Аторвастатин-АЛСИ Таблетки, коробка, 30 шт, 80 мг, для приема внутрь, в пленочной оболочке

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Низкая системная биодоступность обусловлена пресистемным метаболизмом в слизистой оболочке желудочно-кишечного тракта и при \"первом прохождении\" через печень."}},{"type":"paragraph","data":{"text":"Средний объем распределения - 381 л связь с белками плазмы крови - 98%."}},{"type":"paragraph","data":{"text":"Метаболизируется преимущественно в печени под действием цитохрома CYP3A4 CYP3A5 и CYP3A7 с образованием фармакологически активных метаболитов (орто- и парагидроксилированных производных продуктов бета-окисления)."}},{"type":"paragraph","data":{"text":"In vitro орто- и парагидроксилированные метаболиты оказывают ингибирующее действие на ГМГ-КоА-редуктазу сопоставимое с таковым Аторвастатина. Ингибирующий эффект препарата в отношении ГМГ-КоА-редуктазы примерно на 70% определяется активностью циркулирующих метаболитов."}},{"type":"paragraph","data":{"text":"Выводится с желчью после печеночного и/или внепеченочного метаболизма (не подвергается выраженной кишечно-печеночной рециркуляции)."}},{"type":"paragraph","data":{"text":"Период полувыведения - 14 час."}},{"type":"paragraph","data":{"text":"Ингибирующая активность в отношении ГМГ-КоА-редуктазы сохраняется около 20-30 ч благодаря наличию активных метаболитов. Менее 2% от принятой внутрь дозы препарата определяется в моче."}},{"type":"paragraph","data":{"text":"Не выводится в ходе гемодиализа."}}]},{"id":1,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Аторвастатин применяется:"}},{"type":"paragraph","data":{"text":"- в сочетании с диетой для снижения повышенных уровней общего холестерина холестерина/ЛПНП аполипопротеина В и триглицеридов и повышения уровня холестерина ЛПВП у больных с первичной гиперхолестеринемией гетерозиготной семейной и несемейной гиперхолестеринемией и комбинированной (смешанной) гиперлипидемией (типы IIа и IIb по Фредриксону);"}},{"type":"paragraph","data":{"text":"- в сочетании с диетой для лечения больных с повышенными сывороточными уровнями триглицеридов (тип IV по Фредриксону) и больных с дисбеталипопротеинемией (тип III по Фредриксону) у которых диетотерапия не дает адекватного эффекта;"}},{"type":"paragraph","data":{"text":"- для снижения уровней общего холестерина и холестерина/ЛПНП у больных с гомозиготной семейной гиперхолестеринемией когда диетотерапия и другие нефармакологические методы лечения оказываются недостаточно эффективными."}}]},{"id":2,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"- Повышенная чувствительность к компонентам препарата;"}},{"type":"paragraph","data":{"text":"- активные заболевания печени или повышение активности \"печеночных\" ферментов неясного генеза (более чем в 3 раза по сравнению с верхней границей нормы);"}},{"type":"paragraph","data":{"text":"- печеночная недостаточность (степень тяжести по классификации Чайлд-Пьюга А и В)"}},{"type":"paragraph","data":{"text":"- беременность;"}},{"type":"paragraph","data":{"text":"- период лактации;"}},{"type":"paragraph","data":{"text":"- возраст до 18 лет (эффективность и безопасность не установлены)."}}]},{"id":14,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Злоупотребление алкоголем заболевания печени в анамнезе тяжелые нарушения электролитного баланса эндокринные и метаболические нарушения артериальная гипотензия тяжелые острые инфекции (сепсис) неконтролируемая эпилепсия обширные хирургические вмешательства травмы заболевания скелетных мышц."}}]},{"id":3,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Аторвастатин противопоказан к применению во время беременности и в период лактации (грудного вскармливания)."}},{"type":"paragraph","data":{"text":"Неизвестно выводится ли Аторвастатин-АЛСИ с грудным молоком. Учитывая возможность нежелательных явлений у грудных детей при необходимости применения препарата в период лактации следует решить вопрос о прекращении грудного вскармливания."}},{"type":"paragraph","data":{"text":"Женщины репродуктивного возраста во время лечения должны пользоваться адекватными методами контрацепции. Аторвастатин можно назначать женщинам репродуктивного возраста только в том случае если вероятность беременности у них очень низкая а пациентка информирована о возможном риске лечения для плода."