Гиперчувствительность в том числе и к другим пенициллинам цефалоспоринам.
Инструкция
Регистрационный номер
Р N003931/01
Торговое название препарата
Бензилпенициллина натриевая соль
Лекарственная форма
порошок для приготовления раствора для внутримышечного и подкожного введения
Состав
Активное вещество: Бензилпенициллин натрия (бензилпенициллина натриевая соль) - 500000 ЕД и 1000000 ЕД.
Описание
Белый порошок.
Фармакотерапевтическая группа
Антибиотик - пенициллин биосинтетический
Фармакологические свойства
Фармакодинамика:
Бактерицидный антибиотик из группы биосинтетических ("природных") пенициллинов. Подавляет синтез клеточной стенки микроорганизмов.
Активен в отношении грамположительных возбудителей: Staphylococcus spp. (необразующие пенициллиназу) Streptococcus spp. (в т.ч. Streptococcus pneumoniae) Corynebacterium spp. (в т.ч. Corynebacterium diphtheriae) Bacillus anthracis Actinomyces spp.; грамотрицательных микроорганизмов: Neisseria gonorrhoeae Neisseria meningitidis а также в отношении Treponema spp. класса Spirochaetes.
Heактивен в отношении большинства грамотрицательных бактерий (в т.ч. Pseudomonas aeruginosa) Rickettsia spp. простейших. К действию препарата устойчивы Staphylococcus spp. продуцирующие пенициллиназу.
Фармакокинетика:
Время необходимое для достижения максимальной концентрации в плазме крови при внутримышечном введении - 20-30 мин. Связь с белками плазмы - 60%. Проникает в органы ткани и биологические жидкости кроме ликвора тканей глаза и предстательной железы при воспалении менингеальных оболочек проникает через гематоэнцефалический барьер. Выводится почками в неизмененном виде. Период полувыведения 30-60 мин при почечной недостаточности - 4-10 ч и более.
Внутримышечно: при среднетяжелом течении заболевания (инфекции верхних и нижних дыхательных путей мочевыводящих и желчевыводящих путей инфекция мягких тканей и др.) - 4-6 млн. ЕД/сут за 4 введения.
Суточная доза для детей в возрасте до 1 года - 50-100 тыс. ЕД/кг старше 1 года - 50 тыс. ЕД/кг; при необходимости - 200-300 тыс. ЕД/кг по "жизненным" показаниям - увеличение до 500 тыс. ЕД /кг. Кратность введения - 4-6 раз в сутки.
Подкожно для обкалывания инфильтратов в концентрации 100-200 тыс. ЕД в 1 мл 025-05% раствора прокаина.
Длительность лечения бензилпенициллином в зависимости от формы и тяжести течения заболевания - 7-10 дней.
Способ приготовления растворов
Растворы используют сразу после приготовления не допуская добавления к ним других лекарственных средств.
Для внутримышечных инъекций к содержимому флакона добавляют 1-3 мл воды для инъекций 09% раствора натрия хлорида или 05% раствора прокаина (новокаина). Полученный раствор вводят глубоко в мышцу.
При разведении бензилпенициллина в растворе прокаина может наблюдаться помутнение раствора вследствие образования кристаллов бензилпенициллин прокаина что не является препятствием для внутримышечного и подкожного введения препарата.
Для подкожного введения содержимое флакона разводят в 025-05% раствора прокаина: 500 тыс. ЕД в 25-5 мл 1 млн. ЕД в 5-10 мл соответственно.
Побочное действие
Аллергические реакции: гипертермия крапивница кожная сыпь сыпь на слизистых оболочках артралгия эозинофилия ангионевротический отек интерстициальный нефрит бронхоспазм анафилактический шок. В начале курса лечения (особенно при лечении врожденного сифилиса) - лихорадка озноб повышенное потоотделение обострение заболевания реакция Яриша-Герксгеймера.
Со стороны сердечно-сосудистой системы: нарушение насосной функции миокарда аритмии остановка сердца хроническая сердечная недостаточность (т.к. при введении больших доз может возникнуть гипернатриемия).
