04.10.2020

Creon 10 thousand units. Creon for children: instructions and features of use for each age. Terms of sale in pharmacies

ABBOTT PRODUCTS GmbH (Germany)

ATX: A09AA02 (Multienzymes (lipase, protease etc.))

Enzyme preparation

ICD: C25 Malignant neoplasm of the pancreatic E84 Cystose fibrosis K83.1 Zaging of the bile duct K85 acute pancreatitis K86.1 other chronic pancreatitis K86.8 Other clarified diseases of the pancreas (atrophy, stones, cirrhosis, fibrosis of the pancreas) K90.3 pancreat Thectic steatore K91 .1 Syndromes of the operated stomach K91.2 Malabsorption after surgery, not elsewhere classified

An enzyme preparation that improves digestion. Pancreatic enzymes, which are part of the drug, facilitate the digestion of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine.
Creon 10,000 capsules, containing pancreatin in the form of enteric-coated minimicrospheres, quickly dissolve in the stomach, releasing hundreds of minimicrospheres. The aim of this principle is to mix the mini-microspheres 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 destroyed (at pH>5.5), pancreatic enzymes are released with lipolytic, amylolytic and proteolytic activity, which leads to the breakdown of fats, carbohydrates and proteins.
The substances obtained as a result of splitting are then either absorbed directly or subjected to further hydrolysis by intestinal enzymes.

Indications

In animal studies, no absorption of whole (non-digested) enzymes has been demonstrated and, as a result, classical pharmacokinetic studies have not been performed. Preparations containing pancreatic enzymes

Contraindications

- hypersensitivity to any of the components of the drug.

Dosage

The drug is taken orally. The dose is determined 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, not broken...

Overdose

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

drug interaction

Studies on the interaction of the drug Creon 10,000 with other drugs have not been conducted.

Side effect

From the digestive system: very often (≥1 / 10) - pain in the abdomen; often (≥1/100, see full

During pregnancy and lactation

There are no clinical data on the use of drugs containing pancreatic enzymes during pregnancy. Prescribe Creon 10,000 during pregnancy with caution if the expected benefit to the mother outweighs the potential ...

Use in children

Application is possible according to the dosing regimen.

special instructions

In patients with cystic fibrosis treated with high doses of pancreatin preparations, strictures of the ileum and caecum and large intestine (fibrosing colonopathy) have been described. As a precautionary measure, if unusual symptoms or changes in...

Special admission conditions

use with caution during pregnancy, may be used while breastfeeding, may be used for children

Pharmacokinetics

In animal studies, no absorption of whole (non-digested) enzymes has been demonstrated and, as a result, classical pharmacokinetic studies have not been performed. Preparations containing pancreatic enzymes

Terms of dispensing from pharmacies

The drug is approved for use as a means of OTC.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C in a tightly closed package. Shelf life - 2 years.
After the first opening of the vial, the shelf life is 3 months.

Release form

Enteric-soluble hard gelatin capsules, size No. 2, with a colorless transparent body and a brown opaque cap; the contents of the capsules are minimicrospheres of light brown color.
1 caps.
pancreatin
150 mg
which matches...

Dear doctors!

If you have experience in prescribing this drug to your patients - share the result (leave a comment)! Did this medicine help the patient, did any side effects occur during treatment? Your experience will be of interest to both your colleagues and patients.

Dear patients!

If you have been prescribed this medicine and have been on therapy, tell us if it was effective (helped), if there were any side effects, what you liked / did not like. Thousands of people search the Internet for reviews of various medicines. But only a few leave them. If you personally do not leave a review on this topic, the rest will have nothing to read.

Thank you very much!

Last update of the description by the manufacturer 08.08.2007

Filterable List

Active substance:

ATX

Pharmacological group

3D images

Composition and form of release

Creon ® 10000

Creon ® 25000

in a blister 10 pcs.; in a cardboard pack 2 blisters; in a blister 25 pcs.; in a pack of cardboard 2 or 4 blisters; in polyethylene bottles of 20 and 50 pieces; in a pack of cardboard 1 bottle.

Description of the dosage form

Bicolor hard gelatin capsules (brown opaque cap and clear colorless base).

Capsule contents: Beige enteric-soluble mini-microspheres.

pharmachologic effect

pharmachologic effect- replenishing the deficiency of pancreatic enzymes.

