Creon 10,000 is a drug to compensate for the lack of pancreatic enzymes.

Release form and composition

The drug is available in the form of enteric capsules: hard gelatin, with a transparent, colorless body and an opaque brown cap, size No. 2; Light brown mini-microspheres are visible inside the capsules (20, 50 and 100 pieces each in white polyethylene bottles with a screw cap; in a cardboard pack there is one bottle and instructions for use of Creon 10,000).

Composition per 1 capsule:

• active substance: pancreatin – 150 mg (corresponds to the content of protease – 600 IU Ph.Eur., lipase – 10,000 IU Ph.Eur., amylase – 8000 IU Ph.Eur.);
• auxiliary components: hypromellose phthalate, cetyl alcohol, macrogol 4000, dimethicone, triethyl citrate;
• capsule body and cap: sodium lauryl sulfate, gelatin, black iron oxide dye, titanium dioxide, yellow iron oxide dye, red iron oxide dye.

Pharmacological properties

Pharmacodynamics

Creon 10,000 is an enzyme agent that improves food digestion in children and adults. As a result of using the drug, the severity of symptoms of enzyme deficiency is significantly reduced (the frequency and consistency of stool changes, abdominal pain and flatulence disappear). Creon 10,000 enzymes facilitate the digestion of fats, proteins and carbohydrates, and this contributes to their more complete absorption in the small intestine.

Porcine pancreatin is contained in capsules of the drug in the form of minimicrospheres, which are coated with an acid-resistant shell. Once the capsules dissolve in the stomach, hundreds of minimicrospheres are released. Together with food, they enter the intestines, mix thoroughly with the intestinal contents, and then reach the small intestine, where the enteric coating is quickly destroyed. The released enzymes actively break down proteins, carbohydrates and fats. Then the resulting substances are absorbed directly or broken down by intestinal enzymes into smaller units.

Pharmacokinetics

Classical studies of the pharmacokinetics of the drug have not been carried out, since pancreatic enzymes exert their therapeutic effect directly in the lumen of the small intestine before absorption. According to their chemical structure, these are proteins that are broken down in the gastrointestinal tract into amino acids and peptides, in the form of which they are absorbed into the intestinal walls.

Indications for use

Creon 10,000 is used in children and adults as replacement therapy for pancreatic enzyme insufficiency, which occurs as a result of a decrease in its enzyme activity due to impaired production of pancreatic enzymes, regulation of their secretion, delivery to the site of action, and also increased destruction in the intestine. The listed disorders are caused by various diseases of the digestive tract and most often occur in chronic pancreatitis, cystic fibrosis, pancreatic cancer, Shwachman-Diamond syndrome, obstruction of the common bile duct or pancreatic ducts, after complete or partial removal of the stomach, after surgery on the pancreas, with conditions after attacks of acute pancreatitis and subsequent resumption of nutrition.

Contraindications

Creon 10,000 is contraindicated in patients with hypersensitivity to pancreatin or any auxiliary component of the drug.

Creon 10,000: instructions for use (dosage and method)

Creon 10,000 capsules are taken orally, without chewing or breaking, with water or other liquid.

Doses are selected individually (the composition of the diet and the severity of the disease are taken into account). The drug should be taken during or after meals, at every meal, even with a light snack.

It is not always possible for small children or elderly patients to swallow the capsule whole. In such cases, it is opened and the contents are added to soft foods or drinks with a sour taste (yogurt, fruit juice, applesauce). The pH of the liquid or food should be less than 5.5. The prepared mixture of minimicrospheres with a drink or liquid cannot be stored and should be taken immediately after mixing.

Chewing capsules or using liquids or foods with a pH greater than 5.5 to mix with minimicrospheres may result in breakdown of the enteric coating and early release of enzymes into the oral cavity. As a result, the effectiveness of the drug is reduced, and the mucous membranes of the oral cavity are irritated.

Patients should receive sufficient fluid intake, especially as fluid requirements increase. Otherwise, constipation may occur or become worse.

