— первичная гиперхолестеринемия, включая гетерозиготную семейную гиперхолестеринемию (гиперлипидемия IIа типа по классификации Фредриксона) или смешанная гиперхолестеринемия(гиперлипидемия IIb типа по классификации Фредриксона), гипертриглицеридемия (гиперлипидемия IV типа но классификации Фредриксона) в качестве дополнения к диете, когда диета и другие ...
Повышенная чувствительность к питавастатину, вспомогательным компонентам препарата и другим ингибиторам ГМГ-КоА-редуктазы (статинам)
Тяжелая печеночная недостаточность (более 9 баллов по шкале Чайлд-Пью) или класс С по классификации Чайлд-Пью, заболевания печени и активной фазе, включая стойкое повышение активности "печеночных" трансаминаз в сыворотке крови (более чем в 3 раза по сравнению с верхней границей нормы (ВГН))
Непереносимость лактозы, дефицит лактазы или глюкозо-галактозная мальабсорбция
Питавастатин кальция 2.09 мг,; что соответствует содержанию питавастатина 2 мг; Вспомогательные вещества: лактозы моногидрат - 126.17 мг, гипролоза низкозамещенная - 25.08 мг, гипромеллоза - 2.66 мг, магния алюминометасиликат - 3.2 мг, магния стеарат - 0.8 мг.; Состав пленочной оболочки: Опадрай белый - 5 мг, в т. ч. гипромеллоза - 3.3065 мг, титана диоксид - 1.338 мг, триэтилацетат - 0.3305 мг, кремния диоксид коллоидный - 0.025 мг.
Фармакологические свойства
Питавастатин - конкурентный ингибитор ГМГ-КоА (З-гидрокси-З-метилглютарилкоэнзим А) редуктазы, фермента, катализирующего начальную стадию синтеза холестерина образование мевалоновой кислоты из ГМГ-КоА. Поскольку превращение ГМГ-КоА и мевалоновую кислоту представляет собой начальную стадию синтеза холестерина, то применение питавастатина не вызывает накопления в организме потенциально токсичных стеролов. ГМГ-КоА легко метаболизируется до ацетил-КоА. который участвует во многих процессах синтеза в организме. Клинические исследования показали эффективность препарата Ливазо в отношении снижения концентрации общего холестерина (ОХС) в плазме крови, холестерина липопротеинов низкой плотности (ХС ЛПНП), холестерина липопротеинов очень низкой плотности (ХС ЛПОНП). триглицеридов (ТГ) и аполипопротеина В (Аро-В), а также повышения концентрации холестерина липопротеинов высокой плотности (ХС ЛПВП) и аполипопротеина А1 (Аро-Al).
Показания к применению
— первичная гиперхолестеринемия, включая гетерозиготную семейную гиперхолестеринемию (гиперлипидемия IIа типа по классификации Фредриксона) или смешанная гиперхолестеринемия(гиперлипидемия IIb типа по классификации Фредриксона), гипертриглицеридемия (гиперлипидемия IV типа но классификации Фредриксона) в качестве дополнения к диете, когда диета и другие немедикаментозные методы лечения (например, физические упражнения, снижение массы тела) оказываются недостаточными.
Противопоказания
Повышенная чувствительность к питавастатину, вспомогательным компонентам препарата и другим ингибиторам ГМГ-КоА-редуктазы (статинам)
Тяжелая печеночная недостаточность (более 9 баллов по шкале Чайлд-Пью) или класс С по классификации Чайлд-Пью, заболевания печени и активной фазе, включая стойкое повышение активности "печеночных" трансаминаз в сыворотке крови (более чем в 3 раза по сравнению с верхней границей нормы (ВГН))
Непереносимость лактозы, дефицит лактазы или глюкозо-галактозная мальабсорбция
Миопатия
Одновременный прием циклоспорина
Беременность, период грудного вскармливания, отсутствие адекватных методов контрацепции у женщин детородного возраста
Возраст до 18 лет (эффективность и безопасность не установлены)
С осторожностью
При наличие риска развития миопатии/рабдомиолиза - почечная недостаточность, гипотиреоз, личный или семейный анамнез наследственных мышечных заболеваний и предшествующий анамнез мышечной токсичности при применении других ингибиторов ГМГ-КоА-рсдуктазы или фибратов, чрезмерное употребление алкоголя, возраст старше 70 лет, заболевания печени в анамнезе.
