Памидроновая кислота является ингибитором резорбции костной ткани, опосредуемой остеокластами. Она прочно связывается с кристаллами кальция фосфата (гидроксианатита), препятствуя их растворению in vitro. Блокирование резорбции костной ткани остеокластами in vivo может быть неполным, и, как минимум, является следствием связывания препарата с минералами костной ткани.
Памидроновая кислота тормозит миграцию предшественников остеокластов в костную ткань, нарушая их созревание. Однако, местный и прямой антирезорбтивный эффект бисфосфонатов, обусловленный сродством к минеральным компонентам кости, является превалирующим механизмом действия in vivo и in vitro.
Биохимические изменения, характеризующие угнетающий эффект памидроновой кислоты на индуцированную опухолью гиперкальциемию, проявляются снижением показателей кальция, фосфатов и, вторично, снижением экскреции кальция, фосфатов и гидроксипролина с мочой. Доза 90 мг обеспечивает нормокальциемию у более, чем 90% пациентов.
Гиперкальциемия может приводить к снижению объёма внеклеточной жидкости и снижению объёма клубочковой фильтрации. Контролируя гиперкальциемию, памидроновая кислота улучшает клубочковую фильтрацию и снижает повышенные показатели креатинина у большинства пациентов.
У пациентов с костными метастазами (преимущественно остеолитического характера) злокачественных опухолей и миеломной болезнью препарат предотвращает или замедляет прогрессирование изменений скелета и их последствий (гиперкальциемия, переломы, потребность в лучевой терапии и хирургических вмешательствах, компрессия спинного мозга), а также уменьшает боль в костях.
Фармакокинетика
Памидроновая кислота имеет выраженную тропность по отношению к кальцифицированным тканям, которые считаются "местом кажущейся элиминации" памидроновой кислоты.
Концентрация памидроновой кислоты в плазме быстро возрастает сразу после начала инфузии и быстро снижается после её окончания. Период полувыведения из плазмы крови составляет около 0,8 часа. Равновесная концентрация достигается в течение более чем 2-3 часов. При внутривенной инфузии 60 мг препарата продолжительностью более 1 часа, максимальная концентрация памидроновой кислоты в плазме (Сmах) составляет около 10 нмоль/мл.
Близкий процент (приблизительно 50%) памидроновой кислоты распределяется в организме после назначения различных доз (30-90 мг) независимо от продолжительности инфузии (4 или 24 часа). Таким образом, накопление памидроновой кислоты в костях неограничено в количественном отношении и зависит исключительно от общей кумулятивной дозы. Количество циркулирующей памидроновой кислоты, связанной с белками плазмы, относительно низкое (менее 50%) и может повышаться при патологическом увеличении концентрации кальция.
Считается, что памидроновая кислота не подвергается биотрансформации и выводится почти исключительно почками. После внутривенного введения около 20-55% введенной дозы обнаруживается в моче в течение 72 часов в неизмененном виде. Остаточные фракции от введенной дозы могут обнаруживаться в организме. Выведение памидроновой кислоты с мочой двухфазно, кажущиеся периоды полувыведения составляют, соответственно, 1.6 и 27 часов. Общий плазменный и почечный клиренс составляют 88254 мл/минуту и 38-60 мл/минуту соответственно. В среднем плазменный клиренс составляет около 180 мл/минуту. Средний почечный клиренс - 54 мл/минуту. Почечный клиренс памидроновой кислоты коррелирует с клиренсом креатинина.
Печеночный и метаболический клиренс памидроновой кислоты незначителен. В связи с этим нарушение функции печени не влияет на фармакокинетику памидроната динатрия.
Разницы между содержанием памидроновой кислоты в плазме у пациентов с нормальной функцией почек и у пациентов с легкими или умеренными нарушениями функции почек не существует. У больных с тяжелыми нарушениями функции почек (клиренс креатинина 30 мл/минуту) содержание памидроната было приблизительно в три раза выше, чем у пациентов с нормальными показателями функции почек (клиренс креатинина >90 мл/минуту).
Повышенная чувствительность к памидроновой кислоте или другим бисфосфонатам, а также к другим ингредиентам, входящим в состав препарата.
Беременность и период кормления грудью.
