英文药名：BASEN OD Tablets（Voglibose） 中文药名：伏格列波糖口腔崩解片 生产厂家：武田药品 ベイスンOD錠0.2／ベイスンOD錠0.3 药物分类名称 餐后高血糖改善剂 批准日期：2004年7月 商標名 BASEN OD Tablets 0.2 BASEN OD Tablets 0.3 化学構造式 一般名 ボグリボース（Voglibose）〔JAN〕 化学名 3,4-Dideoxy-4-［2-hydroxy-1-（hydroxymethyl）ethylamino］-2-C-（hydroxymethyl）-D-epi-inositol 分子式 C10H21NO7 分子量 267.28 融点 163～168℃ 性状 伏格列波糖是一种白色结晶或结晶粉末。 它易溶于水，易溶于乙酸（100），难溶于甲醇，极难溶于乙醇（99.5）。 溶于0.1mol/L盐酸试剂溶液。 药效药理 此药物抑制负责从肠道中的二糖（α-葡糖苷酶）降解为单糖二糖水解酶，提高了通过延迟糖类的消化和吸收的餐后高血糖。 （1）作用机制 1）分别表示大约20倍和大约270倍和190倍的阿卡波糖，30倍抗猪肠道麦芽糖酶和蔗糖酶，大鼠肠麦芽糖酶和蔗糖酶的抑制活性阿卡波糖更强的抑制作用（体外） 。抗猪和大鼠胰α-淀粉同时抑制作用为约阿卡波糖的1/3000，它显示了对β-葡糖苷酶没有抑制活性（体外）。 2）从大鼠小肠蔗糖酶 - 反对二糖水解酶复合物异麦芽糖酶抑制方式是竞争性的拮抗（体外）。 （2）血糖升高抑制作用 1）口服给药时的正常大鼠，淀粉，抑制血糖值升高之后麦芽糖和蔗糖负荷是无效的葡萄糖，果糖和乳糖负载（体内后葡萄糖的增加）。 2）健康成人呼吸氢气的测量执行在临床剂量本发明的药剂和基于碳水化合物的二糖部分分解抑制的轻微吸收抑制的蔗糖负荷血糖升高抑制作用，其结果据推测，这是由于吸收延迟。 （3）生物等效性 交叉研究盆OD片剂和片剂盆口服给予健康的成年男性，血浆葡萄糖水平的差异（在每种0.2mg的片剂和0.3mg的片剂的情况下进行）上升抑制蔗糖负荷（C max）的影响后，观察到它没有完成。 适应症 ○改善糖尿病餐后高血糖症 （但是，如果饮食疗法和运动疗法的患者没有足够的效果，或者使用口服降糖药或胰岛素制剂的患者除了饮食疗法和锻炼疗法之外是足够有效的 只有当它不能被获得） ○抑制2型糖尿病的葡萄糖耐量异常（仅限于OD片剂0.2） （但是，即使饮食疗法/运动疗法充分进行也不会改善） 用法与用量 ○餐后高血糖症的改善 通常，成人在每顿饭之前每天口服一次0.2mg，每天一次伏格列波糖三次。 如果效果不够，一次观察到足够的剂量可以增加到0.3毫克。 ○抑制2型糖尿病的葡萄糖耐量异常的情况下（仅OD试剂0.2） 通常，成人在每顿饭之前每天口服一次0.2mg，每天一次伏格列波糖三次。 包装规格 OD片 0.2毫克:100片（10片×10），500片（10片×50），1,000片（10片×100），2,100片（21片×100） 0.3毫克：100片（10片×10），500片（10片×50），1,000片（10片×100），2,100片（21片×100） 制造商 武田特瓦制药有限公司 注：以上中文资料不够完整，使用者以原处方为准。 完整说明书附件：http://www.info.pmda.go.jp/go/pack/3969004F3023_2_03/ ベイスンOD錠：BASEN OD Tablets（Voglibose） BASEN OD Tablets 0.2（ベイスンOD錠0.2） Brand name : BASEN OD Tablets 0.2 　Active ingredient: Voglibose 　Dosage form: yellowish white tablets, φ7.6 mm, thickness 2.7 mm 　Print on wrapping: (Face) 341 0.2 (Back) ベイスンOD0.2　食直前に服用 0.2 BASEN OD Tablets 0.3（ベイスンOD錠0.3） Brand name : BASEN OD Tablets 0.3 　Active ingredient: Voglibose 　Dosage form: slightly yellow tablets, φ8.6 mm, thickness 3.2 mm 　Print on wrapping: (Face) 342 0.3 (Back) ベイスンOD0.3 食直前に服用 Effects of this medicine This medicine delays glucose absorption from the small intestine by blocking the enzyme which degrades carbohydrates to glucose. It suppresses a rapid elevation of postprandial blood glucose in patients with diabetes mellitus. Usually, used for treatment of diabetes mellitus. 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 have severe ketosis, diabetic coma or precoma, or infection; are in a pre- or postoperative state; have a serious injury; have undergone a laparotomy; have experienced bowel obstruction; or have Roemheld syndrome, intestinal disorder, liver disorder, or renal disorder. •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 <<o be written by a healthcare professional>> •General dosage regimen: for adults, take 0.2 mg of the active ingredient at a time immediately before meal, three times a day. The dosage may be increased up to 0.3 mg of the active ingredient at a time immediately before meal, three times a day, if the effect is insufficient. Each tablet contains 0.3 mg of the active ingredient. Strictly follow the instructions of your doctor/pharmacist. •This medicine may be moistened with saliva on the tongue, then lightly squashed with the tongue, and swallowed with saliva. It may also be taken with water like usual medicines. •If you miss a dose, take one dose immediately before the next meal. 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 •Strictly adhere to dietary instructions given and to kinesitherapy prescribed. •Hypoglycemia may occur. Ingest glucose in case of symptoms of hypoglycemia. Possible adverse reactions to this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: diarrhea, soft stool, borborygmus, abdominal pain, constipation, loss of appetite, nausea, vomiting, heart burn, dry mouth, dizziness, anemia, numbness, edema of the face and other regions, blurred vision, glow, malaise, lassitude, sweating, hair loss, rash, itching, photosensitivity, 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. •cold sweat, hungry feeling, trembling of hands/feet [hypoglycemia] •enlarged feeling of abdomen, increased flatus [bowel obstruction-like symptoms] •yellowing of the skin and whites of the eyes, general malaise, loss of appetite [serious liver dysfunction, jaundice] •constipation, disturbance of consciousness [exacerbation of hyperammonemia in patients with liver cirrhosis] 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 humidity. •Discard the remainder. Do not store them. Takeda Chemical Industries, Ltd.Internal Revised: 10/2009 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.