Анальгин ЭкстраКап Капсулы, 10 шт, 500 мг

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Согласно результатам исследований метамизол и его активный метаболит (4Ы-метиламиноантипирин) обладают центральным и периферическим механизмом действия. Неселективно ингибирует циклооксигеназу и снижает образование простагландинов из арахидоновой кислоты."}},{"type":"paragraph","data":{"text":"Фармакокинетика:"}},{"type":"paragraph","data":{"text":"После приема внутрь метамизол натрия гидролизуется до фармакологически активного 4N-метиламиноантипирина (МАА). Биодоступность МАА после приема внутрь составляет 90 %, что несколько выше, чем при парентеральном введении. Одновременный прием пищи не оказывает значимого влияния на фармакокинетику метамизола натрия."}},{"type":"paragraph","data":{"text":"Клиническая эффективность определяется преимущественно МАА, а также в меньшей степени метаболитами 4N-аминоантипирина (АА). Величина площади под кривой \"концентрация- время\" (AUC) АА составляют 25 % от этой величины для МАА. Метаболиты 4N- ацетиламиноантипирин (ААА) и 4N-формиламиноантипирин (ФАА) не обладают фармакологической активностью. Всем метаболитам присуща нелинейная фармакокинетика. Клиническая значимость этого явления не известна. При краткосрочном применении кумуляция метаболитов не играет большой роли."}},{"type":"paragraph","data":{"text":"Метамизол натрия проникает через плаценту. Метаболиты метамизола проникают в грудное молоко. Связь с белками плазмы МАА составляет 58 %, АА - 48 %, ФАА - 18 % и ААА - 14 %. После однократного приема внутрь 85 % дозы обнаруживается в моче в виде метаболитов, из них 3±1 % - МАА, 6±3 % - АА, 26±8 % - ААА и 23±4 % - ФАА. Почечный клиренс после однократного приема 1 г метамизола натрия внутрь для МАА равен 5±2 мл/мин, АА - 38±13 мл/мин, ААА - 61 ±8 мл/мин и ФАА - 49±5 мл/мин. Соответствующие периоды полувыведения из плазмы для МАА - 2,7±0,5 ч, АА - 3,7±1,3 ч, ААА - 9,5±1,5 ч и ФАА - 11,2±1,5 ч."}},{"type":"paragraph","data":{"text":"Пожилые пациенты"}},{"type":"paragraph","data":{"text":"У пожилых пациентов AUC повышается в 2-3 раза. У пациентов с циррозом печени периоды полувыведения МАА и ФАА при однократном приеме препарата увеличиваются примерно в 3 раза, тогда как периоды полувыведения АА и ААА не следуют той же закономерности. У таких пациентов следует избегать применения высоких доз."}},{"type":"paragraph","data":{"text":"Нарушение функции почек"}},{"type":"paragraph","data":{"text":"Согласно имеющимся данным при почечной недостаточности скорость выведения некоторых метаболитов (ААА и ФАА) снижается. У таких пациентов следует избегать применения высоких доз."}}]},{"id":7,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Тяжелый острый или хронический болевой синдром при травмах и послеоперационном болевом синдроме, при коликах, при онкологических заболеваниях и других состояниях, где противопоказаны другие терапевтические меры."}},{"type":"paragraph","data":{"text":"Лихорадка, устойчивая к другим методам лечения."}}]},{"id":8,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к метамизолу натрия и другим производным пиразолона, а также к пиразолидинам, например, фенилбутазону (включая пациентов, перенесших агранулоцитоз вследствие применения этих препаратов), или другим компонентам препарата;"}},{"type":"paragraph","data":{"text":"- Анальгетическая бронхиальная астма или непереносимость анальгетиков (по типу крапивница-ангионевротический отек), т.е. пациенты с бронхоспазмом или другими формами анафилактоидных реакций (например, крапивница, ринит, ангионевротический отек) в ответ на применение салицилатов, парацетамола или нестероидных противовоспалительных препаратов, таких как диклофенак, ибупрофен, индометацин или напроксен;"}},{"type":"paragraph","data":{"text":"- Нарушение костномозгового кроветворения (например, после цитостатической терапии) или заболевания кроветворных органов;"}},{"type":"paragraph","data":{"text":"- Наследственный дефицит глюкозо-6-фосфатдегидрогеназы (гемолиз);"}},{"type":"paragraph","data":{"text":"- Острая интермиттирующая печеночная порфирия (риск развития приступов порфирии);"}},{"type":"paragraph","data":{"text":"- Беременность и период грудного вскармливания;"}},{"type":"paragraph","data":{"text":"- Детский возраст до 15 лет."