Солонэкс Капли, флакон, 20 мл, 10 мг / мл, для приема внутрь

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В 6-недельном\nплацебо-контролируемом исследовании с участием             186 пациентов с аллергическим\nринитом и сопутствующей бронхиальной астмой легкого и среднетяжелого течения\nпоказано, что прием цетиризина в дозе 10 мг один раз в сутки уменьшает симптомы\nринита и не влияет на функцию легких."}},{"type":"paragraph","data":{"text":"Результаты данного\nисследования подтверждают безопасность применения цетиризина у пациентов,\nстрадающих аллергией и бронхиальной астмой легкого и среднетяжелого течения."}},{"type":"paragraph","data":{"text":"В плацебо-контролируемом\nисследовании показано, что прием цетиризина в дозе 60 мг в сутки в течение 7\nдней не вызывал клинически значимого удлинения интервала QT."}},{"type":"paragraph","data":{"text":"Прием цетиризина в\nрекомендуемой дозе показал улучшение качества жизни пациентов с круглогодичным\nи сезонным аллергическими ринитами."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДети\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"В 35-дневном исследовании\nс участием пациентов в возрасте 5-12 лет не выявлено признаков\nневосприимчивости к антигистаминному эффекту цетиризина. Нормальная реакция\nкожи на гистамин восстанавливалась в течение трех дней после отмены препарата\nпри его неоднократном применении."}},{"type":"paragraph","data":{"text":"В 7-дневном\nплацебо-контролируемом исследовании препарата в лекарственной форме сироп с\nучастием 42 пациентов в возрасте от 6 до 11 месяцев продемонстрирована\nбезопасность применения препарата. Цетиризин назначался в дозе 0,25 мг/кг два\nраза в день, что приблизительно соответствовало 4,5 мг в день (диапазон доз\nсоставлял от 3,4 до 6,2 мг в день).   "}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eПрименение у детей от 6\nдо 12 месяцев возможно только по назначению врача и под строгим медицинским\nконтролем.\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eФармакокинетика\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Фармакокинетические\nпараметры цетиризина при его применении в дозах от 5 до 60 мг изменяются\nлинейно."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВсасывание \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Максимальная\nконцентрация (C\u003csub\u003emax\u003c/sub\u003e) в плазме\nкрови достигается через 1 ± 0,5 часа и составляет 300 нг/мл."}},{"type":"paragraph","data":{"text":"Различные фармакокинетические\nпараметры, такие как максимальная концентрация в плазме крови и площадь под\nкривой «концентрация-время» имеют однородный характер."}},{"type":"paragraph","data":{"text":"Прием пищи\nне влияет на полноту абсорбции цетиризина, хотя скорость ее уменьшается."}},{"type":"paragraph","data":{"text":"Биодоступность\nразличных лекарственных форм цетиризина (раствор, капсулы, таблетки)\nсопоставима."}},{"type":"paragraph","data":{"text":"\u003ci\u003eРаспределение \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Цетиризин\nна 93 ± 0,3 % связывается с белками плазмы крови. Объем распределения (V\u003csub\u003ed\u003c/sub\u003e) составляет 0,5 л/кг. Цетиризин не\nвлияет на связывание варфарина с белками."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМетаболизм \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Цетиризин\nне подвергается экстенсивному первичному метаболизму."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВыведение \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Период\nполувыведения (Т\u003csub\u003e1/2\u003c/sub\u003e) составляет примерно 10 часов."}},{"type":"paragraph","data":{"text":"При приеме\nпрепарата в суточной дозе 10 мг в течение 10 дней кумуляции цетиризина не\nнаблюдалось."}},{"type":"paragraph","data":{"text":"Примерно\n2/3 принятой дозы препарата выводится с мочой в неизменном виде."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПациенты пожилого возраста\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"У 16 пациентов\nпожилого возраста при однократном приеме препарата в дозе 10 мг       Т\u003csub\u003e1/2\u003c/sub\u003e был выше на 50 %, а\nклиренс – ниже на 40 % по сравнению с лицами не пожилого возраста."