英文药名: Coumadin(Warfarin Sodium Tablets) 中文药名: 华法林钠片 生产厂家: Bristol Meyers Squibb 药品名称 通用名：华法林钠片　 英文名：Warfarin Sodium Tablets　　 化学名称：3-（3-氧代-1-苯基丁基）-4-羟基-2H-1-苯并吡喃二酮钠盐与异丙醇的包含物。　 分子式：C19H15NaO4　　分子量：330.31 性状: 本品为糖衣片，除去糖衣后显白色。 药理毒理　 本品为双香豆素类中效抗凝剂。其作用机制为竞争性对抗维生素K的作用，抑制肝细胞中凝血因子的合成，还具有降低凝血酶诱导的血小板聚集反应的作用，因而具有抗凝和抗血小板聚集功能。　 药代动力学　　　 口服胃肠道吸收迅速而完全，生物利用度高达100％。吸收后与血浆蛋白结合率达98％～99％，能透过胎盘，母乳中极少。主要由肺、肝、脾和肾中储积。由肝脏代谢，代谢产物由肾脏排泄。服药后12～18小时起效，36～48小时达抗凝高峰，维持3～6d，t1/2约37小时。 适应症　　 适用于需长期持续抗凝的患者：　 ①能防止血栓的形成及发展，用于治疗血栓栓塞性疾病；　　 ②治疗手术后或创伤后的静脉血栓形成，并可作心肌梗死的辅助用药； ③对曾有血栓栓塞病患者及有术后血栓并发症危险者，可予预防性用药。 用法用量　 口服，成人常用量：避免冲击治疗口服第1～3天3～4mg（年老体弱及糖尿病患者半量即可），3天后可给维持量一日2.5～5mg（可参考凝血时间调整剂量使INR值达2～3）。 因本品起效缓慢，治疗初3天由于血浆抗凝蛋白细胞被抑制可以存在短暂高凝状态，如须立即产生抗凝作用，可在开始同时应用肝素，待本品充分发挥抗凝效果后再停用肝素。　 任何疑问，请遵医嘱！ 不良反应　　 过量易致各种出血。早期表现有瘀斑、紫癜、牙龈出血、鼻衄、伤口出血经久不愈，月经量过多等。出血可发生在任何部位，特别是泌尿和消化道。肠壁血肿可致亚急性肠梗阻，也可见硬膜下颅内血肿和穿刺部位血肿。偶见不良反应有恶心、呕吐、腹泻、瘙痒性皮疹，过敏反应及皮肤坏死。大量口服甚至出现双侧乳房坏死，微血管病或溶血性贫血以及大范围皮肤坏疽；一次量过大的尤其危险。 禁忌　　 肝肾功能损害、严重高血压、凝血功能障碍伴有出血倾向、活动性溃疡、外伤、先兆流产、近期手术者禁用。妊娠期禁用。 注意事项　 （1）老年人或月经期应慎用。 （2）严格掌握适应症，在无凝血酶原测定的条件时，切不可滥用本品。 （3）个体差异较大，治疗期间应严密观察病情，并依据凝血酶原时间INR值调整用量。治疗期间还应严密观察口腔黏膜、鼻腔、皮下出血及大便隐血、血尿等，用药期间应避免不必要的手术操作，选期手术者应停药7天，急诊手术者需纠正PTINR值≤1.6，避免过度劳累和易致损伤的活动。 （4）若发生轻度出血，或凝血酶原时间已显著延长至正常的2.5倍以上,应即减量或停药。严重出血可静注维生素Kl10～20mg，用以控制出血，必要时可输全血、血浆或凝血酶原复合物。 （5）由于本品系间接作用抗凝药，半衰期长，给药5～7日后疗效才可稳定，因此，维持量足够与否务必观察5～7天后方能定论。　　 孕妇及哺乳期妇女用药　 （1）易通过胎盘并致畸胎。妊娠期使用本品可致"胎儿华法林综合征"，发生率可达5％～30％。表现为骨骺分离、鼻发育不全、视神经萎缩、智力迟纯，心、肝、脾、胃肠道、头部等畸形。妊娠后期应用可致出血和死胎，故妊娠早期3个月及妊娠后期3 个月禁用本品。遗传性易栓症孕妇应用本品治疗时可给予小剂量肝素并接受严密的实验监控。 （2）少量华法林可由乳汁分泌，哺乳期妇女每日服 5～10mg，血药浓度一般为0.48～1.8μg/ml，乳汁及婴儿血浆中药物浓度极低，对婴儿影响较小。 儿童用药　　 应按个体所需调整剂量。 老年患者用药　 老年人应慎用, 且用量应适当减少并个体化。　　 药物相互作用　 增强本品抗凝作用的药物有：阿司匹林、水杨酸钠、胰高血糖素、奎尼丁、吲哚美辛、保泰松、奎宁、利尿酸、甲磺丁脲、甲硝唑、别嘌呤醇、红霉素、氯霉素、某些氨基糖苷类抗生素、头孢菌素类、苯碘达隆、西米替丁、氯贝丁酯、右旋甲状腺素、对乙酰氨基酚等。降低本品抗凝作用的药物：苯妥英钠、巴比妥类、口服避孕药、雌激素、考来烯胺、利福平、维生素K类、氯噻酮、螺内酯、扑痛酮、皮质激素等。不能与本品合用的药物：盐酸肾上腺素、阿米卡星、维生素B12、间羟胺、缩宫素、盐酸氯丙嗪、盐酸万古霉素等。 本品与水合氯醛合用，其药效和毒性均增强，应减量慎用。维生素K的吸收障碍或合成下降也影响本品的抗凝作用。 药品规格[注；以下美国产品，购者以咨询为准]： COUMADIN TAB 10MG UD 100  WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0174-75 COUMADIN TAB 10MG 100     WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0174-70     COUMADIN TAB 1MG 100      WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0169-70      COUMADIN TAB 1MG 1000=    WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0169-90  COUMADIN TAB 1MG UD 100   WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0169-75   COUMADIN TAB 2.5MG 100    WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0176-70    COUMADIN TAB 2.5MG 1000=  WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0176-90 COUMADIN TAB 2.5MG UD 100 WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0176-75 COUMADIN TAB 2MG 100      WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0170-70      COUMADIN TAB 2MG 1000=    WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0170-90  COUMADIN TAB 2MG UD 100   WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0170-75   COUMADIN TAB 3MG 100      WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0188-70      COUMADIN TAB 3MG UD 100   WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0188-75   COUMADIN TAB 4MG 100      WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0168-70      COUMADIN TAB 4MG UD 100   WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0168-75   COUMADIN TAB 5MG 100      WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0172-70      COUMADIN TAB 5MG 1000=    WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0172-90  COUMADIN TAB 5MG UD 100   WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0172-75   COUMADIN TAB 6MG 100      WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0189-70      COUMADIN TAB 6MG UD 100   WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0189-75   COUMADIN TAB 7.5MG 100    WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0173-70    COUMADIN TAB 7.5MG UD 100 WARFARIN SODIUM  ER SQUIBB & SONS LLC  00056-0173-75 https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=55770 Coumadin(Warfarin Sodium Tablets) Generic name: Warfarin Sodium Coumadin (Warfarin) Read the Medication Guide provided by your pharmacist before you start taking warfarin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor or other health care professional BRAND NAME: Coumadin GENERIC NAME: Warfarin COUMADIN NOTES: Warfarin can cause very