英文药名：SEIBULE OD Tab（Miglitol） 中文药名：米格列醇口腔崩解片 生产厂家：三和化学制药 治疗类别名称 糖尿病餐后高血糖改善剂 商標名 SEIBULE OD Tab 一般名 Miglitol　ミグリトール 化学名 (－)-(2R,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)piperidine-3,4,5-triol 分子式 C8H17NO5 分子量 207.22 構造式 融点 144～147℃ 性状 米格列醇是好的淡黄白色结晶性粉末。它易溶于水，并在乙醇（99.5）几乎不溶。 药理作用 本品为第二代糖苷酶抑制药。本品为小分子化合物，其结构与葡萄糖相似。在食物的消化过程中，α-葡萄糖苷酶(包括麦芽糖酶、异麦芽糖酶、蔗糖酶、葡萄糖淀粉酶等)可以将食物中的多糖及低聚糖水解为单糖(包括葡萄糖)。α-糖苷酶抑制药可延缓葡萄糖的生成及吸收，从而缓解糖尿病患者餐后高血糖及其后血糖的急剧变化。本品主要作用于小肠，对结肠内碳水化合物水解影响较小，由未吸收的糖类发酵继发的胃肠道不良反应较阿卡波糖少见。 适用症： 用于治疗成人2型糖尿病。 剂量和给药方法 成人通常给药一次口服50毫克，每天三次。注意，当效果不足，单剂量，同时充分观察的过程中可以增加至75毫克 包装规格： *口腔崩解片：50mg 100錠（PTP 10錠×10）、210錠（PTP 21錠×10）、500錠（PTP 10錠×50）、1050錠（PTP 21錠×50） *口腔崩解片：75mg 100錠（PTP10錠×10）、500錠（PTP10錠×50） 生产厂商 三和化学研究所有限公司 SEIBULE OD Tablets（Miglitol） SEIBULE OD Tablets 50mg（セイブルOD錠50mg） Brand name : SEIBULE OD Tablets 50mg 　Active ingredient: Miglitol 　Dosage form: white tablet, diameter: 8.5 mm, thickness: 2.8 mm 　Print on wrapping: セイブルOD錠50mg, セイブル, OD, OD50, 糖尿病のお薬, SEIBULE OD Tab.50mg, 食直前に服用, 口腔内崩壊錠, Sc50 ------------------------------------------ SEIBULE OD Tablets 75mg（セイブルOD錠75mg） Brand name : SEIBULE OD Tablets 75mg 　Active ingredient: Miglitol 　Dosage form: white tablet, diameter: 10.0 mm, thickness: 3.0 mm 　Print on wrapping: セイブルOD錠75mg, セイブル, OD, OD75, 糖尿病のお薬, SEIBULE OD Tab.75mg, 食直前に服用, 口腔内崩壊錠, Sc75 Effects of this medicine This medicine delays glucose absorption from the small intestine by inhibiting the enzyme activity which degrades carbohydrates to glucose. It is usually used for the treatment of diabetes mellitus by suppressing a rapid elevation of postprandial glucose. 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: ketosis, diabetic coma or precoma, infection or injury. If you are just after/before having surgery. •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 50 mg of the active ingredient at a time, 3 times a day, immediately before meals. If you do not respond to this medicine sufficiently, a dose may be increased up to 1 tablet (75 mg). This preparation contains 75 mg of the active ingredient in a tablet. Strictly follow the instructions. •Soften the tablet with saliva and crush it lightly with the tongue and swallow the tablet with saliva. You can also take it with a glass of water as you do to take other tablets. •If you miss a dose, take a dose as soon as possible during a meal. If you notice except during a meal, skip the missed dose and continue your regular dosing schedule. 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 •Take 10 g of glucose not sucrose (sugar) when hypoglycemic symptoms occur. •This medicine may cause hypoglycemic symptoms. Pay close attention when you perform dangerous operations such as driving a car, operating machinery or working at heights. Possible adverse reactions to this medicine The most commonly reported adverse reactions include borborygmus, abdomen enlarged, diarrhea, hypoglycemia, and rash. 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. •cold sweat, a sense of hunger, tremor of limbs [hypoglycemia] •stoppage of stool, abdominal pain, abdomen enlarged feeling [intestinal obstruction] •general malaise, nausea, yellowing of the skin and the conjunctiva [liver dysfunction, jaundice] 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. SANWA KAGAKU KENKYUSHO CO.,LTD.Internal Published: 6/2015 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. http://www.info.pmda.go.jp/go/pack/3969009F4022_1_02/