доброкачественная гиперплазия предстательной железы; задержка оттока мочи и симптомы, связанные с доброкачественной гиперплазией предстательной железы; артериальная гипертензия (в составе комбинированной терапии).
Противопоказания
повышенная чувствительность к хиназолинам, доксазозину или любому из вспомогательных компонентов препарата; дефицит лактазы, непереносимость лактозы, глюкозо-галактозная мальабсорбция; возраст до 18 лет; тяжелая печеночная недостаточность в связи с отсутствием опыта применения у данной категории пациентов; инфекции мочевыводящих путей; анурия; прогрессирующая ...
доброкачественная гиперплазия предстательной железы; задержка оттока мочи и симптомы, связанные с доброкачественной гиперплазией предстательной железы; артериальная гипертензия (в составе комбинированной терапии).
Противопоказания
повышенная чувствительность к хиназолинам, доксазозину или любому из вспомогательных компонентов препарата; дефицит лактазы, непереносимость лактозы, глюкозо-галактозная мальабсорбция; возраст до 18 лет; тяжелая печеночная недостаточность в связи с отсутствием опыта применения у данной категории пациентов; инфекции мочевыводящих путей; анурия; прогрессирующая почечная недостаточность; гипотензия и склонность к ортостатическим нарушениям (в т.ч. в анамнезе); сопутствующая обструкция верхних мочевыводящих путей; камни в мочевом пузыре.
С осторожностью: митральный и аортальный стеноз, сердечная недостаточность с повышением минутного выброса, правожелудочковая недостаточность, обусловленная эмболией легочной артерии или экссудативным перикардитом, левожелудочковая недостаточность с низким давлением наполнения, нарушения мозгового кровообращения, пожилой возраст, одновременное применение с ингибиторами фосфодиэстеразы 5-го типа (ФДЭ-5), т.к. может возникать симптоматическая гипотензия, печеночная недостаточность.
Применение при беременности и в период грудного вскармливания
Хотя в экспериментах на животных препарат не оказывал тератогенное действие, но при применении его в исключительно высоких дозах наблюдалось снижение выживаемости плода. Указанные дозы примерно в 300 раз превосходили максимальные рекомендуемые дозы для человека. Из-за отсутствия адекватных хорошо контролируемых исследований у беременных или кормящих женщин, безопасность применения препарата Кардура во время беременности или в период кормления грудью еще не установлена. В связи с этим во время беременности или в период лактации препарат Кардура может быть использован только тогда, когда по мнению врача, потенциальная польза для матери превышает потенциальный риск для плода или ребенка.
Способ применения и дозы
Внутрь (возможно применение как утром, так и вечером).; ДГПЖ; Рекомендуемая начальная доза препарата Кардура составляет 1 мг 1 раз в сутки для того, чтобы свести к минимуму возможность развития постуральной гипотензии и/или синкопального состояния (обморок) (см. «Особые указания»). В зависимости от индивидуальных особенностей показателей уродинамики и наличия симптомов ДГПЖ, дозу можно увеличить до 2 мг, а затем - до 4 мг и до максимальной рекомендуемой дозы - 8 мг. Рекомендуемый интервал для повышения дозы составляет 1–2 нед. Обычно рекомендуемая доза равна 2–4 мг 1 раз в сутки.; Артериальная гипертензия; Дозировка варьирует от 1 до 16 мг/сут. Лечение рекомендуется начинать с 1 мг 1 раз в сутки в течение 1 или 2 нед для того, чтобы свести к минимуму возможность развития постуральной гипотензии и/или синкопального состояния (обморок) (феномен первой дозы) (см. «Особые указания»). После приема первой дозы пациенту необходимо мониторирование АД в течение 6–8 ч. Это требуется в связи с возможностью развития феномена первой дозы, особенно выраженной на фоне предшествующего приема диуретиков.; В течение последующих 1 или 2 нед доза может быть увеличена до 2 мг 1 раз в сутки. Для достижения желаемого снижения АД, если необходимо, суточную дозу следует увеличивать постепенно, соблюдая равномерные интервалы до 4 мг, 8 мг и до максимальной - 16 мг, в зависимости от выраженности реакции пациента на прием препарата.; Обычно доза составляет 2–4 мг 1 раз в сутки.; Если к терапии добавляется диуретик или другое гипотензивное средство, необходимо корректировать дозу препарата Кардура в зависимости от состояния пациента с дальнейшим ее титрованием под контролем врача.; В случае если терапия препаратом Кардура была прервана на несколько дней, возобновлять применение препарата следует с начальной дозы.; Применение у пациентов пожилого возраста. Корректировка дозы не требуется.; Применение при почечной недостаточности. Фармакокинетика доксазозина у больных почечной недостаточностью не меняется, а сам препарат не ухудшает имеющуюся почечную дисфункцию, поэтому у таких больных его применяют в обычных дозах.; Применение при печеночной недостаточности. Необходимо соблюдать осторожность (см. «Особые указания»).; Применение у детей. Опыт применения препарата Кардура у детей отсутствует.
