Creon 120000 [USP'U]/1
Pancrelipase · CAPSULE, DELAYED RELEASE PELLETS · AbbVie Inc.
Creon is a capsule, delayed release pellets containing pancrelipase at 120000 [USP'U]/1, taken oral. Manufactured by AbbVie Inc..
Key Facts
- Brand Name
- Creon
- Generic Name
- Pancrelipase
- NDC Code (Product)
0032-1224- Manufacturer
- AbbVie Inc.
- Strength
- 120000 [USP'U]/1
- Dosage Form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Marketing Status
- Application #
- BLA020725
- Marketing Start
- 04/30/2009
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
AbbVie Inc
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
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 CREON ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) CREON 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 CREON. When switching from another pancreatic enzyme product to CREON, 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/meal for ad…
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 R eactions ( 6.1 ) C ystic fibrosis adult and pediatric patients : 7 years and older (≥4%): vomiting, dizziness, cough. 4 months to 6 years (6%): vomiting, irritability, decreased appetite. C hronic pancreatitis or pancreatectomy patient s: Adults (≥ 4%): hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, nasopharyngitis. To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 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 …
Frequently Asked Questions
What is Creon used for?
Creon contains Pancrelipase. It is a capsule, delayed release pellets taken oral. Consult your doctor for specific uses.
Is Creon a controlled substance?
Creon is not classified as a controlled substance by the DEA.
What is the generic name for Creon?
The generic name for Creon is Pancrelipase. There are 8 other brand versions of Pancrelipase.
What is the NDC code for Creon 120000 [USP'U]/1?
The NDC (National Drug Code) for Creon 120000 [USP'U]/1 is 0032-1224, listed by AbbVie Inc..