Депо-Провера – противоопухолевый препарат, гестаген - депо ф... Инструкция
Показания к применению
Дополнительное и паллиативное лечение рецидивирующего и метастатического рака эндометрия или рака почки, паллиативное лечение при гормонозависимых формах рецидивирующего рака молочной железы у женщин в постменопаузном периоде.
Инструкция
Состав
Медроксипрогестерон, хлорид натрия, метилпарагидроксибензоат, пропилпарагидроксибензоат, полисорбат 80, макроголь 3350, гидроксид натрия (для доведения pH), хлористоводородная кислота (для доведения pH), вода для инъекций.
Описание
Депо-Провера – противоопухолевый препарат, гестаген - депо форма. Не обладает андрогенной и эстрогенной активностью. Депо-Провера угнетает секрецию гонадотропных гормонов (особенно ЛГ). В малых дозах подавляет овуляцию. Оказывает тормозящее действие на изменения, необходимые для подготовки эндометрия к имплантации оплодотворенной яйцеклетки и повышает вязкость слизи шейки матки. Депо-Провера в более высоких дозах оказывает противоопухолевое действие при гормоночувствительных злокачественных новообразованиях. Этот эффект обусловлен, по-видимому, действием на рецепторы стероидных гормонов и на гипофизарно-гонадную систему.
Показания к применению
Дополнительное и паллиативное лечение рецидивирующего и метастатического рака эндометрия или рака почки, паллиативное лечение при гормонозависимых формах рецидивирующего рака молочной железы у женщин в постменопаузном периоде.
Применение при беременности и в период грудного вскармливания
Медроксипрогестерон противопоказан при беременности. Имеются сообщения о том, что при определенных условиях отмечается связь между применением прогестагенов во время первого триместра беременности и нарушениями развития гениталий у плода. Новорожденные, в случае незапланированной беременности, наступившей в течение 1-2 месяцев после инъекции медроксипрогестерона, имеют больший риск развития гипотрофии, что, в свою очередь, повышает риск интранатальной и неонатальной смертности. Риск развития подобных осложнений относительно низок, так как беременность на фоне применения медроксипрогестерон развивается редко. В случае если на фоне применения медроксипрогестерона развилась беременность, пациентку следует предупредить о возможном риске для плода. Медроксипрогестерон выводится с грудным молоком. Отсутствуют данные о том, что это может нанести какой-либо вред новорожденному, находящемуся на грудном вскармливании. Однако применение медроксипрогестерон в первые шесть недель послеродового периода не рекомендуется.
Способ применения и дозы
Устанавливают индивидуально, в зависимости от показаний, стадии заболевания, схемы терапии. При раке эндометрия и раке почки начальная доза составляет 400-1000 мг в неделю внутримышечно. Если в течение нескольких недель или месяцев наступило улучшение и достигнута стабилизация процесса, то назначают поддерживающую терапию в дозе 400 мг в месяц. При раке молочной железы препарат назначают внутримышечно в начальной дозе 500 мг в сутки в течение 28 дней. Затем применяют поддерживающие дозы - по 500 мг 2 раза в неделю. Лечение продолжают до появления признаков прогрессирования болезни. Непосредственно перед использованием флакон следует хорошо взболтать, чтобы вводимый препарат приобрел вид однородной суспензии.
Побочное действие
Аллергические реакции: анафилаксия и анафилактоидные реакции, крапивница. Со стороны системы свертывания крови: тромбоэмболии, тромбофлебит. Со стороны ЦНС: повышенная нервная возбудимость, бессонница, сонливость, усталость, депрессия, головокружение, головная боль. Дерматологические реакции: зуд, сыпь, акне, гирсутизм и алопеция. Со стороны половой системы: дисфункциональное маточное кровотечение, кровянистые выделения из половых путей, аменорея, снижение либидо или аноргазмия, вагинит, бели, приливы, боли в низу живота, болезненность молочных желез, галакторея. Со стороны пищеварительной системы: боли или неприятные ощущения в животе, тошнота, метеоризм. Со стороны костно-мышечной системы: судороги икроножных мышц, боли в спине и суставах. Прочие: астения, гипертермия, изменение массы тела и лунообразное лицо.
Передозировка
Применение очень высоких доз препарата может вызвать ряд симптомов, в том числе увеличение массы тела (с некоторой задержкой жидкости в организме), повышенную утомляемость, а также в некоторых случаях наблюдаются эффекты, присущие глюкокортикостероидам. Следует прекратить применение препарата. Специфического лечения не требуется.
Особые указания
Необходимо строго соблюдать соответствие используемой лекарственной формы препарата показаниям к применению. С особой осторожностью медроксипрогестерон следует применять у пациентов с тромбофлебитом, тромбоэмболическими осложнениями, тяжелыми нарушениями функции печени, гиперкальциемией. Перед применением медроксипрогестерона для лечения гинекологических заболеваний и контрацепции необходимо исключить наличие у пациентки опухоли половых органов или молочных желез. При проведении патогистологического исследования определенных органов и тканей необходимо предупредить гистолога о предыдущем лечении прогестагенами. На фоне применения медроксипрогестерона возможны изменения результатов следующих исследований: определение уровня гонадотропинов, определение уровня прогестерона, кортизола, тестостерона (у мужчин), эстрогенов (у женщин) в плазме крови, определение уровня прегнандиола в моче, проведение пробы с сахарной нагрузкой, проведение теста с метапироном.
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