Побочное действие
Частота нежелательных реакций представлена по следующей классификации: очень часто - ≥10%; часто - ≥1% и <10%; нечасто - ≥0,1% и <1%; редко - ≥0,01% и <0,1%; очень редко - <0,01%.; ДГПЖ; По данным контролируемых клинических исследований, у больных ДГПЖ встречались те же побочные реакции, что и у больных артериальной гипертензией.; При постмаркетинговом применении препарата сообщалось о следующих нежелательных реакциях.; Со стороны кроветворной и лимфатической системы: очень редко - лейкопения, тромбоцитопения.; Со стороны органа слуха и вестибулярного аппарата: нечасто - шум в ушах.; Со стороны органа зрения: часто - нарушение цветового восприятия; нечасто - синдром атоничной радужки.; Со стороны ЖКТ: часто - боль в животе, диарея, диспепсия, сухость слизистой оболочки полости рта; нечасто - метеоризм, запор, рвота.; Со стороны печени: очень редко - холестаз, гепатит, желтуха.; Со стороны иммунной системы: очень редко - анафилактические реакции.; Лабораторные показатели: нечасто - увеличение массы тела; очень редко - повышение активности печеночных трансаминаз.; Со стороны обмена веществ: нечасто - анорексия.; Со стороны опорно-двигательного аппарата: нечасто - артралгия, боль в спине, мышечные спазмы, мышечная слабость, миалгия.; Со стороны ЦНС и периферической нервной системы: часто - парестезии; нечасто - гипестезии, тремор.; Со стороны психики: часто - возбуждение, беспокойство, бессонница; нечасто - депрессия.; Со стороны мочевыводящих путей: нечасто - учащение мочеиспускания, полиурия, недержание мочи; очень редко - дизурия, гематурия, никтурия.; Со стороны репродуктивной системы: очень редко - гинекомастия, импотенция, приапизм; очень редко - ретроградная эякуляция.; Со стороны дыхательной системы: часто - одышка, ринит; нечасто - кашель, носовое кровотечение; очень редко - обострение имеющегося бронхоспазма.; Со стороны кожных покровов: нечасто - алопеция, кожный зуд, кожная сыпь, пурпура; очень редко - крапивница.; Со стороны ССС: нечасто - приливы крови к коже лица, выраженное снижение АД, постуральная гипотензия.; Прочие: нечасто - боли различной локализации.; Артериальная гипертензия; В контролируемых клинических исследованиях препарата Кардура наиболее часто встречались побочные реакции, которые можно отнести к типу постуральных (изредка связанные с обмороком) или неспецифических, которые включали перечисленные ниже реакции.; Со стороны органа слуха и вестибулярного аппарата: часто - вертиго.; Со стороны ЖКТ: часто - тошнота.; Со стороны ЦНС и периферической нервной системы: очень часто - головокружение, головная боль; часто - постуральное головокружение (после приема первой дозы может развиться выраженное снижение АД, которое может привести к ортостатическому головокружению, в тяжелых случаях, особенно при быстром переходе из положения лежа в положение стоя или в положение сидя - к обмороку), сонливость.; Со стороны дыхательной системы: часто - ринит.; Прочие: часто - астения, отеки нижних конечностей, утомляемость, слабость.; Следующие побочные реакции отмечалась в процессе маркетингового применении препарата Кардура у больных артериальной гипертензией, хотя в целом такие симптомы могли наблюдаться и при отсутствии лечения этим препаратом: часто - тахикардия, ощущение сердцебиения, боль в грудной клетке; нечасто - стенокардия, инфаркт миокарда и аритмии; очень редко - брадикардия, нарушения мозгового кровообращения.