For cystic fibrosis, the dose of Creon 10,000 depends on the patient’s body weight. At the beginning of therapy, children under 4 years of age are prescribed 1000 lipase units per kg of body weight at each meal. For children over 4 years of age and adults, the starting dose is 500 lipase units per kg of body weight with each meal. Subsequently, the dose of the drug is increased, taking into account the severity of the symptoms of the disease, controlling steatorrhea and maintaining adequate nutritional status. As a rule, the daily dose does not exceed 10,000 lipase units per kg of body weight or 4,000 lipase units per g of fat consumed.

For other conditions with pancreatic enzyme insufficiency, the dose of Creon 10,000 is set individually, taking into account the fat content in food and the degree of digestive insufficiency. During the main meal, the dose of pancreatin is 25,000–80,000 IU of lipase, during or after a light snack - 1/2 of the individual dose.

Side effects

• digestive system: very often – abdominal pain; often - vomiting, nausea, bloating, diarrhea or constipation; with an unknown frequency - fibrosing colonopathy (in patients with cystic fibrosis who received high doses of pancreatin);
• immune system: with unknown frequency - anaphylactic reactions (mainly from the skin);
• skin and subcutaneous fat: uncommon – rash; with unknown frequency – urticaria, itching.

Overdose

In case of an overdose of the drug, an increased level of uric acid is observed in the blood and urine.

Creon 10,000 should be discontinued and symptomatic treatment should be started.

Special instructions

If the patient experiences abdominal changes or other unusual symptoms during drug therapy, a medical examination should be performed to rule out strictures of the cecum, ileum, and colon. The likelihood of fibrosing colonopathy increases in patients with cystic fibrosis receiving Creon 10,000 in a daily dose of 10,000 units of lipase or more.

Impact on the ability to drive vehicles and complex mechanisms

The effect of the drug on the ability to drive vehicles is negligible or absent.

Use during pregnancy and lactation

Experimental studies have shown that pancreatin is not teratogenic. Despite this, the use of the drug during pregnancy is possible only in exceptional cases when the benefit of treatment for the mother outweighs the possible risk to the fetus.

Use in childhood

In children, Creon 10,000 capsules are used according to indications, adhering to the recommended dosage regimen. The high activity of lipase, which is contained in pancreatin, increases the risk of constipation in children.

Drug interactions

The effectiveness of Pancreatin may be reduced in combination with antacids containing magnesium hydroxide and/or calcium carbonate.

Creon 10,000 may reduce iron absorption. It is theoretically possible that the effectiveness of acarbose may be reduced by the action of pancreatin.

Analogs

Analogues of Creon 10,000 are: Creon 25,000, Creon 40,000, Mezim 20,000, Mezim forte 10,000, Pangrol 25,000, Gastenorm forte 10,000, Gastenorm forte, Penzital, Pancreatin, PanziCam, Micrazim, Creon Micro, Pancreazim, atin- LekT, Mezim forte, Pancreatin forte, Ermital, Panzim forte, Enzistal-P, etc.

Terms and conditions of storage

Store in a tightly closed bottle at a temperature not exceeding 25 °C. Keep away from children.

Shelf life – 2 years. Capsules from an opened bottle must be used within 3 months.

P N 015581/01

Trade name: Creon ® 10000

International nonproprietary name or generic name:

pancreatin

Dosage form:

enteric capsules

Compound:

1 capsule contains:

Active substance: pancreatin - 150 mg, which corresponds to: 10,000 units EUR.F. lipase, 8000 units Eur.F. amylase, 600 units Eur.F. proteases. Excipients: macrogol 4000 - 37.50 mg, hypromellose phthalate - 56.34 mg, dimethicone 1000 - 1.35 mg, cetyl alcohol - 1.18 mg, triethyl citrate - 3.13 mg. Hard gelatin capsule: gelatin - 60.44 mg, red iron oxide dye (E 172) - 0.23 mg, yellow iron oxide dye (E 172) - 0.05 mg, black iron oxide dye (E 172) - 0.09 mg, titanium dioxide (E 171) - 0.07 mg, sodium lauryl sulfate -0.12 mg.

Description: hard gelatin capsules No. 2, consisting of brown opaque

cap and transparent colorless body.

