Препарат гормонов щитовидной железы. Синтетический левовращающий изомер тироксина. После частичного превращения в трийодтиронин (в печени и почках) и перехода в клетки организма, оказывает влияние на развитие и рост тканей, на обмен веществ. В малых дозах обладает анаболическим действием на белковый и жировой обмен. В средних дозах стимулирует рост и развитие, повышает потребность тканей в кислороде, стимулирует метаболизм белков, жиров и углеводов, повышает функциональную активность сердечно-сосудистой системы и ЦНС. В больших дозах угнетает выработку тиреотропин-рилизинг гормона гипоталамуса и тиреотропного гормона гипофиза. Терапевтический эффект наблюдается через 7-12 дней, в течение этого же времени сохраняется действие после отмены препарата. Клинический эффект при гипотиреозе проявляется через 3-5 сут. Диффузный зоб уменьшается или исчезает в течение 3-6 мес.
Показания к применению
Гипотиреоз
Эутиреоидный зоб
В качестве заместительной терапии и для профилактики рецидива зоба после резекции щитовидной железы
Рак щитовидной железы (после оперативного лечения)
Диффузный токсический зоб после достижения эутиреоидного состояния тиреостатиками (в качестве комбинированной терапии или монотерапии)
В качестве диагностического средства при проведении теста тиреоидной супрессии
Противопоказания
Повышенная индивидуальная чувствительность к препарату
Нелеченый тиреотоксикоз
Нелеченая гипофизарная недостаточность
Нелеченая надпочечниковая недостаточность
Применение при беременности в комбинации с антитиреоидными средствами. Не следует начинать лечение при остром инфаркте миокарда, остром миокардите, остром панкардите. Не рекомендовано пациентам с редкими наследственными заболеваниями, связанными с непереносимостью галактозы, дефицитом лактазы или синдромом глюкозо-галактозной мальабсорбции (в связи с наличием в составе препарата лактозы). С осторожностью следует назначать препарат при ИБС (атеросклероз, стенокардия, инфаркт миокарда в анамнезе), артериальной гипертензии, аритмии, при сахарном диабете, при тяжелом длительно существующем гипотиреозе, синдроме мальабсорбции (может потребоваться коррекция дозы), у пациентов с предрасположенностью к психотическим реакциям
Применение при беременности и в период грудного вскармливания
При беременности и в период грудного вскармливания терапия препаратом, назначенным по поводу гипотиреоза, должна продолжаться. При беременности может потребоваться увеличение дозы препарата из-за повышения уровня содержания тироксин-связывающего глобулина. Нет данных о возникновении тератогенных и фетотоксичных эффектов при применении препарата в рекомендуемых терапевтических дозах. Применение препарата при беременности в чрезмерно высоких дозах может негативно влиять на плод и постнатальное развитие. Применение при беременности препарата в комбинации с тиреостатиками противопоказано, т.к. прием левотироксина натрия может потребовать увеличения доз тиреостатиков. Поскольку тиреостатики, в отличие от левотироксина натрия, могут проникать через плацентарный барьер, то у плода может развиться гипотиреоз. В период грудного вскармливания препарат следует принимать строго в рекомендуемых дозах под наблюдением врача. При применении препарата в рекомендуемых терапевтических дозах концентрация тиреоидного гормона, секретируемого с грудным молоком, недостаточна для того, чтобы вызвать гипертиреоз и подавление секреции ТТГ у ребенка.
