Гиперхолестеринемия: первичная гиперхолестеринемия (тип IIa и IIb) 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 ...
Противопоказания: заболевания печени в активной фазе, стойкое повышение активности печеночных ферментов неясной этиологии, заболевания скелетной мускулатуры (миопатия), — беременность, период лактации (грудное вскармливание), детский и подростковый возраст до 18 лет (эффективность и безопасность не установлены), повышенная чувствительность к симвастатину ...
Таблетки Симгал - гиполипидемический препарат, снижающий уровень общего холестерина.
Фармакологические свойства
Гиполипидемический препарат, ингибитор ГМГ-КоА-редуктазы, получаемый синтетическим путем из продукта ферментации Aspergillus terreus. Является неактивным лактоном, в организме подвергается гидролизу с образованием гидроксикислотного производного. Активный метаболит ингибирует ГМГ-КоА-редуктазу, фермент, катализирующий начальную реакцию образования мевалоната из ГМГ-КоА. Поскольку превращение ГМГ-КоА в мевалонат представляет собой ранний этап синтеза холестерина (Хс), то применение симвастатина не вызывает накопления в организме потенциально токсичных стеролов. ГМГ-КоА легко метаболизируется до ацетил-КоА, который участвует во многих процессах синтеза в организме. Вызывает понижение содержания в плазме крови ТГ, ЛПНП, ЛПОНП и общего Хс (в случаях гетерозиготной семейной и несемейной форм гиперхолестеринемии, при смешанной гиперлипидемии, когда повышенное содержание холестерина является фактором риска). Повышает содержание ЛПВП и уменьшает соотношение ЛПНП/ЛПВП и общий Хс/ЛПВП. 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 Хс постепенно возвращается к исходному уровню.
Показания к применению
Гиперхолестеринемия: первичная гиперхолестеринемия (тип IIa и IIb) 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 корригируемые специальной диетой и физической нагрузкой. ИБС: профилактика инфаркта миокарда, уменьшение риска смерти, замедление прогрессирования атеросклероза, уменьшение риска процедур реваскуляции. Цереброваскулярная болезнь: инсульт или транзиторные ишемические нарушения.
Противопоказания
Противопоказания: заболевания печени в активной фазе, стойкое повышение активности печеночных ферментов неясной этиологии, заболевания скелетной мускулатуры (миопатия), — беременность, период лактации (грудное вскармливание), детский и подростковый возраст до 18 лет (эффективность и безопасность не установлены), повышенная чувствительность к симвастатину и другим компонентам препарата (в т.ч. наследственная непереносимость лактозы), а также к другим препаратам статинового ряда (ингибиторам ГМГ-КоА-редуктазы) в анамнезе.
Применение при беременности и в период грудного вскармливания
Противопоказано
Способ применения и дозы
Препарат следует принимать 1 раз/сут, вечером, перед едой или во время еды. Терапевтическое действие Симгала наступает приблизительно через 2 недели, а максимальный эффект достигается через 4-6 недель от начала лечения. Дозы и продолжительность лечения устанавливают индивидуально. При гиперхолестеринемии назначают по 10 мг 1 раз/сут вечером, при ИБС начальная доза препарата составляет 20 мг. При необходимости дозы повышают с интервалом в 4 недели. Максимальная суточная доза — 80 мг. При применении препарата на фоне иммунодепрессивной терапии у больных, получающих циклоспорин, фибраты, никотиновую кислоту совместно с Симгалом, рекомендуемая начальная доза составляет 5 мг/сут. Максимальная суточная доза составляет 10 мг. При применении препарата у пациентов с почечной недостаточностью легкой и средней степени тяжести коррекции режима дозирования не требуется, поскольку симвастатин выводится почками в незначительной степени. При тяжелой степени почечной недостаточности (КК менее 30 мл/мин) лечение начинают с дозы не более 10 мг/сут. Необходим тщательный медицинский контроль состояния данной категории больных на протяжении всего периода лечения.
