Твердые желатиновые капсулы № 0, корпус и крышечка белого цвета. Содержимое капсул — порошок белого цвета.
Фармакологические свойства
Фармакокинетика
Урсодезоксихолевая кислота абсорбируется в тонкой кишке за счет пассивной диффузии (около 90%), а в подвздошной кишке посредством активного транспорта. Максимальная концентрация в плазме крови (С max ) при приеме внутрь 50 мг через 30, 60, 90 мин — 3,8 ммоль/л, 5,5 ммоль/л и 3,7 ммоль/л соответственно. С max достигается через 1–3 ч. Связь с белками плазмы высокая — до 96–99%. Проникает через плацентарный барьер. При систематическом приеме урсодезоксихолевая кислота становится основной желчной кислотой в сыворотке крови и составляет около 48% от общего количества желчных кислот в крови. Терапевтический эффект препарата зависит от концентрации урсодезоксихолевой кислоты в желчи.
Метаболизируется в печени (клиренс при первичном прохождении через печень) в тауриновый и глициновый конъюгаты. Образующиеся конъюгаты секретируются в желчь. Около 50–70% общей дозы препарата выводится желчью. Незначительное количество не всосавшейся урсодезоксихолевой кислоты поступает в толстый кишечник, где подвергается расщеплению бактериями (7‑дегидроксилирование); образующаяся литохолевая кислота частично всасывается из толстой кишки, но сульфатируется в печени и быстро выводится в виде сульфолитохолилглицинового и сульфолитохолилтауринового конъюгата.
Фармакодинамика
Гепатопротекторное средство, оказывает также желчегонное, холелитолитическое, гиполипидемическое и некоторое иммуномодулирующее действие. Обладая высокими полярными свойствами, урсодезоксихолевая кислота образует нетоксичные смешанные мицеллы с аполярными (токсичными) желчными кислотами, что снижает способность желудочного рефлюктата повреждать клеточные мембраны при билиарном рефлюкс‑гастрите и рефлюкс-эзофагите. Кроме того, урсодезоксихолевая кислота образует двойные молекулы, способные включаться в состав клеточных мембран (гепатоцитов, холангиоцитов, эпителиоцитов ЖКТ), стабилизировать их и делать невосприимчивыми к действию цитотоксичных мицелл. Уменьшая концентрацию токсичных для печеночной клетки желчных кислот и стимулируя холерез, богатый бикарбонатами, урсодезоксихолевая кислота эффективно способствует разрешению внутрипеченочного холестаза. Уменьшает насыщенность желчи холестерином за счет угнетения его абсорбции в кишечнике, подавления синтеза в печени и понижения секреции в желчь; повышает растворимость холестерина в желчи, образуя с ним жидкие кристаллы; уменьшает литогенный индекс желчи. Результатом является растворение холестериновых желчных камней и предупреждение образования новых конкрементов. Иммуностимулирующее действие обусловлено угнетением экспрессии антигенов HLA -1 на мембранах гепатоцитов и HLA -2 на холангиоцитах, нормализацией естественной киллерной активности лимфоцитов и др. Достоверно задерживает прогрессирование фиброза у больных с первичным биллиарным циррозом, муковисцидозом и алкогольным стеатогепатитом, уменьшает риск развития варикозного расширения вен пищевода. Урсодезоксихолевая кислота замедляет процессы преждевременного старения и гибели клеток (гепатоцитов, холангиоцитов и др.).
Хотя урсодезоксихолевая кислота не имеет возрастных ограничений в применении, с осторожностью применяют препарат у детей в возрасте от 3-х до 4-х лет, т.к. возможно затруднение при проглатывании капсул.
Применение при беременности и в период грудного вскармливания
Женщинам детородного возраста в период применения препарата рекомендуется применять негормональные средства контрацепции. Применение урсодезоксихолевой кислоты при беременности возможно только в том случае, когда ожидаемая польза для матери превышает потенциальный риск для плода. Данные о выделении урсодезоксихолевой кислоты с грудным молоком в настоящее время отсутствуют. При необходимости применения урсодезоксихолевой кислоты в период лактации следует решить вопрос о прекращении грудного вскармливания.
Способ применения и дозы
Внутрь, не разжевывая, запивая достаточным количеством воды.