}}]},{"id":15,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Перед назначением Аторвастатина-АЛСИ больному необходимо рекомендовать стандартную гиполипидемическую диету которую он должен продолжать соблюдать в течение всего периода терапии."}},{"type":"paragraph","data":{"text":"Начальная доза составляет в среднем 10 мг 1 раз/сут."}},{"type":"paragraph","data":{"text":"Доза варьирует от 10 до 80 мг 1 раз/сут."}},{"type":"paragraph","data":{"text":"Препарат можно принимать в любое время дня с пищей или независимо от времени приема пищи."}},{"type":"paragraph","data":{"text":"Дозу подбирают с учетом исходных уровней холестерина/ЛПНП цели терапии и индивидуального эффекта."}},{"type":"paragraph","data":{"text":"В начале лечения и/или во время повышения дозы Аторвастатина-АЛСИ необходимо каждые 2-4 недели контролировать уровни липидов в плазме крови и соответствующим образом корригировать дозу."}},{"type":"paragraph","data":{"text":"Первичная гиперхолестеринемия и смешанная гиперлипидемия а также тип III и IV по Фредриксону"}},{"type":"paragraph","data":{"text":"В большинстве случаях бывает достаточно назначения дозы 10 мг препарата Аторвастатин-АЛСИ 1 раз в сутки."}},{"type":"paragraph","data":{"text":"Существенный терапевтический эффект наблюдается через 2 недели как правило и максимальный терапевтический эффект обычно наблюдается уже через 4 недели. При длительном лечении этот эффект сохраняется."}},{"type":"paragraph","data":{"text":"Гомозиготная семейная гиперхолестеринемия."}},{"type":"paragraph","data":{"text":"Назначают в дозе 80 мг (4 таблетки по 20 мг) 1 раз в сутки."}},{"type":"paragraph","data":{"text":"Применение препарата у больных с почечной недостаточностью и заболеваниями почек не оказывает влияние на уровень Аторвастатина-АЛСИ в плазме крови или степень снижения содержания холестерина/ЛПНП при его применении поэтому изменение дозы препарата не требуется."}},{"type":"paragraph","data":{"text":"При печеночной недостаточности дозы необходимо снижать (см. раздел \"С осторожностью\" и \"Особые указания\")."}},{"type":"paragraph","data":{"text":"При применении препарата у пожилых пациентов различий в безопасности эффективности или достижении целей гиполипидемической терапии в сравнении с общей популяцией не отмечалось."}}]},{"id":4,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны нервной системы: чаще 2% - бессонница головокружение; реже 2% - головная боль астения недомогание сонливость кошмарные сновидения парестезии периферическая невропатия амнезия эмоциональная лабильность атаксия паралич лицевого нерва гиперкинезы мигрень депрессия гипестезия потеря сознания."}},{"type":"paragraph","data":{"text":"Со стороны органов чувств: реже 2% - амблиопия звон в ушах сухость конъюнктивы нарушение аккомодации кровоизлияние в сетчатую оболочку глаза глухота глаукома паросмия потеря вкусовых ощущений извращение вкуса."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: чаще 2% - боль в груди; реже 2% - сердцебиение симптомы вазодилатации ортостатическая гипотензия повышение артериального давления флебит аритмия стенокардия."}},{"type":"paragraph","data":{"text":"Со стороны системы кроветворения: реже 2% - анемия лимфаденопатия тромбоцитопения."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: чаще 2% - бронхит ринит; реже 2% - пневмония диспноэ обострение бронхиальной астмы носовое кровотечение."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: чаще 2% - тошнота; реже 2% - изжога запор или диарея метеоризм гастралгия боль в животе снижение или повышение аппетита сухость во рту отрыжка дисфагия рвота стоматит эзофагит глоссит эрозивно-язвенные поражения слизистой оболочки полости рта гастроэнтерит гепатит желчная колика хейлит язва 12-перстной кишки панкреатит холестатическая желтуха нарушение функции печени ректальное кровотечение мелена кровоточивость десен тенезмы."}},{"type":"paragraph","data":{"text":"Со стороны опорно-двигательного аппарата: чаще 2% - артрит; реже 2% - судороги мышц ног бурсит тендосиновит миозит миопатия артралгии миалгия рабдомиолиз кривошея мышечный гипертонус контрактуры суставов."}},{"type":"paragraph","data":{"text":"Со стороны мочеполовой системы: чаще 2% - урогенитальные инфекции периферические отеки; реже 2% - дизурия (в т.