зрения, тошнота) следует немедленно прекратить введение препарата.
Описано несколько случаев развития у пациентов с сахарным диабетом на фоне
приема тиоктовой кислоты аутоиммунного инсулинового синдрома, который
характеризовался частыми гипогликемиями в условиях наличия аутоантител
к инсулину. Возможность появления аутоиммунного инсулинового синдрома
определяется наличием у пациентов гаплотипов HLA-DRB1*0406 и HLA-DRB1*0403.
Во время лечения необходимо строго воздерживаться от употребления алкоголя, так
как терапевтический эффект тиоктовой (альфа-липоевой) кислоты ослабляется при
возде йствии алкоголя, а также является фактором риска развития и прогрессирования
нейропатии.
При появлении симптомов повышенной чувствительности следует немедленно
прекратить введение препарата.
Препарат является светочувствительным, поэтому ампулы следует доставать из
у паковки только непосредственно перед использованием.
Влияние на способность управлять автомобилем и движущимися механизмами
Влияние на способность управлять транспортными средствами и другими
механизмами специально не изучалось. Рекомендуется соблюдать осторожность
при управлении транспортными средствами и другими механизмами и з анятиях
другими потенциально опасными видами деятельности, требующими повышенной
концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Концентрат для приготовления раствора для инфузий, 25 мг/мл.
По 12 мл или 24 мл в ампулы темного стекла. По 5 ампул по 12 мл или 24 мл в
пластиковый поддон. 2 пластиковых поддона с 5 ампулами по 12 мл или 1 пластиковый
поддон с 5 ампулами по 24 мл вместе с инструкцией по применению помещают в пачку
картонную.
Условия хранения
Хранить при температуре не выше 25 °С в защищенном от света месте.
Хранить в недоступном для детей месте!
Срок годности
3 года.
Срок годности приготовленного для применения раствора после разведения в
изотоническом растворе натрия хлорида составляет максимум 6 часов при хранении
его в защищенном от света месте.
Не применять по истечении срока годности!
Условия отпуска
По рецепту.
Производитель
Зигфрид Хамельн ГмбХ,
Лангес Фельд 13, 31789 Хамельн, Германия.
Организация, принимающая претензии потребителей
115114, г. Москва, ул. Летниковская, д. 16, оф. 306
тел.: +7(499) 579-33-70,
факс: +7(499) 579-33-71
e-mail: info@esparma-gmbh.ru
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
Начните сравнивать цены и заказывать лекарства прямо в приложении
Наведите камеру на QR-код, чтобы скачать
Информация предоставляется в справочных целях. Не занимайтесь самолечением. При первых признаках заболевания обратитесь к врачу.
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свойства","slug":"","body":[{"type":"paragraph","data":{"text":"Тиоктовая (альфа-липоевая) кислота - эндогенный антиоксидант (связывает свободные"}},{"type":"paragraph","data":{"text":"радикалы), в организме образуется при окислительном декарбоксилировании"}},{"type":"paragraph","data":{"text":"альфа-кетокислот. В качестве кофермента митохондриальных мультиферментных"}},{"type":"paragraph","data":{"text":"комплексов участвует в окислительном декарбоксилировании пировиноградной"}},{"type":"paragraph","data":{"text":"кислоты и альфа-кетокислот. Способствует снижению концентрации глюкозы в крови"}},{"type":"paragraph","data":{"text":"и увеличению гликогена в печени, а также преодолению инсулинорезистентности."}},{"type":"paragraph","data":{"text":"По характеру биохимического действия близка к витаминам группы В. Участвует в"}},{"type":"paragraph","data":{"text":"регулировании липидного и углеводного обмена, стимулирует обмен холестерина,"}},{"type":"paragraph","data":{"text":"улучшает функцию печени. Оказывает гепатопротекторное, гиполипидемическое,"}},{"type":"paragraph","data":{"text":"гипохолестеринемическое, гипогликемическое действие. Улучшает трофику нейронов."