Овальные таблетки, покрытые пленочной оболочкой белого или почти белого цвета. На одной стороне - гравировка "LC5". На поперечном разрезе ядро белого или почти белого цвета.
Фармакотерапевтическая группа
Н1-гистаминовых рецепторов антагонист
Фармакологические свойства
Фармакодинамика
Фармакокинетика
Фармакокинетические параметры левоцетиризина меняются линейно и практически не отличаются от фармакокинетики цетиризина.
Всасывание. После приема внутрь левоцетиризин быстро всасывается в желудочно-кишечном тракте. Прием пищи не влияет на степень абсорбции, хотя скорость ее уменьшается. После однократного приема внутрь в терапевтической дозе максимальная концентрация (Сmax) в плазме крови у взрослых достигается через 0,9 ч и составляет 207 нг/мл, после повторного приема в дозе 5 мг/сут - 308 нг/мл. Биодоступность составляет 100%.
Распределение. Равновесная концентрация достигается через 2 суток. Связывание левоцетиризина с белками плазмы составляет 90%. Объем распределения препарата составляет 0,4 л/кг.
Метаболизм. Менее 14% метаболизируется в печени путем включения процессов окисления ароматических соединений, N- и О-деалкилирования и конъюгации таурина. Деалкилирование происходит в присутствии изофермента CYP3A4, а в окислении ароматических соединений участвуют многочисленные и/или не идентифицированные изоферменты Р450. Левоцетиризин не оказывает влияния на активность изоферментов CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 и CYP3A4 в концентрации значительно превышающей Сmax после приема внутрь дозы 5 мг. Из-за низкого уровня метаболизма и отсутствия метаболического потенциала взаимодействие левоцетиризина с другими лекарственными препаратами представляется маловероятным.
Выведение. У взрослых период полувыведения (Т1/2)) составляет 7,9±1,9 ч, общий клиренс- 0,63 мл/мин/кг. Полностью выводится из организма в течение 96 ч. Около 85,4% дозы выводится почками в неизмененном виде путем клубочковой фильтрации и канальцевой секреции; около 12,9% выводится с калом.
Фармакокинетика в особых клинических случаях. У пациентов с почечной недостаточностью (клиренс креатинина (КК) менее 40 мл/мин) клиренс левоцетиризина уменьшается, а Т1/2 увеличивается (у пациентов, находящихся на гемодиализе, общий клиренс снижается на 80%), что требует соответствующего изменения режима дозирования. Менее 10% левоцетиризина удаляется в ходе стандартной 4-часовой процедуры гемодиализа. У детей младшей возрастной группы Т1/2 уменьшается.
Показания к применению
Симптоматическое лечение круглогодичного и сезонного аллергического ринита и конъюнктивита (зуд, чиханье, ринорея, слезотечение, гипермия конъюнктивы); сенной лихорадки (поллиноз); крапивницы, в т.ч. хронической идиопатической крапивницы; отека Квинке; аллергических дерматозов, сопровождающихся зудом и высыпаниями.
Противопоказания
Почечная недостаточность тяжелой степени (КК ниже 10 мл/мин); детский возраст до 2 лет; повышенная чувствительность к левоцетиризину.
С осторожностью
Средняя и тяжелая степень почечной недостаточности (КК более 10 мл/мин, но менее 50 мл/мин); пожилой возраст (возможно снижение клубочковой фильтрации).
Применение при беременности и в период грудного вскармливания
Недостаточно клинических данных о применении левоцетиризина у беременных женщин, поэтому не следует применять препарат Левоцетиризин -Тева при беременности.
Левоцетиризин выделяется с грудным молоком. При необходимости применения препарата Левоцетиризин -Тева грудное вскармливание следует прекратить.
Способ применения и дозы
Принимают внутрь, независимо от приема пищи.
Взрослым и детям в возрасте старше 6 лет - по 5 мг 1 раз/сут.