ч. поллакиурия никтурия недержание мочи или задержка мочеиспускания императивные позывы на мочеиспускание) нефрит гематурия вагинальное кровотечение нефроуролитиаз метроррагия эпидидимит снижение либидо импотенция нарушение эякуляции."}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов: чаще 2% - алопеция ксеродермия повышенное потоотделение экзема себорея экхимозы петехии."}},{"type":"paragraph","data":{"text":"Аллергические реакции: реже 2% - кожный зуд кожная сыпь контактный дерматит редко - крапивница ангионевротический отек отек лица фотосенсибилизация анафилаксия мультиформная экссудативная эритема (в т.ч. синдром Стивенса-Джонсона) токсический эпидермальный некролиз (синдром Лайелла)."}},{"type":"paragraph","data":{"text":"Лабораторные показатели: реже 2% - гипергликемия гипогликемия повышение сывороточной КФК альбуминурия."}},{"type":"paragraph","data":{"text":"Прочие: реже 2% - увеличение массы тела гинекомастия мастодиния обострение подагры."}}]},{"id":16,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Лечение: специфического антидота нет проводится симптоматическая терапия."}},{"type":"paragraph","data":{"text":"Гемодиализ неэффективен."}}]},{"id":17,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Риск миопатии во время лечения другими лекарственными средствами этого класса повышается при одновременном применении циклоспорина фибратов эритромицина противогрибковых средств относящихся к азолам и никотиновой кислоты."}},{"type":"paragraph","data":{"text":"При одновременном приеме внутрь Аторвастатина-АЛСИ и суспензии содержащей магния и алюминия гидроокиси снижались концентрации Аторвастатина-АЛСИ в плазме крови примерно на 35% однако степень уменьшения уровня холестерина/ЛПНП при этом не менялась."}},{"type":"paragraph","data":{"text":"При одновременном применении Аторвастатин-АЛСИ не влияет на фармакокинетику антипирина (феназона) поэтому взаимодействие с другими средствами метаболизирующимися теми же изоферментами цитохрома не ожидается."}},{"type":"paragraph","data":{"text":"При одновременном применении колестипола концентрации Аторвастатина-АЛСИ в плазме крови снижались примерно на 25%. Однако гиполипидемический эффект комбинации Аторвастатина-АЛСИ и колестипола превосходил таковой каждого препарата по отдельности."}},{"type":"paragraph","data":{"text":"При повторном приеме дигоксина и Аторвастатина-АЛСИ в дозе 10 мг равновесные концентрации дигоксина в плазме крови не менялись. Однако при применении дигоксина в комбинации с Аторвастатином-АЛСИ в дозе 80 мг/сут. концентрация дигоксина увеличивалась примерно на 20%. Больных получающих дигоксин в сочетании с Аторвастатином-АЛСИ следует наблюдать."}},{"type":"paragraph","data":{"text":"При одновременном применении Аторвастатина-АЛСИ и эритромицина (500 мг 4 раза/сут) или кларитромицина (500 мг 2 раза/сут) которые ингибируют цитохром Р450 ЗА4 наблюдалось повышение концентрации Аторвастатина-АЛСИ в плазме крови."}},{"type":"paragraph","data":{"text":"При одновременном применении Аторвастатина-АЛСИ (10 мг 1 раз/сут) и азитромицина (500 мг 1 раз/сут) концентрация Аторвастатина-АЛСИ в плазме крови не менялась."}},{"type":"paragraph","data":{"text":"Аторвастатин-АЛСИ не оказывал клинически значимого влияния на концентрацию терфенадина в плазме крови который метаболизируется главным образом цитохромом Р450 3А4; в связи с этим представляется мало вероятным что Аторвастатин-АЛСИ способен существенно повлиять на фармакокинетические параметры других субстратов цитохрома Р450 3А4."}},{"type":"paragraph","data":{"text":"При одновременном применении Аторвастатина-АЛСИ и контрацептива для приема внутрь содержащего норэтиндрон и этинилэстрадиол наблюдалось значительное повышение AUC норэтиндрона и этинилэстрадиола примерно на 30% и 20% соответственно. Этот эффект следует учитывать при выборе перорального контрацептива для женщины получающей Аторвастатин-АЛСИ."}},{"type":"paragraph","data":{"text":"Одновременное применение с лекарственными средствами снижающими концентрацию эндогенных стероидных гормонов (в том числе циметидином кетоконазолом спиронолактоном) увеличивает риск снижения эндогенных стероидных гормонов (следует соблюдать осторожность)."