Болевой синдром (слабой и умеренной выраженности): в т.ч. головная, мигренозная, зубная боль, невралгия, миалгия, корешковый синдром, альгодисменорея; при почечной, печеночной и желчной коликах (в комбинации со спазмолитическими средствами). Анальгин может использоваться для уменьшения болей после хирургических и диагностических вмешательств. Повышенная ...
повышенная чувствительность к производным пиразолона (пропифеназон, феназон или фенилбутазон); - бронхиальная астма, индуцированная приемом ацетилсалициловой кислоты, салицилатов или других нестероидных противовоспалительных препаратов (НПВП); - бронхообструкция, ринит, крапивница, спровоцированные приемом ацетилсалициловой кислоты или других НПВП (в т.ч. в анамнезе), состояние после проведения АКШ; - угнетение кроветворения (агранулоцитоз, цитостатическая или инфекционная нейтропения); - выраженные нарушения функции печени или почек; - печеночная порфирия; - подтвержденная гиперкалиемия, эрозивно-язвенные изменения слизистой оболочки желудка и 12-перстной кишки, активное желудочно-кишечное кровотечение, воспалительные заболевания кишечника, анемия, лейкопения; - наследственная гемолитическая анемия, связанная с дефицитом глюкозо-6-фосфатдегидрогеназы; - беременность (особенно в I триместре и в последние 6 недель), период лактации; - младенческий возраст (до 3-х месяцев с массой тела менее 5 кг).
Инструкция
Состав
Состав на 1 мл:
Активное вещество:
метамизола натрия - 250 мг или 500 мг
Вспомогательные вещества:
вода для инъекций - до 1 мл.
Фармакотерапевтическая группа
Анальгезирующее ненаркотическое средство.
Фармакологические свойства
Метамизол натрия является производным пиразолона. Обладает обезболивающим, жаропонижающим и слабым противовоспалительным действием, механизм которого связан с угнетением синтеза простагландинов. По механизму действия практически не отличается от других нестероидных противовоспалительных препаратов.
Показания к применению
Болевой синдром (слабой и умеренной выраженности): в т.ч. головная, мигренозная, зубная боль, невралгия, миалгия, корешковый синдром, альгодисменорея; при почечной, печеночной и желчной коликах (в комбинации со спазмолитическими средствами). Анальгин может использоваться для уменьшения болей после хирургических и диагностических вмешательств. Повышенная температура тела при «простудных» и других инфекционно-воспалительных заболеваниях. Целесообразность применения препарата решается в каждом случае в зависимости от выраженности, характера и переносимости лихорадки.
Противопоказания
повышенная чувствительность к производным пиразолона (пропифеназон, феназон или фенилбутазон); - бронхиальная астма, индуцированная приемом ацетилсалициловой кислоты, салицилатов или других нестероидных противовоспалительных препаратов (НПВП); - бронхообструкция, ринит, крапивница, спровоцированные приемом ацетилсалициловой кислоты или других НПВП (в т.ч. в анамнезе), состояние после проведения АКШ; - угнетение кроветворения (агранулоцитоз, цитостатическая или инфекционная нейтропения); - выраженные нарушения функции печени или почек; - печеночная порфирия; - подтвержденная гиперкалиемия, эрозивно-язвенные изменения слизистой оболочки желудка и 12-перстной кишки, активное желудочно-кишечное кровотечение, воспалительные заболевания кишечника, анемия, лейкопения; - наследственная гемолитическая анемия, связанная с дефицитом глюкозо-6-фосфатдегидрогеназы; - беременность (особенно в I триместре и в последние 6 недель), период лактации; - младенческий возраст (до 3-х месяцев с массой тела менее 5 кг).
Применение при беременности и в период грудного вскармливания
Метамизол натрия проникает через плаценту. Поскольку нет достаточных данных о применении при беременности, метамизол натрия не должен применяться в первом триместре беременности, во втором триместре беременности метамизол натрия может применяться, только если ожидаемая польза для матери превышает потенциальный риск для плода. Несмотря на то, что метамизол натрия слабо ингибирует синтез простагландинов, нельзя исключить возможность преждевременного (внутриутробного) закрытия артериального (Боталлова) протока, а также перинатальных осложнений, обусловленных нарушением агрегации тромбоцитов у матери или новорожденного. Поэтому метамизол натрия противопоказан в третьем триместре беременности. Метаболиты метамизола натрия проникают в грудное молоко, поэтому при применении препарата, а также в течение 48 ч после приема последней дозы, необходимо прекратить грудное вскармливание.
