десмопрессина ацетат 0,1 мг (в виде тригидрата 0,105 мг), в пересчете на десмопрессин 0,089 мг;
вспомогательные вещества:
крахмал кукурузный прежелатинизированный 35,3 мг,
карбоксиметилкрахмал натрия 3 мг,
маннитол 62 мг,
магния стеарат 0,6 мг,
целлюлоза микрокристаллическая 19 мг
Фармакологические свойства
Препарат Ноурем содержит десмопрессин - структурный аналог естественного гормона аргинин-вазопрессина. Десмопрессин получен в результате изменений в строении молекулы вазопрессина - дезаминирование I-цистеина и замещение 8-L-аргинина на 8-D-aргинин.
Эти структурные изменения приводят в сочетании со значительно усиленной антидиуретической способностью к менее выраженному действию на гладкую мускулатуру сосудов и внутренних органов по сравнению с вазопрессином, что обусловливает отсутствие нежелательных спастических побочных эффектов.
В отличие от вазопрессина действует более длительно и не вызывает повышение АД. Препарат увеличивает проницаемость эпителия дистальных извитых канальцев нефрона для воды и повышает ее реабсорбцию. Применение препарата Ноурем приводит к уменьшению объема выделяемой мочи и одновременному повышению осмоляриости мочи и снижению осмолярности плазмы крови.
Это приводит к снижению частоты мочеиспускания и уменьшению ночной полиурин. После приема внутрь аптидиурегический эффект наступает уже через 15 минут.
Максимальный антидиуретический эффект наступает при приеме внутрь через 4-7 ч. Антидиуретическое действие при приеме внутрь в дозе 0.1-0.2 мг - до 8 ч, в дозе 0.4 мг - до 12 ч.
Показания к применению
Несахарный диабет центрального генеза;
первичный ночной энурез у детей старше 5 лет;
ночная полиурия у взрослых (в качестве симптоматической терапии).
Противопоказания
Повышенная чувствительность к десмопрессину или другим компонентам препарата;
привычная или психогенная полидипсия;
сердечная недостаточность и другие состояния, требующие назначения мочегонных препаратов;
гипонатриемия, в том числе в анамнезе (концентрация ионов натрия в плазме крови ниже 135 ммоль/л);
почечная недостаточность средней и тяжелой степени тяжести (клиренс креатинина (КК) ниже 50 мл/мин);
синдром неадекватной продукции антидиуретического гормона.
детский возраст до 4 лет (для лечения несахарного диабета) и 5 лет (для лечения первичного ночного энуреза).
С осторожностью
С осторожностью следует применять препарат при хронической почечной недостаточности (КК более 50 мл/мин), фиброзе мочевого пузыря, при нарушениях водно-электролитного баланса, потенциальном риске повышения внутричерепного давления, во время беременности, а также у пациентов с заболеваниями сердечно-сосудистой системы, с бронхиальной астмой, эпилепсией и мигренью в анамнезе (в случае необходимости следует снизить дозу препарата).
С особой осторожностью назначают препарат пациентам пожилого возраста (65 лет и старше) в связи с высоким риском развития побочных эффектов (в том числе, задержка жидкости, гипонатриемия). Если решение о лечении десмопрессином принято, то до назначения, через 3 дня после начала приема и при каждом увеличении дозы необходимо определять концентрацию натрия в плазме крови и контролировать состояние пациента.
Препарат необходимо принимать спустя некоторое время после еды, так как прием пищи может повлиять на абсорбцию препарата и его эффективность.
Несахарный диабет центрального генеза
Рекомендуемая начальная доза для детей старше 4 лет и взрослых 0,1 мг 1-3 раза в день. В последующем дозу изменяют в зависимости от реакции на лечение. Обычно дневная доза находится в пределах 0,2-1,2 мг. Для большинства пациентов оптимальной поддерживающей дозой является 0,1-0,2 мг 1-3 раза в день.