Pharmacodynamics

An enzyme preparation that improves digestion. Pancreatic enzymes, which are part of the drug, facilitate the breakdown of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine. Capsules containing enteric-coated mini-microspheres dissolve rapidly in the stomach, releasing hundreds of mini-microspheres. The aim of the multi-unit dose principle is to mix the mini-microspheres with the intestinal contents, and ultimately a better distribution of the enzymes after their release within the intestinal contents.

Pharmacokinetics

When the mini-microspheres reach the small intestine, the enteric coating breaks down, releasing enzymes with lipolytic, amylolytic, and proteolytic activities that promote the breakdown of fats, starches, and proteins.

Indications for Creon ® 10000

replacement therapy for insufficiency of exocrine pancreatic function in cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, duct obstruction (pancreatic ducts or common bile duct) due to neoplasm, Shwachman-Diamond syndrome, in old age;

symptomatic therapy of digestive disorders with partial resection of the stomach (Billroth-I / II), total gastrectomy; after cholecystectomy, with duodeno- and gastrostasis, biliary obstruction, cholestatic hepatitis, cirrhosis of the liver, pathology of the terminal part of the small intestine, excessive bacterial growth in the small intestine.

Contraindications

increased individual sensitivity to the components of the drug;

acute pancreatitis;

exacerbation of chronic pancreatitis.

Use during pregnancy and lactation

Due to the lack of sufficient data on the safety of the use of pancreatic enzymes in women during pregnancy and lactation, the drug should be prescribed to pregnant women and breastfeeding mothers only if the expected benefit to the mother outweighs the possible risk to the fetus or child.

Side effects

Allergic reactions, rarely - diarrhea, constipation, discomfort in the stomach, nausea.

Interaction

There are no reports of interaction with other drugs.

Dosage and administration

inside. The dose is selected individually depending on the severity of the disease and the composition of the diet. It is recommended to take 1/3 or 1/2 of a single dose at the beginning of a meal, the rest with a meal. When swallowing is difficult (for example, in young children or elderly patients), the capsules are carefully opened, and the mini-microspheres are added to liquid food that does not require chewing, or taken with liquid. Any mixture of Mini Microspheres with food or liquid should not be stored and should be taken immediately after preparation. Crushing or chewing mini-microspheres, as well as adding them to food with a pH above 5.5, leads to the destruction of their shell, which protects against the action of gastric juice.

In cystic fibrosis, the dose depends on body weight and is at the beginning of treatment in children under 4 years old - 1000 lipase units / kg for each meal, over 4 years - 500 lipase units / kg during meals. The dose depends on the severity of the symptoms of the disease, the results of the control of steatorrhea and the maintenance of a good nutritional status. In most patients, the dose should not exceed 10,000 IU/kg/day.

In other conditions accompanied by exocrine pancreatic insufficiency, the dose is set taking into account the individual characteristics of the patient (degree of indigestion, fat content in food). The dose with the main meal (breakfast, lunch and dinner) is 20,000-75,000 IU of lipase EF, while taking a light snack - 5,000-25,000 IU of lipase EF.

The usual initial dosage of Creon ® is 10,000-25,000 units of lipase EF with the main meal. To reduce steatorrhea and maintain the optimal condition of the patient, it is possible to increase the dose. According to the usual clinical practice, the patient should receive with food at least 20,000-50,000 units of lipase EF.

Overdose

Symptoms: hyperuricuria, hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

special instructions

In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum and caecum, colitis are described. In studies by the "case-control" method, no data were obtained indicating a relationship with Creon and the occurrence of fibrosing colonopathy. As a precautionary measure to rule out colonic involvement in patients with cystic fibrosis, it is recommended that any unusual symptoms or changes in the abdominal cavity be monitored, especially if the patient is taking more than 10,000 units of lipase/kg/day.

The drug does not affect the ability to drive a car and to control machines and mechanisms.

Storage conditions for Creon ® 10000

At temperatures not exceeding 25 °C, in tightly closed packaging.

Keep out of the reach of children.

Shelf life of Creon ® 10000

enteric capsules 10,000 IU - 2 years. After opening - 3 months.

capsules 300 mg - 3 years. After opening the package - 3 months.

Do not use after the expiry date stated on the packaging.

