метилпарагидроксибензоат - 0.1 г, пропилпарагидроксибензоат - 0.02 г, сахароза (67% раствор, в пересчете на сухое вещество) - 60 г, сорбитол 70% (кристаллизующийся) - 15 г, глицерол - 15 г, искусственный ароматизатор вишневый - 0.03 г, хлористоводородная кислота концентрированная или раствор натрия гидроксида концентрированный - q.s. до pH 7.3-7.7, вода очищенная - q.s. до 100 мл.
Фармакологические свойства
Противоэпилептический препарат широкого спектра действия. Вальпроат осуществляет действие преимущественно на центральную нервную систему. Фармакологические исследования на животных показали, что Депакин обладает антиконвульсивными свойствами в широком спектре экспериментальных эпилепсий (генерализованных и фокальных форм). У людей Депакин также проявил противоэпилептическую активность при различных типах эпилепсий. Основной механизм его действия, по-видимому, связан с усилением ГАМК-эргических метаболических путей. В нескольких экспериментах in vitro показано, что вальпроат натрия стимулирует репликацию вируса HIV-1; однако, это действие проявляется умеренно, непостоянно, не связано с дозой и не отмечалось у людей
Показания к применению
Взрослые
В качестве монотерапии или в комбинации с другими противоэпилептическими средствами:
лечение парциальных эпилептических приступов (парциальные приступы с вторичной генерализацией или без нее);
профилактика рецидивов фебрильных судорог при наличии в анамнезе одного или нескольких эпизодов судорог, обусловленных лихорадкой, если профилактика производными бензодиазепина неэффективна.
Противопоказания
Острый гепатит Хронический гепатит Сверхчувствительность к вальпроату натрия Печеночная порфирия
Применение при беременности и в период грудного вскармливания
Противопоказано
Способ применения и дозы
Данная лекарственная форма препарата Депакин® (сироп) преимущественно предназначена для приема детьми.
Препарат принимают внутрь. Препарат следует принимать только с помощью дозировочного шприца, находящегося в картонной пачке. На дозировочном шприце нанесена градуировка в миллиграммах вальпроата натрия.
После вскрытия флакона можно хранить при температуре не выше 25°С.
Дозу следует устанавливать с учетом возраста и массы тела пациента.
Суточную дозу рекомендуется делить:
на 2 приема пациентам в возрасте до 1 года;
на 3 приема пациентам в возрасте старше 1 года.
Начальная суточная доза для взрослых и детей с массой тела более 25 кг составляет обычно 5-10 мг/кг, затем ее повышают на 5 мг/кг каждые 4-7 дней до достижения оптимальной дозы, позволяющей предупреждать возникновение приступов эпилепсии.
Средняя суточная доза:
для детей (до 14 лет) - 30 мг/кг массы тела (предпочтителен прием препарата в форме сиропа);
для подростков 14-18 лет - 25 мг/кг массы тела (предпочтителен прием твердых лекарственных форм препарата Депакин®);
для взрослых и пациентов пожилого возраста (масса тела от 60 кг и выше) - 20 мг/кг массы тела (предпочтителен прием твердых лекарственных форм препарата Депакин®).
Таким образом, рекомендуются представленные ниже средние суточные дозы.
ВозрастМасса телаСредняя суточная доза* (мг/сут)Грудные дети 3-6 мес5.5-7.5 кг150 мгГрудные дети от 6 до 12 месОколо 7.5-10 кг150-300 мгДети от 1 до 3 летОколо 10-15 кг300-450 мгДети от 3 до 6 летОколо 15-25 кг450-750 мгДети от 7 до 14 летОколо 25-40 кг750-1200 мгПодростки от 14 летОколо 40-60 кг1000-1500 мгВзрослыеОт 60 кг и выше1200-2100 мг
* доза в пересчете на количество миллиграммов вальпроата натрия
Средняя суточная доза может быть увеличена под контролем концентрации вальпроевой кислоты в крови.
В некоторых случаях полный терапевтический эффект вальпроевой кислоты появляется не сразу, а развивается в течение 4-6 недель. Поэтому не следует увеличивать суточную дозу выше рекомендуемой средней суточной дозы раньше этого срока.
Хотя суточная доза определяется в зависимости от возраста и массы тела больного, следует принимать во внимание широкий спектр индивидуальной чувствительности к вальпроевой кислоте.
