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Digestive and biliary disorders
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Drug Name:


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.

Therapeutic Use:

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.

Pharmacological Class:

Pancreatic enzymes (porcine).

Adverse Reactions:

Abdominal pain, flatulence, diarrhea, abnormal feces, fatigue; fibrosing colonpathy (with high doses), hyperuricemia.

How Supplied:


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