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Creon Pancrelipase 36000 [USP'U]/1; 180000 [USP'U]/1; 114000 [USP'U]/1 Capsule, Delayed Release Pellets, 250-count
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- The enzymes in pancrelipase only work when there's food for them to digest — so timing really does matter. Even a small snack needs about half your usual meal dose. Skipping doses...
- Why do I have to take this with every meal? Can I skip it if I'm not very hungry?
- Yes, but carefully. You can sprinkle the contents onto a small amount of soft, acidic food like applesauce — just make sure to swallow it right away without chewing. What you absol...
- Can I open the capsule if I have trouble swallowing it?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Pancrelipase (prescription drug) — tap one for details:
Pancrelipase (prescription drug) may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 5C69YCD2YJ
Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
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Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
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Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
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FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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Hypromellose phthalate is a plant-derived polymer coating material. It's used to coat tablets or capsules so the medicine dissolves in the intestines rather than the stomach, protecting it from stomach acid or reducing stomach irritation.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
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A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
13 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $11.975 | $2,993.70 / 250 capsules |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Creon 36000 [USP'U]/1; 180000 [USP'U]/1; 114000 [USP'U]this 00032-3016-28 | AbbVie | 250 capsules | $11.975 | — | FDA listed | — |
| Creon 36000 [USP'U]/1; 180000 [USP'U]/1; 114000 [USP'U] 00032-2637-01 | AbbVie | 100 capsules | $12.671 | — | Availability likely | +6% |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00032-3016-12 | 1 BOTTLE in 1 CARTON (0032-3016-12) / 12 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE | — | — | 2013-03-14 | Active |
| 00032-3016-13 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-3016-13) | $12.67 / ea | $1,267.10 | 2013-03-14 | Active |
| 00032-3016-28 You're viewing this | 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-3016-28) | $11.97 / ea | $2,993.70 | 2013-03-14 | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($11.97 NADAC).
This pack shows little to no recent Medicaid volume — the 100 capsules pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 00032-3016-28?
What is the difference between NDC 00032-3016-28 and NDC 00032-3016-12?
What NDC number is used to bill for this package of Creon Pancrelipase 36000 [USP'U]/1; 180000 [USP'U]/1; 114000 [USP'U]/1 Capsule, Delayed Release Pellets?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE CREON ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) CREON is a mixture of enzymes including lipases, proteases, and amylases, and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion. Individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.
Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation. ( 5.1 ) The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed dose for a meal.
Do not substitute other pancreatic enzyme products for CREON. When switching from another pancreatic enzyme product to CREON, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed. Recommended Dosage ( 2.2 ) Adult and Pediatric Patients Greater than 12 Months : The recommended initial starting dosage is: 500 lipase units/kg/meal for adult and pediatric patients 4 years and older.
500 to 1,000 lipase units/kg/meal for adult patients with chronic pancreatitis or pancreatectomy. 1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years. Titrate the dosage to either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day.
Higher dosages may be administered if documented effective by fecal fat measures or improvement of malabsorption. Pediatric Patients Birth to 12 Months : The recommended dosage is 3,000 lipase units (one capsule) per 120 mL of formula or per breastfeeding. Preparation and Administration Instructions ( 2.3 ) Swallow capsules whole.
For patients unable to swallow intact capsule(s), the capsule contents may be sprinkled on soft acidic food (e.g., applesauce, bananas, plain Greek yogurt). Do not crush or chew CREON capsules or capsule contents. Consume sufficient liquids to ensure complete swallowing of CREON.
( 5.2 ) See the full prescribing information for additional information on administering to pediatric patients birth to 12 months.
2.1Important Dosing Information CREON is a mixture of enzymes including lipases, proteases, and amylases. CREON dosing is based on lipase units. Use either an actual body weight or fat ingestion-based dosing scheme.
Start at the lowest recommended dosage and individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Changes in dosage may require an adjustment period of several days. Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation [see Warnings and Precautions ( 5.1 )] .
The total daily dosage in adult and pediatric patients greater than 12 months of age should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed CREON dose for a meal. Do not substitute other pancreatic enzyme products for CREON.
When switching from another pancreatic enzyme product to CREON, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed.
2.2Recommended Dosage Adult and Pediatric Patients Greater than 12 Months of Age The recommended oral initial starting dosage is: 500 lipase units/kg/meal for adult and pediatric patients 4 years of age and older. 500 to 1,000 lipase units/kg/meal for adult patients with chronic pancreatitis or pancreatectomy. 1,000 lipase units/kg/meal for pediatric patients greater than 12 months to less than 4 years of age.
