Медикамент Роксера успешно используется при гиперлипидемии (второго типа А), смешанной дислипидемии, семейной гомозиготной гиперхолестеринемии и при гипертриглицеридемии в комплексе со специальной диетой. Пациентам с наличием холестериновых бляшек препарат назначают для замедления дальнейшего развития болезни. Роксеру рекомендуется использовать для ...
Медикамент Роксера категорически запрещено использовать для лечения пациентов с аллергией на его компоненты, заболеваниями печени в период обострения, стойким увеличением активности печеночных трансаминаз, тяжелыми нарушениями работы почек (при показателе клубочковой фильтрации менее 30 мл/мин), миопатией. Препарат противопоказан для применения в педиатрии. ...
Медикамент Роксера успешно используется при гиперлипидемии (второго типа А), смешанной дислипидемии, семейной гомозиготной гиперхолестеринемии и при гипертриглицеридемии в комплексе со специальной диетой. Пациентам с наличием холестериновых бляшек препарат назначают для замедления дальнейшего развития болезни. Роксеру рекомендуется использовать для профилактики патологий сердца и кровеносных сосудов.
Противопоказания
Медикамент Роксера категорически запрещено использовать для лечения пациентов с аллергией на его компоненты, заболеваниями печени в период обострения, стойким увеличением активности печеночных трансаминаз, тяжелыми нарушениями работы почек (при показателе клубочковой фильтрации менее 30 мл/мин), миопатией. Препарат противопоказан для применения в педиатрии. При лечении медикаментом женщин детородного возраста, следует позаботиться о надежном методе контрацепции. Лечение фармацевтическим препаратом Роксера противопоказано при терапии циклоспорином. Назначение Роксера свыше 30 мг/сут. противопоказано при гипотиреозе, алкоголизме, лечение фибратами, дефиците лактазы, сепсисе, артериальной гипотензии, людям старше 65 лет и пациентам монголоидной расы.
Применение при беременности и в период грудного вскармливания
Препарат Роксера противопоказан при беременности и в период лактации. Женщины репродуктивного возраста должны применять адекватные методы контрацепции. Поскольку холестерин и вещества, синтезируемые из холестерина, важны для развития плода, потенциальный риск ингибирования ГМГ-КоА-редуктазы для плода превышает пользу от применения препарата при беременности. В случае наступления беременности в процессе терапии применение препарата должно быть немедленно прекращено. Данные о выделении розувастатина с грудным молоком отсутствуют (известно, что другие ингибиторы ГМГ-КоА-редуктазы способны выделяться с грудным молоком), поэтому в период кормления грудью применение препарата необходимо прекратить.
Способ применения и дозы
Препарат назначают строго по результатам лабораторного исследования крови. Рекомендуемая начальная доза составляет 5 мг/сут. Пересмотреть дозировку и сделать коррекцию нужно не ранее чем через месяц после применения минимальной дозы. Максимальная суточная доза Роксера составляет не более 40 мг (при почечной недостаточности легкой и средней степени – не более 30 мг/сут., при предрасположенности к миотоксическим осложнениям – не более 20 мг/сут., с одновременным лечением гемифибразилом – не более 10 мг/сут.). Особенностью дозировки Роксера является применение средства для лечения пациентов монголоидной расы (китайцы, японцы, монголы и прочие). Клиническими исследованиями доказана повышенная степень всасывания препарата, поэтому дозировка в 40 мг/сутки для них строго противопоказана. Таблетки следует употреблять перорально, независимо от времени суток, не разжевывая, запив водой.
Побочное действие
Лечение препаратом Роксера часто сопровождается головной болью, головокружением, тошнотой, рвотой, запорами, болями в мышцах, наличием белка в моче, астенией. Редко лечение сопровождается повышением восприимчивости к аллергенам, полинейропатией, панкреатитом, повышением печеночных трансаминаз, аллергическими проявлениями (зуд, сыпь, крапивница), миопатией и рабдомиолизом. Очень редко побочные явления проявляются потерей памяти, желтухой, расстройством стула в виде диареи, гепатитом, злокачественной экссудативной эритемой, болями в суставах, гематурией.
Передозировка
Случаи передозировки не зарегистрированы.
