Стимулирует развитие мужских половых органов и вторичных пол... Инструкция
Показания к применению
Гормонозаместительная терапия: посткастрационный синдром, евнухоидизм, гипопитуитаризм, эндокринная импотенция, климактерические нарушения у мужчин (в т.ч. снижение либидо, умственной и физической активности), остеопороз, обусловленный дефицитом андрогенов.
Противопоказания
Карцинома простаты или молочной железы (в т.ч. подозреваемая).
Лекарственная форма выпуска Сустанона-250 – раствор для внутримышечного введения: масляный, от желтого до почти бесцветного с незначительным желтоватым оттенком (в стеклянных бесцветных ампулах по 1 мл, в картонной пачке 1 ампула).
1 ампула с 1 мл масляного раствора для инъекций содержит тестостерона пропионата 30 мг, тестостерона фенилпропионата 60 мг, тестостерона изокапроната 60 мг, тестостерона деканоата 100 мг; в контурной ячейковой упаковке, в коробке 1 шт.
Описание
от почти бесцветного со слабым желтоватым оттенком до жёлтого цвета масляный раствор.
Фармакотерапевтическая группа
Андроген
Фармакологические свойства
Стимулирует развитие мужских половых органов и вторичных половых признаков, контролирует сперматогенез, влияет на белковый, азотистый и фосфорный обмен.
Фармакодинамика
Андрогенные эффекты развиваются быстро и продолжаются в течение 3 нед (т.к. раствор содержит четыре эфира тестостерона, различающиеся по скорости поступления и длительности действия).
Показания к применению
Гормонозаместительная терапия: посткастрационный синдром, евнухоидизм, гипопитуитаризм, эндокринная импотенция, климактерические нарушения у мужчин (в т.ч. снижение либидо, умственной и физической активности), остеопороз, обусловленный дефицитом андрогенов.
Противопоказания
Карцинома простаты или молочной железы (в т.ч. подозреваемая).
С осторожностью
У мальчиков в препубертатном периоде необходимо применять препарат Сустанон-250 с осторожностью, т.к. безопасность и эффективность у детей и подростков изучены недостаточно.
С осторожностью применять у пациентов пожилого возраста (старше 65 лет). Имеющиеся ограниченные данные не указывают на необходимость коррекции дозы препарата Сустанон-250 упациентов пожилого возраста (старше 65 лет).
Применение при беременности и в период грудного вскармливания
Препарат Сустанон-250 не показан для применения у женщин, в связи с чем его применение в период беременности и грудного вскармливания противопоказано. Применение тестостерона в период беременности может привести к вирилизации плода женского пола.
Способ применения и дозы
В/м, глубоко в мышцу. Режим дозирования подбирается в соответствии с индивидуальной реакцией; как правило, по 1 мл 1 раз в 3 нед.
Применение препарата в особых клинических группах пациентов
Имеющиеся ограниченные данные не указывают на необходимость коррекции дозы препарата Сустанон-250 у пациентов пожилого возраста (старше 65 лет).
Дети и подростки до 18 лет: у мальчиков в препубертатном периоде необходимо применять препарат Сустанон-250 с осторожностью, т.к. безопасность и эффективность у детей и подростков изучены недостаточно. (см. раздел "Особые указания").
Побочное действие
Возможные нежелательные реакции при применении тестостерона распределены по системно-органным классам с указанием частоты их возникновения согласно рекомендациям ВОЗ: часто (≥ 1/100, <1/10) и частота неизвестна (невозможно оценить на основании имеющихся данных).
Доброкачественные, злокачественные и неуточненные новообразования (включая кисты и полипы): частота неизвестна - рак предстательной железы1.
Со стороны половых органов и грудной железы: частота неизвестна - нарушение эякуляции, гинекомастия (феминизация), олигоспермия, приапизм, доброкачественная гиперплазия предстательной железы2.
Со стороны костно-мышечной системы и соединительной ткани: частота неизвестна - миалгия.
Со стороны кожи и подкожных тканей: частота неизвестна - кожный зуд, акне.
Со стороны обмена веществ и питания: часто - увеличение массы тела; частота неизвестна - задержка жидкости.
Со стороны ЖКТ: частота неизвестна - тошнота.
Со стороны печени и желчевыводящих путей: частота неизвестна - нарушение функции печени.
Со стороны крови и лимфатической системы: частота неизвестна - полицитемия.
Со стороны сосудов: частота неизвестна - артериальная гипертензия (повышение АД).
Нарушения психики: частота неизвестна - депрессия, нервозность, изменение настроения, изменение либидо.
Лабораторные и инструментальные данные: частота неизвестна - снижение концентрации ЛПВП, ЛПНП и триглицеридов3, увеличение ПСА; часто - увеличение содержания гемоглобина и гематокрита, количества эритроцитов.