Synonyms of nosological groups

Category ICD-10	Synonyms of diseases according to ICD-10
C25 Malignant neoplasm of pancreas	VIPoma
	Glucagonomas
	Carcinoid tumor of the pancreas
	Locally advanced adenocarcinoma of the pancreas
	Inoperable pancreatic cancer
	Tumors of the pancreas
	Tumors of the pancreas, exocrine
	Tumors of the pancreas, endocrine
	Pancreas cancer
E84.1 Cystic fibrosis with intestinal manifestations	Cystic pneumatosis of the intestine
	Cystic fibrosis of the pancreas
	Fibrosis of the pancreas
K31.5 Duodenal obstruction	duodenal obstruction
K31.8 Other specified diseases of stomach and duodenum	Anacid state
K74 Fibrosis and cirrhosis of the liver	Inflammatory liver disease
	Cystic fibrosis of the liver
	Edema-ascitic syndrome in liver cirrhosis
	Precirrhotic state
	Cirrhosis of the liver with portal hypertension
	Cirrhosis of the liver with ascites
	Cirrhosis of the liver with ascites and edema
	Cirrhosis of the liver with portal hypertension
	Cirrhosis of the liver with portal hypertension and edematous-ascitic syndrome
	Cirrhosis of the liver with symptoms of portal hypertension
	Cirrhotic ascites
	Cirrhotic and precirrhotic state
K83.1 Obstruction of bile duct	Biliary obstruction
	Gallstone obstruction
	Itching with partial obstruction of the biliary tract
	Obstruction of the common bile duct
	Recurrent benign intrahepatic cholestasis
	cholestasis
	cholestatic hepatitis
	cholestatic syndrome
K86.1 Other chronic pancreatitis	Exacerbation of chronic pancreatitis
	Pancreatitis recurrent
	Pancreatitis with exocrine insufficiency
	Chronic pancreatitis
	Chronic pancreatitis
K86.8 Other specified diseases of pancreas	Blockage of the pancreatic and bile ducts
	Obstruction of the pancreatic ducts
	Fistula of the pancreas
K86.8.0* Pancreatic hypofunction, exocrine	Exocrine pancreatic insufficiency
	Hypofunction of the pancreas
	pancreatic dysfunction
	Violation of the exocrine function of the pancreas
	Pancreatic dysfunction
	Violation of the exocrine function of the pancreas
	Insufficiency of enzyme formation in the pancreas
	Pancreatic insufficiency
	Exocrine pancreatic insufficiency
	Pancreatopathy
	Shwachman-Diamond Syndrome
	Enzyme deficiency of the pancreas
K91.5 Postcholecystectomy syndrome	Condition after removal of the gallbladder
R54 Old age	External signs of aging
	age-related eye disease
	Age-related visual impairment
	Age related vascular disease
	age constipation
	Age-related changes in visual acuity
	Age-related involutional changes in the brain
	age disorders
	Age-related hearing loss
	Gerontological practice
	dementia senile
	Calcium and vitamin D3 deficiency in the elderly
	Brain disease of a vascular and age-related nature
	involutional depression
	Involutional depressions
	Correction of metabolism in the elderly and senile age
	Malnutrition in the elderly and senile age.
	Conduct disorders in the elderly
	Senile dementia
	Senile dementia
	Senile depression
	Senile colpitis
	Senile psychosis
	Age involutional syndrome
	Hearing loss age
	Aging
	Brain aging
	Body aging
	senile dementia
	Senile age
	Senile involutional psychosis
	senile psychosis
	Memory impairment in elderly patients
Z100* CLASS XXII Surgical practice	Abdominal surgery
	Adenomectomy
	Amputation
	Angioplasty of coronary arteries
	Angioplasty of the carotid arteries
	Antiseptic skin treatment for wounds
	Antiseptic hand treatment
	Appendectomy
	Atherectomy
	Balloon coronary angioplasty
	Vaginal hysterectomy
	Crown bypass
	Interventions on the vagina and cervix
	Bladder interventions
	Intervention in the oral cavity
	Restorative and reconstructive operations
	Hand hygiene of medical personnel
	Gynecological surgery
	Gynecological interventions
	Gynecological operations
	Hypovolemic shock during surgery