The contents of the capsules are minimicrospheres of light brown color.

Pharmacotherapeutic group:

digestive enzyme agent

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics

An enzyme preparation that improves digestion processes. Pancreatic enzymes included in the drug facilitate the breakdown of proteins, fats, and carbohydrates, which leads to their complete absorption in the small intestine.

Creon ® 10000 contains porcine pancreatin in the form of minimicrospheres, enteric-coated (acid-resistant) in gelatin capsules. The capsules quickly dissolve in the stomach, releasing hundreds of minimicrospheres. This principle is designed to thoroughly mix the minimicrospheres with the intestinal contents, and ultimately to better distribute the enzymes after their release within the intestinal contents. When the minimicrospheres reach the small intestine, the enteric coating is rapidly destroyed (at pH > 5.5), releasing enzymes with lipolytic, amylolytic and proteolytic activity, resulting in the breakdown of fats, carbohydrates and proteins. The resulting substances are then either absorbed directly or undergo further hydrolysis by intestinal enzymes.

Pharmacokinetics

Animal studies have demonstrated a lack of absorption of intact (uncleaved) enzymes and, as a result, classical pharmacokinetic studies have not been performed. Drugs containing pancreatic enzymes do not require absorption to produce their effects. On the contrary, the therapeutic activity of these drugs is fully realized in the lumen of the gastrointestinal tract. By their chemical structure they are proteins and, therefore, when passing through the gastrointestinal tract, they undergo proteolytic cleavage until they are absorbed in the form of peptides and amino acids.

Indications for use

Replacement therapy for exocrine pancreatic insufficiency in children and adults. Insufficiency of exocrine pancreatic function is associated with a variety of diseases of the gastrointestinal tract and most often occurs with:

Cystic fibrosis,

Chronic pancreatitis,

After pancreatic surgery,

After gastrectomy,

pancreatic cancer,

Partial gastrectomy (for example, Billroth II),

Obstruction of the pancreatic duct or common bile duct (for example, due to a neoplasm),

Shwachman-Diamond syndrome.

To avoid complications, use only after consulting a doctor.

Contraindications

Hypersensitivity to porcine pancreatin or to one of the excipients,

Acute pancreatitis,

Exacerbation of chronic pancreatitis.

Use during pregnancy and breastfeeding

Pregnancy

There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. Animal studies have not revealed the absorption of pancreatic enzymes of porcine origin, therefore toxic effects on reproductive function and fetal development are not expected.

The drug should be prescribed to pregnant women with caution if the expected benefit to the mother outweighs the potential risk to the fetus. Breastfeeding period

Based on animal studies in which no systematic negative effects of pancreatic enzymes were detected, no harmful effects of the drug on the nursing infant through breast milk are expected.

You can take pancreatic enzymes while breastfeeding.

If necessary during pregnancy or lactation, the drug should be taken in doses sufficient to maintain adequate nutritional status.

Directions for use and doses

Doses of the drug are selected individually depending on the severity of the disease and the composition of the diet.

Capsules should be taken during or immediately after each meal (including snacks), swallowed whole, without breaking or chewing, and with sufficient liquid.

If swallowing is difficult (for example, in young children or elderly patients), the capsules are carefully opened and the minimicrospheres are added to liquid foods that do not require chewing and have a sour taste, such as applesauce or fruit juice (pH< 5,5). Не рекомендуется добавлять содержимое капсул в горячую пищу. Любая смесь минимикросфер с пищей или жидкостью не подлежит хранению, и ее следует принимать сразу же после приготовления.

It is important to ensure that the patient maintains adequate fluid intake, especially if there is increased fluid loss. Inadequate fluid intake can cause or worsen constipation.

Dose for adults and children with cystic fibrosis

The dose depends on body weight and at the beginning of treatment should be 1000 lipase units/kg per meal for children under four years of age, and 500 lipase units/kg per meal for children over four years of age.

The dose should be determined depending on the severity of symptoms of the disease, the results of control of steatorrhea and the maintenance of adequate nutritional status.

In most patients, the dose should remain less than or not exceed 10,000 lipase units/kg body weight per day or 4,000 lipase units/g fat intake.

