伊格列净L-脯氨酸片(Suglat Tablets 50mg)

产地国家:日本

处 方 药:是

所属类别:50毫克/片 140片/盒

包装规格:50毫克/片 140片/盒

计价单位:盒

生产厂家中文参考译名:安斯泰来

生产厂家英文名:Astellas

原产地英文商品名:Suglat50mg/Tablets 140Tablets/box

原产地英文药品名:Ipragliflozin L-Proline

中文参考商品译名:Suglat50毫克/片 140片/盒

中文参考药品译名:伊格列净L-脯氨酸

简介

部份中文伊格列净L-脯氨酸处方资料(仅供参考)

英文名:Ipragliflozin L-Proline

商标名:Suglat Tablets

中文名:伊格列净L-脯氨酸

生产商:安斯泰来

药品简介

近日,降糖新药Suglat(ipragliflozin L-proline,伊格列净L-脯氨酸)用于治疗1型糖尿病的额外适应症以及额外的剂量和给药方案已获得日本监管机构批准。

药效分类:sglt2抑制剂-糖尿病治疗剂

批准日期:2018年12月23日

商標名

Suglat Tablets 25mg

Suglat Tablets 50mg

一般名:イプラグリフロジン L-プロリン(Ipragliflozin L-Proline)

化学名:(1S)-1,5-Anhydro-1-C -{3-[(1-benzothiophen-2-yl)methyl]-4-fluorophenyl}-D-glucitol-(2S)-pyrrolidine-2-carboxylic acid(1:1)

分子式:C21H21FO5S・C5H9NO2

分子量:519.58

融点:約205℃(分解)

性状:褐皮带褐白色晶莹白色结晶或粉末。容易溶化成二甲基磺酸钠,而很难溶于乙醇(99.5),几乎不溶于水。

批准条件:在制定医药品风险管理计划的基础上适当实施。

药效药理

1.作用机制

na+/葡萄糖共同运输载体(sglt: na+-glucose cotransporter)是将na+浓度梯度作为驱动力,能将葡萄糖输送到细胞内的变压器者。就人的sglt1和sglt2的功能而言,消化管的葡萄糖吸收由sglt1负责,肾近位尿细管的葡萄糖再吸收由sglt2分别担任主要作用的33)。伊拉弗洛镇阻碍了肾近位尿细管表现的sglt2,将血液中多余的葡萄糖排出体外,发挥降低血糖的作用。

2.药理作用

(1)人sglt2阻碍作用

isplenfrogene表示对人sglt2的选择性阻碍作用,其中50%的阻碍浓度(ic50值)为7.38nmol/l。针对sglt1, ic50值是1880nmol/l。

(2)尿中葡萄糖促进排泄和降血糖作用

该聚合物对正常白鼠、酰胺/链霉素诱发轻微症2型糖尿病老鼠和2型糖尿病kk – ay鼠标进行了单次口服,增加了从被服用后到24小时的累积尿液中的葡萄糖排泄量。另外,异丙烯丙基在这些老鼠的单次口服后抑制了液体营养剂负载后血糖值的上升。更加,非placefrofin对2型糖尿病kk – ay鼠标并排的db/db鼠中,1天1次28天的重复口服介绍了hba红糖化。

异丙氨酸诱发的1型糖尿病老鼠的单次口服使体内累积的尿中葡萄糖的排泄量增加,抑制了葡萄糖溶液负载后血糖值的上升。还有1天1次28天的重复口服介绍了hba1c下降的作用。

以2型糖尿病患者为对象,每天服用50毫克、100毫克或安慰剂,连续14天持续服用该药,结果显示,从服用该药群开始到24小时的累积尿液中葡萄糖的排泄量的基线开始,变化量明显增加。另外,空腹时从血糖值的基本线上开始的变化量也有所增加。

以1型糖尿病患者为对象,每天服用本药剂为25mg、50mg、100mg或placebo 14天,之后服用本药剂之后一直持续到第一次注射后及最终注射后24小时的累计尿中从葡萄糖的排泄量的基线开始,变化量有所增加。另外,空腹时从血糖值的基本线上开始的变化量也有所增加。

适应症

2型糖尿病

1型糖尿病

用法与用量

2型糖尿病

通常,成人每天在早餐前或吃早餐后服用50毫克补充剂,作为补充剂。注意,效果不充分时,可在充分观察经过的同时将其递增至100mg1天1次。

1型糖尿病

通常成年人每日服用50毫克补充剂,每天在早餐前或早饭后服用一次,作为胰岛素制剂。注意,效果不充分时,可在充分观察经过的同时将其递增至100mg1天1次。

包装

錠25mg:100錠(10錠×10)140錠(14錠×10)

錠50mg:100錠(10錠×10)140錠(14錠×10)300錠(バラ)500錠(10錠×50)

制造销售

安斯泰来制药公司

提携

寿製薬株式会社

注:以上中文处方资料不够完整,使用者以原处方资料为准。

英文版说明书

Suglat Tablets(Ipragliflozin L-Proline)

Description

This medicine inhibits SGLT2 which resorbs glucose in the kidney, thus reducing blood glucose through the excretion of excess glucose into urine.

It is usually used for the treatment of type 2 diabetes.

Presentation

Feature

Active Ingredients

Ipragliflozin L-Proline

Effect/Efficacy

Usage/Dosage

In general, for adults, take 1 tablet (50 mg of ipragliflozin) at a time, once a day before or after breakfast. If the effect of this medicine is insufficient, it may be increased up to 2 tablets (100 mg) once a day while carefully following the course of the disease. If you have a severe hepatic impairment, the dosage may be started with low doses. Strictly follow the instructions.

If you miss a 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.

Cautions

Strictly follow the instructions on dietary/exercise therapy.

This medicine may cause hypoglycemic symptoms. Be aware of operating in potentially hazardous activities such as driving a car and working at heights.

Take foods containing sugar or drink juice if any hypoglycemic symptoms occur. If you are taking in conjunction with α-glucosidase inhibitors (medicines which delay the uptake of glucose) and hypoglycemic symptoms develop, you must take in glucose.

Take a larger amount of water, since this medicine may cause dehydration. Intake of water or tea is desirable, since drink including sugar such as isotonic drink may increase blood glucose.

Do not stop taking water or decrease the amount of water on your own judgment.

Stop taking the medicine if you have repeated diarrhea/vomiting or cannot take food or water continuously due to decreased appetite.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include urinary frequency, thirst, constipation, and weight loss. 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.

light headedness, lassitude, sweating, hunger, shaking of hands and feet [hypoglycemia]

chills, fever, flank pain, back pain, lower back pain [pyelonephritis]

Thirst/dry mouth, large urinary volume, dizziness/lightheadedness [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.

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