Описание
Озурдекс (Ozurdex) – современное офтальмологическое средство интравитреального способа введения для устранения отека макулы, обусловленного окклюзией вен сетчатки. Выраженная форма подобного состояния потенциально опасна необратимой потерей зрения. Отек макулы не является самостоятельным заболеванием. Как следствие, он появляется на фоне травм глазного яблока, диабетической ретинопатии, увеитов, офтальмологических операций, окклюзии вен сетчатки.
Озурдекс — это внутриглазной имплантат, помещаемый внутрь стекловидного тела. Главное его действующее вещество — дексаметазон, непрерывно выделяется небольшими дозами, создавая многокомпонентное длительное воздействие. Благодаря этому купируются признаки имеющегося воспаления, ликвидируется отек, идет устранение окклюзии вен сетчатки. Действие имплантата после интравитреального введения сохраняется от трех месяцев до полугода.
Состав
Один имплантат содержит: дексаметазон — 0.7 мг
Показания к применению
- Макулярный отек по причине окклюзии центральной вены сетчатки и/или ее ветвей.
Фармакодинамика
Представляя собой сильнодействующий глюкокортикостероид, дексаметазон подавляет воспаление, снижая отложение фибрина, проницаемость капилляров, выраженность отека и миграцию фагоцитов к месту воспаления. При непосредственной аппликации на сосуды оказывает вазоконстрикторный эффект. Снижает количество циркулирующих лимфоцитов (T- и B-клеток), эозинофилов, моноцитов и базофилов по причине их перемещения из сосудистого русла в лимфоидную ткань, ингибирует образование антител.
Дексаметазон ингибирует экспрессию фактора роста эндотелия сосудов, а также не допускают высвобождения простагландинов, часть из которых является медиаторами цистоидного макулярного отека. Не обладает минералокортикоидной активностью.
Фармакокинетика
При использовании в офтальмологии впитывается через роговицу во влагу передней камеры глаза. При повреждении слизистой оболочки и роговицы или воспалении тканей глаза скорость впитывания дексаметазона достоверно повышается. Связывание с белками плазмы — 60-70%. Проникает через гистогематические барьеры. В небольшом количестве выделяется с грудным молоком. Метаболизируется в печени. Период полувыведения составляет 2-3 ч. Выводится почками.
На основании исследований у животных показано, что дексаметазон в стекловидном теле определяется на протяжении 6 месяцев с момента введения. Количественно препарат распределяется следующим образом: сетчатка > радужка > ресничное тело > витреальная жидкость > водянистая влага > плазма. Период полувыведения из стекловидного тела составляет около 3 часов. Скорость выведения из стекловидного тела составляет примерно 12 мл/сутки. Дексаметазон подвергается метаболизму до водо- и жирорастворимых метаболитов. Выделяется с желчью и мочой.
Фармацевтические характеристики
Имплантат для интравитреального введения 0,7 мг
Упаковка, срок годности, условия хранения
По одному имплантату в пластиковом аппликаторе в форме ручки, состоящего из корпуса с колпачком из поликарбоната, иглы из нержавеющей стали для подкожных инъекций калибра 22, фиксатора и актуатора.
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