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SYPRINE 盐酸曲恩汀胶囊

通用名称盐酸曲恩汀胶囊 Trientine Dihydrochloride
品牌名称SYPRINE
产地|公司美国(USA) | 默克(Merck)
技术状态
成分|含量250mg
包装|存储100粒/盒 室温
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通用中文 盐酸曲恩汀胶囊 通用外文 Trientine Dihydrochloride
品牌中文 品牌外文 SYPRINE
其他名称
公司 默克(Merck) 产地 美国(USA)
含量 250mg 包装 100粒/盒
剂型给药 胶囊 口服 储存 室温
适用范围 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
通用中文 盐酸曲恩汀胶囊
通用外文 Trientine Dihydrochloride
品牌中文
品牌外文 SYPRINE
其他名称
公司 默克(Merck)
产地 美国(USA)
含量 250mg
包装 100粒/盒
剂型给药 胶囊 口服
储存 室温
适用范围 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

使用说明书

(免责声明:本说明书仅供参考,不作为治疗的依据,不可取代任何医生、药剂师等专业性的指导。本站不提供治疗建议,药物是否适合您,请专业医生(或药剂师)决定。)
等待内容更新

中文说明

(免责声明:本说明书仅供参考,不作为治疗的依据,不可取代任何医生、药剂师等专业性的指导。本站不提供治疗建议,药物是否适合您,请专业医生(或药剂师)决定。)
    1.1 药品名称

盐酸曲恩汀

1.2 英文名称

Trientine

1.3 盐酸曲恩汀的别名

曲恩汀;三乙撑四胺;Trientine Dihydrochloride;TrienHydrochloride;Triethylenetetramine Dihydrochloride;Trientine Hydrochloride

1.4 分类

消化系统药物 > 其他

1.5 剂型

219.2。

2.片剂 每片0.25克;0.5克。

1.6 盐酸曲恩汀的药理作用

曲恩盐酸曲恩汀是铜的络合剂,用于治疗Wilson病,作用与青霉胺相似,可促进铜经肾排泄,虽然效力不及青霉胺,但可供不能耐受青霉胺的患者选用。

1.7 盐酸曲恩汀的药代动力学

口服吸收后半衰期在2h以上,乙酰唑胺和呋塞米两药能增加肾脏对盐酸曲恩汀的排泄。

1.8 盐酸曲恩汀的适应证

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。

1.9 盐酸曲恩汀的禁忌证

对盐酸曲恩汀过敏者禁用。

1.10 注意事项

注意服用铁剂和盐酸曲恩汀,两者应间隔至少2h以上,分别给予。

1.11 盐酸曲恩汀的不良反应

不良反应为引起体内缺铁,可用短程补铁治疗。个别曾对青霉胺有系统性红斑狼疮反应的患者,用盐酸曲恩汀后出现症状复发的报道。

1.12 盐酸曲恩汀的用法用量

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。

1.13 盐酸曲恩汀与其它药物的相互作用

近年有人采用大鼠肾刷状缘膜泡(brushborder membrane vesi-cles)对盐酸曲恩汀与利尿药的相互作用进行了研究,结果观察到乙酰唑胺和呋塞米两药能增加肾脏对盐酸曲恩汀的排泄。不良反应为引起体内缺铁,可用短程补铁治疗。应注意,服用铁剂和盐酸曲恩汀,两者应间隔至少2h以上,分别给予。

外文说明

(免责声明:本说明书仅供参考,不作为治疗的依据,不可取代任何医生、药剂师等专业性的指导。本站不提供治疗建议,药物是否适合您,请专业医生(或药剂师)决定。)
Trientine

Medically reviewed on Feb 20, 2019

 

Index Terms

· 2,2,2-tetramine

· Trien

· Trientine HCl

· Trientine Hydrochloride

· Triethylene Tetramine Dihydrochloride

 

 

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as hydrochloride:

Syprine: 250 mg

Generic: 250 mg

Brand Names: U.S.

· Syprine

Pharmacologic Category

· Chelating Agent

Pharmacology

Trientine is an oral chelating agent structurally dissimilar from penicillamine and other available chelating agents; an effective oral chelator of copper used to induce adequate cupriuresis

Absorption

Poor (Roberts 2008)

Metabolism

To acetyltrien (chelating activity significantly less than parent) (Roberts 2008)

Excretion

Urine (1% as parent; 8% as metabolite) (Roberts 2008)

Use: Labeled Indications

Wilson disease: Treatment of patients with Wilson disease who are intolerant to penicillamine.

Limitations of use: Not recommended in cystinuria or rheumatoid arthritis; not indicated for biliary cirrhosis.

Contraindications

Hypersensitivity to trientine or any component of the formulation.

