профилактика и лечение ишемических неврологических расстройств, вызванных спазмом сосудов головного мозга на фоне субарахноидального кровоизлияния вследствие разрыва аневризмы (после проведения в/в терапии инфузионным раствором);
выраженные нарушения функции головного мозга у пожилых пациентов (в т.ч. снижение памяти и способности к концентрации внимания, эмоциональная лабильность).
Противопоказания
выраженные нарушения функции печени (для терапии нарушений функций мозга);
Блокатор медленных кальциевых каналов (БМКК), производное 1,4-дигидропиридина, оказывает преимущественно церебровазодилатирующее и противоишемическое действие. Может предотвращать или устранять спазм сосудов, вызываемый различными вазоактивными веществами (в т.ч. серотонином, простагландинами, гистамином). Благодаря высокой липофильности проникает через ГЭБ.
Практически не влияет на проводимость в синоатриальном и атриовентрикулярном узлах, а также сократимость миокарда. Рефлекторно увеличивает ЧСС в ответ на расширение сосудов.
У пациентов с острыми нарушениями мозгового кровообращения нимодипин, расширяя сосуды головного мозга, улучшает мозговое кровообращение. При этом дополнительная перфузия, как правило, выражена в поврежденных областях и в участках головного мозга с недостаточным кровоснабжением. Применение нимодипина позволяет значительно снизить смертность и частоту развития ишемических неврологических расстройств на фоне субарахноидального кровоизлияния.
Фармакокинетика
Всасывание и распределение
Абсорбция - практически полная. Биодоступность - 8-12% (выраженный эффект "первого прохождения" через печень). Tmax - 0.5-1 ч, Cmax составляет 31 нг/мл. Css (через 0.6-1.6 ч после очередного приема) в плазме составляет 12.3-17.5 нг/мл у молодых и 26 нг/мл - у пожилых людей. Отмечается пропорциональный рост концентрации в плазме при повышении разовой дозы до 90 мг.
Нимодипин в значительной степени связывается с белками плазмы крови (97-99%). Проникает через плацентарный барьер. Концентрация нимодипина и его метаболитов в грудном молоке существенно превышает концентрацию в плазме крови.
Метаболизм и выведение
Выводится почками (менее 1% - в неизмененном виде) и с желчью (99%) в виде метаболитов (первостепенную роль играют дегидрогенизация дигидропиридинового кольца и окислительное расщепление сложных эфиров). Метаболиты практически лишены фармакологической активности. Кинетика выведения - линейная.
Показания к применению
профилактика и лечение ишемических неврологических расстройств, вызванных спазмом сосудов головного мозга на фоне субарахноидального кровоизлияния вследствие разрыва аневризмы (после проведения в/в терапии инфузионным раствором);
выраженные нарушения функции головного мозга у пожилых пациентов (в т.ч. снижение памяти и способности к концентрации внимания, эмоциональная лабильность).
Противопоказания
выраженные нарушения функции печени (для терапии нарушений функций мозга);
С осторожностью: артериальная гипотензия (систолическое АД менее 100 мм рт.ст.), выраженная брадикардия, ишемия миокарда, тяжелая сердечная недостаточность, выраженная хроническая почечная (СКФ менее 20 мл/мин) и/или печеночная недостаточность, внутричерепная гипертензия, генерализованный отек тканей головного мозга.
С осторожностью следует назначать одновременно с дизопирамидом и флекаинамидом (возможно усиление выраженности отрицательного инотропного действия).
Следует соблюдать осторожность у пожилых пациентов вследствие наибольшей вероятности возрастных нарушений функции почек.
Применение при беременности и в период грудного вскармливания
Противопоказано применение препарата при беременности и в период грудного вскармливания.
Способ применения и дозы
Препарат принимают внутрь, независимо от приема пищи. Таблетки следует проглатывать целиком, запивая небольшим количеством жидкости. Интервалы между приемами должны составлять не менее 4 ч.
При отсутствии других назначений рекомендуется соблюдать следующий режим дозирования:
субарахноидальное кровоизлияние после разрыва аневризмы: рекомендуемая доза - 60 мг 6 раз/сут в течение 7 дней (после инфузионной терапии раствором нимодипина).
нарушение функций головного мозга у пациентов пожилого возраста: рекомендуемая доза – 30 мг 3 раза/сут.
Побочное действие
Аллергические реакции: кожный зуд, сыпь.
