英文药名：GLACTIV Tablets(Sitagliptin Phosphate Hydrate)

中文药名：磷酸西他列汀水合物

生产厂家：小野制药
药品介绍
磷酸西他列汀适用于2型糖尿病患者；用于运动，饮食、药物控制不佳时，使用本药能起到一定疗效。
剂型与规格：片剂：25mg 50mg 100mg
【适应症】适用于2型糖尿病患者；用于运动，饮食、药物控制不佳时，使用本药能起到一定疗效。
【用量用法】口服，每日1次，每次100mg；或遵医嘱。
【药理毒理】属于一类全新的突破性创新药物—二肽基肽酶-4（DPP-4）抑制剂。它能够提高一种被称为“肠促胰岛激素”的生理机制，通过影响胰腺中的β细胞和α细胞来调节葡萄糖水平。只有当β细胞出现功能障碍而引起胰岛素水平降低或者当α细胞和β细胞发生功能障碍，令肝糖产生无节制增加时，才会通过抑制二肽基肽酶起作用。
【药代动力学】西他列汀为口服制剂，每日1次，每次100mg。研究发现，24h中只要血浆中西他列汀浓度>100nmol/L，就能起到有效抑制DPP～4的作用(抑制≥80%的DPP-4的活性)。同时也有研究发现，西他列汀200mg的治疗效果并不优于100mg。该药的相对吸收速度较快，平均达峰时间为在药物吸收后1～4h，且不受饮食影响，t-z=12.4h，浓度一时问曲线下面积(AUC)为8.52／g·h·L，生物利用度为87%，与血浆蛋白的结合率较低(约38%)而且具有可逆性，但在组织中分布较广，分布体积为198L，其清除主要是通过肾脏直接排出(79%)，其余的经代谢后排出。对于肾脏功能不好的患者，应适当减少其用量。研究发现，对于轻度肾功能损害(内生肌酐清除率为30～50mL·min)患者，只需用药量的1/2，对于重度肾功能损害(内生肌酐清除率<30mL·min)患者，只需用药量的1/4。与其它降糖药物合用时，西他列汀不会很明显的改变其它降糖药物的药动学途径，而其它降糖药物也不会明显改变西他列汀的代谢途径。
【不良反应】详细可对照“二甲双胍”，较其轻。具体见说明书。

グラクティブ錠12.5mg／グラクティブ錠25mg／グラクティブ錠50mg ／グラクティブ錠100mg

GLACTIV Tablets(Sitagliptin Phosphate Hydrate)
Brand name : GLACTIV Tablets 12.5mg 25mg 50mg 100mg
　Active ingredient: Sitagliptin phosphate hydrate
　Dosage form: faintly reddish yellow tablet, φ: 7.9 mm, thickness: 3.3 mm
　Printings on wrapping: GLACTIV 12.5mg 25mg 50mg 100mg, グラクティブ12.5mg 25mg 50mg 100mg, 糖尿病用薬, ono661, 1日1回服用
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, tell your doctor/pharmacist
If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are a patient with ketosis, diabetic coma or precoma stage, type 1 diabetes, renal dysfunction, infection, injury, pituitary gland disorder, adrenal gland disorder, insufficient diet, or are in pre/postoperative period, or are debilitated.
If you exercise intensely or drink a lot of alcohol.
If you are pregnant or breastfeeding.
If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.)
Dosage regimen (proper use of this medicine)
Your dosage regimen is:(order of your doctor)
General dosage regimen:
For patients with normal renal function or mild renal dysfunction, for adults, take 1 tablet (50 mg of the active ingredient) at a time, once a day. If the dose seems to be insufficient, it may be increased up to 2 tablets (100 mg of the active ingredient) at a time, once a day, adequately monitoring the condition. Strictly follow the instructions of your doctor/pharmacist.
For patients with moderate renal dysfunction, for adults, take 25 mg of the active ingredient at a time, once a day. If the dose seems to be insufficient, it may be increased up to 1 tablet (50 mg of the active ingredient) at a time, once a day, adequately monitoring the condition. Strictly follow the instructions of your doctor/pharmacist.
Missed 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. DO NOT take double doses to make up for the missed dose.
Overdose: If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
Others: Do not stop taking the medicine without the instructions of your doctor.
Precautions while using this medicine
Strictly follow diet and exercise therapy instructed by your doctor.
Pay close attention that the medicine may cause hypoglycemia.
In case hypoglycemia 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 (drugs which delay absorption of sugar), ingest glucose in case of any hypoglycemic symptoms occur.
Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: hypoglycemia, constipation, etc.In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately.
breathing difficulty, hives, swelling around eyes and lips [anaphylactic reaction]
fever, erythema, bloodshot eyes [Stevens-Johnson syndrome, exfoliative dermatitis ]
chills, craving for food, tremor in the limbs [hypoglycemia]
loss of appetite, general malaise, yellowness in skin or conjunctiva [hepatic dysfunction, jaundice]
decreased urination output, general swelling, malaise [acute renal failure]
severe pain in the upper abdomen, back pain, nausea[acute pancreatitis]
fever, dry cough, breathing difficulty[interstitial pneumonia]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom. 
Storage and other information
Keep out the reach of children. Store away from direct sunlight, heat and moisture.
Discard the remainder. Do not store them.
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.
Manufacturer's name : Ono Pharmaceutical Co., Ltd. 621970701
Revised: 06/2011

http://www.info.pmda.go.jp/go/pack/3969010F1026_1_26/
http://di-pedia.com:808/DIC_GOOCO%5CAttach%5C3969010F1026_1_20.html
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产地国家: 日本
原产地英文商品名:
GLACTIV(グラクティブ錠) 12.5mg/Tabs 100Tabs/box 
原产地英文药品名:
Sitagliptin Phosphate Hydrate
中文参考商品译名:
GLACTIV片(グラクティブ錠) 12.5毫克/片 100片/盒
中文参考药品译名:
磷酸西他列汀水合物
生产厂家中文名:               
小野薬品
生产厂家英文名:
Ono Yakuhin

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产地国家: 日本
原产地英文商品名:
GLACTIV(グラクティブ錠)25mg/Tabs 100Tabs/box 
原产地英文药品名:
Sitagliptin Phosphate Hydrate
中文参考商品译名:
GLACTIV片(グラクティブ錠)25毫克/片 100片/盒
中文参考药品译名:
磷酸西他列汀水合物
生产厂家中文名:               
小野薬品
生产厂家英文名:
Ono Yakuhin

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产地国家: 日本
原产地英文商品名:
GLACTIV(グラクティブ錠) 50mg/Tabs 100Tabs/box
原产地英文药品名:
Sitagliptin Phosphate Hydrate
中文参考商品译名:
GLACTIV片(グラクティブ錠) 50毫克/片 100片/盒
中文参考药品译名:
磷酸西他列汀水合物
生产厂家中文名:               
小野薬品
生产厂家英文名:
Ono Yakuhin

-----------------------------------------------
产地国家: 日本
原产地英文商品名:
GLACTIV(グラクティブ錠) 100mg/Tabs 100mgTabs/box
原产地英文药品名:
Sitagliptin Phosphate Hydrate
中文参考商品译名:
GLACTIV片(グラクティブ錠) 100毫克/片 100片/盒
中文参考药品译名:
磷酸西他列汀水合物
生产厂家中文名:               
小野薬品
生产厂家英文名:
Ono Yakuhin