Первичный ночной энурез
Рекомендуемая начальная доза 0,2 мг на ночь. При отсутствии эффекта доза может быть увеличена до 0,4 мг. Необходим контроль за соблюдением ограничения приема жидкости в вечернее время. Рекомендуемый курс непрерывного лечения составляет 3 месяца. Решение о продолжении лечения должно быть принято на основании клинических данных, которые будут наблюдаться после отмены препарата в течение 1 недели.
Ночная полиурия у взрослых
Рекомендуемая начальная доза 0,1 мг на ночь. При отсутствии эффекта в течение 1 недели дозу увеличивают до 0,2 мг и в последующем до 0,4 мг при увеличении дозы с частотой не более 1 раз в неделю. Следует помнить об опасности задержки жидкости в организме. Если после 4 недель лечения и корректировки дозы адекватного клинического эффекта не наблюдается, продолжать прием препарата не рекомендуется
Побочное действие
Со стороны центральной нервной системы: головная боль, головокружение.
Со стороны пищеварительной системы: тошнота, рвота, сухость во рту.
Прием десмопрессина без одновременного ограничения приема жидкости может привести к задержке жидкости в организме, сопровождающейся гипонатриемией, повышением массы тела, периферическими отеками, и, в тяжелых случаях, судорогами.
При одновременном применении с имипрамином или оксибутинином возможны гипонатриемические судороги.
Передозировка
Передозировка приводит к увеличению длительности действия десмопрессина и повышению риска возникновения задержки жидкости и гипонатриемии. Лечение гипонатриемии должно быть индивидуальным, обязательным является прекращение приема препарата и отмена ограничения по приему жидкости.
При наличии симптомов передозировки возможна инфузия 0,9% или гипертонического раствора натрия хлорида. В случае выраженной задержки жидкости (судороги и потеря сознания) к терапии следует присоединить фуросемид.
В случае передозировки необходимо обратиться к врачу.
Взаимодействие с другими лекарственными средствами
При одновременном применении десмопрессин усиливает действие гипертензивных средств. При одновременном применении буформин, тетрациклин, препараты лития, норэпинефрин ослабляют антидиуретическое действие десмопрессина.
При одновременном применении десмопрессина с нестероидными противовоспалительными препаратами (НПВП) возможно повышение риска возникновения побочных эффектов. При одновременном применении индометацин усиливает, но не увеличивает продолжительность действия десмопрессина.
При одновременном применении трициклические антидепрессанты, селективные ингибиторы обратного захвата серотонина, наркотические анальгетики, НПВП, ламотриджин, хлорпромазин и карбамазепин, способные вызвать синдром неадекватной секреции антидиуретического гормона, могут усиливать антидиуретический эффект десмопрессина и приводить к повышению риска задержки жидкости и гипонатриемии.
При применении десмопрессина с лоперамидом возможно троекратное повышение концентрации десмопрессина в плазме, что существенно повышает риск задержки жидкости и возникновение гипонатриемии. Возможно, другие лекарственные препараты, замедляющие перистальтику, могут вызвать аналогичный эффект.
При одновременном применении десмопрессина с диметиконом возможно уменьшение абсорбции десмопрессина.
Особые указания
Во избежание развития побочных эффектов обязательным является ограничение до минимума приема жидкости за 1 час до приема и в течение 8 часов после приема препарата у пациентов при первичном ночном энурезе. Несоблюдение этого правила приводит к развитию побочных эффектов.
Клинические исследования показали, что наиболее часто гипонатриемия возникает у пациентов пожилого возраста (65 лет и старше). Высокий риск развития побочных эффектов имеют пациенты пожилого возраста с исходно низкой концентрацией натрия в плазме крови и полиурией от 2,8 до 3,0 литров.
Десмопрессин не следует применять в тех случаях, когда имеются другие дополнительные причины для задержки жидкости и электролитных расстройств.
Профилактика развития гипонатриемии состоит в увеличении частоты определения натрия в плазме крови, особенно в случаях одновременного приема с препаратами, которые вызывают синдром неадекватной секреции антидиуретического гормона (трициклические антидепрессанты, селективные ингибиторы серотонина, хлорпромазин и карбамазепин) и НПВП.