Способ применения и дозы
Суточная доза определяется индивидуально в зависимости от показаний. Эутирокс в суточной дозе принимают внутрь утром натощак, по крайней мере, за 30 мин до приема пищи, запивая таблетку небольшим количеством жидкости (половина стакана воды) и не разжевывая. При проведении заместительной терапии при гипотиреозе у пациентов в возрасте до 55 лет при отсутствии сердечно-сосудистых заболеваний Эутирокс назначают в суточной дозе 1.6-1.8 мкг/кг массы тела; у пациентов в возрасте старше 55 лет или при сопутствующих сердечно-сосудистых заболеваниях - 0.9 мкг/кг массы тела. При заместительной терапии при гипотиреозе начальная доза для пациентов в возрасте до 55 лет (при отсутствии сердечно-сосудистых заболеваний) составляет для женщин 75-100 мкг/сут, для мужчин - 100-150 мкг/сут. Для пациентов старше 55 лет или при сопутствующих сердечно-сосудистых заболеваниях начальная доза составляет 25 мкг/сут; увеличивать дозу следует на 25 мкг с интервалом 2 мес до нормализации уровня ТТГ в крови; при появлении или ухудшении симптомов со стороны сердечно-сосудистой системы необходимо провести коррекцию терапии сердечно-сосудистых заболеваний. При тяжелом длительно существующем гипотиреозе лечение следует начинать с особой осторожностью с малых доз - 12.5 мкг/сут. Дозу увеличивают до поддерживающей через более продолжительные интервалы времени - на 12.5 мкг/сут каждые 2 недели - и чаще определяют уровень ТТГ в крови. При лечении врожденного гипотиреоза у детей дозы препарата зависят от возраста. Возраст Суточная доза левотироксина (мкг) Доза левотироксина в расчете на массу тела (мкг/кг) 0-6 мес 25-50 10-15 6-12 мес 50-75 6-8 1-5 лет 75-100 5-6 6-12 лет 100-150 4-5 старше 12 лет 100-200 2-3 Грудным детям и детям до 3 лет суточную дозу препарата Эутирокс дают в 1 прием за 30 мин до первого кормления. Таблетку растворяют в воде до тонкой взвеси непосредственно перед приемом препарата. При лечении эутиреоидного зоба назначают 75-200 мкг/сут. Для профилактики рецидива после хирургического лечения эутиреоидного зоба - 75-200 мкг/сут. В комплексной терапии тиреотоксикоза - 50-100 мкг/сут. Для супрессивной терапии рака щитовидной железы - 150-300 мкг/сут. При проведении теста тиреоидной супрессии используют следующую схему дозирования препарата: Дозы препарата Эутирокс за 4 недели до теста за 3 недели до теста за 2 недели до теста за 1 неделю до теста 75 мкг/сут 75 мкг/сут 150-200 мкг/сут 150-200 мкг/сут При гипотиреозе Эутирокс принимают, как правило, в течение всей жизни. При тиреотоксикозе Эутирокс используют в комплексной терапии с тиреостатиками после достижения эутиреоидного состояния. Во всех случаях длительность лечения препаратом определяется индивидуально.
Побочное действие
При правильном применении препарата Эутирокс под контролем врача побочные эффекты не наблюдаются. При повышенной чувствительности к препарату могут наблюдаться аллергические реакции.
Передозировка
При передозировке препарата наблюдаются значительное увеличение скорости обмена веществ. Клинические признаки гипертиреоза могут возникнуть в случае передозировки, если превышен индивидуальный порог переносимости левотироксина натрия, или если доза препарата с момента начала терапии повышается слишком быстро. Симптомы, характерные для гипертиреоза: нарушение ритма сердца, тахикардия, ощущение сердцебиения, стенокардия, головная боль, мышечная слабость и мышечные судороги, гиперемия (особенно кожи лица), лихорадка, рвота, нарушение менструального цикла, доброкачественная внтуричерепная гипертензия, тремор, беспокойство, бессонница, повышенная потливость, снижение массы тела, диарея. Были зарегистрированы случаи внезапной остановки сердечной деятельности у пациентов, которые принимали чрезмерно высокие дозы левотироксина натрия в течение многих лет. У предрасположенных пациентов отмечались отдельные случаи возникновения судорог при превышении индивидуального порога переносимости. Передозировка левотироксина натрия может привести к появлению симптомов острого психоза, особенно у пациентов с предрасположенностью к психотическим расстройствам. Лечение: в зависимости от выраженности симптомов показано уменьшение суточной дозы препарата, перерыв в лечении на несколько дней, назначение бета-адреноблокаторов. При применении препарата в предельно высоких дозах может быть назначен плазмаферез. После исчезновения побочных эффектов лечение следует начинать с осторожностью с более низкой дозы.
