Меропенем Порошок, флакон, 1 шт, 1 г, для приготовления раствора

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мембраны тормозит синтез пептидогликанового слоя клеточной стенки подавляет транспептидазу способствует высвобождению аутолитических ферментов клеточной стенки что в итоге вызывает ее повреждение и гибель бактерий."}},{"type":"paragraph","data":{"text":"Спектр антибактериальной активности меропенема включает в себя большинство клинически значимых грамположительных и грамотрицательных аэробных и анаэробных штаммов бактерий:"}},{"type":"paragraph","data":{"text":"Грамположительные аэробы:"}},{"type":"paragraph","data":{"text":"Enterococcus faecalis (включая ванкомицин-уетойчивые штаммы). Staphylococcus aureus(пенициллиназонепродуцирующие и пенициллиназопроду- цирующие [метициллин-чувствительные]); Streptococcus agalactiae Streptococcus pneumoniae (только пенициллин-чувствительные); Streptococcus pyogenes. Streptococcus spp. группы viridans."}},{"type":"paragraph","data":{"text":"Грамотрицательные аэробы:"}},{"type":"paragraph","data":{"text":"Escherichia coli Haemophilus influenzae (пенициллиназонепродуцирующие и пенициллиназопродуцирующие) Klebsiella pneumoniae Neisseria meningitidis. Pseudomonas aeruginosa Proteus mirabilis."}},{"type":"paragraph","data":{"text":"Анаэробные бактерии:"}},{"type":"paragraph","data":{"text":"Bacteroides fragilis Bacteroides thetaiotaomicron Peptostreptococcus spp."}},{"type":"paragraph","data":{"text":"Меропенем эффективен in vitro в отношении нижеуказанных микроорганизмов однако клинически его эффективность при заболеваниях вызываемых этими возбудителями не доказана:"}},{"type":"paragraph","data":{"text":"Грамположительные аэробы:"}},{"type":"paragraph","data":{"text":"Staphylococcus epidermidis (пенициллиназонепродуцирующие и пенициллиназопродуцирующие [метициллин-чувствительные])."}},{"type":"paragraph","data":{"text":"Грамотрицательные аэробы:"}},{"type":"paragraph","data":{"text":"Acinetobacter spp. Aeromonas hydrophila Campylobacter jejuni Citrobac-ter diversus Citrobacter ffeundii Enterobacter cloacae Haemophilus influenzae (ампициллин-устойчивые пенициллиназонепродуцирующие штаммы) Hafnia alvei Klebsiella oxytoca Moraxella catarrhalis (пенициллиназонепродуцирующие и пенициллиназопродуцирующие) Morganella morganii Pasteurella multocida Proteus vulgaris. Salmonella spp. Serratia marcescens. Shigella spp. Yersinia enterocolitica."}},{"type":"paragraph","data":{"text":"Анаэробные бактерии:"}},{"type":"paragraph","data":{"text":"Bacteroides distasonis Bacteroides ovatus Bacteroides uniformis Bacteroides ureolyticus Bacteroides vulgatus Clostridium difficile Clostridium perfringens Eubacterium lentum Fusobacterium spp. Prevotella bivia Prevotella intermedia Prevotella melaninogenica Porphyromonas asaccharolytica Propionibacterium acnes."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"При внутривенном (в/в) введении 250 мг в течение 30 мин максимальная концентрация (C\u003csub\u003emax\u003c/sub\u003e) - 11 мкг/мл для дозы 500 мг - 23 мкг/мл 1 г - 49 мкг/мл (абсолютной фармакокинетической пропорциональной зависимости от введенной дозы для С\u003csub\u003emax\u003c/sub\u003e и AUC (площадь под фармакокинетической кривой \"концентрация- время\") нет). При увеличении дозы с 025 до 2 г клиренс уменьшается с 287 до 205 мл/мин. При в/в болюсном введении в течение 5 мин 500 мг С\u003csub\u003emax\u003c/sub\u003e - 52 мкг/мл 1 г -112 мкг/мл. Связь с белками плазмы - 2 %."}},{"type":"paragraph","data":{"text":"Хорошо проникает в большинство тканей и жидкостей организма в т.ч. в цереброспинальную жидкость больных бактериальным менингитом достигая концентраций превышающих требуемые для подавления большинства бактерий (бактерицидные концентрации создаются через 05-15 ч после начала инфузии). В незначительных количествах проникает в грудное молоко."