Финастерид является синтетическим 4-азастероидным соединением, конкурентным и специфическим ингибитором изоэнзима II типа стероидной 5--редуктазы, преобразующей тестостерон в активный андроген 5--дигидротестостерон (ДГТ). Финастерид препятствует стимулирующему действию тестостерона на развитие опухоли; подавление образования дигидрогеназы сопровождается уменьшением объема предстательной железы, увеличением максимальной скорости оттока мочи и уменьшением симптомов непроходимости мочевыводящих путей. При постоянном приеме статистически значимый эффект регистрируется через 3 месяцев (уменьшение объема железы) и 7 месяцев, (уменьшение выраженности симптомов, связанных с гиперплазией предстательной железы).; В организме человека встречаются 2 вида 5--редуктазы: I и II. Их распределение в тканях не одинаково: в предстательной железе, яичках и их придатках, головке полового члена, мошонке, семенных везикулах, печени и в грудной клетке встречается изоэнзим II типа; I тип встречается, главным образом, в коже головы, спины и груди, сальных железах, в печени, надпочечниках и почках. Финастерид угнетает в первую очередь изоэнзим II типа, ответственный за большую часть ДГТ в крови. Одноразовая доза финастерида быстро и существенно изменяет уровень ДГТ в плазме. Однократная 5 мг доза финастерида снижает уровень ДГТ в плазме на 75%, который на 24 часу достигает своего минимума, затем, в течение 7 дней возвращается к исходному уровню.; При многократном приеме финастерид сохраняет эффективность. Финастерид снижает уровень ДГТ в самой предстательной железе на ≤15% и обеспечивает соответствующее увеличение уровня тестостерона в предстательной железе. По сравнению с хирургическим или химическим кастрированием, лечение финастеридом сопровождается значительно большим снижением уровня ДГТ в предстательной железе.; Простатоспецифический антиген (ПСА) - чувствительный и специфический андрогенозависимый маркер карциномы предстательной железы. В большинстве случаев, после нескольких месяцев лечения финастеридом наблюдается быстрое снижение уровня ПСА, и затем установление на новых исходных отметках.; После 1 года приема 5 мг доз финастерида средняя концентрация ПСА снижается на 50%.; Финастерид не проявляет сродства к андрогенным рецепторам и не оказывает иного гормонального действия. Вслед за открытием 5--редуктазы и описанием синдрома недостаточности 5--редуктазы II типа (гермафродитизм мужского типа) роль андрогенов в доброкачественной гиперплазии предстательной железы была вновь пересмотрена.; Развитие предстательной железы зависит от ДГТ, сильного андрогена. При недостаточности 5--редуктазы на фоне нормального или высокого уровня тестостерона во взрослом возрасте наблюдается атрофия предстательной железы.; ДГТ активирует андрогенные рецепторы, образовав после присоединения к ним димеры, которые, вступая в связь с ДНК, прямо или косвенно способствуют пролиферации клеток за счет изменения экспрессии генов, отвечающих за пролиферацию и апоптоз. В интактной предстательной железе процессы апоптоза и пролиферации находятся в равновесии. Несмотря на то, что факторы, провоцирующие гиперплазию предстательной железы на молекулярном уровне не известны, роль ДГТ в этом весьма вероятна. Специфические ингибиторы 5--редуктазы II типа способны снижать уровень ДГТ в предстательной железе и способствовать обратному развитию гиперплазированной простаты. Отмечалась значительная летальность у мышей и крыс обоих полов при скармливании первым однократной дозы финастерида, равной 1500 мг/м (500 мг/кг), а вторым - 2360 мг/м2 (400 мг/кг - самкам) и 5900 мг/м2 (1000 мг/кг - самцам). Малые дозы препарата, скармливаемые беременным крысам, вызывали пороки развития гениталий у самцов-потомков.
