Меропенем — антибиотик класса карбапенемов, предназначен для... Инструкция
Показания к применению
Инфекционно-воспалительные заболевания (монотерапия или в комбинации с другими противомикробными лекарственными средствами (ЛС)), вызванные чувствительными к меропенему возбудителями:
инфекции нижних дыхательных путей (в т.ч. пневмонии, включая госпитальные);
интраабдоминальные инфекции (в т.ч. осложненный аппендицит, перитонит);
инфекции мочевыводящей системы (в т.ч. пиелонефрит, пиелит);
Меропенем — антибиотик класса карбапенемов, предназначен для парентерального применения, относительно устойчив к дегидропептидазе-1 (ДГП-1) человека, не требует дополнительного введения ингибитора ДГП-1.
Меропенем оказывает бактерицидное действие за счёт воздействия на синтез клеточной стенки бактерий. Высокая бактерицидная активность меропенема в отношении широкого спектра аэробных и анаэробных бактерий объясняется высокой способностью меропенема проникать через клеточную стенку бактерий, высоким уровнем стабильности к большинству β-лактамаз и значительной аффинностью к пенициллинсвязывающим белкам (ПСБ). Минимальные бактерицидные концентрации (МБК) обычно такие же, как и минимальные ингибирующие концентрации (МИК). Для 76 % протестированных видов бактерий соотношение МБК/МИК было 2 или меньше.
Тесты in vitro показывают, что меропенем действует синергетически с различными антибиотиками. В тестах in vitro и in vivo показано, что меропенем обладает постантибиотическим эффектом.
Микроорганизмы могут обладать одним или несколькими из перечисленных механизмов резистентности к меропенему: нарушение проницаемости клеточной стенки грамотрицательных бактерий из-за нарушения синтеза поринов; уменьшение сродства к целевым ПСБ; активация механизмов эффлюкса; продукция бета-лактамаз, под действием которых происходит гидролиз карбапенемов.
Единственные рекомендуемые критерии чувствительности к меропенему основываются на фармакокинетике препарата и на корреляции клинических и микробиологических данных — диаметр зоны и МИК, определяемых для соответствующих возбудителей.
Фармакокинетика
Максимальная концентрация меропенема при внутривенном введении в течение 30 мин в плазме крови равна примерно 11 мкг/мл для дозы 250 мг, 23 мкг/мл для дозы 500 мг и 49 мкг/мл для дозы 1 г.
Однако в отношении максимальной концентрации (Сmах) и площади под фармакокинетической кривой «концентрация–время» (AUC) нет абсолютной фармакокинетической пропорциональной зависимости от введенной дозы. Отмечено уменьшение плазменного клиренса с 287 до 205 мл/мин для доз от 250 мг до 2 г.
При внутривенной болюсной инъекции меропенема в течение 5 мин максимальная концентрация препарата в плазме составляет примерно 52 мкг/мл для дозы 500 мг и 112 мкг/мл для дозы 1 г.
Через 6 часов после внутривенного введения 500 мг концентрация меропенема в плазме крови снижается до 1 мкг/мл и ниже.
При многократном введении меропенема с интервалом в 8 часов пациентам с нормальной функцией почек кумуляции препарата не наблюдается. У пациентов с нормальной функцией почек период полувыведения составляет примерно 1 час.
Связывание с белками плазмы примерно 2 %.
Около 70 % внутривенной дозы меропенема выводится с мочой в неизменённом виде в течение 12 часов, после чего определяется незначительная экскреция с мочой. Концентрации меропенема в моче, превышающие 10 мкг/мл, поддерживаются в течение 5 часов после введения дозы 500 мг. При режимах введения 500 мг каждые 8 часов или 1 г каждые 6 часов не наблюдалось кумуляции меропенема в плазме крови и в моче у пациентов с нормальной функцией печени.
Единственный метаболит меропенема микробиологически неактивен.
Меропенем хорошо проникает в большинство тканей и жидкостей организма, в грудное молоко, в цереброспинальную жидкость пациентов с бактериальным менингитом, достигая концентраций, превышающих требуемые для подавления большинства бактерий.