При диффузных заболеваниях печени, желчекаменной болезни (холестериновые желчные камни и билиарный сладж): в суточной дозе от 10 мг/кг массы тела до 12–15 мг/кг массы тела (2–5 капсул) непрерывно в течение длительного времени (от нескольких мес до нескольких лет). При диффузных заболеваниях печени суточная доза препарата делится на 2–3 приема, капсулы принимают вместе с едой. При желчекаменной болезни вся суточная доза принимается однократно на ночь. Продолжительность приема препарата для растворения камней — до полного растворения плюс еще 3 мес для профилактики рецидивов камнеобразования.
Для растворения холестериновых камней желчного пузыря рекомендуемая доза урсодезоксихолевой кислоты составляет 10 мг на 1 кг массы тела в сутки, что соответствует:
Масса тела/Суточная доза
До 60 кг/500 мг (2 капсулы)
61–80 кг/750 мг (3 капсулы)
81–100 кг/1000 мг (4 капсулы)
Свыше 100 кг/1250 мг (5 капсул)
При билиарном рефлюкс-гастрите и рефлюкс-эзофагите : по 250 мг (1 капсула) в сутки, перед сном. Курс лечения — от 10–14 дней до 6 мес., при необходимости до 2-х лет.
При холецистэктомии, для профилактики повторного холелитиаза, рекомендуемая доза — 250 мг 2 раза в сутки в течение нескольких мес.
При токсических, лекарственных поражениях печени, алкогольной болезни печени и атрезии желчных путей: суточная доза по 10–15 мг/кг массы тела в 2–3 приема. Курс лечения — 6–12 мес. и более.
При первичном билиарном циррозе: по 10–15 мг/кг/сут (при необходимости до 20 мг/кг) в 2–3 приема. Курс лечения — от 6 мес до нескольких лет.
При первичном склерозирующем холангите: по 12–15 мг/кг/сут (до 20 мг/кг) в 2–3 приема. Курс лечения — от 6 мес до нескольких лет.
При неалкогольном стеатогепатите: по 13–15 мг/кг/сут в 2–3 приема. Курс лечения — от 6 мес до нескольких лет.
При муковисцидозе: по 20–30 мг/кг/сут в 2–3 приема. Курс лечения — от 6 мес до нескольких лет.
Детям в возрасте старше 3-х лет препарат назначают индивидуально из расчета 10–20 мг/кг/сут.
Побочное действие
Боль в спине, эпигастральной области и правом подреберье, тошнота, рвота, диарея (может быть дозозависимой), запор, преходящее (транзиторное) повышение активности «печеночных» трансаминаз, аллергические реакции, редко (>0,01% и <0,1%) — кальцинирование желчных камней, обострение ранее имевшегося псориаза, алопеция.
Передозировка
Случаев передозировки не выявлено. В случае передозировки проводят симптоматическое лечение.
Взаимодействие с другими лекарственными средствами
Колестимарин, колестипол и антациды, содержащие алюминия гидроксид или алюминия оксид, снижают абсорбцию урсодезоксихолевой кислоты в кишечнике и, таким образом, уменьшают ее всасывание и эффективность. Если же использование препаратов, содержащих хотя бы одно из этих веществ, все же является необходимым, их нужно принимать минимум за 2 ч до приема препарата урсодезоксихолевой кислоты.
Урсодезоксихолевая кислота может усилить всасывание циклоспорина из кишечника. Поэтому у больных, принимающих циклоспорин, врач должен проверить концентрацию циклоспорина в крови и скорректировать дозу циклоспорина в случае необходимости.
В отдельных случаях урсодезоксихолевая кислота может снижать всасывание ципрофлоксацина.
Гиполипидемические лекарственные средства (особенно клофибрат), эстрогены, неомицин и прогестины увеличивают насыщение желчи холестерином и могут снижать способность растворять холестериновые желчные конкременты.
Особые указания
Для успешного растворения необходимо, чтобы камни были чисто холестериновые, размером не более 15–20 мм, желчный пузырь заполнен камнями не более чем на половину и желчевыводящие пути полностью сохраняли свою функцию.
При назначении с целью растворения желчных камней необходим контроль активности «печеночных» трансаминаз и щелочной фосфатазы, γ-глутаминтрансферазы, концентрации билирубина. Холецистографию следует проводить каждые 4 недели в первые 3 мес лечения, в дальнейшем — каждые 3 мес. Контроль эффективности лечения проводить каждые 6 мес в ходе УЗИ в течение первого года терапии.