Побочное действие
При применении терапевтических рекомендуемых доз препарат Симгал, как правило, хорошо переносится. Со стороны пищеварительной системы: возможны тошнота, рвота, боли в животе, запор, диарея, панкреатит, метеоризм, гепатит, повышение активности печеночных трансаминаз, ЩФ, КФК. Со стороны ЦНС и периферической нервной системы: астенический синдром, головная боль, головокружение, бессонница, судороги, парестезии, периферическая невропатия, расплывчатость зрения, нарушение вкусовых ощущений. Со стороны костно-мышечной системы: миопатия, судороги мышц, миалгия, слабость, редко - рабдомиолиз. Со стороны мочевыделительной системы: острая почечная недостаточность (вследствие рабдомиолиза). Со стороны системы кроветворения: тромбоцитопения, анемия. Аллергические реакции: ангионевротический отек, ревматическая полимиалгия, васкулит, артрит, крапивница, гиперемия кожи, волчаночноподобный синдром, лихорадка, повышение СОЭ, эозинофилия. Дерматологические реакции: фотосенсибилизация, кожная сыпь, зуд, алопеция, дерматомиозит. Прочие: приливы, одышка, сердцебиение, снижение потенции.
Особые указания
В начале терапии препаратом Симгал возможно преходящее повышение уровня печеночных ферментов. Поэтому перед началом терапии и далее регулярно проводить исследование функции печени (контролировать активность печеночных ферментов каждые 6 недель в течение первых 3 мес, затем каждые 8 недель в течение оставшегося первого года, и затем 1 раз в 6 мес), а также при повышении доз следует проводить тест на определение функции печени. При повышении дозы до 80 мг необходимо проводить тест каждые 3 мес. При стойком повышении активности трансаминаз (более чем в 3 раза по сравнению с исходным уровнем) прием препарата Симгал следует прекратить. Препарат Симгал, как и другие ингибиторы ГМГ-Ко-А-редуктазы, не следует применять при повышенном риске развития рабдомиолиза и почечной недостаточности (на фоне тяжелой острой инфекции, артериальной гипотензии, планируемой большой хирургической операции, травм, тяжелых метаболических нарушений). Отмена гиполипидемических средств при беременности не оказывает существенного влияния на результаты длительного лечения первичной гиперхолестеринемии. В связи с тем, что ингибиторы ГМГ-КоА-редуктазы тормозят синтез холестерина, а холестерин и другие продукты его синтеза играют существенную роль в развитии плода, включая синтез стероидов и клеточных мембран, симвастатин может оказывать неблагоприятное воздействие на плод при назначении его беременным (женщины репродуктивного возраста должны избегать зачатия). Если в процессе лечения наступила беременность, препарат должен быть отменен, а женщина предупреждена о возможной опасности для плода. Применение препарата Симгал не рекомендуется у женщин детородного возраста, не использующих контрацептивные средства. У пациентов с пониженной функцией щитовидной железы (гипотиреоз) или при наличии некоторых заболеваний почек (нефротический синдром) при повышении уровня холестерина следует сначала проводить терапию основного заболевания. Препарат Симгал с осторожностью назначают лицам, которые злоупотребляют алкоголем и/или имеют в анамнезе заболевания печени. До начала и во время лечения пациент должен находиться на гипохолестериновой диете. Одновременный прием грейпфрутового сока может усилить степень выраженности побочных явлений, связанных с приемом препарата Симгал, поэтому следует избегать их одновременного приема. Препарат Симгал не показан в тех случаях, когда имеется гипертриглицеридемия I, IV и V типов.
