Повышенная чувствительность к препарату; атриовентрикулярная блокада I-III степени (AV блокада); выраженная почечная недостаточность (если клиренс креатинина менее 20 мл/мин); выраженная артериальная гипотензия; состояния связанные с дефицитом кальция и угнетением дыхательного центра; брадикардия; предродовый период (за 2 часа до родов).
Инструкция
Регистрационный номер
П N016215/01 от 09.06.10
Торговое название препарата
Магния сульфат
Лекарственная форма
раствор для внутривенного и внутримышечного введения
Состав
В 100 мл раствора содержится:
Действующее вещество:
Магния сульфата - 25 г.
Вспомогательное вещество: Вода для инъекций.
Описание
Прозрачная бесцветная жидкость.
Фармакотерапевтическая группа
Вазодилатирующее средство
Фармакологические свойства
Фармакодинамика:
При парентеральном введении оказывает седативное диуретическое артериодилатирующее противосудорожное антиаритмическое гипотензивное спазмолитическое в больших дозах - курареподобное (угнетающее влияние на нервно-мышечную передачу) токолитическое снотворное и наркотическое действие подавляет дыхательный центр.
Магний является физиологическим антагонистом кальция и способен вытеснять его из мест связывания. Регулирует обменные процессы межнейронную передачу и мышечную возбудимость препятствует поступлению кальция через пресинаптическую мембрану снижает количество ацетилхолина в периферической нервной системе и центральной нервной системе (ЦНС). Расслабляет гладкую мускулатуру снижает артериальное давление (АД) (преимущественно повышенное) усиливает диурез.
Противосудорожное действие - магний уменьшает высвобождение ацетилхолина из нервно- мышечных синапсов подавляя при этом нервно-мышечную передачу оказывает прямое угнетающее действие на ЦНС.
Антиаритмическое действие - магний снижает возбудимость миоцитов восстанавливает ионное равновесие стабилизирует клеточные мембраны нарушает ток натрия медленный входящий ток кальция и односторонний ток калия.
Кардиопротекторный эффект обусловлен расширением коронарных артерий снижением общего периферического сосудистого сопротивления и агрегации тромбоцитов.
Токолитическое действие - магний угнетает сократительную способность миометрия (снижение поглощения связывания и распределения кальция в клетках гладкой мускулатуры) усиливает кровоток в матке в результате расширения ее сосудов.
Является антидотом при отравлениях солями тяжелых металлов.
Системные эффекты развиваются почти мгновенно после внутривенного (в/в) и через 1 ч после внутримышечного (в/м) введения. Длительность действия при в/в введении - 30 мин при в/м - 3-4 ч.
Фармакокинетика:
Равновесная концентрация (Css) - 2-35 ммоль/л. Проникает через гематоэнцефалический и плацентарный барьеры создает в материнском молоке концентрации в 2 раза превышающие концентрации в плазме.
Выведение осуществляется почками скорость почечной экскреции пропорциональна концентрации в плазме и уровню клубочковой фильтрации.
Показания к применению
Артериальная гипертензия (в т.ч. гипертонический криз с явлениями отека мозга) полиморфная желудочковая тахикардия (типа “пируэт”) судорожный синдром (для подавления судорог при эклампсии; для предупреждения судорог при тяжелой преэклампсии; для снятия сильных сокращений матки) отравление солями тяжелых металлов (ртуть мышьяк тетраэтилсвинец) гипомагниемия (в т.ч. повышенная потребность в магнии и острая гипомагниемия - тетания).
Противопоказания
Повышенная чувствительность к препарату; атриовентрикулярная блокада I-III степени (AV блокада); выраженная почечная недостаточность (если клиренс креатинина менее 20 мл/мин); выраженная артериальная гипотензия; состояния связанные с дефицитом кальция и угнетением дыхательного центра; брадикардия; предродовый период (за 2 часа до родов).
С осторожностью
Миастения хроническая почечная недостаточность (если клиренс креатинина более 20 мл/мин) заболевания органов дыхания острые воспалительные заболевания желудочно- кишечного тракта пожилой возраст беременность период лактации детский возраст.
Применение при беременности и в период грудного вскармливания
С осторожностью принимать в период беременности и лактации
Способ применения и дозы
Внутримышечно внутривенно.
Дозы уточняют с учетом терапевтического эффекта и концентрации ионов магния в сыворотке крови.