Детям в возрасте 2-6 лет - по 1.25 мг 2 раза/сут.
Продолжительность лечения зависит от вида, длительности и течения симптомов. Для лечения сенной лихорадки требуется 3-6 недель, а при кратковременном воздействии пыльцы обычно достаточно приема препарата в течение 1 недели.
Побочное действие
Частота развития побочных эффектов классифицирована согласно рекомендациям Всемирной организации здравооохранения: очень часто - не менее 10%; часто - не менее 1%, но менее 10%; нечасто - не менее 0,1%, но менее 1%; редко - не менее 0,01%, но менее 0,1%; очень редко - менее 0,01%, включая единичные случаи.
Со стороны нервной системы: часто - головная боль, сонливость, агрессия, возбуждение, судороги; редко - мигрень, головокружение.
Со стороны органа зрения: часто - нарушения зрения.
Со стороны сердечно-сосудистой системы: очень редко - тахикардия.
Со стороны дыхательной системы: очень редко - диспноэ.
Со стороны пищеварительной системы: часто - сухость слизистой оболочки полости рта; нечасто - боль в животе; очень редко - тошнота, диспепсия, диарея, изменение функциональных проб печени, гепатит.
Со стороны опорно-двигательного аппарата: редко - миалгия.
Со стороны обмена веществ: редко - увеличение массы тела.
Аллергические реакции: очень редко - кожный зуд, кожная сыпь, крапивница, ангионевротический отек, анафилаксия.
Прочие: часто - быстрая утомляемость, ощущение усталости; нечасто - астения.
Передозировка
Симптомы: сонливость (у взрослых), возбуждение и беспокойство, сменяющиеся сонливостью (у детей).
Лечение симптоматическое: сразу после приема препарата провести промывание желудка или вызвать искусственную рвоту. Рекомендуется применение активированного угля, проведение симптоматической и поддерживающей терапии. Специфического антидота нет. Гемодиализ неэффективен.
Взаимодействие с другими лекарственными средствами
При изучении лекарственного взаимодействия левоцетиризина с псевдоэфедрином, циметидином, кетоконазолом, эритромицином, азитромицином, глипизидом и диазепамом клинически значимого нежелательного взаимодействия не выявлено. Одновременное применение с макролидами или кетоконазолом не вызывало достоверных изменений на ЭКГ.
При одновременном применении с теофиллином (400 мг/сут) общий клиренс цетиризина снижается на 16%, фармакокинетические параметры теофиллина не меняются.
В ряде случаев при одновременном применении левоцетиризина с этанолом или лекарственными препаратами, оказывающими угнетающее действие на центральную нервную систему (ЦНС), возможно усиление их влияния на ЦНС, хотя доказано, что левоцетиризин не усиливает эффект этанола.
Особые указания
Нельзя превышать рекомендуемую суточную дозу.
Пациента необходимо предупредить о том, что употребление алкоголя во время лечения левоцетиризином не рекомендуется.
Влияние на способность управлять автомобилем и движущимися механизмами
Способность к вождению автотранспорта и работе с механизмами при применении левоцетиризина в рекомендуемой дозе не изменяется. Тем не менее, учитывая, что в период лечения могут развиться побочные реакции (сонливость, головокружение) необходимо соблюдать осторожность во время занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Таблетки, покрытые пленочной оболочкой 5 мг.
По 7 таблеток в блистер из алюминиевой ламинированной фольги. 1 или 2 блистера с инструкцией по применению в пачке картонной.
По 10 таблеток в блистер из алюминиевой ламинированной фольги. 1 блистер с инструкцией по применению в пачке картонной.
Условия хранения
Хранить при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
3 года.
Не применять по истечении срока годности, указанного на упаковке.