Способ применения и дозы
Внутрь, таблетки необходимо проглатывать целиком.; Предпочтителен прием таблетки в одно и то же время суток, лучше вечером, в соответствии с циркадным ритмом липидного обмена. До начала лечения и в процессе пациенты должны придерживаться гипохолестеринемической диеты.; Начальная доза препарата 1 мг/сут однократно. При необходимоcти дозу препарата увеличивают с интервалами не менее 4 недель до 2 мг/сут. Дозу следует подбирать индивидуально в соответствии с концентрациями ХС ЛПНП, целью лечения и ответом пациента на лечение. Большинству пациентов требуется доза 2 мг. Максимальная суточная доза - 1 мг.; Пациенты с легкими и умеренными нарушениями функции печени: рекомендована максимальная суточная доза 2 мг.; Пациенты с нарушением функции почек: при нарушении функции почек легкой степени гяжести (желательно объективно оценить данную степень с отражением КК или скорости клубочковой фильтрации), препарат Ливазо следует применять с осторожностью. Данные по применению максимальной суточной дозы препарата 4 мг при нарушениях функции почек любой степени тяжести ограничены, поэтому назначать максимальную суточную дозу 4 мг необходимо только при тщательном контроле функции почек после постепенного повышения дозы. Не рекомендуется пациентам с тяжелыми нарушениями функции почек назначать максимальную суточную дозу в 4 мг; рекомендуется рассмотреть ограничение максимальной суточной дозы до 2 мг при тяжелой почечной недостаточности.; Пациенты пожилого возрасте: коррекция дозы не требуется.
Побочное действие
В контролируемых клинических исследованиях при приеме рекомендованных доз менее 4% пациентов, получавших лечение препаратом Лнвазо. было исключено из исследования в связи с развитием нежелательных реакций. Наиболее распространенной была миапгия.; В зависимости от частоты возникновения выделяют следующие нежелательные реакции в соответствии с классификацией ВОЗ: очень часто: ≥10, часто: от ≥1/100 до <1/10, нечасто: от ≥1/1000 до <1/100, редко: от ≥1/10000 до <1/10000, очень редко: <1/10000 н частота неизвестна (имеющиеся данные не позволяют определить частоту).; Со стороны органов кроветворения: нечасто - анемия.; Со стороны обмена веществ: нечасто - анорексия.; Нарушение психики: часто - бессонница.; Со стороны нервной системы: часто - головная боль; нечасто - головокружение, нарушение вкуса, сонливость.; Со стороны органов чувств: нечасто - звон в ушах; редко - снижение остроты зрения.; Со стороны кожных покровов: нечасто - кожный зуд, супь; редко - крапивница, эритема.; Со стороны опорно-двигательного аппарата: часто - миалгия, артралгия; нечасто - мышечные спазмы.; Со стороны мочевыделительной системы: нечасто - поллакиурия.; Со стороны пищеварительной системы: часто - запор, диарея, диспепсия, тошнота; нечасто - боли в животе, сухость слизистой оболочки полости рта, рвота; редко - глоссодиния, острый панкреатит, холестатическая желтуха.; Лабораторные показатели: нечасто - понышенне активности "печеночных" трансаминаз ACT, АЛТ, повышение активности креатинфосфокиназы (КФК).; В клинических исследований после приема Ливазо наблюдалось повышение активности КФК в 3 раза выше ВГН у 49 пациентов из 2800 (1.8%). Уровни превышения ВГН в 10 раз и более с сопутствующими мышечными симптомами отмечались редко, и наблюдались только у одного пациента из 2406 пациентов, получавших 4 мг Ливазо (0.04%) в программе клинических исследований.; Прочие: нечасто - астении, недомогание, повышенная утомляемость, периферические отеки.; Опыт постмаркетингового применения; Двухлетнее проспективное исследование пострегистрационного наблюдения было проведено приблизительно у 20000 пациентов в Японии. Подавляющее большинство из этих пациентов получали питавастатин в дозе 1 или 2 мг, а не 4 мг. У 10.4 % пациентов были зарегистрированы нежелательные реакции, у которых