英文药名：Xarelto Fine Granules（Rivaroxaban）

中文药名：利伐沙班细颗粒

生产厂家：拜耳公司

イグザレルト細粒分包10mg／イグザレルト細粒分包15mg

治疗类别名称
选择性直接Xa因子抑制剂
批准日期：2015年12月
商品標名
Xarelto Fine Granules
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-oxomorpho-lin-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。
条件批准
*在建立药品风险管理计划的顶部，要正确实施。
药效药理
1. 作用机序
这种药物是一种选择性和直接Xa因子抑制剂，示出了通过口服给药的效果。内在的和外在的血液凝固级联，该药物以抑制，凝血酶产生和血栓形成的Ⅹa因子被抑制。这种药物不抑制凝血酶，也不具有对血小板有直接的影响。
2. 抗血栓效果
这种药物，小鼠，大鼠或兔的静脉和动脉血栓形成模型中，以剂量依赖性方式的血栓形成被抑制。另外，在兔静脉血栓形成模型中，抑制血栓的后血栓形成的增加。
适应病症
● 抑制非瓣膜性缺血的房颤患者卒中和全身性栓塞的发生
● 深静脉血栓和肺栓塞的治疗和复发抑制
用法用量
● 抑制非瓣膜性缺血的房颤患者卒中和全身性栓塞的发生
成人每天一次15毫克给药。应当指出的是，对于肾功能衰竭患者，以在一个时间10Mg1_nichi减肥取决于对肾功能的程度。
● 深静脉血栓和肺栓塞的治疗和复发抑制
成人初始三周饭后口服给药，一天两次，15毫克如利伐沙班，然后一餐每天一次15毫克后口服给药
包装规格
細粒剤
10mg　90包（3包×30）
15mg　90包（3包×30）

 
制造厂商
拜耳药品
Xarelto Fine Granules（Rivaroxaban）
Xarelto Fine Granules 10mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation]（イグザレルト細粒分包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 Fine Granules 10mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation]
　Active ingredient: Rivaroxaban
　Dosage form: white fine granules
　Print on wrapping: white fine granules
Xarelto Fine Granules 15mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation]（イグザレルト細粒分包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 Fine Granules 15mg [prevention of onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation]
　Active ingredient: Rivaroxaban
　Dosage form: white fine granules
　Print on wrapping: イグザレルト細粒分包15mg,Xarelto Fine Granules (0.75g)
Xarelto Fine Granules 15mg [treatment and prevention of recurrence of deep-vein thrombosis and pulmonary thromboembolism]（イグザレルト細粒分包15mg［深静脉血栓和肺栓塞的治疗和抑制复发］）
Brand name : Xarelto Fine Granules 15mg [treatment and prevention of recurrence of deep-vein thrombosis and pulmonary thromboembolism]
　Active ingredient: Rivaroxaban
　Dosage form: white fine granules
　Print on wrapping: イグザレルト細粒分包15mg,Xarelto Fine Granules (0.75g)
Effects of this medicine
This medicine inhibits blood coagulation factor Xa to prevent blood clotting. It improves clotting tendency in the atrium and prevents thromboembolism, a disease caused by blood coagulation in the vessels.
It is usually used to prevent onset of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
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, once a day after meals. If you have renal disorder, the dosage may be decreased to 10 mg at a time, once a day. This preparation contains 10 mg of the active ingredient in a tablet. Strictly follow the instructions.
•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.
•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 nasal bleeding, subcutaneous bleeding, gum bleeding, bloody urine, conjunctival bleeding, anemia, wound bleeding, hemoptysis (coughing up blood), bleeding in the mouth, hemorrhoidal bleeding, retinal bleeding and melena (black 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.
https://di-pedia.cocoyaku.jp/drugs/?action_drugs_detail=true&id=3339003C2024
http://www.info.pmda.go.jp/go/pack/3339003C1028_1_03/