Generic Name

Pancrelipase

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Classification

FDA Approved Indications

• Pancreatic exocrine insufficiency (PEI) due to chronic pancreatitis, cystic fibrosis, pancreatectomy, or other conditions resulting in pancreatic enzyme deficiency.

Mechanism of Action

Pancrelipase supplies exogenous enzymes (amylase, lipase, protease) that aid in the digestion of fats, carbohydrates, and proteins, thereby improving nutrient absorption and reducing malabsorption symptoms.

Dosage and Administration

Adult: Dosing varies based on individual patient needs, severity of condition, and enzyme activity units prescribed. Typically, doses are adjusted to optimize digestion with the lowest effective dose, usually 13,000-50,000 units of lipase per meal.

Pediatric: Dosing is based on weight and clinical response; commonly initiated at 500-2,500 units of lipase per kg/day, divided among meals.

Geriatric: Similar to adult dosing; adjustments may be necessary based on renal and hepatic function.

Renal Impairment: No specific dose adjustment recommended, but caution advised.

Hepatic Impairment: No specific dose adjustment recommended.

Pharmacokinetics

Absorption: Minimal systemic absorption; enzymes act locally in the gastrointestinal tract.

Distribution: Locally active in the GI tract.

Metabolism: Degradation by gastrointestinal enzymes and proteases; minimal systemic absorption.

Excretion: Metabolites excreted in feces. No significant renal excretion.

Half Life: Not applicable due to local activity and rapid degradation within GI lumen.

Contraindications

• Hypersensitivity to pancrelipase or components.
• Acute pancreatitis (use cautiously).

Precautions

• Use with caution in patients with allergic reactions to pork proteins, as pancrelipase is derived from pig pancreas. Monitor for gastrointestinal irritation, especially in patients with suspected or known allergies. Adjust doses in cases of intestinal or gastric surgery. Use during pregnancy and lactation only if clearly indicated.

Adverse Reactions - Common

• Gastrointestinal discomfort (bloating, cramps, nausea) (Common)
• Diarrhea or constipation (Common)

Adverse Reactions - Serious

• Allergic reactions (rash, difficulty breathing, anaphylaxis) (Rare)
• Respiratory symptoms if inhaled (especially in occupational settings) (Rare)

Drug-Drug Interactions

• May decrease the absorption of tetracyclines and ciprofloxacin if taken simultaneously; separate administration by at least 1-2 hours.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Take capsules with meals and snacks.
• Swallow capsules whole; do not crush or chew.
• Report any allergic reactions, GI symptoms, or intolerances.
• Maintain regular follow-up for dosing adjustments.

Special Considerations

Black Box Warnings:

• Use with caution in patients hypersensitive to pork products.
• Oral pancrelipase should not be inhaled due to risk of respiratory reactions.

Genetic Factors: None specific; derived from porcine sources.

Lab Test Interference: May interfere with fecal fat tests or other pancreatic enzyme tests.

Overdose Management

Signs/Symptoms: Gastrointestinal symptoms such as nausea, vomiting, diarrhea, abdominal pain.

Treatment: Supportive care; discontinue pancrelipase; symptomatic treatment. No specific antidote.

Storage and Handling

Storage: Store at room temperature away from moisture and heat.

Stability: Stable until expiration date provided on packaging.