Нифедипин - селективный блокатор медленных кальциевых каналов, производное 1.4-дигидропиридина. Оказывает антиангинальное и гипотензивное действие. Уменьшает ток ионов кальция через медленные кальциевые каналы внутрь клеток, преимущественно внутрь кардиомиоцитов, гладкомышечных клеток коронарных и периферических артерий, понижая при этом периферическое сосудистое сопротивление и расширяя коронарные артерии, особенно крупные кровоснабжающие сосуды, и даже интактные сегменты стенок частично стенозированных сосудов. Кроме того, нифедипин понижает тонус гладкой мускулатуры коронарных артерий, тем самым предотвращая ангиоспазм, усиливая кровоток в постстенотических отделах сосудов и увеличивая доставку кислорода к миокарду . уменьшается потребность миокарда в кислороде за счет снижения периферического сосудистого сопротивления (постнагрузки), а при длительном приеме он способен предотвращать развитие новых атеросклеротических повреждений в коронарных артериях. Нифедипин снижает тонус гладкой мускулатуры артериол, тем самым уменьшая повышенное периферическое сосудистое сопротивление и, следовательно, АД. В начале лечения Адалатом может происходить временное рефлекторное повышение ЧСС и, как следствие этого, величины сердечного выброса. Однако это повышение не настолько значительно, чтобы компенсировать расширение кровеносных сосудов. Кроме того, нифедипин при кратковременном и при длительном применении увеличивает выведение натрия и воды из организма. Гипотензивное действие нифедипина особенно выражено у пациентов, страдающих артериальной гипертензией.
Показания к применению
Стенокардия Принцметала
Гипертонический криз
Противопоказания
Беременность (до 20 недель)
Период грудного вскармливания
Кардиогенный шок
Нестабильная стенокардия
Острый инфаркт миокарда (в первые 4 недели после перенесенного инфаркта миокарда)
Одновременное назначение с рифампицином
Возраст до 18 лет (безопасность и эффективность не установлены)
Повышенная чувствительность к нифедипину или любому другому компоненту препарата. С осторожностью: острая сердечная недостаточность, хроническая сердечная недостаточность III-IV функционального класса по классификации NYHA, выраженный аортальный стеноз, выраженная брадикардия (ЧСС менее 50 уд./мин), печеночная недостаточность, выраженная артериальная гипотензия (систолическое АД менее 90 мм рт.ст.), у пациентов со злокачественной артериальной гипертензией и гиповолемией, находящихся на гемодиализе, беременность (после 20 недель)
Применение при беременности и в период грудного вскармливания
Применение препарата Адалат противопоказано при беременности до 20 недель. Контролируемые клинические исследования применения препарата Адалат у беременных не проводились . соответственно данные контролируемых клинических исследований по безопасности и эффективности применения препарата Адалат у беременных отсутствуют. Испытания на животных показали наличие эмбриотоксичности, плацентотоксичности, фетотоксичности и тератогенности при приеме нифедипина в течение и по окончании периода органогенеза. По имеющимся клиническим данным нельзя оценить специфический пренатальный риск. Вместе с тем имеются данные об увеличении вероятности перинатальной асфиксии, кесарева сечения, преждевременных родов и задержки внутриутробного развития плода. Неясно, являются ли перечисленные случаи следствием основного заболевания (артериальной гипертензии), проводимого лечения или специфическим эффектом препарата Адалат. Имеющаяся информация является недостаточной для того, чтобы исключить вероятность возникновения побочных эффектов, представляющих опасность для плода и новорожденного. Поэтому применение препарата Адалат после 20-й недели беременности требует тщательной индивидуальной оценки соотношения риска и пользы для пациентки, плода и/или новорожденного и может рассматриваться только в тех случаях, когда другие способы терапии противопоказаны или неэффективны. Следует проводить тщательный контроль АД у беременных при применении препарата Адалат одновременно с в/в магния сульфата вследствие возможности чрезмерного снижения АД, что представляет опасность как для матери, так и для плода и/или новорожденного. Нифедипин выделяется с грудным молоком, поэтому, если применение препарата Адалат необходимо в период лактации, грудное вскармливание следует прекратить.
