ИНСТРУКЦИЯ
по медицинскому применению препарата
Регистрационный номер:
Торговое название: Альфа-Токоферола ацетат (витамин Е)
МНН или группировочное название: витамин Е
Лекарственная форма:
Состав:
Описание
Капсулы шарообразной формы красного цвета, заполнены маслянистой жидкостью от светло-желтого до темно-желтого цвета, без прогорклого запаха.
Фармакотерапевтическая группа:
Код АТХ: А11НА03.
Фармакологическое действие
Витамин Е является антиоксидантом. Предохраняет клеточные мембраны тканей организма от окислительных изменений; стимулирует синтез гема и гемсодержащих ферментов — гемоглобина, миоглобина, цитохромов, каталазы, пероксидазы. Тормозит окисление ненасыщенных жирных кислот и селена. Ингибирует синтез холестерина. Предупреждает гемолиз эритроцитов, повышение проницаемости и ломкость капилляров, нарушение функции семенных канальцев и тестикул, плаценты, нормализует репродуктивную функцию.
Фармакокинетика
Абсорбция из 12-перстной кишки (требует присутствия солей желчных кислот, жиров, нормальной функции поджелудочной железы) — 50 — 80 %. Связывается с бета-липопротеинами крови. При нарушении обмена белков транспорт затрудняется. ТСmах -4 ч. Депонируется во всех органах и тканях, особенно в жировой ткани. Проникает через плаценту в недостаточных количествах: в кровь плода проникает 20-30 % от концентрации в крови матери. Проникает в грудное молоко. Метаболизируется в печени до производных, имеющих хиноновую структуру (некоторые из них обладают витаминной активностью). Выводится с желчью — более 90 % (некоторое количество вновь всасывается и подвергается энтерогепатической циркуляции), почками — 6 % (в виде глюкуронидов токоферониевой кислоты и ее гамма — лактона).
Показания к применению
Гиповитаминоз Е.
В комплексной терапии: мышечных дистрофий; дерматомиозита; атеросклероза, миокардиодистрофий; нарушений менструального цикла; угрозы прерывания беременности, нарушений функции половых желез у мужчин; дерматозов, псориаза.
Противопоказания
Повышенная индивидуальная чувствительность к компонентам препарата, острый инфаркт миокарда, детский возраст.
С осторожностью: гипопротромбинемия, тяжелый кардиосклероз, перенесенный инфаркт миокарда, повышенный риск тромбоэмболии.
Период беременности и грудного вскармливания
Препарат в данной дозировке не рекомендован к применению при нормальном течении беременности. Для беременных и кормящих матерей рекомендована доза витамина Е -10-14 мг.
Способ применения и дозы
Внутрь по 100-300 мг/сут, при необходимости до 1 г/сут.
При заболеваниях нервно-мышечной системы — по 100 мг в сутки в течение 1-2 месяцев. Повторные курсы через 2-3 месяца.
При нарушениях сперматогенеза и потенции — по 100 — 300 мг в сутки в сочетании с гормональной терапией в течение месяца.
При угрожающем аборте — по 100 мг в сутки в течение 7-14 дней, при привычном аборте и ухудшении внутриутробного развития плода — по 100 мг в сутки первые 2-3 месяца беременности ежедневно или через день.
При заболеваниях периферических сосудов, миокардиодистрофии, атеросклерозе -по 100 мг в сутки (с витамином А) в течение 20 — 40 дней, через 3-6 месяцев курс лечения можно повторить.
В дерматологии — по 100 мг в сутки в течение 20 — 40 дней.
Побочное действие
Возможны аллергические реакции, диспепсия.
Передозировка
Симптомы: при приеме витамина Е в течение длительного периода в дозах 400-800 мг/сут: — нечеткость зрительного восприятия, головокружение, головная боль, тошнота, повышенная утомляемость, диарея, гастралгия, астения.