Особые указания
До начала заместительной терапии гормонами щитовидной железы или до выполнения теста тиреоидной супрессии необходимо исключить или провести лечение следующих заболеваний или патологических состояний: острой коронарной недостаточности, стенокардии, атеросклероза, артериальной гипертензии, недостаточности гипофиза или надпочечниковой недостаточности. Также до начала терапии гормонами щитовидной железы следует исключить или провести лечение функциональной автономии щитовидной железы. У пациентов с риском развития психотических расстройств рекомендуется начинать терапию с низкой дозы левотироксина натрия с последующим медленным ее увеличением в начале терапии. Рекомендуется наблюдение за пациентами. В случае обнаружения признаков психотических расстройств, принимаемая доза левотироксина натрия должна быть скорректирована. Необходимо исключить возможность возникновения даже незначительного лекарственно-обусловленного гипертиреоза у пациентов с коронарной недостаточностью, сердечной недостаточностью или тахиаритмиями. Поэтому в этих случаях необходим регулярный мониторинг концентрации тиреоидных гормонов. До проведения заместительной терапии гормонами щитовидной железы необходимо выяснить этиологию вторичного гипотиреоза. При необходимости следует начать заместительную терапию с целью компенсации надпочечниковой недостаточности. При подозрении на развитие функциональной автономии щитовидной железы до начала терапии рекомендуется выполнение ТРГ-теста или супрессивной сцинтиграфии. У женщин в постменопаузе с диагностированным гипотиреозом и имеющих повышенный риск остеопороза, необходимо исключить наличие превышающих физиологические концентраций левотироксина натрия в сыворотке. В этом случае рекомендован тщательный мониторинг функции щитовидной железы. Применение левотироксина натрия не рекомендуется при наличии метаболических нарушений, сопровождающихся гипертиреозом. Исключением является применение во время терапии гипертиреоза антитиреоидными препаратами. С момента начала терапии левотироксином натрия в случае перехода с одного препарата на другой рекомендуется скорректировать дозу в зависимости от клинического ответа пациента на терапию и результатов лабораторного исследования. При одновременном применении орлистата и левотироксина натрия может развиться гипотиреоз и/или произойти снижение контроля гипотиреоза. Пациенты, принимающие левотироксин натрия, должны проконсультироваться с врачом до начала применения орлистата, т.к. возможно потребуется принимать орлистат и левотироксин натрия в разное время суток и скорректировать дозу левотироксина натрия. В дальнейшем рекомендуется мониторинг функции щитовидной железы. Влияние на способность к вождению автотранспорта и управлению механизмами Исследования влияния препарата на способность управлять транспортными средствами и механизмами не проводились. Тем не менее, т.к. левотироксин натрия идентичен природному тиреоидному гормону, влияния на способность управлять транспортными средствами и механизмами не ожидается.
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Вспомогательные вещества: крахмал кукурузный - 25."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат гормонов щитовидной железы. Синтетический левовращающий изомер тироксина. После частичного превращения в трийодтиронин (в печени и почках) и перехода в клетки организма, оказывает влияние на развитие и рост тканей, на обмен веществ. В малых дозах обладает анаболическим действием на белковый и жировой обмен. В средних дозах стимулирует рост и развитие, повышает потребность тканей в кислороде, стимулирует метаболизм белков, жиров и углеводов, повышает функциональную активность сердечно-сосудистой системы и ЦНС. В больших дозах угнетает выработку тиреотропин-рилизинг гормона гипоталамуса и тиреотропного гормона гипофиза. Терапевтический эффект наблюдается через 7-12 дней, в течение этого же времени сохраняется действие после отмены препарата. Клинический эффект при гипотиреозе проявляется через 3-5 сут. Диффузный зоб уменьшается или исчезает в течение 3-6 мес."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Гипотиреоз","Эутиреоидный зоб","В качестве заместительной терапии и для профилактики рецидива зоба после резекции щитовидной железы","Рак щитовидной железы (после оперативного лечения)","Диффузный токсический зоб после достижения эутиреоидного состояния тиреостатиками (в качестве комбинированной терапии или монотерапии)","В качестве диагностического средства при проведении теста тиреоидной супрессии"]}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Повышенная индивидуальная чувствительность к препарату","Нелеченый тиреотоксикоз","Нелеченая гипофизарная недостаточность","Нелеченая надпочечниковая недостаточность","Применение при беременности в комбинации с антитиреоидными средствами. Не следует начинать лечение при остром инфаркте миокарда, остром миокардите, остром панкардите. Не рекомендовано пациентам с редкими наследственными заболеваниями, связанными с непереносимостью галактозы, дефицитом лактазы или синдромом глюкозо-галактозной