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"Абсорбция и распределение. При внутривенном введении время достижения"}},{"type":"paragraph","data":{"text":"максимальной концентрации - 10-11 мин, максимальная концентрация - 25-38 мкг/мл,"}},{"type":"paragraph","data":{"text":"площадь под кривой «концентрация-время» - около 5 мкг/ч/мл."}},{"type":"paragraph","data":{"text":"Тиоктовая (альфа-липоевая) кислота обладает эффектом «первого прохождения»"}},{"type":"paragraph","data":{"text":"через печень. Биодоступность – 30 %. Объем распределения - около 450 мл/кг."}},{"type":"paragraph","data":{"text":"Метаболизм и выведение. Образование метаболитов происходит в результате"}},{"type":"paragraph","data":{"text":"окисления боковой цепи и конъюгирования. Тиоктовая (альфа-липоевая) кислота и ее"}},{"type":"paragraph","data":{"text":"метаболиты выводятся почками (80-90 %). Период полувыведения - 20-50 мин. Общий"}},{"type":"paragraph","data":{"text":"плазменный клиренс - 10-15 мл/мин."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"- диабетическая полинейропатия;"}},{"type":"paragraph","data":{"text":"- алкогольная полинейропатия."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- повышенная чувствительность к компонентам препарата;"}},{"type":"paragraph","data":{"text":"- детский возраст до 18 лет (эффективность и безопасность применения препарата не"}},{"type":"paragraph","data":{"text":"установлены);"}},{"type":"paragraph","data":{"text":"- беременность, период грудного вскармливания (отсутствует достаточный опыт"}},{"type":"paragraph","data":{"text":"применения препарата)."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Внутривенное введение препарата следует проводить с осторожностью у пациентов"}},{"type":"paragraph","data":{"text":"пожилого возраста (старше 75 лет)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Ввиду отсутствия достаточного клинического опыта применения тиоктовой кислоты"}},{"type":"paragraph","data":{"text":"при беременности и в период грудного вскармливания, применение препарата у"}},{"type":"paragraph","data":{"text":"соответствующей категории пациенток противопоказано."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат предназначен для приготовления раствора для инфузий после"}},{"type":"paragraph","data":{"text":"предварительного разведения в изотоническом растворе хлорида натрия."}},{"type":"paragraph","data":{"text":"Тяжелые формы диабетической или алкогольной полинейропатии"}},{"type":"paragraph","data":{"text":"Один раз в сутки в виде внутривенных капельных инфузий 24 мл раствора в 250 мл"}},{"type":"paragraph","data":{"text":"изотонического раствора хлорида натрия (что соответствует 600 мг альфа-липоевой"}},{"type":"paragraph","data":{"text":"кислоты в сутки). Препарат рекомендуется применять в течение 2-4 недель. Растворы"}},{"type":"paragraph","data":{"text":"для инфузий следует вводить в течение 50 минут."}},{"type":"paragraph","data":{"text":"Приготовленные растворы необходимо хранить в защищенном от света месте и"}},{"type":"paragraph","data":{"text":"использов ать максимально в течение 6 часов после приготовления."}},{"type":"paragraph","data":{"text":"Далее следует перейти на поддерживающую терапию в форме таблеток в дозе 600 мг"}},{"type":"paragraph","data":{"text":"в сутки. Минимальный срок лечения таблетками - 3 месяца."}},{"type":"paragraph","data":{"text":"В некоторых случаях прием препарата предполагает более длительное применение,"}},{"type":"paragraph","data":{"text":"сроки которого определяются лечащим врачом."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"По данным Всемирной организации здравоохранения (ВОЗ) нежелательные эффекты"}},{"type":"paragraph","data":{"text":"классифицированы в соответствии с их частотой развития следующим образом: очень"}},{"type":"paragraph","data":{"text":"часто (≥ 1/10), часто (≥ 1/100, ˂1/10), нечасто (≥ 1/1000, ˂1/100), редко (≥ 1/10000,"}},{"type":"paragraph","data":{"text":"˂1/1000) и очень редко (˂ 1/10000); частота неизвестна (частоту возникновения явлений"}},{"type":"paragraph","data":{"text":"нельзя определить на основании имеющихся данных)."