Острое нарушение мозгового кровообращения, тяжелые нарушения функции почек (клиренс креатинина менее 30 мл/мин) и/или печени (в т.ч. с печеночной энцефалопатией), гипокалиемия, беременность, период лактации, возраст до 18 лет (эффективность и безопасность не установлены), повышенная чувствительность к индапамиду, другим производным сульфонамида или ...
Таблетки Индапамид ретард, покрытые пленочной оболочкой пролонгированного действия - гипотензивное средство, тиазидоподобный диуретик с умеренным по силе и длительным по продолжительности действием. Оказывают антигипертензивный эффект.
Фармакологические свойства
Гипотензивное средство, тиазидоподобный диуретик с умеренным по силе и длительным по продолжительности действием, производное бензамидов. Обладает умеренным салуретическим и диуретическим эффектами, которые связаны с блокадой реабсорбции ионов натрия, хлора, водорода, и в меньшей степени ионов калия в проксимальных канальцах и кортикальном сегменте дистального канальца нефрона. Сосудорасширяющие эффекты и снижение общего периферического сопротивления сосудов имеют в своей основе следующие механизмы: снижение реактивности сосудистой стенки к норадреналину и ангиотензину II, увеличение синтеза простагландинов, обладающих сосудорасширяющей активностью, угнетение тока ионов кальция в гладкомышечные стенки сосудов. Снижает тонус гладкой мускулатуры артерий, уменьшает общее периферическое сопротивление сосудов. Способствует уменьшению гипертрофии левого желудочка сердца. В терапевтических дозах не влияет на липидный и углеводный обмен (в том числе у больных с сопутствующим сахарным диабетом). Антигипертензивный эффект развивается в конце первой/начале второй недели при постоянном приеме препарата и сохраняется в течение 24 часов на фоне однократного приема.
Показания к применению
Артериальная гипертензия
Противопоказания
Острое нарушение мозгового кровообращения, тяжелые нарушения функции почек (клиренс креатинина менее 30 мл/мин) и/или печени (в т.ч. с печеночной энцефалопатией), гипокалиемия, беременность, период лактации, возраст до 18 лет (эффективность и безопасность не установлены), повышенная чувствительность к индапамиду, другим производным сульфонамида или другим компонентам препарата. Данные таблетки содержат лактозы моногидрат (сахар молочный), в связи с этим препарат не должны принимать пациенты с редкими наследственными заболеваниями, такими как непереносимость лактозы, дефицит лактазы или глюкозо-галактозная мальабсорбция.
Применение при беременности и в период грудного вскармливания
Противопоказано при беременности и кормлении грудью.
Способ применения и дозы
Внутрь, не разжевывая, запивая достаточным количеством жидкости, независимо от приема пищи, преимущественно в утренние часы в дозе 1.5 мг (1 таблетка)/сутки. Если через 4-8 недель лечения не достигается желаемый терапевтический эффект, дозу препарата повышать не рекомендуется (возрастает риск побочных эффектов без усиления антигипертензивного эффекта). Вместо этого в схему медикаментозного лечения рекомендуется включить другой антигипертензивный препарат, не являющийся диуретиком. В случаях, когда лечение необходимо начинать с приема двух препаратов, доза Индапамида ретард остается равной 1.5 мг утром однократно в сутки. У пожилых пациентов следует контролировать плазменную концентрацию креатинина с учетом возраста, массы тела и пола, препарат можно применять пожилым пациентам с нормальной или незначительно нарушенной функцией почек.