Общие расстройства и нарушения в месте введения: частота неизвестна - воспаление и боль в месте инъекции, зуд, гиперемия.
1 Прогрессирование доклинических стадий рака предстательной железы
2 Рост предстательной железы (до эугонадного состояния)
3 Снижение концентраций ХС-ЛПНП, ХС-ЛПВП и триглицеридов в сыворотке крови
Дети
У мальчиков в препубертатном периоде, принимающих андрогены, отмечались следующие нежелательные эффекты (см. раздел "Особые указания"): преждевременное половое созревание, увеличение частоты эрекции, увеличение полового члена и преждевременное закрытие эпифизов.
После прекращения терапии препаратом Сустанон-250 нежелательные реакции сохраняются еще определенное время.
Передозировка
Острая токсичность препарата Сустанон-250 при в/м введении очень низкая. Приапизм у мужчин является симптомом хронической передозировки.
Лечение: в случае развития приапизма лечение препаратом Сустанон-250 следует временно прекратить и после исчезновения указанного симптома возобновить в более низких дозах.
Взаимодействие с другими лекарственными средствами
Лекарственные средства, вызывающие индукцию или ингибирование ферментов, могут соответственно снижать или повышать концентрацию тестостерона. Поэтому может потребоваться коррекция дозы и/или интервалов между инъекциями.
Андрогены могут повышать толерантность к глюкозе и снижать потребность в инсулине или других гипогликемических препаратов у лиц, страдающих сахарным диабетом.
Высокие дозы андрогенов могут усиливать действие антикоагулянтов кумаринового типа, что позволяет сократить дозы этих препаратов.
Особые указания
Должен осуществляться врачебный контроль за пациентами, получающими Сустанон-250, до начала лечения и ежеквартально в течение 12 месяцев и впоследствии 1 раз в год.
Должны проводится следующие исследования:
— пальцевое ректальное исследование (ПРИ) для исключения доброкачественной гиперплазии предстательной железы (см. в этом же предложении) и определение специфического антигена предстательной железы (ПСА) для исключения субклинических форм рака предстательной железы.
— измерение гематокрита и гемоглобина для исключения полицитемии.
У пациентов, с существовавшей ранее патологией сердца, почек или печени, лечение андрогенами может вызвать осложнения, характеризующиеся отеками с острой сердечной недостаточностью (или без нее).
В случае возникновения нежелательных реакций, связанных с применением андрогенов, лечение препаратом Сустанон-250 следует временно прервать, и после исчезновения симптомов возобновить в более низкой дозе.
Применение андрогенов не по назначению, а для усиления выносливости у спортсменов, представляет серьёзные риски для здоровья. Применение андрогенов, в том числе Сустанона-250, у пожилых пациентов повышает вероятность развития гипертрофии или рака предстательной железы.
Влияние на способность к вождению автотранспорта и управлению механизмами
До настоящего времени не сообщалось о каком-либо влиянии на концентрацию внимания и быстроту психомоторных реакций при применении препарата Сустанон-250.
Влияние на способность управлять автомобилем и движущимися механизмами
Влияние на способность к управлению транспортными средствами и механизмами
Применение препарата Сустанон-250 не оказывает влияния на способность к управлению транспортными средствами и механизмами.
Форма выпуска
Раствор для в/м введения (масляный) прозрачный, светло-желтого цвета.
Условия хранения
В защищенном от света месте, при температуре 8–30°C.
Хранить в недоступном для детей месте.
Срок годности
5 лет.
Не применять по истечении срока годности, указанного на упаковке.