Преэклампсия и эклампсия. Дозу устанавливают индивидуально в зависимости от клинической ситуации. Доза насыщения - 2-4 г через 5-20 мин (инфузия). Поддерживающая доза- 1-2 г в час. Тетания матки. Доза насыщения - 4 г через 20 мин (инфузия). Поддерживающая доза - сначала - 1-2 г в час позже - 1 г в час (можно вводить капельно 24-72 ч).
Гипомагниемия.
У новорожденных. Суточная доза - 02-08 мг/кг в/м или в/в медленно.
У взрослых. Легкая. Раствор магния сульфата применяют парентерально если невозможен или нецелесообразен пероральный путь введения препаратов магния (из-за тошноты рвоты нарушенной резорбции в желудке и др.). Суточная доза - 1-2 г в/м. Эту дозу вводят однократно или в 2-3 приема. Место введения следует менять.
Тяжелая. Начальная доза - 5 г. Дозу вливают в 1 л инфузионного раствора и медленно вводят в/в. Дозируют в зависимости от концентрации препарата в сыворотке крови. Профилактика гипомагниемии у больных получающих только парентеральное питание. Если в питательных растворах нет магния его добавляют дополнительно. Суточная доза - 15-4 г. Обычно в 1 л раствора парентерального питания прибавляют 1 г магния сульфата.
Максимальная суточная доза магния сульфата взрослым - 40 г.
При гипертонических кризах вводят в/м или в/в (медленно!!) 5-20 мл 25% раствора магния сульфата.
Для купирования аритмий в/в вводят 1-2 г в течение около 5 минут возможно повторное введение.
Дозы Магния сульфата указаны в граммах.
Им соответствует количество раствора: 1 г - 5 мл (20%) - 4 мл (25%); 2 г - 10 мл (20%) - 8 мл (25%); 3 г - 1 5 мл (20%) - 12 мл (25%); 4 г - 20 мл (20%) - 16 мл (25%); 5 г - 25 мл (20%) - 20 мл (25%); 10 г - 50 мл (20%) - 40 мл (25%); 15 г - 75 мл (20%) -60 мл (25%); 20 г - 100 мл (20%) - 80 мл (25%); 30 г - 150 мл (20%) - 120 мл (25%); 40 г - 200 мл (20%) - 160 мл (25%).
Раствор магния сульфата в ампулах разбавляют инъекционными растворами: 09% натрия хлорида или 5% декстрозы (глюкозы).
Побочное действие
Замедление частоты дыхания; одышка; острая недостаточность кровообращения; ослабление рефлексов; гиперемия; артериальная гипотензия; гипотермия; ослабление мышечного тонуса; атония матки; гипергидроз; тревожность; выраженная седация; полиурия; урежение частоты сердечных сокращений; изменения в электрокардиограмме. Препарат понижает возбудимость дыхательного центра большие дозы препарата при парентеральном введении легко могут вызвать паралич дыхательного центра.
Ранние признаки и симптомы гипермагниемии: брадикардия диплопия внезапный прилив крови к лицу головная боль снижение АД тошнота одышка смазанная речь рвота общая слабость. Признаки гипермагниемии ранжированные в порядке повышения концентрации ионов магния в сыворотке крови: снижение глубоких сухожильных рефлексов (2-35 ммоль/л) удлинение интервала PQ и расширение комплекса QRS на электрокардиограмме (25-5 ммоль/л) снижение сухожильных рефлексов (4-5 ммоль/л) угнетение дыхательного центра (5-65 ммоль/л) нарушение проводимости сердца (75 ммоль/л) остановка сердца (125 ммоль/л).
Передозировка
Симптомы: исчезновение коленного рефлекса тошнота рвота резкое снижение АД брадикардия угнетение дыхания и ЦНС.
Лечение: следует в/в медленно ввести раствор кальция хлорида или кальция глюконата - 5-10 мл 10% проводят оксигенотерапию вдыхание карбогена искусственное дыхание перитонеальный диализ или гемодиализ симптоматическую терапию.
Взаимодействие с другими лекарственными средствами
Пациенты которые вместе с магния сульфатом применяют и другие лекарственные средства должны сообщить об этом врачу.
Усиливает эффект других лекарственных средств угнетающих ЦНС.
Сердечные гликозиды увеличивают риск нарушения проводимости и атриовентрикулярной блокады (особенно при одновременном в/в введении солей кальция).
Миорелаксанты и нифедипин усиливают нервно-мышечную блокаду.
