Лечение острой боли легкой и средней степени тяжести у взрослых.
Противопоказания
повышенная чувствительность к действующему веществу или любому другому компоненту препарата; риск развития печеночной энцефалопатии и холестаз, т.к. может развиться энцефалопатия или усугубиться течение уже имеющейся энцефалопатии или атаксии; миастения gravis в связи с миорелаксирующим действием флупиртина; сопутствующие заболевания печени или алкоголизм; ...
Лечение острой боли легкой и средней степени тяжести у взрослых.
Противопоказания
повышенная чувствительность к действующему веществу или любому другому компоненту препарата; риск развития печеночной энцефалопатии и холестаз, т.к. может развиться энцефалопатия или усугубиться течение уже имеющейся энцефалопатии или атаксии; миастения gravis в связи с миорелаксирующим действием флупиртина; сопутствующие заболевания печени или алкоголизм; одновременное применение флупиртина с другими лекарственными препаратами, которые могут оказывать гепатотоксическое действие; недавно излеченный или имеющийся звон в ушах, в связи с высоким риском повышения активности печеночных ферментов; детский возраст до 18 лет.
С осторожностью: почечная недостаточность; гипоальбуминемия; пожилой возраст (пациенты старше 65 лет).
Применение при беременности и в период грудного вскармливания
Препарат Катадолон форте следует применять в том случае, если лечение другими обезболивающими препаратами (например НПВС или легкие опиоидные препараты) противопоказано.; У пациентов со сниженной функцией почек следует контролировать концентрацию креатинина в плазме крови.; У пациентов старше 65 лет или с выраженными признаками почечной недостаточности требуется коррекция дозы.; Во время лечения препаратом Катадолон форте 1 раз в неделю следует контролировать состояние функции печени, т.к. при терапии флупиртином возможно повышение активности печеночных трансаминаз, развитие гепатита и печеночной недостаточности. Если результаты исследования печени отклоняются от нормы или проявляются клинические симптомы, которые указывают на поражение печени, то следует прекратить применение препарата Катадолон форте. Пациентов следует предупредить о том, что во время лечения препаратом Катадолон форте необходимо обращать внимание на любые симптомы поражения печени (например отсутствие аппетита, тошнота, рвота, боль в желудке, усталость, темная моча, желтуха, зуд). При проявлении таких симптомов следует прекратить прием препарата Катадолон форте и в срочном порядке обратиться к врачу.; При лечении флупиртином возможны ложноположительные реакции теста с диагностическими полосками на билирубин, уробилиноген и белок в моче. Аналогичная реакция возможна при количественном определении концентрации билирубина в плазме крови.; При применении препарата в высоких дозах в отдельных случаях может отмечаться окрашивание мочи в зеленый цвет, что не является клиническим признаком какой-либо патологии.; Влияние на способность управлять транспортными средствами и работать с механизмами. При применении препарата Катадолон форте следует воздержаться от вождения автотранспорта и управления механизмами, в связи с тем, что у пациентов может развиться сонливость и головокружение, что может повлиять на концентрацию внимания и скорость психомоторных реакций. Особо важно это помнить при одновременном употреблении алкоголя.
Способ применения и дозы
Внутрь, не разжевывая таблетку и запивая достаточным количеством жидкости (предпочтительно воды).; По 400 мг (1 табл.) 1 раз в день для уменьшения боли в течение максимально короткого промежутка времени. Эта доза является суммарной суточной дозой. Если такая доза не может оказать достаточный обезболивающий эффект, можно применять капсулы Катадолон с большей суточной дозой.; Дозу подбирают в зависимости от интенсивности боли и индивидуальной переносимости препарата. Следует применять минимально эффективную дозу в течение максимально короткого промежутка времени. Продолжительность лечения не должна превышать 2 нед.; Пожилые пациенты старше 65 лет: начальная доза — 200 мг (1/2 табл.) 1 раз в день. При хорошей переносимости доза может быть увеличена до 400 мг (1 табл.) 1 раз в день. Максимальная суточная доза — 400 мг.; Пациенты с почечной недостаточностью: следует контролировать концентрацию креатинина в плазме крови. У пациентов с легкой и умеренной почечной недостаточностью коррекция дозы не требуется. При тяжелой почечной недостаточности начальная доза — 200 мг (1/2 табл.) 1 раз в день. При хорошей переносимости доза может быть увеличена до 400 мг (1 табл.) 1 раз в день. При необходимости применения препарата в более высокой дозе такие пациенты должны находиться под наблюдением врача.; Пациенты с гипоальбуминемией: нет данных по эффективности и безопасности применения препарата Катадолон форте, таблетки пролонгированного действия, 400 мг, у пациентов с гипоальбуминемией. У пациентов с гипоальбуминемией следует применять препарат Катадолон, капсулы, 100 мг.
