Орсотен показан для продолжительного лечения пациентов с ожирением с индексом массы тела (ИМТ) > 30 кг/м , или пациентов с избыточной массой тела (ИМТ > 28 кг/м), в том числе имеющих ассоциированные с ожирением факторы риска, в сочетании с умеренно низкокалорийной диетой. Орсотен можно назначать в сочетании с гипогликемическими препаратами и/или умеренно ...
Синдром хронической мальабсорбции; холестаз; повышенная чувствительность к орлистату или любым другим компонентам препарата; беременность и кормление грудью: детский возраст до 18 лет (эффективность и безопасность не изучены)
Специфический ингибитор желудочно-кишечных липаз, обладающий продолжительным действием. Оказывает терапевтическое действие в просвете желудка и тонкой кишки, образуя ковалентную связь с активным сериновым участком желудочной и кишечной липаз. Инактивированный таким образом фермент теряет способность расщеплять пищевые жиры, поступающие в форме триглицеридов, на всасывающиеся свободные жирные кислоты и моноглицериды. Поскольку нерасщепленные триглицериды не всасываются, поступление калорий в организм уменьшается, что приводит к снижению массы тела. Терапевтическое действие препарата осуществляется без всасывания в системный кровоток. Действие орлистата приводит к повышению содержания жира в каловых массах уже через 24-48 ч после приема препарата. После отмены препарата содержание жира в каловых массах обычно возвращается к исходному уровню через 48-72 ч.
Показания к применению
Орсотен показан для продолжительного лечения пациентов с ожирением с индексом массы тела (ИМТ) > 30 кг/м , или пациентов с избыточной массой тела (ИМТ > 28 кг/м), в том числе имеющих ассоциированные с ожирением факторы риска, в сочетании с умеренно низкокалорийной диетой. Орсотен можно назначать в сочетании с гипогликемическими препаратами и/или умеренно низкокалорийной диетой пациентам с сахарным диабетом 2 типа с избыточной массой тела или ожирением.
Противопоказания
Синдром хронической мальабсорбции; холестаз; повышенная чувствительность к орлистату или любым другим компонентам препарата; беременность и кормление грудью: детский возраст до 18 лет (эффективность и безопасность не изучены)
Применение при беременности и в период грудного вскармливания
По результатам доклинических исследований тератогенность и эмбриотоксичность при приеме орлистата не наблюдались. Клинические данные относительно применения орлистата при беременности отсутствуют, поэтому не следует назначать препарат в данный период. Т.к. данные о применении в период лактации отсутствуют, орлистат не следует назначать в период лактации.
Способ применения и дозы
Рекомендуемая разовая доза орлистата составляет одну капсулу 120 мг, которую принимают внутрь, запивая водой, непосредственно перед каждым основным приемом пищи, во время еды или не позднее, чем через час после еды. Если прием пищи пропускают, или, если пища не содержит жира, то прием орлистата можно пропустить. Дозы орлистата свыше 120 мг 3 раза в день не усиливают его терапевтический эффект. Длительность терапии не более 2 лет Коррекция дозы не требуется для пациентов пожилого возраста или пациентов с нарушениями функции печени или почек
Побочное действие
Побочные реакции в основном отмечались со стороны ЖКТ и были обусловлены повышенным количеством жира в кале. Обычно наблюдаемые побочные реакции слабо выражены и имеют преходящий характер. Появление этих реакций наблюдалось на начальном этапе лечения в течение первых 3 мес. (но не более одного случая). При продолжительном применении орлистата количество случаев побочных явлений снижается. Со стороны пищеварительной системы: метеоризм, сопровождающийся выделениями из прямой кишки, позывы на дефекацию, жирный/масляный стул, маслянистые выделения из прямой кишки, жидкий стул, мягкий стул, включения жира в кале (стеаторея), боль/чувство дискомфорта в области живота, учащение дефекации, боль/дискомфорт в прямой кишке, императивные позывы на дефекацию, недержание кала, поражение зубов и десен, гипогликемия у больных сахарным диабетом типа 2; очень редко – дивертикулит, желчнокаменная болезнь, гепатит, возможно в тяжелой степени, повышение уровня печеночных трансаминаз и ЩФ. Со стороны ЦНС: головная боль, чувство тревоги. Аллергические реакции: зуд, сыпь, крапивница, ангионевротический отек, бронхоспазм, анафилаксия; очень редко - буллезная сыпь. Прочие: гриппоподобный синдром, чувство усталости, инфекции верхних отделов дыхательных путей, инфекции мочевыводящих путей, дисменорея.
