Инструкция по применению
Немного фактов
В последнее время распространяются сосудистые нарушения, это приводит к гипоксии тканей. Больше всего от данного явления страдает центральная нервная система. Препарат Кавинтон Комфорте предназначен для лечения и профилактики ишемии. Он обладает антигипоксическими, церебропротекторными, антиоксидантными и антиагрегантными свойствами. Применение средства целесообразно в восстановительный период для устранения последствий цереброваскулярных заболеваний и травм головного мозга.
Фармакологический эффект
Терапевтическое действие препарата обусловлено свойствами активного компонента – винпоцетина. Нейропротекторное воздействие заключается в ослаблении токсичного воздействия на клетки головного мозга реакций, протекающих за счёт стимуляции аминокислотами. Также средство аккумулирует защитные эффекты аденозина. Оно обеспечивает головной мозг основными энергетическими субстратами – кислородом и глюкозой. Усиливает их транспорт и захват клетками, включает в процессы метаболизма. Значительно повышает содержание цАМФ за счёт ингибирования фосфодиэстеразы. Предотвращает возникновение гипоксии и улучшает микроциркуляцию в ЦНС. Благодаря антиоксидантной активности связывает свободные радикалы и их цитотоксическое воздействие. Винпоцетин выступает в качестве антиагреганта и улучшает реологические свойства крови. Способен увеличить церебральную фракцию сердечного выброса, при этом не обкрадывая зоны ишемии.
Состав препарата
В состав антигипоксанта Кавинтон Комфорте входит действующее вещество (винпоцетин) и вспомогательные компоненты. Препарат предназначен для перорального приема, производится в виде таблеток, растворяющихся в полости рта.
Показания к использованию
Кавинтон Комфорте предназначен для лечения сосудистых нарушений различной этиологии. Среди показаний отмечают ишемические атаки и нарушения мозгового кровообращения. Применение при энцефалопатиях позволяет остановить прогрессирование болезни. Средство также эффективно для терапии васкулярных заболеваний органов зрения и слуха (ретинопатии, окклюзия сосудов сетчатки, нейросенсорная потеря слуха, шум в ушах).
Побочные эффекты
Необходимо придерживаться инструкции по применению таблеток Кавинтон Комфорте для предотвращения нежелательных эффектов. Побочное действие выражается в нарушении сердечного ритма, агранулоцитозе, бессоннице и снижении аппетита. Одним из противопоказаний является фенилкетонурия, так как средство содержит в себе источник фенилаланина. Также стоит отметить индивидуальную непереносимость компонентов, тяжелые случаи ИБС и аритмий, период лактации и вынашивания ребенка.
Беременность и лактация
Вещество способно преодолевать плацентарный барьер и попадать в кровоток плода. Также может возникнуть нежелательное усиление кровотока в плаценте, что является угрозой прерывания беременности. Данные свойства препарата делают его применение опасным для организма беременной женщины и ребенка. На время приема необходимо отказаться от грудного вскармливания, поскольку средство проникает в молоко матери.
Инструкция
Кавинтон Комфорте назначается по 1 таблетке 3 раза в сутки. Максимальная суточная доза не должна превышать 30 миллиграмм. Улучшение состояния наступает через неделю после начала терапии.
Особенности приема
Перед приемом таблеток Кавинтон Комфорте следует получить консультацию врача, который определяет длительность курса и дозировку, также предупреждает о возможных побочных реакциях и проверяет наличие противопоказаний. Данных о влиянии средства на внимание и способность управлять транспортным средством нет.
Совместимость с алкоголем
Алкоголь при попадании в кровяное русло проникает к клеткам головного мозга и оказывает токсическое воздействие. Средство увеличивает доставку кислорода к тканям, при совместном приеме организм использует весь запас О2 для утилизации продуктов метаболизма спиртных напитков и эффективности от такой терапии не будет. Поэтому при употреблении препарата необходимо отказаться от алкоголя.
Взаимодействие с другими лекарствами
Кавинтон Комфорте при взаимодействии с метилдопа усиливает гипотензивный эффект, поэтому при необходимости данной комбинации следует контролировать уровень артериального давления. Средство может усилить или подавить фармакологический эффект других веществ. Поэтому любые комбинации должны контролироваться лечащим врачом и подбираются индивидуально.
Передозировка
Несоблюдение рекомендованной дозировки может привести к пагубным последствиям для организма. При нарушении самочувствия необходимо прекратить прием препарата и обратиться за медицинской помощью. Дезинтоксикационные мероприятия заключаются в промывании желудка, приеме сорбентов и симптоматических средств.