Показания к применению
Лечение доброкачественной гиперплазии предстательной железы с целью:
Уменьшения размеров предстательной железы
Увеличения максимальной скорости оттока мочи и уменьшения симптомов, связанных с гиперплазией
Снижения риска возникновения острой задержки мочи и связанной с этим вероятности хирургического вмешательства
Противопоказания
Рак предстательной железы
Обструкция мочевыводящих путей
Детский возраст
Повышенная чувствительность к финастериду или другим компонентам препарата
С осторожностью следует назначать препарат при печеночой недостаточности.
Препарат не должен назначаться женщинам.
Применение при беременности и в период грудного вскармливания
Малые дозы финастерида могут вызывать нарушения развития наружных гениталий у плода мужского пола при попадании препарата каким-либо путем в организм беременной женщины. Количества финастерида, всасывающиеся при прикосновении с разломанной таблеткой или со спермой мужчины, принимавшего финастерид, неизвестны. Во избежание поражения плода мужского пола беременные женщины и женщины с подозрением на беременность не должны прикасаться к разломанным таблеткам финастерида и к сперме мужчин, находящихся на лечении этим препаратом. В связи с тем, что остается неизвестным как долго после окончания лечения финастерид продолжает выделяться со спермой, мужчинам рекомендуется продолжать соблюдать меры предосторожности и в последующие после завершения курса лечения 2 месяца.
Способ применения и дозы
Предназначен исключительно для мужчин.; Препарат назначают в дозе 5 мг (1 таб.)/сут, в течение не менее 6 мес.; Пациентам пожилого возраста изменения дозы не требуется, несмотря на замедленное выведение из организма (около 8 ч).; При почечной недостаточности снижения дозы не требуется, т.к. выведение осуществляется преимущественно с каловыми массами; основные кинетические параметры (период полувыведения, максимальная концентрация, AUC) сходны с таковыми здоровых людей.
Побочное действие
Лечение обычно хорошо переносится, описанные побочные реакции не слишком часты и чаще всего носят легкую форму и временный характер.; Со стороны эндокринной системы: часто - импотенция, снижение либидо, уменьшение количества эякулята; возможно - гинекомастия, болезненность грудных желез; иногда - повышение уровня ЛГ и ФСГ в крови (примерно на 10%, при этом они остаются в пределах нормы).; Аллергические реакции: иногда - реакции повышенной чувствительности (иногда - ангионевротический отек губ, кожная сыпь.
Передозировка
Максимальная однократная доза финастерида 400 мг, а также ежедневный прием 80 мг на протяжении 3 месяцев не вызывали развития побочных реакций. При передозировке нет необходимости в проведении специфического лечения.
Особые указания
До начала терапии необходимо исключить заболевания с симптомами сходными с проявлениями доброкачественной гиперплазии предстательной железы, такие как рак предстательной железы, инфекционный простатит, стриктура уретры, гипотоничный мочевой пузырь и ряд изменений со стороны мочевыводящей системы, возникающих при некоторых заболеваниях нервной системы.; С осторожностью назначают препарат пациентам с нарушениями функции печени.; Поскольку при применении финастерида наблюдается снижение простат-специфического антигена, периодически в процессе терапии необходимо производить обследование пациентов для исключения у них рака предстательной железы.; Прежде, чем приступить к лечению финастеридом, следует исключить наличие заболеваний, симулирующих доброкачественную гиперплазию предстательной железы: рак предстательной железы, стриктуру уретры, гипотонию мочевого пузыря, нарушение его иннервации, инфекционный простатит. Улучшение наступает не сразу, поэтому при больших остаточных объeмах мочи или тяжелых формах затруднения мочеиспускания целесообразно установить наблюдение за больным во избежание развития обструктивной уропатии.; Финастерид вызывает снижение ПСА на 48% через 12 месяцев после приема (даже при одновременном наличии карциномы предстательной железы), затрудняя распознавание карциномы предстательной железы, поэтому рекомендуется проводить предварительное ректальное дигитальное обследование органа, затем периодически повторять его в ходе лечения для исключения наличия карциномы.; Рекомендуется проводить лабораторные анализы функции печени и почек, осадка мочи перед лечением и каждые 6 месяцев в ходе его.; Влияние на способность управления автомобилем и рабочими механизмами; Не наблюдалось.
