Pancreatin [High Lipase]

• Exocrine Pancreatic Insufficiency (EPI):
• Chronic pancreatitis
• Cystic fibrosis-associated pancreatic insufficiency
• Pancreatic resection or trauma
• Pancreatic duct obstruction from cancer or other causes
• Post-pancreatectomy enzyme deficiency
• Malabsorption Syndromes:
• Resulting from pancreatic enzyme deficiency, manifesting as steatorrhea, weight loss, and malnutrition
• Other clinically accepted uses:
• Adjunctive treatment in digestive enzyme deficiencies leading to impaired nutrient absorption

Route: Oral, taken with meals and snacks

• Adults:
• Initial dose generally 40,000 to 80,000 USP lipase units per meal
• For snacks, use about half the mealtime dose
• Dose adjusted based on symptom relief and nutritional status
• Maximum dose should not exceed 10,000 lipase units/kg/day
• Pediatrics:
• Dose individualized by weight and severity, typically 500 to 4,000 lipase units/kg per meal
• Adjust according to stool fat content and clinical response
• Elderly:
• No special dosing adjustments; start with standard dose and titrate
• Special Populations:
• No dose adjustment required for renal or hepatic impairment
• Capsules should be swallowed whole; if unable, sprinkle contents on acidic soft food and swallow immediately without chewing

Pancreatin [High Lipase] contains exogenous digestive enzymes—lipase, amylase, and protease—that supplement deficient pancreatic enzymes. Lipase catalyzes the hydrolysis of triglycerides into free fatty acids and monoglycerides, enhancing fat digestion and absorption. Amylase and protease digest carbohydrates and proteins, respectively. These enzymes act locally in the small intestine, improving nutrient breakdown and absorption, thereby alleviating symptoms related to pancreatic enzyme insufficiency.

• Absorption: Enzymes act locally in the gastrointestinal tract; systemic absorption is negligible
• Distribution: Not applicable
• Metabolism: Proteolytic degradation occurs within the gastrointestinal tract
• Excretion: Enzymes are degraded and excreted in feces
• Onset of Action: Immediate with ingestion alongside meals
• Duration: Activity persists through the digestion phase of the meal

• Pregnancy:
• No adequate, well-controlled human studies available
• Animal studies show no teratogenic effects
• Use during pregnancy only if clearly needed
• Lactation:
• Unknown if excreted in human milk
• Minimal systemic absorption suggests low risk to breastfed infants
• Use cautiously with clinical monitoring

• Primary Class: Digestive enzyme replacement therapy
• Subclass: Pancreatic enzymes with high lipase concentration

• Known hypersensitivity to pancreatin or any component of the formulation
• Acute exacerbation of pancreatitis
• Intestinal obstruction or ileus (unless resolved)

• Fibrosing Colonopathy:
• Rare but serious risk with high-dose, long-term use especially in cystic fibrosis patients
• Monitor for signs of colonic strictures such as abdominal pain and obstruction
• Hypersensitivity Reactions:
• Rash, pruritus, and in rare cases anaphylaxis can occur
• Oral and Esophageal Irritation:
• Avoid chewing or crushing capsules to prevent mucosal damage
• Gastrointestinal Side Effects:
• May include abdominal discomfort, diarrhea, nausea, particularly when starting or adjusting doses
• Nutritional Monitoring:
• Fat-soluble vitamin levels (A, D, E, K) should be periodically assessed in long-term therapy

• Common:
• Abdominal pain
• Flatulence
• Nausea
• Diarrhea or constipation
• Rare/Serious:
• Fibrosing colonopathy
• Allergic reactions (rash, urticaria, bronchospasm)
• Hyperuricemia

• No significant drug interactions documented
• Antacids and Proton Pump Inhibitors: May increase gastric pH, potentially reducing enzyme activity; separate administration times advised
• Iron Supplements: Possible decreased absorption when co-administered

• Current guidelines recommend dose individualization based on clinical response and symptom control
• Emphasis on enteric-coated, delayed-release formulations for optimal enzyme delivery
• Heightened awareness for fibrosing colonopathy risk in cystic fibrosis with high-dose treatment
• Ongoing development of formulations with improved enzyme stability and bioavailability

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