	Disinfection of purulent wounds
	Disinfection of wound edges
	Diagnostic interventions
	Diagnostic procedures
	Diathermocoagulation of the cervix
	Long-term surgery
	Replacement of fistula catheters
	Infection during orthopedic surgery
	Artificial heart valve
	cystectomy
	Brief outpatient surgery
	Short-term operations
	Short term surgical procedures
	Cricothyrotomy
	Blood loss during surgery
	Bleeding during surgery and in the postoperative period
	Culdocentesis
	Laser coagulation
	Laser coagulation
	Laser coagulation of the retina
	Laparoscopy
	Laparoscopy in gynecology
	CSF fistula
	Minor gynecological surgeries
	Minor surgical interventions
	Mastectomy and subsequent plasty
	Mediastinotomy
	Microsurgical operations on the ear
	Mucogingival operations
	Suturing
	Minor surgical interventions
	Neurosurgical operation
	Immobilization of the eyeball in ophthalmic surgery
	Orchiectomy
	Complications after tooth extraction
	Pancreatectomy
	Pericardectomy
	The period of rehabilitation after surgical operations
	The period of convalescence after surgical interventions
	Percutaneous transluminal coronary angioplasty
	Pleural thoracocentesis
	Pneumonia postoperative and post-traumatic
	Preparation for surgical procedures
Preparing for surgery
Preparation of the surgeon's hands before surgery
Preparing the colon for surgery
Postoperative aspiration pneumonia in neurosurgical and thoracic operations
Postoperative nausea
Postoperative bleeding
Postoperative granuloma
Postoperative shock
Early postoperative period
Myocardial revascularization
Resection of the apex of the tooth root
Resection of the stomach
Bowel resection
Uterine resection
Liver resection
Resection of the small intestine
Resection of a part of the stomach
Reocclusion of the operated vessel
Bonding tissue during surgery
Removal of stitches
Condition after eye surgery
Condition after surgery
Condition after surgical interventions in the nasal cavity
Condition after resection of the stomach
Condition after resection of the small intestine
Condition after tonsillectomy
Condition after removal of the duodenum
Condition after phlebectomy
Vascular surgery
Splenectomy
Sterilization of the surgical instrument
Sterilization of surgical instruments
Sternotomy
Dental operations
Dental intervention on periodontal tissues
Strumectomy
Tonsillectomy
Thoracic Surgery
Thoracic surgery
Total gastrectomy
Transdermal intravascular coronary angioplasty
Transurethral resection
Turbinectomy
Removal of a tooth
Cataract removal
Removal of cysts
Tonsil removal
Removal of fibroids
Removal of mobile milk teeth
Removal of polyps
Removal of a broken tooth
Removal of the body of the uterus
Suture removal
Urethrotomy
CSF fistula
Frontoethmoidogaimorotomy
Surgical infection
Surgical treatment of chronic leg ulcers
Surgery
Surgery in the anus
Surgical operation on the large intestine
Surgical practice
surgical procedure
Surgical interventions
Surgical interventions on the gastrointestinal tract
Surgical interventions on the urinary tract
Surgical interventions on the urinary system
Surgical interventions on the genitourinary system
Surgical interventions on the heart
Surgical manipulations
Surgical operations
Surgical operations on the veins
Surgical intervention
Surgical intervention on the vessels
Surgical treatment of thrombosis
Surgery
Cholecystectomy
Partial resection of the stomach
Transperitoneal hysterectomy
Percutaneous transluminal coronary angioplasty
Percutaneous transluminal angioplasty
Bypass coronary arteries
Tooth extirpation
Extraction of milk teeth
Pulp extirpation
extracorporeal circulation
Tooth extraction
Extraction of teeth
Cataract Extraction
Electrocoagulation
Endourological interventions
Episiotomy
Ethmoidectomy

