Солпадеин Фаст в растворимой форме оказывает обезболивающее действие при мигрени, головной боли, зубной и периодических болях.*
Солпадеин Фаст - направленное действие против боли!
* Инструкция по медицинскому применению, РУ No П N 014417/01 от 18.11.2008.
Фармакотерапевтическая группа
Анальгетик-антипиретик комбинированного состава, содержит комбинацию двух активных ингредиентов: парацетамола и кофеина. Оказывает жаропонижающее и анальгезирующее действие.
Парацетамол блокирует ЦОГ в ЦНС, воздействуя на центры боли и терморегуляции (в воспаленных тканях клеточные пероксидазы нейтрализуют влияние парацетамола на ЦОГ), что объясняет практически полное отсутствие противовоспалительного эффекта. Отсутствие влияния на синтез простагландинов в периферических тканях обусловливает отсутствие у него отрицательного влияния на водно-солевой обмен (задержка натрия и воды) и слизистую ЖКТ.
Кофеин стимулирует психомоторные центры головного мозга, оказывает аналептическое действие, усиливает эффект анальгетиков, устраняет сонливость и чувство усталости, повышает физическую и умственную работоспособность.
Фармакологические свойства
Парацетамол быстро и практически полностью всасывается из ЖКТ, распределение в жидкостях организма относительно равномерно. Связывание парацетамола с белками плазмы минимально при терапевтической концентрации.
Парацетамол метаболизируется в печени и выводится с мочой в виде глюкуронидных и сульфатных метаболитов - менее чем 5% выводится в неизмененном виде. T1/2 при приеме терапевтической дозы составляет 2-3 ч.
Кофеин быстро всасывается из ЖКТ и распределяется по всему организму. Кофеин почти полностью метаболизируется в печени путем окисления и деметилирования в виде метаболитов, которые выводятся с мочой. T1/2 составляет 4-9 ч.
Показания к применению
— головная боль;
— мигрень;
— зубная боль;
— боль в пояснице;
— невралгия;
— мышечная и ревматическая боль;
— болезненные менструации;
— боли в горле;
— симптоматическое лечение простудных заболеваний и гриппа (для снижения повышенной температуры тела).
Противопоказания
— выраженные нарушения функции печени;
— выраженные нарушения функции почек;
— артериальная гипертензия;
— глаукома;
— нарушения сна;
— эпилепсия;
— детский возраст до 12 лет;
— повышенная чувствительность к компонентам препарата.
С осторожностью следует применять препарат при доброкачественных гипербилирубинемиях (в т.ч. синдром Жильбера), вирусном гепатите, алкогольном поражении печени, дефиците глюкозо-6-фосфатдегидрогеназы, алкоголизме.
С осторожностью
Противопоказание: выраженные нарушения функции печени.
Противопоказание: выраженные нарушения функции почек.
Противопоказание: детский возраст до 12 лет.
Применение возможно согласно режиму дозирования.
Применение при беременности и в период грудного вскармливания
Препарат Солпадеин Фаст содержит кофеин. При приеме кофеина существует высокий риск рождения ребенка с низкой массой тела, риск самопроизвольного аборта.
Попадая в грудное молоко, кофеин может оказывать стимулирующее действие на ребенка, находящегося на грудном вскармливании.
Солпадеин Фаст не следует применять препарат при беременности и в период лактации (грудного вскармливания).
Способ применения и дозы
Таблетки растворимые Солпадеин Фаст перед приемом внутрь следует растворить не менее чем в 100 мл (полстакана) воды.
Взрослым (включая пожилых) и детям старше 12 лет назначают по 1-2 таб. 3-4 раза/сут, если необходимо. Интервал между приемами - не менее 4 ч. Максимальная разовая доза - 2 таб., максимальная суточная доза - 8 таб.
Препарат не рекомендуется применять более пяти дней как обезболивающее и более трех дней как жаропонижающее без назначения и наблюдения врача.
Увеличение суточной дозы препарата или продолжительности лечения возможно только под наблюдением врача.
Побочное действие
В рекомендованных дозах препарат обычно хорошо переносится.
Определение частоты побочных эффектов: очень часто (≥1/10), часто (≥1/100 и <1/10), нечасто (≥1/1000 и <1/100), редко (≥1/10 000 и <1/1000), очень редко (≥1/100 000 и <1/10 000).
Нижеперечисленные побочные эффекты выявлены спонтанно в ходе пострегистрационного применения препарата.