Dose for other conditions accompanied by exocrine pancreatic insufficiency

The dose should be set taking into account the individual characteristics of the patient, which include the degree of digestive insufficiency and the fat content of food. The dose required by the patient with the main meal varies from 25,000 to 80,000 units of lipase, and half the individual dose when taking a snack.

Side effects

Gastrointestinal disorders

Often (> 1/100,<1/10): тошнота, рвота, запор и вздутие живота.

Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of the following adverse reactions was lower or similar to that observed with placebo: diarrhea (common, >1/100,<1/10), боли в области живота (очень часто, >1/10).

Skin and subcutaneous tissue disorders Uncommon (>1/1000,<1/100): сыпь. Частота неизвестна: зуд, крапивница. Immune system disorders

Frequency unknown: hypersensitivity (anaphylactic reactions). Allergic reactions were observed mainly from the skin, but other manifestations of allergies were also noted. Reports of these side effects were received during post-marketing use and were spontaneous. There are insufficient data to accurately estimate the incidence of cases.

Overdose

Symptoms: hyperuricosuria and hyperuricemia. Treatment: drug withdrawal, symptomatic therapy.

Interaction with other drugs

No interaction studies have been conducted.

Special instructions

In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, cecum and colon (fibrosing colonopathy) have been described. In case-control studies, there was no evidence of a relationship between the occurrence of fibrosing colonopathy and the use of Creon® 10000. As a precaution, if unusual symptoms or changes in the abdominal cavity occur, a medical examination is necessary to exclude fibrosing colonopathy. colonopathy, especially in patients who take the drug at a dose of more than 10,000 lipase units/kg per day.

Like all currently used porcine pancreatin preparations, Creon® 10000 is produced from pancreatic tissue from pigs specially raised for human consumption. Although the risk of transmission of an infectious agent to humans has been minimized by testing and inactivation of certain viruses during the manufacturing process, there is a theoretical risk of transmission of viral disease, including diseases caused by new or unknown viruses. The presence of swine viruses that can infect humans cannot be completely excluded. However, over a long period of time using porcine pancreas extracts, not a single case of infectious disease transmission has been recorded.

Impact on the ability to drive a car and other mechanisms

The use of Creon® 10000 does not affect or has an insignificant effect on the ability to drive a car and operate machinery.

Release form

Enteric capsules 10000 units. 20, 50 or 100 capsules in a white high-density polyethylene bottle with a polypropylene screw cap with tamper evident. A label is placed on the bottle. 1 bottle along with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 °C in tightly closed packaging. Keep out of the reach of children!

Best before date

Shelf life after first opening the bottle is 3 months.

Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

Over the counter.

Name and legal address of the manufacturer

Abbott Products GmbH Hans-Bockler-Allee 20, 30173 Hannover, Germany.

Name and actual address of the manufacturer

Abbott Products GmbH Justus von Liebig Strasse 33, 31535 Neustadt, Germany.

Quality complaints should be sent to:

Abbott Products LLC 119334, Russia, Moscow, st. Vavilova, 24.

Composition and release form of the drug

◊ Enteric capsules hard gelatin, size No. 2, with a colorless transparent body and a brown opaque cap; the contents of the capsules are minimicrospheres of light brown color.

Excipients: macrogol 4000 - 37.5 mg, hypromellose phthalate - 56.34 mg, dimethicone 1000 - 1.35 mg, cetyl alcohol - 1.18 mg, triethyl citrate - 3.13 mg.

Composition of hard gelatin capsule: gelatin - 60.44 mg, red iron oxide dye (E172) - 0.23 mg, yellow iron oxide dye (E172) - 0.05 mg, black iron oxide dye (E172) - 0.09 mg, titanium dioxide (E171) - 0.07 mg, sodium lauryl sulfate - 0.12 mg.

20 pcs. - white high-density polyethylene bottles with a polypropylene screw cap (1) - cardboard packs.
50 pcs. - white high-density polyethylene bottles with a polypropylene screw cap (1) - cardboard packs.
100 pcs. - white high-density polyethylene bottles with a polypropylene screw cap (1) - cardboard packs.

