制造商: 类药物: 活性成分(S): 指示(S): 药理学: 临床试验: 两项随机,双盲研究(记录1和2)择期全髋关节置换手术的患者相比,利伐沙班10毫克,每日一次开始与依诺肝素40毫克的伤口封闭后至少有6至8小时,每日一次术前12小时开始。记录1,1513例患者接受利伐沙班; 1473例患者接受依诺肝素。经历静脉血栓栓塞(VTE)的患者占总数的百分比是1.1%,利伐沙班与依诺肝素组为3.9%,相对风险减少(RRR)为71%。在记录2,834例患者接受利伐沙班; 835例患者接受依诺肝素。在这项研究中,研究武器(利伐沙班:33.5 + / - 6.9天;依诺肝素:12.4 + / - 2.9天)治疗的时间长短不同的。经历VTE患者总数的百分比为2%,利伐沙班与依诺肝素组为8.4%,存款准备金率是76%。 择期全膝关节置换手术的患者进行了创纪录的3期试验。患者无论是利伐沙班10毫克,每天一次(813)或依诺肝素40毫克,每天一次(871)。在利伐沙班组,总VTE的比例为9.7%,依诺肝素组有18.8%;存款准备金率是48%。
成人: 儿童: 禁忌(S): 警告/注意事项: 相互作用(S): 不良反应(S): 如何提供: FDA:Xarelto减轻膝髋关节置换术病人血凝风险 2011年7月1日,美国食品药物监管局(FDA)批准Xarelto (利伐沙班)用于减轻膝关节或髋关节替换手术后血栓、深静脉血栓(DVT)以及肺栓塞(PE)的形成。Xarelto每日服用一片。膝关节替换术后的病人应服用12天,髋关节置换术病人服用35天。 其他FDA批准的防止血液凝固的药物包括只用于髋关节置换术的Lovenox(依诺肝素),依诺肝素的仿制药,Arixtra(fondaparinux),Fragmin(达肝素钠)。Coumadin(华法林)和肝素。 XARELTO Manufacturer:Janssen Therapeutics Pharmacological Class:Factor Xa inhibitor. Active Ingredient(s):Rivaroxaban 10mg; tablets. Indication(s):Prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee and hip replacement surgery. Pharmacology:Rivaroxaban is an orally bioavailable factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Antithrombin III) for activity. Activation of factor X to factor Xa via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation. Clinical Trials:Three trials were conducted to evaluate the safety and efficacy of rivaroxaban. Two randomized, double-blind, studies (RECORD 1 and 2) involving patients undergoing elective total hip replacement surgery compared rivaroxaban 10mg once daily starting at least 6 to 8 hours after wound closure versus enoxaparin 40mg once daily started 12 hours preoperatively. In RECORD 1, 1513 patients received rivaroxaban; 1473 patients received enoxaparin. The total percentage of patients experiencing venous thromboembolism (VTE) was 1.1% for the rivaroxaban group versus 3.9% for the enoxaparin group; relative risk reduction (RRR) was 71%. In RECORD 2, 834 patients received rivaroxaban; 835 patients received enoxaparin. In this study the treatment duration differed between study arms (rivaroxaban: 33.5 +/- 6.9 days; enoxaparin: 12.4 +/- 2.9 days). The total percentage of patients experiencing VTE was 2% for the rivaroxaban group versus 8.4% for the enoxaparin group; RRR was 76%. The RECORD 3 trial was conducted in patients undergoing elective total knee replacement surgery. Patients were given either rivaroxaban 10mg once daily (813) or enoxaparin 40mg once daily (871). In the rivaroxaban group, the percentage of total VTE was 9.7%; the enoxaparin group had 18.8%; RRR was 48%. Legal Classification:Rx Adults:Take 6–10 hours after surgery once hemostasis established. 10mg once daily. Hip: treat for 35 days. Knee: treat for 12 days. Concomitant P-gp and strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s wort): avoid; may increase to 20mg once daily with food if necessary. Children:Not recommended. Contraindication(s):Active major bleeding. Warnings/Precautions:Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture; monitor for signs/symptoms of neurological impairment. Conditions with increased risk of hemorrhage. Severe renal impairment (CrCl<30mL/min), moderate or severe hepatic impairment, hepatic disease associated with coagulopathy: avoid. Monitor closely for blood loss with moderate renal impairment; discontinue if acute renal failure develops. Elderly. Labor & delivery. Pregnancy (Cat. C); use with caution, risk of pregnancy-related hemorrhage. Nursing mothers: not recommended. Interaction(s):See Adult dose. Increased risk of bleeding with concomitant platelet aggregation inhibitors, other antithrombotic agents, fibrinolytic therapy, thienopyridines, chronic use of NSAIDs. Avoid with concomitant combined P-gp and strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir, conivaptan). May be potentiated with concomitant renal impairment and combined P-gp and weak or moderate CYP3A4 inhibitors (eg, erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine). Adverse Reaction(s):Bleeding, wound secretion, pain in extremity, muscle spasm, syncope, pruritus, blister. How Supplied:Tabs—30, 100 (10x10 blister cards) |
Xarelto(rivaroxaban,利伐沙班片)简介:
制造商:西安杨森治疗
类药物:Xa因子抑制剂。
活性成分(S):利伐沙班10毫克;片。
指示(S):预防的深静脉血栓(DVT),这可能会导致膝关节和髋关节置换手术病人的肺栓塞(PE)的。
药理学:利伐 ... 责任编辑:admin |
最新文章更多推荐文章更多热点文章更多 |