Нейродистрофические заболевания (например, демиелинизированная форма синдрома Шарко-Мари-Тута);
беременность;
период лактации;
повышенная чувствительность к винкаалкалоидам.
Инструкция
Описание
Противоопухолевое средство растительного происхождения
Фармакологические свойства
Противоопухолевое средство растительного происхождения.
Винкристин - алкалоид барвинка розового, относится к цитостатическим химиотерапевтическим средствам. Винкристин связывается с белком-тубулином и приводит к нарушению микротубулярного аппарата клеток и к разрыву митотического веретена. Подавляет митоз в метафазе. Он также препятствует метаболизму глютамата и возможному синтезу нуклеиновой кислоты, оказывает иммунодепрессивное действие.
Показания к применению
Острые лейкозы;
ходжкинские и неходжкинские лимфомы;
опухоль Вильмса;
рабдомиосаркома;
нейробластома;
миелома;
саркома Капоши;
саркомы костей и мягких тканей;
мелкоклеточный рак легкого;
хориокарцинома матки;
опухоли мозга.
Винкристин также применяется при идиопатической тромбоцитопенической пурпуре (при устойчивости к кортикостероидным препаратам и неэффективности спленэктомии).
Противопоказания
Нейродистрофические заболевания (например, демиелинизированная форма синдрома Шарко-Мари-Тута);
беременность;
период лактации;
повышенная чувствительность к винкаалкалоидам.
Применение при беременности и в период грудного вскармливания
Противопоказан при беременности и в период лактации (грудного вскармливания).
Способ применения и дозы
Интратекальное введение винкристина запрещено.
Винкристин вводится строго в/в с интервалом в 1 неделю. Длительность инъекции должна составлять примерно 1 мин.
Перед введением содержимое флакона разводится в прилагаемом растворителе с добавлением необходимого количества 0.9% раствора натрия хлорида до получения концентрации 0.1 мг/мл.
При введении необходимо соблюдать осторожность для избежания экстравазации.
Доза подбирается индивидуально. В среднем доза составляет для взрослых: 1.4 мг/м2 поверхности тела, разовая доза не должна превышать 2 мг; для детей - 1.5-2 мг/м2 поверхности тела. Для детей c массой до 10 кг начальная доза должна составлять 0.05 мг/кг в неделю.
У пациентов с нарушениями функции печени и концентрацией билирубина в плазме крови выше 51.3 мкмоль/л рекомендуется снижение дозы на 50%.
Побочное действие
Со стороны ЦНС и периферической нервной системы: судороги с повышением АД, парестезии, невралгии, нейропатия, боли в челюстях, понижение мышечной силы, потеря рефлексов сухожилий, атаксия, головная боль, депрессия, галлюцинации, нарушения сна, диплопия, птоз, преходящая слепота и атрофия зрительного нерва. Нейротоксичность является ограничивающим дозу фактором.
Со стороны пищеварительной системы: тошнота, рвота, стоматиты, запоры, паралитическая кишечная непроходимость (особенно часто у детей), боли в брюшной полости, некроз тонкого кишечника и/или перфорация, диареяю.
Со стороны мочевыделительной системы: полиурия, дизурия, задержка мочи вследствие атонии мочевого пузыря, отеки.
Со стороны сердечно-сосудистой системы: повышение или понижение АД. У больных с ранее облученным средостением при применении полихимиотерапии с включением винкристина возможно возникновение стенокардии и инфаркта миокарда.
Со стороны дыхательной системы: острая одышка и тяжелый бронхоспазм наблюдались при применении винкристина с митомицином С.
Со стороны эндокринной системы: редко наблюдается синдром, обусловленный нарушением секреции антидиуретического гормона, который характеризуется большим выделением натрия с мочой и вызывает гипонатриемию. При этом отсутствуют признаки поражения почек и надпочечников, артериальная гипотензия, дегидратация, азотемия и отеки.
Со стороны системы кроветворения: не оказывает существенного влияния на кроветворение. Однако могут наблюдаться умеренная лейкопения, тромбоцитопения и анемия.
Местные реакции: при попадании препарата под кожу может развиться целлюлит, флебит, и даже, некроз.
Прочие: алопеция, сыпь, аменорея, азооспермия.
Передозировка
При случайной передозировке следует ожидать усиления побочных эффектов Винкристина. Специфический антидот не известен.
