Твердые желатиновые капсулы №1; корпус и крышечка непрозрачные, белого цвета. Содержимое капсул: круглые пеллеты (гранулы) белого цвета.
Фармакотерапевтическая группа
Глюкокортикостероид
Фармакологические свойства
Фармакодинамика:
Будесонид является негалогеновым глюкокортикостероидом с противовоспалительными противоаллергическими антиэкссудативными и противоотечными свойствами.
Эти свойства основаны на:
- уменьшении выделения медиаторов из тучных клеток базофилов и макрофагов; перераспределении и подавлении миграции воспалительных клеток ингибировании воспалительных реакций;
- мембраностабилизирующем действии.
Индукция некоторых протеинов (например макрокортина) является одним из специфических механизмов действия будесонида. Ингибируя фосфолипазу А2 эти протеины участвуют в метаболизме арахидоновой кислоты и таким образом предупреждают образование медиаторов воспаления лейкотриенов и простагландинов. Так как процесс индукции синтеза протеинов требует некоторого промежутка времени полный терапевтический эффект будесонида развивается постепенно.
Фармакокинетика:
Будесонид обладает выраженными липофильными свойствами и быстро абсорбируется в кишечнике вследствие хорошей тканевой проницаемости.
По сравнению с классическими глюкокортикостероидами будесонид имеет очень высокую степень сродства к рецепторам. Благодаря этим свойствам Буденофальк обладает целенаправленным местным действием.
Приблизительно 90% будесонида метаболизируется в печени при "первом прохождении" и только около 10% оказывает системное воздействие. Из этого количества 90% будесонида связано с альбумином и за счет этого находится в биологически неактивной форме.
Показания к применению
- Легкая и среднетяжелая формы болезни Крона с вовлечением подвздошной и/или восходящей ободочной кишки;
Гиперчувствительность к будесониду или другим компонентам препарата цирроз печени инфекционные заболевания кишечника (бактериальная грибковая амебная вирусная инфекции) период лактации (грудное вскармливание) непереносимость лактозы фруктозы галактозы дефицит лактазы дефицит сахаразы/изомальтазы глюкозо-галактозная мальабсорбция детский возраст до 3 лет.
С осторожностью
Следует применять при туберкулезе артериальной гипертензии сахарном диабете остеопорозе пептической язве глаукоме катаракте отягощенном семейном анамнезе по диабету или глаукоме беременность.
Применение при беременности и в период грудного вскармливания
Во время беременности применение Буденофалька возможно только в тех случаях когда ожидаемая польза для матери превышает потенциальный риск для плода. У женщин детородного возраста до начала терапии Буденофальком должна быть исключена возможная беременность а во время лечения должны применяться надежные методы контрацепции.
До настоящего времени неизвестно способен ли будесонид проникать в грудное молоко поэтому в период лечения необходимо отказаться от грудного вскармливания.
Способ применения и дозы
Болезнь Крона
Взрослые ( старше 18 лет)
Рекомендуемая суточная доза составляет три капсулы один раз в день утром или одну капсулу (содержащую 3 мг будесонида) 3 раза в сутки (утром днем и вечером).
Коллагенозный (коллагеновый) колит
Взрослые (старше 18 лет)
Рекомендуемая суточная доза составляет три капсулы один раз утром до завтрака (соответствует суточной дозе 9 мг будесонида).
Курс лечения при болезни Крона и коллагенозном (коллагеновом) колите обычно составляет 8 недель.
Как правило полный эффект наступает через 2-4 недели.
Аутоиммунный гепатит
Взрослые (старше 18 лет)
Лечение активного гепатита
Рекомендуемая суточная доза составляет 1 капсулу 3 раза в день (утром днем и вечером).
Поддерживающее лечение
1 капсулу два раза в день (утром и вечером).
Курс лечения длительный и может составлять до 6-12 месяцев при активном гепатите (обострении) и до 24 месяцев при поддерживающей терапии.
Продолжительность и частота приема препарата определяется лечащим врачом.
Капсулы необходимо принимать приблизительно за 30 минут до еды проглатывая их целиком с достаточным количеством жидкости.
Если у пациента имеются проблемы с глотанием он может вскрыть твердые капсулы и принять содержащиеся там устойчивые к действию желудочного сока гранулы не разжевывая их и запивая достаточным количеством жидкости что не повлияет на эффективность препарата.
