Бетасерк лонг Таблетки, 28 шт, 48 мг, для взрослых, покрытые оболочкой

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Также показано, что бетагистин усиливает кровоток головного мозга у человека."}},{"type":"paragraph","data":{"text":"·           Облегчение процесса центральной вестибулярной компенсации"}},{"type":"paragraph","data":{"text":"Бетагистин ускоряет восстановление вестибулярной функции у животных после односторонней вестибулярной нейрэктомии, ускоряя и облегчая центральную вестибулярную компенсацию за счет антагонизма с Н3-гистаминовыми рецепторами."}},{"type":"paragraph","data":{"text":"Время восстановления после вестибулярной нейрэктомии у человека при лечении бетагистином также уменьшается."}},{"type":"paragraph","data":{"text":"·              Подавление возбуждения нейронов в вестибулярных ядрах"}},{"type":"paragraph","data":{"text":"Дозозависимо снижает генерацию потенциалов действия в нейронах латеральных и медиальных вестибулярных ядер."}},{"type":"paragraph","data":{"text":"Фармакодинамические свойства, выявленные на животных, обеспечивают положительный терапевтический эффект бетагистина в вестибулярной системе."}},{"type":"paragraph","data":{"text":"Эффективность бетагистина была продемонстрирована у пациентов с вестибулярным головокружением и синдромом Меньера, что проявлялось уменьшением выраженности и частоты головокружений."}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eФармакокинетика\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"\u003ci\u003eВсасывание\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"При пероральном приеме бетагистин быстро и практически полностью всасывается в желудочно-кишечном тракте. После всасывания препарат быстро и почти полностью метаболизируется с образованием неактивного метаболита 2-пиридилуксусной кислоты. Концентрация бетагистина в плазме крови очень низкая. Таким образом, фармакокинетические анализы основаны на измерении концентрации метаболита"}},{"type":"paragraph","data":{"text":"2-пиридилуксусной кислоты (2-РАА) в плазме и моче."}},{"type":"paragraph","data":{"text":"Для препарата Бетасерк Лонг максимальная концентрация (С\u003csub\u003emax\u003c/sub\u003e) составляет в среднем (±SD) 847±147 нг/мл, время достижения максимальной концентрации (T\u003csub\u003emax\u003c/sub\u003e) – 0,333-2,0 ч (медиана 1,0 ч), время задержки Т\u003csub\u003elag\u003c/sub\u003e – 0 ч. Конечный период полувыведения (T\u003csub\u003e1/2\u003c/sub\u003e) составляет 5,54±1,57 ч, конечная константа элиминации (λ\u003csub\u003ez\u003c/sub\u003e) – 0,134±0,036 ч\u003csup\u003e-1\u003c/sup\u003e. Общая экспозиция 2-РАА в плазме крови составляет: AUC\u003csub\u003e0-inf\u003c/sub\u003e – 7266±1338 ч×нг/мл (геометрическое среднее 7141 ч×нг/мл), AUC\u003csub\u003e0-t\u003c/sub\u003e – 7159±1327 ч×нг/мл (геометрическое среднее 7035 ч×нг/мл), AUC\u003csub\u003e0-24\u003c/sub\u003e, что соответствует AUC\u003csub\u003e0-\u003c/sub\u003e\u003csub\u003et\u003c/sub\u003e, – 6621±1111 ч×нг/мл (геометрическое среднее 6524 ч×нг/мл)."}},{"type":"paragraph","data":{"text":"При однократном приеме препарата Бетасерк Лонг C\u003csub\u003emax\u003c/sub\u003e 2-РАА увеличилась в 1,2 раза по сравнению с последовательным приемом двух таблеток препарата Бетасерк 24 мг с 12-часовым интервалом. Т\u003csub\u003emax\u003c/sub\u003e при приеме Бетасерк Лонг в среднем увеличено на 0,33 ч. Период полувыведения 2-РАА при приеме Бетасерк Лонг в среднем увеличился в 1,4 раза. Общая экспозиция при приеме 1 таблетки Бетасерк Лонг составляет в среднем 0,91 от AUC\u003csub\u003e0-24\u003c/sub\u003e, 0,83 от AUC\u003csub\u003e0-t \u003c/sub\u003eи 0,84 от АUC\u003csub\u003e0-inf\u003c/sub\u003e при приеме 2-х таблеток Бетасерк 24 мг. "}},{"type":"paragraph","data":{"text":"При приеме однократной дозы препарата Бетасерк\u003csup\u003e \u003c/sup\u003eЛонг достигается экспозиция 2-РАА в плазме крови, сравнимая с двукратным приемом препарата Бетасерк 24 мг, но без значительного увеличения максимальной концентрации в плазме крови."