Лечение носит симптоматический характер и должно включать в себя ограничение потребления жидкости, назначение диуретических средств (для предупреждения осложнений, связанных с развитием синдрома повышенной секреции антидиуретического гормона), применение фенобарбитала (для предупреждения судорог), применение слабительных препаратов (предупреждение непроходимости кишечника). Необходимо также наблюдать за деятельностью сердечно-сосудистой системы и осуществлять гематологический контроль. Гемодиализ не эффективен.
Помимо вышеперечисленного может быть назначен лейковорин в дозе 100 мг в/в каждые 3 ч в течение 24 ч и затем каждые 6 ч в течение, по крайней мере, 48 ч.
Взаимодействие с другими лекарственными средствами
Винкристин может снизить противосудорожный эффект фенитоина.
При одновременном применении с нейротоксическими препаратами (изониазид, итраконазол, нифедипин) наблюдается усиление побочных явлений со стороны нервной системы.
При одновременном применении винкристин ослабляет действие противоподагрических препаратов. При одновременном применении с лекарственными средствами, повышающими уровень мочевой кислоты в сыворотке крови, увеличивается риск нефропатии.
При назначении в комбинации с митомицином С винкристин может вызвать тяжелый бронхоспазм.
При необходимости применения препарата в комплексе с L-аспарагиназой винкристин нужно вводить за 12-24 ч до применения L-аспарагиназы. Назначение аспарагиназы до введения винкристина может нарушить его выведение из печени.
Одновременное применение винкристина с другими миелодепрессивными препаратами и преднизолоном может усилить угнетение костномозгового кроветворения.
Особые указания
Применение у детей доза подбирается индивидуально. В среднем доза составляет для детей - 1.5-2 мг/м2 поверхности тела. Для детей c массой до 10 кг начальная доза должна составлять 0.05 мг/кг в неделю. Ограничения для детей применяется с осторожностью.
У пациентов с концентрацией билирубина в плазме крови выше 51.3 мкмоль/л рекомендуется снижение дозы на 50%. У пациентов с нарушениями функции печени рекомендуется снижение дозы на 50%.
Интратекальное введение винкристина может привести к смерти.
Во время лечения следует осуществлять регулярный гематологический контроль. В случае развития лейкопении при введении повторных доз следует соблюдать особую предосторожность.
При повышении уровня мочевой кислоты рекомендуется ощелачивание мочи и назначение ингибиторов урикосинтеза.
При повышении уровня печеночных проб дозу винкристина следует снизить.
Периодически следует определять концентрацию ионов натрия в сыворотке крови. Для коррекции гипонатриемии рекомендуется введение соответствующих растворов.
Особому контролю подлежат больные имевшие в анамнезе невропатию.
С осторожностью следует назначать Винкристин пожилым пациентам, т.к. нейротоксичность у них может быть более выраженной.
Любые жалобы на боль в глазах или снижение зрения требуют тщательного офтальмологического обследования.
Избегать попадания раствора винкристина в глаза. Если это произошло, следует срочно обильно и тщательно промыть глаза большим количеством жидкости.
Влияние на способность к управлению транспортными средствами и механизмами
Нейротоксичность Винкристина может отрицательно повлиять на способность управления транспортным средством.
Условия хранения
Хранить раствор при температуре 2-8° С в недоступном для детей месте; срок годности - 2 года. Хранить лиофилизированный порошок при температуре 2-8° С в недоступном для детей месте.
