Противоэпилептическое средство. По химической структуре имее... Инструкция
Показания к применению
Лечение нейропатической боли у взрослых (18 лет и старше). Эффективность и безопасность у пациентов в возрасте до 18 лет не установлены; монотерапия парциальных судорог при эпилепсии со вторичной генерализацией и без нее у взрослых и детей в возрасте старше 12 лет. Эффективность и безопасность монотерапии у детей в возрасте до 12 лет не установлены; ...
Противоэпилептическое средство. По химической структуре имеет сходство с GABA, выполняющей функцию тормозного медиатора в ЦНС. Полагают, что механизм действия габапентина отличается от других противосудорожных средств, действующих через синапсы GABA (включая вальпроат, барбитураты, бензодиазепины, ингибиторы GABA-трансаминазы, ингибиторы захвата GABA, агонисты GABA и пролекарства GABA). В исследованиях in vitro показано, что габапентин характеризуется наличием нового пептидного места связывания в тканях мозга крыс, включая гиппокамп и кору головного мозга, которое может иметь отношение к противосудорожной активности габапентина и его производных. Габапентин в клинически значимых концентрациях не связывается с другими обычными препаратами и нейромедиаторными рецепторами в мозге, в т.ч. с GABAA-, GABAB-, бензодиазепиновыми рецепторами, с NMDA-рецепторами.; Окончательно механизм действия габапентина не установлен.
Показания к применению
Лечение нейропатической боли у взрослых (18 лет и старше). Эффективность и безопасность у пациентов в возрасте до 18 лет не установлены; монотерапия парциальных судорог при эпилепсии со вторичной генерализацией и без нее у взрослых и детей в возрасте старше 12 лет. Эффективность и безопасность монотерапии у детей в возрасте до 12 лет не установлены; в качестве дополнительного средства при лечении парциальных судорог при эпилепсии со вторичной генерализацией и без нее у взрослых и детей в возрасте 3 лет и старше. Безопасность и эффективность дополнительной терапии габапентином у детей в возрасте менее 3 лет не установлены.
Противопоказания
детский возраст до 3 лет; повышенная чувствительность к габапентину или вспомогательным компонентам препарата.
С осторожностью следует назначать препарат при почечной недостаточности
Применение при нарушениях функции почек; С осторожностью следует назначать препарат при почечной недостаточности.
Пациентам, находящимся на гемодиализе, которые ранее не принимали габапентин, препарат рекомендуется назначать в насыщающей дозе 300-400 мг, а затем применять его по 200-300 мг каждые 4 ч гемодиализа.
Применение при беременности и в период грудного вскармливания
Адекватных и строго контролируемых исследований по безопасности применения габапентина при беременности и в период лактации у человека не проводилось. При необходимости применения при беременности и в период лактации следует тщательно взвесить ожидаемую пользу терапии для матери и потенциальный риск для плода или грудного ребенка.; Габапентин выделяется с грудным молоком. При применении в период лактации характер действия габапентина на грудного ребенка не установлен.
