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Pancreatin
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
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
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
Specific Populations
Pregnancy
Lactation
Not known whether pancreatin is distributed into milk.100 101 Caution advised if pancreatin is used.100101
Interaction
Comments
Antacids
Used to therapeutic
advantagea
Used to therapeutic
advantagea
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
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
Route
s
Dosage
Forms
Strengths
Brand Names
Manufacturer
Oral
Capsules
ku-zyme
Schwarz
Pharma
kutrase
Schwarz
Pharma
Pancreatin 4X
USP Tablets
Vitaline
Pancreatin 8X
USP Tablets
Vitalin
Tablets