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Pancrelipase Dosage

Medically reviewed on August 6, 2018.

Applies to the following strengths: 10,000 units-32,000 units-42,000 units; 15,000 units-47,000 units-63,000 units; 20,000 units-63,000 units-84,000 units; 3000 units-10,000 units-14,000 units; 40,000 units-126,000 units-168,000 units; 5000 units-17,000 units-24,000 units; 25,000 units-79,000 units-105,000 units; 8000 units-30,000 units-30,000 units; 16,800 units-70,000 units-70,000 units/0.7 g; 3000 units-9500 units-15,000 units; 5000 units-18,750 units-16,600 units; 6000 units-19,000 units-30,000 units; 10,000 units-37,500 units-33,200 units; 12,000 units-38,000 units-60,000 units; 20,000 units-75,000 units-66,400 units; 24,000 units-76,000 units-120,000 units; 36,000 units-114,000 units-180,000 units; 4500 units-25,000 units-20,000 units; 4000 units-12,000 units-12,000 units; 10,000 units-30,000 units-30,000 units; 16,000 units-48,000 units-48,000 units; 20,000 units-44,000 units-56,000 units; 5000 units-20,000 units-20,000 units; 12,000 units-24,000 units-24,000 units; 1200 units-15,000 units-15,000 units; 2400 units-30,000 units-30,000 units; 18,000 units-58,500 units-58,500 units; 12,000 units-39,000 units-39,000 units; 20,000 units-65,000 units-65,000 units; 16,000 units-60,000 units-60,000 units; 4000 units-25,000 units-20,000 units; 30 mg-2 mg-25 mg-6 mg; 11,000 units-30,000 units-30,000 units; 5000 units-17,000 units-27,000 units; 10,000 units-34,000 units-55,000 units; 15,000 units-51,000 units-82,000 units; 20,000 units-68,000 units-109,000 units; 3000 units-10,000 units-16,000 units; 25,000 units-85,000 units-136,000 units; 40,000 units-136,000 units-218,000 units; 4200 units-24,600 units-14,200 units; 10,500 units-61,500 units-35,500 units; 16,800 units-98,400 units-56,800 units; 21,000 units-83,900 units-54,700 units; 2600 units-10,850 units-6200 units; 13,800 units-27,600 units-27,600 units; 23,000 units-46,000 units-46,000 units; 20,700 units-41,400 units-41,400 units; 10,440 units-39,150 units-39,150 units; 20,880 units-78,300 units-78,300 units; 8000 units-40,000 units-45,000 units; 4000 units-25,000 units-25,000 units; 16,000 units-52,000 units-52,000 units; 4000 units-14,375 units-15,125 units; 8000 units-28,750 units-30,250 units; 16,000 units-57,500 units-60,500 units; 24,000 units-86,250 units-90,750 units

Usual Adult Dose for Pancreatic Exocrine Dysfunction

Initial dose: 500 lipase units/kg orally per meal
Maintenance dose: Up to 2500 lipase units/kg orally per meal
Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

Comments:
-Snack doses are usually half of a meal dose, and should be given with each snack.
-The maximum dose includes 3 meals plus 2 to 3 snacks/day.
-Doses should be decreased in older patients, as they tend to ingest less fat/kg but may weigh more.

Use: Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions

Usual Adult Dose for Cystic Fibrosis

Initial dose: 500 lipase units/kg orally per meal
Maintenance dose: Up to 2500 lipase units/kg orally per meal
Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

Comments:
-Snack doses are usually half of a meal dose, and should be given with each snack.
-The maximum dose includes 3 meals plus 2 to 3 snacks/day.
-Doses should be decreased in older patients, as they tend to ingest less fat/kg but may weigh more.

Use: Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions

Usual Adult Dose for Chronic Pancreatitis

Initial dose: 500 lipase units/kg orally per meal
Maintenance dose: Up to 2500 lipase units/kg orally per meal
Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

Comments:
-Tablet formulations should be taken with a proton pump inhibitor (PPI), as they may not be enteric-coated.
-Tablets should be taken with meals and snacks with sufficient fluid.
-Snack doses are usually half of a meal dose, and should be given with each snack.
-The maximum dose includes 3 meals plus 2 to 3 snacks/day.
-Clinical trials have used doses of 72,000 to 125,280 lipase units per meal with consumption of 100 grams/fat per day; however, lower starting doses are recommended in the Cystic Fibrosis Foundation guidelines.

