Снижение повышенного ВГД у пациентов с открытоугольной глаукомой и внутриглазной гипертензией:- в качестве монотерапии у пациентов с недостаточной реакцией на препараты первой линии терапии или при непереносимости или наличии противопоказаний к препаратам первой линии терапии;- в качестве дополнительной терапии к бета-адреноблокаторам.
Противопоказания
Гиперчувствительность к тафлупросту, возраст до 18 лет (данные по клиническому применению отсутствуют).
Снижение повышенного ВГД у пациентов с открытоугольной глаукомой и внутриглазной гипертензией:- в качестве монотерапии у пациентов с недостаточной реакцией на препараты первой линии терапии или при непереносимости или наличии противопоказаний к препаратам первой линии терапии;- в качестве дополнительной терапии к бета-адреноблокаторам.
Противопоказания
Гиперчувствительность к тафлупросту, возраст до 18 лет (данные по клиническому применению отсутствуют).
Применение при беременности и в период грудного вскармливания
Категория действия на плод по FDA— C.Беременность. Данные о применении тафлупроста у беременных женщин отсутствуют. Тафлупрост может оказывать неблагоприятное фармакологическое воздействие на течение беременности и/или на плод/новорожденного ребенка. Исследования на животных продемонстрировали репродуктивную токсичность. В связи с этим тафлупрост не следует применять во время беременности, за исключением случаев, когда нет других вариантов лечения.Тафлупрост не должны применять женщины репродуктивного возраста, если они не используют адекватные средства контрацепции.Период грудного вскармливания. Неизвестно, проникает ли тафлупрост или его метаболиты в грудное молоко человека. В исследованиях на крысах была установлена экскреция тафлупроста в грудное молоко после местного применения.Поэтому тафлупрост не следует применять в период грудного вскармливания.Фертильность. У самок и самцов крыс способность к спариванию и рождаемость оставались неизменными при введении тафлупроста до 100 мкг/кг/сут внутривенно.
Побочное действие
В рамках проведенных клинических исследований свыше 1400 пациентов подвергались лечению тафлупростом с консервантом— как в качестве монотерапии, так и в качестве дополнительного ЛС к лечению 0,5% тимололом. Наиболее часто выявляемым побочным эффектом, связанным с лечением, была гиперемия глаз, которая отмечалась примерно у 13% пациентов, принимавших участие в клинических исследованиях тафлупроста с консервантом в Европе и США. В большинстве случаев гиперемия была умеренной и привела к прекращению лечения в среднем у 0,4% пациентов. В 3-месячном исследовании III фазы в США при сравнении состава тафлупроста 0,0015% без консерванта с тимололом, также без консерванта, гиперемия глаз отмечалась у 4,1% (13/320) пациентов, получавших тафлупрост.Для обозначения частоты нежелательных явлений используется следующая классификация: очень часто (≥1/10 случаев); часто (≥1/100, <1/10); нечасто (≥1/1000, <1/100); редко (≥1/10000, <1/1000); очень редко (<1/10000) и неизвестно (частота не может быть определена из имеющихся данных).Ниже представлены наиболее часто встречавшиеся побочные эффекты при применении тафлупроста в виде 0,0015% офтальмологического раствора.Со стороны нервной системы: часто— головная боль.Со стороны органа зрения: очень часто— гиперемия конъюнктивы/глаз; часто— зуд в глазах, раздражение глаз, боль в глазах, изменения ресниц (увеличение длины, толщины и числа ресниц), сухость глаз, изменение цвета ресниц, ощущение инородного тела в глазах, эритема век, поверхностный точечный кератит, затуманивание зрения, повышенная слезоточивость, снижение остроты зрения, светобоязнь и повышенная пигментация радужной оболочки; нечасто— астенопия, отек конъюнктивы, блефарит, опалесценция влаги передней камеры, конъюнктивальные фолликулы, аллергический конъюнктивит, клеточная реакция влаги передней камеры, пигментация конъюнктивы, чувство дискомфорта в глазах, пигментация век, отек век, выделения из глаз; неизвестно— ирит/увеит, углубление складки века. Сообщалось об очень редких случаях отложения кальцификатов в ткани роговицы в связи с применением фосфатсодержащих глазных капель у некоторых пациентов со значительным поражением роговицы.