}},{"type":"paragraph","data":{"text":"С осторожностью:"}},{"type":"paragraph","data":{"text":"- Артериальная гипотензия (систолическое артериальное давление ниже 100 мм. рт. ст.), снижение объема циркулирующей крови, нестабильность гемодинамики (инфаркт миокарда, множественная травма, начинающийся шок), начинающаяся сердечная недостаточность, высокая лихорадка (повышенный риск резкого снижения артериального давления)."}},{"type":"paragraph","data":{"text":"- Заболевания, при которых значительное снижение артериального давления может обладать повышенной опасностью (пациенты с тяжелой ишемической болезнью сердца и стенозом артерий головного мозга)."}},{"type":"paragraph","data":{"text":"- Хроническое злоупотребление алкоголем."}},{"type":"paragraph","data":{"text":"- Бронхиальная астма, особенно в сочетании с сопутствующим полипозным риносинуситом; хроническая крапивница и другие виды атопии (аллергических заболеваний, в развитии которых значительная роль принадлежит наследственной предрасположенности к сенсибилизации: поллинозы, аллергический ринит и т.п.) (повышенный риск развития анафилактических/анафилактоидных реакций)."}},{"type":"paragraph","data":{"text":"- Непереносимость алкоголя (реакция даже на незначительные количества определенных алкогольных напитков с такими симптомами как зуд, слезотечение и выраженное покраснение лица) (повышенный риск развития анафилактических/анафилактоидных реакций)."}},{"type":"paragraph","data":{"text":"- Непереносимость красителей (например, тартразина) или консервантов (например, бензоатов) (повышенный риск развития анафилактических/анафилактоидных реакций)."}},{"type":"paragraph","data":{"text":"- Тяжелые нарушения функции печени и почек (рекомендуется применение низких доз в связи с возможностью замедления выведения метамизола натрия)."}},{"type":"paragraph","data":{"text":"Если у Вас одно из перечисленных заболеваний/состояний, перед приемом препарата обязательно проконсультируйтесь с врачом."}}]},{"id":10,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Применение при беременности и в период грудного вскармливания противопоказано."}},{"type":"paragraph","data":{"text":"Беременность"}},{"type":"paragraph","data":{"text":"Метамизол натрия проникает через плацентарный барьер. Данные о применении метами­зола натрия во время беременности ограничены. По результатам доклинических исследо­ваний тератогенное действие метамизола натрия у крыс и кроликов не обнаружено, в вы­соких дозах наблюдалась фетотоксичность."}},{"type":"paragraph","data":{"text":"Поскольку адекватных данных о применении у людей нет, метамизол натрия не должен приниматься в первом триместре беременности, во втором триместре беременности метамизол натрия может применяться, только если ожидаемая польза для матери превышает потенциальный риск для плода."}},{"type":"paragraph","data":{"text":"Несмотря на то, что метамизол натрия слабо ингибирует синтез простагландинов, нельзя исключить воз­можность преждевременного (внутриутробного) закрытия артериального (Боталова) про­тока, а также перинатальных осложнений, обусловленных нарушением агрегации тромбо­цитов у матери или новорожденного. Поэтому метамизол натрия противопоказан в треть­ем триместре беременности."}},{"type":"paragraph","data":{"text":"Период лактации"}},{"type":"paragraph","data":{"text":"Метаболиты метамизола натрия проникают в грудное молоко, поэтому при применении препарата, а также в течение 48 ч после приема последней дозы необходимо прекратить кормление грудью."}}]},{"id":11,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Доза зависит от выраженности боли или лихорадки, а также индивидуальной восприим­чивости к действию анальгетиков."}},{"type":"paragraph","data":{"text":"Капсулы следует проглатывать целиком, запивая достаточным количеством жидкости (например, стаканом воды)."}},{"type":"paragraph","data":{"text":"Изначально следует применять наименьшую эффективную дозу."}},{"type":"paragraph","data":{"text":"Максимальное действие препарата развивается, как правило, спустя 30-60 мин после при­ема внутрь."