}},{"type":"paragraph","data":{"text":"Подвергается незначительному метаболизму в печени с образованием единственного неактивного метаболита. Период полувыведения (Т\u003csub\u003e1/2\u003c/sub\u003e) - 1 ч у детей до 2 лет - 15-23 ч. В диапазоне доз 10-40 мг/кг у взрослых и детей наблюдается линейная зависимость фармакокинетических параметров. Не кумулирует. Выводится почками - 70 % в неизмененном виде в течение 12 ч. Концентрация меропенема в моче превышающая 10 мкг/мл поддерживается в течение 5 ч после введения 500 мг. У больных с почечной недостаточностью клиренс коррелирует с клиренсом креатинина (КК). У пожилых пациентов снижение клиренса меропенема коррелирует со снижением КК связанным с возрастом. Т\u003csub\u003e1/2\u003c/sub\u003e - 15 ч. Выводится при гемодиализе.\n\n"}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Инфекционно-воспалительные заболевания вызванные чувствительными к препарату микроорганизмами в том числе при полимикробных инфекциях (в качестве монотерапии или комбинации с другими антибактериальными противовирусными и противогрибковыми лекарственными средствами):"}},{"type":"paragraph","data":{"text":"- внутрибрюшные инфекции (в т.ч. осложненный аппендицит перитонит пельвиоперитонит);"}},{"type":"paragraph","data":{"text":"- инфекции нижних дыхательных путей(в т.ч. пневмонии включая госпитальные);"}},{"type":"paragraph","data":{"text":"- инфекции мочевыводящей системы (в т.ч. пиелонефрит пиелит);"}},{"type":"paragraph","data":{"text":"- инфекции кожи и мягких тканей (в т.ч. рожа импетиго вторично инфицированные дерматозы);"}},{"type":"paragraph","data":{"text":"- инфекции органов малого таза (в т.ч.эндометрит);"}},{"type":"paragraph","data":{"text":"- бактериальный менингит;"}},{"type":"paragraph","data":{"text":"- септицемия;- эмпирическое лечение (в виде монотерапии или в комбинации с противовирусными или противогрибковыми ЛС) при подозрении на инфекцию у взрослых пациентов с фебрильными эпизодами с нейтропенией;"}},{"type":"paragraph","data":{"text":"- эффективность препарата доказана как в режиме монотерапии так и в комбинации с другими антимикробными средствами при лечении полимикробных инфекций."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к меропенему или другим препаратам группы карбапенемов в анамнезе."}},{"type":"paragraph","data":{"text":"Выраженная гиперчувствительность(анафилактические реакции тяжелые кожные реакции) к любому антибактериальному средству имеющему бета-лактамную структуру (г.е. к пенициллинам или цефалоспоринам). Дети до 3 месяцев."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"- Одновременное назначение с нефротоксичными препаратами;"}},{"type":"paragraph","data":{"text":"- пациентам с колитами."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Применение препарата во время беременности возможно только в тех случаях когда предполагаемая польза для матери превышает потенциальный риск для плода. При необходимости применения препарата в период лактации следует решить вопрос о прекращении грудного вскармливания."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутривенно."}},{"type":"paragraph","data":{"text":"Раствор препарата меропенем вводят путем внутривенной болюсной инъекции в течение не менее 5 минут или путем внутривенной инфузии продолжительностью от 15 минут до 30 минут."}},{"type":"paragraph","data":{"text":"Способ приготовления раствора для виутривенного введения: для приготовления раствора для внутривенных болюсных инъекций препарат следует растворить стерильной водой для инъекций (5 мл на 250 мг) при этом концентрация раствора составляет 50 мг/мл. Для приготовления раствора для внутривенных инфузий препарат следует растворить 09 % раствором натрия хлорида либо 5 % раствором декстрозы при этом концентрация раствора должна составить от 1 до 20 мг/мл."}},{"type":"paragraph","data":{"text":"Доза препарата и длительность терапии устанавливаются в зависимости от тяжести инфекции и состояния пациента. Рекомендуются следующие дозы."}},{"type":"paragraph","data":{"text":"Взрослым:"}},{"type":"paragraph","data":{"text":"- при пневмонии инфекциях мочевыводящих путей инфекционно-воспалительных заболеваниях органов малого таза инфекциях кожи и мягких тканей - в/в по 500 мг каждые 8 ч;"}},{"type":"paragraph","data":{"text":">- при госпитальной пневмонии перитоните подозрении на бактериальную инфекцию у пациентов с нейтропенией септицемии - в/в по 1 г 3 раза в сутки;"}},{"type":"paragraph","data":{"text":"- при менингите - по 2 г каждые 8 ч."