Фармакологическое действие — антигипертензивное. Инструкция
Показания к применению
Артериальная гипертензия (пациенты, которым показана комбинированная терапия амлодипином и рамиприлом в дозах, как в комбинации).
Противопоказания
Амлодипинповышенная чувствительность к амлодипину и другим производным дигидропиридина;тяжелая артериальная гипотензия (сАД менее 90 мм рт. ст.), шок (включая кардиогенный);обструктивный процесс, затрудняющий выброс крови из левого желудочка (например клинически значимый стеноз аорты);гемодинамически нестабильная сердечная недостаточность после инфаркта ...
Капсулы1 капс.активные вещества:амлодипина безилат6,95/6,95/13,9/13,9 мг(соответствует амлодипину— 5/5/10/10 мг)рамиприл5/10/5/10 мгвспомогательные вещества: кросповидон— 20/40/40/40 мг; гипромеллоза— 1,18/2,36/2,36/2,36 мг; МКЦ— 114,82/229,64/229,64/229,64 мг; глицерила дибегенат— 2,05/4,1/4,1/4,1 мгКапсулы, 5 мг+5 мг; твердая желатиновая капсула (CONI-SNAP 3), код цвета крышки и основания— 51072: краситель бриллиантовый голубой (Е133), краситель красный очаровательный (Е129), титана диоксид, желатинКапсулы, 5 мг+10 мг; твердая желатиновая капсула (CONI-SNAP 0), код цвета крышки и основания— 51072/37350: крышка— титана диоксид; краситель бриллиантовый голубой (Е133), краситель красный очаровательный (Е129); желатин; основание— титана диоксид; краситель железа оксид красный (Е172); желатинКапсулы, 10 мг+5 мг; твердая желатиновая капсула (CONI-SNAP 0), код цвета крышки и основания— 33007/37350: крышка— титана диоксид; краситель азорубин (Е122); индигокармин (Е132); желатин; основание— титана диоксид; краситель железа оксид красный (Е172); желатинКапсулы, 10 мг+10 мг; твердая желатиновая капсула (CONI-SNAP 0), код цвета крышки и основания— 33007: краситель азорубин (Е122), индигокармин (Е132), титана диоксид, желатин
Описание
Капсулы 5 мг+5 мг: твердые желатиновые CONI-SNAP 3, самозакрывающиеся, с основанием и крышкой светло-бордового цвета.Капсулы 5 мг+10 мг: твердые желатиновые CONI-SNAP 0, самозакрывающиеся, с основанием светло-розового цвета и крышкой светло-бордового цвета.Капсулы 10 мг+5 мг: твердые желатиновые CONI-SNAP 0, самозакрывающиеся, с основанием светло-розового цвета и крышкой темно-бордового цвета.Капсулы 10 мг+10 мг: твердые желатиновые капсулы CONI-SNAP 0, самозакрывающиеся, с основанием и крышкой темно-бордового цвета.Содержимое капсул: смесь гранул и порошков белого или почти белого цвета, без или почти без запаха.
Фармакологические свойства
Фармакологическое действие — антигипертензивное.
Показания к применению
Артериальная гипертензия (пациенты, которым показана комбинированная терапия амлодипином и рамиприлом в дозах, как в комбинации).
