Круглые, плоскоцилиндрические таблетки белого или почти белого цвета, с фаской и риской.
Фармакотерапевтическая группа
Гистамина препарат
Фармакологические свойства
Фармакодинамика:
Механизм действия бетагистина известен только частично. Существует несколько возможных гипотез представленных ниже подтвержденных доклиническими и клиническими данными.
Влияние на гистаминергическую систему
Частичный агонист H1-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 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.
Возбуждение 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.
Фармакокинетика:
Всасывание
При приеме внутрь быстро и полностью абсорбируется в желудочно-кишечном тракте. Прием пищи замедляет всасывание бетагистина однако суммарная абсорбция одинакова при приеме натощак и с пищей.
Распределение
Связь с белками плазмы крови низкая - менее 5%. Время достижения максимальной концентрации в плазме крови - 1 ч.
Метаболизм
Быстро и почти полностью метаболизируется в печени с образованием неактивных метаболитов: 2-пиридилуксусной кислоты (основной метаболит) и диметилбетагистина.
Выведение
85-90% выводится почками в виде 2-пиридилуксусной кислоты в течение 24 ч. Выведение бетагистина и диметилбетагистина почками незначительно. Кишечником выводится лишь небольшая часть бетагистина и его метаболитов. Период полувыведения - 3-4 ч. Скорость выведения при приеме внутрь 8-48 мг бетагистина остается постоянной указывая на линейность фармакокинетики бетагистина.
Показания к применению
- Лечение синдрома Меньера характеризующегося головокружением (сопровождающимся тошнотой и рвотой) снижением слуха и шумом в ушах;
- симптоматическое лечение и профилактика вестибулярного головокружения (вертиго) различной этиологии.
Противопоказания
- Повышенная чувствительность к бетагистину и другим компонентам препарата;
- возраст до 18 лет (безопасность и эффективность применения не установлены).
С осторожностью
- Язвенная болезнь желудка или 12-перстной кишки (в анамнезе);
- бронхиальная астма.
Применение при беременности и в период грудного вскармливания
Противопоказано применение препарата в связи с отсутствием достаточного количества данных о безопасности его применения при 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.
Если беременность выявлена в период лечения бетагистином препарат следует отменить.
Способ применения и дозы
Внутрь во время еды не разжевывая запивая небольшим количеством воды.
По 1 таблетке 2 раза в сутки.
Максимальная суточная доза - 48 мг.
Дозу и длительность лечения следует подбирать индивидуально в зависимости от реакции пациента на лечение. Лечение длительное.
Улучшение иногда наблюдается через несколько недель лечения. Наилучшие результаты иногда достигаются после нескольких месяцев лечения.
У пациентов с почечной или печеночной недостаточностью а также у пациентов пожилого возраста коррекции дозы не требуется.
Побочное действие
Классификация частоты развития побочных эффектов согласно рекомендациям Всемирной организации здравоохранения (ВОЗ):
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 боли в области желудочно-кишечного тракта вздутие живота.
Со стороны центральной нервной системы:
часто - головная боль.
Со стороны кожных покровов:
частота неизвестна - покраснение крапивница кожная сыпь кожный зуд.
Аллергические реакции:
частота неизвестна - реакции гиперчувствительности в том числе анафилактические реакции ангионевротический отек.
Передозировка
Симптомы
Боль в животе тошнота сонливость (после приема бетагистина в дозах до 640 мг); судороги сердечно-легочные осложнения (после приема бетагистина в дозах более 640 мг или в сочетании с другими лекарственными препаратами).
Взаимодействие с другими лекарственными средствами
Исследования in vivo направленные на изучение взаимодействия бетагистина с другими лекарственными препаратами не проводились.
Основываясь на данных in vitro можно предположить отсутствие ингибирования активности изоферментов цитохрома Р450.
При одновременном применении с блокаторами Н1-гистаминовых рецепторов терапевтический эффект бетагистина может снизиться.
По данным исследований in vitro ингибиторы моноаминоксидазы (МАО) в том числе селективные ингибиторы МАО подтипа В ингибируют метаболизм бетагистина. При одновременном применении с ингибиторами МАО в том числе селективными ингибиторами МАО подтипа В возможно повышение концентрации бетагистина в плазме крови.
