Описание
Ибандроновая кислота или ибандронат натрия, лекарственное вещество, являющийся эффективным препаратом группы бисфосфонатов III поколения, применяемых в профилактике и лечении остеопороза, а также используемая для лечения гиперкальциемии (повышенного уровеня кальция).
Ибандронат показан для профилактики и терапии остеопороза только у женщин в постменопаузе. Он утвержден и рекомендован в качестве препарата для ежедневного лечения постклимактерического остеопороза. Основой для таких утверждений были тщательно проведённые исследований женщин с пост-менопаузным остеопорозом. Одновременно каждая участница также получала дозу кальция и 400 МЕ витамина D. По результатам исследования, обе дозы сильно снизили риск возникновения новых переломов позвонков на 50-52% по сравнению с эффектами препарата плацебо.
Состав
Одна таблетка содержит
- активное вещество — натрия ибандроната моногидрата 168.75 мг, что эквивалентно кислоте ибандроновой 150.00 мг,
- дополнительные вещества: лактозы моногидрат, повидон (К 25), целлюлоза микрокристаллическая, кросповидон, стеариновая кислота, диоксид кремния безводный коллоидный.
- состав оболочки: опадрай 00А28646 (гипромеллоза, титана диоксид, тальк), макрогол 6000.
Показания к применению
Таблетки 150 мг:
- Постменопаузный остеопороз для профилактики переломов.
Фармакодинамика
Ибандроновая кислота – высокоактивный азот-содержащий бисфосфонат, способный специфически подавлять активность остеокластов, не влияя на их количество. Оказывает характерное избирательное действие на костную ткань, вследствии высокого сродства к минеральным компонентам кости, а именно к гидроксиапатиту, который составляет минеральную основу костной ткани. Ибандроновая кислота уменьшает резорбцию костной ткани, без оказывания прямого влияния на формирование кости, предотвращает костную деструкцию, вызванную блокадой функции половых желез. Не влияет на минерализацию костной ткани. У женщин в постменопаузе препарат уменьшает скорость деструкции костной ткани до уровня репродуктивного возраста, что приводит к нарастающему увеличению костной массы, в особенности позвоночника.
Фармакокинетика
При пероральном приеме ибандронат в верхних отделах желудочно-кишечного тракта всасывается быстро. через 0,5 – 2 часа (при приеме натощак), максимальная концентрация достигается, абсолютная биодоступность составляет 0,6%. Одновременное использование ибандроновой кислоты с пищей или напитками (за исключением чистой воды) на 90% уменьшает биодоступность. Прием напитков или пищи через 0,5 часа после использования ибандроновой кислоты на 30% уменьшает ее биодоступность. При приеме ибандроната за один час до еды не наблюдается значимого уменьшения биодоступности.
Концентрация ибандрононата в плазме крови повышается пропорционально принятой внутрь дозе (до 100 мг) или введенного в/в (в дозе до 6 мг) лекарственного препарата.
Распределение
После проникновения в кровоток ибандроновая кислота быстро связывается с костной тканью либо выводится с мочой. Примерно 40–50% количества препарата, циркулирующего в крови, хорошо проникает в костную ткань и накапливается в ней. Кажущийся конечный объем распределения 90 л. Связь с белками плазмы крови 85%.
Метаболизм
Не существует пока данных о метаболизме ибандроновой кислоты.
Выведение
Около 40-50% циркулирующего в крови препарат выводится путем костной абсорбции, а остальная часть выводится в неизменном виде почками. Не впитавшийся при пероральном приеме препарат выделяется в неизмененном виде с калом. Выведение ибандроновой кислоты имеет двухфазный характер. Терминальный период полувыведения составляет 10 – 60 часов. Общий клиренс составляет 130 мл/мин. Почечный клиренс составляет 88 мл/мин, объем распределения равен 150 л. Разница между общим и почечным клиренсом показывает сколько вещества впиталось костной тканью. Концентрация препарата в крови снижается быстро и составляет 10% от максимальной через 8 ч после перорального приема.
Фармакокинетика у особых групп пациентов
Пациенты с нарушениями функции почек
Почечный клиренс ибандроновой кислоты зависит линейно от клиренса креатинина (КК). Для лиц с нарушением функции почек легкой или средней степени тяжести (КК ≥30 мл/мин) коррекции дозы не требуется. У больных с тяжелым нарушением функции почек (КК <30 мл/мин), принимавших препарат в дозе 10 мг перорально длительностью 21 день, концентрация ибандроновой кислоты в плазме крови в 2–3 раза больше, чем у лиц с нормальной функцией почек. При тяжелой степени нарушении функции почек, общий клиренс ибандроновой кислоты снижается до 44 мл/мин. Однако увеличение системной концентрации не ухудшает переносимость препарата. Требуется коррекция дозы препарата у лиц с нарушением функции почек средней и тяжелой степени Препарат выводится в процессе гемодиализа (37 % в течение 4 ч).
Пациенты с нарушениями функции печени
Отсутствуют данные о фармакокинетике ибандроновой кислоты у людей с нарушением функции печени. В клиренсе ибандроновой кислоты, которая не метаболизируется печенью, а выводится через почки, печень не играет существенной роли. Поэтому для людей с нарушением функции печени не требуется коррекции дозы.
Пожилой возраст
Изученные фармакокинетические параметры не зависят от возраста. Следует учесть возможное снижение функции почек у пожилых
Дети
Отсутствуют данные о применении ибандроновой кислоты у лиц моложе 18 лет .
Фармацевтические характеристики
Таблетки продолговатой формы. Покрыты оболочкой белого или почти белого цвета; с маркировкой «150» на одной стороне.
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