Способ применения и дозы
50 мл раствора Адалат вводят в/в инфузионно в течение, примерно, 4-8 ч (со скоростью 6.3-12.5 мл/ч, что соответствует 0.63-1.25 мг нифедипина/ч). Максимальная доза препарата, вводимого в течение 24 ч, не должна превышать 150-300 мл (что соответствует 15-30 мг нифедипина/24 ч). Инфузионная терапия может проводиться непрерывно в течение 3 дней. Затем рекомендуется переход на пероральную терапию нифедипином. Безопасность и эффективность применения препарата Адалат у детей и подростков до 18 лет не установлена. У пациентов пожилого возраста из-за нарушений фармакокинетики может потребоваться уменьшение поддерживающей дозы (по сравнению с более молодыми пациентами). У пациентов с нарушениями функции печени препарат применяют с осторожностью под контролем функции печени, при тяжелых нарушениях функции печени необходимо уменьшить дозу. У пациентов с нарушениями функции почек коррекции дозы не требуется.
Побочное действие
При применении нифедипина побочные эффекты были оценены в плацебо-контролируемых исследованиях. Ниже перечисленные побочные эффекты классифицировали следующим образом: часто (≥ .1/100, меньше 1/10), нечасто (≥ .1/1000, меньше 1/100), редко (≥ .1/10 000, меньше 1/1000). Степень градации побочных реакций "часто" оценивалась как менее 3%, за исключением отека (9.9%) и головной боли (3.9%). Побочные эффекты, которые отмечались только в ходе постмаркетинговых наблюдений, и частота которых не оценивалась, обозначены "в отдельных случаях". Со стороны сердечно-сосудистой системы: часто - периферические отеки, симптомы вазодилатации (покраснение кожи лица, ощущение жара) . нечасто - тахикардия, учащенное сердцебиение, снижение АД, обморок . в отдельных случаях - боль за грудиной (стенокардия). Со стороны ЦНС: часто - головная боль . нечасто - головокружение, мигрень, тремор, вертиго, тревожность, нарушения сна, редко - парестезии, дизестезии . в отдельных случаях - гипестезии, сонливость. Со стороны пищеварительной системы: часто - запор, нечасто гастроинтестинальная и абдоминальная боль (боль в области желудка и кишечника), тошнота, диспепсия, метеоризм, сухость слизистой оболочки полости рта, преходящее повышение активности печеночных трансаминаз . редко - гиперплазия десен . в отдельных случаях - рвота, недостаточность кардиального сфинктера, желтуха. Со стороны дыхательной системы: нечасто - носовое кровотечение, заложенность носа . в отдельных случаях - одышка. Со стороны костно-мышечной системы: нечасто - мышечные судороги, отечность суставов . в отдельных случаях - артралгия, миалгия. Со стороны мочевыделительной системы: нечасто - полиурия, дизурия. Со стороны иммунной системы: нечасто - аллергические реакции в виде аллергического/ангионевротического отека (включая потенциально опасный для жизни отек гортани) . редко - кожный зуд, сыпь, крапивница . в отдельных случаях - анафилактические/анафилактоидные реакции. Со стороны кожных покровов и подкожно-жировой клетчатки: нечасто - эритема . в отдельных случаях - токсический эпидермальный некролиз, фотосенсибилизация, аллергические реакции, пурпура. Со стороны органа зрения: нечасто - нарушение четкости зрения . в отдельных случаях - боль в глазах. Со стороны репродуктивной системы: нечасто - эректильная дисфункция. Со стороны кроветворной системы: в отдельных случаях - агранулоцитоз, лейкопения. Метаболические нарушения: в отдельных случаях - гипергликемия. Местные реакции: нечасто - реакции в месте введения (в т.ч. тромбофлебит). Прочие: часто - плохое самочувствие . нечасто - неспецифический болевой синдром, озноб. У пациентов со злокачественной артериальной гипертензией и гиповолемией и находящихся на диализе падение АД может быть обусловлено вазодилатацией.
