Pancrelipase amylase, pancrelipase lipase, and pancrelipase protease
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Do not exceed the recommended dosage, unless clinically indicated. ( 2.1 , 5.1 ) Irritation of the Oral Mucosa : May occur due to loss of protective enteric coating on the capsule contents. ( 2.3 , 5.2 ) Hyperuricemia : Reported with high dosages; consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia.
High dosages have been associated with hyperuricosuria and hyperuricemia [see Overdosage ]. Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia during treatment with ZENPEP. 5.4 Risk of Viral Transmission ZENPEP is sourced from pancreatic tissue from swine used for food consumption.
Preparation and administration
Preparation and Administration Instructions Instruct adult and pediatric patients greater than 12 months of age, or their caregivers, of the following: Take ZENPEP during meals or snacks. If a dose is missed, take the next dose with the next meal or snack. Swallow capsules whole. For patients who are unable to swallow intact capsules, carefully open the capsules and sprinkle the entire contents on a small amount of acidic soft food with a pH of 4.5 or less (e.g., commercially available preparations of applesauce, bananas, or pears).
Consume the entire mixture immediately. Do not crush or chew ZENPEP capsules or capsule contents. Consume sufficient liquids (water or juice) to ensure complete swallowing of ZENPEP [see Warnings and Precautions ]. Instruct caregivers of pediatric patients birth to 12 months of age of the following: Immediately prior to each breast-feeding session or each administration of 120 mL of formula, carefully open one ZENPEP capsule (containing 3,000 USP units of lipase) and administer the entire contents using one of the following two methods: Sprinkle on a small amount of acidic soft food with a pH of 4.5 or less (e.g., commercially available preparations of applesauce, bananas or pears) being careful not to crush the capsule contents.
The entire mixture should be given to the infant immediately. Sprinkle the capsule contents directly into the infant's mouth. Immediately administer additional breast milk or formula after ZENPEP to ensure complete swallowing of the capsule contents. Do not mix the ZENPEP capsule contents directly into a bottle of breast milk or formula.
Do not crush ZENPEP capsule contents, and visually inspect the infant's mouth to ensure that no drug is retained in the mouth [see Warnings and Precautions ] . If a dose is missed, administer the next dose with the next feeding.
Contraindications
None. None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. Animal reproduction studies have not been conducted with pancrelipase. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.