PANCREAZE 149900 [USP'U]/1
PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE · CAPSULE, DELAYED RELEASE · VIVUS LLC
Pancreaze is a prescription medication containing pancreatic enzymes that help digest fats, carbohydrates, and proteins in people whose pancreas cannot produce enough of these enzymes naturally. It is taken by mouth as a delayed-release capsule and is used to treat conditions like cystic fibrosis and chronic pancreatitis where enzyme replacement is needed.
Key Facts
- Brand Name
- PANCREAZE
- Generic Name
- PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE
- NDC Code (Product)
62541-406- Manufacturer
- VIVUS LLC
- Strength
- 149900 [USP'U]/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- BLA022523
- Marketing Start
- 07/01/2021
Recall History
Vivus, Inc.
Failed Stability Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PANCREAZE ® 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 ) PANCREAZE 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 PANCREAZE. When switching from another pancreatic enzyme product to PANCREAZE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed. Recommended Dosage ( 2.2 ): Adult and Pediatric Patients Greater than 12 Months : The recommended initial starting dosage is: 500 lipase units/kg…
Contraindications
4 CONTRAINDICATIONS None. None.
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) ] The data described below reflect exposure to PANCREAZE in 57 adult and pediatric patients with exocrine pancreatic insufficiency due to cystic fibrosis in two clinical trials. Study 1 was conducted in 40 patients, aged 8 years to 57 years; Study 2 was conducted in 17 pediatric patients, aged 6 months to 30 months [see Clinical Studies (14) ] . The most common adverse reactions were gastrointestinal, including diarrhea and vomiting. The following adverse reactions have been identified during post-approval use of PANCREAZE or other pancreatic enzyme products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. …
Frequently Asked Questions
What is PANCREAZE used for?
Pancreaze is a prescription medication containing pancreatic enzymes that help digest fats, carbohydrates, and proteins in people whose pancreas cannot produce enough of these enzymes naturally. It is taken by mouth as a delayed-release capsule and is used to treat conditions like cystic fibrosis and chronic pancreatitis where enzyme replacement is needed.
Is PANCREAZE a controlled substance?
PANCREAZE is not classified as a controlled substance by the DEA.
What is the generic name for PANCREAZE?
The generic name for PANCREAZE is PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE. There are no other listed brand versions of PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE.
What is the NDC code for PANCREAZE 149900 [USP'U]/1?
The NDC (National Drug Code) for PANCREAZE 149900 [USP'U]/1 is 62541-406, listed by VIVUS LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)