одновременное применение с сильными ингибиторами изоферментов CYP1A2 (в т.ч. флувоксамин или ципрофлоксацин);
повышенная чувствительность к тизанидину или к любому другому компоненту препарата.
Инструкция
Состав
Таблетки белого или белого с желтоватым оттенком цвета, с фаской; круглые, плоскоцилиндрические.
1 таб.
тизанидиа гидрохлорид 2.288 мг,
что соответствует содержанию тизанидина 2 мг
Фармакологические свойства
Миорелаксирующее, центральное.
Оказывает также центральный умеренно выраженный анальгезирующий эффект.
На уровне промежуточных нейронов спинного мозга происходит подавление полисинаптической передачи возбуждения.
Эффективен при хронической спастичности спинального и церебрального генеза.
Уменьшает спастичность и клонические судороги, вследствие чего снижается сопротивление пассивным движениям и увеличивается объем активных движений.
Показания к применению
Болезненный мышечный спазм:
связанный со статическими и функциональными заболеваниями позвоночника (шейный и поясничный синдромы);
после хирургических вмешательств, например, по поводу грыжи межпозвонкового диска или остеоартроза тазобедренного сустава.
Спастичность скелетных мышц при неврологических заболеваниях, например, при:
рассеянном склерозе;
хронической миелопатии;
дегенеративных заболеваниях спинного мозга;
последствиях нарушений мозгового кровообращения;
детском церебральном параличе (пациенты старше 18 лет).
Код МКБ-10 Показание
S06 Внутричерепная травма
R25.2 Судорога и спазм
I63 Инфаркт мозга
G83.9 Паралитический синдром неуточненный
G35 Рассеянный склероз
Противопоказания
Выраженные нарушения функции печени;
одновременное применение с сильными ингибиторами изоферментов CYP1A2 (в т.ч. флувоксамин или ципрофлоксацин);
повышенная чувствительность к тизанидину или к любому другому компоненту препарата.
Способ применения и дозы
Внутрь, дозы следует подбирать индивидуально.
При болезненном мышечном спазме назначают в дозе 2 мг или 4 мг 3 раза в сутки.
В тяжелых случаях перед сном можно дополнительно принять 2 мг или 4 мг.
При спастичности скелетных мышц, обусловленной неврологическими заболеваниями, начальная суточная доза не должна превышать 6 мг разделенных на 3 приема.
Дозу можно повышать постепенно, на 2-4 мг, с интервалами от 3-4 до 7 дней.
Обычно оптимальный терапевтический эффект достигается при суточной дозе от 12 до 24 мг разделенной на 3 или 4 приема через равные промежутки времени.
Не следует превышать дозу 36 мг в сутки.
Лечение больных с почечной недостаточностью ( клиренс креатинина менее 25 мл/мин) рекомендуется начинать с дозы 2 мг 1 раз в день.
Повышение дозы проводят малыми *шагами* с учетом переносимости и эффективности.
Если необходимо получить более выраженный эффект, рекомендуется сначала увеличить дозу, назначаемую 1 раз в сутки, после чего увеличивают кратность назначения.
Побочное действие
Со стороны нервной системы: часто - сонливость, слабость, головокружение; редко - галлюцинации, бессонница, нарушения сна.
Со стороны сердечно-сосудистой системы: часто - брадикардия, снижение АД; в отдельных случаях - выраженное снижение АД вплоть до коллапса и потери сознания.
Со стороны пищеварительной системы: часто - сухость во рту; редко - тошнота, желудочно-кишечные расстройства, повышение активности печеночных трансаминаз; очень редко - гепатит, печеночная недостаточность.
Со стороны костно-мышечной системы: редко - мышечная слабость.
Прочие: часто - повышенная утомляемость.
При приеме в малых дозах, рекомендуемых для купирования болезненного мышечного спазма, отмечались сонливость, повышенная утомляемость, головокружение, сухость во рту, снижение АД, тошнота, желудочно-кишечные расстройства, повышение активности печеночных трансаминаз. Обычно вышеописанные реакции умеренно выражены и преходящи.
При приеме в более высоких дозах, рекомендуемых для лечения спастичности, вышеперечисленные побочные реакции возникают чаще и более выражены, однако они редко бывают настолько тяжелыми, чтобы лечение пришлось прервать. Кроме того могут возникать следующие явления: снижение АД, брадикардия, мышечная слабость, бессонница, нарушение сна, галлюцинации, гепатит.
Передозировка
Симптомы: тошнота, рвота, снижение АД, головокружение, сонливость, миоз, беспокойство, нарушение дыхания, кома.
Лечение: для выведения препарата из организма рекомендуется многократное назначение активированного угля. Форсированный диурез также, возможно, ускорит выведение. В дальнейшем проводят симптоматическое лечение.
Взаимодействие с другими лекарственными средствами
Одновременное применение тизанидина и флувоксамина, ингибитора цитохрома Р450 1А2 приводит к 33-кратному увеличению концентрации тизанидина.
Одновременное назначение препарата с антигипертензивными препаратами, включая мочегонные, иногда может вызывать снижение АД и брадикардию.
Алкоголь или седативные препараты могут усилить седативное действие препарата, поэтому не рекомендуется одновременное применение с другими седативными препаратами и/или алкоголем.
По данным литературы одновременный прием пероральных контрацептивов и тизанидина приводит к значительному снижению клиренса тизанидина.
Особые указания
Рекомендуется контролировать функциональные печеночные пробы 1 раз в месяц в первые 4 месяца лечения у тех пациентов, которым назначается тизанидин в суточной дозе 12 мг и выше, а также в тех случаях, когда наблюдаются клинические признаки, позволяющие предположить нарушение функции печени, - такие как необъяснимая тошнота, анорексия, чувство усталости.
В случае, когда уровни АЛТ и АСТ в сыворотке стойко превышают верхнюю границу нормы в 3 раза и более, применение препарата следует прекратить.
Не следует резко отменять препарат в форме 6 мг, дозу препарата снижают постепенно.
При резкой его отмене после продолжительного лечения и/или приема высоких доз препарата (а также после одновременного применения с антигипертензивными лекарственными средствами) отмечалось развитие тахикардии и повышение АД, в отдельных случаях могущее привести к острому нарушению мозгового кровообращения.
Больным, у которых отмечается сонливость, следует воздержаться от видов работ, требующих высокой концентрации внимания и быстрой реакции, например, вождения транспортных средств или работы с машинами и механизмами.
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