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У новорожденных развивались артериальная гипотензия почечная недостаточность гиперкалиемия гипоплазия костей черепа. Возможно развитие олигогидрамниона по-видимому вследствие нарушения функции почек плода. Это может приводить к контрактуре конечностей деформации костей черепа включая его лицевую часть и гипоплазии лёгких. Если женщина принимала ингибитор АПФ во втором и третьем триместрах беременности рекомендуется провести ультразвуковое исследование почек и черепа плода / новорожденного и контролировать АД."}},{"type":"paragraph","data":{"text":"В тех редких случаях когда применение ингибитора АПФ во время беременности считается необходимым следует проводить периодические ультразвуковые исследования (УЗИ) для оценки индекса амниотической жидкости. В случае выявления в ходе УЗИ олигогидрамниона необходимо прекратить приём препарата Энап® - HJI 20. Пациенты и врач должны знать что олигогидрамнион развивается при необратимом повреждении плода. Если ингибиторы АПФ применяются во время беременности и наблюдается развитие олигогидрамниона то в зависимости от недели беременности для оценки функционального состояния плода может быть необходимо проведение стрессового теста нестрессового теста или определение биофизического профиля плода. Новорожденные матери которых принимали ингибиторы АПФ во время беременности должны находиться под наблюдением учитывая риск развития артериальной гипотензии олигурии и гиперкалиемии."}},{"type":"paragraph","data":{"text":"Эналаприл который проникает через плаценту может быть частично удалён из кровообращения новорожденного с помощью перитонеального диализа теоретически он может быть удалён посредством обменного переливания крови."}},{"type":"paragraph","data":{"text":"Применение гидрохлоротиазида при беременности не рекомендуется поскольку может ухудшить перфузию плаценты и вызвать желтуху плода / новорожденного тромбоцитопению нарушение водно-электролитного баланса и возможно другие нежелательные реакции наблюдавшиеся у взрослых."}},{"type":"paragraph","data":{"text":"Нет данных о возможности удаления из крови новорожденного гидрохлоротиазида который также проникает через плацентарный барьер."}},{"type":"paragraph","data":{"text":"Применение в период грудного вскармливания"}},{"type":"paragraph","data":{"text":"Эналаприл и гидрохлоротиазид проникают в грудное молоко поэтому при необходимости применения препарата Энап® - HЛ 20 грудное вскармливание следует прекратить."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Препарат Энап®- HЛ20 следует принимать регулярно в одно и то же время предпочтительно утром во время или после еды не разжёвывая запивая небольшим количеством жидкости. Рекомендуемая доза - 1 таблетка в сутки. При необходимости доза может быть увеличена до максимальной суточной дозы - 2 таблетки принимать 1 раз в сутки."}},{"type":"paragraph","data":{"text":"У пациентов находящихся на терапии диуретиками рекомендуется отменить лечение или снизить дозу диуретиков как минимум за 3 дня до начала лечения препаратом Энап®- HЛ 20 для предотвращения развития симптоматической артериальной гипотензии. Перед началом лечения должна быть исследована функция почек. Длительность лечения устанавливается врачом."}},{"type":"paragraph","data":{"text":"Доза при нарушенной функции почек"}},{"type":"paragraph","data":{"text":"Препарат Энап® - HЛ 20 у пациентов с почечной недостаточностью (КК < 80 мл/мин и > 30 мл/мин) должен применяться только в том случае если предварительное титрование дозы эналаприла показало адекватность дозы содержащейся в комбинированном препарате Энап® - HЛ 20"}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"list","data":{"style":"ordered","items":["сухой кашель, ","фарингит, ","ларингит,","головокружение при занятии вертикального положения, сердцебиение, боли в грудной клетке,","нарушение функции почек и картины крови,","тошнота, рвота, боли в животе,","кожные аллергические реакции,","головная боль, депрессия, нарушения сна,","увеличение калия в крови."]