Особые указания
При применении нифедипина побочные эффекты были оценены в плацебо-контролируемых исследованиях. Ниже перечисленные побочные эффекты классифицировали следующим образом: часто (≥ .1/100, меньше 1/10), нечасто (≥ .1/1000, меньше 1/100), редко (≥ .1/10 000, меньше 1/1000). Степень градации побочных реакций "часто" оценивалась как менее 3%, за исключением отека (9.9%) и головной боли (3.9%). Побочные эффекты, которые отмечались только в ходе постмаркетинговых наблюдений, и частота которых не оценивалась, обозначены "в отдельных случаях". Со стороны сердечно-сосудистой системы: часто - периферические отеки, симптомы вазодилатации (покраснение кожи лица, ощущение жара) . нечасто - тахикардия, учащенное сердцебиение, снижение АД, обморок . в отдельных случаях - боль за грудиной (стенокардия). Со стороны ЦНС: часто - головная боль . нечасто - головокружение, мигрень, тремор, вертиго, тревожность, нарушения сна, редко - парестезии, дизестезии . в отдельных случаях - гипестезии, сонливость. Со стороны пищеварительной системы: часто - запор, нечасто гастроинтестинальная и абдоминальная боль (боль в области желудка и кишечника), тошнота, диспепсия, метеоризм, сухость слизистой оболочки полости рта, преходящее повышение активности печеночных трансаминаз . редко - гиперплазия десен . в отдельных случаях - рвота, недостаточность кардиального сфинктера, желтуха. Со стороны дыхательной системы: нечасто - носовое кровотечение, заложенность носа . в отдельных случаях - одышка. Со стороны костно-мышечной системы: нечасто - мышечные судороги, отечность суставов . в отдельных случаях - артралгия, миалгия. Со стороны мочевыделительной системы: нечасто - полиурия, дизурия. Со стороны иммунной системы: нечасто - аллергические реакции в виде аллергического/ангионевротического отека (включая потенциально опасный для жизни отек гортани) . редко - кожный зуд, сыпь, крапивница . в отдельных случаях - анафилактические/анафилактоидные реакции. Со стороны кожных покровов и подкожно-жировой клетчатки: нечасто - эритема . в отдельных случаях - токсический эпидермальный некролиз, фотосенсибилизация, аллергические реакции, пурпура. Со стороны органа зрения: нечасто - нарушение четкости зрения . в отдельных случаях - боль в глазах. Со стороны репродуктивной системы: нечасто - эректильная дисфункция. Со стороны кроветворной системы: в отдельных случаях - агранулоцитоз, лейкопения. Метаболические нарушения: в отдельных случаях - гипергликемия. Местные реакции: нечасто - реакции в месте введения (в т.ч. тромбофлебит). Прочие: часто - плохое самочувствие . нечасто - неспецифический болевой синдром, озноб. У пациентов со злокачественной артериальной гипертензией и гиповолемией и находящихся на диализе падение АД может быть обусловлено вазодилатацией.
