Блокатор гистаминовых Н1-рецепторов из группы этаноламинов. Препарат оказывает снотворное, седативное и м-холиноблокирующее действие. Сокращает время засыпания, повышает длительность и качество сна, при этом не изменяет фазы сна. Длительность действия - 6-8 ч.
Фармакокинетика
Всасывание и распределение Cmax в среднем достигается через 2 ч после приема внутрь. Абсорбция высокая.
Метаболизм и выведение Хорошо проникает через гистогематические барьеры (включая ГЭБ). Метаболизируется в печени. T1/2 - около 10 ч. Выводится на 60% почками в неизменном виде, частично - через ЖКТ.
Фармакокинетика у особых групп пациентов У пациентов старше 65 лет, а также при печеночной и почечной недостаточности T1/2 может удлиняться. При повторении курсов лечения стабильная концентрация препарата и его метаболитов в плазме крови достигается позже и на более высоком уровне.
Показания к применению
Нарушения сна; аллергические реакции, кожный зуд; простудные заболевания и кашель (в составе комбинированных препаратов).
Противопоказания
повышенная чувствительность к доксиламину и другим компонентам препарата, или к другим антигистаминным средствам;
закрытоугольная глаукома или семейный анамнез закрытоугольной глаукомы;
заболевания уретры и предстательной железы, сопровождающиеся нарушением оттока мочи;
Пациентам со случаями апноэ в анамнезе - в связи с тем, что доксиламина сукцинат может усугублять синдром ночного апноэ (внезапная остановка дыхания во сне); пациентам старше 65 лет - в связи с возможными головокружениями и замедленными реакциями с опасностью падений (например, при ночных пробуждениях после приема снотворных), а также в связи с возможным увеличением T1/2; пациентам с почечной и печеночной недостаточностью (T1/2 может увеличиваться. Применять с осторожностью пациентам с печеночной недостаточностью (T1/2 может увеличиваться). Применять с осторожностью пациентам с почечной недостаточностью (T1/2 может увеличиваться). Противопоказан в детском и подростковом возрасте до 15 лет. С осторожностью: пациентам старше 65 лет - в связи с возможными головокружениями и замедленными реакциями с опасностью падения (например, при ночных пробуждениях после приема снотворных).
Применение при беременности и в период грудного вскармливания
На основании адекватных и хорошо контролируемых исследований доксиламин может применяться у беременных женщин на протяжении всего периода беременности. В случае назначения препарата на поздних сроках беременности следует принимать во внимание атропиноподобные и седативные свойства доксиламина при наблюдении за состоянием новорожденного. Неизвестно, проникает ли доксиламин в грудное молоко. В связи с возможностью развития седативного или возбуждающего эффекта у ребенка кормить грудью при применении препарата не следует.
Способ применения и дозы
Внутрь. По 1/2-1 таб./сут, запивая небольшим количеством жидкости, за 15-30 мин до сна. Если лечение неэффективно, по рекомендации врача доза может быть увеличена до 2 таб. Продолжительность лечения от 2 до 5 дней; если бессонница сохраняется, необходимо обратиться к врачу. Пациенты с почечной и печеночной недостаточностью: в связи с данными об увеличении концентрации в плазме и уменьшении плазменного клиренса доксиламина, рекомендуется коррекция дозы в сторону уменьшения. Пациенты пожилого возраста старше 65 лет: блокаторы гистаминовых Н1-рецепторов следует с осторожностью назначать данной группе пациентов в связи с возможным головокружением и замедленными реакциями с опасностью падения (например, при ночных пробуждениях после приема снотворных). Ввиду данных об увеличении концентрации в плазме, уменьшении плазменного клиренса и увеличении T1/2 рекомендуется коррекция дозы в сторону уменьшения.
Побочное действие
Со стороны пищеварительной системы: запор, сухость во рту. Со стороны сердечно-сосудистой системы: ощущение сердцебиения. Со стороны органа зрения: нарушения зрения и аккомодации, нечеткое зрение. Со стороны мочевыделительной системы: задержка мочи. Со стороны нервной системы: сонливость в дневное время (в этом случае доза препарата должна быть уменьшена); спутанность сознания, галлюцинации. Со стороны костно-мышечной системы: рабдомиолиз. Со стороны лабораторных показателей: увеличение уровня КФК. Если любые из указанных выше побочных эффектов усугубляются или появляются другие побочные эффекты, не указанные в инструкции, пациент должен сообщить об этом врачу.
