英文商品名: WARFARIN SODIUM(COUMADIN GERENIC)
商品译名: 华法林钠(可密定仿制药) 10毫克/片 30片/瓶
药品译名: 华法林钠
【规格】WARFARIN SODIUM(COUMADIN GERENIC) 10mg/tab 30tabs/bottle（华法林钠(可密定仿制药) 10毫克/片 30片/瓶 ） 、WARFARIN SODIUM(COUMADIN GERENIC) 7.5mg/tab 30tabs/bottle （华法林钠(可密定仿制药) 7.5毫克/片 30片/瓶 ）、WARFARIN SODIUM(COUMADIN GERENIC) 6mg/tab 30tabs/bottle （华法林钠(可密定仿制药) 6毫克/片 30片/瓶 ）、WARFARIN SODIUM(COUMADIN GERENIC) 4mg/tab 30tabs/bottle （华法林钠(可密定仿制药) 4毫克/片 30片/瓶 ）、WARFARIN SODIUM(COUMADIN GERENIC) 3mg/tab 30tabs/bottle （华法林钠(可密定仿制药) 3毫克/片 30片/瓶 ）、WARFARIN SODIUM(COUMADIN GERENIC) 2.5mg/tab 30tabs/bottle （华法林钠(可密定仿制药) 2.5毫克/片 30片/瓶 ）、WARFARIN SODIUM(COUMADIN GERENIC) 2mg/tab 30tabs/bottle （华法林钠(可密定仿制药) 2毫克/片 30片/瓶 ）、WARFARIN SODIUM(COUMADIN GERENIC) 1mg/tab 30tabs/bottle （华法林钠(可密定仿制药) 1毫克/片 30片/瓶 ）
【药物名称】可密定 Coumadin
【药理毒理】为香豆素类口服抗凝血药，竞争性拮抗维生素K的作用可阻断lit K环氧化物转变为氢醌形式。
【适 应 证】预防和/或治疗静脉血栓的形成及扩展，肺栓塞；预防和/或治疗房颤和/或心脏瓣膜置换后引起的血栓栓塞并发症；减少心肌梗塞后死亡率、复发率和血栓栓塞并发症如卒中或体循环栓塞
【不良反应】组织器官出血，根据出血的部位和程度不同的表现；皮肤或其它组织的坏死；其它少见的不良反应如：过敏反应、紫癜、皮疹、水肿、皮炎、腹痛、昏睡、不适、恶心、呕吐、头痛等。
【用法用量】可密定属治疗窗较小药物，其剂量和给药必须根据病人的PT或INR（国际标准化比值）而个体化给药。除置换有机械性瓣膜的病人INR应控制在2.5-3.5，其余情况INR应控制在2.0-3.0。
用药要从小剂量开始，一般为每天2～3mg（老年人应略低），然后根据PT或INR值调整剂量，疗程一般到血栓形成或血栓的危险消失。
【注意事项】用抗凝治疗后任何局部或全身的出血危险性大于治疗所得到的临床受益情况都视为禁忌症。如：妊娠妇女服用时，可密定可通过胎盘屏障，引起宫内胎儿出血或畸形；出血倾向或血质不调；近期有手术情况，特别是中枢神经系统、眼和其他创伤性手术；活动性溃疡或其他组织隐性出血倾向；消化道、泌尿生殖道和呼吸道‘脑血管；动脉瘤；心包炎心包积液和细菌性心内膜炎等；先兆流产、子痫或先兆子痫；无人照顾的老年病人，酗酒者，精神病和其他不合作病人；脊髓穿刺和其他可引起出血的诊断和治疗措施；其他大面积区域麻醉或腰部阻滞麻醉、恶性高血压和对香豆类药过敏者等。在长期应用最低维持量期间，如需手术，可先静脉注lit K，50mg，进行中枢神经系统或眼科手术前，应先停药。胃肠手术后，应检查大便隐血。
Warfarin is a prescription drug, a blood thinning medication that should only be consumed under strict medical guidance. Warfarin that is medically known as coumadin is an anti-coagulant drug taken to treat certain blood clotting diseases like thrombosis. Coumadin is a synthetic derivative of Coumarin which in turn is extracted from certain plants. It derives its anti-coagulant effect by interfering with Vitamin K metabolism. If you have been prescribed Warfarin, you must be by now made aware as to how strong this medicine is as an anti-coagulant and it is a true life saver. But more importantly one needs to be made aware of the Warfarin side effects and consequences of over dosage or even improper intake.