При сохранении повышенных показателей препарат следует отменить. После полного растворения конкрементов рекомендуется продолжить применение в течение по крайней мере 3 мес, для того чтобы способствовать растворению остатков конкрементов, размеры которых слишком малы для их обнаружения и для профилактики рецидива камнеобразования. Если в течение 6–12 мес после начала терапии частичного растворения конкрементов не произошло, маловероятно, что лечение будет эффективным. Обнаружение во время лечения не визуализируемого желчного пузыря является свидетельством того, что полного растворения конкрементов не произошло, и лечение следует прекратить.
Влияние на способность управлять автомобилем и движущимися механизмами
Не имеется данных о влиянии урсодезоксихолевой кислоты на способность управлять автотранспортом и работать с механизмами.
Форма выпуска
Капсулы 250 мг. По 10 капсул в контурной ячейковой упаковке. По 1, 2, 3, 5 или 10 контурных ячейковых упаковок вместе с инструкцией по применению в пачке из картона.
Условия хранения
В защищенном от света месте, при температуре не выше 25 °C
Срок годности
5 лет
Условия отпуска
По рецепту.
Производитель
ЗАО «Обнинская химико-фармацевтическая компания»
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номер","slug":"","body":[{"type":"paragraph","data":{"text":"ЛП-003465"}}]},{"id":2,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Урсодезоксихолевая кислота(Ursodesoxycholic acid)"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"Состав на одну капсулу"}},{"type":"paragraph","data":{"text":"\u003ci\u003eАктивное вещество:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Урсодезоксихолевая кислота 250,00 мг"}},{"type":"paragraph","data":{"text":"\u003ci\u003eВспомогательные вещества:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Крахмал кукурузный 72,80 мг"}},{"type":"paragraph","data":{"text":"Кремния диоксид коллоидный безводный 1,60 мг"}},{"type":"paragraph","data":{"text":"Магния стеарат 0,60 мг"}},{"type":"paragraph","data":{"text":"\u003ci\u003eОболочка капсулы:\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Титана диоксид (Е171) 1,92 мг"}},{"type":"paragraph","data":{"text":"Желатин 94,08 мг"}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Твердые желатиновые капсулы № 0, корпус и крышечка белого цвета. Содержимое капсул — порошок белого цвета."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакокинетика","level":3}},{"type":"paragraph","data":{"text":"Урсодезоксихолевая кислота абсорбируется в тонкой кишке за счет пассивной диффузии (около 90%), а в подвздошной кишке посредством активного транспорта. Максимальная концентрация в плазме крови (С\u003csub\u003e max\u003c/sub\u003e ) при приеме внутрь 50 мг через 30, 60, 90 мин — 3,8 ммоль/л, 5,5 ммоль/л и 3,7 ммоль/л соответственно. С\u003csub\u003e max\u003c/sub\u003e достигается через 1–3 ч. Связь с белками плазмы высокая — до 96–99%. Проникает через плацентарный барьер. При систематическом приеме урсодезоксихолевая кислота становится основной желчной кислотой в сыворотке крови и составляет около 48% от общего количества желчных кислот в крови. Терапевтический эффект препарата зависит от концентрации урсодезоксихолевой кислоты в желчи."}},{"type":"paragraph","data":{"text":"Метаболизируется в печени (клиренс при первичном прохождении через печень) в тауриновый и глициновый конъюгаты. Образующиеся конъюгаты секретируются в желчь. Около 50–70% общей дозы препарата выводится желчью. Незначительное количество не всосавшейся урсодезоксихолевой кислоты поступает в толстый кишечник, где подвергается расщеплению бактериями (7‑дегидроксилирование); образующаяся литохолевая кислота частично всасывается из толстой кишки, но сульфатируется в печени и быстро выводится в виде сульфолитохолилглицинового и сульфолитохолилтауринового конъюгата."