Тамсулозин избирательно и конкурентно блокирует постсинаптич... Инструкция
Показания к применению
Лечение функциональных расстройств при доброкачественной гиперплазии предстательной железы
Противопоказания
Ортостатическая гипотензия (в т.ч. в анамнезе);
Выраженная печеночная недостаточность
Возраст до 18 лет (эффективность и безопасность не установлены)
Повышенная чувствительность к компонентам препарата. С осторожностью следует применять препарат при хронической почечной недостаточности (КК менее 10 мл/мин), артериальной гипотензии (в т.ч. ортостатической), запланированной операции по поводу катаракты, при одновременном применении мощных и умеренно активных ингибиторов изофермента CYP3А4 (например, кетоконазол, вориконазол). Противопоказано применение препарата при выраженной печеночной недостаточности. Применение при нарушениях функции почекС осторожностью следует применять препарат при хронической почечной недостаточности (КК менее 10 мл/мин)
1 капсула содержит тамсулозина гидрохлорид 400 мкг. Вспомогательные вещества: сополимер метакриловой кислоты и этилакрилата (1: 1) 30% дисперсия - 74.9 мг (в форме твердого вещества)*, целлюлоза микрокристаллическая - 257.1 мг, дибутилсебакат - 8.4 мг, полисорбат 80 - 500 мкг, кремния диоксид коллоидный - 3.7 мг, тальк - 300 мкг.* для одной капсулы используется 30% дисперсия сополимера метакриловой кислоты и этилакрилата (1: 1) в количестве 249.67 мг, которое соответствует 74.9 мг в форме твердого вещества. Состав оболочки капсулы: краситель азорубин - 0.2%, краситель синий патентованный - 0.12%, желатин - до 100%.
Фармакологические свойства
Тамсулозин избирательно и конкурентно блокирует постсинаптические α1А-адренорецепторы гладкой мускулатуры предстательной железы, шейки мочевого пузыря и простатической части уретры и α1Д-адренорецепторы мочевого пузыря, что приводит к снижению тонуса гладкой мускулатуры предстательной железы, шейки мочевого пузыря и простатической части уретры, улучшению функции детрузора и уменьшению симптомов обструкции и раздражения, связанных с доброкачественной гиперплазией предстательной железы. Как правило, терапевтический эффект развивается через 2 нед. после начала приема препарата, хотя у ряда пациентов уменьшение выраженности симптомов отмечается после приема первой дозы. Способность тамсулозина воздействовать на α1А-адренорецепторы в 20 раз превосходит его способность воздействовать на α1Д-адренорецепторы гладких мышц сосудов. Благодаря такой высокой селективности препарат не вызывает какого-либо клинически значимого снижения системного АД как у пациентов с артериальной гипертензией, так и у пациентов с нормальным исходным АД.
Показания к применению
Лечение функциональных расстройств при доброкачественной гиперплазии предстательной железы
Противопоказания
Ортостатическая гипотензия (в т.ч. в анамнезе);
Выраженная печеночная недостаточность
Возраст до 18 лет (эффективность и безопасность не установлены)
Повышенная чувствительность к компонентам препарата. С осторожностью следует применять препарат при хронической почечной недостаточности (КК менее 10 мл/мин), артериальной гипотензии (в т.ч. ортостатической), запланированной операции по поводу катаракты, при одновременном применении мощных и умеренно активных ингибиторов изофермента CYP3А4 (например, кетоконазол, вориконазол). Противопоказано применение препарата при выраженной печеночной недостаточности. Применение при нарушениях функции почекС осторожностью следует применять препарат при хронической почечной недостаточности (КК менее 10 мл/мин)
Применение при беременности и в период грудного вскармливания
Фокусин не предназначен для применения у женщин
Способ применения и дозы
Препарат принимают внутрь в дозе 400 мкг (1 капс.)/сут. Капсулы следует принимать после первого приема пищи, не разжевывая, запивая достаточным количеством воды. Фокусин может применяться как в качестве монотерапии, так и в сочетании с ингибиторами 5α-редуктазы (финастерид, дутастерид)
Побочное действие
Частота нежелательных реакций представлена в соответствии с классификацией 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 - реакции 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 сердечно-сосудистой системы: нечасто - ощущение сердцебиения, ортостатическая гипотензия; частота неизвестна - тахикардия. Со стороны дыхательной системы: нечасто - ринит; частота неизвестна - носовое кровотечение. Со стороны пищеварительной системы: 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 - многоформная 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: нечасто - астенический синдром; частота неизвестна - боль в спине, боль в грудной клетке.
