Непафенак - предшественник активной формы нестероидных проти... Инструкция
Показания к применению
Профилактика и лечение послеоперационной боли и воспалительных явлений при хирургических вмешательствах по поводу удаления катаракты.
Противопоказания
бронхиальная астма, крапивница, острый ринит, вызванные приемом ацетилсалициловой кислоты или других нестероидных противовоспалительных препаратов; - возраст до 18 лет (безопасность и эффективность применения препарата у детей не исследовались); - повышенная чувствительность к компонентам препарата и к другим НПВП.
На 1 мл: непафенак 1 мг. Вспомогательные вещества: бензалкония хлорид (в виде 50 % раствора) 0.05 мг, карбомер 974Р 5.0 мг, тилоксапол 0.1 мг, динатрия эдетат 0.1 мг, маннитол 24.0 мг, натрия хлорид 4.0 мг, натрия гидроксид и/или кислота хлористоводородная до доведения pH, вода очищенная до 1 мл.
Фармакологические свойства
Непафенак - предшественник активной формы нестероидных противовоспалительных препаратов с противовоспалительным и анальгезирующим действием. При местном применении непафенак проникает через роговицу глаза, где при помощи гидролаз происходит его превращение в амфенак, активную форму. Амфенак ингибирует действие циклооксигеназы (простагландин-Н-синтазы), фермента, необходимого для продукции простагландинов. При местном применении непафенак уменьшает отек тканей глаза и боль, не оказывает значимого эффекта на внутриглазное давление.
Показания к применению
Профилактика и лечение послеоперационной боли и воспалительных явлений при хирургических вмешательствах по поводу удаления катаракты.
Противопоказания
бронхиальная астма, крапивница, острый ринит, вызванные приемом ацетилсалициловой кислоты или других нестероидных противовоспалительных препаратов; - возраст до 18 лет (безопасность и эффективность применения препарата у детей не исследовались); - повышенная чувствительность к компонентам препарата и к другим НПВП.
Применение при беременности и в период грудного вскармливания
Не рекомендуется применение при беременности и в период лактации. При необходимости назначения в период лактации грудное вскармливание рекомендуется прекратить на время лечения. Испытания на животных выявили репродуктивную токсичность. При исследовании воздействия непафенака на репродуктивные органы крыс, прием токсических доз >10 мг/кг приводил к дистоции, увеличению количества самопроизвольных абортов на этапе после имплантации, снижению массы тела и роста эмбрионов, снижению выживаемости эмбрионов. У беременных крольчих прием малотоксичных доз 30 мг/кг приводил к увеличению пороков развития потомства.
Способ применения и дозы
Местно. Перед применением флакон встряхивать. По 1 капле в конъюнктивальный мешок глаза (глаз) 3 раза/сут. Лечение начинают за 1 день до хирургического вмешательства по поводу удаления катаракты и продолжают в течение первых 2 недель послеоперационного периода (включая день операции). За 30-120 мин до операции необходимо закапать дополнительную каплю препарата.
Побочное действие
Местные: в 1-10% случаев наблюдается точечный кератит, боль и зуд в глазу, неясность зрения, сухость конъюнктивы, ощущение инородного тела, образование корок на краях век. В 0.1-1% случаев - ирит, кератит, отложения в роговице, хориоидальный выпот, выделения из глаз, фотофобия, раздражение глаз, аллергический конъюнктивит, нарушения со стороны век, дискомфорт в глазах, повышенное слезоотделение, гиперемия конъюнктивы. Системные побочные эффекты: в 1-10% случаев - головная боль. В 1-4% случаев - повышение АД, тошнота, рвота, синусит. В 0.1-1% случаев - сухость во рту, растяжимость кожи (дерматохалазис), повышенная чвствительность чувствительность. Постмаркетинговые наблюдения (частота неизвестна): язвенный кератит, дефект/заболевание эпителия роговицы, повреждение роговицы, образование воспалительного инфильтрата в передней камере глаза, ухудшение процесса заживления роговицы, снижение остроты зрения, рубец на роговице, помутнение роговицы. Пациентам с признаками повреждения роговицы следует немедленно отменить применение препарата и тщательно обследовать состояние роговицы. Опыт применения нестероидных противовоспалительных препаратов для местного применения предполагает, что пациенты с осложнениями после хирургических офтальмологических вмешательств, денервацией роговицы, дефектами эпителия роговицы, сахарным диабетом, поверхностными заболеваниями глаз (например, синдром сухого глаза), ревматоидным артритом или повторными хирургическими вмешательствами, проведенными в течение короткого промежутка времени, могут иметь повышенный риск развития побочных реакций со стороны роговицы, что может создать угрозу потери зрения.