}},{"type":"paragraph","data":{"text":"Прием пищи не оказывает влияния на фармакокинетику 2-РАА при приеме препарата Бетасерк\u003csup\u003e \u003c/sup\u003eЛонг."}},{"type":"paragraph","data":{"text":"\u003ci\u003eРаспределение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Связывание бетагистина с белками плазмы крови составляет менее 5 %."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМетаболизм\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"После всасывания бетагистин быстро и почти полностью метаболизируется с образованием метаболита 2-РАА (который не обладает фармакологической активностью)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВыведение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"2-РАА быстро выводится с мочой. При приеме препарата в дозе 48 мг около 85 % начальной дозы обнаруживается в моче. Выведение бетагистина почками или через кишечник незначительно."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛинейность\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Скорость выведения остается постоянной при пероральном приеме 48 мг препарата, указывая на линейность фармакокинетики бетагистина, и позволяет предположить, что задействованный метаболический путь остается ненасыщенным. "}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Синдром Меньера, характеризующийся следующими основными симптомами:"}},{"type":"paragraph","data":{"text":"·      головокружение (сопровождающееся тошнотой/рвотой)"}},{"type":"paragraph","data":{"text":"·      снижение слуха (тугоухость)"}},{"type":"paragraph","data":{"text":"·      шум в ушах"}},{"type":"paragraph","data":{"text":"Симптоматическое лечение вестибулярного головокружения (вертиго)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"·              Повышенная чувствительность к любому из компонентов препарата "}},{"type":"paragraph","data":{"text":"·              Непереносимость лактозы, дефицит лактазы и глюкозо-галактозная мальабсорбция в связи с наличием в составе препарата лактозы"}},{"type":"paragraph","data":{"text":"·              Феохромоцитома"}},{"type":"paragraph","data":{"text":"·               Не рекомендуется для применения у детей в возрасте до 18 лет в связи с недостаточностью данных по эффективности и безопасности"}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Пациенты с бронхиальной астмой, язвенной болезнью желудка и/или двенадцатиперстной кишки требуют тщательного наблюдения в период лечения."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eБеременность\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Имеющихся данных о применении бетагистина беременными женщинами недостаточно. "}},{"type":"paragraph","data":{"text":"Исследования на животных не выявили прямой или непрямой репродуктивной токсичности. Бетагистин не должен использоваться во время беременности за исключением случаев абсолютной необходимости."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПериод грудного вскармливания\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Неизвестно, выделяется ли бетагистин с грудным молоком у человека. Бетагистин выделяется с грудным молоком у крыс. Исследования на животных были ограничены применением препарата в очень высоких дозах. Вопрос о назначении лекарственного препарата матери должен приниматься только после сопоставления пользы грудного вскармливания с потенциальным риском для грудного ребенка."}},{"type":"paragraph","data":{"text":"\u003ci\u003eФертильность\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"В исследованиях на животных (крысах) влияния на фертильность не выявлено."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь. Во время еды."