Способ применения и дозы
Препарат Катэна; назначают внутрь, независимо от приема пищи. Если необходимо снизить дозу, отменить препарат или заменить его на альтернативное средство, это следует делать постепенно в течение минимум одной недели.; Нейропатическая боль у взрослых; Начальная суточная доза составляет 900 мг (в 3 приема равными дозами); при необходимости, в зависимости от эффекта, дозу постепенно увеличивают до максимальной - 3.6 г/сут. Лечение можно начинать сразу с дозы 900 мг/сут (по 300 мг 3 раза/сут) или в течение первых 3-х дней дозу можно увеличивать постепенно до 900 мг в сутки по следующей схеме: 1-й день: 300 мг 1 раз/сут; 2-й день: по 300 мг 2 раза/сут; 3-й день: по 300 мг 3 раза/сут.; Парциальные судороги; Взрослые и дети в возрасте старше 12 лет; Эффективная доза - от 900 мг до 3.6 г в сутки. Терапию можно начать с дозы 300 мг 3 раза/сут в 1-й день или увеличивать постепенно до 900 мг по схеме, описанной выше (см. раздел Нейропатическая боль у взрослых). В последующем доза может быть увеличена до максимальной - 3.6 г/сут в 3 приема равными дозами. Максимальный интервал между дозами при трехкратном приеме препарата не должен превышать 12 ч во избежание возобновления судорог. Отмечена хорошая переносимость препарата в дозах до 4.8 г/сут.; Дети в возрасте 3-12 лет; Начальная доза препарата варьирует от 10 до 15 мг/кг/сут, которую назначают равными дозами 3 раза/сут и повышают до эффективной приблизительно в течение 3-х дней. Эффективная доза габапентина у детей в возрасте 5 лет и старшесоставляет 25-35 мг/кг/сут равными дозами в 3 приема. Эффективная доза габапентина у детей в возрасте от 3 до 5 лет составляет 40 мг/кг/сут равными дозами в 3 приема. Отмечена хорошая переносимость препарата в дозах до 50 мг/кг/сут при длительном применении. Максимальный интервал между приемом доз препарата не должен превышать 12 ч во избежание возобновления судорог.; Нет необходимости контролировать концентрацию габапентина в плазме. Препарат Катэна; может использоваться в комбинации с другими противосудорожными препаратами без учета изменения его концентрации в плазме или концентрации других противосудорожных препаратов в сыворотке.; Подбор дозы при почечной недостаточности; Пациентам с почечной недостаточностью рекомендуется снижение дозы габапентина согласно таблице.; Клиренс креатинина (мл/мин) Суточная доза (мг/сут)*;>80 900-3600; 50-79 600-1800; 30-49 300-900; 15-29 150**-600; 150**-300;* Суточную дозу следует назначать в 3 приема.; ** Назначают по 300 мг через день.; Пациентам, находящимся на гемодиализе, которые ранее не принимали габапентин, препарат рекомендуется назначать в насыщающей дозе 300-400 мг, а затем применять его по 200-300 мг каждые 4 ч гемодиализа.
Побочное действие
Со стороны сердечно-сосудистой системы: симптомы вазодилатации, гипертензия.; Со стороны пищеварительной системы: диспепсия, метеоризм, тошнота, рвота, боль в животе, запор, диарея, сухость во рту или глотке, анорексия, гингивит, заболевания зубов, увеличение аппетита, повышение активности печеночных трансаминаз.; Со стороны костно-мышечной системы: миалгия, артралгия, боль в спине, повышенная ломкость костей.; Со стороны нервной системы: сонливость, головокружение, атаксия, амнезия, спутанность сознания, нарушение координации, повышенная утомляемость, нарушение мышления, тремор, гипестезия, депрессия, дизартрия, бессонница, нервозность, нистагм, усиление, ослабление или отсутствие рефлексов, астения, тревожность, враждебность, гиперкинезия, эмоциональная лабильность.; Со стороны дыхательной системы: фарингит, ринит, одышка, кашель, пневмония, бронхит, респираторные инфекции.; Со стороны мочеполовой системы: инфекции мочевых путей, импотенция.; Со стороны органов чувств: нарушение зрения, амблиопия, диплопия.; Со стороны органов кроветворения: лейкопения, пурпура (чаще всего ее описывают как кровоподтеки, возникавшие при физической травме).; Аллергические реакции: кожная сыпь, зуд, акне.; Прочие: лихорадка, вирусная инфекция, увеличение массы тела, боль различной локализации, периферические отеки, отек лица, головная боль.; Пострегистрационный опыт применения; Зарегистрированы случаи внезапной необъяснимой смерти, связь которых с лечением габапентином не установлена.; Другие нежелательные явления: острая почечная недостаточность, аллергические реакции, включая крапивницу, алопеция, ангионевротический отек, генерализованный отек; колебания концентрации глюкозы в крови у больных сахарным диабетом, боль в груди, увеличение в объеме молочных желез, гинекомастия, повышение показателей функции печени, многоформная экссудативная эритема (в т.ч. синдром Стивенса-Джонсона), галлюцинации, двигательные расстройства, такие как хореоатетоз, дискинезия и дистония, сердцебиение, панкреатит, шум в ушах, тромбоцитопения, недержание мочи, миоклонус.