Передозировка
Симптомы: выраженное снижение АД. Лечение: проведение кардиотропной терапии, общей поддерживающей терапии, контроль функции почек, введение объемозамещающих растворов или сосудосуживающих препаратов. Для предотвращения дальнейшей абсорбции тамсулозина возможно промывание желудка, прием активированного угля или осмотического слабительного.
Особые указания
До начала терапии препаратом Фокусин необходимо исключить наличие других заболеваний, которые могут вызывать такие же симптомы, как и доброкачественная гиперплазия предстательной железы. Перед началом лечения и регулярно во время терапии следует проводить обследование предстательной железы (пальцевое ректальное обследование, определение ПСА). Как и при применении других альфа1-адреноблокаторов, при лечении препаратом Фокусин в отдельных случаях может наблюдаться снижение АД, которое может приводить к обморочному состоянию. Препарат Фокусин следует применять с осторожностью у пациентов с предрасположенностью к ортостатической гипотензии. При первых признаках ортостатической гипотензии (головокружение, слабость) пациента следует усадить или уложить. При развитии ангионевротического отека, а также других иммунологических реакций, таких как синдром Стивенса-Джонсона, применение препарата следует немедленно прекратить. Пациент должен находиться под наблюдением врача до ликвидации данного патологического состояния; повторное назначение тамсулозина не допускается. При проведении хирургических операций по поводу катаракты у некоторых пациентов, получавших тасмулозина гидрохлорид на момент операции и в прошлом, имело место развитие синдрома интраоперационной нестабильности радужной оболочки глаза (синдром узкого зрачка). Возникновение синдрома интраоперационной нестабильности радужной оболочки глаза может приводить к повышению риска осложнений со стороны органа зрения во время и после операции. Тамсулозина гидрохлорид не следует применять в комбинации с мощными ингибиторами изофермента CYP3А4 у пациентов с фенотипом медленного метаболизма по изоферменту CYP2D6. Влияние на способность к вождению автотранспорта и управлению механизмамиСледует соблюдать осторожность при управлении транспортными средствами и занятиях, требующих повышенной концентрации внимания и быстроты психомоторных реакций. В случае возникновения головокружения необходимо воздержаться от управления автотранспортом и выполнения других потенциально опасных видов деятельности
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Вспомогательные вещества: сополимер метакриловой кислоты и этилакрилата (1: 1) 30% дисперсия - 74.9 мг (в форме твердого вещества)*, целлюлоза микрокристаллическая - 257.1 мг, дибутилсебакат - 8.4 мг, полисорбат 80 - 500 мкг, кремния диоксид коллоидный - 3.7 мг, тальк - 300 мкг.* для одной капсулы используется 30% дисперсия сополимера метакриловой кислоты и этилакрилата (1: 1) в количестве 249.67 мг, которое соответствует 74.9 мг в форме твердого вещества. Состав оболочки капсулы: краситель азорубин - 0.2%, краситель синий патентованный - 0.12%, желатин - до 100%."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Тамсулозин избирательно и конкурентно блокирует постсинаптические α1А-адренорецепторы гладкой мускулатуры предстательной железы, шейки мочевого пузыря и простатической части уретры и α1Д-адренорецепторы мочевого пузыря, что приводит к снижению тонуса гладкой мускулатуры предстательной железы, шейки мочевого пузыря и простатической части уретры, улучшению функции детрузора и уменьшению симптомов обструкции и раздражения, связанных с доброкачественной гиперплазией предстательной железы. Как правило, терапевтический эффект развивается через 2 нед. после начала приема препарата, хотя у ряда пациентов уменьшение выраженности симптомов отмечается после приема первой дозы. Способность тамсулозина воздействовать на α1А-адренорецепторы в 20 раз превосходит его способность воздействовать на α1Д-адренорецепторы гладких мышц сосудов. Благодаря такой высокой селективности препарат не вызывает какого-либо клинически значимого снижения системного АД как у пациентов с артериальной гипертензией, так и у пациентов с нормальным исходным АД."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение функциональных расстройств при доброкачественной гиперплазии предстательной железы"}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Ортостатическая гипотензия (в т.