Парацетамол
Аллергические реакции: очень редко - кожная сыпь, ангионевротический отек (отек Квинке), синдром Стивенса-
Джонсона, анафилаксия.
Со стороны системы кроветворения: очень редко - лейкопения, тромбоцитопения, метгемоглобинемия, агранулоцитоз, гемолитическая анемия.
Со стороны дыхательной системы: очень редко - бронхоспазм (у пациентов с гиперчувствительностью к ацетилсалициловой кислоте и НПВП).
Со стороны гепатобилиарной системы: очень редко - нарушение функции печени.
При длительном применении в высоких дозах повышается вероятность гепатотоксического действия, нефротоксического действия и панцитопении. Также в случаях длительного применения в высоких дозах необходим контроль картины крови.
Кофеин
Возможно: диспептические явления (в т.ч. тошнота, эпигастральная боль), повышенная возбудимость, головокружение, нарушения сна, тахикардия.
При избыточном употреблении кофеинсодержащих пищевых продуктов (в т.ч. чая, кофе) во время приема препарата возможно появление беспокойства, тревожности, раздражительности, бессонницы, головной боли, нарушений со стороны пищеварительной системы, тахикардии, сердечной аритмии.
При возникновении любого из перечисленных побочных эффектов, следует прекратить прием препарата и немедленно обратиться к врачу.
Передозировка
Симптомы, обусловленные парацетамолом: в течение 24 ч возможны бледность кожных покровов, тошнота, рвота, анорексия, боли в желудке; через 1-2 сут могут проявиться признаки поражения печени (болезненность в области печени, повышение активности печеночных ферментов). Возможно нарушение углеводного обмена и признаки метаболического ацидоза. У взрослых пациентов поражение печени развивается после приема более 10 г парацетамола. При наличии факторов, оказывающих влияние на токсичность парацетамола для печени, поражение печени возможно после приема парацетамола в количестве 5 г и более. В тяжелых случаях передозировки может развиться энцефалопатия, кровотечения, гипогликемия, отек мозга, вплоть до летального исхода. Возможно развитие острой почечной недостаточности с острым тубулярным некрозом, характерными признаками которого является боль в поясничной области, гематурия, протеинурия, при этом тяжелое поражение печени может отсутствовать. Имеются сообщения о случаях нарушений сердечного ритма, панкреатита.
Лечение: при подозрении на передозировку, даже при отсутствии выраженных первых симптомов, необходимо прекратить применение препарата и немедленно обратиться за врачебной помощью. В течение 1 ч после передозировки рекомендуется промывание желудка и прием энтеросорбентов (активированный уголь, полифепан). Следует определить концентрацию парацетамола в плазме крови, но не ранее чем через 4 ч после передозировки (более ранние результаты недостоверны). Введение ацетилцистеина в течение 24 ч после передозировки. Максимальное защитное действие обеспечивается в течение первых 8 ч после передозировки, со временем эффективность антидота резко падает. При необходимости вводят ацетилцистеин в/в. При отсутствии рвоты до поступления пациента в стационар возможно применение метионина. Необходимость в проведении дополнительных терапевтических мероприятий (дальнейшее введение
метионина, в/в введение ацетилцистеина) определяется в зависимости от концентрации парацетамола в крови, а также от времени, прошедшего после его приема. Лечение пациентов с серьезным нарушением функции печени через 24 ч после приема парацетамола должно проводиться совместно со специалистами токсикологического центра или специализированного отделения заболеваний печени.
стимуляция ЦНС (бессонница, беспокойство, ажитация, тревога, повышенная нервно-рефлекторная возбудимость, тремор и судороги). Следует, однако, учитывать, что появление клинически значимых симптомов передозировки кофеина при приеме данного препарата всегда связано с тяжелым поражением печени на фоне передозировки парацетамола.
Лечение: специфический антидот отсутствует. Лечение включает поддерживающие мероприятия, например, обильное питье и поддержание жизненно важных показателей. В течение от 1 ч до 4 ч после передозировки рекомендуется прием активированного угля. Для уменьшения воздействия передозировки кофеином на функции ЦНС рекомендуется введение седативных препаратов в/в.
Взаимодействие с другими лекарственными средствами
При регулярном приеме в течение длительного времени препарат усиливает действие непрямых антикоагулянтов (варфарин и другие кумарины), что увеличивает риск кровотечений. Эпизодический прием разовой дозы препарата не оказывает значимого влияния на действие непрямых антикоагулянтов.
Препарат усиливает действие ингибиторов МАО.