}},{"type":"paragraph","data":{"text":"Таблетку Бетасерк\u003csup\u003e \u003c/sup\u003eЛонг нельзя делить на части, так как она покрыта пленочной оболочкой с целью постепенного высвобождения действующего вещества."}},{"type":"paragraph","data":{"text":"Доза Бетасерк Лонг для взрослых составляет:"}},{"type":"paragraph","data":{"text":"По 1 таблетке в день утром."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПожилой возраст\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Несмотря на ограниченность данных клинических исследований, обширный пострегистрационный опыт предполагает, что коррекция дозы у этой группы пациентов не требуется."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПациенты с почечной/ печеночной недостаточностью\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Специальные клинические исследования в этой группе пациентов не проводились, однако пострегистрационный опыт дает основания предполагать, что коррекция дозы у данной категории пациентов не требуется."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Ниже представлены нежелательные лекарственные реакции (НЛР), возникавшие при применении препарата в клинических исследованиях с указанием частоты их возникновения. НЛР сгруппированы в соответствии с классификацией органов и систем органов MedDRA."}},{"type":"paragraph","data":{"text":"Частота встречаемости определяется следующим образом: \u003ci\u003eочень часто\u003c/i\u003e (≥ 1/10), \u003ci\u003eчасто\u003c/i\u003e (≥ 1/100 и < 1/10), \u003ci\u003eнечасто\u003c/i\u003e(≥ 1/1000 и < 1/100), \u003ci\u003eредко\u003c/i\u003e (≥ 1/10000 и < 1/1000), \u003ci\u003eочень редко\u003c/i\u003e (< 1/10000, включая отдельные случаи)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны нервной системы:\u003c/i\u003e\u003ci\u003e \u003c/i\u003eчасто: головная боль."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны желудочно-кишечного тракта:\u003c/i\u003e\u003ci\u003e \u003c/i\u003eчасто: тошнота и диспепсия."}},{"type":"paragraph","data":{"text":"При приеме Бетасерк Лонг нежелательные явления со стороны желудочно-кишечного тракта и центральной нервной системы (головная боль) развивались с меньшей частотой, что было статистически подтверждено проведением дополнительного анализа в клиническом исследовании эффективности и безопасности препарата Бетасерк Лонг."}},{"type":"paragraph","data":{"text":"Кроме этих эффектов, выявленных при проведении клинических исследований, в процессе пострегистрационного применения бетагистина и в научной литературе сообщалось о нижеследующих нежелательных эффектах. Имеющихся данных недостаточно, чтобы оценить их частоту."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны иммунной системы:\u003c/i\u003e\u003ci\u003e \u003c/i\u003eреакция гиперчувствительности, в том числе, анафилактическая реакция."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны желудочно-кишечного тракта:\u003c/i\u003e\u003ci\u003e \u003c/i\u003eумеренные расстройства, такие как рвота, желудочно-кишечные боли, вздутие живота. Эти эффекты обычно исчезают после приема препарата одновременно с пищей. "}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения со стороны кожи и подкожных тканей:\u003c/i\u003e\u003ci\u003e \u003c/i\u003eреакции гиперчувствительности со стороны кожи и подкожной клетчатки, в особенности, ангионевротический отек, зуд и сыпь."}},{"type":"paragraph","data":{"text":"Если любые из указанных в инструкции побочных эффектов усугубятся или Вы заметили любые другие побочные эффекты, не упомянутые в данной инструкции, или какой-либо побочный эффект принял серьезный характер, уведомите, пожалуйста, \u003cb\u003eВашего лечащего врача.\u003c/b\u003e"}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Информация о передозировке Бетасерк Лонг отсутствует."