Таблетки почти белого или белого с кремоватым оттенком цвета, круглые, плоскоцилиндрические с фаской (дозировка 8 мг) или с фаской и риской (дозировки 16 мг и 24 мг). Допускается незначительная мраморность.
Фармакотерапевтическая группа
Гистамина препарат
Фармакологические свойства
Фармакодинамика:
Механизм 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 центральной нервной системы обладает незначительной активностью в отношении Н2-гистаминовых рецепторов. Бетагистин увеличивает обмен гистамина и его высвобождение путем блокирования пресинаптических Н3-гистаминовых рецепторов и снижения количества Н3-гистаминовых 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 мозговой кровоток у человека.
Облегчение процесса центральной вестибулярной компенсации. Бетагистин ускоряет восстановление вестибулярной функции у животных после односторонней вестибулярной нейрэктомии ускоряя и облегчая нейтральную вестибулярную компенсацию за счет антагонизма с Н3-гистаминовыми рецепторами. Время восстановления после вестибулярной нейрэктомии у человека при лечении бетагистином также уменьшается.
Возбуждение нейронов в вестибулярных ядрах. Дозозависимо снижает генерацию потенциалов действия в нейронах латеральных и медиальных вестибулярных ядер. Фармакологические 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.
Фармакокинетика:
Всасывание
При пероральном приеме бетагистин быстро и практически полностью всасывается в желудочно-кишечном тракте. После всасывания препарат быстро и почти полностью метаболизируется с образованием метаболита 2-пиридилуксусной кислоты. Концентрация бетагистина в плазме крови очень низкая. Таким образом фармакокинетические анализы основаны на измерении концентрации метаболита 2-пиридилуксусиой кислоты в плазме и моче. При приеме препарата с пищей максимальная концентрация Сmах препарата в крови ниже чем при приеме натощак. Однако суммарная абсорбция бетагистина одинакова в обоих случаях что указывает на то что прием пищи лишь замедляет всасывание бетагистина.
Распределение
Связывание бетагистина с белками плазмы крови составляет менее 5%.
Биотрансформация
После всасывания бетагистин быстро и почти полностью метаболизируется с образованием метаболита 2-пиридилуксусной кислоты (который не обладает фармакологической активностью). Максимальная концентрация 2-пиридилуксусной кислоты в плазме крови (или моче) достигается через час после приема. Период полувыведения приблизительно 35 часа.
Выведение
2-пиридилуксусная кислота быстро выводится с мочой. При приеме препарата в дозе 8-48 мг около 85% начальной дозы обнаруживается в моче. Выведение бетагистина почками или через кишечник незначительно.
Линейность
Скорость выведения остается постоянной при пероральном приеме 8-48 мг препарата указывая на линейность фармакокинетики бетагистина и позволяет предположить что задействованный метаболический путь остается ненасыщенным.
Показания к применению
Лечение синдрома Меньера характеризующегося головокружением (сопровождающимся тошнотой и рвотой) снижением слуха и шумом в ушах.
- возраст до 18 лет (эффективность и безопасность не установлены).
С осторожностью
Язвенная болезнь желудка или 12-перстной кишки (в анамнезе) бронхиальная астма пациенты с артериальной гипотензией.
Применение при беременности и в период грудного вскармливания
Прием бетагистина при беременности и в период грудного вскармливания противопоказан из-за отсутствия достаточного количества данных о его безопасности во время беременности и в период грудного вскармливания. Неизвестно выделяется ли бетагистин с грудным молоком; если прием препарата необходим в период грудного вскармливания кормление грудью необходимо прекратить.
Способ применения и дозы
Внутрь во время еды.
Таблетки 8 мг: 1-2 таблетки 3 раза в день.
Таблетки 16 мг: ½-1 таблетка 3 раза в день.
Таблетка 24 мг: по 1 таблетке 2 раза в день.
Курс лечения определяется индивидуально. Лечение длительное.
Не требуется коррекции дозы у пациентов пожилого возраста а также у пациентов с печеночной и/или почечной недостаточностью.
Улучшение иногда наблюдается через несколько недель лечения; наилучшие результаты иногда достигаются после нескольких месяцев лечения.
Побочное действие
Классификация частоты развития побочных эффектов согласно рекомендациям Всемирной Организации Здравоохранения: очень часто (≥1/10) часто (от ≥1/100 до <1/10) нечасто (от ≥1/1000 до <1/100) редко (от ≥1/10000 до <1/1000) очень редко (<1/10000) включая отдельные сообщения; частота неизвестна - по имеющимся данным установить частоту возникновения не представляется возможным.
Со стороны пищеварительной системы:
часто - тошнота диспепсия;
частота неизвестна - рвота ощущение тяжести в эпигастрии абдоминальная боль вздутие живота.
