Pertzye Generic Name & Formulations
Legal Class
Rx
General Description
Lipase/protease/amylase: 4000Units/14375Units/15125Units, 8000Units/28750Units/30250Units, 16000Units/57500Units/60500Units, 24000Units/86250Units/90750Units; del-rel caps.
Pharmacological Class
Pancreatic enzymes (porcine).
How Supplied
Caps 4000 lipase units—100; 8000, 16000 lipase units—100, 250
Manufacturer
Generic Availability
NO
Pertzye Indications
Indications
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Pertzye Dosage and Administration
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. 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. 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.
Pertzye Contraindications
Not Applicable
Pertzye Boxed Warnings
Not Applicable
Pertzye Warnings/Precautions
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.
Pertzye Pharmacokinetics
See Literature
Pertzye Interactions
Not Applicable
Pertzye Adverse Reactions
Adverse Reactions
Diarrhea, dyspepsia, cough; allergic reactions.
Pertzye Clinical Trials
See Literature
Pertzye Note
Not Applicable
Pertzye Patient Counseling
See Literature