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; inside the capsules, light brown mini-microspheres are visible (20, 50 and 100 pieces in white polyethylene bottles with a screw cap; in a pack of cardboard one bottle and instructions for use 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 enzymatic agent that improves the digestion of food in children and adults. As a result of the use of the drug, the severity of symptoms of enzyme deficiency is significantly reduced (the frequency and consistency of the stool changes, pain in the abdomen 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.

Pork pancreatin is contained in capsules of the drug in the form of minimicrospheres, which are coated with an acid-resistant shell. After dissolution of the capsules in the stomach, hundreds of minimicrospheres are released. Together with food, they enter the intestine, thoroughly mixed with intestinal contents, and then reach the small intestine, where the enteric membrane is rapidly 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 conducted, since pancreatic enzymes exert their therapeutic effect directly in the lumen of the small intestine before absorption. According to the chemical structure, these are proteins that break down in the gastrointestinal tract to amino acids and peptides, in the form of which they are absorbed into the intestinal wall.

Indications for use

Creon 10,000 is used in children and adults as a replacement therapy for pancreatic enzyme deficiency resulting from a decrease in its enzyme activity due to a violation of the production of pancreatic enzymes, regulation of their secretion, delivery to the site of action and also increased destruction in the intestine. These 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 refeeding.

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

It is not always possible for young 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 is not subject to storage and must be taken immediately after mixing.

Chewing capsules or using a liquid or food with a pH level greater than 5.5 to mix with the minimicrospheres may result in disruption of the enteric coating and early release of enzymes in 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 fluids, especially when the need for it increases. Otherwise, constipation may occur or increase.

In cystic fibrosis, the dose of Creon 10,000 depends on the patient's body weight. Children under 4 years of age at the beginning of therapy are prescribed 1000 lipase units per kg of body weight at each meal. For children over 4 years of age and adults, the initial dose is 500 lipase units per kg of body weight during each meal. In the future, the dose of the drug is increased, taking into account the severity of the symptoms of the disease, controlling steatorrhea and maintaining an 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.

In other conditions with pancreatic enzyme deficiency, the dose of Creon 10,000 is set individually, taking into account the fat content in the meal and the degree of indigestion. At the main meal, the dose of pancreatin is 25,000-80,000 IU of lipase, during or after a light snack - 1/2 of an 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 an unknown frequency - anaphylactic reactions (mainly from the skin);
• skin and subcutaneous fat: infrequently - rash; with an unknown frequency - urticaria, pruritus.

Overdose

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

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

special instructions

If during therapy with the drug the patient develops changes in the abdominal cavity or other unusual symptoms, a medical examination should be carried out to exclude strictures of the caecum, ileum and colon. The likelihood of fibrosing colonopathy is increased in patients with cystic fibrosis receiving Creon 10,000 at a daily dose of 10,000 IU of lipase or more.

Influence on the ability to drive vehicles and complex mechanisms

The effect of the drug on the ability to drive vehicles is insignificant 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.

Application in childhood

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

drug interaction

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. Theoretically, it is possible to reduce the effectiveness of acarbose under the action of pancreatin.

Analogues

Creon 10,000 analogues 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, PanziKam, Micrasim, Creon Micro, Pancreazim, Pancreatin - LekT, Mezim forte, Pancreatin forte, Ermital, Panzim forte, Enzistal-P, etc.

Terms and conditions of storage

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

Shelf life - 2 years. Capsules from an opened vial must be used within 3 months.

P N 015581/01

Tradename: Creon ® 10000

International non-proprietary name or grouping name:

pancreatin

Dosage form:

enteric capsules

Compound:

1 capsule contains:

Active substance: pancreatin - 150 mg, which corresponds to: 10000 IU Evr.F. lipases, 8000 IU Evr.F. amylase, 600 IU Evr.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, iron dye red oxide (E 172) - 0.23 mg, iron dye yellow oxide (E 172) - 0.05 mg, iron dye black oxide (E 172) - 0.09 mg, titanium dioxide (E 171) - 0.07 mg, sodium lauryl sulfate - 0.12 mg.

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

caps and transparent colorless body.

The contents of the capsules are light brown minimicrospheres.

Pharmacotherapeutic group:

digestive enzyme remedy

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics

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

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

Pharmacokinetics

In animal studies, the absence of absorption of intact (non-digested) enzymes has been demonstrated, as a result of which classical pharmacokinetic studies have not been conducted. Preparations containing pancreatic enzymes do not require absorption to exert their effects. On the contrary, the therapeutic activity of these drugs is fully realized in the lumen of the gastrointestinal tract. They are proteins in their chemical structure and therefore undergo proteolytic cleavage as they pass through the gastrointestinal tract until they are absorbed as peptides and amino acids.

