Описание
Компания Medical&Pharma предлагает одно из самых высокоэффективных противовирусных лекарственных препаратов Вальцит (Валганцикловир), который содержит активное вещество Валганцикловир — L-валиловый эфир, предшественник ганцикловира, после приема внутрь быстро превращается в ганцикловир под действием печеночных и кишечных эстераз. Лекарство выписывают пациентам со СПИД. Прием препарата Вальцит проявляется снижением выделения ЦМВ из организма больных СПИД с исходных 46% до 7% через 4 недели лечения.
Состав
Одна таблетка содержит
- валганцикловира гидрохлорид 496,30 мг (соответствует валганцикловиру свободному безводному основанию — 450 мг)
- вспомогательные вещества: кросповидон, повидон К-30, целлюлоза микрокристаллическая, кислота стеариновая
- оболочка Опадри Розовый 15В24005: гипромеллоза 2910-6 сР, гипромеллоза 2910-3 сР, титана диоксид (Е 171), железа (III) оксид красный (Е172), полиэтиленгликоль 400, полисорбат 80.
Показания к применению
- лечение цитомегаловирусного ретинита у больных СПИД
- профилактика ЦМВ-инфекции у лиц в группе риска после трансплантации органов.
Фармакодинамика
Валганцикловир представляет собой L-валиловый эфир — это предшественник ганцикловира, после приема внутрь быстро превращается в ганцикловир под действием печеночных и кишечных эстераз. Ганцикловир — синтетический аналог 2′-дезоксигуанозина — вещество, подавляющее размножение вирусов герпес-группы. Из вирусов человека, чувствительных к ганцикловиру, относятся вирусы простого герпеса -1 и -2 (Herpes simplex 1 и 2), цитомегаловирус (ЦМВ), вирус герпеса человека типов 6, 7 и 8 (HHV-6, HHV-7, HHV-8), вирус Эпштейна-Барра (EBV), вирус гепатита В и вирус ветряной оспы (Varicella/zoster).
Под действием вирусной протеинкиназы UL97 в ЦМВ-инфицированных клетках ганцикловир сначала фосфорилируется с образованием монофосфата ганцикловира. В дальнейшем происходит фосфорилирование под действием клеточных киназ с образованием ганцикловира трифосфата, который после подвергается медленному внутриклеточному метаболизму. Известно, что данный метаболизм происходит в клетках, инфицированных вирусом простого герпеса и ЦМВ, при этом после пропадания ганцикловира из внеклеточной жидкости период внутриклеточного полувыведения вещества составляет между 6 и 24 часами, в среднем 18 часов. На основании того, что фосфорилирование ганцикловира в очень сильно зависит от действия вирусной киназы, процесс происходит главным образом в инфицированных клетках.
Виростатическая активность ганцикловира определена подавлением процесса синтеза вирусной ДНК посредством: 1) под действием вирусной ДНК-полимеразы конкурентного подавления встраивания дезоксигуанозина трифосфата в ДНК, 2) включением ганцикловира трифосфата в вирусную ДНК, что приводит к ингибированию репликации вирусной ДНК или очень небольшой ее репликации. Характерная противовирусная подавляющая концентрация (IC50) в отношении ЦМВ, находится в диапазоне от 0,08 мкМ (0,02 мкг/мл) до 14 мкМ (3,5 мкг/мл) Клинический противовирусный результат действия препарата Вальцит проявляется снижением выделения ЦМВ из организма больных СПИД с исходных 46% до 7% через 4 недели лечения.
Эффективность
Использование Вальцита позволяет получить такое же системное воздействие ганцикловира, как при применении рекомендованных внутривенных доз ганцикловира, эффективных при лечении ЦМВ-ретинита. Обнаружено, что AUC ганцикловира коррелирует с величиной времени до прогрессирования ЦМВ-ретинита.
Частота ЦМВ заболевания в течение первых 6 мес после трансплантации составила 12,1 % у пациентов, получавших Вальцит (в дозе 900 мг/сут) и 15,2% — у больных, получавших пероральный ганцикловир (в дозе 1000 мг по 3 раза в сутки) с 10-го по 100-й день после трансплантации. Частота острого отторжения в первые 6 мес была 29,7% у пациентов в группе валганцикловира и 36% — в группе ганцикловира.
Вирусная резистентность
При продолжительном приеме валганцикловира может появиться вирус, с устойчивостью к ганцикловиру, что обусловлено селекцией мутаций либо в гене вирусной полимеразы (UL54), либо в гене вирусной киназы (UL97), отвечающей за монофосфорилирование ганцикловира. Вирус, с мутацией только в гене UL97, резистентен только к ганцикловиру, однако вирус с мутациями гена UL54 может обладать перекрестной устойчивостью к другим аналогичным противовирусным препаратам, и наоборот.
Генотипирование ЦМВ в полиморфноядерных лейкоцитах показало, что через 3, 6, 12 и 18 мес лечения валганцикловиром, соответственно, в 2, 7, 14 и 18% лейкоцитов выявляются мутации UL97. Фенотипической устойчивости не наблюдалось, однако исследование проводилось на очень небольшом числе культур ЦМВ.
Доклинические данные по безопасности
Валганцикловир и ганцикловир проявляют кластогенный эффект в клетках млекопитающих и мутагенное действие в клетках мышиной лимфомы, также эти эффекты соответствуют положительным результатам исследования канцерогенности ганцикловира на мышах. Как и ганцикловир, валганцикловир является потенциальным канцерогеном.
