Поражение сухожилий при ранее проводившемся лечении фторхинолонами, беременность, лактация, повышенная чувствительность к офлоксацину или другим производным хинолона; для системного применения - детский и подростковый возраст до 18 лет; для приема внутрь - эпилепсия (в т.ч. в анамнезе), снижение порога судорожной готовности, хроническая почечная недостаточность ...
Таблетки, покрытые пленочной оболочкой белого цвета, овальные, двояковыпуклые, с риской на обеих сторонах; на одной стороне таблетки с одной стороны от риски гравировка "200", с другой - "Δ".
Состав оболочки: гипромеллоза, тальк, макрогол 6000, титана диоксид, полисорбат 80.
10 шт. - блистеры (1) - пачки картонные.
Фармакотерапевтическая группа
Противомикробное средство группы фторхинолонов широкого спектра действия. Бактерицидное действие офлоксацина связано с блокадой фермента ДНК-гиразы в бактериальных клетках.
Высокоактивен в отношении большинства грамотрицательных бактерий: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (в т.ч. Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionella pneumophila, Acinetobacter spp., а также Chlamydia spp.
Активен в отношении некоторых грамположительных микроорганизмов (в т.ч. Staphylococcus spp., Streptococcus spp., особенно бета-гемолитических стрептококков).
К офлоксацину умеренно чувствительны Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp.
К офлоксацину не чувствительны анаэробные бактерии (кроме Bacteroides ureolyticus).
Устойчив к действию β-лактамаз.
Фармакологические свойства
После приема внутрь быстро и полностью абсорбируется из ЖКТ. Прием пищи незначительно влияет на степень абсорбции, но может замедлить ее скорость. Cmax в плазме крови достигается через 2 ч.
Связывание с белками - 25%. Офлоксацин широко распределяется в тканях и жидкостях организма (органы мочевыводящей системы, половые органы, предстательная железа, легкие, ЛОР-органы, желчный пузырь, кости, кожа).
Выводится с мочой в неизмененном виде (около 80% за 24 ч). Концентрации офлоксацина в моче существенно превышали МПК90 для большинства микроорганизмов после приема последней дозы (по 300 мг 2 раза/сут в течение 14 дней). Небольшая часть активного вещества (около 4%) выводится с калом. T1/2 составляет 6 ч. У пациентов старческого возраста при КК в среднем 50 мл/мин возможно увеличение T1/2 до 13.3 ч.
Показания к применению
Для системного применения: инфекционно-воспалительные заболевания, вызванные чувствительными к офлоксацину микроорганизмами, в т.ч.: заболевания нижних отделов дыхательных путей, уха, горла, носа, кожи, мягких тканей, костей, суставов, инфекционно-воспалительные заболевания органов брюшной полости (за исключением бактериального энтерита) и малого таза, инфекции почек и мочевыводящих путей, простатит, гонорея.
Для местного применения: блефарит; ячмень; конъюнктивит; дакриоцистит; кератит; язва роговицы; хламидийная инфекция глаз; профилактика и лечение бактериальных инфекций после травм глаза и хирургических вмешательств; наружный отит, хронический гнойный средний отит, в т.ч. с перфорацией барабанной перепонки; профилактика инфекционных осложнений при хирургических вмешательствах у взрослых; наружный отит и острый средний отит с установленной тимпаностомической трубкой у детей от 1 до 11 лет.
Противопоказания
Поражение сухожилий при ранее проводившемся лечении фторхинолонами, беременность, лактация, повышенная чувствительность к офлоксацину или другим производным хинолона; для системного применения - детский и подростковый возраст до 18 лет; для приема внутрь - эпилепсия (в т.ч. в анамнезе), снижение порога судорожной готовности, хроническая почечная недостаточность (КК<50 мл/мин); для местного применения - небактериальные заболевания придаточного аппарата глаза, переднего и заднего отрезка глаз; небактериальный отит; детский возраст до 1 года.
С осторожностью
С осторожностью применять у пациентов с нарушениями функции печени. Противопоказания: для системного применения - детский и подростковый возраст до 18 лет; для местного применения - детский возраст до 1 года. У пациентов пожилого возраста применять с учетом нарушения функции почек.
