Creon (Pancrelipase Capsules)
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Creon (Pancrelipase Capsules)

CREON
(pancrelipase)

DRUG DESCRIPTION

CREON is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases.

Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether.

Each delayed-release capsule for oral administration contains enteric-coated spheres (0.71–1.60 mm in diameter).

The active ingredient evaluated in clinical trials is lipase. CREON is dosed by lipase units.

Other active ingredients include protease and amylase.

CREON contains the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.

3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase capsules have a white opaque cap with imprint “CREON 1203” and a white opaque body. The shells contain titanium dioxide and hypromellose.

6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase capsules have a Swedish-orange opaque cap with imprint “CREON 1206” and a blue opaque body. The shells contain FD&C Blue No. 2, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.

12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase capsules have a brown opaque cap with imprint “CREON 1212” and a colorless transparent body. The shells contain black iron oxide, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.

24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase capsules have a Swedish-orange opaque cap with imprint “CREON 1224” and a colorless transparent body. The shells contain gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.

What are the possible side effects of pancrelipase?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

  • nausea or vomiting;
  • mild stomach pain or upset;
  • diarrhea or constipation;
  • bloating or gas.
  • greasy stools;
  • rectal irritation;
  • headache, dizziness;
  • cough; or
  • weight...

Read All Potential Side Effects and See Pictures of Creon »

What are the precautions when taking pancrelipase capsules (Creon)?

Before taking pancrelipase, tell your doctor or pharmacist if you are allergic to it; or to pork protein; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: gout, kidney disease, high uric acid level in the blood (hyperuricemia), intestinal problems (such as blockage).

This drug may...

Read All Potential Precautions of Creon »

Last reviewed on RxList: 6/23/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

CREON® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.

DOSAGE AND ADMINISTRATION

CREON is not interchangeable with other pancrelipase products.

CREON is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of CREON should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet as described in the Limitations on Dosing below [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Administration

Infants (up to 12 months)

CREON should be administered to infants immediately prior to each feeding, using a dosage of 3,000 lipase units per 120 mL of formula or prior to breast-feeding. Contents of the capsule may be administered directly to the mouth or with a small amount of applesauce. Administration should be followed by breast milk or formula. Contents of the capsule should not be mixed directly into formula or breast milk as this may diminish efficacy. Care should be taken to ensure that CREON is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa.

Children and Adults

CREON should be taken during meals or snacks, with sufficient fluid. CREON capsules and capsule contents should not be crushed or chewed. Capsules should be swallowed whole.

For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents added to a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, at room temperature. The CREON-soft food mixture should be swallowed immediately without crushing or chewing, and followed with water or juice to ensure complete ingestion. Care should be taken to ensure that no drug is retained in the mouth.

Dosage

Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences.1, 2, 3 CREON should be administered in a manner consistent with the recommendations of the Cystic Fibrosis Foundation Consensus Conferences (also known as Conferences) provided in the following paragraphs, except for infants. Although the Conferences recommend doses of 2,000 to 4,000 lipase units in infants up to 12 months, CREON is available in a 3,000 lipase unit capsule. Therefore, the recommended dose of CREON in infants up to 12 months is 3,000 lipase units per 120 mL of formula or per breast-feeding. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.

Additional recommendations for pancreatic enzyme therapy in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy are based on a clinical trial conducted in these populations.

Infants (up to 12 months)

CREON is available in the strength of 3,000 USP units of lipase thus infants may be given 3,000 lipase units (one capsule) per 120 mL of formula or per breast-feeding. Do not mix CREON capsule contents directly into formula or breast milk prior to administration [see Administration].

Children Older than 12 Months and Younger than 4 Years

Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 Years and Older and Adults

Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Usually, half of the prescribed CREON 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.

Enzyme doses expressed as lipase units/kg of body weight per meal should be decreased in older patients because they weigh more but tend to ingest less fat per kilogram of body weight.

Adults with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy

The initial starting dose and increases in the dose per meal should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.

In one clinical trial, patients received CREON at a dose of 72,000 lipase units per meal while consuming at least 100 g of fat per day [see Clinical Studies]. Lower starting doses recommended in the literature are consistent with the 500 lipase units/kg of body weight per meal lowest starting dose recommended for adults in the Cystic Fibrosis Foundation Consensus Conferences Guidelines.1, 2, 3, 4 Usually, half of the prescribed CREON dose for an individualized full meal should be given with each snack.

