Альфа-токоферола ацетат – это жирорастворимый витамин Е, который является природным антиоксидантом.
Состав, форма выпуска и аналоги
Альфа-токоферола ацетат выпускают в форме капсул и масляного раствора для инъекций, а также раствора для приема внутрь. Активным действующим компонентом в составе всех форм выступает витамин Е (100 мг). Вспомогательным веществом в капсулах Альфа-токоферола ацетата является масло соевых бобов.
В состав оболочек капсул входит также метилпарагидроксибензоат, глицерол и желатин. Раствор препарата для приема внутрь, кроме основного компонента в виде витамина Е, содержит масло подсолнечное рафинированное, иногда дезодорированное.
Капсулы Альфа-токоферола ацетата имеют шарообразную форму и красный цвет. Они заполнены жидкостью светло- или темно-желтого оттенка, не обладают прогорклым запахом. Одна капсула – 0.5 г. Стеклянная банка содержит 15 штук.
Масляный раствор Альфа-токоферола ацетата 5 или 10% для внутримышечных инъекций производится в ампулах по 1 мл. Одна картонная упаковка содержит 10 ампул. Для приема внутрь используется 50% раствор препарата, который представляет собой маслянистую жидкость светло- или темно-желтого оттенка без прогорклого запаха. Она иногда может обладать зеленоватым оттенком.
Среди аналогов Альфа-токоферола ацетата следует выделить следующие препараты:
- Адаптовит;
- Биовиталь Витамин Е;
- Витамин Е;
- Витамин Е Зентива;
- Витрум Витамин Е;
- Сант-Е-гал;
- Эвитол;
- Токоферола ацетат.
Фармакологическое действие Альфа-токоферола ацетата
Витамин Е является природным антиоксидантом и защищает от окислительных процессов клеточные мембраны тканей организма. Он также организует стимуляцию синтеза гемосодержащих ферментов, к которым относятся миоглобин, каталаза, гемоглобин, цитохромы. Витамин Альфа-токоферола ацетат выступает жизненно важной составляющей для правильной работы нервной и мышечной систем. Он играет роль кофактора определенных ферментных систем, поскольку предупреждает окисление ненасыщенных жирных кислот. Это обусловлено свойством витамина в комбинации с селеном тормозить гемолиз эритроцитов.
Важно отметить, что нехватка в организме витамина Альфа-токоферола ацетата сильно влияет на изменения в скелетных мышцах и в структурах тканей, которые нередко способны привести к необратимым последствиям. Его недостаток иногда провоцирует ломкость и повышение проницаемости капилляров, а также поражения клеток печени и нервных тканей.
Альфа-токоферола ацетат восполняет нехватку витамина Е в организме. Он предупреждает нарушение функции яичек, семенных каналов и плаценты, способствует нормализации репродуктивной функции. Препарат улучшает сократительную способность и питание миокарда, а также приводит к снижению потребления кислорода миокардом. Витамин Альфа-токоферола ацетат способствует стимуляции синтеза белков (структурных, ферментных и сократительных белков мышц миокарда) и улучшает тканевое дыхание.
Показания к применению Альфа-токоферола ацетата
Согласно инструкции к Альфа-токоферола ацетату, данный медикамент применяется в первую очередь при дегенеративных изменениях связочного аппарата, мышечной дистрофии и гиповитаминозе. Нередко препарат назначается и после различных заболеваний, протекающих с лихорадочным синдромом. Капсулы Альфа-токоферола ацетата и масляный раствор для инъекций часто применяются для лечения гипофункции половых желез у мужчин, а также при угрожающем аборте, климаксе, дисменорее.
По инструкции к Альфа-токоферола ацетату, его используют также в случаях:
- Неврастении;
- Атеросклероза;
- Ревматоидного артрита;
- Неврастенического и астенического синдромов;
- Переутомления;
- Спазмов периферических сосудов.
Альфа-токоферола ацетат применяется и в педиатрии. Его назначают детям при расстройстве питания и склеродермии (системном заболевании кожи). Кроме того, препарат практикуют в качестве антиоксиданта при лечении сердечно-сосудистых и глазных болезней.
