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PANCREAZE
Digestive and biliary disorders
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Drug Name:

PANCREAZE Rx

Generic Name and Formulations:
Lipase/protease/amylase: 2600Units/6200Units/10850Units; 4200Units/10000Units/17500Units; 10500Units/25000Units/43750Units; 16800Units/40000Units/70000Units; 21000Units/37000Units/61000Units; e-c microtabs in caps.

Company:
Janssen Pharmaceuticals, Inc.

Therapeutic Use:

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.

Warnings/Precautions:

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.

Pharmacological Class:

Pancreatic enzymes (porcine).

Adverse Reactions:

Abdominal pain, flatulence, diarrhea, abnormal feces, fatigue; allergic reactions.

How Supplied:

Caps—100

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