Повышенная чувствительность к азитромицину, эритромицину, другим макролидам или кетолидам, а также другим компонентам препарата, нарушение функции почек (КК менее 40 мл/мин), нарушение функции печени тяжелой степени (нет данных по эффективности и безопасности), период грудного вскармливания, детский возраст (до 6 мес.), фенилкетонурия, одновременный ...
Порошок для суспензии Суитрокс – антибиотик для лечения инфекции дыхательных путей, кожи и мягких тканей.
Фармакологические свойства
Азитромицин - бактериостатический антибиотик широкого спектра действия из группы макролидов-азалидов. Связываясь с 50S-субъединицей рибосом, угнетает пептидтранслоказу на стадии трансляции, подавляет синтез белка, замедляет рост и размножение бактерий, в высоких концентрациях оказывает бактерицидный эффект. Обладает активностью в отношении ряда грамположительных, грамотрицательных, внутриклеточных и других микроорганизмов. Грамположительные аэробы:\0009Staphylococcus aureus (метициллинчувствителmysq), Streptococcus pneumoniae (пенициллинчувствительный), Streptococcus pyogenes, Streptococcus agalactiae, Mycobacterium avium комплекс. Грамотрицательные аэробы:\0009Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae. Анаэробные микроорганизмы: виды рода Prevotella, Clostridium perfringens. Внутриклеточные: виды рода Chlamydia psittacci, Chlamydia trachomatis, Chlamydophila pneumonia, виды рода Mycoplasma, Legionella pneumophila, Borrelia burgdorferi. Микроорганизмы, способные развить устойчивость к азитромицину: Streptococcus pneumonia (пенициллнустойчивый), устойчивые микроорганизмы: Enterococcus faecalis, Staphylococcus spp. (метициллинустойчивые стафилококки с очень высокой частотой обладают приобретенной устойчивостью к макролидам), грамположительные бактерии, устойчивые к эритромицину, Bacteroides fragilis. Описаны случаи перекрестной резистентности между Streptococcus pneumoniae, Streptococcus pyogenes (бета-гемолитический стрептококк группы A), Enterococcus faecalis и Staphylococcus aureus, включая Staphylococcus aureus (метициллинрезистентные штаммы) к эритромицину, азигромицину, другим макролидам и линкозамидам.
Показания к применению
Инфекционные заболевания, вызываемые микроорганизмами, чувствительными к азитромицину: инфекции верхних дыхательных путей и ЛОР-органов: фарингит, тонзиллит, синусит, средний отит, инфекции нижних дыхательных путей: пневмония (в т.ч. вызванная атипичными возбудителями), острый бронхит, обострение хронического бронхита, инфекции кожи и мягких тканей: хроническая мигрирующая эритема (болезнь Лайма) - начальная стадия, рожа, импетиго, вторично инфицированные дерматозы.
Противопоказания
Повышенная чувствительность к азитромицину, эритромицину, другим макролидам или кетолидам, а также другим компонентам препарата, нарушение функции почек (КК менее 40 мл/мин), нарушение функции печени тяжелой степени (нет данных по эффективности и безопасности), период грудного вскармливания, детский возраст (до 6 мес.), фенилкетонурия, одновременный прием эрготамина и дигидроэрготамина, дефицит сахаразы/изомальтазы, непереносимость фруктозы, глюкозо- галактозная мальабсорбция.