}},{"type":"paragraph","data":{"text":"Со стороны крови и лимфатической системы:"}},{"type":"paragraph","data":{"text":"очень редко: петехиальные кровоизлияния в слизистые оболочки, кожу;"}},{"type":"paragraph","data":{"text":"тромбоцитопатия, геморрагическая сыпь (пурпура), тромбофлебит, гипокоагуляция."}},{"type":"paragraph","data":{"text":"Со стороны иммунной системы:"}},{"type":"paragraph","data":{"text":"очень редко: крапивница, кожная сыпь, зуд, экзема, системные аллергические реакции"}},{"type":"paragraph","data":{"text":"(вплоть до развития анафилактического шока)."}},{"type":"paragraph","data":{"text":"Со стороны обмена веществ и питания:"}},{"type":"paragraph","data":{"text":"очень редко: гипогликемия (в связи с улучшением утилизации глюкозы, симптомы"}},{"type":"paragraph","data":{"text":"которой включают головокружение, повышенное потоотделение, головную боль,"}},{"type":"paragraph","data":{"text":"нарушение зрения); развитие у пациентов с сахарным диабетом аутоиммунного"}},{"type":"paragraph","data":{"text":"инсулинового синдрома, который характеризуется частыми гипогликемиями в условиях"}},{"type":"paragraph","data":{"text":"наличия аутоантител к инсулину."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы"}},{"type":"paragraph","data":{"text":"очень редко: изменение или нарушение вкусовых ощущений, судороги, «приливы»."}},{"type":"paragraph","data":{"text":"Со стороны органа зрения:"}},{"type":"paragraph","data":{"text":"очень редко: диплопия, нечеткость зрения."}},{"type":"paragraph","data":{"text":"Со стороны сердца:"}},{"type":"paragraph","data":{"text":"частота неизвестна: при быстром введении препарата возможны боль в области"}},{"type":"paragraph","data":{"text":"сердца, тахикардия."}},{"type":"paragraph","data":{"text":"Со стороны желудо чно-кишечного тракта:"}},{"type":"paragraph","data":{"text":"часто: тошнота, рвота;"}},{"type":"paragraph","data":{"text":"очень редко: боль в животе, диарея."}},{"type":"paragraph","data":{"text":"Со стороны печени и желчевыводящих путей:"}},{"type":"paragraph","data":{"text":"очень редко: повышение активности «печеночных» ферментов."}},{"type":"paragraph","data":{"text":"Общие расстройства и нарушения в месте введения:"}},{"type":"paragraph","data":{"text":"очень редко: слабость, чувство жжения в месте введения, раздражение, гиперемия,"}},{"type":"paragraph","data":{"text":"припухлость."}},{"type":"paragraph","data":{"text":"Прочие:"}},{"type":"paragraph","data":{"text":"очень редко: при быстром введении возможно самопроизвольно проходящее"}},{"type":"paragraph","data":{"text":"повышение внутричерепного давления (возникновение чувства тяжести в голове),"}},{"type":"paragraph","data":{"text":"затруднение дыхания."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: головная боль, тошнота, рвота."}},{"type":"paragraph","data":{"text":"В тяжелых случаях (при приеме тиоктовой кислоты в дозе 10-40 г): психомоторное"}},{"type":"paragraph","data":{"text":"возбуждение или помутнение сознания, генерализованные судороги, выраженные"}},{"type":"paragraph","data":{"text":"нарушения кислотно-щелочного баланса, лактоацидоз, гипогликемия (вплоть до"}},{"type":"paragraph","data":{"text":"развития комы), острый некроз скелетных мышц, синдром диссеминированного"}},{"type":"paragraph","data":{"text":"внутрисосудистого свертывания (ДВС-синдром), гемолиз, подавление деятельности"}},{"type":"paragraph","data":{"text":"костного мозга, полиорганна я недостаточность."