Детский возраст (опыт применения у детей отсутствует)
С осторожностью: нарушение функции почек.
Способ применения и дозы
Препарат Памидронат Медак вводят внутривенно капельно. В случае метастазов злокачественных опухолей в кости, множественной миеломы - 90 мг, однократно в виде 2-4-часовой инфузии каждые 4 недели, при проведении одновременной противоопухолевой терапии через каждые 3 недели.
Побочное действие
Со стороны системы кроветворения: часто - лимфоцитопения; нечасто - анемия, лейкопения; очень редко - тромбоцитопения.
Со стороны иммунной системы: нечасто - гиперчувствительность, включая анафилактические реакции, бронхоспазм, одышку, ангионевротический отек; очень редко - анафилактический шок, реактивация вирусов herpes simplex и herpes zoster.
Со стороны нервной системы: часто - головная боль; нечасто - возбуждение, признаки спутанности сознания, головокружение, бессонница, повышенная сонливость, заторможенность; очень редко - эпилептоидные судороги, зрительные галлюцинации, клинические проявления гипокальциемии (парестезии, тетания, мышечный спазм)
Со стороны органов зрения: нечасто - увеиты (ирит, иридоциклит), склерит, эписклерит, конъюнктивит; очень редко - ксантопсия (видение в желтом цвете), воспаление орбиты
Со стороны сердечно-сосудистой системы: нечасто - повышение артериального давления; очень редко - снижение артериального давления, обострение болезней сердца (левожелудочковая недостаточность/сердечная недостаточность), сопровождающееся одышкой, отеком легких из-за скопления избыточной жидкости.
Со стороны желудочно-кишечного тракта: часто - тошнота, рвота; нечасто - боль в животе, анорексия, диарея, запор, диспепсия; очень редко - гастрит.
Со стороны кожных покровов: нечасто - сыпь, зуд.
Со стороны костно-мышечной системы: часто - транзиторные боли в костях, артралгия, миалгия; нечасто - мышечные спазмы; редко - остеонекроз с вовлечением костей челюсти.
Со стороны мочевыделительной системы: редко - локальный сегментарный гломерулосклероз, включая коллаптоидный вариант, нефротический синдром, гломерулонефропатия, туболоингерстициальный нефрит; очень редко - обострение сопутствующих заболеваний почек, гематурия, острая почечная недостаточность.
Местные реакции: часто - боль, покраснение, отечность, уплотнение, флебит, тромбофлебит в месте введения препарата.
Со стороны лабораторных показателей: очень часто - гипокальциемия, гипофосфатемия; часто - гипомагниемия, повышение концентрации креатинина в сыворотке крови; нечасто - гипокалиемия, гиперкалиемия, гипернатриемия, изменения функциональных печеночных проб, повышение концентрации мочевины в сыворотке крови; очень редко - гипернатриемия с признаками спутанности сознания.
Прочие: очень часто - лихорадка и гриппоподобные симптомы, сопровождающиеся недомоганием, ознобом, повышенной утомляемостью и приливами жара.
Форма выпуска
Концентрат Памидронат медак для приготовления раствора для инфузий прозрачный, бесцветный.