}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Если пациент принял слишком большое количество таблеток за один прием, следует немедленно вызвать врача. "}},{"type":"paragraph","data":{"text":"Симптомы: чрезмерное снижение артериального давления (АД) вплоть до развития коллапса, инфаркта миокарда, острого нарушения мозгового кровообращения или тромбоэмболических осложнений, судороги, ступор."}},{"type":"paragraph","data":{"text":"Лечение: больного переводят в горизонтальное положение с низким изголовьем. В легких случаях показаны промывание желудка и прием внутрь солевого раствора, в более серьезных случаях - мероприятия, направленные на стабилизацию артериального давления (АД), в/в введение физиологического раствора, плазмозаменителей, при необходимости - в/в введение ангиотензина II, гемодиализ (скорость выведения эналаприлата - 62 мл/мин)."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Пациенту следует воздержаться от приема алкогольных напитков, поскольку этанол усиливает снижение артериального давления (АД) эналаприлом. "}},{"type":"paragraph","data":{"text":"Одновременное применение эналаприла и диуретиков или других гипотензивных средств повышает эффективность этих препаратов. "}},{"type":"paragraph","data":{"text":"Взаимодействие с лекарственными средствами, применяемыми для лечения сердечной недостаточности (сердечные гликозиды) не имеет клинического значения. "}},{"type":"paragraph","data":{"text":"Перед хирургическим вмешательством следует сообщить врачу, что пациент принимает эналаприл, поскольку существует риск развития артериальной гипотензии при проведении общей анестезии. "}},{"type":"paragraph","data":{"text":"Одновременное применение эналаприла и нестероидных противовоспалительных препаратов (НПВП) или ацетилсалициловой кислоты (аспирин), а так же эстрогенов может снизить эффективность эналаприла и увеличить риск нарушения функции почек. "}},{"type":"paragraph","data":{"text":"Одновременное применение некоторых диуретиков (спиронолактон, амилорид или триамтерен) и/или дополнительное назначение таблеток, содержащих калий, может вызвать повышение уровня содержания калия в сыворотке крови (гиперкалиемия). "}},{"type":"paragraph","data":{"text":"Лекарственные средства, вызывающие угнетение костного мозга, повышают риск развития нейтропении и/или агранулоцитоза. "}},{"type":"paragraph","data":{"text":"Иммунодепрессанты, аллопуринол, цитостатики усиливают гематотоксичность. "}},{"type":"paragraph","data":{"text":"Эналаприл ослабляет действие средств, содержащих теофиллин. "}},{"type":"paragraph","data":{"text":"Одновременное применение препаратов лития может усилить побочное действие лития. "}},{"type":"paragraph","data":{"text":"При одновременном приеме препарата Энап с циметидином увеличивается период полувыведения (Т 1/2) Энапа. Если пациент уже принимает указанные выше препараты или ему советуют принимать какой-либо из них, ему следует сообщить врачу, что он принимает Энап."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Артериальная гипотензия"}},{"type":"paragraph","data":{"text":"Симптоматическая артериальная гипотензия развивается редко у пациентов с неосложненной артериальной гипертензией. Артериальная гипотензия со всеми клиническими проявлениями может наблюдаться после первого приёма препарата Энап® - HЛ20 у пациентов с ХСН III-IV функционального класса по классификации NYHA и гипонатриемией тяжёлой почечной недостаточностью или дисфункцией левого желудочка и в особенности у пациентов с гиповолемией в результате терапии диуретиками диеты с ограничением поваренной соли диареи рвоты или гемодиализа. С особой осторожностью следует применять препарат пациентам с ИБС или цереброваскулярными заболеваниями поскольку чрезмерное снижение АД может привести к развитию инфаркта миокарда или инсульта."