CREON 10000 Pancreatin 150mg Capsule 1's
RXDRUG-DR-XY45454-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Treatment of pancreatic exocrine insufficiency in pediatric and adult patients often associated with, but not limited to: Cystic fibrosis; chronic pancreatitis; pancreatic surgery; gastrectomy; pancreatic cancer; gastrointestinal bypass surgery (e.g. Billroth II gastroenterostomy); ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm); Shwachman-Diamond Syndrome; status after an attack of acute pancreatitis and initiation of enteral or oral feeding.
Dosage/Direction for Use
The posology aims at individual needs and depends on the severity of the disease and the composition of food.
It is recommended to take the enzymes during or immediately after the meals.
The capsules should be swallowed intact, without crushing or chewing, with enough fluid during or after each meal or snack.
When swallowing of capsules is difficult (e.g. small children or elderly patients), the capsules may be carefully opened and the minimicrospheres added to acidic soft food [pH <5.5] that does not require chewing, e.g. applesauce, or the minimicrospheres can be taken with acidic liquid [pH <5.5]. This could be apple sauce or yogurt or fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. This mixture should not be stored. Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be taken that no product is retained in the mouth.
It is important to ensure adequate hydration at all times, especially during periods of increased loss of fluids. Inadequate hydration may aggravate constipation. Any mixture of the minimicrospheres with food or liquids should be used immediately and should not be stored.
Dosing In Pediatric and Adult Patients With Cystic Fibrosis: Based upon a recommendation of the Cystic Fibrosis (CF) Consensus Conference, the US CF Foundation case-control study, and the UK case-control study, the following general dosage recommendation for pancreatic enzyme replacement therapy can be proposed: Weight-based enzyme dosing should begin with 1000 lipase units/kg/meal for children less than four years of age and with 500 lipase units/kg/meal for those over age four; Dosage should be adjusted according to the severity of the disease, control of steatorrhea and maintenance of good nutritional status; most patients should remain below or should not exceed 10000 lipase units/kg body weight per day or 4000 lipase units/gram fat intake.
Dosing In Other Conditions Associated With Exocrine Pancreatic Insufficiency: Dosage should be individualized by patients according to the degree of maldigestion and the fat content of the meal. The required dose for a meal ranges from about 25000 to 80000 Ph. Eur. units of lipase and half of the individual dose for snacks.
It is recommended to take the enzymes during or immediately after the meals.
The capsules should be swallowed intact, without crushing or chewing, with enough fluid during or after each meal or snack.
When swallowing of capsules is difficult (e.g. small children or elderly patients), the capsules may be carefully opened and the minimicrospheres added to acidic soft food [pH <5.5] that does not require chewing, e.g. applesauce, or the minimicrospheres can be taken with acidic liquid [pH <5.5]. This could be apple sauce or yogurt or fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. This mixture should not be stored. Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be taken that no product is retained in the mouth.
It is important to ensure adequate hydration at all times, especially during periods of increased loss of fluids. Inadequate hydration may aggravate constipation. Any mixture of the minimicrospheres with food or liquids should be used immediately and should not be stored.
Dosing In Pediatric and Adult Patients With Cystic Fibrosis: Based upon a recommendation of the Cystic Fibrosis (CF) Consensus Conference, the US CF Foundation case-control study, and the UK case-control study, the following general dosage recommendation for pancreatic enzyme replacement therapy can be proposed: Weight-based enzyme dosing should begin with 1000 lipase units/kg/meal for children less than four years of age and with 500 lipase units/kg/meal for those over age four; Dosage should be adjusted according to the severity of the disease, control of steatorrhea and maintenance of good nutritional status; most patients should remain below or should not exceed 10000 lipase units/kg body weight per day or 4000 lipase units/gram fat intake.
Dosing In Other Conditions Associated With Exocrine Pancreatic Insufficiency: Dosage should be individualized by patients according to the degree of maldigestion and the fat content of the meal. The required dose for a meal ranges from about 25000 to 80000 Ph. Eur. units of lipase and half of the individual dose for snacks.
Overdosage
Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricemia.