}},{"type":"paragraph","data":{"text":"При изучении взаимодействия Аторвастатина-АЛСИ с варфарином и циметидином признаков клинически значимого взаимодействия не обнаружено."}},{"type":"paragraph","data":{"text":"При одновременном применении Аторвастатина-АЛСИ 80 мг и амлодипина 10 мг фармакокинетика Аторвастатина-АЛСИ в равновесном состоянии не изменялась."}},{"type":"paragraph","data":{"text":"Не отмечено клинически значимого нежелательного взаимодействия Аторвастатина-АЛСИ и антигипертензивных средств."}},{"type":"paragraph","data":{"text":"Одновременное применение Аторвастатина-АЛСИ с ингибиторами протеаз известными как ингибиторы цитохрома Р450 3А4 сопровождалось увеличением концентрации Аторвастатина-АЛСИ в плазме крови."}},{"type":"paragraph","data":{"text":"Фармацевтическая несовместимость не известна."}}]},{"id":5,"name":"Особые указания","slug":"","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Перед началом терапии Аторвастатином-АЛСИ больному необходимо назначить стандартную гипохолестестериновую диету которую он должен соблюдать во время всего периода лечения."}},{"type":"paragraph","data":{"text":"Применение ингибиторов ГМГ-КоА-редуктазы для снижения уровня липидов в крови может приводить к изменению биохимических показателей отражающих функцию печени. Функцию печени следует контролировать перед началом терапии через 6 недель 12 недель после начала приема Аторвастатина-АЛСИ и после каждого повышения дозы а также периодически например каждые 6 месяцев. Повышение активности \"печеночных\" ферментов в сыворотке крови может наблюдаться в течение терапии Аторвастатином-АЛСИ. Пациенты у которых отмечается повышение уровня ферментов должны находиться под контролем до возвращения уровня ферментов в норму. В том случае если значения аланинаминотрансферазы (АЛТ) или аспарагинаминотрансферазы (ACT) более чем в 3 раза превышают уровень верхнего допустимого предела рекомендуется снизить дозу Аторвастатина-АЛСИ или прекратить лечение."}},{"type":"paragraph","data":{"text":"Аторвастатин-АЛСИ следует применять с осторожностью у больных злоупотребляющих алкоголем и/или имеющих заболевание печени."}},{"type":"paragraph","data":{"text":"Активное заболевание печени или стойкое повышение активности аминотрансфераз неясного генеза служат противопоказаниям к назначению Аторвастатина-АЛСИ."}},{"type":"paragraph","data":{"text":"Лечение Аторвастатином-АЛСИ может вызвать миопатию. Диагноз миопатии (боль и слабость в мышцах в сочетании с повышением активности креатинфосфокиназы (КФК) более чем в 10 раз по сравнению с верхней границей нормы) следует обсуждать у больных с распространенными миалгиями болезненностью или слабостью мышц и/или выраженным повышением активности КФК. Больных необходимо предупредить о том что им следует немедленно сообщить врачу о появлении необъяснимых болей или слабости в мышцах если они сопровождаются недомоганием или лихорадкой. Терапию Аторвастатином-АЛСИ следует прекратить в случае выраженного повышения активности КФК или при наличии подтвержденной или предполагаемой миопатии."}},{"type":"paragraph","data":{"text":"Риск миопатии при лечении другими препаратами этого класса повышался при одновременном применении циклоспорина фибратов эритромицина никотиновой кислоты или азольных противогрибковых средств. Многие из этих препаратов ингибируют метаболизм опосредованный цитохромом Р450 3А4 и/или транспорт лекарственных средств."}},{"type":"paragraph","data":{"text":"Аторвастатин биотрансформируется под действием CYP ЗА4. Назначая Аторвастатин-АЛСИ в комбинации с фибратами эритромицином иммуносупрессивными средствами азльными противогрибковыми средствами или никотиновой кислотой в гиполипидемических дозах следует тщательно взвесить ожидаемую пользу и риск лечения и регулярно наблюдать больных с целью выявления болей или слабости в мышцах особенно в течение первых месяцев лечения и в периоды повышения дозы любого препарата. В подобных ситуациях можно рекомендовать периодическое определение активности КФК хотя такой контроль не позволяет предотвратить развитие тяжелой миопатии."}},{"type":"paragraph","data":{"text":"При применении Аторвастатина-АЛСИ как и других средств этого класса описаны случаи рабдомиолиза с острой почечной недостаточностью обусловленной миоглобинурией."