Creon® for Pancreatic Enzyme Replacement Therapy

2019-05-13

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Pancreatic enzyme replacement therapy helps replace necessary digestive enzymes that may be lacking in your system by taking a capsule containing what is known as an enzyme supplement.  The supplement contains a mixture of three necessary pancreatic enzymes.

How does pancreatic enzyme replacement work?

A normally functioning pancreas secretes about 8 cups of pancreatic juice daily. This fluid contains bicarbonate to neutralize stomach acid as well as pancreatic enzymes, which break down the food we consume, including fats, proteins and carbohydrates.

When you take your supplement with food, it goes to your stomach where the capsule breaks down and releases the enzymes. They then mix with your food and activate in your small intestine and help break down the food so your nutrients in the food are absorbed.

What are pancreatic enzymes and what do they do?

There are 3 types of pancreatic enzymes.

  1. Lipase – it works together with bile to break down fat molecules so they can be absorbed and used by the body.
  2. Protease – this enzyme breaks down protein molecules, it also helps to keep the intestine free of parasites.
  3. Amylase – it breaks down carbohydrates (starch) into sugars which are more easily absorbed by the body.

How are pancreatic enzymes taken?

The dosing guidelines for PERT are based on the lipase content of the product. Your doctor will determine the starting dose of pancreatic enzymes replacement either by the grams of fat ingested or, more commonly, by your weight, and calculate the required amount of lipase. The medication should be taken with food, and your doctor will usually recommend a dose to be taken with meals and snacks (e.g. 3 capsules 3 times daily with meals and 1 capsule with snacks).

The most popular pancreatic enzyme replacement is prescription Creon®.

Creon® strengths can be somewhat confusing when you compare the product sold in the US, Canada and the UK. Although they are all sold as brand name Creon®, the exact amounts of the 3 types of enzymes per capsule are not identical. For example, if you were looking for an alternative to Creon® 24,000 sold in the US you will find that it contains 24,000 USP units of lipase (the fat digestive enzyme which is the basis for dosing the medication), as well as 76,000 USP units of protease and 120,000 USP units of amylase.

The closest dosage of Creon® capsules available in the UK contains 25,000 PhEur units of lipase (the key enzyme) plus 18,000 PhEur units of amylase and 1,000 PhEur units of protease.

The closest Canadian Creon® Minimicrospheres version contains 25,000 PhEur units of lipase plus 25,500 PhEur units of amylase and 1,600 PhEur units of protease. 

You will likely have noticed that not only the numbers, but also the units on these products are different.  In the USA, USP standards are used for pancrelipase, while in Europe other standards are used including European Pharmacopoeia (Ph. Eur.)/Fédération Internationale Pharmaceutique (FIP) units. Standardization of lipase units has occurred (1 USP=1 Ph. Eur.=1 FIP unit) but there are differences with regards to amylase and protease unit standards.

If you wanted to go through the calculation yourself, conversion of the units is as follows:

Amylase: 1 Ph. Eur. Unit = 1 BP Unit = 1 FIP Unit 1~4.15 USP Units

Lipase: 1 Ph. Eur. Unit = 1 BP Unit = 1 FIP Unit ~ 1 USP Unit

Protease: 1 Ph. Eur. Unit = 1 BP Unit = 1 FIP Unit ~ 62.5 USP Units

(Sharpe et al. 1997)

You can now see that once the units are converted, while not identical, the three Creon® products are much more similar than it appeared at first glance.

Creon® ingredient strengths in USP Standards Units:

Creon

Lipase

Amylase

Protease

United States

24,000

120,000

76,000

United Kingdom

25,000

74,700

62,500

Canada

25,000

103,750

100,000

Creon® ingredient strengths in European Pharmacopoeia (PhEur) Units:

Creon

Lipase (PhEur Units)

Amylase (PhEur units)

Protease (PhEur Units)

United States

24,000

28916

1216

United Kingdom

25,000

18,000

1,000

Canada

25,000

25,000

1,600

Because the doses are very similar but not exactly the same, in order to substitute the UK or Canadian version of your US Creon your doctor will need to authorize it.  The ingredients are all relatively close and the key ingredient (lipase) is very close in strength across the various countries.  The pharmacy is willing and able to contact your physician to discuss substitution. 

Tips to Remember:

  • Store your enzymes at room temperature
  • Do not let your enzymes get hot, as heat damages pancreatic enzymes
  • Do not take your pancreatic enzymes with hot beverages
  • Try to eat a balanced diet. Speak to your doctor about dietary changes that may help you.
  • Enzyme replacement products are made from pork derived ingredients, with no available alternative. For those who may have a religious objection to ingesting pork, special dispensation by some religious organizations have been granted as these products are a medicine.

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