Способ применения и дозы
Взрослые и подростки 15 лет и старше: в качестве разовой дозы рекомендуется 1-2 мл раствора Анальгина 500 мг/мл или 2-4 мл раствора Анальгина 250 мг/мл (в/м или в/в), суточная доза может составлять до 4-8 мл инъекционного раствора 500 мг/мл или инъекционного раствора 250 мг/мл (не более 2 г), разделенная на 2-3 приема. Максимальная разовая доза может составлять 1 г (2мл раствора 500 мг/мл или 4 мл раствора 250 мг/мл). Дети и новорожденные: Анальгин нельзя вводить новорожденным в возрасте до 3-х месяцев или при массе тела менее 5 кг. Детям Анальгин назначается в дозе 5-10 мг на 1 кг массы тела (0,1-0,2 мл раствора 500 мг/мл или 0,2-0,4 мл раствора 250 мг/мл). Разовая доза может быть назначена до 2-3 раз в сутки. Перед введением раствор рекомендуется нагреть до температуры тела. Для детей в возрасте 3-12 месяцев введение осуществляется только внутримышечно! (масса тела ребенка от 5 до 9 кг). При слишком быстром введении препарата может наблюдаться критическое падение артериального давления и шок. Внутривенное введение должно осуществляться медленно (скорость введения не более 1 мл (500 мг метамизола натрия в минуту)) в положении лежа, при контроле за артериальным давлением, пульсом и частотой дыхания.
Побочное действие
Со стороны мочевыделительной системы: нарушение функции почек, олигурия, анурия, протеинурия, очень редко развитие острого интерстициального нефрита, окрашивание мочи в красный цвет (за счет выделения метаболита – рубазоновой кислоты). Аллергические реакции: крапивница, в том числе на конъюктиве и слизистых оболочках носоглотки, отек Квинке; в редких случаях – злокачественная экссудативная эритема (синдром Стивенса-Джонсона), анафилактический шок, токсический эпидермальный некролиз (синдром Лайелла), бронхоспастический синдром (не только при склонности к бронхоспазму). Со стороны органов кроветворения: лейкопения, редко агранулоцитоз и тромбоцитопения иммунного генеза. Прочие: возможно снижение артериального давления, нарушение сердечного ритма. Местные реакции: при в/м введении возможны инфильтраты в месте введения.
Передозировка
В случае передозировки необходимо проконсультироваться с врачом. Возможно появление следующих симптомов: тошнота, рвота, боли в желудке, олигурия, гипотермия, снижение артериального давления, тахикардия, одышка, шум в ушах, сонливость, бред, нарушения сознания, острый агранулоцитоз, геморрагический синдром, острая почечная и/или печеночная недостаточность, судороги, паралич дыхательной мускулатуры. Лечение: симптоматическое. Специфического антидота для метамизола натрия не существует. В условиях лечебного учреждения – проведение форсированного диуреза, гемодиализа, при развитии судорожного синдрома – внутривенное введение диазепама и быстродействующих барбитуратов.
Взаимодействие с другими лекарственными средствами
С циклоспорином
Метамизол натрия может снижать концентрацию циклоспорина в сыворотке крови, поэтому при их совместном применении следует контролировать концентрацию циклоспорина.
С другими ненаркотическими анальгезирующими средствами
Одновременное применение метамизола натрия с другими ненаркотическими анальгезирующими средствами может привести к взаимному усилению токсических эффектов.
С трициклическими антидепрессантами, пероральными контрацептивами, аллопуринолом
Трициклические антидепрессанты, пероральные контрацептивы, аллопуринол нарушают метаболизм метамизола натрия в печени и повышают его токсичность.
С барбитуратами, фенилбутазоном и другими индукторами микросомальных ферментов печени
Барбитураты, фенилбутазон и другие индукторы микросомальных ферментов печени ослабляют действие метамизола натрия.
С седативными средствами и транквилизаторами
Седативные средства и транквилизаторы усиливают обезболивающее действие метамизола натрия. Одновременное применение с хлорпромазином или другими производными фенотиазина может привести к развитию выраженной гипотермии.
С лекарственными средствами, имеющими высокую связь с белками плазмы (пероральные гипогликемические средства, непрямые антикоагулянты, глюкокортикостероиды и индометацин)
крови пероральные гипогликемические препарата, непрямые антикоагулянты, глюкокортикостероиды и индометацин, увеличивает их активность.
