Осмотический диуретик. За счет повышения осмотического давле... Инструкция
Показания к применению
Отек мозга; внутричерепная гипертензия (при почечной и/или печеночной недостаточности); олигурия при острой почечной и/или печеночной недостаточности с сохраненной фильтрационной способностью почек (в составе комбинированной терапии); повышение внутриглазного давления (при неэффективности других лекарственных средств снижающих внутриглазное давление); ...
Повышенная чувствительность к компонентам препарата анурия на фоне острого некроза канальцев почек при их тяжелом поражении; дегидратация тяжелой степени тяжести; отек легких; острая левожелудочковая сердечная недостаточность; хроническая сердечная недостаточность III-IV функциональных классов согласно классификации хронической сердечной недостаточности ...
Вспомогательные вещества: натрия хлорид -9 г, вода для инъекций - до 1 л.
Ионный состав на 1 л препарата: маннит - 823 ммоль, натрия ион (Na+) - 154 ммоль, хлорида ион (Сl-) - 154 ммоль.
Теоретическая осмолярность 1131 мОсм/л.
Описание
Бесцветная прозрачная жидкость.
Фармакологические свойства
Фармакодинамика:
Осмотический диуретик. За счет повышения осмотического давления плазмы и фильтрации в почечных клубочках без последующей канальцевой реабсорбции приводит к удерживанию воды в канальцах ночек и увеличению объема мочи. Действует в основном в проксимальных канальцах не влияет на клубочковую фильтрацию. Повышая осмолярность плазмы крови вызывает перемещение жидкости из тканей (в частности глазного яблока головного мозга) в сосудистое русло. Не проникает через клеточно-тканевые барьеры (в том числе и гематоэнцефалический) не повышает содержание остаточного азота в крови. Диурез сопровождается умеренным увеличением натрийуреза без существенного влияния на выведение ионов калия. Диуретический эффект тем выше чем больше концентрация (доза). Не эффективен при нарушении фильтрационной функции почек а также при азотемии у больных с циррозом печени и с асцитом. Вызывает повышение объема циркулирующей крови.
Фармакокинетика:
Маннитол распределяется только в экстрацеллюлярном секторе поэтому его объем распределения соответствует объему внеклеточной жидкости. Подвергается незначительному метаболизму в печени с образованием гликогена. Период полу-выведения (Т1/2) около 100 минут у пациентов с почечной недостаточностью может увеличиваться до 36 часов. Выводится почками выведение регулируется клубочковой фильтрацией. После внутривенного введения 100 г маннитола 80 % от введенной дозы определяется в моче в течение 3-х часов.
Показания к применению
Отек мозга; внутричерепная гипертензия (при почечной и/или печеночной недостаточности); олигурия при острой почечной и/или печеночной недостаточности с сохраненной фильтрационной способностью почек (в составе комбинированной терапии); повышение внутриглазного давления (при неэффективности других лекарственных средств снижающих внутриглазное давление); посттрансфузионные осложнения после введения несовместимой крови; форсированный диурез при отравлениях лекарственными средствами медикаментами химическими и ядовитыми веществами (в том числе барбитуратами салицилатами); для профилактики гемолиза при операциях с экстракорпоральным кровообращением; с целью предупреждения ишемии ночек и связанной с ней острой почечной недостаточности во время хирургических операций в том числе па сердце и сосудах.
Противопоказания
Повышенная чувствительность к компонентам препарата анурия на фоне острого некроза канальцев почек при их тяжелом поражении; дегидратация тяжелой степени тяжести; отек легких; острая левожелудочковая сердечная недостаточность; хроническая сердечная недостаточность III-IV функциональных классов согласно классификации хронической сердечной недостаточности Нью-Йоркской кардиологической ассоциации (NYHA); геморрагический инсульт субарахноидальное кровоизлияние (кроме кровотечений во время трепанации черепа); нарушение проницаемости гематоэнцефалического барьера; выраженные гипонатриемия гипохлоремия и гипокалиемия; детский возраст до 12 лет (эффективность и безопасность не установлены).
С осторожностью
С осторожностью принимать в период беременности период лактации и пожилого возраста
Применение при беременности и в период грудного вскармливания
Адекватных и строго контролируемых исследований у человека не проводилось. Данные о выделении маннитола с грудным молоком отсутствуют. Применение маннитола при беременности возможно в случаях когда предполагаемая польза для матери превышает возможный риск для плода. На период применения препарата в период лактации грудное вскармливание следует прекратить.
Способ применения и дозы
Внутривенно (медленно струйно или капельно). Доза вводимого препарата зависит от возраста веса состояния пациента и сопутствующей терапии.
Профилактическая доза составляет 05 г/кг массы тела лечебная 10-15 г/кг; суточная доза не должна превышать 140-180 г.
