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Лекарственный препарат Сирдалуд МР

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            [DETAIL_TEXT_TYPE] => text
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            [WF_NEW] => 
            [LOCK_STATUS] => green
            [WF_LOCKED_BY] => 
            [WF_DATE_LOCK] => 
            [WF_COMMENTS] => 
            [IN_SECTIONS] => N
            [SHOW_COUNTER] => 
            [SHOW_COUNTER_START] => 
            [SHOW_COUNTER_START_X] => 
            [CODE] => 
            [TAGS] => 
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            [EXTERNAL_ID] => 22801
            [TMP_ID] => 9a14b78125ae1d5a8cfdcd61a2f573ed
            [USER_NAME] => (Midnik) Ivan VIS
            [LOCKED_USER_NAME] => 
            [CREATED_USER_NAME] => (Midnik) Ivan VIS
            [LANG_DIR] => /
            [LID] => s1
            [IBLOCK_TYPE_ID] => offers
            [IBLOCK_CODE] => offers
            [IBLOCK_NAME] => Торговые предложения
            [IBLOCK_EXTERNAL_ID] => 
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            [LIST_PAGE_URL] => /catalog/
            [CANONICAL_PAGE_URL] => 
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            [BP_PUBLISHED] => Y
            [PROPERTIES] => Array
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                            [PROPERTY_TYPE] => N
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                            [XML_ID] => 
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                            [VERSION] => 1
                            [USER_TYPE] => 
                            [USER_TYPE_SETTINGS] => 
                            [HINT] => 
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                            [TIMESTAMP_X] => 2019-10-14 16:10:42
                            [IBLOCK_ID] => 26
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                            [XML_ID] => 
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                            [VERSION] => 1
                            [USER_TYPE] => 
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                            [XML_ID] => 
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                            [VERSION] => 1
                            [USER_TYPE] => 
                            [USER_TYPE_SETTINGS] => 
                            [HINT] => 
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                    [COLOR] => Array
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                            [IBLOCK_ID] => 26
                            [NAME] => Цвет
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                            [SORT] => 500
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                            [XML_ID] => 
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                            [TMP_ID] => 
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                            [WITH_DESCRIPTION] => N
                            [SEARCHABLE] => N
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                            [VERSION] => 1
                            [USER_TYPE] => directory
                            [USER_TYPE_SETTINGS] => Array
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                                    [width] => 0
                                    [group] => N
                                    [multiple] => N
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                            [XML_ID] => 
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                            [SORT] => 500
                            [CODE] => NAME
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                            [LIST_TYPE] => L
                            [MULTIPLE] => N
                            [XML_ID] => 
                            [FILE_TYPE] => 
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                            [TMP_ID] => 
                            [LINK_IBLOCK_ID] => 0
                            [WITH_DESCRIPTION] => N
                            [SEARCHABLE] => N
                            [FILTRABLE] => N
                            [IS_REQUIRED] => N
                            [VERSION] => 1
                            [USER_TYPE] => 
                            [USER_TYPE_SETTINGS] => 
                            [HINT] => 
                            [PROPERTY_VALUE_ID] => 
                            [VALUE] => 
                            [DESCRIPTION] => 
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                            [VALUE_XML_ID] => 
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                            [~DESCRIPTION] => 
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                    [URL] => Array
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                            [NAME] => URL
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                            [CODE] => URL
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                            [COL_COUNT] => 30
                            [LIST_TYPE] => L
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                            [XML_ID] => 
                            [FILE_TYPE] => 
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                            [TMP_ID] => 
                            [LINK_IBLOCK_ID] => 0
                            [WITH_DESCRIPTION] => N
                            [SEARCHABLE] => N
                            [FILTRABLE] => N
                            [IS_REQUIRED] => N
                            [VERSION] => 1
                            [USER_TYPE] => 
                            [USER_TYPE_SETTINGS] => 
                            [HINT] => 
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                            [DESCRIPTION] => 
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                            [~DESCRIPTION] => 
                            [~NAME] => URL
                            [~DEFAULT_VALUE] => 
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                    [DATA] => Array
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                            [XML_ID] => 
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                            [SORT] => 500
                            [CODE] => PHARMACIES
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                            [LIST_TYPE] => L
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                            [XML_ID] => 
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                            [IS_REQUIRED] => N
                            [VERSION] => 1
                            [USER_TYPE] => 
                            [USER_TYPE_SETTINGS] => 
                            [HINT] => 
                            [PROPERTY_VALUE_ID] => 
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                            [~VALUE] => 
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                            [~DEFAULT_VALUE] => 
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                            [TIMESTAMP_X] => 2019-10-14 16:10:42
                            [IBLOCK_ID] => 26
                            [NAME] => Партнерская ссылка
                            [ACTIVE] => Y
                            [SORT] => 500
                            [CODE] => PARTNER_URL
                            [DEFAULT_VALUE] => 
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                            [COL_COUNT] => 30
                            [LIST_TYPE] => L
                            [MULTIPLE] => N
                            [XML_ID] => 
                            [FILE_TYPE] => 
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                            [TMP_ID] => 
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                            [WITH_DESCRIPTION] => N
                            [SEARCHABLE] => N
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                            [VERSION] => 1
                            [USER_TYPE] => 
                            [USER_TYPE_SETTINGS] => 
                            [HINT] => 
                            [PROPERTY_VALUE_ID] => 
                            [VALUE] => 
                            [DESCRIPTION] => 
                            [VALUE_ENUM] => 
                            [VALUE_XML_ID] => 
                            [VALUE_SORT] => 
                            [~VALUE] => 
                            [~DESCRIPTION] => 
                            [~NAME] => Партнерская ссылка
                            [~DEFAULT_VALUE] => 
                            [VALUE_ENUM_ID] => 
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                    [ID_PARTNER_LEK] => Array
                        (
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                            [TIMESTAMP_X] => 2019-10-14 19:00:11
                            [IBLOCK_ID] => 26
                            [NAME] => ID лекарства в партнерке
                            [ACTIVE] => Y
                            [SORT] => 500
                            [CODE] => ID_PARTNER_LEK
                            [DEFAULT_VALUE] => 
                            [PROPERTY_TYPE] => S
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                            [COL_COUNT] => 30
                            [LIST_TYPE] => L
                            [MULTIPLE] => N
                            [XML_ID] => 
                            [FILE_TYPE] => 
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                            [TMP_ID] => 
                            [LINK_IBLOCK_ID] => 0
                            [WITH_DESCRIPTION] => N
                            [SEARCHABLE] => N
                            [FILTRABLE] => N
                            [IS_REQUIRED] => N
                            [VERSION] => 1
                            [USER_TYPE] => 
                            [USER_TYPE_SETTINGS] => 
                            [HINT] => 
                            [PROPERTY_VALUE_ID] => 
                            [VALUE] => 
                            [DESCRIPTION] => 
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                            [VALUE_XML_ID] => 
                            [VALUE_SORT] => 
                            [~VALUE] => 
                            [~DESCRIPTION] => 
                            [~NAME] => ID лекарства в партнерке
                            [~DEFAULT_VALUE] => 
                            [VALUE_ENUM_ID] => 
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                )