Передозировка
Симптомы: дневная сонливость, возбуждение, расширение зрачка (мидриаз), нарушения аккомодации, сухость во рту, покраснение кожи лица и шеи (гиперемия), повышение температуры тела (гипертермия), синусовая тахикардия, расстройство сознания, галлюцинации, снижение настроения, тревога, нарушение координации движений, дрожь (тремор), непроизвольные движения (атетоз), судороги (эпилептический синдром), кома. Непроизвольные движения иногда являются предвестниками судорог, что может свидетельствовать о тяжелой степени отравления. Даже при отсутствии судорог тяжелые отравления доксиламином могут вызвать развитие рабдомиолиза, который часто сопровождается острой почечной недостаточностью. В таких случаях показана стандартная терапия с постоянным контролем уровня КФК. При появлении симптомов отравления следует немедленно обратиться к врачу. Лечение: симптоматическое (м-холиномиметики и др.), в качестве средства первой помощи показан прием активированного угля (в количестве 50 г - для взрослых и 1 г/кг массы тела для детей).
Взаимодействие с другими лекарственными средствами
При одновременном приеме препарата Донормил® с седативными антидепрессантами (амитриптилин, доксепин, миансерин, миртазапин, тримипрамин), барбитуратами, бензодиазепинами, клонидином, производными морфина (анальгетиками, противокашлевыми препаратами), нейролептиками, анксиолитиками, блокаторами гистаминовых Н1-рецепторов с седативным действием, центральными антигипертензивными препаратами, талидомидом, баклофеном, пизотифеном усиливается угнетающее действие на ЦНС. При одновременном приеме с м-холиноблокирующими средствами (атропин, имипраминовые антидепрессанты, антипаркинсонические препараты, атропиновые спазмолитики, дизопирамид, фенотиазиновые нейролептики) повышается риск возникновения таких побочных эффектов, как задержка мочи, запор, сухость во рту. Т.к. алкоголь усиливает седативный эффект большинства блокаторов гистаминовых Н1-рецепторов, в т.ч. и препарата Донормил®, необходимо избегать его одновременного употребления с алкогольными напитками и лекарственными препаратами, содержащими алкоголь.
Особые указания
Следует принимать во внимание, что бессонница может быть вызвана рядом причин, при которых нет необходимости в назначении данного лекарственного препарата. Препарат оказывает седативное действие, подавляет когнитивные способности и замедляет психомоторные реакции. Первое поколение блокаторов гистаминовых H1-рецепторов может оказывать м-холиноблокирующий, α-адреноблокирующий и антисеротониновый эффекты, что может вызывать сухость во рту, запор, задержку мочи, нарушения аккомодации и зрения. Как все снотворные или седативные препараты, доксиламина сукцинат может усугублять синдром ночного апноэ (внезапная остановка дыхания во сне) - увеличивая число и продолжительность приступов апноэ. Возможное злоупотребление блокаторами гистаминовых H1-рецепторов первого поколения, включая доксиламин, может приводить к физической и психологической зависимости, о которой сообщалось на фоне преднамеренного приема более высоких доз препарата, чем рекомендованные. В одной таблетке препарата содержится 100 мг лактозы моногидрата, что следует принимать во внимание у пациентов с редкой врожденной непереносимостью галактозы, дефицитом лактазы lapp или глюкозо-галактозной мальабсорбцией.
Влияние на способность управлять автомобилем и движущимися механизмами
В связи с возможной сонливостью в дневное время суток следует избегать управления автотранспортом, работы с механизмами и иных видов деятельности, требующих быстрых психических и двигательных реакций.
Форма выпуска
Таблетки.
Условия хранения
При температуре 15–25°C. Хранить в недоступном для детей месте.