Indications for use

Replacement therapy for exocrine pancreatic insufficiency in children and adults. Exocrine pancreatic insufficiency is associated with a variety of diseases of the gastrointestinal tract and is most common in:

cystic fibrosis,

chronic pancreatitis,

After pancreatic surgery,

After gastrectomy,

pancreatic cancer,

Partial resection of the stomach (for example, Billroth II),

Obstruction of the ducts of the pancreas 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 pancreatin of porcine origin or to one of the excipients,

acute pancreatitis,

Exacerbation of chronic pancreatitis.

Use during pregnancy and during breastfeeding

Pregnancy

Clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes are not available. In animal studies, no absorption of porcine pancreatic enzymes has been detected, so toxic effects on reproductive function and fetal development are not expected.

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

Based on animal studies, during which there was no systematic negative effect of pancreatic enzymes, no harmful effect of the drug on the nursing child through breast milk is expected.

You can take pancreatic enzymes while breastfeeding.

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

Dosage and administration

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, not broken or chewed, with plenty of liquid.

When swallowing is difficult (for example, in young children or elderly patients), the capsules are carefully opened, and the minimicrospheres are added to a liquid food that does not require chewing and has 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 sufficient continuous fluid intake by the patient, especially with increased fluid loss. Inadequate fluid intake can lead to or worsen constipation.

Dose for Adults and Children with Cystic Fibrosis

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

The dose should be determined depending on the severity of the symptoms of the disease, the results of the control of steatorrhea and the maintenance of an 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 associated with exocrine pancreatic insufficiency

The dose should be determined taking into account the individual characteristics of the patient, which include the degree of indigestion and the fat content of the food. The dose required by the patient along with the main meal varies from 25,000 to 80,000 IU of lipase, and while taking a light snack, half the individual dose.

Side effects

Gastrointestinal disorders

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

Gastrointestinal disorders are associated mainly with the underlying disease. The incidence of the following adverse reactions was lower or similar to placebo: diarrhea (often, >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 allergy were also noted. Reports of these side effects were received during the period of post-marketing use and were of a spontaneous nature. The available data are insufficient to accurately estimate the incidence of cases.

Overdose

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

Interaction with other drugs

Interaction studies have not been conducted.

special instructions

In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, caecum, and large intestine (fibrosing colonopathy) have been described. In studies conducted using the case-control method, no data were obtained indicating a relationship between the occurrence of fibrosing colonopathy and the use of the drug Creon® 10000. As a precautionary measure, if unusual symptoms or changes in the abdominal cavity appear, a medical examination is necessary to rule out fibrosing 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 preparations of porcine pancreatin, Creon® 10000 is produced from the pancreatic tissue of pigs specially bred for human consumption. Although the risk of transmission of an infectious agent to humans has been minimized by screening and inactivation of certain viruses during the manufacturing process, there is a theoretical risk of transmission of a viral disease, including diseases caused by new or unknown viruses. The presence of swine viruses that can infect humans cannot be completely ruled out. However, over a long period of time using porcine pancreatic extracts, not a single case of transmission of an infectious disease has been registered.

Influence on the ability to drive a car and other mechanisms

The use of the drug Creon® 10000 does not affect or has a slight effect on the ability to drive a car and mechanisms.

Release form

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

Storage conditions

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

Best before date

Shelf life after the first opening of the vial - 3 months.

Do not use after the expiry date stated on the packaging.

Terms of 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 claims should be sent to:

LLC "Abbott Products" 119334, Russia, Moscow, st. Vavilov, d. 24.

You should consult your doctor before using CREON 10,000. These instructions for use are for informational purposes only. For more information, please refer to the manufacturer's annotation.

Clinical and pharmacological group

11.018 (Enzymatic preparation)

Release form, composition and packaging

Enteric-soluble hard gelatin capsules, 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, hypromellose phthalate, dimethicone 1000, cetyl alcohol, triethyl citrate.

The composition of the capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate.

20 pcs. - high-density polyethylene bottles (1) - cardboard packs. 50 pcs. - high-density polyethylene bottles (1) - cardboard packs. 100 pcs. - high-density polyethylene bottles (1) - cardboard packs.

pharmachologic effect

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

Creon® 10,000 capsules, containing pancreatin in the form of enteric-coated minimicrospheres, rapidly dissolve in the stomach, releasing hundreds of minimicrospheres. The aim of this principle is to mix the mini-microspheres 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 breaks down (at pH>5.5), pancreatic enzymes are released with lipolytic, amylolytic and proteolytic activity, resulting in the breakdown of fats, carbohydrates and proteins.