Warfarin is a drug prescribed in situations where mostly patients have a blood clot in an important place like heart or near the heart. A clot near heart can start a stroke and hence needs to be taken care with urgency. Similarly, blood clots near lungs or other veins, called as venous thrombosis is also a critical condition and needs to be treated.
In people with artificial heart valves or defective heart valves, blood clotting inside heart is common and hence Warfarin is prescribed for treatment.
Easily notable Warfarin side effects start with the fact that you see your blood would not clot easily. This can be noticed if a person under Warfarin consumption has experienced an injury like a cut. Any injury in a person consuming Warfarin would lead to profuse bleeding since blood would not congeal like in normal people. The severity of bleeding increases also with age, it is more serious in older people over 75 years of age. Other serious Warfarin side effects are passing blood in stool or rectum bleeding, fever, skin allergies like hives, swelling of various parts, bruising like symptoms without any actual injury, chest pain. Some lesser severe symptoms are vomiting and diarrhoea, muscle numbness or tingling sensation in body extremities, difficulty in movement, painful erection lasting for a long time. Some people also might face side effects like indigestion and gas, paleness of skin, fatigue, hair loss, change in taste of food etc.
Extreme Warfarin side effects may lead to gangrene leading to amputation of body parts. Hence one needs to be careful to see if any notable symptoms are developing in the body within seven to eight days of consumption of Warfarin drug. Fever, swelling on skin, discolouration or bruising on skin with pain are symptoms to be careful of. If is advisable to tell your near and dear ones and all your health care providers that you take Warfarin to avoid any further complications. Also it is important for any Warfarin consumer to stay away from obvious injury related sport activities.
Generic Name: Warfarin sodium
Dosage Form: tablet
WARNING: BLEEDING RISK
•Warfarin sodium can cause major or fatal bleeding [see Warnings and Precautions (5.1)].
•Perform regular monitoring of INR in all treated patients [see Dosage and Administration (2.1)].
•Drugs, dietary changes, and other factors affect INR levels achieved with Warfarin sodium therapy [see Drug Interactions (7)].
•Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information (17)].
1. INDICATIONS AND USAGE
Warfarin sodium tablets,USP are indicated for:
•Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
•Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
•Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use
Warfarin sodium tablets, USP have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
2. DOSAGE AND ADMINISTRATION
Individualized Dosing
The dosage and administration of Warfarin sodium must be individualized for each patient according to the patient’s INR response to the drug. Adjust the dose based on the patient’s INR and the condition being treated. Consult the latest evidence-based clinical practice guidelines from the American College of Chest Physicians (ACCP) to assist in the determination of the duration and intensity of anticoagulation with Warfarin sodium [see References (15)].
Recommended Target INR Ranges and Durations for Individual Indications
An INR of greater than 4 appears to provide no additional therapeutic benefit in most patients and is associated with a higher risk of bleeding.
Venous Thromboembolism (including deep venous thrombosis [DVT] and PE)
Adjust the Warfarin dose to maintain a target INR of 2.5 (INR range, 2 to 3) for all treatment durations. The duration of treatment is based on the indication as follows:
•For patients with a DVT or PE secondary to a transient (reversible) risk factor, treatment with Warfarin for 3 months is recommended.
•For patients with an unprovoked DVT or PE, treatment with Warfarin is recommended for at least 3 months. After 3 months of therapy, evaluate the risk-benefit ratio of long-term treatment for the individual patient.
•For patients with two episodes of unprovoked DVT or PE, long-term treatment with Warfarin is recommended. For a patient receiving long-term anticoagulant treatment, periodically reassess the risk-benefit ratio of continuing such treatment in the individual patient.