}},{"type":"paragraph","data":{"text":"Однократная доза для взрослых и подростков старше 15 лет (с массой тела >53 кг) состав­ляет 500-1000 мг (1-2 капсулы). При недостаточном эффекте однократную дозу допуска­ется принимать до 4 раз в сутки. Максимальная суточная доза - 4000 мг (8 капсул). Продолжительность приема не более 5 дней в качестве обезболивающего средства и не более 3 дней в качестве жаропонижающего."}},{"type":"paragraph","data":{"text":"Пожилые пациенты"}},{"type":"paragraph","data":{"text":"Пожилым пациентам необходимо снизить дозу, поскольку у них может быть снижено вы­ведение метаболитов метамизола натрия."}},{"type":"paragraph","data":{"text":"Тяжелое общее состояние и нарушение клиренса креатинина"}},{"type":"paragraph","data":{"text":"Пациентам с тяжелым общим состоянием и нарушением клиренса креатинина необходимо снизить дозу, поскольку у них может быть снижено выведение метаболитов метамизола натрия."}},{"type":"paragraph","data":{"text":"Почечная или печеночная недостаточность"}},{"type":"paragraph","data":{"text":"Поскольку у пациентов с нарушением функции почек или печени скорость выведения препарата снижается, следует избегать многократного приема высоких доз. При кратко­срочном применении снижения дозы не требуется. Опыт длительного применения отсут­ствует."}}]},{"id":12,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Нежелательные реакции классифицированы следующим образом, согласно классификации ВОЗ (Всемирной организации здравоохранения): очень часто (≥1/10), часто (≥1/100 до <1/10), нечасто (≥1/1000 до <1/100), редко (≥1/10000 до <1/1000), очень редко (до <1/ 10000) и частота неизвестна (невозможно оценить на основании имеющихся данных)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны сердца"}},{"type":"paragraph","data":{"text":"Частота неизвестна: синдром Коуниса (аллергический коронарный синдром, проявляется клиническими и лабораторными признаками стенокардии, вызванной медиаторами воспаления)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны иммунной системы"}},{"type":"paragraph","data":{"text":"Редко: анафилактические/анафилактоидные реакции."}},{"type":"paragraph","data":{"text":"Очень редко: анальгетическая бронхиальная астма."}},{"type":"paragraph","data":{"text":"Частота неизвестна: анафилактический шок."}},{"type":"paragraph","data":{"text":"Метамизол натрия может вызывать анафилактические или анафилактоидные реакции, которые в очень редких случаях могут быть тяжелыми и угрожающими жизни. Они могут возникать даже в случае, если ранее препарат принимался много раз без каких-либо осложнений."}},{"type":"paragraph","data":{"text":"Такие лекарственные реакции могут развиться немедленно или через несколько часов после приема метамизола натрия, как правило, в течение одного часа."}},{"type":"paragraph","data":{"text":"В более легких случаях они проявляются в виде кожных симптомов и симптомов со стороны слизистых оболочек (зуд, жжение, гиперемия, крапивница, отек) или в виде одышки, или жалоб со стороны желудочно-кишечного тракта. В тяжелых случаях эти реакции переходят в генерализованную крапивницу, тяжелый ангионевротический отек (особенно с вовлечением гортани), тяжелый бронхоспазм, нарушение ритма сердца, резкое снижение артериального давления (которому иногда предшествует повышение артериального давления) и с развитием циркуляторного шока. У лиц с синдромом анальгетической бронхиальной астмы при непереносимости анальгезирующих препаратов эти реакции проявляются в виде приступов бронхиальной астмы."}},{"type":"paragraph","data":{"text":"Нарушения со стороны кожи и подкожных тканей"}},{"type":"paragraph","data":{"text":"Нечасто: фиксированный лекарственный дерматит."}},{"type":"paragraph","data":{"text":"Редко: кожная сыпь."}},{"type":"paragraph","data":{"text":"Частота неизвестна: синдром Стивенса-Джонсона, синдром Лайелла (токсический эпидермальный некролиз)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны кроки и лимфатической системы"}},{"type":"paragraph","data":{"text":"Редко: лейкопения."}},{"type":"paragraph","data":{"text":"Очень редко: агранулоцитоз, включая случаи с летальным исходом и тромбоцитопения."}},{"type":"paragraph","data":{"text":"Частота неизвестна: апластическая анемия, панцитопения, включая случаи с летальным исходом."