Побочное действие
Усиливает действие алкоголя, седативных средств и миорелаксантов.; В связи с тем, что флупиртин имеет высокую степень связи с белками, он может изменять степень связывания с белками других одновременно применяемых препаратов. В результате исследования in vitro взаимодействия флупиртина с варфарином, диазепамом, ацетилсалициловой кислотой, бензилпенициллином, дигоксином, глибенкламидом, пропранололом, клонидином, было выявлено, что только верапамил и диазепам вытесняются флупиртином из связи с белками плазмы, что может приводить к усилению их активности.; При одновременном применении флупиртина и непрямых антикоагулянтов — производных кумарина (варфарин) рекомендуется регулярный контроль ПВ для того, чтобы своевременно скорректировать дозу непрямых антикоагулянтов. Данных о взаимодействии с другими антикоагулянтными и антиагрегантными средствами нет (в т.ч. ацетилсалициловая кислота).; При одновременном применении флупиртина с препаратами, которые метаболизируются в печени, требуется регулярный контроль активности печеночных ферментов. Следует избегать комбинированного применения флупиртина и ЛС, содержащих парацетамол и карбамазепин.
Передозировка
Нежелательные реакции классифицированы по частоте следующим образом: очень часто (≥1/10); часто (≥1/100, но <1/10); нечасто (≥1/1000, но <1/100); редко (≥1/10000, но <1/1000); очень редко (<1/10000); частота неизвестна (невозможно оценить на основании имеющихся данных).; Со стороны гепатобилиарной системы: очень часто — повышение активности печеночных трансаминаз; частота неизвестна — гепатит, печеночная недостаточность.; Со стороны иммунной системы: нечасто — повышенная чувствительность к препарату, аллергические реакции (в отдельных случаях сопровождающиеся повышенной температурой тела, кожной сыпью, крапивницей, кожным зудом).; Со стороны обмена веществ: часто — отсутствие аппетита.; Со стороны нервной системы: часто — нарушение сна, депрессия, беспокойство/нервозность, головокружение, тремор, головная боль; нечасто — спутанное сознание.; Со стороны органа зрения: нечасто — нарушение зрения.; Со стороны ЖКТ: часто — диспепсия, тошнота, рвота, боль в области желудка, запор, боль в животе, сухость слизистой оболочки полости рта, метеоризм, диарея.; Со стороны кожи и подкожных тканей: часто — потливость.; Прочие: очень часто — усталость/слабость (у 15% больных), особенно в начале лечения.; Побочные действия в основном зависят от дозы препарата (за исключением аллергических реакций). Во многих случаях они исчезают сами по себе по мере проведения или после окончания лечения.
Особые указания
Имеются сообщения о единичных случаях передозировки с суицидальными намерениями. При этом прием дозы 5 г флупиртина вызывал следующие симптомы: тошнота, тахикардия, состояние прострации, плаксивость, спутанность сознания, оглушенность сознания, сухость слизистой оболочки полости рта.; После индукции рвоты или применения форсированного диуреза, приема активированного угля и введения электролитов самочувствие восстанавливалось в течение 6–12 ч. Об опасных для жизни состояниях не сообщалось.; В случае передозировки или признаках интоксикации следует иметь ввиду возможность возникновения нарушений со стороны ЦНС, а также проявления гепатотоксичности по типу усиления метаболических нарушений в печени.; Лечение: симптоматическое. Специфический антидот препарата неизвестен.