Со стороны сердечно-сосудистой системы: снижение АД, брадикардия или тахикардия, аритмии, гиперемия кожи лица, развитие или усугубление имеющейся сердечной недостаточности и ишемии миокарда (особенно у больных с тяжелым обструктивным поражением коронарных артерий).
Со стороны пищеварительной системы: тошнота, диарея или запор, метеоризм, сухость во рту, изменение аппетита (обычно повышение), гиперплазия десен (кровоточивость, болезненность, отечность), в редких случаях – паралитическая кишечная непроходимость.
Со стороны системы кроветворения: тромбоцитопения, агранулоцитоз.
Со стороны дыхательной системы: затруднение дыхания, кашель, стридорозное дыхание.
Со стороны костно-мышечной системы: болезненность и отечность суставов.
Влияние на лабораторные показатели: повышение активности печеночных трансаминаз, ЩФ и ГГТ, повышение концентрации мочевины в плазме крови, гиперкреатининемия.
Прочие: периферические отеки, повышенное потоотделение, снижение функции почек, галакторея, увеличение массы тела.
Взаимодействие с другими лекарственными средствами
Ксенобиотики, влияющие на активность изофермента CYP3A4, могут менять метаболический клиренс нимодипина.
Исходя из опыта применения нифедипина, можно ожидать, что рифампицин, индуцируя активность ферментов печени, способен ускорить метаболизм нимодипина и при их одновременном применении эффективность нимодипина снижается.
Предшествующее длительное назначение индукторов микросомального окисления (фенобарбитала, фенитоина или карбамазепина) повышает метаболизм нимодипина.
Грейпфрутовый сок подавляет метаболизм дигидропиридинов. Сочетания грейпфрутового сока и нимодипина следует избегать, т.к. это может привести к непредсказуемому повышению концентрации нимодипина в плазме.
Одновременное применение нимодипина с циметидином или вальпроевой кислотой также может привести к повышению концентрации нимодипина в плазме.
Сочетанное применение нимодипина и флуоксетина сопровождается повышением концентрации нимодипина в плазме (на 50%), при этом концентрация флуоксетина значительно снижается, а концентрация его активного метаболита норфлуоксетина остается неизменной.
Одновременное длительное применение нимодипина и нортриптилина приводит к небольшому снижению концентрации нимодипина (при этом концентрация нортриптилина в плазме крови не изменяется).
У пациентов, находящихся на долговременной терапии галоперидолом, не обнаружено лекарственного взаимодействия нимодипина с галоперидолом.
Нимодипин при одновременном в/в назначении с зидовудином приводит к значительному увеличению AUC последнего и снижению его Vd и клиренса.
Подавляет метаболизм празозина и других альфа-адреноблокаторов, вследствие чего возможно усиление гипотензивного эффекта.
У пациентов, принимающих гипотензивные препараты (диуретики, бета-адреноблокаторы, ингибиторы АПФ, антагонисты рецепторов ангиотензина II, другие БМКК, альфа-адреноблокаторы, метилдопа, симпатолитики и другие), назначение Нимопина усиливает выраженность гипотензивного действия. В силу этого во время применения нимодипина недопустимо в/в введение бета-адреноблокаторов.
С осторожностью следует назначать одновременно с дизопирамидом, флекаинидом, прокаинамидом, хинидином и другими препаратами, вызывающими удлинение интервала QT (возможно усиление выраженности отрицательного инотропного действия и удлинения интервала QT).
Одновременное назначение с нимодипином потенциально нефротоксичных препаратов (например, аминогликозидов, цефалоспоринов, фуросемида) может привести к нарушению функции почек. В случае необходимости их одновременного применения, а также у больных с почечной недостаточностью, лечение должно проводиться под тщательным контролем функции почек. При обнаружении нарушения функции почек прием нимодипина следует прекратить.
Усиливает аритмогенное действие лекарственных препаратов, способствующих выведению ионов калия.
Гипотензивный эффект усиливается при одновременном назначении с ингаляционными анестетиками.
Гипотензивный эффект снижают симпатомиметики, НПВП (подавление синтеза простагландинов, задержка натрия и жидкости в организме), эстрогены (задержка жидкости в организме).
Особые указания
Назначение нимодипина пациентам пожилого возраста с большим количеством сопутствующих заболеваний, тяжелой почечной недостаточностью (СКФ менее 20 мл/мин) и тяжелыми сердечно-сосудистыми заболеваниями должно быть особенно тщательно обосновано. Во время терапии и после ее окончания такие пациенты нуждаются в регулярном врачебном наблюдении (включая неврологическое).
