на 1 г: Активные вещества: клиндамицин (в форме фосфата) - 100 мг.; Вспомогательные вещества: твердый жир (Witepsol H-32, смесь триглицеридов, диглицеридов и моноглицеридов) - около 2.4 г.
Фармакологические свойства
Антибиотик группы линкозамидов для местного применения.; Клиндамицина фосфат не активен in vitro, но быстро гидролизуется in vivo с образованием клиндамицина, обладающего антибактериальной активностью. Клиндамицин ингибирует синтез белков в микробной клетке за счет взаимодействия с 50S-субъединицей рибосом.; В условиях in vitro к клиндамицину чувствительны следующие микроорганизмы, вызывающие бактериальные вагинозы: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.
Показания к применению
— бактериальный вагиноз.
Противопоказания
Повышенная чувствительность к клиндамицину, линкомицину или любому компоненту препарата
Антибиотик-ассоциированный колит в анамнезе
Возраст до 18 лет (данные по безопасности и эффективности отсутствуют)
Применение при беременности и в период грудного вскармливания
При применении клиндамицина интравагинально во II или III триместре беременности увеличения частоты врожденных аномалий плода не отмечалось. Если Далацин; суппозитории вагинальные применяется во время II или III триместров беременности (хотя официальных исследований по применению суппозиториев у беременных женщин не проводилось), то неблагоприятное влияние на плод представляется маловероятным. Применение препарата во II-III триместре беременности возможно, если потенциальная польза для матери превосходит риск для плода.; Адекватных контролируемых исследований по применению препарата в I триместре беременности не проводилось, поэтому Далацин; суппозитории вагинальные можно назначать женщинам в I триместре беременности только по абсолютным показаниям, т.е. когда потенциальная польза терапии препаратом превосходит потенциальный риск для плода.; В исследованиях на животных при введении клиндамицина п/к или внутрь каких-либо отрицательных влияний на плод не обнаружено, за исключением случаев приема препарата в дозах, токсичных для матери.; Неизвестно, выделяется ли клиндамицин с грудным молоком после интравагинального применения. Клиндамицин обнаружен в грудном молоке после перорального или парентерального введения, поэтому в период грудного вскармливания следует либо отменить применение препарата, либо прекратить грудное вскармливание, учитывая степень важности применения препарата для матери.
Способ применения и дозы
Рекомендуемая доза составляет 1 суппозиторий интравагинально предпочтительно перед сном в течение 3 дней подряд.; Правила использования препарата; Введение суппозиториев без аппликатора; 1. Необходимо извлечь суппозиторий из фольги.; 2. В положении лежа на спине подтянуть колени к груди.; 3. Осторожно ввести суппозиторий во влагалище с помощью среднего пальца руки как можно глубже.; Введение суппозиториев с помощью аппликатора; 1. Пластиковый аппликатор, находящийся в упаковке с препаратом, предназначен для облегчения введения суппозитория во влагалище.; 2. Необходимо извлечь суппозиторий из фольги.; 3. Следует поместить плоский конец суппозитория в отверстие аппликатора.; 4. В положении лежа на спине подтянуть колени к груди.; 5. Держа аппликатор горизонтально за ребристый конец корпуса, осторожно ввести его во влагалище как можно глубже.; 6. Медленно нажимая на поршень, ввести суппозиторий во влагалище.; 7. Следует осторожно извлечь аппликатор из влагалища.; 8. После каждого использования аппликатор следует вымыть теплой водой с мылом и дать ему полностью высохнуть.
Побочное действие
Безопасность применения клиндамицина в виде свечей оценивали у небеременных женщин в клинических исследованиях.; Частота развития побочных реакций следующая: очень часто — ≥1/10; часто — ≥1/100, <1/10; нечасто — ≥1/1000, <1/100; редко — ≥1/10000, <1/1000; частота неизвестна — невозможно оценить на основании имеющихся данных.; Инфекционные и паразитарные заболевания: часто — грибковые инфекции, вызываемые грибами рода Candida.; Со стороны нервной системы: часто — головная боль.; Со стороны ЖКТ: часто — боль в животе, диарея, тошнота; нечасто — рвота; частота неизвестна — псевдомембранозный колит.; Со стороны кожи и подкожных тканей: часто — зуд кожи; нечасто — сыпь.; Со стороны скелетно-мышечной и соединительной ткани: нечасто — боль в боку.; Со стороны почек и мочевыводящих путей: нечасто — пиелонефрит, дизурия.; Со стороны половых органов и молочной железы: часто — вульвовагинальный кандидоз, вульвовагинальная боль, вульвовагинальные расстройства; нечасто — вагинальные инфекции, выделения из влагалища, нарушение менструального цикла.; Общие расстройства и реакции в месте введения: нечасто — боль в месте введения, зуд в месте введения, локализованный отек, боль, гипертермия.
