Product: Zenpep

Company: Eurand

Pharmacologic class: Pancreatic enzymes (porcine)

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Active ingredients: Lipase 5,000 units, protease 17,000 units, amylase 27,000 units; delayed-release caps.

Also: ZENPEP 10,000

Active ingredients: Lipase 10,000 units, protease 34,000 units, amylase 55,000 units; delayed-release caps.

Also: ZENPEP 15,000

Active ingredients: Lipase 15,000 units, protease 51,000 units, amylase 82,000 units; delayed-release caps.

Also: ZENPEP 20,000

Active ingredients: Lipase 20,000 units, protease 68,000 units, amylase 109,000 units; delayed-release caps.

Indication: Exocrine pancreatic insufficiency (e.g., cystic fibrosis).

Pharmacology: Pancrelipase is a group of digestive enzymes including lipases, amylases, and proteases. These enzymes catalyze the hydrolysis of fats to monoglycerol, glycerol and fatty acids, protein into peptides and amino acids, and starch into dextrins and short chain sugars in the duodenum and proximal small intestine.

Zenpep is a pancrelipase product that is prepared from an extract of porcine pancreatic glands. The capsules contain enteric-coated beads that vary in diameter and activity levels. The coating is designed to protect the enzymes from gastric acids and to release the enzymes at a pH ≥5.5.

Clinical trials: Study 1 involved 34 patients aged 7 to 23 years with exocrine pancreatic insufficiency associated with cystic fibrosis. In this double-blind crossover study, patients were randomized to either Zenpep or matching placebo for six or seven days, followed by crossover to the alternative treatment for another six to seven days. The mean dose ranged from 3,900 to 5,700 lipase units/kg per day. All patients consumed a high-fat diet during treatment. The primary efficacy endpoint was the mean difference in the coefficient of fat absorption (CFA) between Zenpep and placebo. Mean CFA for Zenpep was 88% compared with 63% with placebo treatment.

In study 2, an open-label, uncontrolled study in 19 patients aged 1 to 6 years compared fat malabsorption before and after Zenpep administration with meals/snacks. Patients were switched to Zenpep from their usual treatment. Following a screening period on their usual treatment, patients were given Zenpep at individually titrated doses ranging from 2,300 to 10,000 lipase units/kg per day for 14 days. Patients showed similar control of fat malabsorption by spot fecal fat testing when switched to Zenpep treatment at similar doses.

Adults and children: Base dose on lipase units. Swallow whole (do not crush); may mix contents with applesauce or other acidic food, follow with water or juice; take with meals; do not let any drug remain in mouth. Infants: 2,000-4,000 units per 120 mL formula or per breast-feeding (do not mix directly into formula or breast milk); 12 months-4 years: 1,000 units/kg per meal; maximum 2,500 units/kg per meal (or ≤10,000 units/kg/day); >4 years: 500 units/kg per meal; maximum 2,500 units/kg per meal (or ≤10,000 units/kg/day), or <4,000 units/g fat ingested per day. Adjust per diet and clinical response (e.g., steatorrhea).

Precautions:Not interchangeable with similar products. Gout. Renal impairment. Hyperuricemia. Pregnancy (Cat. C). Nursing mothers.

Adverse reactions: Abdominal pain, flatulence, headache, cough, decreased weight, early satiety, contusion; fibrosing colonopathy, hyperuricemia, allergic reactions.

How supplied: Caps (5,000, 10,000, 15,000 lipase units)—12, 100 20,000 lipase units—12, 100, 500

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