левокабастина гидрохлорид (0,54 мг) в пересчете на левокабастин 0,5 мг;
вспомогательные вещества:
пропиленгликоль 48,26 мкл, натрия гидрофосфат 8,66 мг, натрия гидрофосфата моногидрат 5,38 мг, гипромеллоза (2910 5 мПа.с) 2,50 мг, полисорбат 80 1,00 мг, бензалкония хлорид 0,15 мг (в виде 50 % раствора 0,03 мл), динатрия эдетат 0,15 мг, вода для инъекций до 1,0 мл.
Описание
Белая однородная суспензия
Фармакотерапевтическая группа
Противоаллергическое средство – H1-гистаминовых рецепторов блокатор.
Фармакологические свойства
Фармакодинамика
Левокабастин – селективный блокатор Н1-гистаминовых рецепторов с продолжительным действием. Местный эффект наступает через 5 минут, а действие продолжается в течение 12 часов. После интраназального введения назальный спрей «Тизин Алерджи» устраняет симптомы аллергического ринита: выделения из носа, чихание, зуд в носовой полости.
Фармакокинетика
При каждом интраназальном введении из расчета 50 мкг/доза абсорбируется примерно 30–40 мкг левокабастина, максимальная концентрация левокабастина в плазме крови достигается примерно через 3 часа после назального введения.
Левокабастин связывается с белками плазмы крови приблизительно на 55 %.
Основной метаболит левокабастина, ацилглюкуронид, образуется при глюкуронировании, представляющего собой основной путь метаболизма.
Левокабастин экскретируется преимущественно с мочой в неизмененном виде (около 70 % от абсорбированного количества). Период полувыведения левокабастина составляет около 35–40 часов.
Показания к применению
Симптоматическая терапия сезонных и круглогодичных аллергических ринитов.
Противопоказания
Гиперчувствительность к любому из компонентов препарата.
Детский возраст до 6 лет.
Применение при беременности и в период грудного вскармливания
Достоверные данные по применению назального спрея «Тизин Алерджи» у беременных женщин отсутствуют. Поэтому назальный спрей «Тизин Алерджи» не должен применяться во время беременности за исключением тех случаев, когда предполагаемая польза для матери оправдывает потенциальный риск для плода.
Основываясь на определении концентрации левокабастина в слюне и грудном молоке кормящих женщин, которые однократно перорально получали 0,5 мг левокабастина, ожидается, что примерно 0,6 % общей интраназальной дозы левокабастина может передаваться ребенку во время грудного вскармливания. Вследствие ограниченного числа клинических и экспериментальных данных рекомендовано соблюдать осторожность при применении назального спрея «Тизин Алерджи» у кормящих женщин. При необходимости назначения препарата в период лактации следует прекратить грудное вскармливание.
Способ применения и дозы
Интраназально взрослым и детям старше 6 лет по 2 дозы (100 мкг) в каждый носовой ход 2 раза в сутки. Применение препарата следует продолжать до устранения симптомов.
В случае выраженности симптомов можно применять 3–4 раза в сутки.
Пациентов следует предупредить о необходимости освободить носовые ходы перед использованием спрея и сделать вдох через нос во время введения.
Перед первым применением снять защитный колпачок и несколько раз нажать на распылительную насадку до появления облачка «тумана». Флакон готов к дальнейшему использованию.
Перед каждым применением встряхивать флакон. Препарат вдыхать через нос.
Побочное действие
Очень часто (> 1/10), часто (> 1/100, < 1/10), нечасто (> 1/1000, < 1/100), редко (> 1/10000, < 1/1000), очень редко (< 1/10000, включая отдельные сообщения), частота неизвестна (частота возникновения не может быть оценена на основании имеющихся данных).
Нежелательные явления, которые отмечались у пациентов в ходе клинических исследований
Нарушения со стороны желудочно-кишечного тракта: тошнота (часто).
Общие расстройства и нарушения в месте введения: усталость, боль в месте введения (часто), раздражение в месте введения, боль в месте введения, сухость в месте введения, беспокойство (нечасто), жжение в месте введения, дискомфорт в месте введения (редко).
Инфекционные и паразитарные заболевания: синусит (часто).
Нарушения со стороны нервной системы: головная боль (очень часто), сонливость, головокружение (часто).
Нарушения со стороны дыхательной системы, органов грудной клетки и средостения: боль в глотке и гортани, носовое кровотечение (часто), одышка, заложенность носа (нечасто), отек слизистой оболочки носа (редко), бронхоспазм, кашель (частота неизвестна).