У пациентов с нарушениями функции печени из-за снижения интенсивности выраженного эффекта "первого прохождения" через печень и замедления метаболической инактивации биодоступность нимодипина может повышаться. Вследствие этого основное и побочное действие нимодипина, в частности его гипотензивный эффект, могут усиливаться. В таких случаях дозу препарата следует снизить в зависимости от степени снижения АД, а при необходимости применение нимодипина следует прекратить.
Несмотря на отсутствие у БМКК синдрома "отмены", перед прекращением лечения рекомендуется постепенное уменьшение доз.
Если во время терапии пациенту требуется провести хирургическое вмешательство под общей анестезией, необходимо проинформировать врача-анестезиолога о том, что пациент принимает нимодипин.
Влияние на способность к управлению транспортными средствами и механизмами
В период лечения необходимо соблюдать осторожность при вождении автотранспорта и занятии другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
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Может предотвращать или устранять спазм сосудов, вызываемый различными вазоактивными веществами (в т.ч. серотонином, простагландинами, гистамином). Благодаря высокой липофильности проникает через ГЭБ."}},{"type":"paragraph","data":{"text":"Практически не влияет на проводимость в синоатриальном и атриовентрикулярном узлах, а также сократимость миокарда. Рефлекторно увеличивает ЧСС в ответ на расширение сосудов."}},{"type":"paragraph","data":{"text":"У пациентов с острыми нарушениями мозгового кровообращения нимодипин, расширяя сосуды головного мозга, улучшает мозговое кровообращение. При этом дополнительная перфузия, как правило, выражена в поврежденных областях и в участках головного мозга с недостаточным кровоснабжением. Применение нимодипина позволяет значительно снизить смертность и частоту развития ишемических неврологических расстройств на фоне субарахноидального кровоизлияния."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"\u003ci\u003eВсасывание и распределение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Абсорбция - практически полная. Биодоступность - 8-12% (выраженный эффект \"первого прохождения\" через печень). T\u003csub\u003emax\u003c/sub\u003e - 0.5-1 ч, C\u003csub\u003emax\u003c/sub\u003e составляет 31 нг/мл. C\u003csub\u003ess\u003c/sub\u003e (через 0.6-1.6 ч после очередного приема) в плазме составляет 12.3-17.5 нг/мл у молодых и 26 нг/мл - у пожилых людей. Отмечается пропорциональный рост концентрации в плазме при повышении разовой дозы до 90 мг."}},{"type":"paragraph","data":{"text":"Нимодипин в значительной степени связывается с белками плазмы крови (97-99%). Проникает через плацентарный барьер. Концентрация нимодипина и его метаболитов в грудном молоке существенно превышает концентрацию в плазме крови."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМетаболизм и выведение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Выводится почками (менее 1% - в неизмененном виде) и с желчью (99%) в виде метаболитов (первостепенную роль играют дегидрогенизация дигидропиридинового кольца и окислительное расщепление сложных эфиров). Метаболиты практически лишены фармакологической активности. Кинетика выведения - линейная."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["профилактика и лечение ишемических неврологических расстройств, вызванных спазмом сосудов головного мозга на фоне субарахноидального кровоизлияния вследствие разрыва аневризмы (после проведения в/в терапии инфузионным раствором);","выраженные нарушения функции головного мозга у пожилых пациентов (в т.ч. снижение памяти и способности к концентрации внимания, эмоциональная лабильность)."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["выраженные нарушения функции печени (для терапии нарушений функций мозга);","беременность;","период лактации;","возраст до 18 лет;","терапия противоэпилептическими средствами;","одновременное применение с рифампицином;","индивидуальная непереносимость компонентов препарата"]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eС осторожностью:\u003c/i\u003e артериальная гипотензия (систолическое АД менее 100 мм рт.ст.), выраженная брадикардия, ишемия миокарда, тяжелая сердечная недостаточность, выраженная хроническая почечная (СКФ менее 20 мл/мин) и/или печеночная недостаточность, внутричерепная гипертензия, генерализованный отек тканей головного мозга."}},{"type":"paragraph","data":{"text":"С осторожностью следует назначать одновременно с дизопирамидом и флекаинамидом (возможно усиление выраженности отрицательного инотропного действия)."}},{"type":"paragraph","data":{"text":"Следует соблюдать осторожность у пожилых пациентов вследствие наибольшей вероятности возрастных нарушений функции почек."