Brand Name: Creon
Generic Name: Pancrelipase
FDA Approval Information: The FDA approved Creon on May 1, 2009 for the treatment of pancreatic insufficiency in patients with cystic fibrosis or other diseases. A REMS program was designed for the drug at the request of the FDA, due to the potential risk of developing fibrosing colonopathy with the higher doses of the pancreatic enzymes.1
Pharmacology: Creon’s mechanism of action is very simple. It’s composed of porcine pancreatic glands: lipase, amylase and protease. The capsule is designed to dissolve in the slightly more basic pH of the duodenum rather than the stomach so that they can break down fats, protein and starches.5
Pharmacokinetics:
Absorption It is not significantly absorbed in the …show more content…
3
Precautions/Contraindications:
Contraindications: No contraindications are listed in any resources. 3
Precautions: if the capsules are chewed or crushed, the early release of the enzymes are potentially irritating to the oral mucosa and gastrointestinal tract. Caution needs to be used for patients with gout due to potential increase in concentrations of uric acid. 3
Look alike/Sound Alike: None.
Drug-Drug Interactions:
Drug Class Description
Iron Salts May decrease the absorption of iron salts3
Multivitamins/Minerals May decrease serum concentration of multivitamins3
Efficacy/Clinical Trial:
One clinical trial of Creon was aimed to test the efficacy and safety of Creon in patients with chronic pancreatitis and a resulting pancreatic exocrine insufficiency. It was a one week, double blind, randomized, placebo controlled study that took place in India. They tested 62 total chronic pancreatitis/pancreatic exocrine insufficiency patients over the age of 18, with 28 of them having the placebo, 34 with Creon. Each patient was given two Creon 40000 capsules (this strength is unavailable as of 2015) before their main meal and one capsule before snacks. The placebo group received placebo group received placebo capsules instead of the
Generic Name: Pancrelipase
FDA Approval Information: The FDA approved Creon on May 1, 2009 for the treatment of pancreatic insufficiency in patients with cystic fibrosis or other diseases. A REMS program was designed for the drug at the request of the FDA, due to the potential risk of developing fibrosing colonopathy with the higher doses of the pancreatic enzymes.1
Pharmacology: Creon’s mechanism of action is very simple. It’s composed of porcine pancreatic glands: lipase, amylase and protease. The capsule is designed to dissolve in the slightly more basic pH of the duodenum rather than the stomach so that they can break down fats, protein and starches.5
Pharmacokinetics:
Absorption It is not significantly absorbed in the …show more content…
3
Precautions/Contraindications:
Contraindications: No contraindications are listed in any resources. 3
Precautions: if the capsules are chewed or crushed, the early release of the enzymes are potentially irritating to the oral mucosa and gastrointestinal tract. Caution needs to be used for patients with gout due to potential increase in concentrations of uric acid. 3
Look alike/Sound Alike: None.
Drug-Drug Interactions:
Drug Class Description
Iron Salts May decrease the absorption of iron salts3
Multivitamins/Minerals May decrease serum concentration of multivitamins3
Efficacy/Clinical Trial:
One clinical trial of Creon was aimed to test the efficacy and safety of Creon in patients with chronic pancreatitis and a resulting pancreatic exocrine insufficiency. It was a one week, double blind, randomized, placebo controlled study that took place in India. They tested 62 total chronic pancreatitis/pancreatic exocrine insufficiency patients over the age of 18, with 28 of them having the placebo, 34 with Creon. Each patient was given two Creon 40000 capsules (this strength is unavailable as of 2015) before their main meal and one capsule before snacks. The placebo group received placebo group received placebo capsules instead of the