Ципротерон ацетат является синтетическим антиандрогеннным пр... Инструкция
Показания к применению
У мужчин:
Метастазирующий или неоперабельный рак предстательной железы (без и после орхиэктомии, а также в сочетании с агонистами лютеинизирующего гормона - рилизинг гормона)
Коррекция патологических отклонений в сфере полового поведения (при необходимости снижения сексуальной активности). У женщин:
Выраженные явления андрогенизации, в том числе различные формы гирсутизма и акне
Ципротерон ацетат является синтетическим антиандрогеннным препаратом. Механизм действия основан на конкурентном связывании с андрогеновыми рецепторами в андроген-зависимых органах, что приводит к снижению их функциональной активности. В дополнение к антиандрогенному действию, ципротерон ацетат обладает также сильными антигонадотропными свойствами и гестагенной активностью.
Показания к применению
У мужчин:
Метастазирующий или неоперабельный рак предстательной железы (без и после орхиэктомии, а также в сочетании с агонистами лютеинизирующего гормона - рилизинг гормона)
Коррекция патологических отклонений в сфере полового поведения (при необходимости снижения сексуальной активности). У женщин:
Выраженные явления андрогенизации, в том числе различные формы гирсутизма и акне
Андрогенная алопеция
Противопоказания
Повышенная чувствительностью к ципротерону или к другим составным частям препарата
Беременность и период кормления грудью
Выраженные нарушения функции печени
Синдром Дубина-Джонсона и синдром Ротора
Опухоли печени, в том числе в анамнезе (за исключением метастатического поражения печени при раке предстательной железы)
Тяжелый сахарный диабет с сосудистыми осложнениями
Кахексия (за исключением больных раком предстательной железы)
Серповидно-клеточная анемия
Тромбоэмболические процессы (в том числе в анамнезе)
Тяжелые хронические депрессивные состояния
Идеопатическая желтуха, герпес или зуд во время предыдущих беременностей
Подростковый возраст до завершения периода полового созревания
Применение при беременности и в период грудного вскармливания
Противопоказано применять препарат при беременности и в период лактации.
Способ применения и дозы
Для лечения рака предстательной железы Ципротерон-Тева назначается в дозе 200-300 мг в сут разделенной на 2-3 приема, длительно до появления признаков прогрессирования заболевания. Для снижения сексуальной активности: 100-200 мг в сут (по 1-2 таблетки два раза в день) обычно в течение нескольких недель до достижения терапевтического эффекта. Далее переходят на поддерживающие дозы - 50 мг (по половине таблетки 2 раза в день). При прекращении лечения препарат следует отменять постепенно (на 25 мг в неделю). У женщин детородного возраста Ципротерон-Тева применяется в дозе 100 мг 1 раз в день, начиная с первого дня менструального цикла, в течение 10 дней с одновременным приемом пероральных контрацептивов. Следующий 10-дневный курс лечения начинают строго через 4 недели. При наступлении терапевтического эффекта доза препарата может быть снижена до 25-50 мг в день. У женщин в постменопаузе Ципроперон-Тева применяется в дозе 25-50 мг в день на протяжении 21 дня с последующим недельным перерывом, пациенткам с удаленной маткой препарат можно назначать в тех же дозах без перерыва. Таблетки Ципротерон-Тева следует принимать после еды, запивая большим количеством воды (до 100 мл).
Побочное действие
В начале лечения могут наблюдаться боли в животе, тошнота, повышенная утомляемость, мышечная слабость, сухость кожи, общая апатия, депрессивные состояния или состояние беспокойства. Может увеличиваться или уменьшаться масса тела. В индивидуальных случаях при применении высоких доз наблюдались одышка и нарушения функции печени. У мужчин возможно появление гинекомастии и подавление сперматогенеза, у женщин - болей, напряжения или увеличения молочных желез, снижения либидо, нарушения менструального цикла, у женщин в постменопаузе могут наблюдаться циклические кровотечения.
Передозировка
При передозировке, если больной в сознании и без спонтанной рвоты, следует вызвать рвоту. Необходимо применять симптоматическую терапию при постоянном наблюдении за больным и жизненно-важными функциями.
Особые указания
Лечение Ципротероном-Тева следует проводить под контролем функции печени, коры надпочечников и картины периферической крови, уровня глюкозы в крови. При наличии признаков гепатотоксичности прием препарата следует отменить. У лиц, страдающих алкоголизмом, применение ципротерона обычно неэффективно. Больные с органическими нарушениями головного мозга и психическими болезнями, страдающие сексуальными нарушениями, обычно резистентны к лечению Ципротероном-Тева. Если у больного имеются нарушения фертильности, рекомендуется перед началом лечения осуществить анализ сперматограммы. Перед началом лечения женщинам необходимо провести эндокринологические тесты и получить консультацию гинеколога. У больных, страдающих легкими формами сахарного диабета, мониторинг уровня сахара должен проводиться чаще, чем обычно (например, каждые 8 недель). При эпилепсии, множественном склерозе, порфирии, отосклерозе, столбняке, артериальной гипертонии риск развития побочных реакций повышается. При начале лечения Ципротероном-Тева беременность должна быть полностью исключена. Женщинам детородного возраста наряду с пероральными контрацептивами рекомендуется использовать барьерные противозачаточные средства. Если в процессе проведения лечения прекращаются менструации, препарат следует отменить до окончательного исключения беременности. Негативного влияния Ципротерона-Тева на фертильность после прекращения лечения не отмечено. В период лечения необходимо воздерживаться от видов деятельности, требующих повышенного внимания.
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