英文药名: Creon 5(Pancreatic Digestive Enzymes)

中文药名: 胰腺消化酶胶囊

生产品牌药厂家: Solvay Pharma

药品介绍

美国FDA批准Solvay制药公司的胰脂肪酶控释胶囊（pancrelipase，Creon）上市，用于治疗囊性纤维化(CF)或其它原因引起的胰腺外分泌不足（EPI）。 　

以往20年美国胰腺酶类药物不需正式批准可以处方药销售，2004年美国FDA要求所有胰腺酶生产厂商必需递交新药申请方可上市。本品是按新准则规定批准的首个和迄今唯一的胰腺酶新药。 　　

若胰腺外分泌不足不治疗，可造成消化不良、吸收不良和营养不良，最终威胁生命。治疗EPI的目标是要达到对食物和营养品的最佳化消化和吸收，防止儿童营养不良、发育不全和成人体重减轻。胰腺酶药品在EPI患者体内通过将胰腺酶释至小肠来帮助降解食物中的脂肪、蛋白质和碳水化合物，因而可替代患者生理分泌的消化酶。胰腺酶可作为整个生命中有效治疗EPI的重要组分。 　　
美国FDA批准本品是基于纳入32例囊性纤维化患者的随机双盲安慰剂对照交叉临床研究的疗效。此疗效主要判断终点是脂肪吸收系数（CFA）——相对饮食摄入脂肪的脂肪吸收百分率。Creon的平均CFA值显著大于研究中的安慰剂。以Creon治疗的平均CFA为89％，安慰剂为49％。Creon对成人（>18岁）和青少年（12～18岁）在统计学上显著增加CFA，疗效大小两个治疗组无相关性差异。在治疗中出现的不良反应是腹痛、粪便异常、咳嗽、眩晕、气胀、头痛和体重减轻。

Generic Name for ZENPEP 5000

Lipase 5000 units, protease 17000 units, amylase 27000 units; del-rel caps.

Legal Classification:

Rx

Pharmacological Class for ZENPEP 5000

Pancreatic enzymes (porcine).

Manufacturer of ZENPEP 5000

Eurand

Indications for ZENPEP 5000

Exocrine pancreatic insufficiency (eg, cystic fibrosis).

Adults and Children:

Base dose on lipase units. Swallow whole (do not crush); may mix contents with applesauce or other acidic food, follow with water or juice; take with meals; do not let any drug remain in mouth. Infants: 2000–4000 units per 120mL formula or per breast-feeding (do not mix directly into formula or breast milk); 12mos–4yrs: 1000 units/kg per meal; max 2500 units/kg per meal (or ≤10000 units/kg/day); >4yrs: 500 units/kg per meal; max 2500 units/kg per meal (or ≤10000 units/kg/day), or <4000 units/g fat ingested per day. Adjust per diet and clinical response (eg, steatorrhea).

Also:

Warnings/Precautions for ZENPEP 5000

Not interchangeable with similar products. Gout. Renal impairment. Hyperuricemia. Pregnancy (Cat.C). Nursing mothers.

Adverse Reactions for ZENPEP 5000

Abdominal pain, flatulence, headache, cough, decreased weight, early satiety, contusion; fibrosing colonopathy, hyperuricemia, allergic reactions.

How is ZENPEP 5000 supplied?

Caps (5000, 10000, 15000 lipase units)—12, 100; 20000 lipase units—12, 100, 500