Administration
Should be taken with food: Swallow whole, do not chew/crush. Alternatively, open cap & mix granules w/ soft food or take w/ liqd (pH <5.5). If mixed w/ soft food, swallow immediately w/o chewing.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Special Precautions
Strictures of the ileo-cecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10000 units of lipase/kg/day.
Effects on Ability to Drive and Use Machines: Pancreatin (Creon 10000) has no or negligible influence on the ability to drive and use machines.
Effects on Ability to Drive and Use Machines: Pancreatin (Creon 10000) has no or negligible influence on the ability to drive and use machines.
Use In Pregnancy & Lactation
Fertility and Pregnancy: For pancreatic enzymes no clinical data on exposed pregnancies are available. Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected.
Caution should be exercised when prescribing to pregnant women.
Lactation: No effects on the suckling child are anticipated since animal studies suggest no systemic exposure of the breastfeeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breastfeeding.
If required during pregnancy and lactation Pancreatin (Creon 10000) should be used in doses sufficient to provide adequate nutritional status.
Caution should be exercised when prescribing to pregnant women.
Lactation: No effects on the suckling child are anticipated since animal studies suggest no systemic exposure of the breastfeeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breastfeeding.
If required during pregnancy and lactation Pancreatin (Creon 10000) should be used in doses sufficient to provide adequate nutritional status.
Adverse Reactions
In clinical trials, more than 900 patients were exposed to Pancreatin (Creon 10000).
The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity.
The following adverse reactions have been observed during clinical trials with the indicated frequencies as follows. (See table.)
The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity.
The following adverse reactions have been observed during clinical trials with the indicated frequencies as follows. (See table.)
Strictures of the ileo-cecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations, see Precautions.
Allergic reactions mainly but not exclusively limited to the skin have been observed and identified as adverse reactions during post-approval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.
Pediatric population: No specific adverse reactions were identified in the pediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.
Allergic reactions mainly but not exclusively limited to the skin have been observed and identified as adverse reactions during post-approval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.
Pediatric population: No specific adverse reactions were identified in the pediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.
Caution For Usage
Incompatibilities: Not applicable.
Storage
Store at temperatures not exceeding 25°C.
Shelf Life: 24 months.
Shelf Life: 24 months.
Action
Pharmacotherapeutic Group: Multienzymes (amylase, lipase, protease). ATC code: A09A A02.
Pharmacology: Pharmacodynamics: Pancreatin (Creon 10000) contains porcine pancreatin formulated as enteric-coated (acid-resistant) minimicrospheres within gelatin capsules.
The capsules dissolve rapidly in the stomach releasing plenty of minimicrospheres, a multi-dose principle which is designed to achieve good mixing with the chyme, emptying from the stomach together with the chyme and after release, good distribution of enzymes within the chyme.
When the minimicrospheres reach the small intestine the coating rapidly disintegrates (at pH >5.5) to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or following further hydrolysis by intestinal enzymes.
Clinical efficacy: Overall 30 studies investigating the efficacy of Pancreatin (Creon 10000) in patients with pancreatic exocrine insufficiency have been conducted. Ten of these were placebo controlled studies performed in patients with cystic fibrosis, chronic pancreatitis or post-surgical conditions.
In all randomized, placebo-controlled, efficacy studies, the pre-defined primary objective was to show superiority of Pancreatin (Creon 10000) over placebo on the primary efficacy parameter, the coefficient of fat absorption (CFA).
The coefficient of fat absorption determines the percentage of fat that is absorbed into the body taking into account fat intake and fecal fat excretion. In the placebo-controlled PEI studies, the mean CFA (%) was higher with Pancreatin (Creon 10000) treatment (83.0%) as compared to placebo (62.6%). In all studies, irrespective of the design, the mean CFA (%) at the end of the treatment period with Pancreatin (Creon 10000) was similar to the mean CFA values for Pancreatin (Creon 10000) in the placebo-controlled studies.
Treatment with Pancreatin (Creon 10000) markedly improves the symptoms of pancreatic exocrine insufficiency including stool consistency, abdominal pain, flatulence and stool frequency, independent of the underlying disease.
