近日，美国FDA宣布再批准=种胰酶制剂(P EP)—pancre1ipase(Pancreaze)缓释胶囊。本品是获得FDA批准的第3个胰酶制剂。本品由强生公司生产，为美国至少200000例需接受此类药品治疗的患者提供了更多选择。

胰酶制剂能帮助体内无法产生足够胰酶的患者改善消化功能。这些患者包括囊性纤维化患者、慢性胰腺炎患者、胰腺肿瘤患者、部分或全部胰腺摘除者。

PANCREAZE™（胰）缓释胶囊美国首次批准-2010  公司：扬森制药公司

适应症及用法

PANCREAZE™是猪来源的脂肪酶，蛋白酶和淀粉酶，表明的组合用于治疗胰腺外分泌功能不全所致囊性纤维化或其他条件。
 
【用法用量】
剂量

PANCREAZE™是任何其他的胰脂肪酶产品不能互换。

幼儿（12个月）

每120毫升的配方或每哺乳婴儿可给予2000到4000脂酶单位。
不要混用PANCREAZE胶囊，内容物直接进入配方奶或母乳给药前。
12个月以上儿童，4岁以下

酶活性的剂量应该开始与1,000脂肪酶单位/公斤体重每餐2,500脂肪酶单位/公斤体重每餐（或者小于或等于10,000脂酶单位/公斤体重每天最多），或更小比4000脂酶单位/克脂肪摄入每一天。
4岁及以上儿童及成人

酶活性的剂量应该开始用500个脂肪酶单位/公斤体重每餐2,500脂肪酶单位/公斤体重每餐（或少于或等于10,000脂酶单位/公斤体重每天最多），或更小比4000脂酶单位/克脂肪摄入每一天。
对计量的限制

给药剂量不超过推荐的最大剂量，由囊性纤维化基金会共识会议原则规定。
管理

PANCREAZE应整粒吞服。对于婴儿或病人不能吞咽完好胶囊，内容可洒在软的酸性食品的pH为4.5或更小，例如，苹果酱。
 
剂型和优势
胶囊剂：4,200 USP单位的脂肪酶10000 USP单位的蛋白酶17,500 USP单位的淀粉酶。胶囊有一个黄色的不透明体和明确的上限，印有“麦克尼尔”和“MT 4”
胶囊：10,500 USP单位的脂肪酶; 25,000 USP单位的蛋白酶，淀粉酶43,750 USP单位。胶囊有一个粉红色不透明体和明确的上限，印有“麦克尼尔”和“MT 10”
胶囊：16,800 USP单位的脂肪酶; 40,000 USP单位的蛋白酶，淀粉酶70000 USP单位。胶囊鲑鱼不透明体和明确的上限，印有“麦克尼尔”和“MT 16”
胶囊：21,000脂肪酶的USP单位37000 USP单位的蛋白酶61,000 USP单位的淀粉酶。胶囊有一个白色的不透明体和帽，印有“麦克内尔”和“MT 20”
 
禁忌
无。
 
警告和注意事项
纤维化的大肠病变与高剂量使用的胰腺酶替代。运动谨慎，当剂量PANCREAZE超过2500单位/公斤体重每餐（或大于10,000脂酶单位/公斤体重每天）脂肪。
为了避免刺激口腔黏膜，不嚼PANCREAZE或保留在口中。
处方时，一定要谨慎PANCREAZE痛风，肾功能损害，或高尿酸血症患者。
病毒传播与胰脏酵素产品，包括PANCREAZE有理论上的风险。
管理时一定要谨慎，胰病人与已知过敏的蛋白质的猪源。
不良反应
治疗出现的不良事件中至少有2名患者（大于或等于10％）接受PANCREAZE或安慰剂发生腹痛，腹部疼痛上，胀气，腹泻，粪便异常，疲劳。

报告疑似不良反应，联系麦克尼尔儿科1-800-526-7736或FDA在1-800-FDA-1088或www.fda.gov / medwatch

特殊人群中使用
小儿患者

在儿童患者中，年龄在6至30个月大，年龄在8岁至17岁之间的PANCREAZE的安全性和有效性进行了评估。
胰脏酵素产品的不同配方的胰脂肪酶在儿童患者中的安全性和有效性已在医学文献中，并通过临床经验。

日期：04/2010

IMPORTANT SAFETY INFORMATION
What is PANCREAZE®?

PANCREAZE® is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. PANCREAZE® may help your body use fats, proteins, and sugars from food.

PANCREAZE® contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.

PANCREAZE® is safe and effective in children when taken as prescribed by your doctor.

IMPORTANT SAFETY INFORMATION (CONSUMER)

What is the most important information I should know about PANCREAZE®?

PANCREAZE® may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you. Take PANCREAZE® exactly as prescribed by your doctor. Do not take more or less PANCREAZE® than directed by your doctor.

Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea.

What should I tell my doctor before taking PANCREAZE®?

Tell your doctor if you:

are allergic to pork (pig) products
have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy)
have gout, kidney disease, or high blood uric acid (hyperuricemia)
have trouble swallowing capsules
have any other medical condition
are pregnant or plan to become pregnant.
are breast-feeding or plan to breast-feed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

What are the possible side effects of PANCREAZE®?

PANCREAZE® may cause serious side effects, including :

A rare bowel disorder called fibrosing colonopathy.
Irritation of the inside of your mouth. This can happen if PANCREAZE® is not swallowed completely.
Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels
Allergic reactions including trouble with breathing, skin rashes, or swollen lips.

Call your doctor right away if you have any of these symptoms.

Other possible side effects: PANCREAZE® and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

The most common side effects include pain in your stomach (abdominal pain) and gas.

These are not all the side effects of PANCREAZE®. Talk to your doctor about any side effect that bothers you or does not go away. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN.

How do I take PANCREAZE®?

Do not crush or chew the PANCREAZE® capsules or their contents, and do not hold the capsule or contents in your mouth. Take PANCREAZE® exactly as your doctor tells you. Read the Medication Guide for directions on how to give PANCREAZE® to adults and children (children older than 12 months)
Read the Medication Guide for directions on how to give PANCREAZE® to infants (children up to 12 months)

Last updated on July 2011