英文药名：Xarelto Tablets（Rivaroxaban） 中文药名：利伐沙班片 生产厂家：拜耳公司 イグザレルト錠10mg／イグザレルト錠15mg 治疗类别名称 选择性直接Xa因子抑制剂 批准上市：2012年4月 商標名 Xarelto Tablets 構造式 一般名 リバーロキサバン（Rivaroxaban）JAN （rivaroxaban）INN 化学名 5-Chloro-N-（｛（5S）-2-oxo-3-［4-（3-oxomorpholin-4-yl）phenyl］-1,3-oxazolidin-5-yl｝methyl）thiophene-2-carboxamide 分子式 C19H18ClN3O5S 分子量 435.88 性状 本品为白色粉末至浅黄色。的产品，N，N-二甲基甲酰胺，略溶于二甲亚砜或N-甲基吡咯烷酮，乙腈微溶，在乙醇（99.5）非常微溶，并且几乎不溶于水。 适应证和用途 XARELTO一种因子Xa抑制剂适用于在正在膝或髋关节置换手术患者中预防深部静脉血栓形成(DVT)，后者可能导致肺栓塞(PE)。 剂量和给药方法 10mg口服，每天1次 禁忌证 （1）对XARELTO超敏性 （2）活动性重要出血 警告和注意事项 （1）出血的风险：XARELTO可引起严重和致命性出血。及时评价失血的征象和症状。 （2）妊娠相关出血：在妊娠妇女中由于潜在的产科出血和/或紧急剖宫产慎用XARELTO。及时评价失血征象和症状。 不良反应 最常见不良反应(>5%)是出血。 药物相互作用 （1）P-gp和强CYP3A4抑制剂联用：避免同时使用除非证明缺乏明显相互作用。 （2）P-gp和弱或中度CYP3A4抑制剂联用：避免同时使用除非在有肾受损患者权衡效益胜于出血风险。 （3）P-gp和强CYP3A4诱导剂联用：避免同时使用或考虑增加剂量。 （4）抗凝剂：避免同时使用。 （5）氯吡格雷[Clopidogrel]：避免同时使用除非权衡获益胜于出血风险。 特殊人群中使用 （1）哺乳母亲：终止药物或终止哺乳 （2）肾受损：避免在有严重受损(CrCl <30mL/min)患者中使用。在中度受损(CrCl 30至<50 mL/min)慎用 （3）肝受损：避免在有中度(Child-Pugh B)或严重(Child-Pugh C)肝受损患者或伴有凝血病有任何程度肝病患者中使用。 包装规格 片剂 10mg： PTP包装100片（10片×10），140片（14片×10），500片（10片×50） *瓶装500片 15mg PTP包装100片（10片×10），140片（14片×10），500片（10片×50） *瓶装500片 制造厂商（进口） 拜耳日本公司 完整处方资料附件： 1）：http://www.info.pmda.go.jp/go/pack/3339003F1024_1_12/ 2）：http://di-pedia.com:808/DIC_GOOCO/Attach/3339003F1024_1_07.html Xarelto Tablets（Rivaroxaban）利伐沙班片 Xarelto Tablets 10mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation]（イグザレルト錠10mg［抑制缺血性卒中和全身性栓塞的发生在非瓣膜性房颤患者］）  Brand name: Xarelto Tablets 10mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation] 　Active ingredient: Rivaroxaban 　Dosage form: pale red tablet, diameter: 6 mm, thickness: 2.8 mm 　Print on wrapping: (face) イグザレルト10mg, ▽10 (back) Xarelto 10mg Xarelto Tablets 15mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation]（イグザレルト錠15mg[抑制缺血性卒中和全身性栓塞的发生在非瓣膜性房颤患者]）  Brand name: Xarelto Tablets 15mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation] 　Active ingredient: Rivaroxaban 　Dosage form: red tablet, diameter: 6 mm, thickness: 2.8 mm 　Print on wrapping: (face) イグザレルト15mg, ▽15 (back) Xarelto 15mg Xarelto Tablets 15mg [treatment and prevention of recurrence of deep-vein thrombosis and pulmonary thromboembolism]（イグザレルト錠15mg［深静脉血栓和肺栓塞的治疗和抑制复发］） Brand name: Xarelto Tablets 15mg [treatment and prevention of recurrence of deep-vein thrombosis and pulmonary thromboembolism] 　Active ingredient: Rivaroxaban 　Dosage form: red tablet, diameter: 6 mm, thickness: 2.8 mm 　Print on wrapping: (face) イグザレルト15mg, ▽15 (back) Xarelto 15mg Effects of this medicine This medicine inhibits blood coagulation factor Xa to prevent blood clotting. It improves clotting tendency and treats or prevents thromboembolism, a disease caused by blood coagulation in the vessels It is usually used for treatment and prevention of recurrence of deep-vein thrombosis and pulmonary thromboembolism. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have bleeding (intracranial bleeding, gastrointestinal bleeding, etc.), liver disorder, renal disorder, acute bacterial endocarditis, bleeding tendency, prolonged bleeding or low body weight. If you are at high risk of bleeding (If you have recently had gastrointestinal tract ulcer, intracranial bleeding or cerebrospinal/eye surgery. If you have a history of bronchiectasis or lung bleeding. If you have gastric ulcer, duodenal ulcer, malignant tumor or hypertension). •If you are pregnant, possibly pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, for adults, take 15 mg of the active ingredient at a time, twice a day after meals for the first 3 weeks. Subsequently, take 15 mg of the active ingredient at a time, once a day. This preparation contains 15 mg of the active ingredient in a tablet. Strictly follow the instructions. •For the first 3 weeks (1 tablet at a time, twice a day): If you miss a dose, take a missed dose as soon as possible. If you remember the missed dose at the time of the next dose, take two doses at one time and follow your regular dosing schedule. After the first 3 weeks (1 tablet at a time, once a day): If you miss a dose, take a missed dose as soon as possible. However, there should be 12 hours or more before the next scheduled dose. You should never take two doses at one time. •If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop taking this medicine unless your doctor instructs you to do so. Precautions while taking this medicine •If you will receive dental treatment, endoscopic examination or surgery, make sure to inform your doctor in advance that you are taking this medicine. If you will receive treatment in other medical institutions or buy other medicines at pharmacies, etc., inform your doctor or pharmacist that you are taking this medicine. •Pay attention not to get injured since this medicine lead to prolonged bleeding. If bleeding time is prolonged or the injury involves a large area, immediately contact your doctor. Pay extra attention for the first 3 weeks (1 tablet at a time, twice a day). •Avoid taking any food containg hypericum perforatum (St. John's wort), since it may diminish medicinal effects. Possible adverse reactions to this medicine The most commonly reported adverse reactions include subcutaneous bleeding, nasal bleeding and bloody stool. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •nausea, vomiting, headache [bleeding (gastrointestinal bleeding, intracranial bleeding, etc.)] •nausea, dull, yellowing of the skin and the white of eyes [liver dysfunction, jaundice] •coughing, bloody phlegm, breathing difficulty, shortness of breath, fever [interstitial lung disease] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions 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. Bayer Yakuhin, Ltd.Internal Revised: 9/2015 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.