}},{"type":"paragraph","data":{"text":"Безопасность приема дозы 2 г в виде болюсной инъекции недостаточно изучена."}},{"type":"paragraph","data":{"text":"Меропенем выводится при гемодиализе и гемофильтрации. Если требуется продолжение лечения рекомендуется чтобы единица дозы (определяется в зависимости от типа и тяжести инфекции) вводилась по завершении процедуры гемодиализа чтобы восстановить эффективную концентрацию в плазме. Опыт применения меропенема у пациентов подвергающихся перитонеальному диализу отсутствует. У пациентов с печеночной недостаточностью нет необходимости в корректировке дозы. У пациентов пожилого возраста с нормальной функцией почек или КК более 50 мл/мин не требуется корректировать дозу."}},{"type":"paragraph","data":{"text":"Детям:"}},{"type":"paragraph","data":{"text":"- в возрасте от 3 мес. до 12 лет (с массой тела менее 50 кг.) разовая доза для в/в введения - 10-20 мг/кг каждые 8 часов;"}},{"type":"paragraph","data":{"text":"- детям с массой тела более 50 кг применяют дозы для взрослых;"}},{"type":"paragraph","data":{"text":"- при менингите - в/в 40 мг/кг каждые 8 ч."}},{"type":"paragraph","data":{"text":"Безопасность приема дозы 40 мг/кг в виде болюсной инъекции недостаточно изучена. Нет опыта применения препарата у детей с нарушениями печени и почек."}},{"type":"paragraph","data":{"text":"У пациентов с печеночной недостаточностью нет необходимости коррекции дозы."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: боли в эпигастральной области тошнота рвота диарея запор анорексия желтуха холестатический гепатит гипербилирубинемия повышение активности \"печеночных\" трансаминаз щелочной фосфатазы лактатдегидрогеназы редко - кандидоз полости рта псевдомембранозный колит."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: развитие или усугубление сердечной недостаточности остановка сердца тахи- или брадикардия снижение или повышение артериального давления обморочные состояния инфаркт миокарда тромбоэмболия ветвей легочной артерии."}},{"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 бессонница сонливость повышенная возбудимость ажитация тревожность депрессия нарушение сознания галлюцинации эпилептиформные припадки судороги."}},{"type":"paragraph","data":{"text":"Лабораторные показатели: эозинофилия нейтропения лейкопения редко - агранулоцитоз гипокалиемия лейкоцитоз обратимая тромбоцитопения снижение частичного тромбопластинового времени."}},{"type":"paragraph","data":{"text":"Местные реакции: воспаление флебит тромбофлебит болезненность в месте введения."}},{"type":"paragraph","data":{"text":"Прочие: ложноположительная прямая или непрямая пробы Кумбса анемия гиперволемия диспноэ вагинальный кандидоз."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"В случае передозировки возможной преимущественно при лечении пациентов с нарушенной функцией почек проводят симптоматическое лечение. Возможно проведение гемодиализа."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Пробенецид конкурирует с меропенемом за активную канальцевую секрецию и таким образом ингибирует почечную экскрецию меропенема вызывая увеличение его периода полувыведения и концентрации в плазме. Так как эффективность и длительность действия меропенема без пробенецида являются адекватными совместное введение пробенецида с меропенемом не рекомендуется."}},{"type":"paragraph","data":{"text":"Меропенем не должен смешиваться или добавляться к другим лекарственным препаратам."}},{"type":"paragraph","data":{"text":"Меропенем снижает плазменную концентрациювальпроевой кислоты что может привести к снижению противосудорожного эффекта."}},{"type":"paragraph","data":{"text":"Лекарственные средства блокирующие канальцевую секрецию замедляют выведение и повышают концентрацию в плазме."