При совместном применении магния сульфата для парентерального введения с другими вазодилататорами возможно усиление гипотензивного эффекта.
Нарушает всасывание антибиотиков группы тетрациклина ослабляет действие стрептомицина и тобрамицина.
Соли кальция уменьшают действие магния сульфата.
Фармацевтически несовместим (образует осадок) с препаратами кальция карбонатами бикарбонатами и фосфатами щелочных металлов клиндамицина фосфатом гидрокортизона натрия сукцинатом полимиксина В сульфатом прокаина гидрохлоридом салицилатами и тартратами.
При концентрациях ионов магния выше 10 ммоль/мл в смесях для полного парентерального питания возможно разделение жировых эмульсий.
Особые указания
Следует учитывать что в\м инъекции крайне болезненны и приводят к образованию инфильтратов.
Магния сульфат следует применять осторожно чтобы не возникла токсическая концентрация препарата. Лицам пожилого возраста обычно следует применять уменьшенную дозу так как у них снижена функция почек. Больные с нарушением функции почек (если клиренс креатинина более 20 мл/мип) и олигурией не должны получать более 20 г магния сульфата (81 ммоль Mg2+) в течение 48 ч не следует вводить магния сульфат в/в слишком быстро. Рекомендуется контроль концентрации ионов магния в сыворотке крови (должна быть не выше 08-12 ммоль/л). диуреза (не менее 100 мл/ч) частоты дыхания (не менее 16/мин) АД.
При введении магния сульфата необходимо иметь приготовленный для в/в введения раствор кальция например 10% раствор кальция глюконата. При необходимости одновременного в/в введения магния и кальция их вводят в разные вены. При применении магния сульфата могут быть искажены результаты радиологических исследований для которых применяется технеций.
Влияние на способность управлять автомобилем и движущимися механизмами
В период лечения пациентам следует воздержаться от управления транспортными средствами и занятий другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций (риск развития диплопии, головокружения, головной боли).
Форма выпуска
Раствор для внутривенного и внутримышечного введения 250 мг/мл.
Условия хранения
При температуре не выше 25° С.
Хранить в недоступном для детей месте.
Срок годности
3 года.
Не использовать позже срока указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Открытое акционерное общество "Борисовский завод медицинских препаратов" (ОАО "БЗМП")
Организация, принимающая претензии потребителей
ОАО "БЗМП"
Для описания товара использована информация от партнера 36.6
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Регулирует обменные процессы межнейронную передачу и мышечную возбудимость препятствует поступлению кальция через пресинаптическую мембрану снижает количество ацетилхолина в периферической нервной системе и центральной нервной системе (ЦНС). Расслабляет гладкую мускулатуру снижает артериальное давление (АД) (преимущественно повышенное) усиливает диурез."}},{"type":"paragraph","data":{"text":"Противосудорожное действие - магний уменьшает высвобождение ацетилхолина из нервно- мышечных синапсов подавляя при этом нервно-мышечную передачу оказывает прямое угнетающее действие на ЦНС."}},{"type":"paragraph","data":{"text":"Антиаритмическое действие - магний снижает возбудимость миоцитов восстанавливает ионное равновесие стабилизирует клеточные мембраны нарушает ток натрия медленный входящий ток кальция и односторонний ток калия."}},{"type":"paragraph","data":{"text":"Кардиопротекторный эффект обусловлен расширением коронарных артерий снижением общего периферического сосудистого сопротивления и агрегации тромбоцитов."}},{"type":"paragraph","data":{"text":"Токолитическое действие - магний угнетает сократительную способность миометрия (снижение поглощения связывания и распределения кальция в клетках гладкой мускулатуры) усиливает кровоток в матке в результате расширения ее сосудов."}},{"type":"paragraph","data":{"text":"Является антидотом при отравлениях солями тяжелых металлов."}},{"type":"paragraph","data":{"text":"Системные эффекты развиваются почти мгновенно после внутривенного (в/в) и через 1 ч после внутримышечного (в/м) введения. 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Дозируют в зависимости от концентрации препарата в сыворотке крови. Профилактика гипомагниемии у больных получающих только парентеральное питание. Если в питательных растворах нет магния его добавляют дополнительно. Суточная доза - 15-4 г. Обычно в 1 л раствора парентерального питания прибавляют 1 г магния сульфата."