Препарат быстро всасывается после перорального приема и опре... Инструкция
Показания к применению
Хронический вирусный гепатит B, хронический вирусный гепатит C, сопровождающиеся повышением активности печеночных трансаминаз, у пациентов с неэффективностью ранее проведенных курсов противовирусной терапии или отсутствием мотивации на проведение противовирусной терапии или с наличием известной гиперчувствительности к препаратам стандартной противовирусной ...
Гиперчувствительность к любому из компонентов препарата, детский возраст до 18 лет, беременность, период грудного вскармливания. Аутоиммунный гепатит, гепатоцеллюлярная карцинома, суб- и декомпенсированный цирроз печени (класс B и C по классификации Чайлд-Пью). Дефицит сахаразы/изомальтазы, непереносимость фруктозы, глюкозо-галактозная мальабсорбция....
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Фармакотерапевтическая группа
Действующее вещество препарата Бициклол по химической структуре является лигнаном.
Применение препарата Бициклол способствует снижению повышенной активности печеночных трансаминаз при гепатитах различной этиологии.
Протективный эффект препарата Бициклол был доказан в моделях in vitro и in vivo, моделирующих различные формы повреждения печени: четыреххлористым углеродом (CCl4) — повреждение биомембран, некроз, фиброз печени; ацетаминофеном (AP) — истощение глутатиона в гепатоцитах; D‑галактозамином — повреждение ДНК ядра гепатоцита; вакциной BCG и конкавалином A (ConA) — иммунное повреждение. Под действием Бициклола в различной степени восстанавливаются патоморфологические нарушения структуры печеночной ткани. Бициклол угнетает продукцию фактора некроза опухоли (ФНО‑a) активными нейтрофилами, купферовскими клетками и макрофагами, а также способствует уменьшению интенсивности протекания свободнорадикальных процессов в клетках. Бициклол угнетает окислительную активность, вызванную нарушением функции митохондрий, что предупреждает некроз и апоптоз гепатоцитов. Бициклол также тормозит апоптоз гепатоцитов, стимулированный ФНО‑a и цитотоксическими T‑-клетками, приводя к восстановлению повреждений ядра и ДНК гепатоцитов. В исследованиях in vivo в модели повреждения печени AP было продемонстрировано, что предварительное назначение бициклола существенно уменьшает степень повреждения гепатоцитов, что выражается в снижении активности аланинаминотрансферазы (АЛТ) и аспартатаминотрансферазы (АСТ) — маркеров некроза гепатоцита, в уменьшении высвобождения цитохрома C и апоптоз-индуцирующих факторов из митохондрий, а также предупреждении дефрагментации ДНК.В исследованиях in vitro также было установлено, что Бициклол способен подавлять экскрецию HBeAg, HBsAg и репликацию ДНК вируса гепатита B. Результаты клинических исследований препарата Бициклол у пациентов с хроническим вирусным гепатитом C умеренной степени активности продемонстрировали, что при его назначении в дозе 150 мг в сутки в течение 12 недель имеет место статистически достоверное снижение биохимических показателей воспалительного процесса в печени (активности трансаминаз (АЛТ, АСТ), общего, прямого и непрямого билирубина), а также уменьшение проявлений астено-вегетативного синдрома и повышение качества жизни пациентов. Полученные данные свидетельствуют о наличии противовоспалительного гепатопротективного эффекта у препарата Бициклол при его использовании в виде монотерапии у пациентов с хроническим вирусным гепатитом C.Препарат Бициклол при его назначении в дозе 150 мг в сутки в течение 12 недель характеризуется благоприятным профилем безопасности и хорошей переносимостью.
Фармакологические свойства
Препарат быстро всасывается после перорального приема и определяется в крови через 15 мин. Период полувыведения в первую фазу двухфазной модели (T1/2ka) составляет 0,84 ч, период полувыведения во вторую фазу двухфазной модели (T1/2ke) составляет 6,26 ч, время достижения максимальной концентрации в плазме крови (Tmax) — 1,8 ч, максимальная концентрация в плазме крови (Cmax) — 50 нг/мл. Максимальная концентрация Cmax и площадь под кривой «концентрация–время» AUC находятся в прямой зависимости от дозы препарата и соответствуют характеристикам линейной фармакокинетики. Максимальная концентрация в плазме крови может повышаться при приеме препарата после еды. При многократном приеме в терапевтической дозе препарат не кумулирует в организме человека. Степень связывания с белками плазмы крови достигает 78%. Максимальная концентрация препарата Бициклол в печени достигается через 4 ч после приема препарата. Метаболизм препарата происходит в печени с участием изоферментов цитохрома P450; основной метаболит препарата Бициклол в организме человека — 4,4’‑гидроксибициклол. Менее 30% препарата выводится из организма кишечником на протяжении 24 ч. Около 1,3% препарата выводится почками, 0,03% — с желчью.
