а также на развитие в постнатальном периоде; течение беременности и родов также не изменялось. Адекватных и строго контролируемых клинических исследований по безопасности применения препарата при беременности не проводилось. Применение препарата при беременности противопоказано. Левоцетиризин выделяется с грудным молоком, поэтому при необходимости применения препарата в период лактации рекомендуется прекратить грудное вскармливание."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат следует принимать внутрь во время еды или натощак. Таблетки принимают, не разжевывая, запивая небольшим количеством воды. Для приема препарата в форме капель следует использовать чайную ложку. При необходимости дозу препарата можно разбавить в небольшом количестве воды непосредственно перед употреблением. Рекомендуемая доза взрослым и детям старше 6 лет, пожилым пациентам (при условии нормальной функции почек) составляет 5 мг (1 таб. или 1 мл капель или 20 капель из капельницы)/сут. Максимальная суточная доза - 5 мг. Детям в возрасте от 2 до 6 лет препарат назначают в форме капель для приема внутрь по 1.25 мг (5 капель) 2 раза/сут; суточная доза - 2.5 мг (10 капель). Длительность приема зависит от заболевания. При лечении круглогодичного (персистирующего) аллергического ринита (наличие симптомов более 4 дней в неделю и их общая продолжительность более 4 недель) лечение может продолжаться в течение всего периода воздействия аллергенов. При лечении сезонного (интермиттирующего) аллергического ринита наличие симптомов менее 4 дней в неделю или их общая продолжительность менее 4 недель) длительность лечения зависит от характера заболевания; лечение может быть прекращено при исчезновении симптомов и возобновлено при появлении симптомов. Курс лечения поллиноза в среднем составляет 1-6 недель. При хронических заболеваниях (в т.ч. хроническая идиопатическая крапивница) курс лечения может быть более длительным по согласованию с врачом. Существует клинический опыт непрерывного применения препарата у взрослых пациентов продолжительностью до 6 мес. Поскольку левоцетиризин выводится из организма почками, при назначении препарата пациентам с почечной недостаточностью и пациентам пожилого возраста дозу следует корректировать в зависимости от величины клиренса креатинина (КК). КК для мужчин можно рассчитать, исходя из концентрации сывороточного креатинина, по следующей формуле: КК (мл/мин) = [140 - возраст (годы)] × масса тела (кг) / 72 × КК сыворотки (мг/дл)КК для женщин можно рассчитать, умножив полученное значение на коэффициент 0.85. Пациентам с сочетанной почечной и печеночной недостаточностью дозирование осуществляется по следующей таблице. Почечная недостаточность КК (мл/мин) Режим дозированияНорма \u003e80 5 мг/сутЛегкая 50-79 5 мг/сутСредняя 30-49 5 мг/сут × 1 раз в 2 дняТяжелая \u003c30 5 мг/сут × 1 раз в 3 дняТерминальная стадия - пациенты, находящиеся на диализе \u003c10 Прием препарата противопоказанПациентам с нарушением только функции печени коррекция режима дозирования не требуется."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Во время проведения клинических исследований у лиц мужского и женского пола в возрасте от 12 лет до 71 года часто (≥1/100, \u003c1/10) встречались следующие нежелательные явления: головная боль, сонливость, сухость во рту, утомляемость; нечасто (≥1/1000, \u003c1/100) - астения и боль в животе. У детей в возрасте от 6 до 12 лет часто (≥1/100, \u003c1/10) встречались головная боль и сонливость. В период пострегистрационного применения препарата наблюдались следующие побочные эффекты, частота которых неизвестна из-за недостаточности данных. Со стороны иммунной системы: реакции гиперчувствительности, включая анафилаксию. Со стороны психики: тревога, агрессия, возбуждение, бессонница, галлюцинации, депрессия, суицидальные мысли. Со стороны нервной системы: судороги, тромбоз синусов твердой мозговой оболочки, парестезия, головокружение, обморок, тремор, дисгевзия. Со стороны слуха: вертиго. Со стороны органа зрения: нарушение зрения, нечеткость зрительного восприятия, воспалительные проявления. Со стороны сердечно-сосудистой системы: ощущение сердцебиения, тахикардия, тромбоз яремной вены. Со стороны дыхательной системы: одышка, усиление симптомов ринита. Со стороны пищеварительной системы: повышение аппетита, тошнота, рвота. Со стороны гепатобилиарной системы: гепатит, изменение функциональных проб печени. Со стороны мочевыделительной системы: дизурия, задержка мочи. Со стороны кожи и мягких тканей: сыпь, зуд, гипотрихоз, трещины. Аллергические реакции: ангионевротический отек, стойкая лекарственная эритема, крапивница, фотосенсибилизация. Со стороны костно-мышечной системы: боль в мышцах. Прочие: периферические отеки, увеличение массы тела, перекрестная реактивность. Если любые указанные в инструкции побочные эффекты усугубляются, или отмечаются другие побочные эффекты, не указанные в инструкции, пациенту следует сообщить об этом врачу."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: у взрослых - сонливость, у детей - возбуждение, беспокойство, которые сменяются сонливостью. Лечение: промывание желудка или прием активированного угля, если после приема препарата прошло мало времени. Рекомендуется проведение симптоматической и поддерживающей терапии. Специфического антидота нет. Гемодиализ неэффективен."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Уменьшение клиренса цетиризина (16%) наблюдалось при многократных введениях теофиллина (400 мг 1 раз/сут); при этом фармакокинетика теофиллина при одновременном введении цетиризина не изменялась."}},{"type":"paragraph","data":{"text":"У восприимчивых пациентов одновременное применение левоцетиризина и этанола или других угнетающих ЦНС средств может приводить к потенцированию угнетающего влияния на ЦНС."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"С осторожностью следует применять препарат у пациентов с повреждением спинного мозга, гиперплазией предстательной железы, а так же при наличии других предрасполагающих факторов к задержке мочи, поскольку левоцетиризин может увеличивать риск задержки мочи. 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