}},{"type":"paragraph","data":{"text":"В случае развития артериальной гипотензии необходимо уложить пациента на спину с низким изголовьем и при необходимости восполнить ОЦК путём внутривенной инфузии 09 % раствора натрия хлорида. Преходящая артериальная гипотензия возникшая после приёма первой дозы не является противопоказанием для дальнейшего лечения. После восполнения ОЦК и нормализации АД терапия препаратом Энап® - HЛ 20 может быть возобновлена в меньших дозах или каждый из компонентов препарата может быть назначен в отдельности."}},{"type":"paragraph","data":{"text":"Нарушения водно-электролитного баланса"}},{"type":"paragraph","data":{"text":"Необходим регулярный контроль сывороточного содержания электролитов в период лечения для выявления возможного дисбаланса и своевременного принятия необходимых мер. Определение сывороточного содержания электролитов обязательно для пациентов с длительной диареей рвотой."}},{"type":"paragraph","data":{"text":"У пациентов принимающих препарат Энап® - HЛ20 необходимо выявлять признаки нарушения водно-электролитного баланса такие как: сухость слизистой оболочки полости рта жажда слабость сонливость повышенная возбудимость миалгия и судороги (преимущественно икроножных мышц) чрезмерное снижение АД тахикардия олигурия и желудочно-кишечные нарушения (тошнота рвота)."}},{"type":"paragraph","data":{"text":"Аортальный стеноз /митральный стеноз /ГОКМП"}},{"type":"paragraph","data":{"text":"Как и все препараты обладающие вазодилатирующим действием ингибиторы АПФ должны с осторожностью применяться у пациентов со стенозом аортального и / или митрального клапана обструкцией выносящего тракта левого желудочка."}},{"type":"paragraph","data":{"text":"Нарушения функции почек"}},{"type":"paragraph","data":{"text":"Препарат Энап® - HЛ 20 у пациентов с почечной недостаточностью (КК < 80 мл/мин и >30 мл/мин) должен применяться только в том случае если предварительное титрование дозы эналаприла показало адекватность дозы содержащейся в комбинированном препарате Энап®-НЛ20. При одновременном применении эналаприла и диуретика у некоторых пациентов с артериальной гипертензией отмечалось увеличение концентраций мочевины и креатинина в сыворотке крови. В этом случае терапию препаратом Энап® - HЛ 20 следует прекратить. Подобная ситуация указывает на возможность скрытого стеноза почечной артерии."}},{"type":"paragraph","data":{"text":"Реноваскулярная гипертензия"}},{"type":"paragraph","data":{"text":"При применении ингибиторов АПФ у пациентов с двусторонним стенозом почечных артерий или стенозом артерии единственной почки существует повышенный риск развития артериальной гипотензии и почечной недостаточности. У пациентов с повышенной сывороточной концентрацией креатинина в плазме крови возможно ухудшение функции почек. Таким пациентам терапию ингибиторами АПФ следует начинать с низких доз тщательно подбирать дозу препарата и контролировать функцию почек."}},{"type":"paragraph","data":{"text":"Двойная блокада РААС"}},{"type":"paragraph","data":{"text":"Одновременное применение с алискиреном у пациентов с сахарным диабетом или"}},{"type":"paragraph","data":{"text":"умеренными и тяжелыми нарушениями функции почек (КК < 60 мл/мин или скорость"}},{"type":"paragraph","data":{"text":"клубочковой фильтрации (СКФ) < 60 мл/мин/173 м\u003csup\u003e2\u003c/sup\u003e) противопоказано."}},{"type":"paragraph","data":{"text":"Риск развития артериальной гипотензии гиперкалиемии и нарушений функции почек (в"}},{"type":"paragraph","data":{"text":"том числе острой почечной недостаточности) выше в случае двойной блокады РААС т. е."}},{"type":"paragraph","data":{"text":"при одновременном применении АРА II ингибиторов АПФ в сравнении с применением"}},{"type":"paragraph","data":{"text":"препарата одной из перечисленных групп. Такая комбинация не рекомендуется."}},{"type":"paragraph","data":{"text":"При необходимости одновременного применения препаратов рекомендовано"}},{"type":"paragraph","data":{"text":"контролировать функцию почек (в том числе периодический контроль содержания калия"}},{"type":"paragraph","data":{"text":"и концентрации креатинина в сыворотке крови)."