Эстрадиол.Эстрадиола гемигидрат, входящий в состав препарата... Инструкция
Показания к применению
Заместительная гормональная терапия расстройств, обусловленных дефицитом эстрогенов у женщин в постменопаузе (не ранее чем через 12 месяцев после последней менструации).
Противопоказания
Повышенная чувствительность к компонентам препарата; диагностированный или предполагаемый рак молочной железы; диагностированные или предполагаемые эстрогензависимые злокачественные новообразования (например, рак эндометрия); диагностированные или предполагаемые прогестагензависимые новообразования (например, менингиома); кровотечения из влагалища неясной ...
Таблетки покрытые пленочной оболочкой Фемостон мини - противоклимактерическое комбинированное низкодозированное гормональное средство. Эстрадиола гемигидрат, входящий в состав препарата Фемостон мини, при растворении переходит в 17-β-эстрадиол, идентичный эндогенному эстрадиолу человека, который является наиболее активным эстрогеном. Эстрадиол восполняет дефицит эстрогенов в организме у женщин в постменопаузальном периоде и уменьшает выраженность менопаузальных симптомов. При назначении препарата Фемостон мини снижение частоты "приливов" средней тяжести и тяжелой степени было статистически достоверным по сравнению с плацебо, начиная с 4 недели терапии. Количество умеренных и выраженных приливов далее снижалось на 13 неделе до прекращения терапии. Дидрогестерон - прогестаген, эффективный при приеме внутрь и имеющий схожую с парентерально вводимым прогестероном активность. Поскольку эстрогены способствуют пролиферации эндометрия, заместительная гормональная терапия (ЗГТ) только эстрогенами повышает риск гиперплазии эндометрия и рака. Включение дидрогестерона значительно снижает увеличенный под действием эстрогенов риск развития гиперплазии эндометрия у женщин с сохраненной маткой. В ходе клинических исследований было показано, что препарат Фемостон мини обеспечивает ослабление симптомов, связанных с нехваткой эстрогенов, и характера кровотечений. Ослабление менопаузальных симптомов достигалось в течение первых недель лечения.
Фармакотерапевтическая группа
Дидрогестерон + Эстрадиол.
Фармакологические свойства
Эстрадиол. Эстрадиола гемигидрат, входящий в состав препарата Фемостонмини, при растворении переходит в 17-β-эстрадиол, идентичный эндогенному эстрадиолу человека, который является наиболее активным эстрогеном. Эстрадиол восполняет дефицит эстрогенов в организме у женщин в постменопаузальном периоде и уменьшает выраженность менопаузальных симптомов.
Дидрогестерон. Дидрогестерон – прогестаген, эффективный при приеме внутрь и имеющий схожую с парентерально вводимым прогестероном активность. Поскольку эстрогены способствуют пролиферации эндометрия, заместительная гормональная терапия (ЗГТ) только эстрогенами повышает риск гиперплазии эндометрия и рака. Включение дидрогестерона значительно снижает увеличенный под действием эстрогенов риск развития гиперплазии эндометрия у женщин с сохраненной маткой. В ходе клинических исследований было показано, что препарат Фемостон мини обеспечивает ослабление симптомов, связанных с нехваткой эстрогенов, и характера кровотечений.
Показания к применению
Заместительная гормональная терапия расстройств, обусловленных дефицитом эстрогенов у женщин в постменопаузе (не ранее чем через 12 месяцев после последней менструации).
Противопоказания
Повышенная чувствительность к компонентам препарата; диагностированный или предполагаемый рак молочной железы; диагностированные или предполагаемые эстрогензависимые злокачественные новообразования (например, рак эндометрия); диагностированные или предполагаемые прогестагензависимые новообразования (например, менингиома); кровотечения из влагалища неясной этиологии; нелеченная гиперплазия эндометрия; тромбозы (артериальные и венозные) и тромбоэмболии в настоящее время или в анамнезе (в том числе тромбоз, тромбоз глубоких вен; тромбоэмболия легочной артерии; инфаркт миокарда; ишемические или геморрагические цереброваскулярные нарушения); острые или хронические заболевания печени в настоящее время или в анамнезе (до нормализации показателей функциональных проб печени), в том числе злокачественные опухоли печени; порфирия; множественные или выраженные факторы артериального или венозного тромбоза, связанные с врожденной или приобретенной предрасположенностью, например, недостаточность протеина С, недостаточность протеина S, недостаточность антитромбина III, наличие антител к фосфолипидам (антитела к кардиолипину, волчаночный антикоагулянт), стенокардия, длительная иммобилизация, тяжелые формы ожирения (индекс массы тела более 30 кг/м2), заболевания сосудов головного мозга или коронарных артерий, транзиторные ишемические атаки, осложненные поражения клапанного аппарата сердца, фибрилляция предсердий; беременность и период грудного вскармливания; непереносимость галактозы, недостаточность лактазы, синдром мальабсорбции глюкозы-галактозы; менингиома.