Побочное действие
Большинство побочных реакций (лабораторные и клинические показатели) носят дозозависимый характер. Частота побочных реакций, которые могут быть вызваны тиазидоподобными диуретиками, включая индапамид, приведена в виде следующих градаций: очень часто (>1/10), часто (>1/100, <1/10), нечасто (>1/1000, <1/100), редко (>1/10 000, <1/1000), очень редко (<1/10 000), неуточненной частоты (частота не может быть подсчитана по доступным данным). Со стороны системы кроветворения: очень редко - тромбоцитопения, лейкопения, агранулоцитоз, апластическая анемия, гемолитическая анемия. Со стороны центральной нервной системы: редко - головокружение, утомляемость, головная боль, парестезии. Со стороны сердечно-сосудистой системы: очень редко - аритмия, снижение АД. Со стороны пищеварительной системы: нечасто - рвота, редко - тошнота, запор, сухость во рту, очень редко - панкреатит. Со стороны мочевыделительной системы: очень редко - почечная недостаточность. Со стороны печени и желчевыводящих путей: очень редко - нарушение функции печени, неуточненной частоты - возможность развития печеночной энцефалопатии в случае печеночной недостаточности. Со стороны кожных покровов: реакции повышенной чувствительности, в основном дерматологические, у пациентов с предрасположенностью к аллергическим и астматическим реакциям, часто - макулопапулезная сыпь, нечасто - геморрагический васкулит, очень редко - ангионевротический отек и /или крапивница, токсический эпидермальный некролиз, синдром Стивенса-Джонсона, неуточненной частоты - возможно ухудшение при наличии острой формы диссеминированной красной волчанки. Описаны случаи фоточувствительности. Лабораторные показатели: в клинических исследованиях гипокалиемия (содержание калия в плазме крови ≤3.4 ммоль/л) наблюдалась у 10% пациентов и 3.2 ммоль/л – у 4% пациентов после 4-6 недель лечения. После 12 недель терапии уровень калия в плазме крови снизился, в среднем, на 0.23 ммоль/л. Очень редко - гиперкальциемия, неуточненной частоты - гипокалиемия, гипонатриемия, сопровождающаяся гиповолемией, дегидратацией и ортостатической гипотензией. Одновременная потеря ионов хлора может приводить к компенсаторному метаболическому алкалозу, однако частота развития алкалоза и его выраженность не значительна, повышение уровня мочевой кислоты и глюкозы в плазме крови.
Передозировка
Симптомы: тошнота, рвота, слабость, нарушение функции ЖКТ (тошнота, рвота), водно-электролитные нарушения, выраженное снижение артериального давления, головокружение, сонливость, спутанность сознания, угнетение дыхания, полиурия, олигоурия вплоть до анурии, у пациентов с нарушением функции печени возможно развитие печеночной комы. Лечение: промывание желудка и/или назначение активированного угля с последующим восстановлением нормального водно-электролитного баланса, симптоматическая терапия. Специфического антидота нет.
Особые указания
Нарушения функции печени. У пациентов с печеночной недостаточностью при назначении тиазидоподобных диуретиков возможно развитие печеночной энцефалопатии, особенно при нарушении показателей водно-электролитного баланса. При ее развитии прием диуретиков следует прекратить. Фоточувствительность. При применении тиазидоподобных диуретиков отмечены случаи развития реакций фоточувствительности. В случае их развития прием препарата следует прекратить. На фоне терапии препаратом Индапамид ретард необходимо защищать открытые участки тела от воздействия солнечных лучей и искусственного ультрафиолетового излучения. Водно-электролитный баланс. Содержание ионов натрия в плазме крови: все диуретические препараты могут вызывать гипонатриемию. Содержание ионов натрия в плазме крови следует измерять перед началом лечения препаратом Индапамид ретард, а затем регулярно в период лечения. Определение содержания ионов натрия в плазме крови необходимо проводить до начала терапии препаратом Индапамид ретард, а так же в период терапии. Важно регулярно контролировать содержание ионов натрия в плазме крови, т.к. изначально гипонатриемия может протекать бессимптомно. Наиболее тщательный контроль содержания ионов натрия показан пациентам пожилого возраста и пациентам с циррозом печени. Содержание ионов калия в плазме крови: наибольшим риском при лечении тиазидоподобными диуретиками является гипокалиемия. Особое внимание в целях профилактики гипокалиемии (менее 3,4 ммоль/л) необходимо уделить внимание в следующих случаях: ослабленные пациенты и/или получающие другую терапию (антиаритмические препараты и средства, которые могут удлинять интервал QT на ЭКГ), в пожилом возрасте, пациентам с циррозом печени, периферическими отеками и асцитом, с ишемической болезнью сердца и хронической сердечной недостаточностью. Гипокалиемия у таких пациентов усиливает токсическое действие сердечных гликозидов и повышает риск развития аритмии. К группе повышенного риска также