If signs and symptoms of malabsorption persist, increase the dosage. Titrate to either 2,500 lipase…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Delayed-release capsules are available in the following strengths: 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase in a two-piece capsule with a white opaque cap imprinted with “CREON 1203” and a white opaque body. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase in a two-piece capsule with an orange opaque cap imprinted with “CREON 1206” and a blue opaque body. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase in a two-piece capsule with a brown opaque cap imprinted with “CREON 1212” and a colorless transparent body.
24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase in a two-piece capsule with an orange opaque cap imprinted with “CREON 1224” and a colorless transparent body. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase in a two-piece capsule with a blue opaque cap imprinted with “CREON 1236” and a colorless transparent body. Delayed-Release Capsules ( 3 ): 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Fibrosing C olonopathy : Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease.
Do not exceed the recommended dosage, unless clinically indicated. ( 2.1 , 5.1 ) I rritation of the O ral M ucosa : May occur due to loss of protective enteric coating on the capsule contents. ( 2.3 , 5.2 ) Hyperuricemia: Reported with high dosages; consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia.
( 5.3 ) Risk of Viral Transmission: The presence of porcine viruses that might infect humans cannot be definitely excluded. ( 5.4 ) Hypersensitivity Reactions: Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment.
( 5.5 )
5.1Fibrosing Colonopathy Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with use of high-dose pancreatic enzyme products, usually over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. Pancreatic enzyme products exceeding 6,000 lipase units/kg/meal have been associated with colonic stricture, a complication of fibrosing colonopathy, in pediatric patients less than 12 years of age.
The underlying mechanism of fibrosing colonopathy remains unknown. If there is history of fibrosing colonopathy, monitor patients during treatment with CREON because some patients may be at risk of progressing to colonic stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs.
Do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation . Higher dosages may be administered if they are documented to be effective by fecal fat measures or an improvement in signs or symptoms of malabsorption including measures of nutritional status. Patients receiving dosages higher than 6,000 lipase units/kg/meal should be frequently monitored for symptoms of fibrosing colonopathy and the dosage decreased or titrated downward to a lower range if clinically appropriate [see Dosage and Administration ( 2.1 )] .
5.2Irritation of the Oral Mucosa Crushing or chewing CREON capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity. Instruct the patient or caregiver of the following: Swallow capsules whole. For patients who cannot swallow the capsules whole, the capsules can be opened, and the contents sprinkled in a small amount of acidic soft food with a pH of 4.5 or less (e.g., applesauce, bananas, plain Greek yogurt).
Do not crush or chew CREON capsules or capsule contents. Consume sufficient liquids (juice, water, breast milk, or formula) immediately following administration of CREON to ensure complete swallowing. Visually inspect the mouth of pediatric patients less than 12 months of age and of patients who are unable to swallow intact capsules to ensure no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration ( 2.3 )] .
5.3Hyperuricemia Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia [see Overdosage ( 10 )]. Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperur…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions ( 5.1 )] Irritation of the Oral Mucosa [see Warnings and Precautions ( 5.2 )] Hyperuricemia [see Warnings and Precautions ( 5.3 )] Risk of Viral Transmission [see Warnings and Precautions ( 5.4 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] Most Common Adverse R eactions ( 6.1 ) C ystic fibrosis adult and pediatric patients : 7 years and older (≥4%): vomiting, dizziness, cough.
4 months to 6 years (6%): vomiting, irritability, decreased appetite. C hronic pancreatitis or pancreatectomy patient s: Adults (≥ 4%): hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, nasopharyngitis. To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to CREON in 92 patients: 67 patients aged 4 months to 43 years with exocrine pancreatic insufficiency due to cystic fibrosis (Studies 1, 2, and 3) and 25 adults with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy (Study 4) [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14.1 , 14.2 )] .
Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis in Adult and Pediatric Patients Adult and Pediatric Patients 7 Years of Age and Older The most common adverse reactions, reported in at least 2 CREON-treated patients (greater than or equal to 4%) and at a higher rate than in placebo-treated patients in Studies 1 and 2, are shown in Table 1. Table 1: Adverse Reactions* in Clinical Trials of Adult and Pediatric Patients 7 Years of Age and Older with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis (Studies 1 and 2) Adverse Reaction CREON N = 49 n (%) Placebo N = 47 n (%) Vomiting 3 (6%) 1 (2%) Dizziness 2 (4%) 1 (2%) Cough 2 (4%) 0 (0%) * Reported in at least 2 CREON-treated patients (greater than or equal to 4%) and at a higher rate than placebo-treated patients.
