Дуодарт - комбинированный препарат дутастерида и тамсулозина... Инструкция
Показания к применению
Лечение и профилактика прогрессирования ДГПЖ посредством уменьшения ее размеров, устранения симптомов, увеличения скорости мочеиспускания, снижения риска возникновения острой задержки мочи и необходимости оперативного вмешательства.
Противопоказания
Повышенная чувствительность к дутастериду, другим ингибиторам 5α .-редуктазы, тамсулозину или любому другому компоненту, входящему в состав препарата
1 капсула содержит дутастерида 0,5 мг и тамсулозина гидрохлорида 0,4 мг . вспомогательные вещества: монодиглицериды кислоты каприловой, бутилгидрокситолуол (Е 321), желатин, глицерин, титана диоксид (Е171), железа оксид желтый (Е172), триглицериды средней цепи и лецитин . целлюлоза микрокристаллическая, метакрилатного сополимера дисперсия, тальк, триэтилцитрат . оболочка твердой капсулы: каррагинан (Е 407), калия хлорид, титана диоксид (Е 171), FD & C Yellow 6 (E 110), гипромеллоза, воск карнаубский, крахмал кукурузный, железа оксид красный (Е 172), SW-9008 Black Ink (шеллак, пропиленгликоль, железа оксид черный (Е172), калия гидроксид).
Фармакологические свойства
Дуодарт - комбинированный препарат дутастерида и тамсулозина с комплементарным механизмом действия. Дутастерид – двойственный ингибитор 5α .-редуктазы, подавляет активность изоферментов 5α .-редуктазы 1-го и 2-го типов, которые ответственны за превращение тестостерона в 5α .-дигидротестостерон. Дигидротестостерон (ДГТ) является основным андрогеном, ответственным за гиперплазию железистой ткани предстательной железы. Дутастерид снижает уровень ДГТ, уменьшает размеры предстательной железы, уменьшает симптомы заболевания, приводит к улучшению мочеиспускания, снижению риска возникновения острой задержки мочи и потребности в хирургическом лечении. Максимальное влияние дутастерида на снижение концентрации ДГТ является дозозависимым и наблюдается через 1–2 недели после начала лечения. Через 1–2 недели приема дутастерида в дозе 0.5 мг/сут медианные значения концентраций ДГТ в сыворотке снижаются на 85–90% соответственно. У пациентов с доброкачественной гиперплазией предстательной железы (ДГПЖ) при приеме дутастерида в дозе 0.5 мг/сут средние показатели снижения уровня ДГТ составили 94% в течение первого года и 93% - в течение второго года терапии . средние показатели тестостерона в сыворотке увеличились на 19% в течение первого и второго годов лечения. Данный эффект обусловлен снижением уровня 5α .-редуктазы и не ведет к развитию каких-либо известных побочных реакций. Тамсулозина гидрохлорид – блокатор постсинаптических α .1a-адренорецепторов, находящихся в гладкой мускулатуре предстательной железы, шейки мочевого пузыря и простатической части уретры. Блокада α .1a-адренорецепторов приводит к снижению тонуса гладкой мускулатуры предстательной железы, шейки мочевого пузыря и простатической части уретры и улучшению оттока мочи. Одновременно уменьшаются как обструктивные симптомы, так и ирритативные симптомы, обусловленные повышенным тонусом гладкой мускулатуры и детрузорной гиперактивностью при ДГПЖ.
Показания к применению
Лечение и профилактика прогрессирования ДГПЖ посредством уменьшения ее размеров, устранения симптомов, увеличения скорости мочеиспускания, снижения риска возникновения острой задержки мочи и необходимости оперативного вмешательства.
Противопоказания
Повышенная чувствительность к дутастериду, другим ингибиторам 5α .-редуктазы, тамсулозину или любому другому компоненту, входящему в состав препарата
Ортостатическая гипотензия (в т.ч. в анамнезе)
Выраженная печеночная недостаточность
Возраст до 18 лет
Применение препарата противопоказано женщинам и детям
Побочное действие
Нежелательные явления, обусловленные применением тамсулозинагидрохлорида в комбинации с дутастеридом: Очень редко ( меньше 1/10 000): аллергические реакции(сыпь, зуд, крапивница, локализированный отек и ангионевротический отек), приапизм, потеря сознания Редко (≥ .1/10 000 и меньше 1/1 000): алопеция, гипертрихоз Нечасто (≥ .1/1 000 и меньше 1/100): нарушение эякуляции, ретроградная эякуляция Часто (≥ .1/100 и меньше 1/10): гинекомастия, снижение либидо, эректильная дисфункция, головокружение Нежелательные явления, обусловленные применением тамсулозинагидрохлорида в качестве монотерапии Очень редко ( меньше 1/10 000): приапизм Редко (≥ .1/10 000 и меньше 1/1 000): потеря сознания, ангионевротический отек Нечасто (≥ .1/1 000 и меньше 1/100): учащенное сердцебиение запор, диарея, рвотаастения нарушение эякуляции ринит сыпь, зуд, крапивница постуральная гипотензия Часто (≥ .1/100 и меньше 1/10): головокружение, ортостатическая гипотония
Особые указания
Нежелательные явления, обусловленные применением тамсулозинагидрохлорида в комбинации с дутастеридом: Очень редко ( меньше 1/10 000): аллергические реакции(сыпь, зуд, крапивница, локализированный отек и ангионевротический отек), приапизм, потеря сознания Редко (≥ .1/10 000 и меньше 1/1 000): алопеция, гипертрихоз Нечасто (≥ .1/1 000 и меньше 1/100): нарушение эякуляции, ретроградная эякуляция Часто (≥ .1/100 и меньше 1/10): гинекомастия, снижение либидо, эректильная дисфункция, головокружение Нежелательные явления, обусловленные применением тамсулозинагидрохлорида в качестве монотерапии Очень редко ( меньше 1/10 000): приапизм Редко (≥ .1/10 000 и меньше 1/1 000): потеря сознания, ангионевротический отек Нечасто (≥ .1/1 000 и меньше 1/100): учащенное сердцебиение запор, диарея, рвотаастения нарушение эякуляции ринит сыпь, зуд, крапивница постуральная гипотензия Часто (≥ .1/100 и меньше 1/10): головокружение, ортостатическая гипотония
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