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свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Памидронат Медак - ингибирующее костную резорбцию."}},{"type":"paragraph","data":{"text":"Фармакодинамика "}},{"type":"paragraph","data":{"text":"Памидроновая кислота является ингибитором резорбции костной ткани, опосредуемой остеокластами. Она прочно связывается с кристаллами кальция фосфата (гидроксианатита), препятствуя их растворению in vitro. Блокирование резорбции костной ткани остеокластами in vivo может быть неполным, и, как минимум, является следствием связывания препарата с минералами костной ткани. "}},{"type":"paragraph","data":{"text":"Памидроновая кислота тормозит миграцию предшественников остеокластов в костную ткань, нарушая их созревание. Однако, местный и прямой антирезорбтивный эффект бисфосфонатов, обусловленный сродством к минеральным компонентам кости, является превалирующим механизмом действия in vivo и in vitro. "}},{"type":"paragraph","data":{"text":"Биохимические изменения, характеризующие угнетающий эффект памидроновой кислоты на индуцированную опухолью гиперкальциемию, проявляются снижением показателей кальция, фосфатов и, вторично, снижением экскреции кальция, фосфатов и гидроксипролина с мочой. Доза 90 мг обеспечивает нормокальциемию у более, чем 90% пациентов. "}},{"type":"paragraph","data":{"text":"Гиперкальциемия может приводить к снижению объёма внеклеточной жидкости и снижению объёма клубочковой фильтрации. Контролируя гиперкальциемию, памидроновая кислота улучшает клубочковую фильтрацию и снижает повышенные показатели креатинина у большинства пациентов. "}},{"type":"paragraph","data":{"text":"У пациентов с костными метастазами (преимущественно остеолитического характера) злокачественных опухолей и миеломной болезнью препарат предотвращает или замедляет прогрессирование изменений скелета и их последствий (гиперкальциемия, переломы, потребность в лучевой терапии и хирургических вмешательствах, компрессия спинного мозга), а также уменьшает боль в костях."}},{"type":"paragraph","data":{"text":"Фармакокинетика "}},{"type":"paragraph","data":{"text":"Памидроновая кислота имеет выраженную тропность по отношению к кальцифицированным тканям, которые считаются \"местом кажущейся элиминации\" памидроновой кислоты. "}},{"type":"paragraph","data":{"text":"Концентрация памидроновой кислоты в плазме быстро возрастает сразу после начала инфузии и быстро снижается после её окончания. Период полувыведения из плазмы крови составляет около 0,8 часа. Равновесная концентрация достигается в течение более чем 2-3 часов. При внутривенной инфузии 60 мг препарата продолжительностью более 1 часа, максимальная концентрация памидроновой кислоты в плазме (Сmах) составляет около 10 нмоль/мл. "}},{"type":"paragraph","data":{"text":"Близкий процент (приблизительно 50%) памидроновой кислоты распределяется в организме после назначения различных доз (30-90 мг) независимо от продолжительности инфузии (4 или 24 часа). Таким образом, накопление памидроновой кислоты в костях неограничено в количественном отношении и зависит исключительно от общей кумулятивной дозы. Количество циркулирующей памидроновой кислоты, связанной с белками плазмы, относительно низкое (менее 50%) и может повышаться при патологическом увеличении концентрации кальция. "}},{"type":"paragraph","data":{"text":"Считается, что памидроновая кислота не подвергается биотрансформации и выводится почти исключительно почками. После внутривенного введения около 20-55% введенной дозы обнаруживается в моче в течение 72 часов в неизмененном виде. Остаточные фракции от введенной дозы могут обнаруживаться в организме. Выведение памидроновой кислоты с мочой двухфазно, кажущиеся периоды полувыведения составляют, соответственно, 1.6 и 27 часов. Общий плазменный и почечный клиренс составляют 88254 мл/минуту и 38-60 мл/минуту соответственно. В среднем плазменный клиренс составляет около 180 мл/минуту. Средний почечный клиренс - 54 мл/минуту. Почечный клиренс памидроновой кислоты коррелирует с клиренсом креатинина. "}},{"type":"paragraph","data":{"text":"Печеночный и метаболический клиренс памидроновой кислоты незначителен. В связи с этим нарушение функции печени не влияет на фармакокинетику памидроната динатрия. "}},{"type":"paragraph","data":{"text":"Разницы между содержанием памидроновой кислоты в плазме у пациентов с нормальной функцией почек и у пациентов с легкими или умеренными нарушениями функции почек не существует. У больных с тяжелыми нарушениями функции почек (клиренс креатинина 30 мл/минуту) содержание памидроната было приблизительно в три раза выше, чем у пациентов с нормальными показателями функции почек (клиренс креатинина >90 мл/минуту)."