Условия отпуска
По рецепту
Производитель
Производитель: ORGANON, N.V. (Нидерланды)
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href=\"https://medum.ru/p-n013419-01\"\u003eП N013419/01\u003c/a\u003e"}}]},{"id":1,"name":"Торговое название препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Сустанон-250"}}]},{"id":2,"name":"Лекарственная форма","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nЛекарственная форма выпуска Сустанона-250 – раствор для внутримышечного введения: масляный, от желтого до почти бесцветного с незначительным желтоватым оттенком (в стеклянных бесцветных ампулах по 1 мл, в картонной пачке 1 ампула)."}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.rlsnet.ru/mnn_index_id_3346.htm\"\u003eТестостерон (смесь эфиров) (Testosterone [mixture of esters])\u003c/a\u003e"}},{"type":"paragraph","data":{"text":"1 ампула с 1 мл масляного раствора для инъекций содержит тестостерона пропионата 30 мг, тестостерона фенилпропионата 60 мг, тестостерона изокапроната 60 мг, тестостерона деканоата 100 мг; в контурной ячейковой упаковке, в коробке 1 шт."}}]},{"id":3,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"\n\nот почти бесцветного со слабым желтоватым оттенком до жёлтого цвета масляный раствор."}}]},{"id":5,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":" Андроген"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Стимулирует развитие мужских половых органов и вторичных половых признаков, контролирует сперматогенез, влияет на белковый, азотистый и фосфорный обмен."}},{"type":"header","data":{"text":"Фармакодинамика","level":4}},{"type":"paragraph","data":{"text":"Андрогенные эффекты развиваются быстро и продолжаются в течение 3 нед (т.к. раствор содержит четыре эфира тестостерона, различающиеся по скорости поступления и длительности действия)."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Гормонозаместительная терапия: посткастрационный синдром, евнухоидизм, гипопитуитаризм, эндокринная импотенция, климактерические нарушения у мужчин (в т.ч. снижение либидо, умственной и физической активности), остеопороз, обусловленный дефицитом андрогенов."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Карцинома простаты или молочной железы (в т.ч. подозреваемая)."}}]},{"id":6,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"У мальчиков в препубертатном периоде необходимо применять препарат Сустанон-250 с осторожностью, т.к. безопасность и эффективность у детей и подростков изучены недостаточно."}},{"type":"header","data":{"text":"При нарушениях функции почек","level":4}},{"type":"paragraph","data":{"text":"С осторожностью следует назначать препарат при тяжелой \u003ca href=\"https://health.mail.ru/disease/pochechnaya_nedostatochnost/\"\u003eпочечной недостаточности\u003c/a\u003e."}},{"type":"header","data":{"text":"При нарушениях функции печени","level":4}},{"type":"paragraph","data":{"text":"С осторожностью следует назначать препарат при тяжелой печеночной недостаточности."}},{"type":"header","data":{"text":"Применение в пожилом возрасте","level":4}},{"type":"paragraph","data":{"text":"Диагнозы"}},{"type":"list","data":{"style":"ordered","items":["\u003ca href=\"https://health.mail.ru/disease/adrenogenitalnyj_sindrom/\"\u003eАдреногенитальный синдром\u003c/a\u003e","\u003ca href=\"https://health.mail.ru/disease/akromegaliya/\"\u003eАкромегалия\u003c/a\u003e","\u003ca href=\"https://health.mail.ru/disease/gestatcionnyi_saharnyi_diabet/\"\u003eГестационный сахарный диабет\u003c/a\u003e","\u003ca href=\"https://health.mail.ru/disease/ginekomastia/\"\u003eГинекомастия у мужчин\u003c/a\u003e"]}},{"type":"paragraph","data":{"text":"С осторожностью применять у пациентов пожилого возраста (старше 65 лет). Имеющиеся ограниченные данные не указывают на необходимость коррекции дозы препарата Сустанон-250 у\u003cb\u003eпациентов пожилого возраста (старше 65 лет).\u003c/b\u003e"}}]},{"id":10,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Препарат Сустанон-250 не показан для применения у женщин, в связи с чем его применение в период беременности и грудного вскармливания противопоказано. Применение тестостерона в период беременности может привести к вирилизации плода женского пола."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"В/м, глубоко в мышцу. Режим дозирования подбирается в соответствии с индивидуальной реакцией; как правило, по 1 мл 1 раз в 3 нед."}},{"type":"paragraph","data":{"text":"\u003cb\u003eПрименение препарата в особых клинических группах пациентов\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Имеющиеся ограниченные данные не указывают на необходимость коррекции дозы препарата Сустанон-250 у\u003cb\u003e пациентов пожилого возраста (старше 65 лет).\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"\u003cb\u003eДети и подростки до 18 лет: \u003c/b\u003eу мальчиков в препубертатном периоде необходимо применять препарат Сустанон-250 с осторожностью, т.к. безопасность и эффективность у детей и подростков изучены недостаточно. (см. раздел \"Особые указания\")."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Возможные нежелательные реакции при применении тестостерона распределены по системно-органным классам с указанием частоты их возникновения согласно рекомендациям ВОЗ: часто (≥ 1/100, <1/10) и частота неизвестна (невозможно оценить на основании имеющихся данных)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДоброкачественные, злокачественные и неуточненные новообразования (включая \u003c/i\u003e\u003ci\u003eкисты и полипы): \u003c/i\u003eчастота неизвестна - рак предстательной железы\u003csup\u003e1\u003c/sup\u003e."