Показания к применению
Хронический вирусный гепатит B, хронический вирусный гепатит C, сопровождающиеся повышением активности печеночных трансаминаз, у пациентов с неэффективностью ранее проведенных курсов противовирусной терапии или отсутствием мотивации на проведение противовирусной терапии или с наличием известной гиперчувствительности к препаратам стандартной противовирусной терапии. Неалкогольный стеатогепатит, хронический алкогольный гепатит, хронический токсический гепатит, в том числе лекарственный (в составе комплексной терапии).
Противопоказания
Гиперчувствительность к любому из компонентов препарата, детский возраст до 18 лет, беременность, период грудного вскармливания. Аутоиммунный гепатит, гепатоцеллюлярная карцинома, суб- и декомпенсированный цирроз печени (класс B и C по классификации Чайлд-Пью). Дефицит сахаразы/изомальтазы, непереносимость фруктозы, глюкозо-галактозная мальабсорбция.
С осторожностью
Гастрит, холецистит, панкреатит. У пациентов с наличием сопутствующих заболеваний желудочно-кишечного тракта, таких как гастрит, холецистит, панкреатит, прием препарата Бициклол может сопровождаться клинически значимым повышением активности АСТ, щелочной фосфатазы (ЩФ) и гамма-глутамилтранспептидазы (ГГТП). В связи с этим терапию таких пациентов препаратом Бициклол следует проводить с осторожностью под дополнительным контролем функциональных показателей гепато-билиарной системы.
Применение при беременности и в период грудного вскармливания
Данные о применении Бициклола у беременных и кормящих женщин отсутствуют. Применение препарата при беременности противопоказано. Неизвестно, выделяется ли препарат в грудное молоко. В случае необходимости применения препарата Бициклол в период лактации, необходимо прекратить грудное вскармливание.
Способ применения и дозы
Внутрь. По 25–50 мг 3 раза в день после еды. Курс лечения 12 недель. По рекомендации врача курс лечения (с использованием дозы 25 мг 3 раза в день) может быть продлен до 6 месяцев.
Побочное действие
Препарат Бициклол обычно хорошо переносится; нежелательные явления обычно носят преходящий характер, выражены в легкой или средней степени тяжести и купируются самостоятельно после отмены препарата или с помощью симптоматической терапии.
Со стороны нервной системы Нарушение сна, головокружение, головная боль.
Со стороны желудочно-кишечного тракта Тошнота, рвота, вздутие живота, боль в эпигастрии.
Со стороны системы кожи и подкожно-жировой клетчатки Кожная сыпь, кожный зуд, крапивница.
Лабораторные данные Повышение активности АСТ, ЩФ, ГГТП, удлинение протромбинового времени, повышение гемоглобина, лейкопения, повышение концентрации общего билирубина и активности трансаминаз, уменьшение количества тромбоцитов, транзиторное повышение концентрации глюкозы и креатинина крови.
Передозировка
Случаев передозировки препарата Бициклол не описано
Взаимодействие с другими лекарственными средствами
Взаимодействие препарата Бициклол с другими лекарственными средствами не изучалось.
Особые указания
В период лечения необходимо проводить периодический контроль показателей функции печени и клинической картины заболевания согласно стандартам ведения соответствующей патологии.
У пациентов с наличием сопутствующих заболеваний желудочно-кишечного тракта, таких как гастрит, холецистит, панкреатит, прием препарата Бициклол может сопровождаться клинически значимым повышением активности АСТ, ЩФ и ГГТП. В связи с этим терапию таких пациентов препаратом Бициклол следует проводить с осторожностью под дополнительным контролем функциональных показателей гепато-билиарной системы.
Влияние на способность управлять автомобилем и движущимися механизмами
Исследований препарата Бициклол на способность управлять транспортными средствами и занятия другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций, не проводилось.
В период лечения препаратом Бициклол следует соблюдать осторожность при управлении транспортными средствами и занятиями другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций в связи с возможностью развития головокружения.
Форма выпуска
Таблетки по 25 мг.
По 9 таблеток в контурную ячейковую упаковку из пленки поливинилхлоридной и фольги алюминиевой (блистер).
2, 10 контурных ячейковых упаковок помещают вместе с инструкцией по медицинскому применению в картонную пачку.
Условия хранения
В сухом месте при температуре от 8 до 25 °C.
Хранить в недоступном для детей месте!