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Известно несколько случаев передозировки бетагистином. У некоторых пациентов наблюдались легкие и умеренные симптомы (тошнота, сонливость, боль в животе) после приема бетагистина в дозах до 640 мг. Более серьезные осложнения (судороги, сердечно-легочные осложнения) наблюдались при преднамеренном приеме повышенных доз бетагистина, особенно в сочетании с передозировкой других лекарственных средств."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Рекомендуется симптоматическое лечение."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Если в настоящее время или в недавнем прошлом Вы принимали другие лекарственные средства, в том числе без назначения врача, сообщите об этом, пожалуйста, Вашему лечащему врачу."}},{"type":"paragraph","data":{"text":"Исследования \u003ci\u003ein\u003c/i\u003e\u003ci\u003e \u003c/i\u003e\u003ci\u003evivo\u003c/i\u003e,\u003ci\u003e \u003c/i\u003eнаправленные на изучение взаимодействия с другими лекарственными препаратами, не проводились\u003ci\u003e.\u003c/i\u003e Основываясь на данных \u003ci\u003ein\u003c/i\u003e\u003ci\u003e \u003c/i\u003e\u003ci\u003evitro\u003c/i\u003e, можно предположить отсутствие ингибирования активности изоферментов цитохрома P450 \u003ci\u003ein\u003c/i\u003e\u003ci\u003e \u003c/i\u003e\u003ci\u003evivo\u003c/i\u003e."}},{"type":"paragraph","data":{"text":"Данные \u003ci\u003ein\u003c/i\u003e\u003ci\u003e \u003c/i\u003e\u003ci\u003evitro\u003c/i\u003e показали ингибирование метаболизма бетагистина под действием препаратов, которые ингибируют моноаминоксидазу (MAO), включая MAO подтипа B (например, селегилин). Следует соблюдать осторожность при одновременном применении бетагистина и ингибиторов MAO (включая MAO-B)."}},{"type":"paragraph","data":{"text":"Бетагистин является аналогом гистамина, взаимодействие бетагистина с блокаторами"}},{"type":"paragraph","data":{"text":"Н1-гистаминовых рецепторов теоретически может влиять на эффективность одного из этих лекарственных средств. "}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Бетагистин не влияет или незначительно влияет на способность управлять транспортными средствами и работать с механизмами, в клинических исследованиях нежелательные реакции, которые могли бы повлиять на такую способность, не выявлены."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки с модифицированным высвобождением, покрытые пленочной оболочкой, 48 мг."}},{"type":"paragraph","data":{"text":"По 14 таблеток в контурную ячейковую упаковку из пленки ПВХ/ПВДХ и фольги алюминиевой печатной лакированной. "}},{"type":"paragraph","data":{"text":"2, 4 или 7 контурные(х) ячейковые(х) упаковки(ок) вместе с инструкцией по применению помещают в пачку из картона."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте!"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года. Не применять по истечении срока годности."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003cb\u003eПроизводитель\u003c/b\u003e\u003cb\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"АО «ВЕРОФАРМ», Россия "}},{"type":"paragraph","data":{"text":"308013, г. Белгород, ул. Рабочая, д. 14"}},{"type":"paragraph","data":{"text":"\u003cb\u003eВладелец регистрационного удостоверения \u003c/b\u003e"}},{"type":"paragraph","data":{"text":"«Эбботт Продактс Оперейшнз ЭйДжи», Швейцария"}},{"type":"paragraph","data":{"text":"Хегенхаймерматтвег 127, 4123 Альшвиль, Швейцария."}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ООО «Эбботт Лэбораториз»"}},{"type":"paragraph","data":{"text":"125171, г. Москва, Ленинградское шоссе, д. 16А, стр. 1"}},{"type":"paragraph","data":{"text":"Тел.: +7 (495) 258-42-80"}},{"type":"paragraph","data":{"text":"Факс: +7 (495) 258-42-81"}},{"type":"paragraph","data":{"text":"abbott-russia@abbott.com\u003cb\u003e\u003c/b\u003e"}}]}],"source":null},"description_toggle":false,"short_description":"ФармакодинамикаМеханизм действия бетагистина известен только частично. Существует несколько возможных гипотез, подтвержденных доклиническими