}},{"type":"paragraph","data":{"text":"Снижение\nклиренса цетиризина у пациентов пожилого возраста, вероятно, связано с\nуменьшением функции почек у этой категории пациентов."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПациенты с почечной недостаточностью\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"У пациентов\nс почечной недостаточностью легкой степени тяжести (клиренс креатинина (КК)\n> 40 мл/мин) фармакокинетические параметры аналогичны таковым у здоровых\nдобровольцев с нормальной функцией почек."}},{"type":"paragraph","data":{"text":"У пациентов\nс почечной недостаточностью средней степени тяжести и у пациентов, находящихся\nна гемодиализе (КК < 7 мл/мин), при приеме препарата внутрь в дозе 10 мг Т\u003csub\u003e1/2\u003c/sub\u003e\nудлиняется в 3 раза, а общий клиренс снижается на 70 % относительно здоровых\nдобровольцев с нормальной функцией почек."}},{"type":"paragraph","data":{"text":"Для\nпациентов с почечной недостаточностью средней или тяжелой степени требуется\nсоответствующее изменение режима дозирования (см. раздел «Способ применения и\nдозы»\u003ci\u003e)\u003c/i\u003e."}},{"type":"paragraph","data":{"text":"Цетиризин\nплохо удаляется из организма при гемодиализе."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПациенты с печеночной недостаточностью\u003c/i\u003e"}},{"type":"header","data":{"text":"У пациентов с хроническими заболеваниями печени (гепатоцеллюлярным,\nхолеста-тическим и билиарным циррозом) при однократном приеме препарата в дозе 10\nили 20 мг Т\u003csub\u003e1/2\u003c/sub\u003e увеличивается примерно на 50 %, а клиренс снижается\nна 40 % по сравнению со здоровыми субъектами. Коррекция дозы необходима только\nв случае, если у пациента с печеночной недостаточностью имеется также\nсопутствующая почечная недостаточность.","level":4}},{"type":"paragraph","data":{"text":"\u003ci\u003eДети\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Т\u003csub\u003e1/2\u003c/sub\u003e у детей от 6 до 12\nлет составляет 6 часов, от 2 до 6 лет – 5 часов, от 6 месяцев до 2 лет –\nснижено до 3,1 часа."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Применение препарата\nпоказано у взрослых и детей с 6 месяцев и старше для облегчения:"}},{"type":"paragraph","data":{"text":"- назальных и\nглазных симптомов круглогодичного (персистирующего) и сезонного\n(интермиттирующего) аллергического ринита и аллергического конъюнктивита: зуда,\nчиханья, заложенности носа, ринореи, слезотечения, гиперемии конъюнктивы;"}},{"type":"paragraph","data":{"text":"- симптомов\nхронической идиопатической крапивницы."}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eПрименение у детей от 6 до 12 месяцев возможно только по назначению врача\nи под строгим медицинским контролем.\u003c/i\u003e\u003c/b\u003e"}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- Повышенная\nчувствительность к цетиризину, гидроксизину или любым производным пиперазина, а\nтакже к другим компонентам препарата."}},{"type":"paragraph","data":{"text":"- Терминальная\nстадия почечной недостаточности (КК < 10 мл/мин)."}},{"type":"paragraph","data":{"text":"- Детский возраст до\n6 месяцев (ввиду ограниченности данных по эффективности и безопасности\nприменения препарата)."}},{"type":"paragraph","data":{"text":"- Беременность."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"- Хроническая\nпочечная недостаточность (при КК > 10 мл/мин требуется коррекция режима\nдозирования)."}},{"type":"paragraph","data":{"text":"- Пациенты\nпожилого возраста (при возрастном снижении скорости клубочковой фильтрации)."}},{"type":"paragraph","data":{"text":"- Эпилепсия\nи пациенты с повышенной судорожной готовностью."}},{"type":"paragraph","data":{"text":"- Пациенты\nс предрасполагающими факторами к задержке мочи (см. раздел «Особые указания»)."}},{"type":"paragraph","data":{"text":"- Детский\nвозраст до 1 года."}},{"type":"paragraph","data":{"text":"- Период\nгрудного вскармливания."}},{"type":"paragraph","data":{"text":"- При одновременном применении с алкоголем."