Действующее вещество: Трипторелин (Triptorelin)Концентрация действующего вещества (мг): 3, 75
Фармакологические свойства
Синтетический декапептид, аналог природного ГнРГ. Диферелин, после короткого начального периода стимуляции гонадотропной функции гипофиза, оказывает ингибирующее действие на секрецию гонадотропина с последующим подавлением функции яичек и яичников. Постоянное применение препарата Диферелин ингибирует секрецию эстрогенов яичниками до состояния менопаузы, а также снижает секрецию тестостерона, концентрации которого могут достигать показателей, которые наблюдаются после хирургической кастрации.
Показания к применению
рак предстательной железы; преждевременное половое созревание; генитальный и экстрагенитальный эндометриоз; фибромиома матки (перед оперативным вмешательством); женское бесплодие (в программе экстракорпорального оплодотворения).
Противопоказания
Повышенная чувствительность к Диферелину или другим аналогам гонадотропин - рилизинг гормона, беременность и период кормления грудью.
Применение при беременности и в период грудного вскармливания
Диферелин противопоказан к применению при беременности и в период лактации (грудного вскармливания).
Способ применения и дозы
Рак предстательной железы: Диферелин вводится в дозе 3,75 мг каждые 4 недели, длительно.
Побочное действие
Аллергические реакции, такие как крапивница, сыпь, зуд и очень редко отек Квинке. Описаны несколько случаев тошноты, рвоты, увеличение массы тела, артериальной гипертензии, повышенной эмоциональной лабильности, нарушения зрения, болей в месте инъекции и повышения температуры тела, ощущения “приливов”. Длительное применение аналогов гонадотропин - рилизинг гормона может привести к деминерализации костей и является возможным фактором риска развития остеопороза. У мужчин - снижение потенции. В начале лечения больные раком предстательной железы могут испытывать временное усиление болей в костях, пораженных метастазами (лечение симптоматическое). Отмечаются отдельные случаи непроходимости мочеточников и симптомов, связанных с компрессией метастазами спинного мозга (проходят через 1-2 недели). Также в этот период может наблюдаться временное повышение активности кислой фосфатазы в плазме крови. У женщин - головная боль, депрессия, потливость и изменение либидо, сухость слизистой влагалища, диспареуния и изменение размера молочных желез. При применении Диферелина в комбинации с гонадотропинами, сообщалось о случаях развития синдрома гиперстимуляции яичников. При лечении преждевременного полового созревания у девочек могут наблюдаться кровянистые выделения из влагалища. Длительное применение препарата может вызвать гипогонадотропную аменорею. После прекращения лечения функция яичников восстанавливается и овуляция происходит в среднем на 58 день после последней инъекции препарата. Первая менструация наступает на 70 день после последней инъекции Диферелина. Это необходимо учитывать в планировании контрацепции.
Передозировка
До настоящего времени о случаях передозировки препарата Диферелин не сообщалось.
Особые указания
В начале лечения возможно усиление клинических симптомов, в связи с чем следует с осторожностью назначать Диферелин больным раком предстательной железы, подверженным риску развития непроходимости мочеточников или сдавления спинного мозга. Необходимо тщательное врачебное наблюдение данных пациентов в течение первого месяца терапии. До начала терапии Диферелином необходимо подтвердить отсутствие беременности. С осторожностью применяют препарат у пациенток с синдромом поликистоза яичников при проведении схем стимуляции овуляции. Это связано с тем, что у небольшого количества пациенток может возрастать количество индуцированных фолликулов. Необходимо тщательно мониторировать уровень стимуляции цикла при экстракорпоральном оплодотворении, чтобы выявить пациенток с риском развития синдрома гиперстимуляции яичников, поскольку выраженность и частота проявлений синдрома может зависеть от режима дозирования гонадотропина. При необходимости введение хорионического гонадотропина человека следует прекратить. Влияние на способность к вождению автотранспорта и управлению механизмамиСведения отсутствуют.
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