Местные реакции: болезненность и уплотнение в месте внутримышечного введения.
При длительном применении: дисбактериоз развитие суперинфекции.
Если любые из указанных в инструкции побочных эффектов усугубляются или Вы заметили любые другие побочные эффекты не указанные в инструкции сообщите об этом врачу.
Передозировка
Проявляется токсическим действием на центральную нервную систему (судороги головная боль миалгия артралгия).
Лечение симптоматическое.
Взаимодействие с другими лекарственными средствами
Бактерицидные антибиотики (в т.ч. цефалоспорины ванкомицин рифампицин аминогликозиды) оказывают синергидное действие; бактериостатические (в т.ч. макролиды хлорамфеникол линкозамиды тетрациклины) - антагонистическое.
Повышает эффективность непрямых антикоагулянтов (подавляя кишечную микрофлору снижает протромбиновый индекс); снижает эффективность пероральных контрацептивов лекарственных средств в процессе метаболизма которых образуется парааминобензойная кислота.
Аллопуринол повышает риск развития аллергических реакций (кожной сыпи).
Особые указания
Растворы препарата готовят непосредственно перед введением.
Если через 2-3 дня (максимум 5 дней) после начала применения препарата эффекта не отмечается следует перейти к применению других антибиотиков или комбинированной терапии.
В связи с возможностью развития грибковых поражений целесообразно при длительном лечении бензилпенициллином назначать витамины группы В а при необходимости - противогрибковые препараты.
Необходимо учитывать что применение недостаточных доз препарата или слишком раннее прекращение лечения часто приводит к появлению резистентных штаммов возбудителей.
Влияние на способность управлять автомобилем и движущимися механизмами
Во время ведения препарата следует соблюдать осторожность при управлении транспортными средствами механизмами и при выполнении других потенциально опасных видов деятельности требующих повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Порошок для приготовления раствора для внутримышечного и подкожного введения 500000 ЕД и 1000000 ЕД.
Условия хранения
В сухом месте при температуре от 15 до 25 °С.
Хранить в местах недоступных для детей.
Срок годности
3 года.
Не использовать по истечению срока годности указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Открытое акционерное общество "Акционерное Курганское общество медицинских препаратов и изделий "Синтез" (ОАО "Синтез"), 640008, Курганская обл., г. Курган, проспект Конституции, д. 7, Россия
Организация, принимающая претензии потребителей
ОАО "Синтез"
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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Подавляет синтез клеточной стенки микроорганизмов."}},{"type":"paragraph","data":{"text":"Активен в отношении грамположительных возбудителей: Staphylococcus spp. (необразующие пенициллиназу) Streptococcus spp. (в т.ч. Streptococcus pneumoniae) Corynebacterium spp. (в т.ч. Corynebacterium diphtheriae) Bacillus anthracis Actinomyces spp.; грамотрицательных микроорганизмов: Neisseria gonorrhoeae Neisseria meningitidis а также в отношении Treponema spp. класса Spirochaetes."}},{"type":"paragraph","data":{"text":"Heактивен в отношении большинства грамотрицательных бактерий (в т.ч. Pseudomonas aeruginosa) Rickettsia spp. простейших. К действию препарата устойчивы Staphylococcus spp. продуцирующие пенициллиназу."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"Время необходимое для достижения максимальной концентрации в плазме крови при внутримышечном введении - 20-30 мин. Связь с белками плазмы - 60%. Проникает в органы ткани и биологические жидкости кроме ликвора тканей глаза и предстательной железы при воспалении менингеальных оболочек проникает через гематоэнцефалический барьер. Выводится почками в неизмененном виде. Период полувыведения 30-60 мин при почечной недостаточности - 4-10 ч и более."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Бактериальные инфекции вызванные чувствительными к пенициллину возбудителями: внебольничная пневмония эмпиема плевры бронхит; перитонит; остеомиелит; инфекции мочеполовой системы (пиелонефрит пиелит цистит уретрит цервицит) желчевыводящих путей (холангит холецистит); раневая инфекция инфекции кожи и мягких тканей: рожа импетиго вторично инфицированные дерматозы; дифтерия; скарлатина; сибирская язва; актиномикоз; инфекции ЛОР-органов; гонорея сифилис."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность в том числе и к другим пенициллинам цефалоспоринам."