}},{"type":"paragraph","data":{"text":"Эти реакции являются иммунологическими реакциями по своей природе. Они могут возникать даже в случае, если ранее препарат принимался много раз без каких-либо осложнений."}},{"type":"paragraph","data":{"text":"Типичными симптомами агранулоцитоза являются поражения слизистых оболочек (роговой полости и глотки, аноректальной области и половых органов), боль в горле, лихорадка. Однако при применении антибиотиков эти явления могут быть слабо выраженными. Иногда, но не всегда, отмечается небольшое увеличение лимфатических узлов или селезенки. "}},{"type":"paragraph","data":{"text":"Скорость оседания эритроцитов значительно увеличивается, содержание гранулоцитов резко снижено или они не определяются. Как правило, показатели гемоглобина, эритроцитов и тромбоцитов остаются нормальными, но могут встречаться и отклонения. Типичными симптомами тромбоцитопении являются повышенная склонность к кровотечению и возникновение петехий на коже и слизистых оболочках."}},{"type":"paragraph","data":{"text":"Если отмечается неожиданное ухудшение общего состояния, лихорадка не спадает или появляются новые или болезненные изъязвления на слизистых оболочках, особенно во рту, носу или горле, тактика лечения предполагает немедленную отмену препарата, не дожидаясь результатов лабораторных исследований."}},{"type":"paragraph","data":{"text":"При развитии панцитопении препарат следует отменить и контролировать общий анализ крови до возвращения его показателей к норме (см. \"Особые указания\")."}},{"type":"paragraph","data":{"text":"Нарушения со стороны сосудов"}},{"type":"paragraph","data":{"text":"Нечасто: изолированная артериальная гипотензия."}},{"type":"paragraph","data":{"text":"После приема препарата возможно изолированное транзиторное снижение артериального давления (возможно фармакологически обусловленное и не сопровождающееся другими проявлениями анафилактических/анафилактоидных реакций); в редких случаях снижение артериального давления может быть очень резко выраженным. При лихорадке также возможно дозозависимое резкое снижение артериального давления без других признаков реакции гиперчувствительности."}},{"type":"paragraph","data":{"text":"Нарушения со стороны ночек и мочевыводящих путей"}},{"type":"paragraph","data":{"text":"Очень редко: нарушение функции почек."}},{"type":"paragraph","data":{"text":"Частота неизвестна: интерстициальный нефрит."}},{"type":"paragraph","data":{"text":"В очень редких случаях у пациентов с нарушенной функцией почек возможно острое ухудшение почечной функции (острая почечная недостаточность), в некоторых случаях с олигурией, анурией или протеинурией."}},{"type":"paragraph","data":{"text":"Общие расстройства"}},{"type":"paragraph","data":{"text":"Нечасто: возможно окрашивание мочи в красный цвет вследствие присутствия в моче метаболита - рубазоновой кислоты."}}]},{"id":13,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Не следует превышать рекомендуемую дозу и длительность применения!"}},{"type":"paragraph","data":{"text":"Симптомы"}},{"type":"paragraph","data":{"text":"Острая передозировка проявляется тошнотой, рвотой, болью в животе, нарушением функ­ции почек/острой почечной недостаточностью (например, как проявление интерстициаль­ного нефрита) и, редко, симптомами со стороны центральной нервной системы (голово­кружением, сонливостью, комой, судорогами) и снижением артериального давления, при­водящим к тахикардии и шоку, нарушением сердечного ритма (тахикардией), гипотерми­ей, одышкой, острым агранулоцитозом, геморрагическим синдромом, параличом дыха­тельных мышц."}},{"type":"paragraph","data":{"text":"При высокой передозировке экскреция рубазоновой кислоты может окрасить мочу в крас­ный цвет."}},{"type":"paragraph","data":{"text":"Лечение"}},{"type":"paragraph","data":{"text":"Специфический антидот не известен. При недавней передозировке в целях ограничения поступления препарата в организм проводят первичную детоксикацию (например, промы­вание желудка) или сорбционную терапию (например, активированный уголь). Основной метаболит (4N-метиламиноантипирин) удаляется при гемодиализе, гемофильтрации, ге­моперфузии и плазмафильтрации."