Limitations on Dosing

Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.1, 2, 3 If symptoms and signs of steatorrhea persist, the dosage may be increased by the healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in response to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted. Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture, indicative of fibrosing colonopathy, in children less than 12 years of age [see WARNINGS AND PRECAUTIONS]. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

HOW SUPPLIED

Dosage Forms And Strengths

The active ingredient in CREON evaluated in clinical trials is lipase. CREON is dosed by lipase units.

Other active ingredients include protease and amylase. Each CREON capsule strength contains the specified amounts of lipase, protease, and amylase as follows:

  • 3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase capsules have a white opaque cap with imprint “CREON 1203” and a white opaque body.
  • 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase capsules have an orange opaque cap with imprint “CREON 1206” and a blue opaque body.
  • 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase capsules have a brown opaque cap with imprint “CREON 1212” and a colorless transparent body.
  • 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase capsules have an orange opaque cap with imprint “CREON 1224” and a colorless transparent body.
CREON (pancrelipase) Delayed-Release Capsules

3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase

Each CREON capsule is available as a two-piece hypromellose capsule with a white opaque cap with imprint “CREON 1203” and a white opaque body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:

70 capsules (NDC 0032-1203-70)

CREON (pancrelipase) Delayed-Release Capsules

6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase

Each CREON capsule is available as a two-piece gelatin capsule with orange opaque cap with imprint “CREON 1206” and a blue opaque body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:

100 capsules (NDC 0032-1206-01)
250 capsules (NDC 0032-1206-07)

CREON (pancrelipase) Delayed-Release Capsules

12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase

Each CREON capsule is available as a two-piece gelatin capsule with a brown opaque cap with imprint “CREON 1212” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:

100 capsules (NDC 0032-1212-01)
250 capsules (NDC 0032-1212-07)

CREON (pancrelipase) Delayed-Release Capsules

24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase

Each CREON capsule is available as a two-piece gelatin capsule with orange opaque cap with imprint “CREON 1224” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:

100 capsules (NDC 0032-1224-01)
250 capsules (NDC 0032-1224-07)

Storage and Handling

CREON must be stored at room temperature up to 25°C (77°F) and protected from moisture. Temperature excursions are permitted between 25°C to 40°C (77°F and 104°F) for up to 30 days. Product should be discarded if exposed to higher temperature and moisture conditions higher than 70%. After opening, keep bottle tightly closed between uses to protect from moisture.

Bottles of CREON 3,000 USP units of lipase must be stored and dispensed in the original container.

Do not crush CREON delayed-release capsules or the capsule contents.

REFERENCES

1 Borowitz DS, Grand RJ, Durie PR, et al. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Journal of Pediatrics. 1995; 127: 681-684.

2 Borowitz DS, Baker RD, Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. Journal of Pediatric Gastroenterology Nutrition. 2002 Sep; 35: 246-259.

3 Stallings VA, Stark LJ, Robinson KA, et al. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. Journal of the American Dietetic Association. 2008; 108: 832-839.

4 Dominguez-Munoz JE. Pancreatic enzyme therapy for pancreatic exocrine insufficiency. Current Gastroenterology Reports. 2007; 9: 116-122.

Manufactured y: Abbott Products Gmbh Hannover, Germany. Marketed By: Abbott Laboratories, North Chicago, IL 60064, U.S.A. Revised: June 2011

Last reviewed on RxList: 6/23/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy, hyperuricemia and allergic reactions [see WARNINGS AND PRECAUTIONS].

Clinical 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 short-term safety of CREON was assessed in clinical trials conducted in 103 patients with exocrine pancreatic insufficiency (EPI): 49 patients with EPI due to cystic fibrosis (CF) and 25 patients with EPI due to chronic pancreatitis or pancreatectomy were treated with CREON.

Cystic Fibrosis

Studies 1 and 2 were randomized, double-blind, placebo-controlled, crossover studies of 49 patients, ages 7 to 43 years, with EPI due to CF. Study 1 included 32 patients ages 12 to 43 years and Study 2 included 17 patients ages 7 to 11 years. In these studies, patients were randomized to receive CREON at a dose of 4,000 lipase units/g fat ingested per day or matching placebo for 5 to 6 days of treatment, followed by crossover to the alternate treatment for an additional 5 to 6 days. The mean exposure to CREON during these studies was 5 days.

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.

