Диспергируемые таблетки Сумамед - бактериостатический антибиотик группы макролидов-азалидов. Обладает широким спектром антимикробного действия. Механизм действия азитромицина связан с подавлением синтеза белка микробной клетки. Связываясь с 50S-субъединицей рибосомы, угнетает пептидтранслоказу на стадии трансляции и подавляет синтез белка, замедляя рост и размножение бактерий. В высоких концентрациях оказывает бактерицидное действие. Обладает активностью в отношении ряда грамположительных, грамотрицательных, анаэробов, внутриклеточных и других микроорганизмов. Микроорганизмы могут изначально быть устойчивыми к действию антибиотика или могут приобретать устойчивость к нему.
Показания к применению
Инфекционно-воспалительные заболевания, вызванные чувствительными к препарату микроорганизмами:
Инфекции верхних дыхательных путей и ЛОР-органов (фарингит/тонзиллит, синусит, средний отит),
Инфекции нижних дыхательных путей (острый бронхит, обострение хронического бронхита, пневмония, в т.ч. вызванные атипичными возбудителями),
Инфекции кожи и мягких тканей (рожа, импетиго, вторично инфицированные дерматозы,
Начальная стадия болезни Лайма (боррелиоз) - мигрирующая эритема (erythema migrans),
Инфекции мочеполовых путей (уретрит, цервицит), вызванные Chlamydia trachomatis
Применение при беременности и в период грудного вскармливания
При беременности и в период грудного вскармливания применение препарата возможно только в том случае, если ожидаемая потенциальная польза терапии для матери превосходит потенциальный риск для плода и ребенка. При необходимости применения препарата в период лактации грудное вскармливание следует приостановить. ВОЗ рекомендует азитромицин в качестве препарата выбора при лечении хламидийной инфекции у беременных.
Способ применения и дозы
Препарат назначают внутрь 1 раз/сут, по крайней мере, за 1 ч до или через 2 ч после еды. Таблетки и капсулыВзрослые (в т.ч. пациенты пожилого возраста) и дети старше 12 лет с массой тела >45 кгПри инфекциях ЛОР-органов, верхних и нижних отделов дыхательных путей, кожи и мягких тканей препарат назначают в дозе 500 мг 1 раз/сут в течение 3 дней, курсовая доза - 1.5 г. При мигрирующей эритеме препарат назначают 1 раз/сут в течение 5 дней: в 1-й день - 1 г, затем со 2 по 5-й дни - по 500 мг, курсовая доза - 3 г. Инфекции мочеполовых путей, вызванные Chlamydia trachomatis (уретрит, цервицит): принеосложненном уретрите/цервиците препарат назначают в дозе 1 г однократно. При акне вульгарис средней степени тяжести препарат назначают в таблетках в дозе 500 мг 1 раз/сут в течение 3 дней, затем 500 мг 1 раз в неделю в течение 9 недель. Курсовая доза - 6 г. Первую еженедельную дозу следует принять через 7 дней после приема первой ежедневной дозы (8-й день от начала лечения), последующие 8 еженедельных доз следует принимать с интервалом в 7 дней. Дети в возрасте от 3 до 12 лет с массой телаПри инфекциях ЛОР-органов, верхних и нижних отделов дыхательных путей, кожи и мягких тканей препарат назначают из расчета 10 мг/кг массы тела 1 раз/сут в течение 3 дней, курсовая доза - 30 мг/кг. Препарат в форме таблеток 125 мг дозируют с учетом массы тела ребенка, как представлено в таблице 1. Таблица 1. Масса тела Доза азитромицина (в таблетках 125 мг)18-30 кг 2 таблетки (250 мг)31-44 кг 3 таблетки (375 мг)≥45кг дозы, рекомендованные для взрослыхПри фарингите/тонзиллите, вызванных Streptococcus pyogenes Сумамед назначают в дозе 20 мг/кг/сут в течение 3 дней. Курсовая доза - 60 мг/кг. Максимальная суточная доза составляет 500 мг. При начальной стадии болезни Лайма (боррелиоз) - мигрирующей эритеме (erythema migrans)назначают в 1-й день в дозе 20 мг/кг 1 раз/сут, затем со 2 по 5-й дни - из расчета 10 мг/кг 1 раз/сут. Курсовая доза - 60 мг/кг. Таблетки следует принимать не разжевывая. Для удобства применения у детей курсовой дозы 60 мг/кг рекомендуется использовать Сумамед в форме порошка для приготовления суспензии для приема внутрь 100 мг/5 мл иСумамед форте в форме порошка для приготовления суспензии для приема внутрь 200 мг/5 мл.