}},{"type":"paragraph","data":{"text":"Терапию Аторвастатином-АЛСИ следует временно прекратить или полностью отменить при появлении признаков возможной миопатии или наличии фактора риска развития почечной недостаточности на фоне рабдомиолиза (например тяжелая острая инфекция артериальная гипотензия серьезная операция травма тяжелые обменные эндокринные и электролитные нарушения и неконтролируемые судороги)."}},{"type":"paragraph","data":{"text":"Перед началом терапии Аторвастатином-АЛСИ необходимо попытаться добиться контроля гиперхолестеринемии путем адекватной диетотерапии повышения физической активности снижения массы тела у больных с ожирением и лечения других состояний."}},{"type":"paragraph","data":{"text":"Пациентов необходимо предупредить о том что им следует немедленно обратиться к врачу при появлении необъяснимых болей или слабости в мышцах особенно если они сопровождаются недомоганием или лихорадкой."}}]},{"id":18,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"О неблагоприятном влиянии Аторвастатина-АЛСИ на способность управлять автомобилем и работу смеханизмами не сообщалось."}}]},{"id":19,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки покрытые пленочной оболочкой 10 мг и 20 мг."}}]},{"id":6,"name":"Условия хранения","slug":"storage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В сухом, защищенном от света месте, при температуре не выше 25°C. Хранить в недоступном для детей месте."}}]},{"id":7,"name":"Срок годности","slug":"expiry_date","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России"}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":21,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"ЗАО \"АЛСИ Фарма\", 610044, Кировская область, Киров, ул. Луганская, д.53 в, Россия"}}]},{"id":22,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ЗАО \"АЛСИ Фарма\""}}]}],"source":{"title":"ЭркаФарм","url":"https://erkapharm.com"}},"description_toggle":false,"short_description":"Гиполипидемическое средство из группы статинов. 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Снижает уровень общего холестерина на 30-46% ЛПНП - на 41-61% аполипопротеина В - на 34-50% и ТГ - на 14-33%; вызывает повышение уровня холестерина-ЛПВП (липопротеинов высокой плотности) и аполипопротеина А. Дозозависимо снижает уровень ЛПНП у больных с гомозиготной наследственной гиперхолестеринемией резистентной к терапии другими гиполипидемическими средствами. Абсорбция - высокая. Максимальная концентрация (Сmах) в плазме крови достигается через 1-2 ч Сmаху женщин выше на 20% площадь под кривой/концентрация время (AUC) - ниже на 10%; Сmаху больных алкогольным циррозом печени в 16 раз AUC - в 11 раз выше нормы. Пища несколько снижает скорость и длительность абсорбции препарата (на 25% и 9% соответственно) однако снижение холестерина ЛПНП сходно с таковым при применении Аторвастатина без пищи. Концентрация Аторвастатина при применении в вечернее время ниже чем в утреннее (приблизительно на 30%). Выявлена линейная зависимость между степенью всасывания и дозой препарата. Биодоступность - 12% системная биодоступность ингибирующей активности в отношении ГМГ-КоА-редуктазы - 30%. Низкая системная биодоступность обусловлена пресистемным метаболизмом в слизистой оболочке желудочно-кишечного тракта и при \"первом прохождении\" через печень. Средний объем распределения - 381 л связь с белками плазмы крови - 98%. Метаболизируется преимущественно в печени под действием цитохрома CYP3A4 CYP3A5 и CYP3A7 с образованием фармакологически активных метаболитов (орто- и парагидроксилированных производных продуктов бета-окисления). In vitro орто- и парагидроксилированные метаболиты оказывают ингибирующее действие на ГМГ-КоА-редуктазу сопоставимое с таковым Аторвастатина. Ингибирующий эффект препарата в отношении ГМГ-КоА-редуктазы примерно на 70% определяется активностью циркулирующих метаболитов. Выводится с желчью после печеночного и/или внепеченочного метаболизма (не подвергается выраженной кишечно-печеночной рециркуляции). Период полувыведения - 14 час. Ингибирующая активность в отношении ГМГ-КоА-редуктазы сохраняется около 20-30 ч благодаря наличию активных метаболитов. Менее 2% от принятой внутрь дозы препарата определяется в моче. 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