In Study 2, adverse reactions that occurred in at least 2 patients (greater than or equal to 12%) treated with CREON were vomiting and headache. Vomiting occurred in 2 patients treated with CREON and did not occur in patients treated with placebo; headache occurred in 2 patients treated with CREON and did not occur in patients treated with placebo.

The most common adverse reactions (greater than or equal to 4%) were vomiting, dizziness, and cough. Table 1 enumerates adverse reactions that occurred in at least 2 patients (greater than or equal to 4%) treated with CREON at a higher rate than with placebo in Studies 1 and 2.

Table 1: Adverse Reactions Occurring in at Least 2 Patients (greater than or equal to 4%) in Cystic Fibrosis (Studies 1 and 2)

Adverse Reaction CREON Capsules
n = 49 (%)
Placebo
n = 47 (%)
Vomiting 3 (6) 1 (2)
Dizziness 2 (4) 1 (2)
Cough 2 (4) 0

Chronic Pancreatitis or Pancreatectomy

Study 3 was a randomized, double-blind, placebo-controlled, parallel group study of 54 adult patients, ages 32 to 75 years, with EPI due to chronic pancreatitis or pancreatectomy. Patients received single-blind placebo treatment during a 5-day run-in period followed by an intervening period of up to 16 days of investigator-directed treatment with no restrictions on pancreatic enzyme replacement therapy. Patients were then randomized to receive CREON or matching placebo for 7 days. The CREON dose was 72,000 lipase units per main meal (3 main meals) and 36,000 lipase units per snack (2 snacks). The mean exposure to CREON during this study was 6.8 days in the 25 patients that received CREON.

The most common adverse reactions reported during the study were related to glycemic control and were reported more commonly during CREON treatment than during placebo treatment.

Table 2 enumerates adverse reactions that occurred in at least 1 patient (greater than or equal to 4%) treated with CREON at a higher rate than with placebo in Study 3.

Table 2: Adverse Reactions in at least 1 Patient (greater than or equal to 4%) in Chronic Pancreatitis or Pancreatectomy (Study 3)

Adverse Reaction CREON Capsules
n = 25 (%)
Placebo
n = 29 (%)
Hyperglycemia 2 (8) 2 (7)
Hypoglycemia 1 (4) 1 (3)
Abdominal Pain 1 (4) 1 (3)
Abnormal Feces 1 (4) 0
Flatulence 1 (4) 0
Frequent Bowel Movements 1 (4) 0
Nasopharyngitis 1 (4) 0

Postmarketing Experience

Postmarketing data from this formulation of CREON have been available since 2009. The following adverse reactions have been identified during post approval use of this formulation of CREON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders (including abdominal pain, diarrhea, flatulence, constipation and nausea), skin disorders (including pruritus, urticaria and rash), blurred vision, myalgia, muscle spasm, and asymptomatic elevations of liver enzymes have been reported with this formulation of CREON.

Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature. The most serious adverse reactions included fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS), recurrence of pre-existing carcinoma, and severe allergic reactions including anaphylaxis, asthma, hives, and pruritus.

Read the Creon (pancrelipase capsules) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No drug interactions have been identified. No formal interaction studies have been conducted.

Last reviewed on RxList: 6/23/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Fibrosing Colonopathy

Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products.5,6 Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture in children less than 12 years of age.1 Patients with fibrosing colonopathy should be closely monitored because some patients may be at risk of progressing to stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs.1 It is generally recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/kg of body weight per meal (or less than 10,000 lipase units/kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day [see DOSAGE AND ADMINISTRATION].

Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Patients receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

Potential for Irritation to Oral Mucosa

Care should be taken to ensure that no drug is retained in the mouth. CREON should not be crushed or chewed or mixed in foods having a pH greater than 4.5. These actions can disrupt the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity [see DOSAGE AND ADMINISTRATION and PATIENT INFORMATION]. For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents added to a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, at room temperature. The CREON-soft food mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion.

Potential for Risk of Hyperuricemia

Caution should be exercised when prescribing CREON to patients with gout, renal impairment, or hyperuricemia. Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels.

Potential Viral Exposure from the Product Source

CREON is sourced from pancreatic tissue from swine used for food consumption. Although the risk that CREON will transmit an infectious agent to humans has been reduced by testing for certain viruses during manufacturing and by inactivating certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Thus, the presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.

Allergic Reactions

Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus, have been reported with other pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase). The risks and benefits of continued CREON treatment in patients with severe allergy should be taken into consideration with the overall clinical needs of the patient.