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                                    [CURRENCY] => RUB
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                                    [TYPE] => BASE
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                        )

                    [BASKET] => Array
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                            [PRICE] => Array
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                                    [PRINT_VALUE] => 594 руб.
                                    [TYPE] => BASE
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                        )

                    [QUANTITY] => Array
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                            [RATIO] => 1
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                        )

                    [AVAILABLE] => 1
                    [OFFER] => Array
                        (
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                            [PROPERTIES] => Array
                                (
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                )

            [PRICE] => Array
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                    [TYPE] => BASE
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                    [DISCOUNT_DIFF_PERCENT] => 0
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            [CATALOG_QUANTITY] => 100
            [MAX_QUANTITY] => 100
            [CATALOG_MEASURE_RATIO] => 1
            [MEASURE] => 
            [CAN_BUY] => 1
            [CAN_BUY_ZERO] => 
        )

    [25066] => Array
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            [DATE_CREATE] => 31.01.2019 18:23:47
            [DATE_CREATE_UNIX] => 1548933827
            [CREATED_BY] => 1
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            [IBLOCK_SECTION_ID] => 
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            [ACTIVE_FROM] => 
            [ACTIVE_TO] => 
            [DATE_ACTIVE_FROM] => 
            [DATE_ACTIVE_TO] => 
            [SORT] => 500
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Рецептурный препарат Рецептурный препарат. Рецепт остается в аптеке

Инструкция по применению Сирдалуд МР

Производитель

Новартис Фармасьютика С.А.

Страна происхождения

Испания

Группа товаров

Нервная система

Миорелаксант центрального действия

Формы выпуска

  • 10 - блистеры (1) - пачки картонные. 10 - блистеры (2) - пачки картонные. 10 - блистеры (3) - пачки картонные

Описание лекарственной формы

  • Капсулы с модифицированным высвобождением твердые желатиновые, размер №2, с белой непрозрачной крышечкой и белым непрозрачным корпусом, на крышечке серая надпись "Sirdalud", на корпусе серая надпись "6 mg"; содержимое капсул - круглые пеллеты от белого до слегка желто-коричневого цвета.

Фармакологическое действие

Миорелаксант центрального действия. Основная точка приложения его действия находится в спинном мозге. Стимулируя пресинаптические альфа2-рецепторы, тизанидин подавляет высвобождение возбуждающих аминокислот, стимулирующих рецепторы, чувствительные к N-метил-D-аспартату (NMDA-рецепторы). Вследствие этого на уровне промежуточных нейронов спинного мозга происходит подавление полисинаптической передачи возбуждения. Поскольку именно этот механизм отвечает за избыточный мышечный тонус, то при его подавлении мышечный тонус снижается. В дополнение к миорелаксирующим свойствам тизанидин оказывает также центральный умеренно выраженный анальгезирующий эффект. Сирдалуд® МР эффективен при хронической спастичности спинального и церебрального генеза. Уменьшает спастичность и клонические судороги, вследствие чего снижается сопротивление пассивным движениям и увеличивается объем активных движений.