In Study 1, one patient experienced duodenitis and gastritis of moderate severity 16 days after completing treatment with CREON. Transient neutropenia without clinical sequelae was observed as an abnormal laboratory finding in one patient receiving CREON and a macrolide antibiotic. Pediatric Patients 4 Months to 6 Years of Age Adverse reactions reported in 18 CREON-treated pediatric patients aged 4 months to 6 years in Study 3 were vomiting, irritability, and decreased appetite, each occurring in 6% of patients [see Use in Specific Populations ( 8.4 )] .
Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy in Adults Adverse reactions reported in at least 1 adult CREON-treated patient (greater than or equal to 4%) and at a higher rate than in placebo-treated patients in Study 4 is shown in Table 2. Table 2: Adverse Reactions* in a Clinical Trial of Adult Patients with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy (Study 4) Adverse Reaction CREON N = 25 n (%) Placebo N = 29 n (%) Hyperglycemia 2 (8%) 2 (7%) Hypoglycemia 1 (4%) 1 (3%) Abdominal Pain 1 (4%) 1 (3%) Abnormal Feces 1 (4%) 0 (0%) Flatulence 1 (4%) 0 (0%) Frequent Bowel Movements 1 (4%) 0 (0%) Nasopharyngitis 1 (4%) 0 (0%) * Reported in at least 1 CREON-treated patient (greater than or equal to 4%) and at a higher rate than placebo-treated patients.
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of CREON or other pancreatic enzyme products. Because these reactions are repor…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. Animal reproduction studies have not been conducted with pancrelipase.
The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
8.2Lactation Risk Summary There are no data on the presence of pancrelipase in either human or animal milk, the effects on the breastfed infant or the effects on milk production. Pancrelipase is minimally absorbed systemically following oral administration; therefore, maternal use is not expected to result in clinically relevant exposure of breastfed infants to the drug. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CREON and any potential adverse effects on the breastfed infant from CREON or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of CREON for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of CREON for this indication is supported by two adequate and well-controlled trials in adult and pediatric patients 12 years and older (Study 1) and in pediatric patients 7 to 11 years of age (Study 2) along with supportive data from an open-label, single-arm, study in 18 pediatric patients 4 months to six years of age (Study 3). All three study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis.
The safety in pediatric patients 7 years of age and older in Studies 1 and 2 were similar to that observed adult patients [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . In Study 3, patients received their usual pancreatic enzyme replacement therapy (mean dose of 7,000 lipase units/kg/day for a mean duration of 18.2 days) followed by CREON (mean dose of 7,500 lipase units/kg/day for a mean duration of 12.6 days). The mean daily fat intake was 48 grams during treatment with usual pancreatic enzyme replacement therapy and 47 grams during treatment with CREON.
Adverse reactions that occurred in patients during treatment with CREON in Study 3 were vomiting, irritability, and decreased appetite [see Adverse Reactions ( 6.1 )] . Dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. If there is a history of fibrosing colonopathy, monitor patients during treatment with CREON because some patients may be at risk of progressing to stricture formation.
Do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in pediatric patients greater than 12 months of age without further investigation [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] . Crushing or chewing CREON capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity.
Instruct the patient or caregiver of the following: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure no drug is retained in the mo…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. Animal reproduction studies have not been conducted with pancrelipase.
The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of CREON for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. Use of CREON for this indication is supported by two adequate and well-controlled trials in adult and pediatric patients 12 years and older (Study 1) and in pediatric patients 7 to 11 years of age (Study 2) along with supportive data from an open-label, single-arm, study in 18 pediatric patients 4 months to six years of age (Study 3). All three study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis.
The safety in pediatric patients 7 years of age and older in Studies 1 and 2 were similar to that observed adult patients [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . In Study 3, patients received their usual pancreatic enzyme replacement therapy (mean dose of 7,000 lipase units/kg/day for a mean duration of 18.2 days) followed by CREON (mean dose of 7,500 lipase units/kg/day for a mean duration of 12.6 days). The mean daily fat intake was 48 grams during treatment with usual pancreatic enzyme replacement therapy and 47 grams during treatment with CREON.
Adverse reactions that occurred in patients during treatment with CREON in Study 3 were vomiting, irritability, and decreased appetite [see Adverse Reactions ( 6.1 )] . Dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. If there is a history of fibrosing colonopathy, monitor patients during treatment with CREON because some patients may be at risk of progressing to stricture formation.
