Противомикробный препарат из группы фторхинолонов широкого с... Инструкция
Показания к применению
Лечение инфекционно-воспалительных заболеваний, вызванных чувствительными к офлоксацину микроорганизмами:- инфекции дыхательных путей (за исключением случаев пневмококковой инфекции); - инфекции уха, горла, носа (за исключением случаев острого тонзиллита); - инфекции брюшной полости и желчевыводящих путей; - инфекции почек, мочевыводящих путей, предстательной ...
эпилепсия; - поражения центральной нервной системы с пониженным судорожным порогом (после черепно-мозговой травмы, инсульта, воспалительных процессов в области центральной нервной системы (ЦНС); - поражения сухожилий при ранее проводившемся лечении хинолонами; - возраст до 18 лет; - беременность и период лактации; - повышенная чувствительность к офлоксацину, другим хинолонам или компонентам препарата.
Противомикробный препарат из группы фторхинолонов широкого спектра действия. Действует бактерицидно. Механизм действия офлоксацина связан с блокадой фермента ДНК-гиразы в бактериальных клетках. Высокоактивен в отношении большинства грамотрицательных и некоторых грамположительных микроорганизмов: Aeromonas hydrophila, Branhamella catarrhalis, Brucella spp., Clostridium perfringens, Esherichia coli, Salmonella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae and parainfluenzae, Haemophilus ducreyi, Plesiomonas, Legionella, Shigella spp., Proteus spp., включая Proteus mirabilis, Proteus vulgaris (indole + и indole -), Moraxella morganii, Klebsiella spp., включая Klebsiella pneumoniae, Helicobacter pylori, Mycoplasma spp., Vibrio spp., Gardnerella vaginalis. Neisseria gonorrhoeae, Neisseria meningitidis, Chlamydia trachomatis, Staphylococcus aureus methi-S, Staphylococcus coagulase negative. Умеренно чувствительны к офлоксацину Acinetobacter spp., Ureaplasma urealyticum, Bacteroides fragilis, Mycobacterium tuberculosis, Mycobacterium leprae, Chlamidia psittaci, анаэробные грамположительные кокки, Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp, Streptococcus spp. (особенно бета-гемолитический). К офлоксацину нечувствительны Acinetobacter braumanmii, Clostridium difficile, Enterococci, Listeria monocytogenes, Staphylococci methi-R, Nocardia spp.. Офлоксацин неактивен в отношении Treponema pallidum.
Показания к применению
Лечение инфекционно-воспалительных заболеваний, вызванных чувствительными к офлоксацину микроорганизмами:- инфекции дыхательных путей (за исключением случаев пневмококковой инфекции); - инфекции уха, горла, носа (за исключением случаев острого тонзиллита); - инфекции брюшной полости и желчевыводящих путей; - инфекции почек, мочевыводящих путей, предстательной железы, уретры (в т.ч. гонококковой природы); - инфекции органов малого таза; - инфекции костей и суставов; - инфекции кожи и мягких тканей; - профилактика инфекций у больных с нарушением иммунного статуса (в т.ч. при нейтропении).
Противопоказания
эпилепсия; - поражения центральной нервной системы с пониженным судорожным порогом (после черепно-мозговой травмы, инсульта, воспалительных процессов в области центральной нервной системы (ЦНС); - поражения сухожилий при ранее проводившемся лечении хинолонами; - возраст до 18 лет; - беременность и период лактации; - повышенная чувствительность к офлоксацину, другим хинолонам или компонентам препарата.
Применение при беременности и в период грудного вскармливания
Противопоказан при беременности и в период лактации
Способ применения и дозы
Внутрь. Доза офлоксацина и длительность лечения зависят от тяжести и вида инфекции, общего состояния больного и функции почек. Средняя суточная доза для взрослых - от 200 мг до 600 мг. Продолжительность лечения -7-10 дней. Дозу до 400 мг/сут можно назначать в 1 прием, предпочтительно утром. Дозы свыше 400 мг/сут следует разделить на 2 приема с равным промежутком времени. Таблетки следует принимать целиком, запивая их водой как до, так и во время еды. Необходимо избегать одновременного приема вместе с антацидами. При тяжелых инфекциях или при лечении больных с избыточным весом суточная доза может быть увеличена до 800 мг. При неосложненных инфекциях нижних отделов мочевыводящих путей препарат назначают в дозе 200 мг/сут в течение 3-5 дней. При гонорее назначают 400 мг однократно. У пациентов с нарушениями функции почек доза должна быть уменьшена в зависимости от клиренса креатинина. У больных с печеночной недостаточностью не рекомендуется превышать максимальную суточную дозу 400 мг. Начатое в/в лечение офлоксацином может быть продолжено таблетированной формой препарата в той же дозе (при улучшении состояния больного).