Pediatric population: In cystic fibrosis (CF) the efficacy of Pancreatin (Creon 10000) was demonstrated in 288 pediatric patients covering an age range from newborns to adolescents. In all studies, the mean end-of-treatment CFA values exceeded 80% on Pancreatin (Creon 10000) comparably in all pediatric age groups.
Pharmacokinetics: Animal studies showed no evidence for absorption of intact enzymes and therefore classical pharmacokinetic studies have not been performed. Pancreatic enzyme supplements do not require absorption to exert their effects. On the contrary, their full therapeutic activity is exerted from within the lumen of the gastrointestinal tract. Furthermore, they are proteins, and as such undergo proteolytic digestion while passing along the gastrointestinal tract before being absorbed as peptides and amino acids.
Toxicology: Preclinical Safety Data: Preclinical data show no relevant acute, subchronic or chronic toxicity. Studies on genotoxicity, carcinogenicity or toxicity to reproduction have not been performed.
Pharmacology: Pharmacodynamics: Pancreatin (Creon 10000) contains porcine pancreatin formulated as enteric-coated (acid-resistant) minimicrospheres within gelatin capsules.
The capsules dissolve rapidly in the stomach releasing plenty of minimicrospheres, a multi-dose principle which is designed to achieve good mixing with the chyme, emptying from the stomach together with the chyme and after release, good distribution of enzymes within the chyme.
When the minimicrospheres reach the small intestine the coating rapidly disintegrates (at pH >5.5) to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or following further hydrolysis by intestinal enzymes.
Clinical efficacy: Overall 30 studies investigating the efficacy of Pancreatin (Creon 10000) in patients with pancreatic exocrine insufficiency have been conducted. Ten of these were placebo controlled studies performed in patients with cystic fibrosis, chronic pancreatitis or post-surgical conditions.
In all randomized, placebo-controlled, efficacy studies, the pre-defined primary objective was to show superiority of Pancreatin (Creon 10000) over placebo on the primary efficacy parameter, the coefficient of fat absorption (CFA).
The coefficient of fat absorption determines the percentage of fat that is absorbed into the body taking into account fat intake and fecal fat excretion. In the placebo-controlled PEI studies, the mean CFA (%) was higher with Pancreatin (Creon 10000) treatment (83.0%) as compared to placebo (62.6%). In all studies, irrespective of the design, the mean CFA (%) at the end of the treatment period with Pancreatin (Creon 10000) was similar to the mean CFA values for Pancreatin (Creon 10000) in the placebo-controlled studies.
Treatment with Pancreatin (Creon 10000) markedly improves the symptoms of pancreatic exocrine insufficiency including stool consistency, abdominal pain, flatulence and stool frequency, independent of the underlying disease.
Pediatric population: In cystic fibrosis (CF) the efficacy of Pancreatin (Creon 10000) was demonstrated in 288 pediatric patients covering an age range from newborns to adolescents. In all studies, the mean end-of-treatment CFA values exceeded 80% on Pancreatin (Creon 10000) comparably in all pediatric age groups.
Pharmacokinetics: Animal studies showed no evidence for absorption of intact enzymes and therefore classical pharmacokinetic studies have not been performed. Pancreatic enzyme supplements do not require absorption to exert their effects. On the contrary, their full therapeutic activity is exerted from within the lumen of the gastrointestinal tract. Furthermore, they are proteins, and as such undergo proteolytic digestion while passing along the gastrointestinal tract before being absorbed as peptides and amino acids.
Toxicology: Preclinical Safety Data: Preclinical data show no relevant acute, subchronic or chronic toxicity. Studies on genotoxicity, carcinogenicity or toxicity to reproduction have not been performed.
MedsGo Class
Digestives
Features
Brand
Creon 10000
Full Details
Dosage Strength
150 mg
Drug Ingredients
- Pancreatin
Drug Packaging
Capsule 1's
Generic Name
Pancreatin
Dosage Form
Capsule
Registration Number
DR-XY45454
Drug Classification
Prescription Drug (RX)
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