и клиническими данными: · Влияние на гистаминергическую систему Частичный агонист Н1-гистаминовых и антагонист Н3-гистаминовых рецепторов вестибулярных ядер ЦНС, обладает незначительной активностью в отношении Н2-рецепторов. Бетагистин увеличивает обмен гистамина и его высвобождение путем блокирования пресинаптических Н3-рецепторов и снижения количества Н3-рецепторов. · Усиление кровотока кохлеарной области, а также всего головного мозга Согласно доклиническим исследованиям бетагистин улучшает кровообращение в сосудистой полоске внутреннего уха за счет расслабления прекапиллярных сфинктеров сосудов внутреннего уха. Также показано, что бетагистин усиливает кровоток головного мозга у человека. · Облегчение процесса центральной вестибулярной компенсации Бетагистин ускоряет восстановление вестибулярной функции у животных после односторонней вестибулярной нейрэктомии, ускоряя и облегчая центральную вестибулярную компенсацию за счет антагонизма с Н3-гистаминовыми рецепторами. Время восстановления после вестибулярной нейрэктомии у человека при лечении бетагистином также уменьшается. · Подавление возбуждения нейронов в вестибулярных ядрах Дозозависимо снижает генерацию потенциалов действия в нейронах латеральных и медиальных вестибулярных ядер. Фармакодинамические свойства, выявленные на животных, обеспечивают положительный терапевтический эффект бетагистина в вестибулярной системе. Эффективность бетагистина была продемонстрирована у пациентов с вестибулярным головокружением и синдромом Меньера, что проявлялось уменьшением выраженности и частоты головокружений.ФармакокинетикаВсасываниеПри пероральном приеме бетагистин быстро и практически полностью всасывается в желудочно-кишечном тракте. После всасывания препарат быстро и почти полностью метаболизируется с образованием неактивного метаболита 2-пиридилуксусной кислоты. Концентрация бетагистина в плазме крови очень низкая. Таким образом, фармакокинетические анализы основаны на измерении концентрации метаболита 2-пиридилуксусной кислоты (2-РАА) в плазме и моче. Для препарата Бетасерк Лонг максимальная концентрация (Сmax) составляет в среднем (±SD) 847±147 нг/мл, время достижения максимальной концентрации (Tmax) – 0,333-2,0 ч (медиана 1,0 ч), время задержки Тlag– 0 ч. Конечный период полувыведения (T1/2) составляет 5,54±1,57 ч, конечная константа элиминации (λz) – 0,134±0,036 ч-1. Общая экспозиция 2-РАА в плазме крови составляет: AUC0-inf– 7266±1338 ч×нг/мл (геометрическое среднее 7141 ч×нг/мл), AUC0-t– 7159±1327 ч×нг/мл (геометрическое среднее 7035 ч×нг/мл), AUC0-24, что соответствует AUC0-t, – 6621±1111 ч×нг/мл (геометрическое среднее 6524 ч×нг/мл). При однократном приеме препарата Бетасерк Лонг Cmax2-РАА увеличилась в 1,2 раза по сравнению с последовательным приемом двух таблеток препарата Бетасерк 24 мг с 12-часовым интервалом. Тmaxпри приеме Бетасерк Лонг в среднем увеличено на 0,33 ч. Период полувыведения 2-РАА при приеме Бетасерк Лонг в среднем увеличился в 1,4 раза. Общая экспозиция при приеме 1 таблетки Бетасерк Лонг составляет в среднем 0,91 от AUC0-24, 0,83 от AUC0-tи 0,84 от АUC0-infпри приеме 2-х таблеток Бетасерк 24 мг. При приеме однократной дозы препарата БетасеркЛонг достигается экспозиция 2-РАА в плазме крови, сравнимая с двукратным приемом препарата Бетасерк 24 мг, но без значительного увеличения максимальной концентрации в плазме крови. Прием пищи не оказывает влияния на фармакокинетику 2-РАА при приеме препарата БетасеркЛонг.РаспределениеСвязывание бетагистина с белками плазмы крови составляет менее 5 %.МетаболизмПосле всасывания бетагистин быстро и почти полностью метаболизируется с образованием метаболита 2-РАА (который не обладает фармакологической активностью).Выведение2-РАА быстро выводится с мочой. При приеме препарата в дозе 48 мг около 85 % начальной дозы обнаруживается в моче. 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