Со стороны дыхательной системы, органов грудной клетки и средостения: неизвестно— обострение бронхиальной астмы, диспноэ.Со стороны кожи и подкожной ткани: нечасто— гипертрихоз век.RxList.comРезультаты клинических испытаний. Так как клинические испытания проведены с различным набором условий, частота встречаемости побочных реакций, отмеченных в этих исследованиях, может не совпадать с полученной в других исследованиях и с наблюдаемой в клинической практике.Тафлупрост в виде 0,0015% офтальмологического раствора, содержащего или не содержащего консервант, оценивался у 905 пациентов в 5 контролируемых клинических исследованиях продолжительностью до 24 мес. Чаще всего у пациентов, подвергшихся лечению тафлупростом, наблюдалась побочная реакция в виде гиперемии конъюнктивы (от 4 до 20% пациентов). Приблизительно 1% пациентов прекратили терапию из-за глазных побочных эффектов.Глазные побочные эффекты, наблюдавшиеся с частотой ≥2% в указанных выше клинических исследованиях, включали жжение/раздражение (7%), зуд, включая аллергический конъюнктивит (5%), катаракту (3%), сухость глаз (3%), боль в глазах (3%), потемнение ресниц (2%), рост ресниц (2%) и затуманивание зрения (2%).К неглазным побочным эффектам, наблюдавшимся с частотой от 2 до 6% у пациентов, подвергавшихся лечению тафлупростом в виде 0,0015% офтальмологического раствора в этих клинических исследованиях, относились головная боль (6%), насморк (4%), кашель (3%) и инфекции мочевого тракта (2%).Постмаркетинговые исследования. Данные о побочных реакциях в постмаркетинговый период получены на добровольной основе от популяции неустановленного размера, поэтому они не всегда могут реально отражать их частоту или свидетельствовать о реальной связи с применением лекарства. Эти данные включают:Со стороны органов дыхания: обострение астмы, одышка.Нарушения органа зрения: воспаление радужной оболочки глаза, увеит.В постмаркетинговых исследованиях с применением аналогов простагландина наблюдались периорбитальные изменения и изменения век, включая углубление верхней борозды век.
Особые указания
До начала лечения пациенты должны быть предупреждены о возможности роста ресниц, потемнения кожи век и усиления пигментации радужной оболочки глаза. Некоторые из этих изменений могут оказаться постоянными, и это может привести к возникновению различий между глазами, если лечению подвергался только один глаз.Изменение пигментации радужной оболочки происходит медленно и в течение нескольких месяцев может оставаться незаметным. Изменение цвета глаз наблюдается преимущественно у пациентов с радужными оболочками смешанных цветов, например, если глаза коричнево-голубые, серо-коричневые, желто-коричневые или зелено-коричневые. Лечение только одного глаза может привести к стойкой гетерохромии.Сообщалось, что бензалкония хлорид, который обычно применяют в качестве консерванта в офтальмологических препаратах, вызывает точечную кератопатию и/или токсическую язвенную кератопатию. Поскольку тафлупрост в виде офтальмологического раствора содержит бензалкония хлорид, необходим тщательный мониторинг в случаях частого или продолжительного применения у пациентов с сухостью глаз, а также в случаях, когда роговица повреждена.Бензалкония хлорид, содержащийся в глазных каплях тафлупроста, также может вызывать раздражение глаз. Следует избегать контакта офтальмологического раствора тафлупроста с мягкими контактными линзами. Необходимо удалять контактные линзы перед инстилляцией тафлупроста и использовать их снова не ранее, чем через 15 мин после его применения. Известно, что бензалкония хлорид обесцвечивает мягкие контактные линзы.