В 1 мл содержится дорзоламида гидрохлорид 22.26 мг, что соответствует содержанию дорзоламида основания 20 мг, тимолола малеат 6.83 мг, что соответствует содержанию тимолола основания 5 мг. Вспомогательные вещества: бензалкония хлорид (в виде 50% раствора бензалкония хлорида) - 0.075 мг (0.15 мг), натрия цитрат - 2.94 мг, маннитол - 16 мг, гиэтеллоза (гидроксиэтилцеллюлоза) - 4.75 мг, 1М раствор натрия гидроксида - q.s. до pH 5.6, вода д/и - q.s. до 1 мл.
Фармакологические свойства
Противоглаукомный препарат, содержит два активных компонента: дорзоламида гидрохлорид и тимолола малеат, каждый из которых уменьшает повышенное внутриглазное давление за счет снижения секреции внутриглазной жидкости. Совместное действие этих веществ в составе комбинированного препарата Косопт приводит к более выраженному снижению внутриглазного давления. Дорзоламида гидрохлорид - селективный ингибитор карбоангидразы II типа. Ингибирование карбоангидразы цилиарного тела приводит к снижению секреции внутриглазной жидкости, предположительно за счет уменьшения образования бикарбонатных ионов, что в свою очередь приводит к замедлению транспорта натрия и жидкости. Тимолола малеат - неселективный бета-адреноблокатор. Хотя точный механизм действия тимолола малеата в снижении внутриглазного давления до сих пор не установлен, ряд исследований показали преимущественное снижение образования, а также незначительное усиление оттока жидкости
Показания к применению
Для лечения повышенного внутриглазного давления при: открытоугольной глаукоме, псевдоэксфолиативной глаукоме
Противопоказания
Бронхиальная астма, бронхиальная астма в анамнезе, тяжелая ХОБЛ;
Синусовая брадикардия, AV-блокада II и III степени, выраженная сердечная недостаточность, кардиогенный шок
Почечная недостаточность тяжелой степени (КК < 30 мл/мин)
Дистрофические процессы в роговице
Беременность
Период лактации (грудного вскармливания)
Детский и подростковый возраст до 18 лет (в связи с недостатком данных по эффективности и безопасности)
Повышенная чувствительность к компонентам препарата
Применение при беременности и в период грудного вскармливания
Противопоказано
Способ применения и дозы
Косопт назначают по 1 капле в конъюнктивальный мешок пораженного глаза (или обоих глаз) 2 раза/сут. В случае если Косопт назначают в качестве замены другого офтальмологического препарата для лечения глаукомы, последний следует отменить за день до начала терапии Косоптом. В случае совместного использования с другим местным офтальмологическим препаратом, Косопт следует назначать с интервалом не менее 10 мин
Побочное действие
Косопт в целом хорошо переносится. В клинических исследованиях побочных эффектов, свойственных исключительно этому комбинированному препарату, не наблюдалось. Побочное реакции ограничивались уже известными побочными эффектами дорзоламида гидрохлорида и/или тимолола малеата. В целом системные Побочное эффекты были слабо выражены и не приводили к отмене препарата. В клинических исследованиях Косопт назначался 1035 пациентам. Около 2.4% пациентов препарат был отменен в связи с местными побочными реакциями со стороны глаза. Приблизительно 1.2% пациентов препарат был отменен из-за местных побочных реакций по типу гиперчувствительности или аллергии. Наиболее часто наблюдались Побочное эффекты со стороны органа зрения: чувство жжения или зуда в глазу, искажение вкуса, эрозии роговицы, инъекции конъюнктивы, нечеткость зрения, слезотечение. Ниже приведены возможные Побочное эффекты компонентов препарата. Дорзоламида гидрохлоридСо стороны органа зрения: воспаление века, раздражение и шелушение века, иридоциклит, точечный кератит, транзиторная миопия (проходящая после отмены препарата). Со стороны нервной системы: головная боль, головокружение, парестезии. Аллергические реакции: ангионевротический отек, бронхоспазм, крапивница, зуд. Прочие: астения/усталость, носовое кровотечение, раздражение глотки, сухость во рту, сыпь. Тимолола малеат (местное применение)Со стороны органа зрения: конъюнктивит, блефарит, кератит, снижение чувствительности роговицы, сухость; расстройства зрения, включающие изменения преломляющей способности глаза (в ряде случаев из-за отмены миотиков), диплопия, птоз. Со стороны сердечно-сосудистой системы: звон в ушах, аритмия, гипотензия, обморок, сердечно-сосудистые нарушения, нарушения ритма, остановка сердца, отеки, хромота, парестезии, феномен Рейно, снижение температуры рук и ног. Со стороны дыхательной системы: бронхоспазм (преимущественно у пациентов с предшествующей бронхообструктивной патологией), кашель. Дерматологические реакции: алопеция, псориазоподобные высыпания или обострение псориаза. Аллергические реакции: анафилаксия, ангионевротический отек, крапивница, локальные или генерализованные высыпания. Со стороны ЦНС: головокружение; депрессия, бессонница, кошмарные сновидения, снижение памяти, нарастание симптомов миастении. Со стороны пищеварительной системы: диарея, диспепсия, сухость во рту. Со стороны организма в целом: головная боль, астения, усталость, боль в груди, снижение либидо, болезнь Пейрони, системная красная волчанка
