Ингибитор костной резорбции. Алендронат натрия является бисфосфонатом, синтетическим аналогом пирофосфата, связывающего гидроксиапатит костной ткани. Являясь негормональным специфическим ингибитором активности остеокластов, препятствует резорбции костной ткани. Не влияет на процессы формирования костной ткани. Стимулирует остеогенез, восстанавливает положительный баланс между резорбцией и восстановлением кости. Прогрессивно увеличивает минеральную плотность костей (регулирует фосфорно-кальциевый обмен), способствует формированию костной ткани нормального состава и структуры.
Показания к применению
— лечение постменопаузного остеопороза с целью предупреждения переломов позвоночника и бедра.
Противопоказания
Аномалии пищевода и другие факторы, затрудняющие проходимость пищевода (в т.ч. ахалазия, стриктура)
Неспособность больного оставаться в вертикальном положении, хотя бы сидя, в течение 30 мин
Гипокальциемия
Хроническая почечная недостаточность (КК меньше 35 мл/мин)
Беременность
Период лактации (грудного вскармливания)
Детский возраст
Дефицит витамина D
Тяжелые нарушения минерального обмена
Повышенная чувствительность к компонентам препарата
С осторожностью следует применять препарат при заболеваниях пищеварительного тракта в фазе обострения (дисфагия, заболевания пищевода, гастрит, дуоденит, язва, серьезное заболевание ЖКТ в предшествующие 12 месяцев, например, пептическая язва, желудочно-кишечное кровотечение, хирургическое вмешательство, за исключением операций на спастическом привратнике желудка).
Применение при беременности и в период грудного вскармливания
Ввиду отсутствия необходимого клинического опыта применение препарата Остерепар при беременности противопоказано.; Данных о проникновении алендроната в грудное молоко нет. Прием препарата Остерепар в период грудного вскармливания противопоказан.
Способ применения и дозы
Препарат принимают внутрь. Рекомендуемая доза - 70 мг 1 раз в неделю. Для обеспечения оптимальной всасываемости препарат следует принимать утром натощак, за 2 ч (не менее 30 мин) до первого приема пищи или жидкости, запивая простой питьевой водой. Другие напитки, в т.ч. минеральные воды, пища, ряд лекарственных средств могут ухудшать всасываемость алендроната.; Во избежание местного раздражения слизистой ротовой полости и пищевода утром, сразу же после подъема с постели следует выпить не менее 200 мл простой воды, затем принять таблетку, не разжевывая и не давая ей раствориться во рту, в течение последующих 30 мин нельзя принимать горизонтальное положение тела, по истечении этого срока следует принять завтрак. Нельзя принимать таблетку утром, до подъема с постели или вечером, после отхода ко сну.; Лечение алендронатом следует дополнить приемом кальция и витамина D.; Пациентам пожилого возраста коррекция дозы не требуется.; При КК > 35 мл/мин коррекция дозы не требуется. При почечной недостаточности с КК меньше 35 мл/мин назначать препарат не следует из-за отсутствия клинического опыта.
Побочное действие
Со стороны пищеварительной системы: часто (1/100, меньше 1/10) - боли в животе, диспепсия, запор, диарея, метеоризм, язва пищевода, дисфагия, вздутие живота, изжога; нечасто (1/1000, меньше 1/1000) - тошнота, рвота, гастрит, эзофагит, эрозия пищевода, мелена; редко (1/10 000, меньше 1/1000) - сужение пищевода, орофарингеальная язва, перфорация верхних отделов ЖКТ, язва, кровотечение, однако связь с лечением не всегда однозначна.; Со стороны костно-мышечной системы: часто (1/100, меньше 1/10) - осталгия, артралгия, миалгия.; Со стороны нервной системы: часто (1/100, меньше 1/10) - головная боль, раздражительность.; Со стороны кожных покровов: нечасто (1/1000, меньше 1/1000) - зуд, сыпь, гиперемия кожи; редко (1/10 000, меньше 1/1000) - фотосенсибилизация.; Аллергические реакции: редко (1/10 000, меньше 1/1000) - крапивница, ангионевротический отек, синдром Стивенса-Джонсона, токсический эпидермальный некролиз; преходящие симптомы, напоминающие фазу острой реакции (миалгия, слабость, плохое самочувствие, редко - высокая температура тела) чаще всего развиваются в начале лечения.; Со стороны обмена веществ: редко (1/10 000, меньше 1/1000) - гипокальциемия (часто в сопровождении предрасполагающих факторов).; Со стороны органов чувств: редко (1/10 000, меньше 1/1000) - увеит, склерит.; Лабораторные показатели: редко (1/10 000, меньше 1/1000) - временные, слабо выраженные асимптоматические гипокальциемия и гипофосфатемия.
