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:

• Tablet formulations should be taken with a proton pump inhibitor (PPI), as they may not be enteric-coated.
• 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:

• Tablet formulations should be taken with a proton pump inhibitor (PPI), as they may not be enteric-coated.
• 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 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: In combination with a PPI for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy

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

Safety and efficacy of some tablet formulations have not been established in pediatric patients.

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 or 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 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.

Frequently asked questions

• What are enteric-coated tablets?