Гиперчувствительность, склонность к кровотечениям (болезнь Виллебранда, гемофилия, тромбоцитопения, нарушения функций тромбоцитов, геморрагический диатез), острый ДВС-синдром, дефицит белков С и S, условия, предрасполагающие к кровотечениям (в т.ч. желудочно-кишечные кровотечения в анамнезе, язвенная болезнь желудка и 12-перстной кишки в стадии обострения, ...
Варфарекс - круглые плоскоцилиндрические таблетки голубого цвета с более темными вкраплениями.
Фармакологические свойства
Варфарекс является антикоагулянтом непрямого действия, который предотвращает витамин К-зависимый синтез факторов свертывания крови (II, VII, IX и Х) и белков С и S в печени за счет дозозависимого ингибирования С1-субъединицы витамин К-эпоксидредуктазы, в результате чего снижается продукция витамин К1-эпоксида. S-изомер варфарина по активности примерно в 5 раз превосходит R-изомер. В терапевтических дозах варфарин уменьшает скорость синтеза факторов свертывания на 30-50 % и снижает их биологическую активность. Начало противосвертывающего действия наблюдается: через 36-72 ч от начала приема препарата с развитием максимального эффекта на 5-7 день от начала его применения. После прекращения приема препарата восстановление активности витамин К-зависимых факторов свертывания крови происходит в течение 4-5 дней.
Показания к применению
Лечение и профилактика тромбоза глубоких вен и эмболии легочной артерии, транзиторных ишемических атак и ишемического инсульта. Вторичная профилактика инфаркта миокарда и профилактика тромбоэмболических осложнений после инфаркта миокарда. Профилактика тромбоэмболических осложнений у пациентов с фибрилляцией предсердий, поражениями сердечных клапанов или с протезированными клапанами сердца.
Противопоказания
Гиперчувствительность, склонность к кровотечениям (болезнь Виллебранда, гемофилия, тромбоцитопения, нарушения функций тромбоцитов, геморрагический диатез), острый ДВС-синдром, дефицит белков С и S, условия, предрасполагающие к кровотечениям (в т.ч. желудочно-кишечные кровотечения в анамнезе, язвенная болезнь желудка и 12-перстной кишки в стадии обострения, дивертикулез, злокачественные опухоли, варикозное расширение вен пищевода, аневризма артерий, люмбальная пункция), недавно перенесенное внутричерепное кровоизлияние (в т.ч. аневризма церебральных артерий, геморрагический инсульт), недавно перенесенные или предполагаемые сложные операции ЦНС, офтальмологические операции и диагностические процедуры, деменция, психоз, алкоголизм и другие состояния, при которых отмечается недостаточная возможность оценки состояния свертывающей, системы крови с помощью лабораторных методов, тяжелая артериальная гипертензия. Выраженная почечная и/или печеночная недостаточность, тяжелые заболевания печени или почек, механическая желтуха, инфекционный эндокардит или экссудативный перикардит, сахарный диабет, склонность к падению, беременность, дефицит лактазы, непереносимость лактозы, глюкозо-галактозная мальабсорбция.
Применение при беременности и в период грудного вскармливания
Противопоказано.
Способ применения и дозы
Внутрь в один прием, желательно в одно и то же время суток. Продолжительность лечения определяется врачом в соответствии с показаниями к применению. Перед началом лечения определяют международное нормализованное отношение (MHO). В дальнейшем лабораторный контроль проводят регулярно каждые 4-8 недель. Продолжительность лечения зависит от клинического состояния пациента. Лечение можно отменять сразу. Пациентам с нормальной массой тела и исходным MHO менее 1,2 назначают 10,5 мг варфарина в течение грех последовательных дней. Затем доза рассчитывается в соответствии с приведенной ниже таблицей, основанной на измерении MHO на четвертый день терапии. В амбулаторных условиях и у пациентов с с тромбофилиями (наследственной недостаточностью протеина С или S) рекомендуемая начальная доза варфарина составляет 4,5 мг в течение грех последовательных дней. Затем доза рассчитывается в соответствии с приведенной ниже таблицей, основанной на измерении MHO на четвертый день терапии. Для пожилых пациентов, пациентов с небольшой массой тела с MHO более 1,2, или имеющих сопутствующие заболевания, или получающих какие-либо лекарственные препараты, влияющие на эффективность антикоагулянтной терапии, рекомендуемая начальная доза варфарина составляет 4,5 мг в течение двух последовательных дней. Затем доза рассчитывается в соответствии с приведенной ниже таблицей, основанной на измерении MHO на третий день терапии. Данные о применении варфарина у детей ограничены. Начальная доза обычно составляет 0,2 мг/кг в день при нормальной функции печени и 0,1 мг/кг в день при нарушении функции печени. Поддерживающая доза подбирается в соответствии с показателями MHO. Рекомендуемые уровни MHO такие же, как и у взрослых. Решение о назначении варфарина у детей должен принимать опытный специалист. Лечение должно проводиться под наблюдением опытного педиатра. Дозы подбирают в соответствии с приведенной ниже таблицей. Для пациентов которые ранее принимали варфарин рекомендуемая стартовая доза составляет двойную дозу известной поддерживающей дозы варфарина и назначается в течение первых 2 дней. Затем лечение продолжают с помощью известной поддерживающей дозы. На 5 день лечения проводят контроль MHO и коррекцию дозы в соответствии с этим показателем. Рекомендуется поддерживать показатель MHO от 2 до 3 в случае профилактики и лечения венозного тромбоза, эмболии легочной артерии, фибрилляции предсердий, дилятационной кардиомиопатии, осложненных заболеваний клапанов сердца, протезирования клапанов сердца биопротезами. Более высокие показатели MHO от 2,5 до 3,5 рекомендуются при протезировании клапанов сердца механическими протезами и осложненном остром инфаркте миокарда.
