Тяжелые инфекции вызванные чувствительными к полимиксину В грамотрицательными микроорганизмами с множественной устойчивостью к другим антибиотикам: сепсис менингит (вводится интратекально) пневмония генерализованная раневая инфекция.
Противопоказания
Повышенная чувствительность к полимиксинам миастения.
Инструкция
Лекарственная форма
лиофилизат для приготовления раствора для инъекций
Состав
активное вещество: полимиксина В сульфата в пересчете на сумму полимиксинов Bl, В2, В3, В1-I - 25 мг/50 мг.
Описание
Порошок белого или почти белого цвета, без запаха или со слабым запахом.
Восстановленный раствор: жидкость от бесцветного до желто-коричневого цвета, не содержит нерастворенных частиц порошка.
Фармакотерапевтическая группа
Антибиотик-полипептид циклический
Фармакологические свойства
Антибиотик продуцируемый спорообразующими бактериями Bacillus polymyxa. Каждый мг очищенного полимиксина В основания эквивалентен 10000 ЕД полимиксина В. Оказывает бактерицидное действие связанное с нарушением целостности мембраны микробной клетки. Адсорбируется на фосфолипидах мембраны увеличивает ее проницаемость вызывает лизис бактерий.
Активен в отношении большинства грамотрицательных бактерий в т.ч. Pseudomonas aeruginosa Salmonella spp. Shigella spp. Escherichia coli Klebsiella spp. Bordetella pertussis Haemophilus influenzae Enterobacter spp. Умеренно чувствительны Fusobacterium spp. и Bacteroides spp. (в т.ч. Bacteroides fragilis).
He действуетна кокковые аэробные (Staphylococcus spp. Streptococcus spp. (в т.ч. Streptococcus pneumoniae) Neisseria gonorrhoeae Neisseria meningitidis) и анаэробные микроорганизмы Corynebacterium diphtheriae на большинство штаммов Proteus spp. Mycobacterium tuberculosis и грибы. Устойчивость развивается медленно но является перекрестной с колистином и полимиксином Е.
Показания к применению
Тяжелые инфекции вызванные чувствительными к полимиксину В грамотрицательными микроорганизмами с множественной устойчивостью к другим антибиотикам: сепсис менингит (вводится интратекально) пневмония генерализованная раневая инфекция.
Противопоказания
Повышенная чувствительность к полимиксинам миастения.
С осторожностью
Хроническая почечная недостаточность
Применение при беременности и в период грудного вскармливания
Полимиксин В противопоказан при беременности.
При необходимости применения препарата в период лактации следует отказаться от грудного вскармливания.
Способ применения и дозы
Внутривенное введение:
- для взрослых и детей (старше 1 года) с нормальной функцией почек суточная доза 15-25 мг/кг (принимая во внимание что 1 мг очищенного полимиксина В основания эквивалентен 10000 ЕД полимиксина В) в 2 введения с интервалом 12 часов. Максимальная суточная доза не должна превышать 25 мг/кг4
- у детей младше 1 года с нормальной функцией почек при необходимости суточная доза может быть увеличена до 4 мг/кг которую делят на 2 введения и вводят с интервалом 12 часов.
Для приготовления раствора для внутривенного введения взрослым 50 мг препарата растворяют в 300-500 мл 5% раствора декстрозы и вводят капельно со скоростью 60-80 кап/мин. У детей дозу препарата предназначенную для внутривенного введения растворяют в 30-100 мл 5-10% раствора декстрозы.
Внутримышечное введение (только при невозможности внутривенного введения):
- для взрослых и детей (старше 1 года) с нормальной функцией почек суточная доза - 25-3 мг/кг в 3-4 введения каждые 6-8 часов;
- у детей до 1 года с нормальной функцией почек при необходимости суточная доза может быть увеличена до 4 мг/кг которую делят на 4 введения и вводят с интервалом 6 часов.
Для приготовления раствора для внутримышечного введения 50 мг препарата растворяют в 2 мл 1% раствора прокаина воды для инъекций или 09% раствора натрия хлорида.
Интратекальное введение (является терапией выбора при менингите вызванном Pseudomonas aeruginosa):
- взрослым и детям (старше 2 лет): 5 мг 1 раз в сутки в течение 3-4 дней затем через день еще в течение 2 недель после получения отрицательного результата бактериологического посева и нормализации концентрации глюкозы в спинномозговой жидкости;
- детям до 2 лет: 2 мг 1 раз в сутки в течение 3-4 дней или по 25 мг 1 раз в 2 дня. Затем в дозе 25 мг через день еще в течение 2 недель после получения отрицательного результата бактериологического посева и нормализации концентрации глюкозы в спинномозговой жидкости.