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eБеременность \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"При анализе проспективных данных\nболее чем 700 случаев исходов беременности не выявлено случаев формирования\nпороков развития, эмбриональной и неонатальной токсичности с четкой\nпричинно-следственной связью. "}},{"type":"paragraph","data":{"text":"Экспериментальные исследования на\nживотных не выявили каких-либо прямых или косвенных неблагоприятных эффектов\nцетиризина на развивающийся плод (в том числе в постнатальном периоде), течение\nбеременности и постнатальное развитие."}},{"type":"paragraph","data":{"text":"Адекватных и строго контролируемых\nклинических исследований по безопасности применения препарата во время\nбеременности не проводилось, поэтому Солонэкс не следует применять при\nбеременности."}},{"type":"paragraph","data":{"text":"Грудное\nвскармливание"}},{"type":"paragraph","data":{"text":"Не следует применять препарат в\nпериод грудного вскармливания, так как цетиризин экскретируется с грудным\nмолоком."}},{"type":"paragraph","data":{"text":"\u003ci\u003eФертильность\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Доступные данные о\nвлиянии на фертильность человека ограничены, однако отрицательного влияния на\nфертильность не выявлено."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь, накапать в ложку\nили растворить в воде."}},{"type":"paragraph","data":{"text":"Количество воды для\nрастворения препарата должно соответствовать количеству жидкости, которое\nпациент (особенно ребенок) в состоянии проглотить."}},{"type":"paragraph","data":{"text":"Раствор следует принимать\nсразу после приготовления."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВзрослые\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"10 мг (20 капель) 1 раз в\nдень."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПациенты пожилого возраста \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Нет необходимости в\nснижении дозировки у пациентов пожилого возраста, если функция почек не\nнарушена."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПациенты с почечной недостаточностью\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Поскольку цетиризин выводится из организма в\nосновном почками (см. подраздел «Фармакокинетика»), при невозможности\nальтернативного лечения пациентам с почечной недостаточностью режим дозирования\nпрепарата следует корректировать в зависимости от функции почек (величины КК)."}},{"type":"paragraph","data":{"text":"КК для мужчин можно рассчитать,\nисходя из концентрации сывороточного креатинина в плазме крови, по следующей\nформуле:"}},{"type":"paragraph","data":{"text":"КК (мл/мин) =  [140 – возраст (годы)] × масса тела (кг)"}},{"type":"paragraph","data":{"text":"  \n 72 × КК\u003csub\u003eсыворот \u003c/sub\u003e(мг/дл)"}},{"type":"paragraph","data":{"text":"КК для женщин можно\nрассчитать, умножив полученное значение на коэффициент 0,85."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПациенты с нарушением функции печени\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"У пациентов с нарушением\nтолько функции печени коррекции режима дозирования не требуется."}},{"type":"paragraph","data":{"text":"У пациентов с \u003ci\u003eнарушением и функции печени, и функции почек\u003c/i\u003e\nрекомендуется коррекция дозирования (см. таблицу выше)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДети \u003c/i\u003e"}},{"type":"header","data":{"text":"\u003cb\u003e\u003ci\u003eПрименение у детей от 6\nдо 12 месяцев возможно только по назначению врача и под строгим медицинским\nконтролем.\u003c/i\u003e\u003c/b\u003e","level":4}},{"type":"paragraph","data":{"text":"\u003ci\u003eДети от 6 до 12 месяцев  \u003c/i\u003e2,5 мг (5 капель) 1 раз в\nдень "}},{"type":"paragraph","data":{"text":"\u003ci\u003eДети от 1 года до 6 лет \u003c/i\u003e2,5 мг (5 капель) 2 раза\nв день "}},{"type":"paragraph","data":{"text":"\u003ci\u003eДети от 6 до 12 лет \u003c/i\u003e5 мг (10 капель) 2 раза в\nдень"}},{"type":"paragraph","data":{"text":"\u003ci\u003eДети старше 12 лет \u003c/i\u003e10 мг (20 капель) 1 раз в\nдень"}},{"type":"paragraph","data":{"text":"Иногда начальной дозы 5\nмг (10 капель) может быть достаточно, если это позволяет достичь\nудовлетворительного контроля симптомов."