Особые указания
Нарушение функции почек. У пациентов, получавших высокие дозы розувастатина (в частности 40 мг/сут), наблюдалась канальцевая протеинурия, которая выявлялась при помощи тест-полосок и в большинстве случаев была периодической или кратковременной. Такая протеинурия не свидетельствует об остром заболевании или прогрессировании сопутствующего заболевания почек. Частота серьезных нарушений функции почек, отмеченная при постмаркетинговом изучении розувастатина, выше при приеме дозы 40 мг/сут. У пациентов, принимающих препарат Роксера в дозе 30 или 40 мг/сут, рекомендуется контролировать показатели функции почек во время лечения (не реже чем 1 раз в 3 мес). Влияние на опорно-двигательный аппарат. При применении розувастатина во всех дозах, но в особенности в дозах, превышающих 20 мг/сут, сообщалось о следующих воздействиях на опорно-двигательный аппарат: миалгия, миопатия, в редких случаях рабдомиолиз. Отмечены очень редкие случаи рабдомиолиза при одновременном применении ингибиторов ГМГ-КоА-редуктазы и эзетимиба. Такая комбинация должна применяться с осторожностью, так как нельзя исключить фармакодинамического взаимодействия. Как и в случае других ингибиторов ГМГ-КоА-редуктазы, частота рабдомиолиза при постмаркетинговом применении препарата Роксера выше при применении дозы 40 мг/сут. Определение активности КФК. Активность КФК нельзя определять после интенсивных физических нагрузок и при наличии других возможных причин повышения ее активности; это может привести к неверной интерпретации полученных результатов. В случае если исходная активность КФК существенно превышена (в 5 раз выше ВГН), через 5–7 дней следует провести повторный анализ. Нельзя начинать терапию, если результаты повторного анализа подтверждают исходную высокую активность КФК (более чем 5-кратное превышение ВГН). Перед началом терапииВ зависимости от суточной дозы препарат Роксера должен назначаться с осторожностью пациентам с имеющимися факторами риска миопатии/рабдомиолиза или применение препарата противопоказано (см. «Противопоказания» и «С осторожностью»). К таким факторам относятся:- нарушение функции почек;- гипотиреоз;- заболевания мышц в анамнезе (в том числе в семейном);- миотоксические явления при приеме других ингибиторов ГМГ-КоА-редуктазы или фибратов в анамнезе;- чрезмерное употребление алкоголя;- возраст старше 65 лет;- состояния, при которых может повышаться концентрация розувастатина в плазме крови;- одновременное применение фибратов. У таких пациентов необходимо оценить риск и возможную пользу терапии. Также рекомендуется проводить клинический мониторинг. Если исходная активность КФК выше более чем в 5 раз по сравнению с ВГН, терапию препаратом Роксера начинать нельзя. В период терапии препаратомСледует проинформировать пациента о необходимости немедленного обращения к врачу в случае неожиданного появления мышечных болей, мышечной слабости или спазмов, особенно в сочетании с недомоганием и лихорадкой. У таких пациентов следует определять активность КФК. Терапия должна быть прекращена, если активность КФК значительно увеличена (более чем в 5 раз по сравнению с ВГН) или если симптомы со стороны мышц резко выражены и вызывают ежедневный дискомфорт (даже, если активность КФК не более чем в 5 раз превышает ВГН). Если симптомы исчезают и активность КФК возвращается к норме, следует рассмотреть вопрос о возобновлении применения препарата Роксера или других ингибиторов ГМГ-КоА-редуктазы в меньших дозах при тщательном медицинском наблюдении. Контроль активности КФК при отсутствии симптомов нецелесообразен. Отмечены очень редкие случаи иммуноопосредованной некротизирующей миопатии с клиническими проявлениями в виде стойкой слабости проксимальных мышц и повышения активности КФК в сыворотке крови во время терапии или при прекращении применения ингибиторов ГМГ-КоА-редуктазы, в т.