Передозировка
Данные по передозировке препарата отсутствуют. При попадании в глаза избыточного количества препарата рекомендуется промыть глаза теплой водой
Особые указания
Пациентам следует избегать воздействия солнечного света. Применение НПВП для местного применения может привести к развитию кератита. У некоторых восприимчивых пациентов длительное применение нестероидных противовоспалительных препаратов для местного применения может вызвать разрыв клеток эпителия, истончение роговицы, эрозию роговицы, образование язвы на роговице или перфорацию роговицы. Эти побочные явления могут создавать риск потери зрения. Пациенты с признаками разрыва клеток эпителия роговицы должны немедленно прекратить применение препарата, и находиться под наблюдением, целью которого является мониторинг состояния роговицы. Применение НПВП для местного применения может замедлять или задерживать процесс заживления. Также известно, что глюкокортикостероиды для местного применения замедляют или задерживают заживление. Одновременное применение НПВП для местного применения и ГКС для местного применения может замедлять или задерживать процесс заживления. Опыт применения НПВП для местного применения предполагает, что пациенты с осложнениями после хирургических офтальмологических вмешательств, денервацией роговицы, дефектами эпителия роговицы, сахарным диабетом, поверхностными заболеваниями глаз (например, синдромом сухого глаза), ревматоидным артритом или повторными хирургическими вмешательствами, проведенными в течение короткого промежутка времени, могут иметь повышенный риск развития побочных реакций со стороны роговицы, что может создать угрозу потери зрения. НПВП для местного применения должны использоваться с осторожностью при лечении таких пациентов. Длительное применение может увеличить риск возникновения и степень тяжести побочных реакций со стороны роговицы. Применение НПВП для местного применения в сочетании с хирургической операцией на глазах могут вызывать интенсивное кровотечение в тканях глаза (включая гифему). Препарат Неванак должен использоваться с осторожностью у пациентов, в анамнезе которых зафиксирована склонность к кровотечению, или если пациенты получают другие лекарственные препараты, которые могут повышать время свертываемости крови. Данные по одновременному применению аналогов простагландина и препарата Неванак отсутствуют. Учитывая механизмы их действия, одновременное применение не рекомендуется. Препарат содержит консервант бензалкония хлорид, который может вызывать раздражение глаз и обесцвечивание мягких контактных линз. Кроме того, ношение контактных линз не рекомендуется во время послеоперационного периода после хирургической операции по поводу катаракты. Не рекомендуется использовать контактные линзы при лечении препаратом Неванак. Исследования показали, что бензалкония хлорид, который содержится в препарате Неванак, может вызывать точечный кератит и/или токсичный язвенный кератит. Поэтому при частом или длительном использовании препарата необходимо тщательное медицинское наблюдение за состоянием пациентов. Применение НПВП для местного применения может препятствовать своевременному распознаванию признаков острой глазной инфекции, т.к. они не обладают какими-либо противомикробными свойствами. В случае развития глазной инфекции, применение нестероидных противовоспалительных препаратов для местного применения одновременно с антибактериальными средствами должно осуществляться с соблюдением мер предосторожности. Перекрестная чувствительностьПри применении непафенака существует возможность развития перекрестной чувствительности к ацетилсалициловой кислоте, производным феннлуксусной кислоты, а также другим НПВП. Не следует прикасаться кончиком флакона-капельницы к какой-либо поверхности, чтобы избежать загрязнения флакона и его содержимого. Флакон необходимо закрывать после каждого использования. Влияние на способность к вождению автотранспорта и управлению механизмамиПосле применения препарата возможно временное снижение четкости зрительного восприятия, и до ее восстановления не рекомендуется управлять автомобилем и заниматься видами деятельности, требующими повышенного внимания и реакции.