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДетям с почечной недостаточностью \u003c/i\u003eдозу корректируют с учетом КК и массы\nтела."}},{"type":"paragraph","data":{"text":"Если после лечения\nулучшения не наступает или симптомы усугубляются, или появляются новые\nсимптомы, необходимо проконсультироваться с врачом."}},{"type":"paragraph","data":{"text":"Применяйте\nпрепарат только согласно тем показаниям, тому способу применения и в тех дозах,\nкоторые указаны в инструкции."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы \u003c/i\u003e"}},{"type":"paragraph","data":{"text":"При однократном приеме препарата в\nдозе 50 мг могут наблюдаться следующие \u003ci\u003eсимптомы:\u003c/i\u003e\nспутанность сознания, диарея, головокружение, повышенная утомляемость, головная\nболь, недомогание, мидриаз, зуд, беспокойство, слабость, седативный эффект,\nсонливость, ступор, тахикардия, тремор, задержка мочи."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Немедленно после приема\nпрепарата – промывание желудка или стимуляция рвоты. Рекомендуется прием\nактивированного угля, проведение симптоматической и поддерживающей терапии.\nСпецифического антидота нет. Гемодиализ неэффективен."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Одновременное применение с\nазитромицином, циметидином, эритромицином, кетоконазолом или псевдоэфедрином не\nвлияет на фармакокинетические параметры цетиризина. Фармакокинетических\nвзаимодействий не наблюдалось. Согласно испытаниям \u003ci\u003ein\u003c/i\u003e\u003ci\u003e \u003c/i\u003e\u003ci\u003evitro\u003c/i\u003e,\nцетиризин не влияет на эффект связывания белка варфарина. Одновременный прием\nазитромицина, эритромицина, кетоконазола, теофиллина и псевдоэфедрина не выявил\nсущественных изменений в клинических лабораторных показателях, жизненно важных\nфункциях и ЭКГ. В исследовании с одновременным приемом теофиллина (400 мг в\nдень) и цетиризина (20 мг в день) было обнаружено незначительное, но\nстатистически достоверное повышение 24-часовой AUC (площади под кривой) на 19 %\nдля цетиризина и на 11 % для теофиллина. Кроме того, максимальные уровни в\nплазме крови увеличились до 7,7 % и 6,4 % соответственно для цетиризина и\nтеофиллина. Одновременно клиренс цетиризина уменьшился на 16 %, а также на 10 %\nв случае теофиллина, когда цетиризин принимали пациенты, которые ранее получали\nлечение теофиллином. Тем не менее, предварительное лечение цетиризином не\nоказало существенного влияния на фармакокинетические параметры теофиллина.\nПосле однократного приема цетиризина в дозе 10 мг эффект алкоголя (0,8 ‰)\nзначительно не усиливался; статистически значимое взаимодействие с 5 мг\nдиазепама было доказано в одном из 16 психометрических тестов. Одновременный\nприем 10 мг цетиризина в день с глипизидом привел к незначительному снижению\nпоказателей глюкозы. Этот эффект не имеет клинического значения. Тем не менее,\nрекомендуется раздельный прием – глипизид утром и цетиризин вечером. "}},{"type":"paragraph","data":{"text":"Если Вы применяете\nвышеперечисленные или другие лекарственные препараты (в том числе безрецептурные)\nперед применением препарата проконсультируйтесь с врачом."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Ввиду потенциального угнетающего\nвлияния на центральную нервную систему следует соблюдать осторожность при\nназначении препарата детям в возрасте до 1 года при наличии следующих факторов\nриска возникновения синдрома внезапной детской смерти, таких как (но не\nограничиваясь этим списком):"}},{"type":"paragraph","data":{"text":"- синдром апноэ во сне или синдром\nвнезапной детской смерти детей грудного возраста у брата или сестры;"}},{"type":"paragraph","data":{"text":"- злоупотребление матери наркотиками или\nкурением во время беременности;"}},{"type":"paragraph","data":{"text":"- молодой возраст матери (19 лет и\nмоложе);"}},{"type":"paragraph","data":{"text":"- злоупотребление курением няни,\nухаживающей за ребенком (одна пачка сигарет в день или более);"}},{"type":"paragraph","data":{"text":"- дети, регулярно засыпающие лицом\nвниз и которых не укладывают на спину;"}},{"type":"paragraph","data":{"text":"- недоношенные (гестационный возраст\nменее 37 недель) или рожденные с недостаточной массой тела (ниже 10-го\nперцентиля от гестационного возраста) дети;"}},{"type":"paragraph","data":{"text":"- при совместном приеме препаратов,\nоказывающих угнетающее влияние на центральную нервную систему. "}},{"type":"paragraph","data":{"text":"В состав препарата входят\nвспомогательные вещества метилпарагидроксибензоат и пропилпарагидроксибензоат,\nкоторые могут вызвать аллергические реакции, в том числе замедленного типа."