制造商：
网址制药
药理分类：
贝特
活性成分（补）：
Fenofibric酸35mg，105mg;标签。
指示（补）：
配合饮食严重高甘油三酯血症（≥500mg/dL），并降低总胆固醇升高（总三），低密度脂蛋白胆固醇（LDL - C的），载脂蛋白（APO）的B和甘油三酯（TG），并增加高密度脂蛋白胆固醇和混合性高血脂原发性高胆固醇血症（HDL - C的）。
药理作用：
总水平升高- C和低密度脂蛋白胆固醇，载脂蛋白B，和降低HDL - C和它的传输复杂，载脂蛋白AI和载脂蛋白的A -二水平已显示增加动脉粥样硬化的风险。 Fenofibric酸，非诺贝特活性成分，是一种脂质改性剂可提高脂肪和甘油三酯丰富颗粒从血浆脂蛋白脂肪酶激活消除和减少对载脂蛋白CIII生产。
临床试验：
两项随机，双盲，安慰剂对照的临床试验中进行了147例高甘油三酯血症患者血清甘油三酯评估的非诺贝特的影响。患者与非诺贝特八周或安慰剂治疗根据不同的协议，因为只有进入了一个协议的500-1500mg/dL基线TG水平和TG水平的350-500mg/dL其他病人。在试验1和2，与高甘油三酯血症和正常胆固醇血症或无hyperchylomicronemia，在与非诺贝特治疗剂量的病人相当于Fibricor 105mg减少了46.2％和54.5％，分别甘油三酯，极低密度脂蛋白44.1（极低密度脂蛋白），甘油三酯％和50.6％，分别和VLDL - C的44.7％和49.4％，分别为（P均<0.05与安慰剂）。
四随机，安慰剂对照，双盲，平行组临床试验进行评估的剂量相当于原发性高脂血症和混合性高血脂患者Fibricor非诺贝特105mg的影响。患者接受治疗，为期3-6个月。在汇集队列，非诺贝特治疗降低了18.7％，LDL - C的总- C的20.6％，28.9％，甘油三酯，并提高了11％（均P <0.05与安慰剂），高密度脂蛋白胆固醇。在对病人的子集，载脂蛋白B的测量进行了评价。非诺贝特显着降低载脂蛋白B从基线到终点相比，安慰剂组（25.1％和2.4％; p“0.0001）。
法律分类：
接收
成人：
高甘油三酯血症：35-105mg/day，调整为4-8周的间隔。高胆固醇血症，高血脂：105mg/day。肾功能障碍：最初35mg/day。如果停止后2个月，最大剂量不足的反应。
儿童：
不推荐。
禁忌（补）：
严重肾功能不全（包括透析）。活动性肝病。原发性胆汁性肝硬化。原因不明的持续肝功能异常。胆囊疾病。哺乳的母亲。
警告/注意事项：
肾功能损害。监视器CBCs第一年，监测肝功能;停止，如果ALT水平> 3xULN坚持。如果停止CPK的水平明显升高，肌病，或胆结石的发生。老人。妊娠（Cat.C）。
互动（补）：
口服抗凝血剂，会增强（监视器）。允许前或4-6小时后，胆汁酸螯合剂至少1小时。注意与免疫抑制剂（如环孢菌素），其他肾毒性药物。
不良反应（补）：
增加肝测试，腹部疼痛，背部疼痛，头痛，CPK的升高，肌病，胆石症，胰腺炎，血清肌酐升高，皮疹，短暂性血液变化，血液恶液质，血栓性疾病，横纹肌溶解症。
如何提供：
制表- 30，60，90，100，250，500，1000
最后更新：
10/8/2009
FIBRICOR
Manufacturer:
URL Pharma
Pharmacological Class:
Fibrate
Active Ingredient(s):
Fenofibric acid 35mg, 105mg; tabs.
Indication(s):
Adjunct to diet in severe hypertriglyceridemia (≥500mg/dL), and to reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein (Apo) B, and triglyceride (TG), and to increase high-density lipoprotein cholesterol (HDL-C), in primary hypercholesterolemia and mixed dyslipidemia.
Pharmacology:
Elevated levels of total-C, LDL-C, Apo B, and decreased levels of HDL-C and its transport complex, Apo A-I and Apo A-II, have been shown to increase the risk for atherosclerosis. Fenofibric acid, the active moiety of fenofibrate, is a lipid modifying agent that increases lipolysis and the elimination of TG-rich particles from plasma by activating lipoprotein lipase and reducing the production of apolipoprotein CIII.
Clinical Trials:
Two randomized, double-blind, placebo-controlled clinical trials were conducted in 147 patients with hypertriglyceridemia to evaluate the effects of fenofibrate on serum triglycerides. Patients were treated for eight weeks with fenofibrate or placebo under protocols that differed only in that one protocol entered patients with baseline TG levels of 500–1500mg/dL, and the other TG levels of 350–500mg/dL. In Studies 1 and 2, in patients with hypertriglyceridemia and normal cholesterolemia with or without hyperchylomicronemia, treatment with fenofibrate at dosages equivalent to 105mg of Fibricor reduced TG by 46.2% and 54.5%, respectively; very low density lipoprotein (VLDL) TG by 44.1% and 50.6%, respectively; and VLDL-C by 44.7% and 49.4%, respectively (all p<0.05 versus placebo).
Four randomized, placebo-controlled, double-blind, parallel-group clinical trials were conducted to evaluate the effects of fenofibrate at doses equivalent to Fibricor 105mg in patients with primary hyperlipidemia and mixed dyslipidemia. Patients were treated for a duration of 3–6 months. In the pooled cohort, fenofibrate therapy lowered total-C by 18.7%, LDL-C by 20.6%, TG by 28.9%, and raised HDL-C by 11% (all p<0.05 versus placebo). In a subset of patients, measurement of Apo B was evaluated. Fenofibrate significantly reduced Apo B from baseline to endpoint as compared to placebo (25.1% versus 2.4%; p<0.0001).
Legal Classification:
Rx
Adults:
Hypertriglyceridemia: 35–105mg/day, adjust at 4–8 week intervals. Hypercholesterolemia, dyslipidemia: 105mg/day. Renal impairment: initially 35mg/day. Discontinue if inadequate response after 2 months on max dose.
Children:
Not recommended.
Contraindication(s):
Severe renal dysfunction (including dialysis). Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers.
Warnings/Precautions:
Renal impairment. Monitor CBCs for first year; monitor liver function; discontinue if ALT levels >3xULN persist. Discontinue if markedly elevated CPK levels, myopathy, or gallstones occur. Elderly. Pregnancy (Cat.C).
Interaction(s):
May potentiate oral anticoagulants (monitor). Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with immunosuppressants (eg, cyclosporine), other nephrotoxic drugs.
Adverse Reaction(s):
Increased liver tests, abdominal pain, back pain, headache; elevated CPK, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, rash, transient hematologic changes, blood dyscrasias, thromboembolic disorders, rhabdomyolysis.
How Supplied:
Tabs—30, 60, 90, 100, 250, 500, 1000