Pancreatic exocrine insufficiency

Active Ingredient: Pancreatin

Indication for Pancreatin

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

For the treatment of pancreatic exocrine insufficiency.

For this indication, competent medicine agencies globally authorize below treatments:

450-900 mg in 3 divided doses daily

Route of admnistration


Defined daily dose

450 - 900 mg

Dosage regimen

From 150 To 300 mg 3 time(s) per day every day

Detailed description

Initially 150 mg or 300 mg during or immediately after each meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.

The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing.

This could be apple sauce or yoghurt or any fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. If the granules are mixed with fluid or food it is important that they are taken immediately and the mixture not stored, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed. Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be taken to ensure that no product is retained in the mouth.

It is important to ensure adequate hydration of patients at all times whilst dosing pancreatin.

Fibrosing colonopathy has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day.

Dosage considerations

It should be taken during or immediately after each meal.

Active ingredient


Pancreatin when reaching the small intestine disintegrates (at pH>5.5) to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or following further hydrolysis by intestinal enzymes.

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