Побочное действие
Частота побочных эффектов классифицирована в соответствии с рекомендациями ВОЗ: очень часто (≥10%), часто (≥1%-<10%), нечасто (≥0.1%-<1%), редко (≥0.01%-<0.1%), очень редко (<0.01%), неизвестная частота (невозможно оценить на основании имеющихся данных). Инфекционные заболевания: нечасто - кандидоз (в т.ч. слизистой оболочки полости рта и гениталий), пневмония, фарингит, гастроэнтерит, респираторные заболевания, ринит, неизвестная частота - псевдомембранозный колит. Со стороны крови и лимфатической системы: нечасто - лейкопения, нейтропения, эозинофилия, очень редко - тромбоцитопения, гемолитическая анемия. Со стороны обмена веществ: нечасто - анорексия. Аллергические реакции: нечасто - ангионевротический отек, реакция гиперчувствительности, неизвестная частота - анафилактическая реакция. Со стороны нервной системы: часто - головная боль, нечасто - головокружение, нарушение вкусовых ощущений, парестезия, сонливость, бессонница, нервозность, редко - ажитация, неизвестная частота - гипестезия, тревога, агрессия, обморок, судороги, психомоторная гиперактивность, потеря обоняния, извращение обоняния, потеря вкусовых ощущений, миастения, бред, галлюцинации. Со стороны органа зрения: нечасто - нарушение зрения. Со стороны органа слуха и лабиринтные нарушения: нечасто - расстройство слуха, вертиго, неизвестная частота - нарушение слуха вплоть до глухоты и/или шум в ушах. Со стороны сердечно-сосудистой системы: нечасто - ощущение сердцебиения, приливы крови к лицу, неизвестная частота - снижение АД, увеличение интервала QT на ЭКГ, аритмия типа "пируэт", желудочковая тахикардия. Со стороны дыхательной системы: нечасто - одышка, носовое кровотечение. Со стороны ЖКТ: очень часто - диарея, часто - тошнота, рвота, боль в животе, нечасто - метеоризм, диспепсия, запор, гастрит, дисфагия, вздутие живота, сухость слизистой оболочки полости рта, отрыжка, язвы слизистой оболочки полости рта, повышение секреции слюнных желез, очень редко - изменение цвета языка, панкреатит. Со стороны печени и желчевыводящих путей: нечасто - гепатит, редко - нарушение функции печени, холестатическая желтуха, неизвестная частота - печеночная недостаточность (в редких случаях с летальным исходом в основном на фоне тяжелого нарушения функции печени), некроз печени, фульминантный гепатит. Со стороны кожи и подкожных тканей: нечасто - кожная сыпь, зуд, крапивница, дерматит, сухость кожи, потливость, редко - реакция фотосенсибилизации, неизвестная частота - синдром Стивенса-Джонсона, токсический эпидермальный некролиз, многоформная эритема. Со стороны опорно-двигательного аппарата: нечасто - остеоартрит, миалгия, боль в спине, боль в шее, неизвестная частота - артралгия. Со стороны почек и мочевыводящих путей: нечасто - дизурия, боль в области почек, неизвестная частота - интерстициальный нефрит, острая почечная недостаточность. Со стороны половых органов и молочной железы: нечасто - метроррагии, нарушение функции яичек. Прочие: нечасто - астения, недомогание, ощущение усталости, отек лица, боль в груди, лихорадка, периферические отеки. Лабораторные данные: часто - снижение количества лимфоцитов, повышение количества эозинофилов, повышение количества базофилов, повышение количества моноцитов, повышение количества нейтрофилов, снижение концентрации бикарбонатов в плазме крови, нечасто - повышение активности АСТ, АЛТ, повышение концентрации билирубина в плазме крови, повышение концентрации мочевины в плазме крови, повышение концентрации креатинина в плазме крови, изменение содержания калия в плазме крови, повышение активности ЩФ в плазме крови, повышение содержания хлора в плазме крови, повышение концентрации глюкозы в крови, увеличение количества тромбоцитов, повышение гематокрита, повышение концентрации бикарбонатов в плазме крови, изменение содержания натрия в плазме крови.