В случаях острого возникновения недержания мочи, дизурии и/или никтурии, инфекции мочевых путей, при подозрении на опухоль мочевого пузыря или предстательной железы, при наличии полидипсии и декомпенсированного сахарного диабета диагностика и лечение указанных состояний и заболеваний должны быть проведены до начала лечения десмопрессином.
При развитии на фоне лечения системных инфекций, лихорадки, гастроэнтерита прием препарата необходимо прекратить.
Влияние на способность управления транспортными средствами и механизмами
В настоящее время данные о возможном влиянии десмопрессина на способность управлять транспортными средствами и механизмами отсутствуют.
Тем не менее, применение препарата Ноурем® может привести к развитию таких побочных эффектов как головокружение, головная боль, которые могут отрицательно влиять на способность управлять транспортными средствами и выполнять потенциально опасные виды деятельности, требующие повышенной концентрации внимания и быстроты психомоторных реакций.
Рекомендуется соблюдать осторожность при управлении транспортными средствами и механизмами.
Форма выпуска
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препарата","slug":"","body":[{"type":"paragraph","data":{"text":"Ноурем"}}]},{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"paragraph","data":{"text":"1 таблетка содержит:"}},{"type":"paragraph","data":{"text":"активное вещество:"}},{"type":"paragraph","data":{"text":"десмопрессина ацетат 0,1 мг (в виде тригидрата 0,105 мг), в пересчете на десмопрессин 0,089 мг;"}},{"type":"paragraph","data":{"text":"вспомогательные вещества:"}},{"type":"paragraph","data":{"text":" крахмал кукурузный прежелатинизированный 35,3 мг,"}},{"type":"paragraph","data":{"text":"карбоксиметилкрахмал натрия 3 мг,"}},{"type":"paragraph","data":{"text":"маннитол 62 мг,"}},{"type":"paragraph","data":{"text":"магния стеарат 0,6 мг,"}},{"type":"paragraph","data":{"text":"целлюлоза микрокристаллическая 19 мг"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"\n\nПрепарат Ноурем содержит десмопрессин - структурный аналог естественного гормона аргинин-вазопрессина. Десмопрессин получен в результате изменений в строении молекулы вазопрессина - дезаминирование I-цистеина и замещение 8-L-аргинина на 8-D-aргинин."}},{"type":"paragraph","data":{"text":"Эти структурные изменения приводят в сочетании со значительно усиленной антидиуретической способностью к менее выраженному действию на гладкую мускулатуру сосудов и внутренних органов по сравнению с вазопрессином, что обусловливает отсутствие нежелательных спастических побочных эффектов."}},{"type":"paragraph","data":{"text":"В отличие от вазопрессина действует более длительно и не вызывает повышение АД. Препарат увеличивает проницаемость эпителия дистальных извитых канальцев нефрона для воды и повышает ее реабсорбцию. Применение препарата Ноурем приводит к уменьшению объема выделяемой мочи и одновременному повышению осмоляриости мочи и снижению осмолярности плазмы крови."}},{"type":"paragraph","data":{"text":"Это приводит к снижению частоты мочеиспускания и уменьшению ночной полиурин. После приема внутрь аптидиурегический эффект наступает уже через 15 минут."}},{"type":"paragraph","data":{"text":"Максимальный антидиуретический эффект наступает при приеме внутрь через 4-7 ч. Антидиуретическое действие при приеме внутрь в дозе 0.1-0.2 мг - до 8 ч, в дозе 0.4 мг - до 12 ч.\n\n"}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Несахарный диабет центрального генеза;"}},{"type":"paragraph","data":{"text":"первичный ночной энурез у детей старше 5 лет;"}},{"type":"paragraph","data":{"text":"ночная полиурия у взрослых (в качестве симптоматической терапии)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к десмопрессину или другим компонентам препарата;"}},{"type":"paragraph","data":{"text":"привычная или психогенная полидипсия;"}},{"type":"paragraph","data":{"text":"сердечная недостаточность и другие состояния, требующие назначения мочегонных препаратов;"}},{"type":"paragraph","data":{"text":"гипонатриемия, в том числе в анамнезе (концентрация ионов натрия в плазме крови ниже 135 ммоль/л);"}},{"type":"paragraph","data":{"text":"почечная недостаточность средней и тяжелой степени тяжести (клиренс креатинина (КК) ниже 50 мл/мин);"}},{"type":"paragraph","data":{"text":"синдром неадекватной продукции антидиуретического гормона."