Перед введением препарат следует подогреть до температуры 37 °С (можно на водяной бане).
Пациентам с олигурией или подозрением на почечную недостаточность следует предварительно ввести внутривенно капельно пробную дозу (200 мг/кг массы тела) в течение 3-5 минут. Ответ на тест-дозу считается достаточным если уровень диуреза в течение 2-3 часов после введения составляет 30-50 мл/ч. В случае отсутствия адекватного ответа возможно повторное введение тест-дозы. При отсутствии эффекта после повторного введения от дальнейшего применения препарата следует отказаться.
При острой почечной недостаточности суточная доза для взрослых составляет 50-180 г маннитола. В большинстве случаев адекватный терапевтический эффект достигается при применении 50-100 г в сутки. Вначале вводят в дозе 200 мг/кг в течение 5 минут; затем доза и скорость введения корректируется для поддержания диуреза на уровне 3( -50 мл/час.
Для профилактики интра- и послеоперационной ишемии почек и связанной с ней острой почечной недостаточности маннитол вводят в дозе 50-100 г во время или сразу после операции.
Для предупреждения гемолиза при операциях с искусственным кровообращением препарат вводят в аппарат искусственного кровообращения в дозе 20-40 г непосредственно перед началом перфузии.
Для снижения повышенного внутриглазного давления доза маннитола составляет 1.5-20 г/кг массы тела которую вводят инфузионно в течение 30-60 минут. При подготовке пациента к офтальмологической операции для достижения максимального эффекта маннитол в дозе 15-20 г/кг вводят за 1-15 часа до операции.
Для снижения повышенного внутричерепного давления и лечения отека мозга клинический эффект достигался с применением в дозе 025-05 г/кг которую вводили не чаще чем каждые 6-8 часов.
Для обеспечения форсированного диуреза (при отравлениях лекарственными средствами медикаментами химическими и ядовитыми веществами посттрансфузиоиных осложнениях после введения несовместимой крови) первоначальная нагрузочная доза составляет около 25 г далее дозу препарата корректируют с учетом поддержания диуреза на уровне 100 мл/час.
Побочное действие
Со стороны обмена веществ и питания: обезвоживание (основные симптомы - сухость кожи и слизистых оболочек диспепсия сухость во рту. жажда снижение артериального давления) нарушение водно-электролитного баланса (увеличение объема циркулирующей крови гипонатриемия гипокалиемия).
Со стороны желудочно-кишечного тракта: тошнота рвота.
Со стороны иммунной системы: крапивница.
Со стороны кожи и подкожных тканей: кожная сыпь.
Со стороны нервной системы: галлюцинации головная боль головокружение судороги мышечная слабость.
Со стороны почек и мочевыводящих путей: избыточный диурез осмотический нефроз задержка мочи острая почечная недостаточность.
Со стороны сердечно-сосудистой системы: тахикардия боли за грудиной повышение артериального давления сердечная недостаточность.
Со стороны органов дыхания: отек легких.
Общие нарушения и расстройства в месте введения: озноб лихорадка тромбофлебит.
Передозировка
Симптомы: возможно усиление проявлений дозозависимых побочных действий. При быстром введении особенно при сниженной клубочковой фильтрации могут появиться гинерволемия повышение внутричерепного и внутриглазного давления.
Лечение: симптоматическое.
Взаимодействие с другими лекарственными средствами
Возможно увеличение токсического действия сердечных гликозидов (связано с гипокалиемией). Потенцирует действие других диуретических средств. При сочетании с аминогликозидами возрастает риск развития ото- и нефротоксических реакций. Увеличивает выведение с мочой препаратов лития поэтому может потребоваться корректировка дозы. Может снижать эффект пероральных антикоагулянтов за счет повышения концентрации факторов свертывания крови связанного с дегидратацией. Фармацевтически несовместимыми с маннитолом являются растворы цефепима имипенема/циластатина филграстима. Добавление хлорида калия и хлорида натрия в раствор маннитола может привести к выпадению в осадок последнего.
Особые указания
Необходим контроль артериального давления диуреза концентрации электролитов в сыворотке крови (ионы калия ионы натрия ионы хлора).
В случае появления при введении препарата головной боли рвоты головокружения нарушения зрения следует прекратить введение и исключить развитие такого осложнения как субдуральное и субарахноидальное кровотечение.
Возможно применение при сердечной недостаточности (только в комбинации с "петлевыми" диуретиками) и при гипертоническом кризе с энцефалопатией.
Повторное введение препарата Маннит должно проводиться под контролем показателей водно-электролитного баланса крови.
При появлении признаков обезвоживания необходимо введение жидкостей.
Введение препарата Маннит при анурии вызванной органическими заболеваниями почек может привести к развитию отека легких.
Не следует одновременно вводить маннитол и проводить гемотрансфузию через одну инфузионную систему из-за риска развития псевдоагглютинации.