Передозировка
Симптомы: гипокальциемия, гипофосфатемия, побочные реакции со стороны верхних отделов ЖКТ (изжога, эзофагит, гастрит, язва).; Лечение: специфического лечения нет. Рекомендуется прием молока, антацидов. Во избежание раздражения пищевода нельзя вызывать рвоту, больной должен принять вертикальное положение (стоя или сидя).
Особые указания
Алендронат может вызывать местное раздражение слизистой оболочка пищеварительного тракта. Течение заболеваний верхних отделов пищеварительного тракта может ухудшиться во время лечения алендронатом.; Известны случаи побочных реакций со стороны пищевода (эзофагит, язва или эрозия пищевода), иногда протекавших в тяжелой форме, требовавших стационарного лечения, и осложнявшихся формированием стриктуры. Следует особо обратить внимание больных на то, что при появлении признаков раздражения пищевода (дисфагия, загрудинная боль при глотании, появление или ухудшение течения приступов изжоги), прием препарата следует прекратить и обратиться к врачу. Риск поражения пищевода выше у больных, не соблюдающих правила приема препарата, либо продолжающих лечение вопреки появлению признаков раздражения пищевода. Чрезвычайно важно своевременно проинформировать больных о значении соблюдения правил по приему препарата и убедиться в том, что больной понял это.; Лечение можно начать лишь после устранения гипокальциемии, нарушений минерального и витаминного обменов (например, недостаточности витамина D). Прием алендроната приводит к увеличению содержания минеральных солей в костной ткани, процесс может сопровождаться бессимптомным изменением уровней кальция и фосфора. Обеспечение соответствующего приема кальция и витамина D особенно важно в случае лечения больного ГКС.; Лечение следует сочетать с диетой, обогащенной солями кальция.; Следует предупредить больных о том, что в случае пропуска очередной дозы препарата, пропущенную таблетку следует принять на следующее утро; ни в коем случае не следует принимать 2 таблетки в один день.; Использование в педиатрии; Из-за отсутствия клинических данных детям препарат не назначают.; Влияние на способность к вождению автотранспорта и управлению механизмами; Препарат не влияет на способность управлять транспортными средствами и выполнять работы, связанные с высоким риском травматизма, однако при наличии побочных реакций со стороны органа зрения управление транспортом и рабочими механизмами противопоказано до момента полного исчезновения побочных реакций.