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Вспомогательные вещества: аскорбиновая кислота, бутилгидроксианизол, лимонной кислоты моногидрат, микрокристаллическая целлюлоза, прежелатинизированный крахмал, стеарат магния, моногидрат лактозы. Состав оболочки: опадрай (поливиниловый спирт, диоксид титана, очищенный тальк, лецитин, ксантана камедь, оксид железа красный, оксид оксид железа желтый, индигокарминовый лак)."}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Таблетки Симгал - гиполипидемический препарат, снижающий уровень общего холестерина."}}]},{"id":3,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Гиполипидемический препарат, ингибитор ГМГ-КоА-редуктазы, получаемый синтетическим путем из продукта ферментации Aspergillus terreus. Является неактивным лактоном, в организме подвергается гидролизу с образованием гидроксикислотного производного. Активный метаболит ингибирует ГМГ-КоА-редуктазу, фермент, катализирующий начальную реакцию образования мевалоната из ГМГ-КоА. Поскольку превращение ГМГ-КоА в мевалонат представляет собой ранний этап синтеза холестерина (Хс), то применение симвастатина не вызывает накопления в организме потенциально токсичных стеролов. ГМГ-КоА легко метаболизируется до ацетил-КоА, который участвует во многих процессах синтеза в организме. Вызывает понижение содержания в плазме крови ТГ, ЛПНП, ЛПОНП и общего Хс (в случаях гетерозиготной семейной и несемейной форм гиперхолестеринемии, при смешанной гиперлипидемии, когда повышенное содержание холестерина является фактором риска). Повышает содержание ЛПВП и уменьшает соотношение ЛПНП/ЛПВП и общий Хс/ЛПВП. 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 Хс постепенно возвращается к исходному уровню."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Гиперхолестеринемия: первичная гиперхолестеринемия (тип IIa и IIb) 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 корригируемые специальной диетой и физической нагрузкой. ИБС: профилактика инфаркта миокарда, уменьшение риска смерти, замедление прогрессирования атеросклероза, уменьшение риска процедур реваскуляции. Цереброваскулярная болезнь: инсульт или транзиторные ишемические нарушения."}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказания: заболевания печени в активной фазе, стойкое повышение активности печеночных ферментов неясной этиологии, заболевания скелетной мускулатуры (миопатия), — беременность, период лактации (грудное вскармливание), детский и подростковый возраст до 18 лет (эффективность и безопасность не установлены), повышенная чувствительность к симвастатину и другим компонентам препарата (в т.ч. наследственная непереносимость лактозы), а также к другим препаратам статинового ряда (ингибиторам ГМГ-КоА-редуктазы) в анамнезе."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказано"}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат следует принимать 1 раз/сут, вечером, перед едой или во время еды. Терапевтическое действие Симгала наступает приблизительно через 2 недели, а максимальный эффект достигается через 4-6 недель от начала лечения. Дозы и продолжительность лечения устанавливают индивидуально. При гиперхолестеринемии назначают по 10 мг 1 раз/сут вечером, при ИБС начальная доза препарата составляет 20 мг. При необходимости дозы повышают с интервалом в 4 недели. Максимальная суточная доза — 80 мг. При применении препарата на фоне иммунодепрессивной терапии у больных, получающих циклоспорин, фибраты, никотиновую кислоту совместно с Симгалом, рекомендуемая начальная доза составляет 5 мг/сут. Максимальная суточная доза составляет 10 мг. При применении препарата у пациентов с почечной недостаточностью легкой и средней степени тяжести коррекции режима дозирования не требуется, поскольку симвастатин выводится почками в незначительной степени. При тяжелой степени почечной недостаточности (КК менее 30 мл/мин) лечение начинают с дозы не более 10 мг/сут. Необходим тщательный медицинский контроль состояния данной категории больных на протяжении всего периода лечения."