ч. розувастатина. Может потребоваться проведение дополнительных исследований мышечной и нервной системы, серологических исследований, а также терапия иммунодепрессивными средствами. Признаков увеличения воздействия на скелетную мускулатуру при приеме розувастатина и сопутствующей терапии не отмечено. Однако сообщалось об увеличении числа случаев миозита и миопатии у пациентов, принимавших другие ингибиторы ГМГ-КоА-редуктазы в сочетании с производными фиброевой кислоты (например гемфиброзил), циклоспорином, никотиновой кислотой в липидснижающих дозах (более 1 г/сут), противогрибковыми средствами - производными азола, ингибиторами протеазы ВИЧ и макролидными антибиотиками. При одновременном применении с некоторыми ингибиторами ГМГ-КоА-редуктазы гемфиброзил увеличивает риск развития миопатии. Таким образом, одновременное применение препарата Роксера и гемфиброзила не рекомендуется. Преимущества дальнейшего изменения плазменной концентрации липидов при комбинированном применении препарата Роксера с фибратами или никотиновой кислотой в липидснижающих дозах должны быть тщательно взвешены с учетом возможного риска. Препарат Роксера в дозе 30 мг/сут противопоказан для комбинированной терапии с фибратами. В связи с увеличением риска рабдомиолиза препарат Роксера не следует применять пациентам с острыми состояниями, которые могут привести к миопатии или состояниям, предрасполагающим к развитию почечной недостаточности (например сепсис, артериальная гипотензия, обширные хирургические вмешательства, травмы, тяжелые метаболические, эндокринные и электролитные нарушения или неконтролируемые судороги). Печень. В зависимости от суточной дозы, препарат Роксера должен с осторожностью применяться у пациентов с чрезмерным употреблением алкоголя и/или имеющих в анамнезе заболевания печени или его применение противопоказано (см. «Противопоказания» и «С осторожностью»). Рекомендуется проводить определение функциональных проб печени до начала терапии и через 3 мес после ее начала. Применение препарата Роксера следует прекратить или уменьшить дозу препарата, если активность печеночных трансаминаз в сыворотке крови в 3 раза превышает ВГН. У пациентов с гиперхолестеринемией вследствие гипотиреоза или нефротического синдрома до начала лечения препаратом Роксера должна проводиться терапия основных заболеваний. Этнические особенности. В ходе фармакокинетических исследований у представителей монголоидной расы по сравнению с представителями европеоидной расы отмечено увеличение плазменной концентрации розувастатина. Препарат Роксера содержит лактозу, в связи с чем его не следует применять пациентам с непереносимостью лактозы, дефицитом лактазы, синдромом глюкозо-галактозной мальабсорбции. Интерстициальное заболевание легких. При применении некоторых ингибиторов ГМГ-КоА-редуктазы, особенно в течение длительного времени, сообщалось о единичных случаях интерстициального заболевания легких. Проявлениями заболевания могут являться одышка, непродуктивный кашель и ухудшение общего самочувствия (слабость, снижение веса и лихорадка). При подозрении на интерстициальное заболевание легких следует прекратить терапию ингибиторами ГМГ-КоА-редуктазы. Сахарный диабет типа 2. У пациентов с концентрацией глюкозы от 5,6 до 6,9 ммоль/л терапия розувастатином ассоциировалась с повышенным риском развития сахарного диабета типа 2. Влияние на способность управлять автомобилем или выполнять работы, требующие повышенной скорости физических и психических реакций. Исследования по изучению влияния препарата Роксера на способность управлять транспортными средствами и работу с механизмами не проводились. Тем не менее, учитывая возможность развития головокружения и других побочных эффектов, необходимо соблюдать осторожность при управлении транспортными средствами и другими механизмами, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
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Назначение Роксера свыше 30 мг/сут. противопоказано при гипотиреозе, алкоголизме, лечение фибратами, дефиците лактазы, сепсисе, артериальной гипотензии, людям старше 65 лет и пациентам монголоидной расы."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат Роксера противопоказан при беременности и в период лактации. Женщины репродуктивного возраста должны применять адекватные методы контрацепции. Поскольку холестерин и вещества, синтезируемые из холестерина, важны для развития плода, потенциальный риск ингибирования ГМГ-КоА-редуктазы для плода превышает пользу от применения препарата при беременности. В случае наступления беременности в процессе терапии применение препарата должно быть немедленно прекращено. Данные о выделении розувастатина с грудным молоком отсутствуют (известно, что другие ингибиторы ГМГ-КоА-редуктазы способны выделяться с грудным молоком), поэтому в период кормления грудью применение препарата необходимо прекратить."