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Беременность аллергические заболевания (бронхиальная астма поллиноз) почечная недостаточность."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Применение препарата в период беременности возможно только в том случае когда предполагаемая польза для матери превышает потенциальный риск для плода."}},{"type":"paragraph","data":{"text":"При необходимости назначения препарата в период лактации следует прекратить грудное вскармливание."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Бензилпенициллина натриевую соль вводят внутримышечно подкожно."}},{"type":"paragraph","data":{"text":"Внутримышечно: при среднетяжелом течении заболевания (инфекции верхних и нижних дыхательных путей мочевыводящих и желчевыводящих путей инфекция мягких тканей и др.) - 4-6 млн. 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В начале курса лечения (особенно при лечении врожденного сифилиса) - лихорадка озноб повышенное потоотделение обострение заболевания реакция Яриша-Герксгеймера."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: нарушение насосной функции миокарда аритмии остановка сердца хроническая сердечная недостаточность (т.к. при введении больших доз может возникнуть гипернатриемия)."}},{"type":"paragraph","data":{"text":"Местные реакции: болезненность и уплотнение в месте внутримышечного введения."}},{"type":"paragraph","data":{"text":"При длительном применении: дисбактериоз развитие суперинфекции."}},{"type":"paragraph","data":{"text":"Если любые из указанных в инструкции побочных эффектов усугубляются или Вы заметили любые другие побочные эффекты не указанные в инструкции сообщите об этом врачу."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Проявляется токсическим действием на центральную нервную систему (судороги головная боль миалгия артралгия)."}},{"type":"paragraph","data":{"text":"Лечение симптоматическое."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Бактерицидные антибиотики (в т.ч. цефалоспорины ванкомицин рифампицин аминогликозиды) оказывают синергидное действие; бактериостатические (в т.ч. макролиды хлорамфеникол линкозамиды тетрациклины) - антагонистическое."}},{"type":"paragraph","data":{"text":"Повышает эффективность непрямых антикоагулянтов (подавляя кишечную микрофлору снижает протромбиновый индекс); снижает эффективность пероральных контрацептивов лекарственных средств в процессе метаболизма которых образуется парааминобензойная кислота."}},{"type":"paragraph","data":{"text":"Диуретики аллопуринол блокаторы канальцевой секреции фенилбутазон нестероидные противовоспалительные препараты снижая канальцевую секрецию повышают концентрацию бензилпенициллина."}},{"type":"paragraph","data":{"text":"Аллопуринол повышает риск развития аллергических реакций (кожной сыпи)."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Растворы препарата готовят непосредственно перед введением."}},{"type":"paragraph","data":{"text":"Если через 2-3 дня (максимум 5 дней) после начала применения препарата эффекта не отмечается следует перейти к применению других антибиотиков или комбинированной терапии."}},{"type":"paragraph","data":{"text":"В связи с возможностью развития грибковых поражений целесообразно при длительном лечении бензилпенициллином назначать витамины группы В а при необходимости - противогрибковые препараты."}},{"type":"paragraph","data":{"text":"Необходимо учитывать что применение недостаточных доз препарата или слишком раннее прекращение лечения часто приводит к появлению резистентных штаммов возбудителей."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Во время ведения препарата следует соблюдать осторожность при управлении транспортными средствами механизмами и при выполнении других потенциально опасных видов деятельности требующих повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Порошок для приготовления раствора для внутримышечного и подкожного введения 500000 ЕД и 1000000 ЕД."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В сухом месте при температуре от 15 до 25 °С."}},{"type":"paragraph","data":{"text":"Хранить в местах недоступных для детей."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}},{"type":"paragraph","data":{"text":"Не использовать по истечению срока годности указанного на упаковке."}}]},{"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":"Открытое акционерное общество \"Акционерное Курганское общество медицинских препаратов и изделий \"Синтез\" (ОАО \"Синтез\"), 640008, Курганская обл., г. 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