Печеночная и/или почечная недостаточность; - Киста яичника (за исключением синдрома поликистоза яичников); - Опухоль или гипофункция гипофиза; - Нарушения функции щитовидной железы; - Нарушения функции надпочечников; - Метроррагия неясной этиологии; - Длительно существующие или недавно развившиеся нарушения зрения; - Новообразования половых органов; - Эндометриоз; - Недостаточность функции яичников на фоне гиперпролактинемии; - Беременность; - Лактация (грудное вскармливание); - Непереносимость галактозы, лактазная недостаточность или мальабсорбция глюкозы; - Повышенная чувствительность к компонентам препарата.
Антиэстрогенный препарат нестероидной структуры. Механизм действия обусловлен специфическим связыванием с эстрогенными рецепторами яичников и гипофиза. При низком содержании в организме эстрогенов проявляет умеренный эстрогенный эффект, при высоком содержании - антиэстрогенное действие. В малых дозах усиливает секрецию гонадотропинов (пролактина, ФСГ и ЛГ), стимулирует овуляцию; в высоких дозах тормозит секрецию гонадотропинов. Гестагенной и андрогенной активностью не обладает.
Печеночная и/или почечная недостаточность; - Киста яичника (за исключением синдрома поликистоза яичников); - Опухоль или гипофункция гипофиза; - Нарушения функции щитовидной железы; - Нарушения функции надпочечников; - Метроррагия неясной этиологии; - Длительно существующие или недавно развившиеся нарушения зрения; - Новообразования половых органов; - Эндометриоз; - Недостаточность функции яичников на фоне гиперпролактинемии; - Беременность; - Лактация (грудное вскармливание); - Непереносимость галактозы, лактазная недостаточность или мальабсорбция глюкозы; - Повышенная чувствительность к компонентам препарата.
Применение при беременности и в период грудного вскармливания
Противопоказано применение при беременности и в период грудного вскармливания.
Способ применения и дозы
При бесплодии доза и продолжительность курса лечения зависят от чувствительности (реакции на препарат) яичников. Пациенткам с регулярным менструальным циклом рекомендуется начинать лечение на 5-й день цикла (или на 3-й день цикла при ранней овуляции или продолжительности фолликулярной фазы менее 12 дней). При аменорее лечение можно начинать в любой день. Схема I: 50 мг/сут в течение 5 дней с одновременным контролем реакции яичников при помощи клинических и лабораторных исследований. Овуляция обычно наступает между 11 и 15 днями цикла. Если такое лечение не приводит к овуляции, то следует применять схему II. Схема II: с 5 дня следующего цикла назначают по 100 мг/сут в течение 5 дней. Если в это время овуляция не наблюдается, то следует еще раз повторить ту же схему (по 100 мг/сут). В случае продолжающейся ановуляции прием препарата следует прервать на 3 месяца, а затем повторить лечение в течение 3 месяцев. При неэффективности второго курса последующее лечение препаратом также не эффективно. Максимальная общая доза препарата, принимаемая в течение каждого курса, составляет 750 мг. При синдроме поликистоза яичников, в связи с тенденцией к гиперстимуляции, начальная доза препарата составляет 50 мг/сут. При постконтрацептивной аменорее препарат следует назначать в дозе 50 мг/сут ежедневно. Как правило, при применении схемы I пятидневный курс лечения оказывается успешным. Мужчинам в соответствии с показаниями препарат назначают по 50 мг 1-2 раза/сут в течение 6 недель под систематическим контролем спермограммы.
Побочное действие
Определение частоты побочных эффектов: часто - >1%; редко - < 1%. Со стороны пищеварительной системы: тошнота, рвота; редко - гастралгия, метеоризм, диарея, синдром острого живота, повышение аппетита. Со стороны ЦНС: головная боль, головокружение, сонливость; редко - замедление психических и двигательных реакций, повышенная возбудимость, депрессия, бессонница. Со стороны органов чувств: нарушения зрения (в т.ч. нарушение восприятия света, двоение, размытость контуров, светобоязнь). Со стороны мочевыделительной системы: учащение мочеиспускания, полиурия. Со стороны половой системы: боли внизу живота, сухость влагалища. Со стороны эндокринной системы: уплотнение молочных желез, дисменорея, патологическое маточное кровотечение, увеличение размеров яичника (в т.ч. кистозное); редко - болезненность в области грудных желез. При лечении кломифеном повышается вероятность многоплодной беременности, внематочной беременности, эндометриоза, роста имеющейся фибромы матки. Возможно кистозное увеличение яичников, особенно при синдроме Штейна-Левенталя. В этих случаях размер яичников может достигать 4-8 см. При этом следует следить за температурой тела и прекратить лечение, как только она станет двухфазной. Дерматологические реакции: редко - алопеция. Со стороны обмена веществ: редко - увеличение или уменьшение массы тела. Аллергические реакции: редко - сыпь, крапивница, аллергический дерматит, вазомоторные расстройства. Прочие: ощущения прилива крови к лицу с чувством жара (прекращаются после окончания приема препарата).
Передозировка
Симптомы: тошнота, рвота, вазомоторные реакции, ощущения прилива крови к лицу, нарушения зрения (снижение остроты зрения, вспышки, скотома), увеличение яичников и боль в тазовых органах и в животе. Лечение: меры, направленные на выведение кломифена из организма; проведение поддерживающей терапии. Данные о возможности выведения кломифена при диализе отсутствуют.
Особые указания
До начала приема препарата рекомендуется исследовать функцию печени. Перед началом лечения следует провести тщательное гинекологическое обследование. Лечение начинают, когда суммарное содержание гонадотропина в моче нормальное или ниже нижней границы нормы, состояние яичников при пальпации в норме, функции щитовидной железы и надпочечников соответствуют норме. В случае отсутствия овуляции до начала применения препарата следует исключить или вылечить все другие возможные формы бесплодия. При возникновении на фоне приема препарата увеличения яичников или кистозных изменений лечение следует прекратить до тех пор, пока размер яичников не вернется к норме. В дальнейшем прием можно возобновить, но при этом уменьшить дозу препарата или продолжительность лечения. В процессе лечения необходимо постоянное наблюдение гинеколога, следует контролировать функции яичников, проводить влагалищные исследования, наблюдать за феноменом зрачка. Часто во время курса лечения трудно определить момент овуляции, также часто наблюдается недостаточность желтого тела. Поэтому после зачатия рекомендуется провести профилактическое лечение прогестероном. Повышает вероятность развития многоплодной беременности. Препарат противопоказан пациентам с непереносимостью галактозы, лактазной недостаточностью или мальабсорбцией глюкозы, т.к. каждая таблетка содержит 100 мг лактозы. Влияние на способность к вождению автотранспорта и управлению механизмамиПоскольку препарат может вызывать нарушения зрения, в период лечения пациенты должны соблюдать осторожность при вождении автотранспорта и занятии другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
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