Лечение инфекций переднего отдела глаза вызванных чувствительными к левофлоксацину микроорганизмами.
Противопоказания
Гиперчувствительность к компонентам препарата; беременность период лактации детский возраст до 1 года.
Инструкция
Регистрационный номер
ЛСР-008567/10 от 23.08.10
Торговое название препарата
Левофлоксацин
Лекарственная форма
капли глазные
Состав
Состав на 1 мл:
активное вещество: левофлоксацина гемигидрат (в пересчете на левофлоксацин) - 5 мг;
вспомогательные вещества: бензалкония хлорид - 0,04 мг, натрия хлорид - 9 мг, динатрия эдетат - 0,1 мг, хлористоводородной кислоты раствор 1 М - до pH 6,4, вода для инъекций - до 1 мл.
Описание
Прозрачная желтовато-зеленого цвета жидкость.
Фармакотерапевтическая группа
Противомикробное средство - фторхинолон
Фармакологические свойства
Фармакодинамика:
Противомикробный препарат из группы фторхинолонов левовращающий изомер офлоксацина. Обладает широким спектром антибактериального (бактерицидного) действия. Ингибирует бактериальные ДНК-гиразу и топоизомеразу IV ферменты отвечающие за репликацию транскрипцию репарацию и рекомбинацию бактериальной ДНК. Вызывает глубокие морфологические изменения в цитоплазме клеточной стенке и мембране бактерий.
После инстиляции в глаз левофлоксацин хорошо сохраняется в слезной пленке. После однократного применения глазных капель концентрация левофлоксацина в слезной пленке составляет 170 мкг/мл и 66 мкг/мл через 4 и 6 ч соответственно. Максимальная концентрация левофлоксацина равная 225 нг/мл наблюдается на 4-е сутки после 2-х суточного применения каждые 2 ч (8 раз в сутки). При длительном применении в виде глазных капель концентрация левофлоксацина в плазме крови составляет 094 нг/мл и 215 нг/мл на 1-е и 15-е сутки соответственно что в 1000 раз ниже концентраций при приеме внутрь стандартных рекомендуемых доз.
Показания к применению
Лечение инфекций переднего отдела глаза вызванных чувствительными к левофлоксацину микроорганизмами.
Противопоказания
Гиперчувствительность к компонентам препарата; беременность период лактации детский возраст до 1 года.
Применение при беременности и в период грудного вскармливания
Препарат противопоказан при беременности.
При необходимости назначения препарата в период лактации грудное вскармливание необходимо прекратить.
Способ применения и дозы
Местно. Препарат закапывают в конъюнктивальный мешок по 1-2 капли раствора в один или оба пораженных глаза каждые 2 ч (до 8 раз в сутки) в течение первых 2-х суток. Затем каждые 4 ч (до 4 раз в сутки) в течение 3-7 суток. Длительность лечения составляет 5-7 суток. При одновременном применении нескольких офтальмологических препаратов для местного применения необходимо соблюдать 15-минутный интервал между инстилляциями.
Во избежание загрязнения раствора кончиком капельницы не следует прикасаться к векам и тканям вокруг глаза.
Рекомендации по использованию флаконов с крышками-капельницами: перед применением препарата удалить с флакона алюминиевый колпачок снять резиновую пробку и закрыть флакон крышкой-капельницей предварительно освобожденной от упаковки. Затем снять колпачок с крышки-капельницы перевернуть флакон закапать необходимое количество капель препарата. После применения флакон вернуть в вертикальное положение и надеть колпачок на крышку-капельницу.
Рекомендации по использованию тюбик-капельницы (т/к): перед применением препарата снять защитный колпачок ножницами отрезать мембрану горловины корпуса не повреждая резьбовую часть. Перевернуть корпус т/к с лекарственным средством горловиной вниз и мягким движением нажать на корпус т/к используя его как пипетку. После применения рекомендуемой по назначению врача или указанной в инструкции по применению лекарственного средства дозы корпус т/к перевернуть резьбовой частью вверх и накрутить защитный колпачок.
Побочное действие
Часто (1 - 10 %): кратковременное жжение в глазу покраснение глаза снижение остроты зрения.
Нечасто (01-1 %): появление слизи в виде тяжей.
Редко (01 - 001 %): блефарит хемоз сосочковые разрастания и появление фолликулов на конъюнктиве синдром "сухого глаза" эритема век зуд и боль в глазу светобоязнь аллергические реакции головная боль ринит.
Поскольку препарат содержит бензалкония хлорид возможно развитие контактного дерматита и раздражение глаза.
Передозировка
Передозировка препаратом в виде глазных капель маловероятна.
Симптомы: раздражение тканей глаза (жжение покраснение отек резь слезотечение).
Лечение: промыть чистой (водопроводной) водой комнатной температуры симптоматическая терапия.
Взаимодействие с другими лекарственными средствами
Специальных исследований взаимодействия левофлоксацина в виде глазных капель не проводилось. Так как максимальная концентрация левофлоксацина в плазме после местного применения в 1000 раз меньше чем при пероральном приеме эффекты взаимодействия с другими лекарственными средствами маловероятны.
Особые указания
Капли не следует применять при ношении мягких контактных линз в связи с наличием в каплях консерванта бензалкония хлорида который может абсорбироваться контактными линзами и оказать неблагоприятное действие на ткани глаза и вызвать изменение цвета контактных линз.