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Винкристин связывается с белком-тубулином и приводит к нарушению микротубулярного аппарата клеток и к разрыву митотического веретена. Подавляет митоз в метафазе. Он также препятствует метаболизму глютамата и возможному синтезу нуклеиновой кислоты, оказывает иммунодепрессивное действие."}}]},{"id":7,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["Острые лейкозы;","ходжкинские и неходжкинские лимфомы;","опухоль Вильмса;","рабдомиосаркома;","нейробластома;","миелома;","саркома Капоши;","саркомы костей и мягких тканей;","мелкоклеточный рак легкого;","хориокарцинома матки;","опухоли мозга."]}},{"type":"paragraph","data":{"text":"Винкристин также применяется при идиопатической тромбоцитопенической пурпуре (при устойчивости к кортикостероидным препаратам и неэффективности спленэктомии)."}}]},{"id":8,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["Нейродистрофические заболевания (например, демиелинизированная форма синдрома Шарко-Мари-Тута);","беременность;","период лактации;","повышенная чувствительность к винкаалкалоидам."]}}]},{"id":10,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказан при беременности и в период лактации (грудного вскармливания)."}}]},{"id":11,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Интратекальное введение винкристина запрещено."}},{"type":"paragraph","data":{"text":"Винкристин вводится строго в/в с интервалом в 1 неделю. Длительность инъекции должна составлять примерно 1 мин."}},{"type":"paragraph","data":{"text":"Перед введением содержимое флакона разводится в прилагаемом растворителе с добавлением необходимого количества 0.9% раствора натрия хлорида до получения концентрации 0.1 мг/мл."}},{"type":"paragraph","data":{"text":"При введении необходимо соблюдать осторожность для избежания экстравазации."}},{"type":"paragraph","data":{"text":"Доза подбирается индивидуально. В среднем доза составляет для \u003cb\u003eвзрослых\u003c/b\u003e: 1.4 мг/м\u003csup\u003e2\u003c/sup\u003e поверхности тела, разовая доза не должна превышать 2 мг; для \u003cb\u003eдетей -\u003c/b\u003e 1.5-2 мг/м\u003csup\u003e2\u003c/sup\u003e поверхности тела. Для \u003cb\u003eдетей c массой до 10 кг\u003c/b\u003e начальная доза должна составлять 0.05 мг/кг в неделю."}},{"type":"paragraph","data":{"text":"У \u003cb\u003eпациентов с нарушениями функции печени и концентрацией билирубина в плазме крови выше 51.3 мкмоль/л\u003c/b\u003e рекомендуется снижение дозы на 50%."}}]},{"id":12,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны ЦНС и периферической нервной системы: \u003c/i\u003eсудороги с повышением АД, парестезии, невралгии, нейропатия, боли в челюстях, понижение мышечной силы, потеря рефлексов сухожилий, атаксия, головная боль, депрессия, галлюцинации, нарушения сна, диплопия, птоз, преходящая слепота и атрофия зрительного нерва. Нейротоксичность является ограничивающим дозу фактором."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы:\u003c/i\u003e тошнота, рвота, стоматиты, запоры, паралитическая кишечная непроходимость (особенно часто у детей), боли в брюшной полости, некроз тонкого кишечника и/или перфорация, диареяю."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны мочевыделительной системы: \u003c/i\u003eполиурия, дизурия, задержка мочи вследствие атонии мочевого пузыря, отеки."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы: \u003c/i\u003eповышение или понижение АД. У больных с ранее облученным средостением при применении полихимиотерапии с включением винкристина возможно возникновение стенокардии и инфаркта миокарда."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны дыхательной системы: \u003c/i\u003eострая одышка и тяжелый бронхоспазм наблюдались при применении винкристина с митомицином С."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны эндокринной системы: \u003c/i\u003eредко наблюдается синдром, обусловленный нарушением секреции антидиуретического гормона, который характеризуется большим выделением натрия с мочой и вызывает гипонатриемию. При этом отсутствуют признаки поражения почек и надпочечников, артериальная гипотензия, дегидратация, азотемия и отеки."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны системы кроветворения:\u003c/i\u003e не оказывает существенного влияния на кроветворение. Однако могут наблюдаться умеренная лейкопения, тромбоцитопения и анемия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМестные реакции: \u003c/i\u003eпри попадании препарата под кожу может развиться целлюлит, флебит, и даже, некроз."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие: \u003c/i\u003eалопеция, сыпь, аменорея, азооспермия."}}]},{"id":13,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"При случайной передозировке следует ожидать усиления побочных эффектов Винкристина. Специфический антидот не известен."