The substances obtained as a result of splitting are then either absorbed directly or subjected to further hydrolysis by intestinal enzymes.

Pharmacokinetics

In animal studies, no absorption of whole (non-digested) enzymes has been demonstrated and, as a result, classical pharmacokinetic studies have not been performed. Preparations containing pancreatic enzymes do not require absorption to exert their effects. On the contrary, the therapeutic activity of these drugs is fully realized in the lumen of the gastrointestinal tract. Moreover, they are proteins in their chemical structure and, therefore, during the passage through the gastrointestinal tract, they undergo proteolytic cleavage until they are absorbed in the form of peptides and amino acids.

CREON 10,000: DOSAGE

The drug is taken orally. The dose is determined 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, not broken or chewed, with plenty of liquid.

When swallowing is difficult (for example, in young children or elderly patients), the capsules are carefully opened, and the mini-microspheres are added to a liquid food that does not require chewing and has a sour taste, such as applesauce or fruit juice (pH

It is important to ensure sufficient continuous fluid intake by the patient, especially with increased fluid loss. Inadequate fluid intake can lead to or worsen constipation.

In cystic fibrosis, the initial dose of lipase for children under 4 years of age is 1000 IU / kg of body weight for each meal, for children over the age of 4 years and adults - 500 IU / kg of body weight for each meal. The dose should be determined depending on the severity of the symptoms of the disease, the results of the control of steatorrhea and the maintenance of good nutritional status. In most patients, the dose of lipase should not exceed 10,000 U/kg body weight/day or 4,000 U/g fat intake.

In other conditions accompanied by exocrine pancreatic insufficiency, the dose is set taking into account the degree of insufficiency of digestion and the fat content in food. The dose of lipase required by the patient along with the main meal varies from 25,000 to 80,000 IU Ph. Eur., while taking a light snack - half of the individual dose.

Overdose

Symptoms: hyperuricuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

drug interaction

Studies on the interaction of the drug Creon® 10,000 with other drugs have not been conducted.

CREON 10 000:
Pregnancy and lactation

There are no clinical data on the use of drugs containing pancreatic enzymes during pregnancy. Prescribe the drug with caution if the intended benefit to the mother outweighs the potential risk to the fetus.

In the course of experimental studies, no absorption of pancreatic enzymes of porcine origin was detected, therefore, toxic effects on reproductive function and fetal development are not expected.

During lactation (breastfeeding), you can take pancreatic enzymes, incl. preparation Creon® 10 000.

In the course of experimental studies, no systemic negative effect of pancreatic enzymes was detected, therefore, no harmful effect of the drug on an infant is expected when breastfeeding.

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

CREON 10 000: SIDE EFFECTS

From the digestive system: often (≥1 / 100,

Allergic reactions: rarely (≥ 1/1000,

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C in a tightly closed package. Shelf life - 2 years.

After the first opening of the vial, the shelf life is 3 months.

Indications

Replacement therapy for exocrine pancreatic insufficiency in children and adults, which is most common in the following conditions:

• cystic fibrosis;
• chronic pancreatitis;
• condition after surgery on the pancreas;
• after gastrectomy;
• pancreas cancer;
• partial resection of the stomach (for example,
• Billroth II);
• obstruction of the ducts of the pancreas or common bile duct (for example,
• due to neoplasm);
• Shwachman-Diamond syndrome.

Contraindications

• acute pancreatitis;
• exacerbation of chronic pancreatitis;
• hypersensitivity to pancreatin of porcine origin and other components of the drug.

special instructions

In patients with cystic fibrosis treated with high doses of pancreatin preparations, strictures of the ileum and caecum and large intestine (fibrosing colonopathy) have been described. In studies conducted using the case-control method, no data were obtained indicating a relationship between the occurrence of fibrosing colonopathy and the use of Creon® 10,000. As a precautionary measure, if unusual symptoms or changes in the abdominal cavity appear, a medical examination is necessary to rule out fibrosing colonopathy, especially in patients who take the drug at a dose (based on lipase) of more than 10,000 IU / kg body weight / day.

Influence on the ability to drive vehicles and control mechanisms

The use of the drug Creon® 10,000 does not affect or has a slight effect on the ability to drive a car and mechanisms.