Применение при беременности и в период грудного вскармливания
Противопоказано применение при беременности и в период грудного вскармливания.
Способ применения и дозы
Индивидуальный.
Внутрь в суточной дозе 200-800 мг, кратность применения 2 раза/сут. Для пациентов с нарушением функции почек (КК 20-50 мл/мин) первая доза составляет 200 мг, затем по 100 мг каждые 24 ч. При КК менее 20 мл/мин первая доза - 200 мг, затем по 100 мг каждые 48 ч.
В/в в виде медленной инфузии вводят по 200 мг 2 раза/сут или в дозе 400 мг 1 раз/сут. При лечении тяжелых инфекций или у пациентов с избыточной массой тела суточная доза может быть увеличена до 600 мг.
Местно в соответствующих лекарственных формах: закапывают в в нижний конъюнктивальный мешок пораженного глаза 2-4 раза/сут не более 2 недель; в пораженное ухо - 2 раза/сут в течение 10 дней.
Побочное действие
Со стороны пищеварительной системы: тошнота, рвота, диарея, боли и спазмы в животе, ухудшение аппетита, сухость во рту, метеоризм, нарушения функции ЖКТ, запор; редко - нарушения функции печени, некроз печени, желтуха, гепатит, перфорация кишечника, псевдомембранозный колит, кровотечения из ЖКТ, нарушения слизистой оболочки полости рта, изжога, повышение активности печеночных ферментов, включая ГГТ и ЛДГ, увеличение уровня билирубина в сыворотке крови.
Со стороны нервной системы: бессонница, головокружение, усталость, сонливость, нервозность; редко - судороги, тревога, когнитивные изменения, депрессия, патологические сновидения, эйфория, галлюцинации, парестезии, синкопе, тремор, спутанность сознания, нистагм, суицидальные мысли или попытки, дезориентация, психотические реакции, паранойя, фобия, ажитация, агрессивность, эмоциональная лабильность, периферическая невропатия, атаксия, нарушения координации, обострение экстрапирамидных нарушений, нарушение речи.
Со стороны половой системы: зуд в области наружных гениталий у женщин, вагинит, выделения из влагалища; редко - жжение, раздражение, боли и сыпь в области гениталий у женщин, дисменорея, меноррагия, метроррагия, вагинальный кандидоз.
Со стороны сердечно-сосудистой системы: редко - остановка сердца, отеки, артериальная гипертензия, артериальная гипотензия, пальпитация, вазодилатация, церебральный тромбоз, отек легких, тахикардия.
Со стороны мочевыделительной системы: редко - дизурия, учащение мочеиспускания, задержка мочи, анурия, полиурия образования камней в почках, почечная недостаточность, нефрит, гематурия, альбуминурия, кандидурия.
Со стороны костно-мышечной системы: редко - артралгия, миалгия, тендинит, мышечная слабость, обострение миастении.
Со стороны обмена веществ: редко - жажда, уменьшение массы тела, гипер- или гипогликемия (особенно у пациентов с сахарным диабетом, получающих инсулин или пероральные гипогликемические средства), ацидоз, увеличение в сыворотке ТГ, холестерола, калия.
Со стороны дыхательной системы: редко - кашель, выделения из носа, остановка дыхания, диспноэ, бронхоспазм, стридор.
Со стороны органов чувств: редко - ухудшение слуха, тиннит, диплопия, нистагм, нарушение четкости зрительного восприятия, нарушения вкуса, обоняния, фотофобия.
Дерматологические реакции: редко - фотосенсибилизация, гиперпигментация, везикуло-буллезные высыпания.
Со стороны системы кроветворения: редко - анемия, кровотечения, панцитопения, агранулоцитоз, лейкопения, обратимое угнетение костно-мозгового кроветворения, тромбоцитопения, тромбоцитопеническая пурпура, петехии, экхимозы, увеличение протромбинового времени.
Прочие: боли в грудной клетке, фарингит, повышение температуры тела, боли в теле; редко - астения, озноб, общее недомогание, носовое кровотечение, повышенное потоотделение.