относятся пациенты с удлиненным интервалом QT на ЭКГ. Гипокалиемия является предрасполагающим фактором возникновения тяжелой аритмии, и особенно аритмии типа «пируэт», которая может привести к летальному исходу. Во всех описанных случаях необходимо регулярно контролировать содержание калия в плазме крови. Первое определение содержания калия в плазме крови должно быть проведено в течение первой недели терапии препаратом Индапамид ретард. При выявлении гипокалиемии следует провести соответствующую терапию. Содержание ионов кальция в плазме крови: тиазидоподобные и тиазидные диуретики могут уменьшать выведения ионов кальция почками, приводя к незначительной и/или временной гиперкальциемии. Выраженная гиперкальциемия на фоне приема препарата Индапамид ретард может быть следствием ранее недиагностированного гиперпаратиреоза. Следует отменить прием диуретиков перед исследованием функции паращитовидных желез. Концентрация глюкозы в плазме крови: у пациентов с сахарным диабетом, особенно при наличии гипокалиемии, необходим контроль концентрации глюкозы в плазме крови. Мочевая кислота: у пациентов с гиперурикемией может увеличивать частоту возникновения приступов или обострения течения подагры. Функция почек и диуретические препараты. Тиазидные и тиазидоподобные диуретики эффективны, в полной мере, только у пациентов с нормальной или незначительно сниженной (креатинин плазмы крови у взрослых менее 25 мг/л или 220 мкмоль/л) функцией почек. Выраженная гиповолемия может привести к развитию острой почечной недостаточности (снижение скорости клубочковой фильтрации), что может сопровождаться повышением концентрации мочевины и креатинина в плазме крови. При нормальной функции почек преходящая функциональная почечная недостаточность, как правило, проходит без последствий. При существующей почечной недостаточности состояние пациента может ухудшиться. Пациенты пожилого возраста. Рекомендуется регулярный контроль концентрации креатинина и содержания калия в плазме крови с учетом возраста пациента, массы тела и пола. Индапамид ретард можно назначать пациентам пожилого возраста при сохраненной или незначительно нарушенной функции почек (КК выше 30 мл/мин). Спортсмены. Индапамид ретард может дать положительный результат при проведении допинг-контроля. Влияние на способность к вождению автотранспорта и управлению механизмами. Применение индапамида ретард не приводит к нарушению психомоторных реакций. Однако у некоторых пациентов в ответ на снижение АД могут развиться различные индивидуальные реакции, особенно в начале терапии или при добавлении к проводимой терапии других гипотензивных средств. В этой связи в начале лечения препаратом Индапамид ретард не рекомендуется управлять автотранспортом или другими сложными механизмами, требующими повышенного внимания.
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Обладает умеренным салуретическим и диуретическим эффектами, которые связаны с блокадой реабсорбции ионов натрия, хлора, водорода, и в меньшей степени ионов калия в проксимальных канальцах и кортикальном сегменте дистального канальца нефрона. Сосудорасширяющие эффекты и снижение общего периферического сопротивления сосудов имеют в своей основе следующие механизмы: снижение реактивности сосудистой стенки к норадреналину и ангиотензину II, увеличение синтеза простагландинов, обладающих сосудорасширяющей активностью, угнетение тока ионов кальция в гладкомышечные стенки сосудов. Снижает тонус гладкой мускулатуры артерий, уменьшает общее периферическое сопротивление сосудов. Способствует уменьшению гипертрофии левого желудочка сердца. В терапевтических дозах не влияет на липидный и углеводный обмен (в том числе у больных с сопутствующим сахарным диабетом). Антигипертензивный эффект развивается в конце первой/начале второй недели при постоянном приеме препарата и сохраняется в течение 24 часов на фоне однократного приема."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Артериальная гипертензия"}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Острое нарушение мозгового кровообращения, тяжелые нарушения функции почек (клиренс креатинина менее 30 мл/мин) и/или печени (в т.ч. с печеночной энцефалопатией), гипокалиемия, беременность, период лактации, возраст до 18 лет (эффективность и безопасность не установлены), повышенная чувствительность к индапамиду, другим производным сульфонамида или другим компонентам препарата. Данные таблетки содержат лактозы моногидрат (сахар молочный), в связи с этим препарат не должны принимать пациенты с редкими наследственными заболеваниями, такими как непереносимость лактозы, дефицит лактазы или глюкозо-галактозная мальабсорбция."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказано при беременности и кормлении грудью."