Pharmacological action

Enzyme agent. Contains pancreatic enzymes - amylase, lipase and proteases, which facilitate the digestion of carbohydrates, fats and proteins, which facilitates their more complete absorption in the small intestine. In diseases of the pancreas, it compensates for the insufficiency of its exocrine function and helps improve the digestion process.

Pharmacokinetics

The pharmacokinetics of pancreatin have not been studied.

Indications

Insufficiency of the exocrine function of the pancreas (including in chronic, cystic fibrosis).

Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gall bladder; conditions after resection or irradiation of these organs, accompanied by disturbances in the digestion of food, diarrhea (as part of combination therapy).

To improve the digestion of food in patients with normal gastrointestinal function in case of errors in nutrition, as well as in cases of disorders of chewing function, forced long-term immobilization, and a sedentary lifestyle.

Preparation for x-ray and ultrasound examination of the abdominal organs.

Contraindications

Acute pancreatitis. Hypersensitivity to pancreatin.

Dosage

The dose (in terms of lipase) depends on age and the degree of pancreatic insufficiency. The average dose for adults is 150,000 units/day. In case of complete insufficiency of the exocrine function of the pancreas - 400,000 units/day, which corresponds to the daily requirement of an adult for lipase.

Maximum daily dose is 15,000 units/kg.

Children under 1.5 years old - 50,000 units/day; over 1.5 years - 100,000 units/day.

The duration of treatment can vary from several days (if the digestive process is disrupted due to errors in the diet) to several months and even years (if constant replacement therapy is necessary).

Side effects

When used in average therapeutic doses, side effects are observed in less than 1%.

From the digestive system: in some cases - constipation, discomfort in the stomach, nausea. The cause-and-effect relationship between the development of these reactions and the action of pancreatin has not been established, because These phenomena refer to symptoms of exocrine pancreatic insufficiency.

Allergic reactions: in some cases - skin manifestations.

From the side of metabolism: with long-term use in high doses, hyperuricosuria may develop; in excessively high doses, an increase in the level of uric acid in the blood.

Others: When using pancreatin in high doses in children, perianal irritation may occur.

Drug interactions

When used simultaneously with antacids containing calcium carbonate and/or magnesium hydroxide, the effectiveness of pancreatin may be reduced.

With simultaneous use, it is theoretically possible to reduce the clinical effectiveness of acarbose.

When used simultaneously with iron supplements, a decrease in iron absorption may occur.

Special instructions

The dose should be adequate to the amount of enzymes that is necessary for the absorption of fats, taking into account the quality and quantity of food consumed.

In cystic fibrosis, the use of pancreatin in doses of more than 10,000 IU/kg/day (in terms of lipase) is not recommended due to the increased risk of developing strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon.

With high lipase activity contained in pancreatin, the likelihood of developing constipation in children increases. Increasing the dose of pancreatin in this category of patients should be carried out gradually.

Digestive system disorders may occur in patients with hypersensitivity to pancreatin, or in patients with meconium ileus or a history of intestinal resection.

Pregnancy and lactation

The safety of using pancreatin has not been sufficiently studied. Use is possible in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

In experimental studies It has been established that pancreatin does not have a teratogenic effect.

Use in childhood

Application is possible according to the dosage regimen. With high lipase activity contained in pancreatin, the likelihood of developing constipation in children increases.

Against the backdrop of an unhealthy diet and poor ecology, digestive problems arise even in children. Against the background of complementary feeding, the imperfect digestive system of infants can malfunction due to a lack of enzymatic activity.

Diarrhea, pain, constipation, heartburn, increased gas production and flatulence - such symptoms are considered the most characteristic of gastrointestinal disorders. In such a situation, to normalize digestion and eliminate pathological symptoms, gastroenterologists recommend taking.

Can a child take this drug?

Digestive problems occur in patients of any age, both adults and very young children.