нельзя исключить причинную связь с питавастатином, и 7.4% пациентов прекратили лечение в связи с развитием нежелательных реакций. Частота возникновнения миалгии составляла 1.08%. Большинство нежелательных реакций были легкими. На протяжении 2-х лет частота нежелательных реакций была выще у пациентов, имевших в анамнезе лекарственную аллергию (20.4%) или заболевание печени или почек (13.5%).; Нежелательные реакции и частота их возникновения, наблюдавшиеся в проспективном исследовании пострегистрационного наблюдения, но не в международных контролируемых клинических исследованиях при применении препарата и рекомендуемых дозах приведены ниже.; Со стороны печени и желчевыводящих путей: редко - нарушение функции печени.; Со стороны опорно-двигательного аппарата: редко - миопатия, рабдомиолиз.; В исследовании пострегистрационного наблюдения имелись два сообщения о рабдомиолизе, при котором пациенты нуждались в госпитализации (0.01% пациентов).; Кроме того, имеются спонтанные сообщения об эффектах со стороны опорно-двигательного аппарата, включающие миалгию и миопатию у пациентов, лечившихся Ливазо во всех рекомендуемых дозах. Были также получены сообщения о рабдомиолизе с острой почечной недостаточностью и без нее, в т.ч., о рабдомиолизе с летальным исходом.; Были также получены спонтанные сообщения о следующих нежелательных реакциях (частота основана на случаях, наблюдаемых в пострегистрационных исследованиях).; Со стороны нервной системы: нечасто - гипестезия.; Со стороны пищеварительной системы: редко - абдомиальный дискомфорт.; Нежелательные явления при применении других статинов:;- нарушение сна, включая кошмарные сновидения; - амнезия; - сексуальная дисфункция; - депрессия; - интеретициальное заболевание легких; - сахарный диабет: частота нозникновения зависит от наличия или отсутсвия факторов риска (концентрация глюкозы в крови натощак ≥5 ммоль/л, ИМТ>30 кг/м2, повышенная концентрация ТГ, артериальная гипертензия в анамнезе); - повышение гликозилированного гемоглобина.
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кальция 2.09 мг,; что соответствует содержанию питавастатина 2 мг; Вспомогательные вещества: лактозы моногидрат - 126.17 мг, гипролоза низкозамещенная - 25.08 мг, гипромеллоза - 2.66 мг, магния алюминометасиликат - 3.2 мг, магния стеарат - 0.8 мг.; Состав пленочной оболочки: Опадрай белый - 5 мг, в т. ч. гипромеллоза - 3.3065 мг, титана диоксид - 1.338 мг, триэтилацетат - 0.3305 мг, кремния диоксид коллоидный - 0.025 мг."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Питавастатин - конкурентный ингибитор ГМГ-КоА (З-гидрокси-З-метилглютарилкоэнзим А) редуктазы, фермента, катализирующего начальную стадию синтеза холестерина образование мевалоновой кислоты из ГМГ-КоА. Поскольку превращение ГМГ-КоА и мевалоновую кислоту представляет собой начальную стадию синтеза холестерина, то применение питавастатина не вызывает накопления в организме потенциально токсичных стеролов. ГМГ-КоА легко метаболизируется до ацетил-КоА. который участвует во многих процессах синтеза в организме. Клинические исследования показали эффективность препарата Ливазо в отношении снижения концентрации общего холестерина (ОХС) в плазме крови, холестерина липопротеинов низкой плотности (ХС ЛПНП), холестерина липопротеинов очень низкой плотности (ХС ЛПОНП). триглицеридов (ТГ) и аполипопротеина В (Аро-В), а также повышения концентрации холестерина липопротеинов высокой плотности (ХС ЛПВП) и аполипопротеина А1 (Аро-Al)."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"— первичная гиперхолестеринемия, включая гетерозиготную семейную гиперхолестеринемию (гиперлипидемия IIа типа по классификации Фредриксона) или смешанная гиперхолестеринемия(гиперлипидемия IIb типа по классификации Фредриксона), гипертриглицеридемия (гиперлипидемия IV типа но классификации Фредриксона) в качестве дополнения к диете, когда диета и другие немедикаментозные методы лечения (например, физические упражнения, снижение массы тела) оказываются недостаточными."