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 Antacids Histamine H2-receptor antagonist (e.g., cimetidine) Interaction Decreases the inactivation of enzyme activitya Decreases the inactivation of enzyme activitya Comments 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

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 Oral Capsules Strengths Brand Names Manufacturer Schwarz Pharma Schwarz Pharma Vitaline

1,200 USP units Lipase activity, 15,000 ku-zyme USP units Amylase activity, and 15,000 USP units Protease activity 2,400 USP units Lipase activity, 30,000 kutrase USP units Amylase activity, and 30,000 USP units Protease activity

Tablets

12,000 USP units Lipase activity, Pancreatin 4X 60,000 USP units Amylase activity, and USP Tablets 60,000 USP units Protease activity 22,500 USP units Lipase activity, 180,000 USP units Amylase activity, and 180,000 USP units Protease activity Pancreatin 8X USP Tablets

Vitalin