• , gastritis, cystic fibrosis and pancreatic pathologies are often found even in very young patients. It is these patients who are recommended to take Creon capsules, which are safe even for newborns and infants.
• Creon is one of the most modern enzyme preparations of the newest generation. It was developed to normalize digestion by replenishing the deficiency of enzymatic pancreatic activity.
• The drug has many advantages, because its main active ingredient is placed in microgranules coated with a coating that is resistant to stomach acid.
• Microspheres are placed in a gelatin-based capsule. When the capsule reaches the stomach, it dissolves there, releasing hundreds of small microspheres. They mix evenly with food masses and penetrate with a bolus of food into the intestinal cavity, where the shell of the microsphere dissolves, releasing pancreatic enzymes that will help food be better broken down and absorbed.

Composition of the medicine

The main active ingredient in the drug is pancreatin, obtained through an extract from the pancreas of pigs. Each Creon capsule contains the amount of enzymes - amylase, protease and lipase, recommended and safe for children.

In fact, Creon is not a medicine in the generally accepted sense, because it does not force the children’s body to produce the missing enzymes, but simply supplies them to the body in a ready-made form.

That is, in fact, Creon is prescribed for enzyme replacement therapy. When the child stops taking the drug, the lack of enzymes may appear again.

Indications and contraindications

• Infants should be given only half the contents of the capsule at a time before each full meal.
• Children over the age of one year are prescribed one capsule also before a full meal.

Child over 3 years old

Children over 3 years of age can usually swallow the capsule on their own, but if it causes vomiting or difficulty swallowing, then the medicine should be given in the same way as children under three years of age, i.e., mixing microgranules with food or drink.

It is better to mix the microspheres from the capsule with something sour that does not require chewing. For children, this could be yogurt, applesauce or juice.

Before each full meal, the child is given 1-2 capsules of Creon. Typically, such children are prescribed to take the drug up to 3-5 times a day.

Parents also need to know that pancreatin from Creon impairs the absorption of iron, so with long-term treatment, iron deficiency anemia may occur. During treatment with Creon, you need to give your child more fluids to avoid constipation.

Side effects

If the dosage is not observed, Creon is taken for an unreasonably long time, or the child has intolerance, adverse reactions may occur such as:

• Problems with bowel movements, such as diarrhea or constipation;
• An allergic reaction to the drug in the form of rashes, vomiting, etc.;
• Painful discomfort in the epigastric region.

To eliminate the possibility of developing adverse reactions, you must first read the attached leaflet, studying the contraindications and possible reactions to the drug.

You should be especially careful when treating children under one year of age. The drug can be taken by children who are fed only breast milk, but only as prescribed by a doctor.

Creon 10000: instructions for use and reviews

Creon 10000 is a digestive enzyme agent.

Release form and composition

Dosage form of Creon 10000 – enteric capsules: size No. 2, gelatin, hard, with a brown opaque cap and a colorless transparent body; contents – light brown mini-microspheres (20, 50 and 100 pcs. in polyethylene bottles with a screw cap and first opening control, 1 bottle in a cardboard box).

Active ingredient of the drug: pancreatin, 1 capsule – 150 mg, which corresponds to the content:

• lipase – 10,000 European Pharmacopoeia units (Eur. F. units);
• amylase – 8000 units Eur. F.;
• protease – 600 units Eur. F.

Additional components (their content in 1 capsule):

• excipients: hypromellose phthalate (56.34 mg), macrogol 4000 (37.5 mg), triethyl citrate (3.13 mg), dimethicone 1000 (1.35 mg), cetyl alcohol (1.18 mg);
• composition of the capsule shell: gelatin (60.44 mg), sodium lauryl sulfate (0.12 mg), titanium dioxide (E 171) (0.07 mg), as well as yellow iron oxide dyes (E 172) (0.05 mg) , iron oxide red (E 172) (0.23 mg) and iron oxide black (E 172) (0.09 mg).

Pharmacological properties

Pharmacodynamics

Pancreatin is an enzymatic substance that improves the processes of food digestion, which significantly reduces the symptoms of pancreatic enzyme insufficiency, such as flatulence, abdominal pain, changes in the consistency and frequency of stools. Pancreatic enzymes facilitate the digestion of fats, carbohydrates and proteins, so that they are completely absorbed in the small intestine.

