Хемомицин Лиофилизат, флакон, 1 шт, 500 мг, для раствора для инфузий

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В/в введение должно сменяться последующим пероральным назначением азитромицина в виде однократной суточной дозы 500 мг до полного завершения 7-10 дневного общего курса лечения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eИнфекционно-воспалительные заболевания органов малого таза\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"500 мг однократно/сут в/в в течение не менее 2-х дней. В/в введение должно сменяться последующим пероральным назначением азитромицина в виде однократной суточной дозы 250 мг до полного завершения 7 дневного общего курса лечения."}},{"type":"paragraph","data":{"text":"Сроки перехода на пероральное лечение определяются в соответствии с данными клинического обследования."}},{"type":"paragraph","data":{"text":"Для \u003cb\u003eпациентов с умеренными нарушениями функции печени и почек (клиренс креатинина >40 мл/мин)\u003c/b\u003e коррекция дозы не нужна."}},{"type":"paragraph","data":{"text":"\u003cb\u003eПравила приготовления раствора\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Раствор для инфузии готовится в 2 этапа:"}},{"type":"paragraph","data":{"text":"1 этап - приготовление востановленного раствора: во флакон с 500 мг препарата добавляют 4.8 мл стерильной воды для инъекций и тщательно встряхивают до полного растворения порошка. В 1 мл полученного раствора содержится 100 мг азитромицина. Приготовленный раствор остается стабильным в течение 24 ч при комнатной температуре."}},{"type":"paragraph","data":{"text":"2 этап - разведение восстановленного раствора (100 мг/мл) проводится непосредственно перед введением"}},{"type":"paragraph","data":{"text":"Восстановленный раствор вносят во флакон с растворителем (0.9% раствор хлорида натрия, 5% декстроза, раствор Рингера) до получения конечной концентрации азитромицина 1-2 мг/мл в инфузионном растворе."}},{"type":"paragraph","data":{"text":"Раствор Хемомицина нельзя вводить в/в струйно или в/м. Рекомендуется вводить приготовленный раствор в/в в виде инфузии, капельно (не менее 1 ч)."}},{"type":"paragraph","data":{"text":"Перед введением раствор подвергают визуальному контролю. Если готовый раствор содержит частицы вещества, то он не должен использоваться. Приготовленный раствор стабилен при комнатной температуре в течение 24 ч."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны нервной системы: головокружение/вертиго, головная боль, сонливость, судороги, гипестезия, парестезии, астения, бессонница, обморок, агрессивность, нервозность, ажитация, бред, галлюцинации, тревога, гиперактивность, миастения."}},{"type":"paragraph","data":{"text":"Со стороны органов чувств: расстройство слуха, шум в ушах, обратимое нарушение слуха вплоть до глухоты (при приеме высоких доз в течение длительного времени), нарушение зрения, нарушение восприятия вкуса и запаха, извращение обоняния, потеря обоняния, потеря вкусовых ощущений."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: ощущение сердцебиения, аритмия, включая желудочковую тахикардию, увеличение интервала QT, двунаправленная желудочковая тахикардия, снижение артериального давления."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: тошнота, рвота, диарея, абдоминальные боли, вздутие живота, метеоризм, дисфагия, сухость слизистой оболочки полости рта, отрыжка, язвы слизистой оболочки полости рта, повышение секреции слюнных желез, расстройство пищеварения, холестатическая желтуха, гепатит, гастрит, гастроэнтерит, изменение лабораторных показателей функции печени, запор, изменение цвета языка, псевдомембранозный колит, панкреатит, фульминантный гепатит, некроз печени, печеночная недостаточность (возможно со смертельным исходом)."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: пневмония, респираторные заболевания, ринит, одышка."