Барбитураты, карбамазепин, фенитоин, примидон, этанол, рифампицин, фенилбутазон, препараты зверобоя, трициклические антидепрессанты и другие индукторы микросомального окисления увеличивают продукцию гидроксилированных активных метаболитов, обуславливая возможность развития тяжелого поражения печени при небольших передозировках парацетамола (5 г и более).
Ингибиторы микросомального окисления (циметидин) снижают риск гепатотоксического действия.
Под воздействием парацетамола время выведения хлорамфеникола увеличивается в 5 раз.
Кофеин ускоряет всасывание эрготамина.
Одновременный прием парацетамола и алкогольных напитков повышает риск развития гепатотоксических эффектов и острого панкреатита.
Метоклопрамид и домперидон увеличивают, а колестирамин снижает скорость всасывания парацетамола.
Препарат может снижать эффективность урикозурических препаратов.
Особые указания
Если при приеме препарата улучшение состояния не наблюдается или головная боль становится постоянной, необходимо обратиться к врачу.
Во время приема препарата не рекомендуется избыточное употребление кофеинсодержащих пищевых продуктов (в т.ч. чая, кофе), т.к. это может привести к появлению беспокойства, тревожности, раздражительности, бессонницы, головной боли, нарушениями со стороны ЖКТ, тахикардии, сердечной аритмии.
В случаях длительного применения в высоких дозах необходим контроль картины крови.
Дефицит глутатиона вследствие расстройства пищевого поведения, цистического фиброза, ВИЧ-инфекции, голодания, истощения обусловливает возможность развития тяжелого поражения печени при небольших передозировках парацетамола (5 г и более).
Препарат не следует принимать одновременно с другими парацетамолсодержащими препаратами.
Во избежание токсического поражения печени парацетамол не следует сочетать с приемом алкогольных напитков, а также принимать лицам, склонным к хроническому потреблению алкоголя.
У больных, страдающих атонической бронхиальной астмой, поллинозами, имеется повышенный риск развития аллергических реакций.
У пациентов с почечной и недостаточностью препарат следует применять с осторожностью и только после консультации с врачом.
При приеме препарата у пациентов с неалкогольным циррозом печени есть высокий риск передозировки.
При проведении анализов на определение мочевой кислоты и содержания глюкозы в крови следует сообщить врачу о приеме препарата.
На фоне приема препарата возможно изменение результатов анализов допинг-контроля спортсменов.
Форма выпуска
Таблетки, покрытые пленочной оболочкой белого цвета, капсуловидной формы с плоским краем, с тиснением знака в виде треугольника и "+" на одной стороне таблетки.
12 шт. - блистеры (1) - пачки картонные.
Условия хранения
Препарат следует хранить в недоступном для детей месте при температуре не выше 25°С.
Срок годности
4 года.
Условия отпуска
Без рецепта.
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При приеме кофеина существует высокий риск рождения ребенка с низкой массой тела, риск самопроизвольного аборта."}},{"type":"paragraph","data":{"text":"Попадая в грудное молоко, кофеин может оказывать стимулирующее действие на ребенка, находящегося на грудном вскармливании."}},{"type":"paragraph","data":{"text":"Солпадеин Фаст не следует применять препарат при беременности и в период лактации (грудного вскармливания)."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Таблетки растворимые Солпадеин Фаст перед приемом внутрь следует растворить не менее чем в 100 мл (полстакана) воды."}},{"type":"paragraph","data":{"text":"Взрослым (включая пожилых) и детям старше 12 лет назначают по 1-2 таб. 3-4 раза/сут, если необходимо. Интервал между приемами - не менее 4 ч. Максимальная разовая доза - 2 таб., максимальная суточная доза - 8 таб."}},{"type":"paragraph","data":{"text":"Препарат не рекомендуется применять более пяти дней как обезболивающее и более трех дней как жаропонижающее без назначения и наблюдения врача."}},{"type":"paragraph","data":{"text":"Увеличение суточной дозы препарата или продолжительности лечения возможно только под наблюдением врача."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"В рекомендованных дозах препарат обычно хорошо переносится."}},{"type":"paragraph","data":{"text":"Определение частоты побочных эффектов: очень часто (≥1/10), часто (≥1/100 и <1/10), нечасто (≥1/1000 и <1/100), редко (≥1/10 000 и <1/1000), очень редко (≥1/100 000 и <1/10 000)."}},{"type":"paragraph","data":{"text":"Нижеперечисленные побочные эффекты выявлены спонтанно в ходе пострегистрационного применения препарата."