Применение при беременности и в период грудного вскармливания
Противопоказан в период грудного вскармливания
Способ применения и дозы
Внутрь, за 1 ч до или через 2 ч после еды 1 раз в сутки. После приема Суитрокса ребенку необходимо обязательно предложить выпить несколько глотков воды, чтобы он смог проглотить остатки суспензии. Перед каждым приемом Суитрокса содержимое флакона тщательно взбалтывают до получения однородной суспензии. Если необходимый объем суспензии не был отобран из флакона в течение 20 мин после взбалтывания, суспензию следует взболтать снова, отобрать необходимый объем и дать ребенку. Необходимую дозу Суитрокса отмеряют с помощью шприца для дозирования с ценой деления 1 мл, вложенного в картонную упаковку вместе с флаконом. После использования шприц (предварительно разобрав) промывают проточной водой. Сушат и хранят в сухом месте до следующего приема препарата. При инфекциях верхних и нижних дыхательных путей и ЛОР-органов. кожи и мягких тканей: из расчета 10 мг/кг массы тела 1 раз в день в течение 3 дней (курсовая доза 30 мг/кг). При фариигите/тоизилите, вызванных Streptococcus pyogenes, препарат применяют в дозе 20 мг/кг/сут в течение 3 дней (курсовая доза 60 мг/кг). Максимальная суточная доза составляет 500 мг. При болезни Лайма (начальная стадия боррелиоза) - мигрирующей эритеме (Erythema mi wans): в 1-ый день в дозе 20 мг Суитрокса/кг/сут, затем со 2-ого по 5-ый день в дозе 10 мг/кг/сут (курсовая дозы 60 мг/кг).
Побочное действие
По данным Всемирной организации здравоохранения (ВОЗ) нежелательные реакции 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 - по имеющимся данным установить частоту возникновения не представлялось возможным. Инфекционные заболевания нечасто: кандидоз, в том числе слизистой оболочки полости рта и гениталий, пневмония, грибковые инфекции, бактериальные инфекции, фарингит, гастроэнтерит, респираторные заболевания, ринит, вагинальные инфекции, очень редко: псевдомембранозный колит. Со стороны обмена веществ и питания нечасто: анорексия. Аллергические реакции часто: кожный зуд, кожная сыпь, нечасто: реакции гиперчувствительности, реакция фотосенсибилизации, крапивница, синдром Стивенса-Джонсона, ангионевротический отек, очень редко: анафилактическая реакция, мультиформная эритема, токсический эпидермальный некролиз. Со стороны крови и лимфатической системы нечасто: эозинофилия, лейкопения, нейтропения, частота неизвестна: тромбоцитопения, гемолитическая анемия. Со стороны нервной системы часто: головная боль, головокружение, парестезии, нарушение вкусовых ощущений, нервозность, нечасто: гипестезия, сонливость, бессонница, редко: ажитация, очень редко: тревога, агрессия, обморок, судороги, психомоторная гиперактивность, потеря обоняния (аносмия) и вкусовых ощущений, миастения, беспокойство, частота неизвестна: бред, галлюцинации. Со стороны органов чувств нечасто: нарушение четкости зрения, нарушения слуха, вертиго, частота неизвестна: нарушения слуха, включая глухоту и/или звон в ушах. Со стороны сердечно-сосудистой системы нечасто: ощущение сердцебиения, ощущение жара и «приливов» крови к коже лица, редко: снижение артериального давления, увеличение интервала QT, аритмия типа «пируэт», желудочковая тахикардия. Со стороны желудочно-кишечного тракта очень часто: диарея, тошнота, метеоризм, боль в области живота, часто: диспепсия, рвота, нечасто: запор, гастрит, дисфагия, вздутие живота, очень редко: сухость слизистой оболочки полости рта, отрыжка, язвы слизистой оболочки полости рта, гиперсекреция слюнных желез, изменение цвета языка, панкреатит. Со стороны печени и желчевыводящих путей нечасто: повышение активности «печеночных» трансаминаз, повышение концентрации билирубина, гепатит, редко: нарушение функции печени, очень редко: холестагическая желтуха, печеночная недостаточность (в редких случаях с легальным исходом, в основном на фоне тяжелого нарушения функции печени), некроз печени, фульминантный гепатит. Со стороны костно-мышечной системы и соединительной ткани часто: артралгия, нечасто: остеоартрит, миалгия, боль в спине, боль в шее, Со стороны почек и мочевыводяших путей нечасто: повышение концентрации мочевины и креатинина в плазме крови, очень редко: интерстициальный нефрит, острая почечная недостаточность, дизурия, боль в почках, Со стороны половых органов и молочной железы нечасто: метроррагия, нарушения функции яичек. Прочее нечасто: отеки, боль в груди, периферические отеки, отеки лица, астения, недомогание, слабость, боль в месте введения, подъем температуры, дерматит, сухость кожи, потливость, одышка, носовое кровотечение. Влияние на результаты лабораторных и инструментальных исследований часто: уменьшение числа лимфоцитов, увеличение числа эозинофилов, снижение концентрации бикарбонатов в плазме крови, увеличение числа базофилов, увеличение числа моноцитов, увеличение числа нейтрофилов, нечасто: изменение концентрации калия, увеличение концентрации щелочной фосфатазы в плазме крови, увеличение содержания хлоридов, увеличение концентрации глюкозы, увеличение числа тромбоцитов, снижение гематокрита, увеличение концентрации бикарбонатов, изменение содержания натрия.