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказано применение препарата при беременности и в период грудного вскармливания."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат принимают внутрь, независимо от приема пищи. Таблетки следует проглатывать целиком, запивая небольшим количеством жидкости. Интервалы между приемами должны составлять не менее 4 ч."}},{"type":"paragraph","data":{"text":"При отсутствии других назначений рекомендуется соблюдать следующий режим дозирования:"}},{"type":"list","data":{"style":"ordered","items":["\u003ci\u003eсубарахноидальное кровоизлияние после разрыва аневризмы:\u003c/i\u003e рекомендуемая доза - 60 мг 6 раз/сут в течение 7 дней (после инфузионной терапии раствором нимодипина).","\u003ci\u003eнарушение функций головного мозга у пациентов пожилого возраста:\u003c/i\u003e рекомендуемая доза – 30 мг 3 раза/сут."]}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e кожный зуд, сыпь."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e снижение АД, брадикардия или тахикардия, аритмии, гиперемия кожи лица, развитие или усугубление имеющейся сердечной недостаточности и ишемии миокарда (особенно у больных с тяжелым обструктивным поражением коронарных артерий)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы:\u003c/i\u003e тошнота, диарея или запор, метеоризм, сухость во рту, изменение аппетита (обычно повышение), гиперплазия десен (кровоточивость, болезненность, отечность), в редких случаях – паралитическая кишечная непроходимость."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы:\u003c/i\u003e головная боль, головокружение, астения, экстрапирамидные нарушения (атаксия, маскообразное лицо, мышечная ригидность, тремор, затруднение глотания), симптомы возбуждения ЦНС (бессонница, повышенная двигательная активность, возбуждение, агрессивность), депрессия, чрезмерная утомляемость, сонливость."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны системы кроветворения:\u003c/i\u003e тромбоцитопения, агранулоцитоз."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны дыхательной системы:\u003c/i\u003e затруднение дыхания, кашель, стридорозное дыхание."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны костно-мышечной системы:\u003c/i\u003e болезненность и отечность суставов."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние на лабораторные показатели:\u003c/i\u003e повышение активности печеночных трансаминаз, ЩФ и ГГТ, повышение концентрации мочевины в плазме крови, гиперкреатининемия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e периферические отеки, повышенное потоотделение, снижение функции почек, галакторея, увеличение массы тела."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Ксенобиотики, влияющие на активность изофермента CYP3A4, могут менять метаболический клиренс нимодипина."}},{"type":"paragraph","data":{"text":"Исходя из опыта применения нифедипина, можно ожидать, что рифампицин, индуцируя активность ферментов печени, способен ускорить метаболизм нимодипина и при их одновременном применении эффективность нимодипина снижается."}},{"type":"paragraph","data":{"text":"Предшествующее длительное назначение индукторов микросомального окисления (фенобарбитала, фенитоина или карбамазепина) повышает метаболизм нимодипина."}},{"type":"paragraph","data":{"text":"Грейпфрутовый сок подавляет метаболизм дигидропиридинов. Сочетания грейпфрутового сока и нимодипина следует избегать, т.к. это может привести к непредсказуемому повышению концентрации нимодипина в плазме."}},{"type":"paragraph","data":{"text":"Одновременное применение нимодипина с циметидином или вальпроевой кислотой также может привести к повышению концентрации нимодипина в плазме."}},{"type":"paragraph","data":{"text":"Сочетанное применение нимодипина и флуоксетина сопровождается повышением концентрации нимодипина в плазме (на 50%), при этом концентрация флуоксетина значительно снижается, а концентрация его активного метаболита норфлуоксетина остается неизменной."}},{"type":"paragraph","data":{"text":"Одновременное длительное применение нимодипина и нортриптилина приводит к небольшому снижению концентрации нимодипина (при этом концентрация нортриптилина в плазме крови не изменяется)."}},{"type":"paragraph","data":{"text":"У пациентов, находящихся на долговременной терапии галоперидолом, не обнаружено лекарственного взаимодействия нимодипина с галоперидолом."}},{"type":"paragraph","data":{"text":"Нимодипин при одновременном в/в назначении с зидовудином приводит к значительному увеличению AUC последнего и снижению его V\u003csub\u003ed\u003c/sub\u003e и клиренса."}},{"type":"paragraph","data":{"text":"Подавляет метаболизм празозина и других альфа-адреноблокаторов, вследствие чего возможно усиление гипотензивного эффекта."