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При применении терапевтических рекомендуемых доз препарат Симгал, как правило, хорошо переносится. Со стороны пищеварительной системы: возможны тошнота, рвота, боли в животе, запор, диарея, панкреатит, метеоризм, гепатит, повышение активности печеночных трансаминаз, ЩФ, КФК. Со стороны ЦНС и периферической нервной системы: астенический синдром, головная боль, головокружение, бессонница, судороги, парестезии, периферическая невропатия, расплывчатость зрения, нарушение вкусовых ощущений. Со стороны костно-мышечной системы: миопатия, судороги мышц, миалгия, слабость, редко - рабдомиолиз. Со стороны мочевыделительной системы: острая почечная недостаточность (вследствие рабдомиолиза). Со стороны системы кроветворения: тромбоцитопения, анемия. Аллергические реакции: ангионевротический отек, ревматическая полимиалгия, васкулит, артрит, крапивница, гиперемия кожи, волчаночноподобный синдром, лихорадка, повышение СОЭ, эозинофилия. Дерматологические реакции: фотосенсибилизация, кожная сыпь, зуд, алопеция, дерматомиозит. Прочие: приливы, одышка, сердцебиение, снижение потенции."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В начале терапии препаратом Симгал возможно преходящее повышение уровня печеночных ферментов. Поэтому перед началом терапии и далее регулярно проводить исследование функции печени (контролировать активность печеночных ферментов каждые 6 недель в течение первых 3 мес, затем каждые 8 недель в течение оставшегося первого года, и затем 1 раз в 6 мес), а также при повышении доз следует проводить тест на определение функции печени. При повышении дозы до 80 мг необходимо проводить тест каждые 3 мес. При стойком повышении активности трансаминаз (более чем в 3 раза по сравнению с исходным уровнем) прием препарата Симгал следует прекратить. Препарат Симгал, как и другие ингибиторы ГМГ-Ко-А-редуктазы, не следует применять при повышенном риске развития рабдомиолиза и почечной недостаточности (на фоне тяжелой острой инфекции, артериальной гипотензии, планируемой большой хирургической операции, травм, тяжелых метаболических нарушений). Отмена гиполипидемических средств при беременности не оказывает существенного влияния на результаты длительного лечения первичной гиперхолестеринемии. В связи с тем, что ингибиторы ГМГ-КоА-редуктазы тормозят синтез холестерина, а холестерин и другие продукты его синтеза играют существенную роль в развитии плода, включая синтез стероидов и клеточных мембран, симвастатин может оказывать неблагоприятное воздействие на плод при назначении его беременным (женщины репродуктивного возраста должны избегать зачатия). Если в процессе лечения наступила беременность, препарат должен быть отменен, а женщина предупреждена о возможной опасности для плода. Применение препарата Симгал не рекомендуется у женщин детородного возраста, не использующих контрацептивные средства. У пациентов с пониженной функцией щитовидной железы (гипотиреоз) или при наличии некоторых заболеваний почек (нефротический синдром) при повышении уровня холестерина следует сначала проводить терапию основного заболевания. Препарат Симгал с осторожностью назначают лицам, которые злоупотребляют алкоголем и/или имеют в анамнезе заболевания печени. До начала и во время лечения пациент должен находиться на гипохолестериновой диете. Одновременный прием грейпфрутового сока может усилить степень выраженности побочных явлений, связанных с приемом препарата Симгал, поэтому следует избегать их одновременного приема. Препарат Симгал не показан в тех случаях, когда имеется гипертриглицеридемия I, IV и V типов."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Гиполипидемический препарат, ингибитор ГМГ-КоА-редуктазы, получаемый синтетическим путем из продукта ферментации Aspergillus terreus. Является неактивным лактоном, в организме подвергается гидролизу с образованием гидроксикислотного производного. Активный метаболит ингибирует ГМГ-КоА-редуктазу, фермент, катализирующий начальную реакцию образования мевалоната из ГМГ-КоА. Поскольку превращение ГМГ-КоА в мевалонат представляет собой ранний этап синтеза холестерина (Хс), то применение симвастатина не вызывает накопления в организме потенциально токсичных стеролов. ГМГ-КоА легко метаболизируется до ацетил-КоА, который участвует во многих процессах синтеза в организме. 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