Урсодезоксихолевая кислота-ВЕРТЕКС Капсулы, 50 шт, 250 мг

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В целях оптимизации эффективности лечения терапию урсодезоксихолевой кислотой следует начинать как можно раньше после установления диагноза CFAHD."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"После приема внутрь урсодезоксихолевая кислота быстро абсорбируется в тощей кишке и в проксимальной части подвздошной кишки за счет пассивной диффузии а в дистальной части подвздошной кишки - за счет активного транспорта. Всасывается примерно 60-80%."}},{"type":"paragraph","data":{"text":"После всасывания урсодезоксихолевая кислота практически полностью конъюгирует в печени с глицином и таурином и выводится с желчью. При первом прохождении через печень метаболизируется до 60%."}},{"type":"paragraph","data":{"text":"В зависимости от суточной дозы вида заболевания и состояния печени в желчи накапливается большее или меньшее количество урсодезоксихолевой кислоты. В то же время наблюдается относительное снижение содержания других более липофильных желчных кислот."}},{"type":"paragraph","data":{"text":"Под воздействием кишечных бактерий урсодезоксихолевая кислота частично разрушается с образованием 7-кето-литохолевой и литохолевой кислот. Литохолевая кислота гепатотоксична у некоторых видов животных она вызывает повреждение паренхимы печени. В организме человека она всасывается лишь в небольшом количестве. В процессе метаболизма происходит ее сульфатирование в печени за счет чего она обезвреживается еще до того как происходит экскреция в желчь и выводится через кишечник."}},{"type":"paragraph","data":{"text":"Период полувыведения урсодезоксихолевой кислоты составляет 35-58 дня."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"- Растворение холестериновых камней желчного пузыря;"}},{"type":"paragraph","data":{"text":"- билиарный рефлюкс-гастрит;"}},{"type":"paragraph","data":{"text":"- первичный билиарный цирроз печени при отсутствии признаков декомпенсации;"}},{"type":"paragraph","data":{"text":"- хронические гепатиты различного генеза;"}},{"type":"paragraph","data":{"text":"- первичный склерозирующий холангит;"}},{"type":"paragraph","data":{"text":"- муковисцидоз (кистозный фиброз);"}},{"type":"paragraph","data":{"text":"- неалкогольный стеатогепатит;"}},{"type":"paragraph","data":{"text":"- алкогольная болезнь печени;"}},{"type":"paragraph","data":{"text":"- дискинезия желчевыводящих путей."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- Повышенная чувствительность к компонентам препарата и другим желчным кислотам;"}},{"type":"paragraph","data":{"text":"- рентгеноположительные (с высоким содержанием кальция) желчные камни;"}},{"type":"paragraph","data":{"text":"- нарушение сократительной способности желчного пузыря;"}},{"type":"paragraph","data":{"text":"- закупорка желчных путей (закупорка общего желчного протока или пузырного протока);"}},{"type":"paragraph","data":{"text":"- частые эпизоды желчной колики;"}},{"type":"paragraph","data":{"text":"- острые воспалительные заболевания желчного пузыря и желчных протоков;"}},{"type":"paragraph","data":{"text":"- цирроз печени в стадии декомпенсации;"}},{"type":"paragraph","data":{"text":"- выраженная печеночная и/или почечная недостаточность;"}},{"type":"paragraph","data":{"text":"- детский возраст до 3-х лет (не рекомендуется для применения в данной лекарственной форме)."}},{"type":"paragraph","data":{"text":"Педиатрическая популяция"}},{"type":"paragraph","data":{"text":"- неудачно выполненная портоэнтеростомия или случаи отсутствия восстановления нормального потока желчи у детей с атрезией желчевыводящих путей."}},{"type":"paragraph","data":{"text":"Урсодезоксихолевая кислота не имеет возрастных ограничений в применении но детям в возрасте до 3 лет рекомендуется применять препарат в виде суспензии так как могут возникать затруднения при проглатывании капсул."