}},{"type":"paragraph","data":{"text":"У пациентов, принимающих гипотензивные препараты (диуретики, бета-адреноблокаторы, ингибиторы АПФ, антагонисты рецепторов ангиотензина II, другие БМКК, альфа-адреноблокаторы, метилдопа, симпатолитики и другие), назначение Нимопина усиливает выраженность гипотензивного действия. В силу этого во время применения нимодипина недопустимо в/в введение бета-адреноблокаторов."}},{"type":"paragraph","data":{"text":"С осторожностью следует назначать одновременно с дизопирамидом, флекаинидом, прокаинамидом, хинидином и другими препаратами, вызывающими удлинение интервала QT (возможно усиление выраженности отрицательного инотропного действия и удлинения интервала QT)."}},{"type":"paragraph","data":{"text":"Одновременное назначение с нимодипином потенциально нефротоксичных препаратов (например, аминогликозидов, цефалоспоринов, фуросемида) может привести к нарушению функции почек. В случае необходимости их одновременного применения, а также у больных с почечной недостаточностью, лечение должно проводиться под тщательным контролем функции почек. При обнаружении нарушения функции почек прием нимодипина следует прекратить."}},{"type":"paragraph","data":{"text":"Усиливает аритмогенное действие лекарственных препаратов, способствующих выведению ионов калия."}},{"type":"paragraph","data":{"text":"Повышает риск развития побочных эффектов сердечных гликозидов, хинидина, карбамазепина, циклоспорина, теофиллина, вальпроевой кислоты, препаратов лития."}},{"type":"paragraph","data":{"text":"Гипотензивный эффект усиливается при одновременном назначении с ингаляционными анестетиками."}},{"type":"paragraph","data":{"text":"Гипотензивный эффект снижают симпатомиметики, НПВП (подавление синтеза простагландинов, задержка натрия и жидкости в организме), эстрогены (задержка жидкости в организме)."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Назначение нимодипина пациентам пожилого возраста с большим количеством сопутствующих заболеваний, тяжелой почечной недостаточностью (СКФ менее 20 мл/мин) и тяжелыми сердечно-сосудистыми заболеваниями должно быть особенно тщательно обосновано. Во время терапии и после ее окончания такие пациенты нуждаются в регулярном врачебном наблюдении (включая неврологическое)."}},{"type":"paragraph","data":{"text":"У пациентов с нарушениями функции печени из-за снижения интенсивности выраженного эффекта \"первого прохождения\" через печень и замедления метаболической инактивации биодоступность нимодипина может повышаться. Вследствие этого основное и побочное действие нимодипина, в частности его гипотензивный эффект, могут усиливаться. В таких случаях дозу препарата следует снизить в зависимости от степени снижения АД, а при необходимости применение нимодипина следует прекратить."}},{"type":"paragraph","data":{"text":"Несмотря на отсутствие у БМКК синдрома \"отмены\", перед прекращением лечения рекомендуется постепенное уменьшение доз."}},{"type":"paragraph","data":{"text":"Если во время терапии пациенту требуется провести хирургическое вмешательство под общей анестезией, необходимо проинформировать врача-анестезиолога о том, что пациент принимает нимодипин."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние на способность к управлению транспортными средствами и механизмами\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"В период лечения необходимо соблюдать осторожность при вождении автотранспорта и занятии другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]}],"source":null},"description_toggle":false,"short_description":"Блокатор медленных кальциевых каналов (БМКК), производное 1,4-дигидропиридина, оказывает преимущественно церебровазодилатирующее и противоишемическое действие. Может предотвращать или устранять спазм сосудов, вызываемый различными вазоактивными веществами (в т.ч. серотонином, простагландинами, гистамином). Благодаря высокой липофильности проникает через ГЭБ. Практически не влияет на проводимость в синоатриальном и атриовентрикулярном узлах, а также сократимость миокарда. Рефлекторно увеличивает ЧСС в ответ на расширение сосудов. У пациентов с острыми нарушениями мозгового кровообращения нимодипин, расширяя сосуды головного мозга, улучшает мозговое кровообращение. При этом дополнительная перфузия, как правило, выражена в поврежденных областях и в участках головного мозга с недостаточным кровоснабжением. Применение нимодипина позволяет значительно снизить смертность и частоту развития ишемических неврологических расстройств на фоне субарахноидального кровоизлияния.Всасывание и распределениеАбсорбция - практически полная. Биодоступность - 8-12% (выраженный эффект \"первого прохождения\" через печень). Tmax- 0.5-1 ч, Cmaxсоставляет 31 нг/мл. 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