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат назначают строго по результатам лабораторного исследования крови. Рекомендуемая начальная доза составляет 5 мг/сут. Пересмотреть дозировку и сделать коррекцию нужно не ранее чем через месяц после применения минимальной дозы. Максимальная суточная доза Роксера составляет не более 40 мг (при почечной недостаточности легкой и средней степени – не более 30 мг/сут., при предрасположенности к миотоксическим осложнениям – не более 20 мг/сут., с одновременным лечением гемифибразилом – не более 10 мг/сут.). Особенностью дозировки Роксера является применение средства для лечения пациентов монголоидной расы (китайцы, японцы, монголы и прочие). Клиническими исследованиями доказана повышенная степень всасывания препарата, поэтому дозировка в 40 мг/сутки для них строго противопоказана. Таблетки следует употреблять перорально, независимо от времени суток, не разжевывая, запив водой."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение препаратом Роксера часто сопровождается головной болью, головокружением, тошнотой, рвотой, запорами, болями в мышцах, наличием белка в моче, астенией. Редко лечение сопровождается повышением восприимчивости к аллергенам, полинейропатией, панкреатитом, повышением печеночных трансаминаз, аллергическими проявлениями (зуд, сыпь, крапивница), миопатией и рабдомиолизом. Очень редко побочные явления проявляются потерей памяти, желтухой, расстройством стула в виде диареи, гепатитом, злокачественной экссудативной эритемой, болями в суставах, гематурией."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Случаи передозировки не зарегистрированы."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Нарушение функции почек. У пациентов, получавших высокие дозы розувастатина (в частности 40 мг/сут), наблюдалась канальцевая протеинурия, которая выявлялась при помощи тест-полосок и в большинстве случаев была периодической или кратковременной. Такая протеинурия не свидетельствует об остром заболевании или прогрессировании сопутствующего заболевания почек. Частота серьезных нарушений функции почек, отмеченная при постмаркетинговом изучении розувастатина, выше при приеме дозы 40 мг/сут. У пациентов, принимающих препарат Роксера в дозе 30 или 40 мг/сут, рекомендуется контролировать показатели функции почек во время лечения (не реже чем 1 раз в 3 мес). Влияние на опорно-двигательный аппарат. При применении розувастатина во всех дозах, но в особенности в дозах, превышающих 20 мг/сут, сообщалось о следующих воздействиях на опорно-двигательный аппарат: миалгия, миопатия, в редких случаях рабдомиолиз. Отмечены очень редкие случаи рабдомиолиза при одновременном применении ингибиторов ГМГ-КоА-редуктазы и эзетимиба. Такая комбинация должна применяться с осторожностью, так как нельзя исключить фармакодинамического взаимодействия. Как и в случае других ингибиторов ГМГ-КоА-редуктазы, частота рабдомиолиза при постмаркетинговом применении препарата Роксера выше при применении дозы 40 мг/сут. Определение активности КФК. Активность КФК нельзя определять после интенсивных физических нагрузок и при наличии других возможных причин повышения ее активности; это может привести к неверной интерпретации полученных результатов. В случае если исходная активность КФК существенно превышена (в 5 раз выше ВГН), через 5–7 дней следует провести повторный анализ. Нельзя начинать терапию, если результаты повторного анализа подтверждают исходную высокую активность КФК (более чем 5-кратное превышение ВГН). Перед началом терапииВ зависимости от суточной дозы препарат Роксера должен назначаться с осторожностью пациентам с имеющимися факторами риска миопатии/рабдомиолиза или применение препарата противопоказано (см. «Противопоказания» и «С осторожностью»). К таким факторам относятся:- нарушение функции почек;- гипотиреоз;- заболевания мышц в анамнезе (в том числе в семейном);- миотоксические явления при приеме других ингибиторов ГМГ-КоА-редуктазы или фибратов в анамнезе;- чрезмерное употребление алкоголя;- возраст старше 65 лет;- состояния, при которых может