Нарушения со стороны сердца: ощущение сердцебиения (нечасто), тахикардия (редко).
Нарушения со стороны органа зрения: отек век (частота неизвестна).
Нарушения со стороны иммунной системы: гиперчувствительность (нечасто), анафилактические реакции (частота неизвестна).
Пострегистрационные данные
Нарушения со стороны сердца: ощущение сердцебиения, тахикардия (очень редко).
Нарушения со стороны органа зрения: отек век (очень редко).
Общие расстройства и нарушения в месте введения: недомогание (нечасто).
Нарушения со стороны иммунной системы: анафилактические реакции, гиперчувствительность (очень редко).
Нарушения со стороны дыхательной системы, органов грудной клетки и средостения: бронхоспазм, одышка, отек слизистой оболочки носа (очень редко).
Передозировка
Симптомы
Сообщений по поводу передозировки левокабастина не поступало. При случайном приеме внутрь возможно снижение артериального давления, тахикардия, небольшая седация.
Лечение
В случае приема внутрь пациенту следует выпить большое количество жидкости, чтобы ускорить выделение левокабастина через почки.
Взаимодействие с другими лекарственными средствами
Взаимодействия с алкоголем в клинических исследованиях не отмечалось. Также не было отмечено усиления действия алкоголя или диазепама при использовании обычных дозировок назального спрея «Тизин Алерджи».
Одновременное применение ингибиторов изоферментов CYP3A4 кетоконазола или эритромицина не влияло на фармакокинетику левокабастина при назальном введении.
Возможные местные взаимодействия с другими назальными препаратами изучены недостаточно, за исключением взаимодействия с оксиметазолином, который может транзиторно снижать абсорбцию левокабастина при назальном введении.
Особые указания
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Влияние на способность управлять автомобилем и движущимися механизмами
Назальный спрей «Тизин Алерджи» в рекомендованной дозе обычно не оказывает клинически выраженного седативного эффекта и не снижает быстроту реакции по сравнению с плацебо. В случае возникновения сонливости не следует заниматься потенциально опасными видами деятельности, требующими повышенного внимания и быстроты психомоторных реакций.
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Местный эффект наступает через 5 минут, а действие продолжается в течение 12 часов. После интраназального введения назальный спрей «Тизин Алерджи» устраняет симптомы аллергического ринита: выделения из носа, чихание, зуд в носовой полости."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"При каждом интраназальном введении из расчета 50 мкг/доза абсорбируется примерно 30–40 мкг левокабастина, максимальная концентрация левокабастина в плазме крови достигается примерно через 3 часа после назального введения."}},{"type":"paragraph","data":{"text":"Левокабастин связывается с белками плазмы крови приблизительно на 55 %."}},{"type":"paragraph","data":{"text":"Основной метаболит левокабастина, ацилглюкуронид, образуется при глюкуронировании, представляющего собой основной путь метаболизма."}},{"type":"paragraph","data":{"text":"Левокабастин экскретируется преимущественно с мочой в неизмененном виде (около 70 % от абсорбированного количества). Период полувыведения левокабастина составляет около 35–40 часов."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптоматическая терапия сезонных и круглогодичных аллергических ринитов."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к любому из компонентов препарата."}},{"type":"paragraph","data":{"text":"Детский возраст до 6 лет."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Достоверные данные по применению назального спрея «Тизин Алерджи» у беременных женщин отсутствуют. Поэтому назальный спрей «Тизин Алерджи» не должен применяться во время беременности за исключением тех случаев, когда предполагаемая польза для матери оправдывает потенциальный риск для плода."}},{"type":"paragraph","data":{"text":"Основываясь на определении концентрации левокабастина в слюне и грудном молоке кормящих женщин, которые однократно перорально получали 0,5 мг левокабастина, ожидается, что примерно 0,6 % общей интраназальной дозы левокабастина может передаваться ребенку во время грудного вскармливания. Вследствие ограниченного числа клинических и экспериментальных данных рекомендовано соблюдать осторожность при применении назального спрея «Тизин Алерджи» у кормящих женщин. При необходимости назначения препарата в период лактации следует прекратить грудное вскармливание."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Интраназально взрослым и детям старше 6 лет по 2 дозы (100 мкг) в каждый носовой ход 2 раза в сутки. Применение препарата следует продолжать до устранения симптомов."}},{"type":"paragraph","data":{"text":"В случае выраженности симптомов можно применять 3–4 раза в сутки."}},{"type":"paragraph","data":{"text":"Пациентов следует предупредить о необходимости освободить носовые ходы перед использованием спрея и сделать вдох через нос во время введения."