}},{"type":"paragraph","data":{"text":"Нарушения функции печени"}},{"type":"paragraph","data":{"text":"Препарат Энап® - HЛ20 необходимо с осторожностью применять у пациентов с печёночной недостаточностью или прогрессирующими заболеваниями печени так как гидрохлоротиазид может вызвать печёночную кому даже при минимальных нарушениях водно-электролитного баланса. Сообщалось о нескольких случаях развития острой печёночной недостаточности с холестатической желтухой фульминантным некрозом печени и летальным исходом (редко) во время лечения ингибиторами АПФ. Механизм развития этого синдрома не установлен. При возникновении желтухи и повышении активности \"печёночных\" трансаминаз лечение препаратом Энап® - HЛ 20 должно быть немедленно прекращено пациенты должны находиться под наблюдением."}},{"type":"paragraph","data":{"text":"Нейтропения / агранулоцитоз"}},{"type":"paragraph","data":{"text":"У пациентов принимающих ингибиторы АПФ возможны случаи развития нейтропении / агранулоцитоза тромбоцитопении и анемии. У пациентов с нормальной функцией почек в отсутствие других осложнений нейтропения развивается редко и проходит самостоятельно после отмены ингибиторов АПФ."}},{"type":"paragraph","data":{"text":"Эналаприл необходимо с большой осторожностью применять у пациентов с заболеваниями соединительной ткани и одновременно получающих иммуносупрессивную терапию аллопуринол или прокаинамид особенно при существующих нарушениях функции почек. У таких пациентов могут развиваться тяжёлые инфекции не поддающиеся интенсивной антибактериальной терапии. В случае применения эналаприла рекомендуется периодически контролировать количество лейкоцитов в крови. Пациент должен быть предупреждён о том что в случае появления каких-либо признаков инфекционного заболевания (боль в горле повышение температуры тела) необходимо немедленно обратиться к врачу."}},{"type":"paragraph","data":{"text":"Метаболические и эндокринные эффекты"}},{"type":"paragraph","data":{"text":"Осторожность необходима у всех пациентов получающих лечение гипогликемическими средствами для приёма внутрь или инсулином так как гидрохлоротиазид может ослаблять а эналаприл - усиливать их действие."}},{"type":"paragraph","data":{"text":"Тиазидные диуретики могут уменьшать выведение кальция почками и вызывать незначительное и преходящее повышение содержания кальция в сыворотке крови. Выраженная гиперкальциемия может быть признаком скрытого гиперпаратиреоза. Перед проведением исследования функции паращитовидных желёз тиазидные диуретики необходимо отменить."}},{"type":"paragraph","data":{"text":"На фоне лечения тиазидными диуретиками могут повышаться концентрации холестерина и триглицеридов в сыворотке крови."}},{"type":"paragraph","data":{"text":"Терапия тиазидными диуретиками у некоторых пациентов может усугублять гиперурикемию и / или обострять течение подагры. Однако эналаприл усиливает выведение мочевой кислоты почками тем самым противодействуя гиперурикемическому эффекту гидрохлоротиазида."}},{"type":"paragraph","data":{"text":"Аллергические реакции / ангионевротический отёк"}},{"type":"paragraph","data":{"text":"При развитии ангионевротического отёка лица обычно бывает достаточно отмены терапии и назначения пациенту антигистаминных средств."}},{"type":"paragraph","data":{"text":"Ангионевротический отёк языка глотки или гортани может оказаться летальным. При ангионевротическом отёке языка глотки или гортани который может привести к обструкции дыхательных путей необходимо немедленно ввести эпинефрин (03-05 мл раствора эпинефрина (адреналина) подкожно в соотношении 1:1000) и поддерживать проходимость дыхательных путей (интубация или трахеостомия)."}},{"type":"paragraph","data":{"text":"Среди пациентов негроидной расы получающих терапию ингибитором АПФ частота развития ангионевротического отёка выше чем среди пациентов другой расовой принадлежности."}},{"type":"paragraph","data":{"text":"Пациенты с ангионевротическим отёком в анамнезе не связанным с применением ингибиторов АПФ имеют повышенный риск развития ангионевротического отёка при приёме любого ингибитора АПФ."