Кетонал Дуо Капсулы, 30 шт, 150 мг, с модифицированным высвобождением

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Биодоступность как обычных капсул, так и капсул с модифицированным высвобождением одинакова, и составляет 90 %."}},{"type":"paragraph","data":{"text":"Прием пищи не влияет на общую биодоступность (AUC) кетопрофена, но уменьшает скорость всасывания."}},{"type":"paragraph","data":{"text":"После приема внутрь кетопрофена в виде капсул с модифицированным высвобождением 150 мг максимальная плазменная концентрация (Cmax) = 9036,64 нг/мл достигается в течение 1,76 ч."}},{"type":"paragraph","data":{"text":"Распределение"}},{"type":"paragraph","data":{"text":"Кетопрофен на 99 % связан с белками плазмы крови, преимущественно с альбуминовой фракцией."}},{"type":"paragraph","data":{"text":"Объем распределения в тканях составляет 0,1-0,2 л/кг. Препарат хорошо проникает в синовиальную жидкость и достигает там концентрации, равной 30 % плазменной."}},{"type":"paragraph","data":{"text":"Значимые концентрации кетопрофена в синовиальной жидкости стабильны и сохраняются до 30 ч, в результате чего на длительное время уменьшается болевой синдром и скованность суставов."}},{"type":"paragraph","data":{"text":"Метаболизм и выведение"}},{"type":"paragraph","data":{"text":"Кетопрофен подвергается интенсивному метаболизму при посредстве микросомальных ферментов печени, период полувыведения (Т1/2) кетопрофена менее 2 ч. Он связывается с глюкуроновой кислотой и выводится из организма в виде глюкуронида. Активных метаболитов кетопрофена нет."}},{"type":"paragraph","data":{"text":"До 80 % кетопрофена выводится почками в течение 24 ч, в основном в форме глюкуронида кетопрофена. При применении препарата в дозировке 100 мг и более выведение почками может быть затруднено. У пациентов с тяжелой почечной недостаточностью большая часть препарата выделяется через кишечник. При приеме высоких доз печеночный клиренс также увеличивается. Через кишечник выводится до 40 % препарата."}},{"type":"paragraph","data":{"text":"У пациентов с печеночной недостаточностью плазменная концентрация кетопрофена увеличена в два раза (вероятно, за счет гипоальбуминемии, и вследствие этого высокого уровня несвязанного активного кетопрофена); таким пациентам необходимо назначение препарата в минимальной терапевтической дозе."}},{"type":"paragraph","data":{"text":"У пациентов с почечной недостаточностью клиренс кетопрофена снижен, что также требует снижения дозировки."}},{"type":"paragraph","data":{"text":"У пациентов пожилого возраста метаболизм и выведение кетопрофена происходят медленнее, но это имеет клиническое значение только для пациентов с пониженной функцией почек.\n\n"}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"\n\nСимптоматическая терапия болезненных и воспалительных процессов различного происхождения, в том числе:"}},{"type":"paragraph","data":{"text":"- воспалительные и дегенеративные заболевания опорно-двигательного аппарата:"}},{"type":"paragraph","data":{"text":"• ревматоидный артрит;"}},{"type":"paragraph","data":{"text":"• серонегативные артриты: анкилозирующий спондилоартрит – болезнь Бехтерева, псориатический артрит, реактивный артрит (синдром Рейтера);"}},{"type":"paragraph","data":{"text":"• подагра, псевдоподагра;"}},{"type":"paragraph","data":{"text":"• остеоартроз;"}},{"type":"paragraph","data":{"text":"- болевой синдром:"}},{"type":"paragraph","data":{"text":"• головная боль;"}},{"type":"paragraph","data":{"text":"• тендинит, бурсит, миалгия, невралгия, радикулит;"}},{"type":"paragraph","data":{"text":"• посттравматический и послеоперационный болевой синдром;"}},{"type":"paragraph","data":{"text":"• болевой синдром при онкологических заболеваниях;"}},{"type":"paragraph","data":{"text":"• альгодисменорея.