Generic Name: pancreatin

Brand Names: Hi-Vegi-Lip, Pancreatin 4X, Donnazyme, Digipepsin

Uses

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).

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

Functional Indigestion

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

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

Not effective in the treatment of functional digestive disorders unrelated to pancreatic insufficiency. 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.

Dosage and Administration

Administration

Oral Administration

Administer orally before or with each meal or snack.

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

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

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.

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

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

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.

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

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

Functional Indigestion

Oral

Approximately 1200–2400 USP units of lipase activity before or with each meal or snack.

Cautions

Contraindications

• Hypersensitivity to pork protein.
• Acute pancreatitis.
• Acute exacerbations of chronic pancreatic diseases.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity to Pork

Use with extreme caution, if at all, in patients with known hypersensitivity to pork products. (See Contraindications.)

If hypersensitivity occurs, discontinue pancreatin and treat symptoms.

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.

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

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether pancreatin is distributed into milk. Caution advised if pancreatin is used.

Common Adverse Effects

Irritation of mucous membranes and respiratory tract, diarrhea or other transient intestinal upset (with excessive dosage), hyperuricosuria and hyperuricemia (with extremely high doses).

Interactions

Specific Drugs

Pharmacokinetics

Absorption

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

Stability

Storage

Oral

Capsules

15–30°C. Protect from high humidity.

Tablets

Tight containers, preferably not exceeding 30°C.

Actions

• Enhances digestion of proteins, starch, and fat in GI tract.
• Does not exert systemic pharmacologic effects.

Advice to Patients

• Advise patients to avoid inhalation of powder if capsules are opened. Sensitive individuals may experience allergic reactions.
• 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.
• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.
• 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.

AHFS Drug Information. © Copyright, 1959-2009, Selected Revisions December 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.