Побочное действие
Очень часто: повышенная кровоточивость. Часто: повышенная чувствительность к варфарину после длительного применения. Нечасто: анемия, рвота, боль в животе, тошнота, диарея. Редко: эозинофилия, повышение активности "печеночных" ферментов, желтуха, сыпь, крапивница, зуд, экзема, некроз кожи, васкулит, выпадение волос, нефрит, уролитиаз, тубулярный некроз, ладонно-подошвенный синдром.
Передозировка
Симптомы: кровотечения. Лечение: в зависимости от показателя МНО. При МНО менее 5 следует пропустить следующую дозу и продолжать прием более низких доз до достижения терапевтического значения МНО. При МНО 5-9 следует пропустить 1-2 дозы и продолжать прием более низких доз до достижения терапевтического значения МНО или пропустить 1 дозу варфарина и принять внутрь 1-2,5 мг менадиона натрия бисульфита (витамин К). При МНО более 9 следует прекратить прием варфарина, принять внутрь 3-5 мг менадиона натрия бисульфита. При МНО 5-9 за 24 ч до операции следует прекратить прием варфарина и принять внутрь 2-4 мг менадиона натрия бисульфита, при МНО более 20 или тяжелом кровотечении варфарин следует отменить и ввести внутривенно 10 мг менадиона натрия бисульфита, перелить концентрат факторов свёртывания крови, свежезамороженную плазму или цельную кровь. При необходимости следует повторять введение менадиона натрия бисульфита каждые 12 ч.
Особые указания
Обязательным условием терапии варфарексом является строгое соблюдение больным приема рекомендованной дозы препарата.
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Лечение можно отменять сразу. Пациентам с нормальной массой тела и исходным MHO менее 1,2 назначают 10,5 мг варфарина в течение грех последовательных дней. Затем доза рассчитывается в соответствии с приведенной ниже таблицей, основанной на измерении MHO на четвертый день терапии. В амбулаторных условиях и у пациентов с с тромбофилиями (наследственной недостаточностью протеина С или S) рекомендуемая начальная доза варфарина составляет 4,5 мг в течение грех последовательных дней. Затем доза рассчитывается в соответствии с приведенной ниже таблицей, основанной на измерении MHO на четвертый день терапии. Для пожилых пациентов, пациентов с небольшой массой тела с MHO более 1,2, или имеющих сопутствующие заболевания, или получающих какие-либо лекарственные препараты, влияющие на эффективность антикоагулянтной терапии, рекомендуемая начальная доза варфарина составляет 4,5 мг в течение двух последовательных дней. Затем доза рассчитывается в соответствии с приведенной ниже таблицей, основанной на измерении MHO на третий день терапии. Данные о применении варфарина у детей ограничены. Начальная доза обычно составляет 0,2 мг/кг в день при нормальной функции печени и 0,1 мг/кг в день при нарушении функции печени. Поддерживающая доза подбирается в соответствии с показателями MHO. Рекомендуемые уровни MHO такие же, как и у взрослых. Решение о назначении варфарина у детей должен принимать опытный специалист. Лечение должно проводиться под наблюдением опытного педиатра. Дозы подбирают в соответствии с приведенной ниже таблицей. Для пациентов которые ранее принимали варфарин рекомендуемая стартовая доза составляет двойную дозу известной поддерживающей дозы варфарина и назначается в течение первых 2 дней. Затем лечение продолжают с помощью известной поддерживающей дозы. На 5 день лечения проводят контроль MHO и коррекцию дозы в соответствии с этим показателем. 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