CREON
  • CREON

  • QTY 270 • 36K-114K • CAPSULE DR • Near 77381

PANCRELIPASE (pan cre LI pase) helps to improve digestion of food by replacing digestive enzymes. This medicine is used to treat health conditions that cause your body to produce less of these enzymes.

CREON Pediatric Monographs
  • General Administration Information
    For storage information, see the specific product information within the How Supplied section.

    Route-Specific Administration

    Oral Administration
    -Administer with or immediately prior to meals and snacks.
    -Do not retain preparations in the mouth prior to swallowing because the enzymes can cause mucosal irritation and stomatitis.
    -Follow oral dosage with a glass of water or juice (or formula or breast milk for infants).
    Oral Solid Formulations
    Delayed-release capsules
    -Do not chew or crush to avoid destruction of enteric coating. The enteric coating will dissolve if in prolonged contact with foods having a pH more than 5.5, which may reduce efficacy.
    -For patients unable to swallow whole capsules, the capsules may be opened and the contents administered with soft acidic food (pH 4 or 4.5 or less, e.g., commercially available preparations of bananas, pears, and applesauce). The soft food mixture should be swallowed immediately without chewing. Administer water, juice, or breast milk/formula immediately after the dose to ensure no enzymes remain in the mouth.
    -Do not mix directly with infant formula or breast-milk.

    Tablets
    -Do not chew or crush. Instruct patients to swallow whole.



    Other Administration Route(s)
    Administration via Gastrostomy Tube
    -Administration of pancrelipase products via a gastrostomy tube presents a complex challenge; the risk of clogging the feeding tube must be balanced with the risk of reducing enzyme effectiveness.
    -Consider the feeding tube size, feeding schedule (continuous or intermittent), pancrease product (specifically the size of the microspheres/beads), and other concurrent medications (i.e., medications that suppress gastric acid production) when determining the most appropriate method of administration for a specific patient.

    Pertzye 4,000 USP lipase unit capsules (14 Fr gastrostomy tube or larger; no more than 2 capsules may be administered at a time)
    -Transfer at least 10 mL of applesauce into a small bowl or medicine cup.
    -Mix the capsule contents thoroughly with the transferred applesauce to create a uniform suspension. Do not crush the enzyme microspheres. Use immediately.
    -Remove the plunger from a 35 mL slip tip syringe. While covering the tip of the syringe with a finger, transfer the Pertzye-applesauce mixture into the syringe. Replace the plunger partially back into the syringe.
    -Shake or tap the syringe lightly with the syringe tip facing upward and carefully push the plunger slowly until the residual air is removed.
    -Connect the syringe directly into the gastrostomy tube feeding port and push the syringe contents using steady pressure until empty.
    -Flush the gastrostomy tube with approximately 10 mL of water. Discard any unused portion of the mixture.
    -If dose requires more than 2 capsules, repeat the above steps until the desired dose is achieved.

    Other delayed-release capsules
    -Two main methods of administration have been described: 1.) opening the capsules and mixing the contents with a thickened acidic liquid or thin food (e.g., baby food) and 2.) opening the capsule and dissolving the contents in sodium bicarbonate. These methods have different risks and advantages that must be considered on an individual patient basis.
    -Mixing with thickened liquid (risk: tube occlusion; benefit: maintaining integrity of enteric coating which may preserve efficacy)-Using a mildly thickened liquid as the vehicle is thought to reduce the risk of tube occlusion compared to using water or other thin liquid because a thin liquid allows the enteric-coated microspheres/beads to settle and clump together in the feeding tube.
    -Adequate flushing of the feeding tube before and after administration is critical. If direct contact occurs between the acidic fruit juice and enteral feedings inside the tube, an interaction can occur that may clog the feeding tube.
    -Some dietary experts have proposed the following technique, which can be used for tube sizes 10 Fr and above. However, if sizes 10 Fr or 12 Fr are in place, the use of low-dose enzyme capsules (3,000 to 5,000 units of lipase) are recommended because they contain the smallest sized microspheres/beads.-Prepare 50 to 100 mL of mildly thickened fruit juice using a thickening agent (e.g., Nectar Thick).
    -Open the pancrease capsule(s) into a small clean container.
    -Add sufficient mildly thickened liquid to completely coat the microspheres/beads and stir gently to evenly suspend them in the liquid.
    -If the patient is receiving continuous feedings, stop the tube feeds.
    -Flush the feeding tube with an appropriate amount of water.
    -Draw up the mixture with an enteral syringe of appropriate size for the volume and feeding tube size. Administer the mixture slowly through the feeding tube with slow, gentle pressure.
    -Flush the feeding tube with water, and resume feeds.