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Вспомогательные вещества: натрия хлорид - 12 мг, хлористоводородная кислота - до pH 3.3-5.5, вода д/и - до требуемого объема. 10 мл - флаконы темного стекла (1) - пачки картонные. 20 мл - флаконы темного стекла (1) - пачки картонные."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Нифедипин - селективный блокатор медленных кальциевых каналов, производное 1.4-дигидропиридина. Оказывает антиангинальное и гипотензивное действие. Уменьшает ток ионов кальция через медленные кальциевые каналы внутрь клеток, преимущественно внутрь кардиомиоцитов, гладкомышечных клеток коронарных и периферических артерий, понижая при этом периферическое сосудистое сопротивление и расширяя коронарные артерии, особенно крупные кровоснабжающие сосуды, и даже интактные сегменты стенок частично стенозированных сосудов. Кроме того, нифедипин понижает тонус гладкой мускулатуры коронарных артерий, тем самым предотвращая ангиоспазм, усиливая кровоток в постстенотических отделах сосудов и увеличивая доставку кислорода к миокарду . уменьшается потребность миокарда в кислороде за счет снижения периферического сосудистого сопротивления (постнагрузки), а при длительном приеме он способен предотвращать развитие новых атеросклеротических повреждений в коронарных артериях. Нифедипин снижает тонус гладкой мускулатуры артериол, тем самым уменьшая повышенное периферическое сосудистое сопротивление и, следовательно, АД. В начале лечения Адалатом может происходить временное рефлекторное повышение ЧСС и, как следствие этого, величины сердечного выброса. Однако это повышение не настолько значительно, чтобы компенсировать расширение кровеносных сосудов. Кроме того, нифедипин при кратковременном и при длительном применении увеличивает выведение натрия и воды из организма. Гипотензивное действие нифедипина особенно выражено у пациентов, страдающих артериальной гипертензией."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Стенокардия Принцметала","Гипертонический криз"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Беременность (до 20 недель)","Период грудного вскармливания","Кардиогенный шок","Нестабильная стенокардия","Острый инфаркт миокарда (в первые 4 недели после перенесенного инфаркта миокарда)","Одновременное назначение с рифампицином","Возраст до 18 лет (безопасность и эффективность не установлены)","Повышенная чувствительность к нифедипину или любому другому компоненту препарата. 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Испытания на животных показали наличие эмбриотоксичности, плацентотоксичности, фетотоксичности и тератогенности при приеме нифедипина в течение и по окончании периода органогенеза. По имеющимся клиническим данным нельзя оценить специфический пренатальный риск. Вместе с тем имеются данные об увеличении вероятности перинатальной асфиксии, кесарева сечения, преждевременных родов и задержки внутриутробного развития плода. Неясно, являются ли перечисленные случаи следствием основного заболевания (артериальной гипертензии), проводимого лечения или специфическим эффектом препарата Адалат. Имеющаяся информация является недостаточной для того, чтобы исключить вероятность возникновения побочных эффектов, представляющих опасность для плода и новорожденного. Поэтому применение препарата Адалат после 20-й недели беременности требует тщательной индивидуальной оценки соотношения риска и пользы для пациентки, плода и/или новорожденного и может рассматриваться только в тех случаях, когда другие способы терапии противопоказаны или неэффективны. Следует проводить тщательный контроль АД у беременных при применении препарата Адалат одновременно с в/в магния сульфата вследствие возможности чрезмерного снижения АД, что представляет опасность как для матери, так и для плода и/или новорожденного. Нифедипин выделяется с грудным молоком, поэтому, если применение препарата Адалат необходимо в период лактации, грудное вскармливание следует прекратить."