serious (possibly fatal) bleeding. This is more likely to occur when you first start taking this medication or if you take too much warfarin. To decrease your risk for bleeding, your doctor or other health care provider will monitor you closely and check your lab results (INR test) to make sure you are not taking too much warfarin. Keep all medical and laboratory appointments. Tell your doctor right away if you notice any signs of serious bleeding. See also Side Effects section. USES: This medication is used to treat blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE) and/or to prevent new clots from forming in your body. Preventing harmful blood clots helps to reduce the risk of a stroke or heart attack. Conditions that increase your risk of developing blood clots include a certain type of irregular heart rhythm (atrial fibrillation), heart valve replacement, recent heart attack, and certain surgeries (such as hip/knee replacement).Warfarin is commonly called a "blood thinner," but the more correct term is "anticoagulant." It helps to keep blood flowing smoothly in your body by decreasing the amount of certain substances (clotting proteins) in your blood. HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking warfarin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor or other health care professional, usually once a day. It is very important to take it exactly as directed. Do not increase the dose, take it more frequently, or stop using it unless directed by your doctor.Dosage is based on your medical condition, laboratory tests (such as INR), and response to treatment. Your doctor or other health care provider will monitor you closely while you are taking this medication to determine the right dose for you.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.It is important to eat a balanced, consistent diet while taking warfarin. Some foods can affect how warfarin works in your body and may affect your treatment and dose. Avoid sudden large increases or decreases in your intake of foods high in vitamin K (such as broccoli, cauliflower, cabbage, brussels sprouts, kale, spinach, and other green leafy vegetables, liver, green tea, certain vitamin supplements). If you are trying to lose weight, check with your doctor before you try to go on a diet.Cranberry products may also affect how your warfarin works. Limit the amount of cranberry juice (16 ounces/480 milliliters a day) or other cranberry products you may drink or eat. SIDE EFFECTS: Nausea, loss of appetite, or stomach/abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication can cause serious bleeding if it affects your blood clotting proteins too much (shown by unusually high INR lab results). Even if your doctor stops your medication, this risk of bleeding can continue for up to a week. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual/easy bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools, chest pain, shortness of breath, difficulty swallowing.Tell your doctor right away if any of these unlikely but serious side effects occur: persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin.This drug rarely has caused very serious (possibly fatal) problems if its effects lead to small blood clots (usually at the beginning of treatment). This can lead to severe skin/tissue damage that may require surgery or amputation if left untreated. Patients with certain blood conditions (protein C or S deficiency) may be at greater risk. Get medical help right away if any of these rare but serious side effects occur: painful/red/purplish patches on the skin (such as on the toe, breast, abdomen), change in the amount of urine, vision changes, confusion, slurred speech, weakness on one side of the body.