Creon

Drug overview for CREON (lipase/protease/amylase):

Generic name: LIPASE/PROTEASE/AMYLASE (PAN-kree-LYE-pase)
Drug class: Digestive Enzymes
Therapeutic class: Gastrointestinal Therapy Agents

Pancrelipase, a substance containing enzymes (principally lipase, with amylase and protease), is a digestant.

Pancrelipase is used as replacement therapy in the symptomatic treatment of malabsorption syndrome caused by established pancreatic insufficiency of organic origin, as in cystic fibrosis of the pancreas, chronic pancreatitis, pancreatectomy, GI bypass surgery (e.g., Billroth II gastroenterostomy), cancer of the pancreas, or other conditions in which pancreatic insufficiency impairs fat digestion. Pancreatic exocrine replacement therapy should not delay or supplant treatment of the primary disorder. Although pancrelipase has been used in treating steatorrhea of postgastrectomy syndrome and bowel resection, pancreatic extracts are less likely to be effective in this condition and in cases of malabsorption associated with ileitis, tuberculosis, or lymphomas.

Pancrelipase is not effective in the treatment of functional digestive disorders unrelated to pancreatic insufficiency. Pancrelipase may be used as a presumptive test for pancreatic funtion (e.g., pancreatic insufficiency associated with chronic pancreatitis).

DRUG IMAGES

CREON DR 12,000 UNIT CAPSULE
CREON DR 24,000 UNIT CAPSULE
CREON DR 6,000 UNIT CAPSULE
CREON DR 36,000 UNIT CAPSULE
CREON DR 3,000 UNIT CAPSULE

The following indications for CREON (lipase/protease/amylase) have been approved by the FDA:

Indications:
Exocrine pancreatic insufficiency

Professional Synonyms:
None.

The following dosing information is available for CREON (lipase/protease/amylase):

Dosing
Administration
CREON
Generic

Dosage of pancrelipase depends on the condition being treated and the digestive requirements as related to the diet of the patient. Considerable variation in dosage exists, in part, because of the susceptibility of pancrelipase to acid-peptic inactivation of enzyme activity in the stomach and duodenum. Delayed-release preparations (i.e., capsules containing enteric-coated spheres, microspheres, or microtablets of the drug) are reportedly less susceptible to acid-peptic inactivation since they are designed to disintegrate at a relatively high GI pH (e.g., greater than 5.5-6).

Concomitant administration of conventional pancrelipase preparations and antacids or a histamine H2-receptor antagonist (e.g., cimetidine) has been used to decrease the inactivation of enzyme activity.

It has been suggested that pancrelipase dosage be determined by the fat content of the diet and that approximately 8000 USP units of lipase activity be given for each 17 g of dietary fat. The usual initial adult dosage of pancrelipase is approximately 4000-33,000 USP units of lipase activity before or with each meal or snack. Dosage may be increased as necessary and then reduced as symptomatic improvement occurs.

For the treatment of severe deficiency, one manufacturer states that the dose may be increased to 88,000 USP units of lipase activity with each meal or the dosing interval may be increased to hourly if necessary and if nausea, cramping, and/or diarrhea do not occur.

Dosage for children younger than 6 months of age has not been established. Children 6 months to younger than 1 year of age have responded to 2000 USP units of lipase activity given with each meal. Children 1 to younger than 7 years of age may receive 4000-8000 USP units of lipase activity with each meal and 4000 USP units of lipase with each snack.

Children younger than 6 years of age receiving the delayed-release capsules may receive 5000-10,000 USP units of lipase activity with each meal or snack. Children 7-12 years of age have received 4000-12,000 USP units of lipase activity with each meal or snack; this dosage may be increased if needed. Children 6 years of age and older receiving the delayed-release capsules may receive an initial dosage of 10,000-20,000 USP units of lipase activity with each meal or snack.

Growth curves have been used as end points to aid in the assessment of response in children.

When used for symptomatic treatment of malabsorption syndrome caused by cystic fibrosis in children younger than 6 years of age, pancrelipase may be given at a dosage of 1500-3000 USP units of lipase activity per kg per meal (units/kg per meal). Dosage should be adjusted according to severity of disease, control of steatorrhea, and nutritional status. Doses exceeding 6000 USP units of lipase activity per kg per meal (units/kg per meal) are not recommended.

If dosage needs to be increased, body weight and stool fat content should be monitored carefully. If the patient is switched to a pancrelipase preparation of different strength, care should be taken to ensure that the new regimen provides an equivalent number of lipase units per dose.

Pancrelipase is administered orally with meals or snacks. Pancrelipase delayed-release capsules containing enteric-coated spheres, microspheres, or microtablets may be opened and the contents administered with liquids or mixed with soft food; care should be taken so that the powder is not inhaled. Following administration, the patient should drink a glass of water or juice to ensure that the spheres or microtablets are swallowed.