    -Mixing with baby food/applesauce (risk: tube occlusion; benefit: maintaining integrity of enteric coating which may preserve efficacy)-In an in vitro study, Creon capsules were opened and the contents sprinkled onto approximately 15 mL of baby food (applesauce or bananas with a pH less than 4.5) per capsule. The mixture was stirred gently and allowed to sit for 15 minutes. The mixture was then administered slowly through various gastrostomy tubes at a rate of about 15 mL per 10 to 15 seconds using a 35 mL syringe. The tube was then flushed with 10 to 30 mL of water.
    -Pancrelipase doses were successfully administered through the following G-tubes: Kimberly-Clark MIC Bolus size 18 Fr and above, Kimberly-Clark MIC-KEY 16 Fr and above, Bard Tri-Funnel 18 Fr and above, and Bard Button 18 Fr and above. The tubes that were sizes smaller than those indicated as having successful administration became clogged with at least one of the baby foods tested. Administration was successful if there was no clogging of the tube and no visible pellet damage.

    -Mixing with sodium bicarbonate solution (risk: reduced efficacy because enteric coat is removed; benefit: lower risk of tube occlusion)-When pancreatic enzyme products are administered into a feeding tube that is placed duodenally or jejunally, some experts recommend opening the capsules, crushing the enteric coated beads, and then mixing with sodium bicarbonate. For each 10,000 units of lipase, 10 mL of 8.4% sodium bicarbonate is recommended. Alternatively, the uncrushed bead/microspheres can be mixed with the sodium bicarbonate and allowed to dissolve (about 20 to 30 minutes). Administer the solution slowly through the feeding tube. Flush the tube with water before and after each dose.
    -Although there is debate about using this method of administration for feeding tubes placed in the stomach because of the risk for enzyme inactivation, some centers use this method to avoid feeding tube occlusion. Monitor efficacy carefully.

    NOTE: While incidences of adverse reactions are reported when provided in the FDA-approved labeling or published literature, the majority of trials were conducted with a small number of patients; therefore, the true incidence of adverse reactions in the larger patient population is unknown.

    Although the relationship to pancrelipase therapy has not been defined, one of the most severe adverse events reported in the FDA-approved product labeling is recurrence of pre-existing carcinoma.

    Gastrointestinal effects are among the most common adverse reactions reported with pancrelipase therapy; however, in several studies, GI effects were more common in patients that received placebo than in those who received pancrelipase. In clinical trials, diarrhea (0-10%), abnormal feces (1-4%), flatulence (3-9%), and abdominal pain (4-18%) were the most common GI effects. However, these are also common signs and symptoms of pancreatic insufficiency and may represent the need for a dosage increase, particularly if accompanied by steatorrhea. Other reported GI effects in patients with cystic fibrosis include: dyspepsia (<= 10%), early satiety (6%), vomiting (6%), nausea, and constipation. Severe or persistent GI symptoms warrant careful evaluation to rule out a more serious condition, such as colonic stricture or distal intestinal obstruction syndrome (DIOS). Ascites and pruritus ani have been reported with the use of pancrelipase tablets (Viokace) in adults with chronic pancreatitis/pancreatectomy.