Показания к применению
Инфекционно-воспалительные заболевания (монотерапия или в комбинации с другими противомикробными лекарственными средствами (ЛС)), вызванные чувствительными к меропенему возбудителями:
инфекции нижних дыхательных путей (в т.ч. пневмонии, включая госпитальные);
интраабдоминальные инфекции (в т.ч. осложненный аппендицит, перитонит);
инфекции мочевыводящей системы (в т.ч. пиелонефрит, пиелит);
инфекции кожи и мягких тканей (в т.ч. рожа, импетиго, вторично инфицированные дерматозы);
инфекции органов малого таза (в т.ч. эндометрит, пельвиоперитонит);
бактериальный менингит;
септицемия, подозрение на бактериальную инфекцию у взрослых с фебрильной нейтропенией (эмпирическое лечение в виде монотерапии или в комбинации с противовирусными или противогрибковыми ЛС).
Противопоказания
гиперчувствительность к меропенему или другим бета-лактамным антибиотикам в анамнезе;
детский возраст до 3 мес.
С осторожностью
Одновременное назначение с потенциально нефротоксичными препаратами, пациентам с колитами.
Способ применения и дозы
Внутривенно (в/в) болюсно или инфузионно.
Взрослым и детям старше 12 лет - 500 мг каждые 8 ч при пневмонии, инфекциях мочевыводящих путей, инфекционио-воспалительных заболеваниях органов малого таза, инфекциях кожи и мягких тканей; 1,0 г каждые 8 ч при госпитальной пневмонии, перитоните, подозрении на бактериальную инфекцию у больных с симптомами фебрильной нейтропении, септицемии; 2,0 г каждые 8 ч при менингите.
При хронической почечной недостаточности (ХПН) дозу корректируют в зависимости от КК.
Меропенем выводится при гемодиализе. Для восстановления эффективной плазменной концентрации по завершении процедуры гемодиализа необходимо ввести рекомендованную для соответствующей патологии разовую дозу меропенема.
Коррекция дозы не требуется у больных с печеночной недостаточностью, пожилых пациентов с нормальной функцией почек (КК более 50 мл/мин).
Детям в возрасте от 3 мес до 12 лет - 10-20 мг/кг каждые 8 ч, в зависимости от типа и тяжести инфекции, чувствительности патогенного микроорганизма и состояния пациента. Детям до 12 лет, но с массой тела более 50 кг, следует использовать дозы для взрослых. При менингите - 40 мг/кг каждые 8 ч.
Опыт применения у детей с нарушениями функции почек отсутствует.
Приготовление и введение растворов препарата:
для внутривенной болюсной инъекции разводить водой для инъекций до концентрации раствора 50 мг/мл (10 мл на каждые 500 мг), вводить в течение 5 мин.
для внутривенной инфузии разводить в 50-100 мл совместимого инфузионного раствора (0,9 % раствор натрия хлорида, 5-10 % раствор декстрозы, 5 % раствор декстрозы с 0,225 % натрия хлорида, 5 % раствор декстрозы с 0,15 % калия хлорида, 2,5 и 10 % раствор маннитола), вводить в течение 15-30 мин.
Побочное действие
Со стороны пищеварительной системы: боли в эпигастралыюй области, тошнота, рвота, диарея, запор, анорексия, желтуха; кандидоз слизистой оболочки полости рта; псевдомембранозный колит.
Со стороны мочевыделительной системы: дизурия, отеки, нарушение функции почек (гиперкреатининемия, повышение концентрации мочевины в плазме), гематурия.
Со стороны нервной системы: головная боль, головокружение, парестезии, ажитация, нарушение сознания, эпилептиформные припадки, судороги.
Лабораторные показатели: тромбоцитоз, эозинофилия, тромбоцитопения, снижение гемоглобина, гематокрита, лейкопения, укорочение протромбинового и частичного тромбопластинового времени, лейкоцитоз, гипокалиемия, гипербилирубинемия, повышение активности АЛТ, ACT, ЩФ, ЛДГ.
Местные реакции: воспаление, флебит, тромбофлебит, болезненность, отек в месте введения.
Причинно-следственная связь с приемом меропенема не установлена: обморок, галлюцинации, депрессия, тревожность, повышенная возбудимость, бессонница, холестатический гепатит, сердечная недостаточность, остановка сердца, тахикардия, брадикардия, инфаркт миокарда, снижение или повышение артериального давления, тромбоэмболия ветвей легочной артерии, одышка.
