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Трувада: инструкция по применению, показания

14.07.2018 Раздел: Разное Комментарии: (62) Размер текста: A+ / A-

Биоэквивалентность одной покрытой пленочной оболочкой таблетки Трувады, одной твердой капсулы эмтрицитабина 200 мг и одной покрытой пленочной оболочкой таблетки тенофовира дизопроксила фумарата 245 мг была установлена после применения разовой дозы здоровыми добровольцами натощак.

После перорального приёма Трувады здоровыми добровольцами эмтрицитабин и тенофовира дизопроксила фумарат быстро всасываются, а тенофовира дизопроксила фумарат превращается в тенофовир. Максимальные концентрации эмтрицитабина и тенофовира наблюдаются в сыворотке в диапазоне от 0,5 до 3,0 часов после введения натощак.

160531_truvada_prep_c719ca227d45cdae128f3c74fca35af7.nbcnews-ux-2880-1000Приём Трувады с едой приводил к задержке достижения максимальных концентраций тенофовира приблизительно на три четверти часа и увеличению значений AUC и Сmax тенофовира приблизительно на 35% и 15%, соответственно, при приёме с пищей с высоким или низким содержанием жиров по сравнению с приёмом натощак. Для оптимизации всасывания тенофовира рекомендуется принимать Труваду вместе с пищей.

Распределение.

После внутривенного введения объем распределения эмтрицитабина и тенофовира составлял около 1,4 л/кг и 800 мл/кг, соответственно. После перорального введения эмтрицитабина или тенофовира дизопроксила фумарата эмтрицитабин и тенофовир широко распределяются во всем организме. In vitro связывание эмтрицитабина с белками плазмы крови человека составляло <4% и не зависело от концентрации в диапазоне от 0,02 до 200 мкг/мл. Связывание тенофовира in vitro с белками плазмы или с белками сыворотки крови составляло менее 0,7 и 7,2%, соответственно, в диапазоне концентраций тенофовира от 0,01 до 25 мкг/мл.

Биотрансформация.

Метаболизм эмтрицитабина ограничен. Биотрансформация эмтрицитабина включает окисление тиоловой части с образованием 3’-сульфоксид диастереомеров (приблизительно 9% от дозы) и соединение с глюкуроновой кислотой с образованием 2’-О-глюкуронида (приблизительно 4% дозы). Исследования in vitro показали, что ни тенофовира дизопроксила фумарат, ни тенофовир не являются субстратами ферментов CYP450. Ни эмтрицитабин, ни тенофовир не ингибировали in vitro метаболизм препарата, который опосредовался любой из основных изоформ CYP450 человека, принимающих участие в биотрансформации препарата. Также эмтрицитабин не ингибировал уридин-5’-дифосфоглюкуронил трансферазу – фермент, который отвечает за глюкуронидацию, также смотрите трувада цена.

Выведение.

Эмтрицитабин главным образом выводится почками при полном определении достигнутой дозы в моче (приблизительно 86%) и фекалиях (приблизительно 14%). 13% дозы эмтрицитабина определялись в моче как три метаболита. Системный клиренс эмтрицитабина в среднем составлял 307 мл/мин. После перорального введения период полувыведения эмтрицитабина составляет около 10 часов, также смотрите где трувада цена купить.

Тенофовир главным образом выводится почками, как путем фильтрации, так и с помощью активной тубулярной транспортной системы, при этом после внутривенного введения приблизительно 70-80% дозы выводится в неизменённом состоянии с мочой. Примерный средний клиренс тенофовира составляет около 307 мл/мин.

09152217.950707.7018Почечный клиренс был оценен в приблизительно 210 мл/мин, что превышает скорость гломерулярной фильтрации. Это указывает на то, что тубулярная секреция является важной частью выведения тенофовира. После перорального введения период полувыведения тенофовира составляет около 12-18 часов.

Возраст.

Фармакокинетические исследования эмтрицитабина или тенофовира у пациентов пожилого возраста (в возрасте от 65 лет) не проводились. В целом, фармакокинетика эмтрицитабина у новорожденных, детей младшего возраста и подростков (возрастной диапазон от 4 месяцев до 18 лет) подобна той, которая наблюдается у взрослых. Исследования фармакокинетики тенофовира у детей и подростков (младше 18 лет) не проводились, более подробнее смотрите на сайте https://apteka.hk/.

Трувада: инструкция по применению, показания Reviewed by Vash-Remontik.ru on . Биоэквивалентность одной покрытой пленочной оболочкой таблетки Трувады, одной твердой капсулы эмтрицитабина 200 мг и одной покрытой пленочной оболочкой таблетки Биоэквивалентность одной покрытой пленочной оболочкой таблетки Трувады, одной твердой капсулы эмтрицитабина 200 мг и одной покрытой пленочной оболочкой таблетки Rating: 0
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