Creon


Also found in: Dictionary, Thesaurus, Acronyms, Encyclopedia, Wikipedia.

pancrelipase

Creon, Pancreaze, Ultresa, Viokace, Zenpep

Pharmacologic class: Pancreatic enzyme

Therapeutic class: Digestant

Pregnancy risk category C

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.

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.

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

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.

pancrelipase

(pan-kre-li-pase) ,

Creon

(trade name),

Pancrease-V

(trade name),

Pancreaze

(trade name),

Pertyze

(trade name),

Ultresa

(trade name),

Viokace

(trade name),

Zenpep

(trade name)

Classification

Therapeutic: digestive agent
Pharmacologic: pancreatic enzymes
Pregnancy Category: C

Indications

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

Action

Contains lipolytic, amylolytic, and proteolytic activity.

Therapeutic effects

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

Pharmacokinetics

Absorption: Unknown.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (digestant effects)

ROUTEONSETPEAKDURATION
POrapidunknownunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity to hog proteins.
Use Cautiously in: Gout, renal impairment, or hyperuricemia (may ↑ uric acid levels); Obstetric / Lactation: Safety not established.

Adverse Reactions/Side Effects

Ear, Eye, Nose, Throat

  • nasal stuffiness

Respiratory

  • dyspnea
  • shortness of breath
  • wheezing

Gastrointestinal

  • fibrosing colonopathy (high doses only) (life-threatening)
  • abdominal pain (high doses only) (most frequent)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • stomach cramps (most frequent)
  • oral irritation

Genitourinary

  • hematuria

Dermatologic

  • hives
  • rash

Metabolic

  • hyperuricemia

Miscellaneous

  • allergic reactions

Interactions

Drug-Drug interaction

Antacids (calcium carbonate or magnesium hydroxide ) may ↓ effectiveness of pancrelipase.May ↓ the absorption of concurrently administered iron supplements.Alkaline foods destroy coating on enteric-coated products.

Route/Dosage

Oral (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).
Oral (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).
Oral (Children ≤1 yr) 2000–4000 lipase units per 120 mL of formula or breast milk.

Availability (generic available)

Delayed-release capsules: 3000 units lipase/9500 units protease/15,000 units amylase, 4000 units lipase/12,000 units protease and amylase, 4200 units lipase/10,000 units protease/17,500 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 and amylase, 10,000 units lipase/30,000 units protease and amylase, 10,000 units lipase/34,000 units protease/55,000 units amylase, 10,440 units lipase/39,150 units protease/39,150 units amylase, 10,500 units lipase/25,000 units protease/43,750 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, 20,000 units lipase/44,000 units protease/56,000 units amylase, 20,000 units lipase/55,000 units protease and 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, 20,880 units lipase/78,300 units protease/78,300 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

Nursing implications

Nursing assessment

  • 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.
  • Lab Test Considerations: May cause ↑ serum and urine uric acid concentrations.

Potential Nursing Diagnoses

Imbalanced nutrition: less than body requirements (Indications)

Implementation

    • Pancreaze is not interchangerable with any other pancrelipase product.
  • Oral: Administer immediately before or with meals and snacks.
    • 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 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 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 minutes. Contents of the capsule may also be administered directly to the mouth. Follow administration with breast milk or formula.
    • 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.
    • Do not chew or retain Ultressa capsule in mouth.

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 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 notify health care professional if symptoms of fibrosing colonopathy (abdominal pain, distention, vomiting, constipation) occur. 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 years.
  • Instruct patient to notify health care professional if joint pain, swelling of legs, gastric distress, or rash occurs.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected, or if breast feeding.

Evaluation/Desired Outcomes

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

Creon

A brand name for PANCREATIN.
Mentioned in ?
References in periodicals archive ?
There is a further irony in the surprising representation of Creon as a black servant of apartheid masters.
Although some critics have, often rather tenuously, identified the national question as the key issue in Kennelly's Antigone, it is my view that the defiance of his Antigone in the 1980s instead embodies a challenge to the inflexible clericalism that Creon represents, to both the Catholic Church and the Irish 'moral majority'.
Held up by 3lb claiming conditional rider Liam Cooper, the tactics were slightly overdone as Creon could not quite peg back Unlimited Free and was a neck down at the line.
He was held up by 3lb claiming conditional rider Liam Cooper that day but Creon could not quite peg back Unlimited Free and was a neck down at the line.
Creon, their uncle, now king of Thebes, buried Eteocles with full honors as defender of the city.
Of course Creon will not let the sister off lightly, and orders that she be buried alive.
Important Safety Information CREON may increase the chance of having a rare bowel disorder called fibrosing colonopathy.
He said: "I have to take my hat off to Surrey and to what Creon has done this season.
Pericles' tightness with money and hatred of corruption "probably lies somewhere behind Sophocles' portrayal of Creon [in Antigone] as mean-minded and as one who naturally assumes .
The main differences between the new and old versions of Creon is that the capsules containing the new formulation will no longer be "overfilled," and will contain the exact amount if lipase listed in the product's label, a spokesperson for Solvay said.
TEES Valley Mohawks have begun to rebuild for the new season following the announcement that Tony Hanson will replace Creon Raftopoulos as head coach.
Now he has been ordered to report to police in Portimao on Monday with a list of his clients - although his fortress-style Creon Starlight furnaces were supposed to be closed down from last February after neighbours complained about the smell.