Противопоказания
Согласно инструкции к Альфа-токоферола ацетату, данный медикамент противопоказан при повышенной чувствительности к его компонентам, инфаркте миокарда и кардиосклерозе.
Способ применения Альфа-токоферола ацетата
Суточная доза препарата при заболеваниях нервной и мышечной систем составляет 50-100 мг. При заболеваниях периферических сосудов и атеросклерозе – 100 мг, нарушениях потенции – 100-300 мг.
При угрозе выкидыша назначается по 100-150 мг ежедневно в течение месяца. В первом триместре беременности – 100-150 мг в случаях ухудшения состояния эмбриона.
Побочные действия
Альфа-токоферола ацетат в редких случаях может вызывать аллергические реакции в виде сыпи, зуда и гиперемии кожи. Если курс лечения рассчитан на долгое время, возможны следующие побочные эффекты:
- Слабость организма;
- Диарея;
- Повышенная утомляемость;
- Запоры;
- Головные боли;
- Тошнота;
- Нарушение функции половых желез.
А в случаях злоупотребления дозами могут наблюдаться такие сопутствующие проявления как нарушение зрения, болевые ощущения в области головы и головокружения, а также боли в эпигастрии и расстройства желудка.
Лекарственное взаимодействие Альфа-токоферола ацетата
Нельзя применять Альфа-токоферола ацетат внутрь с антикоагулянтами непрямого действия, а также с препаратами серебра и железа. Препарат способен повысить эффективность противосудорожных средств у пациентов, страдающих эпилепсией, и действие нестероидных противовоспалительных средств.
Прием медикамента снижает токсическое действие сердечных гликозидов. Он способствует усвоению ретинола, но оказывает антагонистическое действие к витамину К.
Условия хранения
Альфа-токоферола ацетат необходимо хранить в сухом месте при температуре 15-25°C. Срок годности составляет 2 года.
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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.
Показания к применению
Гиповитаминоз Е и повышенная потребность организма в витамине Е (в т.ч. у новорожденных, недоношенных или с низкой массой тела, у детей младшего возраста при недостаточном поступлении витамина Е с пищей, при периферической невропатии, некротизирующей миопатии, абеталипопротеинемии, гастрэктомии, хроническом холестазе, циррозе печени, атрезии желчных путей, обструктивной желтухе, целиакии, тропической спру, болезни Крона, мальабсорбции, при парентеральном питании, беременности (особенно при многоплодной беременности), никотиновой зависимости, наркомании, в период лактации, при приеме колестирамина, колестипола, минеральных масел и железосодержащих продуктов, при назначении диеты с повышенным содержанием полиненасыщенных жирных кислот).
Новорожденным с низкой массой тела: для профилактики развития гемолитической анемии, бронхопульмональной дисплазии, осложнений ретролентальной фиброплазии.
Возможные аналоги (заменители)
Действующее вещество, группа
Лекарственная форма
капсулы, пастилки жевательные, раствор для внутримышечного введения [масляный], раствор для внутримышечного введения [масляный-оливковое масло], раствор для внутримышечного введения [масляный-персиковое масло], раствор для приема внутрь [масляный]
Мы часто задаемся вопросом: «Можно ли открыть капсулу с лекарственным препаратом?». Причины могут быть разные – нежелание или невозможность проглотить капсулу, необходимость уменьшить дозировку, смешать с детским питанием для ребенка и т.п. Читать далее.
Противопоказания
Гиперчувствительность к препарату. C осторожностью. Гипопротромбинемия (на фоне дефицита витамина K — может усиливаться при дозе препарата более 400 МЕ).
Как применять: дозировка и курс лечения
Согласно нормам среднего суточного потребления витаминов, утвержденным МЗ РФ в 1991 г., потребность в препарате для детей 1-6 лет — 5-7 мг, 7-17 лет — 10-15 мг, мужчин и женщин — 10 мг, для беременных и кормящих матерей — 10-14 мг.