С миелотоксичными лекарственными средствами
Миелотоксичные лекарственные средства усиливают проявление гематотоксичности метамизола натрия.
С метотрексатом
Добавление метамизола натрия к лечению метотрексатом может усиливать гематотоксическое действие метотрексата, особенно у пациентов пожилого возраста. Поэтому данной комбинации следует избегать.
С тиамазолом и сарколизином
Тиамазол и сарколизин повышают риск развития лейкопении.
С кодеином, блокаторами Н2-гистаминовых рецепторов и пропранололом
Кодеин, блокаторы Н2-гистаминовых рецепторов и пропранолол усиливают эффекты метамизола натрия.
С рентгеноконтрастными веществами, коллоидными кровезаменителями и пенициллином
Рентгеноконтрастные вещества, коллоидные кровезаменители и пенициллин не должны применяться во время лечения метамизолом натрия (повышенный риск развития анафилактических/анафилактоидных реакций).
С ацетилсалициловой кислотой
При совместном применении с ацетилсалициловой кислотой метамизол натрия может уменьшать влияние ацетилсалициловой кислоты на агрегацию тромбоцитов. Поэтому данную комбинацию следует применять с осторожностью при лечении пациентов, принимающих низкие дозы ацетилсалициловой кислоты для кардиопротекции (профилактики тромбообразования).
С бупропионом
Метамизол натрия может снижать концентрацию бупропиона в крови, что следует принимать во внимание при одновременном применении метамизола натрия и бупропиона.
Из-за высокой вероятности фармацевтической несовместимости метамизол натрия нельзя смешивать с другими лекарственными средствами в одном шприце.
С вальпроевой кислотой
Предполагается, что метамизол натрия в дозе 4 г/сутки оказывает соответствующее влияние на уровень вальпроата (снижает содержание) и связанный с ним клинический исход. Это может быть связано с возможной индукцией CYPB6 и усилением метаболизма вальпроата. В случае лечение вальпроатом в сочетании с метамизолом натриярекомендуется тщательный мониторинг уровня вальпроата в плазме крови.
Особые указания
У больных, страдающих бронхиальной астмой и поллинозами возможно развитие реакций повышенной чувствительности. При длительном применении (более 7 суток) необходимо контролировать картину периферической крови. На фоне приема метамизола натрия возможно развитие агранулоцитоза, в связи с чем при выявлении немотивированного подъема температуры, озноба, болей в горле, затрудненного глотания, стоматита, эрозивно-язвенных поражений ротовой полости, вагинита или проктита, необходима немедленная отмена препарата. Не применять для снятия острых болей в животе (до выяснения причин). Для снижения риска развития нежелательных явлений со стороны желудочно-кишечного тракта следует использовать минимально эффективную дозу минимально возможным коротким курсом. При лечении больных, получающих цитостатические средства, прием метамизола натрия должен проводится только под наблюдением врача. При в/м введении необходимо использовать длинную иглу. Беременность и кормление грудью: в течение первых и последних трех месяцев беременности принимать Анальгин нельзя. С четвертого по шестой месяцы беременности прием Анальгина должен осуществляться по строгим медицинским показаниям. После приема Анальгина кормление грудью должно быть прекращено на 48 часов.
Влияние на способность управлять автомобилем и движущимися механизмами
Учитывая побочное действие лекарственного препарата, в период лечения необходимо соблюдать осторожность при управлении транспортными средствами и занятии другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Условия хранения
При комнатной температуре.
Условия отпуска
По рецепту.