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Вспомогательные вещества: бензалкония хлорид (в виде 50 % раствора) 0.05 мг, карбомер 974Р 5.0 мг, тилоксапол 0.1 мг, динатрия эдетат 0.1 мг, маннитол 24.0 мг, натрия хлорид 4.0 мг, натрия гидроксид и/или кислота хлористоводородная до доведения pH, вода очищенная до 1 мл."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Непафенак - предшественник активной формы нестероидных противовоспалительных препаратов с противовоспалительным и анальгезирующим действием. При местном применении непафенак проникает через роговицу глаза, где при помощи гидролаз происходит его превращение в амфенак, активную форму. Амфенак ингибирует действие циклооксигеназы (простагландин-Н-синтазы), фермента, необходимого для продукции простагландинов. При местном применении непафенак уменьшает отек тканей глаза и боль, не оказывает значимого эффекта на внутриглазное давление."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Профилактика и лечение послеоперационной боли и воспалительных явлений при хирургических вмешательствах по поводу удаления катаракты."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["бронхиальная астма, крапивница, острый ринит, вызванные приемом ацетилсалициловой кислоты или других нестероидных противовоспалительных препаратов; - возраст до 18 лет (безопасность и эффективность применения препарата у детей не исследовались); - повышенная чувствительность к компонентам препарата и к другим НПВП."]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Не рекомендуется применение при беременности и в период лактации. При необходимости назначения в период лактации грудное вскармливание рекомендуется прекратить на время лечения. Испытания на животных выявили репродуктивную токсичность. При исследовании воздействия непафенака на репродуктивные органы крыс, прием токсических доз \u003e10 мг/кг приводил к дистоции, увеличению количества самопроизвольных абортов на этапе после имплантации, снижению массы тела и роста эмбрионов, снижению выживаемости эмбрионов. У беременных крольчих прием малотоксичных доз 30 мг/кг приводил к увеличению пороков развития потомства."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Местно. Перед применением флакон встряхивать. По 1 капле в конъюнктивальный мешок глаза (глаз) 3 раза/сут. Лечение начинают за 1 день до хирургического вмешательства по поводу удаления катаракты и продолжают в течение первых 2 недель послеоперационного периода (включая день операции). За 30-120 мин до операции необходимо закапать дополнительную каплю препарата."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Местные: в 1-10% случаев наблюдается точечный кератит, боль и зуд в глазу, неясность зрения, сухость конъюнктивы, ощущение инородного тела, образование корок на краях век. В 0.1-1% случаев - ирит, кератит, отложения в роговице, хориоидальный выпот, выделения из глаз, фотофобия, раздражение глаз, аллергический конъюнктивит, нарушения со стороны век, дискомфорт в глазах, повышенное слезоотделение, гиперемия конъюнктивы. Системные побочные эффекты: в 1-10% случаев - головная боль. В 1-4% случаев - повышение АД, тошнота, рвота, синусит. В 0.1-1% случаев - сухость во рту, растяжимость кожи (дерматохалазис), повышенная чвствительность чувствительность. Постмаркетинговые наблюдения (частота неизвестна): язвенный кератит, дефект/заболевание эпителия роговицы, повреждение роговицы, образование воспалительного инфильтрата в передней камере глаза, ухудшение процесса заживления роговицы, снижение остроты зрения, рубец на роговице, помутнение роговицы. Пациентам с признаками повреждения роговицы следует немедленно отменить применение препарата и тщательно обследовать состояние роговицы. Опыт применения нестероидных противовоспалительных препаратов для местного применения предполагает, что пациенты с осложнениями после хирургических офтальмологических вмешательств, денервацией роговицы, дефектами эпителия роговицы, сахарным диабетом, поверхностными заболеваниями глаз (например, синдром сухого глаза), ревматоидным артритом или повторными хирургическими вмешательствами, проведенными в течение короткого промежутка времени, могут иметь повышенный риск развития побочных реакций со стороны роговицы, что может создать угрозу потери зрения."