Особые указания
Терапевтический эффект обычно отмечается уже в начале терапии но может быть постепенным и проявляться в течение нескольких недель лечения. Стабильный терапевтический эффект в некоторых случаях достигается после нескольких месяцев лечения.
У пациентов с артериальной гипотензией применять с осторожностью и под контролем лечащего врача.
Влияние на способность управлять автомобилем и движущимися механизмами
По результатам клинических исследований считается что влияние бетагистина на способность управлять транспортными средствами и механизмами отсутствует или незначительно поскольку эффектов потенциально влияющих на эту способность не обнаружено.
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.
Форма выпуска
Таблетки 24 мг.
Условия хранения
Хранить в 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 "ВЕРТЕКС" (ЗАО "ВЕРТЕКС"), г. Санкт-Петербург, Васильевский остров, 24-я линия, д. 27, лит. А, Россия
Организация, принимающая претензии потребителей
ЗАО "ВЕРТЕКС"
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Мобильное приложение «Все аптеки»
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препарат"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Механизм действия бетагистина известен только частично. Существует несколько возможных гипотез представленных ниже подтвержденных доклиническими и клиническими данными."}},{"type":"paragraph","data":{"text":"Влияние на гистаминергическую систему"}},{"type":"paragraph","data":{"text":"Частичный агонист H\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."}},{"type":"paragraph","data":{"text":"Усиление кровотока кохлеарной области а также всего головного мозга"}},{"type":"paragraph","data":{"text":"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."}},{"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 Н\u003csub\u003e3\u003c/sub\u003e-гистаминовыми рецепторами."}},{"type":"paragraph","data":{"text":"Время восстановления после вестибулярной нейрэктомии у человека при лечении бетагистином также уменьшается."}},{"type":"paragraph","data":{"text":"Возбуждение 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":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Всасывание"}},{"type":"paragraph","data":{"text":"При приеме внутрь быстро и полностью абсорбируется в желудочно-кишечном тракте. Прием пищи замедляет всасывание бетагистина однако суммарная абсорбция одинакова при приеме натощак и с пищей."}},{"type":"paragraph","data":{"text":"Распределение"}},{"type":"paragraph","data":{"text":"Связь с белками плазмы крови низкая - менее 5%. Время достижения максимальной концентрации в плазме крови - 1 ч."}},{"type":"paragraph","data":{"text":"Метаболизм"}},{"type":"paragraph","data":{"text":"Быстро и почти полностью метаболизируется в печени с образованием неактивных метаболитов: 2-пиридилуксусной кислоты (основной метаболит) и диметилбетагистина."}},{"type":"paragraph","data":{"text":"Выведение"}},{"type":"paragraph","data":{"text":"85-90% выводится почками в виде 2-пиридилуксусной кислоты в течение 24 ч. Выведение бетагистина и диметилбетагистина почками незначительно. Кишечником выводится лишь небольшая часть бетагистина и его метаболитов. Период полувыведения - 3-4 ч. Скорость выведения при приеме внутрь 8-48 мг бетагистина остается постоянной указывая на линейность фармакокинетики бетагистина."}}]},{"id":8,"name":"Показания к применению","slug":"indications","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 и профилактика вестибулярного головокружения (вертиго) различной этиологии."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"- Повышенная чувствительность к бетагистину и другим компонентам препарата;"}},{"type":"paragraph","data":{"text":"- феохромоцитома;"}},{"type":"paragraph","data":{"text":"- дефицит лактазы непереносимость лактозы глюкозо-галактозная мальабсорбция;"}},{"type":"paragraph","data":{"text":"- беременность;"}},{"type":"paragraph","data":{"text":"- период грудного вскармливания;"}},{"type":"paragraph","data":{"text":"- возраст до 18 лет (безопасность и эффективность применения не установлены)."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"- Язвенная болезнь желудка или 12-перстной кишки (в анамнезе);"}},{"type":"paragraph","data":{"text":"- бронхиальная астма."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказано применение препарата в связи с отсутствием достаточного количества данных о безопасности его применения при беременности и в период грудного вскармливания."}},{"type":"paragraph","data":{"text":"Неизвестно выделяется ли бетагистин с грудным молоком."}},{"type":"paragraph","data":{"text":"Если прием препарата необходим в период грудного вскармливания кормление грудью необходимо прекратить."