Dosing: Adult

Wilson disease: Oral: Initial: 750 to 1,250 mg/day in divided doses 2 to 4 times daily; increase dose if clinical response not adequate or the concentration of free serum copper is persistently >20 mcg/dL; maximum dose: 2,000 mg/day. AASLD practice guidelines suggest typical doses of 750 to 1,500 mg/day in 2 to 3 divided doses with maintenance therapy of 750 to 1,000 mg/day (Roberts 2008). Optimal long-term maintenance dosage should be determined at 6- to 12-month intervals.

Dosing: Geriatric

Refer to adult dosing. Use with caution; initiate at lower end of the dosing range.

Dosing: Pediatric

Wilson disease: Children and Adolescents: Oral: Initial: 500 to 750 mg/day in divided doses 2 to 4 times daily; increase dose if clinical response not adequate or the concentration of free serum copper is persistently >20 mcg/dL; maximum in children ≤12 years: 1,500 mg/day. AASLD practice guidelines suggest 20 mg/kg/day rounded off to the nearest 250 mg, given in 2 to 3 divided doses (Roberts 2008). Optimal long-term maintenance dosage should be determined at 6- to 12-month intervals.

Administration

Administer at least1 hour before or 2 hours after meals and at least 1 hour apart from any drug, food, or milk. Do not open or chew capsule, swallow whole with water; any skin exposed to the contents of a capsule should be promptly washed with water.

Dietary Considerations

Should be taken 1 hour before or 2 hours after meals and at least 1 hour apart from any drug, food, or milk.

Storage

Store at 2°C to 8°C (36°F to 46°F).

Drug Interactions

Antacids: May decrease the absorption of Trientine. Management: Separate trientine dosing from other oral drugs (eg, antacids) by at least 1 hour. Monitor for decreased therapeutic effects of trientine if an antacid is initiated/dose increased, or increased effects if an antacid is discontinued/dose decreased.Consider therapy modification

Calcium Salts: May decrease the serum concentration of Trientine. Trientine may decrease the serum concentration of Calcium Salts. Consider therapy modification

Carbonic Anhydrase Inhibitor Diuretics: May decrease the serum concentration of Trientine. Monitor therapy

Iron Salts: Trientine may decrease the serum concentration of Iron Salts. Iron Salts may decrease the serum concentration of Trientine. Management: Trientine manufacturer recommends avoiding concurrent use with oral iron salts due to the risk for impaired GI absorption of both trientine and the iron salt. Short courses of iron may be used; however, separate administration by at least 2 hours.Exceptions: Ferric Carboxymaltose; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. Consider therapy modification

Magnesium Salts: Trientine may decrease the serum concentration of Magnesium Salts. Magnesium Salts may decrease the serum concentration of Trientine. Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Trientine. Management: Trientine manufacturer recommends avoiding concurrent administration with oral minerals due to the risk for impaired GI absorption of both trientine and the mineral. Short courses of iron may be used; however, separate administration by at least 2 hours. Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Trientine. Management: Trientine manufacturer recommends avoiding concurrent administration with oral minerals. The recommendation is that trientine be taken at least one hour before or two hours after meals and at least one hour apart from any drug, food, or milk. Consider therapy modification

Zinc Salts: Trientine may decrease the serum concentration of Zinc Salts. Zinc Salts may decrease the serum concentration of Trientine. Consider therapy modification

Adverse Reactions

Frequency not defined.

Central nervous system: Dystonia, myasthenia gravis, neurological deterioration (worsening; European Association for the Study of the Liver 2012)

Endocrine & metabolic: Iron deficiency

Gastrointestinal: Gastritis (Roberts 2008)

Hypersensitivity: Fixed drug eruption (Roberts 2008)

Neuromuscular & skeletal: Muscle spasm, systemic lupus erythematosus

<1%, postmarketing, and/or case reports: Aplastic anemia (Roberts 2008), pancytopenia (Roberts 2008), sideroblastic anemia (reversible; Roberts 2008)

Warnings/Precautions

Concerns related to adverse effects:

• Anemia: May cause iron-deficiency anemia; monitor closely, especially women.

• Copper deficiency: Induced by treatment; may lead to hepatic iron overload and/or sideroblastic anemia; reassess dose (Roberts 2008).

• Neurologic worsening: May occur with treatment initiation; less common than with penicillamine (Roberts 2008).

Other warnings/precautions:

• Hypersensitivity: Not reported with use; however, industrial workers exposed to trientine for prolonged periods have reported asthma, bronchitis, and dermatitis.

Monitoring Parameters

Periodic 24-hour urinary copper assessment (every 6 to 12 months); serum non-ceruloplasmin bound copper; LFTs; CBC; INR; urinalysis (Roberts 2008); fever and skin changes during the first month of therapy

Pregnancy Considerations

Treatment of Wilson disease should be maintained during pregnancy; dose reduction (25% to 50% of prepregnancy dose) should be considered (Roberts 2008).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), difficulty moving, muscle spasm, severe loss of strength and energy, or muscle weakness (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.