盐酸曲恩汀胶囊Trientine(Syprine 250mg Capsule)说明书

产地国家:英国 处方药:是 所属类别: 250毫克/胶囊 100胶囊/瓶 包装规格: 250毫克/胶囊 100胶囊/瓶 计价单位:瓶 生产厂家英文名:merck 原产地英文商品名:SYPRINE 250MG/apsules 100Capsules/BOTTLE 原产地英文药品名:trientine hydrochloride 中文参考商品译名:SYPRINE 250毫克/胶囊 100胶囊/瓶 中文参考药品译名:盐酸曲恩汀

简介

部份中文盐酸曲恩汀处方资料(仅供参考) 英文药名:SYPRINE CAP(TRIENTINE HCL) 中文药名:盐酸曲恩汀胶囊 生产厂家:默克药品 药效类别:抗威尔逊氏病药 开发单位:Merck 首次上市:1986年 药理作用:为铜离子络合剂,作用类似青霉胺。 适应症 用于治疗肝豆状核变性(Wilson病),可供不能耐受青霉胺的患者选用。用法用量 由小剂量开始,成人0.75~1.25g/d、儿童0.5~0.7g/d分2~4次空腹口服,以后根据需要渐增,最大剂量成人2g/d,儿童1.5g/d。 禁忌症 对本品过敏者禁用。 不良反应 可引起铁离子不足、全身红斑狼疮等,偶见胃灼热、腹部疼痛、贫血、急性胃炎、食欲减退、皮疹、肌痛等。 制剂规格 (二盐酸盐)胶囊0.25g。 注意事项 (1)应监测血清铜浓度。(2)整个用药期间,应在医师监护下。(3)如铁严重不足,可于短期内补给,在服铁剂后须间隔2小时再服本品。(4)服用本品至少间隔1小时才能服用其他食物、药物或乳制品。(5)孕妇、哺乳妇女用本品时,应考虑利弊慎用。(6)本品和青霉胺不可互相交换使用。(7)不适用于胱氨酸尿、风湿性关节炎和胆汁性肝硬变患者的治疗。

英文版说明书

Syprine 250mg Capsule(Trientine)Wilson’s disease (WD), the most common inherited disorder of copper metabolism, results from a failure of the copper excretory pathway. This leads to toxic accumulation of copper in the liver and eventually other organs.1 The worldwide preva lence of WD is estimated to be one in 30,000 individuals.2The condition can be treated with a low copper diet and chelating agents that bind copper to facilitate its excretion from the body. SYPRINE® (trientine hydrochloride) is a chelating agent indicated for treatment of patients with WD who are intolerant of the first-line treatment, penicillamine.3INDICATIONS AND USAGESyprine® (trientine hydrochloride) is indicated in the treatment of patients with Wilson’s disease who are intolerant of penicillamine. Clinical experience with Syprine is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient’s dose have not been well defined. Syprine and penicillamine cannot be considered interchangeable. Syprine should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.Unlike penicillamine, Syprine is not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, Syprine was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.Syprine is not indicated for treatment of biliary cirrhosis.IMPORTANT SAFETY INFORMATIONSyprine is contraindicated in patients hypersensitive to Syprine or any components of the formulation. Patients should be observed closely for signs of possible hypersensitivity.Patients receiving Syprine should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia.The treatment can be monitored by the determination of free copper in the serum. Therapy may be monitored with a 24-hour urinary copper analysis periodically (i.e., every 6-12 months).Patients should be directed to take Syprine on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed. For the first month of treatment, the patient should have his temperature taken nightly, and he should be asked to report any symptom such as fever or skin eruption.In general, mineral supplements should not be given since they may block the absorption of Syprine.Syprine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.The following adverse reactions have been reported in a clinical study: iron deficiency, systemic lupus erythematosus. In addition, dystonia, muscular spasm, myasthenia gravis have been reported in marketed use.
用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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