Перед введением препарат (50 мг) растворяют в 10 мл 09% раствора натрия хлорида (концентрация приготовленного раствора 5 мг/мл).
У пациентов с нарушением функции почек дозу препарата уменьшают и увеличивают интервал между введениями в соответствии с клиренсом креатинина (при клиренсе креатинина 20-50 мл/мин применяют 75-100% от дозы при нормальной функции почек с интервалом между введениями 12 часов; при клиренсе креатинина 5-20 мл/мин применяют 50% от дозы при нормальной функции почек с интервалом между введениями 12 часов; при клиренсе креатинина менее 5 мл/мин применяют 15% от дозы при нормальной функции почек с интервалом между введениями 12 часов).
Побочное действие
Со стороны нервной системы: головокружение атаксия нарушение сознания сонливость парестезии нервно-мышечная блокада.
Со стороны мочевыделительной системы: альбуминурия цилиндрурия азотемия протеинурия почечный тубулярный некроз.
Со стороны дыхательной системы: паралич дыхательной мускулатуры апноэ.
Со стороны пищеварительной системы: боль в эпигастральной области тошнота снижение аппетита; псевдомембранозный колит.
Со стороны органов чувств: нарушение зрения.
Аллергические реакции: кожная сыпь зуд эозинофилия.
Местные реакции: флебит перифлебит тромбофлебит болезненность в месте в/м инъекции.
Прочие: суперинфекция кандидоз при интратекальном введении - менингеальные симптомы (покраснение лица головная боль лихорадка ригидность затылочных мышц увеличение количества клеток и белка в спинномозговой жидкости).
Лечение: поддерживающая и симптоматическая терапия.
Взаимодействие с другими лекарственными средствами
Одновременное применение с недеполяризующими миорелаксантами (угроза развития паралича дыхательных мышц) и другими нейротоксичными препаратамине рекомендуется.
При одновременном использовании наблюдается синергизм действия с хлорамфениколом карбенициллином тетрациклином сульфаниламидами и триметопримом в отношении Pseudomonas aeruginosa Proteus spp. Serratia spp.; с ампициллином - в отношении большинства грамотрицательных бактерий.
При сочетании с аминогликозидами (канамицином стрептомицином неомицином гентамицином) повышается риск развития ото- и нефротоксичности а также блокады нервно-мышечной передачи. Повышает нефротоксичность амфотерицина В.
Фармацевтически несовместим с натриевой солью ампициллина хлорамфениколом антибиотиками группы цефалоспоринов тетрациклином растворами аминокислот гепарином; их не следует смешивать в одном шприце или инфузионной среде.
Особые указания
При инфекциях вызванных грамотрицательными микроорганизмами (Enterobacter spp. Pseudomonas aeruginosa и др.) назначают только при устойчивости возбудителя к другим менее токсичным препаратам.
При длительном лечении необходимо контролировать функцию почек 1 раз в 2 дня.
Парентерально применяют только в условиях стационара.
Внутримышечные инъекции болезненны поэтому для приготовления раствора для в/м введения рекомендуется использовать местный анестетик (1% раствор прокаина).
Псевдомембранозный колит вызываемый Clostridium difficile может появляться как на фоне длительного применения так и через 2-3 недели после прекращения лечения; проявляется диареей лейкоцитозом лихорадкой болями в животе (иногда сопровождающимися выделением с каловыми массами крови и слизи). При возникновении этих явлений в легких случаях достаточно отмены лечения и применения ионообменных смол (колестирамин колестипол) в тяжелых случаях показано возмещение потери жидкости электролитов и белка назначение ванкомицина или метронидазола. Нельзя применять лекарственные средства тормозящие перистальтику кишечника.
Проявлениями побочного действия полимиксина В могут быть нарушения функции почек (нефротоксичность) и нервной системы (нейротоксичность) риск развития которых выше у пациентов с хронической почечной недостаточностью и/или при одновременном применении с другими лекарственными препаратами обладающими нейротоксическими и/или нефротоксическими свойствами.
Веллобактин-В® следует применять с осторожностью при хронической почечной недостаточности.
Следует избегать одновременного применения препарата Веллобактин-В® с другими нейро- и нефротоксичными препаратами.
