Лечение инфекций дыхательных путей, вызванных Pseudomonas aeruginosa у больных с муковисцидозом.
Противопоказания
Повышенная чувствительность к препарату Брамитоб; детский возраст до 6 лет;
Инструкция
Торговое название препарата
Брамитоб
Лекарственная форма
Раствор для ингаляций
Состав
1 мл раствора для ингаляций содержит:
действующее вещество: тобрамицин 75 мг,
вспомогательные вещества: натрия хлорид, натрия гидроксид, серная кислота, вода для инъекций.
Фармакотерапевтическая группа
После ингаляции 300 мг БРАМИТОБА больными муковисцидозом через 30 минут в мокроте достигается максимальная концентрация, равная примерно 1289 мкг/г, в то время как в плазме максимальная концентрация, равная 758 нг/мл, достигается примерно через 1,5 часа. Период полувыведения составляет 4,5 часа.
Выведение препарата, всосавшегося в кровь, происходит через почки путем клубочковой фильтрации.
Фармакологические свойства
Тобрамицин - аминогликозидный антибиотик, продуцируемый микроорганизмами рода Streptomyces tenebrarius . Основной механизм его действия - нарушение синтеза белка, что ведет к изменению проницаемости клеточной мембраны, нарастающему повреждению клеточной оболочки и последующей гибели клетки. Тобрамицин обладает бактерицидным действием в концентрациях, равных или несколько превышающих подавляющие концентрации.
Тобрамицин более активен, чем гентамицин, в отношении Pseudomonas aeruginosa и некоторых штаммов протея; около 50% штаммов Pseudomonas aeruginosa, устойчивой к гентамицину, являются чувствительными к тобрамицину.
При ингаляционном введении минимальная подавляющая концентрация (МПК) тобрамицина в мокроте больных муковисцидозом существенно выше, чем при парентеральном введении.
Показания к применению
Лечение инфекций дыхательных путей, вызванных Pseudomonas aeruginosa у больных с муковисцидозом.
Противопоказания
Повышенная чувствительность к препарату Брамитоб; детский возраст до 6 лет;
С осторожностью
Ишемическая болезнь сердца, хроническая сердечная недостаточность в стадии декомпенсации, сахарный диабет, беременность. Почечная недостаточность, нарушение слуха, дисфункция вестибулярного аппарата или нейромышечная патология, такая как паркинсонизм или другие состояния, характеризующиеся мышечной слабостью, в том числе myasthenia gravis, острое кровохарканье.
Способ применения и дозы
Ингаляционно, с использованием небулайзера. Взрослые и дети старше 6 лет:
- по одной ампуле (300 мг) два раза в сутки (утром и вечером) в течение 28 дней. Интервал между ингаляциями должен составлять около 12 часов, но не менее 6 часов.
После применения БРАМИТОБА в течение 28 дней, необходимо сделать перерыв на 28 дней, после чего, продолжить терапию в течение последующих 28 дней.
Режим дозирования не учитывает массу тела. Всем пациентам следует назначать по одной ампуле Брамитоба (300 мг тобрамицина) два раза в сутки.
Указания к правильному использованию.
Согнуть отделяемую ампулу от полоски в обоих направлениях.
Отделить ампулу от полоски, вначале верхнюю часть, затем среднюю.
Открыть ампулу, повернув ее верхнюю часть относительно корпуса в направлении, указанном стрелкой.
Умеренно нажимая на стенки, вылить лекарственный препарат в стеклянное горлышко небулайзера.
Содержимое одной ампулы (300 мг), перелитое в небулайзер, вводится путем ингаляции за 10-15 минут с помощью многоразового небулайзера PARI LC PLUS с компрессорами, которые при подсоединении к небулайзеру PARI LC Plus, обеспечивают поставку 4-6 л/мин и/или обратное давление, равное 110-217 кПа.
Ингаляции Брамитоба проводятся в положении больного сидя или стоя, при обычном дыхании через загубник небулайзера. Носовой зажим может помочь пациенту дышать ртом.
Указания по очистке и дезинфекции небулайзера.
После окончания процедуры ингаляции небулайзер следует разобрать, отдельные его части (за исключением трубки) тщательно промыть горячей водой и жидким моющим средством, прополоскать и насухо вытереть чистой сухой тряпочкой, не оставляющей волокон. Для регулярной дезинфекции небулайзера рекомендуется опустить его отдельные части (кроме трубки), очищенные в соответствии с данными выше указаниями, в раствор, состоящий из одной части 9% уксусной кислоты и трех частей горячей воды, на один час, затем промыть горячей водой и насухо вытереть чистой тряпочкой.
После завершения дезинфекции использованный раствор следует сразу же вылить.
В качестве альтернативы дезинфекцию можно проводить путем кипячения в течение 10 минут.
Побочное действие
Тошнота, рвота. сонливость. нарушение слуха. нарушение функции почек. нарушения картины крови. аллергические реакции.
Передозировка
Симптомом передозировки может быть выраженная осиплость голоса.
При случайном попадании БРАМИТОБА внутрь токсическое действие маловероятно, поскольку тобрамицин плохо всасывается из желудочно-кишечного тракта.
При случайном внутривенном введении БРАМИТОБА могут развиться симптомы и признаки передозировки тобрамицина, такие как головокружение, потеря слуха, звон в ушах, вертиго, респираторный дистресс-синдром, блокада нейромышечной проводимости и нарушение функции почек.
В случае проявления признаков передозировки БРАМИТОБ следует немедленно отменить и провести исследование показателей функции почек. Для контроля передозировки может быть полезным определение концентраций тобрамицина в сыворотке крови.
Взаимодействие с другими лекарственными средствами
Не выявлено значимого лекарственного взаимодействия БРАМИТОБА при совместном применении с муколитиками, β 2- адреномиметиками, ингаляционными кортикостероидами и другими пероральными и парентеральными антибиотиками с антипсевдомонадной активностью.
Следует избегать одновременного или последовательного применения ингаляционного тобрамицина и других потенциально нефро- или ототоксичных лекарственных препаратов. Некоторые диуретики могут усиливать токсичность аминогликозидов, изменяя концентрации антибиотика в сыворотке и тканях. Ингаляционный тобрамицин не следует назначать одновременно с этакриновой кислотой, фуросемидом, мочевиной или маннитолом.
Токсичность аминогликозидов может увеличиваться при парентеральном введении следующих препаратов: амфотерицина В, цефалотина, циклоспорина, такролимуса, полимиксинов (риск усиления нефротоксичности), препаратов платины (риск усиления нефротоксичности и ототоксичности) а так же ингибиторов холинэстеразы и ботулотоксина (нейромышечные эффекты).
Особые указания
Лечение БРАМИТОБОМ должен назначать врач, имеющий опыт ведения больных муковисцидозом. Длительность курсового лечения определяется врачом, исходя из клинической картины заболевания. В случае подтвержденного ухудшения легочных функций следует назначить дополнительную антибактериальную терапию.
Во время лечения БРАМИТОБОМ пациенту следует продолжать стандартную физиотерапию грудной клетки. Применение бронходилататоров должно продолжаться по клиническим показаниям. При использовании нескольких методов лечения дыхательных нарушений рекомендуется следующий порядок: бронходилататор, дыхательная физиотерапия, другие ингаляционные лекарственные средства и в конце - Брамитоб.
Брамитоб не следует смешивать с другими ингаляционными лекарственными средствами.
БРАМИТОБ следует применять с большой осторожностью у больных с паркинсонизмом или другими состояниями, характеризующимися мышечной слабостью, включая myasthenia gravis, поскольку аминогликозиды могут усиливать мышечную слабость из-за возможного курареподобного действия на нейромышечную проводимость.
Препарат следует применять с осторожностью у больных с доказанной или подозреваемой почечной недостаточностью, при условии мониторинга концентраций тобрамицина в сыворотке крови.
Необходимо периодически оценивать показатели функции почек (уровень мочевины и креатинина не менее одного раза в течение 6 курсов терапии БРАМИТОБОМ). При появлении признаков нефротоксичности, лечение тобрамицином следует прервать до снижения минимальных концентраций препарата в сыворотке менее 2 мкг/мл. Затем лечение БРАМИТОБОМ можно возобновить по медицинским показаниям. Пациентов, одновременно получающих парентеральную терапию другими аминогликозидами, следует тщательно наблюдать из-за возможности развития кумулятивной токсичности.
При использовании аминогликозидов возможно развитие ототоксичности (гипоакузия, системное и несистемное головокружение, атаксия).
При ингаляции возможно появление кашлевого рефлекса. Применение ингаляционного тобрамицина у больных с острым кровохарканьем должно проводиться только в том случае, если польза от лечения превышает риск провокации дальнейшего кровотечения.
У некоторых больных, получавших тобрамицин, отмечается повышение МПК аминогликозидов в отношении изученных выделенных штаммов P. aeruginosa. Возможно развитие резистентности штаммов P. aeruginosa, к внутривенно вводимому тобрамицину.