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Детский возраст от 3 лет (возможно затруднение при проглатывании капсул)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Беременность"}},{"type":"paragraph","data":{"text":"Данные о применении урсодезоксихолевой кислоты во время беременности носят ограниченный характер или отсутствуют. Исследования на животных показали наличие репродуктивной токсичности на ранней стадии беременности."}},{"type":"paragraph","data":{"text":"Во время беременности урсодезоксихолевая кислота использоваться не должна за исключением случаев когда это явно необходимо."}},{"type":"paragraph","data":{"text":"Фертильность"}},{"type":"paragraph","data":{"text":"По данным исследований на животных урсодезоксихолевая кислота не оказывает влияния на фертильность. Данные о влиянии лечения урсодезоксихолевой кислотой на фертильность у человека отсутствуют."}},{"type":"paragraph","data":{"text":"Применение- препарата женщинами детородного возраста возможно только при условии использования надежных методов контрацепции. Рекомендуется использовать негормональные противозачаточные средства либо пероральные контрацептивы с низким содержанием эстрогенов. Однако пациентам принимающим урсодезоксихолевую кислоту для растворения камней в желчном пузыре следует использовать эффективные негормональные контрацептивы так как гормональные пероральные контрацептивы могут повышать образование желчных камней. До начала лечения следует исключить возможную беременность."}},{"type":"paragraph","data":{"text":"Грудное вскармливание"}},{"type":"paragraph","data":{"text":"Согласно данным нескольких документально подтвержденных случаев уровень урсодезоксихолевой кислоты в грудном молоке у женщин очень низок и поэтому возникновение побочных реакций у детей находящихся на грудном вскармливании не ожидается."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь. Детям и взрослым с массой тела менее 47 кг рекомендуется применять урсодезоксихолевую кислоту в виде суспензии."}},{"type":"paragraph","data":{"text":"Растворение холестериновых желчных камней"}},{"type":"paragraph","data":{"text":"Рекомендуемая доза урсодезоксихолевой кислоты зависит от массы тела и составляет 10 мг/кг/сутки (см. табл.1)."}},{"type":"paragraph","data":{"text":"Таблица 1. Расчет суточного количества капсул препарата в зависимости от массы тела"}},{"type":"paragraph","data":{"text":"Масса тела кг/Количество капсул шт."}},{"type":"paragraph","data":{"text":"до 60/2"}},{"type":"paragraph","data":{"text":"61-80/3"}},{"type":"paragraph","data":{"text":"81-100/4"}},{"type":"paragraph","data":{"text":"свыше 100/5"}},{"type":"paragraph","data":{"text":"Препарат необходимо принимать ежедневно вечером перед сном (капсулы не разжевывают) запивая небольшим количеством жидкости. Длительность лечения 6-12 месяцев."}},{"type":"paragraph","data":{"text":"Для профилактики повторного холелитиаза рекомендован прием препарата в течение нескольких месяцев после растворения камней."}},{"type":"paragraph","data":{"text":"Лечение билиарного рефлюкс-гастрита"}},{"type":"paragraph","data":{"text":"1 капсула препарата ежедневно вечером перед сном (капсулы не разжевывают) запивая небольшим количеством воды."}},{"type":"paragraph","data":{"text":"Курс лечения от 10-14 дней до 6 месяцев при необходимости - до 2 лет."}},{"type":"paragraph","data":{"text":"Лечение первичного билиарного цирроза"}},{"type":"paragraph","data":{"text":"Суточная доза зависит от массы тела и составляет от 3 до 7 капсул (примерно 14±2 мг/кг урсодезоксихолевой кислоты)."}},{"type":"paragraph","data":{"text":"В первые 3 месяца лечения применение препарата следует разделить на несколько приемов в течение дня. После улучшения печеночных показателей суточную дозу можно принимать 1 раз вечером."}},{"type":"paragraph","data":{"text":"Капсулы следует принимать регулярно не разжевывая запивая небольшим количеством жидкости."}},{"type":"paragraph","data":{"text":"Применение препарата для лечения первичного билиарного цирроза может быть продолжено в течение неограниченного времени. У пациентов с первичным билиарным циррозом в редких случаях клинические симптомы могут ухудшиться в начале лечения например может участиться зуд. В этом случае лечение следует продолжить принимая по 1 капсуле ежедневно далее следует постепенно повышать дозу (увеличивая суточную дозу еженедельно на 1 капсулу) до тех пор пока вновь не будет достигнут рекомендованный режим дозирования."