Patient Counseling Information

[See Medication Guide]

Dosing and Administration

  • Instruct patients and caregivers that CREON should only be taken as directed by their healthcare professional. Patients should be advised that the total daily dose should not exceed 10,000 lipase units/kg body weight/day unless clinically indicated. This needs to be especially emphasized for patients eating multiple snacks and meals per day. Patients should be informed that if a dose is missed, the next dose should be taken with the next meal or snack as directed. Doses should not be doubled [see DOSAGE AND ADMINISTRATION].
  • Instruct patients and caregivers that CREON should always be taken with food. Patients should be advised that CREON delayed-release capsules and the capsule contents must not be crushed or chewed as doing so could cause early release of enzymes and/or loss of enzymatic activity. Patients should swallow the intact capsules with adequate amounts of liquid at mealtimes. If necessary, the capsule contents can also be sprinkled on soft acidic foods [see DOSAGE AND ADMINISTRATION].

Fibrosing Colonopathy

Advise patients and caregivers to follow dosing instructions carefully, as doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures in children below the age of 12 years [see DOSAGE AND ADMINISTRATION].

Allergic Reactions

Advise patients and caregivers to contact their healthcare professional immediately if allergic reactions to CREON develop [see WARNINGS AND PRECAUTIONS].

Pregnancy and Breast Feeding

  • Instruct patients to notify their healthcare professional if they are pregnant or are thinking of becoming pregnant during treatment with CREON [see Use in Specific Populations].
  • Instruct patients to notify their healthcare professional if they are breast feeding or are thinking of breast feeding during treatment with CREON [see Use In Specific Populations].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed.

Use In Specific Populations

Pregnancy

Teratogenic effects

Pregnancy Category C: Animal reproduction studies have not been conducted with pancrelipase. It is also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CREON should be given to a pregnant woman only if clearly needed. The risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. Adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. Reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CREON is administered to a nursing woman. The risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a nursing mother with exocrine pancreatic insufficiency.

Pediatric Use

The short-term safety and effectiveness of CREON were assessed in two randomized, double-blind, placebo-controlled, crossover studies of 49 patients with exocrine pancreatic insufficiency due to cystic fibrosis, 25 of whom were pediatric patients. Study 1 included 8 adolescents between 12 and 17 years of age. Study 2 included 17 children between 7 and 11 years of age. The safety and efficacy in pediatric patients in these studies were similar to adult patients [see ADVERSE REACTIONS and Clinical Studies].

The safety and efficacy of pancreatic enzyme products with different formulations of pancrelipase consisting of the same active ingredient (lipases, proteases, and amylases) for treatment of children with exocrine pancreatic insufficiency due to cystic fibrosis have been described in the medical literature and through clinical experience.

Dosing of pediatric patients should be in accordance with recommended guidance from the Cystic Fibrosis Foundation Consensus Conferences [see DOSAGE AND ADMINISTRATION]. Doses of other pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with fibrosing colonopathy and colonic strictures in children less than 12 years of age [see WARNINGS AND PRECAUTIONS].

REFERENCES

1 Borowitz DS, Grand RJ, Durie PR, et al. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Journal of Pediatrics. 1995; 127: 681-684.

5 Smyth RL, Ashby D, O'Hea U, et al. Fibrosing colonopathy in cystic fibrosis: results of a case-control study. Lancet. 1995; 346: 1247-1251.

6 FitzSimmons SC, Burkhart GA, Borowitz DS, et al. High-dose pancreatic-enzyme supplements and fibrosing colonopathy in children with cystic fibrosis. New England Journal of Medicine. 1997; 336: 1283-1289.

Last reviewed on RxList: 6/23/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There have been no reports of overdose in clinical trials or postmarketing surveillance with this formulation of CREON. Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]. High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment [see WARNINGS AND PRECAUTIONS].

CONTRAINDICATIONS

None.

Last reviewed on RxList: 6/23/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

The pancreatic enzymes in CREON (pancrelipase capsules) 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.

Pharmacokinetics

The pancreatic enzymes in CREON (pancrelipase capsules) are enteric-coated to minimize destruction or inactivation in gastric acid. CREON (pancrelipase capsules) is designed to release most of the enzymes in vivo at an approximate pH of 5.5 or greater. Pancreatic enzymes are not absorbed from the gastrointestinal tract in appreciable amounts.

