英文药名：Equa Tablets（Vildagliptin） 中文药名：维达列汀片（那格列奈） 生产厂家：瑞士诺华日本公司 エクア錠50mg 治疗类别名称 选择性DPP-4抑制剂[2型糖尿病的治疗] 商標名 Equa Tablets 50mg 構造式 一般名 ビルダグリプチン（Vildagliptin） 化学名 （2S）-1-｛［（3-Hydroxytricyclo［3.3.1.13,7］dec-1-yl）amino］acetyl｝pyrrolidine-2-carbonitrile 分子式 C17H25N3O2 分子量 303.40 性状 白色至浅黄色或细灰白色粉末。易溶于水和乙醇（99.5）。 熔点 150℃左右 分配系数 1.255（1-辛醇/水），0.0042（1-辛醇/0.1mol/L盐酸），0.035（1-辛醇/pH4.0缓冲液），0.25（1-辛醇/pH6.8缓冲液） 药效药理 胰高血糖素样肽-1（GLP-1）具有胰岛素分泌促进作用和胰高血糖素分泌抑制作用，它在糖代谢中起重要作用。维格列汀是选择性地和可逆地抑制DPP-4，通过增加内源性的GLP-1的浓度，抑制胰高血糖素分泌一起促进葡萄糖依赖性胰岛素分泌，并显示出降血糖作用。 (1) DPP-4抑制作用 Galvus人血浆DPP-4以浓度依赖的方式抑制，IC50值为2.7纳米。另外，维格列汀，对人DPP-4（重组的）具有高亲合力，Ki值是2〜3纳米。 (2) 对血浆GLP-1的作用 这种药物为50mg反复口服给药7天，每天给患者的2型糖尿病的两倍，血浆GLP-1浓度增加。 (3) 对胰岛素抵抗的作用 2型糖尿病患者的这种药物50毫克，每天41天重复口服给药两次，被进行了胰岛素钳夹试验中，胰岛素抵抗的指标得到改善。（外国数据) (4) 降血糖作用及糖耐量改进措施 1）当单剂量10周在预糖尿病阶段和2型糖尿病的食蟹猴重复口服每日维格列汀，糖化血红蛋白由0.6％和1.2％减少，分别相比于给药前的值。 2）这种药物为50mg2次7天每天重复口服给药的患者的2型糖尿病，餐后血糖和空腹血糖降低。 适应病症 2型糖尿病 用法与用量 成人，每日口服二次，每次50毫克，口服晚上服用。此外，能根据在早晨所述患者每天一次的条件来管理50毫克。 包装规格 片剂 50毫克：100片（PTP）420片（PTP）500片（PTP）500粒（瓶）1,000片（PTP） 制造和销售 诺华制药有限公司 完整资料附件：http://www.info.pmda.go.jp/go/pack/3969011F1020_1_21/ Brand name : Equa Tablets 50mg 　Active ingredient: Vildagliptin 　Dosage form: white to pale yellowish white tablet with a split line, φ: 8.0 mm, thickness: 3.4 mm 　Print on wrapping: エクア50mg, Equa 50mg, NVR, FB  Effects of this medicine This medicine inhibits the enzyme which degrades incretin, a hormone adjusting blood glucose level. It enhances insulin secretion depending on blood glucose level, and consequently improves blood glucose control. It is usually used to treat type 2 diabetes mellitus. 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 are a patient with diabetic ketoacidosis, diabetic coma, type 1 diabetes mellitus, hepatic dysfunction, infection, external injury or are in perioperative period. •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>> •In general, for adults, take 1 tablet (50 mg of the active ingredient) at a time, twice a day, in the morning and in the evening. The dose can be 1 tablet (50 mg) at a time, once a day in the morning according to your symptoms. Strictly follow the instructions. For patients with moderate or severe renal dysfunction or end stage renal disease on dialysis, the dose can be 1 tablet (50 mg) at a time, once a day in the morning. Strictly follow the instructions. •If you missed a dose, take a dose as soon as possible. However, if it is almost time for the next dose, 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 •Strictly follow diet and exercise therapy instructed by your doctor. •The medicine may cause hypoglycemia. Pay attention when you work at heights, drive a car or operate dangerous machinery. •If you noticed any symptoms of hypoglycemia, take sufficient amount of sugar (sugar, glucose, soft drink, etc.). If you are taking the medicine concomitantly with an α-glucosidase inhibitor (drugs which delay absorption of sugar), ingest glucose in case of any hypoglycemic symptoms. Possible adverse effects of this medicine The most commonly reported adverse reactions include hungry, constipation and asthenia. 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 effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •general malaise, yellowness in skin or conjunctiva, loss of appetite[hepatitis, hepatic dysfunction] •swelling in eyelid/lips/tongue, breathlessness, hives[angioedema] •light-headedness, feeling of weakness, cold sweat[hypoglycemia] •muscle pain, muscle weakness, red-brown urine[rhabdomyolysis] •severe pain in upper abdomen, low back pain, vomiting[acute pancreatitis] •abdominal full feeling, continued abdominal pain, vomiting[intestinal obstruction] •dry cough, breathing difficulty, fever[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 the reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. 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。