мальабсорбции (в связи с наличием в составе препарата лактозы). С осторожностью следует назначать препарат при ИБС (атеросклероз, стенокардия, инфаркт миокарда в анамнезе), артериальной гипертензии, аритмии, при сахарном диабете, при тяжелом длительно существующем гипотиреозе, синдроме мальабсорбции (может потребоваться коррекция дозы), у пациентов с предрасположенностью к психотическим реакциям"]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При беременности и в период грудного вскармливания терапия препаратом, назначенным по поводу гипотиреоза, должна продолжаться. При беременности может потребоваться увеличение дозы препарата из-за повышения уровня содержания тироксин-связывающего глобулина. Нет данных о возникновении тератогенных и фетотоксичных эффектов при применении препарата в рекомендуемых терапевтических дозах. Применение препарата при беременности в чрезмерно высоких дозах может негативно влиять на плод и постнатальное развитие. Применение при беременности препарата в комбинации с тиреостатиками противопоказано, т.к. прием левотироксина натрия может потребовать увеличения доз тиреостатиков. Поскольку тиреостатики, в отличие от левотироксина натрия, могут проникать через плацентарный барьер, то у плода может развиться гипотиреоз. В период грудного вскармливания препарат следует принимать строго в рекомендуемых дозах под наблюдением врача. При применении препарата в рекомендуемых терапевтических дозах концентрация тиреоидного гормона, секретируемого с грудным молоком, недостаточна для того, чтобы вызвать гипертиреоз и подавление секреции ТТГ у ребенка."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Суточная доза определяется индивидуально в зависимости от показаний. Эутирокс в суточной дозе принимают внутрь утром натощак, по крайней мере, за 30 мин до приема пищи, запивая таблетку небольшим количеством жидкости (половина стакана воды) и не разжевывая. При проведении заместительной терапии при гипотиреозе у пациентов в возрасте до 55 лет при отсутствии сердечно-сосудистых заболеваний Эутирокс назначают в суточной дозе 1.6-1.8 мкг/кг массы тела; у пациентов в возрасте старше 55 лет или при сопутствующих сердечно-сосудистых заболеваниях - 0.9 мкг/кг массы тела. При заместительной терапии при гипотиреозе начальная доза для пациентов в возрасте до 55 лет (при отсутствии сердечно-сосудистых заболеваний) составляет для женщин 75-100 мкг/сут, для мужчин - 100-150 мкг/сут. Для пациентов старше 55 лет или при сопутствующих сердечно-сосудистых заболеваниях начальная доза составляет 25 мкг/сут; увеличивать дозу следует на 25 мкг с интервалом 2 мес до нормализации уровня ТТГ в крови; при появлении или ухудшении симптомов со стороны сердечно-сосудистой системы необходимо провести коррекцию терапии сердечно-сосудистых заболеваний. При тяжелом длительно существующем гипотиреозе лечение следует начинать с особой осторожностью с малых доз - 12.5 мкг/сут. Дозу увеличивают до поддерживающей через более продолжительные интервалы времени - на 12.5 мкг/сут каждые 2 недели - и чаще определяют уровень ТТГ в крови. При лечении врожденного гипотиреоза у детей дозы препарата зависят от возраста. Возраст Суточная доза левотироксина (мкг) Доза левотироксина в расчете на массу тела (мкг/кг) 0-6 мес 25-50 10-15 6-12 мес 50-75 6-8 1-5 лет 75-100 5-6 6-12 лет 100-150 4-5 старше 12 лет 100-200 2-3 Грудным детям и детям до 3 лет суточную дозу препарата Эутирокс дают в 1 прием за 30 мин до первого кормления. Таблетку растворяют в воде до тонкой взвеси непосредственно перед приемом препарата. При лечении эутиреоидного зоба назначают 75-200 мкг/сут. Для профилактики рецидива после хирургического лечения эутиреоидного зоба - 75-200 мкг/сут. В комплексной терапии тиреотоксикоза - 50-100 мкг/сут. Для супрессивной терапии рака щитовидной железы - 150-300 мкг/сут. При проведении теста тиреоидной супрессии используют следующую схему дозирования препарата: Дозы препарата Эутирокс за 4 недели до теста за 3 недели до теста за 2 недели до теста за 1 неделю до теста 75 мкг/сут 75 мкг/сут 150-200 мкг/сут 150-200 мкг/сут При гипотиреозе Эутирокс принимают, как правило, в течение всей жизни. При тиреотоксикозе Эутирокс используют в комплексной терапии с тиреостатиками после достижения эутиреоидного состояния. Во всех случаях длительность лечения препаратом определяется индивидуально."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При правильном применении препарата Эутирокс под контролем врача побочные эффекты не наблюдаются. При повышенной чувствительности к препарату могут наблюдаться аллергические реакции."