}},{"type":"paragraph","data":{"text":"Со стороны кровеносной и лимфатической систем: эозинофилия, гемолитическая анемия, снижение количества лимфоцитов, тромбоцитопения, нейтропения, лейкопения, нейтрофилия, повышение количества базофилов, моноцитов, тромбоцитов."}},{"type":"paragraph","data":{"text":"Аллергические реакции: реакция гиперчувствительности, зуд, кожные высыпания, ангионевротический отек, крапивница, фотосенсибилизация, анафилактическая реакция, включая отек (в редких случаях со смертельным исходом), многоформная эритема, синдром Стивенса-Джонсона, токсический эпидермальный некролиз, лекарственная сыпь с эозинофилией и системной симптоматикой (DRESS-синдром)."}},{"type":"paragraph","data":{"text":"Со стороны опорно-двигательного аппарата: артралгия, остеоартрит, миалгия."}},{"type":"paragraph","data":{"text":"Со стороны мочеполовой системы: нефрит, острая почечная недостаточность, дизурия, боль в области почек, метроррагия, нарушение функции яичек."}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов: дерматит, сухость кожи, потливость."}},{"type":"paragraph","data":{"text":"Лабораторные показатели: в плазме крови: снижение или повышение концентрации бикарбонатов, повышение активности щелочной фосфатазы, повышение содержания хлора, изменение содержания калия, повышение концентрации глюкозы, изменение содержания натрия, повышение гематокрита, повышение активности аланинаминотрансферазы, повышение активности аспартатаминотрансферазы, повышение концентрации билирубина, мочевины, креатинина."}},{"type":"paragraph","data":{"text":"Местные реакции: боль и воспаление в месте введения препарата."}},{"type":"paragraph","data":{"text":"Прочие: кандидоз, в т. ч. полости рта и половых органов, усталость, недомогание, анорексия, фарингит, «приливы» крови к лицу, носовое кровотечение, боль в спине, боль в шее, боль в груди, периферические отеки, отек лица, лихорадка."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: сильная тошнота, временная потеря слуха, рвота, диарея, абдоминальная боль, нарушение функции печени."}},{"type":"paragraph","data":{"text":"Лечение: симптоматическое."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Цетиризин"}},{"type":"paragraph","data":{"text":"Одновременное применение в течение 5 дней у здоровых добровольцев азитромицина с цетиризином (20 мг) не привело к фармакокинетическому взаимодействию и существенному изменению интервала QT."}},{"type":"paragraph","data":{"text":"Диданозин (дидезоксиинозин)"}},{"type":"paragraph","data":{"text":"Одновременное применение азитромицина (1200 мг/сут) и диданозина (400 мг/сут) у 6 ВИЧ-инфицированных пациентов не выявило изменений фармакокинетических показателей диданозина по сравнению с группой плацебо."}},{"type":"paragraph","data":{"text":"Дигоксин (субстраты Р-гликопротеина)"}},{"type":"paragraph","data":{"text":"Одновременное применение макролидных антибиотиков, в том числе азитромицина, с субстратами Р-гликопротеина, такими как дигоксин, приводит к повышению концентрации субстрата Р-гликопротеина в сыворотке крови. Таким образом, при одновременном применении азитромицина и дигоксина необходимо учитывать возможность повышения концентрации дигоксина в сыворотке крови."}},{"type":"paragraph","data":{"text":"Зидовудин"}},{"type":"paragraph","data":{"text":"Одновременное применение азитромицина (одноразовый прием 1000 мг и многократный прием 1200 мг или 600 мг) оказывает незначительное влияние на фармакокинетику, в том числе выведение почками, зидовудина или его глюкуронидного метаболита. Однако применение азитромицина вызывало увеличение концентрации фосфорилированного зидовудина, клинически активного метаболита в мононуклеарах периферической крови. Клиническое значение этого факта неясно."}},{"type":"paragraph","data":{"text":"Азитромицин слабо взаимодействует с изоферментами системы цитохрома Р450. Не выявлено, что азитромицин участвует в фармакокинетических взаимодействиях аналогичных эритромицину и другим макролидам. Азитромицин не является ингибитором и индуктором изоферментов цитохрома Р450."