    Fibrosing colonopathy and distal intestinal obstruction syndrome (DIOS) are two of the most serious adverse events reported in association with pancreatic enzyme replacement therapy (PERT). Fibrosing colonopathy is a rare adverse reaction that has been associated with high doses of pancreatic enzymes taken for prolonged periods and is most commonly reported among pediatric patients with cystic fibrosis. In its most advanced form, fibrosing colonopathy leads to colonic stricture. Consider fibrosing colonopathy in patients who have evidence of GI obstruction, bloody diarrhea, or chylous ascites and in patients who have a combination of abdominal pain with continuing diarrhea, poor weight gain, or both. Patients at highest risk include those who are < 12 years old, have taken > 6000 lipase units/kg/meal for more than 6 months, have a history of meconium ileus or distal intestinal obstruction syndrome (DIOS), have had any intestinal surgery, or have a diagnosis of inflammatory bowel disease. The underlying mechanism of fibrosing colonopathy is unknown and once present, regression is uncertain. In an effort to minimize the risk of fibrosing colonopathy, The Cystic Fibrosis Foundation (CFF) recommends limiting pancreatic enzyme supplementation to <= 2500 lipase units/kg/meal, < 10,000 lipase units/kg/day, and < 4000 lipase units per gram dietary fat per day. In select cases, doses > 2500 lipase units/kg/meal may be warranted; however, these doses should be used cautiously and only with documentation of 3-day fecal fat measures indicating a significantly improved coefficient of absorption.

    Pancrelipase can cause mucosal irritation, oral ulceration, and stomatitis if the enzymes come into direct contact with mucosa; care should be taken with all dosage forms to ensure that no drug is retained in the mouth after administration. Retention of the dosage form in the esophagus could cause esophagitis.The delayed-release capsules contain enteric-coated pancreatic enzymes. If that enteric coating becomes compromised (e.g., by chewing, crushing, or through premature contact with an alkaline environment [pH > 4.5]), the pancreatic enzymes would be more likely to cause mucosal irritation and enzyme efficiency would most likely be reduced. At least 1 case of gastritis and duodenitis of moderate severity has also been reported.

    Large doses of pancrelipase have been associated with hyperuricemia and hyperuricosuria. Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels. Caution is warranted when prescribing pancrelipase to patients with gout, renal impairment, or hyperuricemia.

    Rarely, severe allergic reactions including anaphylactoid reactions, asthma (bronchospasm), hives, pruritus, rash (unspecified), and urticaria have been reported with pancreatic enzyme products. Pancrelipase causes skin rash (maculopapular rash) in a small percentage of patients. This appears to be part of a porcine hypersensitivity reaction to the pork protein in pancrelipase.

    Headache (3-15%) and dizziness (4-6%) are among the most common adverse reactions reported with pancrelipase use and have been associated with multiple products. Other general adverse reactions reported with various products include: contusion (6%), epistaxis (7%), lymphadenopathy (11%), infection (3-11%), cough (4-10%), nasal congestion (14%), naso-pharyngitis (4%), pharyngolaryngeal pain (7%), ear pain (11%), and neck pain (<= 14%). During post-marketing experience, blurred vision, myalgia, and muscle cramps have been reported with at least one formulation.

    Pancreatic enzyme replacement therapy (PERT) may affect glycemic control in patients at risk for abnormal glucose concentrations. In a trial of adult patients with chronic pancreatitis or who had undergone pancreatectomy, 2 of 25 patients experienced hyperglycemia and 1 of 25 patients experienced hypoglycemia. Consider monitoring glucose more closely during pancrelipase therapy in patients with tenuous glycemic control.

    During postmarketing experience, asymptomatic elevated hepatic enzymes have been reported with the Creon brand delayed-release pancrelipase capsules. Anemia, peripheral edema, cholelithiasis, hydro-cholecystitis, and renal cyst have been reported in clinical trials of adults taking pancrelipase tablets for chronic pancreatitis or after pancreatectomy.

