55．美吡达

出处：按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第307页（6254字）

【中文释文】：

(格列吡嗪)

〔品名〕

正式品名，格列吡嗪片

英文名：Glipizide Tablets

拉丁名：Tabellae Glipizidi

本品化学名为1-环己基-3-(4-〔2-(5-甲基吡嗪-2-甲酰胺基)乙基〕苯磺酰)脲。

〔性状〕

本品为白色片，在水中迅速崩解。

〔药理作用〕

本品为第二代磺脲类口服降血糖药。即能促进胰岛素β-细胞分泌胰岛素，又能增强胰岛对靶组织的作用。

〔吸收、分布、消除〕

主要通过小肠吸收，人口服后30min见效。具有快速持久的降糖作用。药物在体内代谢成无活性物质，由肾脏排出体外，不会造成药物积蓄性低血糖。

〔适应证〕

主要用于非胰岛素依赖型糖尿病。

〔用法应量〕

口服剂量因人而异。一般推荐剂量2．5～20mg／d，饭前30min服用。

单用饮食疗法失败者：开始2．5～5mg，以后根据血糖和尿糖情况增减剂量，每次增减2．5～5mg。每日剂量超过15mg时，分2～3次餐前给药。

已使用其它口服磺酰脲类降糖药者：停用其它磺酰脲药3d，复查血糖后开始用本药。从5mg开始逐渐加大剂量。直至产生理想的治疗效果，最大剂量不超过30mg／d。

〔不良反应〕

较常见为胃肠道症状(如恶心、上腹涨满症)及头痛等，减少剂量即可缓解。个别病人可出现皮疹。老年体弱病人、活动过度者、不规则进食或饮酒病人及肝肾功能损害的病人，使用本品偶而可出现低血糖，偶见造血系统可逆性的改变。

〔禁忌证〕

胰岛素依赖型糖尿病、糖尿病酮症、糖尿病昏迷前期或昏迷者、孕妇、肝、肾功能不全、肾上腺功能不全及对本品过敏者禁用。

〔注意事项〕

病人用药时应遵医嘱，注意饮食量和用药时间。治疗中注意早期出现的低血糖症状：头痛、兴奋、失眠、震颤和大量出汗，以便及时采取措施。严重的要静滴葡萄糖液，对有创伤，术后、感染或发热的病人应给予胰岛素以维持正常血糖代谢。避免饮酒，以免引起类戒断反应。本药与双香豆素类、单胺氧化酶抑制剂、保泰松、磺胺类药、氯霉素、环磷酰胺、丙磺舒、水杨酸类药合用可增加其降血糖作用。与肾上腺素、皮质激素、口服避孕药、噻嗪类利尿药合并使用，可降低其降血糖作用。与β-阻断药并用时应谨慎。

应妥善保管勿造成小孩误服。

〔规格〕

5mg／片。

〔包装〕

铝塑包装，15片／板，2板／盒。

〔贮藏〕

密闭，室温保存。

〔使用期限〕

3．5年。

〔生产厂家〕

意大利爱宝大药厂

(附本品别名：吡磺环已脲，格列甲嗪，灭糖尿，格列匹散得，CP-28702，K4024，Mindiab，Minodiab，Glibenese，Glydiazinamide)

【外文释文】：

(Glipizide Tablets)

Name

Formal Name：Glipizide Tablets

Latin Name：Tabellae Glipizidi

Chemical Name：1-cyclohexyl-3-(4-[-2-(5-methylpyrazine-2-carboxamido)-ethyl]benzene-sulphonyl)urea．

Characters

White tablets，dissolving promptly in the water．

Pharmocological actions

As the second generation of oral hypoglycaemic agents belonging to the sulphonylureas category，Glipizide Tablets are able to stimulate the pancreatic beta-cells to produce insulin，enhancing the action of insulin on target cells．

Absorption，distribution and excretion

Mainly absorbed by the small intestine，Glipizide produces the desired effects thirty minutes after the oral administration and is endowed with prompt and constant hypoglycaemic activity．The drug is metabolized to virtually inactive substances and is excreted through the kidney without the risk of episodes of hypoglycaemia due to accumulation．

Indications

Mainly noninsulin-dependent diabetes．

Dosage and administrations

The dosage should be adapted to patients individually．Normally the recommended dose is 2．5 to 20 mg of Glipizide Tablets(1／2 to 4 tablets daily)，taken orally 30 minutes before the meals．Patients treated unsuccessfully with diet alone：it is advisable to start with the dose of 2．5 to 5 mg per day，increasing or decreasing them by 2．5-5 mg each time on the basis of periodic tests of glycosuria and blood sugar．If the daily dosage is over 15 mg they should be split into two or three doses to be administered immediately before the meals．

Patients already treated with other oral hypoglycaemic agents belonging to the sulphonylureas category：three daysafter the end of the previous sulphonylureas，the patient’s blood sugar should be checked before he starts using Glipizide Tablets．Start with 5 mg and gradually increase the dosage until the ideal therapy effects are produced．The maximum dosage should never be over 30 mg per day．

Side effects

Very common is the appearance of gastroenteric disturbances(such as nausea or a sense of epigastric fullness)and headache，which may be alleviated when the dose is reduced．Few cases may complain of rashes．Occasionally hypoglycamic episodes may occur during the treatment with Glipizide Tablets，in debilitated or elderly patients and in subjects after unusual physical exertion，when food intake is irregular or alcoholic beverages are taken and when kidney and liver function is impaired．Occasionally，reversible alternations to the haemopoietic system may occur．

Contraindications

Glipizide Tablets are contraindicated in insulin-dependent diabetes，diabetic ketosis，diabctic precoma or coma，pregnancy subjects with impaired kidney or liver function，adrenal insufficiency，cases of confirmed individual hypersensitivity to the drug．

Warnings

(1)Patients should follow closely their physician’s prescription while taking the drug and should look to the quantity of diets and the time of the administration．(2)During the treatment，be cautious of the early symptoms of hypoglycaemia that generally are headache，irritability，sleep disorders．tremor and heavy sweating so an effective measure may be adopted in good time．In more severe cases，and iv infusion of glucose solution should be administered．In patients with trauma，after surgery，infectious or febrile disease，insulin should be administered in order to maintain a normal metabolism of blood sugar．(3)Alcohol intake which may result in abstinence-like reactions should be avoided．(4)Should the drug be administered together with dicoumarol monoamine oxidase inhibitor，phenybutazone，sulphonamides，chloramphenicol，cyelophosphamide，probenecid and salicylates，its hypoglycaemic activity may be increased．(5)Hypoglycaemic effect may be reduced by concomitant use of adrenalin corticosteroids，oral contraceptives and thiazide diuretics．(6)Be cautiouswhen beta-blockers are administered at the same time．Take good care of the drug to avoid the mistaken intake by children．

Specification

Each tablet contains 5 mg Glipizide．

Presentations

Box of two plates with thirty tablets．

Storage

Keep the drug hermetically at room temperature．

Time limit of use

Three a half years．

Manufacturer

Erba，Ltd．Italy