Передозировка
Данные по случайной или преднамеренной передозировке Косопта отсутствуют. Симптомы: описаны случаи неумышленной передозировки глазных капель, содержащих тимолола малеат, с развитием системных эффектов передозировки бета-адреноблокаторов, принимаемых внутрь: головокружение, головная боль, одышка, брадикардия, бронхоспазм, остановка сердца. Наиболее ожидаемыми симптомами передозировки дорзоламида являются нарушение электролитного баланса, развитие ацидоза, возможные побочные эффекты со стороны ЦНС. Лечение: проведение симптоматической и поддерживающей терапии. Следует контролировать уровень электролитов (прежде всего натрия) и рН плазмы крови. В исследованиях также показано, что тимолол не удаляется при диализе.
Особые указания
49% пациентов в клинических исследованиях были в возрасте 65 лет и старше, 13% пациентов - в возрасте 75 лет и старше. Разницы в эффективности и безопасности препарата в этих возрастных группах по сравнению с более молодыми пациентами не было. Тем не менее, не следует исключать возможности более высокой чувствительности к препарату у некоторых пожилых пациентов. Активные вещества препарата Косопт могут абсорбироваться в системный кровоток. Входящий в состав препарата тимолол является бета-адреноблокатором, таким образом побочные реакции, известные при системном применении бета-адреноблокаторов, могут отмечаться при местном применении препарата, в т.ч. обострение вазоспастической стенокардии (стенокардии Принцметала), нарушения периферического и центрального кровообращения, артериальная гипотензия. Необходим адекватный контроль сердечной недостаточности перед началом лечения Косоптом. Пациенты с тяжелой патологией сердца в анамнезе и признаками сердечной недостаточности должны находиться под тщательным наблюдением, необходимо следить за ЧСС у таких пациентов. При появлении первых признаков или симптомов сердечной недостаточности использование Косопта следует прекратить. Зарегистрированы сообщения о смерти в результате бронхоспазма у пациентов с бронхиальной астмой и сердечной недостаточностью на фоне применения глазных капель, содержащих тимолола малеат. Не проводилось исследований применения Косопта у пациентов с печеночной недостаточностью, в связи с чем препарат у таких пациентов следует применять с осторожностью. Применение системных ингибиторов карбоангидразы может приводить к нарушению КЩР и сопровождаться уролитиазом, особенно у пациентов с мочекаменной болезнью в анамнезе. Во время применения Косопта подобных нарушений не наблюдалось, сообщения об уролитиазе были редкими. Т.к. в состав Косопта входит ингибитор карбоангидразы, который при местном применении может абсорбироваться и проникать в системный кровоток, то риск развития уролитиаза у пациентов с мочекаменной болезнью в анамнезе может повышаться при лечении Косоптом. Терапия бета-адреноблокаторами может искажать некоторые симптомы гипогликемии у пациентов с сахарным диабетом или гипогликемией. Бета-адреноблокаторы могут сглаживать течение гипертиреоза. Прекращение приема бета-адреноблокаторов может быть причиной ухудшения состояния. В случае предстоящего оперативного вмешательства под общей анестезией, необходимо отменить препарат за 48 ч до операции, т.к. тимолол усиливает действие миорелаксантов и общих анестетиков. В состав Косопта входит консервант бензалкония хлорид, который может быть причиной возникновения раздражения глаза. Линзы следует вынуть перед закапыванием препарата и подождать в течение не менее 15 мин после закапывания перед тем, как вновь их надеть. Бензалкония хлорид способен обесцвечивать мягкие контактные линзы. Влияние на способность к вождению автотранспорта и управлению механизмамиПри применении Косопта возможно развитие побочных эффектов, которые у некоторых пациентов могут затруднять управление автомобилем или работу со сложными механизмами
