pan-kre-LI-pase

Therapeutic Classification: digestive agent

Pharmacologic Classification: pancreatic enzymes

• Pancreatic insufficiency associated with:
  • Chronic pancreatitis,
  • Pancreatectomy,
  • Cystic fibrosis,
  • GI bypass surgery,
  • Ductal obstruction secondary to tumor.

• Contains lipolytic, amylolytic, and proteolytic activity.

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

Absorption: Unknown.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: Unknown.

(digestant effects)

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 breast-fed infant not expected.

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.

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.

• 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.

(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;

• Assess patient’s nutritional status (height, weight, skin-fold thickness, arm muscle circumference, and lab values) prior to and periodically throughout therapy.
• Monitor stools for high fat content (steatorrhea). Stools will be foul-smelling and frothy.
• Assess patient for allergy to pork; sensitivity to pancrelipase may exist.

• May cause ↑ serum and urine uric acid concentrations.

• Pancreaze is not interchangeable with any other pancrelipase product.
• PO: Administer immediately before or with meals and snacks.
  • DNC: Swallow tablets whole; do not crush, break, or chew.
  • Swallow capsules whole. If unable to swallow, capsules may be opened and sprinkled on foods. Delayed-release capsules filled should not be chewed (sprinkle on soft, acidic foods that can be swallowed without chewing, such as applesauce or Jell-O) and followed immediately by water or juice to ensure complete ingestion. These medications should not be chewed or mixed with alkaline foods prior to ingestion or coating will be destroyed.
  • Half of the prescribed Pancreaze and Pertzye dose for an individualized full meal should be given with each snack. The total daily dose should reflect approximately three meals plus two or three snacks per day.
  • Do not mix contents of Pancreaze, Pertzye, or Creon capsules directly into breast milk or formula. Capsule contents may be sprinkled on small amounts of acidic soft food with a pH of 4.5 or less (applesauce) and given to the infant within 15 min. Contents of the capsule may also be administered directly to the mouth. Follow administration with breast milk or formula. Applesauce mixture of Pertzye can also be administered via a gastric tube.
  • Do not mix Zenpep capsule contents directly into formula or breast milk prior to administration. Administer with applesauce, bananas, or pears (commercially prepared) and follow with breast milk or formula.

• 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 increase 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 exceeding 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 below the age of 12 yr.
• Instruct patient to notify health care professional if joint pain, swelling of legs, gastric distress, or rash occurs.
• Rep: Advise female patients to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.

• Improved nutritional status in patients with pancreatic insufficiency.
  • Normalization of stools in patients with steatorrhea.

Creon, Pancreaze, Pertzye, Viokace, Zenpep

Cotazym, Pancrease MT

NDC Code^*

• 0032- AbbVie Inc.
  • 0032-1203- Creon
    • 0032-1203-64- 1 BOTTLE in 1 CARTON (0032-1203-64) > 70 CAPSULE, DELAYED RELEASE in 1 BOTTLE

• 0032- AbbVie Inc.
  • 0032-1203- Creon
    • 0032-1203-70- 1 BOTTLE in 1 CARTON (0032-1203-70) > 70 CAPSULE, DELAYED RELEASE in 1 BOTTLE

• 0032- AbbVie Inc.
  • 0032-1206- Creon
    • 0032-1206-01- 1 BOTTLE in 1 CARTON (0032-1206-01) > 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

• 0032- AbbVie Inc.
  • 0032-1206- Creon
    • 0032-1206-07- 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1206-07)

• 0032- AbbVie Inc.
  • 0032-1206- Creon
    • 0032-1206-56- 1 BOTTLE in 1 CARTON (0032-1206-56) > 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

• 0032- AbbVie Inc.
  • 0032-1212- Creon
    • 0032-1212-01- 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1212-01)

• 0032- AbbVie Inc.
  • 0032-1212- Creon
    • 0032-1212-07- 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1212-07)

• 0032- AbbVie Inc.
  • 0032-1212- Creon
    • 0032-1212-13- 1 BOTTLE in 1 CARTON (0032-1212-13) > 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

• 0032- AbbVie Inc.
  • 0032-1224- Creon
    • 0032-1224-01- 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1224-01)

• 0032- AbbVie Inc.
  • 0032-1224- Creon
    • 0032-1224-07- 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1224-07)

• 0032- AbbVie Inc.
  • 0032-1224- Creon
    • 0032-1224-46- 1 BOTTLE in 1 CARTON (0032-1224-46) > 12 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

• 0032- AbbVie Inc.
  • 0032-3016- Creon
    • 0032-3016-12- 1 BOTTLE in 1 CARTON (0032-3016-12) > 12 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