Похожие препараты
Винпоцетин также является действующим веществом ряда других препаратов: Вицеброл Форте, Нейровин, Оксопотин. Сходный фармакологический эффект проявляют Глицин, Бифрен, Аксотилин.
Условия продажи
Средство Кавинтон Комфорте в наличии во многих аптечных сетях. Распространение разрешено только по рецепту.
Отзывы пациентов и врачей
Кавинтон Комфорте часто назначается врачами в комплексной терапии сосудистых нарушений. Он заявил себя, как эффективный метод борьбы с кислородным голоданием организма. Пациенты отмечают улучшение общего состояния и увеличение работоспособности. Средство хорошо переносится и приводит к ожидаемым эффектам.
Правила хранения
Лекарственное средство необходимо хранить в сухом, темном и недоступном для детей месте. Температурный режим не должен превышать отметку в 30 градусов. Пригоден к употреблению 2 года от даты производства.
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Клинико-фармакологическая группа
Действующее вещество
Форма выпуска, состав и упаковка
Таблетки диспергируемые белого или почти белого цвета, круглые, двояковыпуклые, с гравировкой "N83" на одной стороне.
| 1 таб. | |
| винпоцетин | 10 мг |
Вспомогательные вещества: маннитол — 75.6 мг, крахмал кукурузный прежелатинизированный — 38 мг, бутилметакрилата сополимер — 9 мг, гипролоза низкозамещенная — 8 мг, кросповидон — 8 мг, магния стеарат — 2.85 мг, натрия стеарилфумарат — 2.8 мг, кремния диоксид коллоидный — 1.6 мг, аспартам — 1.28 мг, стеариновая кислота — 1.26 мг, натрия лаурилсульфат — 0.9 мг, диметикон — 0.39 мг, ароматизатор апельсиновый — 0.32 мг.
15 шт. — блистеры (2) — пачки картонные.
15 шт. — блистеры (6) — пачки картонные.
Фармакологическое действие
Механизм действия винпоцетина складывается из нескольких элементов: он улучшает мозговой кровоток и обмен веществ, оказывает благоприятное воздействие на реологические свойства крови.
Нейропротекторное действие реализуется за счет снижения неблагоприятного цитотоксического влияния возбуждающих аминокислот. Блокирует Na + — и Са 2+ -каналы и NMDA- и АМРА-рецепторы. Винпоцетин стимулирует метаболизм в головном мозге: увеличивает захват и потребление глюкозы и кислорода. Повышает толерантность к гипоксии: увеличивает транспорт глюкозы, единственного источника энергии для ткани головного мозга, через ГЭБ; смещает метаболизм глюкозы в сторону энергетически более выгодного аэробного пути. Селективно ингибирует Са 2+ -кальмодулинзависимую цГМФ-фосфодиэстеразу. Повышает обмен серотонина и норадреналина в головном мозге, стимулирует норадренергическую нейромедиаторную систему и оказывает антиоксидантное действие.
Улучшает микроциркуляцию в головном мозге за счет ингибирования агрегации тромбоцитов, снижения патологически повышенной вязкости крови, увеличения деформируемости эритроцитов и ингибирования обратного захвата аденозина; способствует переходу кислорода в клетки за счет снижения к нему сродства эритроцитов. Избирательно увеличивает мозговой кровоток за счет снижения церебрального сосудистого сопротивления без существенного влияния на системные показатели кровообращения (АД, сердечный выброс, ЧСС, ОПСС); не вызывает эффект "обкрадывания".
Фармакокинетика
Винпоцетин быстро всасывается после приема внутрь и через 1 ч достигает C max . Всасывание происходит главным образом в проксимальных отделах кишечника. Не подвергается метаболизму при прохождении через стенку кишечника.
В доклинических исследованиях введения радиоактивно меченого винпоцетина внутрь он определялся в наивысших концентрациях в печени и ЖКТ. C max в тканях отмечается через 2-4 ч после приема внутрь.
Количество радиоактивного изотопа в головном мозге не превышало такового в крови. Связывание с белками в организме человека — 66%. V d составляет 246.7±88.5 л, что свидетельствует о значительном связывании с тканями. Биодоступность при приеме внутрь — 7%.
При многократном приеме внутрь в дозах 5 мг и 10 мг кинетика носит линейный характер; при этом C ss в плазме крови составили 1.2±0.27 нг/мл и 2.1±0.33 нг/мл соответственно.
Метаболизм и выведение
Клиренс составляет 66.7%, что превышает общий плазменный объем печени (50 л/ч) и свидетельствует о внепеченочном метаболизме. T 1/2 у человека составляет 4.83 ± 1.29 ч. В исследованиях с радиоактивно меченым препаратом было выявлено, что основными путями элиминации являются выведение почками и через кишечник в соотношении 3:2. В доклинических исследованиях наибольшая радиоактивность определялась в желчи, однако подтверждений значимой кишечно-печеночной циркуляции не найдено. Аповинкаминовая кислота выводится почками путем простой клубочковой фильтрации, T 1/2 зависит от принятой дозы и пути введения винпоцетина. Основным метаболитом винпоцетина является аповинкаминовая кислота (АВК), доля которой у человека составляет 25-30%. После приема винпоцетина внутрь AUC АВК в 2 раза больше таковой после в/в введения. Это свидетельствует о том, что АВК образуется в процессе метаболизма первого прохождения винпоцетина. Другими известными метаболитами являются гидроксивинпоцетин, гидрокси-АВК, дигидрокси-АВК-глицинат, а также их конъюгаты с глюкуронидами и/или сульфатами. В неизмененном виде винпоцетин выделяется в небольшом количестве.
Важной и полезной характеристикой винпоцетина является отсутствие необходимости коррекции дозы при заболеваниях печени и почек в связи с отсутствием кумуляции из-за особенностей его метаболизма.
Фармакокинетика у особых групп пациентов
Выявлено, что фармакокинетика винпоцетина у пожилых пациентов значимо не отличается от таковой у молодых пациентов, кумуляция препарата отсутствует. Поэтому винпоцетин можно назначать пациентам с нарушениями функции печени и почек длительно и в обычных дозах.
Показания
— симптоматическая терапия последствий ишемического инсульта, сосудистой вертебробазилярной недостаточности, сосудистой деменции, атеросклероза сосудов головного мозга, посттравматической, гипертонической энцефалопатии.
— хронические сосудистые заболевания сетчатки и сосудистой оболочки глаза.
— снижение слуха перцептивного типа;
Противопоказания
— повышенная чувствительность к винпоцетину и другим компонентам препарата;
— острая фаза геморрагического инсульта;
— тяжелая форма ИБС;
— период лактации (кормления грудью);
— детский и подростковый возраст до 18 лет (в связи с недостаточностью данных).
Дозировка
Курс лечения и доза определяются лечащим врачом.
Препарат назначают внутрь, после еды. Суточная доза препарата составляет 30 мг (по 1 таб. 10 мг 3 раза/сут). Терапевтический эффект развивается приблизительно через неделю от начала приема препарата.
Таблетки диспергируемые Кавинтон Комфорте можно проглатывать целиком с небольшим количеством воды, при затруднении глотания таблетку следует поместить на язык для рассасывания. Если пациенту нравится апельсиновый вкус таблеток диспергируемых Кавинтон Комфорте, то их можно принимать рассасывая.
При заболеваниях почек и печени препарат назначают в обычной дозе.
Побочные действия
Побочные эффекты достаточно редки. Данные представлены по системно-органным классам в соответствии с классификацией MedDRA и со следующей частотой: нечасто (от ≥1/1000 до Со стороны крови и лимфатической системы: редко — лейкопения, тромбоцитопения; очень редко — анемия, агглютинация эритроцитов.
Со стороны иммунной системы: очень редко — гиперчувствительность.
Со стороны обмена веществ и питания: нечасто — гиперхолестеринемия; редко — снижение аппетита, анорексия, сахарный диабет.
Нарушения психики: редко — бессонница, нарушения сна, возбуждение, неусидчивость; очень редко — эйфория, депрессия.
Со стороны нервной системы: нечасто — головная боль; редко — головокружение, нарушения вкуса, ступор, гемипарез, сонливость, амнезия; очень редко — тремор, спазмы.
Со стороны органа зрения: редко — отек диска зрительного нерва; очень редко — гиперемия конъюнктивы.
Со стороны органа слуха и лабиринта: нечасто — вертиго; редко — гиперакузия, гипоакузия, звон в ушах.
Со стороны сердца: редко — ишемия/инфаркт миокарда, стенокардия, брадикардия, тахикардия, экстрасистолы, ощущение сердцебиения; очень редко — аритмия, фибрилляция предсердий.
Со стороны сосудов: нечасто — артериальная гипотензия; редко — артериальная гипертензия, "приливы", тромбофлебит; очень редко — колебания АД.
Со стороны ЖКТ: нечасто — дискомфорт в животе, сухость во рту, тошнота; редко — боль в животе, запор, диарея, диспепсия, рвота; очень редко — дисфагия, стоматит.
