PERTZYE 30250 [USP'U]/1

pancrelipase · CAPSULE, DELAYED RELEASE · Digestive Care, Inc.

No Recall History

Plain English

PERTZYE is a capsule, delayed release containing pancrelipase at 30250 [USP'U]/1, taken oral. Manufactured by Digestive Care, Inc..

Key Facts

Brand Name: PERTZYE
Generic Name: pancrelipase
NDC Code (Product): 59767-008
Manufacturer: Digestive Care, Inc.
Strength: 30250 [USP'U]/1
Dosage Form: CAPSULE, DELAYED RELEASE
Route: ORAL
Marketing Status
Application #: BLA022175
Marketing Start: 05/17/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea248 reports

nausea165 reports

dyspnoea142 reports

infective pulmonary exacerbation of cystic fibrosis135 reports

fatigue134 reports

off label use131 reports

vomiting125 reports

pneumonia122 reports

abdominal pain119 reports

pyrexia118 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE PERTZYE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PERTZYE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) PERTZYE is a mixture of enzymes including lipases, proteases, and amylases and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion. Individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation. ( 5.1 ) The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed dose for a meal. Do not substitute other pancreatic enzyme products for PERTZYE. When switching from another pancreatic enzyme product to PERTZYE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed. Recommended Dosage ( 2.2 ) Adults and Pediatric Patients Greater than 12 Months : The recommended initial starting dosage is: 500 lipase units/kg/meal …

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions (5.1) ] Irritation of the Oral Mucosa [see Warnings and Precautions (5.2) ] Hyperuricemia [see Warnings and Precautions (5.3) ] Risk of Viral Transmission [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥ 10%) are: diarrhea, dyspepsia, and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Digestive Care Inc. at 1-877-882-5950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to PERTZYE in 21 patients, aged 8 to 43 years, with exocrine pancreatic insufficiency due to cystic fibrosis in a placebo-controlled clinical trial [see Clinical Studies (14) ] . Table 1 enumerates…

Frequently Asked Questions

What is PERTZYE used for?

PERTZYE contains pancrelipase. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.

Is PERTZYE a controlled substance?

PERTZYE is not classified as a controlled substance by the DEA.

What is the generic name for PERTZYE?

The generic name for PERTZYE is pancrelipase. There are 10 other brand versions of pancrelipase.

What is the NDC code for PERTZYE 30250 [USP'U]/1?

The NDC (National Drug Code) for PERTZYE 30250 [USP'U]/1 is 59767-008, listed by Digestive Care, Inc..

Product NDC

59767-008

Package NDC

59767-008-00

Other PERTZYE Dosages

Other Pancrelipase Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)