Clinical Studies

The short-term safety and efficacy of CREON (pancrelipase capsules) were evaluated in three studies conducted in 103 patients with exocrine pancreatic insufficiency (EPI). Studies 1 and 2 were conducted in 49 patients with EPI due to cystic fibrosis (CF); Study 3 was conducted in 54 patients with EPI due to chronic pancreatitis or pancreatectomy.

Cystic Fibrosis

Studies 1 and 2 were randomized, double-blind, placebo-controlled, crossover studies in 49 patients, ages 7 to 43 years, with exocrine pancreatic insufficiency due to cystic fibrosis. Study 1 included patients aged 12 to 43 years (n = 32). The final analysis population was limited to 29 patients; 3 patients were excluded due to protocol deviations. Study 2 included patients aged 7 to 11 years (n = 17). The final analysis population was limited to 16 patients; 1 patient withdrew consent prior to stool collection during treatment with CREON (pancrelipase capsules) . In each study, patients were randomized to receive CREON (pancrelipase capsules) at a dose of 4,000 lipase units/g fat ingested per day or matching placebo for 5 to 6 days of treatment, followed by crossover to the alternate treatment for an additional 5 to 6 days. All patients consumed a high-fat diet (greater than or equal to 90 grams of fat per day, 40% of daily calories derived from fat) during the treatment periods.

The coefficient of fat absorption (CFA) was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured. Each patient's CFA during placebo treatment was used as their no-treatment CFA value.

In Study 1, mean CFA was 89% with CREON (pancrelipase capsules) treatment compared to 49% with placebo treatment. The mean difference in CFA was 41 percentage points in favor of CREON (pancrelipase capsules) treatment with 95% CI: (34, 47) and p < 0.001.

In Study 2,mean CFA was 83% with CREON (pancrelipase capsules) treatment compared to 47% with placebo treatment. The mean difference in CFA was 35 percentage points in favor of CREON (pancrelipase capsules) treatment with 95% CI: (27,44) and p < 0.001.

Subgroup analyses of the CFA results in Studies 1 and 2 showed that mean change in CFA with CREON (pancrelipase capsules) treatment was greater in patients with lower no-treatment (placebo) CFA values than in patients with higher no-treatment (placebo) CFA values. There were no differences in response to CREON (pancrelipase capsules) by age or gender, with similar responses to CREON (pancrelipase capsules) observed in male and female patients, and in younger (under 18 years of age) and older patients.

The coefficient of nitrogen absorption (CNA) was determined by a 72-hour stool collection during both treatments, when nitrogen excretion was measured and nitrogen ingestion from a controlled diet was estimated (based on the assumption that proteins contain 16% nitrogen). Each patient's CNA during placebo treatment was used as their no-treatment CNA value.

In Study 1, mean CNA was 86% with CREON (pancrelipase capsules) treatment compared to 49% with placebo treatment. The mean difference in CNA was 37 percentage points in favor of CREON (pancrelipase capsules) treatment with 95% CI: (31, 42) and p < 0.001.

In Study 2, mean CNA was 80% with CREON (pancrelipase capsules) treatment compared to 45% with placebo treatment. The mean difference in CNA was 35 percentage points in favor of CREON (pancrelipase capsules) treatment with 95% CI: (26, 45) and p < 0.001.

Chronic Pancreatitis or Pancreatectomy

Study 3 was a randomized, double-blind, placebo-controlled, parallel group study of 54 adult patients, ages 32 to 75 years, with EPI due to chronic pancreatitis or pancreatectomy. The final analysis population was limited to 52 patients; 2 patients were excluded due to protocol violations. Ten patients had a history of pancreatectomy (7 were treated with CREON (pancrelipase capsules) ). In this study, patients received placebo for 5 days (run-in period), followed by pancreatic enzyme replacement therapy as directed by the investigator for 16 days; this was followed by randomization to CREON (pancrelipase capsules) or matching placebo for 7 days of treatment (double-blind period). Only patients with CFA less than 80% in the run-in period were randomized to the double-blind period. The dose of CREON (pancrelipase capsules) during the double-blind period was 72,000 lipase units per main meal (3 main meals) and 36,000 lipase units per snack (2 snacks). All patients consumed a high-fat diet (greater than or equal to 100 grams of fat per day) during the treatment period.

The CFA was determined by a 72-hour stool collection during the run-in and double-blind treatment periods, when both fat excretion and fat ingestion were measured. The mean change in CFA from the run-in period to the end of the double-blind period in the CREON (pancrelipase capsules) and Placebo groups is shown in Table 3.

