PERTZYE 8000
Manufacturer:
Digestive Care, Inc.
Pharmacological Class:
Pancreatic enzymes (porcine).
Active Ingredient(s):
Lipase 8000 units, protease 28750 units, amylase 30250 units; delayed-release caps.
Also:
PERTZYE 16000
Lipase 16000 units, protease 57500 units, amylase 60500 units; delayed-release caps.
Indication(s):
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Pharmacology:
Pertzye is a pancreatic enzyme preparation for oral administration consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. The pancreatic enzymes in Pertzye catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.
Clinical Trials:
The short-term safety and efficacy of Pertzye were evaluated in a randomized, double-blind, placebo-controlled, crossover study conducted in 24 patients ages 8–43 years (mean age = 20 years) with exocrine pancreatic insufficiency due to cystic fibrosis. The efficacy analysis population included 21 patients who completed both double-blind treatment periods. Patients were randomized to receive Pertzye at individually titrated doses (not to exceed 2500 lipase units per kilogram per meal) or matching placebo for 6–8 days of treatment, followed by crossover to the alternate treatment for an additional 6–8 days.
The primary efficacy endpoint was the mean difference in coefficient of fat absorption (CFA) between Pertzye and placebo treatment. The CFA was determined by a 72 hour stool collection during both treatments, when both fat ingestion and excretion were measured. Mean CFA was 83% with Pertzye treatment compared to 46% with placebo treatment. The mean difference in CFA was 36 percentage points in favor of Pertzye treatment with 95% CI: (28, 45) and P<0.001.
The coefficient of nitrogen absorption (CNA) was determined by a 72-hour stool collection during both treatments, when nitrogen excretion was measured and nitrogen ingestion from a controlled diet was estimated (based on the assumption that proteins contain 16% nitrogen). Each patient’s CNA during placebo treatment was used as their no-treatment CNA value. Mean CNA was 79% with Pertzye treatment compared to 47% with placebo treatment. The mean difference in CNA was 32 percentage points in favor of Pertzye treatment and this was a statistically significant change.
Legal Classification:
Rx
Adults & Children:
See literature. Start at the lowest recommended dose and increase gradually. Individualize based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Swallow whole; do not crush or chew caps. May mix contents with applesauce or other acidic soft food (pH≤ 4.5); swallow mixture immediately, follow with water or juice; take with meals; do not let any drug remain in mouth. 12mos–<4yrs and ≥8kg: initially 1000 lipase units/kg per meal. ≥4yrs and ≥16kg: initially 500 lipase units/kg per meal. Both: max 2500 lipase units/kg per meal (or ≤10000 lipase units/kg/day), or <4000 lipase units/g fat ingested per day.
Warnings/Precautions:
Not interchangeable with other pancrelipase products. Fibrosing colonopathy (with high doses); risk of stricture formation (monitor). Pork allergy. Potential viral transmission. Gout. Renal impairment. Hyperuricemia; consider monitoring uric acid levels. Contents irritating to oral mucosa. Pregnancy (Cat.C). Nursing mothers.
Adverse Reaction(s):
Diarrhea, dyspepsia, cough; allergic reactions.
How Supplied:
Caps—100, 250
Last Updated:
7/2/2012
制造商：
消化护理，公司
类药物：
胰腺酶（猪）。
活性成分（S）：
脂肪酶8000单位，28750单位蛋白酶，淀粉酶30250台;缓释上限。
另外：
PERTZYE 16000
脂肪酶16000单位，57500单位蛋白酶，淀粉酶60500台;缓释上限。
指示（S）：
由于囊肿性纤维化或其他条件的胰腺外分泌功能不全的治疗。
药理作用：
pertzye是胰腺酶制剂为口服胰，猪胰腺所得的提取物组成的管理。胰含有多种酶，包括猪源性脂肪酶，蛋白酶和淀粉类，。在Pertzye胰腺酶催化脂肪水解为甘油，单甘酯和游离脂肪酸，蛋白质成多肽和氨基酸，以及成糊精和短链糖类，如麦芽糖和麦芽三糖在十二指肠和近端小肠淀粉，从而行事像由胰腺分泌的消化酶的生理。
临床试验：
短期的安全性和疗效Pertzye在一项随机，双盲，安慰剂对照，交叉年龄8-43岁（平均年龄为20岁）因囊肿性纤维化的胰腺外分泌功能不全24例患者进行的研究进行了评估。疗效分析人口，包括21例完成双盲治疗期。患者随机接受Pertzye单独滴定剂量（不超过2500公斤每人每餐的脂肪单位）或匹配安慰剂6-8天的治疗，随后通过交叉替代治疗一个额外的6-8天。
主要疗效终点是在平均差系数之间Pertzye和安慰剂治疗（CFA），对脂肪的吸收。终审法院的决定72小时粪便收集在两种治疗时，脂肪的摄入和排泄的测定。平均终审法院Pertzye治疗的83％，46％与安慰剂治疗相比。在终审法院的平均相差36个百分点，赞成Pertzye治疗95％CI：（28 45）和P <0.001。
两种治疗期间，测量氮排泄和氮从控制饮食摄入估计基于假设，蛋白质中含有16％的氮，氮的吸收（中央社）系数测定72小时的粪便收集。中央社每个病人的安慰剂治疗期间被用来作为他们没有治疗中央社价值。平均中央社Pertzye治疗79％，47％与安慰剂治疗相比。中央社平均相差32个百分点赞成Pertzye治疗，这是一个统计上的显著变化。
法律分类：
RX
成人和儿童：
见文献。在最低推荐剂量开始，逐渐增加。基于个性化的临床症状，脂溢性目前的程度，饮食中的脂肪含量。整个吞下，不压碎或咀嚼帽。可以混合苹果酱或其他软酸性食品（pH值≤4.5）的内容;燕子的混合物，立即与水或果汁;带餐;不要让任何药物留在嘴里。 12mos <4yrs≥8公斤：每餐最初1000脂酶单位/公斤。 ≥4yrs≥16公斤：每餐最初500酶单位/公斤。两个：最大2500脂酶单位/千克（或≤10000脂酶单位/公斤/天），或<4000脂酶单位/克脂肪，每天每餐摄入。
警告/注意事项：
胰与其他产品不能互换。纤维化大肠（高剂量）;狭窄的形成（显示器）的风险。猪肉过敏。潜在的病毒传播。痛风。肾功能不全。高尿酸血症;考虑监测尿酸水平。口腔粘膜刺激性的内容。怀孕（Cat.C）。哺乳的母亲。
不良反应（S）：
腹泻，消化不良，咳嗽，过敏性反应。
如何提供：
CAPS-100，250
最后更新：
2012年7月2日