Таблетки Симвор - гиполипидемическое средство из группы стат... Инструкция
Показания к применению
Первичная гиперхолестеринемия (тип Н а и M b) при неэффективности диетотерапии с низким содержанием холестерина и других немедикаментозных мероприятий (физическая нагрузка и снижение массы тела) у пациентов с повышенным риском возникновения коронарного атеросклероза. Комбинированная гиперхолестеринемия и гипертриглицеридемия, не корректируемые специальной ...
Таблетки Симвор - гиполипидемическое средство из группы статинов, ингибитор ГМГ-КоА-редуктазы. Является пролекарством, поскольку имеет в своей структуре закрытое лактоновое кольцо, которое после поступления в организм гидролизуется. Начало проявления эффекта - через 2 недели от начала приема, максимальный терапевтический эффект достигается через 4-6 недель. Действие сохраняется при продолжении лечения, при прекращении терапии содержание холестерина постепенно возвращается к исходному уровню.
Показания к применению
Первичная гиперхолестеринемия (тип Н а и M b) при неэффективности диетотерапии с низким содержанием холестерина и других немедикаментозных мероприятий (физическая нагрузка и снижение массы тела) у пациентов с повышенным риском возникновения коронарного атеросклероза. Комбинированная гиперхолестеринемия и гипертриглицеридемия, не корректируемые специальной диетой и физической нагрузкой. Ишемическая болезнь сердца. Для профилактики инфаркта миокарда, для уменьшения риска смерти, уменьшения риска сердечно-сосудистых нарушений (инсульт или транзиторные ишемические приступы), замедления прогрессирования атеросклероза коронарных сосудов, уменьшения риска процедур реваскуляризации.
Применение при беременности и в период грудного вскармливания
Препарат Симвор противопоказан беременным. Имеется несколько сообщений о развитии аномалий у новорожденных, матери которых принимали симвастатин. Женщины детородного возраста, принимающие симвастатин, должны избегать зачатия. Если в процессе лечения беременность все же наступила, препарат Симвор должен быть отменен, а женщина должна быть предупреждена о возможной опасности для плода. Данные о выделении симвастатина с материнским молоком отсутствуют. При необходимости назначения препарата Симвор.
Способ применения и дозы
До начала лечения препаратом Симвор пациенту следует назначить стандартную гипохолестериновую диету, которая должна соблюдаться в течение всего курса лечения. Препарат Симвор следует принимать 1 раз в сутки вечером, запивая достаточным количеством воды. Время приема препарата не следует связывать с приемом пищи. Рекомендуемая доза препарата Симвор для лечения гиперхолестеринемии варьирует от 10 до 80 мг 1 раз с сутки вечером. Рекомендуемая начальная доза препарата для пациентов с гиперхолестеринемией, составляет 10 мг. Максимальная суточная доза - 80 мг. Изменения (подбор) дозы следует проводить с интервалами в 4 недели. У большинства пациентов оптимальный эффект достигается при приеме препарата в дозах до 20 мг в сутки. У пациентов с гомозиготной наследственной гиперхолестеринемией рекомендуемая суточная доза препарата Симвор составляет 40 мг 1 раз в сутки вечером или 80 мг в три приема (20 мг утром, 20 мг днем и 40 мг вечером). При лечении пациентов с ишемической болезнью сердца (ИБС) или высоким риском развития ИБС эффективные дозы препарата Симвор составляют 20-40 мг в сутки. Поэтому рекомендуемая начальная доза у таких пациентов - 20 мг в сутки. Изменения (подбор) дозы следует проводить с интервалами в 4 недели, при необходимости дозу можно увеличить до 40 мг в сутки. Если содержание ЛПНП менее 75 мг/дл (1,94 ммоль/л), содержание общего холестерина менее 140 мг/дл (3,6 ммоль/л), дозу препарата необходимо уменьшить. У пациентов пожилого возраста или имеющих почечную недостаточность легкой или умеренной степени изменений дозировки препарата не требуется. У пациентов с хронической почечной недостаточностью (клиренс креатинина менее 30 мл/мин) или получающих циклоспорин, фибраты, даназол, гемфиброзил или другие фибраты (кроме фенофибрата), ниацин в дозах, снижающих содержание липидов, (≥ 1 г/сутки), максимально рекомендуемая доза препарата Симвор не должна превышать 10 мг в сутки. Суточная доза препарата Симвор у пациентов, принимающих одновременно с ним амиодарон или верапамил, не должна превышать 20 мг.
Побочное действие
Пищеварительная система: возможны боли в животе, запор, метеоризм, тошнота, диарея, панкреатит, рвота, гепатит, повышение активности «печеночных» ферментов, щелочной фосфотазы и креатинфосфокиназы (КФК). Нервная система и органы чувств: астенический синдром, головная боль, головокружение, бессонница, мышечные судороги, парестезии, периферическая нейропатия, расплывчатость зрения, нарушение вкусовых ощущений Аллергические и иммунопатологические реакции: ангионевротический отек, ревматическая полимиалгия, васкулит, тромбоцитопения, увеличение СОЭ, лихорадка, артрит, крапивница, фотосенсибилизация, гиперемия кожи, приливы, одышка, волчаночноподобный синдром, эозинофилия. Дерматологические реакции: редко кожная сыпь, зуд, алопеция, дерматомиозит. Со стороны опорно-двигательного аппарата: миопатия, миалгия, судороги мышц, слабость, редко - рабдомиолиз. Прочие: анемия, сердцебиение, острая почечная недостаточность (вследствие рабдомиолиза), снижение потенции.
Передозировка
Симптомы: ни в одном из известных нескольких случаев передозировки (максимально принятая доза 450 мг) специфических симптомов выявлено не было. Лечение: вызвать рвоту, принять активированный уголь. Симптоматическая терапия. Следует контролировать функции печени и почек, уровень КФК в сыворотке крови. При развитии миопатии с рабдомиолизом и острой почечной недостаточностью (редкий, но тяжелый побочный эффект) следует немедленно прекратить прием препарата и ввести больному диуретик и натрия бикарбонат (внутривенная инфузия). При необходимости показан гемодиализ. Рабдомиолиз может вызвать гиперкалиемию, которую можно устранить внутривенным введением кальция хлорида и кальция глюконата, инфузией глюкозы с инсулином, использованием калиевых ионообменников или в тяжелых случаях с помощью гемодиализа.
Особые указания
Противопоказания:- повышенная чувствительность к симвастатину или к другим компонентам препарата, а также к другим препаратам статинового ряда (ингибиторам ГМГ-КоА - редуктазы) в анамнезе,- заболевания печени в активной фазе, стойкое повышение активности «печеночных» ферментов неясной этиологии, - порфирия,- заболевания скелетной мускулатуры (миопатия),- возраст до 18 лет (эффективность и безопасность не установлены).
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Нервная система и органы чувств: астенический синдром, головная боль, головокружение, бессонница, мышечные судороги, парестезии, периферическая нейропатия, расплывчатость зрения, нарушение вкусовых ощущений Аллергические и иммунопатологические реакции: ангионевротический отек, ревматическая полимиалгия, васкулит, тромбоцитопения, увеличение СОЭ, лихорадка, артрит, крапивница, фотосенсибилизация, гиперемия кожи, приливы, одышка, волчаночноподобный синдром, эозинофилия. Дерматологические реакции: редко кожная сыпь, зуд, алопеция, дерматомиозит. Со стороны опорно-двигательного аппарата: миопатия, миалгия, судороги мышц, слабость, редко - рабдомиолиз. 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