COTAZYM® (pancrelipase capsules, USP) capsules are indicated for treatment of steatorrhea due to exocrine pancreatic enzyme deficiency in such conditions as cystic fibrosis and chronic pancreatitis.

Cystic Fibrosis

The dosage of COTAZYM® (pancrelipase capsules, USP) must be individualized according to the patient's remaining exocrine pancreatic function, pH of the gut lumen (if such measurements are routinely taken) and intake of fat and protein. Dosage should depend on nutritional intake as well as body weight, and varies with age. A high caloric diet with unrestricted fat appropriate to age and clinical status should be consumed. While the dose may need to be adjusted for control of steatorrhea, a total daily dose should not exceed 2500 lipase units/kg per meal without careful evaluation of the patient. A dose higher than 6000 lipase units/kg per meal should not be administered ⁵ (see PRECAUTIONS ).

Prior to treatment, the patient's stool should be evaluated microscopically for the presence of fat droplets. If visible, a 72-hour fat balance study should be performed while monitoring nutrient intake, to determine the extent of malabsorption. In patients with meconium ileus, a fat balance study is not required prior to establishing a dosage and beginning treatment with COTAZYM®. Do not exceed recommended dosage. Based on 2500 lipase units/kg per meal, the maximum recommended dosage for a 70 kg patient would be 20 capsules per meal (60 capsules/day for 3 meals). Dosages greater than 2500 lipase units/kg per meal should only be used with caution and only if safely tolerated by the patient and documented to be effective by 3 day fecal fat measures that indicate a significantly improved coefficient of absorption. ⁵ Infants should be given a total of 2000 to 4000 lipase units for each 120 mL (4 oz.) of formula or each breast feeding. For other children less than 4 years of age, dosing should begin with 1000 lipase units/kg for each meal. For children 4 years of age or older, 500 lipase units/kg for each meal should be initiated. For a snack, half the dose for a meal should be given.

Chronic Pancreatitis

One or two capsules should be administered for control of symptoms and adjusted as needed.

COTAZYM® (pancrelipase capsules, USP) are opaque green capsules imprinted with "Organon" and "381". COTAZYM® is supplied in bottles of 100, NDC# 0052-0381-91, and bottles of 500, NDC# 0052-0381-95.

Storage:   Not to exceed 25°C (77°F). Store in dry place when opened.

Dispense:   In tight container as defined in the USP.

REFERENCES

1. Dutta SK, Rubin J, Harvey J. Comparative Evaluation of the Therapeutic Efficacy of a pH-Sensitive Enteric Coated Pancreatic Enzyme Preparation with Conventional Pancreatic Enzyme Therapy in the Treatment of Exocrine Pancreatic Insufficiency. Gastroenterology 1983;84:476-482.
2. Dutta SK, Hubbard VS, Appler M. Critical examination of therapeutic efficacy of a pH-sensitive enteric-coated pancreatic enzyme preparation in treatment of exocrine pancreatic insufficiency secondary to cystic fibrosis. Dig Dis and Sci 1988;33:1237-1244.
3. Data on File at Organon Inc., W. Orange, NJ, USA
4. Mischler EH, Parrell S, Farrell PM, Odell GB. Comparison of effectiveness of pancreatic enzyme preparations in cystic fibrosis. Am J Dis Child 1982;136:1060-1063.
5. Borowitz DS, Grand RJ, Durie PR, and the Consensus Committee. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. J Ped 1995;127:681-684.

Caution:   Federal law prohibits dispensing without a prescription.

Organon' Inc.
375 Mt. Pleasant Avenue
West Orange, NJ 07052

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