}},{"type":"paragraph","data":{"text":"У пациентов с повреждением спинного\nмозга, гиперплазией предстательной железы, а также при наличии других\nпредрасполагающих факторов к задержке мочи требуется соблюдение осторожности,\nтак как цетиризин может увеличивать риск задержки мочи."}},{"type":"paragraph","data":{"text":"Рекомендовано соблюдать осторожность\nпри применении цетиризина одновременно с алкоголем."}},{"type":"paragraph","data":{"text":"Осторожность следует соблюдать у\nпациентов с эпилепсией и повышенной судорожной готовностью."}},{"type":"paragraph","data":{"text":"Перед назначением аллергологических\nпроб рекомендован трехдневный «отмывочный» период ввиду того, что Н\u003csub\u003e1\u003c/sub\u003e-гистаминовых\nрецепторов блокаторы ингибируют развитие кожных аллергических реакций."}},{"type":"paragraph","data":{"text":"После прекращения\nприменения цетиризина может появиться зуд и/или крапивница, даже если эти\nсимптомы отсутствовали в начале лечения. В некоторых случаях симптомы могут\nбыть интенсивными и требовать возобновления приема цетиризина. Симптомы исчезают\nпри возобновлении приема цетиризина."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"При объективной оценке\nспособности к вождению автотранспорта и управлению механизмами достоверно не\nвыявлено каких-либо нежелательных явлений при приеме препарата в рекомендуемой\nдозе. Однако пациентам с проявлениями сонливости на фоне приема препарата\nцелесообразно воздерживаться от управления автомобилем, занятий потенциально\nопасными видами деятельности или управлением механизмами, требующими повышенной\nконцентрации внимания и быстроты психомоторных реакций."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не\nвыше 25 ºС. "}},{"type":"paragraph","data":{"text":"Хранить в недоступном для\nдетей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года. После вскрытия флакона – 6 месяцев."}},{"type":"paragraph","data":{"text":"Не применять\nпосле окончания срока годности!"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Без рецепта."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"ООО «Гротекс»"}},{"type":"paragraph","data":{"text":"Россия, 195279, г. Санкт-Петербург"}},{"type":"paragraph","data":{"text":"Индустриальный проспект, д. 71, корп. 2, лит. А"}},{"type":"paragraph","data":{"text":"Тел.: +7 812 385 47 87"}},{"type":"paragraph","data":{"text":"Факс: +7 812 385 47 88"}},{"type":"paragraph","data":{"text":"\u003ca href=\"http://www.solopharm.com\"\u003ewww.solopharm.com\u003c/a\u003e"}},{"type":"paragraph","data":{"text":"www.soloneks.ru"}}]}],"source":null},"description_toggle":false,"short_description":"ФармакодинамикаЦетиризин – действующее вещество препарата – является метаболитом гидроксизина, относится к группе конкурентных антагонистов гистамина и блокирует Н1-гистаминовые рецепторы. В дополнение к антигистаминному эффекту цетиризин предупреждает развитие и облегчает течение аллергических реакций: в дозе 10 мг один или два раза в день ингибирует позднюю фазу агрегации эозинофилов в коже и конъюнктиве пациентов, подверженных атопии.Клиническая эффективность и безопасностьИсследования на здоровых добровольцах показали, что цетиризин в дозах 5 или 10 мг значительно ингибирует реакцию в виде сыпи и покраснения на введение в кожу гистамина в высокой концентрации, однако корреляция с эффективностью не установлена. В 6-недельном плацебо-контролируемом исследовании с участием 186 пациентов с аллергическим ринитом и сопутствующей бронхиальной астмой легкого и среднетяжелого течения показано, что прием цетиризина в дозе 10 мг один раз в сутки уменьшает симптомы ринита и не влияет на функцию легких. Результаты данного исследования подтверждают безопасность применения цетиризина у пациентов, страдающих аллергией и бронхиальной астмой легкого и среднетяжелого течения. В плацебо-контролируемом исследовании показано, что прием цетиризина в дозе 60 мг в сутки в течение 7 дней не вызывал клинически значимого удлинения интервала QT. Прием цетиризина в рекомендуемой дозе показал улучшение качества жизни пациентов с круглогодичным и сезонным аллергическими ринитами.