1 таб. амлодипина бесилат 6.94 мг, что соответствует содержанию амлодипина 5 мг валсартан А субстанция-гранулы 251.35 мг, что соответствует содержанию валсартана 160 мг. Вспомогательные вещества: маннитол - 50.
Показания к применению
— артериальная гипертензия у пациентов, которым показана комбинированная терапия.
Противопоказания
Тяжелая печеночная недостаточность (более 9 балов по шкале Чайлд-Пью)
Билиарный цирроз и холестаз
Тяжелая почечная недостаточность (КК менее 30 мл/мин)
Применение у пациентов, находящихся на гемодиализе
Выраженная артериальная гипотензия (систолическое АД менее 90 мм рт.ст.)
Коллапс, шок (включая кардиогенный шок)
Обструкция выносящего тракта левого желудочка (в т.ч. гипертрофическая обструктивная кардиомиопатия (ГОКМП) и аортальный стеноз тяжелой степени)
Гемодинамически нестабильная сердечная недостаточность после острого инфаркта миокарда
Одновременное применение с алискиреном у пациентов с сахарным диабетом или нарушением функции почек (КК менее 60 мл/мин)
Первичный гиперальдостеронизм
Беременность
Период лактации (грудного вскармливания)
Повышенная чувствительность к амлодипину, другим производным дигидропиридинового ряда, валсартану или к другим компонентам препарата. Безопасность применения препарата Вамлосет у пациентов после перенесенной трансплантации почки, а также детей и подростков в возрасте до 18 лет не установлена. С осторожностью следует назначать препарат при нарушениях функции печени легкой (5-6 баллов по шкале Чайлд-Пью) и умеренной (7-9 баллов по шкале Чайлд-Пью) степени тяжестиобструктивных заболеваниях желчных путейнарушениях функции почек легкой и средней степени тяжести (КК 30-50 мл/мин)одностороннем или двустороннем стенозе почечных артерий или стенозе артерии единственной почкихронической сердечной недостаточности III-IV функционального класса по классификации NYHAгиперкалиемиигипонатриемиисоблюдении диеты с ограничением потребления поваренной солисниженном ОЦК (в т.ч. при диарее, рвоте)у пациентов с наследственным ангионевротическим отеком, либо отеком на фоне предшествующей терапии антагонистами рецепторов ангиотензина IIу пациентов с митральным и аортальным стенозом легкой и умеренной степени
Способ применения и дозы
Препарат следует принимать внутрь, 1 раз/сут, независимо от приема пищи, запивая небольшим количеством воды. Рекомендуемая суточная доза - 1 таб. препарата Вамлосет, содержащая комбинацию амлодипин/валсартан в дозе 5 мг/80 мг, 5 мг/160 мг, 10 мг/160 мг, 5 мг/320 мг или 10 мг/320 мг. Начальная доза препарата Вамлосет - 5 мг/80 мг 1 раз/сут. Увеличивать дозу можно через 1-2 недели после начала терапии. Максимальная суточная доза составляет 5 мг/320 мг (в пересчете на валсартан) или 10 мг/160 мг (в пересчете на амлодипин) или 10 мг/320 мг. Амлодипин Пациентам с нарушением функции почек коррекции дозы не требуется. Пациентам с нарушением функции печени следует с осторожностью применять препарат. Пациентам пожилого возраста коррекции дозы и режима дозирования не требуется. Валсартан У пациентов с нарушением функции почек (КК >30 мл/мин) коррекции начальной дозы не требуется. Валсартан противопоказан пациентам с тяжелой печеночной недостаточностью, билиарным циррозом и холестазом. Максимальная суточная доза валсартана при печеночной недостаточности легкой и средней степени тяжести - 80 мг. Препарат Вамлосет в дозе 5 мг/160 мг, 5 мг/320 мг, 10 мг/160 и 10 мг/320 мг противопоказан. У пациентов пожилого возраста коррекции дозы не требуется.