частота неизвестна - реакции повышенной чувствительности в т.ч. анафилактические реакции.
Со стороны центральной нервной системы:
часто - головная боль.
Передозировка
Симптомы: тошнота, абдоминальная боль, сонливость (при приеме в дозе до 640 мг), судороги, сердечно-легочные осложнения (при приеме в дозе более 640 мг или в сочетании с другими лекарственными препаратами). Лечение: промывание желудка, прием активированного угля, симптоматическая терапия.
Взаимодействие с другими лекарственными средствами
Исследования in vivo направленные на изучение взаимодействия с другими лекарственными препаратами не проводились. Основываясь на данных in vitro можно предположить отсутствие ингибирования активности изоферментов цитохрома Р450 in vivo.
Данные in vitro показали ингибирование метаболизма бетагистина под действием препаратов которые ингибируют моноаминоксидазу (МАО) включая МАО подтипа В (например селегинин). Следует соблюдать осторожность при одновременном назначении бетагистина и ингибиторов МАО (включая МАО-В).
Бетагистин является аналогом гистамина взаимодействие бетагистина с блокаторами H1-гистаминовых рецепторов теоретически может влиять на эффективность одного из этих лекарственных средств.
Особые указания
Терапевтический эффект в ряде случаев нарастает в течение нескольких месяцев от начала лечения.
Улучшение иногда наблюдается через несколько недель лечения; наилучшие результаты иногда достигаются после нескольких месяцев лечения.
У пациентов с язвенной болезнью желудка или 12-перстной кишки (в анамнезе) бронхиальной астмой артериальной гипотензией препарат следует применять с осторожностью и под контролем лечащего врача.
Влияние на способность управлять автомобилем и движущимися механизмами
Бетагистин показан для лечения синдрома Меньера который характеризуется триадой основных симптомов: головокружением снижением слуха шумом в ушах а также для симптоматического лечения вестибулярного головокружения. Оба состояния могут негативно влиять на способность управлять автомобилем и работать с механизмами. По результатам клинических исследований доказано что влияние бетагистина на способность управлять транспортными средствами и работать с механизмами отсутствует или незначительно.
Форма выпуска
Таблетки 8 мг 16 мг и 24 мг.
Условия хранения
В сухом защищенном от света месте при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
2 года.
Не применять по истечении срока годности.
Условия отпуска
По рецепту
Производитель
Закрытое акционерное общество "Канонфарма продакшн" (ЗАО "Канонфарма продакшн"), 141100, Московская обл., г. Щелково, ул. Заречная, д. 105, Россия
Организация, принимающая претензии потребителей
ЗАО "Канонфарма продакшн"
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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Допускается незначительная мраморность."}}]},{"id":13,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"Гистамина препарат"}}]},{"id":3,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Механизм действия бетагистина известен только частично. Существует несколько возможных гипотез подтвержденных доклиническими и клиническими данными:"}},{"type":"list","data":{"style":"ordered","items":["Влияние на гистаминергическую систему. Частичный агонист Н\u003csub\u003e1\u003c/sub\u003e-гистаминовых и антагонист Н\u003csub\u003e3\u003c/sub\u003e-гистаминовых рецепторов вестибулярных ядер центральной нервной системы обладает незначительной активностью в отношении Н\u003csub\u003e2\u003c/sub\u003e-гистаминовых рецепторов. Бетагистин увеличивает обмен гистамина и его высвобождение путем блокирования пресинаптических Н\u003csub\u003e3\u003c/sub\u003e-гистаминовых рецепторов и снижения количества Н\u003csub\u003e3\u003c/sub\u003e-гистаминовых 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 мозговой кровоток у человека.","Облегчение процесса центральной вестибулярной компенсации. Бетагистин ускоряет восстановление вестибулярной функции у животных после односторонней вестибулярной нейрэктомии ускоряя и облегчая нейтральную вестибулярную компенсацию за счет антагонизма с Н\u003csub\u003e3\u003c/sub\u003e-гистаминовыми рецепторами. Время восстановления после вестибулярной нейрэктомии у человека при лечении бетагистином также уменьшается.","Возбуждение нейронов в вестибулярных ядрах. Дозозависимо снижает генерацию потенциалов действия в нейронах латеральных и медиальных вестибулярных ядер. Фармакологические 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."]}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Всасывание"}},{"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 метаболита 2-пиридилуксусной кислоты. Концентрация бетагистина в плазме крови очень низкая. Таким образом фармакокинетические анализы основаны на измерении концентрации метаболита 2-пиридилуксусиой кислоты в плазме и моче. При приеме препарата с пищей максимальная концентрация С\u003csub\u003emах\u003c/sub\u003e препарата в крови ниже чем при приеме натощак. Однако суммарная абсорбция бетагистина одинакова в обоих случаях что указывает на то что прием пищи лишь замедляет всасывание бетагистина."