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны половых органов и грудной железы: \u003c/i\u003eчастота неизвестна - нарушение эякуляции, гинекомастия (феминизация), олигоспермия, приапизм, доброкачественная гиперплазия предстательной железы\u003csup\u003e2\u003c/sup\u003e."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны костно-мышечной системы и соединительной ткани: \u003c/i\u003eчастота неизвестна - миалгия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны кожи и подкожных тканей: \u003c/i\u003eчастота неизвестна - кожный зуд, акне."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны \u003c/i\u003e\u003ci\u003eобмена веществ и питания: \u003c/i\u003eчасто - увеличение массы тела; частота неизвестна - задержка жидкости."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны ЖКТ: \u003c/i\u003eчастота неизвестна - тошнота."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны печени и желчевыводящих путей: \u003c/i\u003eчастота неизвестна - нарушение функции печени."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны крови и лимфатической системы: \u003c/i\u003eчастота неизвестна - полицитемия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сосудов: \u003c/i\u003eчастота неизвестна - артериальная гипертензия (повышение АД)."}},{"type":"paragraph","data":{"text":"\u003ci\u003eНарушения \u003c/i\u003e\u003ci\u003eпсихики: \u003c/i\u003eчастота неизвестна - депрессия, нервозность, изменение настроения, изменение либидо."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛабораторные и инструментальные данные: \u003c/i\u003eчастота неизвестна - снижение концентрации ЛПВП, ЛПНП и триглицеридов\u003csup\u003e3\u003c/sup\u003e, увеличение ПСА; часто - увеличение содержания гемоглобина и гематокрита, количества эритроцитов."}},{"type":"paragraph","data":{"text":"\u003ci\u003eОбщие расстройства и нарушения в месте введения: \u003c/i\u003eчастота неизвестна - воспаление и боль в месте инъекции, зуд, гиперемия."}},{"type":"paragraph","data":{"text":"\u003csup\u003e1\u003c/sup\u003e Прогрессирование доклинических стадий рака предстательной железы"}},{"type":"paragraph","data":{"text":"\u003csup\u003e2\u003c/sup\u003e Рост предстательной железы (до эугонадного состояния)"}},{"type":"paragraph","data":{"text":"\u003csup\u003e3\u003c/sup\u003e Снижение концентраций ХС-ЛПНП, ХС-ЛПВП и триглицеридов в сыворотке крови"}},{"type":"paragraph","data":{"text":"\u003cb\u003eДети\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"У мальчиков в препубертатном периоде, принимающих андрогены, отмечались следующие нежелательные эффекты (см. раздел \"Особые указания\"): преждевременное половое созревание, увеличение частоты эрекции, увеличение полового члена и преждевременное закрытие эпифизов."}},{"type":"paragraph","data":{"text":"После прекращения терапии препаратом Сустанон-250 нежелательные реакции сохраняются еще определенное время."}}]},{"id":11,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Острая токсичность препарата Сустанон-250 при в/м введении очень низкая. Приапизм у мужчин является \u003ci\u003eсимптомом хронической передозировки\u003c/i\u003e."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e в случае развития приапизма лечение препаратом Сустанон-250 следует временно прекратить и после исчезновения указанного симптома возобновить в более низких дозах."}}]},{"id":14,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Лекарственные средства, вызывающие индукцию или ингибирование ферментов, могут соответственно снижать или повышать концентрацию тестостерона. Поэтому может потребоваться коррекция дозы и/или интервалов между инъекциями."}},{"type":"paragraph","data":{"text":"Андрогены могут повышать толерантность к глюкозе и снижать потребность в инсулине или других гипогликемических препаратов у лиц, страдающих сахарным диабетом."}},{"type":"paragraph","data":{"text":"Высокие дозы андрогенов могут усиливать действие антикоагулянтов кумаринового типа, что позволяет сократить дозы этих препаратов."}}]},{"id":15,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Должен осуществляться врачебный контроль за пациентами, получающими Сустанон-250, до начала лечения и ежеквартально в течение 12 месяцев и впоследствии 1 раз в год."}},{"type":"paragraph","data":{"text":"Должны проводится следующие исследования:"}},{"type":"paragraph","data":{"text":"— пальцевое ректальное исследование (ПРИ) для исключения доброкачественной гиперплазии предстательной железы (см. в этом же предложении) и определение специфического антигена предстательной железы (ПСА) для исключения субклинических форм рака предстательной железы."}},{"type":"paragraph","data":{"text":"— измерение гематокрита и гемоглобина для исключения полицитемии."}},{"type":"paragraph","data":{"text":"У пациентов, с существовавшей ранее патологией сердца, почек или печени, лечение андрогенами может вызвать осложнения, характеризующиеся отеками с острой сердечной недостаточностью (или без нее)."}},{"type":"paragraph","data":{"text":"В случае возникновения нежелательных реакций, связанных с применением андрогенов, лечение препаратом Сустанон-250 следует временно прервать, и после исчезновения симптомов возобновить в более низкой дозе."}},{"type":"paragraph","data":{"text":"Применение андрогенов не по назначению, а для усиления выносливости у спортсменов, представляет серьёзные риски для здоровья. 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