Table 3: Change in CFA in Study 3 (Run-in Period to End of Double-Blind Period)

  CREON
n = 24
Placebo
n = 28
CFA [%]
  Run-in Period (Mean, SD) 54 (19) 57 (21)
  End of Double-Blind Period (Mean, SD) 86(6) 66 (20)
Change in CFA *[%]
  Run-in Period to End of Double-Blind Period (Mean, SD) 32(18) 9(13)
  Treatment Difference (95% CI) 21 (14, 28)
*p < 0.0001

Subgroup analyses of the CFA results showed that mean change in CFA was greater in patients with lower run-in period CFA values than in patients with higher run-in period CFA values. Only 1 of the patients with a history of total pancreatectomy was treated with CREON (pancrelipase capsules) in the study. That patient had a CFA of 26% during the run-in period and a CFA of 73% at the end of the double-blind period. The remaining 6 patients with a history of partial pancreatectomy treated with CREON (pancrelipase capsules) on the study had a mean CFA of 42% during the run-in period and a mean CFA of 84% at the end of the double-blind period.

Last reviewed on RxList: 6/23/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Medication Guide

CREON®
(kre on)
(pancrelipase) Delayed-Release Capsules

Read this Medication Guide before you start taking CREON and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

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. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you. Call your doctor right away if you have any unusual or severe:

Take CREON exactly as prescribed. Do not take more or less CREON than directed by your doctor.

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 due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions. CREON may help your body use fats, proteins, and sugars from food.

CREON contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.

What should I tell my doctor before taking CREON?

Before taking CREON, tell your doctor about all your medical conditions, including if you:

  • are allergic to pork (pig) products
  • have a history of intestinal 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. It is not known if CREON will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if CREON passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take CREON?

  • Take CREON exactly as your doctor tells you.
  • You should not switch CREON with any other pancreatic enzyme product without first talking to your doctor.
  • Do not take more capsules in a day than the number your doctor tells you to take (total daily dose).
  • Always take CREON with a meal or snack and enough liquid 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 doctor may change your dose based on the amount of fatty foods you eat or based on your weight.
  • 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 infants (children up to 12 months)

  1. Give CREON right before each feeding of formula or breast milk.
  2. Do not mix CREON capsule contents directly into formula or breast milk.
  3. Open the capsules and sprinkle the contents directly into your infant's mouth or mix the contents in a small amount of room temperature acidic soft food such as applesauce. These foods should be the kind found in baby food jars that you buy at the store, or other food recommended by your doctor.
  4. If you sprinkle the CREON on food, give the CREON and food mixture to your child right away. Do not store CREON that is mixed with food.
  5. Give your child enough liquid to completely swallow the CREON contents or the CREON and food mixture.
  6. Look in your child's mouth to make sure that all of the medicine has been swallowed.

Giving CREON to children and adults

  1. Swallow CREON capsules whole and take them with enough liquid to swallow them right away.
  2. If you have trouble swallowing capsules, open the capsules and sprinkle the contents on a small amount of room temperature acidic food such as applesauce. Ask your doctor about other foods you can mix with CREON.
  3. If you sprinkle CREON on food, swallow it right after you mix it and drink enough water or juice to make sure the medicine is swallowed completely. Do not store CREON that is mixed with food.
  4. If you forget to take CREON, call your doctor or wait until your next meal and take your usual number of capsules. Take your next dose at your usual time. Do not make up for missed doses.

What are the possible side effects of CREON?

CREON may cause serious side effects, including:

  • See “What is the most important information I should know about CREON?
  • Irritation of the inside of your mouth. This can happen if CREON is not swallowed completely.
  • Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels.
  • Allergic reactions including trouble with breathing, skin rashes, or swollen lips.

Call your doctor right away if you have any of these symptoms.

The most common side effects of CREON include:

Other Possible Side Effects:

CREON and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the side effects of CREON. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

You may also report side effects to Abbott Laboratories at 1-800-241-1643.

How should I store CREON?

  • Store CREON at room temperature below 77°F (25°C). Avoid heat.
  • You may store CREON at a temperature between 77°F to 104°F (25°C to 40°C) for up to 30 days. Throw away any CREON stored at these temperatures for more than 30 days.
  • Keep CREON in a dry place and in the original container.
  • After opening the bottle, keep it closed tightly between uses to protect from moisture.