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001335-081211"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Левоцетиризин -Тева"}}]},{"id":3,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"таблетки, покрытые пленочной оболочкой"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"\n\nВ 1 таблетке содержится:"}},{"type":"paragraph","data":{"text":"активное вещество: левоцетиризина дигидрохлорид 5,00 мг;"}},{"type":"paragraph","data":{"text":"вспомогательные вещества: целлюлоза микрокристаллическая 30,00 мг, лактозы моногидрат 63,50 мг, кремния диоксид коллоидный 0,50 мг, магния стеарат 1,00 мг;"}},{"type":"paragraph","data":{"text":"оболочка Опадрай Y1-7000H белый: макрогол-400 0,1875 мг, титана диоксид (Е171) 0,9375 мг, гипромеллоза-2910 (Е464) 1,875 мг.\n\n"}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Овальные таблетки, покрытые пленочной оболочкой белого или почти белого цвета. На одной стороне - гравировка \"LC5\". На поперечном разрезе ядро белого или почти белого цвета."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Н1-гистаминовых рецепторов антагонист"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Фармакодинамика"}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"Фармакокинетические параметры левоцетиризина меняются линейно и практически не отличаются от фармакокинетики цетиризина."}},{"type":"paragraph","data":{"text":"Всасывание. После приема внутрь левоцетиризин быстро всасывается в желудочно-кишечном тракте. Прием пищи не влияет на степень абсорбции, хотя скорость ее уменьшается. После однократного приема внутрь в терапевтической дозе максимальная концентрация (С\u003csub\u003emax\u003c/sub\u003e) в плазме крови у взрослых достигается через 0,9 ч и составляет 207 нг/мл, после повторного приема в дозе 5 мг/сут - 308 нг/мл. Биодоступность составляет 100%."}},{"type":"paragraph","data":{"text":"Распределение. Равновесная концентрация достигается через 2 суток. Связывание левоцетиризина с белками плазмы составляет 90%. Объем распределения препарата составляет 0,4 л/кг."}},{"type":"paragraph","data":{"text":"Метаболизм. Менее 14% метаболизируется в печени путем включения процессов окисления ароматических соединений, N- и О-деалкилирования и конъюгации таурина. Деалкилирование происходит в присутствии изофермента CYP3A4, а в окислении ароматических соединений участвуют многочисленные и/или не идентифицированные изоферменты Р450. Левоцетиризин не оказывает влияния на активность изоферментов CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 и CYP3A4 в концентрации значительно превышающей С\u003csub\u003emax\u003c/sub\u003e после приема внутрь дозы 5 мг. Из-за низкого уровня метаболизма и отсутствия метаболического потенциала взаимодействие левоцетиризина с другими лекарственными препаратами представляется маловероятным."}},{"type":"paragraph","data":{"text":"Выведение. У взрослых период полувыведения (Т1/2)) составляет 7,9±1,9 ч, общий клиренс- 0,63 мл/мин/кг. Полностью выводится из организма в течение 96 ч. Около 85,4% дозы выводится почками в неизмененном виде путем клубочковой фильтрации и канальцевой секреции; около 12,9% выводится с калом."}},{"type":"paragraph","data":{"text":"Фармакокинетика в особых клинических случаях. У пациентов с почечной недостаточностью (клиренс креатинина (КК) менее 40 мл/мин) клиренс левоцетиризина уменьшается, а Т\u003csub\u003e1/2\u003c/sub\u003e увеличивается (у пациентов, находящихся на гемодиализе, общий клиренс снижается на 80%), что требует соответствующего изменения режима дозирования. Менее 10% левоцетиризина удаляется в ходе стандартной 4-часовой процедуры гемодиализа. У детей младшей возрастной группы Т\u003csub\u003e1/2\u003c/sub\u003e уменьшается."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Симптоматическое лечение круглогодичного и сезонного аллергического ринита и конъюнктивита (зуд, чиханье, ринорея, слезотечение, гипермия конъюнктивы); сенной лихорадки (поллиноз); крапивницы, в т.ч. хронической идиопатической крапивницы; отека Квинке; аллергических дерматозов, сопровождающихся зудом и высыпаниями."