Взаимодействие с другими лекарственными средствами
При одновременном применении с антацидами, содержащими кальций, магний или алюминий, с сукральфатом, с препаратами, содержащими двух- и трехвалентные катионы, такими как железо, или с мультивитаминами, содержащими цинк, возможно нарушение абсорбции хинолонов, приводящее к уменьшению их концентрации в организме. Эти препараты не следует применять в течение 2 ч до или в течение 2 ч после приема офлоксацина.
При одновременном применении офлоксацина и НПВС повышается риск развития стимулирующего действия на ЦНС и судорог.
При одновременном применении с теофиллином возможно повышение его концентрации в плазме крови (в т.ч. в равновесном состоянии), увеличение T1/2. Это повышает риск развития побочных реакций, связанных с действием теофиллина.
При одновременном применении офлоксацина с бета-лактамными антибиотиками, аминогликозидами и метронидазолом отмечено аддитивное взаимодействие.
Особые указания
С осторожностью применять у пациентов с нарушениями функции почек и печени.
В период лечения требуется проводить контроль уровня глюкозы в крови. При длительной терапии необходимо периодически контролировать функции почек, печени, картину периферической крови.
При применении офлоксацина следует обеспечить достаточную гидратацию организма, пациент не должен подвергаться ультрафиолетовому облучению.
В экспериментальных исследованиях мутагенный потенциал не выявлен. Длительные исследования по определению канцерогенности офлоксацина не проводились.
В исследованиях на молодых животных нескольких видов офлоксацин вызывал артропатию и остеохондроз.
Безопасность и эффективность у детей и подростков в возрасте до 18 лет не установлена.
Влияние на способность к управлению транспортными средствами и механизмами
С осторожностью применять у пациентов, деятельность которых связана с необходимостью высокой концентрации внимания и быстроты психомоторных реакций.
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Staphylococcus spp., Streptococcus spp., особенно бета-гемолитических стрептококков)."}},{"type":"paragraph","data":{"text":"К офлоксацину умеренно чувствительны Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp."}},{"type":"paragraph","data":{"text":"К офлоксацину не чувствительны анаэробные бактерии (кроме Bacteroides ureolyticus)."}},{"type":"paragraph","data":{"text":"Устойчив к действию β-лактамаз."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"После приема внутрь быстро и полностью абсорбируется из ЖКТ. Прием пищи незначительно влияет на степень абсорбции, но может замедлить ее скорость. C\u003csub\u003emax \u003c/sub\u003eв плазме крови достигается через 2 ч."}},{"type":"paragraph","data":{"text":"Связывание с белками - 25%. 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У пациентов старческого возраста при КК в среднем 50 мл/мин возможно увеличение T\u003csub\u003e1/2\u003c/sub\u003e до 13.3 ч."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Для системного применения: инфекционно-воспалительные заболевания, вызванные чувствительными к офлоксацину микроорганизмами, в т.ч.: заболевания нижних отделов дыхательных путей, уха, горла, носа, кожи, мягких тканей, костей, суставов, инфекционно-воспалительные заболевания органов брюшной полости (за исключением бактериального энтерита) и малого таза, инфекции почек и мочевыводящих путей, простатит, гонорея."}},{"type":"paragraph","data":{"text":"Для местного применения: блефарит; ячмень; конъюнктивит; дакриоцистит; кератит; язва роговицы; хламидийная инфекция глаз; профилактика и лечение бактериальных инфекций после травм глаза и хирургических вмешательств; наружный отит, хронический гнойный средний отит, в т.ч. с перфорацией барабанной перепонки; профилактика инфекционных осложнений при хирургических вмешательствах у взрослых; наружный отит и острый средний отит с установленной тимпаностомической трубкой у детей от 1 до 11 лет."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Поражение сухожилий при ранее проводившемся лечении фторхинолонами, беременность, лактация, повышенная чувствительность к офлоксацину или другим производным хинолона; для системного применения - детский и подростковый возраст до 18 лет; для приема внутрь - эпилепсия (в т.