英文药名：URSO granules 5％(Ursodeoxycholic Acid) 中文药名：熊去氧胆酸5％顆粒 生产厂家：田边三菱制药 ウルソ顆粒5％ 药品治疗名称 肝.胆.消化功能改善剂 商標名 URSO granules 5％ 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 白色结晶或粉末，味微苦。甲醇，乙醇（99.5），或可溶于乙酸（100），并且几乎不溶于水。 融点 200～204℃ 适应症 本品用于胆固醇型胆结石，形成及胆汁缺乏性脂肪泻，也可用于预防药物性结石形成及治疗脂肪痢。 用法与用量 以下利胆性疾病 ・胆管，胆囊系统疾病和胆汁淤积相关胆肝疾病 口服给药，成人每次为50mg，一天三次。此外，增加或减少取决于患者的年龄和症状。 ・改善慢性肝病的肝功能 口服给药，成人每次为50mg，一天三次。此外，增加或减少取决于患者的年龄和症状。 以下消化不良疾病 ・小肠切除后遗症，炎性肠道疾病 口服给药，成人每次为50mg，一天三次。此外，增加或减少取决于患者的年龄和症状。 ・胆固醇结石系统的溶解不承认外壳钙化 口服给药，成人每次为50mg，一天三次。此外，增加或减少取决于患者的年龄和症状。 包装规格 颗粒5％：500克 颗粒5％：1KG 生产厂商 田边三菱制药株式会社 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/2362001D1060_2_07/ URSO granules 5％(Ursodeoxycholic Acid ウルソ顆粒5％) Brand name : Urso granules 5% 　Active ingredient: Ursodeoxycholic acid 　Dosage form: white granules 　Print on wrapping:  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 liver function in chlonic liver disease, improve dyspepsia after small intestine resection and that in inflammatory disease of small intestine, and dissolve cholesterol gallstones. 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 1 g (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 g (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. •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 reactions to this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: diarrhea, nausea, itching, urticaria, rash, erythema, etc. 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. •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. Mitsubishi Tanabe Pharma CorporationInternal Revised: 12/2010