}},{"type":"header","data":{"text":"Фармакодинамика","level":3}},{"type":"paragraph","data":{"text":"Гепатопротекторное средство, оказывает также желчегонное, холелитолитическое, гиполипидемическое и некоторое иммуномодулирующее действие. Обладая высокими полярными свойствами, урсодезоксихолевая кислота образует нетоксичные смешанные мицеллы с аполярными (токсичными) желчными кислотами, что снижает способность желудочного рефлюктата повреждать клеточные мембраны при билиарном рефлюкс‑гастрите и рефлюкс-эзофагите. Кроме того, урсодезоксихолевая кислота образует двойные молекулы, способные включаться в состав клеточных мембран (гепатоцитов, холангиоцитов, эпителиоцитов ЖКТ), стабилизировать их и делать невосприимчивыми к действию цитотоксичных мицелл. Уменьшая концентрацию токсичных для печеночной клетки желчных кислот и стимулируя холерез, богатый бикарбонатами, урсодезоксихолевая кислота эффективно способствует разрешению внутрипеченочного холестаза. Уменьшает насыщенность желчи холестерином за счет угнетения его абсорбции в кишечнике, подавления синтеза в печени и понижения секреции в желчь; повышает растворимость холестерина в желчи, образуя с ним жидкие кристаллы; уменьшает литогенный индекс желчи. Результатом является растворение холестериновых желчных камней и предупреждение образования новых конкрементов. Иммуностимулирующее действие обусловлено угнетением экспрессии антигенов HLA -1 на мембранах гепатоцитов и HLA -2 на холангиоцитах, нормализацией естественной киллерной активности лимфоцитов и др. Достоверно задерживает прогрессирование фиброза у больных с первичным биллиарным циррозом, муковисцидозом и алкогольным стеатогепатитом, уменьшает риск развития варикозного расширения вен пищевода. Урсодезоксихолевая кислота замедляет процессы преждевременного старения и гибели клеток (гепатоцитов, холангиоцитов и др.)."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":[" неосложненная желчекаменная болезнь (биллиарный сладж, растворение холестериновых желчных камней в желчном пузыре при функционирующем желчном пузыре; профилактика рецидивов камнеобразования пойле холецистэктомии);"," хронические гепатиты различного генеза;"," токсические (в том числе лекарственные) поражения печени;"," алкогольная болезнь печени;"," неалкогольный стеатогепатит;"," первичный билиарный цирроз печени;"," первичный склерозирующий холангит;"," муковисцидоз;"," дискинезия желчевыводящих путей;"," билиарный рефлюкс-гастрит и рефлюкс-эзофагит."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":[" гиперчувствительность;"," рентгенположительные (с высоким содержанием кальция) желчные камни;"," нефункционирующий желчный пузырь;"," желчно-желудочный свищ;"," острый холецистит;"," острый холангит;"," цирроз печени в стадии декомпенсации;"," острые инфекционные заболевания желчного пузыря, желчных протоков и кишечника;"," выраженная печеночная и/или почечная недостаточность;"," обструкция желчевыводящих путей;"," эмпиема желчного пузыря;"," детский возраст до 3-х лет."]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Хотя урсодезоксихолевая кислота не имеет возрастных ограничений в применении, с осторожностью применяют препарат у детей в возрасте от 3-х до 4-х лет, т.к. возможно затруднение при проглатывании капсул."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Женщинам детородного возраста в период применения препарата рекомендуется применять негормональные средства контрацепции. Применение урсодезоксихолевой кислоты при беременности возможно только в том случае, когда ожидаемая польза для матери превышает потенциальный риск для плода. Данные о выделении урсодезоксихолевой кислоты с грудным молоком в настоящее время отсутствуют. При необходимости применения урсодезоксихолевой кислоты в период лактации следует решить вопрос о прекращении грудного вскармливания."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь, не разжевывая, запивая достаточным количеством воды."}},{"type":"paragraph","data":{"text":"При диффузных заболеваниях печени, желчекаменной болезни (холестериновые желчные камни и билиарный сладж): в суточной дозе от 10 мг/кг массы тела до 12–15 мг/кг массы тела (2–5 капсул) непрерывно в течение длительного времени (от нескольких мес до нескольких лет). При диффузных заболеваниях печени суточная доза препарата делится на 2–3 приема, капсулы принимают вместе с едой. При желчекаменной болезни вся суточная доза принимается однократно на ночь. Продолжительность приема препарата для растворения камней — до полного растворения плюс еще 3 мес для профилактики рецидивов камнеобразования."}},{"type":"paragraph","data":{"text":"Для растворения холестериновых камней желчного пузыря рекомендуемая доза урсодезоксихолевой кислоты составляет 10 мг на 1 кг массы тела в сутки, что соответствует:"}},{"type":"paragraph","data":{"text":"Масса тела/Суточная доза"}},{"type":"paragraph","data":{"text":"До 60 кг/500 мг (2 капсулы)"}},{"type":"paragraph","data":{"text":"61–80 кг/750 мг (3 капсулы)"}},{"type":"paragraph","data":{"text":"81–100 кг/1000 мг (4 капсулы)"}},{"type":"paragraph","data":{"text":"Свыше 100 кг/1250 мг (5 капсул)"}},{"type":"paragraph","data":{"text":"При билиарном рефлюкс-гастрите и рефлюкс-эзофагите : по 250 мг (1 капсула) в сутки, перед сном. Курс лечения — от 10–14 дней до 6 мес., при необходимости до 2-х лет."