Передозировка
Симптомы: выраженное снижение АД, иногда сопровождающееся обмороками.; Лечение: необходимо немедленно уложить больного на спину и приподнять ноги, при необходимости провести симптоматическую терапию. Связывание доксазозина с белками плазмы крови высокое, поэтому диализ неэффективен.
Особые указания
Постуральная гипотензия/обморок; Как и при лечении любыми альфа-адреноблокаторами, в особенности в начале терапии, у очень незначительного процента пациентов наблюдалась постуральная гипотензия, проявлявшаяся головокружением и слабостью или потерей сознания (обмороком) (см. «Способ применения и дозы»). Перед началом назначения любого альфа-адреноблокатора пациента необходимо предупредить, каким образом следует избегать симптомов развития постуральной гипотензии, в частности необходимо воздерживаться от быстрых перемен положения тела. В начале лечения препаратом Кардура пациенту следует дать рекомендации о необходимости соблюдать осторожность в случае появления слабости или головокружения.; Препарат Кардура следует применять с осторожностью у пожилых пациентов в связи с возможностью развития ортостатической гипотензии. С возрастом увеличивается риск возникновения головокружения, нарушения зрения и обморока.; Пациента необходимо проинформировать об увеличении риска развития ортостатической гипотензии при употреблении алкоголя, длительном стоянии или выполнении физических упражнений, а также при жаркой погоде.; ДГПЖ; У больных ДГПЖ препарат можно назначать как при наличии артериальной гипертензии, так и при нормальном АД. При применении препарата у больных с ДГПЖ с нормальным АД изменение последнего несущественно. При этом у больных с сочетанием артериальной гипертензии и ДГПЖ возможно применение препарата в монотерапии.; Перед началом терапии гиперплазии предстательной железы необходимо исключить ее раковое перерождение.; Доксазозин не влияет на концентрацию простатспецифического антигена в плазме крови.; Интраоперационный синдром атоничной радужки; Интраоперационный синдром атоничной радужки (вариант синдрома узкого зрачка) наблюдался у некоторых пациентов при проведении операции по поводу катаракты, которые получают или получали лечение альфа1-адреноблокаторами. В связи с тем, что интраоперационный синдром атоничной радужки может привести к учащению осложнений во время хирургических вмешательств, необходимо предупредить оперирующего хирурга о том, что альфа1-адреноблокаторы принимаются на данный момент или принимались ранее до операции.; Совместное применение с ингибиторами ФДЭ-5; Следует соблюдать осторожность при совместном применении препарата Кардура с ингибиторами ФДЭ-5, поскольку у некоторых пациентов это может привести к симптоматической гипотензии.; Нарушение функции печени; Необходимо соблюдать осторожность при назначении препарата Кардура, равно как и других ЛС, полностью подвергающихся биотрансформации в печени, пациентам с нарушением функции печени (см. «Фармакокинетика»), избегая назначения максимальных доз.; Влияние на способность управлять автомобилем или выполнять работы, требующие повышенной скорости физических и психических реакций. В период лечения необходимо соблюдать осторожность при управлении транспортными средствами и занятиями другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.; Несовместимость. Не известна.