}},{"type":"paragraph","data":{"text":"Алкалоиды спорыньи"}},{"type":"paragraph","data":{"text":"Учитывая теоретическую возможность возникновения эрготизма, одновременное применение азитромицина с производными алкалоидов спорыньи не рекомендуется. Были проведены фармакокинетические исследования одновременного применения азитромицина и препаратов, метаболизм которых происходит с участием изоферментов системы цитохрома Р450."}},{"type":"paragraph","data":{"text":"Аторвастатин"}},{"type":"paragraph","data":{"text":"Одновременное применение аторвастатина (10 мг ежедневно) и азитромицина (500 мг ежедневно) не вызывало изменения концентраций аторвастатина в плазме крови (на основе анализа ингибирования ГМК-КоА-редуктазы). Однако, в пострегистрационном периоде были получены отдельные сообщения о случаях рабдомиолиза у пациентов, получающих одновременно азитромицин и статины."}},{"type":"paragraph","data":{"text":"Карбамазепин"}},{"type":"paragraph","data":{"text":"В фармакокинетических исследованиях с участием здоровых добровольцев не выявлено существенного влияния на концентрацию карбамазепина и его активного метаболита в плазме крови у пациентов, получавших одновременно азитромицин."}},{"type":"paragraph","data":{"text":"Циметидин"}},{"type":"paragraph","data":{"text":"В фармакокинетических исследованиях влияния разовой дозы циметидина на фармакокинетику азитромицина не выявлено изменений фармакокинетики азитромицина, при условии применения циметидина за 2 часа до азитромицина."}},{"type":"paragraph","data":{"text":"Антикоагулянты непрямого действия (производные кумарина)"}},{"type":"paragraph","data":{"text":"В фармакокинетических исследованиях азитромицин не влиял на антикоагулянтный эффект однократной дозы 15 мг варфарина, принимаемого здоровыми добровольцами. Сообщалось о потенцировании антикоагулянтного эффекта после одновременного применения азитромицина и антикоагулянтов непрямого действия (производные кумарина). Несмотря на то, что причинная связь не установлена, следует учитывать необходимость проведения частого мониторинга протромбинового времени при применении азитромицина у пациентов, которые получают пероральные антикоагулянты непрямого действия (производные кумарина)."}},{"type":"paragraph","data":{"text":"Циклоспорин"}},{"type":"paragraph","data":{"text":"В фармакокинетическом исследовании с участием здоровых добровольцев, которые в течение 3 дней принимали внутрь азитромицин (500 мг/сут однократно), а затем циклоспорин (10 мг/кг/сут однократно), было выявлено достоверное повышение максимальной концентрации в плазме крови (Cmax) и площади под кривой «концентрация-время» (AUC0-5) циклоспорина. Следует соблюдать осторожность при одновременном применении этих препаратов. В случае необходимости одновременного применения этих препаратов, необходимо проводить мониторинг концентрации циклоспорина в плазме крови и соответственно корректировать дозу."}},{"type":"paragraph","data":{"text":"Эфавиренз"}},{"type":"paragraph","data":{"text":"Одновременное применение азитромицина (600 мг/сут однократно) и эфавиренза (400 мг/сут) ежедневно в течение 7 дней не вызывало какого-либо клинически значимого фармакокинетического взаимодействия."}},{"type":"paragraph","data":{"text":"Флуконазол"}},{"type":"paragraph","data":{"text":"Одновременное применение азитромицина (1200 мг однократно) не меняло фармакокинетику флуконазола (800 мг однократно). Общая экспозиция и период полувыведения азитромицина не изменялись при одновременном применении флуконазола, однако при этом наблюдали снижение Cmax азитромицина (на 18%), что не имело клинического значения."}},{"type":"paragraph","data":{"text":"Индинавир"}},{"type":"paragraph","data":{"text":"Одновременное применение азитромицина (1200 мг однократно) не вызывало статистически достоверного влияния на фармакокинетику индинавира (по 800 мг три раза в сутки в течение 5 дней)."