药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201411322185330.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文LIXIANA处方资料(仅供参考)
口服抗凝血药Lixiana®在日本上市 4月22日,日本厚生省批准了第一三共的Lixiana®(甲苯磺酸依度沙班水合物) 15 mg和30 mg用于预防骨科大手术后静脉血栓栓塞,这是Lixiana®获得的首个上市许可。
Lixiana®系每日1次的口服抗凝血药,其活性成分依度沙班(Edoxaban)能直接抑制凝血因子Xa,临床结果显示,Lixiana®对全膝关节置换术、全髋关节置换术和髋骨折手术患者有良好的治疗益处。
2010年3月,第一三共递交了Lixiana®用于静脉血栓栓塞适应症的上市申请,12月,公司公开了最新III期临床试验(Stars J-V)的正面结果,发现依度沙班能预防全髋关节置换术后静脉血栓栓塞事件,且有效性优于依诺肝素。
依度沙班还在进行多个全球临床试验,适应症有预防房颤患者中风,以及预防和治疗静脉血栓栓塞复发。正在进行的III期AF-TMI试验,共入组21,000例患者,评估依度沙班对房颤患者预防中风和全身性栓塞事件的作用。正在进行的VTE试验,共入组7,500例患者,评估依度沙班对复方静脉血栓栓塞的预防和治疗作用。
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit (effects) it will do. The patient's cooperation is indispensable here.
Brand name : LIXIANA TABLETS 30 mg
Active ingredient: Edoxaban tosilate hydrate
Dosage form: slightly red tablet, φ: 8.6 mm, thickness: 3.8 mm
Printings on wrapping: 甲苯磺酸依度沙班片 30mg DSC472 LIXIANA 30mg
Effects of this medicine
This medicine suppresses coagulation by inhibiting active blood coagulation factor X in the process of coagulation. After surgery, coagulation tends to occur because of hemostatic action, and with vascular injury and bedrest, blood is more likely to come coagulated. Especially, when blood clots (thrombi) are formulated on the leg and move through vessels to lung, they may become stuck in the lung vessels. The medicine suppresses thrombus formation.
It is used for suppression of venous thrombosis in patients who underwent surgery for total knee replacement, total hip replacement or hip fracture.
Before using this medicine, tell your doctor/pharmacist
•If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are patients with bleeding (intracranial hemorrhage, retroperitoneal hemorrhage or other hemorrhage from vital organs, etc.).
If you have a bleeding tendency or difficulty in stopping bleeding.
If you are a patient with acute bacterial endocarditis or peptic ulcer.
If you recently have intracranial hemorrhage, eye surgery or cerebrospinal surgery.
If you are a patient with renal or hepatic dysfunction.
If your weight is less than 40 kg.
•If you are pregnant or breastfeeding.
•If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.
Dosage regimen (proper use of this medicine)
•Your dosage regimen is:(order of your doctor)
•General dosage regimen: For adults, take 1 tablet (30 mg of edoxaban) at a time, once daily. Strictly follow the instructions of your doctor/pharmacist.
•Missed dose: Take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.
•Overdose: If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
•Others: Do not stop taking the medicine without the instructions of your doctor.
Precautions while using this medicine
Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: anemia, hematuria, subcutaneous bleeding, wound bleeding, nasal bleeding, rash, etc.
In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately.•subcutaneous bleeding, nasal bleeding, gum bleeding, black stool, melena, hematuria[bleeding]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.
Storage and other information
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them. |