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пролонгированного действия, состав (1 табл.): активное вещество: флупиртина малеат — 400 мг; вспомогательные вещества: метилметакрилата и этилакрилата сополимер (2: 1) — 22,5 мг; тальк — 22,5 мг; кальция гидрофосфата дигидрат — 38 мг; МКЦ — 59,74 мг; кроскармеллоза натрия — 34,95 мг; гипромеллоза — 8 мг; краситель железа оксид желтый (Е172) — 6,25 мг; кремния диоксид коллоидный безводный — 2,06 мг; магния стеарат — 6 мг"}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"миорелаксирующее, нейропротективное, анальгезирующее центральное"}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение острой боли легкой и средней степени тяжести у взрослых."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"повышенная чувствительность к действующему веществу или любому другому компоненту препарата; риск развития печеночной энцефалопатии и холестаз, т.к. может развиться энцефалопатия или усугубиться течение уже имеющейся энцефалопатии или атаксии; миастения gravis в связи с миорелаксирующим действием флупиртина; сопутствующие заболевания печени или алкоголизм; одновременное применение флупиртина с другими лекарственными препаратами, которые могут оказывать гепатотоксическое действие; недавно излеченный или имеющийся звон в ушах, в связи с высоким риском повышения активности печеночных ферментов; детский возраст до 18 лет."}},{"type":"paragraph","data":{"text":"С осторожностью: почечная недостаточность; гипоальбуминемия; пожилой возраст (пациенты старше 65 лет)."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат Катадолон форте следует применять в том случае, если лечение другими обезболивающими препаратами (например НПВС или легкие опиоидные препараты) противопоказано.; У пациентов со сниженной функцией почек следует контролировать концентрацию креатинина в плазме крови.; У пациентов старше 65 лет или с выраженными признаками почечной недостаточности требуется коррекция дозы.; Во время лечения препаратом Катадолон форте 1 раз в неделю следует контролировать состояние функции печени, т.к. при терапии флупиртином возможно повышение активности печеночных трансаминаз, развитие гепатита и печеночной недостаточности. Если результаты исследования печени отклоняются от нормы или проявляются клинические симптомы, которые указывают на поражение печени, то следует прекратить применение препарата Катадолон форте. Пациентов следует предупредить о том, что во время лечения препаратом Катадолон форте необходимо обращать внимание на любые симптомы поражения печени (например отсутствие аппетита, тошнота, рвота, боль в желудке, усталость, темная моча, желтуха, зуд). При проявлении таких симптомов следует прекратить прием препарата Катадолон форте и в срочном порядке обратиться к врачу.; При лечении флупиртином возможны ложноположительные реакции теста с диагностическими полосками на билирубин, уробилиноген и белок в моче. Аналогичная реакция возможна при количественном определении концентрации билирубина в плазме крови.; При применении препарата в высоких дозах в отдельных случаях может отмечаться окрашивание мочи в зеленый цвет, что не является клиническим признаком какой-либо патологии.; Влияние на способность управлять транспортными средствами и работать с механизмами. При применении препарата Катадолон форте следует воздержаться от вождения автотранспорта и управления механизмами, в связи с тем, что у пациентов может развиться сонливость и головокружение, что может повлиять на концентрацию внимания и скорость психомоторных реакций. Особо важно это помнить при одновременном употреблении алкоголя."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, не разжевывая таблетку и запивая достаточным количеством жидкости (предпочтительно воды).; По 400 мг (1 табл.) 1 раз в день для уменьшения боли в течение максимально короткого промежутка времени. Эта доза является суммарной суточной дозой. Если такая доза не может оказать достаточный обезболивающий эффект, можно применять капсулы Катадолон с большей суточной дозой.; Дозу подбирают в зависимости от интенсивности боли и индивидуальной переносимости препарата. Следует применять минимально эффективную дозу в течение максимально короткого промежутка времени. Продолжительность лечения не должна превышать 2 нед.; Пожилые пациенты старше 65 лет: начальная доза — 200 мг (1/2 табл.) 1 раз в день. При хорошей переносимости