Прием препарата Фемостон мини следует прекратить при выявлении противопоказаний и/или при возникновении следующих состояний: желтухи и/или нарушения функции печени; неконтролируемой артериальной гипертензии; впервые появившейся на фоне применения препаратов для ЗГТ мигренеподобной головной боли, беременности.
С осторожностью
ЗГТ назначается женщинам, если какое-либо из перечисленных состояний диагностировано в настоящее время, случалось ранее и/или усиливалось во время беременности или предшествующей гормональной терапии: лейомиома матки, эндометриоз; наличие факторов риска для возникновения эстрогензависимых опухолей (например, родственников 1-ой степени родства с раком молочной железы); артериальная гипертензия; доброкачественные опухоли печени; сахарный диабет, как при наличии сосудистых осложнений, так и в случае их отсутствия; холелитиаз; мигрень или сильная головная боль; системная красная волчанка; гиперплазия эндометрия в анамнезе; эпилепсия; бронхиальная астма; отосклероз.
Необходимо соблюдать меры предосторожности в следующих случаях: у пациенток с хронической сердечной и почечной недостаточностью; у пациенток в случае наличия факторов риска развития тромбозов и тромбоэмболий в семейном анамнезе (тромбоэмболические осложнения у родственников 1-й степени родства в молодом возрасте); у пациенток, получающих антикоагулянтную терапию.
Применение при беременности и в период грудного вскармливания
Препарат противопоказан при беременности и в период грудного вскармливания.
Способ применения и дозы
Препарат принимают внутрь ежедневно, в непрерывном режиме по 1 таблетке в сутки (желательно в одно и то же время суток), независимо от приема пищи.
Пациентки, делающие переход с другого непрерывного последовательного или циклического режима приема препарата, должны закончить текущий цикл, а затем перейти на препарат Фемостонмини.
Пациентки, не получающие препараты для ЗГТ или переходящие с непрерывного режима применения комбинированных препаратов для ЗГТ, могут начать прием препарата Фемостон мини в любой день.
Прием комбинированного препарата для ЗГТ Фемостон мини у женщин с естественной менопаузой можно начинать не ранее, чем через 12 месяцев после последней менструации.
Женщины, у которых менопауза обусловлена хирургическим вмешательством, могут начинать прием препарата сразу (по назначению врача в случае наличия симптомов).
Побочное действие
В клинических исследованиях у пациенток, получавших терапию комбинацией эстрадиол/дидрогестерон, наиболее часто встречались: головная боль, боль в животе, напряжение/болезненность молочных желез и боль в спине.
Перечень всех побочных эффектов представлен в инструкции по медицинскому применению.
Передозировка
Симптомы: тошнота, рвота, напряжение молочных желез, головокружение, боль в области живота, сонливость/слабость и кровотечение "отмены". Лечение: Симптоматическое.
Взаимодействие с другими лекарственными средствами
Исследований по изучению взаимодействия с другими лекарственными препаратами не проводилось. Метаболизм эстрогенов и прогестагенов может усиливаться при одновременном приёме с препаратами-индукторами микросомальных ферментов печени: противосудорожными (фенобарбитал, карбамазепин, фенитоин) и противомикробными препаратами (рифампицин, рифабутин, невирапин, эфавиренз); Ритонавир и нелфинавир при одновременном применении с половыми гормонами могут усиливать их метаболизм; Препараты, содержащие зверобой продырявленный (Hypericum perforatum), могут усиливать метаболизм эстрогенов и прогестагенов; Усиление метаболизма эстрогенов и прогестагенов клинически может проявляться снижением эффекта от применения препарата и появлением кровянистых выделений из влагалища.
Особые указания
Препарат назначают только при наличии симптомов, неблагоприятно влияющих на качество жизни. Терапию следует продолжать до тех пор, пока польза от приема препарата превышает риск развития побочных эффектов.
Опыт применения препарата у женщин старше 65 лет ограничен.