повышаться концентрация розувастатина в плазме крови;- одновременное применение фибратов. У таких пациентов необходимо оценить риск и возможную пользу терапии. Также рекомендуется проводить клинический мониторинг. Если исходная активность КФК выше более чем в 5 раз по сравнению с ВГН, терапию препаратом Роксера начинать нельзя. В период терапии препаратомСледует проинформировать пациента о необходимости немедленного обращения к врачу в случае неожиданного появления мышечных болей, мышечной слабости или спазмов, особенно в сочетании с недомоганием и лихорадкой. У таких пациентов следует определять активность КФК. Терапия должна быть прекращена, если активность КФК значительно увеличена (более чем в 5 раз по сравнению с ВГН) или если симптомы со стороны мышц резко выражены и вызывают ежедневный дискомфорт (даже, если активность КФК не более чем в 5 раз превышает ВГН). Если симптомы исчезают и активность КФК возвращается к норме, следует рассмотреть вопрос о возобновлении применения препарата Роксера или других ингибиторов ГМГ-КоА-редуктазы в меньших дозах при тщательном медицинском наблюдении. Контроль активности КФК при отсутствии симптомов нецелесообразен. Отмечены очень редкие случаи иммуноопосредованной некротизирующей миопатии с клиническими проявлениями в виде стойкой слабости проксимальных мышц и повышения активности КФК в сыворотке крови во время терапии или при прекращении применения ингибиторов ГМГ-КоА-редуктазы, в т.ч. розувастатина. Может потребоваться проведение дополнительных исследований мышечной и нервной системы, серологических исследований, а также терапия иммунодепрессивными средствами. Признаков увеличения воздействия на скелетную мускулатуру при приеме розувастатина и сопутствующей терапии не отмечено. Однако сообщалось об увеличении числа случаев миозита и миопатии у пациентов, принимавших другие ингибиторы ГМГ-КоА-редуктазы в сочетании с производными фиброевой кислоты (например гемфиброзил), циклоспорином, никотиновой кислотой в липидснижающих дозах (более 1 г/сут), противогрибковыми средствами - производными азола, ингибиторами протеазы ВИЧ и макролидными антибиотиками. При одновременном применении с некоторыми ингибиторами ГМГ-КоА-редуктазы гемфиброзил увеличивает риск развития миопатии. Таким образом, одновременное применение препарата Роксера и гемфиброзила не рекомендуется. Преимущества дальнейшего изменения плазменной концентрации липидов при комбинированном применении препарата Роксера с фибратами или никотиновой кислотой в липидснижающих дозах должны быть тщательно взвешены с учетом возможного риска. Препарат Роксера в дозе 30 мг/сут противопоказан для комбинированной терапии с фибратами. В связи с увеличением риска рабдомиолиза препарат Роксера не следует применять пациентам с острыми состояниями, которые могут привести к миопатии или состояниям, предрасполагающим к развитию почечной недостаточности (например сепсис, артериальная гипотензия, обширные хирургические вмешательства, травмы, тяжелые метаболические, эндокринные и электролитные нарушения или неконтролируемые судороги). Печень. В зависимости от суточной дозы, препарат Роксера должен с осторожностью применяться у пациентов с чрезмерным употреблением алкоголя и/или имеющих в анамнезе заболевания печени или его применение противопоказано (см. «Противопоказания» и «С осторожностью»). Рекомендуется проводить определение функциональных проб печени до начала терапии и через 3 мес после ее начала. Применение препарата Роксера следует прекратить или уменьшить дозу препарата, если активность печеночных трансаминаз в сыворотке крови в 3 раза превышает ВГН. У пациентов с гиперхолестеринемией вследствие гипотиреоза или нефротического синдрома до начала лечения препаратом Роксера должна проводиться терапия основных заболеваний. Этнические особенности. В ходе фармакокинетических исследований у представителей монголоидной расы по сравнению с представителями европеоидной расы отмечено увеличение плазменной концентрации розувастатина. Препарат Роксера содержит лактозу, в связи с чем его не следует применять пациентам с непереносимостью лактозы, дефицитом лактазы, синдромом глюкозо-галактозной мальабсорбции. Интерстициальное заболевание легких. 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