Cystic fibrosisAdult & childn ≥4 yr Initially 500 lipase u/kg/meal, max: 2,500 lipase u/kg/meal (≤10,000 lipase u/kg/day or <4,000 lipase u/g fat/day); childn >12 mth & <4 yr Initially 1,000 lipase u/kg/meal. Max: 2,500 lipase u/kg/meal (or ≤10,000 lipase u/kg/day or <4,000 lipase u/g fat/day). Infant up to 12 mth 2,000-4,000 lipase u/120 mL of formula or per breastfeeding. Other pancreatic exocrine insufficiency disorders Individualized dosage according to the degree of maldigestion & fat content of the meal. Required dosage range for a meal: 25,000-80,000 lipase u & ½ of individual dose for snacks.
Should be taken with food: Take during or after meals. Swallow whole w/ sufficient
amount of fluid, do not chew/crush. For patients w/ swallowing difficulty, cap may be carefully opened
& contents may be added to an acidic soft food (eg, applesauce/yogurt)
or liquid (eg, apple/orange/pineapple juice). Consume mixt immediately.
Hypersensitivity to proteins of porcine origin. Not to be mixed directly into formula or breast milk prior to administration in infants up to 12 mth. Fibrosing colonopathy on high doses of pancreatic enzyme use. Assess changes or unusual abdominal symptoms in patients taking >10,000 lipase u/kg daily. Examine & decrease dosage in patients receiving higher doses (>6,000 lipase u/kg/meal). Potential for irritation to oral mucosa. Patients w/ gout, renal impairment or hyperuricemia. Pregnancy. Possible colonic stricture in doses >6,000 lipase u/kg/meal in childn <12 yr.
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