Влияние на способность управления транспортными средствами и механизмами. Тафлупрост не оказывает влияние на способность управлять автомобилем и работать с механизмами. Как и при применении любых других офтальмологических средств, после инстилляции тафлупроста может возникнуть кратковременное затуманивание зрения, поэтому необходимо воздержаться от управления транспортными средствами и выполнения видов деятельности, требующих повышенной концентрации внимания и быстроты психомоторных реакций, до восстановления зрения.RxList.comПигментацияИмеются сообщения, что офтальмологический раствор тафлупроста вызывает изменения в пигментированных тканях. Чаще всего эти изменения проявлялись в виде усиления пигментации радужной оболочки глаза, периорбитальных тканей (веко) и ресниц. Предполагается, что пигментация усиливается в течение всего периода применения тафлупроста. Изменения в пигментации вызваны скорее увеличением содержания меланина, чем увеличением числа меланоцитов. После прекращения применения тафлупроста пигментация радужной оболочки остается неизменной, в то время как у некоторых пациентов изменения пигментации периорбитальных тканей и ресниц бывают обратимыми. Пациенты, которые получают лечение тафлупростом, должны быть проинформированы о возможных изменениях пигментации. Долгосрочные эффекты усиления пигментации неизвестны.Изменение цвета радужной может оставаться незаметным в период от нескольких месяцев до нескольких лет. Как правило, пигментация коричневого цвета вокруг зрачка расширяется концентрически к периферии радужной оболочки и приводит к тому, что вся радужная оболочка или ее часть становятся коричневатыми. Ни невус, ни пятнышки на радужной оболочке не поддаются лечению. Пациенты, у которых обнаружено усиление пигментации радужной оболочки, должны регулярно наблюдаться в процессе лечения тафлупростом.Изменения ресницТафлупрост может вызвать постепенные изменения ресниц и пушковых волос в области глаза, подвергшегося лечению. Эти изменения включают увеличение длины ресниц, изменение их цвета, толщины, формы и числа и обычно обратимы после прекращения лечения.Внутриглазное воспалениеТафлупрост следует применять с осторожностью у пациентов с активным внутриглазным воспалением (например ирит/увеит) из-за опасности обострения заболевания.Отек макулы глазаПри лечении аналогами простагландина F2α были отмечены случаи отека макулы глаза, включая цистоидный макулярный отек. Тафлупрост следует применять с осторожностью у пациентов с афакией, псевдофакией с «задним» разрывом капсулы хрусталика или у пациентов с известными факторами риска макулярного отека.
Условия хранения
При температуре 2–8°C. Хранить в недоступном для детей месте.
Срок годности
3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России
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Данные о применении тафлупроста у беременных женщин отсутствуют. Тафлупрост может оказывать неблагоприятное фармакологическое воздействие на течение беременности и/или на плод/новорожденного ребенка. Исследования на животных продемонстрировали репродуктивную токсичность. В связи с этим тафлупрост не следует применять во время беременности, за исключением случаев, когда нет других вариантов лечения.Тафлупрост не должны применять женщины репродуктивного возраста, если они не используют адекватные средства контрацепции.Период грудного вскармливания. Неизвестно, проникает ли тафлупрост или его метаболиты в грудное молоко человека. В исследованиях на крысах была установлена экскреция тафлупроста в грудное молоко после местного применения.Поэтому тафлупрост не следует применять в период грудного вскармливания.Фертильность. У самок и самцов крыс способность к спариванию и рождаемость оставались неизменными при введении тафлупроста до 100 мкг/кг/сут внутривенно."}}]},{"id":4,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В рамках проведенных клинических исследований свыше 1400 пациентов подвергались лечению тафлупростом с консервантом— как в качестве монотерапии, так и в качестве дополнительного ЛС к лечению 0,5% тимололом. Наиболее часто выявляемым побочным эффектом, связанным с лечением, была гиперемия глаз, которая отмечалась примерно у 13% пациентов, принимавших участие в клинических исследованиях тафлупроста с консервантом в Европе и США. В большинстве случаев гиперемия была умеренной и привела к прекращению лечения в среднем у 0,4% пациентов. В 3-месячном исследовании III фазы в США при сравнении состава тафлупроста 0,0015% без консерванта с тимололом, также без консерванта, гиперемия глаз отмечалась у 4,1% (13/320) пациентов, получавших тафлупрост.