Сведения о рисках, связанных с ЗГТ в случае преждевременной менопаузы, ограничены. Из-за низкого уровня абсолютного риска у женщин более молодого возраста, отношение «польза/риск» у них может быть в пользу ЗГТ по сравнению с женщинами старшего возраста.
Влияние на способность управлять автомобилем и движущимися механизмами
Следует соблюдать осторожность при управлении транспортными средствами и механизмами, учитывая риск возникновения побочных реакций со стороны нервной системы.
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Вспомогательные вещества: моногидрат лактозы, гипромеллоза (НРМС 2910), кукурузный крахмал, коллоидный диоксид кремния, стеарат магния. Пленочная оболочка: пленочное покрытие Yellow 1 (макрогол 3350, поливиниловый спирт, тальк, диоксид титана, краситель железа оксид желтый - Е172)."}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Таблетки покрытые пленочной оболочкой Фемостон мини - противоклимактерическое комбинированное низкодозированное гормональное средство. Эстрадиола гемигидрат, входящий в состав препарата Фемостон мини, при растворении переходит в 17-β-эстрадиол, идентичный эндогенному эстрадиолу человека, который является наиболее активным эстрогеном. Эстрадиол восполняет дефицит эстрогенов в организме у женщин в постменопаузальном периоде и уменьшает выраженность менопаузальных симптомов. При назначении препарата Фемостон мини снижение частоты \"приливов\" средней тяжести и тяжелой степени было статистически достоверным по сравнению с плацебо, начиная с 4 недели терапии. Количество умеренных и выраженных приливов далее снижалось на 13 неделе до прекращения терапии. Дидрогестерон - прогестаген, эффективный при приеме внутрь и имеющий схожую с парентерально вводимым прогестероном активность. Поскольку эстрогены способствуют пролиферации эндометрия, заместительная гормональная терапия (ЗГТ) только эстрогенами повышает риск гиперплазии эндометрия и рака. Включение дидрогестерона значительно снижает увеличенный под действием эстрогенов риск развития гиперплазии эндометрия у женщин с сохраненной маткой. В ходе клинических исследований было показано, что препарат Фемостон мини обеспечивает ослабление симптомов, связанных с нехваткой эстрогенов, и характера кровотечений. Ослабление менопаузальных симптомов достигалось в течение первых недель лечения."}}]},{"name":"Фармакотерапевтическая группа","slug":"","id":11,"body":[{"type":"paragraph","data":{"text":"Дидрогестерон + Эстрадиол."}}]},{"name":"Фармакологические свойства","slug":"pharmacologic_effects","id":12,"body":[{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eЭстрадиол. \u003c/i\u003e\u003c/b\u003eЭстрадиола гемигидрат, входящий в состав препарата Фемостон\u003csup\u003e \u003c/sup\u003eмини, при растворении переходит в 17-β-эстрадиол, идентичный эндогенному эстрадиолу человека, который является наиболее активным эстрогеном. Эстрадиол восполняет дефицит эстрогенов в организме у женщин в постменопаузальном периоде и уменьшает выраженность менопаузальных симптомов. "}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eДидрогестерон. \u003c/i\u003e\u003c/b\u003eДидрогестерон – прогестаген, эффективный при приеме внутрь и имеющий схожую с парентерально вводимым прогестероном активность. Поскольку эстрогены способствуют пролиферации эндометрия, заместительная гормональная терапия (ЗГТ) только эстрогенами повышает риск гиперплазии эндометрия и рака. Включение дидрогестерона значительно снижает увеличенный под действием эстрогенов риск развития гиперплазии эндометрия у женщин с сохраненной маткой. В ходе клинических исследований было показано, что препарат Фемостон мини обеспечивает ослабление симптомов, связанных с нехваткой эстрогенов, и характера кровотечений. "}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Заместительная гормональная терапия расстройств, обусловленных дефицитом эстрогенов у женщин в постменопаузе (не ранее чем через 12 месяцев после последней менструации). "}}]},{"name":"Противопоказания","slug":"contraindications","id":13,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к компонентам препарата; диагностированный или предполагаемый рак молочной железы; диагностированные или предполагаемые эстрогензависимые злокачественные новообразования (например, рак эндометрия); диагностированные или предполагаемые прогестагензависимые новообразования (например, менингиома); кровотечения из влагалища неясной этиологии; нелеченная гиперплазия эндометрия; тромбозы (артериальные и венозные) и тромбоэмболии в настоящее время или в анамнезе (в том