}},{"type":"paragraph","data":{"text":"Парацетамол"}},{"type":"paragraph","data":{"text":"Аллергические реакции: очень редко - кожная сыпь, ангионевротический отек (отек Квинке), синдром Стивенса-"}},{"type":"paragraph","data":{"text":"Джонсона, анафилаксия."}},{"type":"paragraph","data":{"text":"Со стороны системы кроветворения: очень редко - лейкопения, тромбоцитопения, метгемоглобинемия, агранулоцитоз, гемолитическая анемия."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: очень редко - бронхоспазм (у пациентов с гиперчувствительностью к ацетилсалициловой кислоте и НПВП)."}},{"type":"paragraph","data":{"text":"Со стороны гепатобилиарной системы: очень редко - нарушение функции печени."}},{"type":"paragraph","data":{"text":"При длительном применении в высоких дозах повышается вероятность гепатотоксического действия, нефротоксического действия и панцитопении. Также в случаях длительного применения в высоких дозах необходим контроль картины крови."}},{"type":"paragraph","data":{"text":"Кофеин"}},{"type":"paragraph","data":{"text":"Возможно: диспептические явления (в т.ч. тошнота, эпигастральная боль), повышенная возбудимость, головокружение, нарушения сна, тахикардия."}},{"type":"paragraph","data":{"text":"При избыточном употреблении кофеинсодержащих пищевых продуктов (в т.ч. чая, кофе) во время приема препарата возможно появление беспокойства, тревожности, раздражительности, бессонницы, головной боли, нарушений со стороны пищеварительной системы, тахикардии, сердечной аритмии."}},{"type":"paragraph","data":{"text":"При возникновении любого из перечисленных побочных эффектов, следует прекратить прием препарата и немедленно обратиться к врачу."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы, обусловленные парацетамолом: в течение 24 ч возможны бледность кожных покровов, тошнота, рвота, анорексия, боли в желудке; через 1-2 сут могут проявиться признаки поражения печени (болезненность в области печени, повышение активности печеночных ферментов). Возможно нарушение углеводного обмена и признаки метаболического ацидоза. У взрослых пациентов поражение печени развивается после приема более 10 г парацетамола. При наличии факторов, оказывающих влияние на токсичность парацетамола для печени, поражение печени возможно после приема парацетамола в количестве 5 г и более. В тяжелых случаях передозировки может развиться энцефалопатия, кровотечения, гипогликемия, отек мозга, вплоть до летального исхода. Возможно развитие острой почечной недостаточности с острым тубулярным некрозом, характерными признаками которого является боль в поясничной области, гематурия, протеинурия, при этом тяжелое поражение печени может отсутствовать. Имеются сообщения о случаях нарушений сердечного ритма, панкреатита."}},{"type":"paragraph","data":{"text":"Лечение: при подозрении на передозировку, даже при отсутствии выраженных первых симптомов, необходимо прекратить применение препарата и немедленно обратиться за врачебной помощью. В течение 1 ч после передозировки рекомендуется промывание желудка и прием энтеросорбентов (активированный уголь, полифепан). Следует определить концентрацию парацетамола в плазме крови, но не ранее чем через 4 ч после передозировки (более ранние результаты недостоверны). Введение ацетилцистеина в течение 24 ч после передозировки. Максимальное защитное действие обеспечивается в течение первых 8 ч после передозировки, со временем эффективность антидота резко падает. При необходимости вводят ацетилцистеин в/в. При отсутствии рвоты до поступления пациента в стационар возможно применение метионина. Необходимость в проведении дополнительных терапевтических мероприятий (дальнейшее введение"}},{"type":"paragraph","data":{"text":"метионина, в/в введение ацетилцистеина) определяется в зависимости от концентрации парацетамола в крови, а также от времени, прошедшего после его приема. Лечение пациентов с серьезным нарушением функции печени через 24 ч после приема парацетамола должно проводиться совместно со специалистами токсикологического центра или специализированного отделения заболеваний печени."}},{"type":"paragraph","data":{"text":"Симптомы, обусловленные кофеином: боль в эпигастрии, рвота, частое мочеиспускание, тахикардия, аритмия,"}},{"type":"paragraph","data":{"text":"стимуляция ЦНС (бессонница, беспокойство, ажитация, тревога, повышенная нервно-рефлекторная возбудимость, тремор и судороги). Следует, однако, учитывать, что появление клинически значимых симптомов передозировки кофеина при приеме данного препарата всегда связано с тяжелым поражением печени на фоне передозировки парацетамола."