Побочное действие
Отдельные случаи:• Анафилактические/анафилактоидные реакции, реакции со стороны кожи и слизистыхНечасто встречающиеся: Редкие: Симптомы, такие как: зуд, сыпь, жжение в глазах, сухой кашель, ринит. Анафилактические/анафилактоидные реакции такие как: крапивница, ангионевротический отек, удушье/бронхоспазм; гиперемия, потоотделение, папулезная сыпь. Анафилактический/анафилактоидный шок, мультиформная экссудативная эритема, токсический эпидермальный некролиз, фотосенсибилизация, стойкая лекарственная сыпь, сосудистая пурпура, буллезный геморрагический дерматит, точечные кровоизлияния, васкулит, который в исключительных случаях может приводить к некрозу кожи. Отдельные Синдром Стивенса-Джонсона, тяжелое удушье, аллергическийСлучаи: пневмонит, аллергический нефрит.• Со стороны желудочно-кишечного трактаНечасто Боли в животе, диарея, тошнота, рвота, снижение аппетита, Встречающиеся: Редкие: Анорексия, метеоризм, энтероколит, который может в отдельныхСлучаях быть геморрагическим. Очень редкие: Псевдомембранозный колит.• НеврологическиеВозбуждение, головокружение, головная боль, нарушения сна/бессонница. Психотические реакции (например, галлюцинации), тревожное состояние, спутанность сознания, интенсивные или «кошмарные» сновидения, депрессия, сонливость, нарушения периферической чувствительности, такие как парестезия, нарушения вкуса и обоняния, нарушение цветовосприятия, диплопия. Нарушения слуха, такие как шум в ушах или потеря слуха, эпилептические припадки, экстрапирамидные расстройства или другие расстройства мышечной координации, гипестезия, тремор, судороги. Психотические реакции, сопровождающиеся опасным для пациента поведением, включая склонность к суициду, повышение внутричерепного давления. Сердечно-сосудистыеСнижение артериального давления, тахикардия. Опорно-двигательныеРедкие: Тендинит. Очень редко: Артралгия, миалгия. Разрыв сухожилия (т.е. ахиллова сухожилия); как при применении других фторхинолонов этот побочный эффект может наблюдаться в пределах 48 часов после начала лечения и может быть билатеральным. Отдельные Рабдомиолизис (острый некроз скелетных мышц) и/или миопатия. Случаи: Мышечная слабость, которая может иметь особенно важноезначение у пациентов с тяжелой псевдопаралитической миастенией.• Со стороны печениХолестатическая желтуха. Гепатит, который может быть тяжелым. Редкие: Повышение печеночных ферментов (ACT, АЛТ, ЛДГ, ГТТ и/илищелочной фосфатазы) и/или билирубина. Со стороны мочевыделительной системыГиперкреатинемия, повышение концентрации мочевины . Острая почечная недостаточность. Интерстициальный нефрит. Анемия, гемолитическая анемия, лейкопения, эозинофилия, тромбоцитопен ия. Агранулоцитоз, панцитопения, угнетение костномозгового кроветворения. Развитие вторичной инфекции, вызываемой устойчивыми к препарату микроорганизмами и грибками. Острые приступы порфирии у пациентов с порфирией, вагинит, дисбактериоз кишечника, гипогликемия у больных с сахарным диабетом, получающих лечение гипогликемическими препаратами.
Передозировка
Наиболее важными симптомами передозировки являются симптомы со стороны ЦНС: головокружение, спутанность сознания, заторможенность, дезориентация, сонливость, а также реакции со стороны желудочно-кишечного тракта: рвота. В случае передозировки рекомендуется провести промывание желудка (относится к таблеткам) и симптоматическую терапию. Специфического антидота не существует.