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Почечная недостаточность тяжелой степени (КК ниже 10 мл/мин); детский возраст до 2 лет; повышенная чувствительность к левоцетиризину."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Средняя и тяжелая степень почечной недостаточности (КК более 10 мл/мин, но менее 50 мл/мин); пожилой возраст (возможно снижение клубочковой фильтрации)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"\n\nНедостаточно клинических данных о применении левоцетиризина у беременных женщин, поэтому не следует применять препарат Левоцетиризин -Тева при беременности."}},{"type":"paragraph","data":{"text":"Левоцетиризин выделяется с грудным молоком. При необходимости применения препарата Левоцетиризин -Тева грудное вскармливание следует прекратить.\n\n"}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Принимают внутрь, независимо от приема пищи."}},{"type":"paragraph","data":{"text":"Взрослым и детям в возрасте старше 6 лет - по 5 мг 1 раз/сут."}},{"type":"paragraph","data":{"text":"Детям в возрасте 2-6 лет - по 1.25 мг 2 раза/сут."}},{"type":"paragraph","data":{"text":"Продолжительность лечения зависит от вида, длительности и течения симптомов. Для лечения сенной лихорадки требуется 3-6 недель, а при кратковременном воздействии пыльцы обычно достаточно приема препарата в течение 1 недели."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\n\nЧастота развития побочных эффектов классифицирована согласно рекомендациям Всемирной организации здравооохранения: очень часто - не менее 10%; часто - не менее 1%, но менее 10%; нечасто - не менее 0,1%, но менее 1%; редко - не менее 0,01%, но менее 0,1%; очень редко - менее 0,01%, включая единичные случаи."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: часто - головная боль, сонливость, агрессия, возбуждение, судороги; редко - мигрень, головокружение."}},{"type":"paragraph","data":{"text":"Со стороны органа зрения: часто - нарушения зрения."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: очень редко - тахикардия."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: очень редко - диспноэ."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: часто - сухость слизистой оболочки полости рта; нечасто - боль в животе; очень редко - тошнота, диспепсия, диарея, изменение функциональных проб печени, гепатит."}},{"type":"paragraph","data":{"text":"Со стороны опорно-двигательного аппарата: редко - миалгия."}},{"type":"paragraph","data":{"text":"Со стороны обмена веществ: редко - увеличение массы тела."}},{"type":"paragraph","data":{"text":"Аллергические реакции: очень редко - кожный зуд, кожная сыпь, крапивница, ангионевротический отек, анафилаксия."}},{"type":"paragraph","data":{"text":"Прочие: часто - быстрая утомляемость, ощущение усталости; нечасто - астения. \n\n"}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\n\nСимптомы: сонливость (у взрослых), возбуждение и беспокойство, сменяющиеся сонливостью (у детей)."}},{"type":"paragraph","data":{"text":"Лечение симптоматическое: сразу после приема препарата провести промывание желудка или вызвать искусственную рвоту. Рекомендуется применение активированного угля, проведение симптоматической и поддерживающей терапии. Специфического антидота нет. Гемодиализ неэффективен. \n\n"}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"\n\nПри изучении лекарственного взаимодействия левоцетиризина с псевдоэфедрином, циметидином, кетоконазолом, эритромицином, азитромицином, глипизидом и диазепамом клинически значимого нежелательного взаимодействия не выявлено. Одновременное применение с макролидами или кетоконазолом не вызывало достоверных изменений на ЭКГ."}},{"type":"paragraph","data":{"text":"При одновременном применении с теофиллином (400 мг/сут) общий клиренс цетиризина снижается на 16%, фармакокинетические параметры теофиллина не меняются."}},{"type":"paragraph","data":{"text":"В ряде случаев при одновременном применении левоцетиризина с этанолом или лекарственными препаратами, оказывающими угнетающее действие на центральную нервную систему (ЦНС), возможно усиление их влияния на ЦНС, хотя доказано, что левоцетиризин не усиливает эффект этанола.