Противопоказания к применению— повышенная чувствительность к азитромицину, эритромицину, другим макролидам или кетолидам, или другим компонентам препарата,— нарушение функции печени тяжелой степени,— нарушения функции почек тяжелой степени (КК < 40 мл/мин),— фенилкетонурия,— одновременный прием с эрготамином и дигидроэрготамином,— детский возраст до 3 лет. С осторожностью: миастения, нарушения функции печени легкой и средней степени тяжести, нарушения функции почек легкой и средней степени тяжести (КК >40 мл/мин), у пациентов с наличием проаритмогенных факторов (особенно у пожилых пациентов) - с врожденным или приобретенным удлинением интервала QT, у пациентов, получающих терапию антиаритмическими препаратами классов IA (хинидин, прокаинамид) и III (дофетилид, амиодарон и соталол), цизапридом, терфенадином, антипсихотическими препаратами (пимозид), антидепрессантами (циталопрам), фторхинолонами (моксифлоксацин и левофлоксацин), с нарушениями водно-электролитного баланса, особенно при гипокалиемии или гипомагниемии, с клинически значимой брадикардией, аритмией или с тяжелой сердечной недостаточностью, при одновременном применении дигоксина, варфарина, циклоспорина. Применение при нарушениях функции печениПротивопоказание: нарушения функции печени тяжелой степени. С осторожностью: нарушения функции печени легкой и средней степени тяжести. Применение при нарушениях функции почекПротивопоказание: нарушения функции почек тяжелой степени (КК < 40 мл/мин). С осторожностью: нарушения функции почек легкой и средней степени тяжести (КК >40 мл/мин),
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дигидрат 1048.218 мг, что соответствует содержанию азитромицина 1000 мг. Вспомогательные вещества: натрия сахарината дигидрат - 78 мг, целлюлоза микрокристаллическая (Avicel PH 101) - 39.782 мг, целлюлоза микрокристаллическая (Avicel PH 102) - 657.6 мг, кросповидон тип А - 165.2 мг, повидон К30 - 44 мг, натрия лаурилсульфат - 6.4 мг, кремния диоксид коллоидный - 8.8 мг, стеарат магния - 22 мг, ароматизатор апельсиновый - 52 мг, аспартам - 78 мг."}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Диспергируемые таблетки Сумамед - бактериостатический антибиотик группы макролидов-азалидов. Обладает широким спектром антимикробного действия. Механизм действия азитромицина связан с подавлением синтеза белка микробной клетки. Связываясь с 50S-субъединицей рибосомы, угнетает пептидтранслоказу на стадии трансляции и подавляет синтез белка, замедляя рост и размножение бактерий. В высоких концентрациях оказывает бактерицидное действие. Обладает активностью в отношении ряда грамположительных, грамотрицательных, анаэробов, внутриклеточных и других микроорганизмов. Микроорганизмы могут изначально быть устойчивыми к действию антибиотика или могут приобретать устойчивость к нему."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Инфекционно-воспалительные заболевания, вызванные чувствительными к препарату микроорганизмами:"}},{"type":"list","data":{"style":"unordered","items":["Инфекции верхних дыхательных путей и ЛОР-органов (фарингит/тонзиллит, синусит, средний отит),","Инфекции нижних дыхательных путей (острый бронхит, обострение хронического бронхита, пневмония, в т.ч. вызванные атипичными возбудителями),","Инфекции кожи и мягких тканей (рожа, импетиго, вторично инфицированные дерматозы,","Начальная стадия болезни Лайма (боррелиоз) - мигрирующая эритема (erythema migrans),","Инфекции мочеполовых путей (уретрит, цервицит), вызванные Chlamydia trachomatis"]}}]},{"id":4,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При беременности и в период грудного вскармливания применение препарата возможно только в том случае, если ожидаемая потенциальная польза терапии для матери превосходит потенциальный риск для плода и ребенка. При необходимости применения препарата в период лактации грудное вскармливание следует приостановить. ВОЗ рекомендует азитромицин в качестве препарата выбора при лечении хламидийной инфекции у беременных."