ч. в анамнезе), снижение порога судорожной готовности, хроническая почечная недостаточность (КК<50 мл/мин); для местного применения - небактериальные заболевания придаточного аппарата глаза, переднего и заднего отрезка глаз; небактериальный отит; детский возраст до 1 года."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"С осторожностью применять у пациентов с нарушениями функции печени. Противопоказания: для системного применения - детский и подростковый возраст до 18 лет; для местного применения - детский возраст до 1 года. У пациентов пожилого возраста применять с учетом нарушения функции почек."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказано применение при беременности и в период грудного вскармливания."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Индивидуальный."}},{"type":"paragraph","data":{"text":"Внутрь в суточной дозе 200-800 мг, кратность применения 2 раза/сут. Для пациентов с нарушением функции почек (КК 20-50 мл/мин) первая доза составляет 200 мг, затем по 100 мг каждые 24 ч. При КК менее 20 мл/мин первая доза - 200 мг, затем по 100 мг каждые 48 ч."}},{"type":"paragraph","data":{"text":"В/в в виде медленной инфузии вводят по 200 мг 2 раза/сут или в дозе 400 мг 1 раз/сут. При лечении тяжелых инфекций или у пациентов с избыточной массой тела суточная доза может быть увеличена до 600 мг."}},{"type":"paragraph","data":{"text":"Местно в соответствующих лекарственных формах: закапывают в в нижний конъюнктивальный мешок пораженного глаза 2-4 раза/сут не более 2 недель; в пораженное ухо - 2 раза/сут в течение 10 дней."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы:\u003c/i\u003e тошнота, рвота, диарея, боли и спазмы в животе, ухудшение аппетита, сухость во рту, метеоризм, нарушения функции ЖКТ, запор; редко - нарушения функции печени, некроз печени, желтуха, гепатит, перфорация кишечника, псевдомембранозный колит, кровотечения из ЖКТ, нарушения слизистой оболочки полости рта, изжога, повышение активности печеночных ферментов, включая ГГТ и ЛДГ, увеличение уровня билирубина в сыворотке крови."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы:\u003c/i\u003e бессонница, головокружение, усталость, сонливость, нервозность; редко - судороги, тревога, когнитивные изменения, депрессия, патологические сновидения, эйфория, галлюцинации, парестезии, синкопе, тремор, спутанность сознания, нистагм, суицидальные мысли или попытки, дезориентация, психотические реакции, паранойя, фобия, ажитация, агрессивность, эмоциональная лабильность, периферическая невропатия, атаксия, нарушения координации, обострение экстрапирамидных нарушений, нарушение речи."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции:\u003c/i\u003e кожная сыпь, зуд; редко - ангионевротический отек, крапивница, васкулит, аллергический пневмонит, анафилактический шок, многоформная эритема, синдром Стивенса-Джонсона, узловатая эритема, эксфолиативный дерматит, токсический эпидермальный некролиз, конъюнктивит."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны половой системы:\u003c/i\u003e зуд в области наружных гениталий у женщин, вагинит, выделения из влагалища; редко - жжение, раздражение, боли и сыпь в области гениталий у женщин, дисменорея, меноррагия, метроррагия, вагинальный кандидоз."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e редко - остановка сердца, отеки, артериальная гипертензия, артериальная гипотензия, пальпитация, вазодилатация, церебральный тромбоз, отек легких, тахикардия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны мочевыделительной системы:\u003c/i\u003e редко - дизурия, учащение мочеиспускания, задержка мочи, анурия, полиурия образования камней в почках, почечная недостаточность, нефрит, гематурия, альбуминурия, кандидурия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны костно-мышечной системы:\u003c/i\u003e редко - артралгия, миалгия, тендинит, мышечная слабость, обострение миастении."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны обмена веществ:\u003c/i\u003e редко - жажда, уменьшение массы тела, гипер- или гипогликемия (особенно у пациентов с сахарным диабетом, получающих инсулин или пероральные гипогликемические средства), ацидоз, увеличение в сыворотке ТГ, холестерола, калия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны дыхательной системы:\u003c/i\u003e редко - кашель, выделения из носа, остановка дыхания, диспноэ, бронхоспазм, стридор."