Фармакокинетика

Всасывание При приеме внутрь тизанидин всасывается почти полностью. Среднее значение Cmax достигается в течение 8.5 ч и составляет приблизительно половину величины Cmax при приеме таблеток Сирдалуд® в аналогичной суточной дозе, разделенной на 3 приема, при этом суммарная экспозиция (AUC) остается неизмененной. Распределение Длительное высвобождение тизанидина из лекарственной формы капсулы с модифицированным высвобождением обуславливает "смягченный" фармакокинетический профиль, что обеспечивает поддержание стабильной терапевтической концентрации тизанидина в плазме крови на протяжении 24 ч. Связывание с белками плазмы составляет 30%. Метаболизм Тизанидин быстро и в значительной степени метаболизируется в печени. In vitro было показано, что тизанидин в основном метаболизируется изоферментом CYP1А2. Метаболиты неактивны. Выведение Тизанидин выводится преимущественно почками (приблизительно 70% дозы) в виде метаболитов; на долю неизмененного вещества приходится лишь около 2.7%. Фармакокинетика в особых клинических случаях Пол не влияет на фармакокинетические параметры тизанидина.

Особые условия

Сообщалось о случаях нарушений функции печени, связанных с тизанидином, однако при применении суточной дозы до 12 мг эти случаи отмечались редко. В связи с этим 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 ВГН в 3 раза и более, применение Сирдалуда МР следует прекратить. Не следует резко отменять Сирдалуд® МР, дозу препарата снижают постепенно. При резкой отмене Сирдалуда МР 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. Следует соблюдать осторожность при применении Сирдалуда МР у пациентов с почечной недостаточностью. При применении Сирдалуда МР у пациентов с почечной недостаточностью (КК менее 25 мл/мин) необходима коррекция режима дозирования. Следует соблюдать осторожность при применении Сирдалуда МР у пожилых пациентов. Опыт применения Сирдалуда МР у пациентов пожилого возраста ограничен. На основании фармакокинетических данных можно предположить, что в некоторых случаях почечный клиренс у этих пациентов может быть значительно снижен. Использование в педиатрии Опыт применения препарата у детей ограничен. Поэтому применение Сирдалуда МР у данной категории пациентов не рекомендуется. Влияние на способность к вождению автотранспорта и управлению механизмами При развитии сонливости, головокружения или снижения АД на фоне терапии Сирдалудом МР следует воздержаться от видов работ, требующих высокой концентрации внимания и быстрой реакции, например, управления автотранспортом или работы с механизмами.

Состав

  • тизанидин (в форме гидрохлорида) 6 мг Вспомогательные вещества: этилцеллюлоза, шеллак, тальк, крахмал кукурузный, сахароза, титана диоксид, железа оксид черный, желатин.

Сирдалуд МР показания к применению

  • — спастичность скелетных мышц при неврологических заболеваниях (например, при рассеянном склерозе, хронической миелопатии, дегенеративных заболеваниях спинного мозга, последствиях нарушений мозгового кровообращения и детского церебрального паралича /пациенты старше 18 лет/).

Сирдалуд МР 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. Применение Сирдалуда МР у детей не рекомендуется, т.к. опыт применения препарата у детей ограничен.

Сирдалуд МР побочные действия

  • 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.

Лекарственное взаимодействие

При применении Сирдалуда МР вместе с ингибиторами изофермента CYP1A2 возможно повышение концентрации тизанидина в плазме крови Одновременное применение тизанидина с флувоксамином или ципрофлоксацином, ингибиторами изофермента 1А2 цитохрома P450, приводит соответственно к 33-кратному или к 10-кратному увеличению AUC тизанидина. Результатом сочетанного применения может оказаться клинически значимое и продолжительное снижение АД, приводящее к сонливости, слабости, заторможенным психомоторным реакциям (в отдельных случаях вплоть до коллапса и потери сознания). Одновременное применение тизанидина с флувоксамином или ципрофлоксацином - противопоказано. Не рекомендуется одновременное назначение тизанидина с другими ингибиторами изофермента CYP1A2 – антиаритмическими препаратами (амиодарон, мексилетин, пропафенон), циметидином, фторхинолонами (эноксацин, пефлоксацин, ципрофлоксацин, норфлоксацин), рофекоксибом, пероральными контрацептивами, тиклопидином.

Передозировка

тошнота, рвота, снижение АД, удлинение интервала QTс, головокружение, сонливость, миоз, беспокойство, нарушение дыхания, кома.

Условия хранения

  • хранить при комнатной температуре 15-25 градусов
  • беречь от детей
Отзывы Сирдалуд МР
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