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"50 мл раствора Адалат вводят в/в инфузионно в течение, примерно, 4-8 ч (со скоростью 6.3-12.5 мл/ч, что соответствует 0.63-1.25 мг нифедипина/ч). Максимальная доза препарата, вводимого в течение 24 ч, не должна превышать 150-300 мл (что соответствует 15-30 мг нифедипина/24 ч). Инфузионная терапия может проводиться непрерывно в течение 3 дней. Затем рекомендуется переход на пероральную терапию нифедипином. Безопасность и эффективность применения препарата Адалат у детей и подростков до 18 лет не установлена. У пациентов пожилого возраста из-за нарушений фармакокинетики может потребоваться уменьшение поддерживающей дозы (по сравнению с более молодыми пациентами). У пациентов с нарушениями функции печени препарат применяют с осторожностью под контролем функции печени, при тяжелых нарушениях функции печени необходимо уменьшить дозу. У пациентов с нарушениями функции почек коррекции дозы не требуется."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При применении нифедипина побочные эффекты были оценены в плацебо-контролируемых исследованиях. Ниже перечисленные побочные эффекты классифицировали следующим образом: часто (≥ .1/100, меньше 1/10), нечасто (≥ .1/1000, меньше 1/100), редко (≥ .1/10 000, меньше 1/1000). Степень градации побочных реакций \"часто\" оценивалась как менее 3%, за исключением отека (9.9%) и головной боли (3.9%). Побочные эффекты, которые отмечались только в ходе постмаркетинговых наблюдений, и частота которых не оценивалась, обозначены \"в отдельных случаях\". Со стороны сердечно-сосудистой системы: часто - периферические отеки, симптомы вазодилатации (покраснение кожи лица, ощущение жара) . нечасто - тахикардия, учащенное сердцебиение, снижение АД, обморок . в отдельных случаях - боль за грудиной (стенокардия). Со стороны ЦНС: часто - головная боль . нечасто - головокружение, мигрень, тремор, вертиго, тревожность, нарушения сна, редко - парестезии, дизестезии . в отдельных случаях - гипестезии, сонливость. Со стороны пищеварительной системы: часто - запор, нечасто гастроинтестинальная и абдоминальная боль (боль в области желудка и кишечника), тошнота, диспепсия, метеоризм, сухость слизистой оболочки полости рта, преходящее повышение активности печеночных трансаминаз . редко - гиперплазия десен . в отдельных случаях - рвота, недостаточность кардиального сфинктера, желтуха. Со стороны дыхательной системы: нечасто - носовое кровотечение, заложенность носа . в отдельных случаях - одышка. Со стороны костно-мышечной системы: нечасто - мышечные судороги, отечность суставов . в отдельных случаях - артралгия, миалгия. Со стороны мочевыделительной системы: нечасто - полиурия, дизурия. Со стороны иммунной системы: нечасто - аллергические реакции в виде аллергического/ангионевротического отека (включая потенциально опасный для жизни отек гортани) . редко - кожный зуд, сыпь, крапивница . в отдельных случаях - анафилактические/анафилактоидные реакции. Со стороны кожных покровов и подкожно-жировой клетчатки: нечасто - эритема . в отдельных случаях - токсический эпидермальный некролиз, фотосенсибилизация, аллергические реакции, пурпура. Со стороны органа зрения: нечасто - нарушение четкости зрения . в отдельных случаях - боль в глазах. Со стороны репродуктивной системы: нечасто - эректильная дисфункция. Со стороны кроветворной системы: в отдельных случаях - агранулоцитоз, лейкопения. Метаболические нарушения: в отдельных случаях - гипергликемия. Местные реакции: нечасто - реакции в месте введения (в т.ч. тромбофлебит). Прочие: часто - плохое самочувствие . нечасто - неспецифический болевой синдром, озноб. У пациентов со злокачественной артериальной гипертензией и гиповолемией и находящихся на диализе падение АД может быть обусловлено вазодилатацией."}}]},{"id":8,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При применении нифедипина побочные эффекты были оценены в плацебо-контролируемых исследованиях. Ниже перечисленные побочные эффекты классифицировали следующим образом: часто (≥ .1/100, меньше 1/10), нечасто (≥ .1/1000, меньше 1/100), редко (≥ .1/10 000, меньше 1/1000). Степень градации побочных реакций \"часто\" оценивалась как менее 3%, за исключением отека (9.9%) и головной боли (3.9%). Побочные эффекты, которые отмечались только в ходе постмаркетинговых наблюдений, и частота которых не оценивалась, обозначены \"в отдельных случаях\". Со стороны сердечно-сосудистой системы: часто - периферические отеки, симптомы вазодилатации (покраснение кожи лица, ощущение жара) . нечасто - тахикардия, учащенное сердцебиение, снижение АД, обморок . в отдельных случаях - боль за грудиной (стенокардия). Со стороны ЦНС: часто - головная боль . нечасто - головокружение, мигрень, тремор, вертиго, тревожность, нарушения