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Повышенная чувствительность к питавастатину, вспомогательным компонентам препарата и другим ингибиторам ГМГ-КоА-редуктазы (статинам)","Тяжелая печеночная недостаточность (более 9 баллов по шкале Чайлд-Пью) или класс С по классификации Чайлд-Пью, заболевания печени и активной фазе, включая стойкое повышение активности \"печеночных\" трансаминаз в сыворотке крови (более чем в 3 раза по сравнению с верхней границей нормы (ВГН))","Непереносимость лактозы, дефицит лактазы или глюкозо-галактозная мальабсорбция","Миопатия","Одновременный прием циклоспорина","Беременность, период грудного вскармливания, отсутствие адекватных методов контрацепции у женщин детородного возраста","Возраст до 18 лет (эффективность и безопасность не установлены)"]}},{"type":"paragraph","data":{"text":"С осторожностью"}},{"type":"paragraph","data":{"text":"При наличие риска развития миопатии/рабдомиолиза - почечная недостаточность, гипотиреоз, личный или семейный анамнез наследственных мышечных заболеваний и предшествующий анамнез мышечной токсичности при применении других ингибиторов ГМГ-КоА-рсдуктазы или фибратов, чрезмерное употребление алкоголя, возраст старше 70 лет, заболевания печени в анамнезе."}}]},{"id":5,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, таблетки необходимо проглатывать целиком.; Предпочтителен прием таблетки в одно и то же время суток, лучше вечером, в соответствии с циркадным ритмом липидного обмена. До начала лечения и в процессе пациенты должны придерживаться гипохолестеринемической диеты.; Начальная доза препарата 1 мг/сут однократно. При необходимоcти дозу препарата увеличивают с интервалами не менее 4 недель до 2 мг/сут. Дозу следует подбирать индивидуально в соответствии с концентрациями ХС ЛПНП, целью лечения и ответом пациента на лечение. Большинству пациентов требуется доза 2 мг. Максимальная суточная доза - 1 мг.; Пациенты с легкими и умеренными нарушениями функции печени: рекомендована максимальная суточная доза 2 мг.; Пациенты с нарушением функции почек: при нарушении функции почек легкой степени гяжести (желательно объективно оценить данную степень с отражением КК или скорости клубочковой фильтрации), препарат Ливазо следует применять с осторожностью. Данные по применению максимальной суточной дозы препарата 4 мг при нарушениях функции почек любой степени тяжести ограничены, поэтому назначать максимальную суточную дозу 4 мг необходимо только при тщательном контроле функции почек после постепенного повышения дозы. Не рекомендуется пациентам с тяжелыми нарушениями функции почек назначать максимальную суточную дозу в 4 мг; рекомендуется рассмотреть ограничение максимальной суточной дозы до 2 мг при тяжелой почечной недостаточности.; Пациенты пожилого возрасте: коррекция дозы не требуется."}}]},{"id":6,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В контролируемых клинических исследованиях при приеме рекомендованных доз менее 4% пациентов, получавших лечение препаратом Лнвазо. было исключено из исследования в связи с развитием нежелательных реакций. Наиболее распространенной была миапгия.; В зависимости от частоты возникновения выделяют следующие нежелательные реакции в соответствии с классификацией ВОЗ: очень часто: ≥10, часто: от ≥1/100 до \u003c1/10, нечасто: от ≥1/1000 до \u003c1/100, редко: от ≥1/10000 до \u003c1/10000, очень редко: \u003c1/10000 н частота неизвестна (имеющиеся данные не позволяют определить частоту).; Со стороны органов кроветворения: нечасто - анемия.; Со стороны обмена веществ: нечасто - анорексия.; Нарушение психики: часто - бессонница.; Со стороны нервной системы: часто - головная боль; нечасто - головокружение, нарушение вкуса, сонливость.; Со стороны органов чувств: нечасто - звон в ушах; редко - снижение остроты зрения.; Со стороны кожных покровов: нечасто - кожный зуд, супь; редко - крапивница, эритема.; Со стороны опорно-двигательного аппарата: часто - миалгия, артралгия; нечасто - мышечные спазмы.; Со стороны мочевыделительной системы: нечасто - поллакиурия.; Со стороны пищеварительной системы: часто - запор, диарея, диспепсия, тошнота; нечасто - боли в животе, сухость слизистой оболочки полости рта, рвота; редко - глоссодиния, острый панкреатит, холестатическая желтуха.; Лабораторные показатели: нечасто - понышенне активности \"печеночных\" трансаминаз ACT, АЛТ, повышение активности креатинфосфокиназы (КФК).; В клинических исследований после приема Ливазо наблюдалось повышение активности КФК в 3 раза выше ВГН у 49 пациентов из 2800 (1.8%). Уровни превышения ВГН в 10 раз и более с сопутствующими мышечными симптомами отмечались редко, и наблюдались только у одного пациента из 2406 пациентов, получавших 4 мг Ливазо (0.04%) в программе клинических исследований.; Прочие: нечасто - астении, недомогание, повышенная утомляемость, периферические отеки.; Опыт постмаркетингового применения; Двухлетнее проспективное исследование пострегистрационного наблюдения было проведено приблизительно у 20000 пациентов в Японии. Подавляющее большинство из этих пациентов получали питавастатин в дозе 1 или 2 мг, а не 4 мг. У 10.4 % пациентов были зарегистрированы нежелательные реакции, у которых нельзя исключить причинную связь с питавастатином, и 7.4% пациентов прекратили лечение в связи с развитием нежелательных реакций. Частота возникновнения миалгии составляла 1.08%. Большинство нежелательных реакций были легкими. На протяжении 2-х лет частота нежелательных реакций была выще у пациентов, имевших в анамнезе лекарственную аллергию (20.4%) или заболевание печени или почек (13.5%).; Нежелательные реакции и частота их возникновения, наблюдавшиеся в проспективном исследовании пострегистрационного наблюдения, но не в международных контролируемых клинических исследованиях при применении препарата и рекомендуемых дозах приведены ниже.; Со стороны печени и желчевыводящих путей: редко - нарушение функции печени.; Со стороны опорно-двигательного аппарата: редко - миопатия, рабдомиолиз.; В исследовании пострегистрационного наблюдения имелись два сообщения о рабдомиолизе, при котором пациенты нуждались в госпитализации (0.01% пациентов).; Кроме того, имеются спонтанные сообщения об эффектах со стороны опорно-двигательного аппарата, включающие миалгию и миопатию у пациентов, лечившихся Ливазо во всех рекомендуемых дозах. Были также получены сообщения о рабдомиолизе с острой почечной недостаточностью и без нее, в т.ч., о рабдомиолизе с летальным исходом.; Были также получены спонтанные сообщения о следующих нежелательных реакциях (частота основана на случаях, наблюдаемых в пострегистрационных исследованиях).; Со стороны нервной системы: нечасто - гипестезия.; Со стороны пищеварительной системы: редко - абдомиальный дискомфорт.; Нежелательные явления при применении других статинов:;- нарушение сна, включая кошмарные сновидения; - амнезия; - сексуальная дисфункция; - депрессия; - интеретициальное заболевание легких; - сахарный диабет: частота нозникновения зависит от наличия или отсутсвия факторов риска (концентрация глюкозы в крови натощак ≥5 ммоль/л, ИМТ\u003e30 кг/м2, повышенная концентрация ТГ, артериальная гипертензия в анамнезе); - повышение гликозилированного гемоглобина."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Питавастатин - конкурентный ингибитор ГМГ-КоА (З-гидрокси-З-метилглютарилкоэнзим А) редуктазы, фермента, катализирующего начальную стадию синтеза холестерина образование мевалоновой кислоты из ГМГ-КоА. 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