    Certain preparations of pancrelipase tablets contain lactose. Administration of such pancrelipase tablets may cause lactose deficiency symptoms such as nausea/vomiting, bloating, abdominal pain (cramps), and flatulence in some patients. Use appropriate precautions when administering to patients with lactose intolerance (lactase deficiency).

    Pancrelipase is produced from porcine pancreatic enzyme concentrate; therefore, it should be used with caution in patients with porcine protein hypersensitivity. Carefully consider the risks and benefits of therapy before continuing treatment in a patient who experiences a hypersensitivity reaction during treatment. Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus, have been reported with some pancreatic enzyme products.

    Fibrosing colonopathy is a rare, serious adverse effect associated with high doses of pancreatic enzyme replacement therapy (PERT). It was initially described in patients taking high doses of pancreatic enzymes for prolonged periods of time, and it is most commonly reported among pediatric patients with cystic fibrosis. In its most advanced form, fibrosing colonopathy leads to colonic stricture. Consider fibrosing colonopathy in patients who have evidence of GI obstruction, bloody diarrhea, or chylous ascites and in patients who have a combination of abdominal pain with continuing diarrhea, poor weight gain, or both. Patients at highest risk include those who are < 12 years old, have taken > 6000 lipase units/kg/meal for more than 6 months, have a history of meconium ileus or distal intestinal obstruction syndrome, have had any intestinal surgery, or have a diagnosis of inflammatory bowel disease. The underlying mechanism of fibrosing colonopathy is unknown and once present, regression is uncertain. In an effort to minimize the risk of fibrosing colonopathy, The Cystic Fibrosis Foundation (CFF) recommends limiting pancreatic enzyme supplementation to <= 2500 lipase units/kg/meal, < 10,000 lipase units/kg/day, and < 4000 lipase units per gram dietary fat per day. In select cases, doses > 2500 lipase units/kg/meal may be warranted; however, these doses should be used cautiously and only with documentation of 3-day fecal fat measures indicating a significantly improved coefficient of absorption.

    Pancrelipase can cause mucosal irritation if the enzymes come into direct contact with mucosa for a prolonged period; care should be taken to ensure that no drug is retained in the mouth after administration. Counsel patients with dysphagia, esophageal stricture, or any other condition that adversely affects swallowing about the risks associated with not completely swallowing the medication. The delayed-release capsules contain enteric-coated pancreatic enzymes to resist inactivation by gastric acid and to release most of the enzymes in the duodenum at a pH greater than 5.5. Therefore, delayed-release capsules should not be crushed, chewed, or mixed in foods having a pH greater than 4 because that could cause premature dissolution of the enteric coating. For patients with difficulty swallowing, the capsules can be opened and the contents added to a small amount of acidic soft food (pH of < 4 or 4.5 depending on the specific product).

    Use pancrelipase with caution in patients with renal impairment, gout, or hyperuricemia. Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels.

    Pancreatic enzyme replacement therapy (PERT) may affect glycemic control in patients at risk for abnormal glucose concentrations (e.g., those with diabetes mellitus). Consider monitoring glucose more closely during pancrelipase therapy in these patients.

    Pancrelipase is sourced from the pancreatic tissue of swine used for food consumption. In order to minimize the risk of viral transmission to humans, certain steps (including testing for and inactivating known viruses) are taken throughout the manufacturing process of pancrelipase. There is, however, a theoretical risk for transmission of a viral infection caused by a novel or unidentified virus. Although there have not been any reported cases of viral transmission associated with the use of porcine pancreatic extracts, the presence of porcine viruses that might infect humans cannot be definitely excluded.