Для обозначения частоты нежелательных явлений используется следующая классификация: очень часто (≥1/10 случаев); часто (≥1/100, \u003c1/10); нечасто (≥1/1000, \u003c1/100); редко (≥1/10000, \u003c1/1000); очень редко (\u003c1/10000) и неизвестно (частота не может быть определена из имеющихся данных).Ниже представлены наиболее часто встречавшиеся побочные эффекты при применении тафлупроста в виде 0,0015% офтальмологического раствора.Со стороны нервной системы: часто— головная боль.Со стороны органа зрения: очень часто— гиперемия конъюнктивы/глаз; часто— зуд в глазах, раздражение глаз, боль в глазах, изменения ресниц (увеличение длины, толщины и числа ресниц), сухость глаз, изменение цвета ресниц, ощущение инородного тела в глазах, эритема век, поверхностный точечный кератит, затуманивание зрения, повышенная слезоточивость, снижение остроты зрения, светобоязнь и повышенная пигментация радужной оболочки; нечасто— астенопия, отек конъюнктивы, блефарит, опалесценция влаги передней камеры, конъюнктивальные фолликулы, аллергический конъюнктивит, клеточная реакция влаги передней камеры, пигментация конъюнктивы, чувство дискомфорта в глазах, пигментация век, отек век, выделения из глаз; неизвестно— ирит/увеит, углубление складки века. Сообщалось об очень редких случаях отложения кальцификатов в ткани роговицы в связи с применением фосфатсодержащих глазных капель у некоторых пациентов со значительным поражением роговицы.Со стороны дыхательной системы, органов грудной клетки и средостения: неизвестно— обострение бронхиальной астмы, диспноэ.Со стороны кожи и подкожной ткани: нечасто— гипертрихоз век.RxList.comРезультаты клинических испытаний. Так как клинические испытания проведены с различным набором условий, частота встречаемости побочных реакций, отмеченных в этих исследованиях, может не совпадать с полученной в других исследованиях и с наблюдаемой в клинической практике.Тафлупрост в виде 0,0015% офтальмологического раствора, содержащего или не содержащего консервант, оценивался у 905 пациентов в 5 контролируемых клинических исследованиях продолжительностью до 24 мес. Чаще всего у пациентов, подвергшихся лечению тафлупростом, наблюдалась побочная реакция в виде гиперемии конъюнктивы (от 4 до 20% пациентов). Приблизительно 1% пациентов прекратили терапию из-за глазных побочных эффектов.Глазные побочные эффекты, наблюдавшиеся с частотой ≥2% в указанных выше клинических исследованиях, включали жжение/раздражение (7%), зуд, включая аллергический конъюнктивит (5%), катаракту (3%), сухость глаз (3%), боль в глазах (3%), потемнение ресниц (2%), рост ресниц (2%) и затуманивание зрения (2%).К неглазным побочным эффектам, наблюдавшимся с частотой от 2 до 6% у пациентов, подвергавшихся лечению тафлупростом в виде 0,0015% офтальмологического раствора в этих клинических исследованиях, относились головная боль (6%), насморк (4%), кашель (3%) и инфекции мочевого тракта (2%).Постмаркетинговые исследования. Данные о побочных реакциях в постмаркетинговый период получены на добровольной основе от популяции неустановленного размера, поэтому они не всегда могут реально отражать их частоту или свидетельствовать о реальной связи с применением лекарства. Эти данные включают:Со стороны органов дыхания: обострение астмы, одышка.Нарушения органа зрения: воспаление радужной оболочки глаза, увеит.В постмаркетинговых исследованиях с применением аналогов простагландина наблюдались периорбитальные изменения и изменения век, включая углубление верхней борозды век."}}]},{"id":5,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"До начала лечения пациенты должны быть предупреждены о возможности роста ресниц, потемнения кожи век и усиления пигментации радужной оболочки глаза. Некоторые из этих изменений могут оказаться постоянными, и это может привести к возникновению различий между глазами, если лечению подвергался только один глаз.