pancrelipase

Contraindicated in:

Hypersensitivity to hog proteins.

Use Cautiously in:

Gout, renal impairment, or hyperuricemia (may ↑ uric acid levels);
OB: Systemic absorption during pregnancy expected to be minimal; significant fetal exposure not expected;
Lactation: Systemic absorption expected to be minimal; significant exposure to breastfed infant not expected.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: hives, rash

EENT: nasal stuffiness

GI: abdominal pain (high doses only), diarrhea, nausea, stomach cramps, FIBROSING COLONOPATHY (HIGH DOSES ONLY), oral irritation

GU: hematuria

Metab: hyperuricemia

Resp: dyspnea, shortness of breath, wheezing

Misc: allergic reactions

Interactions ⬆ ⬇

Drug-drug:

Antacids (calcium carbonate or magnesium hydroxide) may ↓ effectiveness of pancrelipase.
May ↓ the absorption of concurrently administered iron supplements.

Drug-Food:

Alkaline foods destroy coating on enteric-coated products.

Availability ⬆ ⬇

(Generic available)

Tablets: 10,440 units lipase/39,150 units protease/39,150 units amylase; 20,880 units lipase/78,300 units protease/78,300 units amylase
Delayed-release capsules: 2600 units lipase/6200 units protease/10,850 units amylase; 3000 units lipase/9500 units protease/15,000 units amylase; 3000 units lipase/10,000 units protease/16,000 units amylase; 4000 units lipase/14,375 units protease/15,125 units amylase; 4200 units lipase/14,200 units protease/24,600 units amylase; 5000 units lipase/17,000 units protease/27,000 units amylase; 6000 units lipase/19,000 units protease/30,000 units amylase; 8000 units lipase/28,750 units protease/30,250 units amylase; 8000 units lipase/30,000 units protease/30,000 units amylase; 10,000 units lipase/34,000 units protease/55,000 units amylase; 10,500 units lipase/35,500 units protease/61,500 units amylase; 12,000 units lipase/38,000 units protease/60,000 units amylase; 13,800 units lipase/27,600 units protease/27,600 units amylase; 15,000 units lipase/51,000 units protease/82,000 units amylase; 16,000 units lipase/57,500 units protease/60,500 units amylase; 16,800 units lipase/56,800 units protease/98,400 units amylase; 20,000 units lipase/55,000 units protease/55,000 units amylase; 20,000 units lipase/68,000 units protease/109,000 units amylase; 20,700 units lipase/41,400 units protease/41,400 units amylase; 21,000 units lipase/54,700 units protease/83,900 units amylase; 23,000 units lipase/46,000 units protease/46,000 units amylase; 24,000 units lipase/76,000 units protease/120,000 units amylase; 25,000 units lipase/85,000 units protease/136,000 units amylase; 36,000 units lipase/114,000 units protease/180,000 units amylase; 40,000 units lipase/136,000 units protease/218,000 units amylase; 60,000 units lipase/189,600 units protease/252,600 units amylase

Route/Dosage ⬆ ⬇

PO (Adults and Children ≥4 yr): Initiate with 500 lipase units/kg/meal; dose should be adjusted based on weight, clinical symptoms, and stool fat content; maximum dose = 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day).
PO (Children >1 yr and <4 yr): Initiate with 1000 lipase units/kg/meal; dose should be adjusted based on weight, clinical symptoms, and stool fat content; maximum dose = 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day).
PO (Children ≤1 yr): 2000–4000 lipase units per 120 mL of formula or breast milk.

US Brand Names ⬆ ⬇

Creon, Pancreaze, Pertzye, Viokace, Zenpep

Action ⬆ ⬇

Contains lipolytic, amylolytic, and proteolytic activity.

Therapeutic effects:

Increased digestion of fats, carbohydrates, and proteins in the GI tract.

Classifications ⬆ ⬇

Therapeutic Classification: digestive agent

Pharmacologic Classification: pancreatic enzymes

Pharmacokinetics ⬆ ⬇

Absorption: Unknown.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Canadian Brand Names ⬆ ⬇

Cotazym, Pancrease MT

Time/Action Profile ⬆ ⬇

(digestant effects)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Encourage patients to comply with diet recommendations of health care professional (generally high calorie, high protein, low fat). Dose should be adjusted for fat content of diet. Usually 300 mg of pancrelipase is necessary to digest every 17 g of dietary fat. If a dose is missed, it should be omitted and next dose taken with next snack, as directed. Do not ↑ dose without consulting health care professional. Several days may be required to determine correct dose. Advise patient to read Medication Guide before starting therapy and with each Rx refill; information may be updated.
Instruct patient not to chew tablets and to swallow them quickly with plenty of liquid to prevent mouth and throat irritation. Sit upright to enhance swallowing. Eating immediately after taking medication helps further ensure that the medication is swallowed and does not remain in contact with mouth and esophagus for a prolonged period. Patient should avoid sniffing powdered contents of capsules, as sensitization of nose and throat may occur (nasal stuffiness or respiratory distress).
- Advise patients and caregivers to notify health care professional if symptoms of fibrosing colonopathy (abdominal pain, distention, vomiting, constipation) occur. Symptoms occur more frequently with doses >6000 lipase units/kg of body weight per meal (10,000 lipase units/kg of body weight/day) and have been associated with colonic strictures in children <12 yr.
Instruct patient to notify health care professional if joint pain, swelling of legs, gastric distress, or rash occurs.
Instruct patient to notify health care professional immediately if difficulty breathing or hives occur.
Rep: Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