Влияние на способность управлять автомобилем и движущимися механизмами
В случае преходящего снижения остроты зрения после закапывания не рекомендуется управлять автомобилем или работать с потенциально опасными механизмами до его восстановления.
Форма выпуска
Капли глазные 0,5 %.
Условия хранения
В защищенном от света месте при температуре не выше 25 °С.
После вскрытия флакон хранить в течение 4-х недель.
Хранить в недоступном для детей месте.
Срок годности
3 года.
Не использовать по истечении срока годности указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Республиканское унитарное производственное предприятие "Белмедпрепараты" (РУП "Белмедпрепараты"), 220006, г. Минск, ул. Маяковского, 1, Республика Беларусь
Организация, принимающая претензии потребителей
РУП "Белмедпрепараты"
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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Обладает широким спектром антибактериального (бактерицидного) действия. Ингибирует бактериальные ДНК-гиразу и топоизомеразу IV ферменты отвечающие за репликацию транскрипцию репарацию и рекомбинацию бактериальной ДНК. Вызывает глубокие морфологические изменения в цитоплазме клеточной стенке и мембране бактерий."}},{"type":"paragraph","data":{"text":"Препарат активен в отношении микроорганизмов:"}},{"type":"paragraph","data":{"text":"- аэробные грамположительные бактерии: CorynebacteriumspeciesStaphylococcusaureusStaphylococcusepidermidisStreptococcuspneumoniaeStreptococcus (GroupsC/F) Streptococcus (GroupG) Viridansgroupstreptococci."}},{"type":"paragraph","data":{"text":"- аэробные грамотрицательные бактерии: AcinetobacterWaffleHaemophilusinfluenzae Serratiamarcescens."}},{"type":"header","data":{"text":"Фармакокинетика:","level":3}},{"type":"paragraph","data":{"text":"После инстиляции в глаз левофлоксацин хорошо сохраняется в слезной пленке. После однократного применения глазных капель концентрация левофлоксацина в слезной пленке составляет 170 мкг/мл и 66 мкг/мл через 4 и 6 ч соответственно. Максимальная концентрация левофлоксацина равная 225 нг/мл наблюдается на 4-е сутки после 2-х суточного применения каждые 2 ч (8 раз в сутки). При длительном применении в виде глазных капель концентрация левофлоксацина в плазме крови составляет 094 нг/мл и 215 нг/мл на 1-е и 15-е сутки соответственно что в 1000 раз ниже концентраций при приеме внутрь стандартных рекомендуемых доз."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Лечение инфекций переднего отдела глаза вызванных чувствительными к левофлоксацину микроорганизмами."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Гиперчувствительность к компонентам препарата; беременность период лактации детский возраст до 1 года."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Препарат противопоказан при беременности."}},{"type":"paragraph","data":{"text":"При необходимости назначения препарата в период лактации грудное вскармливание необходимо прекратить."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Местно. Препарат закапывают в конъюнктивальный мешок по 1-2 капли раствора в один или оба пораженных глаза каждые 2 ч (до 8 раз в сутки) в течение первых 2-х суток. Затем каждые 4 ч (до 4 раз в сутки) в течение 3-7 суток. Длительность лечения составляет 5-7 суток. При одновременном применении нескольких офтальмологических препаратов для местного применения необходимо соблюдать 15-минутный интервал между инстилляциями."}},{"type":"paragraph","data":{"text":"Во избежание загрязнения раствора кончиком капельницы не следует прикасаться к векам и тканям вокруг глаза."}},{"type":"paragraph","data":{"text":"Рекомендации по использованию флаконов с крышками-капельницами: перед применением препарата удалить с флакона алюминиевый колпачок снять резиновую пробку и закрыть флакон крышкой-капельницей предварительно освобожденной от упаковки. Затем снять колпачок с крышки-капельницы перевернуть флакон закапать необходимое количество капель препарата. После применения флакон вернуть в вертикальное положение и надеть колпачок на крышку-капельницу."}},{"type":"paragraph","data":{"text":"Рекомендации по использованию тюбик-капельницы (т/к): перед применением препарата снять защитный колпачок ножницами отрезать мембрану горловины корпуса не повреждая резьбовую часть. Перевернуть корпус т/к с лекарственным средством горловиной вниз и мягким движением нажать на корпус т/к используя его как пипетку. После применения рекомендуемой по назначению врача или указанной в инструкции по применению лекарственного средства дозы корпус т/к перевернуть резьбовой частью вверх и накрутить защитный колпачок."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Часто (1 - 10 %): кратковременное жжение в глазу покраснение глаза снижение остроты зрения."}},{"type":"paragraph","data":{"text":"Нечасто (01-1 %): появление слизи в виде тяжей."}},{"type":"paragraph","data":{"text":"Редко (01 - 001 %): блефарит хемоз сосочковые разрастания и появление фолликулов на конъюнктиве синдром \"сухого глаза\" эритема век зуд и боль в глазу светобоязнь аллергические реакции головная боль ринит."}},{"type":"paragraph","data":{"text":"Поскольку препарат содержит бензалкония хлорид возможно развитие контактного дерматита и раздражение глаза."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Передозировка препаратом в виде глазных капель маловероятна."}},{"type":"paragraph","data":{"text":"Симптомы: раздражение тканей глаза (жжение покраснение отек резь слезотечение)."}},{"type":"paragraph","data":{"text":"Лечение: промыть чистой (водопроводной) водой комнатной температуры симптоматическая терапия."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Специальных исследований взаимодействия левофлоксацина в виде глазных капель не проводилось. 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