Pancreatin

• Exocrine Pancreatic Insufficiency (EPI):
• Due to chronic pancreatitis, cystic fibrosis, pancreatic surgery, pancreatic cancer, or ductal obstruction
• Post-pancreatectomy or pancreatic trauma
• Malabsorption Syndromes:
• Resulting from pancreatic enzyme deficiency, including steatorrhea, maldigestion, and weight loss
• Other Approved Uses:
• Pancreatic enzyme replacement therapy in cystic fibrosis patients
• Supportive treatment in digestive disorders involving enzyme deficiency
• Off-label/Clinically Accepted Uses:
• As adjunctive therapy in short bowel syndrome
• Some cases of diabetes-associated pancreatic insufficiency

Route: Oral, with meals and snacks

Adults:

• Initial dose usually ranges from 25,000 to 80,000 USP units of lipase per meal, adjusted based on symptoms and stool fat content
• Snacks: Half the mealtime dose
• Dosage titrated to stool consistency, weight gain, and symptom relief
• Maximum dose generally does not exceed 10,000 lipase units/kg/day to avoid adverse effects

Pediatrics:

• Dosage individualized based on body weight, often 500 to 4,000 lipase units/kg per meal
• Adjusted according to clinical response and stool fat content

Elderly:

• No specific dose adjustments required but start low and titrate carefully due to potential comorbidities

Special Populations:

• Renal or Hepatic Impairment: No dose adjustments required
• Administration Instructions:
• Take immediately before or during meals
• Capsules should be swallowed whole; for patients unable to swallow capsules, open capsules and sprinkle contents on acidic soft food (e.g., applesauce), swallow immediately, and rinse mouth to avoid mucosal irritation

Pancreatin is a mixture of digestive enzymes—amylase, lipase, and protease—that supplement endogenous pancreatic enzymes deficient or absent in patients with exocrine pancreatic insufficiency. These enzymes hydrolyze carbohydrates, fats, and proteins in the gastrointestinal tract, facilitating digestion and absorption of nutrients, thereby reducing malabsorption symptoms such as steatorrhea, diarrhea, and weight loss.

• Absorption: Pancreatic enzymes act locally in the gastrointestinal tract; systemic absorption of the enzymes themselves is negligible
• Distribution: Not applicable (local GI activity)
• Metabolism: Enzymes are proteins; they are denatured and degraded by gastric acid and intestinal proteases
• Elimination: Degraded into amino acids and peptides in the GI tract; no systemic elimination
• Onset of Action: Begins immediately with meals as enzymes mix with chyme
• Duration: Effects last throughout the digestive period of the meal

• Pregnancy:
• No well-controlled studies in pregnant women
• Animal studies show no teratogenic effects
• Considered relatively safe; use only if clearly needed
• Lactation:
• Unknown if excreted in breast milk
• Expected to have minimal systemic absorption; unlikely to affect breastfed infant
• Use with caution

• Primary Class: Digestive enzyme replacement therapy
• Subclass: Pancreatic enzymes

• Known hypersensitivity to pancreatin or any component of the formulation
• Acute pancreatitis or exacerbation of chronic pancreatitis (use with caution)
• Obstruction of the gastrointestinal tract (unless relieved)

• Fibrosing Colonopathy:
• Rare but serious risk, mainly in cystic fibrosis patients receiving high doses
• Monitor for signs of colonic strictures or obstruction
• Allergic Reactions:
• Rash, urticaria, or more severe hypersensitivity reactions possible
• Mucosal Irritation:
• May cause mouth or esophageal irritation if capsules are chewed or broken
• Gastrointestinal Symptoms:
• Abdominal pain, diarrhea, or nausea may occur, particularly with dose changes
• Vitamin Deficiencies:
• Long-term use may require monitoring of fat-soluble vitamins (A, D, E, K) due to malabsorption

Common:

• Abdominal pain
• Flatulence
• Diarrhea or constipation
• Nausea

Rare/Serious:

• Fibrosing colonopathy (mostly with high doses in cystic fibrosis)
• Allergic reactions (rash, urticaria, bronchospasm)
• Hyperuricemia (rare)

• No significant clinically relevant drug-drug interactions known
• Antacids and proton pump inhibitors: May increase gastric pH, reducing enzyme activation; avoid concomitant use or separate dosing if possible
• Iron supplements: May have reduced absorption due to changes in GI pH or motility

• Clinical guidelines (e.g., from ESPEN, ACG):
• Emphasize early initiation of enzyme replacement in pancreatic insufficiency
• Recommend dose titration based on clinical response and nutritional status
• Highlight monitoring for vitamin deficiencies and adverse effects
• Regulatory:
• Recent formulations have improved enteric coatings for better enzyme delivery to the duodenum
• Newer delayed-release microsphere formulations offer improved symptom control and dosing flexibility

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture and heat
• Keep in original container with desiccant to prevent moisture exposure
• Do not freeze or expose to high humidity
• Keep out of reach of children