Побочное действие
Классификация частоты развития побочных эффектов ВОЗ: очень часто (1/10), часто (от 1/100 до меньше1/10), нечасто (от 1/1000 до меньше1/100), редко (от 1/10 000 до меньше1/1000), очень редко (от меньше1/10 000), частота неизвестна (не может быть оценена на основании имеющихся данных). Препарат Вамлосет Инфекционные и паразитарные заболевания: часто - грипп. Со стороны обмена веществ: часто - гипокалиемия; нечасто - гиперкальциемия, гиперлипидемия, гиперурикемия, гипонатриемия. Со стороны нервной системы: часто - головная боль; нечасто - нарушение координации, головокружение, постуральное головокружение, парестезия, сонливость; редко - тревожность. Со стороны органа зрения: нечасто - ухудшение зрения; редко - нарушение зрения. Со стороны органа слуха и лабиринтные нарушения: нечасто - вертиго; редко - шум в ушах. Со стороны сердечно-сосудистой системы: нечасто - ощущение сердцебиения, тахикардия, ортостатическая гипотензия; редко - выраженное снижение АД, обморок. Со стороны дыхательной системы: часто - назофарингит; нечасто - кашель, боль в глотке и гортани. Со стороны пищеварительной системы: нечасто - диарея, тошнота, чувство дискомфорта в животе, боль в верхней части живота, запор, сухость во рту. Со стороны кожи и подкожных тканей: нечасто - эритема, кожная сыпь; редко - экзантема, гипергидроз, кожный зуд. Со стороны костно-мышечной системы: нечасто - артралгия, боль в спине, припухлость суставов; редко - мышечные спазмы, ощущение тяжести во всем теле. Со стороны мочевыделительной системы: редко - поллакиурия, полиурия. Со стороны половых органов и молочной железы: редко - эректильная дисфункция. Аллергические реакции: редко - гиперчувствительность. Общие расстройства и нарушения в месте введения: часто - астения, повышенная утомляемость, отек лица, ощущение прилива крови к коже лица, отеки, периферические отеки, пастозность; нечасто - анорексия. У пациентов, получавших комбинацию амлодипин/валсартан, периферические отеки встречались реже (5.8%), чем у пациентов, получавших терапию только амлодипином (9%). Амлодипин Со стороны системы кроветворения: очень редко - лейкопения, тромбоцитопения иногда с пурпурой. Со стороны обмена веществ: очень редко - гипергликемия. Психические нарушения: нечасто - депрессия, бессонница/нарушения сна, лабильность настроения; редко - спутанность сознания. Со стороны нервной системы: часто - головокружение, головная боль, сонливость; нечасто - нарушение вкуса, парестезия, обморок, тремор, гипестезия; очень редко - мышечный гипертонус, периферическая невропатия; частота неизвестна - экстрапирамидные нарушения. Со стороны органа зрения: нечасто - ухудшение зрения, нарушение зрения. Со стороны органа слуха и лабиринтные нарушения: нечасто - шум в ушах. Со стороны сердечно-сосудистой системы: часто - ощущение сердцебиения, ощущение прилива крови к коже лица, выраженное снижение АД; очень редко - аритмии (включая брадикардию, желудочковую тахикардию и фибрилляцию предсердий), инфаркт миокарда, васкулит. Со стороны дыхательной системы: нечасто - одышка, ринит; очень редко - кашель. Со стороны пищеварительной системы: часто - тошнота, чувство дискомфорта в животе, боль в верхней части живота; нечасто - изменение стула, диарея, сухость слизистой оболочки полости рта, диспепсия, рвота; редко - гастрит, гиперплазия десен, панкреатит. Со стороны печени и желчевыводящих путей: очень редко - повышение активности печеночных ферментов (чаще с явлениями холестаза), повышение концентрации билирубина в плазме крови, гепатит, внутрипеченочный холестаз, желтуха. Со стороны кожи и подкожных тканей: нечасто - алопеция, экзантема, эритема, реакции фоточувствительности, кожный зуд, гипергидроз, пурпура, кожная сыпь, изменение цвета кожи; очень редко - многоформная эритема, эксфолиативный дерматит, синдром Стивенса-Джонсона. Со стороны костно-мышечной системы: часто - отек лодыжек; нечасто - артралгия, боль в спине, мышечные спазмы, миалгия. Со стороны мочевыделительной системы: нечасто - нарушение мочеиспускания, никтурия, поллакиурия. Со стороны половых органов и молочной железы: нечасто - эректильная дисфункция, гинекомастия. Общие расстройства и нарушения в месте введения: часто - повышенная утомляемость, периферические отеки; нечасто - астения, дискомфорт, недомогание, некардиогенная боль в сердце, боль. Лабораторные и инструментальные данные: нечасто - снижение/повышение массы тела. Аллергические реакции: очень редко - реакции