Лиофилизат для приготовления раствора для инъекций
активное вещество:
теноксикам - 20 мг,
вспомогательные вещества:
маннитол — 57,33 мг;
натрия гидроксид — 3,28 мг;
трометамол — 3 мг;
натрия метабисульфит — 2 мг;
дтнатрия эдетат — 0,2 мг.
Описание
Mustafa Nevzat Ilac Sanayii A.S., Турция, НПВП;
Фармакологические свойства
Теноксикам, представляющий собой тиенотиазиновое производное оксикама, является НПВС. Помимо противовоспалительного, анальгетического и жаропонижающего действия, препарат также препятствует агрегации тромбоцитов. Теноксикам оказывает свое противовоспалительное действие за счет подавления активности изоферментов ЦОГ, участвующих в метаболизме арахидоновой кислоты, и таким образом подавляет синтез ПГ.
Теноксикам не оказывает воздействия на активность липооксигеназ. Кроме того, теноксикам подавляет некоторые функции лейкоцитов, включая фагоцитоз, высвобождение гистамина и уменьшает содержание активных радикалов в очаге воспаления.
Фармакокинетика
Препарат быстро всасывается из ЖКТ в неизмененном виде. Cmax достигается через 2 ч после приема препарата. При приеме препарата после еды или совместно с антацидами уменьшается скорость, но не степень его всасывания. Средний T1/2 составляет 70 ч. Теноксикам всасывается полностью, его биодоступность — 100%. В крови препарат связывается с белками на 99%.
Препарат хорошо проникает в синовиальную жидкость, характеризуется низким системным клиренсом и продолжительным T1/2, что позволяет принимать теноксикам 1 раз в день.
2/3 принятой дозы препарата выводится с мочой, 1/3 — с калом. При длительном применении кумуляция теноксикама не наблюдается; сывороточное содержание препарата при этом составляет 10–15 мкг/мл.
болевой синдром (слабой и средней интенсивности): артралгия, миалгия, невралгия, мигрень, зубная и головная боль, альгодисменорея;
боль при травмах, ожогах;
воспалительные и дегенеративные заболевания опорно-двигательного аппарата, сопровождающиеся болевым синдромом, такие как ишиалгия, люмбаго, эпикондилит.
Предназначен для симптоматической терапии, уменьшения боли и воспаления на момент использования, на прогрессирование заболевания не влияет.
Противопоказания
гиперчувствительность;
эрозивно-язвенные поражения ЖКТ (в т.ч. в анамнезе);
желудочно-кишечное кровотечение (в т.ч. в анамнезе);
гастрит тяжелого течения;
полное или неполное сочетание бронхиальной астмы, рецидивирующего полипоза носа и околоносовых пазух и непереносимости ацетилсалициловой кислоты или других НПВС (в т.ч. в анамнезе);
гемофилия;
гипокоагуляция;
печеночная и/или почечная недостаточность (Cl креатинина менее 30 мл/мин);
воспалительные заболевания ЖКТ;
прогрессирующие заболевания почек;
активное заболевание печени;
состояние после проведения аорто-коронарного шунтирования;
подтвержденная гиперкалиемия;
снижение слуха;
патология вестибулярного аппарата;
дефицит глюкозо-6-фосфатдегидрогеназы;
заболевания крови;
беременность;
период лактации.
С осторожностью: хроническая сердечная недостаточность; отеки; артериальная гипертензия; сахарный диабет; ишемическая болезнь сердца; цереброваскулярные заболевания; дислипидемия/гиперлипидемия; заболевания периферических артерий; курение; хроническая почечная недостаточность (Cl креатинина 30–60 мл/мин); наличие инфекции Н. pylori; длительное использование НПВС; алкоголизм; тяжелые соматические заболевания; одновременный прием пероральных ГКС (в т.ч. преднизолон), антикоагулянтов (в т.ч. варфарин), антиагрегантов (в т.ч. ацетилсалициловая кислота, клопидогрел), СИОЗС (в т.ч. циталопрам, флуоксетин, пароксетин, сертралин); пожилой возраст
Способ применения и дозы
В/м, в/в. Инъекции препарата Тексаред назначаются при кратковременном лечении — по 20 мг в день; при длительном применении — 10 мг в день.
При подагрическом артрите 1–2 дня назначается 40 мг в день, в последующие 3–5 дней — 20 мг в день. Назначенную дозу следует применять в 1 прием.
Побочное действие
К нежелательным явлениям, которые могут наблюдаться на фоне применения препарата Тексаред в форме лиофилизат для приготовления раствора для инъекций, относятся нижестоящие.
