Action

Catalyzes hydrolysis of fats to mono-glyceride, glycerol, and free fatty acids; proteins into peptides and amino acids; and starches into dextrins and short chain sugars, such as maltose and maltriose, in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas

Availability

Creon

Capsules (delayed-release): 3,000 USP units lipase, 9,500 USP units protease, 15,000 USP units amylase; 6,000 USP units lipase, 19,000 USP units protease, 30,000 USP units amylase; 12,000 USP units lipase, 38,000 USP units protease, 60,000 USP units amylase; 24,000 USP units lipase, 76,000 USP units protease, 120,000 USP units amylase

Pancreaze

Capsules (delayed-release): 4,200 USP units lipase, 10,000 USP units protease, 17,500 USP units amylase; 10,500 USP units lipase, 25,000 USP units protease, 43,750 USP units amylase; 16,800 USP units lipase, 40,000 USP units protease, 70,000 USP units amylase; 21,000 USP units lipase, 37,000 USP units protease, 61,000 USP units amylase

Ultresa

Capsules (delayed-release): 13,800 USP units lipase, 27,600 USP units protease, 27,600 USP units amylase; 20,700 USP units lipase, 41,400 USP units protease, 41,400 USP units amylase; 23,000 USP units lipase, 46,000 USP units protease, 46,000 USP units amylase

Viokace

Tablets: 10,440 USP units of lipase, 39,150 USP units of protease, 39,150 USP units of amylase; 20,880 USP units of lipase, 78,300 USP units of protease, 78,300 USP units of amylase

Zenpep

Capsules (delayed-release): 3,000 USP units lipase, 10,000 USP units protease, 16,000 USP units amylase; 5,000 USP units lipase, 17,000 USP units protease, 27,000 USP units amylase; 10,000 USP units lipase, 34,000 USP units protease, 55,000 USP units amylase; 15,000 USP units lipase, 51,000 USP units protease, 82,000 USP units amylase; 20,000 USP units lipase, 68,000 USP units protease, 109,000 USP units amylase; 25,000 USP units lipase, 85,000 USP units protease, 136,000 USP units amylase

Indications and dosages

➣ Exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy

Adults: Individualize dosage based on clinical symptoms, degree of steatorrhea, and fat content of diet (Viokace)

➣ Exocrine pancreatic insufficiency due to cystic fibrosis (CF), chronic pancreatitis, pancreatectomy, and other conditions

Adults and children age 4 and older: Initially, 500 lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal (or 10,000 lipase units/kg/day or less), or less than 4,000 lipase units/g fat ingested per day (Creon)

Children older than age 12 months and younger than age 4: Initially, 1,000 lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal (or 10,000 lipase units/kg/day or less), or less than 4,000 lipase units/g fat ingested per day (Creon)

Infants up to age 12 months: 3,000 lipase units/120 ml formula or per breastfeeding (Creon)

Don't exceed recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.

➣ Exocrine pancreatic insufficiency due to CF and other conditions

Adults and children age 4 and older: Initially, 500 lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal (or 10,000 lipase units/kg/day or less), or less than 4,000 lipase units/g fat ingested per day (Pancreaze, Zenpep)

Adults and children age 4 and older weighing 28 kg (62 lb) or more: Initially, 500 lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal (or 10,000 lipase units/kg/day or less), or less than 4,000 lipase units/g fat ingested per day (Ultresa)

Children older than age 12 months and younger than age 4: Initially, 1,000 lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal (or 10,000 lipase units/kg/day or less), or less than 4,000 lipase units/g fat ingested per day (Pancreaze, Zenpep)

Children older than age 12 months and younger than age 4 weighing 14 kg (31 lb) or more: Initially, 1,000 lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal (or 10,000 lipase units/kg/day or less), or less than 4,000 lipase units/g fat ingested per day (Ultresa)

Infants up to age 12 months: 2,000 to 4,000 lipase units/120 ml formula or per breastfeeding (Pancreaze); 3,000 lipase units/120 ml formula or per breastfeeding (Zenpep)

Don't exceed recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.

Contraindications

None

Precautions

Use cautiously in:

• proteins of porcine origin allergy

• renal impairment, gout, hyperuricemia

• fibrosing colonopathy (with high doses)

• lactose intolerance

• pregnant or breastfeeding patients

• children younger than age 12 (with high doses).

Administration

• Be aware that brands aren't interchangeable.

• Administer capsules whole with meals.

• Give to infants before each feeding but don't mix capsule contents directly into formula or breast milk.

• For infants or patients unable to swallow intact capsules, sprinkle contents on acidic soft food, such as applesauce, yogurt, or other acidic soft food with pH of 4.5 or less.

• Don't mix capsule contents with alkaline foods, such as milk, breast milk, formula, or ice cream.

• Be aware that attempting to divide capsule contents into small fractions to deliver small doses of lipase isn't recommended.

• Be aware that high-dose use (exceeding 6,000 lipase units/kg/meal) of pancreatic enzyme replacement therapy has been associated with fibrosing colonopathy and colonic strictures in children younger than age 12.

Adverse reactions

CNS: dizziness, headache

EENT: nasopharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, abnormal feces, flatulence, frequent bowel movements, anal pruritus, fibrosing colonopathy

Hepatic: biliary tract stones

Metabolic: hyperglycemia, hypoglycemia, hyperuricemia

Respiratory: cough

Skin: pruritus, urticaria, rash

Other: viral transmission (theoretical risk), severe allergic reactions

Interactions

None

Patient monitoring

• Monitor patient for hyperglycemia, hypoglycemia, and hyperuricemia.

See Closely monitor patient for signs or symptoms of fibrosing colonopathy (such as abdominal pain or distention, vomiting, intermittent diarrhea, and weight loss) that may be associated with high-dose use.

Patient teaching

• Tell patient or caregiver that capsules must be swallowed whole and shouldn't be crushed or chewed.

• Advise patient or caregiver to take drug with food with a full glass of water.

• Tell patient or caregiver not to hold drug in mouth, to avoid mucosal irritation.

• Tell patient or caregiver that for infants or patients who are unable to swallow intact capsules, contents can be sprinkled on soft acidic food, such as applesauce, yogurt, or other soft acidic food.

• Tell patient or caregiver not to mix capsule contents with alkaline foods, such as milk, breast milk, formula, or ice cream.

• Inform patient or caregiver that brands aren't interchangeable.

See Tell patient or caregiver to inform prescriber of pork allergy and to immediately seek medical attention if allergic reaction occurs.

See Tell patient or caregiver to immediately report signs or symptoms of fibrosing colonopathy (such as abdominal pain or distention, vomiting, intermittent diarrhea, or difficulty passing stool).

• Instruct patient or caregiver to report signs or symptoms of high blood sugar (such as extreme thirst), low blood sugar (such as confusion, shakiness, sweating, or hunger), or high uric acid (pain or swelling around joints).

• Advise breastfeeding patient to consider risk and benefit of drug in providing adequate nutritional support for exocrine pancreatic insufficiency.

• Advise female of childbearing age to notify prescriber if she is pregnant, thinking of becoming pregnant, or is breastfeeding during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions.