Лечение ожирения, в т.ч. уменьшение и поддержание массы тела, в сочетании с гипокалорийной диетой . уменьшение риска повторной прибавки массы тела после ее первоначального снижения. Орлистат показан пациентам с ожирением при индексе массы тела (ИМТ) ≥ .30 кг/м2 или ≥ .28 кг/м2 при наличии других факторов риска (сахарный диабет, артериальная гипертензия, ...
Повышенная чувствительность к орлистату или другим компонентам препарата . синдром мальабсорбции . холестаз . одновременный прием с циклоспорином . беременность и кормление грудью . возраст до 18 лет. С осторожностью: наличие гипероксалурии в анамнезе, нефролитиаза (кальциевые оксалатные камни).
Специфический ингибитор желудочно-кишечных липаз. Образует ковалентную связь с активным сериновым участком желудочной и панкреатической липаз в просвете желудка и тонкого кишечника. Инактивированный фермент теряет способность расщеплять жиры пищи, поступающие в форме триглицеридов (ТГ). Нерасщепленные ТГ не всасываются, и возникающее вследствие этого уменьшение поступления калорий в организм приводит к уменьшению массы тела. Увеличивает концентрацию жира в каловых массах через 24–48 ч после приема. Обеспечивает эффективный контроль массы тела, уменьшение депо жира. Для проявления активности не требуется системная абсорбция орлистата, в рекомендуемой терапевтической дозе (120 мг 3 раза/сут) он примерно на 30% ингибирует всасывание поступающих с пищей жиров.
Показания к применению
Лечение ожирения, в т.ч. уменьшение и поддержание массы тела, в сочетании с гипокалорийной диетой . уменьшение риска повторной прибавки массы тела после ее первоначального снижения. Орлистат показан пациентам с ожирением при индексе массы тела (ИМТ) ≥ .30 кг/м2 или ≥ .28 кг/м2 при наличии других факторов риска (сахарный диабет, артериальная гипертензия, дислипидемия). (Расчет ИМТ: ИМТ = M/P2, где M - масса тела, кг . P - рост, м.)
Противопоказания
Повышенная чувствительность к орлистату или другим компонентам препарата . синдром мальабсорбции . холестаз . одновременный прием с циклоспорином . беременность и кормление грудью . возраст до 18 лет. С осторожностью: наличие гипероксалурии в анамнезе, нефролитиаза (кальциевые оксалатные камни).
Применение при беременности и в период грудного вскармливания
Орлистат противопоказано применять в период беременности в связи с отсутствием достоверных клинических данных, подтверждающих безопасность его применения. Не установлено, проникает ли орлистат в грудное молоко, в связи с чем применение препарата Ксеналтен в период грудного вскармливания не рекомендуется.
Способ применения и дозы
Внутрь, 120 мг (1 капс.) 3 раза в сутки во время каждого приема пищи или не позднее чем через 1 ч после еды (если пища не содержит жира, то прием можно пропустить).
Побочное действие
Частота побочных реакций, приведенных ниже, определялась соответственно следующему: очень часто (больше1/10) . часто (больше1/100, меньше1/10) . иногда (больше1/1000, меньше1/100) . редко (больше1/10000, меньше1/1000) . очень редко (меньше1/10000), включая отдельные сообщения. Со стороны ЖКТ: очень часто - маслянистые выделения из прямой кишки, выделение газов с некоторым количеством отделяемого, императивные позывы на дефекацию, стеаторея, учащение дефекации, жидкий стул, метеоризм, боли или дискомфорт в животе. Как правило, указанные побочные реакции являются слабовыраженными и транзиторными, возникают на ранних этапах лечения (в первые 3 мес). Частота этих нежелательных реакций увеличивается при повышении содержания жира в питании. Больных следует информировать о возможности возникновения указанных побочных реакций и обучить, как устранять их путем лучшего соблюдения диеты, особенно в отношении количества содержащегося в ней жира. Часто - мягкий стул, боли или дискомфорт в прямой кишке, недержание кала, вздутие живота, поражение зубов, поражение десен. Со стороны дыхательной системы, органов грудной клетки и средостения: очень часто - инфекции верхних дыхательных путей, часто - инфекции нижних дыхательных путей. Со стороны иммунной системы: редко - зуд, крапивница, сыпь, ангионевротический отек, бронхоспазм, анафилаксия. Со стороны нервной системы: очень часто - головные боли. Со стороны печени и желчевыводящих путей: очень редко - повышение активности трансаминаз и ЩФ, гепатит. Со стороны почек и мочевыводящих путей: часто - инфекции мочевыводящих путей. Прочие: очень часто - грипп . часто - дисменорея, тревога, слабость. Если любые из указанных в инструкции побочных действий усугубляются или замечены любые другие побочные действия, не указанные в инструкции, следует сообщить об этом врачу.
Особые указания
Частота побочных реакций, приведенных ниже, определялась соответственно следующему: очень часто (больше1/10) . часто (больше1/100, меньше1/10) . иногда (больше1/1000, меньше1/100) . редко (больше1/10000, меньше1/1000) . очень редко (меньше1/10000), включая отдельные сообщения. Со стороны ЖКТ: очень часто - маслянистые выделения из прямой кишки, выделение газов с некоторым количеством отделяемого, императивные позывы на дефекацию, стеаторея, учащение дефекации, жидкий стул, метеоризм, боли или дискомфорт в животе. Как правило, указанные побочные реакции являются слабовыраженными и транзиторными, возникают на ранних этапах лечения (в первые 3 мес). Частота этих нежелательных реакций увеличивается при повышении содержания жира в питании. Больных следует информировать о возможности возникновения указанных побочных реакций и обучить, как устранять их путем лучшего соблюдения диеты, особенно в отношении количества содержащегося в ней жира. Часто - мягкий стул, боли или дискомфорт в прямой кишке, недержание кала, вздутие живота, поражение зубов, поражение десен. Со стороны дыхательной системы, органов грудной клетки и средостения: очень часто - инфекции верхних дыхательных путей, часто - инфекции нижних дыхательных путей. Со стороны иммунной системы: редко - зуд, крапивница, сыпь, ангионевротический отек, бронхоспазм, анафилаксия. Со стороны нервной системы: очень часто - головные боли. Со стороны печени и желчевыводящих путей: очень редко - повышение активности трансаминаз и ЩФ, гепатит. Со стороны почек и мочевыводящих путей: часто - инфекции мочевыводящих путей. Прочие: очень часто - грипп . часто - дисменорея, тревога, слабость. Если любые из указанных в инструкции побочных действий усугубляются или замечены любые другие побочные действия, не указанные в инструкции, следует сообщить об этом врачу.
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