Передозировка
В настоящее время о случаях передозировки препарата не сообщалось.
Особые указания
Резкое прекращение терапии противосудорожными средствами у больных с парциальными судорогами может провоцировать судорожный статус. В случае необходимости снижать дозу, отменять габапентин или заменять его на альтернативное средство следует постепенно в течение минимум 1 недели.; Габапентин не является эффективным средством для лечения абсансных судорожных припадков.; При совместном применении с другими противосудорожными средствами были зарегистрированы ложно-положительные результаты теста определения белка в моче. Для определения белка в моче рекомендуется пользоваться более специфичным методом преципитации сульфосалициловой кислоты.; Пациентам с нарушениями функции почек, а также больным, находящимся на гемодиализе требуется коррекция режима дозирования.; Пациентам пожилого возраста может потребоваться коррекция режима дозирования габапентина в связи с тем, что у этой категории больных возможно уменьшение почечного клиренса.; Эффективность и безопасность терапии нейропатической боли у пациентов в возрасте до 18 лет не установлены.; Эффективность и безопасность монотерапии габапентином при лечении парциальных судорог у детей в возрасте до 12 лет и дополнительной терапии габапентином при лечении парциальных судорог у детей в возрасте до 3 лет не установлены.; В период лечения не допускать употребления алкоголя.; Влияние на способность к вождению автотранспорта и управлению механизмами; До определения индивидуальной реакции на лечение пациент должен воздерживаться от потенциально опасных видов деятельности, связанных с необходимостью концентрации внимания и повышенной скорости психомоторных реакций.
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300 мг.; Вспомогательные вещества: лактозы моногидрат, крахмал кукурузный, тальк.; Состав оболочки капсулы: титана диоксид (Е171), краситель железа оксид желтый (Е172), желатин."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противоэпилептическое средство. По химической структуре имеет сходство с GABA, выполняющей функцию тормозного медиатора в ЦНС. Полагают, что механизм действия габапентина отличается от других противосудорожных средств, действующих через синапсы GABA (включая вальпроат, барбитураты, бензодиазепины, ингибиторы GABA-трансаминазы, ингибиторы захвата GABA, агонисты GABA и пролекарства GABA). В исследованиях in vitro показано, что габапентин характеризуется наличием нового пептидного места связывания в тканях мозга крыс, включая гиппокамп и кору головного мозга, которое может иметь отношение к противосудорожной активности габапентина и его производных. Габапентин в клинически значимых концентрациях не связывается с другими обычными препаратами и нейромедиаторными рецепторами в мозге, в т.ч. с GABAA-, GABAB-, бензодиазепиновыми рецепторами, с NMDA-рецепторами.; Окончательно механизм действия габапентина не установлен."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение нейропатической боли у взрослых (18 лет и старше). Эффективность и безопасность у пациентов в возрасте до 18 лет не установлены; монотерапия парциальных судорог при эпилепсии со вторичной генерализацией и без нее у взрослых и детей в возрасте старше 12 лет. Эффективность и безопасность монотерапии у детей в возрасте до 12 лет не установлены; в качестве дополнительного средства при лечении парциальных судорог при эпилепсии со вторичной генерализацией и без нее у взрослых и детей в возрасте 3 лет и старше. Безопасность и эффективность дополнительной терапии габапентином у детей в возрасте менее 3 лет не установлены."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"детский возраст до 3 лет; повышенная чувствительность к габапентину или вспомогательным компонентам препарата."