Нельзя резко прекращать прием препарата. Препарат необходимо отменять постепенно (медленно снижая дозировку). В течение первой недели дозировка должна быть уменьшена до 2 капсул в день (по 1 капсуле утром и вечером). В течение второй недели пациент должен принимать по 1 капсуле в день только утром. Затем лечение может быть прекращено.
Побочное действие
Иногда могут возникать типичные для системных ГКС побочные эффекты (синдром Кушинга). Эти побочные эффекты зависят от дозы, длительности лечения, сопутствующего или предшествующего лечения другими ГКС и индивидуальной чувствительности.
Клинические испытания показали, что частота побочных эффектов, характерных для ГКС, при использовании Буденофалька значительно меньше (приблизительно в 2 раза) по сравнению с частотой нежелательных эффектов при пероральном приеме эквивалентных доз преднизолона. Тем не менее, нельзя полностью исключить возникновение побочных эффектов, типичных для ГКС.
Могут возникать следующие побочные эффекты
Со стороны кожных покровов: аллергическая экзема, красные стрии, петехии, экхимоз, стероидные угри, ухудшение заживления ран, контактный дерматит.
Со стороны опорно-двигательного аппарата: мышечная слабость, остеопороз, асептический некроз костей (бедренной и головки плечевой).
Со стороны эндокринной системы: синдром Кушинга (лунообразное лицо, ожирение, сахарный диабет, снижение толерантности к глюкозе, задержка натрия с формированием отеков, гипокалиемия, снижение функции или атрофия коры надпочечников, нарушение секреции половых гормонов (аменорея, гирсутизм, импотенция).
Со стороны сердечно-сосудистой системы: повышение АД, повышенный риск тромбообразования, васкулит (синдром отмены после длительного лечения).
Со стороны иммунной системы: влияние на иммунный ответ (повышенный риск возникновения инфекционных заболеваний).
При переводе больных с приема системных ГКС на будесонид могут усиливаться или вновь возникать внекишечные симптомы (особенно поражение кожи и суставов).
Передозировка
Случаев передозировки не выявлено.
В случае передозировки проводят симптоматическое лечение.
Взаимодействие с другими лекарственными средствами
Сердечные гликозиды:
Действие сердечных гликозидов может усиливаться из-за дефицита калия.
Во время лечения данным препаратом нельзя пить грейпфрутовый сок так как он может повлиять на эффективность препарата.
Есть данные о повышенных концентрациях эстрогенов в плазме и об усилении эффектов кортикостероидов у женщин принимавших эстрогены или оральные контрацептивы в сочетании с будесонидом. Однако этот эффект не наблюдался в случае приема низкодозированных оральных контрацептивов.
Одновременное назначение циметидина и будесонида может приводить к незначительному повышению уровня будесонида в плазме однако это не имеет клинического значения. Одновременное назначение омепразола не влияет на фармакокинетику будесонида. Теоретически нельзя исключить взаимодействие со смолами способными связывать стероиды (например холестирамином) а так же антацидами. При одновременном приеме этих препаратов с Буденофальком в результате взаимодействия может уменьшаться лечебный эффект будесонида. В этой связи вышеназванные препараты должны приниматься с Буденофальком по крайней мере с интервалом в 2 часа.
Особые указания
Буденофальк может подавлять функцию гипоталамо-гипофизарно-адреналовой системы. Перед оперативным вмешательством или воздействием другого стрессового фактора рекомендуется дополнительное назначение системных глюкокортикостероидов.
Буденофальк 3 мг содержит лактозу и сахарозу. Препарат не следует принимать пациентам с редкими наследственными состояниями непереносимости галактозы или фруктозы недостаточностью сахаразы-изомальтазы или мальабсорбцией глюкозы-галактозы а также лактазной недостаточностью или врожденной недостаточностью лактазы.
У пациентов с аутоиммунным гепатитом следует регулярно контролировать уровень трансаминаз (АЛТ ACT) в сыворотке (каждые 2 недели в течение первого месяца лечения и как минимум через каждые 3 месяца в дальнейшем) с целью возможной коррекции дозировки будесонида.
Влияние на способность управлять автомобилем и движущимися механизмами
Необходимо соблюдать осторожность при управлении транспортными средствами и занятиями потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций так как препарат может вызвать головную боль слабость нарушения со стороны органов зрения и другие побочные эффекты которые могут влиять на указанные способности.
Форма выпуска
Капсулы кишечнорастворимые 3 мг.
Условия хранения
Хранить при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
3 года.