Условия хранения
В защищенном от света месте при температуре не выше 25°С.
Срок годности
2 года
Условия отпуска
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вещество:меропенем."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Меропенем — антибиотик класса карбапенемов, предназначен для парентерального применения, относительно устойчив к дегидропептидазе-1 (ДГП-1) человека, не требует дополнительного введения ингибитора ДГП-1."}},{"type":"paragraph","data":{"text":"Меропенем оказывает бактерицидное действие за счёт воздействия на синтез клеточной стенки бактерий. Высокая бактерицидная активность меропенема в отношении широкого спектра аэробных и анаэробных бактерий объясняется высокой способностью меропенема проникать через клеточную стенку бактерий, высоким уровнем стабильности к большинству β-лактамаз и значительной аффинностью к пенициллинсвязывающим белкам (ПСБ). Минимальные бактерицидные концентрации (МБК) обычно такие же, как и минимальные ингибирующие концентрации (МИК). Для 76 % протестированных видов бактерий соотношение МБК/МИК было 2 или меньше."}},{"type":"paragraph","data":{"text":"Тесты in vitro показывают, что меропенем действует синергетически с различными антибиотиками. В тестах in vitro и in vivo показано, что меропенем обладает постантибиотическим эффектом."}},{"type":"paragraph","data":{"text":"Микроорганизмы могут обладать одним или несколькими из перечисленных механизмов резистентности к меропенему: нарушение проницаемости клеточной стенки грамотрицательных бактерий из-за нарушения синтеза поринов; уменьшение сродства к целевым ПСБ; активация механизмов эффлюкса; продукция бета-лактамаз, под действием которых происходит гидролиз карбапенемов."}},{"type":"paragraph","data":{"text":"Единственные рекомендуемые критерии чувствительности к меропенему основываются на фармакокинетике препарата и на корреляции клинических и микробиологических данных — диаметр зоны и МИК, определяемых для соответствующих возбудителей."}},{"type":"paragraph","data":{"text":"Фармакокинетика"}},{"type":"paragraph","data":{"text":"Максимальная концентрация меропенема при внутривенном введении в течение 30 мин в плазме крови равна примерно 11 мкг/мл для дозы 250 мг, 23 мкг/мл для дозы 500 мг и 49 мкг/мл для дозы 1 г."}},{"type":"paragraph","data":{"text":"Однако в отношении максимальной концентрации (Сmах) и площади под фармакокинетической кривой «концентрация–время» (AUC) нет абсолютной фармакокинетической пропорциональной зависимости от введенной дозы. Отмечено уменьшение плазменного клиренса с 287 до 205 мл/мин для доз от 250 мг до 2 г."}},{"type":"paragraph","data":{"text":"При внутривенной болюсной инъекции меропенема в течение 5 мин максимальная концентрация препарата в плазме составляет примерно 52 мкг/мл для дозы 500 мг и 112 мкг/мл для дозы 1 г."}},{"type":"paragraph","data":{"text":"Через 6 часов после внутривенного введения 500 мг концентрация меропенема в плазме крови снижается до 1 мкг/мл и ниже."}},{"type":"paragraph","data":{"text":"При многократном введении меропенема с интервалом в 8 часов пациентам с нормальной функцией почек кумуляции препарата не наблюдается. У пациентов с нормальной функцией почек период полувыведения составляет примерно 1 час."}},{"type":"paragraph","data":{"text":"Связывание с белками плазмы примерно 2 %."}},{"type":"paragraph","data":{"text":"Около 70 % внутривенной дозы меропенема выводится с мочой в неизменённом виде в течение 12 часов, после чего определяется незначительная экскреция с мочой. Концентрации меропенема в моче, превышающие 10 мкг/мл, поддерживаются в течение 5 часов после введения дозы 500 мг. При режимах введения 500 мг каждые 8 часов или 1 г каждые 6 часов не наблюдалось кумуляции меропенема в плазме крови и в моче у пациентов с нормальной функцией печени."}},{"type":"paragraph","data":{"text":"Единственный метаболит меропенема микробиологически неактивен."