симптоматическое лечение психоорганического синдрома сопровождающегося снижением памяти снижением концентрации внимания и активности изменением настроения расстройством поведения нарушением походки;
лечение головокружения (вертиго) и связанных с ним расстройств равновесия (за исключением головокружений вазомоторного и психогенного происхождения);
кортикальная миоклония (монотерапия или в составе комплексной терапии);
Раствор для внутривенного и внутримышечного введения.
Состав
активное вещество - пирацетам 200 мг;
вспомогательные вещества: натрия ацетата тригидрат - 1 мг, кислота уксусная разведенная 30 % до pH 5,8, вода для инъекций - до 1 мл.
Описание
Прозрачная бесцветная или слегка окрашенная жидкость.
Фармакотерапевтическая группа
Ноотропное средство
Фармакологические свойства
Фармакодинамика:
Циклическое производное гамма-аминомасляной кислоты ноотропное средство; воздействует непосредственно на головной мозг улучшая когнитивные (познавательные) процессы такие как способность к обучению память внимание а также умственную работоспособность. Оказывает влияние на центральную нервную систему различными путями: изменяет скорость распространения возбуждения в головном мозге улучшает метаболические процессы в нервных клетках улучшает микроциркуляцию воздействует на реологические характеристики крови не оказывая при этом вазодилатирующего действия.
Улучшает связь между полушариями головного мозга и синаптическую проводимость в неокортикальных структурах улучшает мозговой кровоток.
Ингибирует агрегацию тромбоцитов и восстанавливает конфигурационные свойства наружной мембраны ригидных эритроцитов а также способность последних к пассажу через сосуды микроциркуляторного русла. В дозе 9.6 г снижает концентрацию фибриногена и фактора Виллебранда на 30-40% и удлиняет время кровотечения.
Оказывает протекторное и восстанавливающее действие при нарушении функции головного мозга вследствие гипоксии и интоксикации.
Снижает выраженность и длительность вестибулярного нистагма.
Фармакокинетика:
Проникает через гематоэнцефалический и плацентарный барьеры удаляется при гемодиализе. Объем распределения составляет 06 л/кг. При исследовании на животных пирацетам избирательно накапливается в тканях коры головного мозга преимущественно в лобных теменных и затылочных долях в мозжечке и базальных ядрах. Не связывается с белками плазмы крови не метаболизируется в организме и выделяется почками в неизменном виде путем почечной фильтрации. Почечный клиренс пирацетама у здоровых добровольцев составляет 86 мл/мин. Период полувыведения препарата из плазмы крови составляет 4-5 часов из спинномозговой жидкости - 85 часов период полувыведения удлиняется при почечной недостаточности (при терминальной хронической почечной недостаточности - до 59 ч). Фармакокинетика пирацетама не изменяется у больных с печеночной недостаточностью.
Показания к применению
У взрослых:
симптоматическое лечение психоорганического синдрома сопровождающегося снижением памяти снижением концентрации внимания и активности изменением настроения расстройством поведения нарушением походки;
лечение головокружения (вертиго) и связанных с ним расстройств равновесия (за исключением головокружений вазомоторного и психогенного происхождения);
кортикальная миоклония (монотерапия или в составе комплексной терапии);
Применение при беременности и в период грудного вскармливания
Контролируемых исследований на беременных не проводилось. Пирацетам проникает через плацентарный барьер и в грудное молоко. Концентрация препарата у новорожденных достигает 70-90 % от концентрации его в крови у матери. Пирацетам не должен назначаться во время беременности. Следует воздержаться от грудного вскармливания при назначении женщине пирацетама.
Способ применения и дозы
Внутривенно струйно или капельно внутримышечно.
Парентеральное введение пирацетама назначается при невозможности применения пероральных форм выпуска препарата (таблетки капсулы раствор для приема внутрь) например при затруднении глотания или когда пациент без сознания. При этом предпочтительным является внутривенное введение.
Внутривенная инфузия суточной дозы выполняется через катетер с постоянной скоростью на протяжении 24 часов в сутки (например при коме или в начальной стадии лечения тяжелой миоклонии). Предварительно препарат разводят в одном из совместимых инфузионных растворов: декстрозы 5% 10% или 20% фруктозы 5% 10% или 20% натрия хлорида 09% декстрана [средняя молекулярная масса 30000-40000] (10% в растворе натрия хлорида 09%) Рингера маннитола 20%. Общий объем раствора предназначенный для введения определяется с учетом клинических показаний и состояния пациента. Болюсное внутривенное введение (например неотложное лечение серповидно-клеточной анемии) выполняется в течение не менее 2 минут суточная доза при этом распределяется на несколько введений (2-4) с равномерными интервалами так чтобы доза на одно введение не превышала 3 г.