    Description: Pancrelipase is an oral pancreatic enzyme replacement therapy (PERT) used to aid in digesting fats, starches, and proteins in patients with exocrine pancreatic insufficiency. By convention, PERT products are labeled according to the amount of lipase that they contain; however, they also contain amylase and protease derived from porcine pancreatic enzymes. In pediatric patients, cystic fibrosis is the most common cause of pancreatic insufficiency. Pancreatic insufficiency products are not clinically interchangeable and are not considered bioequivalent by the FDA. Prior to 2008, pancreatic enzyme replacement therapies did not require FDA-approval. The FDA decided to require new drug applications (NDAs) for these drug products after reviewing data that showed substantial variations in the formulation, dosage, and manufacturing processes, which affected the potency of the enzymes and could significantly affect safety and effectiveness in the clinical treatment of patients. While these agents are typically well tolerated, maximum dosage recommendations by The Cystic Fibrosis Foundation (CFF) should be adhered to in an effort to minimize the risk of fibrosing colonopathy, a rare but serious adverse effect associated with high doses of PERT for extended periods. Some pancrelipase products are FDA-approved for use in pediatric patients as young as neonates, while other products are only approved for use in older age groups.

    General dosing information:
    -Pancrelipase products are NOT interchangeable. In some cases, the substitution of one product for another has resulted in therapeutic failures and adverse events. Dosage must be individualized according to patient need and response.
    -For patients with cystic fibrosis-In general, the Cystic Fibrosis Foundation (CFF) recommends 500-2500 lipase units per kg body weight per meal. The CFF also recommends limiting the pancrelipase dose to <= 10,000 lipase units per kg per day or < 4000 lipase units per gram dietary fat per day. Exceeding the recommended maximum doses increases the risk of fibrosing colonopathy.
    -In select cases, doses > 2500 lipase units/kg/meal may be warranted; however, these doses should be used cautiously and only with documentation of 3-day fecal fat measures indicating a significantly improved coefficient of absorption.


    For the management of exocrine pancreatic insufficiency, such as in patients with cystic fibrosis, chronic pancreatitis, or other conditions:
    Oral dosage (delayed-release capsules: Creon, Pancreaze, Zenpep):
    Neonates and Infants: 2,600 lipase units per 120 mL formula or per breastfeeding PO for Pancreaze brand. 3,000 lipase units per 120 mL formula or per breastfeeding PO for Creon and Zenpep brands. Do not mix capsule contents directly into formula or breast milk.
    Children 1 to 3 years: Initially, 1,000 lipase units/kg/meal PO. Titrate dosage based on clinical symptoms, steatorrhea, and fat content of diet. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram fat ingested/day. As a general guide, half the mealtime dose should be given with snacks.
    Children and Adolescents 4 years and older: Initially, 500 lipase units/kg/meal PO. Titrate dosage based on clinical symptoms, steatorrhea, and fat content of diet. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram fat ingested/day. As a general guide, half the mealtime dose should be given with snacks.
    Oral dosage (delayed-release capsules: Pertzye):
    Neonates and Infants: 4,000 lipase units per 120 mL formula or per breast-feeding PO. Administer immediately prior to each feeding. Do not mix directly in formula or breast milk.
    Children 1 to 3 years weighing 8 kg or more: Initially, 1,000 lipase units/kg/meal PO. Titrate dosage based on clinical symptoms, steatorrhea, and fat content of diet. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram fat ingested/day. As a general guide, half the mealtime dose should be given with snacks.
    Children and Adolescents 4 years and older weighing 16 kg or more: Initially, 500 lipase units/kg/meal PO. Titrate dosage based on clinical symptoms, steatorrhea, and fat content of diet. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram fat ingested/day. As a general guide, half the mealtime dose should be given with snacks.

    For enteral feeding tube occlusion*:
    Feeding tube administration dosage (pancrelipase tablets):
    Adolescents: In a case series that included some adolescents, 1 Viokase tablet (strength not specified) and one 325-mg sodium bicarbonate tablet were crushed and dissolved in 5 mL of warm water. If a clogged Dobbhoff feeding tube (8 Fr) was not able to be cleared using water, then the pancreatic enzyme/sodium bicarbonate solution was instilled into the clogged tube and clamped for 5 minutes. Then, a 50-mL syringe was attached to the feeding tube using an adapter, and the tube was gently flushed with tap water. This procedure was effective in 72% (23 of 32) of the cases, and the authors state that the clearance rate is even higher if the cause of the obstruction is clotted enteral formula and the pancreatic enzyme solution is applied close to clotted formula using a small catheter. The reported data used a formulation of Viokase tablets that is no longer commercially available. The appropriateness of extrapolating to currently available tablet formulations is unknown.