}},{"type":"paragraph","data":{"text":"Меропенем хорошо проникает в большинство тканей и жидкостей организма, в грудное молоко, в цереброспинальную жидкость пациентов с бактериальным менингитом, достигая концентраций, превышающих требуемые для подавления большинства бактерий."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Инфекционно-воспалительные заболевания (монотерапия или в комбинации с другими противомикробными лекарственными средствами (ЛС)), вызванные чувствительными к меропенему возбудителями:"}},{"type":"list","data":{"style":"ordered","items":["инфекции нижних дыхательных путей (в т.ч. пневмонии, включая госпитальные);","интраабдоминальные инфекции (в т.ч. осложненный аппендицит, перитонит);","инфекции мочевыводящей системы (в т.ч. пиелонефрит, пиелит);","инфекции кожи и мягких тканей (в т.ч. рожа, импетиго, вторично инфицированные дерматозы);","инфекции органов малого таза (в т.ч. эндометрит, пельвиоперитонит);","бактериальный менингит;","септицемия, подозрение на бактериальную инфекцию у взрослых с фебрильной нейтропенией (эмпирическое лечение в виде монотерапии или в комбинации с противовирусными или противогрибковыми ЛС)."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["гиперчувствительность к меропенему или другим бета-лактамным антибиотикам в анамнезе;","детский возраст до 3 мес."]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Одновременное назначение с потенциально нефротоксичными препаратами, пациентам с колитами."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутривенно (в/в) болюсно или инфузионно."}},{"type":"paragraph","data":{"text":"Взрослым и детям старше 12 лет - 500 мг каждые 8 ч при пневмонии, инфекциях мочевыводящих путей, инфекционио-воспалительных заболеваниях органов малого таза, инфекциях кожи и мягких тканей; 1,0 г каждые 8 ч при госпитальной пневмонии, перитоните, подозрении на бактериальную инфекцию у больных с симптомами фебрильной нейтропении, септицемии; 2,0 г каждые 8 ч при менингите."}},{"type":"paragraph","data":{"text":"При хронической почечной недостаточности (ХПН) дозу корректируют в зависимости от КК."}},{"type":"paragraph","data":{"text":"Меропенем выводится при гемодиализе. Для восстановления эффективной плазменной концентрации по завершении процедуры гемодиализа необходимо ввести рекомендованную для соответствующей патологии разовую дозу меропенема."}},{"type":"paragraph","data":{"text":"Коррекция дозы не требуется у больных с печеночной недостаточностью, пожилых пациентов с нормальной функцией почек (КК более 50 мл/мин)."}},{"type":"paragraph","data":{"text":"Детям в возрасте от 3 мес до 12 лет - 10-20 мг/кг каждые 8 ч, в зависимости от типа и тяжести инфекции, чувствительности патогенного микроорганизма и состояния пациента. Детям до 12 лет, но с массой тела более 50 кг, следует использовать дозы для взрослых. При менингите - 40 мг/кг каждые 8 ч."}},{"type":"paragraph","data":{"text":"Опыт применения у детей с нарушениями функции почек отсутствует."}},{"type":"paragraph","data":{"text":"Приготовление и введение растворов препарата:"}},{"type":"list","data":{"style":"ordered","items":["для внутривенной болюсной инъекции разводить водой для инъекций до концентрации раствора 50 мг/мл (10 мл на каждые 500 мг), вводить в течение 5 мин.","для внутривенной инфузии разводить в 50-100 мл совместимого инфузионного раствора (0,9 % раствор натрия хлорида, 5-10 % раствор декстрозы, 5 % раствор декстрозы с 0,225 % натрия хлорида, 5 % раствор декстрозы с 0,15 % калия хлорида, 2,5 и 10 % раствор маннитола), вводить в течение 15-30 мин."]}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: боли в эпигастралыюй области, тошнота, рвота, диарея, запор, анорексия, желтуха; кандидоз слизистой оболочки полости рта; псевдомембранозный колит."}},{"type":"paragraph","data":{"text":"Со стороны мочевыделительной системы: дизурия, отеки, нарушение функции почек (гиперкреатининемия, повышение концентрации мочевины в плазме), гематурия."}},{"type":"paragraph","data":{"text":"Аллергические реакции: зуд кожи, кожная сыпь, крапивница, мультиформная экссудативная эритема, злокачественная экссудативная эритема (синдром Стивенса-Джонсона), ангионевротический отек, анафилактический шок."