}},{"type":"paragraph","data":{"text":"Распределение"}},{"type":"paragraph","data":{"text":"Связывание бетагистина с белками плазмы крови составляет менее 5%."}},{"type":"paragraph","data":{"text":"Биотрансформация"}},{"type":"paragraph","data":{"text":"После всасывания бетагистин быстро и почти полностью метаболизируется с образованием метаболита 2-пиридилуксусной кислоты (который не обладает фармакологической активностью). Максимальная концентрация 2-пиридилуксусной кислоты в плазме крови (или моче) достигается через час после приема. Период полувыведения приблизительно 35 часа."}},{"type":"paragraph","data":{"text":"Выведение"}},{"type":"paragraph","data":{"text":"2-пиридилуксусная кислота быстро выводится с мочой. При приеме препарата в дозе 8-48 мг около 85% начальной дозы обнаруживается в моче. Выведение бетагистина почками или через кишечник незначительно."}},{"type":"paragraph","data":{"text":"Линейность"}},{"type":"paragraph","data":{"text":"Скорость выведения остается постоянной при пероральном приеме 8-48 мг препарата указывая на линейность фармакокинетики бетагистина и позволяет предположить что задействованный метаболический путь остается ненасыщенным."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение синдрома Меньера характеризующегося головокружением (сопровождающимся тошнотой и рвотой) снижением слуха и шумом в ушах."}},{"type":"paragraph","data":{"text":"Симптоматическое лечение вестибулярного головокружения (вертиго)."}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"- Повышенная чувствительность к бетагистина или к любому из компонентов препарата;"}},{"type":"paragraph","data":{"text":"- дефицит лактазы непереносимость лактозы глюкозо-галактозная мальабсорбция;"}},{"type":"paragraph","data":{"text":"- феохромоцитома;"}},{"type":"paragraph","data":{"text":"- беременность;"}},{"type":"paragraph","data":{"text":"- период грудного вскармливания;"}},{"type":"paragraph","data":{"text":"- возраст до 18 лет (эффективность и безопасность не установлены)."}}]},{"id":14,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Язвенная болезнь желудка или 12-перстной кишки (в анамнезе) бронхиальная астма пациенты с артериальной гипотензией."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Прием бетагистина при беременности и в период грудного вскармливания противопоказан из-за отсутствия достаточного количества данных о его безопасности во время беременности и в период грудного вскармливания. Неизвестно выделяется ли бетагистин с грудным молоком; если прием препарата необходим в период грудного вскармливания кормление грудью необходимо прекратить."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь во время еды."}},{"type":"paragraph","data":{"text":"Таблетки 8 мг: 1-2 таблетки 3 раза в день."}},{"type":"paragraph","data":{"text":"Таблетки 16 мг: ½-1 таблетка 3 раза в день."}},{"type":"paragraph","data":{"text":"Таблетка 24 мг: по 1 таблетке 2 раза в день."}},{"type":"paragraph","data":{"text":"Курс лечения определяется индивидуально. Лечение длительное."}},{"type":"paragraph","data":{"text":"Не требуется коррекции дозы у пациентов пожилого возраста а также у пациентов с печеночной и/или почечной недостаточностью."}},{"type":"paragraph","data":{"text":"Улучшение иногда наблюдается через несколько недель лечения; наилучшие результаты иногда достигаются после нескольких месяцев лечения."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Классификация частоты развития побочных эффектов согласно рекомендациям Всемирной Организации Здравоохранения: очень часто (≥1/10) часто (от ≥1/100 до <1/10) нечасто (от ≥1/1000 до <1/100) редко (от ≥1/10000 до <1/1000) очень редко (<1/10000) включая отдельные сообщения; частота неизвестна - по имеющимся данным установить частоту возникновения не представляется возможным."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы:"}},{"type":"paragraph","data":{"text":"часто - тошнота диспепсия;"}},{"type":"paragraph","data":{"text":"частота неизвестна - рвота ощущение тяжести в эпигастрии абдоминальная боль вздутие живота."}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов:"}},{"type":"paragraph","data":{"text":"частота неизвестна - кожный зуд сыпь крапивница отек Квинке."}},{"type":"paragraph","data":{"text":"Аллергические реакции:"}},{"type":"paragraph","data":{"text":"частота неизвестна - реакции повышенной чувствительности в т.ч. анафилактические реакции."}},{"type":"paragraph","data":{"text":"Со стороны центральной нервной системы:"}},{"type":"paragraph","data":{"text":"часто - головная боль."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: тошнота, абдоминальная боль, сонливость (при приеме в дозе до 640 мг), судороги, сердечно-легочные осложнения (при приеме в дозе более 640 мг или в сочетании с другими лекарственными препаратами). Лечение: промывание желудка, прием активированного угля, симптоматическая терапия."