Do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in pediatric patients greater than 12 months of age without further investigation [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] . Crushing or chewing CREON capsules or mixing the capsule contents in foods having a pH greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity.
Instruct the patient or caregiver of the following: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.2 ) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of CREON did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between patients aged 65 years and over and younger adult patients.
🆘 Overdosage ▾
10 OVERDOSAGE Chronic high dosages of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see Warnings and Precautions ( 5.1 )] . High dosages of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia [see Warnings and Precautions ( 5.3 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Pancreatic enzyme products contain a mixture of lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglyceride, 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.
12.2Pharmacodynamics For patients consuming a high fat diet in the clinical trials, the coefficient of fat absorption (CFA) was higher in patients who received CREON compared to the placebo treatment group, indicating improved fat absorption [see Clinical Studies ( 14.1 , 14.2 )] .
12.3Pharmacokinetics Following oral administration, the lipases, proteases, and amylases released from CREON are not absorbed from the gastrointestinal tract in appreciable amounts. Drug Interactions The lipases, proteases, and amylases of CREON are not substrates of CYP enzymes or transporters. CYP enzymes or transporters mediated drug interactions are not expected.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Pancreatic enzyme products contain a mixture of lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglyceride, 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING CREON (pancrelipase) delayed-release capsules, containing tan-colored enteric-coated pancrelipase spheres, are supplied as follows: Strength Description Supplied As NDC Number 3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase Two-piece hypromellose capsule, white opaque cap imprinted “CREON 1203”, white opaque body Bottles of 70 0032-0045-70 0032-1203-70 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase Two-piece hypromellose capsule, orange opaque cap imprinted “CREON 1206”, blue opaque body Bottles of 100 0032-0046-70 Two-piece gelatin capsule, orange opaque cap imprinted “CREON 1206”, blue opaque body Bottles of 100 0032-1206-01 Bottles of 250 0032-1206-07 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase Two-piece hypromellose capsule, brown opaque cap imprinted “CREON 1212”, colorless transparent body Bottles of 100 0032-0047-70 Two-piece gelatin capsule, brown opaque cap imprinted “CREON 1212”, colorless transparent body Bottles of 100 0032-1212-01 Bottles of 250 0032-1212-07 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase Two-piece hypromellose capsule, orange opaque cap imprinted “CREON 1224”, colorless transparent body Bottles of 100 0032-2636-01 Bottles of 240 0032-2636-70 Two-piece gelatin capsule, orange opaque cap imprinted “CREON 1224”, colorless transparent body Bottles of 100 0032-1224-01 Bottles of 250 0032-1224-07 36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase Two-piece hypromellose capsule, blue opaque cap imprinted “CREON 1236”, colorless transparent body Bottles of 100 0032-2637-01 Bottles of 240 0032-2637-70 Two-piece gelatin capsule, blue opaque cap imprinted “CREON 1236”, colorless transparent body Bottles of 100 0032-3016-13 Bottles of 250 0032-3016-28 Storage and Handling Store CREON at room temperature, 15°C to 25°C (59°F to 77°F), and protect from moisture.
Temperature excursions are permitted between 25°C to 40°C (77°F to 104°F) for up to 30 days. Discard CREON if exposed to higher temperature and moisture conditions higher than 70%. After opening, keep bottle tightly closed between uses to protect from moisture.
Keep the desiccant in the bottle if present . Store and dispense CREON in the original container.
📋 Description ▾
11 DESCRIPTION Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows: 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride.
6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide.
12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide.
36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2.
CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling ( Medication Guide ). Fibrosing Colonopathy Advise the patient or caregiver that fibrosing colonopathy has been reported with high dosages of pancreatic enzyme products, usually with use over a prolonged period of time and in pediatric patients with cystic fibrosis. Colonic stricture has been reported in pediatric patients less than 12 years of age.
Advise patients and caregivers that if signs and symptoms of colon stricture formation occur (e.g., stomach area (abdominal) pain, bloating, trouble passing stool (constipation), nausea, vomiting, diarrhea) to immediately contact their healthcare provider [see Warnings and Precautions ( 5.1 ) ] . Hyperuricemia Advise the patient or caregiver that hyperuricemia may occur in patients with gout or renal impairment and to contact the healthcare provider if they experience pain, stiffness, redness or swelling of their joints [see Warnings and Precautions ( 5.3 )].
