Аперомид является бисчетвертичным аммониевым соединением сте... Инструкция
Показания к применению
Релаксация скелетной мускулатуры и облегчение проведения эндотрахеальной интубации при операциях и диагностических процедурах в условиях искусственной вентиляции легких.
Противопоказания
Гиперчувствительность. Возраст до 3 мес (дозы у детей в возрасте до 3 мес не определены).
Инструкция
Состав
Бромид пипекурония, маннитол.
Описание
Лиофилизат Аперомид - масса белого или белого с желтоватым оттенком цвета используется для приготовления раствора для внутривенного введения при подготовительных процедурах.
Фармакологические свойства
Аперомид является бисчетвертичным аммониевым соединением стероидной структуры, недеполяризующим миорелаксантом. Конкурентно блокирует N-холинорецепторы скелетных мышц, предотвращая вызываемую ацетилхолином деполяризацию концевой пластинки и возбуждение мышечного волокна. Нервно-мышечная блокада достигается в течение 5,5-6 мин после введения разовой дозы 50 мкг/кг и 3-5 мин - дозы 70-85 мкг/кг. Проведение интубации трахеи возможно уже через 2,5-3 мин после введения 70-100 мкг/кг, при использовании меньшей дозы время достижения уровня миорелаксации, достаточной для проведения интубации, удлиняется. Продолжительность эффекта находится в зависимости от дозы и типа проводимой анестезии. При использовании рекомендуемых доз эффективная релаксация скелетной мускулатуры сохраняется в течение 50-70 мин. В средних дозах не вызывает существенных изменений в деятельности сердечно-сосудистой системы, в больших дозах обладает слабой ганглиоблокирующей, М-холиноблокирующей активностью.
Показания к применению
Релаксация скелетной мускулатуры и облегчение проведения эндотрахеальной интубации при операциях и диагностических процедурах в условиях искусственной вентиляции легких.
Противопоказания
Гиперчувствительность. Возраст до 3 мес (дозы у детей в возрасте до 3 мес не определены).
Применение при беременности и в период грудного вскармливания
Опыт, достаточный для доказательства безопасности пипекурония бромида для беременных и плода, отсутствует. В случае применения для общей анестезии при кесаревом сечении бромид пипекурония не изменяет показатель Апгар, мышечный тонус и кардиоваскулярную адаптацию новорожденных. Данные по применению пипекурония бромида в период лактации отсутствуют.
Способ применения и дозы
Только внутривенно! Непосредственно перед введением содержимое ампулы разводят водой для инъекций или 0,9 % раствором натрия хлорида. Взрослым и детям от 14 лет и старше для полной миорелаксации вводят 70-80 мкг/кг. Максимальная разовая доза - 100 мкг/кг. Для поддержания миорелаксации в течение длительного времени следует вводить повторно в дозах, составляющих 15 % от первоначальной (10-15 мкг/кг). При проведении интубации на фоне суксаметония начальная доза - 40-50 мкг/кг. При хронической почечной недостаточности величина вводимой дозы определяется значениями клиренса креатинина (КК): при КК ниже 100 мл/мин вводят 85 мкг/кг, при КК ниже 80 мл/мин - 70 мкг/кг, при КК ниже 60 мл/мин - 55 мкг/кг, при КК менее 40 мл/мин - 50 мкг/кг. Дозы у детей в возрасте от 3 мес до 12 мес - 40 мкг/кг (обеспечивает мышечную релаксацию продолжительностью от 10 до 44 мин), от 1 года до 14 лет - 57 мкг/кг (мышечная релаксация - от 18 до 52 мин).
Побочное действие
Со стороны опорно-двигательного аппарата: слабость скелетной мускулатуры после прекращения миорелаксации, мышечная атрофия. Со стороны нервной системы: угнетение центральной нервной системы, гипестезия. Со стороны дыхательной системы: угнетение дыхания, гипопноэ, апноэ после прекращения миорелаксации, ателектаз легкого, ларингоспазм. Со стороны сердечно-сосудистой системы: брадикардия, снижение артериального давления, ишемия миокарда (вплоть до развития инфаркта миокарда) и мозга, фибрилляция предсердий, желудочковая экстрасистолия. Со стороны органов кроветворения и системы гемостаза: уменьшение частичного тромбопластинового и протромбинового времени, тромбоз. Со стороны мочевыводящей системы: анурия. Лабораторные показатели: гиперкреатининемия, гипогликемия, гиперкалиемия. Аллергические реакции: кожная сыпь, крапивница.
Передозировка
Симптомы: продолжительный паралич скелетной мускулатуры и апноэ, выраженное снижение артериального давления, шок. Лечение: неостигмин 1-3 мг в комбинации с атропином 0,5-1,25 мг или галантамином 10-30 мг (на фоне продолжающейся искусственной вентиляции легких).
Особые указания
Применяют только под наблюдением опытного анестезиолога, при наличии условий для проведения интубации, искусственной вентиляции легких, оксигенотерапии. Необходим тщательный мониторинг во время операции и в раннем послеоперационном периоде для поддержания жизненных функций до полного восстановления адекватного жизненного тонуса. При расчете дозы следует учитывать применяемую технику анестезии, возможные взаимодействия с препаратами, вводимыми до или во время анестезии, состояние и чувствительность больного. Пациентам с расстройствами нервно-мышечной передачи, ожирением, почечной недостаточностью, заболеваниями печени и желчевыводящих путей, при указаниях в анамнезе на перенесенный полиомиелит необходимо назначать препарат в меньших дозах. Некоторые состояния (гипокалиемия, дигитализация, гипермагниемия, гипокальциемия, гипопротеинемия, дегидратация, ацидоз, гиперкапния, кахексия, гипотермия) могут способствовать удлинению или усилению эффекта. Перед началом анестезии следует провести коррекцию электролитного баланса, кислотнощелочного состояния и устранить дегидратацию. Беременным женщинам, которые для лечения токсикоза принимали соли магния (способные усиливать нервно-мышечную блокаду), пипекурония бромид назначают в уменьшенных дозах. Эффективность и безопасность применения в неонатальном периоде не изучены. Терапевтический эффект у грудных детей от 3 мес до 1 года практически не отличается от такового у взрослых. Дети в возрасте от 1 года до 14 лет менее чувствительны к пипекурония бромиду и продолжительность терапевтического эффекта у них короче, чем у взрослых и грудных детей (младше 1 года).
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