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1 мл содержится дорзоламида гидрохлорид 22.26 мг, что соответствует содержанию дорзоламида основания 20 мг, тимолола малеат 6.83 мг, что соответствует содержанию тимолола основания 5 мг. Вспомогательные вещества: бензалкония хлорид (в виде 50% раствора бензалкония хлорида) - 0.075 мг (0.15 мг), натрия цитрат - 2.94 мг, маннитол - 16 мг, гиэтеллоза (гидроксиэтилцеллюлоза) - 4.75 мг, 1М раствор натрия гидроксида - q.s. до pH 5.6, вода д/и - q.s. до 1 мл."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противоглаукомный препарат, содержит два активных компонента: дорзоламида гидрохлорид и тимолола малеат, каждый из которых уменьшает повышенное внутриглазное давление за счет снижения секреции внутриглазной жидкости. Совместное действие этих веществ в составе комбинированного препарата Косопт приводит к более выраженному снижению внутриглазного давления. Дорзоламида гидрохлорид - селективный ингибитор карбоангидразы II типа. Ингибирование карбоангидразы цилиарного тела приводит к снижению секреции внутриглазной жидкости, предположительно за счет уменьшения образования бикарбонатных ионов, что в свою очередь приводит к замедлению транспорта натрия и жидкости. Тимолола малеат - неселективный бета-адреноблокатор. Хотя точный механизм действия тимолола малеата в снижении внутриглазного давления до сих пор не установлен, ряд исследований показали преимущественное снижение образования, а также незначительное усиление оттока жидкости"}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Для лечения повышенного внутриглазного давления при: открытоугольной глаукоме, псевдоэксфолиативной глаукоме"}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Бронхиальная астма, бронхиальная астма в анамнезе, тяжелая ХОБЛ;"}},{"type":"list","data":{"style":"unordered","items":["Синусовая брадикардия, AV-блокада II и III степени, выраженная сердечная недостаточность, кардиогенный шок","Почечная недостаточность тяжелой степени (КК \u003c 30 мл/мин)","Дистрофические процессы в роговице","Беременность","Период лактации (грудного вскармливания)","Детский и подростковый возраст до 18 лет (в связи с недостатком данных по эффективности и безопасности)","Повышенная чувствительность к компонентам препарата"]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказано"}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Косопт назначают по 1 капле в конъюнктивальный мешок пораженного глаза (или обоих глаз) 2 раза/сут. В случае если Косопт назначают в качестве замены другого офтальмологического препарата для лечения глаукомы, последний следует отменить за день до начала терапии Косоптом. В случае совместного использования с другим местным офтальмологическим препаратом, Косопт следует назначать с интервалом не менее 10 мин"}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Косопт в целом хорошо переносится. В клинических исследованиях побочных эффектов, свойственных исключительно этому комбинированному препарату, не наблюдалось. Побочное реакции ограничивались уже известными побочными эффектами дорзоламида гидрохлорида и/или тимолола малеата. В целом системные Побочное эффекты были слабо выражены и не приводили к отмене препарата. В клинических исследованиях Косопт назначался 1035 пациентам. Около 2.4% пациентов препарат был отменен в связи с местными побочными реакциями со стороны глаза. Приблизительно 1.2% пациентов препарат был отменен из-за местных побочных реакций по типу гиперчувствительности или аллергии. Наиболее часто наблюдались Побочное эффекты со стороны органа зрения: чувство жжения или зуда в глазу, искажение вкуса, эрозии роговицы, инъекции конъюнктивы, нечеткость зрения, слезотечение. Ниже приведены возможные Побочное эффекты компонентов препарата. Дорзоламида гидрохлоридСо стороны органа зрения: воспаление века, раздражение и шелушение века, иридоциклит, точечный кератит, транзиторная миопия (проходящая после отмены препарата). Со стороны нервной системы: головная боль, головокружение, парестезии. Аллергические реакции: ангионевротический отек, бронхоспазм, крапивница, зуд. Прочие: астения/усталость, носовое кровотечение, раздражение глотки, сухость во рту, сыпь. Тимолола малеат (местное применение)Со стороны органа зрения: конъюнктивит, блефарит, кератит, снижение чувствительности роговицы, сухость; расстройства зрения, включающие изменения преломляющей способности глаза (в ряде случаев из-за отмены