Противопоказания
Амлодипинповышенная чувствительность к амлодипину и другим производным дигидропиридина;тяжелая артериальная гипотензия (сАД менее 90 мм рт. ст.), шок (включая кардиогенный);обструктивный процесс, затрудняющий выброс крови из левого желудочка (например клинически значимый стеноз аорты);гемодинамически нестабильная сердечная недостаточность после инфаркта миокарда;беременность;период грудного вскармливания;возраст до 18 лет (безопасность и эффективность не определены).Рамиприлповышенная чувствительность к рамиприлу, другим ингибиторам АПФ;ангионевротический отек в анамнезе (наследственный или идиопатический, а также связанный с предшествующей терапией ингибиторами АПФ);гемодинамически значимый стеноз почечных артерий (двусторонний или односторонний, в случае единственной почки);артериальная гипотензия (сАД менее 90 мм рт. ст.) или состояния с нестабильными показателями гемодинамики;гемодинамически значимый стеноз аортального или митрального клапана или гипертрофическая обструктивная кардиомиопатия;первичный гиперальдостеронизм;тяжелая почечная недостаточность (Cl креатинина <20 мл/мин/1,73 м2);гемодиализ (опыт клинического применения недостаточен);нефропатия, лечение которой проводится ГКС, НПВП, иммуномодуляторами и/или другими цитотоксическими средствами (опыт клинического применения недостаточен);декомпенсированная хроническая сердечная недостаточность (опыт клинического применения недостаточен);гемодиализ или гемофильтрация с применением некоторых видов мембран с отрицательно заряженной поверхностью, таких как высокопроточные мембраны из полиакрилнитрила (опасность развития реакций повышенной чувствительности);аферез ЛПНП с применением декстрана сульфата (опасность развития реакций повышенной чувствительности);десенсибилизирующая терапия при реакциях повышенной чувствительности к ядам насекомых— пчел, ос;острая стадия инфаркта миокарда у пациентов с такими заболеваниями, как тяжелая сердечная недостаточность (IV функциональный класс по NYHA); опасные для жизни желудочковые нарушения ритма сердца; легочное сердце;одновременное применение препаратов, содержащих алискирен, у пациентов с нарушением функции почек (Cl креатинина менее 60 мл/мин) и пациентов с сахарным диабетом;беременность;период грудного вскармливания;возраст до 18 лет (опыт клинического применения недостаточен).Амлодипин + рамиприлповышенная чувствительность к вспомогательным веществам, входящим в состав препарата;почечная недостаточность (Cl креатинина <20 мл/мин/1,73 м2);беременность;период грудного вскармливания;возраст до 18 лет (опыт клинического применения недостаточен).С осторожностью для комбинации амлодипин + рамиприл: атеросклеротические поражения коронарных и церебральных артерий (опасность чрезмерного снижения АД); повышение активности РААС, при котором при ингибировании АПФ имеется риск резкого снижения АД с ухудшением функции почек; выраженная, особенно злокачественная АГ; ХСН, особенно тяжелая или по поводу которой принимаются другие ЛС с антигипертензивным действием; гемодинамически значимый односторонний стеноз почечной артерии (при наличии обеих почек); предшествующий прием диуретиков; нарушения водно-электролитного баланса, снижение ОЦК (в т.ч. на фоне приема диуретиков, бессолевой диеты, диареи, рвоты, обильного потоотделения); одновременное применение с препаратами, содержащими алискирен (при двойной блокаде РААС повышается риск резкого снижения АД, гиперкалиемии и ухудшения функции почек); нарушения функции печени (недостаточность опыта применения: возможно как усиление, так и ослабление эффектов рамиприла; при наличии у пациентов цирроза печени с асцитом и отеками возможна значительная активация РААС); нарушение функции почек (Cl креатинина более 20 мл/мин); состояние после трансплантации почек; системные заболевания соединительной ткани, в т.ч. системная красная волчанка, склеродермия, сопутствующая терапия препаратами, способными вызвать изменения в картине периферической крови (в т.ч. аллопуринол, прокаинамид)— возможно угнетение костномозгового кроветворения, развитие нейтропении или агранулоцитоза; сахарный диабет (риск развития гиперкалиемии); пожилой возраст (риск усиления антигипертензивного действия); гиперкалиемия; гипонатриемия; ХСН неишемической этиологии III–IV функционального класса по классификации NYHA; аортальный стеноз; синдром слабости синусного узла; митральный стеноз; артериальная гипотензия; единственная функционирующая почка; реноваскулярная гипертензия; одновременное применение дантролена, эстрамустина, калийсберегающих диуретиков и препаратов калия, калийсодержащих заменителей пищевой соли, препаратов лития; хирургическое вмешательство/общая анестезия; проведение гемодиализа с применением высокопроточных мембран (например AN69®).
Применение при беременности и в период грудного вскармливания
Препарат противопоказан для применения, т.к. рамиприл может оказать неблагоприятное воздействие на плод— нарушение развития почек плода, снижение АД плода и новорожденных, нарушение функции почек, гиперкалиемия, гипоплазия костей черепа, олигогидрамнион, контрактура конечностей, деформация костей черепа, гипоплазия легких. Перед началом приема препарата у женщин детородного возраста следует исключить беременность.Если женщина планирует беременность, то лечение препаратом должно быть прекращено. В случае наступления беременности во время лечения препаратом следует как можно скорее прекратить его прием и перевести пациентку на прием других препаратов, при применении которых риск для ребенка будет наименьшим.Если лечение препаратом необходимо в период грудного вскармливания, оно должно быть прекращено (данные по выведению амлодипина и рамиприла с грудным молоком женщин отсутствуют).ФертильностьАмлодипин. У некоторых пациентов, получавших БКК, наблюдались обратимые биохимические изменения в головках сперматозоидов. Клинические данные недостаточны для оценки потенциального эффекта амлодипина на фертильность.