Со стороны кожи и подкожных тканей: редко — эритема, повышенная потливость, зуд, крапивница, сыпь; очень редко — дерматит.
Общие расстройства и нарушения в месте введения: редко — астения, утомляемость, чувство жара; очень редко — дискомфорт в грудной клетке, гипотермия.
Влияние на результаты лабораторных и инструментальных исследований: нечасто — снижение АД, редко — повышение АД, повышение концентрации триглицеридов в сыворотке крови, депрессия сегмента ST на ЭКГ, снижение/повышение количества эозинофилов, изменение активности печеночных ферментов; очень редко — увеличение/уменьшение количества лейкоцитов, снижение числа эритроцитов, сокращение тромбинового времени, увеличение массы тела.
Передозировка
В настоящее время данные о передозировке винпоцетином ограничены.
Лечение: промывание желудка, прием активированного угля, симптоматическое лечение.
Лекарственное взаимодействие
Взаимодействия не наблюдается при одновременном применении с бета-адреноблокаторами (хлоранолол, пиндолол), клопамидом, глибенкламидом, дигоксином, аценокумаролом, гидрохлоротиазидом и имипрамином.
Одновременное применение винпоцетина и метилдопы иногда вызывало некоторое усиление гипотензивного эффекта, поэтому при таком лечении требуется регулярный контроль АД.
Несмотря на отсутствие данных, подтверждающих возможность взаимодействия, рекомендуется проявлять осторожность при одновременном назначении Кавинтон Комфорте с препаратами центрального, противоаритмического и антикоагулянтного действия.
Особые указания
Наличие синдрома удлиненного интервала QT и прием препаратов, вызывающих удлинение интервала QT, требуют периодического контроля ЭКГ.
В таблетке диспергируемой Кавинтон Комфорте 10 мг содержится 1.28 мг аспартама, источника фенилаланина, поэтому препарат противопоказан пациентам с фенилкетонурией.
Влияние на способность управлять транспортными средствами и механизмами
Исследования о влиянии на способность управлять транспортными средствами не проводились. При возникновении нежелательных реакций со стороны нервной системы следует соблюдать осторожность при управлении транспортными средствами и работе с механизмами.
Беременность и лактация
Винпоцетин проникает через плацентарный барьер и поэтому противопоказан при беременности. При этом его концентрация в плаценте и в крови плода ниже, чем в крови беременной. При высоких дозах возможно плацентарное кровотечение и спонтанные аборты, вероятно в результате усиления плацентарного кровоснабжения.
В течение часа в грудное молоко проникает 0.25% принятой дозы препарата. При применении препарата необходимо прекратить грудное вскармливание.
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Состав и форма выпуска
Таблетки диспергируемые — 1 таб.:
- Активыне вещества: винпоцетин — 10 мг;
- Вспомогательные вещества: маннитол — 75.6 мг, крахмал кукурузный прежелатинизированный — 38 мг, бутилметакрилата сополимер — 9 мг, гипролоза низкозамещенная — 8 мг, кросповидон — 8 мг, магния стеарат — 2.85 мг, натрия стеарилфумарат — 2.8 мг, кремния диоксид коллоидный — 1.6 мг, аспартам — 1.28 мг, стеариновая кислота — 1.26 мг, натрия лаурилсульфат — 0.9 мг, диметикон — 0.39 мг, ароматизатор апельсиновый — 0.32 мг.
Таблетки диспергируемые 10 мг.
По 15 таблеток в блистере из ПВХ — алюминиевой фольги.
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Препарат, улучшающий кровообращение и метаболизм головного мозга.
Винпоцетин быстро всасывается после приема внутрь и через 1 ч достигает Cmax. Всасывание происходит главным образом в проксимальных отделах кишечника. Не подвергается метаболизму при прохождении через стенку кишечника.
В доклинических исследованиях введения радиоактивно меченого винпоцетина внутрь он определялся в наивысших концентрациях в печени и ЖКТ. Cmax в тканях отмечается через 2-4 ч после приема внутрь.
Количество радиоактивного изотопа в головном мозге не превышало такового в крови. Связывание с белками в организме человека — 66%. Vd составляет 246.7±88.5 л, что свидетельствует о значительном связывании с тканями. Биодоступность при приеме внутрь — 7%.
При многократном приеме внутрь в дозах 5 мг и 10 мг кинетика носит линейный характер; при этом Css в плазме крови составили 1.2±0.27 нг/мл и 2.1±0.33 нг/мл соответственно.