миотиков), диплопия, птоз. Со стороны сердечно-сосудистой системы: звон в ушах, аритмия, гипотензия, обморок, сердечно-сосудистые нарушения, нарушения ритма, остановка сердца, отеки, хромота, парестезии, феномен Рейно, снижение температуры рук и ног. Со стороны дыхательной системы: бронхоспазм (преимущественно у пациентов с предшествующей бронхообструктивной патологией), кашель. Дерматологические реакции: алопеция, псориазоподобные высыпания или обострение псориаза. Аллергические реакции: анафилаксия, ангионевротический отек, крапивница, локальные или генерализованные высыпания. Со стороны ЦНС: головокружение; депрессия, бессонница, кошмарные сновидения, снижение памяти, нарастание симптомов миастении. Со стороны пищеварительной системы: диарея, диспепсия, сухость во рту. Со стороны организма в целом: головная боль, астения, усталость, боль в груди, снижение либидо, болезнь Пейрони, системная красная волчанка"}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Данные по случайной или преднамеренной передозировке Косопта отсутствуют. Симптомы: описаны случаи неумышленной передозировки глазных капель, содержащих тимолола малеат, с развитием системных эффектов передозировки бета-адреноблокаторов, принимаемых внутрь: головокружение, головная боль, одышка, брадикардия, бронхоспазм, остановка сердца. Наиболее ожидаемыми симптомами передозировки дорзоламида являются нарушение электролитного баланса, развитие ацидоза, возможные побочные эффекты со стороны ЦНС. Лечение: проведение симптоматической и поддерживающей терапии. Следует контролировать уровень электролитов (прежде всего натрия) и рН плазмы крови. В исследованиях также показано, что тимолол не удаляется при диализе."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"49% пациентов в клинических исследованиях были в возрасте 65 лет и старше, 13% пациентов - в возрасте 75 лет и старше. Разницы в эффективности и безопасности препарата в этих возрастных группах по сравнению с более молодыми пациентами не было. Тем не менее, не следует исключать возможности более высокой чувствительности к препарату у некоторых пожилых пациентов. Активные вещества препарата Косопт могут абсорбироваться в системный кровоток. Входящий в состав препарата тимолол является бета-адреноблокатором, таким образом побочные реакции, известные при системном применении бета-адреноблокаторов, могут отмечаться при местном применении препарата, в т.ч. обострение вазоспастической стенокардии (стенокардии Принцметала), нарушения периферического и центрального кровообращения, артериальная гипотензия. Необходим адекватный контроль сердечной недостаточности перед началом лечения Косоптом. Пациенты с тяжелой патологией сердца в анамнезе и признаками сердечной недостаточности должны находиться под тщательным наблюдением, необходимо следить за ЧСС у таких пациентов. При появлении первых признаков или симптомов сердечной недостаточности использование Косопта следует прекратить. Зарегистрированы сообщения о смерти в результате бронхоспазма у пациентов с бронхиальной астмой и сердечной недостаточностью на фоне применения глазных капель, содержащих тимолола малеат. Не проводилось исследований применения Косопта у пациентов с печеночной недостаточностью, в связи с чем препарат у таких пациентов следует применять с осторожностью. Применение системных ингибиторов карбоангидразы может приводить к нарушению КЩР и сопровождаться уролитиазом, особенно у пациентов с мочекаменной болезнью в анамнезе. Во время применения Косопта подобных нарушений не наблюдалось, сообщения об уролитиазе были редкими. Т.к. в состав Косопта входит ингибитор карбоангидразы, который при местном применении может абсорбироваться и проникать в системный кровоток, то риск развития уролитиаза у пациентов с мочекаменной болезнью в анамнезе может повышаться при лечении Косоптом. Терапия бета-адреноблокаторами может искажать некоторые симптомы гипогликемии у пациентов с сахарным диабетом или гипогликемией. Бета-адреноблокаторы могут сглаживать течение гипертиреоза. Прекращение приема бета-адреноблокаторов может быть причиной ухудшения состояния. В случае предстоящего оперативного вмешательства под общей анестезией, необходимо отменить препарат за 48 ч до операции, т.к. тимолол усиливает действие миорелаксантов и общих анестетиков. В состав Косопта входит консервант бензалкония хлорид, который может быть причиной возникновения раздражения глаза. 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