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Для достижения желаемого снижения АД, если необходимо, суточную дозу следует увеличивать постепенно, соблюдая равномерные интервалы до 4 мг, 8 мг и до максимальной - 16 мг, в зависимости от выраженности реакции пациента на прием препарата.; Обычно доза составляет 2–4 мг 1 раз в сутки.; Если к терапии добавляется диуретик или другое гипотензивное средство, необходимо корректировать дозу препарата Кардура в зависимости от состояния пациента с дальнейшим ее титрованием под контролем врача.; В случае если терапия препаратом Кардура была прервана на несколько дней, возобновлять применение препарата следует с начальной дозы.; Применение у пациентов пожилого возраста. Корректировка дозы не требуется.; Применение при почечной недостаточности. Фармакокинетика доксазозина у больных почечной недостаточностью не меняется, а сам препарат не ухудшает имеющуюся почечную дисфункцию, поэтому у таких больных его применяют в обычных дозах.; Применение при печеночной недостаточности. Необходимо соблюдать осторожность (см. «Особые указания»).; Применение у детей. Опыт применения препарата Кардура у детей отсутствует."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Частота нежелательных реакций представлена по следующей классификации: очень часто - ≥10%; часто - ≥1% и \u003c10%; нечасто - ≥0,1% и \u003c1%; редко - ≥0,01% и \u003c0,1%; очень редко - \u003c0,01%.; ДГПЖ; По данным контролируемых клинических исследований, у больных ДГПЖ встречались те же побочные реакции, что и у больных артериальной гипертензией.; При постмаркетинговом применении препарата сообщалось о следующих нежелательных реакциях.; Со стороны кроветворной и лимфатической системы: очень редко - лейкопения, тромбоцитопения.; Со стороны органа слуха и вестибулярного аппарата: нечасто - шум в ушах.; Со стороны органа зрения: часто - нарушение цветового восприятия; нечасто - синдром атоничной радужки.; Со стороны ЖКТ: часто - боль в животе, диарея, диспепсия, сухость слизистой оболочки полости рта; нечасто - метеоризм, запор, рвота.; Со стороны печени: очень редко - холестаз, гепатит, желтуха.; Со стороны иммунной системы: очень редко - анафилактические реакции.; Лабораторные показатели: нечасто - увеличение массы тела; очень редко - повышение активности печеночных трансаминаз.; Со стороны обмена веществ: нечасто - анорексия.; Со стороны опорно-двигательного аппарата: нечасто - артралгия, боль в спине, мышечные спазмы, мышечная слабость, миалгия.; Со стороны ЦНС и периферической нервной системы: часто - парестезии; нечасто - гипестезии, тремор.; Со стороны психики: часто - возбуждение, беспокойство, бессонница; нечасто - депрессия.; Со стороны мочевыводящих путей: нечасто - учащение мочеиспускания, полиурия, недержание мочи; очень редко - дизурия, гематурия, никтурия.; Со стороны репродуктивной системы: очень редко - гинекомастия, импотенция, приапизм; очень редко - ретроградная эякуляция.; Со стороны дыхательной системы: часто - одышка, ринит; нечасто - кашель, носовое кровотечение; очень редко - обострение имеющегося бронхоспазма.; Со стороны кожных покровов: нечасто - алопеция, кожный зуд, кожная сыпь, пурпура; очень редко - крапивница.; Со стороны ССС: нечасто - приливы крови к коже лица, выраженное снижение АД, постуральная гипотензия.; Прочие: нечасто - боли различной локализации.; Артериальная гипертензия; В контролируемых клинических исследованиях препарата Кардура наиболее часто встречались побочные реакции, которые можно отнести к типу постуральных (изредка связанные с обмороком) или неспецифических, которые включали перечисленные ниже реакции.; Со стороны органа слуха и вестибулярного аппарата: часто - вертиго.; Со стороны ЖКТ: часто - тошнота.; Со стороны ЦНС и периферической нервной системы: очень часто - головокружение, головная боль; часто - постуральное головокружение (после приема первой дозы может развиться выраженное снижение АД, которое может привести к ортостатическому головокружению, в тяжелых случаях, особенно при быстром переходе