Особые указания
При применении препарата у пациентов с сахарным диабетом, а также при низкокалорийной диете необходимо учитывать, что в состав суспензии входит сахароза (0,32 ХЕ/5 мл). В случае пропуска приема дозы пропущенную дозу следует принять как можно раньше, а последующие - с интервалом в 24 ч. Необходимо соблюдать перерыв 2 ч при одновременном применении антацидов. Препарат следует применять с осторожностью у пациентов с умеренными нарушениями функции печени из-за возможности развития фульминантного гепатита и тяжелой печеночной недостаточности. Сообщалось о возникновении редких серьезных аллергических реакций, таких как ангионевротический отек и анафилаксия (редко с летальным исходом), как и в случаях с эритромицином и другими макролидами. Некоторые из этих реакций на азитромицин становились причиной рецидивирующих симптомов и нуждались в длительном наблюдении и лечении. При наличии симптомов нарушения функции печени, таких как быстро нарастающая астения, желтуха, потемнение мочи, склонность к кровотечениям, печеночная энцефалопатия, терапию препаратом следует прекратить и провести исследование функционального состояния печени. При умеренных нарушениях функции почек (КК более 40 мл/мин) терапию препаратом следует проводить с осторожностью под контролем состояния функции почек. Как и при применении других антибактериальных препаратов, при терапии препаратом следует регулярно обследовать пациентов на наличие невосприимчивых микроорганизмов и признаки развития суперинфекций, в том числе грибковых. Препарат не следует применять более длительными курсами, чем указано в инструкции, так как фармакокинетические свойства азитромицина позволяют рекомендовать короткий и удобный режим дозирования. Сообщалось об усилении симптомов тяжелой миастении и случаях развития миастенического синдрома у пациентов, получающих лечение азитромиципом. Нет данных о возможном взаимодействии между азитромицином и производными эрготамина и дигидроэрготамима, но из-за развития эрготизма при одновременном применении макролидов с производными эрготамина и дигидроэрготамина данная комбинация противопоказана. При длительном приеме препарата возможно развитие псевдомембранозного колита, вызванного Clostridium difficile, как в виде легкой диареи, так и тяжелого колита. При развитии диареи на фоне приема азитромицина, а также в течение 2 месяцев после окончания терапии следует исключить клостридиальный псевдомембранозный колит. Препараты, тормозящие перистальтику кишечника, противопоказаны. После отмены лечения реакции гиперчувствительиости у некоторых пациентов могут сохраняться, что требует специфической терапии под наблюдением врача. Азитромицин следует применять с осторожностью у пациентов с нарушениями функции печени легкой и умеренной степени тяжести, у пациентов с нарушениями функции почек легкой и умеренной степени тяжести. Влияние на способность управлять транспортными средствами, механизмами Во время лечения следует соблюдать осторожность при вождении автомобиля и занятиях потенциально опасными видами деятельности, требующими повышенного внимания и быстроты психомоторных реакций.