Для контроля фармацевтической совместимости при одновременном введении маннитола с другими препаратами следует провести проверку на растворимость и стабильность их в растворе маннитола.
Возможна кристаллизация препарата при хранении препарата при температуре ниже 20 °С. В случае выпадения кристаллов бутылку (контейнер) нагревают до 50-70 °С до растворения осадка. Используют после охлаждения до температуры тела если кристаллы выпадут вновь.
Влияние на способность управлять автомобилем и движущимися механизмами
Клинических исследований по оценке влияния препарата на способность к управлению транспортными средствами и механизмами не проводилось
Форма выпуска
Раствор для инфузий 150 мг/мл.
Условия хранения
При температуре не выше 25 °С. Хранить в недоступном для детей месте. Допускается замораживание при транспортировании.
Срок годности
3 года. Не применять по истечении срока годности.
Условия отпуска
По рецепту
Производитель
Публичное акционерное общество "Красфарма" (ПАО "Красфарма")
Организация, принимающая претензии потребителей
ПАО "Красфарма"
Для описания товара использована информация от партнера 36.6
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Данные о выделении маннитола с грудным молоком отсутствуют. Применение маннитола при беременности возможно в случаях когда предполагаемая польза для матери превышает возможный риск для плода. На период применения препарата в период лактации грудное вскармливание следует прекратить."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутривенно (медленно струйно или капельно). Доза вводимого препарата зависит от возраста веса состояния пациента и сопутствующей терапии."}},{"type":"paragraph","data":{"text":"Профилактическая доза составляет 05 г/кг массы тела лечебная 10-15 г/кг; суточная доза не должна превышать 140-180 г."}},{"type":"paragraph","data":{"text":"Перед введением препарат следует подогреть до температуры 37 °С (можно на водяной бане)."}},{"type":"paragraph","data":{"text":"Пациентам с олигурией или подозрением на почечную недостаточность следует предварительно ввести внутривенно капельно пробную дозу (200 мг/кг массы тела) в течение 3-5 минут. Ответ на тест-дозу считается достаточным если уровень диуреза в течение 2-3 часов после введения составляет 30-50 мл/ч. В случае отсутствия адекватного ответа возможно повторное введение тест-дозы. При отсутствии эффекта после повторного введения от дальнейшего применения препарата следует отказаться."}},{"type":"paragraph","data":{"text":"При острой почечной недостаточности суточная доза для взрослых составляет 50-180 г маннитола. В большинстве случаев адекватный терапевтический эффект достигается при применении 50-100 г в сутки. Вначале вводят в дозе 200 мг/кг в течение 5 минут; затем доза и скорость введения корректируется для поддержания диуреза на уровне 3( -50 мл/час."}},{"type":"paragraph","data":{"text":"Для профилактики интра- и послеоперационной ишемии почек и связанной с ней острой почечной недостаточности маннитол вводят в дозе 50-100 г во время или сразу после операции."}},{"type":"paragraph","data":{"text":"Для предупреждения гемолиза при операциях с искусственным кровообращением препарат вводят в аппарат искусственного кровообращения в дозе 20-40 г непосредственно перед началом перфузии."}},{"type":"paragraph","data":{"text":"Для снижения повышенного внутриглазного давления доза маннитола составляет 1.5-20 г/кг массы тела которую вводят инфузионно в течение 30-60 минут. При подготовке пациента к офтальмологической операции для достижения максимального эффекта маннитол в дозе 15-20 г/кг вводят за 1-15 часа до операции."}},{"type":"paragraph","data":{"text":"Для снижения повышенного внутричерепного давления и лечения отека мозга клинический эффект достигался с применением в дозе 025-05 г/кг которую вводили не чаще чем каждые 6-8 часов."}},{"type":"paragraph","data":{"text":"Для обеспечения форсированного диуреза (при отравлениях лекарственными средствами медикаментами химическими и ядовитыми веществами посттрансфузиоиных осложнениях после введения несовместимой крови) первоначальная нагрузочная доза составляет около 25 г далее дозу препарата корректируют с учетом поддержания диуреза на уровне 100 мл/час."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны обмена веществ и питания: обезвоживание (основные симптомы - сухость кожи и слизистых оболочек диспепсия сухость во рту. жажда снижение артериального давления) нарушение водно-электролитного баланса (увеличение объема циркулирующей крови гипонатриемия гипокалиемия)."}},{"type":"paragraph","data":{"text":"Со стороны желудочно-кишечного тракта: тошнота рвота."}},{"type":"paragraph","data":{"text":"Со стороны иммунной системы: крапивница."}},{"type":"paragraph","data":{"text":"Со стороны кожи и подкожных тканей: кожная сыпь."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: галлюцинации головная боль головокружение судороги мышечная слабость."}},{"type":"paragraph","data":{"text":"Со стороны почек и мочевыводящих путей: избыточный диурез осмотический нефроз задержка мочи острая почечная недостаточность."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: тахикардия боли за грудиной повышение артериального давления сердечная недостаточность."