}},{"type":"paragraph","data":{"text":"С осторожностью следует назначать препарат при почечной недостаточности"}},{"type":"paragraph","data":{"text":"Применение при нарушениях функции почек; С осторожностью следует назначать препарат при почечной недостаточности."}},{"type":"paragraph","data":{"text":"Пациентам, находящимся на гемодиализе, которые ранее не принимали габапентин, препарат рекомендуется назначать в насыщающей дозе 300-400 мг, а затем применять его по 200-300 мг каждые 4 ч гемодиализа."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Адекватных и строго контролируемых исследований по безопасности применения габапентина при беременности и в период лактации у человека не проводилось. При необходимости применения при беременности и в период лактации следует тщательно взвесить ожидаемую пользу терапии для матери и потенциальный риск для плода или грудного ребенка.; Габапентин выделяется с грудным молоком. При применении в период лактации характер действия габапентина на грудного ребенка не установлен."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат Катэна; назначают внутрь, независимо от приема пищи. Если необходимо снизить дозу, отменить препарат или заменить его на альтернативное средство, это следует делать постепенно в течение минимум одной недели.; Нейропатическая боль у взрослых; Начальная суточная доза составляет 900 мг (в 3 приема равными дозами); при необходимости, в зависимости от эффекта, дозу постепенно увеличивают до максимальной - 3.6 г/сут. Лечение можно начинать сразу с дозы 900 мг/сут (по 300 мг 3 раза/сут) или в течение первых 3-х дней дозу можно увеличивать постепенно до 900 мг в сутки по следующей схеме: 1-й день: 300 мг 1 раз/сут; 2-й день: по 300 мг 2 раза/сут; 3-й день: по 300 мг 3 раза/сут.; Парциальные судороги; Взрослые и дети в возрасте старше 12 лет; Эффективная доза - от 900 мг до 3.6 г в сутки. Терапию можно начать с дозы 300 мг 3 раза/сут в 1-й день или увеличивать постепенно до 900 мг по схеме, описанной выше (см. раздел Нейропатическая боль у взрослых). В последующем доза может быть увеличена до максимальной - 3.6 г/сут в 3 приема равными дозами. Максимальный интервал между дозами при трехкратном приеме препарата не должен превышать 12 ч во избежание возобновления судорог. Отмечена хорошая переносимость препарата в дозах до 4.8 г/сут.; Дети в возрасте 3-12 лет; Начальная доза препарата варьирует от 10 до 15 мг/кг/сут, которую назначают равными дозами 3 раза/сут и повышают до эффективной приблизительно в течение 3-х дней. Эффективная доза габапентина у детей в возрасте 5 лет и старшесоставляет 25-35 мг/кг/сут равными дозами в 3 приема. Эффективная доза габапентина у детей в возрасте от 3 до 5 лет составляет 40 мг/кг/сут равными дозами в 3 приема. Отмечена хорошая переносимость препарата в дозах до 50 мг/кг/сут при длительном применении. Максимальный интервал между приемом доз препарата не должен превышать 12 ч во избежание возобновления судорог.; Нет необходимости контролировать концентрацию габапентина в плазме. Препарат Катэна; может использоваться в комбинации с другими противосудорожными препаратами без учета изменения его концентрации в плазме или концентрации других противосудорожных препаратов в сыворотке.; Подбор дозы при почечной недостаточности; Пациентам с почечной недостаточностью рекомендуется снижение дозы габапентина согласно таблице.; Клиренс креатинина (мл/мин) Суточная доза (мг/сут)*;\u003e80 900-3600; 50-79 600-1800; 30-49 300-900; 15-29 150**-600; 150**-300;* Суточную дозу следует назначать в 3 приема.; ** Назначают по 300 мг через день.; Пациентам, находящимся на гемодиализе, которые ранее не принимали габапентин, препарат рекомендуется назначать в насыщающей дозе 300-400 мг, а затем применять его по 200-300 мг каждые 4 ч гемодиализа."