}},{"type":"paragraph","data":{"text":"Лечение передозировки, равно как и профилактика серьезных осложнений может потре­бовать общего и специального интенсивного медицинского наблюдения и лечения."}}]},{"id":14,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"С циклоспорином"}},{"type":"paragraph","data":{"text":"Метамизол натрия может вызывать снижение плазменной концентрации циклоспорина, поэтому при их одновременном применении следует контролировать концентрацию циклоспорина."}},{"type":"paragraph","data":{"text":"С хлорпромазином"}},{"type":"paragraph","data":{"text":"При одновременном применении метамизола натрия и хлорпромазина возможно развитие тяжелой гипотермии."}},{"type":"paragraph","data":{"text":"С метотрексатом"}},{"type":"paragraph","data":{"text":"Одновременное применение метамизола натрия и метотрексата или других миелотоксичных средств может усиливать гематотоксичность последнего, особенно у пациентов пожилого возраста. Поэтому такую комбинацию следует избегать."}},{"type":"paragraph","data":{"text":"С другими ненаркотическими анальгезирующими средствами"}},{"type":"paragraph","data":{"text":"Одновременное применение метамизола натрия с другими ненаркотическими анальгезирующими средствами может привести к взаимному усилению токсических эффектов."}},{"type":"paragraph","data":{"text":"С трициклическими антидепрессантами, пероральными контрацептивами, аллопуринолом"}},{"type":"paragraph","data":{"text":"Трициклические антидепрессанты, пероральные контрацептивы, аллопуринол нарушают метаболизм метамизола натрия в печени и повышают его токсичность."}},{"type":"paragraph","data":{"text":"С барбитуратами, фенилбутазоном и другими индукторами микросомальных ферментов печени"}},{"type":"paragraph","data":{"text":"Барбитураты, фенилбутазон и другие индукторы микросомальных ферментов печени ослабляют действие метамизола натрия."}},{"type":"paragraph","data":{"text":"С седативными средствами и транквилизаторами"}},{"type":"paragraph","data":{"text":"Седативные средства и транквилизаторы усиливают обезболивающее действие метамизола натрия."}},{"type":"paragraph","data":{"text":"С лекарственными средствами, имеющими высокую связь с белками плазмы (пероральные гипогликемические средства, непрямые антикоагулянты, глюкокортикостероиды и индометацин)"}},{"type":"paragraph","data":{"text":"Метамизол натрия, вытесняя из связи с белками плазмы пероральные гипогликемические средства, непрямые антикоагулянты, глюкокортикостероиды и индометацин, увеличивает их активность."}},{"type":"paragraph","data":{"text":"С тимазолом"}},{"type":"paragraph","data":{"text":"Тимазол повышает риск развития лейкопении."}},{"type":"paragraph","data":{"text":"С кодеином, блокаторами Н2-гистаминовых рецепторов и пропранололом"}},{"type":"paragraph","data":{"text":"Кодеин, блокаторы Н2-гистаминовых рецепторов и пропранолол усиливают эффекты метамизола натрия."}},{"type":"paragraph","data":{"text":"С ацетилсалициловой кислотой (АСК)"}},{"type":"paragraph","data":{"text":"При одновременном применении метамизол натрия может уменьшать влияние АСК на агрегацию тромбоцитов. Поэтому данную комбинацию следует применять с осторожностью при лечении пациентов, принимающих АСК в качестве антиагрегантного средства."}},{"type":"paragraph","data":{"text":"С бупропионом"}},{"type":"paragraph","data":{"text":"Метамизол натрия может снижать концентрацию бупропиона в крови, что следует принимать во внимание при одновременном их применении."}},{"type":"paragraph","data":{"text":"С другими лекарственными препаратами"}},{"type":"paragraph","data":{"text":"Хорошо известно, что производные пиразолона могут взаимодействовать с непрямыми антикоагулянтами, каптоприлом, литием и триамтереном, а также влиять на эффективность гипотензивных средств и диуретиков. Лекарственное взаимодействие метамизола натрия с этими лекарственными препаратами пока не изучено. Ввиду повышенного риска развития анафилактических/анафилактоидных реакций во время лечения метамизолом натрия не следует применять рентгеноконтрастные вещества, коллоидные кровезаменители и пенициллин."}}]},{"id":15,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Препарат содержит производное пиразолона - метамизол натрия, который изредка может вызывать угрожающие жизни шок и агранулоцитоз (см. раздел \"Побочное действие\"). Пациенты, у которых в ответ на применение метамизола натрия возникают анафилактоидные реакции, также подвержены риску их развития в ответ на применение других не­наркотических анальгетиков/НПВП."