Четкой корреляции между суточной дозой, концентрацией вальпроевой кислоты в сыворотке крови и терапевтическим эффектом не установлено. Поэтому оптимальная доза препарата должна подбираться, главным образом, на основе клинического ответа. Определение концентрации вальпроевой кислоты в сыворотке крови может послужить дополнением к клиническому наблюдению, если эпилепсия не поддается контролю или подозревается развитие побочных эффектов. Обычно эффективными являются дозы, обеспечивающие сывороточные концентрации вальпроевой кислоты, составляющие 40-100 мг/л (300-700 мкмоль/л). При обоснованной необходимости достижения более высоких концентраций в сыворотке крови следует тщательно взвешивать соотношение ожидаемой пользы и риска возникновения побочных эффектов, в особенности дозозависимых, т.к. при сывороточных концентрациях вальпроевой кислоты свыше 100 мг/л ожидается увеличение побочных эффектов вплоть до развития интоксикации. Поэтому сывороточная концентрация, определяемая перед приемом первой дозы в сутки, не должна превышать 100 мг/л.
Для пациентов, принимавших ранее противоэпилептические препараты, перевод на прием препарата Депакин® сироп следует проводить постепенно, достигая оптимальной дозы препарата примерно в течение 2 недель. При этом сразу снижается доза принимавшегося ранее противоэпилептического препарата, особенно фенобарбитала. Если ранее принимавшийся противоэпилептический препарат отменяется, то его отмена должна проводиться постепенно.
При необходимости комбинации вальпроевой кислоты с другими противоэпилептическими средствами их следует добавлять постепенно.
Т.к. другие противоэпилептические препараты могут обратимо индуцировать микросомальные ферменты печени, следует в течение 4-6 недель после приема последней дозы этих противоэпилептических препаратов мониторировать концентрации вальпроевой кислоты в крови и, при необходимости (по мере уменьшения индуцирующего метаболизм эффекта этих препаратов), снижать суточную дозу препарата Депакин® сироп.
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Вальпроат осуществляет действие преимущественно на центральную нервную систему. Фармакологические исследования на животных показали, что Депакин обладает антиконвульсивными свойствами в широком спектре экспериментальных эпилепсий (генерализованных и фокальных форм). У людей Депакин также проявил противоэпилептическую активность при различных типах эпилепсий. Основной механизм его действия, по-видимому, связан с усилением ГАМК-эргических метаболических путей. В нескольких экспериментах in vitro показано, что вальпроат натрия стимулирует репликацию вируса HIV-1; однако, это действие проявляется умеренно, непостоянно, не связано с дозой и не отмечалось у людей"}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"\u003cb\u003eВзрослые\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"В качестве монотерапии или в комбинации с другими противоэпилептическими средствами:"}},{"type":"list","data":{"style":"ordered","items":["лечение генерализованных эпилептических приступов (клонические, тонические, тонико-клонические, абсансы, миоклонические, атонические);","синдром Леннокса-Гасто;","лечение парциальных эпилептических приступов (парциальные приступы с вторичной генерализацией или без нее)."]}},{"type":"paragraph","data":{"text":"\u003cb\u003eДети\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"В качестве монотерапии или в комбинации с другими противоэпилептическими средствами:"}},{"type":"list","data":{"style":"ordered","items":["лечение генерализованных эпилептических приступов (клонические, тонические, тонико-клонические, абсансы, миоклонические, атонические);","синдром Леннокса-Гасто;","лечение парциальных эпилептических приступов (парциальные приступы с вторичной генерализацией или без нее);","профилактика рецидивов фебрильных судорог при наличии в анамнезе одного или нескольких эпизодов судорог, обусловленных лихорадкой, если профилактика производными бензодиазепина неэффективна."]}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Острый гепатит Хронический гепатит Сверхчувствительность к вальпроату натрия Печеночная порфирия"}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказано"}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Данная лекарственная форма препарата Депакин\u003csup\u003e®\u003c/sup\u003e (сироп) преимущественно предназначена для приема детьми."}},{"type":"paragraph","data":{"text":"Препарат принимают внутрь. Препарат следует принимать только с помощью дозировочного шприца, находящегося в картонной пачке. На дозировочном шприце нанесена градуировка в миллиграммах вальпроата натрия."}},{"type":"paragraph","data":{"text":"После вскрытия флакона можно хранить при температуре не выше 25°С."}},{"type":"paragraph","data":{"text":"Дозу следует устанавливать с учетом возраста и массы тела пациента."