部份中文鲁格列净处方资料（仅供参考）
英文名：Luseogliflozin Hydrate
商品名：Lusefi tablets
中文名：鲁格列净片
生产商：大正制药
药品简介
2014年3月24日，2型糖尿病新药Lusefi（Luseogliflozin Hydrate）在日本PMDA批准上市。该药由日本正大及诺华制药共同研发。用于治疗2型糖尿病，每片含2.5mg或5mg Luseogliflozin Hydrate。推荐使用剂量为每天一次，每次2.5 mg于饭前或饭后服用。
Lusefi是一种选择性钠葡萄糖同转运蛋白2（SGLT2）抑制剂，SGLT2分布于小肠粘膜和肾小管，在近端肾小管葡萄糖再吸收中发挥着关键作用。通过抑制SGLT2，使肾小管中的葡萄糖不能顺利重吸收进入血液而随尿液排出，从而降低血糖浓度。
ルセフィ錠2.5mg/ルセフィ錠5mg
药物类别名称
选择性SGLT2抑制剂
-2型糖尿病治疗-
批准日期：2014年5月
商標名
Lusefi tablets
一般的名称
ルセオグリフロジン水和物（Luseogliflozin Hydrate）
化学名
（2S,3R,4R,5S,6R）-2-｛5-［（4-Ethoxyphenyl）methyl］-2-methoxy-4-methylphenyl｝-6-（hydroxymethyl）thiane-3,4,5-triol hydrate
分子式
C23H30O6S・xH2O
分子量
434.55（無水物として）
性状
它是白色粉末。极易溶于N，N-二甲基甲酰胺，微溶于乙腈，甲醇或乙醇（99.5），几乎不溶于水。光线逐渐变为淡黄白色。
化学结构式
熔点
159.0°摄氏度
药效药理
作用机理
通过抑制负责肾脏近端小管中葡萄糖重吸收的葡萄糖共转运蛋白2（SGLT2）的活性，并排泄尿中过多的血糖，血糖水平降低。
SGLT2抑制作用
由人SGLT2介导的葡萄糖摄取活性（过表达SGLT2的细胞）被选择性抑制（Ki值：1.1nmol/L）（体外）。
尿葡萄糖排泄
在肥胖的2型糖尿病模型（Zucker Fatty大鼠和db/db小鼠）中，单次口服给药可增加尿糖排泄（给药后8或24小时）。另外，在非肥胖的2型糖尿病模型（GK大鼠）中，通过饮食给药20周，尿葡萄糖排泄（给药后24小时）增加。
在2型糖尿病患者中，早餐前7天每天口服一次2.5mg，5mg或5mg的安慰剂。与安慰剂相比，Luceogliflozin最多可在给药后24小时内增加尿葡萄糖排泄。
降血糖作用
在肥胖的2型糖尿病模型（Zucker Fatty大鼠）中，单次口服可抑制葡萄糖负荷后血糖水平的升高。在肥胖的2型糖尿病模型（db/db小鼠）中，每天重复口服一次，持续4周，可以减少糖化血红蛋白相对于基线的变化。此外，在非肥胖的2型糖尿病模型（GK大鼠）中，饮食管理20周可降低糖化血红蛋白水平。
在2型糖尿病患者中，早餐前7天每天口服一次2.5mg，5mg或5mg的安慰剂。与安慰剂相比，Luceogliflozin在早餐，午餐和晚餐后4小时改善了血糖AUC和空腹血糖。
适应症
2型糖尿病
用法与用量
通常，对于成年人，早餐前或早餐后每天口服一次2.5毫克的Ruseogliflozin。如果效果不佳，可以每天一次将剂量增加至5mg，同时仔细观察病情进展。
包装
片剂
2.5mg:
PTP 100片[10片x 10]
PTP 140片[14片x 10]
PTP 500片[10片x 50]
500个塑料瓶[散装]
5mg:
PTP 100片[10片x 10]
PTP 140片[14片x 10]
制造业销售
大正制药有限公司
销售
诺华制药有限公司
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/3969020F1020_2_11/?view=frame&style=XML&lang=ja
Lusefi tab 5mg（Luseogliflozin hydrate）
Brand name : Lusefi tab. 5mg
　Active ingredient: Luseogliflozin hydrate
　Dosage form: white tablet, diameter: 8.6 mm, thickness: 5.0 mm
　Print on wrapping:
Effects of this medicine
This medicine inhibits glucose reabsorption in the renal proximal tubule and excretes excess glucose in urine to reduce blood sugar level.
It is usually used to treat type 2 diabetic 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 have ketosis, diabetic coma/precoma, infections, injury, pituitary gland malfunction, adrenal gland dysfunction, irregular eating habits, insufficient food intake, excessive alcohol intake, urinary tract infection or genital infection.
If you are in a pre- of post-operative state, poor nutritional state, starvation state, debilitated state or performing intense muscular exercise.
•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 2.5 mg of Luseogliflozin at a time once a day before or after breakfast. The dosage may be increased to 5 mg at a time once a day according to your symptoms. This preparation contains 5 mg of Luseogliflozin in 1 tablet. Strictly follow the instructions.
•If you miss a dose, take the missed 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
•Follow the instructions on diet and exercise.
•This medicine may cause hypoglycemia symptom. Pay attention when you work at heights or drive a car.
•If hypoglycemia symptom occurs, take sugar (sugar, candy, juice, glucose, etc.) immediately. If you are taking alpha-glucosidase inhibitor (which delays absorption of glucose) with this medicine, be sure to take glucose when hypoglycemia symptom occurs.
•Drink an adequate amount of water to avoid dehydration.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include frequent urination and hypoglycemia symptom. 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, tremor in limbs, hungry feeling [hypoglycemia]
•fever, flank/hip pain, nausea/vomiting [pyelonephritis]
•thirst, decreased consciousness, hyperpnea [dehydration]
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.
Taisho Toyama Pharmaceutical Co., Ltd.Internal
Revised: 1/2015
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.