Со стороны пищеварительной системы (11,4% случаев): чувство жжения в желудке, боли в желудке, рвота, тошнота, диарея, запор, метеоризм и НПВП-гастропатия, абдоминальные боли, стоматит, анорексия, нарушения функции печени. При длительном применении в больших дозах — изъязвление слизистой оболочки ЖКТ, кровотечение (желудочно-кишечное, десневое, маточное, геморроидальное), перфорация стенок кишечника.
Со стороны ССС: сердечная недостаточность, тахикардия, повышение АД.
Со стороны ЦНС (2,6% случаев): головная боль, головокружения, сонливость, депрессия, возбуждение, снижение слуха, шум в ушах, раздражение глаз, нарушение зрения.
Со стороны кожи и подкожной клетчатки (2,5% случаев): сыпь, зуд, эритема и крапивница, фотодерматит. Крайне редко — синдром Стивенса-Джонсона, синдром Лайелла
Со стороны мочевыделительной системы (1–2% случаев): повышение содержания азота мочевины и креатинина в крови.
Со стороны органов кроветворения (1–2% случаев): агранулоцитоз, лейкопения, анемия, тромбоцитопения.
Со стороны гепатобилиарной системы (1–2% случаев): повышение активности АЛТ, АСТ и ГГТ и уровня билирубина в сыворотке.
Лабораторные показатели: гиперкреатининемия, гипербилирубинемия, повышение концентрации азота мочевины и активности печеночных трансаминаз, удлинение времени кровотечения.
К нежелательным явлениям, наблюдаемым со стороны системы гемопоэза, относятся снижение уровня Hb и гранулоцитопения. Эти нежелательные явления наблюдались крайне редко.
На фоне лечения могут наблюдаться психические нарушения (1,7%) и нарушения обмена веществ (1%).
Взаимодействие с другими лекарственными средствами
Снижает эффективность урикозурических ЛС, усиливает действие антикоагулянтов, антиагрегантов, фибринолитиков, побочные эффекты гормона коры надпочечников и ГКС и эстрогенов; снижает эффективность гипотензивных ЛС и диуретиков; усиливает гипогликемический эффект производных сульфонилмочевины.
Увеличивает концентрацию в крови препаратов лития, метотрексата.
Во время лечения необходим контроль картины периферической крови и функционального состояния печени и почек, протромбинового индекса (на фоне непрямых антикоагулянтов), концентрации глюкозы в крови (на фоне пероральных гипогликемических ЛС).
При необходимости определения 17-кетостероидов препарат следует отменить за 48 ч до исследования.
За несколько дней до хирургического вмешательства отменяют препарат.
Необходимо учитывать возможность задержки натрия и воды в организме при назначении с диуретиками больным с артериальной гипертензией и ХСН.
Для снижения риска развития нежелательных явлений со стороны ЖКТ следует использовать минимальную эффективную дозу минимально возможным коротким курсом.
Влияние на способность к вождению автотранспорта и управлению механизмами. Одним из нежелательных эффектов препарата является головокружение, это следует учитывать в ситуациях, требующих пристального внимания пациента, например при управлении автотранспортным cредством или сложными техническими приборами. 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
В сухом, защищенном от света месте, при температуре не выше 25 °C.
Хранить в недоступном для детей месте.
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приготовления раствора для инъекций"}},{"type":"paragraph","data":{"text":"активное вещество:"}},{"type":"paragraph","data":{"text":"теноксикам - 20 мг,"}},{"type":"paragraph","data":{"text":"вспомогательные вещества:"}},{"type":"paragraph","data":{"text":"маннитол — 57,33 мг;"}},{"type":"paragraph","data":{"text":"натрия гидроксид — 3,28 мг;"}},{"type":"paragraph","data":{"text":"трометамол — 3 мг;"}},{"type":"paragraph","data":{"text":"натрия метабисульфит — 2 мг;"}},{"type":"paragraph","data":{"text":"дтнатрия эдетат — 0,2 мг."}}]},{"id":1,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Mustafa Nevzat Ilac Sanayii A.S., Турция, НПВП;"}}]},{"id":6,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Теноксикам, представляющий собой тиенотиазиновое производное оксикама, является НПВС. Помимо противовоспалительного, анальгетического и жаропонижающего действия, препарат также препятствует агрегации тромбоцитов. Теноксикам оказывает свое противовоспалительное действие за счет подавления активности изоферментов ЦОГ, участвующих в метаболизме арахидоновой кислоты, и таким образом подавляет синтез ПГ."}},{"type":"paragraph","data":{"text":"Теноксикам не оказывает воздействия на активность липооксигеназ. Кроме того, теноксикам подавляет некоторые функции лейкоцитов, включая фагоцитоз, высвобождение гистамина и уменьшает содержание активных радикалов в очаге воспаления."