}},{"type":"paragraph","data":{"text":"Суточную дозу рекомендуется делить:"}},{"type":"list","data":{"style":"ordered","items":["на 2 приема пациентам в \u003cb\u003eвозрасте до 1 года\u003c/b\u003e;","на 3 приема пациентам в \u003cb\u003eвозрасте старше 1 года\u003c/b\u003e."]}},{"type":"paragraph","data":{"text":"Начальная суточная доза для \u003cb\u003eвзрослых и детей с массой тела более 25 кг\u003c/b\u003e составляет обычно 5-10 мг/кг, затем ее повышают на 5 мг/кг каждые 4-7 дней до достижения оптимальной дозы, позволяющей предупреждать возникновение приступов эпилепсии."}},{"type":"paragraph","data":{"text":"Средняя суточная доза:"}},{"type":"list","data":{"style":"ordered","items":["для \u003cb\u003eдетей (до 14 лет)\u003c/b\u003e - 30 мг/кг массы тела (предпочтителен прием препарата в форме сиропа);","для \u003cb\u003eподростков 14-18 лет\u003c/b\u003e - 25 мг/кг массы тела (предпочтителен прием твердых лекарственных форм препарата Депакин\u003csup\u003e®\u003c/sup\u003e);","для \u003cb\u003eвзрослых и пациентов пожилого возраста (масса тела от 60 кг и выше)\u003c/b\u003e - 20 мг/кг массы тела (предпочтителен прием твердых лекарственных форм препарата Депакин\u003csup\u003e®\u003c/sup\u003e)."]}},{"type":"paragraph","data":{"text":"Таким образом, рекомендуются представленные ниже средние суточные дозы."}},{"type":"paragraph","data":{"text":"\u003cb\u003eВозраст\u003c/b\u003e\u003cb\u003eМасса тела\u003c/b\u003e\u003cb\u003eСредняя суточная доза* (мг/сут)\u003c/b\u003eГрудные дети 3-6 мес5.5-7.5 кг150 мгГрудные дети от 6 до 12 месОколо 7.5-10 кг150-300 мгДети от 1 до 3 летОколо 10-15 кг300-450 мгДети от 3 до 6 летОколо 15-25 кг450-750 мгДети от 7 до 14 летОколо 25-40 кг750-1200 мгПодростки от 14 летОколо 40-60 кг1000-1500 мгВзрослыеОт 60 кг и выше1200-2100 мг"}},{"type":"paragraph","data":{"text":"* доза в пересчете на количество миллиграммов вальпроата натрия"}},{"type":"paragraph","data":{"text":"Средняя суточная доза может быть увеличена под контролем концентрации вальпроевой кислоты в крови."}},{"type":"paragraph","data":{"text":"В некоторых случаях полный терапевтический эффект вальпроевой кислоты появляется не сразу, а развивается в течение 4-6 недель. Поэтому не следует увеличивать суточную дозу выше рекомендуемой средней суточной дозы раньше этого срока."}},{"type":"paragraph","data":{"text":"Хотя суточная доза определяется в зависимости от возраста и массы тела больного, следует принимать во внимание широкий спектр индивидуальной чувствительности к вальпроевой кислоте."}},{"type":"paragraph","data":{"text":"Четкой корреляции между суточной дозой, концентрацией вальпроевой кислоты в сыворотке крови и терапевтическим эффектом не установлено. Поэтому оптимальная доза препарата должна подбираться, главным образом, на основе клинического ответа. Определение концентрации вальпроевой кислоты в сыворотке крови может послужить дополнением к клиническому наблюдению, если эпилепсия не поддается контролю или подозревается развитие побочных эффектов. Обычно эффективными являются дозы, обеспечивающие сывороточные концентрации вальпроевой кислоты, составляющие 40-100 мг/л (300-700 мкмоль/л). При обоснованной необходимости достижения более высоких концентраций в сыворотке крови следует тщательно взвешивать соотношение ожидаемой пользы и риска возникновения побочных эффектов, в особенности дозозависимых, т.к. при сывороточных концентрациях вальпроевой кислоты свыше 100 мг/л ожидается увеличение побочных эффектов вплоть до развития интоксикации. Поэтому сывороточная концентрация, определяемая перед приемом первой дозы в сутки, не должна превышать 100 мг/л."}},{"type":"paragraph","data":{"text":"Для пациентов, принимавших ранее противоэпилептические препараты, перевод на прием препарата Депакин\u003csup\u003e®\u003c/sup\u003e сироп следует проводить постепенно, достигая оптимальной дозы препарата примерно в течение 2 недель. При этом сразу снижается доза принимавшегося ранее противоэпилептического препарата, особенно фенобарбитала. Если ранее принимавшийся противоэпилептический препарат отменяется, то его отмена должна проводиться постепенно."}},{"type":"paragraph","data":{"text":"При необходимости комбинации вальпроевой кислоты с другими противоэпилептическими средствами их следует добавлять постепенно."}},{"type":"paragraph","data":{"text":"Т.к. другие противоэпилептические препараты могут обратимо индуцировать микросомальные ферменты печени, следует в течение 4-6 недель после приема последней дозы этих противоэпилептических препаратов мониторировать концентрации вальпроевой кислоты в крови и, при необходимости (по мере уменьшения индуцирующего метаболизм эффекта этих препаратов), снижать суточную дозу препарата Депакин\u003csup\u003e®\u003c/sup\u003e сироп."}}]},{"id":8,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказано при индивидуальной непереносимости компонентов."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Противоэпилептический препарат широкого спектра действия. 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