Срок годности
3 года. Не применять по истечении срока годности, указанного на упаковке.2000-2017. Регистр лекарственных средств России
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сукцинат. \u003ci\u003eВспомогательные вещества\u003c/i\u003e: лактозы моногидрат - 100 мг, кроскармеллоза натрия - 9 мг, целлюлоза микрокристаллическая - 15 мг, магния стеарат - 2 мг."}}]},{"id":13,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.vidal.ru/drugs/clinic-group/85\"\u003eСнотворный препарат\u003c/a\u003e."}}]},{"id":1,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Блокатор гистаминовых Н\u003csub\u003e1\u003c/sub\u003e-рецепторов из группы этаноламинов. Препарат оказывает снотворное, седативное и м-холиноблокирующее действие. Сокращает время засыпания, повышает длительность и качество сна, при этом не изменяет фазы сна. Длительность действия - 6-8 ч."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"\u003ci\u003eВсасывание и распределение \u003c/i\u003eC\u003csub\u003emax \u003c/sub\u003eв среднем достигается через 2 ч после приема внутрь. Абсорбция высокая."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМетаболизм и выведение \u003c/i\u003eХорошо проникает через гистогематические барьеры (включая ГЭБ). Метаболизируется в печени. T\u003csub\u003e1/2\u003c/sub\u003e - около 10 ч. Выводится на 60% почками в неизменном виде, частично - через ЖКТ."}},{"type":"paragraph","data":{"text":"\u003ci\u003eФармакокинетика у особых групп пациентов \u003c/i\u003eУ пациентов старше 65 лет, а также при печеночной и почечной недостаточности T\u003csub\u003e1/2 \u003c/sub\u003eможет удлиняться. При повторении курсов лечения стабильная концентрация препарата и его метаболитов в плазме крови достигается позже и на более высоком уровне."}}]},{"id":2,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Нарушения сна; аллергические реакции, кожный зуд; простудные заболевания и кашель (в составе комбинированных препаратов)."}}]},{"id":3,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"ordered","items":["повышенная чувствительность к доксиламину и другим компонентам препарата, или к другим антигистаминным средствам;","закрытоугольная глаукома или семейный анамнез закрытоугольной глаукомы;","заболевания уретры и предстательной железы, сопровождающиеся нарушением оттока мочи;","врожденная галактоземия, глюкозо-галактозная мальабсорбция, дефицит лактазы;","детский и подростковый возраст до 15 лет."]}}]},{"id":14,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Пациентам со случаями апноэ в анамнезе - в связи с тем, что доксиламина сукцинат может усугублять синдром ночного апноэ (внезапная остановка дыхания во сне); пациентам старше 65 лет - в связи с возможными головокружениями и замедленными реакциями с опасностью падений (например, при ночных пробуждениях после приема снотворных), а также в связи с возможным увеличением T\u003csub\u003e1/2\u003c/sub\u003e; пациентам с почечной и печеночной недостаточностью (T\u003csub\u003e1/2 \u003c/sub\u003eможет увеличиваться. Применять с осторожностью пациентам с печеночной недостаточностью (T\u003csub\u003e1/2 \u003c/sub\u003eможет увеличиваться). Применять с осторожностью пациентам с почечной недостаточностью (T\u003csub\u003e1/2 \u003c/sub\u003eможет увеличиваться). Противопоказан в детском и подростковом возрасте до 15 лет. \u003ci\u003eС осторожностью: \u003c/i\u003eпациентам старше 65 лет - в связи с возможными головокружениями и замедленными реакциями с опасностью падения (например, при ночных пробуждениях после приема снотворных)."}}]},{"id":4,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"На основании адекватных и хорошо контролируемых исследований доксиламин может применяться у беременных женщин на протяжении всего периода беременности. В случае назначения препарата на поздних сроках беременности следует принимать во внимание атропиноподобные и седативные свойства доксиламина при наблюдении за состоянием новорожденного. Неизвестно, проникает ли доксиламин в грудное молоко. В связи с возможностью развития седативного или возбуждающего эффекта у ребенка кормить грудью при применении препарата не следует."}}]},{"id":15,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь. По 1/2-1 таб./сут, запивая небольшим количеством жидкости, за 15-30 мин до сна. Если лечение неэффективно, по рекомендации врача доза может быть увеличена до 2 таб. Продолжительность лечения от 2 до 5 дней; если бессонница сохраняется, необходимо обратиться к врачу. \u003cb\u003eПациенты с почечной и печеночной недостаточностью: \u003c/b\u003eв связи с данными об увеличении концентрации в плазме и уменьшении плазменного клиренса доксиламина, рекомендуется коррекция дозы в сторону уменьшения. \u003cb\u003eПациенты пожилого возраста старше 65 лет: \u003c/b\u003eблокаторы гистаминовых Н\u003csub\u003e1\u003c/sub\u003e-рецепторов следует с осторожностью назначать данной группе пациентов в связи с возможным головокружением и замедленными реакциями с опасностью падения (например, при ночных пробуждениях после приема снотворных). Ввиду данных об увеличении концентрации в плазме, уменьшении плазменного клиренса и увеличении T\u003csub\u003e1/2\u003c/sub\u003e рекомендуется коррекция дозы в сторону уменьшения."