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутрь, не разжевывая, запивая достаточным количеством жидкости, независимо от приема пищи, преимущественно в утренние часы в дозе 1.5 мг (1 таблетка)/сутки. Если через 4-8 недель лечения не достигается желаемый терапевтический эффект, дозу препарата повышать не рекомендуется (возрастает риск побочных эффектов без усиления антигипертензивного эффекта). Вместо этого в схему медикаментозного лечения рекомендуется включить другой антигипертензивный препарат, не являющийся диуретиком. В случаях, когда лечение необходимо начинать с приема двух препаратов, доза Индапамида ретард остается равной 1.5 мг утром однократно в сутки. У пожилых пациентов следует контролировать плазменную концентрацию креатинина с учетом возраста, массы тела и пола, препарат можно применять пожилым пациентам с нормальной или незначительно нарушенной функцией почек."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Большинство побочных реакций (лабораторные и клинические показатели) носят дозозависимый характер. Частота побочных реакций, которые могут быть вызваны тиазидоподобными диуретиками, включая индапамид, приведена в виде следующих градаций: очень часто (\u003e1/10), часто (\u003e1/100, \u003c1/10), нечасто (\u003e1/1000, \u003c1/100), редко (\u003e1/10 000, \u003c1/1000), очень редко (\u003c1/10 000), неуточненной частоты (частота не может быть подсчитана по доступным данным). Со стороны системы кроветворения: очень редко - тромбоцитопения, лейкопения, агранулоцитоз, апластическая анемия, гемолитическая анемия. Со стороны центральной нервной системы: редко - головокружение, утомляемость, головная боль, парестезии. Со стороны сердечно-сосудистой системы: очень редко - аритмия, снижение АД. Со стороны пищеварительной системы: нечасто - рвота, редко - тошнота, запор, сухость во рту, очень редко - панкреатит. Со стороны мочевыделительной системы: очень редко - почечная недостаточность. Со стороны печени и желчевыводящих путей: очень редко - нарушение функции печени, неуточненной частоты - возможность развития печеночной энцефалопатии в случае печеночной недостаточности. Со стороны кожных покровов: реакции повышенной чувствительности, в основном дерматологические, у пациентов с предрасположенностью к аллергическим и астматическим реакциям, часто - макулопапулезная сыпь, нечасто - геморрагический васкулит, очень редко - ангионевротический отек и /или крапивница, токсический эпидермальный некролиз, синдром Стивенса-Джонсона, неуточненной частоты - возможно ухудшение при наличии острой формы диссеминированной красной волчанки. Описаны случаи фоточувствительности. Лабораторные показатели: в клинических исследованиях гипокалиемия (содержание калия в плазме крови ≤3.4 ммоль/л) наблюдалась у 10% пациентов и 3.2 ммоль/л – у 4% пациентов после 4-6 недель лечения. После 12 недель терапии уровень калия в плазме крови снизился, в среднем, на 0.23 ммоль/л. Очень редко - гиперкальциемия, неуточненной частоты - гипокалиемия, гипонатриемия, сопровождающаяся гиповолемией, дегидратацией и ортостатической гипотензией. Одновременная потеря ионов хлора может приводить к компенсаторному метаболическому алкалозу, однако частота развития алкалоза и его выраженность не значительна, повышение уровня мочевой кислоты и глюкозы в плазме крови."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: тошнота, рвота, слабость, нарушение функции ЖКТ (тошнота, рвота), водно-электролитные нарушения, выраженное снижение артериального давления, головокружение, сонливость, спутанность сознания, угнетение дыхания, полиурия, олигоурия вплоть до анурии, у пациентов с нарушением функции печени возможно развитие печеночной комы. Лечение: промывание желудка и/или назначение активированного угля с последующим восстановлением нормального водно-электролитного баланса, симптоматическая терапия. Специфического антидота нет."}}]},{"id":10,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Нарушения функции печени. У пациентов с печеночной недостаточностью при назначении тиазидоподобных диуретиков возможно развитие печеночной энцефалопатии, особенно при нарушении показателей водно-электролитного баланса. При ее развитии прием диуретиков следует прекратить. Фоточувствительность. При применении тиазидоподобных диуретиков отмечены случаи развития реакций фоточувствительности. В случае их развития прием препарата следует прекратить. На фоне терапии препаратом Индапамид ретард необходимо защищать открытые участки тела от воздействия солнечных лучей и искусственного ультрафиолетового излучения. Водно-электролитный баланс. Содержание ионов натрия в плазме крови: все диуретические препараты могут вызывать гипонатриемию. Содержание ионов натрия в плазме крови следует измерять перед началом лечения препаратом Индапамид ретард, а затем регулярно в период лечения. Определение содержания ионов натрия в плазме крови необходимо проводить до начала терапии препаратом Индапамид ретард, а так же в период терапии. Важно регулярно контролировать содержание ионов натрия в плазме крови, т.