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PERTZYE
Digestive and biliary disorders
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Drug Name:

PERTZYE Rx

Generic Name and Formulations:
Lipase/protease/amylase: 4000Units/14375Units/15125Units, 8000Units/28750Units/30250Units, 16000Units/57500Units/60500Units; del-rel caps.

Company:
Digestive Care, Inc.

Therapeutic Use:

Indications for PERTZYE:

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. 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. Also, may give via gastrostomy tube; up to max contents of two 4000unit caps at a time. ≤12mos: 4000 lipase units per 120mL of formula or breastmilk; 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. Both: max 2500 lipase units/kg per meal (or ≤10000 lipase units/kg/day), or <4000 lipase units/g fat ingested per day.

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; consider monitoring uric acid levels. Contents irritating to oral mucosa. Pregnancy (Cat.C). Nursing mothers.

Pharmacological Class:

Pancreatic enzymes (porcine).

Adverse Reactions:

Diarrhea, dyspepsia, cough; allergic reactions.

Generic Availability:

NO

How Supplied:

Caps 4000 lipase units—100; 8000, 16000 lipase units—100, 250

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