Не применять после истечения срока годности указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Д-р Фальк Фарма ГмбХ, Leinenweberstrasse 5, 79108 Freiburg, Germany, Германия
Организация, принимающая претензии потребителей
Д-р Фальк Фарма ГмбХ
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сополимер [2:0,2:1] (Аммонио-метакрилата сополимер (тип А), Эудрагит RL) 2,1 мг; триэтилцитрат 4,2 мг; тальк 44,7 мг."}},{"type":"paragraph","data":{"text":"Оболочка капсулы (корпус): желатин 38,0760 мг, вода 6,6120 мг, титана диоксид 0,9120 мг,"}},{"type":"paragraph","data":{"text":"Оболочка капсулы (крышечка): желатин 25,3840 мг, вода 4,4080 мг, титана диоксид 0,6080 мг."}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Твердые желатиновые капсулы №1; корпус и крышечка непрозрачные, белого цвета. Содержимое капсул: круглые пеллеты (гранулы) белого цвета."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Глюкокортикостероид"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Будесонид является негалогеновым глюкокортикостероидом с противовоспалительными противоаллергическими антиэкссудативными и противоотечными свойствами."}},{"type":"paragraph","data":{"text":"Эти свойства основаны на:"}},{"type":"paragraph","data":{"text":"- уменьшении выделения медиаторов из тучных клеток базофилов и макрофагов; перераспределении и подавлении миграции воспалительных клеток ингибировании воспалительных реакций;"}},{"type":"paragraph","data":{"text":"- мембраностабилизирующем действии."}},{"type":"paragraph","data":{"text":"Индукция некоторых протеинов (например макрокортина) является одним из специфических механизмов действия будесонида. Ингибируя фосфолипазу А2 эти протеины участвуют в метаболизме арахидоновой кислоты и таким образом предупреждают образование медиаторов воспаления лейкотриенов и простагландинов. Так как процесс индукции синтеза протеинов требует некоторого промежутка времени полный терапевтический эффект будесонида развивается постепенно."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Будесонид обладает выраженными липофильными свойствами и быстро абсорбируется в кишечнике вследствие хорошей тканевой проницаемости."}},{"type":"paragraph","data":{"text":"По сравнению с классическими глюкокортикостероидами будесонид имеет очень высокую степень сродства к рецепторам. Благодаря этим свойствам Буденофальк обладает целенаправленным местным действием."}},{"type":"paragraph","data":{"text":"Приблизительно 90% будесонида метаболизируется в печени при \"первом прохождении\" и только около 10% оказывает системное воздействие. Из этого количества 90% будесонида связано с альбумином и за счет этого находится в биологически неактивной форме."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"- Легкая и среднетяжелая формы болезни Крона с вовлечением подвздошной и/или восходящей ободочной кишки;"}},{"type":"paragraph","data":{"text":"- коллагенозный (коллагеновый) колит аутоиммунный гепатит без гистологических признаков цирроза печени."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к будесониду или другим компонентам препарата цирроз печени инфекционные заболевания кишечника (бактериальная грибковая амебная вирусная инфекции) период лактации (грудное вскармливание) непереносимость лактозы фруктозы галактозы дефицит лактазы дефицит сахаразы/изомальтазы глюкозо-галактозная мальабсорбция детский возраст до 3 лет."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Следует применять при туберкулезе артериальной гипертензии сахарном диабете остеопорозе пептической язве глаукоме катаракте отягощенном семейном анамнезе по диабету или глаукоме беременность."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Во время беременности применение Буденофалька возможно только в тех случаях когда ожидаемая польза для матери превышает потенциальный риск для плода. У женщин детородного возраста до начала терапии Буденофальком должна быть исключена возможная беременность а во время лечения должны применяться надежные методы контрацепции."}},{"type":"paragraph","data":{"text":"До настоящего времени неизвестно способен ли будесонид проникать в грудное молоко поэтому в период лечения необходимо отказаться от грудного вскармливания."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Болезнь Крона"}},{"type":"paragraph","data":{"text":"Взрослые ( старше 18 лет)"}},{"type":"paragraph","data":{"text":"Рекомендуемая суточная доза составляет три капсулы один раз в день утром или одну капсулу (содержащую 3 мг будесонида) 3 раза в сутки (утром днем и вечером)."