Особые указания
Почечная недостаточностьВ связи с тем, что офлоксацин выводится в основном через почки, у пациентов с почечной недостаточностью необходима коррекция дозы офлоксацина. Предотвращение фотосенсибилизацииВ период лечения офлоксацином, в связи с риском возникновения фотосенсибилизации, следует избегать воздействия яркого солнечного света и ультрафиолетовых лучей. Вторичная инфекцияКак и при лечении другими антибиотиками, прием офлоксацина, особенно длительный, может вызвать вторичную инфекцию, связанную с ростом устойчивых к препарату микроорганизмов. Необходима повторная оценка состояния пациента. Если вторичная инфекция возникает во время терапии, необходимо принимать соответствующие меры. Псевдомембранозный колитПоявление диареи, особенно в тяжелой форме, персистирующей и/или с примесью крови, во время или после лечения офлоксацином может быть проявлением псевдомембранозного колита. При подозрении на развитие псевдомембранозного колита лечение офлоксацином должно быть немедленно прекращено, и соответствующая специфическая антибактериальная терапия (например, ваякомицин внутрь, тейкопланин внутрь или метронидазол) должна быть назначена безотлагательно. В этой клинической ситуации противопоказаны препараты, подавляющие перистальтику кишечника. Пациенты, предрасположенные к возникновению эпилептических припадковКак и другие хинолоны, офлоксацин должен с особой осторожностью назначаться больным, предрасположенным к развитию эпилептических припадков (больные с повреждением ЦНС в анамнезе, принимающие фенбуфен и подобные нестероидные противовоспалительные препараты или препараты, понижающие порог судорожной активности, например, теофиллин). ТендинитТендинит, возникающий очень редко, может иногда приводить к разрыву сухожилий, преимущественно Ахиллова сухожилия, особенно у пожилых пациентов. В случае появления признаков тендинита (воспаление сухожилия), рекомендуется немедленно прекратить лечение, произвести иммобилизацию Ахиллова сухожилия и обеспечить консультацию ортопеда. Удлинение интервала QTНеобходима определенная осторожность при приеме фторхинолонов, включая офлоксацин, у пациентов с известными факторами риска удлинения интервала QT, такими как:- пожилой возраст;- некорректируемый дисбаланс электролитов (например, гипокалиемия, гипомагниемия);- врожденное удлинение интервала QT;- заболевания сердечно-сосудистой системы (сердечная недостаточность, инфаркт миокарда, брадикардия)- одновременный прием препаратов, удлиняющих интервал QT (IA и III классы антиаритмических препаратов, трициклические антидепрессанты, макролиды). МиастенияОфлоксацин может приводить к ухудшению течения миастении. ПорфирияВозможно учащение приступов порфирии. Во время лечения офлоксацином возможно появление ложноположительных результатов при определении опиатов и порфиринов в моче. ПрочееОфлоксацин препятствует выделению Mycobacterium tuberculosis, приводя к ложноотрицательным результатам при бактериологической диагностике туберкулеза. Также в период лечения не рекомендуется употреблять этанол. При применении препарата женщинам не рекомендуется использовать гигиенические тампоны с связи с повышенным риском развития молочницы. Офлоксацин не является препаратом выбора при пневмонии, вызванной пневмококками. Не показан при лечении острого тонзиллита. Влияние на способность к вождению автотранспорта и управлению механизмамиНекоторые побочные реакции, например: головокружение, сонливость и расстройства зрения могут снижать реакцию и способность к концентрации и в связи с этим повысить риск в ситуациях, в которых наличие этих способностей особенно важно (например при управлении автомобилем или другими механизмами).
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Действует бактерицидно. Механизм действия офлоксацина связан с блокадой фермента ДНК-гиразы в бактериальных клетках. Высокоактивен в отношении большинства грамотрицательных и некоторых грамположительных микроорганизмов: Aeromonas hydrophila, Branhamella catarrhalis, Brucella spp., Clostridium perfringens, Esherichia coli, Salmonella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae and parainfluenzae, Haemophilus ducreyi, Plesiomonas, Legionella, Shigella spp., Proteus spp., включая Proteus mirabilis, Proteus vulgaris (indole + и indole -), Moraxella morganii, Klebsiella spp., включая Klebsiella pneumoniae, Helicobacter pylori, Mycoplasma spp., Vibrio spp., Gardnerella vaginalis. Neisseria gonorrhoeae, Neisseria meningitidis, Chlamydia trachomatis, Staphylococcus aureus methi-S, Staphylococcus coagulase negative. Умеренно чувствительны к офлоксацину Acinetobacter spp., Ureaplasma urealyticum, Bacteroides fragilis, Mycobacterium tuberculosis, Mycobacterium leprae, Chlamidia psittaci, анаэробные грамположительные кокки, Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp, Streptococcus spp. (особенно бета-гемолитический). К офлоксацину нечувствительны Acinetobacter braumanmii, Clostridium difficile, Enterococci, Listeria monocytogenes, Staphylococci methi-R, Nocardia spp.. 