y a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured. Each patient's CFA during placebo treatment was used as their no-treatment CFA value.
Mean CFA was 89% with CREON treatment compared to 49% with placebo treatment. The mean difference in CFA was 41 percentage points in favor of CREON treatment with 95% CI: (34, 47) and p less than 0.001.
Subgroup analyses of the CFA results showed that mean change in CFA was greater in patients with lower no-treatment (placebo) CFA values than in patients with higher no-treatment (placebo) CFA values. There were no differences in response to CREON by age or gender, with similar responses to CREON observed in male and female patients, and in younger (under 18 years of age) and older patients.
15 REFERENCES
1 Borowitz DS, Grand RJ, Durie PR, et al. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Journal of Pediatrics. 1995; 127: 681-684.
2 Borowitz DS, Baker RD, Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. Journal of Pediatric Gastroenterology Nutrition. 2002 Sep; 35: 246-259.
3 Stallings VA, Start LJ, Robinson KA, et al. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. Journal of the American Dietetic Association. 2008; 108: 832-839.
4 Smyth RL, Ashby D, O'Hea U, et al. Fibrosing colonopathy in cystic fibrosis: results of a case-control study. Lancet. 1995; 346: 1247-1251.
5 FitzSimmons SC, Burkhart GA, Borowitz DS, et al. High-dose pancreatic-enzyme supplements and fibrosing colonopathy in children with cystic fibrosis. New England Journal of Medicine. 1997; 336: 1283-1289.
16 HOW SUPPLIED/STORAGE AND HANDLING
CREON (pancrelipase) Delayed-Release Capsules
12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase
Each CREON capsule is available as a two-piece gelatin capsule with a brown opaque cap with imprint “CREON 1212” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
•10 capsules (NDC 54868-6067-0)
•60 capsules (NDC 54868-6067-1)
Storage
CREON must be stored at room temperature up to 25°C (77°F) and protected from moisture. Temperature excursions are permitted between 25°C to 40°C (77°F and 104°F) for up to 30 days. Product should be discarded if exposed to higher temperature and moisture conditions higher than 70%. AFTER OPENING, KEEP BOTTLE TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE.
Keep out of reach of children.
For further information, please call Solvay Pharmaceuticals, Inc.'s Medical Information Department toll-free at 1-800-241-1643.
image of telephone 17 PATIENT COUNSELING INFORMATION
See Medication Guide (17.4).
CREON is available in capsule strengths of:
•6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase
•12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase
•24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase
Healthcare professionals should inform patients of the following important information about CREON.
17.1 Dosing and Administration
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