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Алендронат натрия является бисфосфонатом, синтетическим аналогом пирофосфата, связывающего гидроксиапатит костной ткани. Являясь негормональным специфическим ингибитором активности остеокластов, препятствует резорбции костной ткани. Не влияет на процессы формирования костной ткани. Стимулирует остеогенез, восстанавливает положительный баланс между резорбцией и восстановлением кости. Прогрессивно увеличивает минеральную плотность костей (регулирует фосфорно-кальциевый обмен), способствует формированию костной ткани нормального состава и структуры."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"— лечение постменопаузного остеопороза с целью предупреждения переломов позвоночника и бедра."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Аномалии пищевода и другие факторы, затрудняющие проходимость пищевода (в т.ч. ахалазия, стриктура)","Неспособность больного оставаться в вертикальном положении, хотя бы сидя, в течение 30 мин","Гипокальциемия","Хроническая почечная недостаточность (КК меньше 35 мл/мин)","Беременность","Период лактации (грудного вскармливания)","Детский возраст","Дефицит витамина D","Тяжелые нарушения минерального обмена","Повышенная чувствительность к компонентам препарата"]}},{"type":"paragraph","data":{"text":"С осторожностью следует применять препарат при заболеваниях пищеварительного тракта в фазе обострения (дисфагия, заболевания пищевода, гастрит, дуоденит, язва, серьезное заболевание ЖКТ в предшествующие 12 месяцев, например, пептическая язва, желудочно-кишечное кровотечение, хирургическое вмешательство, за исключением операций на спастическом привратнике желудка)."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Ввиду отсутствия необходимого клинического опыта применение препарата Остерепар при беременности противопоказано.; Данных о проникновении алендроната в грудное молоко нет. 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Нельзя принимать таблетку утром, до подъема с постели или вечером, после отхода ко сну.; Лечение алендронатом следует дополнить приемом кальция и витамина D.; Пациентам пожилого возраста коррекция дозы не требуется.; При КК \u003e 35 мл/мин коррекция дозы не требуется. При почечной недостаточности с КК меньше 35 мл/мин назначать препарат не следует из-за отсутствия клинического опыта."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: часто (1/100, меньше 1/10) - боли в животе, диспепсия, запор, диарея, метеоризм, язва пищевода, дисфагия, вздутие живота, изжога; нечасто (1/1000, меньше 1/1000) - тошнота, рвота, гастрит, эзофагит, эрозия пищевода, мелена; редко (1/10 000, меньше 1/1000) - сужение пищевода, орофарингеальная язва, перфорация верхних отделов ЖКТ, язва, кровотечение, однако связь с лечением не всегда однозначна.; Со стороны костно-мышечной системы: часто (1/100, меньше 1/10) - осталгия, артралгия, миалгия.; Со стороны нервной системы: часто (1/100, меньше 1/10) - головная боль, раздражительность.; Со стороны кожных покровов: нечасто (1/1000, меньше 1/1000) - зуд, сыпь, гиперемия кожи; редко (1/10 000, меньше 1/1000) - фотосенсибилизация.; Аллергические реакции: редко (1/10 000, меньше 1/1000) - крапивница, ангионевротический отек, синдром Стивенса-Джонсона, токсический эпидермальный некролиз; преходящие симптомы, напоминающие фазу острой реакции (миалгия, слабость, плохое самочувствие, редко - высокая температура тела) чаще всего развиваются в начале лечения.; Со стороны обмена веществ: редко (1/10 000, меньше 1/1000) - гипокальциемия (часто в сопровождении предрасполагающих факторов).; Со стороны органов чувств: редко (1/10 000, меньше 1/1000) - увеит, склерит.; Лабораторные показатели: редко (1/10 000, меньше 1/1000) - временные, слабо выраженные асимптоматические гипокальциемия и гипофосфатемия."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: гипокальциемия, гипофосфатемия, побочные реакции со стороны верхних отделов ЖКТ (изжога, эзофагит, гастрит, язва).; Лечение: специфического лечения нет. Рекомендуется прием молока, антацидов. Во избежание раздражения пищевода нельзя вызывать рвоту, больной должен принять вертикальное положение (стоя или сидя)."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Алендронат может вызывать местное раздражение слизистой оболочка пищеварительного тракта. Течение заболеваний верхних отделов пищеварительного тракта может ухудшиться во время лечения алендронатом.; Известны случаи побочных реакций со стороны пищевода (эзофагит, язва или эрозия пищевода), иногда протекавших в тяжелой форме, требовавших стационарного лечения, и осложнявшихся формированием стриктуры. Следует особо обратить внимание больных на то, что при появлении признаков раздражения пищевода (дисфагия, загрудинная боль при глотании, появление или ухудшение течения приступов изжоги), прием препарата следует прекратить и обратиться к врачу. Риск поражения пищевода выше у больных, не соблюдающих правила приема препарата, либо продолжающих лечение вопреки появлению признаков раздражения пищевода. Чрезвычайно важно своевременно проинформировать больных о значении соблюдения правил по приему препарата и убедиться в том, что больной понял это.; Лечение можно начать лишь после устранения гипокальциемии, нарушений минерального и витаминного обменов (например, недостаточности витамина D). Прием алендроната приводит к увеличению содержания минеральных солей в костной ткани, процесс может сопровождаться бессимптомным изменением уровней кальция и фосфора. 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