\n\n"}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"\n\n• гиперчувствительность к кетопрофену или другим компонентам препарата, а также салицилатам или другим нестероидным противовоспалительным препаратам;"}},{"type":"paragraph","data":{"text":"• полное и неполное сочетание бронхиальной астмы, рецидивирующего полипоза слизистой оболочки носа и околоносовых пазух и непереносимости ацетилсалициловой кислоты и других нестероидных противовоспалительных препаратов (НПВП) (в том числе в анамнезе);"}},{"type":"paragraph","data":{"text":"• язвенная болезнь желудка или двенадцатиперстной кишки в стадии обострения, язвенный колит, болезнь Крона в фазе обострения, воспалительные заболевания кишечника в стадии обострения;"}},{"type":"paragraph","data":{"text":"• гемофилия и другие нарушения свертываемости крови;"}},{"type":"paragraph","data":{"text":"• детский возраст (до 15 лет);"}},{"type":"paragraph","data":{"text":"• тяжелая печеночная недостаточность;"}},{"type":"paragraph","data":{"text":"• тяжелая почечная недостаточность (клиренс креатинина (КК) менее 30 мл/мин), прогрессирующие заболевания почек;"}},{"type":"paragraph","data":{"text":"• декомпенсированная сердечная недостаточность;"}},{"type":"paragraph","data":{"text":"• послеоперационный период после аортокоронарного шунтирования;"}},{"type":"paragraph","data":{"text":"• желудочно-кишечные, цереброваскулярные и другие кровотечения (или подозрение на кровотечение);"}},{"type":"paragraph","data":{"text":"• дефицит лактазы, непереносимость лактозы, глюкозо-галактозная мальабсорбция;"}},{"type":"paragraph","data":{"text":"• хроническая диспепсия;"}},{"type":"paragraph","data":{"text":"• III триместр беременности;"}},{"type":"paragraph","data":{"text":"• период лактации.\n\n"}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"язвенная болезнь в анамнезе, бронхиальная астма в анамнезе, клинически выраженные сердечно-сосудистые, цереброваскулярные заболевания и заболевания периферических артерий, дислипидемия, прогрессирующие заболевания печени, гипербилирубинемия, алкогольный цирроз печени, почечная недостаточность (КК 30-60 мл/мин), хроническая сердечная недостаточность, артериальная гипертензия, заболевания крови, дегидратация, сахарный диабет, анамнестические данные о развитии язвенного поражения желудочно-кишечного тракта, курение, сопутствующая терапия антикоагулянтами (например, варфарин), антиагрегантами (например, ацетилсалициловая кислота), глюкокортикостероидами для приема внутрь (например, преднизолон), селективными ингибиторами обратного захвата серотонина (например, циталопрам, сертралин), длительное применение НПВП, наличие инфекции Helicobacter pylori, печеночная недостаточность, пожилой возраст."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"\n\nИнгибирование синтеза простагландинов может оказать нежелательное влияние на течение беременности и/или на эмбриональное развитие. Данные, полученные в ходе эпидемиологических исследований при применении ингибиторов синтеза простагландина на ранних сроках беременности, подтверждают повышение риска самопроизвольного аборта и формирования пороков сердца (~1-1,5 %)."}},{"type":"paragraph","data":{"text":"Назначать препарат беременным женщинам в I и II триместрах беременности возможно только в случае, когда преимущества для матери оправдывают возможный риск для плода."}},{"type":"paragraph","data":{"text":"Противопоказано применение кетопрофена у беременных женщин во время III триместра беременности из-за возможности развития слабости родовой активности матки и/или преждевременного закрытия артериального протока, возможного увеличения времени кровотечения, маловодия и почечной недостаточности."}},{"type":"paragraph","data":{"text":"На сегодняшний момент отсутствуют данные о выделении кетопрофена в грудное молоко, поэтому при необходимости назначения кетопрофена кормящей матери, следует решить вопрос о прекращении грудного вскармливания.\n\n"}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"\n\nВнутрь."}},{"type":"paragraph","data":{"text":"Стандартная доза Кетонал ДУО для взрослых и детей старше 15 лет составляет 150 мг/сутки (1 капсула с модифицированным высвобождением). Капсулы следует принимать во время или после еды, запивая водой или молоком (объем жидкости должен быть не менее 100 мл)."}},{"type":"paragraph","data":{"text":"Максимальная доза кетопрофена составляет 200 мг/сутки.