• 0032- AbbVie Inc.
  • 0032-3016- Creon
    • 0032-3016-13- 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-3016-13)

• 0032- AbbVie Inc.
  • 0032-3016- Creon
    • 0032-3016-28- 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-3016-28)

• 0032- AbbVie Inc.
  • 0032-3016- Creon
    • 0032-3016-50- 50 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-3016-50)

• 42865- Allergan, Inc.
  • 42865-300- ZENPEP
    • 42865-300-01- 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-300-01)

• 42865- Allergan, Inc.
  • 42865-300- ZENPEP
    • 42865-300-02- 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-300-02)

• 42865- Allergan, Inc.
  • 42865-302- ZENPEP
    • 42865-302-01- 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-302-01)

• 42865- Allergan, Inc.
  • 42865-302- ZENPEP
    • 42865-302-02- 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-302-02)

• 42865- Allergan, Inc.
  • 42865-303- ZENPEP
    • 42865-303-01- 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-303-01)

• 42865- Allergan, Inc.
  • 42865-303- ZENPEP
    • 42865-303-02- 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-303-02)

• 42865- Allergan, Inc.
  • 42865-303- ZENPEP
    • 42865-303-04- 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-303-04)

• 42865- Allergan, Inc.
  • 42865-304- ZENPEP
    • 42865-304-01- 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-304-01)

• 42865- Allergan, Inc.
  • 42865-304- ZENPEP
    • 42865-304-02- 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-304-02)

• 42865- Allergan, Inc.
  • 42865-305- ZENPEP
    • 42865-305-01- 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-305-01)

• 42865- Allergan, Inc.
  • 42865-305- ZENPEP
    • 42865-305-02- 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-305-02)

• 42865- Allergan, Inc.
  • 42865-305- ZENPEP
    • 42865-305-04- 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-305-04)

• 42865- Allergan, Inc.
  • 42865-306- ZENPEP
    • 42865-306-01- 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-306-01)

• 42865- Allergan, Inc.
  • 42865-306- ZENPEP
    • 42865-306-02- 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-306-02)

• 42865- Allergan, Inc.
  • 42865-307- ZENPEP
    • 42865-307-01- 12 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-307-01)

• 42865- Allergan, Inc.
  • 42865-307- ZENPEP
    • 42865-307-02- 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-307-02)

• 50458- Janssen Pharmaceuticals, Inc.
  • 50458-347- PANCREAZE
    • 50458-347-60- 1 BOTTLE, GLASS in 1 CARTON (50458-347-60) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS

• 58914- Allergan, Inc.
  • 58914-112- Viokace
    • 58914-112-10- 1 BOTTLE in 1 CARTON (58914-112-10) > 100 TABLET in 1 BOTTLE

• 58914- Allergan, Inc.
  • 58914-117- Viokace
    • 58914-117-10- 1 BOTTLE in 1 CARTON (58914-117-10) > 100 TABLET in 1 BOTTLE

• 68428- Washington Homeopathic Products
  • 68428-552- Pancreatinum
    • 68428-552-03- 75 PELLET in 1 VIAL, GLASS (68428-552-03)

• 68428- Washington Homeopathic Products
  • 68428-552- Pancreatinum
    • 68428-552-05- 150 PELLET in 1 VIAL, GLASS (68428-552-05)

• 68428- Washington Homeopathic Products
  • 68428-552- Pancreatinum
    • 68428-552-06- 1200 PELLET in 1 BOTTLE, GLASS (68428-552-06)

• 68428- Washington Homeopathic Products
  • 68428-552- Pancreatinum
    • 68428-552-11- 300 PELLET in 1 BOTTLE, GLASS (68428-552-11)

• 68428- Washington Homeopathic Products
  • 68428-552- Pancreatinum
    • 68428-552-12- 600 PELLET in 1 BOTTLE, GLASS (68428-552-12)

• 71919- Washington Homeopathic Products
  • 71919-518- Pancreatinum
    • 71919-518-07- 15 mL in 1 VIAL, GLASS (71919-518-07)

• 71919- Washington Homeopathic Products
  • 71919-518- Pancreatinum
    • 71919-518-08- 30 mL in 1 VIAL, GLASS (71919-518-08)

• 71919- Washington Homeopathic Products
  • 71919-518- Pancreatinum
    • 71919-518-09- 50 mL in 1 BOTTLE, GLASS (71919-518-09)

• 71919- Washington Homeopathic Products
  • 71919-518- Pancreatinum
    • 71919-518-10- 100 mL in 1 BOTTLE, GLASS (71919-518-10)