维甲酸，维甲酸胶囊tretinoin （Vesanoid Capsule 10mg）

药店国别：无 产地国家：香港 处方药：是 所属类别： 10毫克/胶囊 100胶囊/瓶 包装规格： 10毫克/胶囊 100胶囊/瓶 计价单位：瓶 生产厂家中文参考译名：无 生产厂家英文名：Roche Hong Kong Limited 原产地英文商品名：Vesanoid 10MG/Capsule 100Capsule/botte 原产地英文药品名：Tretinoin 中文参考商品译名：维A酸 10毫克/胶囊 100胶囊/瓶 中文参考药品译名：维甲酸 曾用名：无

简介

部份中文维A酸资料（仅供参考） 英文品名: Tretinoin 别　　名: Airol, Arotinoid, Retinoic acid, Vesanoid, Vitamin A acid 品种类别: 抗肿瘤药>维生素A衍生物 [药物毒理] 本品是一种肿瘤细胞诱导分化剂，不仅能维持正常上皮细胞的分化作用，而且可使白血病细胞分化为具有正常表现型功能的血细胞，体外可抑制癌细胞增殖。 [药代动力学] 口服吸收后，可通过肝脏与蛋白结合，被运转至全身，经胆汁排出，口服1mg/kg后，血药峰浓度可达0.3～0.5μg/ml。[适应症]1995年上市（Roche，美国）。当与细胞生长抑制剂联用时，维A酸诱导分化和显示较强的抗肿瘤活性，用于急性早幼粒细胞白血病。外用还可能有治疗光损伤皮肤和皮肤癌的潜力。 [规格]20mg [用法用量]每日40～80mg(最高不超过0.12g)，分2～4次口服，疗程4～8周。 [不良反应]皮肤粘膜干燥、消化道反应、头晕及关节痛，停药后消失。 [注意事项] 1．服用本品后需监测肝功能、血脂。 2．不能与四环素及维生素A同时使用。 [孕妇及哺乳期妇女用药]孕妇禁用。 [贮藏]避光，密封，在阴凉干燥处保存

英文版说明

Generic Name for VESANOIDTretinoin 10mg; soft gelatin caps; contain parabens.Legal Classification:RxPharmacological Class for VESANOIDRetinoid.Manufacturer of VESANOIDRoche LaboratoriesIndications for VESANOIDInduction of remission in patients with acute promyelocytic leukemia(APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARα gene who arerefractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated.Adult dose for VESANOIDUse only for induction of remission. 45mg/m2 per day in two divided doses until complete remission is documented. Discontinue 30 days after complete remission or after 90 days of treatment, whichever occurs first.Children's dosing for VESANOIDSee literature.Warnings/Precautions for VESANOIDConfirm APL diagnosis. Monitor for Retinoic Acid-APL (RA-APL) syndrome, leukocytosis, pseudotumor cerebri, or respiratory compromise. Consider temporarily interrupting therapy if moderate to severe RA-APL syndrome develops. Monitor blood counts, coagulation profile, lipids, liver function; consider temporary withdrawal if tests >5XULN. Pregnancy (Cat.D); obtain negative pregnancy test 1 week before starting treatment, counsel patient about need to use 2 effective methods of contraception during, and 1 month after therapy. Nursing mothers: not recommended.Interactions for VESANOIDDo not administer with Vitamin A. May be potentiated or antagonized by CYP450 enzyme inducers or inhibitors.Caution with anti-fibrinolytic agents; and other agents known to cause pseudotumor cerebri/intracranial hypertension.Adverse Reactions for VESANOIDHeadache, fever, skin/mucous membrane dryness, bone pain, GI upset, rash, mucositis, pruritus, increased sweating, visual disturbances, alopecia; RA-APL syndrome, leukocytosis, pseudotumor cerebri, hypercholesterolemia/hypertriglyceridemia, others.How is VESANOID supplied?Caps—100Related Disease:Leukemia, acute promyelocytic