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Исследования in vivo направленные на изучение взаимодействия с другими лекарственными препаратами не проводились. Основываясь на данных in vitro можно предположить отсутствие ингибирования активности изоферментов цитохрома Р450 in vivo."}},{"type":"paragraph","data":{"text":"Данные in vitro показали ингибирование метаболизма бетагистина под действием препаратов которые ингибируют моноаминоксидазу (МАО) включая МАО подтипа В (например селегинин). Следует соблюдать осторожность при одновременном назначении бетагистина и ингибиторов МАО (включая МАО-В)."}},{"type":"paragraph","data":{"text":"Бетагистин является аналогом гистамина взаимодействие бетагистина с блокаторами H\u003csub\u003e1\u003c/sub\u003e-гистаминовых рецепторов теоретически может влиять на эффективность одного из этих лекарственных средств."}}]},{"id":10,"name":"Особые указания","slug":"","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Терапевтический эффект в ряде случаев нарастает в течение нескольких месяцев от начала лечения."}},{"type":"paragraph","data":{"text":"Улучшение иногда наблюдается через несколько недель лечения; наилучшие результаты иногда достигаются после нескольких месяцев лечения."}},{"type":"paragraph","data":{"text":"У пациентов с язвенной болезнью желудка или 12-перстной кишки (в анамнезе) бронхиальной астмой артериальной гипотензией препарат следует применять с осторожностью и под контролем лечащего врача."}}]},{"id":16,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Бетагистин показан для лечения синдрома Меньера который характеризуется триадой основных симптомов: головокружением снижением слуха шумом в ушах а также для симптоматического лечения вестибулярного головокружения. Оба состояния могут негативно влиять на способность управлять автомобилем и работать с механизмами. По результатам клинических исследований доказано что влияние бетагистина на способность управлять транспортными средствами и работать с механизмами отсутствует или незначительно."}}]},{"id":17,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки 8 мг 16 мг и 24 мг."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом защищенном от света месте при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года."}},{"type":"paragraph","data":{"text":"Не применять по истечении срока годности."}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":21,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Закрытое акционерное общество \"Канонфарма продакшн\" (ЗАО \"Канонфарма продакшн\"), 141100, Московская обл., г. Щелково, ул. Заречная, д. 105, Россия"}}]},{"id":22,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ЗАО \"Канонфарма продакшн\""}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Механизм 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 центральной нервной системы обладает незначительной активностью в отношении Н2-гистаминовых рецепторов. Бетагистин увеличивает обмен гистамина и его высвобождение путем блокирования пресинаптических Н3-гистаминовых рецепторов и снижения количества Н3-гистаминовых 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 мозговой кровоток у человека. - Облегчение процесса центральной вестибулярной компенсации. Бетагистин ускоряет восстановление вестибулярной функции у животных после односторонней вестибулярной нейрэктомии ускоряя и облегчая нейтральную вестибулярную компенсацию за счет антагонизма с Н3-гистаминовыми рецепторами. Время восстановления после вестибулярной нейрэктомии у человека при лечении бетагистином также уменьшается. - Возбуждение нейронов в вестибулярных ядрах. Дозозависимо снижает генерацию потенциалов действия в нейронах латеральных и медиальных вестибулярных ядер. Фармакологические 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. Всасывание При пероральном приеме бетагистин быстро и практически полностью всасывается в желудочно-кишечном тракте. После всасывания препарат быстро и почти полностью метаболизируется с образованием метаболита 2-пиридилуксусной кислоты. Концентрация бетагистина в плазме крови очень низкая. Таким образом фармакокинетические анализы основаны на измерении концентрации метаболита 2-пиридилуксусиой кислоты в плазме и моче. При приеме препарата с пищей максимальная концентрация Сmахпрепарата в крови ниже чем при приеме натощак. Однако суммарная абсорбция бетагистина одинакова в обоих случаях что указывает на то что прием пищи лишь замедляет всасывание бетагистина. Распределение Связывание бетагистина с белками плазмы крови составляет менее 5%. Биотрансформация После всасывания бетагистин быстро и почти полностью метаболизируется с образованием метаболита 2-пиридилуксусной кислоты (который не обладает фармакологической активностью). Максимальная концентрация 2-пиридилуксусной кислоты в плазме крови (или моче) достигается через час после приема. Период полувыведения приблизительно 35 часа. Выведение 2-пиридилуксусная кислота быстро выводится с мочой. При приеме препарата в дозе 8-48 мг около 85% начальной дозы обнаруживается в моче. Выведение бетагистина почками или через кишечник незначительно. 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