ULTRESA 13800
药理分类：
胰腺酶。
“活性成分”（词）：
27600，13800脂肪酶，蛋白酶淀粉酶27600 DEL-REL帽;：EC minitabs帽。

另外：
ULTRESA 20700
41400，20700脂肪酶，蛋白酶淀粉酶41400 DEL-REL帽;：EC minitabs帽。

ULTRESA 23000
46000，23000脂肪酶，蛋白酶淀粉酶46000 DEL-REL帽;：EC minitabs帽。

公司
Aptalis制药技术

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：
Ultresa是胰腺酶制剂，胰，来自猪胰腺的提取物。胰含有多种酶类，包括猪源性脂肪酶，淀粉酶和蛋白酶。在Ultresa胰腺酶催化水解的脂肪单酸甘油酯，甘油和游离脂肪酸，蛋白质为肽和氨基酸，和淀粉成糊精和短链的糖，例如麦芽糖和麦芽三糖在十二指肠和小肠近端，从而像生理上由胰腺分泌的消化酶。

临床试验：
由于囊性纤维化的胰腺外分泌功能不全患者40例进行的两项研究的Ultresa的短期疗效和安全性进行了评估。
 
研究1是一个双盲，安慰剂对照，交叉研究的31例患者（年龄8-37）谁是随机接收Ultresa（在剂量不超过2,500脂肪餐或点心的单位/公斤）或安慰剂治疗6-7天的治疗，然后通过交叉替代治疗6-7天。在受控的治疗期间的平均剂量是6,270脂肪酶单位/公斤/天。所有患者在治疗期间消耗，高脂肪的饮食脂肪/公斤体重/天（2G）。在这两种治疗方法，测量时脂肪排泄和脂肪的摄入脂肪的吸收系数（CFA）测定72小时的粪便采集。每个病人的终审法院作为安慰剂治疗过程中没有处理终审法院的价值。平均终审法院为89％至56％，与安慰剂治疗相比，与Ultresa。终审法院的平均差异为35个百分点，有利于Ultresa治疗，95％CI：（25，45），P <0.0001。
研究是一个开放标签研究的9例患者（年龄7-11）由于囊肿性纤维化的胰腺外分泌功能不全。最后分析人口是有限的7例完成的冲刷和治疗阶段的研究。经过了15天的放映期间单独滴定剂量的Ultresa不超过2,500脂酶单位/千克/餐，患者进入为期7天的冲刷阶段（无处理）为期12天的治疗阶段之前，分别在同一滴定剂量的Ultresa。平均每日剂量在治疗阶段的Ultresa 6,846脂肪酶单位/公斤/天。所有患者消耗，高脂肪的饮食脂肪/公斤体重/天（2G）的冲刷阶段和处理阶段。平均CFA测定洗出阶段期间（无处理），和在Ultresa治疗阶段。平均终审法院35％的冲刷阶段，83％期间的Ultresa的治疗阶段。

法律分类：
接收

成年人和儿童：
查看完整标签。在最低推荐剂量开始，逐渐增加。个体化，根据临床症状，的程度的脂肪泻目前，和脂肪含量的饮食。不要压碎或咀嚼上限;整片吞服，或可以打开和内容物洒入少量的酸性食品（pH值≤4），并立即吞下混合。 12个月-4yrs（14公斤）：不建议。 >12个月-4yrs（≥14千克），1000脂酶单位/公斤每餐;≥4yrs（28千克）：不推荐。 ≥4yrs（≥28公斤）：500每餐的脂肪酶单位/千克。每餐最大值：2500脂肪酶单位/公斤（或≤10000脂酶单位/ kg /天），或<4000脂肪酶单位/克脂肪摄入/天。

警告/注意事项：
与任何其他胰脂酶产品不能互换。大肠病变纤维化（瓦特高剂量）;狭窄（监视器）的风险。猪肉过敏。潜在的病毒传播。痛风。肾功能损害。高尿酸血症。内容粘膜有刺激性。怀孕（Cat.C）。哺乳期的母亲。