}},{"type":"paragraph","data":{"text":"Коллагенозный (коллагеновый) колит"}},{"type":"paragraph","data":{"text":"Взрослые (старше 18 лет)"}},{"type":"paragraph","data":{"text":"Рекомендуемая суточная доза составляет три капсулы один раз утром до завтрака (соответствует суточной дозе 9 мг будесонида)."}},{"type":"paragraph","data":{"text":"Курс лечения при болезни Крона и коллагенозном (коллагеновом) колите обычно составляет 8 недель."}},{"type":"paragraph","data":{"text":"Как правило полный эффект наступает через 2-4 недели."}},{"type":"paragraph","data":{"text":"Аутоиммунный гепатит"}},{"type":"paragraph","data":{"text":"Взрослые (старше 18 лет)"}},{"type":"paragraph","data":{"text":"Лечение активного гепатита"}},{"type":"paragraph","data":{"text":"Рекомендуемая суточная доза составляет 1 капсулу 3 раза в день (утром днем и вечером)."}},{"type":"paragraph","data":{"text":"Поддерживающее лечение"}},{"type":"paragraph","data":{"text":"1 капсулу два раза в день (утром и вечером)."}},{"type":"paragraph","data":{"text":"Курс лечения длительный и может составлять до 6-12 месяцев при активном гепатите (обострении) и до 24 месяцев при поддерживающей терапии."}},{"type":"paragraph","data":{"text":"Продолжительность и частота приема препарата определяется лечащим врачом."}},{"type":"paragraph","data":{"text":"Капсулы необходимо принимать приблизительно за 30 минут до еды проглатывая их целиком с достаточным количеством жидкости."}},{"type":"paragraph","data":{"text":"Если у пациента имеются проблемы с глотанием он может вскрыть твердые капсулы и принять содержащиеся там устойчивые к действию желудочного сока гранулы не разжевывая их и запивая достаточным количеством жидкости что не повлияет на эффективность препарата."}},{"type":"paragraph","data":{"text":"Нельзя резко прекращать прием препарата. Препарат необходимо отменять постепенно (медленно снижая дозировку). В течение первой недели дозировка должна быть уменьшена до 2 капсул в день (по 1 капсуле утром и вечером). В течение второй недели пациент должен принимать по 1 капсуле в день только утром. Затем лечение может быть прекращено."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Иногда могут возникать типичные для системных ГКС побочные эффекты (синдром Кушинга). Эти побочные эффекты зависят от дозы, длительности лечения, сопутствующего или предшествующего лечения другими ГКС и индивидуальной чувствительности."}},{"type":"paragraph","data":{"text":"Клинические испытания показали, что частота побочных эффектов, характерных для ГКС, при использовании Буденофалька значительно меньше (приблизительно в 2 раза) по сравнению с частотой нежелательных эффектов при пероральном приеме эквивалентных доз преднизолона. Тем не менее, нельзя полностью исключить возникновение побочных эффектов, типичных для ГКС."}},{"type":"paragraph","data":{"text":"Могут возникать следующие побочные эффекты"}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов: аллергическая экзема, красные стрии, петехии, экхимоз, стероидные угри, ухудшение заживления ран, контактный дерматит."}},{"type":"paragraph","data":{"text":"Со стороны опорно-двигательного аппарата: мышечная слабость, остеопороз, асептический некроз костей (бедренной и головки плечевой)."}},{"type":"paragraph","data":{"text":"Со стороны органов чувств: глаукома, катаракта."}},{"type":"paragraph","data":{"text":"Психические нарушения: депрессия, эйфория, раздражительность."}},{"type":"paragraph","data":{"text":"Со стороны эндокринной системы: синдром Кушинга (лунообразное лицо, ожирение, сахарный диабет, снижение толерантности к глюкозе, задержка натрия с формированием отеков, гипокалиемия, снижение функции или атрофия коры надпочечников, нарушение секреции половых гормонов (аменорея, гирсутизм, импотенция)."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: повышение АД, повышенный риск тромбообразования, васкулит (синдром отмены после длительного лечения)."}},{"type":"paragraph","data":{"text":"Со стороны иммунной системы: влияние на иммунный ответ (повышенный риск возникновения инфекционных заболеваний)."}},{"type":"paragraph","data":{"text":"При переводе больных с приема системных ГКС на будесонид могут усиливаться или вновь возникать внекишечные симптомы (особенно поражение кожи и суставов)."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Случаев передозировки не выявлено."}},{"type":"paragraph","data":{"text":"В случае передозировки проводят симптоматическое лечение."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Сердечные гликозиды:"}},{"type":"paragraph","data":{"text":"Действие сердечных гликозидов может усиливаться из-за дефицита калия."}},{"type":"paragraph","data":{"text":"Салуретики:"}},{"type":"paragraph","data":{"text":"Гипокалиемия может увеличиваться."