ч. в анамнезе);"}},{"type":"list","data":{"style":"unordered","items":["Выраженная печеночная недостаточность","Возраст до 18 лет (эффективность и безопасность не установлены)","Повышенная чувствительность к компонентам препарата. С осторожностью следует применять препарат при хронической почечной недостаточности (КК менее 10 мл/мин), артериальной гипотензии (в т.ч. ортостатической), запланированной операции по поводу катаракты, при одновременном применении мощных и умеренно активных ингибиторов изофермента CYP3А4 (например, кетоконазол, вориконазол). Противопоказано применение препарата при выраженной печеночной недостаточности. Применение при нарушениях функции почекС осторожностью следует применять препарат при хронической почечной недостаточности (КК менее 10 мл/мин)"]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Фокусин не предназначен для применения у женщин"}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат принимают внутрь в дозе 400 мкг (1 капс.)/сут. Капсулы следует принимать после первого приема пищи, не разжевывая, запивая достаточным количеством воды. Фокусин может применяться как в качестве монотерапии, так и в сочетании с ингибиторами 5α-редуктазы (финастерид, дутастерид)"}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Частота нежелательных реакций представлена в соответствии с классификацией MedDRA: очень часто (\u003e10%), часто (≥1%, \u003c10%), нечасто (≥0.1%, \u003c1%), редко (≥0.01%, \u003c0.1%), очень редко (\u003c0.01%), частота неизвестна (определить частоту встречаемости по имеющимся данным не представляется возможным). Со стороны иммунной системы: очень редко - реакции 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 сердечно-сосудистой системы: нечасто - ощущение сердцебиения, ортостатическая гипотензия; частота неизвестна - тахикардия. Со стороны дыхательной системы: нечасто - ринит; частота неизвестна - носовое кровотечение. Со стороны пищеварительной системы: 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 - многоформная 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: нечасто - астенический синдром; частота неизвестна - боль в спине, боль в грудной клетке."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: выраженное снижение АД. Лечение: проведение кардиотропной терапии, общей поддерживающей терапии, контроль функции почек, введение объемозамещающих растворов или сосудосуживающих препаратов. Для предотвращения дальнейшей абсорбции тамсулозина возможно промывание желудка, прием активированного угля или осмотического слабительного."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"До начала терапии препаратом Фокусин необходимо исключить наличие других заболеваний, которые могут вызывать такие же симптомы, как и доброкачественная гиперплазия предстательной железы. Перед началом лечения и регулярно во время терапии следует проводить обследование предстательной железы (пальцевое ректальное обследование, определение ПСА). Как и при применении других альфа1-адреноблокаторов, при лечении препаратом Фокусин в отдельных случаях может наблюдаться снижение АД, которое может приводить к обморочному состоянию. Препарат Фокусин следует применять с осторожностью у пациентов с предрасположенностью к ортостатической гипотензии. При первых признаках ортостатической гипотензии (головокружение, слабость) пациента следует усадить или уложить. При развитии ангионевротического отека, а также других иммунологических реакций, таких как синдром Стивенса-Джонсона, применение препарата следует немедленно прекратить. Пациент должен находиться под наблюдением врача до ликвидации данного патологического состояния; повторное назначение тамсулозина не допускается. При проведении хирургических операций по поводу катаракты у некоторых пациентов, получавших тасмулозина гидрохлорид на момент операции и в прошлом, имело место развитие синдрома интраоперационной нестабильности радужной оболочки глаза (синдром узкого зрачка). Возникновение синдрома интраоперационной нестабильности радужной оболочки глаза может приводить к повышению риска осложнений со стороны органа зрения во время и после операции. Тамсулозина гидрохлорид не следует применять в комбинации с мощными ингибиторами изофермента CYP3А4 у пациентов с фенотипом медленного метаболизма по изоферменту CYP2D6. Влияние на способность к вождению автотранспорта и управлению механизмамиСледует соблюдать осторожность при управлении транспортными средствами и занятиях, требующих повышенной концентрации внимания и быстроты психомоторных реакций. 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