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Каждый мг очищенного полимиксина В основания эквивалентен 10000 ЕД полимиксина В. Оказывает бактерицидное действие связанное с нарушением целостности мембраны микробной клетки. Адсорбируется на фосфолипидах мембраны увеличивает ее проницаемость вызывает лизис бактерий."}},{"type":"paragraph","data":{"text":"Активен в отношении большинства грамотрицательных бактерий в т.ч. Pseudomonas aeruginosa Salmonella spp. Shigella spp. Escherichia coli Klebsiella spp. Bordetella pertussis Haemophilus influenzae Enterobacter spp. Умеренно чувствительны Fusobacterium spp. и Bacteroides spp. (в т.ч. Bacteroides fragilis)."}},{"type":"paragraph","data":{"text":"He действуетна кокковые аэробные (Staphylococcus spp. Streptococcus spp. (в т.ч. Streptococcus pneumoniae) Neisseria gonorrhoeae Neisseria meningitidis) и анаэробные микроорганизмы Corynebacterium diphtheriae на большинство штаммов Proteus spp. Mycobacterium tuberculosis и грибы. Устойчивость развивается медленно но является перекрестной с колистином и полимиксином Е."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Тяжелые инфекции вызванные чувствительными к полимиксину В грамотрицательными микроорганизмами с множественной устойчивостью к другим антибиотикам: сепсис менингит (вводится интратекально) пневмония генерализованная раневая инфекция."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к полимиксинам миастения."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Хроническая почечная недостаточность"}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Полимиксин В противопоказан при беременности."}},{"type":"paragraph","data":{"text":"При необходимости применения препарата в период лактации следует отказаться от грудного вскармливания."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутривенное введение:"}},{"type":"paragraph","data":{"text":"- для взрослых и детей (старше 1 года) с нормальной функцией почек суточная доза 15-25 мг/кг (принимая во внимание что 1 мг очищенного полимиксина В основания эквивалентен 10000 ЕД полимиксина В) в 2 введения с интервалом 12 часов. Максимальная суточная доза не должна превышать 25 мг/кг4"}},{"type":"paragraph","data":{"text":"- у детей младше 1 года с нормальной функцией почек при необходимости суточная доза может быть увеличена до 4 мг/кг которую делят на 2 введения и вводят с интервалом 12 часов."}},{"type":"paragraph","data":{"text":"Для приготовления раствора для внутривенного введения взрослым 50 мг препарата растворяют в 300-500 мл 5% раствора декстрозы и вводят капельно со скоростью 60-80 кап/мин. У детей дозу препарата предназначенную для внутривенного введения растворяют в 30-100 мл 5-10% раствора декстрозы."}},{"type":"paragraph","data":{"text":"Внутримышечное введение (только при невозможности внутривенного введения):"}},{"type":"paragraph","data":{"text":"- для взрослых и детей (старше 1 года) с нормальной функцией почек суточная доза - 25-3 мг/кг в 3-4 введения каждые 6-8 часов;"}},{"type":"paragraph","data":{"text":"- у детей до 1 года с нормальной функцией почек при необходимости суточная доза может быть увеличена до 4 мг/кг которую делят на 4 введения и вводят с интервалом 6 часов."}},{"type":"paragraph","data":{"text":"Для приготовления раствора для внутримышечного введения 50 мг препарата растворяют в 2 мл 1% раствора прокаина воды для инъекций или 09% раствора натрия хлорида."}},{"type":"paragraph","data":{"text":"Интратекальное введение (является терапией выбора при менингите вызванном Pseudomonas aeruginosa):"}},{"type":"paragraph","data":{"text":"- взрослым и детям (старше 2 лет): 5 мг 1 раз в сутки в течение 3-4 дней затем через день еще в течение 2 недель после получения отрицательного результата бактериологического посева и нормализации концентрации глюкозы в спинномозговой жидкости;"}},{"type":"paragraph","data":{"text":"- детям до 2 лет: 2 мг 1 раз в сутки в течение 3-4 дней или по 25 мг 1 раз в 2 дня. Затем в дозе 25 мг через день еще в течение 2 недель после получения отрицательного результата бактериологического посева и нормализации концентрации глюкозы в спинномозговой жидкости."}},{"type":"paragraph","data":{"text":"Перед введением препарат (50 мг) растворяют в 10 мл 09% раствора натрия хлорида (концентрация приготовленного раствора 5 мг/мл)."}},{"type":"paragraph","data":{"text":"У пациентов с нарушением функции почек дозу препарата уменьшают и увеличивают интервал между введениями в соответствии с клиренсом креатинина (при клиренсе креатинина 20-50 мл/мин применяют 75-100% от дозы при нормальной функции почек с интервалом между введениями 12 часов; при клиренсе креатинина 5-20 мл/мин применяют 50% от дозы при нормальной функции почек с интервалом между введениями 12 часов; при клиренсе креатинина менее 5 мл/мин применяют 15% от дозы при нормальной функции почек с интервалом между введениями 12 часов)."