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Данные по передозировке препарата отсутствуют. При попадании в глаза избыточного количества препарата рекомендуется промыть глаза теплой водой"}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Пациентам следует избегать воздействия солнечного света. Применение НПВП для местного применения может привести к развитию кератита. У некоторых восприимчивых пациентов длительное применение нестероидных противовоспалительных препаратов для местного применения может вызвать разрыв клеток эпителия, истончение роговицы, эрозию роговицы, образование язвы на роговице или перфорацию роговицы. Эти побочные явления могут создавать риск потери зрения. Пациенты с признаками разрыва клеток эпителия роговицы должны немедленно прекратить применение препарата, и находиться под наблюдением, целью которого является мониторинг состояния роговицы. Применение НПВП для местного применения может замедлять или задерживать процесс заживления. Также известно, что глюкокортикостероиды для местного применения замедляют или задерживают заживление. Одновременное применение НПВП для местного применения и ГКС для местного применения может замедлять или задерживать процесс заживления. Опыт применения НПВП для местного применения предполагает, что пациенты с осложнениями после хирургических офтальмологических вмешательств, денервацией роговицы, дефектами эпителия роговицы, сахарным диабетом, поверхностными заболеваниями глаз (например, синдромом сухого глаза), ревматоидным артритом или повторными хирургическими вмешательствами, проведенными в течение короткого промежутка времени, могут иметь повышенный риск развития побочных реакций со стороны роговицы, что может создать угрозу потери зрения. НПВП для местного применения должны использоваться с осторожностью при лечении таких пациентов. Длительное применение может увеличить риск возникновения и степень тяжести побочных реакций со стороны роговицы. Применение НПВП для местного применения в сочетании с хирургической операцией на глазах могут вызывать интенсивное кровотечение в тканях глаза (включая гифему). Препарат Неванак должен использоваться с осторожностью у пациентов, в анамнезе которых зафиксирована склонность к кровотечению, или если пациенты получают другие лекарственные препараты, которые могут повышать время свертываемости крови. Данные по одновременному применению аналогов простагландина и препарата Неванак отсутствуют. Учитывая механизмы их действия, одновременное применение не рекомендуется. Препарат содержит консервант бензалкония хлорид, который может вызывать раздражение глаз и обесцвечивание мягких контактных линз. Кроме того, ношение контактных линз не рекомендуется во время послеоперационного периода после хирургической операции по поводу катаракты. Не рекомендуется использовать контактные линзы при лечении препаратом Неванак. Исследования показали, что бензалкония хлорид, который содержится в препарате Неванак, может вызывать точечный кератит и/или токсичный язвенный кератит. Поэтому при частом или длительном использовании препарата необходимо тщательное медицинское наблюдение за состоянием пациентов. Применение НПВП для местного применения может препятствовать своевременному распознаванию признаков острой глазной инфекции, т.к. они не обладают какими-либо противомикробными свойствами. В случае развития глазной инфекции, применение нестероидных противовоспалительных препаратов для местного применения одновременно с антибактериальными средствами должно осуществляться с соблюдением мер предосторожности. Перекрестная чувствительностьПри применении непафенака существует возможность развития перекрестной чувствительности к ацетилсалициловой кислоте, производным феннлуксусной кислоты, а также другим НПВП. Не следует прикасаться кончиком флакона-капельницы к какой-либо поверхности, чтобы избежать загрязнения флакона и его содержимого. Флакон необходимо закрывать после каждого использования. 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