Синтетический прогестаген для приема внутрь. Линэстренол обл... Инструкция
Показания к применению
Полименорея; - меноррагия и метроррагия; - некоторые случаи первичной или вторичной аменореи или олигоменореи; - эндометриоз; - некоторые случаи карциномы эндометрия; - доброкачественные заболевания молочных желез; - для подавления овуляции (не с целью контрацепции), овуляторных болей и менструации; - дисменорея; - для отсрочки нормальной менструации; ...
Беременность или подозреваемая беременность; - период грудного вскармливания; - внематочная беременность (в анамнезе); - тяжелые заболевания печени, такие как холестатическая желтуха или гепатит (или наличие в анамнезе тяжелого заболевания печени, если показатели функции печени не вернулись к норме), гепатома; - синдром Ротора; - синдром Дубина-Джонсона; ...
Действующее вещество: Линэстренол (Lynestrenol)Концентрация действующего вещества (мг): 5
Фармакологические свойства
Синтетический прогестаген для приема внутрь. Линэстренол обладает фармакологическими характеристиками подобными натуральному прогестерону. Оргаметрил оказывает выраженное прогестагенное влияние на эндометрий. При непрерывном приеме препарата линэстренол способен подавлять овуляцию и менструацию. Оргаметрил целесообразно применять в случаях, когда требуется выраженное прогестагенное воздействие.
Показания к применению
Полименорея; - меноррагия и метроррагия; - некоторые случаи первичной или вторичной аменореи или олигоменореи; - эндометриоз; - некоторые случаи карциномы эндометрия; - доброкачественные заболевания молочных желез; - для подавления овуляции (не с целью контрацепции), овуляторных болей и менструации; - дисменорея; - для отсрочки нормальной менструации; - дополнение к эстроген-заместительной терапии в перименопаузе и постменопаузе с целью предотвращения гиперплазии эндометрия.
Противопоказания
Беременность или подозреваемая беременность; - период грудного вскармливания; - внематочная беременность (в анамнезе); - тяжелые заболевания печени, такие как холестатическая желтуха или гепатит (или наличие в анамнезе тяжелого заболевания печени, если показатели функции печени не вернулись к норме), гепатома; - синдром Ротора; - синдром Дубина-Джонсона; - синдром Жильбера; - кровотечения из влагалища неясной этиологии; - состояния (в настоящее время или в анамнезе), которые могут усугубиться приемом половых стероидных гормонов (в т.ч. гестационный герпес, гестационная желтуха, отосклероз, хлоазма беременных, сильный зуд, порфирия); - тяжелая депрессия; - сахарный диабет; - врожденные нарушения обмена холестерина; - нарушение свертываемости крови; - тромбоз/тромбоэмболия (тромбоз глубоких вен, тромбоэмболия легочной артерии, инфаркт, цереброваскулярные нарушения); - повышенная чувствительность к компонентам препарата.
Применение при беременности и в период грудного вскармливания
Препарат противопоказан к применению при беременности. Безопасность применения препарата Оргаметрил в период лактации к настоящему времени не установлена.
Способ применения и дозы
Внутрь. При эндометриозе, дисменорее, для подавления менструации - 1–3 табл. в день в течение не менее 6 мес; при карциноме эндометрия - 6–10 табл. в день; для отсрочки нормальной менструации - 1–2 табл. в день за 1–2 нед до начала ожидаемой менструации. В дополнение к терапии эстрогенами - по 1/2–1 табл. в сутки в течение 12–15 дней каждого месяца во второй фазе цикла. В случае аменореи или олигоменореи после эстрогенной подготовки эндометрия и при других показаниях - 1–2 табл. в день, начиная с 14–25 дня.
Побочное действие
Тошнота, прибавка веса, кровотечения «прорыва», мажущие выделения; редко - головная боль, головокружение, мигрень, нервозность, депрессия, боль в груди, желтуха, изменение функциональных показателей печени и профиля липопротеинов, понижение толерантности к глюкозе, акне, хлоазма, гирсутизм, кожные сыпь и зуд; после окончания лечения - отеки и аменорея.
Передозировка
Симптомы: тошнота, рвота. Лечение: проведение симптоматической терапии.
Особые указания
Лечение следует прервать, если результаты тестов свидетельствуют о нарушении функции печени. При приеме препаратов, содержащих эстроген и/или прогестаген, особенно у женщин с наличием в анамнезе хлоазмы беременных, иногда наблюдается хлоазма. Женщинам, склонным к появлению хлоазмы, следует избегать воздействия на кожу солнечного света или искусственного УФ-излучения. Прием половых гормонов может влиять на специфические лабораторные тесты. У многих пациентов во время лечения препаратом Оргаметрил возможно повышение уровня в крови ЛПНП и снижение уровня ЛПВП. Возможны изменения в параметрах функции печени, обмена углеводов, системе свертывания крови. При длительном лечении показано проведение систематических медицинских обследований; контроль показателей липидного и углеводного обмена, концентрации билирубина, трансаминаз, системы свертывания. Частота и характер систематических медицинских обследований зависят от обстоятельств в каждом индивидуальном случае и должны определяться в соответствии с клиническим заключением, но не реже 1 раза в 6 месяцев. В связи с влиянием линэстренола на уровень глобулина, связывающего половые гормоны, Оргаметрил может проявлять некоторую андрогенную активность. Это может выражаться в легких признаках вирилизации (в основном акне или себорея). Эпидемиологические исследования выявили связь применения прогестагена в сочетании с эстрогенами с повышением частоты случаев венозной тромбоэмболии (тромбоз глубоких вен и тромбоэмболия легочной артерии). Несмотря на то, что клиническая значимость этих данных для линэстренола без эстрогенного компонента неизвестна. В случае тромбоза следует прекратить прием препарата Оргаметрил. Следует также рассмотреть необходимость прекращения приема препарата Оргаметрил в случае длительной иммобилизации вследствие хирургического вмешательства или заболевания. Женщины с тромбоэмболическими заболеваниями в анамнезе должны быть проинформированы о возможности их рецидивов. Необходимо постоянно контролировать состояние пациентов с нарушениями кровообращения (а также, при наличии их в анамнезе), поскольку при приеме пероральных эстроген/гестагенных контрацептивов, незначительно увеличивается риск некоторых сердечно-сосудистых заболеваний или цереброваскулярных состояний. Во время приема препарата Оргаметрил рекомендуется ограничить прием жиров и углеводов (что особенно важно для женщин с исходно повышенной массой тела). При сахарном диабете следует контролировать гликемический профиль (может потребоваться увеличение дозы инсулина). При предрасположенности к артериальной гипертензии необходимо контролировать АД (снизить потребление жидкости до 1.5-2 л/сут). В случае дисфункциональных маточных кровотечений у женщин репродуктивного возраста рекомендуется начинать терапию после лечебно-диагностического выскабливания матки. Неэффективность терапии (рецидивы кровотечений и гиперпластических процессов эндометрия) требует уточнения причин кровотечения. При длительной задержке менструации на фоне терапии препаратом Оргаметрил должна быть исключена внематочная беременность. Оргаметрил содержит в своем составе лактозу в качестве вспомогательного вещества. Поэтому этот препарат не следует назначать пациентам с редкими наследственными нарушениями, такими как непереносимость галактозы, недостаточность лактазы lapp или глюкозо-галактозная мальабсорбция. Влияние на способность к вождению автотранспорта и управлению механизмамиПоскольку препарат может вызывать головокружение, пациентам следует проявлять осторожность при управлении автотранспортом или другой техникой.
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