}},{"type":"paragraph","data":{"text":"У пациентов принимающих тиазидные диуретики реакции повышенной чувствительности могут развиваться как при наличии так и при отсутствии в анамнезе аллергических реакций."}},{"type":"paragraph","data":{"text":"Анафилактоидные реакции во время проведения десенсибилизации аллергеном из яда перепончатокрылых"}},{"type":"paragraph","data":{"text":"В редких случаях у пациентов получающих ингибиторы АПФ развивались угрожающие жизни анафилактоидные реакции во время проведения гипосенсибилизации аллергеном из яда перепончатокрылых. Подобных реакций можно избежать если до начала проведения гипосенсибилизации временно прекратить применение ингибитора АПФ."}},{"type":"paragraph","data":{"text":"Пациенты на гемодиализе"}},{"type":"paragraph","data":{"text":"Применение препарата не показано пациентам с почечной недостаточностью находящихся на гемодиализе. Анафилактоидные реакции наблюдались у пациентов находящихся на диализе с применением высокопроточных мембран (таких как AN69®) одновременно получающих лечение ингибиторами АПФ. У этих пациентов необходимо применять диализные мембраны другого типа или гипотензивные средства других классов."}},{"type":"paragraph","data":{"text":"Хирургические вмешательства / общая анестезия"}},{"type":"paragraph","data":{"text":"Перед хирургическим вмешательством (включая стоматологию) необходимо предупредить врача-анестезиолога о применении ингибиторов АПФ."}},{"type":"paragraph","data":{"text":"Во время хирургических вмешательств или проведения общей анестезии с применением средств вызывающих артериальную гипотензию ингибиторы АПФ могут блокировать образование ангиотензина II в ответ на компенсаторное высвобождение ренина. Если при этом развивается выраженное снижение АД объясняемое подобным механизмом его можно корректировать увеличением ОЦК."}},{"type":"paragraph","data":{"text":"Кашель"}},{"type":"paragraph","data":{"text":"При применении ингибиторов АПФ отмечался сухой длительный кашель который исчезает после прекращения приема ингибиторов АПФ. При дифференциальном диагнозе кашля надо учитывать и кашель вызванный применением ингибиторов АПФ."}},{"type":"paragraph","data":{"text":"Этнические особенности"}},{"type":"paragraph","data":{"text":"Эналаприл (как и другие ингибиторы АПФ) оказывает менее выраженное антигипертензивное действие у пациентов негроидной расы по сравнению с представителями других рас. Гиперкалиемия"}},{"type":"paragraph","data":{"text":"Гиперкалиемия может развиваться во время лечения ингибиторами АПФ в том числе и эналаприлом. Факторами риска гиперкалиемии являются: почечная недостаточность пожилой возраст сахарный диабет некоторые сопутствующие состояния (снижение ОЦК острая сердечная недостаточность в стадии декомпенсации метаболический ацидоз) одновременное применение калийсберегающих диуретиков (спиронолактон эплеренон триамтерен амилорид) а также препаратов калия или калийсодержащих заменителей соли и применение других препаратов способствующих повышению содержания калия в плазме крови (например гепарин). Гиперкалиемия может привести к серьёзным нарушениям сердечного ритма иногда с летальным исходом. Одновременное применение перечисленных выше препаратов необходимо проводить с осторожностью. Одновременное применение эналаприла и гидрохлоротиазида в низкой дозе не исключает возможности развития гиперкалиемии."}},{"type":"paragraph","data":{"text":"Антидопинговый тест"}},{"type":"paragraph","data":{"text":"Гидрохлоротиазид входящий в состав препарата Энап® - HЛ20 может быть причиной"}},{"type":"paragraph","data":{"text":"положительного антидопингового теста."}},{"type":"paragraph","data":{"text":"Общие"}},{"type":"paragraph","data":{"text":"У пациентов с аллергией или бронхиальной астмой или без этих состояний в анамнезе могут развиваться реакции гиперчувствительности на гидрохлоротиазид однако риск их выше при наличии аллергии или бронхиальной астмы в анамнезе. При лечении тиазидными диуретиками включая гидрохлоротиазид описаны случаи обострения или ухудшение течения системной красной волчанки."