\n\n"}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\n\nПо данным Всемирной организации здравоохранения (ВОЗ) нежелательные эффекты классифицированы в соответствии с их частотой развития следующим образом: очень часто (≥1/10), часто (≥1/100, <1/10), нечасто (≥1/1000, <1/100), редко (≥1/10000, <1/1000) и очень редко (<1/10000); частота неизвестна (частоту возникновения явлений нельзя определить на основании имеющихся данных)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны системы кроветворения и лимфатической системы"}},{"type":"paragraph","data":{"text":"редко: геморрагическая анемия;"}},{"type":"paragraph","data":{"text":"частота неизвестна: агранулоцитоз, тромбоцитопения, нарушение функции костного мозга."}},{"type":"paragraph","data":{"text":"Нарушения со стороны иммунной системы"}},{"type":"paragraph","data":{"text":"частота неизвестна: анафилактические реакции (включая анафилактический шок)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны нервной системы"}},{"type":"paragraph","data":{"text":"нечасто: головная боль, головокружение, сонливость;"}},{"type":"paragraph","data":{"text":"редко: парестезии;"}},{"type":"paragraph","data":{"text":"частота неизвестна: судороги, нарушение вкусовых ощущений."}},{"type":"paragraph","data":{"text":"Нарушения психики:"}},{"type":"paragraph","data":{"text":"частота неизвестна: эмоциональная лабильность."}},{"type":"paragraph","data":{"text":"Нарушения со стороны органов чувств"}},{"type":"paragraph","data":{"text":"редко: нечеткость зрения, шум в ушах."}},{"type":"paragraph","data":{"text":"Нарушения со стороны сердечно-сосудистой системы"}},{"type":"paragraph","data":{"text":"частота неизвестна: сердечная недостаточность, повышение артериального давления, вазодилатация."}},{"type":"paragraph","data":{"text":"Нарушения со стороны дыхательной системы"}},{"type":"paragraph","data":{"text":"редко: обострение бронхиальной астмы;"}},{"type":"paragraph","data":{"text":"частота неизвестна: бронхоспазм (в особенности, у пациентов с гиперчувствительностью к НПВП), ринит."}},{"type":"paragraph","data":{"text":"Нарушения со стороны желудочно-кишечного тракта"}},{"type":"paragraph","data":{"text":"часто: тошнота, рвота, диспепсия, боль в области живота;"}},{"type":"paragraph","data":{"text":"нечасто: запор, диарея, вздутие живота, гастрит;"}},{"type":"paragraph","data":{"text":"редко: пептическая язва, стоматит;"}},{"type":"paragraph","data":{"text":"очень редко: обострение язвенного колита или болезни Крона, желудочно-кишечное кровотечение, перфорация."}},{"type":"paragraph","data":{"text":"Нарушения со стороны печени и желчевыводящих путей"}},{"type":"paragraph","data":{"text":"редко: гепатит, повышение активности «печеночных» трансаминаз, повышение концентрации билирубина."}},{"type":"paragraph","data":{"text":"Нарушения со стороны кожных покровов"}},{"type":"paragraph","data":{"text":"нечасто: кожная сыпь, кожный зуд;"}},{"type":"paragraph","data":{"text":"частота неизвестна: фотосенсибилизация, алопеция, крапивница, ангионевротический отек, эритема, буллезная сыпь, включая синдром Стивенса-Джонсона, токсический эпидермальный некролиз."}},{"type":"paragraph","data":{"text":"Нарушения со стороны мочевыделительной системы"}},{"type":"paragraph","data":{"text":"частота неизвестна: острая почечная недостаточность, интерстициальный нефрит, нефритический синдром, нефротический синдром, аномальные значения показателей функции почек."}},{"type":"paragraph","data":{"text":"Прочее"}},{"type":"paragraph","data":{"text":"нечасто: отеки;"}},{"type":"paragraph","data":{"text":"редко: увеличение массы тела;"}},{"type":"paragraph","data":{"text":"частота неизвестна: повышенная утомляемость.\n\n"}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\n\nКак и в случае других НПВП, при передозировке кетопрофена могут отмечаться тошнота, рвота, боль в животе, рвота с кровью, мелена, нарушение сознания, угнетение дыхания, судороги, нарушение функции почек и почечная недостаточность."}},{"type":"paragraph","data":{"text":"При передозировке показано промывание желудка и применение активированного угля."}},{"type":"paragraph","data":{"text":"Лечение – симптоматическое; воздействие кетопрофена на желудочно-кишечный тракт (ЖКТ) можно ослабить с помощью блокаторов Н2-гистаминовых рецепторов, ингибиторов протонной помпы и простагландинов.