Creon 10000 contains pork pancreatin in the form of minimicrospheres, enteric-coated (that is, acid-resistant) in gelatin capsules. Once in the stomach, the capsules quickly dissolve, releasing hundreds of minimicrospheres. This dosage form is designed specifically to ensure that the minimicrospheres are simultaneously thoroughly mixed with the intestinal contents and supplied with food from the stomach to the intestines, i.e., so that the enzymes are better distributed after release.

Once the minimicrospheres reach the small intestine, the capsular membrane is rapidly destroyed (at a pH greater than 5.5), enzymes with proteolytic, lipolytic and amylolytic activity are released, resulting in the breakdown of proteins, fats and carbohydrates. Substances resulting from the breakdown are absorbed directly or undergo further breakdown by intestinal enzymes.

Pharmacokinetics

In animal studies, it was found that there is no absorption of unsplit enzymes, so classical pharmacokinetic studies were not performed.

To exert their effects, drugs containing pancreatic enzymes do not require absorption. On the contrary, their therapeutic activity is fully realized in the lumen of the gastrointestinal tract.

According to their chemical structure, enzymes are proteins, and therefore, when passing through the gastrointestinal tract, they are broken down until they are absorbed in the form of amino acids and peptides.

Indications for use

Creon 10000 is used for replacement therapy of enzyme (exocrine) pancreatic insufficiency due to a decrease in its enzyme activity due to impaired production, regulation of secretion and delivery of pancreatic enzymes or due to their increased destruction in the intestinal lumen caused by various diseases of the gastrointestinal tract (GIT) .

Most often, Creon 10000 is prescribed in the following cases:

• conditions after an attack of acute pancreatitis;
• chronic pancreatitis;
• cystic fibrosis;
• Shwachman-Diamond syndrome;
• partial gastrectomy (for example, Billroth II);
• obstruction of the pancreatic duct or common bile duct (for example, due to a neoplasm);
• pancreatic cancer;
• conditions after pancreatic surgery;
• conditions after extirpation (gastrectomy) of the stomach;
• preparation for ultrasound or x-ray examination of the abdominal organs.

For patients with normal gastrointestinal function, the drug is recommended for errors in nutrition, disorders of chewing function, a sedentary lifestyle or forced long-term immobilization.

Contraindications

The use of Creon 10000 is contraindicated in case of hypersensitivity to its components.

You should not take the drug during an acute attack of pancreatitis.

Instructions for use of Creon 10000: method and dosage

Capsules are taken orally with meals or immediately after each meal, including snacks. They must be swallowed whole and washed down with sufficient liquid. For patients who have difficulty swallowing and children, the capsules may be carefully opened and the minimicrospheres contained in them may be added to soft, sour-tasting, non-chewable foods, or taken with sour-tasting liquids. Foods acceptable for mixing include: applesauce, yogurt, fruit juices (apple, pineapple and orange) with pH< 5,5. Такие смеси не подлежат хранению, поэтому должны быть использованы сразу же после приготовления. Не стоит смешивать содержимое капсул с горячей пищей.

The dose of Creon 10,000 (in terms of lipase) is selected individually, taking into account the type of disorder, the severity of the disease, the composition of the diet and the patient’s body weight.

For cystic fibrosis, at the beginning of treatment, adults and children over 4 years old are prescribed 500 units/kg, children under 4 years old – 1000 units/kg with each meal. Depending on the severity of the symptoms of the disease, the results of steatorrhea control and individual sensitivity, the dose can be adjusted. For most patients, the daily dose does not exceed 10,000 units/kg of body weight or 4,000 units/g of fat consumed.

For other conditions accompanied by pancreatic enzyme deficiency, the dose is determined depending on the individual characteristics of the patient, including the degree of digestive insufficiency and the fat content in the diet. With the main meal, a dose of 25,000–80,000 IU of lipase is usually required, with light snacks - ½ of the therapeutic dose.

For children, Creon 10000 is used only as prescribed by a doctor.