}},{"type":"paragraph","data":{"text":"Пациенты, у которых в ответ на применение метамизола натрия возникают анафилактиче­ские или другие иммуноопосредованные реакции (например, агранулоцитоз), также под­вержены риску их развития в ответ на применение других пиразолонов и пиразолидинов."}},{"type":"paragraph","data":{"text":"Агранулоцитоз"}},{"type":"paragraph","data":{"text":"При появлении признаков агранулоцитоза или тромбоцитопении (см. раздел \"Побочное действие\") препарат необходимо немедленно отменить и провести общий анализ крови (с определением лейкоцитарной формулы). Прекращение терапии не следует откладывать до получения результатов лабораторных исследований."}},{"type":"paragraph","data":{"text":"Панцитопения"}},{"type":"paragraph","data":{"text":"При развитии панцитопении препарат необходимо немедленно отменить и контролиро­вать общий анализ крови до возвращения его показателей к норме (см. раздел \"Побочное действие\"). Всем пациентам следует рекомендовать немедленно обращаться за медицин­ской помощью при возникновении в ходе лечения признаков и симптомов, напоминаю­щих нарушения со стороны крови (например, общая слабость, инфекции, стойкая лихо­радка, появление гематом, кровотечение, бледность)."}},{"type":"paragraph","data":{"text":"Анафилактические/анафилактоидные реакции"}},{"type":"paragraph","data":{"text":"Перед применением метамизола натрия необходимо провести тщательный опрос пациен­та. При выявлении риска развития анафилактоидных реакций применение препарата до­пускается лишь после тщательной оценки возможных рисков и ожидаемой пользы."}},{"type":"paragraph","data":{"text":"Если принято решение о применении метамизола натрия, за пациентом необходимо установить строгое медицинское наблюдение и обеспечить готовность неотложных мер."}},{"type":"paragraph","data":{"text":"Повышен­ный риск развития реакций гиперчувствительности на метамизол натрия обуславливают следующие состояния: анальгетическая бронхиальная астма или непереносимость аналь­гетиков (по типу крапивница-ангионевротический отек) (см. раздел \"Противопоказания\"); бронхиальная астма, особенно сопровождающаяся риносинуситом и полипозом носа; хроническая крапивница; непереносимость красителей (например, тартразина) или кон­сервантов (например, бензоатов); непереносимость алкоголя, на фоне которой даже при приеме незначительного количества алкогольных напитков у пациентов возникают чиха­ние, слезотечение и выраженное покраснение лица."}},{"type":"paragraph","data":{"text":"Непереносимость алкоголя может свидетельствовать о ранее неустановленной анальгетической бронхиальной астме (см. раздел \"Противопоказания)))."}},{"type":"paragraph","data":{"text":"У восприимчивых пациентов может возникнуть анафилактический шок, поэтому у паци­ентов с бронхиальной астмой или атопией следует соблюдать особую осторожность."}},{"type":"paragraph","data":{"text":"Тяжелые кожные реакции"}},{"type":"paragraph","data":{"text":"На фоне применения метамизола натрия были описаны угрожающие жизни кожные реак­ции: синдром Стивенса-Джонсона (ССД) и токсический эпидермальный некролиз (ТЭН). При появлении признаков ССД или ТЭН (таких как прогрессирующая кожная сыпь, часто сопровождаемая волдырями или изъязвлением слизистой оболочки) лечение метамизолом следует немедленно прекратить и никогда его не возобновлять. Пациентов необходимо осведомить о признаках и симптомах данных заболеваний. У них следует тщательно кон­тролировать кожные реакции, особенно в течение первых недель лечения."}},{"type":"paragraph","data":{"text":"Изолированные гипотензивные реакции"}},{"type":"paragraph","data":{"text":"Метамизол натрия может вызывать гипотензивные реакции (см. также раздел \"Побочное действие\"). Эти реакции могут носить дозозависимый характер. Риск таких реакций также повышен при: предшествующей артериальной гипотензии, снижении объема циркулиру­ющей крови или дегидратации, нестабильной гемодинамике или остром нарушении кро­вообращения (например, у пациентов с инфарктом миокарда или травмой), у пациентов с высокой лихорадкой."