Анализ репродуктивной токсичности с валганцикловиром не проводились из-за быстрого и полного перехода препарата в ганцикловир. К обоим лекарствам относится сходное предупреждение о возможной репродуктивной вредности. У животных ганцикловир нарушает фертильность и оказывает тератогенный эффект. Учитывая эксперименты на животных, на которых системное воздействие ганцикловира в низких концентрациях, вызывало аспермию, может быть, что ганцикловир и валганцикловир в человеческом организме также могут угнетать сперматогенез.
Результаты, полученные в модели на плаценте человека ex vivo, указывают, что ганцикловир проникает через плаценту, вероятнее всего, посредством простого переноса. В диапазоне концентраций от 1 до 10 мг/мл переход препарата через плаценту носил ненасыщаемый характер и осуществлялся путем пассивной диффузии.
Фармакокинетика
Фармакокинетика валганцикловира изучалась у ЦМВ- и ВИЧ-сероположительных пациентов и у лиц со СПИДом и ЦМВ-ретинитом и у пациентов, после трансплантации.
Биодоступность ганцикловира была сходной у всех пациентов, получавших валганцикловир. Для реципиентов трансплантата сердца, печени, почки системная экспозиция ганцикловира была подобной с таковой после перорального приема валганцикловира в соответствии с порядком дозирования в зависимости от функции почек.
Всасывание
Валганцикловир хорошо поглощается из желудочно-кишечного тракта, так в стенках печени и кишечника вещество быстро преобразуется в ганцикловир. Абсолютная биодоступность ганцикловира из валганцикловира составляет около 60%, что почти в 10 раз выше, чем при приеме ганцикловира внутрь. Системная экспозиция валганцикловира невысокая и держится недолго. Максимальная концентрация (Смакс) и площадь под кривой «концентрация-время» (AUC) равняются 3% и 1% от концентраций ганцикловира в крови.
Наблюдается линейная зависимость AUC ганцикловира от дозы при приеме валганцикловира в дозах от 450 до 2625 мг при приеме еды. При этом прием валганцикловира в рекомендованной дозе 900 мг влечет за собой увеличение средних значений AUC24 (примерно на 30%), и Смакс (примерно на 14%) ганцикловира. Следовательно, препарат рекомендуется принимать во время еды.
Распределение
По причине быстрого метаболизма валганцикловира в ганцикловир, соединение валганцикловира с белками не определяли. При концентрациях препарата от 0,5 до 51 мкг/мл связывание ганцикловира с белками плазмы составляет 1,2%. Равновесный объем распределения ганцикловира после внутривенного введения равнялся 0,680±0,161 л/кг.
Метаболизм
Валганцикловир быстро гидролизуется с образованием ганцикловира; других метаболитов не было найдено. После однократного приема внутрь 1000 мг меченого радиоактивного ганцикловира, радиоактивность каждого из метаболитов, устанавливаемых моче или в кале, составляла не более 1-2%.
Выведение
Основным способом выведения валганцикловира и ганцикловира, является активная канальцевая секреция и клубочковая фильтрация. На почечный клиренс приходится 81,5± 22% системного клиренса ганцикловира.
Пациенты с почечной недостаточностью
К снижению клиренса ганцикловира, образующегося из валганцикловира, с последующим увеличением периода полувыведения терминальной фазы приводит ухудшение функции почек. Следовательно, пациентам с нарушением функции почек требуется коррекция дозы. Не рекомендуется назначать препарат в виде таблеток пациентам, получающим гемодиализ (клиренс креатинина менее 10 мл/мин) . Это определено тем, что таким лицам требуется индивидуальная доза препарата валганцикловира менее 450 мг.
Пациенты с печеночной недостаточностью
Фармакокинетику валганцикловира изучали у лиц, со стабильно функционирующим трансплантатом печени. В полном объеме биодоступность ганцикловира, получившегося из однократной дозы 900 мг валганцикловира, составляет примерно 60%, что совпадает с показателем у других групп пациентов. Данные по AUC ганцикловира соизмерима с таковой после внутривенного введения ганцикловира в дозе 5 мг/кг лицам, перенесшим пересадку печени.
Фармацевтические характеристики
Таблетки покрытые оболочкой розового цвета. Имеют овальную форму, с выпуклой поверхностью. Имеются маркировк: на одной стороне — «VGC» и на другой — «450».
Упаковка, срок годности, условия хранения
Таблетки, покрытые пленочной оболочкой, 450 мг
По 60 таблеток во флаконе из полиэтилена высокого давления с завинчивающейся крышкой из полипропилена, открывающейся при нажатии. Свободное пространство во флаконе заполнено ватой (другим уплотняющим материалом), горловина флакона герметично закупорена фольгой алюминиевой с ПВХ покрытием. Флакон вместе с инструкцией по применению помещен в пачку картонную.
Срок годности 3 года. Не использовать по истечении срока годности, указанного на упаковке.
Условия хранения. При температуре не выше 30°С. Хранить в недоступном для детей месте.
Наша компания работает как на территории Казахстана, так и осуществляет доставку в страны ближнего зарубежья. Обращайтесь к нам за консультациями по контактным телефонам.
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Работаем и отправляем Вальцит (Валганцикловир) по странам СНГ: Россия, Украина, Кыргызстан (Бишкек), Белоруссия, Узбекистан (Ташкент),
а также можем отправить Вальцит (Валганцикловир) по регионам Казахстана: Нур-Султан (Астана), Шымкент, Талдыкорган, Актау и другие.
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