Побочное действие
Указанные ниже нежелательные эффекты даются в соответствии со следующими градациями частоты их возникновения по классификации ВОЗ: очень часто— более 1/10 (более 10%); часто— более 1/100, но менее 1/10 (более 1%, но менее 10%); нечасто— более 1/1000, но менее 1/100 (более 0,1%, но менее 1%); редко— более 1/10000, но менее 1/1000 (более 0,01%, но менее 0,1%); очень редко— менее 1/10000 (менее 0,01%).АмлодипинСо стороны ССС: часто— периферические отеки (лодыжек и стоп), ощущение сердцебиения; нечасто— чрезмерное снижение АД, ортостатическая гипотензия, васкулит; редко— развитие или усугубление СН; очень редко— нарушения ритма сердца (включая брадикардию, желудочковую тахикардию и мерцание предсердий), ИМ, боли в грудной клетке, мигрень.Со стороны опорно-двигательного аппарата и соединительной ткани: нечасто— артралгия, судороги мышц, миалгия, боль в спине, артроз; редко— миастения.Со стороны ЦНС и периферической нервной системы: часто— ощущение жара и приливов крови к коже лица, повышенная утомляемость, головокружение, головная боль, сонливость; нечасто— недомогание, обморок, повышенное потоотделение, астения, гипестезии, парестезии, периферическая нейропатия, тремор, бессонница, лабильность настроения, необычные сновидения, нервозность, депрессия, тревога; редко— судороги, апатия; очень редко— атаксия, амнезия, зарегистрированы отдельные случаи экстрапирамидного синдрома.Со стороны пищеварительной системы: часто— боль в брюшной полости, тошнота; нечасто— рвота, изменения режима дефекации (включая запор, метеоризм), диспепсия, диарея, анорексия, сухость слизистой оболочки полости рта, жажда; редко— гиперплазия десен, повышение аппетита; очень редко— гастрит, панкреатит, гипербилирубинемия, желтуха (обычно холестатическая), повышение активности печеночных трансаминаз, гепатит.Со стороны крови: очень редко— тромбоцитопеническая пурпура, тромбоцитопения, лейкопения.Метаболические нарушения: очень редко— гипергликемия.Со стороны дыхательной системы: нечасто— одышка, ринит; очень редко— кашель.Со стороны почек и мочевыводящих путей: нечасто— учащенное мочеиспускание, болезненное мочеиспускание, никтурия, импотенция; очень редко— дизурия, полиурия.Аллергические реакции: нечасто— кожный зуд, сыпь; очень редко— ангионевротический отек, мультиформная эритема, крапивница.Прочие: нечасто— алопеция, звон в ушах, гинекомастия, увеличение/снижение массы тела, нарушение зрения, диплопия, нарушение аккомодации, ксерофтальмия, конъюнктивит, боль в глазах, извращение вкуса, озноб, носовое кровотечение; редко— дерматит; очень редко— паросмия, ксеродермия, холодный пот, нарушение пигментации кожи.РамиприлСо стороны сердца: нечасто— ишемия миокарда, включая развитие приступа стенокардии или ИМ, тахикардия, аритмии (появление или усиление), ощущение сердцебиения, периферические отеки.Со стороны сосудов: часто— чрезмерное снижение АД, нарушение ортостатической регуляции сосудистого тонуса (ортостатическая гипотензия), синкопальные состояния; нечасто— приливы крови к коже лица; редко— возникновение или усиление нарушений кровообращения на фоне стенозирующих сосудистых поражений, васкулит; частота неизвестна— синдром Рейно.Со стороны ЦНС: часто— головная боль, ощущение легкости в голове; нечасто— головокружение, агевзия (утрата вкусовой чувствительности), дисгевзия (нару
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веществам, входящим в состав препарата;почечная недостаточность (Cl креатинина \u003c20 мл/мин/1,73 м2);беременность;период грудного вскармливания;возраст до 18 лет (опыт клинического применения недостаточен).С осторожностью для комбинации амлодипин + рамиприл: атеросклеротические поражения коронарных и церебральных артерий (опасность чрезмерного снижения АД); повышение активности РААС, при котором при ингибировании АПФ имеется риск резкого снижения АД с ухудшением функции почек; выраженная, особенно злокачественная АГ; ХСН, особенно тяжелая или по поводу которой принимаются другие ЛС с антигипертензивным действием; гемодинамически значимый односторонний стеноз почечной артерии (при наличии обеих почек); предшествующий прием диуретиков; нарушения водно-электролитного баланса, снижение ОЦК (в т.