Бикалутамид Таблетки, 28 шт, 0.15 г, для внутреннего применения, для взрослых, противоопухолевое средство

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Метаболиты выводятся с мочой и желчью примерно в равных соотношениях."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"- Распространенный рак предстательной железы в комбинации с аналогом ГнРГ (гонадотропин-рилизинг гормон) или хирургической кастрацией;"}},{"type":"paragraph","data":{"text":"- местнораспространенный рак предстательной железы (Т3-Т4 любая N М0; Т1-Т2 N+ М0) в качестве монотерапии или адъювантной терапии в сочетании с радикальной простатэктомией или радиотерапией;"}},{"type":"paragraph","data":{"text":"- местнораспространенный неметастатический рак предстательной железы в случаях когда хирургическая кастрация или другие медицинские вмешательства неприменимы или неприемлемы."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- Повышенная чувствительность к бикалутамиду и вспомогательным компонентам препарата;"}},{"type":"paragraph","data":{"text":"- одновременный прием с терфенадином астемизолом и цизапридом;"}},{"type":"paragraph","data":{"text":"- бикалутамид не должен назначаться детям и женщинам."}},{"type":"paragraph","data":{"text":"В связи с наличием в составе лактозы: дефицит лактазы непереносимость лактозы глюкозо-галактозная мальабсорбция."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Нарушение функции печени."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Бикалутамид противопоказан женщинам и не должен назначаться беременным и кормящим матерям."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Взрослые и пожилые мужчины:"}},{"type":"paragraph","data":{"text":"При распространенном раке предстательной железы в комбинации с аналогом ГнРГ или хирургической кастрацией: внутрь по 50 мг один раз в сутки. Лечение Бикалутамид ом необходимо начинать одновременно с началом приема аналога ГнРГ или хирургической кастрацией."}},{"type":"paragraph","data":{"text":"При местнораспространенном раке предстательной железы: внутрь по 150 мг один раз в сутки. Бикалутамид следует принимать длительно как минимум в течение 2-х лет. При появлении признаков прогрессирования заболевания прием препарата следует прекратить."}},{"type":"paragraph","data":{"text":"Нарушения функции почек: коррекция дозы не требуется."}},{"type":"paragraph","data":{"text":"Нарушения функции печени: коррекция дозы не требуется при легкой и умеренной печеночной недостаточности. При тяжелой печеночной недостаточности несмотря на то что Т\u003csub\u003e1/2 \u003c/sub\u003eактивного энантиомера бикалутамида повышается на 76% однако коррекции дозы не требуется."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Фармакологическое действие бикалутамида может обуславливать следующие побочные эффекты:"}},{"type":"paragraph","data":{"text":"- очень часто (>10%): гинекомастия (может сохраняться даже после прекращения терапии особенно в случае приема препарата в течение длительного времени) болезненность грудных желез “приливы” жара;"}},{"type":"paragraph","data":{"text":"- часто (≥1% и <10%): диарея тошнота транзиторное повышение активности “печеночных” трансаминаз холестаз и желтуха (описанные изменения функции печени редко оценивались как серьезные носили транзиторный характер полностью исчезали или уменьшались при продолжении терапии или после отмены препарата) зуд астения: при применении препарата в суточной дозе 150 мг - алопеция или восстановление роста волос снижение полового влечения сексуальные дисфункции повышение массы тела."}},{"type":"paragraph","data":{"text":"- редко (≥01% - <1%): реакции повышенной чувствительности включая ангионевротический отек и крапивницу интерстициальные заболевания легких; при применении препарата в суточной дозе 150 мг - боль в животе депрессия диспепсия гематурия;"}},{"type":"paragraph","data":{"text":"- очень редко (≥001% - <01%): рвота сухость кожи (при применении препарата в суточной дозе 150 мг сухость кожи наблюдается часто) печеночная недостаточность (причинно-следственная связь с приемом бикалутамида достоверно не установлена)."}},{"type":"paragraph","data":{"text":"При одновременном применении бикалутамида и аналогов ГнРГ могут наблюдаться также следующие побочные явления с частотой ≥ 1% (причинно-следственная связь с приемом препарата не установлена некоторые из отмеченных побочных эффектов встречались у пожилых пациентов):"}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: сердечная недостаточность."}},{"type":"paragraph","data":{"text":"Со стороны желудочно-кишечного тракта: анорексия сухость во рту диспепсия запор метеоризм."}},{"type":"paragraph","data":{"text":"Со стороны центральной нервной системы: головокружение головная боль бессонница повышенная сонливость."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: одышка."}},{"type":"paragraph","data":{"text":"Со стороны мочеполовой системы: сексуальная дисфункция никтурия полиурия."}},{"type":"paragraph","data":{"text":"Со стороны кроветворной системы: анемия."}},{"type":"paragraph","data":{"text":"Со стороны кожи и ее придатков: алопеция кожная сыпь повышенная потливость гирсутизм."}},{"type":"paragraph","data":{"text":"Прочие: сахарный диабет гипергликемия повышение или снижение массы тела боль в животе боль в груди боль в тазовой области озноб."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Случаи передозировки у человека не описаны. Специфического антидота не существует."}},{"type":"paragraph","data":{"text":"Лечение симптоматическое. Проведение диализа не эффективно так как бикалутамид прочно связывается с белками плазмы и не выводится с мочой в неизмененном виде. Показана общая поддерживающая терапия и мониторинг жизненно важных функций организма."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Нет данных о фармакокинетических или фармакодинамических взаимодействиях между бикалутамидом и аналогами ГнРГ."