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Доза офлоксацина и длительность лечения зависят от тяжести и вида инфекции, общего состояния больного и функции почек. Средняя суточная доза для взрослых - от 200 мг до 600 мг. Продолжительность лечения -7-10 дней. Дозу до 400 мг/сут можно назначать в 1 прием, предпочтительно утром. Дозы свыше 400 мг/сут следует разделить на 2 приема с равным промежутком времени. Таблетки следует принимать целиком, запивая их водой как до, так и во время еды. Необходимо избегать одновременного приема вместе с антацидами. При тяжелых инфекциях или при лечении больных с избыточным весом суточная доза может быть увеличена до 800 мг. При неосложненных инфекциях нижних отделов мочевыводящих путей препарат назначают в дозе 200 мг/сут в течение 3-5 дней. При гонорее назначают 400 мг однократно. У пациентов с нарушениями функции почек доза должна быть уменьшена в зависимости от клиренса креатинина. У больных с печеночной недостаточностью не рекомендуется превышать максимальную суточную дозу 400 мг. Начатое в/в лечение офлоксацином может быть продолжено таблетированной формой препарата в той же дозе (при улучшении состояния больного)."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Отдельные случаи:• Анафилактические/анафилактоидные реакции, реакции со стороны кожи и слизистыхНечасто встречающиеся: Редкие: Симптомы, такие как: зуд, сыпь, жжение в глазах, сухой кашель, ринит. Анафилактические/анафилактоидные реакции такие как: крапивница, ангионевротический отек, удушье/бронхоспазм; гиперемия, потоотделение, папулезная сыпь. Анафилактический/анафилактоидный шок, мультиформная экссудативная эритема, токсический эпидермальный некролиз, фотосенсибилизация, стойкая лекарственная сыпь, сосудистая пурпура, буллезный геморрагический дерматит, точечные кровоизлияния, васкулит, который в исключительных случаях может приводить к некрозу кожи. 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Психотические реакции, сопровождающиеся опасным для пациента поведением, включая склонность к суициду, повышение внутричерепного давления. Сердечно-сосудистыеСнижение артериального давления, тахикардия. Опорно-двигательныеРедкие: Тендинит. Очень редко: Артралгия, миалгия. Разрыв сухожилия (т.е. ахиллова сухожилия); как при применении других фторхинолонов этот побочный эффект может наблюдаться в пределах 48 часов после начала лечения и может быть билатеральным. Отдельные Рабдомиолизис (острый некроз скелетных мышц) и/или миопатия. Случаи: Мышечная слабость, которая может иметь особенно важноезначение у пациентов с тяжелой псевдопаралитической миастенией.• Со стороны печениХолестатическая желтуха. Гепатит, который может быть тяжелым. Редкие: Повышение печеночных ферментов (ACT, АЛТ, ЛДГ, ГТТ и/илищелочной фосфатазы) и/или билирубина. Со стороны мочевыделительной системыГиперкреатинемия, повышение концентрации мочевины . Острая почечная недостаточность. Интерстициальный нефрит. Анемия, гемолитическая анемия, лейкопения, эозинофилия, тромбоцитопен ия. Агранулоцитоз, панцитопения, угнетение костномозгового кроветворения. Развитие вторичной инфекции, вызываемой устойчивыми к препарату микроорганизмами и грибками. Острые приступы порфирии у пациентов с порфирией, вагинит, дисбактериоз кишечника, гипогликемия у больных с сахарным диабетом, получающих лечение гипогликемическими препаратами."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Наиболее важными симптомами передозировки являются симптомы со стороны ЦНС: головокружение, спутанность сознания, заторможенность, дезориентация, сонливость, а также реакции со стороны желудочно-кишечного тракта: рвота. В случае передозировки рекомендуется провести промывание желудка (относится к таблеткам) и симптоматическую терапию. Специфического антидота не существует."