ДетиВ 35-дневном исследовании с участием пациентов в возрасте 5-12 лет не выявлено признаков невосприимчивости к антигистаминному эффекту цетиризина. Нормальная реакция кожи на гистамин восстанавливалась в течение трех дней после отмены препарата при его неоднократном применении. В 7-дневном плацебо-контролируемом исследовании препарата в лекарственной форме сироп с участием 42 пациентов в возрасте от 6 до 11 месяцев продемонстрирована безопасность применения препарата. Цетиризин назначался в дозе 0,25 мг/кг два раза в день, что приблизительно соответствовало 4,5 мг в день (диапазон доз составлял от 3,4 до 6,2 мг в день).Применение у детей от 6 до 12 месяцев возможно только по назначению врача и под строгим медицинским контролем.ФармакокинетикаФармакокинетические параметры цетиризина при его применении в дозах от 5 до 60 мг изменяются линейно.ВсасываниеМаксимальная концентрация (Cmax) в плазме крови достигается через 1 ± 0,5 часа и составляет 300 нг/мл. Различные фармакокинетические параметры, такие как максимальная концентрация в плазме крови и площадь под кривой «концентрация-время» имеют однородный характер. Прием пищи не влияет на полноту абсорбции цетиризина, хотя скорость ее уменьшается. Биодоступность различных лекарственных форм цетиризина (раствор, капсулы, таблетки) сопоставима.РаспределениеЦетиризин на 93 ± 0,3 % связывается с белками плазмы крови. Объем распределения (Vd) составляет 0,5 л/кг. Цетиризин не влияет на связывание варфарина с белками.МетаболизмЦетиризин не подвергается экстенсивному первичному метаболизму.ВыведениеПериод полувыведения (Т1/2) составляет примерно 10 часов. При приеме препарата в суточной дозе 10 мг в течение 10 дней кумуляции цетиризина не наблюдалось. Примерно 2/3 принятой дозы препарата выводится с мочой в неизменном виде.Пациенты пожилого возрастаУ 16 пациентов пожилого возраста при однократном приеме препарата в дозе 10 мг Т1/2был выше на 50 %, а клиренс – ниже на 40 % по сравнению с лицами не пожилого возраста. Снижение клиренса цетиризина у пациентов пожилого возраста, вероятно, связано с уменьшением функции почек у этой категории пациентов.Пациенты с почечной недостаточностьюУ пациентов с почечной недостаточностью легкой степени тяжести (клиренс креатинина (КК) \u003e 40 мл/мин) фармакокинетические параметры аналогичны таковым у здоровых добровольцев с нормальной функцией почек. У пациентов с почечной недостаточностью средней степени тяжести и у пациентов, находящихся на гемодиализе (КК\u003c7 мл/мин), при приеме препарата внутрь в дозе 10 мг Т1/2удлиняется в 3 раза, а общий клиренс снижается на 70 % относительно здоровых добровольцев с нормальной функцией почек. Для пациентов с почечной недостаточностью средней или тяжелой степени требуется соответствующее изменение режима дозирования (см. раздел «Способ применения и дозы»). Цетиризин плохо удаляется из организма при гемодиализе.Пациенты с печеночной недостаточностьюДетиТ1/2у детей от 6 до 12 лет составляет 6 часов, от 2 до 6 лет – 5 часов, от 6 месяцев до 2 лет – снижено до 3,1 часа.","substance":[{"id":197,"title":"Цетиризин","title_latin":"Cetirizinum","slug":"tsetirizin_197"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":true,"comments":null,"image_alt":"Солонэкс - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/62314/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/62314/share_default/"}},"diseases":[],"other_packages":[],"other_product_forms":[],"related_products":{"title":"Аналоги","type":"analogs","products":[{"id":183140,"title":"Цетиризин","subtitle":{"full":"Капли, флакон, 20 мл, 10 мг / мл, для приема внутрь","short":"Капли, 20 мл, 10 мг / мл","package":"20 мл, 10 мг / 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