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Связываясь с 50S-субъединицей рибосом, угнетает пептидтранслоказу на стадии трансляции, подавляет синтез белка, замедляет рост и размножение бактерий, в высоких концентрациях оказывает бактерицидный эффект. Обладает активностью в отношении ряда грамположительных, грамотрицательных, внутриклеточных и других микроорганизмов. Грамположительные аэробы:\\0009Staphylococcus aureus (метициллинчувствителmysq), Streptococcus pneumoniae (пенициллинчувствительный), Streptococcus pyogenes, Streptococcus agalactiae, Mycobacterium avium комплекс. Грамотрицательные аэробы:\\0009Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae. Анаэробные микроорганизмы: виды рода Prevotella, Clostridium perfringens. Внутриклеточные: виды рода Chlamydia psittacci, Chlamydia trachomatis, Chlamydophila pneumonia, виды рода Mycoplasma, Legionella pneumophila, Borrelia burgdorferi. Микроорганизмы, способные развить устойчивость к азитромицину: Streptococcus pneumonia (пенициллнустойчивый), устойчивые микроорганизмы: Enterococcus faecalis, Staphylococcus spp. (метициллинустойчивые стафилококки с очень высокой частотой обладают приобретенной устойчивостью к макролидам), грамположительные бактерии, устойчивые к эритромицину, Bacteroides fragilis. 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Со стороны нервной системы часто: головная боль, головокружение, парестезии, нарушение вкусовых ощущений, нервозность, нечасто: гипестезия, сонливость, бессонница, редко: ажитация, очень редко: тревога, агрессия, обморок, судороги, психомоторная гиперактивность, потеря обоняния (аносмия) и вкусовых ощущений, миастения, беспокойство, частота неизвестна: бред, галлюцинации. Со стороны органов чувств нечасто: нарушение четкости зрения, нарушения слуха, вертиго, частота неизвестна: нарушения слуха, включая глухоту и/или звон в ушах. Со стороны сердечно-сосудистой системы нечасто: ощущение сердцебиения, ощущение жара и «приливов» крови к коже лица, редко: снижение артериального давления, увеличение интервала QT, аритмия типа «пируэт», желудочковая тахикардия. Со стороны желудочно-кишечного тракта очень часто: диарея, тошнота, метеоризм, боль в области живота, часто: диспепсия, рвота, нечасто: запор, гастрит, дисфагия, вздутие живота, очень редко: сухость слизистой оболочки полости рта, отрыжка, язвы слизистой оболочки полости рта, гиперсекреция слюнных желез, изменение цвета языка, панкреатит. Со стороны печени и желчевыводящих путей нечасто: повышение активности «печеночных» трансаминаз, повышение концентрации билирубина, гепатит, редко: нарушение функции печени, очень редко: холестагическая желтуха, печеночная недостаточность (в редких случаях с легальным исходом, в основном на фоне тяжелого нарушения функции печени), некроз печени, фульминантный гепатит. Со стороны костно-мышечной системы и соединительной ткани часто: артралгия, нечасто: остеоартрит, миалгия, боль в спине, боль в шее, Со стороны почек и мочевыводяших путей нечасто: повышение концентрации мочевины и креатинина в плазме крови, очень редко: интерстициальный нефрит, острая почечная недостаточность, дизурия, боль в почках, Со стороны половых органов и молочной железы нечасто: метроррагия, нарушения функции яичек. Прочее нечасто: отеки, боль в груди, периферические отеки, отеки лица, астения, недомогание, слабость, боль в месте введения, подъем температуры, дерматит, сухость кожи, потливость, одышка, носовое кровотечение. Влияние на результаты лабораторных и инструментальных исследований часто: уменьшение числа лимфоцитов, увеличение числа эозинофилов, снижение концентрации бикарбонатов в плазме крови, увеличение числа базофилов, увеличение числа моноцитов, увеличение числа нейтрофилов, нечасто: изменение концентрации калия, увеличение концентрации щелочной фосфатазы в плазме крови, увеличение содержания хлоридов, увеличение концентрации глюкозы, увеличение числа тромбоцитов, снижение гематокрита, увеличение концентрации бикарбонатов, изменение содержания натрия."