Generic Name and Formulations:
Lipase/protease/amylase; 13800Units/27600Units/27600Units, 20700Units/41400Units/41400Units, 23000Units/46000Units/46000Units; del-rel caps; e-c minitabs in caps.
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.
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.
Pancreatic enzymes (porcine).
Headache, pharyngolaryngeal pain, epistaxis; fibrosing colonopathy, hyperuricemia, allergic reactions.
Caps (13800, 20700)—100; 23000—100, 500
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