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects PRECAUTIONS: Before taking warfarin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (such as anemia, hemophilia), bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood vessel disorders (such as aneurysms), recent major injury/surgery, liver disease, alcohol use, mental/mood disorders (including memory problems), frequent falls/injuries.It is important that all your doctors and dentists know that you take warfarin. Before having surgery or any medical/dental procedures, tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Avoid getting injections into the muscles. If you must have an injection into a muscle (for example, a flu shot), it should be given in the arm. This way, it will be easier to check for bleeding and/or apply pressure bandages.This medication may cause stomach bleeding. Daily use of alcohol while using this medicine will increase your risk for stomach bleeding and may also affect how this medication works. Limit or avoid alcoholic beverages.If you have not been eating well, if you have an illness or infection that causes fever, vomiting, or diarrhea for more than 2 days, or if you start using any antibiotic medications, contact your doctor or pharmacist immediately because these conditions can affect how warfarin works.This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use great caution with sharp objects like safety razors and nail cutters. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. Avoid activities such as contact sports. If you fall or injure yourself, especially if you hit your head, call your doctor immediately. Your doctor may need to check you.The Food & Drug Administration has stated that generic warfarin products are interchangeable. However, consult your doctor or pharmacist before switching warfarin products. Be careful not to take more than one medication that contains warfarin unless specifically directed by the doctor or health care provider who is monitoring your warfarin treatment.Older adults may be at greater risk for bleeding while using this drug.This medication is not recommended for use during pregnancy because of serious (possibly fatal) harm to an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you are planning pregnancy, discuss a plan for managing your condition with your doctor before you become pregnant. Your doctor may switch the type of medication you use during pregnancy.Very small amounts of this medication may pass into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Warfarin interacts with many prescription, nonprescription, vitamin, and herbal products. This includes medications that are applied to the skin or inside the vagina or rectum. The interactions with warfarin usually result in an increase or decrease in the "blood-thinning" (anticoagulant) effect. Your doctor or other health care professional should closely monitor you to prevent serious bleeding or clotting problems. While taking warfarin, it is very important to tell your doctor or pharmacist of any changes in medications, vitamins, or herbal products that you are taking.Some products that may interact with this drug include: capecitabine, imatinib, mifepristone.Aspirin, aspirin-like drugs (salicylates), and nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen, celecoxib) may have effects similar to warfarin. These drugs may increase the risk of bleeding problems if taken during treatment with warfarin. Carefully check all prescription/nonprescription product labels (including drugs applied to the skin such as pain-relieving creams) since the products may contain NSAIDs or salicylates. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. Low-dose aspirin and related drugs (such as clopidogrel, ticlopidine) should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention. Consult your doctor or pharmacist for more details.Many herbal products interact with warfarin. Tell your doctor before taking any herbal products, especially bromelains, coenzyme Q10, cranberry, danshen, dong quai, fenugreek, garlic, ginkgo biloba, ginseng, and St. John's wort, among others.This medication may interfere with a certain laboratory test to measure theophylline levels, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as INR, complete blood count) must be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. MISSED DOSE: For the best possible benefit, do not miss any doses. If you do miss a dose and remember on the same day, take it as soon as you remember. If you remember on the next day, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up because this could increase your risk for bleeding. Keep a record of missed doses to give to your doctor or pharmacist. Contact your doctor or pharmacist if you miss 2 or more doses in a row. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition and medication can cause complications in a medical emergency.