}},{"type":"paragraph","data":{"text":"Симптоматическое лечение хронических гепатитов различного генеза"}},{"type":"paragraph","data":{"text":"Суточная доза 10-15 мг/кг в 2-3 приема. Длительность лечения 6-12 месяцев и более."}},{"type":"paragraph","data":{"text":"Первичный склерозирующий холангит"}},{"type":"paragraph","data":{"text":"Суточная доза 12-15 мг/кг. При необходимости доза может быть увеличена до 20-30 мг/кг в 2-3 приема. Длительность терапии составляет от 6 месяцев до нескольких лет (см. раздел \"Особые указания\")."}},{"type":"paragraph","data":{"text":"Муковисцидоз (кистозный фиброз)"}},{"type":"paragraph","data":{"text":"Суточная доза 20 мг/кг/сутки в 2-3 приема с дальнейшим увеличением до 30 мг/кг/сутки при необходимости."}},{"type":"paragraph","data":{"text":"Неалкогольный стеатогепатит"}},{"type":"paragraph","data":{"text":"Средняя суточная доза 10-15 мг/кг в 2-3 приема. Длительность терапии составляет от 6-12 месяцев и более."}},{"type":"paragraph","data":{"text":"Алкогольная болезнь печени"}},{"type":"paragraph","data":{"text":"Средняя суточная доза 10-15 мг/кг в 2-3 приема. Длительность терапии составляет от 6-12 месяцев и более."}},{"type":"paragraph","data":{"text":"Дискинезия желчевыводящих путей"}},{"type":"paragraph","data":{"text":"Средняя суточная доза 10 мг/кг в 2 приема в течение от 2 недель до 2 месяцев. При необходимости курс лечения рекомендуется повторить."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Классификация частоты развития побочных эффектов согласно рекомендациям Всемирной организации здравоохранения (ВОЗ):"}},{"type":"paragraph","data":{"text":"очень часто ≥1/10;"}},{"type":"paragraph","data":{"text":"часто от ≥ 1/100 до < 1/10;"}},{"type":"paragraph","data":{"text":"нечасто от≥ 1/1000 до < 1/100;"}},{"type":"paragraph","data":{"text":"редко от≥ 1/10000 до < 1/1000;"}},{"type":"paragraph","data":{"text":"очень редко < 1/10000 включая отдельные сообщения;"}},{"type":"paragraph","data":{"text":"частота неизвестна - по имеющимся данным установить частоту возникновения не представляется возможным."}},{"type":"paragraph","data":{"text":"Желудочно-кишечные нарушения: часто - неоформленный стул или диарея; очень редко - острые боли в правой верхней части живота (при лечении первичного билиарного цирроза)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны печени и желчевыводящих путей: очень редко - кальцинирование желчных камней декомпенсация цирроза печени которая исчезает после отмены препарата (при лечении развитых стадий первичного билиарного цирроза)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны кожи и подкожных тканей: очень редко - аллергические реакции в том числе крапивница."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"При передозировке возможна диарея. Как правило другие симптомы передозировки маловероятны поскольку с увеличением дозы поглощение урсодезоксихолевой кислоты уменьшается и соответственно большее ее количество выводится через кишечник. Необходимости в применении специфических мер при передозировке нет."}},{"type":"paragraph","data":{"text":"Лечение последствий диареи симптоматическое направленное на восполнение объема жидкости и восстановление электролитного баланса."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Колестирамин колестипол и антациды содержащие алюминия гидроксид или смектит (алюминия оксид) снижают абсорбцию урсодезоксихолевой кислоты в кишечнике и таким образом уменьшают ее поглощение и эффективность."}},{"type":"paragraph","data":{"text":"Если использование препаратов содержащих хотя бы одно из этих веществ все же является необходимым их нужно принимать минимум за 2 часа до приема урсодезоксихолевой кислоты."}},{"type":"paragraph","data":{"text":"Урсодезоксихолевая кислота может влиять на абсорбцию циклоспорина из кишечника. Поэтому у пациентов принимающих циклоспорин врач должен проверить концентрацию циклоспорина в крови и в случае необходимости скорректировать его дозу."