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CREON® MINIMICROSPHERES® (pancrelipase delayed-release capsules, USP)
Clinical Information
CREON® MINIMICROSPHERES® are indicated for the treatment of pancreatic exocrine insufficiency that is often associated with cystic fibrosis, chronic pancreatitis, post-pancreatectomy, post-gastrointestinal bypass surgery, and ductal obstruction from neoplasm. No published studies proving the bioequivalence of other generic or branded pancreatic enzyme products to CREON ® MINIMICROSPHERES® are available.
Successful enzyme replacement therapy requires thorough mixing of the enzymes with the chyme as well as inhibition of enzyme inactivation by gastric acid and pepsin such that the enzymes empty into the duodenum concordantly with the chyme and with a sufficiently high degree of activity to promote proper digestion.
CREON® MINIMICROSPHERES® have an acid-resistant, pH-sensitive coating that does not dissolve until a pH of 5 or greater is reached. 97.8% of minimicrospheres in CREON® MINIMICROSPHERES® are optimally sized at 0.8 to 1.6 mm. Within 30 and 60 minutes of reaching the optimal pH, CREON® MINIMICROSPHERES® demonstrated 86% and >95% lipase activity, respectively, at pH >5.5.
In a randomized, multicenter, double-phased (open-label run-in followed by placebo controlled double-blind) study, the efficacy and safety of CREON® MINIMICROSPHERES® in cystic fibrosis (CF) patients with pancreatic exocrine insufficiency (PEI) were evaluated in 47 pediatric/adolescent (7-18 years of age) and 50 adult (18 years of age or older) CF patients. Results showed placebo patients had a significant (p<0.001) mean decrease in CFA (adult, -36.9%; pediatric/adolescent, -34.9%) from open-label to double-blind treatment compared to CREON® patients (adult, -2%; pediatric/adolescent, -3.25%). Clinical global improvement data showed that 83% or greater of CREON® patients improved or remained unchanged. In addition, improved stool consistency as well as reduction in stool frequency was noted in CREON® patients.
CREON® MINIMICROSPHERES® are contraindicated in the early stages of acute pancreatitis or in patients who are known to be hypersensitive to pork protein.
Should symptoms of hypersensitivity appear, discontinue medication and initiate symptomatic and supportive therapy if necessary.
The most frequently reported adverse reactions to pancreatic enzyme containing products are gastrointestinal in nature, which may include nausea, vomiting, bloating, cramping, constipation, or diarrhea. Less frequently, allergic-type reactions have also been observed. Very high doses of pancreatin have been associated with hyperuricosuria and hyperuricemia.
Click below for prescribing and safety information.
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