}},{"type":"paragraph","data":{"text":"В исследованиях in vitro показано что (R)-энантиомер бикалутамида ингибирует изофермент CYP3A4 в меньшей степени влияя на активность изоферментов CYP2C9 2С19 и 2D6. Потенциальной способности бикалутамида к взаимодействию с другими лекарственными препаратами не обнаружено однако при его использовании в течение 28 дней на фоне приема мидазолама площадь под кривой \"концентрация-время\" (AUC) мидазолама увеличивается на 80%."}},{"type":"paragraph","data":{"text":"Несовместим с терфенадином астемизолом цизапридом."}},{"type":"paragraph","data":{"text":"Следует соблюдать осторожность при назначении бикалутамида одновременно с циклоспорином или блокаторами \"медленных\" кальциевых каналов. Возможно потребуется снижение дозы этих препаратов особенно в случае потенцирования или развития побочных явлений. После начала использования или отмены бикалутамида рекомендуют проводить тщательный мониторинг концентрации циклоспорина в плазме и клинического состояния пациента."}},{"type":"paragraph","data":{"text":"Одновременное применение бикалутамида и препаратов ингибиторов микросомального окисления лекарственных средств например с циметидином или кетоконазолом может привести к увеличению концентрации бикалутамида в плазме и возможно к увеличению частоты возникновения побочных эффектов."}},{"type":"paragraph","data":{"text":"Усиливает действие непрямых антикоагулянтов (производных кумарина) в т.ч. варфарина (конкуренция за связь с белками плазмы)."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Учитывая возможность замедления выведения бикалутамида и его кумуляции у больных с нарушением функции печени целесообразно периодически оценивать функцию печени. Большинство изменений функции печени встречаются в течение первых шести месяцев лечения бикалутамидом."}},{"type":"paragraph","data":{"text":"В случае развития выраженных изменений функции печени прием бикалутамида необходимо прекратить."}},{"type":"paragraph","data":{"text":"У пациентов с прогрессированием заболевания на фоне повышения концентрации простатспецифического антигена (ПСА) необходимо рассмотреть вопрос о прекращении лечения бикалутамидом."}},{"type":"paragraph","data":{"text":"При назначении бикалутамида пациентам получающим непрямые антикоагулянты (производные кумарина) в т.ч. варфарин рекомендуется регулярно контролировать протромбиновое время."}},{"type":"paragraph","data":{"text":"Каждая таблетка препарата Бикалутамид 50 мг содержит 61 мг лактозы моногидрата. Каждая таблетка препарата Бикалутамид 150 мг содержит 183 мг лактозы моногидрата."}},{"type":"paragraph","data":{"text":"Учитывая возможность ингибирования бикалутамидом активности цитохрома Р450 (изофермента CYP3A4) следует проявлять осторожность при одновременном назначении бикалутамида с препаратами преимущественно метаболизирующимися с участием изофермента CYP3A4."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Бикалутамид может повлиять на способность пациентов управлять транспортными средствами или заниматься другими потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций вследствие развития головокружения и сонливости при комбинированном применении бикалутамида и аналогов ГнРГ."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"По 7 или 10 таблеток в контурную ячейковую упаковку из пленки поливинилхлоридной и фольги алюминиевой печатной лакированной."}},{"type":"paragraph","data":{"text":"По 21 28 30 или 40 таблеток в банку полимерную для лекарственных средств. Свободное пространство в банке заполняют ватой медицинской гигроскопической."}},{"type":"paragraph","data":{"text":"Каждую банку 4 или 3 контурных ячейковых упаковки (по 7 или 10 таблеток соответственно) вместе с инструкцией по применению помещают в пачку из картона."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом 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."}}]},{"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":"Закрытое акционерное общество \"Р-Фарм\" (ЗАО \"Р-Фарм\"), 150061, г. Ярославль, ул. Громова, д. 15, Россия"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ООО \"Технология лекарств\""}}]}],"source":null},"description_toggle":false,"short_description":"Бикалутамид представляет собой рацемическую смесь с нестероидной антиандрогенной активностью преимущественно (R)-энантиомера не обладает иной эндокринной активностью. Бикалутамид связывается с андрогенными рецепторами и не активируя экспрессию генов подавляет стимулирующее влияние андрогенов. Результатом этого является регрессия злокачественных новообразований предстательной железы. У некоторых пациентов прекращение приёма бикалутамида может привести к развитию клинического \"синдрома отмены антиандрогенов\". После приема внутрь быстро и полностью всасывается из желудочно-кишечного тракта. Прием пищи не влияет на всасывание. (S)-энантиомер выводится из организма гораздо быстрее (R)-энантиомера период полувыведения последнего - около 7 дней. При ежедневном приеме бикалутамида концентрация (R)-энантиомера в плазме увеличивается примерно в 10 раз вследствие длительного периода полувыведения что делает возможным прием препарата один раз в сутки. При ежедневном приеме бикалутамида в дозе 50 мг равновесная концентрация (R)- энантиомера в плазме составляет около 9 мкг/мл. При приеме 150 мг бикалутамида ежедневно равновесная концентрация (R)-энантиомера составляет приблизительно 22 мкг/мл. При равновесном состоянии около 99% всех циркулирующих в крови энантиомеров составляет активный (R)-энантиомер. На фармакокинетику (R)-энантиомера не влияют возраст нарушение функции почек легкое и умеренное нарушение функции печени. Имеются данные о том что у больных с тяжелыми нарушениями функции печени замедляется элиминация (R)-энантиомера из плазмы. Связь с белками плазмы высокая (для рацемической смеси 96% для (R)-энаптиомера 996%). Интенсивно метаболизируется в печени (путем окисления и образования конъюгатов с глюкуроновой кислотой). 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