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: симптомы вазодилатации, гипертензия.; Со стороны пищеварительной системы: диспепсия, метеоризм, тошнота, рвота, боль в животе, запор, диарея, сухость во рту или глотке, анорексия, гингивит, заболевания зубов, увеличение аппетита, повышение активности печеночных трансаминаз.; Со стороны костно-мышечной системы: миалгия, артралгия, боль в спине, повышенная ломкость костей.; Со стороны нервной системы: сонливость, головокружение, атаксия, амнезия, спутанность сознания, нарушение координации, повышенная утомляемость, нарушение мышления, тремор, гипестезия, депрессия, дизартрия, бессонница, нервозность, нистагм, усиление, ослабление или отсутствие рефлексов, астения, тревожность, враждебность, гиперкинезия, эмоциональная лабильность.; Со стороны дыхательной системы: фарингит, ринит, одышка, кашель, пневмония, бронхит, респираторные инфекции.; Со стороны мочеполовой системы: инфекции мочевых путей, импотенция.; Со стороны органов чувств: нарушение зрения, амблиопия, диплопия.; Со стороны органов кроветворения: лейкопения, пурпура (чаще всего ее описывают как кровоподтеки, возникавшие при физической травме).; Аллергические реакции: кожная сыпь, зуд, акне.; Прочие: лихорадка, вирусная инфекция, увеличение массы тела, боль различной локализации, периферические отеки, отек лица, головная боль.; Пострегистрационный опыт применения; Зарегистрированы случаи внезапной необъяснимой смерти, связь которых с лечением габапентином не установлена.; Другие нежелательные явления: острая почечная недостаточность, аллергические реакции, включая крапивницу, алопеция, ангионевротический отек, генерализованный отек; колебания концентрации глюкозы в крови у больных сахарным диабетом, боль в груди, увеличение в объеме молочных желез, гинекомастия, повышение показателей функции печени, многоформная экссудативная эритема (в т.ч. синдром Стивенса-Джонсона), галлюцинации, двигательные расстройства, такие как хореоатетоз, дискинезия и дистония, сердцебиение, панкреатит, шум в ушах, тромбоцитопения, недержание мочи, миоклонус."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"В настоящее время о случаях передозировки препарата не сообщалось."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Резкое прекращение терапии противосудорожными средствами у больных с парциальными судорогами может провоцировать судорожный статус. В случае необходимости снижать дозу, отменять габапентин или заменять его на альтернативное средство следует постепенно в течение минимум 1 недели.; Габапентин не является эффективным средством для лечения абсансных судорожных припадков.; При совместном применении с другими противосудорожными средствами были зарегистрированы ложно-положительные результаты теста определения белка в моче. Для определения белка в моче рекомендуется пользоваться более специфичным методом преципитации сульфосалициловой кислоты.; Пациентам с нарушениями функции почек, а также больным, находящимся на гемодиализе требуется коррекция режима дозирования.; Пациентам пожилого возраста может потребоваться коррекция режима дозирования габапентина в связи с тем, что у этой категории больных возможно уменьшение почечного клиренса.; Эффективность и безопасность терапии нейропатической боли у пациентов в возрасте до 18 лет не установлены.; Эффективность и безопасность монотерапии габапентином при лечении парциальных судорог у детей в возрасте до 12 лет и дополнительной терапии габапентином при лечении парциальных судорог у детей в возрасте до 3 лет не установлены.; В период лечения не допускать употребления алкоголя.; Влияние на способность к вождению автотранспорта и управлению механизмами; До определения индивидуальной реакции на лечение пациент должен воздерживаться от потенциально опасных видов деятельности, связанных с необходимостью концентрации внимания и повышенной скорости психомоторных реакций."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Противоэпилептическое средство. 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