Generic Name and Formulations:
Lipase/protease/amylase: 2600Units/6200Units/10850Units; 4200Units/14200Units/24600Units; 10500Units/35500Units/61500Units; 16800Units/56800Units/98400Units; 21000Units/54700Units/83900Units; e-c microtabs in caps.
Janssen Pharmaceuticals, Inc.
Indications for PANCREAZE:
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Adults and Children:
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: 2600 lipase units per 120mL of formula or per breastfeeding; give prior to each feeding, do not mix directly. >12mos–<4yrs: initially 1000 lipase units/kg per meal. ≥4yrs: initially 500 lipase units/kg per meal. Max (>12mos): 2500 lipase units/kg per meal (or ≤10000 lipase units/kg/day), or <4000 lipase units/g fat ingested per day. See full labeling.
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. Contents irritating to oral mucosa. Pregnancy (Cat.C). Nursing mothers.
Pancreatic enzymes (porcine).
Abdominal pain, flatulence, diarrhea, abnormal feces, fatigue; allergic reactions.
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