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: головная боль, головокружение, парестезии, ажитация, нарушение сознания, эпилептиформные припадки, судороги."}},{"type":"paragraph","data":{"text":"Лабораторные показатели: тромбоцитоз, эозинофилия, тромбоцитопения, снижение гемоглобина, гематокрита, лейкопения, укорочение протромбинового и частичного тромбопластинового времени, лейкоцитоз, гипокалиемия, гипербилирубинемия, повышение активности АЛТ, ACT, ЩФ, ЛДГ."}},{"type":"paragraph","data":{"text":"Местные реакции: воспаление, флебит, тромбофлебит, болезненность, отек в месте введения."}},{"type":"paragraph","data":{"text":"Прочие: ложноположительная прямая или непрямая пробы Кумбса, анемия, гиперволемия, вагинальный кандидоз."}},{"type":"paragraph","data":{"text":"Причинно-следственная связь с приемом меропенема не установлена: обморок, галлюцинации, депрессия, тревожность, повышенная возбудимость, бессонница, холестатический гепатит, сердечная недостаточность, остановка сердца, тахикардия, брадикардия, инфаркт миокарда, снижение или повышение артериального давления, тромбоэмболия ветвей легочной артерии, одышка."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от света месте при температуре не выше 25°С. "}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"по рецепту "}}]}],"source":null},"description_toggle":false,"short_description":"Меропенем — антибиотик класса карбапенемов, предназначен для парентерального применения, относительно устойчив к дегидропептидазе-1 (ДГП-1) человека, не требует дополнительного введения ингибитора ДГП-1. Меропенем оказывает бактерицидное действие за счёт воздействия на синтез клеточной стенки бактерий. Высокая бактерицидная активность меропенема в отношении широкого спектра аэробных и анаэробных бактерий объясняется высокой способностью меропенема проникать через клеточную стенку бактерий, высоким уровнем стабильности к большинству β-лактамаз и значительной аффинностью к пенициллинсвязывающим белкам (ПСБ). Минимальные бактерицидные концентрации (МБК) обычно такие же, как и минимальные ингибирующие концентрации (МИК). Для 76 % протестированных видов бактерий соотношение МБК/МИК было 2 или меньше. Тесты in vitro показывают, что меропенем действует синергетически с различными антибиотиками. В тестах in vitro и in vivo показано, что меропенем обладает постантибиотическим эффектом. Микроорганизмы могут обладать одним или несколькими из перечисленных механизмов резистентности к меропенему: нарушение проницаемости клеточной стенки грамотрицательных бактерий из-за нарушения синтеза поринов; уменьшение сродства к целевым ПСБ; активация механизмов эффлюкса; продукция бета-лактамаз, под действием которых происходит гидролиз карбапенемов. Единственные рекомендуемые критерии чувствительности к меропенему основываются на фармакокинетике препарата и на корреляции клинических и микробиологических данных — диаметр зоны и МИК, определяемых для соответствующих возбудителей. Фармакокинетика Максимальная концентрация меропенема при внутривенном введении в течение 30 мин в плазме крови равна примерно 11 мкг/мл для дозы 250 мг, 23 мкг/мл для дозы 500 мг и 49 мкг/мл для дозы 1 г. Однако в отношении максимальной концентрации (Сmах) и площади под фармакокинетической кривой «концентрация–время» (AUC) нет абсолютной фармакокинетической пропорциональной зависимости от введенной дозы. Отмечено уменьшение плазменного клиренса с 287 до 205 мл/мин для доз от 250 мг до 2 г. При внутривенной болюсной инъекции меропенема в течение 5 мин максимальная концентрация препарата в плазме составляет примерно 52 мкг/мл для дозы 500 мг и 112 мкг/мл для дозы 1 г. Через 6 часов после внутривенного введения 500 мг концентрация меропенема в плазме крови снижается до 1 мкг/мл и ниже. При многократном введении меропенема с интервалом в 8 часов пациентам с нормальной функцией почек кумуляции препарата не наблюдается. 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