сна, редко - парестезии, дизестезии . в отдельных случаях - гипестезии, сонливость. Со стороны пищеварительной системы: часто - запор, нечасто гастроинтестинальная и абдоминальная боль (боль в области желудка и кишечника), тошнота, диспепсия, метеоризм, сухость слизистой оболочки полости рта, преходящее повышение активности печеночных трансаминаз . редко - гиперплазия десен . в отдельных случаях - рвота, недостаточность кардиального сфинктера, желтуха. Со стороны дыхательной системы: нечасто - носовое кровотечение, заложенность носа . в отдельных случаях - одышка. Со стороны костно-мышечной системы: нечасто - мышечные судороги, отечность суставов . в отдельных случаях - артралгия, миалгия. Со стороны мочевыделительной системы: нечасто - полиурия, дизурия. Со стороны иммунной системы: нечасто - аллергические реакции в виде аллергического/ангионевротического отека (включая потенциально опасный для жизни отек гортани) . редко - кожный зуд, сыпь, крапивница . в отдельных случаях - анафилактические/анафилактоидные реакции. Со стороны кожных покровов и подкожно-жировой клетчатки: нечасто - эритема . в отдельных случаях - токсический эпидермальный некролиз, фотосенсибилизация, аллергические реакции, пурпура. Со стороны органа зрения: нечасто - нарушение четкости зрения . в отдельных случаях - боль в глазах. Со стороны репродуктивной системы: нечасто - эректильная дисфункция. Со стороны кроветворной системы: в отдельных случаях - агранулоцитоз, лейкопения. Метаболические нарушения: в отдельных случаях - гипергликемия. Местные реакции: нечасто - реакции в месте введения (в т.ч. тромбофлебит). Прочие: часто - плохое самочувствие . нечасто - неспецифический болевой синдром, озноб. У пациентов со злокачественной артериальной гипертензией и гиповолемией и находящихся на диализе падение АД может быть обусловлено вазодилатацией."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Нифедипин - селективный блокатор медленных кальциевых каналов, производное 1.4-дигидропиридина. Оказывает антиангинальное и гипотензивное действие. Уменьшает ток ионов кальция через медленные кальциевые каналы внутрь клеток, преимущественно внутрь кардиомиоцитов, гладкомышечных клеток коронарных и периферических артерий, понижая при этом периферическое сосудистое сопротивление и расширяя коронарные артерии, особенно крупные кровоснабжающие сосуды, и даже интактные сегменты стенок частично стенозированных сосудов. Кроме того, нифедипин понижает тонус гладкой мускулатуры коронарных артерий, тем самым предотвращая ангиоспазм, усиливая кровоток в постстенотических отделах сосудов и увеличивая доставку кислорода к миокарду . уменьшается потребность миокарда в кислороде за счет снижения периферического сосудистого сопротивления (постнагрузки), а при длительном приеме он способен предотвращать развитие новых атеросклеротических повреждений в коронарных артериях. Нифедипин снижает тонус гладкой мускулатуры артериол, тем самым уменьшая повышенное периферическое сосудистое сопротивление и, следовательно, АД. В начале лечения Адалатом может происходить временное рефлекторное повышение ЧСС и, как следствие этого, величины сердечного выброса. Однако это повышение не настолько значительно, чтобы компенсировать расширение кровеносных сосудов. Кроме того, нифедипин при кратковременном и при длительном применении увеличивает выведение натрия и воды из организма. Гипотензивное действие нифедипина особенно выражено у пациентов, страдающих артериальной гипертензией.","substance":[{"id":101,"title":"Нифедипин","title_latin":"Nifedipinum","slug":"nifedipin_101"}],"branding":null,"valid_for_quick_buy":false,"is_available_to_delivery":false,"comments":null,"image_alt":"Адалат - фото упаковки","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/3503/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/3503/share_default/"}},"diseases":[{"id":"717","title":"Эссенциальная [первичная] гипертензия","slug":"717-essentsialnaya_pervichnaya_gipertenziya"},{"id":"721","title":"Стенокардия","slug":"721-stenokardiya"},{"id":"723","title":"Стенокардия с документально подтвержденным спазмом (стенокардия Принцметала, вариантная стенокардия)","slug":"723-stenokardiya_s_dokumentalno_podtverzhdennym_spazmom_stenokardiya_printsmetala_variantnaya_stenokardiya"},{"id":"763","title":"Синдром 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