简介:
部份中文曲恩汀处方资料(仅供参考)
药物分类名称
威尔逊氏病(对D-青霉胺不耐受时)治疗剂
商標名
METALITE 250 CAPSULES
一般的名称
トリエンチン塩酸塩(trientine hydrochloride)
(参考)国際一般名:trientine
化学名
N,N'-bis(2-aminoethyl)ethane-1,2-diamine dihydrochloride
分子式
C6H18N4・2HCl
分子量
219.16
化学構造式
H2NCH2CH2NHCH2CH2NHCH2CH2NH2・2HCl
性状
本产品为白色至微黄色结晶或结晶性粉末,无臭或有氨味。
本品易溶于水,微溶于甲醇,难溶于乙醇(99.5)。
本产品是吸湿性的。
熔点
大约121°C
药效药理
1. 对铜的螯合作用
曲恩汀盐酸盐与铜离子以1:1的组成比形成络合物,其在pH 7.0和8.0下稳定。
2. 尿铜排泄促进作用
在铜代谢异常引起的肝炎,肝癌自发发作模型(LEC大鼠)中,肝铜含量降低,尿铜排泄增加。
3. 作用机序
曲恩汀盐酸盐与铜离子形成络合物,促进尿铜排泄。
适应证
威尔逊氏病(对D-青霉胺不耐受时)
用法用量
通常,成人每日6粒(盐酸曲恩汀1,500mg)在餐前分2次至4次口服。
另外,根据患者的年龄,症状,对该药的反应等,每天增加或减少4-10胶囊剂(盐酸曲恩汀1,000-2,500mg)。
临床研究
曲恩汀是铜的络合剂,用于治疗Wilson病,作用与青霉胺相似,用于不能耐受青霉胺的患者。注意服用铁剂和曲恩汀,应间隔至少2h以上,不能同时使用。
注:以上中文资料不够完整,使用原处方资料为准。
完整说明书附件:http://www.info.pmda.go.jp/go/pack/3929005M1029_1_14/
Name of drug classification
Wilson's disease (when intolerance to D-penicillamine) Therapeutic agent
Sales name
Metallite 250 Capsules
H 2 NCH 2 CH 2 NHCH 2 CH 2 NHCH 2 CH 2 NH 2. 2 HCl
Property
This product is white to slightly yellow crystalline powder or crystalline and crystalline powder with no odor or slight smell of ammonia.
This product is easily soluble in water, slightly soluble in methanol, slightly soluble in ethanol, and almost insoluble in chloroform or ether.
Melting point
About 121 ° C
composition
This drug contains 250 mg of trientine hydrochloride in 1 capsule. Also, as an additive, the capsule contents contain daily stearic acid, the capsule shell contains daily sodium bisulfite, daily stationary titanium oxide, daily lauryl sodium sulfate, yellow ferric oxide, and ferric oxide.
Indication or effect
Wilson's disease (when intolerance to D-penicillamine)
Usually, 6 capsules per day for adults (1,500 mg as trientine hydrochloride) are orally administered in divided doses two to four times before meals.
Incidentally, depending on the patient's age, symptoms, response to this drug, etc., it is increased or decreased in the range of 4 to 10 capsules daily (1,000 to 2,500 mg as trientine hydrochloride).
This product should be taken on an empty stomach 1 hour before meal or 2 hours after meal, and should be spaced one hour or more after ingesting other medications or ingesting food. (See "Interaction" section)
If the effect of clinical symptoms is not sufficient, or if the concentration of free copper in the serum continues to exceed 20 μg / dL, increase the dose.
Careful Administration
Patients with serious complications (heart disease, malignant tumor, kidney disease, diabetes, blood disorders, cerebrovascular disorders etc.) [No use experience]
Patients with drug allergy
Serious side effects
Systemic lupus erythematosus (SLE) (Frequency unknown)
Since it is reported that SLE appears, if such symptoms appear, discontinue administration and take appropriate measures.
As pulmonary lesions such as interstitial pneumonia are reported in animal experiments, if respiratory symptoms such as fever, cough, dyspnoea etc. appear, discontinue administration and administer adrenocortical hormone drugs etc. Take action.
Medicinal pharmacology
Chelate effect on copper
Trientine hydrochloride forms a complex with copper ion in a composition ratio of 1: 1, which is stable at pH 7.0 and 8.0.
Urinary copper excretion promoting action
In hepatitis induced by abnormal copper metabolism, hepatic cancer spontaneous onset model (LEC rat), hepatic copper content was decreased and urinary copper excretion was promoted.
Mechanism of action
Trientine hydrochloride forms a complex with copper ions and promotes urinary copper excretion. |