Внутримышечно препарат вводится если введение через вену затруднено или пациент перевозбужден. Однако количество препарата которое может быть введено внутримышечно ограничено особенно у детей и пациентов со сниженной массой тела. Кроме того введение препарата внутримышечно может быть болезненным из-за большого объема жидкости. Объем раствора вводимого внутримышечно не может превышать 5 мл. Кратность введения препарата аналогична таковой при его внутривенном или пероральном применении.
При появлении возможности переходят на пероральный прием препарата (см. инструкции по медицинскому применению соответствующих форм выпуска препарата).
Продолжительность лечения определяется врачом в зависимости от заболевания и с учетом динамики симптомов.
Симптоматическое лечение психоорганического синдрома: по 4.8 г/сут в течение первой недели затем переходят на поддерживающую дозу - 1.2-2.4 г/сут.
Лечение головокружения и связанных с ним нарушений равновесия: по 2.4-4.8 г/сут.
Лечение кортикальной миоклонии: начинают с дозы 7.2 г/сут каждые 3-4 дня дозу увеличивают на 4.8 г/сутки до достижения максимальной дозы 24 г/сут. Лечение продолжают на протяжении всего периода заболевания. Каждые 6 месяцев следует пробовать снижать дозу или отменить препарат постепенно снижая дозу на 1.2 г/сут каждые 2 дня. При незначительном терапевтическом эффекте или его отсутствии лечение прекращают.
При купировании серповидно-клеточного вазоокклюзионного криза (у взрослых и детей): в/в по 300 мг/кг/сут разделенные на 4 равные дозы.
Лечение дислексии у детей старше 8 лет (в комплексе с другими методами лечения) - по 3.2 г разделенных на 2 равные дозы.
При хронической почечной недостаточности легкой степени (клиренс креатинина 50-79 мл/мин) - вводят 2/3 суточной дозы разделенной на 2-3 приема; средней (клиренс креатинина 30-49 мл/мин) - 1/3 дозы разделенной на 2 приема; тяжелой (клиренс креатинина 20-30 мл/мин) - 1/6 дозы однократно.
Побочное действие
Со стороны ЦНС: двигательная расторможенность раздражительность сонливость депрессия астения головная боль бессонница психическое возбуждение нарушение равновесия атаксия обострение течения эпилепсии тревога галлюцинации спутанность сознания.
Со стороны пищеварительной системы: тошнота рвота диарея абдоминальная боль.
Со стороны обмена веществ: повышение массы тела.
Со стороны органов чувств: вертиго.
Со стороны кожных покровов: дерматит зуд крапивница.
Аллергические реакции: гиперчувствительность; анафилактические реакции ангионевротический отек.
Местные реакции: боль в месте введения тромбофлебит.
Прочие: лихорадка снижение артериального давления.
Передозировка
Симптомы: абдоминальная боль диарея с примесью крови.
Взаимодействие с другими лекарственными средствами
При одновременном применении с йодсодержащими гормонами щитовидной железы может возникнуть спутанность сознания раздражительность и нарушение сна.
В высоких дозах (9.6 г/сут) у пациентов с венозным тромбозом повышает антикоагулянтный эффект непрямых антикоагулянтов (более выраженное снижение агрегации тромбоцитов содержания фибриногена фактора Виллебранда вязкости крови и плазмы).
С осторожностью назначают пациентам с нарушением гемостаза перед предстоящими обширными хирургическими вмешательствами или у пациентов с симптомами тяжелого кровотечения.
При лечении кортикальной миоклонии следует избегать резкого прекращения лечения т.к. это может вызвать возобновление приступов.
При купировании серповидно-клеточного вазоокклюзионного криза доза менее 160 мг/кг или нерегулярный прием препарата могут вызвать рецидив криза.
При длительной терапии у пациентов пожилого возраста рекомендуется регулярный контроль функции почек при необходимости проводят коррекцию дозы в зависимости от клиренса креатинина.
Проникает через фильтрующие мембраны аппаратов для гемодиализа.