к. изначально гипонатриемия может протекать бессимптомно. Наиболее тщательный контроль содержания ионов натрия показан пациентам пожилого возраста и пациентам с циррозом печени. Содержание ионов калия в плазме крови: наибольшим риском при лечении тиазидоподобными диуретиками является гипокалиемия. Особое внимание в целях профилактики гипокалиемии (менее 3,4 ммоль/л) необходимо уделить внимание в следующих случаях: ослабленные пациенты и/или получающие другую терапию (антиаритмические препараты и средства, которые могут удлинять интервал QT на ЭКГ), в пожилом возрасте, пациентам с циррозом печени, периферическими отеками и асцитом, с ишемической болезнью сердца и хронической сердечной недостаточностью. Гипокалиемия у таких пациентов усиливает токсическое действие сердечных гликозидов и повышает риск развития аритмии. К группе повышенного риска также относятся пациенты с удлиненным интервалом QT на ЭКГ. Гипокалиемия является предрасполагающим фактором возникновения тяжелой аритмии, и особенно аритмии типа «пируэт», которая может привести к летальному исходу. Во всех описанных случаях необходимо регулярно контролировать содержание калия в плазме крови. Первое определение содержания калия в плазме крови должно быть проведено в течение первой недели терапии препаратом Индапамид ретард. При выявлении гипокалиемии следует провести соответствующую терапию. Содержание ионов кальция в плазме крови: тиазидоподобные и тиазидные диуретики могут уменьшать выведения ионов кальция почками, приводя к незначительной и/или временной гиперкальциемии. Выраженная гиперкальциемия на фоне приема препарата Индапамид ретард может быть следствием ранее недиагностированного гиперпаратиреоза. Следует отменить прием диуретиков перед исследованием функции паращитовидных желез. Концентрация глюкозы в плазме крови: у пациентов с сахарным диабетом, особенно при наличии гипокалиемии, необходим контроль концентрации глюкозы в плазме крови. Мочевая кислота: у пациентов с гиперурикемией может увеличивать частоту возникновения приступов или обострения течения подагры. Функция почек и диуретические препараты. Тиазидные и тиазидоподобные диуретики эффективны, в полной мере, только у пациентов с нормальной или незначительно сниженной (креатинин плазмы крови у взрослых менее 25 мг/л или 220 мкмоль/л) функцией почек. Выраженная гиповолемия может привести к развитию острой почечной недостаточности (снижение скорости клубочковой фильтрации), что может сопровождаться повышением концентрации мочевины и креатинина в плазме крови. При нормальной функции почек преходящая функциональная почечная недостаточность, как правило, проходит без последствий. При существующей почечной недостаточности состояние пациента может ухудшиться. Пациенты пожилого возраста. Рекомендуется регулярный контроль концентрации креатинина и содержания калия в плазме крови с учетом возраста пациента, массы тела и пола. Индапамид ретард можно назначать пациентам пожилого возраста при сохраненной или незначительно нарушенной функции почек (КК выше 30 мл/мин). Спортсмены. Индапамид ретард может дать положительный результат при проведении допинг-контроля. Влияние на способность к вождению автотранспорта и управлению механизмами. Применение индапамида ретард не приводит к нарушению психомоторных реакций. Однако у некоторых пациентов в ответ на снижение АД могут развиться различные индивидуальные реакции, особенно в начале терапии или при добавлении к проводимой терапии других гипотензивных средств. В этой связи в начале лечения препаратом Индапамид ретард не рекомендуется управлять автотранспортом или другими сложными механизмами, требующими повышенного внимания."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Гипотензивное средство, тиазидоподобный диуретик с умеренным по силе и длительным по продолжительности действием, производное бензамидов. Обладает умеренным салуретическим и диуретическим эффектами, которые связаны с блокадой реабсорбции ионов натрия, хлора, водорода, и в меньшей степени ионов калия в проксимальных канальцах и кортикальном сегменте дистального канальца нефрона. Сосудорасширяющие эффекты и снижение общего периферического сопротивления сосудов имеют в своей основе следующие механизмы: снижение реактивности сосудистой стенки к норадреналину и ангиотензину II, увеличение синтеза простагландинов, обладающих сосудорасширяющей активностью, угнетение тока ионов кальция в гладкомышечные стенки сосудов. Снижает тонус гладкой мускулатуры артерий, уменьшает общее периферическое сопротивление сосудов. Способствует уменьшению гипертрофии левого желудочка сердца. В терапевтических дозах не влияет на липидный и углеводный обмен (в том числе у больных с сопутствующим сахарным диабетом). 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