Keep CREON and all medicines out of the reach of children.

General information about CREON

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CREON for a condition for which it was not prescribed. Do not give CREON to other people to take, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about CREON. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about CREON that is written for healthcare professionals. For more information, go to www.creon-us.com or call toll-free [1800-241-1643].

What are the ingredients in CREON?

Active Ingredient: lipase, protease, amylase

Inactive Ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.

The shells of the CREON 6,000 USP units of lipase, 12,000 USP units of lipase, and 24,000 USP units of lipase strengths contain: gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.

In addition:

The shells for the CREON 3,000 USP units of lipase contain titanium dioxide and hypromellose.

The shells of the 6,000 USP units of lipase strength capsules contain FD&C Blue No.2.

The shells of the 12,000 USP units of lipase strength capsules contain black iron oxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 6/23/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Medication Guide

CREON®
(kre on)
(pancrelipase) Delayed-Release Capsules

Read this Medication Guide before you start taking CREON and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

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. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you. Call your doctor right away if you have any unusual or severe:

Take CREON exactly as prescribed. Do not take more or less CREON than directed by your doctor.

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 due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions. CREON may help your body use fats, proteins, and sugars from food.

CREON contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.

What should I tell my doctor before taking CREON?

Before taking CREON, tell your doctor about all your medical conditions, including if you:

  • are allergic to pork (pig) products
  • have a history of intestinal 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. It is not known if CREON will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if CREON passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take CREON?

  • Take CREON exactly as your doctor tells you.
  • You should not switch CREON with any other pancreatic enzyme product without first talking to your doctor.
  • Do not take more capsules in a day than the number your doctor tells you to take (total daily dose).
  • Always take CREON with a meal or snack and enough liquid 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 doctor may change your dose based on the amount of fatty foods you eat or based on your weight.
  • 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 infants (children up to 12 months)

  1. Give CREON right before each feeding of formula or breast milk.
  2. Do not mix CREON capsule contents directly into formula or breast milk.
  3. Open the capsules and sprinkle the contents directly into your infant's mouth or mix the contents in a small amount of room temperature acidic soft food such as applesauce. These foods should be the kind found in baby food jars that you buy at the store, or other food recommended by your doctor.
  4. If you sprinkle the CREON on food, give the CREON and food mixture to your child right away. Do not store CREON that is mixed with food.
  5. Give your child enough liquid to completely swallow the CREON contents or the CREON and food mixture.
  6. Look in your child's mouth to make sure that all of the medicine has been swallowed.

Giving CREON to children and adults

  1. Swallow CREON capsules whole and take them with enough liquid to swallow them right away.
  2. If you have trouble swallowing capsules, open the capsules and sprinkle the contents on a small amount of room temperature acidic food such as applesauce. Ask your doctor about other foods you can mix with CREON.
  3. If you sprinkle CREON on food, swallow it right after you mix it and drink enough water or juice to make sure the medicine is swallowed completely. Do not store CREON that is mixed with food.
  4. If you forget to take CREON, call your doctor or wait until your next meal and take your usual number of capsules. Take your next dose at your usual time. Do not make up for missed doses.

What are the possible side effects of CREON?

CREON may cause serious side effects, including:

  • See “What is the most important information I should know about CREON?
  • Irritation of the inside of your mouth. This can happen if CREON is not swallowed completely.
  • Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels.
  • Allergic reactions including trouble with breathing, skin rashes, or swollen lips.

Call your doctor right away if you have any of these symptoms.

The most common side effects of CREON include:

Other Possible Side Effects:

CREON and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the side effects of CREON. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

You may also report side effects to Abbott Laboratories at 1-800-241-1643.

How should I store CREON?

  • Store CREON at room temperature below 77°F (25°C). Avoid heat.
  • You may store CREON at a temperature between 77°F to 104°F (25°C to 40°C) for up to 30 days. Throw away any CREON stored at these temperatures for more than 30 days.
  • Keep CREON in a dry place and in the original container.
  • After opening the bottle, keep it closed tightly between uses to protect from moisture.

Keep CREON and all medicines out of the reach of children.

General information about CREON

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CREON for a condition for which it was not prescribed. Do not give CREON to other people to take, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about CREON. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about CREON that is written for healthcare professionals. For more information, go to www.creon-us.com or call toll-free [1800-241-1643].

What are the ingredients in CREON?