Срок годности
3 года.
Не применять по истечении срока годности, указанного на упаковке.
Условия отпуска
По рецепту.
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является лигнаном."}},{"type":"paragraph","data":{"text":"Применение препарата Бициклол способствует снижению повышенной активности печеночных трансаминаз при гепатитах различной этиологии."}},{"type":"paragraph","data":{"text":"Протективный эффект препарата Бициклол был доказан в моделях \u003ci\u003ein vitro\u003c/i\u003e и \u003ci\u003ein vivo\u003c/i\u003e, моделирующих различные формы повреждения печени: четыреххлористым углеродом (CCl\u003csub\u003e4\u003c/sub\u003e) — повреждение биомембран, некроз, фиброз печени; ацетаминофеном (AP) — истощение глутатиона в гепатоцитах; D‑галактозамином — повреждение ДНК ядра гепатоцита; вакциной BCG и конкавалином A (ConA) — иммунное повреждение. Под действием Бициклола в различной степени восстанавливаются патоморфологические нарушения структуры печеночной ткани. Бициклол угнетает продукцию фактора некроза опухоли (ФНО‑a) активными нейтрофилами, купферовскими клетками и макрофагами, а также способствует уменьшению интенсивности протекания свободнорадикальных процессов в клетках. Бициклол угнетает окислительную активность, вызванную нарушением функции митохондрий, что предупреждает некроз и апоптоз гепатоцитов. Бициклол также тормозит апоптоз гепатоцитов, стимулированный ФНО‑a и цитотоксическими T‑-клетками, приводя к восстановлению повреждений ядра и ДНК гепатоцитов. В исследованиях \u003ci\u003ein vivo\u003c/i\u003e в модели повреждения печени AP было продемонстрировано, что предварительное назначение бициклола существенно уменьшает степень повреждения гепатоцитов, что выражается в снижении активности аланинаминотрансферазы (АЛТ) и аспартатаминотрансферазы (АСТ) — маркеров некроза гепатоцита, в уменьшении высвобождения цитохрома C и апоптоз-индуцирующих факторов из митохондрий, а также предупреждении дефрагментации ДНК.В исследованиях \u003ci\u003ein vitro\u003c/i\u003e также было установлено, что Бициклол способен подавлять экскрецию HBeAg, HBsAg и репликацию ДНК вируса гепатита B. Результаты клинических исследований препарата Бициклол у пациентов с хроническим вирусным гепатитом C умеренной степени активности продемонстрировали, что при его назначении в дозе 150 мг в сутки в течение 12 недель имеет место статистически достоверное снижение биохимических показателей воспалительного процесса в печени (активности трансаминаз (АЛТ, АСТ), общего, прямого и непрямого билирубина), а также уменьшение проявлений астено-вегетативного синдрома и повышение качества жизни пациентов. Полученные данные свидетельствуют о наличии противовоспалительного гепатопротективного эффекта у препарата Бициклол при его использовании в виде монотерапии у пациентов с хроническим вирусным гепатитом C.Препарат Бициклол при его назначении в дозе 150 мг в сутки в течение 12 недель характеризуется благоприятным профилем безопасности и хорошей переносимостью."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Препарат быстро всасывается после перорального приема и определяется в крови через 15 мин. Период полувыведения в первую фазу двухфазной модели (T\u003csub\u003e1/2\u003c/sub\u003ek\u003csub\u003ea\u003c/sub\u003e) составляет 0,84 ч, период полувыведения во вторую фазу двухфазной модели (T\u003csub\u003e1/2\u003c/sub\u003ek\u003csub\u003ee\u003c/sub\u003e) составляет 6,26 ч, время достижения максимальной концентрации в плазме крови (T\u003csub\u003emax\u003c/sub\u003e) — 1,8 ч, максимальная концентрация в плазме крови (C\u003csub\u003emax\u003c/sub\u003e) — 50 нг/мл. Максимальная концентрация C\u003csub\u003emax\u003c/sub\u003e и площадь под кривой «концентрация–время» AUC находятся в прямой зависимости от дозы препарата и соответствуют характеристикам линейной фармакокинетики. Максимальная концентрация в плазме крови может повышаться при приеме препарата после еды. При многократном приеме в терапевтической дозе препарат не кумулирует в организме человека. Степень связывания с белками плазмы крови достигает 78%. Максимальная концентрация препарата Бициклол в печени достигается через 4 ч после приема препарата. Метаболизм препарата происходит в печени с участием изоферментов цитохрома P\u003csub\u003e450\u003c/sub\u003e; основной метаболит препарата Бициклол в организме человека — 4,4’‑гидроксибициклол. Менее 30% препарата выводится из организма кишечником на протяжении 24 ч. Около 1,3% препарата выводится почками, 0,03% — с желчью."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Хронический вирусный гепатит B, хронический вирусный гепатит C, сопровождающиеся повышением активности печеночных трансаминаз, у пациентов с неэффективностью ранее проведенных курсов противовирусной терапии или отсутствием мотивации на проведение противовирусной терапии или с наличием известной гиперчувствительности к препаратам стандартной противовирусной терапии. Неалкогольный стеатогепатит, хронический алкогольный гепатит, хронический токсический гепатит, в том числе лекарственный (в составе комплексной терапии)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к любому из компонентов препарата, детский возраст до 18 лет, беременность, период грудного вскармливания. Аутоиммунный гепатит, гепатоцеллюлярная карцинома, суб- и декомпенсированный цирроз печени (класс B и C по классификации Чайлд-Пью). Дефицит сахаразы/изомальтазы, непереносимость фруктозы, глюкозо-галактозная мальабсорбция."