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение \u003c/i\u003eносит симптоматический характер и должно включать в себя ограничение потребления жидкости, назначение диуретических средств (для предупреждения осложнений, связанных с развитием синдрома повышенной секреции антидиуретического гормона), применение фенобарбитала (для предупреждения судорог), применение слабительных препаратов (предупреждение непроходимости кишечника). Необходимо также наблюдать за деятельностью сердечно-сосудистой системы и осуществлять гематологический контроль. Гемодиализ не эффективен."}},{"type":"paragraph","data":{"text":"Помимо вышеперечисленного может быть назначен лейковорин в дозе 100 мг в/в каждые 3 ч в течение 24 ч и затем каждые 6 ч в течение, по крайней мере, 48 ч."}}]},{"id":14,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Винкристин может снизить противосудорожный эффект фенитоина."}},{"type":"paragraph","data":{"text":"При одновременном применении с нейротоксическими препаратами (изониазид, итраконазол, нифедипин) наблюдается усиление побочных явлений со стороны нервной системы."}},{"type":"paragraph","data":{"text":"При одновременном применении винкристин ослабляет действие противоподагрических препаратов. При одновременном применении с лекарственными средствами, повышающими уровень мочевой кислоты в сыворотке крови, увеличивается риск нефропатии."}},{"type":"paragraph","data":{"text":"При назначении в комбинации с митомицином С винкристин может вызвать тяжелый бронхоспазм."}},{"type":"paragraph","data":{"text":"При необходимости применения препарата в комплексе с L-аспарагиназой винкристин нужно вводить за 12-24 ч до применения L-аспарагиназы. Назначение аспарагиназы до введения винкристина может нарушить его выведение из печени."}},{"type":"paragraph","data":{"text":"Одновременное применение винкристина с другими миелодепрессивными препаратами и преднизолоном может усилить угнетение костномозгового кроветворения."}}]},{"id":15,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":" Применение у детей доза подбирается индивидуально. В среднем доза составляет для \u003cb\u003eдетей -\u003c/b\u003e 1.5-2 мг/м\u003csup\u003e2\u003c/sup\u003e поверхности тела. Для \u003cb\u003eдетей c массой до 10 кг\u003c/b\u003e начальная доза должна составлять 0.05 мг/кг в неделю. Ограничения для детей применяется с осторожностью."}},{"type":"paragraph","data":{"text":" У \u003cb\u003eпациентов с концентрацией билирубина в плазме крови выше 51.3 мкмоль/л\u003c/b\u003e рекомендуется снижение дозы на 50%. У \u003cb\u003eпациентов с нарушениями функции печени \u003c/b\u003eрекомендуется снижение дозы на 50%. "}},{"type":"paragraph","data":{"text":"Интратекальное введение винкристина может привести к смерти."}},{"type":"paragraph","data":{"text":"Во время лечения следует осуществлять регулярный гематологический контроль. В случае развития лейкопении при введении повторных доз следует соблюдать особую предосторожность."}},{"type":"paragraph","data":{"text":"При повышении уровня мочевой кислоты рекомендуется ощелачивание мочи и назначение ингибиторов урикосинтеза."}},{"type":"paragraph","data":{"text":"При повышении уровня печеночных проб дозу винкристина следует снизить."}},{"type":"paragraph","data":{"text":"Периодически следует определять концентрацию ионов натрия в сыворотке крови. Для коррекции гипонатриемии рекомендуется введение соответствующих растворов."}},{"type":"paragraph","data":{"text":"Особому контролю подлежат больные имевшие в анамнезе невропатию."}},{"type":"paragraph","data":{"text":"С осторожностью следует назначать Винкристин пожилым пациентам, т.к. нейротоксичность у них может быть более выраженной."}},{"type":"paragraph","data":{"text":"Любые жалобы на боль в глазах или снижение зрения требуют тщательного офтальмологического обследования."}},{"type":"paragraph","data":{"text":"Избегать попадания раствора винкристина в глаза. Если это произошло, следует срочно обильно и тщательно промыть глаза большим количеством жидкости."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние на способность к управлению транспортными средствами и механизмами\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Нейротоксичность Винкристина может отрицательно повлиять на способность управления транспортным средством."}}]},{"id":18,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить раствор при температуре 2-8° С в недоступном для детей месте; срок годности - 2 года. Хранить лиофилизированный порошок при температуре 2-8° С в недоступном для детей месте."}}]},{"id":19,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}}]},{"id":20,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту."}}]},{"id":21,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://samson-pharma.ru/alphabet_manufact/f/farmakhemi/\"\u003eФармахеми\u003c/a\u003e."}}]}],"source":{"title":"ЗдравСити","url":"https://zdravcity.ru"}},"description_toggle":false,"short_description":"Противоопухолевое средство растительного происхождения. Винкристин - алкалоид барвинка розового, относится к цитостатическим химиотерапевтическим средствам. Винкристин связывается с белком-тубулином и приводит к нарушению микротубулярного аппарата клеток и к разрыву митотического веретена. Подавляет митоз в метафазе. 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