Фармакологическое действие — альфа-адреноблокирующее. Инструкция
Показания к применению
Лечение функциональных расстройств при доброкачественной гиперплазии предстательной железы.
Противопоказания
повышенная чувствительность к компонентам препарата;ортостатическая гипотензия (в т.ч. в анамнезе);выраженная печеночная недостаточность;возраст до 18 лет (эффективность и безопасность не установлены). С осторожностью: хроническая почечная недостаточность (снижение Cl креатинина ниже 10 мл/мин); артериальная гипотензия (в т.ч. ортостатическая); запланированная ...
Капсулы с модифицированным высвобождением1 капс.активное вещество:тамсулозина гидрохлорид0,4 мгвспомогательные вещества: метакриловой кислоты и этилакрилата сополимер [1:1] [30% дисперсия]*— 74,9 (в форме твердого вещества), МКЦ— 257,1 мг; дибутилсебакат— 8,4 мг; полисорбат 80— 0,5 мг; кремния диоксид коллоидный— 3,7 мг; тальк— 0,3 мгоболочка капсулы: краситель азорубин— 0,2 %; краситель синий патентованный— 0,12%; желатин— до 100%*Для одной капсулы используется 30% дисперсия метакриловой кислоты и этакрилата сополимер [1:1] в количестве 249,67 мг, которое соответствует 74,9 мг в форме твердого вещества
Описание
Твердые желатиновые капсулы №1, корпус и крышечка темно-синего цвета, прозрачные.Содержимое капсул: белые или почти белые микропеллеты.
Фармакологические свойства
Фармакологическое действие — альфа-адреноблокирующее.
Показания к применению
Лечение функциональных расстройств при доброкачественной гиперплазии предстательной железы.
Противопоказания
повышенная чувствительность к компонентам препарата;ортостатическая гипотензия (в т.ч. в анамнезе);выраженная печеночная недостаточность;возраст до 18 лет (эффективность и безопасность не установлены). С осторожностью: хроническая почечная недостаточность (снижение Cl креатинина ниже 10 мл/мин); артериальная гипотензия (в т.ч. ортостатическая); запланированная операция по поводу катаракты; совместное использование с мощными или умеренно активными ингибиторами изофермента CYP3A4 (например кетоконазол, вориконазол).
Способ применения и дозы
Внутрь, после первого приема пищи, не разжевывая, запивая достаточным количеством воды. Препарат назначают по 400 мкг (1 капс.)/сут.Фокусин® может назначаться, как в виде монотерапии, так и в сочетании с ингибиторами 5α-редуктазы (финастерид, дутастерид).
Побочное действие
Частота нежелательных реакций представлена в соответствии с классификацией Медицинского словаря по нормативно-правовой деятельности (MedDRA): очень часто (>10%); часто (≥1, <10%); нечасто: (≥0,1, <1%); редко (≥0,01 <0,1%); очень редко (<0,01%); частота неизвестна (определить частоту встречаемости по имеющимся данным не представляется возможным).Со стороны иммунной системы: очень редко— реакция гиперчувствительности.Со стороны нервной системы: часто— головокружение; нечасто— головная боль; редко— синкопальные состояния; частота неизвестна— нарушение сна (сонливость или бессонница).Со стороны органа зрения: частота неизвестна— нечеткость зрения, нарушение зрения.Со стороны сердца: нечасто— сердцебиение; частота неизвестна— тахикардия.Со стороны сосудов: нечасто— ортостатическая гипотензия.Со стороны дыхательной системы, органов грудной клетки и средостения: нечасто— ринит; частота неизвестна— носовое кровотечение.Со стороны ЖКТ: редко— тошнота, рвота, запор или диарея.Со стороны кожи и подкожных тканей: нечасто— кожная сыпь, зуд, крапивница; редко— ангионевротический отек; очень редко— синдром Стивенса-Джонсона; частота неизвестна— мультиформная эритема, эксфолиативный дерматит.Со стороны половых органов и молочной железы: очень редко— приапизм; частота неизвестна— нарушения эякуляции, в т.ч. ретроградная эякуляция, снижение либидо.Общие расстройства и нарушения в месте введения: нечасто— астенический синдром; частота неизвестна— боль в спине, боль в грудной клетке, сухость во рту.
Передозировка
Симптомы: выраженное снижение АД.Лечение: кардиотропная терапия, контроль функции почек, общая поддерживающая терапия, введение объемозамещающих растворов или сосудосуживающих препаратов. Для предотвращения дальнейшей абсорбции тамсулозина возможно промывание желудка, прием активированного угля или осмотического слабительного.
Взаимодействие с другими лекарственными средствами
Одновременное применение тамсулозина с другими α1-адреноблокаторами может привести к снижению АД.Диклофенак и непрямые антикоагулянты (варфарин) несколько увеличивают скорость выведения тамсулозина.Циметидин повышает концентрацию тамсулозина в плазме, а фуросемид снижает (существенного клинического значения не имеет).При совместном применении тамсулозина с атенололом, эналаприлом или теофиллином признаки лекарственного взаимодействия отсутствовали.В условиях in vitro введение диазепама, пропранолола, трихлорметиазида, хлормадинона, амитриптилина, диклофенака, глибенкламида, симвастатина и варфарина не приводило к изменению свободной фракции тамсулозина в плазме крови. Тамсулозин также не оказывал влияние на свободные фракции диазепама, пропранолола, трихлорметиазида и хлормадинона.Совместное применение тамсулозина и мощных ингибиторов изофермента CYP3A4 может вызывать повышение системной экспозиции тамсулозина. Одновременный прием тамсулозина с кетоконазолом (мощным ингибитором изофермента CYP3A4) приводил к возрастанию показателей AUC и Cmax тамсулозина в 2,8 и 2,2 раза соответственно. Тамсулозин не должен применяться в комбинации с мощными ингибиторами изофермента CYP3A4 у пациентов с фенотипом медленного метаболизма по изоферменту CYP2D6.Следует соблюдать осторожность при совместном использовании тамсулозина с мощными или умеренно активными ингибиторами изофермента CYP3A4.
Условия хранения
При температуре не выше 25°C. Хранить в недоступном для детей месте.
Срок годности
3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России
Условия отпуска
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