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"Препарат быстро всасывается из ЖКТ в неизмененном виде. C\u003csub\u003emax\u003c/sub\u003e достигается через 2 ч после приема препарата. При приеме препарата после еды или совместно с антацидами уменьшается скорость, но не степень его всасывания. Средний T\u003csub\u003e1/2\u003c/sub\u003e составляет 70 ч. Теноксикам всасывается полностью, его биодоступность — 100%. В крови препарат связывается с белками на 99%."}},{"type":"paragraph","data":{"text":"Препарат хорошо проникает в синовиальную жидкость, характеризуется низким системным клиренсом и продолжительным T\u003csub\u003e1/2\u003c/sub\u003e, что позволяет принимать теноксикам 1 раз в день."}},{"type":"paragraph","data":{"text":"2/3 принятой дозы препарата выводится с мочой, 1/3 — с калом. При длительном применении кумуляция теноксикама не наблюдается; сывороточное содержание препарата при этом составляет 10–15 мкг/мл."}}]},{"id":7,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"ревматоидный артрит, остеоартрит, анкилозирующий спондилит, суставной синдром при обострении подагры, бурсит, тендовагинит;"}},{"type":"paragraph","data":{"text":"болевой синдром (слабой и средней интенсивности): артралгия, миалгия, невралгия, мигрень, зубная и головная боль, альгодисменорея;"}},{"type":"paragraph","data":{"text":"боль при травмах, ожогах;"}},{"type":"paragraph","data":{"text":"воспалительные и дегенеративные заболевания опорно-двигательного аппарата, сопровождающиеся болевым синдромом, такие как ишиалгия, люмбаго, эпикондилит."}},{"type":"paragraph","data":{"text":"Предназначен для симптоматической терапии, уменьшения боли и воспаления на момент использования, на прогрессирование заболевания не влияет."}}]},{"id":8,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"гиперчувствительность;"}},{"type":"paragraph","data":{"text":"эрозивно-язвенные поражения ЖКТ (в т.ч. в анамнезе);"}},{"type":"paragraph","data":{"text":"желудочно-кишечное кровотечение (в т.ч. в анамнезе);"}},{"type":"paragraph","data":{"text":"гастрит тяжелого течения;"}},{"type":"paragraph","data":{"text":"полное или неполное сочетание бронхиальной астмы, рецидивирующего полипоза носа и околоносовых пазух и непереносимости ацетилсалициловой кислоты или других НПВС (в т.ч. в анамнезе);"}},{"type":"paragraph","data":{"text":"гемофилия;"}},{"type":"paragraph","data":{"text":"гипокоагуляция;"}},{"type":"paragraph","data":{"text":"печеночная и/или почечная недостаточность (Cl креатинина менее 30 мл/мин);"}},{"type":"paragraph","data":{"text":"воспалительные заболевания ЖКТ;"}},{"type":"paragraph","data":{"text":"прогрессирующие заболевания почек;"}},{"type":"paragraph","data":{"text":"активное заболевание печени;"}},{"type":"paragraph","data":{"text":"состояние после проведения аорто-коронарного шунтирования;"}},{"type":"paragraph","data":{"text":"подтвержденная гиперкалиемия;"}},{"type":"paragraph","data":{"text":"снижение слуха;"}},{"type":"paragraph","data":{"text":"патология вестибулярного аппарата;"}},{"type":"paragraph","data":{"text":"дефицит глюкозо-6-фосфатдегидрогеназы;"}},{"type":"paragraph","data":{"text":"заболевания крови;"}},{"type":"paragraph","data":{"text":"беременность;"}},{"type":"paragraph","data":{"text":"период лактации."}},{"type":"paragraph","data":{"text":"С осторожностью: хроническая сердечная недостаточность; отеки; артериальная гипертензия; сахарный диабет; ишемическая болезнь сердца; цереброваскулярные заболевания; дислипидемия/гиперлипидемия; заболевания периферических артерий; курение; хроническая почечная недостаточность (Cl креатинина 30–60 мл/мин); наличие инфекции Н. pylori; длительное использование НПВС; алкоголизм; тяжелые соматические заболевания; одновременный прием пероральных ГКС (в т.ч. преднизолон), антикоагулянтов (в т.ч. варфарин), антиагрегантов (в т.ч. ацетилсалициловая кислота, клопидогрел), СИОЗС (в т.ч. циталопрам, флуоксетин, пароксетин, сертралин); пожилой возраст"}}]},{"id":11,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"В/м, в/в. Инъекции препарата Тексаред назначаются при кратковременном лечении — по 20 мг в день; при длительном применении — 10 мг в день."}},{"type":"paragraph","data":{"text":"При подагрическом артрите 1–2 дня назначается 40 мг в день, в последующие 3–5 дней — 20 мг в день. Назначенную дозу следует применять в 1 прием."}}]},{"id":12,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"К нежелательным явлениям, которые могут наблюдаться на фоне применения препарата Тексаред в форме лиофилизат для приготовления раствора для инъекций, относятся нижестоящие."