Условия хранения
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2 года
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Период полувыведения составляет 4,5 часа."}},{"type":"paragraph","data":{"text":"Выведение препарата, всосавшегося в кровь, происходит через почки путем клубочковой фильтрации.\n\n"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Тобрамицин - аминогликозидный антибиотик, продуцируемый микроорганизмами рода Streptomyces tenebrarius . Основной механизм его действия - нарушение синтеза белка, что ведет к изменению проницаемости клеточной мембраны, нарастающему повреждению клеточной оболочки и последующей гибели клетки. Тобрамицин обладает бактерицидным действием в концентрациях, равных или несколько превышающих подавляющие концентрации."}},{"type":"paragraph","data":{"text":"Тобрамицин более активен, чем гентамицин, в отношении Pseudomonas aeruginosa и некоторых штаммов протея; около 50% штаммов Pseudomonas aeruginosa, устойчивой к гентамицину, являются чувствительными к тобрамицину."}},{"type":"paragraph","data":{"text":"При ингаляционном введении минимальная подавляющая концентрация (МПК) тобрамицина в мокроте больных муковисцидозом существенно выше, чем при парентеральном введении."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Лечение инфекций дыхательных путей, вызванных Pseudomonas aeruginosa у больных с муковисцидозом."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к препарату Брамитоб; детский возраст до 6 лет;"}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Ишемическая болезнь сердца, хроническая сердечная недостаточность в стадии декомпенсации, сахарный диабет, беременность. Почечная недостаточность, нарушение слуха, дисфункция вестибулярного аппарата или нейромышечная патология, такая как паркинсонизм или другие состояния, характеризующиеся мышечной слабостью, в том числе myasthenia gravis, острое кровохарканье."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Ингаляционно, с использованием небулайзера. Взрослые и дети старше 6 лет:"}},{"type":"paragraph","data":{"text":"- по одной ампуле (300 мг) два раза в сутки (утром и вечером) в течение 28 дней. Интервал между ингаляциями должен составлять около 12 часов, но не менее 6 часов."}},{"type":"paragraph","data":{"text":"После применения БРАМИТОБА в течение 28 дней, необходимо сделать перерыв на 28 дней, после чего, продолжить терапию в течение последующих 28 дней."}},{"type":"paragraph","data":{"text":"Режим дозирования не учитывает массу тела. Всем пациентам следует назначать по одной ампуле Брамитоба (300 мг тобрамицина) два раза в сутки."}},{"type":"paragraph","data":{"text":"Указания к правильному использованию."}},{"type":"list","data":{"style":"ordered","items":["Согнуть отделяемую ампулу от полоски в обоих направлениях.","Отделить ампулу от полоски, вначале верхнюю часть, затем среднюю.","Открыть ампулу, повернув ее верхнюю часть относительно корпуса в направлении, указанном стрелкой.","Умеренно нажимая на стенки, вылить лекарственный препарат в стеклянное горлышко небулайзера."]}},{"type":"paragraph","data":{"text":"Содержимое одной ампулы (300 мг), перелитое в небулайзер, вводится путем ингаляции за 10-15 минут с помощью многоразового небулайзера PARI LC PLUS с компрессорами, которые при подсоединении к небулайзеру PARI LC Plus, обеспечивают поставку 4-6 л/мин и/или обратное давление, равное 110-217 кПа."}},{"type":"paragraph","data":{"text":"Ингаляции Брамитоба проводятся в положении больного сидя или стоя, при обычном дыхании через загубник небулайзера. Носовой зажим может помочь пациенту дышать ртом."}},{"type":"paragraph","data":{"text":"Указания по очистке и дезинфекции небулайзера."}},{"type":"paragraph","data":{"text":"После окончания процедуры ингаляции небулайзер следует разобрать, отдельные его части (за исключением трубки) тщательно промыть горячей водой и жидким моющим средством, прополоскать и насухо вытереть чистой сухой тряпочкой, не оставляющей волокон. Для регулярной дезинфекции небулайзера рекомендуется опустить его отдельные части (кроме трубки), очищенные в соответствии с данными выше указаниями, в раствор, состоящий из одной части 9% уксусной кислоты и трех частей горячей воды, на один час, затем промыть горячей водой и насухо вытереть чистой тряпочкой."}},{"type":"paragraph","data":{"text":"После завершения дезинфекции использованный раствор следует сразу же вылить."}},{"type":"paragraph","data":{"text":"В качестве альтернативы дезинфекцию можно проводить путем кипячения в течение 10 минут."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Тошнота, рвота. сонливость. нарушение слуха. нарушение функции почек. нарушения картины крови. аллергические реакции."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\n\nСимптомом передозировки может быть выраженная осиплость голоса."