Uses for Pancreatin

Malabsorption Syndrome
Used as replacement therapy in the symptomatic treatment of malabsorption syndrome caused by
pancreatic insufficiency of organic origin (e.g., cystic fibrosis of the pancreas, chronic pancreatitis,
pancreatectomy, other conditions in which pancreatic insufficiency impairs fat digestion).
a

Pancreatic exocrine replacement therapy should not delay or supplant treatment of the primary
disorder.
a


Functional Indigestion
Used to relieve functional indigestion associated with enzyme deficiency or imbalance.
100

101

May relieve symptoms associated with faulty digestion (e.g., sensation of fullness after meals,
dyspepsia, flatulence, abdominal distention, intolerance to certain foods).
100

101

Not effective in the treatment of functional digestive disorders unrelated to pancreatic
insufficiency.
a
There currently is a lack of substantial evidence from adequate and well-controlled
clinical studies to establish the efficacy of the drug as a digestive aid in the symptomatic treatment of
immediate postprandial upper abdominal distress (IPPUAD) or for the symptomatic treatment of
intestinal distress when pancreatic enzymes are not deficient.
a

Pancreatin Dosage and Administration
Administration
Oral Administration
Administer orally before or with each meal or snack.
a

100

101

Should not be held in the mouth prior to swallowing since it may irritate the oral mucosa.
a

Patients with difficulty swallowing capsules may open capsules and sprinkle contents on food.
100

101

Dosage
Each mg of pancreatin contains not less than 25 USP units of amylase activity, not less than 2 USP
units of lipase activity, and not less than 25 USP units of protease activity.
a

On a weight basis, pancreatin has one-twelfth the lipolytic activity of pancrelipase.
a

Adjust dosage according to individual requirements (e.g., condition being treated, digestive
requirements related to diet, relief of symptoms).
100

101

a
Considerable dosage variation exists, partly
due to the susceptibility of pancreatin to acid-peptic inactivation of the enzymes activity in the
stomach and duodenum.
100

101

a

Adults
Malabsorption Syndrome
Oral
Initially: approximately 800024,000 USP units of lipase activity before or with each meal or snack;
occasionally up to 36,000 USP units of lipase activity may be required with meals.
a

May increase dosage or frequency of administration as needed to reduce steatorrhea if nausea,
vomiting, or diarrhea does not occur.
a

May administer total daily dosage in divided doses at 1- to 2-hour intervals throughout the day.
a

Functional Indigestion
Oral
Approximately 12002400 USP units of lipase activity before or with each meal or snack.
100

101

Cautions for Pancreatin
Contraindications
Hypersensitivity to pork protein.
100

101

a

Acute pancreatitis.
100

101

Acute exacerbations of chronic pancreatic diseases.
100

101

Warnings/Precautions
Sensitivity Reactions
Hypersensitivity to Pork
Use with extreme caution, if at all, in patients with known hypersensitivity to pork products.
100

101

a
(See
Contraindications.)
If hypersensitivity occurs, discontinue pancreatin and treat symptoms.
100

101

Other Hypersensitivity Reactions
Patients may experience allergic reactions if capsules are opened and the powder accidentally
inhaled; inhalation of airborne powder may precipitate asthmatic attack in sensitive individuals.
100101

Other hypersensitivity reactions (e.g., sneezing, lacrimation, rash) may occur.
a

Specific Populations
Pregnancy
Category C.
100

101

Lactation
Not known whether pancreatin is distributed into milk.
100

101
Caution advised if pancreatin is used.
100101

Common Adverse Effects
Irritation of mucous membranes and respiratory tract,
100

101
diarrhea or other transient intestinal upset
(with excessive dosage),
a
hyperuricosuria and hyperuricemia (with extremely high doses).
a

Interactions for Pancreatin
Specific Drugs
Drug Interaction Comments
Antacids Decreases the inactivation of
enzyme activity
a

Used to therapeutic
advantage
a

Histamine H
2
-receptor antagonist
(e.g., cimetidine)
Decreases the inactivation of
enzyme activity
a

Used to therapeutic
advantage
a

Pancreatin Pharmacokinetics
Absorption
Following oral administration (capsules), enzymes rapidly released and are available for digestion of
food in stomach and intestines.
100

101

Stability
Storage
Oral
Capsules
1530C.
100

101
Protect from high humidity.
100

101

Tablets
Tight containers, preferably not exceeding 30C.
a

Actions
Enhances digestion of proteins, starch, and fat in GI tract.
100

101

Does not exert systemic pharmacologic effects.
100

101

Advice to Patients
Advise patients to avoid inhalation of powder if capsules are opened.
100

101
Sensitive individuals
may experience allergic reactions.
100

101

Importance of informing clinicians of existing or contemplated therapy, including prescription and
OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
100

101

Importance of women informing their clinician if they are or plan to become pregnant or plan to
breast-feed.
100

101

Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some
individuals; consult specific product labeling for details.
Pancreatin
Routes Dosage
Forms
Strengths Brand Names Manufacturer
Oral Capsules 1,200 USP units Lipase activity, 15,000
USP units Amylase activity, and 15,000
USP units Protease activity
ku-zyme Schwarz
Pharma

2,400 USP units Lipase activity, 30,000
USP units Amylase activity, and 30,000
USP units Protease activity
kutrase Schwarz
Pharma

Tablets 12,000 USP units Lipase activity,
60,000 USP units Amylase activity, and
60,000 USP units Protease activity
Pancreatin 4X
USP Tablets
Vitaline

22,500 USP units Lipase activity,
180,000 USP units Amylase activity,
and 180,000 USP units Protease
activity
Pancreatin 8X
USP Tablets
Vitalin