}}]},{"id":5,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат назначают внутрь 1 раз/сут, по крайней мере, за 1 ч до или через 2 ч после еды. Таблетки и капсулыВзрослые (в т.ч. пациенты пожилого возраста) и дети старше 12 лет с массой тела \u003e45 кгПри инфекциях ЛОР-органов, верхних и нижних отделов дыхательных путей, кожи и мягких тканей препарат назначают в дозе 500 мг 1 раз/сут в течение 3 дней, курсовая доза - 1.5 г. При мигрирующей эритеме препарат назначают 1 раз/сут в течение 5 дней: в 1-й день - 1 г, затем со 2 по 5-й дни - по 500 мг, курсовая доза - 3 г. Инфекции мочеполовых путей, вызванные Chlamydia trachomatis (уретрит, цервицит): принеосложненном уретрите/цервиците препарат назначают в дозе 1 г однократно. При акне вульгарис средней степени тяжести препарат назначают в таблетках в дозе 500 мг 1 раз/сут в течение 3 дней, затем 500 мг 1 раз в неделю в течение 9 недель. Курсовая доза - 6 г. Первую еженедельную дозу следует принять через 7 дней после приема первой ежедневной дозы (8-й день от начала лечения), последующие 8 еженедельных доз следует принимать с интервалом в 7 дней. Дети в возрасте от 3 до 12 лет с массой телаПри инфекциях ЛОР-органов, верхних и нижних отделов дыхательных путей, кожи и мягких тканей препарат назначают из расчета 10 мг/кг массы тела 1 раз/сут в течение 3 дней, курсовая доза - 30 мг/кг. Препарат в форме таблеток 125 мг дозируют с учетом массы тела ребенка, как представлено в таблице 1. Таблица 1. Масса тела Доза азитромицина (в таблетках 125 мг)18-30 кг 2 таблетки (250 мг)31-44 кг 3 таблетки (375 мг)≥45кг дозы, рекомендованные для взрослыхПри фарингите/тонзиллите, вызванных Streptococcus pyogenes Сумамед назначают в дозе 20 мг/кг/сут в течение 3 дней. Курсовая доза - 60 мг/кг. Максимальная суточная доза составляет 500 мг. При начальной стадии болезни Лайма (боррелиоз) - мигрирующей эритеме (erythema migrans)назначают в 1-й день в дозе 20 мг/кг 1 раз/сут, затем со 2 по 5-й дни - из расчета 10 мг/кг 1 раз/сут. Курсовая доза - 60 мг/кг. Таблетки следует принимать не разжевывая. Для удобства применения у детей курсовой дозы 60 мг/кг рекомендуется использовать Сумамед в форме порошка для приготовления суспензии для приема внутрь 100 мг/5 мл иСумамед форте в форме порошка для приготовления суспензии для приема внутрь 200 мг/5 мл."}}]},{"id":6,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Частота побочных эффектов классифицирована в соответствии с рекомендациями ВОЗ: очень часто (≥10%), часто (≥1%-\u003c10%), нечасто (≥0.1%-\u003c1%), редко (≥0.01%-\u003c0.1%), очень редко (\u003c0.01%), неизвестная частота (невозможно оценить на основании имеющихся данных). Инфекционные заболевания: нечасто - кандидоз (в т.