}},{"type":"paragraph","data":{"text":"При случайном попадании БРАМИТОБА внутрь токсическое действие маловероятно, поскольку тобрамицин плохо всасывается из желудочно-кишечного тракта."}},{"type":"paragraph","data":{"text":"При случайном внутривенном введении БРАМИТОБА могут развиться симптомы и признаки передозировки тобрамицина, такие как головокружение, потеря слуха, звон в ушах, вертиго, респираторный дистресс-синдром, блокада нейромышечной проводимости и нарушение функции почек."}},{"type":"paragraph","data":{"text":"В случае проявления признаков передозировки БРАМИТОБ следует немедленно отменить и провести исследование показателей функции почек. Для контроля передозировки может быть полезным определение концентраций тобрамицина в сыворотке крови.\n\n"}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"\n\nНе выявлено значимого лекарственного взаимодействия БРАМИТОБА при совместном применении с муколитиками, β 2- адреномиметиками, ингаляционными кортикостероидами и другими пероральными и парентеральными антибиотиками с антипсевдомонадной активностью."}},{"type":"paragraph","data":{"text":"Следует избегать одновременного или последовательного применения ингаляционного тобрамицина и других потенциально нефро- или ототоксичных лекарственных препаратов. Некоторые диуретики могут усиливать токсичность аминогликозидов, изменяя концентрации антибиотика в сыворотке и тканях. Ингаляционный тобрамицин не следует назначать одновременно с этакриновой кислотой, фуросемидом, мочевиной или маннитолом."}},{"type":"paragraph","data":{"text":"Токсичность аминогликозидов может увеличиваться при парентеральном введении следующих препаратов: амфотерицина В, цефалотина, циклоспорина, такролимуса, полимиксинов (риск усиления нефротоксичности), препаратов платины (риск усиления нефротоксичности и ототоксичности) а так же ингибиторов холинэстеразы и ботулотоксина (нейромышечные эффекты).\n\n"}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Лечение БРАМИТОБОМ должен назначать врач, имеющий опыт ведения больных муковисцидозом. Длительность курсового лечения определяется врачом, исходя из клинической картины заболевания. В случае подтвержденного ухудшения легочных функций следует назначить дополнительную антибактериальную терапию."}},{"type":"paragraph","data":{"text":"Во время лечения БРАМИТОБОМ пациенту следует продолжать стандартную физиотерапию грудной клетки. Применение бронходилататоров должно продолжаться по клиническим показаниям. При использовании нескольких методов лечения дыхательных нарушений рекомендуется следующий порядок: бронходилататор, дыхательная физиотерапия, другие ингаляционные лекарственные средства и в конце - Брамитоб."}},{"type":"paragraph","data":{"text":"Брамитоб не следует смешивать с другими ингаляционными лекарственными средствами."}},{"type":"paragraph","data":{"text":"БРАМИТОБ следует применять с большой осторожностью у больных с паркинсонизмом или другими состояниями, характеризующимися мышечной слабостью, включая myasthenia gravis, поскольку аминогликозиды могут усиливать мышечную слабость из-за возможного курареподобного действия на нейромышечную проводимость."}},{"type":"paragraph","data":{"text":"Препарат следует применять с осторожностью у больных с доказанной или подозреваемой почечной недостаточностью, при условии мониторинга концентраций тобрамицина в сыворотке крови."}},{"type":"paragraph","data":{"text":"Необходимо периодически оценивать показатели функции почек (уровень мочевины и креатинина не менее одного раза в течение 6 курсов терапии БРАМИТОБОМ). При появлении признаков нефротоксичности, лечение тобрамицином следует прервать до снижения минимальных концентраций препарата в сыворотке менее 2 мкг/мл. Затем лечение БРАМИТОБОМ можно возобновить по медицинским показаниям. Пациентов, одновременно получающих парентеральную терапию другими аминогликозидами, следует тщательно наблюдать из-за возможности развития кумулятивной токсичности."}},{"type":"paragraph","data":{"text":"При использовании аминогликозидов возможно развитие ототоксичности (гипоакузия, системное и несистемное головокружение, атаксия)."}},{"type":"paragraph","data":{"text":"При ингаляции возможно появление кашлевого рефлекса. Применение ингаляционного тобрамицина у больных с острым кровохарканьем должно проводиться только в том случае, если польза от лечения превышает риск провокации дальнейшего кровотечения."}},{"type":"paragraph","data":{"text":"У некоторых больных, получавших тобрамицин, отмечается повышение МПК аминогликозидов в отношении изученных выделенных штаммов P. aeruginosa. Возможно развитие резистентности штаммов P. aeruginosa, к внутривенно вводимому тобрамицину."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"При температуре + 2-8°С, в оригинальной упаковке для защиты от света, вдали от нагревательных приборов. Не замораживать. 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