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При применении препарата у пациентов с сахарным диабетом, а также при низкокалорийной диете необходимо учитывать, что в состав суспензии входит сахароза (0,32 ХЕ/5 мл). В случае пропуска приема дозы пропущенную дозу следует принять как можно раньше, а последующие - с интервалом в 24 ч. Необходимо соблюдать перерыв 2 ч при одновременном применении антацидов. Препарат следует применять с осторожностью у пациентов с умеренными нарушениями функции печени из-за возможности развития фульминантного гепатита и тяжелой печеночной недостаточности. Сообщалось о возникновении редких серьезных аллергических реакций, таких как ангионевротический отек и анафилаксия (редко с летальным исходом), как и в случаях с эритромицином и другими макролидами. Некоторые из этих реакций на азитромицин становились причиной рецидивирующих симптомов и нуждались в длительном наблюдении и лечении. При наличии симптомов нарушения функции печени, таких как быстро нарастающая астения, желтуха, потемнение мочи, склонность к кровотечениям, печеночная энцефалопатия, терапию препаратом следует прекратить и провести исследование функционального состояния печени. При умеренных нарушениях функции почек (КК более 40 мл/мин) терапию препаратом следует проводить с осторожностью под контролем состояния функции почек. Как и при применении других антибактериальных препаратов, при терапии препаратом следует регулярно обследовать пациентов на наличие невосприимчивых микроорганизмов и признаки развития суперинфекций, в том числе грибковых. Препарат не следует применять более длительными курсами, чем указано в инструкции, так как фармакокинетические свойства азитромицина позволяют рекомендовать короткий и удобный режим дозирования. Сообщалось об усилении симптомов тяжелой миастении и случаях развития миастенического синдрома у пациентов, получающих лечение азитромиципом. Нет данных о возможном взаимодействии между азитромицином и производными эрготамина и дигидроэрготамима, но из-за развития эрготизма при одновременном применении макролидов с производными эрготамина и дигидроэрготамина данная комбинация противопоказана. При длительном приеме препарата возможно развитие псевдомембранозного колита, вызванного Clostridium difficile, как в виде легкой диареи, так и тяжелого колита. При развитии диареи на фоне приема азитромицина, а также в течение 2 месяцев после окончания терапии следует исключить клостридиальный псевдомембранозный колит. Препараты, тормозящие перистальтику кишечника, противопоказаны. После отмены лечения реакции гиперчувствительиости у некоторых пациентов могут сохраняться, что требует специфической терапии под наблюдением врача. Азитромицин следует применять с осторожностью у пациентов с нарушениями функции печени легкой и умеренной степени тяжести, у пациентов с нарушениями функции почек легкой и умеренной степени тяжести. Влияние на способность управлять транспортными средствами, механизмами Во время лечения следует соблюдать осторожность при вождении автомобиля и занятиях потенциально опасными видами деятельности, требующими повышенного внимания и быстроты психомоторных реакций."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Азитромицин - бактериостатический антибиотик широкого спектра действия из группы макролидов-азалидов. Связываясь с 50S-субъединицей рибосом, угнетает пептидтранслоказу на стадии трансляции, подавляет синтез белка, замедляет рост и размножение бактерий, в высоких концентрациях оказывает бактерицидный эффект. Обладает активностью в отношении ряда грамположительных, грамотрицательных, внутриклеточных и других микроорганизмов. Грамположительные аэробы:\\0009Staphylococcus aureus (метициллинчувствителmysq), Streptococcus pneumoniae (пенициллинчувствительный), Streptococcus pyogenes, Streptococcus agalactiae, Mycobacterium avium комплекс. Грамотрицательные аэробы:\\0009Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae. Анаэробные микроорганизмы: виды рода Prevotella, Clostridium perfringens. Внутриклеточные: виды рода Chlamydia psittacci, Chlamydia trachomatis, Chlamydophila pneumonia, виды рода Mycoplasma, Legionella pneumophila, Borrelia burgdorferi. Микроорганизмы, способные развить устойчивость к азитромицину: Streptococcus pneumonia (пенициллнустойчивый), устойчивые микроорганизмы: Enterococcus faecalis, Staphylococcus spp. (метициллинустойчивые стафилококки с очень высокой частотой обладают приобретенной устойчивостью к макролидам), грамположительные бактерии, устойчивые к эритромицину, Bacteroides fragilis. 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