ч. слизистой оболочки полости рта и гениталий), пневмония, фарингит, гастроэнтерит, респираторные заболевания, ринит, неизвестная частота - псевдомембранозный колит. Со стороны крови и лимфатической системы: нечасто - лейкопения, нейтропения, эозинофилия, очень редко - тромбоцитопения, гемолитическая анемия. Со стороны обмена веществ: нечасто - анорексия. Аллергические реакции: нечасто - ангионевротический отек, реакция гиперчувствительности, неизвестная частота - анафилактическая реакция. Со стороны нервной системы: часто - головная боль, нечасто - головокружение, нарушение вкусовых ощущений, парестезия, сонливость, бессонница, нервозность, редко - ажитация, неизвестная частота - гипестезия, тревога, агрессия, обморок, судороги, психомоторная гиперактивность, потеря обоняния, извращение обоняния, потеря вкусовых ощущений, миастения, бред, галлюцинации. Со стороны органа зрения: нечасто - нарушение зрения. Со стороны органа слуха и лабиринтные нарушения: нечасто - расстройство слуха, вертиго, неизвестная частота - нарушение слуха вплоть до глухоты и/или шум в ушах. Со стороны сердечно-сосудистой системы: нечасто - ощущение сердцебиения, приливы крови к лицу, неизвестная частота - снижение АД, увеличение интервала QT на ЭКГ, аритмия типа \"пируэт\", желудочковая тахикардия. Со стороны дыхательной системы: нечасто - одышка, носовое кровотечение. Со стороны ЖКТ: очень часто - диарея, часто - тошнота, рвота, боль в животе, нечасто - метеоризм, диспепсия, запор, гастрит, дисфагия, вздутие живота, сухость слизистой оболочки полости рта, отрыжка, язвы слизистой оболочки полости рта, повышение секреции слюнных желез, очень редко - изменение цвета языка, панкреатит. Со стороны печени и желчевыводящих путей: нечасто - гепатит, редко - нарушение функции печени, холестатическая желтуха, неизвестная частота - печеночная недостаточность (в редких случаях с летальным исходом в основном на фоне тяжелого нарушения функции печени), некроз печени, фульминантный гепатит. Со стороны кожи и подкожных тканей: нечасто - кожная сыпь, зуд, крапивница, дерматит, сухость кожи, потливость, редко - реакция фотосенсибилизации, неизвестная частота - синдром Стивенса-Джонсона, токсический эпидермальный некролиз, многоформная эритема. Со стороны опорно-двигательного аппарата: нечасто - остеоартрит, миалгия, боль в спине, боль в шее, неизвестная частота - артралгия. Со стороны почек и мочевыводящих путей: нечасто - дизурия, боль в области почек, неизвестная частота - интерстициальный нефрит, острая почечная недостаточность. Со стороны половых органов и молочной железы: нечасто - метроррагии, нарушение функции яичек. Прочие: нечасто - астения, недомогание, ощущение усталости, отек лица, боль в груди, лихорадка, периферические отеки. Лабораторные данные: часто - снижение количества лимфоцитов, повышение количества эозинофилов, повышение количества базофилов, повышение количества моноцитов, повышение количества нейтрофилов, снижение концентрации бикарбонатов в плазме крови, нечасто - повышение активности АСТ, АЛТ, повышение концентрации билирубина в плазме крови, повышение концентрации мочевины в плазме крови, повышение концентрации креатинина в плазме крови, изменение содержания калия в плазме крови, повышение активности ЩФ в плазме крови, повышение содержания хлора в плазме крови, повышение концентрации глюкозы в крови, увеличение количества тромбоцитов, повышение гематокрита, повышение концентрации бикарбонатов в плазме крови, изменение содержания натрия в плазме крови."}}]},{"id":7,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: тошнота, временная потеря слуха, рвота, диарея. Лечение: симптоматическая терапия."}}]},{"id":8,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказания к применению— повышенная чувствительность к азитромицину, эритромицину, другим макролидам или кетолидам, или другим компонентам препарата,— нарушение функции печени тяжелой степени,— нарушения функции почек тяжелой степени (КК \u003c 40 мл/мин),— фенилкетонурия,— одновременный прием с эрготамином и дигидроэрготамином,— детский возраст до 3 лет. 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