英文药名：URSO（Ursodeoxycholic Acid tablets）

中文药名：胆烷酸片

生产厂家：田边三菱制药

主治病症：原发性胆汁性肝硬变的肝功能的改善

ウルソ錠50mg／ウルソ錠100mg

商標名
URSO tablets
一般名
ウルソデオキシコール酸，Ursodeoxycholic Acid（JAN）
化学名
3α, 7β-Dihydroxy-5β-cholan-24-oic acid
分子式
C24H40O4
分子量
392.57
構造式

性状
白色の結晶又は粉末で，味は苦い．メタノール，エタノール（99.5）又は酢酸（100）に溶けやすく，水にほとんど溶けない．
融点
200～204℃
效果或疗效
剂量效应和/或使用功效
•在下列疾病的利胆
肝病与胆汁淤积和疾病系统（膀胱胆管，胆汁）胆道
由于熊去氧胆酸，通常口服，每天一次50毫克成人的三倍。另外，也将增加或减少取决于患者的年龄和症状。
并改善慢性肝病肝功能
由于熊去氧胆酸，通常口服，每天一次50毫克成人的三倍。另外，也将增加或减少取决于患者的年龄和症状。
•在下列疾病的消化不良
后遗症小肠切除，小肠炎症性疾病
由于熊去氧胆酸，通常口服，每天一次50毫克成人的三倍。另外，也将增加或减少取决于患者的年龄和症状。
与胆固醇结石体系解体不允许外壳钙化
胆固醇结石体系的解体不允许外壳钙化，如熊去氧胆酸，通常把口服三600毫克1日成人。另外，也将增加或减少取决于患者的年龄和症状。
并改善原发性胆汁性肝硬化肝功能
原发性胆汁性肝硬化肝功能的改善，为熊去氧胆酸，通常把口服三600毫克1日成人。另外，也将增加或减少取决于患者的年龄和症状。该是为900mg每日最大剂量增加量的情况下。
并改善C型慢性肝病肝功能
在C型慢性肝病肝功能的改善，为熊去氧胆酸，通常把口服三600毫克1日成人。另外，也将增加或减少取决于患者的年龄和症状。该是为900mg每日最大剂量增加量的情况下。
相关的效果或疗效注意事项
原发性胆汁性肝硬化的肝功能的改善
·当给予黄疸肝硬化阶段高度病人，应给予谨慎，因为有一种可能性，即症状加重。如果观察到血清胆红素水平的提高，而且它采取适当的措施，如施用中断。
在C型慢性肝病肝功能改善
•在C型慢性肝病，考虑到所述第一病毒清除疗法是可取的。因为它们不是病毒清除行动，此药，肝功能改善了C型慢性肝病的长期预后的影响目前尚不清楚，此时，患者不能应用干扰素治疗或干扰素治疗无效的例子病毒清除考虑到特药的管理。
而对于失代偿期肝硬化患者的安全性和有效性尚未确立。当与黄疸程度高施用给患者，并且可以施用小心，因为有一种可能性，即症状加重。如果观察到血清胆红素水平的提高，而且它采取适当的措施，如施用中断。
包装
ウルソ錠50mg：100錠（10錠×10）
ウルソ錠50mg：1,000錠（10錠×100）
ウルソ錠50mg：500錠（バラ）
ウルソ錠100mg：100錠（10錠×10）
ウルソ錠100mg：1,000錠（10錠×100）
ウルソ錠100mg：5,000錠（10錠×500）
ウルソ錠100mg：2,100錠（21錠×100）
ウルソ錠100mg：500錠（バラ）

製造販売元
田辺三菱製薬株式会社

完整处方资料附件：http://www.info.pmda.go.jp/go/pack/2362001F1088_2_07/
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name : Urso Tablets 50 mg
　Active ingredient: Ursodeoxycholic acid
　Dosage form: white tablets, φ6.0 mm, thickness approx. 2.4 mm
　Print on wrapping: ウルソ50mg, URSO50mg
Effects of this medicine
This medicine increases bile secretion and thereby improves the bile flow. This medicine replaces hydrophobic bile acids in the liver, resulting in alleviation of hepatotoxicity. Moreover, this medicine inhibits cytokine/chemokine production and the infiltration of inflammatory cells into the liver, leading to improvement of liver dysfunction. In addition to these effects, this medicine provides dissolution of gallstones and improvement of digestion and absorption.
Usually, it is used to treat disease of biliary system and liver disease resulting from bile flow retention, improve dyspepsia after small intestine resection and that in inflammatory disease of small intestine, dissolve cholesterol gallstones, and improve liver function in chlonic liver disease, primary biliary cirrhosis and chronic liver disease due to hepatitis C virus.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are patients with complete biliary obstruction and fulminant hepatitis.
•If you are 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>>
•General dosage regimen: For treatment of liver disease and improvement of liver function and dyspepsia, for adults, take one tablet (50 mg of the active ingredient) at a time, three times a day. It should be adjusted according to your disease, age and symptom. Strictly follow the instructions of your doctor/pharmacist.
For dissolution of cholesterol gallstones, for adults, take 4 tablets (200 mg of the active ingredient) at a time, three times a day. It should be adjusted according to your age and symptom. Strictly follow the instructions of your doctor/pharmacist.
For improvement of liver function in primary biliary cirrhosis and chronic liver disease due to hepatitis C virus, for adults, take 4 tablets (200 mg of the active ingredient) at a time, three times a day. It should be adjusted according to your disease age and symptom. The maximum daily dosage should be within 18 tablets (900 mg). Strictly follow the instructions of your doctor/pharmacist.
•If you are ordered to use the medicine on regular schedule and you missed a dose, take a dose as soon as possible. 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.
•If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
•Do not stop taking the medicine without the instructions of your doctor.
Precautions while taking this medicine
• Possible adverse effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: diarrhea, loose stools, constipation, nausea, itching, urticaria, rash, erythema, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•fever, dry cough, respiratory distress[interstitial pneumonia]
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 heat, humidity and direct sunlight.
•If any medicine is left, do not store them. You must discard the remainder.