При приеме более 800 мг/сут в течение длительного периода — увеличение риска развития кровотечений у больных с гиповитаминозом К, нарушение метаболизма тиреоидных гормонов, расстройства сексуальной функции, тромбофлебит, тромбоэмболия, некротический колит, сепсис, гипербилирубинемия, почечная недостаточность, кровоизлияние в сетчатую оболочку глаза, геморрагический инсульт, асцит.
Лечение: симптоматическое. Отмена препарата, назначение глюкокортикостероидных препаратов.
Взаимодействие с другими лекарственными средствами
Витамин Е усиливает эффект глюкокортикостероидных препаратов, нестероидных противовоспалительных препаратов, сердечных гликозидов.
Уменьшает эффективность и токсичность витаминов А и Д. Повышает эффективность противоэпилептических средств у больных эпилепсией.
Не рекомендуется одновременный прием других поливитаминных комплексов, содержащих витамин Е, во избежание передозировки.
Одновременный прием больших доз витамина Е с железом, витамином К или антикоагулянтами (средствами, которые предотвращают свертывание крови), увеличивает время свертывания крови.
Особые указания
Не превышать рекомендованную дозировку. Не следует принимать удвоенную дозу, если пропустили предыдущий прием препарата.
Форма выпуска
Капсулы 100 мг.
По 10 капсул в контурную ячейковую упаковку из пленки поливинилхлоридной и бумаги с полимерным покрытием или фольги алюминиевой печатной лакированной.
По 2, 3, 4 контурные ячейковые упаковки вместе с инструкцией по применению помещают в пачку из картона хром-эрзац или картона коробочного.
По 1, 2, 3, 5, 10, 20, 50 контурных ячейковых упаковок вместе с равным количеством инструкций по применению помещают в полиэтиленовый герметично запаянный пакет из светонепроницаемой полиэтиленовой пленки, или из материала комбинированного на бумажной и картонной основе, или из материала комбинированного «Буфлен», или из двухслойного комбинированного материала.
50, 100, 200, 400, 600 контурных ячейковых упаковок вместе с равным количеством инструкций по применению помещают в полиэтиленовый герметично запаянный пакет из светонепроницаемой полиэтиленовой пленки.
Полиэтиленовые упаковки помещают в коробку картонную.
Для стационаров 50, 100, 200, 400, 600 контурных ячейковых упаковок вместе с инструкцией по применению помещают в коробку картонную.
Срок годности
2 года. Не применять по истечении срока годности.
Условия хранения
Хранить в сухом защищенном от света месте при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Условия отпуска из аптек
Без рецепта.
Производитель
ООО «Люми», РФ, 191023, г. Санкт-Петербург, Апраксин двор, корпус 42.
Адрес производства и принятия претензий
РФ, 620100, г. Екатеринбург, Сибирский тракт, 49.
Токоферол (витамин E) — жирорастворимое вещество, являющееся мощным антиоксидантом. Оно необходимо человеку для нормального протекания обмена веществ, замедления старения организма и поддержания репродуктивной функции. Токоферола ацетат — соединение, обладающее витаминными свойствами. Данным витамином богаты подсолнечное, оливковое и соевое масла, зерна пшеницы, кукуруза, соя, бобовые, морепродукты, овсяная и гречневая крупы, рыба (судак, скумбрия), яйца, цитрусовые, яблоки, печень и другие продукты.
Форма выпуска состав и упаковка
Препарат используется в виде капсул и раствора для инъекций.
Капсулы
Витами выпускается в виде капсул по 100 или 200 мг. Количество их в упаковке может быть 30 или 60. Снаружи они покрыты желатиновой оболочкой, которая содержит масло и токоферол. Капсулы помещены в контурные оболочки с ячейками и пачки картонные.
Капли
Токоферол продается в виде раствора для внутримышечного введения во флаконах по 10, 20 и 50 мл. Концентрация составляет 10 или 30%.
