Dosage of pancrelipase depends on the condition being treated and the digestive requirements as related to the diet of the patient. Considerable variation in dosage exists, in part, because of the susceptibility of pancrelipase to acid-peptic inactivation of enzyme activity in the stomach and duodenum. Delayed-release preparations (i.e., capsules containing enteric-coated spheres, microspheres, or microtablets of the drug) are reportedly less susceptible to acid-peptic inactivation since they are designed to disintegrate at a relatively high GI pH (e.g., greater than 5.5-6). Concomitant administration of conventional pancrelipase preparations and antacids or a histamine H2-receptor antagonist (e.g., cimetidine) has been used to decrease the inactivation of enzyme activity.
It has been suggested that pancrelipase dosage be determined by the fat content of the diet and that approximately 8000 USP units of lipase activity be given for each 17 g of dietary fat. The usual initial adult dosage of pancrelipase is approximately 4000-33,000 USP units of lipase activity before or with each meal or snack. Dosage may be increased as necessary and then reduced as symptomatic improvement occurs. For the treatment of severe deficiency, one manufacturer states that the dose may be increased to 88,000 USP units of lipase activity with each meal or the dosing interval may be increased to hourly if necessary and if nausea, cramping, and/or diarrhea do not occur.
Dosage for children younger than 6 months of age has not been established. Children 6 months to younger than 1 year of age have responded to 2000 USP units of lipase activity given with each meal. Children 1 to younger than 7 years of age may receive 4000-8000 USP units of lipase activity with each meal and 4000 USP units of lipase with each snack. Children younger than 6 years of age receiving the delayed-release capsules may receive 5000-10,000 USP units of lipase activity with each meal or snack. Children 7-12 years of age have received 4000-12,000 USP units of lipase activity with each meal or snack; this dosage may be increased if needed. Children 6 years of age and older receiving the delayed-release capsules may receive an initial dosage of 10,000-20,000 USP units of lipase activity with each meal or snack. Growth curves have been used as end points to aid in the assessment of response in children.
When used for symptomatic treatment of malabsorption syndrome caused by cystic fibrosis in children younger than 6 years of age, pancrelipase may be given at a dosage of 1500-3000 USP units of lipase activity per kg per meal (units/kg per meal). Dosage should be adjusted according to severity of disease, control of steatorrhea, and nutritional status. Doses exceeding 6000 USP units of lipase activity per kg per meal (units/kg per meal) are not recommended. If dosage needs to be increased, body weight and stool fat content should be monitored carefully. If the patient is switched to a pancrelipase preparation of different strength, care should be taken to ensure that the new regimen provides an equivalent number of lipase units per dose.