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При передозировке препарата наблюдаются значительное увеличение скорости обмена веществ. Клинические признаки гипертиреоза могут возникнуть в случае передозировки, если превышен индивидуальный порог переносимости левотироксина натрия, или если доза препарата с момента начала терапии повышается слишком быстро. Симптомы, характерные для гипертиреоза: нарушение ритма сердца, тахикардия, ощущение сердцебиения, стенокардия, головная боль, мышечная слабость и мышечные судороги, гиперемия (особенно кожи лица), лихорадка, рвота, нарушение менструального цикла, доброкачественная внтуричерепная гипертензия, тремор, беспокойство, бессонница, повышенная потливость, снижение массы тела, диарея. Были зарегистрированы случаи внезапной остановки сердечной деятельности у пациентов, которые принимали чрезмерно высокие дозы левотироксина натрия в течение многих лет. У предрасположенных пациентов отмечались отдельные случаи возникновения судорог при превышении индивидуального порога переносимости. Передозировка левотироксина натрия может привести к появлению симптомов острого психоза, особенно у пациентов с предрасположенностью к психотическим расстройствам. Лечение: в зависимости от выраженности симптомов показано уменьшение суточной дозы препарата, перерыв в лечении на несколько дней, назначение бета-адреноблокаторов. При применении препарата в предельно высоких дозах может быть назначен плазмаферез. После исчезновения побочных эффектов лечение следует начинать с осторожностью с более низкой дозы."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"До начала заместительной терапии гормонами щитовидной железы или до выполнения теста тиреоидной супрессии необходимо исключить или провести лечение следующих заболеваний или патологических состояний: острой коронарной недостаточности, стенокардии, атеросклероза, артериальной гипертензии, недостаточности гипофиза или надпочечниковой недостаточности. Также до начала терапии гормонами щитовидной железы следует исключить или провести лечение функциональной автономии щитовидной железы. У пациентов с риском развития психотических расстройств рекомендуется начинать терапию с низкой дозы левотироксина натрия с последующим медленным ее увеличением в начале терапии. Рекомендуется наблюдение за пациентами. В случае обнаружения признаков психотических расстройств, принимаемая доза левотироксина натрия должна быть скорректирована. Необходимо исключить возможность возникновения даже незначительного лекарственно-обусловленного гипертиреоза у пациентов с коронарной недостаточностью, сердечной недостаточностью или тахиаритмиями. Поэтому в этих случаях необходим регулярный мониторинг концентрации тиреоидных гормонов. До проведения заместительной терапии гормонами щитовидной железы необходимо выяснить этиологию вторичного гипотиреоза. При необходимости следует начать заместительную терапию с целью компенсации надпочечниковой недостаточности. При подозрении на развитие функциональной автономии щитовидной железы до начала терапии рекомендуется выполнение ТРГ-теста или супрессивной сцинтиграфии. У женщин в постменопаузе с диагностированным гипотиреозом и имеющих повышенный риск остеопороза, необходимо исключить наличие превышающих физиологические концентраций левотироксина натрия в сыворотке. В этом случае рекомендован тщательный мониторинг функции щитовидной железы. Применение левотироксина натрия не рекомендуется при наличии метаболических нарушений, сопровождающихся гипертиреозом. Исключением является применение во время терапии гипертиреоза антитиреоидными препаратами. С момента начала терапии левотироксином натрия в случае перехода с одного препарата на другой рекомендуется скорректировать дозу в зависимости от клинического ответа пациента на терапию и результатов лабораторного исследования. При одновременном применении орлистата и левотироксина натрия может развиться гипотиреоз и/или произойти снижение контроля гипотиреоза. Пациенты, принимающие левотироксин натрия, должны проконсультироваться с врачом до начала применения орлистата, т.к. возможно потребуется принимать орлистат и левотироксин натрия в разное время суток и скорректировать дозу левотироксина натрия. В дальнейшем рекомендуется мониторинг функции щитовидной железы. Влияние на способность к вождению автотранспорта и управлению механизмами Исследования влияния препарата на способность управлять транспортными средствами и механизмами не проводились. Тем не менее, т.к. левотироксин натрия идентичен природному тиреоидному гормону, влияния на способность управлять транспортными средствами и механизмами не ожидается."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Препарат гормонов щитовидной железы. Синтетический левовращающий изомер тироксина. После частичного превращения в трийодтиронин (в печени и почках) и перехода в клетки организма, оказывает влияние на развитие и рост тканей, на обмен веществ. В малых дозах обладает анаболическим действием на белковый и жировой обмен. В средних дозах стимулирует рост и развитие, повышает потребность тканей в кислороде, стимулирует метаболизм белков, жиров и углеводов, повышает функциональную активность сердечно-сосудистой системы и ЦНС. В больших дозах угнетает выработку тиреотропин-рилизинг гормона гипоталамуса и тиреотропного гормона гипофиза. Терапевтический эффект наблюдается через 7-12 дней, в течение этого же времени сохраняется действие после отмены препарата. Клинический эффект при гипотиреозе проявляется через 3-5 сут. 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