}},{"type":"paragraph","data":{"text":"Максимальная суточная доза магния сульфата взрослым - 40 г."}},{"type":"paragraph","data":{"text":"При гипертонических кризах вводят в/м или в/в (медленно!!) 5-20 мл 25% раствора магния сульфата."}},{"type":"paragraph","data":{"text":"Для купирования аритмий в/в вводят 1-2 г в течение около 5 минут возможно повторное введение."}},{"type":"paragraph","data":{"text":"Дозы Магния сульфата указаны в граммах."}},{"type":"paragraph","data":{"text":"Им соответствует количество раствора: 1 г - 5 мл (20%) - 4 мл (25%); 2 г - 10 мл (20%) - 8 мл (25%); 3 г - 1 5 мл (20%) - 12 мл (25%); 4 г - 20 мл (20%) - 16 мл (25%); 5 г - 25 мл (20%) - 20 мл (25%); 10 г - 50 мл (20%) - 40 мл (25%); 15 г - 75 мл (20%) -60 мл (25%); 20 г - 100 мл (20%) - 80 мл (25%); 30 г - 150 мл (20%) - 120 мл (25%); 40 г - 200 мл (20%) - 160 мл (25%)."}},{"type":"paragraph","data":{"text":"Раствор магния сульфата в ампулах разбавляют инъекционными растворами: 09% натрия хлорида или 5% декстрозы (глюкозы)."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Замедление частоты дыхания; одышка; острая недостаточность кровообращения; ослабление рефлексов; гиперемия; артериальная гипотензия; гипотермия; ослабление мышечного тонуса; атония матки; гипергидроз; тревожность; выраженная седация; полиурия; урежение частоты сердечных сокращений; изменения в электрокардиограмме. Препарат понижает возбудимость дыхательного центра большие дозы препарата при парентеральном введении легко могут вызвать паралич дыхательного центра."}},{"type":"paragraph","data":{"text":"Ранние признаки и симптомы гипермагниемии: брадикардия диплопия внезапный прилив крови к лицу головная боль снижение АД тошнота одышка смазанная речь рвота общая слабость. Признаки гипермагниемии ранжированные в порядке повышения концентрации ионов магния в сыворотке крови: снижение глубоких сухожильных рефлексов (2-35 ммоль/л) удлинение интервала PQ и расширение комплекса QRS на электрокардиограмме (25-5 ммоль/л) снижение сухожильных рефлексов (4-5 ммоль/л) угнетение дыхательного центра (5-65 ммоль/л) нарушение проводимости сердца (75 ммоль/л) остановка сердца (125 ммоль/л)."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: исчезновение коленного рефлекса тошнота рвота резкое снижение АД брадикардия угнетение дыхания и ЦНС."}},{"type":"paragraph","data":{"text":"Лечение: следует в/в медленно ввести раствор кальция хлорида или кальция глюконата - 5-10 мл 10% проводят оксигенотерапию вдыхание карбогена искусственное дыхание перитонеальный диализ или гемодиализ симптоматическую терапию."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Пациенты которые вместе с магния сульфатом применяют и другие лекарственные средства должны сообщить об этом врачу."}},{"type":"paragraph","data":{"text":"Усиливает эффект других лекарственных средств угнетающих ЦНС."}},{"type":"paragraph","data":{"text":"Сердечные гликозиды увеличивают риск нарушения проводимости и атриовентрикулярной блокады (особенно при одновременном в/в введении солей кальция)."}},{"type":"paragraph","data":{"text":"Миорелаксанты и нифедипин усиливают нервно-мышечную блокаду."}},{"type":"paragraph","data":{"text":"При совместном применении магния сульфата для парентерального введения с другими вазодилататорами возможно усиление гипотензивного эффекта."}},{"type":"paragraph","data":{"text":"Барбитураты наркотические анальгетики гипотензивные препараты повышают вероятность угнетения дыхательного центра."}},{"type":"paragraph","data":{"text":"Нарушает всасывание антибиотиков группы тетрациклина ослабляет действие стрептомицина и тобрамицина."}},{"type":"paragraph","data":{"text":"Соли кальция уменьшают действие магния сульфата. "}},{"type":"paragraph","data":{"text":"Фармацевтически несовместим (образует осадок) с препаратами кальция карбонатами бикарбонатами и фосфатами щелочных металлов клиндамицина фосфатом гидрокортизона натрия сукцинатом полимиксина В сульфатом прокаина гидрохлоридом салицилатами и тартратами."}},{"type":"paragraph","data":{"text":"При концентрациях ионов магния выше 10 ммоль/мл в смесях для полного парентерального питания возможно разделение жировых эмульсий."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Следует учитывать что в\\м инъекции крайне болезненны и приводят к образованию инфильтратов."