}},{"type":"paragraph","data":{"text":"Метилпреднизолон"}},{"type":"paragraph","data":{"text":"Азитромицин не оказывает существенного влияния на фармакокинетику метилпреднизолона."}},{"type":"paragraph","data":{"text":"Нелфинавир"}},{"type":"paragraph","data":{"text":"Одновременное применение азитромицина (1200 мг) и нелфинавира (по 750 мг 3 раза в день) вызывает повышение равновесных концентраций азитромицина в сыворотке крови. Клинически значимых побочных эффектов не наблюдалось и коррекции дозы азитромицина при его одновременном применении с нелфинавиром не требуется."}},{"type":"paragraph","data":{"text":"Рифабутин"}},{"type":"paragraph","data":{"text":"Одновременное применение азитромицина и рифабутина не влияет на концентрацию каждого из препаратов в сыворотке крови. При одновременном применении азитромицина и рифабутина иногда наблюдалась нейтропения. Несмотря на то, что нейтропения ассоциировалась с применением рифабутина, причинно-следственная связь между применением комбинации азитромицина и рифабутина и нейтропенией не установлена."}},{"type":"paragraph","data":{"text":"Силденафил"}},{"type":"paragraph","data":{"text":"При применении у здоровых добровольцев не получено доказательств влияния азитромицина (500 мг/сут ежедневно в течение 3 дней) на AUC и Cmax силденафила или его основного циркулирующего метаболита."}},{"type":"paragraph","data":{"text":"Терфенадин"}},{"type":"paragraph","data":{"text":"В фармакокинетических исследованиях не было получено доказательств взаимодействия между азитромицином и терфенадином. Сообщалось о единичных случаях, когда возможность такого взаимодействия нельзя было исключить полностью, однако не было ни одного конкретного доказательства, что такое взаимодействие имело место."}},{"type":"paragraph","data":{"text":"Было установлено, что одновременное применение терфенадина и макролидов может вызвать аритмию и удлинение интервала QT."}},{"type":"paragraph","data":{"text":"Теофиллин"}},{"type":"paragraph","data":{"text":"Не выявлено взаимодействие между азитромицином и теофиллином."}},{"type":"paragraph","data":{"text":"Триазолам/мидазолам"}},{"type":"paragraph","data":{"text":"Значительных изменений фармакокинетических показателей при одновременном применении азитромицина с триазоламом или мидазоламом в терапевтических дозах не выявлено."}},{"type":"paragraph","data":{"text":"Триметоприм/сульфаметоксазол"}},{"type":"paragraph","data":{"text":"Одновременное применение триметоприма/сульфаметоксазола с азитромицином не выявило существенного влияния на Cmax, общую экспозицию или экскрецию почками триметоприма или сульфаметоксазола. Концентрации азитромицина в сыворотке крови соответствовали выявляемым в других исследованиях."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Не установлена безопасность применения и эффективность инъекционной формы препарата Хемомицин у детей до 18 лет."}},{"type":"paragraph","data":{"text":"Не следует вводить препарат более длительными курсами, чем указано в инструкции, так как фармакокинетические свойства азитромицина позволяют использовать короткий режим дозирования."}},{"type":"paragraph","data":{"text":"Возможно присоединение суперинфекции (в т. ч. грибковой) при лечении препаратом Хемомицин (как и при проведении любой антибиотикотерапии)."}},{"type":"paragraph","data":{"text":"Азитромицин следует применять с осторожностью у пациентов с нарушениями функции печени легкой и средней степени тяжести из-за возможности развития фульминантного гепатита и тяжелой печеночной недостаточности."}},{"type":"paragraph","data":{"text":"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."}},{"type":"paragraph","data":{"text":"При нарушениях функции почек: у пациентов с СКФ 10-80 мл/мин коррекция дозы не требуется, терапию препаратом Хемомицин следует проводить с осторожностью под контролем состояния функции почек у пациентов с СКФ менее 10 мл/мин."