PANCREAZE (pancrelipase) delayed-release capsules

PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.

Fibrosing Colonopathy: Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated.

Hyperuricemia has been reported with high dosages; consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia.

Irritation of the Oral Mucosa may occur due to loss of protective enteric coating on the capsule contents.

The presence of porcine viruses that might infect humans cannot be definitely excluded.

Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment.

The most common side effects of PANCREAZE include blurred vision, abdominal pain, flatulence, constipation, nausea, pruritus, asymptomatic elevations of liver enzymes, myalgia, muscle spasm, urticaria and rash.