числе тромбоз, тромбоз глубоких вен; тромбоэмболия легочной артерии; инфаркт миокарда; ишемические или геморрагические цереброваскулярные нарушения); острые или хронические заболевания печени в настоящее время или в анамнезе (до нормализации показателей функциональных проб печени), в том числе злокачественные опухоли печени; порфирия; множественные или выраженные факторы артериального или венозного тромбоза, связанные с врожденной или приобретенной предрасположенностью, например, недостаточность протеина С, недостаточность протеина S, недостаточность антитромбина III, наличие антител к фосфолипидам (антитела к кардиолипину, волчаночный антикоагулянт), стенокардия, длительная иммобилизация, тяжелые формы ожирения (индекс массы тела более 30 кг/м\u003csup\u003e2\u003c/sup\u003e), заболевания сосудов головного мозга или коронарных артерий, транзиторные ишемические атаки, осложненные поражения клапанного аппарата сердца, фибрилляция предсердий; беременность и период грудного вскармливания; непереносимость галактозы, недостаточность лактазы, синдром мальабсорбции глюкозы-галактозы; менингиома."}},{"type":"paragraph","data":{"text":" Прием препарата Фемостон мини следует прекратить при выявлении противопоказаний и/или при возникновении следующих состояний: желтухи и/или нарушения функции печени; неконтролируемой артериальной гипертензии; впервые появившейся на фоне применения препаратов для ЗГТ мигренеподобной головной боли, беременности. "}}]},{"name":"С осторожностью","slug":"cautions","id":14,"body":[{"type":"paragraph","data":{"text":"ЗГТ назначается женщинам, если какое-либо из перечисленных состояний диагностировано в настоящее время, случалось ранее и/или усиливалось во время беременности или предшествующей гормональной терапии: лейомиома матки, эндометриоз; наличие факторов риска для возникновения эстрогензависимых опухолей (например, родственников 1-ой степени родства с раком молочной железы); артериальная гипертензия; доброкачественные опухоли печени; сахарный диабет, как при наличии сосудистых осложнений, так и в случае их отсутствия; холелитиаз; мигрень или сильная головная боль; системная красная волчанка; гиперплазия эндометрия в анамнезе; эпилепсия; бронхиальная астма; отосклероз. "}},{"type":"paragraph","data":{"text":"Необходимо соблюдать меры предосторожности в следующих случаях: у пациенток с хронической сердечной и почечной недостаточностью; у пациенток в случае наличия факторов риска развития тромбозов и тромбоэмболий в семейном анамнезе (тромбоэмболические осложнения у родственников 1-й степени родства в молодом возрасте); у пациенток, получающих антикоагулянтную терапию. "}}]},{"id":4,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат противопоказан при беременности и в период грудного вскармливания. "}}]},{"id":5,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат принимают внутрь ежедневно, в непрерывном режиме по 1 таблетке в сутки (желательно в одно и то же время суток), независимо от приема пищи. "}},{"type":"paragraph","data":{"text":"Пациентки, делающие переход с другого непрерывного последовательного или циклического режима приема препарата, должны закончить текущий цикл, а затем перейти на препарат Фемостон\u003csup\u003e \u003c/sup\u003eмини. "}},{"type":"paragraph","data":{"text":"Пациентки, не получающие препараты для ЗГТ или переходящие с непрерывного режима применения комбинированных препаратов для ЗГТ, могут начать прием препарата Фемостон мини в любой день. "}},{"type":"paragraph","data":{"text":"Прием комбинированного препарата для ЗГТ Фемостон мини у женщин с естественной менопаузой можно начинать не ранее, чем через 12 месяцев после последней менструации. "}},{"type":"paragraph","data":{"text":"Женщины, у которых менопауза обусловлена хирургическим вмешательством, могут начинать прием препарата сразу (по назначению врача в случае наличия симптомов). 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"}},{"type":"paragraph","data":{"text":"\u003cb\u003eПеречень всех побочных эффектов представлен в инструкции по медицинскому применению.\u003c/b\u003e"}}]},{"id":7,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы: \u003c/i\u003eтошнота, рвота, напряжение молочных желез, головокружение, боль в области живота, сонливость/слабость и кровотечение \"отмены\". \u003ci\u003eЛечение: \u003c/i\u003eСимптоматическое."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Исследований по изучению взаимодействия с другими лекарственными препаратами не проводилось. 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