}},{"type":"paragraph","data":{"text":"Лечение: специфический антидот отсутствует. Лечение включает поддерживающие мероприятия, например, обильное питье и поддержание жизненно важных показателей. В течение от 1 ч до 4 ч после передозировки рекомендуется прием активированного угля. Для уменьшения воздействия передозировки кофеином на функции ЦНС рекомендуется введение седативных препаратов в/в."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При регулярном приеме в течение длительного времени препарат усиливает действие непрямых антикоагулянтов (варфарин и другие кумарины), что увеличивает риск кровотечений. Эпизодический прием разовой дозы препарата не оказывает значимого влияния на действие непрямых антикоагулянтов."}},{"type":"paragraph","data":{"text":"Препарат усиливает действие ингибиторов МАО."}},{"type":"paragraph","data":{"text":"Барбитураты, карбамазепин, фенитоин, примидон, этанол, рифампицин, фенилбутазон, препараты зверобоя, трициклические антидепрессанты и другие индукторы микросомального окисления увеличивают продукцию гидроксилированных активных метаболитов, обуславливая возможность развития тяжелого поражения печени при небольших передозировках парацетамола (5 г и более)."}},{"type":"paragraph","data":{"text":"Ингибиторы микросомального окисления (циметидин) снижают риск гепатотоксического действия."}},{"type":"paragraph","data":{"text":"Под воздействием парацетамола время выведения хлорамфеникола увеличивается в 5 раз."}},{"type":"paragraph","data":{"text":"Кофеин ускоряет всасывание эрготамина."}},{"type":"paragraph","data":{"text":"Одновременный прием парацетамола и алкогольных напитков повышает риск развития гепатотоксических эффектов и острого панкреатита."}},{"type":"paragraph","data":{"text":"Метоклопрамид и домперидон увеличивают, а колестирамин снижает скорость всасывания парацетамола."}},{"type":"paragraph","data":{"text":"Препарат может снижать эффективность урикозурических препаратов."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Если при приеме препарата улучшение состояния не наблюдается или головная боль становится постоянной, необходимо обратиться к врачу."}},{"type":"paragraph","data":{"text":"Во время приема препарата не рекомендуется избыточное употребление кофеинсодержащих пищевых продуктов (в т.ч. чая, кофе), т.к. это может привести к появлению беспокойства, тревожности, раздражительности, бессонницы, головной боли, нарушениями со стороны ЖКТ, тахикардии, сердечной аритмии."}},{"type":"paragraph","data":{"text":"В случаях длительного применения в высоких дозах необходим контроль картины крови."}},{"type":"paragraph","data":{"text":"Дефицит глутатиона вследствие расстройства пищевого поведения, цистического фиброза, ВИЧ-инфекции, голодания, истощения обусловливает возможность развития тяжелого поражения печени при небольших передозировках парацетамола (5 г и более)."}},{"type":"paragraph","data":{"text":"Препарат не следует принимать одновременно с другими парацетамолсодержащими препаратами."}},{"type":"paragraph","data":{"text":"Во избежание токсического поражения печени парацетамол не следует сочетать с приемом алкогольных напитков, а также принимать лицам, склонным к хроническому потреблению алкоголя."}},{"type":"paragraph","data":{"text":"У больных, страдающих атонической бронхиальной астмой, поллинозами, имеется повышенный риск развития аллергических реакций."}},{"type":"paragraph","data":{"text":"У пациентов с почечной и недостаточностью препарат следует применять с осторожностью и только после консультации с врачом."}},{"type":"paragraph","data":{"text":"При приеме препарата у пациентов с неалкогольным циррозом печени есть высокий риск передозировки."}},{"type":"paragraph","data":{"text":"При проведении анализов на определение мочевой кислоты и содержания глюкозы в крови следует сообщить врачу о приеме препарата."}},{"type":"paragraph","data":{"text":"На фоне приема препарата возможно изменение результатов анализов допинг-контроля спортсменов."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки, покрытые пленочной оболочкой белого цвета, капсуловидной формы с плоским краем, с тиснением знака в виде треугольника и \"+\" на одной стороне таблетки."}},{"type":"paragraph","data":{"text":"12 шт. - блистеры (1) - пачки картонные."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Препарат следует хранить в недоступном для детей месте при температуре не выше 25°С."}}]},{"id":20,"name":"Срок 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