}},{"type":"paragraph","data":{"text":"Непрямые антикоагулянты"}},{"type":"paragraph","data":{"text":"У пациентов получающих антибактериальные препараты часто отмечалось усиление антикоагулянтного действия одновременно принимаемых непрямых антикоагулянтов включая варфарин. Риск развития данного эффекта варьирует в зависимости от вида инфекции возраста и общего состояния пациента поэтому влияние антибиотиков на повышение международного нормализованного отношения (МНО) оценить трудно. При одновременном применении антибиотиков с непрямыми антикоагулянтами и некоторое время после его прекращения рекомендуется частый мониторинг МНО."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Пациенты имеющие в анамнезе гиперчувствительность к карбапенемам пенициллинам или другим бета-лактамным антибиотикам могут проявлять гиперчувствительность к меропенему."}},{"type":"paragraph","data":{"text":"На фоне применения карбапенемов в том числе меропенема нечасто сообщалось о возникновении судорог следует соблюдать осторожность при применении препарата у пациентов со сниженным порогом судорожной готовности."}},{"type":"paragraph","data":{"text":"Лечение пациентов с заболеваниями печени должно проводиться под тщательным контролем активности \"печеночных\" трансаминаз и концентрации билирубина."}},{"type":"paragraph","data":{"text":"В процессе лечения возможно развитие устойчивости возбудителей в связи с чем длительное лечение проводят под постоянным контролем распространения резистентных штаммов. У пациентов с жалобами со стороны желудочно-кишечного тракта особенно с колитами необходимо учитывать возможность развития псевдомембранозного колита (токсин продуцируемый Clostridium difficile является одной из основных причин колитов связанных с антибиотиками) первым симптомом которого может служить развитие диареи на фоне лечения."}},{"type":"paragraph","data":{"text":"При развитии псевдомембранозного колита следует отменить препарат."}},{"type":"paragraph","data":{"text":"Противопоказано применение препаратов тормозящих перистальтику кишечника."}},{"type":"paragraph","data":{"text":"При монотерапии известной или подозреваемой инфекции нижних дыхательных путей тяжелого течения вызываемой Pseudomonas aeruginosa рекомендуется регулярное определение чувствительности возбудителя."}},{"type":"paragraph","data":{"text":"Опыта применения препарата у детей с нейтропенией с первичным или вторичным иммунодефицитом нет."}},{"type":"paragraph","data":{"text":"Имеются клинические и лабораторные признаки перекрестных аллергических реакций между другими карбапенемами и бета-лактамными антибиотиками пенициллинами и цефалоспоринами. Имеются редкие сообщения о случаях реакций гиперчувствительности (в т.ч. с фатальным исходом) при использовании препарата меропенем как и других бета-лактамных антибиотиков (см. раздел \"Побочное действие\"). Перед началом терапии меропенемом необходимо тщательно опросить пациента обратив особое внимание на реакции гиперчувствительности к бета-лактамным антибиотикам в анамнезе. Меропенем должен применяться с осторожностью у пациентов с указаниями в анамнезе на подобные явления. Если возникла аллергическая реакция на меропенем то необходимо прекратить введение препарата и принять соответствующие меры."}},{"type":"paragraph","data":{"text":"Не рекомендуется совместный прием препарата меропенем и препаратов вальпроевой кислоты. Применение препарата при инфекциях вызванных метициллин-резистентным стафилококком не рекомендуется."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В период лечения необходимо соблюдать осторожность при управлении транспортными средствами механизмами и при занятиях другими потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Порошок для приготовления раствора для внутривенного введения 05 г и 1 г."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить в сухом защищенном от света месте при температуре не выше 30 °С."}},{"type":"paragraph","data":{"text":"Хранить в местах недоступных для детей."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года."}},{"type":"paragraph","data":{"text":"Не использовать по истечении срока годности."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"М.