Фумарат дизопроксила темофовира - это фумаратная соль пролек... Инструкция
Показания к применению
Инфекция ВИЧ-1, гепатит В
Противопоказания
Повышенная чувствительность к действующему веществу или любому другому компоненту препарата. Детский возраст до 12 лет и масса тела < 35 кг (эффективность и безопасность не установлены). Дети в возрасте от 12 до 18 лет с нарушением функции почек (отсутствуют рекомендации по режиму дозирования). Почечная недостаточность тяжелой степени (КК<30 мл/мин) ...
Таблетки покрытые пленочной оболочкой Виреад относится к противовирусным ВИЧ средствам, оказывает угнетающее действие на вирусы ВИЧ-1, ВИЧ-2 и вирус гепатита В.
Фармакологические свойства
Фумарат дизопроксила темофовира - это фумаратная соль пролекарства дизопроксила тенофовира превращается в тенофовир, аналог нуклеозидмонофосфата (нуклеотида) аденозина монофосфата. Тенофовир в последующем превращается в активный метаболит - дифосфат тенофовира. Тенофовир - нуклеотидный ингибитор обратной транскриптазы обладает специфичной активностью по отношению к вирусу иммунодефицита человека (ВИЧ-1 и ВИЧ-2), и вирусу гепатита В. Дифосфат тенофовира ингибируют обратную транскриптазу ВИЧ-1 и полимеразу вируса гепатита В по конкурентному механизму, результатом чего является терминация синтеза цепи ДНК. Дифосфат тенофовира является слабым ингибитором ДНК-полимераз млекопитающих. В тестах in vitro тенофовир в концентрациях до 300 мкмоль/л не оказывал влияния на синтез митохондриальной ДНК и образование молочной кислоты.
Показания к применению
Инфекция ВИЧ-1, гепатит В
Противопоказания
Повышенная чувствительность к действующему веществу или любому другому компоненту препарата. Детский возраст до 12 лет и масса тела < 35 кг (эффективность и безопасность не установлены). Дети в возрасте от 12 до 18 лет с нарушением функции почек (отсутствуют рекомендации по режиму дозирования). Почечная недостаточность тяжелой степени (КК<30 мл/мин) или XПН, когда необходимо проведение гемодиализа (безопасность не установлена у данной популяции пациентов). Период лактации. Одновременный прием с другими препаратами, содержащими тенофовир. Одновременный прием с адефовиром. У пациентов с дефицитом лактазы, непереносимостью лактозы, ппокозо-галактозной мальабсорбцией.
Применение при беременности и в период грудного вскармливания
Противопоказано
Способ применения и дозы
Внутрь с едой. Таблетку необходимо проглатывать целиком, запивая водой. Таблетки нельзя разжевывать или разламывать. Лечение должно начинаться и контролироваться врачом, имеющим опыт лечения ВИЧ-инфекции и/или хронического гепатита В. Рекомендованная доза препарата Виреад для лечения ВИЧ и хронического гепатита В - 1 таблетка (300 мг) 1 раз в сутки внутрь, с едой.
Побочное действие
Нарушения со стороны обмена веществ и питания: гипофосфатемия, гипокалиемия, лактоацидоз. Нарушения со стороны нервной системы: головокружение, головная боль. Нарушения со стороны желудочно-кишечного тракта: диарея, рвота, тошнота, боль в животе, вздутие, метеоризм, панкреатит. Нарушения со стороны печени и желчевыводящих путей: повышение активности "печеночных" трансаминаз, жировая дистрофия печени, гепатит. Нарушения со стороны кожи и подкожных тканей: кожная сыпь, ангионевротический отек. Нарушения со стороны скелетно-мышечной и соединительной ткани: рабдомиолиз, мышечная слабость, остеомаляция (проявляющаяся болями в костях и переломами костей в отдельных случаях), миопатия. Нарушения со стороны почек и мочевыводящих путей: повышение креатинина, острая почечная недостаточность, почечная недостаточность, острый тубулярный некроз, проксимальная почечная тубулопатия (в том числе синдром Фанкони), нефрит (в том числе острый интерстициальний нефрит), нефрогенный несахарный диабет. Общие расстройства и нарушения в месте введения: астения, усталось.
Передозировка
Cимптомы: в случае передозировки пациент должен находиться под наблюдением относительно признаков токсичности, при необходимости назначается симптоматическая и по ддерживаюoая терапия. Лечение: тенофовир может выводиться с помощью гемодиализа, медианное значение клиренса тенофовира составляет 134 мл/мин. Неизвестно, возможно ли вывести тенофовир с помощью перитонеального диализа.
Особые указания
Препарат не следует одновременно применять с препаратами Трувада (тенофовир/эмтрицитабин), Атрипла (эфавиренц/эмтрицитабин/тенофовир), или с препаратом Гепсера (адефовир). Пациентам, принимающим препарат Виреад, необходимо соблюдать меры предосторожности, либо избегать управления транспортными средствами и занятий другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций с учетом профиля побочных эффектов. Пациентов следует информировать о том, что лечение антиретровирусными препаратами не предотвращает риск передачи ВИЧ и гепатита В другим людям. При половых контактах следует соблюдать соответствующие меры предосторожности. Лактат-ацидоз, выраженная гепатомегалия с жировой дистрофией При использовании у ВИЧ-инфицированных лиц нуклеозидных аналогов, включая тенофовира дизопроксила фумарат, в сочетании с другими антиретровирусными препаратами, сообщалось о случаях лактат-ацидоза и выраженного увеличения размеров печени с ее жировой дистрофией, иногда с летальным исходом. В случае развития у больного клинических (со стороны пищеварительной системы - тошнота, рвота, боли в животе, общее недомогание, потеря аппетита, потеря веса, нарушение дыхания, неврологические симптомы - нарушение двигательных функций, мышечная слабость) или лабораторных признаков (содержание молочной кислоты в сыворотке крови выше 5 ммоль/л), указывающих на лактат-ацидоз или выраженную гепатотоксичность, терапия препаратом Виреад должна быть приостановлена.
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