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Почечная недостаточностьВ связи с тем, что офлоксацин выводится в основном через почки, у пациентов с почечной недостаточностью необходима коррекция дозы офлоксацина. Предотвращение фотосенсибилизацииВ период лечения офлоксацином, в связи с риском возникновения фотосенсибилизации, следует избегать воздействия яркого солнечного света и ультрафиолетовых лучей. Вторичная инфекцияКак и при лечении другими антибиотиками, прием офлоксацина, особенно длительный, может вызвать вторичную инфекцию, связанную с ростом устойчивых к препарату микроорганизмов. Необходима повторная оценка состояния пациента. Если вторичная инфекция возникает во время терапии, необходимо принимать соответствующие меры. Псевдомембранозный колитПоявление диареи, особенно в тяжелой форме, персистирующей и/или с примесью крови, во время или после лечения офлоксацином может быть проявлением псевдомембранозного колита. При подозрении на развитие псевдомембранозного колита лечение офлоксацином должно быть немедленно прекращено, и соответствующая специфическая антибактериальная терапия (например, ваякомицин внутрь, тейкопланин внутрь или метронидазол) должна быть назначена безотлагательно. В этой клинической ситуации противопоказаны препараты, подавляющие перистальтику кишечника. Пациенты, предрасположенные к возникновению эпилептических припадковКак и другие хинолоны, офлоксацин должен с особой осторожностью назначаться больным, предрасположенным к развитию эпилептических припадков (больные с повреждением ЦНС в анамнезе, принимающие фенбуфен и подобные нестероидные противовоспалительные препараты или препараты, понижающие порог судорожной активности, например, теофиллин). ТендинитТендинит, возникающий очень редко, может иногда приводить к разрыву сухожилий, преимущественно Ахиллова сухожилия, особенно у пожилых пациентов. В случае появления признаков тендинита (воспаление сухожилия), рекомендуется немедленно прекратить лечение, произвести иммобилизацию Ахиллова сухожилия и обеспечить консультацию ортопеда. Удлинение интервала QTНеобходима определенная осторожность при приеме фторхинолонов, включая офлоксацин, у пациентов с известными факторами риска удлинения интервала QT, такими как:- пожилой возраст;- некорректируемый дисбаланс электролитов (например, гипокалиемия, гипомагниемия);- врожденное удлинение интервала QT;- заболевания сердечно-сосудистой системы (сердечная недостаточность, инфаркт миокарда, брадикардия)- одновременный прием препаратов, удлиняющих интервал QT (IA и III классы антиаритмических препаратов, трициклические антидепрессанты, макролиды). МиастенияОфлоксацин может приводить к ухудшению течения миастении. ПорфирияВозможно учащение приступов порфирии. Во время лечения офлоксацином возможно появление ложноположительных результатов при определении опиатов и порфиринов в моче. ПрочееОфлоксацин препятствует выделению Mycobacterium tuberculosis, приводя к ложноотрицательным результатам при бактериологической диагностике туберкулеза. Также в период лечения не рекомендуется употреблять этанол. При применении препарата женщинам не рекомендуется использовать гигиенические тампоны с связи с повышенным риском развития молочницы. Офлоксацин не является препаратом выбора при пневмонии, вызванной пневмококками. Не показан при лечении острого тонзиллита. Влияние на способность к вождению автотранспорта и управлению механизмамиНекоторые побочные реакции, например: головокружение, сонливость и расстройства зрения могут снижать реакцию и способность к концентрации и в связи с этим повысить риск в ситуациях, в которых наличие этих способностей особенно важно (например при управлении автомобилем или другими механизмами)."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Противомикробный препарат из группы фторхинолонов широкого спектра действия. Действует бактерицидно. Механизм действия офлоксацина связан с блокадой фермента ДНК-гиразы в бактериальных клетках. Высокоактивен в отношении большинства грамотрицательных и некоторых грамположительных микроорганизмов: Aeromonas hydrophila, Branhamella catarrhalis, Brucella spp., Clostridium perfringens, Esherichia coli, Salmonella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae and parainfluenzae, Haemophilus ducreyi, Plesiomonas, Legionella, Shigella spp., Proteus spp., включая Proteus mirabilis, Proteus vulgaris (indole + и indole -), Moraxella morganii, Klebsiella spp., включая Klebsiella pneumoniae, Helicobacter pylori, Mycoplasma spp., Vibrio spp., Gardnerella vaginalis. Neisseria gonorrhoeae, Neisseria meningitidis, Chlamydia trachomatis, Staphylococcus aureus methi-S, Staphylococcus coagulase negative. Умеренно чувствительны к офлоксацину Acinetobacter spp., Ureaplasma urealyticum, Bacteroides fragilis, Mycobacterium tuberculosis, Mycobacterium leprae, Chlamidia psittaci, анаэробные грамположительные кокки, Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp, Streptococcus spp. (особенно бета-гемолитический). К офлоксацину нечувствительны Acinetobacter braumanmii, Clostridium difficile, Enterococci, Listeria monocytogenes, Staphylococci methi-R, Nocardia spp.. 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