}},{"type":"paragraph","data":{"text":"детский возраст до 4 лет (для лечения несахарного диабета) и 5 лет (для лечения первичного ночного энуреза)."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"С осторожностью следует применять препарат при хронической почечной недостаточности (КК более 50 мл/мин), фиброзе мочевого пузыря, при нарушениях водно-электролитного баланса, потенциальном риске повышения внутричерепного давления, во время беременности, а также у пациентов с заболеваниями сердечно-сосудистой системы, с бронхиальной астмой, эпилепсией и мигренью в анамнезе (в случае необходимости следует снизить дозу препарата)."}},{"type":"paragraph","data":{"text":"С особой осторожностью назначают препарат пациентам пожилого возраста (65 лет и старше) в связи с высоким риском развития побочных эффектов (в том числе, задержка жидкости, гипонатриемия). Если решение о лечении десмопрессином принято, то до назначения, через 3 дня после начала приема и при каждом увеличении дозы необходимо определять концентрацию натрия в плазме крови и контролировать состояние пациента."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь."}},{"type":"paragraph","data":{"text":"Оптимальную дозу десмопрессина подбирают индивидуально."}},{"type":"paragraph","data":{"text":"Препарат необходимо принимать спустя некоторое время после еды, так как прием пищи может повлиять на абсорбцию препарата и его эффективность."}},{"type":"paragraph","data":{"text":"Несахарный диабет центрального генеза"}},{"type":"paragraph","data":{"text":"Рекомендуемая начальная доза для детей старше 4 лет и взрослых 0,1 мг 1-3 раза в день. В последующем дозу изменяют в зависимости от реакции на лечение. Обычно дневная доза находится в пределах 0,2-1,2 мг. Для большинства пациентов оптимальной поддерживающей дозой является 0,1-0,2 мг 1-3 раза в день."}},{"type":"paragraph","data":{"text":"Первичный ночной энурез"}},{"type":"paragraph","data":{"text":"Рекомендуемая начальная доза 0,2 мг на ночь. При отсутствии эффекта доза может быть увеличена до 0,4 мг. Необходим контроль за соблюдением ограничения приема жидкости в вечернее время. Рекомендуемый курс непрерывного лечения составляет 3 месяца. Решение о продолжении лечения должно быть принято на основании клинических данных, которые будут наблюдаться после отмены препарата в течение 1 недели."}},{"type":"paragraph","data":{"text":"Ночная полиурия у взрослых"}},{"type":"paragraph","data":{"text":"Рекомендуемая начальная доза 0,1 мг на ночь. При отсутствии эффекта в течение 1 недели дозу увеличивают до 0,2 мг и в последующем до 0,4 мг при увеличении дозы с частотой не более 1 раз в неделю. Следует помнить об опасности задержки жидкости в организме. Если после 4 недель лечения и корректировки дозы адекватного клинического эффекта не наблюдается, продолжать прием препарата не рекомендуется"}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны центральной нервной системы: головная боль, головокружение."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: тошнота, рвота, сухость во рту."}},{"type":"paragraph","data":{"text":"Прочие: гиперемия склер, «приливы», транзиторная тахиаритмия, судороги."}},{"type":"paragraph","data":{"text":"Прием десмопрессина без одновременного ограничения приема жидкости может привести к задержке жидкости в организме, сопровождающейся гипонатриемией, повышением массы тела, периферическими отеками, и, в тяжелых случаях, судорогами."}},{"type":"paragraph","data":{"text":"При одновременном применении с имипрамином или оксибутинином возможны гипонатриемические судороги."