    Maximum Dosage Limits:
    -Neonates
    Maximum dosage is brand-specific; 2,600 lipase units per 120 mL formula or per breast-feeding for Pancreaze; 3,000 lipase units per 120 mL formula or per breast-feeding for Creon and Zenpep; 4,000 lipase units per 120 mL formula or per breast-feeding for Pertzye; safety and efficacy not established for other brands.
    -Infants
    2,600 lipase units per 120 mL formula or per breast-feeding for Pancreaze; 3,000 lipase units per 120 mL formula or per breast-feeding for Creon and Zenpep; 4,000 lipase units per 120 mL formula or per breast-feeding for Pertzye; do not exceed 4,000 lipase units per gram of ingested fat per day or 10,000 lipase units/kg per day. Safety and efficacy not established for brands not listed.
    -Children
    10,000 lipase units/kg/day or 4,000 lipase units/gram fat ingested/day. Dosages usually don't exceed 2,500 lipase units/kg/meal, but 3,000 lipase units/kg/meal has been recommended for chronic pancreatitis.
    -Adolescents
    10,000 lipase units/kg/day or 4,000 lipase units/gram fat ingested/day. Dosages usually don't exceed 2,500 lipase units/kg/meal, but 3,000 lipase units/kg/meal has been recommended for chronic pancreatitis.

    Patients with Hepatic Impairment Dosing
    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing
    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    *non-FDA-approved indication

    Monograph content under development

    Mechanism of Action: Physiologically, when the pancreas is stimulated, it releases enzymes into the duodenum that facilitate the hydrolysis of fats into glycerol and fatty acids, starches into dextrins and short chain sugars, and proteins into peptides and amino acids. This digestion normally takes place in the duodenum and proximal small intestine. Pancrelipase products provide lipase, amylase, and protease to aid digestion in patients with exocrine pancreatic insufficiency. An alkaline environment is essential for optimal enzyme activity; acidic environments can denature the pancreatic enzymes. In addition to pH, other factors that influence the effectiveness of pancrelipase are dose and the microsphere size of the product.

    Pharmacokinetics: Pancrelipase is administered orally; pancrelipase products are not interchangeable due to differences in pancreatic enzyme contents and release mechanisms. Pancrelipase is excreted in the feces.

    Affected cytochrome P450 isoenzymes: none


    -Route-Specific Pharmacokinetics
    Oral Route
    Pancrelipase is not absorbed after oral administration but exerts its action locally in the GI tract. Enzymatic activity of pancrelipase formulations can show considerable individual variation dependent on gastric pH.

    Delayed-release capsules
    Delayed-release capsules contain enteric-coated microspheres/beads of pancreatic enzymes. Pancreatic enzymes are not stable in an acidic environment. The enteric coating protects the enzymes from gastric acid. Once the microspheres/beads encounter a less acidic environment, the enteric coating dissolves, releasing the enzymes and allowing them to exert their effect. In a normal physiological environment, this occurs in the duodenum; however, if a patient is also taking a medication that significantly raises gastric pH, the enteric coating may be dissolved in the stomach. In general, delayed-release capsules are designed to release the majority of enzymes at a pH of 5.5 or higher.

    Tablets
    Viokace brand tablets are not enteric-coated. Patients should also receive concomitant proton pump inhibitor therapy at doses sufficient to raise the gastric pH to a level high enough to preserve the efficacy of the enzymes. A pH > 5.5 is thought to be sufficient based on data from other formulations.

DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.

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