Изменение пигментации радужной оболочки происходит медленно и в течение нескольких месяцев может оставаться незаметным. Изменение цвета глаз наблюдается преимущественно у пациентов с радужными оболочками смешанных цветов, например, если глаза коричнево-голубые, серо-коричневые, желто-коричневые или зелено-коричневые. Лечение только одного глаза может привести к стойкой гетерохромии.Сообщалось, что бензалкония хлорид, который обычно применяют в качестве консерванта в офтальмологических препаратах, вызывает точечную кератопатию и/или токсическую язвенную кератопатию. Поскольку тафлупрост в виде офтальмологического раствора содержит бензалкония хлорид, необходим тщательный мониторинг в случаях частого или продолжительного применения у пациентов с сухостью глаз, а также в случаях, когда роговица повреждена.Бензалкония хлорид, содержащийся в глазных каплях тафлупроста, также может вызывать раздражение глаз. Следует избегать контакта офтальмологического раствора тафлупроста с мягкими контактными линзами. Необходимо удалять контактные линзы перед инстилляцией тафлупроста и использовать их снова не ранее, чем через 15 мин после его применения. Известно, что бензалкония хлорид обесцвечивает мягкие контактные линзы.Влияние на способность управления транспортными средствами и механизмами. Тафлупрост не оказывает влияние на способность управлять автомобилем и работать с механизмами. Как и при применении любых других офтальмологических средств, после инстилляции тафлупроста может возникнуть кратковременное затуманивание зрения, поэтому необходимо воздержаться от управления транспортными средствами и выполнения видов деятельности, требующих повышенной концентрации внимания и быстроты психомоторных реакций, до восстановления зрения.RxList.comПигментацияИмеются сообщения, что офтальмологический раствор тафлупроста вызывает изменения в пигментированных тканях. Чаще всего эти изменения проявлялись в виде усиления пигментации радужной оболочки глаза, периорбитальных тканей (веко) и ресниц. Предполагается, что пигментация усиливается в течение всего периода применения тафлупроста. Изменения в пигментации вызваны скорее увеличением содержания меланина, чем увеличением числа меланоцитов. После прекращения применения тафлупроста пигментация радужной оболочки остается неизменной, в то время как у некоторых пациентов изменения пигментации периорбитальных тканей и ресниц бывают обратимыми. Пациенты, которые получают лечение тафлупростом, должны быть проинформированы о возможных изменениях пигментации. Долгосрочные эффекты усиления пигментации неизвестны.Изменение цвета радужной может оставаться незаметным в период от нескольких месяцев до нескольких лет. Как правило, пигментация коричневого цвета вокруг зрачка расширяется концентрически к периферии радужной оболочки и приводит к тому, что вся радужная оболочка или ее часть становятся коричневатыми. Ни невус, ни пятнышки на радужной оболочке не поддаются лечению. Пациенты, у которых обнаружено усиление пигментации радужной оболочки, должны регулярно наблюдаться в процессе лечения тафлупростом.Изменения ресницТафлупрост может вызвать постепенные изменения ресниц и пушковых волос в области глаза, подвергшегося лечению. Эти изменения включают увеличение длины ресниц, изменение их цвета, толщины, формы и числа и обычно обратимы после прекращения лечения.Внутриглазное воспалениеТафлупрост следует применять с осторожностью у пациентов с активным внутриглазным воспалением (например ирит/увеит) из-за опасности обострения заболевания.Отек макулы глазаПри лечении аналогами простагландина F2α были отмечены случаи отека макулы глаза, включая цистоидный макулярный отек. Тафлупрост следует применять с осторожностью у пациентов с афакией, псевдофакией с «задним» разрывом капсулы хрусталика или у пациентов с известными факторами риска макулярного отека."}}]},{"id":6,"name":"Условия хранения","slug":"storage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При температуре 2–8°C. Хранить в недоступном для детей месте."}}]},{"id":7,"name":"Срок годности","slug":"expiry_date","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. 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