To avoid destruction of the enteric coating, the contents should not be chewed or crushed. Contact with food that has a pH greater than 5.5-6 will dissolve the enteric coating. Patients receiving pancreatic enzymes should be adequately hydrated.

Dosing information for CREON
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
CREON DR 3,000 UNIT CAPSULE	Maintenance	Adults take 1 capsule by oral route 3 times per day with meals and 1 capsule with each snack swallowing whole. Do not crush, chew and/or divide.
CREON DR 6,000 UNIT CAPSULE	Maintenance	Adults take 4 capsules by oral route 3 times per day with meals and 2 capsules with each snack
CREON DR 12,000 UNIT CAPSULE	Maintenance	Adults take 2 capsules by oral route 3 times per day with meals and 1 capsule with each snack
CREON DR 24,000 UNIT CAPSULE	Maintenance	Adults take 1 capsule by oral route 3 times per day with meals and 1 capsule with each snack swallowing whole. Do not crush, chew and/or divide.
CREON DR 36,000 UNIT CAPSULE	Maintenance	Adults take 1 capsule by oral route 3 times per day with meals and 1 capsule with each snack swallowing whole. Do not crush, chew and/or divide.

No generic dosing information available.

The following drug interaction information is available for CREON (lipase/protease/amylase):

Contraindicated
Severe
Moderate

There are 1 contraindications. These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.

Drug Interaction	Drug Names
Acarbose; Miglitol/Amylase; Pancreatin SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Digestive enzyme preparations such as amylase or pancreatin may break down acarbose(1) and miglitol.(2) CLINICAL EFFECTS: The concurrent administration digestive enzyme preparations such as amylase or pancreatin may decrease the effectiveness of acarbose(1) and miglitol.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of acarbose states that digestive enzymes such as amylase or pancreatin should not be taken concomitantly with acarbose.(1) The manufacturer of miglitol states that digestive enzymes such as amylase or pancreatin should not be taken concomitantly with miglitol.(2) DISCUSSION: Because digestive enzyme preparations such as amylase or pancreatin may break down acarbose(1) and miglitol(2) and decrease their effectiveness, the manufacturer of acarbose(1) and miglitol(2) state they should not be taken concomitantly with these agents.	ACARBOSE, MIGLITOL, PRECOSE

Drug Interaction

Drug Names

Acarbose; Miglitol/Amylase; Pancreatin

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Digestive enzyme preparations such as amylase or pancreatin may break down acarbose(1) and miglitol.(2)

CLINICAL EFFECTS: The concurrent administration digestive enzyme preparations such as amylase or pancreatin may decrease the effectiveness of acarbose(1) and miglitol.(2)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of acarbose states that digestive enzymes such as amylase or pancreatin should not be taken concomitantly with acarbose.(1) The manufacturer of miglitol states that digestive enzymes such as amylase or pancreatin should not be taken concomitantly with miglitol.(2)

DISCUSSION: Because digestive enzyme preparations such as amylase or pancreatin may break down acarbose(1) and miglitol(2) and decrease their effectiveness, the manufacturer of acarbose(1) and miglitol(2) state they should not be taken concomitantly with these agents.

ACARBOSE, MIGLITOL, PRECOSE

There are 0 severe interactions.

There are 0 moderate interactions.

The following contraindication information is available for CREON (lipase/protease/amylase):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 0 contraindications.

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Gastrointestinal obstruction
Meconium ileus

There are 6 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Crohn's disease
Fibrosing colonopathy
Gastrointestinal tract surgery
Gout
Hyperuricemia
Short bowel syndrome

The following adverse reaction information is available for CREON (lipase/protease/amylase):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 8 severe adverse reactions.

More Frequent	Less Frequent
None.	Abdominal pain with cramps

Rare/Very Rare
Biliary calculus Diarrhea Disorder of the digestive system Fibrosing colonopathy Gastrointestinal obstruction Hyperuricemia Nausea

There are 9 less severe adverse reactions.

More Frequent	Less Frequent
None.	Abdominal distension Cough Dizziness Flatulence Headache disorder

Rare/Very Rare
Pruritus ani Pruritus of skin Skin rash Urticaria

The following precautions are available for CREON (lipase/protease/amylase):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Although there are no adequate and controlled studies to date in humans, diethylphthalate, a component of the enteric coating of Pancrease(R) and Pancrecarb(R) microspheres, has been shown to be teratogenic in rats when administered intraperitoneally in high doses; no teratogenic or embryocidal effects were observed in rats when given up to 100 times the usual human dose of the coating orally. Pancrease(R), Pancrease(R) MT, Pancrecarb(R), or Viokase(R) should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

No enhanced Lactation information available for this drug.

No enhanced Geriatric Use information available for this drug.

Exocrine pancreatic insufficiency
K86.81	Exocrine pancreatic insufficiency
K90.3	Pancreatic steatorrhea