}},{"type":"paragraph","data":{"text":"В связи с этим у таких пациентов следует проводить подробную ди­агностику и устанавливать за ними тщательное наблюдение. В целях снижения риска ги­потензивных реакций могут потребоваться превентивные меры (например, сердечно­сосудистая реанимация). У пациентов, у которых снижение артериального давления сле­дует избегать любой ценой (например, при тяжелой ишемической болезни сердца или значимом стенозе церебральных артерий), метамизол натрия допускается применять лишь при тщательном наблюдении за гемодинамическими параметрами."}},{"type":"paragraph","data":{"text":"Боль в животе"}},{"type":"paragraph","data":{"text":"Недопустимо применение препарата для снятия острых болей в животе (до выяснения их причины)."}},{"type":"paragraph","data":{"text":"Нарушение функции почек или печени"}},{"type":"paragraph","data":{"text":"У пациентов с нарушением функции почек или печени применять метамизол натрия до­пускается лишь после строгой оценки пользы и рисков, соблюдая все необходимые меры предосторожности."}},{"type":"paragraph","data":{"text":"Влияние на способность управлять трансп. ср. и мех.:"}},{"type":"paragraph","data":{"text":"В рекомендуемом диапазоне доз влияние на концентрацию внимания и быстроту психо­моторных реакций не установлено. При приеме высоких доз рекомендуется соблюдать осторожность при управлении транспортными средствами, работы с механизмами и заня­тий другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]},{"id":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года. Не применять по истечении срока годности, указанного на упаковке."}}]}],"source":{"title":"ЗдравСити","url":"https://zdravcity.ru"}},"description_toggle":false,"short_description":"Анальгезирующее ненаркотическое средство. Обладает обезболивающим, жаропонижающим и слабым противовоспалительным действием, является производным пиразолона. Фармакодинамика Механизм действия до конца не изучен. Согласно результатам исследований метамизол и его активный метаболит (4Ы-метиламиноантипирин) обладают центральным и периферическим механизмом действия. Неселективно ингибирует циклооксигеназу и снижает образование простагландинов из арахидоновой кислоты. Фармакокинетика: После приема внутрь метамизол натрия гидролизуется до фармакологически активного 4N-метиламиноантипирина (МАА). Биодоступность МАА после приема внутрь составляет 90 %, что несколько выше, чем при парентеральном введении. Одновременный прием пищи не оказывает значимого влияния на фармакокинетику метамизола натрия. Клиническая эффективность определяется преимущественно МАА, а также в меньшей степени метаболитами 4N-аминоантипирина (АА). Величина площади под кривой \"концентрация- время\" (AUC) АА составляют 25 % от этой величины для МАА. Метаболиты 4N- ацетиламиноантипирин (ААА) и 4N-формиламиноантипирин (ФАА) не обладают фармакологической активностью. Всем метаболитам присуща нелинейная фармакокинетика. Клиническая значимость этого явления не известна. При краткосрочном применении кумуляция метаболитов не играет большой роли. Метамизол натрия проникает через плаценту. Метаболиты метамизола проникают в грудное молоко. Связь с белками плазмы МАА составляет 58 %, АА - 48 %, ФАА - 18 % и ААА - 14 %. После однократного приема внутрь 85 % дозы обнаруживается в моче в виде метаболитов, из них 3±1 % - МАА, 6±3 % - АА, 26±8 % - ААА и 23±4 % - ФАА. Почечный клиренс после однократного приема 1 г метамизола натрия внутрь для МАА равен 5±2 мл/мин, АА - 38±13 мл/мин, ААА - 61 ±8 мл/мин и ФАА - 49±5 мл/мин. Соответствующие периоды полувыведения из плазмы для МАА - 2,7±0,5 ч, АА - 3,7±1,3 ч, ААА - 9,5±1,5 ч и ФАА - 11,2±1,5 ч. Пожилые пациенты У пожилых пациентов AUC повышается в 2-3 раза. У пациентов с циррозом печени периоды полувыведения МАА и ФАА при однократном приеме препарата увеличиваются примерно в 3 раза, тогда как периоды полувыведения АА и ААА не следуют той же закономерности. У таких пациентов следует избегать применения высоких доз. Нарушение функции почек Согласно имеющимся данным при почечной недостаточности скорость выведения некоторых метаболитов (ААА и ФАА) снижается. 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