Zenpep Generic Name & Formulations
Legal Class
Rx
General Description
Lipase/protease/amylase: 3000Units/10000Units/14000Units, 5000Units/17000Units/24000Units, 10000Units/32000Units/42000Units, 15000Units/47000Units/63000Units, 20000Units/63000Units/84000Units, 25000Units/79000Units/105000Units, 40000Units/126000Units/168000Units; del-rel caps.
Pharmacological Class
Pancreatic enzymes (porcine).
How Supplied
Caps—100
Manufacturer
Zenpep Indications
Indications
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.
Zenpep 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. ≤12mos: 3000 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.
Zenpep Contraindications
Not Applicable
Zenpep Boxed Warnings
Not Applicable
Zenpep 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. Contents irritating to oral mucosa. Pregnancy (Cat.C). Nursing mothers.
Zenpep Pharmacokinetics
See Literature
Zenpep Interactions
Not Applicable
Zenpep Adverse Reactions
Adverse Reactions
Abdominal pain, flatulence, headache, cough, decreased weight, early satiety, contusion; allergic reactions.
Zenpep Clinical Trials
See Literature
Zenpep Note
Not Applicable
Zenpep Patient Counseling
See Literature