Thursday, August 13, 2009

New Creon dose - why was there a change?

The Food and Drug Administration (FDA) regulates the efficacy and safety of medications. Drugs marketed prior to 1938 were "grandfathered" in and did not require submission for FDA approval. One example of these types of drug include pancreatic enzymes (Creon, Ultrase, Pancrease, Pancrecarb) commonly used for patients with diseases of the pancreas, cystic fibrosis, and pancreatic enzyme deficiency.

In May of 2009 the FDA approved a new Creon formulation, the first and only FDA approved pancreatic enzyme. The new Creon formulation was available from the manufacturer in July of 2009.

Although the ingredients on the label differ on the old and new formulations, the amount of pancreatic enzymes in each corresponding capsule are the same and no change in dosing is necessary when converting from old to new formulation. The old formulation had "extra enzymes in the capsule that were not included in the label. The new formulation has been labeled with the actual amount of enzymes.

Creon 5 = Creon 6,000
Creon 10 = Creon 12,000
Creon 20 = Creon 24,000

The new formulation does require a new prescription for filling at your pharmacy.

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