Передозировка
При интравагинальном применении суппозиториев Далацин; возможна абсорбция клиндамицина в количествах, достаточных для развития системных реакций.; Случайное попадание препарата в ЖКТ может вызвать системные эффекты, сходные с теми, которые возникают после приема внутрь клиндамицина в терапевтических дозах. К возможным системным побочным эффектам можно отнести диарею, геморрагическую диарею, включая псевдомембранозный колит.; Лечение: проведение симптоматической и поддерживающей терапии.
Особые указания
До назначения препарата с помощью соответствующих лабораторных методов следует исключить вульвовагинит, вызванный Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans и вирусом Herpes simplex.; Интравагинальное применение клиндамицина может привести к усиленному росту нечувствительных микроорганизмов, особенно дрожжеподобных грибов.; Применение клиндамицина (как и практически всех антибиотиков) внутрь или парентерально связано с развитием тяжелой диареи и в ряде случаев псевдомембранозного колита. При развитии выраженной или длительной диареи препарат следует отменить и при необходимости провести соответствующие диагностические и лечебные мероприятия.; Пациенток необходимо предупредить о том, что во время терапии препаратом следует избегать половых контактов, а также применения других средств для интравагинального введения (тампоны, спринцевание).; Препарат содержит компоненты, которые могут уменьшать прочность изделий из латекса или каучука (презервативы, противозачаточные вагинальные диафрагмы). Поэтому использование подобных изделий во время лечения Далацином и в течение 72 ч после применения не рекомендуется.; Не рекомендуется применение препарата Далацин; суппозитории вагинальные в период менструации. Следует отложить начало терапии до окончания менструации.; Влияние на способность к вождению автотранспорта и управлению механизмами; Препарат не оказывает влияния на способность к управлению транспортными средствами и занятию потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
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1 г: Активные вещества: клиндамицин (в форме фосфата) - 100 мг.; Вспомогательные вещества: твердый жир (Witepsol H-32, смесь триглицеридов, диглицеридов и моноглицеридов) - около 2.4 г."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Антибиотик группы линкозамидов для местного применения.; Клиндамицина фосфат не активен in vitro, но быстро гидролизуется in vivo с образованием клиндамицина, обладающего антибактериальной активностью. Клиндамицин ингибирует синтез белков в микробной клетке за счет взаимодействия с 50S-субъединицей рибосом.; В условиях in vitro к клиндамицину чувствительны следующие микроорганизмы, вызывающие бактериальные вагинозы: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"— бактериальный вагиноз."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Повышенная чувствительность к клиндамицину, линкомицину или любому компоненту препарата","Антибиотик-ассоциированный колит в анамнезе","Возраст до 18 лет (данные по безопасности и эффективности отсутствуют)"]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При применении клиндамицина интравагинально во II или III триместре беременности увеличения частоты врожденных аномалий плода не отмечалось. Если Далацин; суппозитории вагинальные применяется во время II или III триместров беременности (хотя официальных исследований по применению суппозиториев у беременных женщин не проводилось), то неблагоприятное влияние на плод представляется маловероятным. Применение препарата во II-III триместре беременности возможно, если потенциальная польза для матери превосходит риск для плода.; Адекватных контролируемых исследований по применению препарата в I триместре беременности не проводилось, поэтому Далацин; суппозитории вагинальные можно назначать женщинам в I триместре беременности только по абсолютным показаниям, т.е. когда потенциальная польза терапии препаратом превосходит потенциальный риск для плода.; В исследованиях на животных при введении клиндамицина п/к или внутрь каких-либо отрицательных влияний на плод не обнаружено, за исключением случаев приема препарата в дозах, токсичных для матери.; Неизвестно, выделяется ли клиндамицин с грудным молоком после интравагинального применения. Клиндамицин обнаружен в грудном молоке после перорального или парентерального введения, поэтому в период грудного вскармливания следует либо отменить применение препарата, либо прекратить грудное вскармливание, учитывая степень важности применения препарата для матери."