Hypersensitivity Reactions Inform the patient or caregiver that severe hypersensitivity reactions, including anaphylaxis, asthma, hives, and pruritus, have been reported with use of pancreatic enzyme products. Seek medical attention if signs or symptoms of a hypersensitivity reaction develop [see Warnings and Precautions ( 5.5 )] . Dos age Advise the patient or caregiver to take or administer CREON as prescribed, and to contact the healthcare provider if signs and symptoms of malabsorption persist [see Dosage and Administration ( 2.2 )] .
Administration Instruct the patient or caregiver as follows: Take CREON during meals and snacks. Swallow capsules whole. For adult and pediatric patients unable to swallow intact capsules, the capsule contents may be sprinkled on a small amount of soft acidic food with a pH of 4.5 or less (e.g., applesauce, bananas, plain Greek yogurt).
For pediatric patients birth to 12 months of age, CREON capsules can also be opened, and the capsule contents sprinkled directly into the infant’s mouth. Consume sufficient liquids (juice, water, breast milk, or formula) and visually inspect an infant’s mouth to ensure complete swallowing of CREON capsules or capsule contents [see Warnings and Precautions ( 5.2 )] . Do not crush or chew CREON capsules or capsule contents.
Do not mix the CREON capsule contents directly into a bottle of breast milk or formula. Storage Instruct the patient or caregiver as follows: Keep CREON in a dry place and protect from heat. After opening, keep the bottle tightly closed between uses to protect from moisture.
Keep CREON in the original container. If there is a desiccant packet in the bottle, keep it in the bottle. Do not eat or throw away the desiccant. © 2009-2024 AbbVie.
All rights reserved. CREON ® is a registered trademark of AbbVie Products LLC. Manufactured by: AbbVie Inc.
North Chicago, IL 60064, U.S.A. US License Number 1889 20082735 February, 2024
💬 Medication Guide ▾
MEDICATION GUIDE CREON® (krē ′ŏn) (pancrelipase) delayed-release capsules, for oral use What is the most important information I should know about CREON? CREON may increase your chance of having a rare bowel disorder called fibrosing colonopathy especially if taken at a high dose for a long time in children with cystic fibrosis. This condition is serious and may require surgery.
The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you. Call your healthcare provider right away if you have any unusual or severe: stomach area (abdominal) pain bloating trouble passing stool (having bowel movements) nausea, vomiting, or diarrhea Take CREON exactly as prescribed. Do not take more or less CREON than directed by your healthcare provider.
What is CREON? CREON is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes. CREON contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.
CREON is safe and effective in adults and children. Before you tak e CREON, tell your healthcare provider about all your medical conditions, including if you: are allergic to pork (pig) products. have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy). have gout, kidney disease, or high blood uric acid (hyperuricemia). have trouble swallowing capsules. have any other medical condition. are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed.
It is not known if CREON passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take CREON. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take CREON?
Take CREON exactly as your healthcare provider tells you. Contact your healthcare provider if you continue to have signs and symptoms of malabsorption (not absorbing nutrients from food) such as abdominal pain, abdominal distention, bloating, fatty stools, or weight loss. Your dose may need to be changed.
You should not switch CREON with any other pancreatic enzyme product without first talking to your healthcare provider. Do not take more capsules in a day than the number your healthcare provider tells you to take (total daily dose). Always take CREON with a meal or snack and enough liquid (water, juice, breast milk, or formula) to swallow CREON completely.
If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose. Your healthcare provider may change your dose based on the amount of fatty foods you eat or based on your weight. CREON capsules should be swallowed whole.
Do not crush or chew CREON capsules or its contents, and do not hold the capsule or capsule contents in your mouth. Crushing, chewing or holding the CREON capsules in your mouth may cause irritation in your mouth or change the way CREON works in your body. Giving CREON to A dults and C hildren O lder than 12 M onths of Age Swallow CREON capsules whole without crushing or chewing them.
If you have trouble swallowing capsules: Carefully open the capsules and sprinkle the entire contents on small amounts of acidic soft food such as applesauce, bananas, or plain Greek yogurt. Ask your healthcare provider about other foods you can use. Mix the capsule contents with the soft food.
Do not crush the contents. Swallow the mixture right away. Do not save it for later use.
Drink enough water or juice right away to make sure the medicine is swallowed completely. If you forget to take CREON, call your healthcare provider or wait until your next meal and take your usual number of capsules. Take your next dose at your usual t…