Влияние на способность управлять автомобилем и движущимися механизмами
В период лечения необходимо соблюдать осторожность при управлении транспортными средствами и занятии др. потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Раствор для внутривенного и внутримышечного введения 200 мг/мл.
Условия хранения
В сухом защищенном от света месте при температуре не выше 25 °С.
Хранить в недоступном для детей месте.
Срок годности
5 лет. Не использовать по истечении срока годности указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Открытое акционерное общество "Фармстандарт-Уфимский витаминный завод" (ОАО "Фармстандарт-УфаВИТА")
Организация, принимающая претензии потребителей
ОАО "Фармстандарт-УфаВИТА"
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свойства","slug":"pharmacologic_effects","body":[{"type":"header","data":{"text":"Фармакодинамика:","level":3}},{"type":"paragraph","data":{"text":"Циклическое производное гамма-аминомасляной кислоты ноотропное средство; воздействует непосредственно на головной мозг улучшая когнитивные (познавательные) процессы такие как способность к обучению память внимание а также умственную работоспособность. Оказывает влияние на центральную нервную систему различными путями: изменяет скорость распространения возбуждения в головном мозге улучшает метаболические процессы в нервных клетках улучшает микроциркуляцию воздействует на реологические характеристики крови не оказывая при этом вазодилатирующего действия."}},{"type":"paragraph","data":{"text":"Улучшает связь между полушариями головного мозга и синаптическую проводимость в неокортикальных структурах улучшает мозговой кровоток."}},{"type":"paragraph","data":{"text":"Ингибирует агрегацию тромбоцитов и восстанавливает конфигурационные свойства наружной мембраны ригидных эритроцитов а также способность последних к пассажу через сосуды микроциркуляторного русла. В дозе 9.6 г снижает концентрацию фибриногена и фактора Виллебранда на 30-40% и удлиняет время кровотечения."}},{"type":"paragraph","data":{"text":"Оказывает протекторное и восстанавливающее действие при нарушении функции головного мозга вследствие гипоксии и интоксикации."}},{"type":"paragraph","data":{"text":"Снижает выраженность и длительность вестибулярного нистагма."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Проникает через гематоэнцефалический и плацентарный барьеры удаляется при гемодиализе. Объем распределения составляет 06 л/кг. При исследовании на животных пирацетам избирательно накапливается в тканях коры головного мозга преимущественно в лобных теменных и затылочных долях в мозжечке и базальных ядрах. Не связывается с белками плазмы крови не метаболизируется в организме и выделяется почками в неизменном виде путем почечной фильтрации. Почечный клиренс пирацетама у здоровых добровольцев составляет 86 мл/мин. Период полувыведения препарата из плазмы крови составляет 4-5 часов из спинномозговой жидкости - 85 часов период полувыведения удлиняется при почечной недостаточности (при терминальной хронической почечной недостаточности - до 59 ч). Фармакокинетика пирацетама не изменяется у больных с печеночной недостаточностью."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"У взрослых:"}},{"type":"list","data":{"style":"ordered","items":["симптоматическое лечение психоорганического синдрома сопровождающегося снижением памяти снижением концентрации внимания и активности изменением настроения расстройством поведения нарушением походки;","лечение головокружения (вертиго) и связанных с ним расстройств равновесия (за исключением головокружений вазомоторного и психогенного происхождения);","кортикальная миоклония (монотерапия или в составе комплексной терапии);","купирование серповидно-клеточного вазоокклюзионного криза."]}},{"type":"paragraph","data":{"text":"У детей:"}},{"type":"list","data":{"style":"ordered","items":["лечение дислексии у детей с 8 лет в комплексе с другими методами","купирование серповидно-клеточного вазоокклюзионного криза."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность тяжелая хроническая почечная недостаточность (клиренс креатинина менее 20 мл/мин) геморрагический инсульт психомоторное возбуждение хорея Гентингтона беременность период лактации."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Нарушение гемостаза обширные хирургические вмешательства тяжелое кровотечение хроническая почечная недостаточность (клиренс креатинина 20-80 мл/мин)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Контролируемых исследований на беременных не проводилось. Пирацетам проникает через плацентарный барьер и в грудное молоко. Концентрация препарата у новорожденных достигает 70-90 % от концентрации его в крови у матери. Пирацетам не должен назначаться во время беременности. Следует воздержаться от грудного вскармливания при назначении женщине пирацетама."