}},{"type":"paragraph","data":{"text":"Урсодезоксихолевая кислота может снижать всасывание ципрофлоксацина."}},{"type":"paragraph","data":{"text":"В клиническом исследовании с участием здоровых добровольцев одновременное применение урсодезоксихолевой кислоты (500 мг/сутки) и розувастатина (20 мг/сутки) приводило к небольшому повышению уровня розувастатина в плазме крови. Клиническая значимость этого взаимодействия в том числе в отношении других статинов неизвестна. Было показано что у здоровых добровольцев урсодезоксихолевая кислота снижает максимальную концентрацию в плазме и площадь под фармакокинетической кривой \"концентрация-время\" блокатора медленных кальциевых каналов - нитрендипина. В случае одновременного применения нитрендипина и урсодезоксихолевой кислоты рекомендуется тщательный мониторинг."}},{"type":"paragraph","data":{"text":"Может потребоваться увеличение дозы нитрендипина."}},{"type":"paragraph","data":{"text":"Имеются также сообщения о взаимодействии с дапсоном которое приводило к уменьшению терапевтического эффекта последнего. Эти наблюдения наряду с данными экспериментов in vitro дают основания полагать что урсодезоксихолевая кислота способна индуцировать ферменты системы цитохрома Р450 3А. Однако в спланированном исследовании взаимодействия с будесонидом который является известным субстратом цитохрома Р450 3А индукция отмечена не была."}},{"type":"paragraph","data":{"text":"Эстрогенные гормоны и препараты снижающие уровень холестерина в крови такие как клофибрат увеличивают секрецию холестерина в печени и следовательно могут стимулировать образование желчных камней что нивелирует эффект урсодезоксихолевой кислоты которая применяется для растворения камней в желчном пузыре."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Прием препарата должен осуществляться под наблюдением врача."}},{"type":"paragraph","data":{"text":"В течение первых 3 месяцев лечения следует контролировать функциональные показатели печени: трансаминазы щелочную фосфатазу и гамма-глютамилтранспептидазу в плазме крови каждые 4 недели а затем каждые 3 месяца. Контроль указанных параметров позволяет выявить нарушения функции печени на ранних стадиях. Также это касается пациентов на поздних стадиях первичного билиарного цирроза. Кроме того так можно быстро определить реагирует ли пациент с первичным билиарным циррозом на проводимое лечение."}},{"type":"paragraph","data":{"text":"При применении препарата для растворения холестериновых желчных камней"}},{"type":"paragraph","data":{"text":"Для того чтобы оценить прогресс в лечении и в целях своевременного выявления признаков кальциноза камней в зависимости от их размера желчный пузырь следует визуализировать (пероральная холецистография) с осмотром затемнений в положении стоя и лежа на спине (ультразвуковое исследовние) через 6-10 месяцев после начала лечения."}},{"type":"paragraph","data":{"text":"Если желчный пузырь невозможно визуализировать на рентгеновских снимках а также в случаях кальциноза камней слабой сократимости желчного пузыря или частых приступов колик препарат применять не следует."}},{"type":"paragraph","data":{"text":"Пациенткам принимающим урсодезоксихолевую кислоту для растворения желчных камней необходимо применять эффективные негормональные методы контрацепции так как гормональные контрацептивы могут увеличивать образование желчных камней (см. разделы \"Взаимодействие с другими лекарственными средствами\" и \"Применение при беременности и в период грудного вскармливания\")."}},{"type":"paragraph","data":{"text":"При лечении пациентов на поздних стадиях первичного билиарного цирроза"}},{"type":"paragraph","data":{"text":"Крайне редко отмечались случаи декомпенсации цирроза печени. После прекращения терапии отмечалось частичное обратное развитие проявлений декомпенсации."}},{"type":"paragraph","data":{"text":"У пациентов с первичным билиарным циррозом в редких случаях в начале лечения возможно усиление клинических симптомов например может усилиться зуд. В этом случае дозу препарата необходимо снизить а затем постепенно вновь увеличивать как описано в разделе \"Способ применения и дозы\"."