}},{"type":"paragraph","data":{"text":"Со стороны органов дыхания: отек легких."}},{"type":"paragraph","data":{"text":"Общие нарушения и расстройства в месте введения: озноб лихорадка тромбофлебит."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: возможно усиление проявлений дозозависимых побочных действий. При быстром введении особенно при сниженной клубочковой фильтрации могут появиться гинерволемия повышение внутричерепного и внутриглазного давления."}},{"type":"paragraph","data":{"text":"Лечение: симптоматическое."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Возможно увеличение токсического действия сердечных гликозидов (связано с гипокалиемией). Потенцирует действие других диуретических средств. При сочетании с аминогликозидами возрастает риск развития ото- и нефротоксических реакций. Увеличивает выведение с мочой препаратов лития поэтому может потребоваться корректировка дозы. Может снижать эффект пероральных антикоагулянтов за счет повышения концентрации факторов свертывания крови связанного с дегидратацией. Фармацевтически несовместимыми с маннитолом являются растворы цефепима имипенема/циластатина филграстима. Добавление хлорида калия и хлорида натрия в раствор маннитола может привести к выпадению в осадок последнего."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Необходим контроль артериального давления диуреза концентрации электролитов в сыворотке крови (ионы калия ионы натрия ионы хлора)."}},{"type":"paragraph","data":{"text":"В случае появления при введении препарата головной боли рвоты головокружения нарушения зрения следует прекратить введение и исключить развитие такого осложнения как субдуральное и субарахноидальное кровотечение."}},{"type":"paragraph","data":{"text":"Возможно применение при сердечной недостаточности (только в комбинации с \"петлевыми\" диуретиками) и при гипертоническом кризе с энцефалопатией."}},{"type":"paragraph","data":{"text":"Повторное введение препарата Маннит должно проводиться под контролем показателей водно-электролитного баланса крови."}},{"type":"paragraph","data":{"text":"При появлении признаков обезвоживания необходимо введение жидкостей."}},{"type":"paragraph","data":{"text":"Введение препарата Маннит при анурии вызванной органическими заболеваниями почек может привести к развитию отека легких."}},{"type":"paragraph","data":{"text":"Не следует одновременно вводить маннитол и проводить гемотрансфузию через одну инфузионную систему из-за риска развития псевдоагглютинации."}},{"type":"paragraph","data":{"text":"Для контроля фармацевтической совместимости при одновременном введении маннитола с другими препаратами следует провести проверку на растворимость и стабильность их в растворе маннитола."}},{"type":"paragraph","data":{"text":"Возможна кристаллизация препарата при хранении препарата при температуре ниже 20 °С. В случае выпадения кристаллов бутылку (контейнер) нагревают до 50-70 °С до растворения осадка. Используют после охлаждения до температуры тела если кристаллы выпадут вновь."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Клинических исследований по оценке влияния препарата на способность к управлению транспортными средствами и механизмами не проводилось"}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для инфузий 150 мг/мл."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"При температуре не выше 25 °С. Хранить в недоступном для детей месте. Допускается замораживание при транспортировании."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года. 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":"Публичное акционерное общество \"Красфарма\" (ПАО \"Красфарма\")"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ПАО \"Красфарма\""}}]}],"source":null},"description_toggle":false,"short_description":"Осмотический диуретик. За счет повышения осмотического давления плазмы и фильтрации в почечных клубочках без последующей канальцевой реабсорбции приводит к удерживанию воды в канальцах ночек и увеличению объема мочи. Действует в основном в проксимальных канальцах не влияет на клубочковую фильтрацию. Повышая осмолярность плазмы крови вызывает перемещение жидкости из тканей (в частности глазного яблока головного мозга) в сосудистое русло. Не проникает через клеточно-тканевые барьеры (в том числе и гематоэнцефалический) не повышает содержание остаточного азота в крови. Диурез сопровождается умеренным увеличением натрийуреза без существенного влияния на выведение ионов калия. Диуретический эффект тем выше чем больше концентрация (доза). Не эффективен при нарушении фильтрационной функции почек а также при азотемии у больных с циррозом печени и с асцитом. Вызывает повышение объема циркулирующей крови. Маннитол распределяется только в экстрацеллюлярном секторе поэтому его объем распределения соответствует объему внеклеточной жидкости. Подвергается незначительному метаболизму в печени с образованием гликогена. Период полу-выведения (Т1/2) около 100 минут у пациентов с почечной недостаточностью может увеличиваться до 36 часов. Выводится почками выведение регулируется клубочковой фильтрацией. 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