Производитель
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Аллергические реакции: крапивница, в том числе на конъюктиве и слизистых оболочках носоглотки, отек Квинке; в редких случаях – злокачественная экссудативная эритема (синдром Стивенса-Джонсона), анафилактический шок, токсический эпидермальный некролиз (синдром Лайелла), бронхоспастический синдром (не только при склонности к бронхоспазму). Со стороны органов кроветворения: лейкопения, редко агранулоцитоз и тромбоцитопения иммунного генеза. Прочие: возможно снижение артериального давления, нарушение сердечного ритма. Местные реакции: при в/м введении возможны инфильтраты в месте введения."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В случае передозировки необходимо проконсультироваться с врачом. Возможно появление следующих симптомов: тошнота, рвота, боли в желудке, олигурия, гипотермия, снижение артериального давления, тахикардия, одышка, шум в ушах, сонливость, бред, нарушения сознания, острый агранулоцитоз, геморрагический синдром, острая почечная и/или печеночная недостаточность, судороги, паралич дыхательной мускулатуры. Лечение: симптоматическое. Специфического антидота для метамизола натрия не существует. В условиях лечебного учреждения – проведение форсированного диуреза, гемодиализа, при развитии судорожного синдрома – внутривенное введение диазепама и быстродействующих барбитуратов."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"С циклоспорином"}},{"type":"paragraph","data":{"text":"Метамизол натрия может снижать концентрацию циклоспорина в сыворотке крови, поэтому при их совместном применении следует контролировать концентрацию циклоспорина."}},{"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. Одновременное применение с хлорпромазином или другими производными фенотиазина может привести к развитию выраженной гипотермии."}},{"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":"крови пероральные гипогликемические препарата, непрямые антикоагулянты, глюкокортикостероиды и индометацин, увеличивает их активность."}},{"type":"paragraph","data":{"text":"С миелотоксичными лекарственными средствами"}},{"type":"paragraph","data":{"text":"Миелотоксичные лекарственные средства усиливают проявление гематотоксичности метамизола натрия."}},{"type":"paragraph","data":{"text":"С метотрексатом"}},{"type":"paragraph","data":{"text":"Добавление метамизола натрия к лечению метотрексатом может усиливать гематотоксическое действие метотрексата, особенно у пациентов пожилого возраста. Поэтому данной комбинации следует избегать."}},{"type":"paragraph","data":{"text":"С тиамазолом и сарколизином"}},{"type":"paragraph","data":{"text":"Тиамазол и сарколизин повышают 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 рентгеноконтрастными веществами, коллоидными кровезаменителями и пенициллином"}},{"type":"paragraph","data":{"text":"Рентгеноконтрастные вещества, коллоидные кровезаменители и пенициллин не должны применяться во время лечения метамизолом натрия (повышенный риск развития анафилактических/анафилактоидных реакций)."}},{"type":"paragraph","data":{"text":"С ацетилсалициловой кислотой"}},{"type":"paragraph","data":{"text":"При совместном применении с ацетилсалициловой кислотой метамизол натрия может уменьшать влияние ацетилсалициловой кислоты на агрегацию тромбоцитов. Поэтому данную комбинацию следует применять с осторожностью при лечении пациентов, принимающих низкие дозы ацетилсалициловой кислоты для кардиопротекции (профилактики тромбообразования)."}},{"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 применении метамизола натрия и бупропиона."}},{"type":"paragraph","data":{"text":"Из-за высокой вероятности фармацевтической несовместимости метамизол натрия нельзя смешивать с другими лекарственными средствами в одном шприце."}},{"type":"paragraph","data":{"text":"С вальпроевой кислотой"}},{"type":"paragraph","data":{"text":"Предполагается, что метамизол натрия в дозе 4 г/сутки оказывает соответствующее влияние на уровень вальпроата (снижает содержание) и связанный с ним клинический исход. Это может быть связано с возможной индукцией CYPB6 и усилением метаболизма вальпроата. В случае лечение вальпроатом в сочетании с метамизолом натриярекомендуется тщательный мониторинг уровня вальпроата в плазме крови."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"У больных, страдающих бронхиальной астмой и поллинозами возможно развитие реакций повышенной чувствительности. При длительном применении (более 7 суток) необходимо контролировать картину периферической крови. На фоне приема метамизола натрия возможно развитие агранулоцитоза, в связи с чем при выявлении немотивированного подъема температуры, озноба, болей в горле, затрудненного глотания, стоматита, эрозивно-язвенных поражений ротовой полости, вагинита или проктита, необходима немедленная отмена препарата. Не применять для снятия острых болей в животе (до выяснения причин). Для снижения риска развития нежелательных явлений со стороны желудочно-кишечного тракта следует использовать минимально эффективную дозу минимально возможным коротким курсом. При лечении больных, получающих цитостатические средства, прием метамизола натрия должен проводится только под наблюдением врача. При в/м введении необходимо использовать длинную иглу. Беременность и кормление грудью: в течение первых и последних трех месяцев беременности принимать Анальгин нельзя. С четвертого по шестой месяцы беременности прием Анальгина должен осуществляться по строгим медицинским показаниям. После приема Анальгина кормление грудью должно быть прекращено на 48 часов."}}]},{"id":16,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Учитывая побочное действие лекарственного препарата, в период лечения необходимо соблюдать осторожность при управлении транспортными средствами и занятии 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":"При комнатной температуре."}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту."}}]},{"id":21,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":" Дальхимфарм ОАО (Россия)."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Метамизол натрия является производным пиразолона. 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