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Гастрит, холецистит, панкреатит. У пациентов с наличием сопутствующих заболеваний желудочно-кишечного тракта, таких как гастрит, холецистит, панкреатит, прием препарата Бициклол может сопровождаться клинически значимым повышением активности АСТ, щелочной фосфатазы (ЩФ) и гамма-глутамилтранспептидазы (ГГТП). В связи с этим терапию таких пациентов препаратом Бициклол следует проводить с осторожностью под дополнительным контролем функциональных показателей гепато-билиарной системы."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Данные о применении Бициклола у беременных и кормящих женщин отсутствуют. Применение препарата при беременности противопоказано. Неизвестно, выделяется ли препарат в грудное молоко. В случае необходимости применения препарата Бициклол в период лактации, необходимо прекратить грудное вскармливание."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь. По 25–50 мг 3 раза в день после еды. Курс лечения 12 недель. По рекомендации врача курс лечения (с использованием дозы 25 мг 3 раза в день) может быть продлен до 6 месяцев."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Препарат Бициклол обычно хорошо переносится; нежелательные явления обычно носят преходящий характер, выражены в легкой или средней степени тяжести и купируются самостоятельно после отмены препарата или с помощью симптоматической терапии."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы \u003c/i\u003eНарушение сна, головокружение, головная боль."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны желудочно-кишечного тракта \u003c/i\u003eТошнота, рвота, вздутие живота, боль в эпигастрии."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны системы кожи и подкожно-жировой клетчатки \u003c/i\u003eКожная сыпь, кожный зуд, крапивница."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛабораторные данные \u003c/i\u003eПовышение активности АСТ, ЩФ, ГГТП, удлинение протромбинового времени, повышение гемоглобина, лейкопения, повышение концентрации общего билирубина и активности трансаминаз, уменьшение количества тромбоцитов, транзиторное повышение концентрации глюкозы и креатинина крови."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":" Случаев передозировки препарата Бициклол не описано "}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":" Взаимодействие препарата Бициклол с другими лекарственными средствами не изучалось. "}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"В период лечения необходимо проводить периодический контроль показателей функции печени и клинической картины заболевания согласно стандартам ведения соответствующей патологии."}},{"type":"paragraph","data":{"text":"У пациентов с наличием сопутствующих заболеваний желудочно-кишечного тракта, таких как гастрит, холецистит, панкреатит, прием препарата Бициклол может сопровождаться клинически значимым повышением активности АСТ, ЩФ и ГГТП. В связи с этим терапию таких пациентов препаратом Бициклол следует проводить с осторожностью под дополнительным контролем функциональных показателей гепато-билиарной системы."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Исследований препарата Бициклол на способность управлять транспортными средствами и занятия другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций, не проводилось."}},{"type":"paragraph","data":{"text":"В период лечения препаратом Бициклол следует соблюдать осторожность при управлении транспортными средствами и занятиями другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций в связи с возможностью развития головокружения."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки по 25 мг."}},{"type":"paragraph","data":{"text":"По 9 таблеток в контурную ячейковую упаковку из пленки поливинилхлоридной и фольги алюминиевой (блистер)."}},{"type":"paragraph","data":{"text":"2, 10 контурных ячейковых упаковок помещают вместе с инструкцией по медицинскому применению в картонную пачку."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом месте при температуре от 8 до 25 °C."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте!"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}},{"type":"paragraph","data":{"text":"Не применять по истечении срока годности, указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту."}}]}],"source":null},"description_toggle":false,"short_description":"Препарат быстро всасывается после перорального приема и определяется в крови через 15 мин. 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