}},{"type":"paragraph","data":{"text":"Ингибиторы цитохрома Р450 (кетаконазол итраконазол ритонавир кларитромицин тролеандомицин эритромицин циклоспорин):"}},{"type":"paragraph","data":{"text":"Глюкокортикостероидный эффект может усиливаться."}},{"type":"paragraph","data":{"text":"Во время лечения данным препаратом нельзя пить грейпфрутовый сок так как он может повлиять на эффективность препарата."}},{"type":"paragraph","data":{"text":"Есть данные о повышенных концентрациях эстрогенов в плазме и об усилении эффектов кортикостероидов у женщин принимавших эстрогены или оральные контрацептивы в сочетании с будесонидом. Однако этот эффект не наблюдался в случае приема низкодозированных оральных контрацептивов."}},{"type":"paragraph","data":{"text":"Одновременное назначение циметидина и будесонида может приводить к незначительному повышению уровня будесонида в плазме однако это не имеет клинического значения. Одновременное назначение омепразола не влияет на фармакокинетику будесонида. Теоретически нельзя исключить взаимодействие со смолами способными связывать стероиды (например холестирамином) а так же антацидами. При одновременном приеме этих препаратов с Буденофальком в результате взаимодействия может уменьшаться лечебный эффект будесонида. В этой связи вышеназванные препараты должны приниматься с Буденофальком по крайней мере с интервалом в 2 часа."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Буденофальк может подавлять функцию гипоталамо-гипофизарно-адреналовой системы. Перед оперативным вмешательством или воздействием другого стрессового фактора рекомендуется дополнительное назначение системных глюкокортикостероидов."}},{"type":"paragraph","data":{"text":"Буденофальк 3 мг содержит лактозу и сахарозу. Препарат не следует принимать пациентам с редкими наследственными состояниями непереносимости галактозы или фруктозы недостаточностью сахаразы-изомальтазы или мальабсорбцией глюкозы-галактозы а также лактазной недостаточностью или врожденной недостаточностью лактазы."}},{"type":"paragraph","data":{"text":"У пациентов с аутоиммунным гепатитом следует регулярно контролировать уровень трансаминаз (АЛТ ACT) в сыворотке (каждые 2 недели в течение первого месяца лечения и как минимум через каждые 3 месяца в дальнейшем) с целью возможной коррекции дозировки будесонида."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Необходимо соблюдать осторожность при управлении транспортными средствами и занятиями потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций так как препарат может вызвать головную боль слабость нарушения со стороны органов зрения и другие побочные эффекты которые могут влиять на указанные способности."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Капсулы кишечнорастворимые 3 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить 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":"3 года."}},{"type":"paragraph","data":{"text":"Не применять после истечения срока годности указанного на упаковке."}}]},{"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":"Д-р Фальк Фарма ГмбХ, Leinenweberstrasse 5, 79108 Freiburg, Germany, Германия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"Д-р Фальк Фарма ГмбХ"}}]}],"source":null},"description_toggle":false,"short_description":"Будесонид является негалогеновым глюкокортикостероидом с противовоспалительными противоаллергическими антиэкссудативными и противоотечными свойствами. Эти свойства основаны на: - уменьшении выделения медиаторов из тучных клеток базофилов и макрофагов; перераспределении и подавлении миграции воспалительных клеток ингибировании воспалительных реакций; - мембраностабилизирующем действии. Индукция некоторых протеинов (например макрокортина) является одним из специфических механизмов действия будесонида. Ингибируя фосфолипазу А2 эти протеины участвуют в метаболизме арахидоновой кислоты и таким образом предупреждают образование медиаторов воспаления лейкотриенов и простагландинов. Так как процесс индукции синтеза протеинов требует некоторого промежутка времени полный терапевтический эффект будесонида развивается постепенно. Будесонид обладает выраженными липофильными свойствами и быстро абсорбируется в кишечнике вследствие хорошей тканевой проницаемости. По сравнению с классическими глюкокортикостероидами будесонид имеет очень высокую степень сродства к рецепторам. Благодаря этим свойствам Буденофальк обладает целенаправленным местным действием. Приблизительно 90% будесонида метаболизируется в печени при \"первом прохождении\" и только около 10% оказывает системное воздействие. 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