Дж.Биофарм Пвт.Лтд"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"М.Дж.Биофарм Пвт.Лтд"}}]}],"source":null},"description_toggle":false,"short_description":"Антибиотик для парентерального применения из группы карабапенемов оказывает бактерицидное действие (подавляет синтез клеточной стенки бактерий) легко проникает через клеточную стенку бактерий устойчив к действию большинства бета-лактамаз. В отличие от имипенема практически не разрушается в почечных канальцах дегидропептидазой-1 (не нуждается в сочетании с циластатином - специфическим ингибитором дегидропептидазы-1) и соответственно не образуются нефротоксические продукты распада обладает высоким аффинитетом к белкам связывающим пенициллин. Бактерицидные и бактериостатические концентрации практически не различаются. Взаимодействует с рецепторами - специфическими пенициллинсвязывающими белками на поверхности цитоплазматической мембраны тормозит синтез пептидогликанового слоя клеточной стенки подавляет транспептидазу способствует высвобождению аутолитических ферментов клеточной стенки что в итоге вызывает ее повреждение и гибель бактерий. Спектр антибактериальной активности меропенема включает в себя большинство клинически значимых грамположительных и грамотрицательных аэробных и анаэробных штаммов бактерий: Грамположительные аэробы: Enterococcus faecalis (включая ванкомицин-уетойчивые штаммы). Staphylococcus aureus(пенициллиназонепродуцирующие и пенициллиназопроду- цирующие [метициллин-чувствительные]); Streptococcus agalactiae Streptococcus pneumoniae (только пенициллин-чувствительные); Streptococcus pyogenes. Streptococcus spp. группы viridans. Грамотрицательные аэробы: Escherichia coli Haemophilus influenzae (пенициллиназонепродуцирующие и пенициллиназопродуцирующие) Klebsiella pneumoniae Neisseria meningitidis. Pseudomonas aeruginosa Proteus mirabilis. Анаэробные бактерии: Bacteroides fragilis Bacteroides thetaiotaomicron Peptostreptococcus spp. Меропенем эффективен in vitro в отношении нижеуказанных микроорганизмов однако клинически его эффективность при заболеваниях вызываемых этими возбудителями не доказана: Грамположительные аэробы: Staphylococcus epidermidis (пенициллиназонепродуцирующие и пенициллиназопродуцирующие [метициллин-чувствительные]). Грамотрицательные аэробы: Acinetobacter spp. Aeromonas hydrophila Campylobacter jejuni Citrobac-ter diversus Citrobacter ffeundii Enterobacter cloacae Haemophilus influenzae (ампициллин-устойчивые пенициллиназонепродуцирующие штаммы) Hafnia alvei Klebsiella oxytoca Moraxella catarrhalis (пенициллиназонепродуцирующие и пенициллиназопродуцирующие) Morganella morganii Pasteurella multocida Proteus vulgaris. Salmonella spp. Serratia marcescens. Shigella spp. Yersinia enterocolitica. Анаэробные бактерии: Bacteroides distasonis Bacteroides ovatus Bacteroides uniformis Bacteroides ureolyticus Bacteroides vulgatus Clostridium difficile Clostridium perfringens Eubacterium lentum Fusobacterium spp. Prevotella bivia Prevotella intermedia Prevotella melaninogenica Porphyromonas asaccharolytica Propionibacterium acnes. При внутривенном (в/в) введении 250 мг в течение 30 мин максимальная концентрация (Cmax) - 11 мкг/мл для дозы 500 мг - 23 мкг/мл 1 г - 49 мкг/мл (абсолютной фармакокинетической пропорциональной зависимости от введенной дозы для Сmaxи AUC (площадь под фармакокинетической кривой \"концентрация- время\") нет). При увеличении дозы с 025 до 2 г клиренс уменьшается с 287 до 205 мл/мин. При в/в болюсном введении в течение 5 мин 500 мг Сmax- 52 мкг/мл 1 г -112 мкг/мл. Связь с белками плазмы - 2 %. Хорошо проникает в большинство тканей и жидкостей организма в т.ч. в цереброспинальную жидкость больных бактериальным менингитом достигая концентраций превышающих требуемые для подавления большинства бактерий (бактерицидные концентрации создаются через 05-15 ч после начала инфузии). В незначительных количествах проникает в грудное молоко. Подвергается незначительному метаболизму в печени с образованием единственного неактивного метаболита. 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