доза может быть увеличена до 400 мг (1 табл.) 1 раз в день. Максимальная суточная доза — 400 мг.; Пациенты с почечной недостаточностью: следует контролировать концентрацию креатинина в плазме крови. У пациентов с легкой и умеренной почечной недостаточностью коррекция дозы не требуется. При тяжелой почечной недостаточности начальная доза — 200 мг (1/2 табл.) 1 раз в день. При хорошей переносимости доза может быть увеличена до 400 мг (1 табл.) 1 раз в день. При необходимости применения препарата в более высокой дозе такие пациенты должны находиться под наблюдением врача.; Пациенты с гипоальбуминемией: нет данных по эффективности и безопасности применения препарата Катадолон форте, таблетки пролонгированного действия, 400 мг, у пациентов с гипоальбуминемией. У пациентов с гипоальбуминемией следует применять препарат Катадолон, капсулы, 100 мг."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Усиливает действие алкоголя, седативных средств и миорелаксантов.; В связи с тем, что флупиртин имеет высокую степень связи с белками, он может изменять степень связывания с белками других одновременно применяемых препаратов. В результате исследования in vitro взаимодействия флупиртина с варфарином, диазепамом, ацетилсалициловой кислотой, бензилпенициллином, дигоксином, глибенкламидом, пропранололом, клонидином, было выявлено, что только верапамил и диазепам вытесняются флупиртином из связи с белками плазмы, что может приводить к усилению их активности.; При одновременном применении флупиртина и непрямых антикоагулянтов — производных кумарина (варфарин) рекомендуется регулярный контроль ПВ для того, чтобы своевременно скорректировать дозу непрямых антикоагулянтов. Данных о взаимодействии с другими антикоагулянтными и антиагрегантными средствами нет (в т.ч. ацетилсалициловая кислота).; При одновременном применении флупиртина с препаратами, которые метаболизируются в печени, требуется регулярный контроль активности печеночных ферментов. Следует избегать комбинированного применения флупиртина и ЛС, содержащих парацетамол и карбамазепин."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Нежелательные реакции классифицированы по частоте следующим образом: очень часто (≥1/10); часто (≥1/100, но \u003c1/10); нечасто (≥1/1000, но \u003c1/100); редко (≥1/10000, но \u003c1/1000); очень редко (\u003c1/10000); частота неизвестна (невозможно оценить на основании имеющихся данных).; Со стороны гепатобилиарной системы: очень часто — повышение активности печеночных трансаминаз; частота неизвестна — гепатит, печеночная недостаточность.; Со стороны иммунной системы: нечасто — повышенная чувствительность к препарату, аллергические реакции (в отдельных случаях сопровождающиеся повышенной температурой тела, кожной сыпью, крапивницей, кожным зудом).; Со стороны обмена веществ: часто — отсутствие аппетита.; Со стороны нервной системы: часто — нарушение сна, депрессия, беспокойство/нервозность, головокружение, тремор, головная боль; нечасто — спутанное сознание.; Со стороны органа зрения: нечасто — нарушение зрения.; Со стороны ЖКТ: часто — диспепсия, тошнота, рвота, боль в области желудка, запор, боль в животе, сухость слизистой оболочки полости рта, метеоризм, диарея.; Со стороны кожи и подкожных тканей: часто — потливость.; Прочие: очень часто — усталость/слабость (у 15% больных), особенно в начале лечения.; Побочные действия в основном зависят от дозы препарата (за исключением аллергических реакций). Во многих случаях они исчезают сами по себе по мере проведения или после окончания лечения."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Имеются сообщения о единичных случаях передозировки с суицидальными намерениями. При этом прием дозы 5 г флупиртина вызывал следующие симптомы: тошнота, тахикардия, состояние прострации, плаксивость, спутанность сознания, оглушенность сознания, сухость слизистой оболочки полости рта.; После индукции рвоты или применения форсированного диуреза, приема активированного угля и введения электролитов самочувствие восстанавливалось в течение 6–12 ч. Об опасных для жизни состояниях не сообщалось.; В случае передозировки или признаках интоксикации следует иметь ввиду возможность возникновения нарушений со стороны ЦНС, а также проявления гепатотоксичности по типу усиления метаболических нарушений в печени.; Лечение: симптоматическое. 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