гиперчувствительности, крапивница, ангионевротический отек. Валсартан Со стороны системы кроветворения: частота неизвестна - снижение гемоглобина и гематокрита, лейкопения, нейтропения, тромбоцитопения иногда с пурпурой. Со стороны органа слуха и лабиринтные нарушения: нечасто - вертиго. Со стороны сердечно-сосудистой системы: частота неизвестна - васкулит. Со стороны дыхательной системы: нечасто - кашель. Со стороны пищеварительной системы: нечасто - чувство дискомфорта в животе, боль в верхней части живота. Со стороны печени и желчевыводящих путей: частота неизвестна - повышение активности печеночных ферментов, повышение концентрации билирубина в плазме крови. Со стороны кожи и подкожных тканей: частота неизвестна - кожный зуд, кожная сыпь. Со стороны костно-мышечной системы: частота неизвестна - миалгия. Со стороны мочевыделительной системы: частота неизвестна - повышение концентрации креатинина в плазме крови, нарушение функции почек, включая острую почечную недостаточность. Общие расстройства и нарушения в месте введения: нечасто - повышенная утомляемость. Лабораторные и инструментальные данные: частота неизвестна - повышение содержания калия в сыворотке крови. Аллергические реакции: очень редко - реакции гиперчувствительности; частота неизвестна - ангионевротический отек. Нежелательные явления, о которых сообщалось ранее при применении каждого из компонентов, могут иметь место при применении препарата Вамлосет, даже если они не наблюдались в клинических исследованиях. Амлодипин Часто: сонливость, головокружение, ощущение сердцебиения, боль в животе, тошнота, отеки лодыжек. Нечасто: бессонница, лабильность настроения (в т.ч. тревожность), депрессия, тремор, нарушение вкуса, обморок, гипестезия, нарушения зрения (в т.ч. диплопия), шум в ушах, выраженное снижение АД, одышка, ринит, рвота, диспепсия, алопеция, пурпура, изменение цвета кожи, гипергидроз, кожный зуд, экзантема, миалгия, судороги в мышцах, боль, нарушение мочеиспускания, учащение мочеиспускания, импотенция, гинекомастия, боль в груди, недомогание, увеличение массы тела, снижение массы тела. Редко: спутанность сознания. Очень редко: лейкопения, тромбоцитопения, аллергические реакции, гипергликемия, мышечный гипертонус, периферическая невропатия, инфаркт миокарда, аритмии (включая брадикардию, желудочковую тахикардию и фибрилляцию предсердий), васкулит, панкреатит, гастрит, гиперплазия десен, гепатит, желтуха, повышение активности печеночных ферментов (чаще всего вследствие холестаза), ангионевротический отек, многоформная эритема, крапивница, эксфолиативный дерматит, синдром Стивенса-Джонсона, фоточувствительность. Описаны отдельные случаи экстрапирамидного синдрома. Валсартан Частота неизвестна: снижение гемоглобина и гематокрита, нейтропения, тромбоцитопения, увеличение содержания калия в сыворотке крови, повышение активности печеночных ферментов, повышение концентрации билирубина в плазме крови, повышение концентрации креатинина в плазме крови, нарушение функции почек, включая почечную недостаточность, ангионевротический отек, миалгия, васкулит, гиперчувствительность, включая сывороточную болезнь.
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Аллергические реакции: редко - гиперчувствительность. Общие расстройства и нарушения в месте введения: часто - астения, повышенная утомляемость, отек лица, ощущение прилива крови к коже лица, отеки, периферические отеки, пастозность; нечасто - анорексия. У пациентов, получавших комбинацию амлодипин/валсартан, периферические отеки встречались реже (5.8%), чем у пациентов, получавших терапию только амлодипином (9%). Амлодипин Со стороны системы кроветворения: очень редко - лейкопения, тромбоцитопения иногда с пурпурой. Со стороны обмена веществ: очень редко - гипергликемия. Психические нарушения: нечасто - депрессия, бессонница/нарушения сна, лабильность настроения; редко - спутанность сознания. Со стороны нервной системы: часто - головокружение, головная боль, сонливость; нечасто - нарушение вкуса, парестезия, обморок, тремор, гипестезия; очень редко - мышечный гипертонус, периферическая невропатия; частота неизвестна - экстрапирамидные нарушения. Со стороны органа зрения: нечасто - ухудшение зрения, нарушение зрения. Со стороны органа слуха и лабиринтные нарушения: нечасто - шум в ушах. Со стороны сердечно-сосудистой системы: часто - ощущение сердцебиения, ощущение прилива крови к коже лица, выраженное снижение АД; очень редко - аритмии (включая брадикардию, желудочковую тахикардию и