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5 мг; Вспомогательные вещества: магния стеарат - 0.75 мг, тальк - 4.5 мг, карбоксиметилкрахмал натрия (тип А) - 7.5 мг, крахмал прежелатинизированный - 15 мг, целлюлоза микрокристаллическая - 15 мг, лактозы моногидрат - 102.25 мг.; Состав пленочной оболочки: титана диоксид (C.I.77891 EEC171) - 0.1881 мг, лактозы моногидрат - 0.3809 мг, макрогол 6000 - 0.6214 мг, гидроксипропилцеллюлоза - 1.9048 мг, гипромеллоза - 1.9048 мг."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Финастерид является синтетическим 4-азастероидным соединением, конкурентным и специфическим ингибитором изоэнзима II типа стероидной 5--редуктазы, преобразующей тестостерон в активный андроген 5--дигидротестостерон (ДГТ). Финастерид препятствует стимулирующему действию тестостерона на развитие опухоли; подавление образования дигидрогеназы сопровождается уменьшением объема предстательной железы, увеличением максимальной скорости оттока мочи и уменьшением симптомов непроходимости мочевыводящих путей. При постоянном приеме статистически значимый эффект регистрируется через 3 месяцев (уменьшение объема железы) и 7 месяцев, (уменьшение выраженности симптомов, связанных с гиперплазией предстательной железы).; В организме человека встречаются 2 вида 5--редуктазы: I и II. Их распределение в тканях не одинаково: в предстательной железе, яичках и их придатках, головке полового члена, мошонке, семенных везикулах, печени и в грудной клетке встречается изоэнзим II типа; I тип встречается, главным образом, в коже головы, спины и груди, сальных железах, в печени, надпочечниках и почках. Финастерид угнетает в первую очередь изоэнзим II типа, ответственный за большую часть ДГТ в крови. Одноразовая доза финастерида быстро и существенно изменяет уровень ДГТ в плазме. Однократная 5 мг доза финастерида снижает уровень ДГТ в плазме на 75%, который на 24 часу достигает своего минимума, затем, в течение 7 дней возвращается к исходному уровню.; При многократном приеме финастерид сохраняет эффективность. Финастерид снижает уровень ДГТ в самой предстательной железе на ≤15% и обеспечивает соответствующее увеличение уровня тестостерона в предстательной железе. По сравнению с хирургическим или химическим кастрированием, лечение финастеридом сопровождается значительно большим снижением уровня ДГТ в предстательной железе.; Простатоспецифический антиген (ПСА) - чувствительный и специфический андрогенозависимый маркер карциномы предстательной железы. В большинстве случаев, после нескольких месяцев лечения финастеридом наблюдается быстрое снижение уровня ПСА, и затем установление на новых исходных отметках.; После 1 года приема 5 мг доз финастерида средняя концентрация ПСА снижается на 50%.; Финастерид не проявляет сродства к андрогенным рецепторам и не оказывает иного гормонального действия. Вслед за открытием 5--редуктазы и описанием синдрома недостаточности 5--редуктазы II типа (гермафродитизм мужского типа) роль андрогенов в доброкачественной гиперплазии предстательной железы была вновь пересмотрена.; Развитие предстательной железы зависит от ДГТ, сильного андрогена. При недостаточности 5--редуктазы на фоне нормального или высокого уровня тестостерона во взрослом возрасте наблюдается атрофия предстательной железы.; ДГТ активирует андрогенные рецепторы, образовав после присоединения к ним димеры, которые, вступая в связь с ДНК, прямо или косвенно способствуют пролиферации клеток за счет изменения экспрессии генов, отвечающих за пролиферацию и апоптоз. В интактной предстательной железе процессы апоптоза и пролиферации находятся в равновесии. Несмотря на то, что факторы, провоцирующие гиперплазию предстательной железы на молекулярном уровне не известны, роль ДГТ в этом весьма вероятна. Специфические ингибиторы 5--редуктазы II типа способны снижать уровень ДГТ в предстательной железе и способствовать обратному развитию гиперплазированной простаты. Отмечалась значительная летальность у мышей и крыс обоих полов при скармливании первым однократной дозы финастерида, равной 1500 мг/м (500 мг/кг), а вторым - 2360 мг/м2 (400 мг/кг - самкам) и 5900 мг/м2 (1000 мг/кг - самцам). Малые дозы препарата, скармливаемые беременным крысам, вызывали пороки развития гениталий у самцов-потомков."