}}]},{"id":5,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы: \u003c/i\u003eзапор, сухость во рту. \u003ci\u003eСо стороны сердечно-сосудистой системы: \u003c/i\u003eощущение сердцебиения. \u003ci\u003eСо стороны органа зрения: \u003c/i\u003eнарушения зрения и аккомодации, нечеткое зрение. \u003ci\u003eСо стороны мочевыделительной системы: \u003c/i\u003eзадержка мочи. \u003ci\u003eСо стороны нервной системы: \u003c/i\u003eсонливость в дневное время (в этом случае доза препарата должна быть уменьшена); спутанность сознания, галлюцинации. \u003ci\u003eСо стороны костно-мышечной системы:\u003c/i\u003e рабдомиолиз. \u003ci\u003eСо стороны лабораторных показателей:\u003c/i\u003e увеличение уровня КФК. Если любые из указанных выше побочных эффектов усугубляются или появляются другие побочные эффекты, не указанные в инструкции, пациент должен сообщить об этом врачу."}}]},{"id":16,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы: \u003c/i\u003eдневная сонливость, возбуждение, расширение зрачка (мидриаз), нарушения аккомодации, сухость во рту, покраснение кожи лица и шеи (гиперемия), повышение температуры тела (гипертермия), синусовая тахикардия, расстройство сознания, галлюцинации, снижение настроения, тревога, нарушение координации движений, дрожь (тремор), непроизвольные движения (атетоз), судороги (эпилептический синдром), кома. Непроизвольные движения иногда являются предвестниками судорог, что может свидетельствовать о тяжелой степени отравления. Даже при отсутствии судорог тяжелые отравления доксиламином могут вызвать развитие рабдомиолиза, который часто сопровождается острой почечной недостаточностью. В таких случаях показана стандартная терапия с постоянным контролем уровня КФК. При появлении симптомов отравления следует немедленно обратиться к врачу. \u003ci\u003eЛечение:\u003c/i\u003e симптоматическое (м-холиномиметики и др.), в качестве средства первой помощи показан прием активированного угля (в количестве 50 г - для взрослых и 1 г/кг массы тела для детей)."}}]},{"id":17,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном приеме препарата Донормил\u003csup\u003e®\u003c/sup\u003e с седативными антидепрессантами (амитриптилин, доксепин, миансерин, миртазапин, тримипрамин), барбитуратами, бензодиазепинами, клонидином, производными морфина (анальгетиками, противокашлевыми препаратами), нейролептиками, анксиолитиками, блокаторами гистаминовых Н\u003csub\u003e1\u003c/sub\u003e-рецепторов с седативным действием, центральными антигипертензивными препаратами, талидомидом, баклофеном, пизотифеном усиливается угнетающее действие на ЦНС. При одновременном приеме с м-холиноблокирующими средствами (атропин, имипраминовые антидепрессанты, антипаркинсонические препараты, атропиновые спазмолитики, дизопирамид, фенотиазиновые нейролептики) повышается риск возникновения таких побочных эффектов, как задержка мочи, запор, сухость во рту. Т.к. алкоголь усиливает седативный эффект большинства блокаторов гистаминовых Н\u003csub\u003e1\u003c/sub\u003e-рецепторов, в т.ч. и препарата Донормил\u003csup\u003e®\u003c/sup\u003e, необходимо избегать его одновременного употребления с алкогольными напитками и лекарственными препаратами, содержащими алкоголь."}}]},{"id":6,"name":"Особые указания","slug":"","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Следует принимать во внимание, что бессонница может быть вызвана рядом причин, при которых нет необходимости в назначении данного лекарственного препарата. Препарат оказывает седативное действие, подавляет когнитивные способности и замедляет психомоторные реакции. Первое поколение блокаторов гистаминовых H\u003csub\u003e1\u003c/sub\u003e-рецепторов может оказывать м-холиноблокирующий, α-адреноблокирующий и антисеротониновый эффекты, что может вызывать сухость во рту, запор, задержку мочи, нарушения аккомодации и зрения. Как все снотворные или седативные препараты, доксиламина сукцинат может усугублять синдром ночного апноэ (внезапная остановка дыхания во сне) - увеличивая число и продолжительность приступов апноэ. Возможное злоупотребление блокаторами гистаминовых H\u003csub\u003e1\u003c/sub\u003e-рецепторов первого поколения, включая доксиламин, может приводить к физической и психологической зависимости, о которой сообщалось на фоне преднамеренного приема более высоких доз препарата, чем рекомендованные. В одной таблетке препарата содержится 100 мг лактозы моногидрата, что следует принимать во внимание у пациентов с редкой врожденной непереносимостью галактозы, дефицитом лактазы lapp или глюкозо-галактозной мальабсорбцией."}}]},{"id":18,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В связи с возможной сонливостью в дневное время суток следует избегать управления автотранспортом, работы с механизмами и иных видов деятельности, требующих быстрых психических и двигательных реакций."}}]},{"id":19,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Таблетки."}}]},{"id":7,"name":"Условия хранения","slug":"storage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При температуре 15–25°C. Хранить в недоступном для детей месте."}}]},{"id":8,"name":"Срок годности","slug":"expiry_date","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"3 года. 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