Generic Name and Formulations:
Lipase/protease/amylase: 4200Units/10000Units/17500Units; 10500Units/25000Units/43750Units; 16800Units/40000Units/70000Units; 21000Units/37000Units/61000Units; 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:
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. Infants: May sprinkle directly into mouth or into a small amount of applesauce; do not mix directly into formula or breastmilk. ≤12months: 2000–4000 lipase units per 120mL of formula or per breastfeeding. Children and adults: Do not crush or chew caps; may open and sprinkle contents into small amount of acidic food (pH≤4.5) and swallow whole. >12months–<4yrs: 1000 lipase units/kg per meal; ≥4yrs: 500 lipase units/kg per meal. Max (for children and adults): 2500 lipase units/kg per meal (or ≤10000 lipase units/kg per day), or <4000 lipase units/g fat ingested per day.
Not interchangeable with any other pancrelipase products. Pork allergy. Potential viral transmission. Gout. Renal impairment. Hyperuricemia. Contents irritating to mucosa. Pregnancy (Cat.C). Nursing mothers.
Pancreatic enzymes (porcine).
Abdominal pain, flatulence, diarrhea, abnormal feces, fatigue; fibrosing colonpathy (with high doses), hyperuricemia.
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