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Рекомендуемая доза составляет 1 суппозиторий интравагинально предпочтительно перед сном в течение 3 дней подряд.; Правила использования препарата; Введение суппозиториев без аппликатора; 1. Необходимо извлечь суппозиторий из фольги.; 2. В положении лежа на спине подтянуть колени к груди.; 3. Осторожно ввести суппозиторий во влагалище с помощью среднего пальца руки как можно глубже.; Введение суппозиториев с помощью аппликатора; 1. Пластиковый аппликатор, находящийся в упаковке с препаратом, предназначен для облегчения введения суппозитория во влагалище.; 2. Необходимо извлечь суппозиторий из фольги.; 3. Следует поместить плоский конец суппозитория в отверстие аппликатора.; 4. В положении лежа на спине подтянуть колени к груди.; 5. Держа аппликатор горизонтально за ребристый конец корпуса, осторожно ввести его во влагалище как можно глубже.; 6. Медленно нажимая на поршень, ввести суппозиторий во влагалище.; 7. Следует осторожно извлечь аппликатор из влагалища.; 8. После каждого использования аппликатор следует вымыть теплой водой с мылом и дать ему полностью высохнуть."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Безопасность применения клиндамицина в виде свечей оценивали у небеременных женщин в клинических исследованиях.; Частота развития побочных реакций следующая: очень часто — ≥1/10; часто — ≥1/100, \u003c1/10; нечасто — ≥1/1000, \u003c1/100; редко — ≥1/10000, \u003c1/1000; частота неизвестна — невозможно оценить на основании имеющихся данных.; Инфекционные и паразитарные заболевания: часто — грибковые инфекции, вызываемые грибами рода Candida.; Со стороны нервной системы: часто — головная боль.; Со стороны ЖКТ: часто — боль в животе, диарея, тошнота; нечасто — рвота; частота неизвестна — псевдомембранозный колит.; Со стороны кожи и подкожных тканей: часто — зуд кожи; нечасто — сыпь.; Со стороны скелетно-мышечной и соединительной ткани: нечасто — боль в боку.; Со стороны почек и мочевыводящих путей: нечасто — пиелонефрит, дизурия.; Со стороны половых органов и молочной железы: часто — вульвовагинальный кандидоз, вульвовагинальная боль, вульвовагинальные расстройства; нечасто — вагинальные инфекции, выделения из влагалища, нарушение менструального цикла.; Общие расстройства и реакции в месте введения: нечасто — боль в месте введения, зуд в месте введения, локализованный отек, боль, гипертермия."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При интравагинальном применении суппозиториев Далацин; возможна абсорбция клиндамицина в количествах, достаточных для развития системных реакций.; Случайное попадание препарата в ЖКТ может вызвать системные эффекты, сходные с теми, которые возникают после приема внутрь клиндамицина в терапевтических дозах. К возможным системным побочным эффектам можно отнести диарею, геморрагическую диарею, включая псевдомембранозный колит.; Лечение: проведение симптоматической и поддерживающей терапии."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"До назначения препарата с помощью соответствующих лабораторных методов следует исключить вульвовагинит, вызванный Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans и вирусом Herpes simplex.; Интравагинальное применение клиндамицина может привести к усиленному росту нечувствительных микроорганизмов, особенно дрожжеподобных грибов.; Применение клиндамицина (как и практически всех антибиотиков) внутрь или парентерально связано с развитием тяжелой диареи и в ряде случаев псевдомембранозного колита. При развитии выраженной или длительной диареи препарат следует отменить и при необходимости провести соответствующие диагностические и лечебные мероприятия.; Пациенток необходимо предупредить о том, что во время терапии препаратом следует избегать половых контактов, а также применения других средств для интравагинального введения (тампоны, спринцевание).; Препарат содержит компоненты, которые могут уменьшать прочность изделий из латекса или каучука (презервативы, противозачаточные вагинальные диафрагмы). Поэтому использование подобных изделий во время лечения Далацином и в течение 72 ч после применения не рекомендуется.; Не рекомендуется применение препарата Далацин; суппозитории вагинальные в период менструации. 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