}},{"type":"paragraph","data":{"text":"Магния сульфат следует применять осторожно чтобы не возникла токсическая концентрация препарата. Лицам пожилого возраста обычно следует применять уменьшенную дозу так как у них снижена функция почек. Больные с нарушением функции почек (если клиренс креатинина более 20 мл/мип) и олигурией не должны получать более 20 г магния сульфата (81 ммоль Mg\u003csup\u003e2+\u003c/sup\u003e) в течение 48 ч не следует вводить магния сульфат в/в слишком быстро. Рекомендуется контроль концентрации ионов магния в сыворотке крови (должна быть не выше 08-12 ммоль/л). диуреза (не менее 100 мл/ч) частоты дыхания (не менее 16/мин) АД."}},{"type":"paragraph","data":{"text":"При введении магния сульфата необходимо иметь приготовленный для в/в введения раствор кальция например 10% раствор кальция глюконата. При необходимости одновременного в/в введения магния и кальция их вводят в разные вены. При применении магния сульфата могут быть искажены результаты радиологических исследований для которых применяется технеций."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В период лечения пациентам следует воздержаться от управления транспортными средствами и занятий другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций (риск развития диплопии, головокружения, головной боли)."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Раствор для внутривенного и внутримышечного введения 250 мг/мл."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"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":"3 года."}},{"type":"paragraph","data":{"text":"Не использовать позже срока 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 \"Борисовский завод медицинских препаратов\" (ОАО \"БЗМП\")"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ОАО \"БЗМП\""}}]}],"source":null},"description_toggle":false,"short_description":"При парентеральном введении оказывает седативное диуретическое артериодилатирующее противосудорожное антиаритмическое гипотензивное спазмолитическое в больших дозах - курареподобное (угнетающее влияние на нервно-мышечную передачу) токолитическое снотворное и наркотическое действие подавляет дыхательный центр. Магний является физиологическим антагонистом кальция и способен вытеснять его из мест связывания. Регулирует обменные процессы межнейронную передачу и мышечную возбудимость препятствует поступлению кальция через пресинаптическую мембрану снижает количество ацетилхолина в периферической нервной системе и центральной нервной системе (ЦНС). Расслабляет гладкую мускулатуру снижает артериальное давление (АД) (преимущественно повышенное) усиливает диурез. Противосудорожное действие - магний уменьшает высвобождение ацетилхолина из нервно- мышечных синапсов подавляя при этом нервно-мышечную передачу оказывает прямое угнетающее действие на ЦНС. Антиаритмическое действие - магний снижает возбудимость миоцитов восстанавливает ионное равновесие стабилизирует клеточные мембраны нарушает ток натрия медленный входящий ток кальция и односторонний ток калия. Кардиопротекторный эффект обусловлен расширением коронарных артерий снижением общего периферического сосудистого сопротивления и агрегации тромбоцитов. Токолитическое действие - магний угнетает сократительную способность миометрия (снижение поглощения связывания и распределения кальция в клетках гладкой мускулатуры) усиливает кровоток в матке в результате расширения ее сосудов. Является антидотом при отравлениях солями тяжелых металлов. Системные эффекты развиваются почти мгновенно после внутривенного (в/в) и через 1 ч после внутримышечного (в/м) введения. Длительность действия при в/в введении - 30 мин при в/м - 3-4 ч. Равновесная концентрация (Css) - 2-35 ммоль/л. Проникает через гематоэнцефалический и плацентарный барьеры создает в материнском молоке концентрации в 2 раза превышающие концентрации в плазме. Выведение осуществляется почками скорость почечной экскреции пропорциональна концентрации в плазме и уровню клубочковой фильтрации.","substance":[{"id":892,"title":"Магния сульфат","title_latin":"Magnesii sulfas","slug":"magniya_sulfat_892"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":false,"comments":null,"image_alt":"Магния сульфат - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/120122/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/120122/share_default/"}},"diseases":[],"other_packages":[{"id":92246,"title":"Магния сульфат","subtitle":{"full":"Раствор, 10 шт, 10 мл, 25 %","short":"Раствор, 10 шт, 10 мл, 25 %","package":"10 шт, 10 мл, 25 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