Бутоконазол - производное имидазола, обладает фунгицидной ак... Инструкция
Показания к применению
Бактериальные, грибковые и смешанные вагинозы, вызванные чувствительными к лекарственному средству микроорганизмами.
Противопоказания
Болезнь Крона; язвенный колит (в т.ч. в анамнезе); псевдомембранозный колит (в т.ч. в анамнезе); детский возраст до 18 лет; повышенная чувствительность к клиндамицину, линкомицину, бутоконазолу или любому компоненту препарата.
Инструкция
Состав
100 г крема содержит: бутоконазола нитрат 2 г; клиндамицин (в форме фосфата) 2 г. Вспомогательные вещества: консервант Euxyl PE 9010 (феноксиэтанол 90%, этилгексилглицерол 10%) - 0.45 мг, пропиленгликоль - 5 г, изопропилмиристат - 8 г, макрогола цетостеарат (макрогола-20 цетостеариловый эфир) - 2 г, цетостеариловый спирт (цетиловый спирт 60%, стеариловый спирт 40%) - 6 г, гидроксипропилдикрахмалфосфат - 8 г, натрия гидроксид - 0.26 г, вода очищенная - до 100 г.
Фармакологические свойства
Бутоконазол - производное имидазола, обладает фунгицидной активностью в отношении грибов родов Candida, Trichophyton, Microsporum, Epidermophyton и некоторых грамположительных бактерий. Наиболее эффективен при кандидозах. Блокируя в клеточной мембране образование эргостерола из ланостерола, увеличивает проницаемость мембраны, что приводит к лизису клетки гриба.; Клиндамицин – бактериостатический антибиотик из группы линкозамидов, обладает широким спектром действия, связывается с 50S субъединицей рибосомальной мембраны и подавляет синтез белка в микробной клетке. В отношении ряда грамположительных кокков возможно бактерицидное действие. Активен в отношении Staphylococcus spp. (в т.ч. Staphylococcus epidermidis, продуцирующих и непродуцирующих пенициллиназу), Streptococcus spp. (исключая Enterococcus faecalis), Streptococcus pneumoniae, Corynebacterium diphtheriae, Mycoplasma spp., анаэробных и микроаэрофильных грамположительных кокков (включая Peptococcus spp. и Peptostreptococcus spp.), Clostridium perfringens, Clostridium tetani, Bacteroides spp. (включая Bacteroides fragilis и Prevotella melaninogenica), Fusobacterium spp., Propionibacterium spp., эубактериум и Actinomyces israelii. Большинство штаммов Clostridium perfringens чувствительны к клиндамицину, но другие виды Clostridium spp. (в т.ч. Clostridium sporogenes, Clostridium tertium) устойчивы к его действию, в связи с чем при инфекциях, вызванных Clostridium spp., рекомендуется определение антибиотикограммы.; Гидрофильная кремовая основа обеспечивает препарату гелеобразную консистенцию при температуре 35-40°С. При интравагинальном применении крем не плавится, в связи с чем активные вещества находятся на слизистой оболочке влагалища в течение 1-3 дней.; Существует перекрестная резистентность между клиндамицином и линкомицином.
Показания к применению
Бактериальные, грибковые и смешанные вагинозы, вызванные чувствительными к лекарственному средству микроорганизмами.
Противопоказания
Болезнь Крона; язвенный колит (в т.ч. в анамнезе); псевдомембранозный колит (в т.ч. в анамнезе); детский возраст до 18 лет; повышенная чувствительность к клиндамицину, линкомицину, бутоконазолу или любому компоненту препарата.
Применение при беременности и в период грудного вскармливания
Применение препарата при беременности и в период лактации возможно только в том случае, если потенциальная польза для матери превышает риск для плода или ребенка.
Способ применения и дозы
Вводится интравагинально с помощью аппликатора. Применяется однократно, предпочтительно перед сном. Рекомендуемая доза составляет 1 полный аппликатор (5 г крема, что соответствует 100 мг бутоконазола нитрата и 100 мг клиндамицина). Курс лечения - ежедневно в течение 3-х дней.; Указания по использованию; Одноразовые аппликаторы, прилагающиеся к упаковке, предназначены для правильного введения крема во влагалище.; 1. Снять колпачок тюбика с кремом. Навинтить пластмассовый аппликатор на снабженное резьбой горлышко тюбика.; 2. Сдавливая тюбик с противоположного конца, мягко выдавить крем в аппликатор. Поршень аппликатора двигается самостоятельно по мере заполнения необходимого объема. Аппликатор заполнен, когда его поршень доходит до упора.; 3. Лежа на спине, взять аппликатор горизонтально и ввести его во влагалище как можно дальше, но так, чтобы не вызвать неприятных ощущений.; 4. Медленно нажать на поршень до упора.; 5. Осторожно извлечь аппликатор из влагалища и выбросить его.
Побочное действие
Препарат обычно хорошо переносится, однако возможно появление раздражения в месте введения, жжение, зуд, болезненность и отек слизистой оболочки влагалища, боли/спазмы в нижней части живота, развитие аллергических реакций.
Передозировка
При интравагинальном применении препарата передозировка не установлена.
Особые указания
Если клинические признаки инфекции сохраняются после завершения лечения, следует провести повторное микробиологическое исследование для выявления возбудителя и подтверждения диагноза.; Появление раздражения слизистой оболочки влагалища или болезненных ощущений, служит показанием к прекращению лечения.; Вагинальный крем не рекомендуется использовать одновременно с другими интравагинальными лекарственными средствами.
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