羟基脲胶囊(HYDREA CAPSULES 500mg)

产地国家:日本

处方药:是

所属类别: 500毫克/胶囊 100胶囊/盒

包装规格: 500毫克/胶囊 100胶囊/盒

计价单位:盒

生产厂家英文名:BRISTOL MYERS SQUIBB

原产地英文商品名:HYDREA(ハイドレアカプセル)500mg/Capsule 100Capsules/box

原产地英文药品名:Hydroxycarbamide

中文参考商品译名:HYDREA(ハイドレアカプセル)500毫克/胶囊 100胶囊/盒

中文参考药品译名:羟基脲

简介:

部份中文羟基脲处方资料(仅供参考)

药品英文名:Hydroxycarbamide

药品别名:氨基甲酰基羟胺、氨基酰羟基胺、氨甲酰基胺、羟基脲素、羟脲、HU、Hydrea、Hydroxicarbamidum、Hydroxycarbamidum、Hydroxyurea、Hydura、Idroxicarbamide

药物剂型:1.片剂:500mg,2.胶囊:400mg。

药理作用:为核苷酸还原酶抑制剂,对多种实验肿瘤有抑制作用。能抑制核糖核酸还原为脱氧核糖核酸,选择性抑制DNA合成,对RNA及蛋白质无阻断作用。本品为细胞周期特异性药物,选择性杀伤S期细胞,并能使癌细胞集中于G1期达到同步化,而G1期细胞对放射线高度敏感,故与放疗合并应用可能起增敏作用。

药动学:口服易吸收,tmax为1h,然后迅速下降。血浆半衰期约2h。1次给药在24h内排出50%~80%。本品能通过血-脑脊液屏障,易透过红细胞膜。

适应症:1.主要用于治疗慢性髓细胞白血病、黑色素瘤、真性红细胞增多症、多发性骨髓瘤。2.对头颈部原发性鳞状细胞癌、复发性转移性卵巢癌、肾细胞癌等亦有一定的疗效。与放射治疗同时应用或作为放射的增敏剂,可增加治疗头颈部肿瘤的疗效。

禁忌症:1.水痘、带状疱疹患者及各种严重感染者。2.儿童、孕妇、哺乳妇女禁用。

注意事项:1.有以下疾病慎用:(1)严重贫血者;(2)骨髓抑制者;(3)肾功能不全者;(4)有痛风、尿酸盐结石史者。2.服用本药6周仍未见效,应考虑停药。

不良反应:1.造血系统:较常见的有白细胞减少、贫血或红细胞形态异常,少见的有血小板减少。白细胞减少通常在治疗开始后约10天发生,少数可合并感染;红细胞可出现巨幼红样变,形态类似恶性贫血,但其发生与维生素B12或叶酸缺乏无关。2.消化系统:较常见的有食欲减退、恶心、呕吐,少见的有便秘,一般用药后6~12h可出现。长期服用本药可发生口腔黏膜炎、口腔溃疡等。3.神经系统:偶见头痛、头晕、嗜睡、幻觉、惊厥等表现。4.其他:皮疹、红斑、瘙痒等皮肤反应较少见。

用法用量:1.成人:(1)口服给药:①慢性粒细胞白血病:可根据患者病情及白细胞计数而决定用药剂量,一般开始剂量为每天20~30mg/kg,一次服用或分2次服用。当起效后,白细胞计数降至10×109/L以下时,应减量至每天20mg/kg维持治疗。②头颈癌:剂量为每次60~80mg/kg或2000~3000mg/m2,每3天口服一次,单独服用或与放疗合用。亦可每天20~30mg/kg,每天1次。③卵巢癌:同头颈癌。④真性红细胞增多症、原发性血小板增多症,用法为:一天30~40mg/kg,每天1次或分2次服用。待红细胞或血小板降至正常高限时改用维持量,即10~20mg/kg,每天1次。⑤急性白血病伴高白细胞血症,有用法为:每次50~70mg/kg,每天1次,通常用2~3天,当白细胞明显成倍下降时,应尽早开始联合化疗。2.儿童:尚不明确。

药物相应作用:1.与可使白细胞或血小板减少的药物合用时,应严密观察患者的血象,并根据白细胞及血小板计数适当调整羟基脲的用量。2.由于服用本药后会使患者的免疫功能受到抑制,也可减弱患者接种疫苗后产生抗体的反应,最好停用本药3个月到1年才接种疫苗。与活疫苗(如轮状病毒疫苗)合用,将增加活疫苗感染的风险。接受免疫抑制化疗的患者不能接种活疫苗。缓解期白血病患者,至少要停止化疗3个月,才允许接种活疫苗。

英文版说明书:

Product name: Hydrea capsule 500 mgMain ingredient: HydroxycarbamideDosage form: Band purple red opaque / bluish green green opaque capsule, long diameter 21.0 mm, short diameter 7.6 mmSheet description: (Table) HYDREA 500 mg, (back) Hydrea 500 mgOn the action and effect of this medicineIt suppresses abnormal proliferation of immature bone marrow by inhibiting cellular DNA synthesis.It is usually used for chronic myeloid leukemia, essential thrombocythemia, polycythemia vera.Be sure to tell your doctor and pharmacist before using any of the following people.• If you used medicine before, it may have allergic symptoms such as itching, rash. Liver disorder, kidney disorder, bleeding tendency, infectious disease, varicella.• Pregnant, potentially pregnant, breastfeeding• You are using other medicines etc. (There is also the possibility of strengthening or weakening each other ‘s actions, so please be careful including other general – use medicines and foods in use).Dosage regimen (how to use this medicine)• Your usage and dose (filled in with medical staff)• Usually, adults take 1 to 4 capsules (500 to 2,000 mg as a main ingredient) in 1 to 3 divided doses a day.To maintain after remission, take 1 to 2 capsules (500 mg to 1,000 mg) per day in 1 to 2 divided doses. The initial dose and maintenance dose are appropriately increased or decreased depending on the symptoms to be treated, age and body weight.Please follow the directions given by your doctor.• If you forget to drink, do not take it immediately, please drink at the next dose. Never drink two doses at the same time.• If you drink too much accidentally, please consult your doctor or pharmacist.• Do not stop drinking at your own discretion without the instruction of your doctor.Living attention• Make sure to visit regularly in order to confirm effects and side effects.Be careful after using this medicine (side effects)Major side effects include rash / rash, nausea / vomiting, anemia, etc. are reported. If you notice such symptoms, please consult your doctor or pharmacist.The following symptoms appear rarely and it is possible that it may be the initial symptom of side effects shown in [].In such cases, please stop using it and get medical attention immediately.• Anemia, fever, bleeding tendency [bone marrow suppression]• Fever, cough, breathing [interstitial pneumonia]• Ulcers such as legs [skin ulcer]These side effects do not describe everything. If any other symptoms are noted besides the above, please consult your doctor or pharmacist.Storage method Other• Keep out of the reach of children, away from light, high temperature, and humidity.• If medicine remains, please discard it without storing it. For disposal please consult the pharmacy or medical institution you received.Bristol-Myers Squibb Co., Ltd. Internal medicineRevised in March 2014Medicines have side effects (risks) as well as effects (benefits). It is important to minimize side effects and maximize effect. Therefore, understanding and cooperation of the patient who is using this medicine is necessary.

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