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы (11,4% случаев): чувство жжения в желудке, боли в желудке, рвота, тошнота, диарея, запор, метеоризм и НПВП-гастропатия, абдоминальные боли, стоматит, анорексия, нарушения функции печени. При длительном применении в больших дозах — изъязвление слизистой оболочки ЖКТ, кровотечение (желудочно-кишечное, десневое, маточное, геморроидальное), перфорация стенок кишечника."}},{"type":"paragraph","data":{"text":"Со стороны ССС: сердечная недостаточность, тахикардия, повышение АД."}},{"type":"paragraph","data":{"text":"Со стороны ЦНС (2,6% случаев): головная боль, головокружения, сонливость, депрессия, возбуждение, снижение слуха, шум в ушах, раздражение глаз, нарушение зрения."}},{"type":"paragraph","data":{"text":"Со стороны кожи и подкожной клетчатки (2,5% случаев): сыпь, зуд, эритема и крапивница, фотодерматит. Крайне редко — синдром Стивенса-Джонсона, синдром Лайелла"}},{"type":"paragraph","data":{"text":"Со стороны мочевыделительной системы (1–2% случаев): повышение содержания азота мочевины и креатинина в крови."}},{"type":"paragraph","data":{"text":"Со стороны органов кроветворения (1–2% случаев): агранулоцитоз, лейкопения, анемия, тромбоцитопения."}},{"type":"paragraph","data":{"text":"Со стороны гепатобилиарной системы (1–2% случаев): повышение активности АЛТ, АСТ и ГГТ и уровня билирубина в сыворотке."}},{"type":"paragraph","data":{"text":"Лабораторные показатели: гиперкреатининемия, гипербилирубинемия, повышение концентрации азота мочевины и активности печеночных трансаминаз, удлинение времени кровотечения."}},{"type":"paragraph","data":{"text":"К нежелательным явлениям, наблюдаемым со стороны системы гемопоэза, относятся снижение уровня Hb и гранулоцитопения. Эти нежелательные явления наблюдались крайне редко."}},{"type":"paragraph","data":{"text":"На фоне лечения могут наблюдаться психические нарушения (1,7%) и нарушения обмена веществ (1%)."}}]},{"id":14,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Снижает эффективность урикозурических ЛС, усиливает действие антикоагулянтов, антиагрегантов, фибринолитиков, побочные эффекты гормона коры надпочечников и ГКС и эстрогенов; снижает эффективность гипотензивных ЛС и диуретиков; усиливает гипогликемический эффект производных сульфонилмочевины."}},{"type":"paragraph","data":{"text":"Увеличивает концентрацию в крови препаратов лития, метотрексата."}},{"type":"paragraph","data":{"text":"Индукторы микросомального окисления в печени (фенитоин, этанол, барбитураты, рифампицин, фенилбутазон, трициклические антидепрессанты) увеличивают продукцию гидроксилированных активных метаболитов."}},{"type":"paragraph","data":{"text":"Антациды и колестирамин снижают абсорбцию."}},{"type":"paragraph","data":{"text":"Другие НПВС — риск развития побочных эффектов, особенно со стороны ЖКТ."}},{"type":"paragraph","data":{"text":"Миелотоксичные ЛС усиливают проявления гематотоксичности препарата."}}]},{"id":15,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Во время лечения необходим контроль картины периферической крови и функционального состояния печени и почек, протромбинового индекса (на фоне непрямых антикоагулянтов), концентрации глюкозы в крови (на фоне пероральных гипогликемических ЛС)."}},{"type":"paragraph","data":{"text":"При необходимости определения 17-кетостероидов препарат следует отменить за 48 ч до исследования."}},{"type":"paragraph","data":{"text":"За несколько дней до хирургического вмешательства отменяют препарат."}},{"type":"paragraph","data":{"text":"Необходимо учитывать возможность задержки натрия и воды в организме при назначении с диуретиками больным с артериальной гипертензией и ХСН."}},{"type":"paragraph","data":{"text":"Для снижения риска развития нежелательных явлений со стороны ЖКТ следует использовать минимальную эффективную дозу минимально возможным коротким курсом."}},{"type":"paragraph","data":{"text":"Влияние на способность к вождению автотранспорта и управлению механизмами. Одним из нежелательных эффектов препарата является головокружение, это следует учитывать в ситуациях, требующих пристального внимания пациента, например при управлении автотранспортным cредством или сложными техническими приборами. 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":"В сухом, защищенном от света месте, при температуре не выше 25 °C."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте."}}]}],"source":{"title":"ЗдравСити","url":"https://zdravcity.ru"}},"description_toggle":false,"short_description":"Теноксикам, представляющий собой тиенотиазиновое производное оксикама, является НПВС. 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