\n\n"}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nНельзя превышать рекомендуемую суточную дозу."}},{"type":"paragraph","data":{"text":"Пациента необходимо предупредить о том, что употребление алкоголя во время лечения левоцетиризином не рекомендуется.\n\n"}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Способность к вождению автотранспорта и работе с механизмами при применении левоцетиризина в рекомендуемой дозе не изменяется. Тем не менее, учитывая, что в период лечения могут развиться побочные реакции (сонливость, головокружение) необходимо соблюдать осторожность во время занятий потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nТаблетки, покрытые пленочной оболочкой 5 мг."}},{"type":"paragraph","data":{"text":"По 7 таблеток в блистер из алюминиевой ламинированной фольги. 1 или 2 блистера с инструкцией по применению в пачке картонной."}},{"type":"paragraph","data":{"text":"По 10 таблеток в блистер из алюминиевой ламинированной фольги. 1 блистер с инструкцией по применению в пачке картонной. \n\n"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"\n\nХранить при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте.\n\n"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"\n\n3 года."}},{"type":"paragraph","data":{"text":"Не применять по истечении срока годности, указанного на упаковке. \n\n"}}]},{"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":"\u003ca href=\"https://www.eapteka.ru/goods/manufacturer/teva/\"\u003eТева Фармацевтические Предприятия Лтд, Израиль\u003c/a\u003e"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"Тева Фармацевтические Предприятия Лтд"}}]}],"source":null},"description_toggle":false,"short_description":"Фармакодинамика Фармакокинетика Фармакокинетические параметры левоцетиризина меняются линейно и практически не отличаются от фармакокинетики цетиризина. Всасывание. После приема внутрь левоцетиризин быстро всасывается в желудочно-кишечном тракте. Прием пищи не влияет на степень абсорбции, хотя скорость ее уменьшается. После однократного приема внутрь в терапевтической дозе максимальная концентрация (Сmax) в плазме крови у взрослых достигается через 0,9 ч и составляет 207 нг/мл, после повторного приема в дозе 5 мг/сут - 308 нг/мл. Биодоступность составляет 100%. Распределение. Равновесная концентрация достигается через 2 суток. Связывание левоцетиризина с белками плазмы составляет 90%. Объем распределения препарата составляет 0,4 л/кг. Метаболизм. Менее 14% метаболизируется в печени путем включения процессов окисления ароматических соединений, N- и О-деалкилирования и конъюгации таурина. Деалкилирование происходит в присутствии изофермента CYP3A4, а в окислении ароматических соединений участвуют многочисленные и/или не идентифицированные изоферменты Р450. Левоцетиризин не оказывает влияния на активность изоферментов CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 и CYP3A4 в концентрации значительно превышающей Сmaxпосле приема внутрь дозы 5 мг. Из-за низкого уровня метаболизма и отсутствия метаболического потенциала взаимодействие левоцетиризина с другими лекарственными препаратами представляется маловероятным. Выведение. У взрослых период полувыведения (Т1/2)) составляет 7,9±1,9 ч, общий клиренс- 0,63 мл/мин/кг. Полностью выводится из организма в течение 96 ч. Около 85,4% дозы выводится почками в неизмененном виде путем клубочковой фильтрации и канальцевой секреции; около 12,9% выводится с калом. Фармакокинетика в особых клинических случаях. У пациентов с почечной недостаточностью (клиренс креатинина (КК) менее 40 мл/мин) клиренс левоцетиризина уменьшается, а Т1/2увеличивается (у пациентов, находящихся на гемодиализе, общий клиренс снижается на 80%), что требует соответствующего изменения режима дозирования. Менее 10% левоцетиризина удаляется в ходе стандартной 4-часовой процедуры гемодиализа. 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