\n\n"}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"\n\nКетопрофен может ослаблять действие диуретиков и гипотензивных средств и усиливать действие гипогликемических средств для приема внутрь и некоторых противосудорожных препаратов (фенитоин)."}},{"type":"paragraph","data":{"text":"Одновременное применение с другими НПВП, салицилатами, глюкокортикостероидами, этанолом повышает риск развития нежелательных явлений со стороны ЖКТ."}},{"type":"paragraph","data":{"text":"Одновременное применение с антикоагулянтами (гепарин, варфарин), тромболитиками, антиагрегантами (тиклопидин, клопидогрел), пентоксифиллином повышает риск развития кровотечений."}},{"type":"paragraph","data":{"text":"Одновременное применение с солями калия, калийсберегающими диуретиками, ингибиторами ангиотензинпревращающего фермента (АПФ), НПВП, низкомолекулярными гепаринами, циклоспорином, такролимусом и триметопримом повышает риск развития гиперкалиемии."}},{"type":"paragraph","data":{"text":"Повышает концентрацию в плазме крови сердечных гликозидов, блокаторов «медленных» кальциевых каналов, препаратов лития, циклоспорина, метотрексата и дигоксина."}},{"type":"paragraph","data":{"text":"Увеличивает токсичность метотрексата и нефротоксичность циклоспорина."}},{"type":"paragraph","data":{"text":"Одновременное применение с пробенецидом значительно снижает клиренс кетопрофена в плазме крови."}},{"type":"paragraph","data":{"text":"Сочетанный прием с глюкокортикостероидами и другими НПВП (включая селективные ингибиторы ЦОГ2) увеличивает вероятность возникновения побочных эффектов (в частности, со стороны ЖКТ)."}},{"type":"paragraph","data":{"text":"НПВП могут уменьшать эффективность мифепристона. Прием НПВП следует начинать не ранее, чем через 8-12 дней после отмены мифепристона.\n\n"}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nНе следует сочетать прием кетопрофена с приемом других НПВП и/или ингибиторов ЦОГ2. При длительном применении НПВП необходимо периодически оценивать клинический анализ крови, контролировать функцию почек и печени, в особенности, у пациентов пожилого возраста (старше 65 лет), проводить анализ кала на скрытую кровь."}},{"type":"paragraph","data":{"text":"Необходимо соблюдать осторожность и чаще контролировать артериальное давление при применении кетопрофена для лечения пациентов, страдающих артериальной гипертензией, сердечно-сосудистыми заболеваниями, которые приводят к задержке жидкости в организме."}},{"type":"paragraph","data":{"text":"При возникновении нарушений со стороны органов зрения лечение следует незамедлительно прекратить."}},{"type":"paragraph","data":{"text":"Как и другие НПВП, кетопрофен может маскировать симптомы инфекционно-воспалительных заболеваний. В случае обнаружения признаков инфекции или ухудшения самочувствия на фоне применения препарата необходимо незамедлительно обратиться к врачу."}},{"type":"paragraph","data":{"text":"При наличии в анамнезе противопоказаний со стороны ЖКТ (кровотечения, перфорация, язвенная болезнь), проведении длительной терапии и применении высоких дозировок кетопрофена пациент должен находиться под тщательным наблюдением врача."}},{"type":"paragraph","data":{"text":"Из-за важной роли простагландинов в поддержании почечного кровотока следует проявлять особую осторожность при назначении кетопрофена пациентам с сердечной или почечной недостаточностью, а также при лечении пожилых пациентов, принимающих диуретики, и пациентов, у которых, по какой-либо причине, наблюдается снижение объема циркулирующей крови. Использование препарата должно быть прекращено перед большим хирургическим вмешательством."}},{"type":"paragraph","data":{"text":"Применение кетопрофена может влиять на женскую фертильность, поэтому пациенткам с бесплодием (в т.ч. проходящим обследование) не рекомендуется использовать препарат.\n\n"}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"  Данных об отрицательном влиянии Кетонал ДУО в рекомендуемых дозах на способности к управлению автомобилем или работе с механизмами нет. При управлении транспортными средствами и занятиях другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций, необходимо соблюдать осторожность, так как препарат может вызывать головокружение и другие побочные эффекты, которые могут влиять на указанные способности.  "}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nКапсулы с модифицированным высвобождением 150 мг"}},{"type":"paragraph","data":{"text":"По 10 капсул в блистер из алюминия/ПВХ/ТЭ/ПВДХ."}},{"type":"paragraph","data":{"text":"По 1, 2 или 3 блистера вместе с инструкцией по применению в картонную пачку.\n\n"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"\n\nВ защищенном от света месте при температуре не выше 25 °С."}},{"type":"paragraph","data":{"text":"В недоступном для детей месте.\n\n"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"\n\n2 года."}},{"type":"paragraph","data":{"text":"Не использовать препарат после истечения срока годности.\n\n"}}]},{"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":"\n\nДержатель РУ: Лек д.д. Веровшкова 57, 1526 Любляна, Словения;"}},{"type":"paragraph","data":{"text":"Произведено: Лек д.д. Веровшкова 57, 1526 Любляна, Словения.\n\n"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ЗАО «Сандоз»"}}]}],"source":null},"description_toggle":false,"short_description":"Фармакодинамика Кетопрофен является нестероидным противовоспалительным препаратом. Кетопрофен обладает противовоспалительным, анальгезирующим и жаропонижающим действием. Кетопрофен блокирует действие фермента циклооксигеназы 1 и 2 (ЦОГ1 и ЦОГ2) и, частично, липооксигеназы, что приводит к подавлению синтеза простагландинов (в том числе и в центральной нервной системе, вероятнее всего, в гипоталамусе). Стабилизирует in vitro и in vivo липосомальные мембраны, при высоких концентрациях in vitro кетопрофен подавляет синтез брадикинина и лейкотриенов. Кетопрофен не оказывает отрицательного влияния на состояние суставного хряща. Фармакокинетика Всасывание Кетонал ДУО представляет собой новую лекарственную форму, отличающуюся от обычных капсул способом высвобождения активного вещества. Капсулы c модифицированным высвобождением содержат два вида пеллет: белые (около 60 % от общего количества) и желтые (40 % от общего количества, покрытые оболочкой). Кетопрофен быстро высвобождается из белых пеллет и медленно из желтых, что обусловливает сочетание быстрого и пролонгированного действия препарата. Препарат хорошо всасывается после приема внутрь. Биодоступность как обычных капсул, так и капсул с модифицированным высвобождением одинакова, и составляет 90 %. Прием пищи не влияет на общую биодоступность (AUC) кетопрофена, но уменьшает скорость всасывания. После приема внутрь кетопрофена в виде капсул с модифицированным высвобождением 150 мг максимальная плазменная концентрация (Cmax) = 9036,64 нг/мл достигается в течение 1,76 ч. Распределение Кетопрофен на 99 % связан с белками плазмы крови, преимущественно с альбуминовой фракцией. Объем распределения в тканях составляет 0,1-0,2 л/кг. Препарат хорошо проникает в синовиальную жидкость и достигает там концентрации, равной 30 % плазменной. Значимые концентрации кетопрофена в синовиальной жидкости стабильны и сохраняются до 30 ч, в результате чего на длительное время уменьшается болевой синдром и скованность суставов. Метаболизм и выведение Кетопрофен подвергается интенсивному метаболизму при посредстве микросомальных ферментов печени, период полувыведения (Т1/2) кетопрофена менее 2 ч. Он связывается с глюкуроновой кислотой и выводится из организма в виде глюкуронида. Активных метаболитов кетопрофена нет. До 80 % кетопрофена выводится почками в течение 24 ч, в основном в форме глюкуронида кетопрофена. При применении препарата в дозировке 100 мг и более выведение почками может быть затруднено. У пациентов с тяжелой почечной недостаточностью большая часть препарата выделяется через кишечник. При приеме высоких доз печеночный клиренс также увеличивается. Через кишечник выводится до 40 % препарата. У пациентов с печеночной недостаточностью плазменная концентрация кетопрофена увеличена в два раза (вероятно, за счет гипоальбуминемии, и вследствие этого высокого уровня несвязанного активного кетопрофена); таким пациентам необходимо назначение препарата в минимальной терапевтической дозе. У пациентов с почечной недостаточностью клиренс кетопрофена снижен, что также требует снижения дозировки. 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