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение доброкачественной гиперплазии предстательной железы с целью:"}},{"type":"list","data":{"style":"unordered","items":["Уменьшения размеров предстательной железы","Увеличения максимальной скорости оттока мочи и уменьшения симптомов, связанных с гиперплазией","Снижения риска возникновения острой задержки мочи и связанной с этим вероятности хирургического вмешательства"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Рак предстательной железы","Обструкция мочевыводящих путей","Детский возраст","Повышенная чувствительность к финастериду или другим компонентам препарата"]}},{"type":"paragraph","data":{"text":"С осторожностью следует назначать препарат при печеночой недостаточности."}},{"type":"paragraph","data":{"text":"Препарат не должен назначаться женщинам."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Малые дозы финастерида могут вызывать нарушения развития наружных гениталий у плода мужского пола при попадании препарата каким-либо путем в организм беременной женщины. Количества финастерида, всасывающиеся при прикосновении с разломанной таблеткой или со спермой мужчины, принимавшего финастерид, неизвестны. Во избежание поражения плода мужского пола беременные женщины и женщины с подозрением на беременность не должны прикасаться к разломанным таблеткам финастерида и к сперме мужчин, находящихся на лечении этим препаратом. В связи с тем, что остается неизвестным как долго после окончания лечения финастерид продолжает выделяться со спермой, мужчинам рекомендуется продолжать соблюдать меры предосторожности и в последующие после завершения курса лечения 2 месяца."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Предназначен исключительно для мужчин.; Препарат назначают в дозе 5 мг (1 таб.)/сут, в течение не менее 6 мес.; Пациентам пожилого возраста изменения дозы не требуется, несмотря на замедленное выведение из организма (около 8 ч).; При почечной недостаточности снижения дозы не требуется, т.к. выведение осуществляется преимущественно с каловыми массами; основные кинетические параметры (период полувыведения, максимальная концентрация, AUC) сходны с таковыми здоровых людей."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение обычно хорошо переносится, описанные побочные реакции не слишком часты и чаще всего носят легкую форму и временный характер.; Со стороны эндокринной системы: часто - импотенция, снижение либидо, уменьшение количества эякулята; возможно - гинекомастия, болезненность грудных желез; иногда - повышение уровня ЛГ и ФСГ в крови (примерно на 10%, при этом они остаются в пределах нормы).; Аллергические реакции: иногда - реакции повышенной чувствительности (иногда - ангионевротический отек губ, кожная сыпь."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Максимальная однократная доза финастерида 400 мг, а также ежедневный прием 80 мг на протяжении 3 месяцев не вызывали развития побочных реакций. При передозировке нет необходимости в проведении специфического лечения."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"До начала терапии необходимо исключить заболевания с симптомами сходными с проявлениями доброкачественной гиперплазии предстательной железы, такие как рак предстательной железы, инфекционный простатит, стриктура уретры, гипотоничный мочевой пузырь и ряд изменений со стороны мочевыводящей системы, возникающих при некоторых заболеваниях нервной системы.; С осторожностью назначают препарат пациентам с нарушениями функции печени.; Поскольку при применении финастерида наблюдается снижение простат-специфического антигена, периодически в процессе терапии необходимо производить обследование пациентов для исключения у них рака предстательной железы.; Прежде, чем приступить к лечению финастеридом, следует исключить наличие заболеваний, симулирующих доброкачественную гиперплазию предстательной железы: рак предстательной железы, стриктуру уретры, гипотонию мочевого пузыря, нарушение его иннервации, инфекционный простатит. Улучшение наступает не сразу, поэтому при больших остаточных объeмах мочи или тяжелых формах затруднения