}},{"type":"paragraph","data":{"text":"При холецистэктомии, для профилактики повторного холелитиаза, рекомендуемая доза — 250 мг 2 раза в сутки в течение нескольких мес."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПри токсических, лекарственных поражениях печени, алкогольной болезни печени и атрезии желчных путей:\u003c/i\u003e суточная доза по 10–15 мг/кг массы тела в 2–3 приема. Курс лечения — 6–12 мес. и более."}},{"type":"paragraph","data":{"text":"При первичном билиарном циррозе: по 10–15 мг/кг/сут (при необходимости до 20 мг/кг) в 2–3 приема. Курс лечения — от 6 мес до нескольких лет."}},{"type":"paragraph","data":{"text":"При первичном склерозирующем холангите: по 12–15 мг/кг/сут (до 20 мг/кг) в 2–3 приема. Курс лечения — от 6 мес до нескольких лет."}},{"type":"paragraph","data":{"text":"При неалкогольном стеатогепатите: по 13–15 мг/кг/сут в 2–3 приема. Курс лечения — от 6 мес до нескольких лет."}},{"type":"paragraph","data":{"text":"При муковисцидозе: по 20–30 мг/кг/сут в 2–3 приема. Курс лечения — от 6 мес до нескольких лет."}},{"type":"paragraph","data":{"text":"Детям в возрасте старше 3-х лет препарат назначают индивидуально из расчета 10–20 мг/кг/сут."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Боль в спине, эпигастральной области и правом подреберье, тошнота, рвота, диарея (может быть дозозависимой), запор, преходящее (транзиторное) повышение активности «печеночных» трансаминаз, аллергические реакции, редко (>0,01% и <0,1%) — кальцинирование желчных камней, обострение ранее имевшегося псориаза, алопеция."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Случаев передозировки не выявлено. В случае передозировки проводят симптоматическое лечение."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Колестимарин, колестипол и антациды, содержащие алюминия гидроксид или алюминия оксид, снижают абсорбцию урсодезоксихолевой кислоты в кишечнике и, таким образом, уменьшают ее всасывание и эффективность. Если же использование препаратов, содержащих хотя бы одно из этих веществ, все же является необходимым, их нужно принимать минимум за 2 ч до приема препарата урсодезоксихолевой кислоты."}},{"type":"paragraph","data":{"text":"Урсодезоксихолевая кислота может усилить всасывание циклоспорина из кишечника. Поэтому у больных, принимающих циклоспорин, врач должен проверить концентрацию циклоспорина в крови и скорректировать дозу циклоспорина в случае необходимости."}},{"type":"paragraph","data":{"text":"В отдельных случаях урсодезоксихолевая кислота может снижать всасывание ципрофлоксацина."}},{"type":"paragraph","data":{"text":"Гиполипидемические лекарственные средства (особенно клофибрат), эстрогены, неомицин и прогестины увеличивают насыщение желчи холестерином и могут снижать способность растворять холестериновые желчные конкременты."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Для успешного растворения необходимо, чтобы камни были чисто холестериновые, размером не более 15–20 мм, желчный пузырь заполнен камнями не более чем на половину и желчевыводящие пути полностью сохраняли свою функцию."}},{"type":"paragraph","data":{"text":"При назначении с целью растворения желчных камней необходим контроль активности «печеночных» трансаминаз и щелочной фосфатазы, γ-глутаминтрансферазы, концентрации билирубина. Холецистографию следует проводить каждые 4 недели в первые 3 мес лечения, в дальнейшем — каждые 3 мес. Контроль эффективности лечения проводить каждые 6 мес в ходе УЗИ в течение первого года терапии."}},{"type":"paragraph","data":{"text":"При сохранении повышенных показателей препарат следует отменить. После полного растворения конкрементов рекомендуется продолжить применение в течение по крайней мере 3 мес, для того чтобы способствовать растворению остатков конкрементов, размеры которых слишком малы для их обнаружения и для профилактики рецидива камнеобразования. Если в течение 6–12 мес после начала терапии частичного растворения конкрементов не произошло, маловероятно, что лечение будет эффективным. Обнаружение во время лечения не визуализируемого желчного пузыря является свидетельством того, что полного растворения конкрементов не произошло, и лечение следует прекратить."