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны органов чувств:\u003c/i\u003e редко - ухудшение слуха, тиннит, диплопия, нистагм, нарушение четкости зрительного восприятия, нарушения вкуса, обоняния, фотофобия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДерматологические реакции:\u003c/i\u003e редко - фотосенсибилизация, гиперпигментация, везикуло-буллезные высыпания."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны системы кроветворения:\u003c/i\u003e редко - анемия, кровотечения, панцитопения, агранулоцитоз, лейкопения, обратимое угнетение костно-мозгового кроветворения, тромбоцитопения, тромбоцитопеническая пурпура, петехии, экхимозы, увеличение протромбинового времени."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e боли в грудной клетке, фарингит, повышение температуры тела, боли в теле; редко - астения, озноб, общее недомогание, носовое кровотечение, повышенное потоотделение."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении с антацидами, содержащими кальций, магний или алюминий, с сукральфатом, с препаратами, содержащими двух- и трехвалентные катионы, такими как железо, или с мультивитаминами, содержащими цинк, возможно нарушение абсорбции хинолонов, приводящее к уменьшению их концентрации в организме. Эти препараты не следует применять в течение 2 ч до или в течение 2 ч после приема офлоксацина."}},{"type":"paragraph","data":{"text":"При одновременном применении офлоксацина и НПВС повышается риск развития стимулирующего действия на ЦНС и судорог."}},{"type":"paragraph","data":{"text":"При одновременном применении с теофиллином возможно повышение его концентрации в плазме крови (в т.ч. в равновесном состоянии), увеличение T\u003csub\u003e1/2\u003c/sub\u003e. Это повышает риск развития побочных реакций, связанных с действием теофиллина."}},{"type":"paragraph","data":{"text":"При одновременном применении офлоксацина с бета-лактамными антибиотиками, аминогликозидами и метронидазолом отмечено аддитивное взаимодействие."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"С осторожностью применять у пациентов с нарушениями функции почек и печени."}},{"type":"paragraph","data":{"text":"В период лечения требуется проводить контроль уровня глюкозы в крови. При длительной терапии необходимо периодически контролировать функции почек, печени, картину периферической крови."}},{"type":"paragraph","data":{"text":"При применении офлоксацина следует обеспечить достаточную гидратацию организма, пациент не должен подвергаться ультрафиолетовому облучению."}},{"type":"paragraph","data":{"text":"В \u003ci\u003eэкспериментальных исследованиях\u003c/i\u003e мутагенный потенциал не выявлен. Длительные исследования по определению канцерогенности офлоксацина не проводились."}},{"type":"paragraph","data":{"text":"В исследованиях на молодых животных нескольких видов офлоксацин вызывал артропатию и остеохондроз."}},{"type":"paragraph","data":{"text":"Безопасность и эффективность у детей и подростков в возрасте до 18 лет не установлена."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние на способность к управлению транспортными средствами и механизмами\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"С осторожностью применять у пациентов, деятельность которых связана с необходимостью высокой концентрации внимания и быстроты психомоторных реакций."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.vidal.ru/drugs/firm/2371\"\u003eMEKOPHAR CHEMICAL-PHARMACEUTICAL, Joint Stock Company \u003c/a\u003e(Вьетнам). "}}]}],"source":null},"description_toggle":false,"short_description":"После приема внутрь быстро и полностью абсорбируется из ЖКТ. Прием пищи незначительно влияет на степень абсорбции, но может замедлить ее скорость. Cmaxв плазме крови достигается через 2 ч. Связывание с белками - 25%. Офлоксацин широко распределяется в тканях и жидкостях организма (органы мочевыводящей системы, половые органы, предстательная железа, легкие, ЛОР-органы, желчный пузырь, кости, кожа). Выводится с мочой в неизмененном виде (около 80% за 24 ч). Концентрации офлоксацина в моче существенно превышали МПК90для большинства микроорганизмов после приема последней дозы (по 300 мг 2 раза/сут в течение 14 дней). Небольшая часть активного вещества (около 4%) выводится с калом. T1/2составляет 6 ч. 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