2012年3月1日，美国食品药监局FDA批准Aptalis医药公司的Ultresa胰脂肪酶缓释胶囊和Viokace胰脂肪酶胶囊上市。
Ultresa缓释胶囊用于治疗由多发性硬化症（CF）引起的胰腺外分泌不足。
Viokace药片用于治疗慢性胰脏炎和胰脏切除引起的胰腺外分泌不足。
Aptalis公司的主席兼首席执行官Frank Verwiel说：“公司希望能够将Ultresa和Viokace带给胰腺外分泌不足患者。随着这些药物的获批，将为患者、医护人员及医生提供治疗选择。”
Ultresa(pancrelipase)delayed-release capsules
ULTRESA Rx
Generic Name and Formulations:
Lipase/protease/amylase; 13800Units/27600Units/27600Units, 20700Units/41400Units/41400Units, 23000Units/46000Units/46000Units; del-rel caps; e-c minitabs in caps.
Company:
Allergan
Select therapeutic use: Digestive and biliary disorders
Indications for ULTRESA:
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.
Adults and 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.
Pharmacological Class:
Pancreatic enzymes (porcine).
Adverse Reactions:
Headache, pharyngolaryngeal pain, epistaxis; fibrosing colonopathy, hyperuricemia, allergic reactions.
Generic Availability:
NO
How Supplied:
Caps (13800, 20700)—100; 23000—100, 500
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=73861076-218d-4f8e-872d-0e0690c374a8
Viokace(pancrelipase)tabs
VIOKACE Rx
Generic Name and Formulations:
Lipase/protease/amylase: 10440Units/39150Units/39150Units; 20880Units/78300Units/78300Units; tabs.
Company:
Allergan
Select therapeutic use: Digestive and biliary disorders
Indications for VIOKACE:
Treatment of exocrine pancreatic insufficiency in adults due to chronic pancreatitis or pancreatectomy, in combination with a proton pump inhibitor.
Adult:
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.
Pharmacological Class:
Pancreatic enzymes (porcine).
Adverse Reactions:
Biliary tract stones, anal pruritus; fibrosing colonopathy, hyperuricemia, allergic reactions.
How Supplied:
Tabs—100
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d85c7e20-4e1d-43cd-a64b-ced3bda70eed |