Фармакологическое действие
Данный витамин следующим образом влияет на человека:
- Оказывает антиоксидантное действие, замедляя реакции перекисного окисления. Он препятствует контакту ненасыщенных жиров мембраны с кислородом.
- Является строительным компонентом клеточных мембран.
- Участвует в образовании фермента глутатионпероксидазы.
- Стабилизирует митохондрии клеток, препятствуя тем самым гипоксии тканей.
- Участвует в образовании креатинфосфата и АТФ.
- Регулирует синтез убихинона.
- Оказывает нейропротекторное действие.
- Уменьшает риск развития злокачественной патологии (рака).
- Снижает уровень холестерина в крови (окисленные формы токоферола).
- Является иммуномодулятором.
- Регулирует образование нуклеиновых кислот.
- Подавляет процесс свертывания крови. Это снижает риск образования тромбов и нарушения кровообращения.
- Снижает риск развития атеросклероза. Достигается это за счет укрепления сосудов и улучшения состояния эндотелия (внутреннего слоя).
- Предупреждает легочные заболевания при вдыхании загрязненного воздуха (в комбинации с витамином A).
- Ускоряет заживление тканей при ранах и ожогах.
- Способен избавить от судорог.
- Улучшает работу мышц.
- Нормализует выработку гормонов и улучшает состояние репродуктивных органов.
- Способствует формированию плаценты во время зачатия ребенка.
- Устраняет фиброзные изменения молочных желез.
- Улучшает потенцию у мужчин и состояние семенной жидкости.
- Уменьшает предменструальные симптомы.
- Способствует снижению артериального давления за счет расширения сосудов. Это важно для людей с гипертензией.
- Благоприятно влияет на орган зрения, снижая риск катаракты (помутнения хрусталика).
- Улучшает работу нервной системы.
Форма выпуска, состав и упаковка
Раствор масляный оральный 5% от светло-желтого до темно-желтого цвета, прозрачный, без прогорклого запаха; допускается зеленоватый оттенок.
| 1 мл | |
| D,L-α-токоферола ацетат (вит. E) | 50 мг |
Вспомогательные вещества: масло подсолнечное рафинированное или масло подсолнечное рафинированное дезодорированное марки "П" вымороженное.
20 мл — флаконы (1) — упаковки.
р-р масляный оральный 10%: фл. 20 мл
Рег. №: 6334/03/08 от 28.06.2008 — Аннулированное
Раствор масляный оральный 10% от светло-желтого до темно-желтого цвета, прозрачный, без прогорклого запаха; допускается зеленоватый оттенок.
| 1 мл | |
| D,L-α-токоферола ацетат (вит. E) | 100 мг |
Вспомогательные вещества: масло подсолнечное рафинированное или масло подсолнечное рафинированное дезодорированное марки "П" вымороженное.
20 мл — флаконы (1) — упаковки.
р-р масляный оральный 30%: фл. 20 мл
Рег. №: 6334/03/08 от 28.06.2008 — Аннулированное
Раствор масляный оральный 30% от светло-желтого до темно-желтого цвета, прозрачный, без прогорклого запаха; допускается зеленоватый оттенок.
| 1 мл | |
| D,L-α-токоферола ацетат (вит. E) | 300 мг |
Вспомогательные вещества: масло подсолнечное рафинированное или масло подсолнечное рафинированное дезодорированное марки "П" вымороженное.
20 мл — флаконы (1) — упаковки.
Фармакологическое действие
Фармакокинетика
Показания к применению
Режим дозирования
Альфа-Токоферола ацетат (Витамин Е) назначают внутрь.
Внутрь препарат применяют в форме 5%, 10% и 30% масляных растворов. В 1 мл раствора содержится соответственно 0.05 г, 0.1 г и 0.3 г альфа-Токоферола ацетата (1 мл раствора содержит 30 капель из глазной пипетки). Дневная суточная потребность — 0.01 г в сутки.