Side effects

• from the digestive system*: very often (≥ 1/10) – pain in the abdomen; often (from ≥ 1/100 to< 1/10) – вздутие живота, запор или диарея, тошнота, рвота; частота неизвестна – стриктуры слепой, толстой и подвздошной кишки (фиброзирующая колонопатия);
• from the skin and subcutaneous tissues: uncommon (from ≥ 1/1000 to< 1/100) – сыпь; частота неизвестна – крапивница, зуд;
• from the immune system**: frequency unknown - hypersensitivity reactions (anaphylactic reactions);
• from the metabolic side: with long-term use of the drug in high doses - hyperuricosuria, in excessively high doses - an increase in the level of uric acid in the blood plasma;
• other: in children, when using the drug in high doses, perianal irritation occurs.

* Gastrointestinal disorders are associated primarily with the underlying disease. The incidence of diarrhea and abdominal pain was similar to or lower than with placebo. Fibrosing colonopathy has been observed in patients with cystic fibrosis taking high doses of pancreatin.

** Allergic reactions occurred more often on the skin, but other manifestations of allergies were also observed.

Overdose

An overdose of pancreatin can manifest itself in the form of hyperuricosuria and hyperuricemia. In this case, the drug is discontinued and symptomatic therapy is carried out.

Special instructions

Due to chewing and crushing of minimicrospheres or their mixing with food/drinks with a pH greater than 5.5, their protective enteric coating may be destroyed and, as a result, early release of enzymes in the oral cavity, irritation of the mucous membranes and a decrease in the effectiveness of pancreatin. Therefore, when using minimicrospheres without a capsule shell, you must ensure that they are all swallowed and nothing is left in the mouth.

During treatment, it is important to ensure constant sufficient fluid intake, especially if there is increased fluid loss. Inadequate fluid intake may cause or worsen constipation.

Patients with cystic fibrosis receiving high doses of pancreatin are at risk of developing fibrosing colonopathy. Therefore, the dose should be adequate to the amount of enzymes necessary for the absorption of fats, taking into account the quantity and quality of food in the diet, and, if possible, should not exceed 10,000 IU/kg per day (in terms of lipase). If unusual symptoms or changes in the abdominal cavity occur, a medical examination is indicated, especially in patients taking Creon 10,000 in daily doses greater than 10,000 units/kg.

Disorders of the digestive system may occur in patients with individual hypersensitivity to pancreatin, patients with meconium ileus and a history of intestinal resection.

Impact on the ability to drive vehicles and complex mechanisms

According to the instructions, Creon 10000 does not have a significant negative effect on the ability to work with complex mechanisms, drive a car and perform work that requires attentiveness and speed of reactions.

Use during pregnancy and lactation

In animal studies, no toxic effects on reproductive function and fetal development were detected, but there is no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes of porcine origin, so the drug is prescribed to them with caution if the expected benefit outweighs the potential risks.

Considering the results of animal studies, in which no negative effects of pancreatic enzymes were detected, there is also no suggestion of a harmful effect of Creon 1000 on an infant through mother's milk. In this regard, the drug can be taken during lactation.

Both pregnant and breastfeeding women are advised to take the drug in moderate doses sufficient to maintain adequate nutritional status.

Use in childhood

The use of Creon 10000 in childhood is possible according to the recommended dosage regimen.

In children, the risk of constipation increases with high activity of the lipase contained in pancreatin, so the dose should be increased gradually.

Drug interactions

Interaction studies with pancreatin have not been conducted.

Pancreatin may reduce the absorption of concomitantly used iron supplements. Theoretically, it may reduce the clinical effectiveness of acarbose.

Analogs

Analogs of Creon 10000 are: Gastenorm forte, Gastenorm forte 10000, Creon 25000, Creon 40000, Creon Micro, Mezim 20000, Mezim forte, Mezim forte 10000, Mikrasim, Pangrol 25000, PanziKam, Panzim forte, Pancreazim, Pancreatin, Pancreatin forte, Pancreatin- LekT, Penzital, Enzistal-P, Ermital.

Terms and conditions of storage

Store in a tightly closed bottle, out of reach of children at temperatures up to 25 °C.

Shelf life – 2 years, after the first opening of the bottle – 3 months.