}},{"type":"paragraph","data":{"text":"При применении у пациентов с первичным склерозирующим холангитом"}},{"type":"paragraph","data":{"text":"Длительная терапия высокими дозами урсодезоксихолевой кислоты (28-30 мг/кг/сутки) у пациентов с данной патологией может вызвать серьезные побочные явления."}},{"type":"paragraph","data":{"text":"У пациентов с диареей следует уменьшить дозу препарата. При персистирующей диарее следует прекратить лечение."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Урсодезоксихолевая кислота не оказывает влияния на способность управлять транспортными средствами и механизмами или же это влияние минимальное."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы 250 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить в защищенном от света месте при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года."}},{"type":"paragraph","data":{"text":"Не применять по истечении срока годности."}}]},{"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":"Акционерное общество \"ВЕРТЕКС\" (АО \"ВЕРТЕКС\"), г. Санкт-Петербург, Дорога в Каменку, д.62, лит. А, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"АО \"ВЕРТЕКС\""}}]}],"source":null},"description_toggle":false,"short_description":"Урсодезоксихолевая кислота - гепатопротекторное средство оказывает желчегонное действие. Уменьшает синтез холестерина в печени всасывание его в кишечнике и концентрацию в желчи повышает растворимость холестерина в желчевыводящей системе стимулирует образование и выведение желчи. Снижает литогенность желчи увеличивает в ней содержание желчных кислот. Вызывает усиление желудочной и панкреатической секреции усиливает активность липазы. Оказывает гипогликемическое действие вызывает частичное или полное растворение холестериновых камней при приеме внутрь уменьшает насыщенность желчи холестерином что способствует мобилизации холестерина из желчных камней. Оказывает иммуномодулирующее действие влияет на иммунологические реакции в печени: уменьшает экспрессию некоторых антигенов на мембране гепатоцитов влияет на количество Т-лимфоцитов образование интерлейкина-2 уменьшает количество эозинофилов. Педиатрическая популяция Муковисцидоз (кистозный фиброз) Согласно данным клинических отчетов имеется многолетний опыт (до 10 лет и более) лечения урсодезоксихолевой кислотой педиатрических пациентов страдающих гепатобилиарной болезнью связанной с муковисцидозом (CFAHD). Имеются данные о том что терапия урсодезоксихолевой кислотой способна снижать пролиферацию желчных протоков замедлять развитие повреждений выявляемых при гистологическом исследовании и даже способствовать обратному развитию изменений гепатобилиарной системы в случае если терапия начинается на ранних стадиях CFAHD. В целях оптимизации эффективности лечения терапию урсодезоксихолевой кислотой следует начинать как можно раньше после установления диагноза CFAHD. После приема внутрь урсодезоксихолевая кислота быстро абсорбируется в тощей кишке и в проксимальной части подвздошной кишки за счет пассивной диффузии а в дистальной части подвздошной кишки - за счет активного транспорта. Всасывается примерно 60-80%. После всасывания урсодезоксихолевая кислота практически полностью конъюгирует в печени с глицином и таурином и выводится с желчью. При первом прохождении через печень метаболизируется до 60%. В зависимости от суточной дозы вида заболевания и состояния печени в желчи накапливается большее или меньшее количество урсодезоксихолевой кислоты. В то же время наблюдается относительное снижение содержания других более липофильных желчных кислот. Под воздействием кишечных бактерий урсодезоксихолевая кислота частично разрушается с образованием 7-кето-литохолевой и литохолевой кислот. Литохолевая кислота гепатотоксична у некоторых видов животных она вызывает повреждение паренхимы печени. В организме человека она всасывается лишь в небольшом количестве. В процессе метаболизма происходит ее сульфатирование в печени за счет чего она обезвреживается еще до того как происходит экскреция в желчь и выводится через кишечник. 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