фибрилляцию предсердий), инфаркт миокарда, васкулит. Со стороны дыхательной системы: нечасто - одышка, ринит; очень редко - кашель. Со стороны пищеварительной системы: часто - тошнота, чувство дискомфорта в животе, боль в верхней части живота; нечасто - изменение стула, диарея, сухость слизистой оболочки полости рта, диспепсия, рвота; редко - гастрит, гиперплазия десен, панкреатит. Со стороны печени и желчевыводящих путей: очень редко - повышение активности печеночных ферментов (чаще с явлениями холестаза), повышение концентрации билирубина в плазме крови, гепатит, внутрипеченочный холестаз, желтуха. Со стороны кожи и подкожных тканей: нечасто - алопеция, экзантема, эритема, реакции фоточувствительности, кожный зуд, гипергидроз, пурпура, кожная сыпь, изменение цвета кожи; очень редко - многоформная эритема, эксфолиативный дерматит, синдром Стивенса-Джонсона. Со стороны костно-мышечной системы: часто - отек лодыжек; нечасто - артралгия, боль в спине, мышечные спазмы, миалгия. Со стороны мочевыделительной системы: нечасто - нарушение мочеиспускания, никтурия, поллакиурия. Со стороны половых органов и молочной железы: нечасто - эректильная дисфункция, гинекомастия. Общие расстройства и нарушения в месте введения: часто - повышенная утомляемость, периферические отеки; нечасто - астения, дискомфорт, недомогание, некардиогенная боль в сердце, боль. Лабораторные и инструментальные данные: нечасто - снижение/повышение массы тела. Аллергические реакции: очень редко - реакции гиперчувствительности, крапивница, ангионевротический отек. Валсартан Со стороны системы кроветворения: частота неизвестна - снижение гемоглобина и гематокрита, лейкопения, нейтропения, тромбоцитопения иногда с пурпурой. Со стороны органа слуха и лабиринтные нарушения: нечасто - вертиго. Со стороны сердечно-сосудистой системы: частота неизвестна - васкулит. Со стороны дыхательной системы: нечасто - кашель. Со стороны пищеварительной системы: нечасто - чувство дискомфорта в животе, боль в верхней части живота. Со стороны печени и желчевыводящих путей: частота неизвестна - повышение активности печеночных ферментов, повышение концентрации билирубина в плазме крови. Со стороны кожи и подкожных тканей: частота неизвестна - кожный зуд, кожная сыпь. Со стороны костно-мышечной системы: частота неизвестна - миалгия. Со стороны мочевыделительной системы: частота неизвестна - повышение концентрации креатинина в плазме крови, нарушение функции почек, включая острую почечную недостаточность. 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Нечасто: бессонница, лабильность настроения (в т.ч. тревожность), депрессия, тремор, нарушение вкуса, обморок, гипестезия, нарушения зрения (в т.ч. диплопия), шум в ушах, выраженное снижение АД, одышка, ринит, рвота, диспепсия, алопеция, пурпура, изменение цвета кожи, гипергидроз, кожный зуд, экзантема, миалгия, судороги в мышцах, боль, нарушение мочеиспускания, учащение мочеиспускания, импотенция, гинекомастия, боль в груди, недомогание, увеличение массы тела, снижение массы тела. Редко: спутанность сознания. Очень редко: лейкопения, тромбоцитопения, аллергические реакции, гипергликемия, мышечный гипертонус, периферическая невропатия, инфаркт миокарда, аритмии (включая брадикардию, желудочковую тахикардию и фибрилляцию предсердий), васкулит, панкреатит, гастрит, гиперплазия десен, гепатит, желтуха, повышение активности печеночных ферментов (чаще всего вследствие холестаза), ангионевротический отек, многоформная эритема, крапивница, эксфолиативный дерматит, синдром Стивенса-Джонсона, фоточувствительность. Описаны отдельные случаи экстрапирамидного синдрома. Валсартан Частота неизвестна: снижение гемоглобина и гематокрита, нейтропения, тромбоцитопения, увеличение содержания калия в сыворотке крови, повышение активности печеночных ферментов, повышение концентрации билирубина в плазме крови, повышение концентрации креатинина в плазме крови, нарушение функции почек, включая почечную недостаточность, ангионевротический отек, миалгия, васкулит, гиперчувствительность, включая сывороточную болезнь."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"","substance":[{"id":87,"title":"Амлодипин","title_latin":"Amlodipinum","slug":"amlodipin_87"},{"id":429,"title":"Валсартан","title_latin":"Valsartanum","slug":"valsartan_429"}],"branding":null,"valid_for_quick_buy":true,"is_available_to_delivery":false,"comments":null,"image_alt":"Вамлосет - фото 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