}},{"type":"paragraph","data":{"text":"Острая миопия и вторичная острая закрытоуголъная глаукома"}},{"type":"paragraph","data":{"text":"Гидрохлоротиазид - это сульфонамид который может вызывать идиосинкразическую реакцию приводящую к развитию преходящей острой миопии и острой закрытоугольной глаукомы. Симптомы включают в себя: внезапное снижение остроты зрения или боль в глазах которые появляются как правило в течение нескольких часов или недель от начала терапии гидрохлоротиазидом. При отсутствии лечения острая закрытоугольная глаукома может привести к стойкой потере зрения."}},{"type":"paragraph","data":{"text":"Лечение: как можно быстрее прекратить приём гидрохлоротиазида. Если внутриглазное давление остаётся неконтролируемым могут потребоваться неотложное медикаментозное лечение или хирургическое вмешательство. Факторами риска развития острой закрытоугольной глаукомы являются: аллергическая реакция на сульфонамид или бензилпенициллин в анамнезе."}},{"type":"paragraph","data":{"text":"Специальная информация по вспомогательным веществам"}},{"type":"paragraph","data":{"text":"Препарат Энап® - HЛ 20 содержит лактозу поэтому препарат противопоказан пациентам с дефицитом лактазы непереносимостью лактозы синдромом глюкозо-галактозной мальабсорбции."}}]},{"id":11,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В начале терапии препаратом Энап® - HЛ20 возможно выраженное снижение АД головокружение и сонливость поэтому в начале лечения не рекомендуется управлять транспортными средствами и заниматься другими потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций в дальнейшем следует соблюдать осторожность."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки Энап светло-оранжевого цвета, плоскоцилиндрические, с риской и фаской; на поверхности и в массе таблетки допускаются белые и коричнево-бордовые вкрапления."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"В защищенном от влаги месте, при температуре не выше 25 °C"}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"АО \"КРКА, д.д., Ново место\", Smarjeska cesta 6, 8501, Novo mesto, Slovenia, Словения"}}]}],"source":null},"description_toggle":false,"short_description":"Энап - антигипертензивный препарат, механизм действия которого связан с угнетением активности ангиотензин-превращающего фермента, приводящего к уменьшению образования ангиотензина-II. Эналаприл является «пролекарством»: в результате его гидролиза образуется эналаприлат, который и ингибирует АПФ. Механизм его действия связан с уменьшением образования из ангиотензина I ангиотензина II, снижение содержания которого ведет к прямому уменьшению выделения альдостерона. При этом понижается общее периферическое сосудистое сопротивление, систолическое и диастолическое артериальное давление (АД), пост- и преднагрузка на миокард. Расширяет артерии в большей степени, чем вены, при этом рефлекторного повышения частоты сердечных сокращений не отмечается. Гипотензивный эффект более выражен при высоком уровне ренина плазмы, чем при нормальном или сниженном его уровне. Снижение артериального давления (АД) в терапевтических пределах не оказывает влияния на мозговое кровообращение, кровоток в сосудах мозга поддерживается на достаточном уровне и на фоне сниженного артериального давления. Усиливает коронарный и почечный кровоток. При длительном применении уменьшается гипертрофия левого желудочка миокарда и миоцитов стенок артерий резистивного типа, предотвращает прогрессирование сердечной недостаточности и замедляет развитие дилатации левого желудочка. Улучшает кровоснабжение ишемизированного миокарда. Снижает агрегацию тромбоцитов. Обладает некоторым диуретическим эффектом. Время наступления гипотензивного эффекта при приеме внутрь - 1 час, достигает максимума через 4-6 часов и сохраняется до 24 часов. У некоторых больных для достижения оптимального уровня артериального давления необходима терапия на протяжении нескольких недель. 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