ч. на фоне приема диуретиков, бессолевой диеты, диареи, рвоты, обильного потоотделения); одновременное применение с препаратами, содержащими алискирен (при двойной блокаде РААС повышается риск 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гипотензия; единственная функционирующая почка; реноваскулярная гипертензия; одновременное применение дантролена, эстрамустина, калийсберегающих диуретиков и препаратов калия, калийсодержащих заменителей пищевой соли, препаратов лития; хирургическое вмешательство/общая анестезия; проведение гемодиализа с применением высокопроточных мембран (например AN69®)."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат противопоказан для применения, т.к. рамиприл может оказать неблагоприятное воздействие на плод— нарушение развития почек плода, снижение АД плода и новорожденных, нарушение функции почек, гиперкалиемия, гипоплазия костей черепа, олигогидрамнион, контрактура конечностей, деформация костей черепа, гипоплазия легких. Перед началом приема препарата у женщин детородного возраста следует исключить беременность.Если женщина планирует беременность, то лечение препаратом должно быть прекращено. В случае наступления беременности во время лечения препаратом следует как можно скорее прекратить его прием и перевести пациентку на прием других препаратов, при применении которых риск для ребенка будет наименьшим.Если лечение препаратом необходимо в период грудного вскармливания, оно должно быть прекращено (данные по выведению амлодипина и рамиприла с грудным молоком женщин отсутствуют).ФертильностьАмлодипин. У некоторых пациентов, получавших БКК, наблюдались обратимые биохимические изменения в головках сперматозоидов. Клинические данные недостаточны для оценки потенциального эффекта амлодипина на фертильность."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Указанные ниже нежелательные эффекты даются в соответствии со следующими градациями частоты их возникновения по классификации ВОЗ: очень часто— более 1/10 (более 10%); часто— более 1/100, но менее 1/10 (более 1%, но менее 10%); нечасто— более 1/1000, но менее 1/100 (более 0,1%, но менее 1%); редко— более 1/10000, но менее 1/1000 (более 0,01%, но менее 0,1%); очень редко— менее 1/10000 (менее 0,01%).АмлодипинСо стороны ССС: часто— периферические отеки (лодыжек и стоп), ощущение сердцебиения; нечасто— чрезмерное снижение АД, ортостатическая гипотензия, васкулит; редко— развитие или усугубление СН; очень редко— нарушения ритма сердца (включая брадикардию, желудочковую тахикардию и мерцание предсердий), ИМ, боли в грудной клетке, мигрень.Со стороны опорно-двигательного аппарата и соединительной ткани: нечасто— артралгия, судороги мышц, миалгия, боль в спине, артроз; редко— миастения.Со стороны ЦНС и периферической нервной системы: часто— ощущение жара и приливов крови к коже лица, повышенная утомляемость, головокружение, головная боль, сонливость; нечасто— недомогание, обморок, повышенное потоотделение, астения, гипестезии, парестезии, периферическая нейропатия, тремор, бессонница, лабильность настроения, необычные сновидения, нервозность, депрессия, тревога; редко— судороги, апатия; очень редко— атаксия, амнезия, зарегистрированы отдельные случаи экстрапирамидного синдрома.Со стороны пищеварительной системы: часто— боль в брюшной полости, тошнота; нечасто— рвота, изменения режима дефекации (включая запор, метеоризм), диспепсия, диарея, анорексия, сухость слизистой оболочки полости рта, жажда; редко— гиперплазия десен, повышение аппетита; очень редко— гастрит, панкреатит, гипербилирубинемия, желтуха (обычно холестатическая), повышение активности печеночных трансаминаз, гепатит.Со стороны крови: очень редко— тромбоцитопеническая пурпура, тромбоцитопения, лейкопения.Метаболические нарушения: очень редко— гипергликемия.Со стороны дыхательной системы: нечасто— одышка, ринит; очень редко— кашель.Со стороны почек и мочевыводящих путей: нечасто— учащенное мочеиспускание, болезненное мочеиспускание, никтурия, импотенция; очень редко— дизурия, полиурия.Аллергические реакции: нечасто— кожный зуд, сыпь; очень редко— ангионевротический отек, мультиформная эритема, крапивница.Прочие: нечасто— алопеция, звон в ушах, гинекомастия, увеличение/снижение массы тела, нарушение зрения, диплопия, нарушение аккомодации, ксерофтальмия, конъюнктивит, боль в глазах, извращение вкуса, озноб, носовое кровотечение; редко— дерматит; очень редко— паросмия, ксеродермия, холодный пот, нарушение пигментации кожи.РамиприлСо стороны сердца: нечасто— ишемия миокарда, включая развитие приступа стенокардии или ИМ, тахикардия, аритмии (появление или усиление), 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