新型胰脂肪酶片Viokac(pancrelipase)e获FDA批准上市，用于治疗慢性胰脏炎和胰脏切除引起的胰腺外分泌不足。 批准日期：2012年3月21日 公司：Aptalis制药 VIOKACE（胰脂肪酶 pancrelipase）片剂 使口服使用 美国初步批准：2012年 作用机制 VIOKACE中的胰腺酶催化脂肪水解为单甘油酯，甘油和游离脂肪酸，蛋白质成肽和氨基酸，并且在十二指肠和近端小肠中淀粉成糊精和短链糖，例如麦芽糖和麦芽三糖， 由胰腺生理分泌的消化酶。 适应症和用法 VIOKACE TM是猪来源的脂肪酶，蛋白酶和淀粉酶的组合。 VIOKACE与质子泵抑制剂组合在成人中指示用于治疗由于慢性胰腺炎或胰腺切除术引起的外分泌胰腺功能不全。 剂量和给药 VIOKACE不能与任何其他胰脂肪酶产品互换。 VIOKACE片剂应整个吞下。不要粉碎或咀嚼片剂。剂量不应超过囊性纤维化基金会共识会议指南中规定的建议最大剂量。 从每个膳食500个脂肪酶单位/kg体重开始，到每个膳食最多2,500个脂肪酶单位/kg体重（或小于或等于10,000个脂肪酶单位/ kg体重每天），或小于4,000个脂肪酶单位/g脂肪每天摄入。 基于临床症状，存在的脂肪的程度和饮食的脂肪含量来个体化剂量。 剂量形式和强度 片剂：10,440USP单位的脂肪酶; 39,150 USP单位的蛋白酶; 39,150USP单位的淀粉酶 片剂：20,880USP单位的脂肪酶; 78,300 USP单位的蛋白酶; 78,300USP单位的淀粉酶 禁忌症 没有。 警告和注意事项 纤维结肠病与胰腺酶替代的高剂量使用有关。当VIOKACE剂量超过每千克体重2,500脂肪酶单位/每餐（或大于10,000脂肪酶单位/ kg体重每天）时，请谨慎行事。 为了避免刺激口腔粘膜，不要咀嚼VIOKACE或留在口中。 在对患有痛风，肾损伤或高尿酸血症的患者开具VIOKACE时应小心谨慎。 存在所有胰腺酶产物（包括VIOKACE）的病毒传播的理论风险。 向对猪来源的蛋白质具有已知过敏反应的患者施用胰脂肪酶时要小心。 不良反应 在接受VIOKACE的至少2例慢性胰腺炎或胰腺切除术患者（大于或等于7％）中发生的不良反应是胆道结石和肛门瘙痒。 在特定人群中使用 VIOKACE在儿科患者中的安全性和有效性尚未确定。 ViokACE在儿科患者中的使用可能导致由于在胃环境中的片剂降解而未达到最佳生长。一般来说，慢性释放（肠溶衣）胶囊应用于儿科患者。 供应/存储和处理 VIOKACE平板电脑 10,440 USP单位的脂肪酶; 39,150 USP单位的蛋白酶; 39,150USP单位的淀粉酶 每个VIOKACE片剂可作为鞣制，圆形，双面的片剂，其一面雕刻有VIO9111，另一面有9111，供给100片片剂（NDC 58914-112-10）。 VIOKACE平板电脑 20,880 USP单位的脂肪酶; 78,300 USP单位的蛋白酶; 78,300USP单位的淀粉酶 每个VIOKACE片剂可作为棕褐色，椭圆形，双面的片剂，在一面上雕刻V16，在另一面上雕刻9116，以100片（NDC 58914-117-10）的瓶子供应。 存储和处理 避免热。 VIOKACE片剂应储存在原始容器中的干燥处。储存在室温（20-25°C，68-77°F），短暂的偏移允许高达40°C（104°F）长达24小时。打开后，保持容器密封，以防止使用之间的湿气。 VIOKACE分装在装有干燥剂的瓶子中。干燥剂包不应食用。干燥剂包将保护产品免受潮湿。 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d85c7e20-4e1d-43cd-a64b-ced3bda70eed Viokace(pancrelipase) tablets Viokace (pancrelipase) 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, amylases, and proteases. The pancreatic enzymes in Viokace act like digestive enzymes physiologically secreted by the pancreas. Viokace is speicifcally approved in combination with a proton pump inhibitor for adults with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. Viokace is supplied as a tablet for oral administration. Since Viokace is not enteric-coated, it should be taken in combination with a proton pump inhibitor. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of Viokace should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Viokace Manufacturer: Aptalis Pharmaceutical Technologies Pharmacological Class: Pancreatic enzymes (porcine). Active Ingredient(s): Lipase 10440 units, protease 39150 units, amylase 39150 units; tabs. Also: VIOKACE 20880 Lipase 20880 units, protease 78300 units, amylase 78300 units; tabs. Indication(s): Treatment of exocrine pancreatic insufficiency in adults due to chronic pancreatitis or pancreatectomy, in combination with a proton pump inhibitor. Pharmacology: Viokace 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, amylases, and proteases. The pancreatic enzymes in Viokace 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 safety and efficacy of Viokace were evaluated in a randomized, double-blind, placebo-controlled, parallel group study comparing Viokace Tablets (20880 USP units of lipase per tablet) to placebo in 50 patients, ages 24 to 70, with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. Eighteen patients had a history of pancreatectomy (11 were treated with Viokace). All patients were maintained on a controlled high fat diet of 100 grams of fat per day. After a wash-out period (6 to 7 days), patients were randomized to a fixed dose of Viokace (22 tablets per day; 6 tablets per meal and 2 tablets with 2 of 3 snacks) or placebo, in combination with a proton pump inhibitor. Forty-nine patients completed the double-blind treatment period (6 to 7 days); 29 patients received Viokace, and 20 patients received placebo. 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. The wash-out period mean CFA was 48% in the Viokace treatment group and was 57% in the placebo group. At the end of the double-blind treatment period, the mean CFA was 86% with Viokace treatment compared to 58% with placebo. The mean difference in CFA at the end of the double-blind treatment period was 28 percentage points in favor of Viokace treatment with 95% Confidence Interval of (21, 37) and P ≤0.0001. Legal Classification: Rx Adults: 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 tabs. Do not allow drug to remain in mouth. Initially 500 lipase units/kg per meal. Max: 2500 lipase units/kg per meal (or ≤10000 lipase units/kg per day), or <4000 lipase units/g fat ingested per day. Children: Not established. Warnings/Precautions: Not interchangeable with any other pancrelipase products. Fibrosing colonopathy (with high doses); risk of stricture formation (monitor). Pork allergy. Potential viral transmission. Gout. Renal impairment. Hyperuricemia. Contents irritating to mucosa. Lactose intolerance. Pregnancy (Cat.C). Nursing mothers. Adverse Reaction(s): Biliary tract stones, anal pruritus; fibrosing colonopathy, hyperuricemia, allergic reactions. How Supplied: Tabs—100 Last Updated: 7/18/2012