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Передозировка приводит к увеличению длительности действия десмопрессина и повышению риска возникновения задержки жидкости и гипонатриемии. Лечение гипонатриемии должно быть индивидуальным, обязательным является прекращение приема препарата и отмена ограничения по приему жидкости. "}},{"type":"paragraph","data":{"text":"При наличии симптомов передозировки возможна инфузия 0,9% или гипертонического раствора натрия хлорида. В случае выраженной задержки жидкости (судороги и потеря сознания) к терапии следует присоединить фуросемид."}},{"type":"paragraph","data":{"text":"В случае передозировки необходимо обратиться к врачу."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении десмопрессин усиливает действие гипертензивных средств. При одновременном применении буформин, тетрациклин, препараты лития, норэпинефрин ослабляют антидиуретическое действие десмопрессина. "}},{"type":"paragraph","data":{"text":"При одновременном применении десмопрессина с нестероидными противовоспалительными препаратами (НПВП) возможно повышение риска возникновения побочных эффектов. При одновременном применении индометацин усиливает, но не увеличивает продолжительность действия десмопрессина. "}},{"type":"paragraph","data":{"text":"При одновременном применении трициклические антидепрессанты, селективные ингибиторы обратного захвата серотонина, наркотические анальгетики, НПВП, ламотриджин, хлорпромазин и карбамазепин, способные вызвать синдром неадекватной секреции антидиуретического гормона, могут усиливать антидиуретический эффект десмопрессина и приводить к повышению риска задержки жидкости и гипонатриемии. "}},{"type":"paragraph","data":{"text":"При применении десмопрессина с лоперамидом возможно троекратное повышение концентрации десмопрессина в плазме, что существенно повышает риск задержки жидкости и возникновение гипонатриемии. Возможно, другие лекарственные препараты, замедляющие перистальтику, могут вызвать аналогичный эффект. "}},{"type":"paragraph","data":{"text":"При одновременном применении десмопрессина с диметиконом возможно уменьшение абсорбции десмопрессина."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Во избежание развития побочных эффектов обязательным является ограничение до минимума приема жидкости за 1 час до приема и в течение 8 часов после приема препарата у пациентов при первичном ночном энурезе. Несоблюдение этого правила приводит к развитию побочных эффектов."}},{"type":"paragraph","data":{"text":"Клинические исследования показали, что наиболее часто гипонатриемия возникает у пациентов пожилого возраста (65 лет и старше). Высокий риск развития побочных эффектов имеют пациенты пожилого возраста с исходно низкой концентрацией натрия в плазме крови и полиурией от 2,8 до 3,0 литров."}},{"type":"paragraph","data":{"text":"Десмопрессин не следует применять в тех случаях, когда имеются другие дополнительные причины для задержки жидкости и электролитных расстройств."}},{"type":"paragraph","data":{"text":"Профилактика развития гипонатриемии состоит в увеличении частоты определения натрия в плазме крови, особенно в случаях одновременного приема с препаратами, которые вызывают синдром неадекватной секреции антидиуретического гормона (трициклические антидепрессанты, селективные ингибиторы серотонина, хлорпромазин и карбамазепин) и НПВП."}},{"type":"paragraph","data":{"text":"В случаях острого возникновения недержания мочи, дизурии и/или никтурии, инфекции мочевых путей, при подозрении на опухоль мочевого пузыря или предстательной железы, при наличии полидипсии и декомпенсированного сахарного диабета диагностика и лечение указанных состояний и заболеваний должны быть проведены до начала лечения десмопрессином."}},{"type":"paragraph","data":{"text":"При развитии на фоне лечения системных инфекций, лихорадки, гастроэнтерита прием препарата необходимо прекратить."}},{"type":"paragraph","data":{"text":"Влияние на способность управления транспортными средствами и механизмами"}},{"type":"paragraph","data":{"text":"В настоящее время данные о возможном влиянии десмопрессина на способность управлять транспортными средствами и механизмами отсутствуют. 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