英文药名：JANUVIA Tablets(Sitagliptin Phosphate Hydrate) 中文药名：磷酸西他列汀水合物 生产厂家：默克日本公司 类别名称 —选择性DPP-4抑制剂— ◎降糖药◎ 磷酸西他列汀片,是一种新型降糖药二肽基肽酶-4(DPP-4)抑制剂,可提 高人体自身降低过高血糖水平的能力。Januvia是DPP-4抑制剂类药物中首种获批准的药物。 磷酸西他列汀作用特点是在刺激胰岛素分泌的同时，能减轻饥饿感，而且不会使体重增加，也不会发生低血糖和水肿现象，适合血糖控制不好且经常发生低血糖的糖尿病患者使用。经临床552例轻中度2型糖尿病患者验证，每天服一次磷酸西他列汀，每次服100毫克，服药12周后可使糖化血红蛋白降低0.6%-1.1%。 通用名：磷酸西他列汀 英文名称：Sitagliptin Phosphate 成份：磷酸西他列汀 适应症：用于2型糖尿病 用法用量：1日1次口服 包装规格 片：12.5毫克： PTP 100片（10片×10）140片（14粒×10）500片（10片×50）瓶100粒 片：25mg： PTP 100片（10片×10）140片（14粒×10）500片（10片×50）瓶100粒 片：50毫克： PTP 100片（10片×10）140片（14粒×10）500片（10片×50）700片（14粒×50）瓶500粒 片：100毫克： PTP 100片（10片×10）140片（14粒×10）500片（10片×50）瓶500粒 制造厂商 MSD有限公司 注：使用以原处方为准：http://www.info.pmda.go.jp/go/pack/3969010F1034_2_24/ JANUVIA Tablets(Sitagliptin Phosphate Hydrate) JANUVIA Tablets 12.5mg（ジャヌビア錠12.5mg）  Brand name : JANUVIA Tablets 12.5mg 　Active ingredient: Sitagliptin phosphate hydrate 　Dosage form: light grey tablet, diameter: 6.1 mm, thickness: 2.7 mm 　Print on wrapping: JANUVIA 12.5mg, ジャヌビア12.5mg, MSD 211 JANUVIA Tablets 25mg（ジャヌビア錠25mg） Brand name : JANUVIA Tablets 25mg 　Active ingredient: Sitagliptin phosphate hydrate 　Dosage form: pale reddish yellow tablet, major axis: 9.1 mm, minor axis:3.8 mm, thickness: 2.5 mm 　Print on wrapping: JANUVIA 25mg, ジャヌビア25mg, MSD 221 JANUVIA Tablets 50mg（ジャヌビア錠50mg）  Brand name : JANUVIA Tablets 50mg 　Active ingredient: Sitagliptin phosphate hydrate 　Dosage form: faintly reddish yellow tablet, diameter: 7.9 mm, thickness: 3.3 mm 　Print on wrapping: JANUVIA 50mg, ジャヌビア50mg, MSD 112 JANUVIA Tablets 100mg（ジャヌビア錠100mg）  Brand name : JANUVIA Tablets 100mg 　Active ingredient: Sitagliptin phosphate hydrate 　Dosage form: pale reddish yellow tablet, diameter: 9.8 mm, thickness: 4.2 mm 　Print on wrapping: JANUVIA 100mg, ジャヌビア100mg, MSD 277 Effects of this medicine This medicine inhibits enzyme that degrades incretin, blood glucose stabilizing substance. It consequently enhances insulinotropic action and effect of lowering glucagon level in state of hyperglycemia to improve blood glucose control. It is usually used to treat type 2 diabetes. 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 stage, type 1 diabetes, infection, injury, renal dysfunction, pituitary gland disorder, adrenal gland disorder, insufficient diet, a history of abdominal surgery or intestinal obstruction. If you are in pre/postoperative period or debilitated. If you exercise intensely or drink a lot of alcohol. 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>> For patients with normal renal function or mild renal dysfunction : In general, for adults, take 50 mg of sitagliptin at a time, once a day. If the dose seems to be insufficient, it may be increased up to 1 tablet (100 mg) at a time, once a day, adequately monitoring the condition. For patients with moderate renal dysfunction : In general, for adults, take 25 mg of sitagliptin at a time, once a day. If the dose seems to be insufficient, it may be increased up to 50 mg at a time, once a day, adequately monitoring the condition. For patients with severe or end stage renal dysfunction : In general, for adults, take 12.5 mg of sitagliptin at a time, once a day. If the dose seems to be insufficient, it may be increased up to 25 mg at a time, once a day, adequately monitoring the condition. This medicine contains 100 mg of sitagliptin per a tablet. In either case, strictly follow the instructions. If you miss a dose, take the missed dose as soon as possible. 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 hypoglycemic symptoms. Pay attention when you work at heights, drive a car or operate dangerous machinery. ?In case hypoglycemic symptoms occurs, take food or drink that contains enough amount of sugar (sugar, glucose, refreshing drink, etc.).If you are taking the medicine concomitantly with an α-glucosidase inhibitor (medicines which delay absorption of sugar), ingest glucose in case of any hypoglycemic symptoms occur. Possible adverse reactions to this medicine The most commonly reported adverse reactions include hypoglycemia and constipation. 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. ?breathing difficulty, hives, swelling around eyes and lips [anaphylactic reaction] fever, erythema, bloodshot eyes [Stevens-Johnson syndrome, dermatitis exfoliativa] chills, craving for food, tremor in limbs [hypoglycemia] loss of appetite, general malaise, yellowness in skin or conjunctiva [hepatic dysfunction, jaundice] decreased urine output, general edema, malaise [acute renal failure] severe pain in the upper abdomen, back pain, nausea [acute pancreatitis] fever, dry cough, breathing difficulty [interstitial pneumonia] failure of passing stool, stomach ache, abdominal bloating [intestinal obstruction] pain of the limb muscle, stiffness, numbness [rhabdomyolysis] continuous bleeding, blue spot, subcutaneous bleeding [thrombopenia] 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. MSD K.K.Internal Revised: 3/2015 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.