Active Ingredient: lipase, protease, amylase

Inactive Ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.

The shells of the CREON 6,000 USP units of lipase, 12,000 USP units of lipase, and 24,000 USP units of lipase strengths contain: gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.

In addition:

The shells for the CREON 3,000 USP units of lipase contain titanium dioxide and hypromellose.

The shells of the 6,000 USP units of lipase strength capsules contain FD&C Blue No.2.

The shells of the 12,000 USP units of lipase strength capsules contain black iron oxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 6/23/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Creon Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PANCRELIPASE ENTERIC-COATED CAPSULE - ORAL

(pan-kreh-LIP-aze)

COMMON BRAND NAME(S): Creon, Pancrease, Protilase, Ultrase, Zenpep, Zymase

USES: This medication contains digestive enzymes to help break down and digest fats, starch, and proteins in food. It is used in conditions where the pancreas cannot make or does not release enough digestive enzymes into the small intestines to digest the food (e.g., chronic pancreatitis, cystic fibrosis, cancer of the pancreas, post-pancreatectomy, post-gastrointestinal bypass surgery).

HOW TO USE: Some brands of this medication have a Medication Guide provided by your pharmacist. If one is available, read the Medication Guide before your start taking this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with meals and snacks as directed by your doctor. Swallow the capsule whole. Do not crush or chew the capsules or keep the capsules in your mouth. Doing so can irritate the mouth and also change the way the medication works.

If swallowing is difficult, then the capsule may be opened and the contents mixed in a small amount of liquid or soft food that does not need to be chewed (such as room-temperature applesauce). Do not mix the contents of the capsule with alkaline food or liquid (such as milk, ice cream, tea). Consult your doctor or pharmacist for more information about what foods/liquids (such as infant formula, breast milk) to avoid when mixing. Swallow the food or liquid right away, making sure not to chew the medication. Drink a glass of water or juice after swallowing the food to make sure all the medication is swallowed. Do not save the medication mixture for later.

Dosage is based on your medical condition, diet, and response to therapy.

Drink plenty of fluids while taking this medication unless your doctor tells you otherwise.

Use this medication regularly to get the most benefit from it. Take it with every meal or snack.

If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication.

Do not change brands or dosage forms of pancrelipase without consulting your doctor or pharmacist. Different products may contain different amounts of the digestive enzymes.

Inform your doctor if your condition persists or worsens.

Disclaimer

Creon Consumer (continued)

SIDE EFFECTS: Diarrhea, constipation, abdominal pain/cramps, dizziness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe constipation, severe stomach/abdominal discomfort, frequent/painful urination, joint pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Creon (pancrelipase capsules) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking pancrelipase, tell your doctor or pharmacist if you are allergic to it; or to pork protein; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: gout, kidney disease, high uric acid level in the blood (hyperuricemia), intestinal problems (such as blockage).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Creon Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: acarbose, miglitol.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting pancrelipase.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this product with others.

MISSED DOSE: If you miss a dose, take the next dose with your next meal or snack as directed. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Check the product package for more details on how to store your brand, or ask your pharmacist. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.

Creon Patient Information Including Side Effects

Brand Names: Cotazym, Creon, Dygase, Kutrase, Ku-Zyme, Ku-Zyme HP, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

Generic Name: pancrelipase (oral) (Pronunciation: pan kre LYE pace)

What is pancrelipase (Creon)?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

Pancrelipase may also be used for other purposes not listed in this medication guide.

Cotazym

green, imprinted with ORGANON, 381

Creon 10

brown/clear, imprinted with SOLVAY, 1210

Lipram

white, imprinted with 0115, 7035

Lipram-CR10

dark brown/light brown, imprinted with 0115, 7036

Pancrease

white, imprinted with Pancrease, McNEIL

Ultrase MT 20

gray/yellow, imprinted with ULTRASE, MT 20

What are the possible side effects of pancrelipase?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

  • nausea or vomiting;
  • mild stomach pain or upset;
  • diarrhea or constipation;
  • bloating or gas.
  • greasy stools;
  • rectal irritation;
  • headache, dizziness;
  • cough; or
  • weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Creon (pancrelipase capsules) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

Creon Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

  • kidney disease;
  • gout;
  • a history of blockage in your intestines;
  • a sudden onset of pancreatitis; or
  • worsening of chronic pancreatic disease.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack.

Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use.

If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F.

Creon Patient Information including If I Miss a Dose

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about pancrelipase.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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