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Не имеется данных о влиянии урсодезоксихолевой кислоты на способность управлять автотранспортом и работать с механизмами."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы 250 мг. По 10 капсул в контурной ячейковой упаковке. По 1, 2, 3, 5 или 10 контурных ячейковых упаковок вместе с инструкцией по применению в пачке из картона."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от света месте, при температуре не выше 25 °C"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"5 лет"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"ЗАО «Обнинская химико-фармацевтическая компания»"}}]}],"source":null},"description_toggle":false,"short_description":"Урсодезоксихолевая кислота абсорбируется в тонкой кишке за счет пассивной диффузии (около 90%), а в подвздошной кишке посредством активного транспорта. Максимальная концентрация в плазме крови (Сmax) при приеме внутрь 50 мг через 30, 60, 90 мин — 3,8 ммоль/л, 5,5 ммоль/л и 3,7 ммоль/л соответственно. Сmaxдостигается через 1–3 ч. Связь с белками плазмы высокая — до 96–99%. Проникает через плацентарный барьер. При систематическом приеме урсодезоксихолевая кислота становится основной желчной кислотой в сыворотке крови и составляет около 48% от общего количества желчных кислот в крови. Терапевтический эффект препарата зависит от концентрации урсодезоксихолевой кислоты в желчи. Метаболизируется в печени (клиренс при первичном прохождении через печень) в тауриновый и глициновый конъюгаты. Образующиеся конъюгаты секретируются в желчь. Около 50–70% общей дозы препарата выводится желчью. Незначительное количество не всосавшейся урсодезоксихолевой кислоты поступает в толстый кишечник, где подвергается расщеплению бактериями (7‑дегидроксилирование); образующаяся литохолевая кислота частично всасывается из толстой кишки, но сульфатируется в печени и быстро выводится в виде сульфолитохолилглицинового и сульфолитохолилтауринового конъюгата. Гепатопротекторное средство, оказывает также желчегонное, холелитолитическое, гиполипидемическое и некоторое иммуномодулирующее действие. Обладая высокими полярными свойствами, урсодезоксихолевая кислота образует нетоксичные смешанные мицеллы с аполярными (токсичными) желчными кислотами, что снижает способность желудочного рефлюктата повреждать клеточные мембраны при билиарном рефлюкс‑гастрите и рефлюкс-эзофагите. Кроме того, урсодезоксихолевая кислота образует двойные молекулы, способные включаться в состав клеточных мембран (гепатоцитов, холангиоцитов, эпителиоцитов ЖКТ), стабилизировать их и делать невосприимчивыми к действию цитотоксичных мицелл. Уменьшая концентрацию токсичных для печеночной клетки желчных кислот и стимулируя холерез, богатый бикарбонатами, урсодезоксихолевая кислота эффективно способствует разрешению внутрипеченочного холестаза. Уменьшает насыщенность желчи холестерином за счет угнетения его абсорбции в кишечнике, подавления синтеза в печени и понижения секреции в желчь; повышает растворимость холестерина в желчи, образуя с ним жидкие кристаллы; уменьшает литогенный индекс желчи. Результатом является растворение холестериновых желчных камней и предупреждение образования новых конкрементов. Иммуностимулирующее действие обусловлено угнетением экспрессии антигенов HLA -1 на мембранах гепатоцитов и HLA -2 на холангиоцитах, нормализацией естественной киллерной активности лимфоцитов и др. Достоверно задерживает прогрессирование фиброза у больных с первичным биллиарным циррозом, муковисцидозом и алкогольным стеатогепатитом, уменьшает риск развития варикозного расширения вен пищевода. Урсодезоксихолевая кислота замедляет процессы преждевременного старения и гибели клеток (гепатоцитов, холангиоцитов и др.).","substance":[{"id":179,"title":"Урсодезоксихолевая кислота","title_latin":"Acidum ursodeoxycholicum","slug":"ursodezoksiholevaya_kislota_179"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":false,"comments":null,"image_alt":"Урсодезоксихолевая кислота - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/197232/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/197232/share_default/"}},"diseases":[],"other_packages":[],"other_product_forms":[],"related_products":{"title":"Аналоги","type":"analogs","products":[{"id":205273,"title":"Урсомакс","subtitle":{"full":"Капсулы, 100 шт, 250 мг","short":"Капсулы, 100 шт, 250 мг","package":"100 шт, 250 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