}},{"type":"paragraph","data":{"text":"Применение азитромицина может спровоцировать развитие миастенического синдрома или вызвать обострение миастении."}},{"type":"paragraph","data":{"text":"При использовании препарата Хемомицин могут развиться диарея/ псевдомембранозный колит, вызванные Clostridium difficile. В связи с этим пациенты с диареей должны тщательно наблюдаться. Применение препаратов, тормозящих перистальтику кишечника, при развитии псевдомембранозного колита противопоказано."}},{"type":"paragraph","data":{"text":"При лечении макролидами, в том числе азитромицином, наблюдалось удлинение сердечной реполяризации и интервала QT, повышающих риск развития сердечных аритмий, в том числе аритмии типа «пируэт»."}},{"type":"paragraph","data":{"text":"Следует соблюдать осторожность при применении азитромицина у пациентов с наличием проаритмогенных факторов (особенно у пожилых пациентов), в том числе с врожденным или приобретенным удлинением интервала QT; у пациентов, принимающих антиаритмические препараты классов IA (хинидин, прокаинамид), III (дофетилид, амиодарон и соталол), цизаприд, терфенадин, антипсихотические препараты (пимозид), антидепрессанты (циталопрам), фторхинолоны (моксифлоксацин и левофлоксацин), у пациентов с нарушениями водно-электролитного баланса, особенно в случае гипокалиемии или гипомагниемии, клинически значимой брадикардией, аритмией сердца, или тяжелой сердечной недостаточностью."}},{"type":"paragraph","data":{"text":"После отмены лечения реакции гиперчувствительности у некоторых пациентов могут сохраняться, что требует специфической терапии под наблюдением врача."}},{"type":"paragraph","data":{"text":"Пациентам, находящимся на диете с ограниченным потреблением натрия, при лечении препаратом Хемомицин необходимо учитывать, что в одном флаконе содержится 6,2 мг натрия (натрия гидроксид – вспомогательное вещество)."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"При развитии нежелательных эффектов со стороны нервной системы и органа зрения следует соблюдать осторожность при выполнении действий, требующих повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Лиофилизат для приготовления раствора для инфузий 500 мг."}},{"type":"paragraph","data":{"text":"По 500 мг азитромицина во флакон из бесцветного стекла I гидролитического класса, вместимостью 13,5 мл, укупоренный пробкой резиновой и запечатанный алюминиевым колпачком с вкладышем в виде пластикового диска (контроль первого вскрытия). 1 флакон вместе с инструкцией по медицинскому применению лекарственного препарата в пачку картонную."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"При температуре от 10 до 25 ˚С."}},{"type":"paragraph","data":{"text":"Хранить в недоступном для детей месте!"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}},{"type":"paragraph","data":{"text":"Не использовать после истечения срока годности, указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Отпускают по рецепту."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Хемофарм А.Д., Сербия"}},{"type":"paragraph","data":{"text":"26300 г. Вршац, Београдский путь бб, Сербия"}},{"type":"paragraph","data":{"text":"тел.: 13/803100, факс: 13/803424"}},{"type":"paragraph","data":{"text":"Организация, принимающая претензии"}},{"type":"paragraph","data":{"text":"АО «Нижфарм», Россия"}},{"type":"paragraph","data":{"text":"603950, г. Нижний Новгород ГСП-458, ул. Салганская, 7 и по"}},{"type":"paragraph","data":{"text":"тел.: (831) 278-80-88; факс: (831) 430-72-28"}},{"type":"paragraph","data":{"text":"Email: \u003ca href=\"mailto:med@stada.ru\"\u003emed@stada.ru\u003c/a\u003e"}}]}],"source":null},"description_toggle":false,"short_description":"Азитромицин - макролидный антибиотик группы азалидов. 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