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутривенно струйно или капельно внутримышечно."}},{"type":"paragraph","data":{"text":"Парентеральное введение пирацетама назначается при невозможности применения пероральных форм выпуска препарата (таблетки капсулы раствор для приема внутрь) например при затруднении глотания или когда пациент без сознания. При этом предпочтительным является внутривенное введение."}},{"type":"paragraph","data":{"text":"Внутривенная инфузия суточной дозы выполняется через катетер с постоянной скоростью на протяжении 24 часов в сутки (например при коме или в начальной стадии лечения тяжелой миоклонии). Предварительно препарат разводят в одном из совместимых инфузионных растворов: декстрозы 5% 10% или 20% фруктозы 5% 10% или 20% натрия хлорида 09% декстрана [средняя молекулярная масса 30000-40000] (10% в растворе натрия хлорида 09%) Рингера маннитола 20%. Общий объем раствора предназначенный для введения определяется с учетом клинических показаний и состояния пациента. Болюсное внутривенное введение (например неотложное лечение серповидно-клеточной анемии) выполняется в течение не менее 2 минут суточная доза при этом распределяется на несколько введений (2-4) с равномерными интервалами так чтобы доза на одно введение не превышала 3 г."}},{"type":"paragraph","data":{"text":"Внутримышечно препарат вводится если введение через вену затруднено или пациент перевозбужден. Однако количество препарата которое может быть введено внутримышечно ограничено особенно у детей и пациентов со сниженной массой тела. Кроме того введение препарата внутримышечно может быть болезненным из-за большого объема жидкости. Объем раствора вводимого внутримышечно не может превышать 5 мл. Кратность введения препарата аналогична таковой при его внутривенном или пероральном применении."}},{"type":"paragraph","data":{"text":"При появлении возможности переходят на пероральный прием препарата (см. инструкции по медицинскому применению соответствующих форм выпуска препарата)."}},{"type":"paragraph","data":{"text":"Продолжительность лечения определяется врачом в зависимости от заболевания и с учетом динамики симптомов."}},{"type":"paragraph","data":{"text":"Симптоматическое лечение психоорганического синдрома: по 4.8 г/сут в течение первой недели затем переходят на поддерживающую дозу - 1.2-2.4 г/сут."}},{"type":"paragraph","data":{"text":"Лечение головокружения и связанных с ним нарушений равновесия: по 2.4-4.8 г/сут."}},{"type":"paragraph","data":{"text":"Лечение кортикальной миоклонии: начинают с дозы 7.2 г/сут каждые 3-4 дня дозу увеличивают на 4.8 г/сутки до достижения максимальной дозы 24 г/сут. Лечение продолжают на протяжении всего периода заболевания. Каждые 6 месяцев следует пробовать снижать дозу или отменить препарат постепенно снижая дозу на 1.2 г/сут каждые 2 дня. При незначительном терапевтическом эффекте или его отсутствии лечение прекращают."}},{"type":"paragraph","data":{"text":"При купировании серповидно-клеточного вазоокклюзионного криза (у взрослых и детей): в/в по 300 мг/кг/сут разделенные на 4 равные дозы."}},{"type":"paragraph","data":{"text":"Лечение дислексии у детей старше 8 лет (в комплексе с другими методами лечения) - по 3.2 г разделенных на 2 равные дозы."}},{"type":"paragraph","data":{"text":"При хронической почечной недостаточности легкой степени (клиренс креатинина 50-79 мл/мин) - вводят 2/3 суточной дозы разделенной на 2-3 приема; средней (клиренс креатинина 30-49 мл/мин) - 1/3 дозы разделенной на 2 приема; тяжелой (клиренс креатинина 20-30 мл/мин) - 1/6 дозы однократно."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны ЦНС: двигательная расторможенность раздражительность сонливость депрессия астения головная боль бессонница психическое возбуждение нарушение равновесия атаксия обострение течения эпилепсии тревога галлюцинации спутанность сознания."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: тошнота рвота диарея абдоминальная боль."}},{"type":"paragraph","data":{"text":"Со стороны обмена веществ: повышение массы тела."}},{"type":"paragraph","data":{"text":"Со стороны органов чувств: вертиго."}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов: дерматит зуд крапивница."}},{"type":"paragraph","data":{"text":"Аллергические реакции: гиперчувствительность; анафилактические реакции ангионевротический отек."}},{"type":"paragraph","data":{"text":"Местные реакции: боль в месте введения тромбофлебит."}},{"type":"paragraph","data":{"text":"Прочие: лихорадка снижение артериального давления."