Тамсулозин является специфическим блокатором постсинаптическ... Инструкция
Показания к применению
Лечение дизурических расстройств при доброкачественной гиперплазии предстательной железы.
Противопоказания
Гиперчувствительность к тамсулозину или любому другому компоненту препарата, ортостатическая гипотензия (в т.ч. в анамнезе), выраженная печеночная недостаточность, детский возраст до 18 лет. С осторожностьюХроническая почечная недостаточность (клиренс креатинина (КК) ниже 10 мл/мин). Артериальная гипотензия.
Тамсулозин является специфическим блокатором постсинаптических альфа1-адренорецепторов, находящихся в гладкой мускулатуре предстательной железы, шейки мочевого пузыря и простатической части уретры. Блокада альфа1-адренорецепторов тамсулозином приводит к снижению тонуса гладкой мускулатуры предстательной железы, шейки мочевого пузыря и простатической части уретры и улучшению оттока мочи. Одновременно уменьшаются как симптомы опорожнения, так и симптомы наполнения, обусловленные повышенным тонусом гладкой мускулатуры и детрузорной гиперактивностью при доброкачественной гиперплазии предстательной железы (ДГПЖ). Способность тамсулозина воздействовать на альфа1A подтип адренорецепторов в 20 раз превосходит его способность взаимодействовать с альфа1B подтипом адренорецепторов, которые расположены в гладких мышцах сосудов. Благодаря своей высокой селективности, тамсулозин не вызывает клинически значимого снижения системного артериального давления (АД) как у пациентов с артериальной гипертензией, так и у пациентов с нормальными показателями АД.
Показания к применению
Лечение дизурических расстройств при доброкачественной гиперплазии предстательной железы.
Противопоказания
Гиперчувствительность к тамсулозину или любому другому компоненту препарата, ортостатическая гипотензия (в т.ч. в анамнезе), выраженная печеночная недостаточность, детский возраст до 18 лет. С осторожностьюХроническая почечная недостаточность (клиренс креатинина (КК) ниже 10 мл/мин). Артериальная гипотензия.
Применение при беременности и в период грудного вскармливания
Препарат Тамсулозин ретард предназначен для применения только у лиц мужского пола.
Способ применения и дозы
Внутрь, после завтрака, запивая водой, принимают 1 таблетку пролонгированного действия, покрытую пленочной оболочкой (0,4 мг) 1 раз в сутки. Таблетку не рекомендуется разжевывать, так как это может повлиять на скорость высвобождения препарата.
Побочное действие
Частота развития нежелательных реакций представлена согласно классификации ВОЗ: очень часто (≥1/10 случаев), часто (≥1/100 и <1/10 случаев), нечасто (≥1/1000 и <1/100 случаев), редко (≥1/10000 и <1/1000 случаев) и очень редко (<1/10000 случаев). Со стороны сердечно-сосудистой системы: нечасто – ощущение сердцебиения, ортостатическая гипотензия. Со стороны желудочно-кишечного тракта: нечасто – запор, диарея, тошнота, рвота. Со стороны нервной системы: часто – головокружение; нечасто – головная боль; редко – обморок. Со стороны репродуктивной системы: нечасто – нарушения эякуляции; очень редко – приапизм. Со стороны органов дыхания, грудной клетки и средостениянечасто – ринит. Со стороны кожи и подкожной клетчаткинечасто – сыпь, зуд, крапивница; редко – ангионевротический отек; очень редко – синдром Стивенса-Джонсона; частота неизвестна – мультиформная экссудативная эритема, эксфолиативный дерматит. Прочие: нечасто – астения; частота неизвестна – носовое кровотечение. Описаны случаи интраоперационной нестабильности радужной оболочки глаза (синдром узкого зрачка) при операции по поводу катаракты и глаукомы у пациентов, принимавших тамсулозин. В дополнение к побочным эффектам, описанным выше, при использовании тамсулозина наблюдались фибрилляция предсердий, аритмия, тахикардия и одышка. В связи с тем, что данные были получены методом спонтанных сообщений в период после регистрации, определение частоты и причинно-следственной связи этих явлений с приемом тамсулозина представляется затруднительным.
Передозировка
Нет сообщений о случаях острой передозировки тамсулозином. Однако, теоретически при передозировке возможно развитие острого снижения артериального давления (АД) и компенсаторной тахикардии, в случае которой необходимо проведение симптоматической терапии. АД и частота сердечных сокращений могут восстановиться при принятии человеком горизонтального положения. При отсутствии эффекта можно применить средства, увеличивающие объем циркулирующей крови и, если необходимо, сосудосуживающие средства. Необходимо контролировать функцию почек. Маловероятно, что диализ будет эффективен, так как тамсулозин сильно связан с белками плазмы. Для предотвращения дальнейшего всасывания препарата целесообразно промывание желудка, прием активированного угля или осмотического слабительного, например, натрия сульфата.
Особые указания
Как и при использовании других альфа1-адреноблокаторов, при лечении препаратом Тамсулозин ретард в отдельных случаях может наблюдаться снижение АД, которое иногда может привести к обморочному состоянию. При первых признаках ортостатической гипотензии (головокружение, слабость) пациент должен сесть или лечь и оставаться в этом положении до тех пор, пока признаки не исчезнут. При оперативных вмешательствах по поводу катаракты на фоне приема препарата возможно развитие синдрома интраоперационной нестабильности радужной оболочки глаза (синдром узкого зрачка), что необходимо учитывать хирургу для предоперационной подготовки пациента и при проведении операции. Целесообразность отмены терапии тамсулозином за 1-2 недели до операции по поводу катаракты или глаукомы до сих пор не доказана. Случаи интраоперационной нестабильности радужной оболочки глаза имели место у пациентов, прекративших прием препарата и в более ранние сроки перед операцией. Не рекомендуется начинать терапию тамсулозином у пациентов, которым запланирована операция по поводу катаракты или глаукомы. Имеются сообщения о случаях развития длительной эрекции и приапизма на фоне терапии альфа1-адреноблокаторами. В случае сохранения эрекции в течение более 4-х часов следует немедленно обратиться за медицинской помощью. Если терапия приапизма не была проведена незамедлительно, это может привести к повреждению тканей полового члена и необратимой утрате потенции. Прежде чем начать терапию препаратом Тамсулозин ретард, пациент должен быть обследован с тем, чтобы исключить наличие других заболеваний, которые могут вызывать такие же симптомы, как и ДГПЖ. Перед началом лечения и регулярно во время терапии должно выполняться пальцевое ректальное обследование и, если требуется, определение простатического специфического антигена. Влияние на способность управлять транспортными средствами и механизмамиНеобходимо соблюдать осторожность при управлении автотранспортом и занятиями потенциально опасными видами деятельности, требующими повышенной концентрации внимания и скорости психомоторных реакций, в связи с тем, что возможно развитие головокружения.
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