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны нервной системы: головокружение атаксия нарушение сознания сонливость парестезии нервно-мышечная блокада."}},{"type":"paragraph","data":{"text":"Со стороны мочевыделительной системы: альбуминурия цилиндрурия азотемия протеинурия почечный тубулярный некроз."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: паралич дыхательной мускулатуры апноэ."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: боль в эпигастральной области тошнота снижение аппетита; псевдомембранозный колит."}},{"type":"paragraph","data":{"text":"Со стороны органов чувств: нарушение зрения."}},{"type":"paragraph","data":{"text":"Аллергические реакции: кожная сыпь зуд эозинофилия."}},{"type":"paragraph","data":{"text":"Местные реакции: флебит перифлебит тромбофлебит болезненность в месте в/м инъекции."}},{"type":"paragraph","data":{"text":"Прочие: суперинфекция кандидоз при интратекальном введении - менингеальные симптомы (покраснение лица головная боль лихорадка ригидность затылочных мышц увеличение количества клеток и белка в спинномозговой жидкости)."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы: паралич дыхательных мышц ототоксичность нефротоксичность."}},{"type":"paragraph","data":{"text":"Лечение: поддерживающая и симптоматическая терапия."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Одновременное применение с недеполяризующими миорелаксантами (угроза развития паралича дыхательных мышц) и другими нейротоксичными препаратамине рекомендуется."}},{"type":"paragraph","data":{"text":"При одновременном использовании наблюдается синергизм действия с хлорамфениколом карбенициллином тетрациклином сульфаниламидами и триметопримом в отношении Pseudomonas aeruginosa Proteus spp. Serratia spp.; с ампициллином - в отношении большинства грамотрицательных бактерий."}},{"type":"paragraph","data":{"text":"При сочетании с аминогликозидами (канамицином стрептомицином неомицином гентамицином) повышается риск развития ото- и нефротоксичности а также блокады нервно-мышечной передачи. Повышает нефротоксичность амфотерицина В."}},{"type":"paragraph","data":{"text":"Фармацевтически несовместим с натриевой солью ампициллина хлорамфениколом антибиотиками группы цефалоспоринов тетрациклином растворами аминокислот гепарином; их не следует смешивать в одном шприце или инфузионной среде."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"При инфекциях вызванных грамотрицательными микроорганизмами (Enterobacter spp. Pseudomonas aeruginosa и др.) назначают только при устойчивости возбудителя к другим менее токсичным препаратам."}},{"type":"paragraph","data":{"text":"При длительном лечении необходимо контролировать функцию почек 1 раз в 2 дня."}},{"type":"paragraph","data":{"text":"Парентерально применяют только в условиях стационара."}},{"type":"paragraph","data":{"text":"Внутримышечные инъекции болезненны поэтому для приготовления раствора для в/м введения рекомендуется использовать местный анестетик (1% раствор прокаина)."}},{"type":"paragraph","data":{"text":"Псевдомембранозный колит вызываемый Clostridium difficile может появляться как на фоне длительного применения так и через 2-3 недели после прекращения лечения; проявляется диареей лейкоцитозом лихорадкой болями в животе (иногда сопровождающимися выделением с каловыми массами крови и слизи). При возникновении этих явлений в легких случаях достаточно отмены лечения и применения ионообменных смол (колестирамин колестипол) в тяжелых случаях показано возмещение потери жидкости электролитов и белка назначение ванкомицина или метронидазола. Нельзя применять лекарственные средства тормозящие перистальтику кишечника."}},{"type":"paragraph","data":{"text":"Проявлениями побочного действия полимиксина В могут быть нарушения функции почек (нефротоксичность) и нервной системы (нейротоксичность) риск развития которых выше у пациентов с хронической почечной недостаточностью и/или при одновременном применении с другими лекарственными препаратами обладающими нейротоксическими и/или нефротоксическими свойствами."}},{"type":"paragraph","data":{"text":"Веллобактин-В® следует применять с осторожностью при хронической почечной недостаточности."}},{"type":"paragraph","data":{"text":"Следует избегать одновременного применения препарата Веллобактин-В® с другими нейро- и нефротоксичными препаратами."}}]}],"source":null},"description_toggle":false,"short_description":"Антибиотик продуцируемый спорообразующими бактериями Bacillus polymyxa. Каждый мг очищенного полимиксина В основания эквивалентен 10000 ЕД полимиксина В. 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