}},{"type":"paragraph","data":{"text":"Лечение: при подозрении на существенную передозировку тиоктовой кислотой"}},{"type":"paragraph","data":{"text":"рекомендуется экстренная госпитализация и немедленное применение мер в"}},{"type":"paragraph","data":{"text":"соответствии с общими принципами, принятыми при случайном отравлении. Терапия"}},{"type":"paragraph","data":{"text":"симптоматическая. Лечение генерализированных судорог, лактоацидоза и других"}},{"type":"paragraph","data":{"text":"угрожающих жизни последствий должно проводиться в соответствии с принципами"}},{"type":"paragraph","data":{"text":"современной интенсивной терапии. Специфического антидота нет. Гемодиализ, методы"}},{"type":"paragraph","data":{"text":"гемоперфузии или гемофильтрации в рамках форсированного выведения тиоктовой"}},{"type":"paragraph","data":{"text":"кислоты не эффективны."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Тиоктовая кислота связывает металлы, по этому ее не следует назначать одновременно"}},{"type":"paragraph","data":{"text":"с препаратами, содержащими металлы."}},{"type":"paragraph","data":{"text":"При одновременном применении с инсулином и пероральными гипогликемическими"}},{"type":"paragraph","data":{"text":"средствами наблюдается усиление гипогликемического эффекта."}},{"type":"paragraph","data":{"text":"Тиоктовая (альфа-липоевая) кислота образует с молекулами сахара (например,"}},{"type":"paragraph","data":{"text":"раствор левулозы) трудно растворимые комплексные соединения, следовательно,"}},{"type":"paragraph","data":{"text":"несовместима с раствором глюкозы, фруктозы и декстрозы, раствором Рингера, а"}},{"type":"paragraph","data":{"text":"также с соединениями, взаимодействующими с дисульфидными и SH-группами."}},{"type":"paragraph","data":{"text":"Тиоктовая (альфа-липоевая) кислота (в виде раствора для инфузий) приводит к"}},{"type":"paragraph","data":{"text":"снижению эффективности цисплатина."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"У пациентов с сахарным диабетом, особенно в начале лечения, необходим постоянный"}},{"type":"paragraph","data":{"text":"контроль концентрации глюкозы в плазме крови. В отдельных случаях требуется"}},{"type":"paragraph","data":{"text":"снижение дозы гипогликемических средств. При развитии гипогликемии и при ее"}},{"type":"paragraph","data":{"text":"симптомах (головокружение, повышенное потоотделение, головная боль, расстройство"}},{"type":"paragraph","data":{"text":"зрения, тошнота) следует немедленно прекратить введение препарата."}},{"type":"paragraph","data":{"text":"Описано несколько случаев развития у пациентов с сахарным диабетом на фоне"}},{"type":"paragraph","data":{"text":"приема тиоктовой кислоты аутоиммунного инсулинового синдрома, который"}},{"type":"paragraph","data":{"text":"характеризовался частыми гипогликемиями в условиях наличия аутоантител"}},{"type":"paragraph","data":{"text":"к инсулину. Возможность появления аутоиммунного инсулинового синдрома"}},{"type":"paragraph","data":{"text":"определяется наличием у пациентов гаплотипов HLA-DRB1*0406 и HLA-DRB1*0403."}},{"type":"paragraph","data":{"text":"Во время лечения необходимо строго воздерживаться от употребления алкоголя, так"}},{"type":"paragraph","data":{"text":"как терапевтический эффект тиоктовой (альфа-липоевой) кислоты ослабляется при"}},{"type":"paragraph","data":{"text":"возде йствии алкоголя, а также является фактором риска развития и прогрессирования"}},{"type":"paragraph","data":{"text":"нейропатии."}},{"type":"paragraph","data":{"text":"При появлении симптомов повышенной чувствительности следует немедленно"}},{"type":"paragraph","data":{"text":"прекратить введение препарата."}},{"type":"paragraph","data":{"text":"Препарат является светочувствительным, поэтому ампулы следует доставать из"}},{"type":"paragraph","data":{"text":"у паковки только непосредственно перед использованием."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Влияние на способность управлять транспортными средствами и другими"}},{"type":"paragraph","data":{"text":"механизмами специально не изучалось. 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