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  药店国别: 美国药房
产地国家: 美国
所属类别: 心血管系统药物->降脂
处方药:处方药
包装规格: 1克/胶囊 120胶囊/盒
计价单位:
  点击放大  
生产厂家英文名:
AMARIN PHARMS
该药品相关信息网址1:
http://www.vascepa.com/
原产地英文商品名:
VASCEPA 1g 120caps/box
原产地英文药品名:
ICOSAPENT ETHYL
中文参考商品译名:
VASCEPA 1克/胶囊 120胶囊/盒
中文参考药品译名:
二十碳五烯酸胶囊
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
hypertriglyceridemia
临床试验期:

中文适应病症参考翻译1:
高甘油三酯血症
药品信息:

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 详细处方信息以本药内容附件(20196916351927.pdf)文件为准
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部分中文 处方资料(仅供参考)



最近,美国食品药品管理局(FDA)已经批准Vascepa(icosapent ethyl)胶囊作为成人重度高甘油三酯血症(TG水平≥500 mg/dl)患者饮食疗法的辅助治疗药物,用于降低甘油三酯(TG)水平。Vascepa是一种超纯的Ω-3脂肪酸产品。 该公司通过一项随机、安慰剂对照、双盲、设平行组的研究对Vascepa的有效性和安全性进行了评估,受试者为空腹TG水平非常高(500~2000 mg/dl)的成人患者。基线时,25%的患者接受Vascepa与他汀配伍治疗,28%患有糖尿病,39%的患者TG水平>750 mg/dl。 4 g剂量的Vascepa治疗组患者在接受12周治疗后甘油三酯中位水平降低了33%,与安慰剂对照组相比具有统计学意义(P<0.001),其低密度脂蛋白胆固醇水平相对于安慰剂对照组未升高。Vascepa治疗组患者中最常报告的不良反应为关节痛。

Vascepa对重度高甘油三脂血症患者胰腺炎风险的影响及其对重度高甘油三脂血症患者心血管死亡率和发病率的影响均尚未确定。 Vascepa的日剂量为4 g,通过口服用药。患者在接受Vascepa治疗前及治疗期间,应适当控制营养摄入量和体力活动。Amarin预计Vascepa在2013年第一季度初上市

美国FDA已经批准了Vascepa(icosapent ethyl, 二十碳五烯酸胶囊)的上市,Vascepa就是深海鱼油里面的一种EPA。 但是Vascepa适用在有严重(≥ 500 mg/dL)高甘油三酯血症成年患者中作为膳食辅助减低甘油三酸酯(TG)水平,推荐每天剂量是4 g。



VASCEPA Pharmacological Class: Lipid-regulating agent. Active Ingredient(s): Icosapent ethyl 1g; soft gelatin capsules. Company Amarin Pharma Indication(s): Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. Limitations of use: The effect of Vascepa on the risk for pancre-atitis in patients with severe hypertriglyceridemia has not been determined. The effect of Vascepa on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined. Pharmacology: Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). Studies suggest that eicosapentaenoic acid reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased ß-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyl-transferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity. Clinical Trials: The effects of Vascepa 4g per day were assessed in a randomized, placebo--controlled, double-blind, parallel-group study of adult patients (76 on Vascepa, 75 on placebo) with severe hypertriglyceridemia. Patients whose baseline TG levels were between 500 and 2,000mg/dL were enrolled in this study for 12 weeks. The median baseline TG and LDL-C levels in these patients were 684mg/dL and 86mg/dL, respectively. Median baseline HDL-C level was 27mg/dL. The randomized population in this study was mostly Caucasian (88%) and male (76%). The mean age was 53 years and the mean body mass index was 31kg/m2. Twenty five percent of patients were on concomitant statin therapy, 28% were diabetics, and 39% of the patients had TG -levels >750mg/dL. At endpoint, patients treated for 12 weeks with the 4g dose of Vascepa demonstrated a statistically significant placebo-adjusted median triglyceride reduction of 33% (p<0.001), and did not show an increase in LDL-C levels relative to placebo. Vascepa 4g per day also showed statistically significant placebo-adjusted median reductions from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) of 18%, total cholesterol (TC) of 16%, very low density lipoprotein cholesterol (VLDL-C) of 29%, and apolipoprotein B (ApoB) of 9%. Among the patients with a baseline TG level>750mg/dL, Vascepa 4g/day reduced the placebo-corrected median TG levels by 45% (p<0.001). Legal Classification: Rx Adults: Swallow whole. Do not crush, dissolve, or chew. 2 capsules twice daily with food; maximum 4g per day. Children: Not established. Warnings/Precautions: Obtain baseline lipids before initiating therapy. Identify other causes of high triglycerides and manage appropriately (eg, diabetes, hypothyroidism, or alcohol intake). Hepatic impairment; monitor ALT and AST levels periodically during therapy. Fish and/or shellfish allergy. Pregnancy (Category C). Nursing mothers. Interaction(s) Monitor periodically with concomitant drugs that affect coagulation (eg, -antiplatelet agents). Adverse Reaction(s) Arthralgia. Notes: To report suspected adverse reactions, contact Amarin Pharma at (855) 827-2372 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

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 详细处方信息以本药内容附件(20196916351927.pdf)文件为准
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