Для профилактики гипоавитаминоза Е у взрослых принимают до 0.01 г (6 капель 5% раствора) в сутки. Для лечения гипоавитаминоза Е принимают от 0.01 г до 0,04 г (3-12 капель 10% раствора) в сутки.
При мышечных дистрофиях, амиотрофическом боковом склерозе, других заболеваниях нервно-мышечной системы суточная доза равна 0.05-0.1 г (15-30 капель 10% раствора). Принимают в течение 30-60 дней с повторением курсов через 2-3 месяца. При нарушении сперматогенеза и потенции у мужчин суточная доза составляет 0.1-0.3 г (1030 капель 30% раствора). В сочетании с гормональной терапией назначают в течение 30 дней.
При угрозе прерывания беременности альфа-Токоферола ацетат (Витамин Е) принимают при суточной дозе 0.1-0.15 г (10-15 капель 30% раствора) в течение 7-14 дней. При аборте и ухудшении внутриутробного развития плода назначают 0.1-0.15 г (10-15 капель 30% раствора) в сутки ежедневно или через день первые 2-3 месяца беременности. При атеросклерозе, миокардиодистрофии, заболеваниях периферических сосудов в сутки вводят совместно с витамином А по 0.1 г (30 капель 10% раствора или 10 капель 30% раствора) препарата. Курс лечения — 20-40 дней с возможным повторением лечения через 3-6 месяцев.
При комплексной терапии сердечнососудистых заболеваний, глазных и других болезней альфа-Токоферола ацетат (Витамин Е) назначают в дозе 0.05-0.1 г (15-30 капель 10% раствора) 1-2 раза в сутки. Курс лечения — 1-3 недели.
При дерматологических болезнях суточная доза препарата равна 0.05-0.1 г (15-30 капель 10% раствора). Курс лечения составляет 20-40 дней.
При гипотрофии и снижении резистентности капилляров у грудных детей применяют в суточной дозе 0.005-0.01 г (3-6 капель 5% раствора).
С профилактической целью препарат применяют по 0.01 г (6 капель 5% раствора) 1 раз в сутки в течение 1-3 нед., детям менее 0.01 г в сутки.
Предпочтительнее применять препарат во время еды.
Побочные действия
В единичных случаях могут наблюдаться аллергические реакции (зуд, гиперемия кожи и сыпь). При длительном лечении в редких случаях возможны тошнота, запор, диарея, головная боль, повышенная утомляемость, слабость, нарушение функции половых желез, тромбофлебиты, гиперхолестеринемия.
При применении значительных доз возможны незначительное временное расстройство желудка, боли в эпигастрии, головная боль, головокружение и нарушение зрения. Прием больших доз может усугубить нарушения свертываемости крови, вызванные недостатком в организме витамина К, нарушение функции щитовидной железы. При выраженном побочном эффекте препарат отменяют.
Противопоказания к применению
Особые указания
Влияние на способность управлять транспортными средствами или работать со сложными механизмами
Нет сведений о влиянии препарата на способность управлять транспортными средствами или работать со сложными механизмами.
Передозировка
Лекарственное взаимодействие
Альфа-Токоферола ацетат (Витамин Е) нельзя применять внутрь совместно с препаратами железа, серебра, щелочнореагирующими средствами, антикоагулянтами непрямого действия. Витамин Е облегчает всасывание и усвоение ретинола, предотвращая развитие авитаминоза А. Витамин Е и его метаболиты оказывают антагонистическое действие по отношению к витамину К. Витамин Е усиливает действие стероидных и нестероидных противовоспалительных препаратов (натрия диклофенака, ибупрофена, преднизолона); снижает токсическое действие сердечных гликозидов (дигитоксин, дигоксин), витаминов А и D.
Витамин Е может повышать эффективность противосудорожных средств у больных с эпилепсией, в крови которых повышена концентрация продуктов перекисного окисления липидов.
Условия отпуска из аптек
Условия хранения препарата
Хранить в защищенном от света месте, при температуре от 15 °С до 25 °С.
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