Pancreatin

Class: Digestants
ATC Class: A09AA
VA Class: GA500
CAS Number: 8049-47-6
Brands: ku-zyme, kutrase

Warning(s)

Special Alerts:

This monograph has been removed from publication effective April 1, 2012. No products are commercially available.

Introduction

Digestant; contains enzymes (principally amylase, lipase, and protease).100 101 a

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

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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 enzyme’s activity in the stomach and duodenum.100 101 a

Adults

Malabsorption Syndrome
Oral

Initially: approximately 8000–24,000 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 1200–2400 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.100 101

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.100 101

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 activitya

Used to therapeutic advantagea

Histamine H2-receptor antagonist (e.g., cimetidine)

Decreases the inactivation of enzyme activitya

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

15–30°C.100 101 Protect from high humidity.100 101

Tablets

Tight containers, preferably not exceeding 30°C.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

Vitaline

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 01, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. Schwarz Pharma. ku-zyme (lipase, amylase, protease) capsules prescribing information. Milwaukee, WI; 2004 Aug.

101. Schwarz Pharma. kutrase (lipase, amylase, protease) capsules prescribing information. Milwaukee, WI; 2007 Feb.

a. AHFS drug information 2007. McEvoy GK, ed. Pancreatin. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2930-1.

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