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Заболевания, сопровождающиеся повышенной активностью остеокластов:"}},{"type":"list","data":{"style":"ordered","items":["костные метастазы злокачественных опухолей (преимущественно остеолитического характера) и миеломная болезнь (множественная миелома);","гиперкальциемия, обусловленная злокачественными опухолями."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["Повышенная чувствительность к памидроновой кислоте или другим бисфосфонатам, а также к другим ингредиентам, входящим в состав препарата.","Беременность и период кормления грудью.","Детский возраст (опыт применения у детей отсутствует)"]}},{"type":"paragraph","data":{"text":"С осторожностью: нарушение функции почек."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат Памидронат Медак вводят внутривенно капельно. В случае метастазов злокачественных опухолей в кости, множественной миеломы - 90 мг, однократно в виде 2-4-часовой инфузии каждые 4 недели, при проведении одновременной противоопухолевой терапии через каждые 3 недели."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны системы кроветворения: часто - лимфоцитопения; нечасто - анемия, лейкопения; очень редко - тромбоцитопения. "}},{"type":"paragraph","data":{"text":"Со стороны иммунной системы: нечасто - гиперчувствительность, включая анафилактические реакции, бронхоспазм, одышку, ангионевротический отек; очень редко - анафилактический шок, реактивация вирусов herpes simplex и herpes zoster. "}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: часто - головная боль; нечасто - возбуждение, признаки спутанности сознания, головокружение, бессонница, повышенная сонливость, заторможенность; очень редко - эпилептоидные судороги, зрительные галлюцинации, клинические проявления гипокальциемии (парестезии, тетания, мышечный спазм) "}},{"type":"paragraph","data":{"text":"Со стороны органов зрения: нечасто - увеиты (ирит, иридоциклит), склерит, эписклерит, конъюнктивит; очень редко - ксантопсия (видение в желтом цвете), воспаление орбиты "}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: нечасто - повышение артериального давления; очень редко - снижение артериального давления, обострение болезней сердца (левожелудочковая недостаточность/сердечная недостаточность), сопровождающееся одышкой, отеком легких из-за скопления избыточной жидкости. "}},{"type":"paragraph","data":{"text":"Со стороны желудочно-кишечного тракта: часто - тошнота, рвота; нечасто - боль в животе, анорексия, диарея, запор, диспепсия; очень редко - гастрит. "}},{"type":"paragraph","data":{"text":"Со стороны кожных покровов: нечасто - сыпь, зуд. "}},{"type":"paragraph","data":{"text":"Со стороны костно-мышечной системы: часто - транзиторные боли в костях, артралгия, миалгия; нечасто - мышечные спазмы; редко - остеонекроз с вовлечением костей челюсти. "}},{"type":"paragraph","data":{"text":"Со стороны мочевыделительной системы: редко - локальный сегментарный гломерулосклероз, включая коллаптоидный вариант, нефротический синдром, гломерулонефропатия, туболоингерстициальный нефрит; очень редко - обострение сопутствующих заболеваний почек, гематурия, острая почечная недостаточность. "}},{"type":"paragraph","data":{"text":"Местные реакции: часто - боль, покраснение, отечность, уплотнение, флебит, тромбофлебит в месте введения препарата. "}},{"type":"paragraph","data":{"text":"Со стороны лабораторных показателей: очень часто - гипокальциемия, гипофосфатемия; часто - гипомагниемия, повышение концентрации креатинина в сыворотке крови; нечасто - гипокалиемия, гиперкалиемия, гипернатриемия, изменения функциональных печеночных проб, повышение концентрации мочевины в сыворотке крови; очень редко - гипернатриемия с признаками спутанности сознания. "}},{"type":"paragraph","data":{"text":"Прочие: очень часто - лихорадка и гриппоподобные симптомы, сопровождающиеся недомоганием, ознобом, повышенной утомляемостью и приливами жара."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Концентрат Памидронат медак для приготовления раствора для инфузий прозрачный, бесцветный."