}},{"type":"paragraph","data":{"text":"Если беременность выявлена в период лечения бетагистином препарат следует отменить."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь во время еды не разжевывая запивая небольшим количеством воды."}},{"type":"paragraph","data":{"text":"По 1 таблетке 2 раза в сутки."}},{"type":"paragraph","data":{"text":"Максимальная суточная доза - 48 мг."}},{"type":"paragraph","data":{"text":"Дозу и длительность лечения следует подбирать индивидуально в зависимости от реакции пациента на лечение. Лечение длительное."}},{"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 почечной или печеночной недостаточностью а также у пациентов пожилого возраста коррекции дозы не требуется."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Классификация частоты развития побочных эффектов согласно рекомендациям Всемирной организации здравоохранения (ВОЗ):"}},{"type":"paragraph","data":{"text":"очень часто ≥1/10;"}},{"type":"paragraph","data":{"text":"часто от ≥ 1/100 до < 1/10;"}},{"type":"paragraph","data":{"text":"нечасто от ≥ 1/1000 до < 1/100;"}},{"type":"paragraph","data":{"text":"редко от ≥ 1/10000 до < 1/1000;"}},{"type":"paragraph","data":{"text":"очень редко < 1/10000 включая отдельные сообщения;"}},{"type":"paragraph","data":{"text":"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 боли в области желудочно-кишечного тракта вздутие живота."}},{"type":"paragraph","data":{"text":"Со стороны центральной нервной системы:"}},{"type":"paragraph","data":{"text":"часто - головная боль."}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов:"}},{"type":"paragraph","data":{"text":"частота неизвестна - покраснение крапивница кожная сыпь кожный зуд."}},{"type":"paragraph","data":{"text":"Аллергические реакции:"}},{"type":"paragraph","data":{"text":"частота неизвестна - реакции гиперчувствительности в том числе анафилактические реакции ангионевротический отек."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы"}},{"type":"paragraph","data":{"text":"Боль в животе тошнота сонливость (после приема бетагистина в дозах до 640 мг); судороги сердечно-легочные осложнения (после приема бетагистина в дозах более 640 мг или в сочетании с другими лекарственными препаратами)."}},{"type":"paragraph","data":{"text":"Лечение"}},{"type":"paragraph","data":{"text":"Промывание желудка прием адсорбентов (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 бетагистина с другими лекарственными препаратами не проводились."}},{"type":"paragraph","data":{"text":"Основываясь на данных in vitro можно предположить отсутствие ингибирования активности изоферментов цитохрома Р450."}},{"type":"paragraph","data":{"text":"При одновременном применении с блокаторами Н\u003csub\u003e1\u003c/sub\u003e-гистаминовых рецепторов терапевтический эффект бетагистина может снизиться."}},{"type":"paragraph","data":{"text":"По данным исследований in vitro ингибиторы моноаминоксидазы (МАО) в том числе селективные ингибиторы МАО подтипа В ингибируют метаболизм бетагистина. При одновременном применении с ингибиторами МАО в том числе селективными ингибиторами МАО подтипа В возможно повышение концентрации бетагистина в плазме крови."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Терапевтический эффект обычно отмечается уже в начале терапии но может быть постепенным и проявляться в течение нескольких недель лечения. Стабильный терапевтический эффект в некоторых случаях достигается после нескольких месяцев лечения."}},{"type":"paragraph","data":{"text":"У пациентов с артериальной гипотензией применять с осторожностью и под контролем лечащего врача."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"По результатам клинических исследований считается что влияние бетагистина на способность управлять транспортными средствами и механизмами отсутствует или незначительно поскольку эффектов потенциально влияющих на эту способность не обнаружено."}},{"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."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки 24 мг."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить в защищенном от света месте 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."}},{"type":"paragraph","data":{"text":"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":"Закрытое акционерное общество \"ВЕРТЕКС\" (ЗАО \"ВЕРТЕКС\"), г. Санкт-Петербург, Васильевский остров, 24-я линия, д. 27, лит. 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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. Возбуждение нейронов в вестибулярных ядрах Дозозависимо снижает генерацию потенциалов действия в нейронах латеральных и медиальных вестибулярных ядер. 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