Внутрь или в/м. Профилактика гиповитаминоза Е: взрослым мужчинам — 10 мг/сут, женщинам — 8 мг/сут, беременным — 10 мг/сут, кормящим матерям — 11-12 мг/сут; детям до 3 лет — 3-6 мг/сут, 4-10 лет — 7 мг/сут.
Длительность лечения гиповитаминоза Е индивидуальна и зависит от тяжести состояния.
Парентерально (подогрев до 37 град.С) вводят в тех же дозах, что и назначают внутрь ежедневно или через день.
Фармакологическое действие
Жирорастворимый витамин, функция которого до конца остается невыясненной. Как антиоксидант, тормозит развитие свободнорадикальных реакций, предупреждает образование перекисей, повреждающих клеточные и субклеточные мембраны, что имеет важное значение для развития организма, нормальной функции нервной и мышечной систем. Совместно с селеном тормозит окисление ненасыщенных жирных кислот (компонент микросомальной системы переноса электронов), предупреждает гемолиз эритроцитов. Является кофактором некоторых ферментных систем.
Побочные действия
Аллергические реакции на компоненты препарата; при в/м введении — болезненность, инфильтрат, кальцификация мягких тканей.
Передозировка. Симптомы: при приеме в течение длительного периода в дозах 400-800 ЕД/сут (1 мг=1.21 МЕ) — нечеткость зрительного восприятия, головокружение, головная боль, тошнота, необычайная усталость, диарея, гастралгия, астения; при приеме более 800 ЕД/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, гепатомегалия, гипербилирубинемия, почечная недостаточность, кровоизлияние в сетчатую оболочку глаза, геморрагический инсульт, асцит.
Лечение — симптоматическое, отмена препарата, назначение ГКС.
Особые указания
1 кап 5-10-30% раствора препарата из глазной пипетки содержит около 1, 2 и 6.5 мг препарата соответственно.
Токоферолы содержатся в зеленых частях растений, особенно в молодых ростках злаков; большие количества токоферолов обнаружены в растительных маслах (подсолнечном, хлопковом, кукурузном, арахисовом, соевом, облепиховом). Некоторое количество их содержится в мясе, жире, яйцах, молоке.
Следует иметь в виду, что у новорожденных с низкой массой тела возможно возникновение гиповитаминоза Е в связи с низкой проницаемостью плаценты (в крови плода содержится лишь 20-30% витамина Е от его концентрации в крови матери).
Диета с повышенным содержанием селена и серосодержащих аминокислот снижает потребность в витамине Е.
При рутинном назначении витамина Е новорожденным следует сопоставлять пользу с потенциальным риском возникновения некротического энтероколита.
В настоящее время эффективность применения витамина Е считается необоснованной при лечении и профилактике следующих заболеваний: бета-талассемии, онкологических заболеваний, фиброзо-кистозной дисплазии молочной железы, воспалительных заболеваний кожи, выпадения волос, привычного выкидыша, заболеваний сердца, "перемежающейся" хромоты, постменопаузного синдрома, бесплодия, пептической язвы, серповидно-клеточной анемии, ожогов, порфирии, нарушений нервомышечной проводимости, тромбофлебитов, импотенции, укусов пчел, старческого лентиго, бурсита, пеленочного дерматита, легочной интоксикации при загрязнении атмосферы, атеросклероза, старения. Недоказанной считают применение витамина Е для повышения сексуальной активности.
Взаимодействие
Усиливает эффект ГКС, НПВП, антиоксидантов.
Увеличивает эффективность и уменьшает токсичность витаминов А, D, сердечных гликозидов.
Назначение витамина Е в высоких дозах может вызвать дефицит витамина А в организме.
Повышает эффективность противоэпилептических ЛС у больных эпилепсией (у которых повышено содержание в крови продуктов перекисного окисления липидов).
Одновременное применение препарата в дозе более 400 ЕД/сут с антикоагулянтами (производными кумарина и индандиона) повышает риск развития гипопротромбинемии и кровотечений.
Колестирамин, колестипол, минеральные масла снижают всасывание.
Высокие дозы Fe усиливают окислительные процессы в организме, что повышает потребность в витамине Е.
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