Use: Treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in combination with a PPI

Usual Pediatric Dose for Pancreatic Exocrine Dysfunction

Up to 12 months: 2000 to 4000 lipase units per 120 mL of formula or breastfeeding

Older than 12 months to younger than 4 years:
-Initial dose: 1000 lipase units/kg orally per meal
-Maintenance dose: Up to 2500 lipase units/kg orally per meal
-Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

4 years and older:
-Initial dose: 500 lipase units/kg orally per meal
-Maintenance dose: Up to 2500 lipase units/kg orally per meal
-Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

Comments:
-Patients up to 12 months: The contents of the capsule should not be mixed into formula or breastmilk; contents should be given directly to the mouth or may be mixed with 10 mL of soft acidic food immediately prior to each feeding with breastmilk or formula.
-Snack doses are usually half of a meal dose, and should be given with each snack.
-The maximum dose includes 3 meals plus 2 to 3 snacks/day.

Use: Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions

Usual Pediatric Dose for Cystic Fibrosis

Up to 12 months: 2000 to 4000 lipase units per 120 mL of formula or breastfeeding

Older than 12 months to younger than 4 years:
-Initial dose: 1000 lipase units/kg orally per meal
-Maintenance dose: Up to 2500 lipase units/kg orally per meal
-Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

4 years and older:
-Initial dose: 500 lipase units/kg orally per meal
-Maintenance dose: Up to 2500 lipase units/kg orally per meal
-Maximum dose: 10,000 lipase units/kg/day OR 4000 lipase units/gram fat ingested per day

Comments:
-Patients up to 12 months: The contents of the capsule should not be mixed into formula or breastmilk; contents should be given directly to the mouth or may be mixed with 10 mL of soft acidic food immediately prior to each feeding with breastmilk or formula.
-Snack doses are usually half of a meal dose, and should be given with each snack.
-The maximum dose includes 3 meals plus 2 to 3 snacks/day.

Use: Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions

Renal Dose Adjustments

Renal dysfunction: Use with caution; healthcare providers should consider monitoring uric acid levels.

Liver Dose Adjustments

Data not available

Dose Adjustments

Initial doses:
-Patients should start with the lowest recommended dose, and then gradually increase based upon response.
-Dosing schemes should be determined by actual body weight OR fat ingestion.

Maintenance doses: Maintenance doses should be determined by clinical symptoms, degree of steatorrhea, and the fat content of the diet.

Patients with gout and/or hyperuricemia: Use with caution.

Persistent signs/symptoms of steatorrhea:
-Healthcare providers may increase the dose; patients may require an adjustment period over several days.
-Patients should be instructed to avoid increasing the dose on their own.
-Further investigation is warranted for doses exceeding 2500 lipase units/kg per meal.

High doses:
-Lipase doses greater than 10,000 units/kg/day (2500 units/kg per meal) given to patients with cystic fibrosis should be used with caution AND only if they are documented to indicate a significantly improved coefficient of fat absorption via 3-day fecal fat measures.
-Patients with cystic fibrosis less than 12 years of age receiving lipase doses higher than 6000 units/kg per meal should be examined, and the dose should either be immediately decreased OR titrated downward to a lower range.

Precautions

CONTRAINDICATIONS:
-None

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Capsule and microtablet formulations should not be crushed or chewed.
-Patients who have difficulty swallowing capsules may carefully open the capsules and either take with liquid or shake onto soft food that does not require chewing; the soft food should be swallowed immediately.
-Some formulations may be given with soft foods with a pH of 4.0 or less via gastrostomy tube; the manufacturer product information should be consulted for further guidance on this route.
-If antacids are necessary, at least 1 hour should elapse between this drug and antacid use.

Storage requirements:
-Protect from moisture.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

General:
-Limitation of use: Brand substitutions with other pancrelipase products should be avoided.
-This drug is dosed in lipase units.
-Inadequate hydration may exaggerate constipation.

Monitoring:
-GASTROINTESTINAL: Fecal fat in patients receiving high doses
-METABOLIC: Serum uric acid levels in patients with hyperuricemia, gout, or renal dysfunction

Patient advice:
-Patients should be instructed to keep medication containers closed when not in use, and to avoid discarding desiccant canisters/packets.
-Patients should be told to immediately contact their healthcare provider if allergic reactions occur.
-Patients should be advised to ensure adequate hydration, especially during periods of increased fluid loss.
-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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