Метаболизм и выведение
Клиренс составляет 66.7%, что превышает общий плазменный объем печени (50 л/ч) и свидетельствует о внепеченочном метаболизме. T1/2 у человека составляет 4.83 ± 1.29 ч. В исследованиях с радиоактивно меченым препаратом было выявлено, что основными путями элиминации являются выведение почками и через кишечник в соотношении 3:2. В доклинических исследованиях наибольшая радиоактивность определялась в желчи, однако подтверждений значимой кишечно-печеночной циркуляции не найдено. Аповинкаминовая кислота выводится почками путем простой клубочковой фильтрации, T1/2 зависит от принятой дозы и пути введения винпоцетина. Основным метаболитом винпоцетина является аповинкаминовая кислота (АВК), доля которой у человека составляет 25-30%. После приема винпоцетина внутрь AUC АВК в 2 раза больше таковой после в/в введения. Это свидетельствует о том, что АВК образуется в процессе метаболизма первого прохождения винпоцетина. Другими известными метаболитами являются гидроксивинпоцетин, гидрокси-АВК, дигидрокси-АВК-глицинат, а также их конъюгаты с глюкуронидами и/или сульфатами. В неизмененном виде винпоцетин выделяется в небольшом количестве.
Важной и полезной характеристикой винпоцетина является отсутствие необходимости коррекции дозы при заболеваниях печени и почек в связи с отсутствием кумуляции из-за особенностей его метаболизма.
Фармакокинетика у особых групп пациентов
Выявлено, что фармакокинетика винпоцетина у пожилых пациентов значимо не отличается от таковой у молодых пациентов, кумуляция препарата отсутствует. Поэтому винпоцетин можно назначать пациентам с нарушениями функции печени и почек длительно и в обычных дозах.
Механизм действия винпоцетина складывается из нескольких элементов: он улучшает мозговой кровоток и обмен веществ, оказывает благоприятное воздействие на реологические свойства крови.
Нейропротекторное действие реализуется за счет снижения неблагоприятного цитотоксического влияния возбуждающих аминокислот. Блокирует Na+- и Са2+-каналы и NMDA- и АМРА-рецепторы. Винпоцетин стимулирует метаболизм в головном мозге: увеличивает захват и потребление глюкозы и кислорода. Повышает толерантность к гипоксии: увеличивает транспорт глюкозы, единственного источника энергии для ткани головного мозга, через ГЭБ; смещает метаболизм глюкозы в сторону энергетически более выгодного аэробного пути. Селективно ингибирует Са2+-кальмодулинзависимую цГМФ-фосфодиэстеразу. Повышает обмен серотонина и норадреналина в головном мозге, стимулирует норадренергическую нейромедиаторную систему и оказывает антиоксидантное действие.
Улучшает микроциркуляцию в головном мозге за счет ингибирования агрегации тромбоцитов, снижения патологически повышенной вязкости крови, увеличения деформируемости эритроцитов и ингибирования обратного захвата аденозина; способствует переходу кислорода в клетки за счет снижения к нему сродства эритроцитов. Избирательно увеличивает мозговой кровоток за счет снижения церебрального сосудистого сопротивления без существенного влияния на системные показатели кровообращения (АД, сердечный выброс, ЧСС, ОПСС); не вызывает эффект "обкрадывания".
Показания к применению Кавинтон комфорте
Неврология: симптоматическая терапия последствий ишемического инсульта, сосудистой вертебробазилярной недостаточности, сосудистой деменции, атеросклероза сосудов головного мозга, посттравматической, гипертонической энцефалопатии.
Офтальмология: хронические сосудистые заболевания сетчатки и сосудистой оболочки глаза.
Отология: снижение слуха перцептивного типа; болезнь Меньера; шум в ушах.
Противопоказания к применению Кавинтон комфорте
- повышенная чувствительность к винпоцетину и другим компонентам препарата;
- острая фаза геморрагического инсульта;
- тяжелая форма ИБС;
- тяжелые аритмии;
- фенилкетонурия;
- беременность;
- период лактации (кормления грудью);
- детский и подростковый возраст до 18 лет (в связи с недостаточностью данных).
Кавинтон комфорте Применение при беременности и детям
Винпоцетин проникает через плацентарный барьер и поэтому противопоказан при беременности. При этом его концентрация в плаценте и в крови плода ниже, чем в крови беременной. При высоких дозах возможно плацентарное кровотечение и спонтанные аборты, вероятно в результате усиления плацентарного кровоснабжения.
В течение часа в грудное молоко проникает 0.25% принятой дозы препарата. При применении препарата необходимо прекратить грудное вскармливание.
Противопоказан детям и подросткам в возрасте до 18 лет (в связи с недостаточностью данных).
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