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: абдоминальная боль диарея с примесью крови."}},{"type":"paragraph","data":{"text":"Лечение: индукция рвоты промывание желудка симптоматическая терапия гемодиализ (эффективность 50-60%). Специфического антидота нет."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении с йодсодержащими гормонами щитовидной железы может возникнуть спутанность сознания раздражительность и нарушение сна."}},{"type":"paragraph","data":{"text":"В высоких дозах (9.6 г/сут) у пациентов с венозным тромбозом повышает антикоагулянтный эффект непрямых антикоагулянтов (более выраженное снижение агрегации тромбоцитов содержания фибриногена фактора Виллебранда вязкости крови и плазмы)."}},{"type":"paragraph","data":{"text":"Фармацевтически совместим с растворами декстрозы (5% 10% 20%) фруктозы (5% 10% 20%) 0.9% раствором хлорида натрия раствором Рингера 20% раствором маннитола гидроксиэтилкрахмалом (6% 10%)."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"С осторожностью назначают пациентам с нарушением гемостаза перед предстоящими обширными хирургическими вмешательствами или у пациентов с симптомами тяжелого кровотечения."}},{"type":"paragraph","data":{"text":"При лечении кортикальной миоклонии следует избегать резкого прекращения лечения т.к. это может вызвать возобновление приступов."}},{"type":"paragraph","data":{"text":"При купировании серповидно-клеточного вазоокклюзионного криза доза менее 160 мг/кг или нерегулярный прием препарата могут вызвать рецидив криза."}},{"type":"paragraph","data":{"text":"При длительной терапии у пациентов пожилого возраста рекомендуется регулярный контроль функции почек при необходимости проводят коррекцию дозы в зависимости от клиренса креатинина."}},{"type":"paragraph","data":{"text":"Проникает через фильтрующие мембраны аппаратов для гемодиализа."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В период лечения необходимо соблюдать осторожность при управлении транспортными средствами и занятии др. потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для внутривенного и внутримышечного введения 200 мг/мл."}}]},{"id":19,"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":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"5 лет. Не использовать по истечении срока годности указанного на упаковке."}}]},{"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":"Открытое акционерное общество \"Фармстандарт-Уфимский витаминный завод\" (ОАО \"Фармстандарт-УфаВИТА\")"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ОАО \"Фармстандарт-УфаВИТА\""}}]}],"source":null},"description_toggle":false,"short_description":"Циклическое производное гамма-аминомасляной кислоты ноотропное средство; воздействует непосредственно на головной мозг улучшая когнитивные (познавательные) процессы такие как способность к обучению память внимание а также умственную работоспособность. Оказывает влияние на центральную нервную систему различными путями: изменяет скорость распространения возбуждения в головном мозге улучшает метаболические процессы в нервных клетках улучшает микроциркуляцию воздействует на реологические характеристики крови не оказывая при этом вазодилатирующего действия. Улучшает связь между полушариями головного мозга и синаптическую проводимость в неокортикальных структурах улучшает мозговой кровоток. Ингибирует агрегацию тромбоцитов и восстанавливает конфигурационные свойства наружной мембраны ригидных эритроцитов а также способность последних к пассажу через сосуды микроциркуляторного русла. В дозе 9.6 г снижает концентрацию фибриногена и фактора Виллебранда на 30-40% и удлиняет время кровотечения. Оказывает протекторное и восстанавливающее действие при нарушении функции головного мозга вследствие гипоксии и интоксикации. Снижает выраженность и длительность вестибулярного нистагма. Проникает через гематоэнцефалический и плацентарный барьеры удаляется при гемодиализе. Объем распределения составляет 06 л/кг. При исследовании на животных пирацетам избирательно накапливается в тканях коры головного мозга преимущественно в лобных теменных и затылочных долях в мозжечке и базальных ядрах. Не связывается с белками плазмы крови не метаболизируется в организме и выделяется почками в неизменном виде путем почечной фильтрации. Почечный клиренс пирацетама у здоровых добровольцев составляет 86 мл/мин. Период полувыведения препарата из плазмы крови составляет 4-5 часов из спинномозговой жидкости - 85 часов период полувыведения удлиняется при почечной недостаточности (при терминальной хронической почечной недостаточности - до 59 ч). 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