Drug reference

Pancreatin

Prokinetic · Digestive enzyme, Enzyme Replacement Therapy

Also known as Pancrelipase, Pancreatic Enzymes, Viokase, Creon, Zenpep, Pancreaze

ProkineticDigestive enzyme, Enzyme Replacement TherapyATC A09AA02

CDSCO approvedOTCJan AushadhiATC A09AA02

EXCRETION

—

not curated

INTERACTIONS

—

none in our sources

PREGNANCY

FDA Pregnancy Category C. However, it is generally considered safe and necessary for pregnant women with pancreatic insufficiency to prevent maternal malnutrition, which could be more harmful to the fetus than the drug itself. Use only if clearly needed.

FDA category + note

Mechanism

Pancreatin is a pancreatic enzyme extract derived from porcine pancreas, primarily containing lipase, amylase, and protease. It functions by supplementing or replacing the deficient endogenous pancreatic enzymes, thereby facilitating the breakdown of fats, carbohydrates, and proteins in the gastrointestinal tract. This enzymatic action improves digestion and absorption of nutrients, alleviating symptoms of malabsorption in patients with exocrine pancreatic insufficiency.

Indications

Exocrine pancreatic insufficiency due to cystic fibrosisChronic pancreatitisPancreatectomyOther conditions causing exocrine pancreatic insufficiency (e.g., pancreatic cancer, gastric bypass surgery, Shwachman-Diamond syndrome, obstructive ductal conditions)

Dosing

Adult: Dosing is highly individualized based on the severity of pancreatic insufficiency, fat content of the diet, and clinical response (e.g., reduction in steatorrhea, improved nutritional status). Typically, 10,000 to 25,000 Ph. Eur. units of lipase per meal or snack are initiated. Doses can be titrated up to 50,000-80,000 units of lipase per meal based on symptom control and stool fat excretion.…
Pediatric: Dosing is highly individualized based on age, weight, and severity of pancreatic insufficiency. For infants (cystic fibrosis), typically 2,000-5,000 lipase units per 120 mL of formula or breastfeeding. For older children, similar to adult dosing but adjusted by weight and meal size, starting with 500-2,500 lipase units/kg/meal. Administer immediately before or with meals and snacks.
Renal adjustment: No specific dose adjustment is typically required as Pancreatin acts locally in the gastrointestinal tract and is minimally absorbed systemically.
Hepatic adjustment: No specific dose adjustment is typically required as Pancreatin acts locally in the gastrointestinal tract and is minimally absorbed systemically.
Geriatric: No specific dose adjustment is typically required based on age alone. However, geriatric patients may be more susceptible to adverse effects, and renal/hepatic function should be assessed, although specific adjustments for Pancreatin related to these are not generally needed as it acts locally.
Max dose: Generally, total daily dose should not exceed 10,000 lipase units/kg/day or 2,500 lipase units/kg/meal (or 4,000 lipase units/gram of fat ingested per day) due to a theoretical risk of fibrosing colonopathy, especially in children with cystic fibrosis.

Pharmacokinetics

Onset

Onset of action is immediate upon mixing with food in the stomach and small intestine.

Peak effect

Not applicable, as systemic absorption is minimal and activity is localized to the GI tract.

Duration

Duration of action is generally limited to the transit time of food through the upper gastrointestinal tract when enzymes are active.

Half-life

Not applicable in the conventional sense, as enzymes are digested and not absorbed into systemic circulation to have a measurable systemic half-life.

Bioavailability

Minimal systemic absorption (enzymes are intended to act locally in the GI tract and are extensively digested themselves).

Protein binding

Not applicable, as enzymes are not significantly absorbed into systemic circulation.

Metabolism

Pancreatin enzymes are self-digested within the gastrointestinal tract, similar to food proteins.

Excretion

Enzymes are digested within the gastrointestinal tract; breakdown products are excreted primarily via feces.

Contraindications

Known hypersensitivity to porcine protein or any component of the formulation
Acute pancreatitis
Acute exacerbation of chronic pancreatitis

Side effects

Common

Abdominal pain/crampsNauseaDiarrheaConstipationBloatingFlatulence

Serious

Fibrosing colonopathy (rare, primarily in children with cystic fibrosis receiving very high doses)
Hypersensitivity reactions (e.g., rash, pruritus, dyspnea, anaphylaxis) to porcine protein
Hyperuricemia/hyperuricosuria (with very high doses due to purine content)

Pregnancy & lactation

Pregnancy

Lactation

Pancreatin is generally considered safe for use during breastfeeding. It is not absorbed systemically and is highly unlikely to be excreted in breast milk or cause harm to the nursing infant.