Передозировка
Случаи передозировки не описаны. Прием однократной дозы орлистата 800 мг или многократных доз до 400 мг 3 раза/сут в течение 15 дней не сопровождался значительными побочными реакциями. Помимо этого, доза 240 мг 3 раза/сут, назначенная пациентам с ожирением в течение 6 мес., не вызвала значительного усиления побочных реакций. В случае передозировки орлистата рекомендуется наблюдать за пациентом в течение 24 ч.
Особые указания
Орлистат эффективен для продолжительного контроля массы тела (снижение массы тела, поддержание ее на соответствующем уровне и предотвращение повторного прибавления массы тела). Лечение орлистатом приводит к улучшению профиля факторов риска и заболеваний, сопутствующих ожирению (включая гиперхолестеринемию, нарушение толерантности к глюкозе, гиперинсулинемию, артериальную гипертензию, сахарный диабет типа 2), и к уменьшению количества висцерального жира. Снижение массы тела во время лечения орлистатом может сопровождаться улучшением компенсации углеводного обмена у пациентов с сахарным диабетом типа 2, что может позволить снизить дозу гипогликемических препаратов. Для обеспечения адекватного питания пациентов рекомендуется принимать поливитаминные препараты. Пациентам следует придерживаться рекомендаций относительно диеты. Они должны получать сбалансированное, умеренно низкокалорийное питание, содержащее не более 30% калорий в виде жиров. Суточное потребление жиров следует распределять на три основных приема пищи. Вероятность развития побочных реакций со стороны ЖКТ может увеличиться, если орлистат принимают на фоне питания, богатого жирами (например, 2000 ккал/сут, > 30% суточного потребления калорий поступают в виде жиров, что составляет приблизительно 67 г жира). Пациенты должны знать, что чем точнее они соблюдают диету (особенно относительно разрешенного количества жира), тем меньше вероятность развития побочных реакций. Диета с низким содержанием жиров уменьшает вероятность развития побочных реакций со стороны ЖКТ и помогает пациентам контролировать и регулировать потребление жира. Если через 12 недель терапии не произошло снижения массы тела, как минимум, на 5%, прием орлистата следует прекратить.
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Оказывает терапевтическое действие в просвете желудка и тонкой кишки, образуя ковалентную связь с активным сериновым участком желудочной и кишечной липаз. Инактивированный таким образом фермент теряет способность расщеплять пищевые жиры, поступающие в форме триглицеридов, на всасывающиеся свободные жирные кислоты и моноглицериды. Поскольку нерасщепленные триглицериды не всасываются, поступление калорий в организм уменьшается, что приводит к снижению массы тела. Терапевтическое действие препарата осуществляется без всасывания в системный кровоток. Действие орлистата приводит к повышению содержания жира в каловых массах уже через 24-48 ч после приема препарата. 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Со стороны пищеварительной системы: метеоризм, сопровождающийся выделениями из прямой кишки, позывы на дефекацию, жирный/масляный стул, маслянистые выделения из прямой кишки, жидкий стул, мягкий стул, включения жира в кале (стеаторея), боль/чувство дискомфорта в области живота, учащение дефекации, боль/дискомфорт в прямой кишке, императивные позывы на дефекацию, недержание кала, поражение зубов и десен, гипогликемия у больных сахарным диабетом типа 2; очень редко – дивертикулит, желчнокаменная болезнь, гепатит, возможно в тяжелой степени, повышение уровня печеночных трансаминаз и ЩФ. Со стороны ЦНС: головная боль, чувство тревоги. Аллергические реакции: зуд, сыпь, крапивница, ангионевротический отек, бронхоспазм, анафилаксия; очень редко - буллезная сыпь. 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Лечение орлистатом приводит к улучшению профиля факторов риска и заболеваний, сопутствующих ожирению (включая гиперхолестеринемию, нарушение толерантности к глюкозе, гиперинсулинемию, артериальную гипертензию, сахарный диабет типа 2), и к уменьшению количества висцерального жира. Снижение массы тела во время лечения орлистатом может сопровождаться улучшением компенсации углеводного обмена у пациентов с сахарным диабетом типа 2, что может позволить снизить дозу гипогликемических препаратов. Для обеспечения адекватного питания пациентов рекомендуется принимать поливитаминные препараты. Пациентам следует придерживаться рекомендаций относительно диеты. Они должны получать сбалансированное, умеренно низкокалорийное питание, содержащее не более 30% калорий в виде жиров. Суточное потребление жиров следует распределять на три основных приема пищи. 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