不良反应（补）
头痛，咽喉疼痛，鼻出血，纤维化大肠，高尿酸血症，过敏性反应。

如何提供：
上限（13800，20700）-100 2300-100 500

最后更新：

2013年1月14日

U.S. Food and Drug Administration (FDA) has approved ULTRESA TM and VIOKACE TM , two pancrelipase products for the treatment of exocrine pancreatic insufficiency.
ULTRESA™ (Pancrelipase) Delayed Release Capsules (formerly called ULTRASE ® ) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis (CF) or other conditions. VIOKACE™ (Pancrelipase) Tablets (formerly called VIOKASE ® ) is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. Aptalis’ original ULTRASE ® MT and VIOKASE ® formulations were sold for more than 18 years in the U.S. under the company name Axcan Pharma. Aptalis ceased distributing the two products on April 28, 2010 in the wake of an FDA decision which mandated that all manufacturers of exocrine pancreatic insufficiency drug products receive a new approval for their products by this date. Aptalis had performed all requisite clinical studies and had submitted a new drug application before that date and no additional studies were required by the FDA since our application was filed.

Pharmacological Class:
Pancreatic enzymes.

Active Ingredient(s):
Lipase 13800, protease 27600, amylase 27600; del-rel caps; e-c minitabs in caps.

Also:
ULTRESA 20700
Lipase 20700, protease 41400, amylase 41400; del-rel caps; e-c minitabs in caps.

ULTRESA 23000
Lipase 23000, protease 46000, amylase 46000; del-rel caps; e-c minitabs in caps.

Company
Aptalis Pharmaceutical Technologies

Indication(s):

Treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.

Pharmacology:

Ultresa is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, amylases, and proteases. The pancreatic enzymes in Ultresa catalyze the hydrolysis of fats to monoglycerides, 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 efficacy and safety of Ultresa were assessed in two studies conducted in 40 patients with exocrine pancreatic insufficiency due to cystic fibrosis.
 
Study 1 was a double-blind, placebo-controlled, crossover study of 31 patients (ages 8–37) who were randomized to receive Ultresa (at a dose not to exceed 2,500 lipase units/kg per meal or snack) or matching placebo for 6–7 days of treatment followed by crossover to the alternate treatment for an additional 6–7 days. The mean dose during the controlled treatment periods was 6,270 lipase units/kg/day. All patients consumed a high-fat diet (2g of fat/kg of body weight/day) during the treatment periods. The coefficient of fat absorption (CFA) was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured. Each patient’s CFA during placebo treatment was used as their no-treatment CFA value. Mean CFA was 89% with Ultresa compared to 56% with placebo treatment. The mean difference in CFA was 35 percentage points in favor of Ultresa therapy with 95% CI: (25, 45) and p<0.0001.
Study 2 was an open-label study of 9 patients (ages 7–11) with exocrine pancreatic insufficiency due to cystic fibrosis. The final analysis population was limited to 7 patients who completed both the washout and treatment phases of the study. After a 15 day screening period on individually-titrated doses of Ultresa not to exceed 2,500 lipase units/kg/meal, patients entered a 7-day washout phase (no treatment) before returning to a 12-day treatment phase on the same individually-titrated dose of Ultresa. The mean daily dose of Ultresa during the treatment phase was 6,846 lipase units/kg/day. All patients consumed a high-fat diet (2g of fat/kg of body weight/day) during both the washout phase and treatment phase. The mean CFA was determined during the washout phase (no treatment) and during the Ultresa treatment phase. Mean CFA was 35% during the washout phase and was 83% during the Ultresa treatment phase.

Legal Classification:

Rx

Adults & Children:

See full labeling. 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. Do not crush or chew caps; swallow whole, or may open and sprinkle contents into small amount of acidic food (pH ≤4) and swallow mixture immediately. >12months–<4yrs (<14kg): not recommended. >12months–<4yrs (≥14kg): 1000 lipase units/kg per meal; ≥4yrs (<28kg): not recommended. ≥4yrs (≥28kg): 500 lipase units/kg per meal. Max: 2500 lipase units/kg per meal (or ≤10000 lipase units/kg/day), or <4000 lipase units/g fat ingested/day.

Warnings/Precautions:

Not interchangeable with any other pancrelipase products. Fibrosing colonopathy (w. high doses); risk of stricture formation (monitor). Pork allergy. Potential viral transmission. Gout. Renal impairment. Hyperuricemia. Contents irritating to mucosa. Pregnancy (Cat.C). Nursing mothers.

Adverse Reaction(s)

Headache, pharyngolaryngeal pain, epistaxis; fibrosing colonopathy, hyperuricemia, allergic reactions.

How Supplied:

Caps (13800, 20700)—100; 2300—100, 500

LAST UPDATED:

1/14/2013