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"При температуре не выше 25 °C (не замораживать)"}}]}],"source":null},"description_toggle":false,"short_description":"Памидронат Медак - ингибирующее костную резорбцию. Фармакодинамика Памидроновая кислота является ингибитором резорбции костной ткани, опосредуемой остеокластами. Она прочно связывается с кристаллами кальция фосфата (гидроксианатита), препятствуя их растворению in vitro. Блокирование резорбции костной ткани остеокластами in vivo может быть неполным, и, как минимум, является следствием связывания препарата с минералами костной ткани. Памидроновая кислота тормозит миграцию предшественников остеокластов в костную ткань, нарушая их созревание. Однако, местный и прямой антирезорбтивный эффект бисфосфонатов, обусловленный сродством к минеральным компонентам кости, является превалирующим механизмом действия in vivo и in vitro. Биохимические изменения, характеризующие угнетающий эффект памидроновой кислоты на индуцированную опухолью гиперкальциемию, проявляются снижением показателей кальция, фосфатов и, вторично, снижением экскреции кальция, фосфатов и гидроксипролина с мочой. Доза 90 мг обеспечивает нормокальциемию у более, чем 90% пациентов. Гиперкальциемия может приводить к снижению объёма внеклеточной жидкости и снижению объёма клубочковой фильтрации. Контролируя гиперкальциемию, памидроновая кислота улучшает клубочковую фильтрацию и снижает повышенные показатели креатинина у большинства пациентов. У пациентов с костными метастазами (преимущественно остеолитического характера) злокачественных опухолей и миеломной болезнью препарат предотвращает или замедляет прогрессирование изменений скелета и их последствий (гиперкальциемия, переломы, потребность в лучевой терапии и хирургических вмешательствах, компрессия спинного мозга), а также уменьшает боль в костях. Фармакокинетика Памидроновая кислота имеет выраженную тропность по отношению к кальцифицированным тканям, которые считаются \"местом кажущейся элиминации\" памидроновой кислоты. Концентрация памидроновой кислоты в плазме быстро возрастает сразу после начала инфузии и быстро снижается после её окончания. Период полувыведения из плазмы крови составляет около 0,8 часа. Равновесная концентрация достигается в течение более чем 2-3 часов. При внутривенной инфузии 60 мг препарата продолжительностью более 1 часа, максимальная концентрация памидроновой кислоты в плазме (Сmах) составляет около 10 нмоль/мл. Близкий процент (приблизительно 50%) памидроновой кислоты распределяется в организме после назначения различных доз (30-90 мг) независимо от продолжительности инфузии (4 или 24 часа). Таким образом, накопление памидроновой кислоты в костях неограничено в количественном отношении и зависит исключительно от общей кумулятивной дозы. Количество циркулирующей памидроновой кислоты, связанной с белками плазмы, относительно низкое (менее 50%) и может повышаться при патологическом увеличении концентрации кальция. Считается, что памидроновая кислота не подвергается биотрансформации и выводится почти исключительно почками. После внутривенного введения около 20-55% введенной дозы обнаруживается в моче в течение 72 часов в неизмененном виде. Остаточные фракции от введенной дозы могут обнаруживаться в организме. Выведение памидроновой кислоты с мочой двухфазно, кажущиеся периоды полувыведения составляют, соответственно, 1.6 и 27 часов. Общий плазменный и почечный клиренс составляют 88254 мл/минуту и 38-60 мл/минуту соответственно. В среднем плазменный клиренс составляет около 180 мл/минуту. Средний почечный клиренс - 54 мл/минуту. Почечный клиренс памидроновой кислоты коррелирует с клиренсом креатинина. Печеночный и метаболический клиренс памидроновой кислоты незначителен. В связи с этим нарушение функции печени не влияет на фармакокинетику памидроната динатрия. Разницы между содержанием памидроновой кислоты в плазме у пациентов с нормальной функцией почек и у пациентов с легкими или умеренными нарушениями функции почек не существует. У больных с тяжелыми нарушениями функции почек (клиренс креатинина 30 мл/минуту) содержание памидроната было приблизительно в три раза выше, чем у пациентов с нормальными показателями функции почек (клиренс креатинина \u003e90 мл/минуту).","substance":[],"branding":null,"valid_for_quick_buy":false,"is_available_to_delivery":false,"comments":null,"image_alt":"Памидронат медак - фото упаковки","image_share":{"isTouch":{"default":null},"isFromTablet":{"default":null}},"diseases":[],"other_packages":[],"other_product_forms":[],"related_products":{"title":"Похожие товары","type":"nondrugs","products":[{"id":114560,"title":"Золедронат-Тева","subtitle":{"full":"Концентрат, флакон, 1 шт, 5 мл, 4/5 мг/мл, для раствора для инфузий","short":"Концентрат, 1 шт, 5 мл, 4/5 мг/мл","package":"1 шт, 5 мл, 4/5 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