}},{"type":"paragraph","data":{"text":"Перед первым применением снять защитный колпачок и несколько раз нажать на распылительную насадку до появления облачка «тумана». Флакон готов к дальнейшему использованию."}},{"type":"paragraph","data":{"text":"Перед каждым применением встряхивать флакон. Препарат вдыхать через нос."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Очень часто (> 1/10), часто (> 1/100, < 1/10), нечасто (> 1/1000, < 1/100), редко (> 1/10000, < 1/1000), очень редко (< 1/10000, включая отдельные сообщения), частота неизвестна (частота возникновения не может быть оценена на основании имеющихся данных)."}},{"type":"paragraph","data":{"text":"Нежелательные явления, которые отмечались у пациентов в ходе клинических исследований"}},{"type":"paragraph","data":{"text":"Нарушения со стороны желудочно-кишечного тракта: тошнота (часто)."}},{"type":"paragraph","data":{"text":"Общие расстройства и нарушения в месте введения: усталость, боль в месте введения (часто), раздражение в месте введения, боль в месте введения, сухость в месте введения, беспокойство (нечасто), жжение в месте введения, дискомфорт в месте введения (редко)."}},{"type":"paragraph","data":{"text":"Инфекционные и паразитарные заболевания: синусит (часто)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны нервной системы: головная боль (очень часто), сонливость, головокружение (часто)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны дыхательной системы, органов грудной клетки и средостения: боль в глотке и гортани, носовое кровотечение (часто), одышка, заложенность носа (нечасто), отек слизистой оболочки носа (редко), бронхоспазм, кашель (частота неизвестна)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны сердца: ощущение сердцебиения (нечасто), тахикардия (редко)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны органа зрения: отек век (частота неизвестна)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны иммунной системы: гиперчувствительность (нечасто), анафилактические реакции (частота неизвестна)."}},{"type":"paragraph","data":{"text":"Пострегистрационные данные"}},{"type":"paragraph","data":{"text":"Нарушения со стороны сердца: ощущение сердцебиения, тахикардия (очень редко)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны органа зрения: отек век (очень редко)."}},{"type":"paragraph","data":{"text":"Общие расстройства и нарушения в месте введения: недомогание (нечасто)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны иммунной системы: анафилактические реакции, гиперчувствительность (очень редко)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны дыхательной системы, органов грудной клетки и средостения: бронхоспазм, одышка, отек слизистой оболочки носа (очень редко)."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы"}},{"type":"paragraph","data":{"text":"Сообщений по поводу передозировки левокабастина не поступало. При случайном приеме внутрь возможно снижение артериального давления, тахикардия, небольшая седация."}},{"type":"paragraph","data":{"text":"Лечение"}},{"type":"paragraph","data":{"text":"В случае приема внутрь пациенту следует выпить большое количество жидкости, чтобы ускорить выделение левокабастина через почки."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Взаимодействия с алкоголем в клинических исследованиях не отмечалось. Также не было отмечено усиления действия алкоголя или диазепама при использовании обычных дозировок назального спрея «Тизин Алерджи»."}},{"type":"paragraph","data":{"text":"Одновременное применение ингибиторов изоферментов CYP3A4 кетоконазола или эритромицина не влияло на фармакокинетику левокабастина при назальном введении."}},{"type":"paragraph","data":{"text":"Возможные местные взаимодействия с другими назальными препаратами изучены недостаточно, за исключением взаимодействия с оксиметазолином, который может транзиторно снижать абсорбцию левокабастина при назальном введении."}}]},{"id":9,"name":"Особые указания","slug":"","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Если лекарственное средство пришло в негодность или истек срок годности – не выбрасывайте его в сточные воды или на улицу! Поместите лекарственное средство в пакет и положите в мусорный контейнер. Эти меры помогут защитить окружающую среду!"}}]},{"id":16,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Назальный спрей «Тизин Алерджи» в рекомендованной дозе обычно не оказывает клинически выраженного седативного эффекта и не снижает быстроту реакции по сравнению с плацебо. В случае возникновения сонливости не следует заниматься потенциально опасными видами деятельности, требующими повышенного внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 25°С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Без рецепта"}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Левокабастин – селективный блокатор Н1-гистаминовых рецепторов с продолжительным действием. Местный эффект наступает через 5 минут, а действие продолжается в течение 12 часов. После интраназального введения назальный спрей «Тизин Алерджи» устраняет симптомы аллергического ринита: выделения из носа, чихание, зуд в носовой полости. 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