мочеиспускания целесообразно установить наблюдение за больным во избежание развития обструктивной уропатии.; Финастерид вызывает снижение ПСА на 48% через 12 месяцев после приема (даже при одновременном наличии карциномы предстательной железы), затрудняя распознавание карциномы предстательной железы, поэтому рекомендуется проводить предварительное ректальное дигитальное обследование органа, затем периодически повторять его в ходе лечения для исключения наличия карциномы.; Рекомендуется проводить лабораторные анализы функции печени и почек, осадка мочи перед лечением и каждые 6 месяцев в ходе его.; Влияние на способность управления автомобилем и рабочими механизмами; Не наблюдалось."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Финастерид является синтетическим 4-азастероидным соединением, конкурентным и специфическим ингибитором изоэнзима II типа стероидной 5--редуктазы, преобразующей тестостерон в активный андроген 5--дигидротестостерон (ДГТ). Финастерид препятствует стимулирующему действию тестостерона на развитие опухоли; подавление образования дигидрогеназы сопровождается уменьшением объема предстательной железы, увеличением максимальной скорости оттока мочи и уменьшением симптомов непроходимости мочевыводящих путей. При постоянном приеме статистически значимый эффект регистрируется через 3 месяцев (уменьшение объема железы) и 7 месяцев, (уменьшение выраженности симптомов, связанных с гиперплазией предстательной железы).; В организме человека встречаются 2 вида 5--редуктазы: I и II. Их распределение в тканях не одинаково: в предстательной железе, яичках и их придатках, головке полового члена, мошонке, семенных везикулах, печени и в грудной клетке встречается изоэнзим II типа; I тип встречается, главным образом, в коже головы, спины и груди, сальных железах, в печени, надпочечниках и почках. Финастерид угнетает в первую очередь изоэнзим II типа, ответственный за большую часть ДГТ в крови. Одноразовая доза финастерида быстро и существенно изменяет уровень ДГТ в плазме. Однократная 5 мг доза финастерида снижает уровень ДГТ в плазме на 75%, который на 24 часу достигает своего минимума, затем, в течение 7 дней возвращается к исходному уровню.; При многократном приеме финастерид сохраняет эффективность. Финастерид снижает уровень ДГТ в самой предстательной железе на ≤15% и обеспечивает соответствующее увеличение уровня тестостерона в предстательной железе. По сравнению с хирургическим или химическим кастрированием, лечение финастеридом сопровождается значительно большим снижением уровня ДГТ в предстательной железе.; Простатоспецифический антиген (ПСА) - чувствительный и специфический андрогенозависимый маркер карциномы предстательной железы. В большинстве случаев, после нескольких месяцев лечения финастеридом наблюдается быстрое снижение уровня ПСА, и затем установление на новых исходных отметках.; После 1 года приема 5 мг доз финастерида средняя концентрация ПСА снижается на 50%.; Финастерид не проявляет сродства к андрогенным рецепторам и не оказывает иного гормонального действия. Вслед за открытием 5--редуктазы и описанием синдрома недостаточности 5--редуктазы II типа (гермафродитизм мужского типа) роль андрогенов в доброкачественной гиперплазии предстательной железы была вновь пересмотрена.; Развитие предстательной железы зависит от ДГТ, сильного андрогена. При недостаточности 5--редуктазы на фоне нормального или высокого уровня тестостерона во взрослом возрасте наблюдается атрофия предстательной железы.; ДГТ активирует андрогенные рецепторы, образовав после присоединения к ним димеры, которые, вступая в связь с ДНК, прямо или косвенно способствуют пролиферации клеток за счет изменения экспрессии генов, отвечающих за пролиферацию и апоптоз. В интактной предстательной железе процессы апоптоза и пролиферации находятся в равновесии. Несмотря на то, что факторы, провоцирующие гиперплазию предстательной железы на молекулярном уровне не известны, роль ДГТ в этом весьма вероятна. Специфические ингибиторы 5--редуктазы II типа способны снижать уровень ДГТ в предстательной железе и способствовать обратному развитию гиперплазированной простаты. 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