dy had a mean CFA of 42% during the run-in period and a mean CFA of 84% at the end of the double-blind period.
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, Stark 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 Dominguez-Munoz JE. Pancreatic enzyme therapy for pancreatic exocrine insufficiency. Current Gastroenterology Reports. 2007; 9: 116-122.
5 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.
6 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.
How Supplied/Storage and Handling
Creon (pancrelipase) Delayed-Release Capsules
3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase
Each Creon capsule is available as a two piece hypromellose capsule with a white opaque cap with imprint “Creon 1203” and a white opaque body that contains tan colored, delayed-release pancrelipase supplied in bottles of:
•70 capsules (NDC 0032-1203-70)
Creon (pancrelipase) Delayed-Release Capsules
6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase
Each Creon capsule is available as a two-piece gelatin capsule with orange opaque cap with imprint “Creon 1206” and a blue opaque body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
•100 capsules (NDC 0032-1206-01)
•250 capsules (NDC 0032-1206-07)
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:
•100 capsules (NDC 0032-1212-01)
•250 capsules (NDC 0032-1212-07)
Creon (pancrelipase) Delayed-Release Capsules
24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase
Each Creon capsule is available as a two-piece gelatin capsule with orange opaque cap with imprint “Creon 1224” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:
•100 capsules (NDC 0032-1224-01)
•250 capsules (NDC 0032-1224-07)
Creon (pancrelipase) Delayed-Release Capsules
36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase
Each Creon capsule is available as a two-piece gelatin capsule with blue opaque cap with imprint “Creon 1236” and a colorless transparent body th