из положения лежа в положение стоя или в положение сидя - к обмороку), сонливость.; Со стороны дыхательной системы: часто - ринит.; Прочие: часто - астения, отеки нижних конечностей, утомляемость, слабость.; Следующие побочные реакции отмечалась в процессе маркетингового применении препарата Кардура у больных артериальной гипертензией, хотя в целом такие симптомы могли наблюдаться и при отсутствии лечения этим препаратом: часто - тахикардия, ощущение сердцебиения, боль в грудной клетке; нечасто - стенокардия, инфаркт миокарда и аритмии; очень редко - брадикардия, нарушения мозгового кровообращения."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: выраженное снижение АД, иногда сопровождающееся обмороками.; Лечение: необходимо немедленно уложить больного на спину и приподнять ноги, при необходимости провести симптоматическую терапию. Связывание доксазозина с белками плазмы крови высокое, поэтому диализ неэффективен."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Постуральная гипотензия/обморок; Как и при лечении любыми альфа-адреноблокаторами, в особенности в начале терапии, у очень незначительного процента пациентов наблюдалась постуральная гипотензия, проявлявшаяся головокружением и слабостью или потерей сознания (обмороком) (см. «Способ применения и дозы»). Перед началом назначения любого альфа-адреноблокатора пациента необходимо предупредить, каким образом следует избегать симптомов развития постуральной гипотензии, в частности необходимо воздерживаться от быстрых перемен положения тела. В начале лечения препаратом Кардура пациенту следует дать рекомендации о необходимости соблюдать осторожность в случае появления слабости или головокружения.; Препарат Кардура следует применять с осторожностью у пожилых пациентов в связи с возможностью развития ортостатической гипотензии. С возрастом увеличивается риск возникновения головокружения, нарушения зрения и обморока.; Пациента необходимо проинформировать об увеличении риска развития ортостатической гипотензии при употреблении алкоголя, длительном стоянии или выполнении физических упражнений, а также при жаркой погоде.; ДГПЖ; У больных ДГПЖ препарат можно назначать как при наличии артериальной гипертензии, так и при нормальном АД. При применении препарата у больных с ДГПЖ с нормальным АД изменение последнего несущественно. При этом у больных с сочетанием артериальной гипертензии и ДГПЖ возможно применение препарата в монотерапии.; Перед началом терапии гиперплазии предстательной железы необходимо исключить ее раковое перерождение.; Доксазозин не влияет на концентрацию простатспецифического антигена в плазме крови.; Интраоперационный синдром атоничной радужки; Интраоперационный синдром атоничной радужки (вариант синдрома узкого зрачка) наблюдался у некоторых пациентов при проведении операции по поводу катаракты, которые получают или получали лечение альфа1-адреноблокаторами. В связи с тем, что интраоперационный синдром атоничной радужки может привести к учащению осложнений во время хирургических вмешательств, необходимо предупредить оперирующего хирурга о том, что альфа1-адреноблокаторы принимаются на данный момент или принимались ранее до операции.; Совместное применение с ингибиторами ФДЭ-5; Следует соблюдать осторожность при совместном применении препарата Кардура с ингибиторами ФДЭ-5, поскольку у некоторых пациентов это может привести к симптоматической гипотензии.; Нарушение функции печени; Необходимо соблюдать осторожность при назначении препарата Кардура, равно как и других ЛС, полностью подвергающихся биотрансформации в печени, пациентам с нарушением функции печени (см. «Фармакокинетика»), избегая назначения максимальных доз.; Влияние на способность управлять автомобилем или выполнять работы, требующие повышенной скорости физических и психических реакций. В период лечения необходимо соблюдать осторожность при управлении транспортными средствами и занятиями другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.; Несовместимость. 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