Description
Release form
Capsules
Pharmacological action
Creon is an enzyme preparation that improves digestion. Pancreatic enzymes, which are part of the drug, facilitate the breakdown of proteins, fats and carbohydrates, which leads to their complete absorption in the small intestine. Creon® 10000 contains pork pancreatin in the form of minimicrospheres, enteric-coated (acid-resistant), in gelatin capsules. Capsules dissolve quickly in the stomach, releasing hundreds of minimicrospheres. This principle was developed with the aim of thoroughly mixing minimicrospheres with intestinal contents, and, ultimately, better distribution of enzymes after their release inside the intestinal contents. When the minimicrospheres reach the small intestine, the enteric membrane rapidly collapses (at pH> 5.5), and enzymes with lipolytic, amylolytic and proteolytic activity are released, which leads to the breakdown of fats, carbohydrates and proteins. The substances obtained as a result of cleavage are then either absorbed directly or are further hydrolyzed by intestinal enzymes.
Pharmacokinetics:
In animal studies, a lack of absorption of intact (non-split) enzymes has been demonstrated, as a result of which no classical pharmacokinetic studies have been conducted. Drugs containing pancreatic enzymes do not require absorption to manifest their effects. On the contrary, the therapeutic activity of these drugs is fully realized in the lumen of the gastrointestinal tract. According to 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
Replacement therapy for pancreatic exocrine pancreatic insufficiency in children and adults, caused by various diseases of the gastrointestinal tract and most common in: crd cystic pancreatitis
gastric pancreatic pancreatic pancreatic pancreatic surgery (e.g. Billroth II)
obstruction of the pancreatic ducts or common bile duct (e.g. due to neoplasm)
Schwachman – Diamond syndrome
condition after an attack of acute pancreatitis and the resumption of nutrition
To avoid complications, use only after consulting a doctor.
Contraindications
Hypersensitivity (including pork intolerance), acute pancreatitis, exacerbation of chronic pancreatitis.
Use during pregnancy and lactation
Pregnancy: There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. In animal studies, absorption of porcine pancreatic enzymes was not detected, therefore, toxic effects on reproductive function and fetal development are not expected. Pregnant women should be prescribed with caution if the intended benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding period: Based on animal studies, during which no systematic negative effect of pancreatic enzymes was revealed, no harmful effect of the drug on the infant through breast milk is expected. During breastfeeding, pancreatic enzymes can be taken. If necessary, during pregnancy or breastfeeding, the drug should be taken in doses sufficient to maintain an adequate nutritional status.
Specific instructions
Icreatic strictures of the ileum, cecum, and colon (fibrosing colonopathy) are described in patients with cystic fibrosis who received high doses of pancreatin preparations. As a precaution, if unusual symptoms or abdominal changes occur, 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, CreonВ® 10,000 is made from the pancreatic tissue of pigs specially grown for human consumption. Although the probability of transmission of an infectious agent to humans has been minimized by checking and inactivating certain viruses during production, 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 pig pancreatic extracts, not a single case of transmission of an infectious disease has been reported.
Composition
1 capsule contains: active substance: pancreatin 300 mg
excipients: macrogol 4000, paraffin liquid, hypromellose phthalate, dimethicone 1000, dibutyl phthalate
capsule shell composition: red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate, gelatin
Dosage and administration
Capsules are taken orally, washed down with water. Take half a dose or a third of it at the beginning of the meal, the rest – during. If swallowing is difficult, the capsule is carefully opened, and the contents are consumed with liquid or liquid food (the mixture cannot be stored). Crushing or chewing the contents of the capsule, or taking it with food, with a pH above 5.5, is prohibited.
Dose is determined individually depends on the severity of the symptoms of the disease and the composition of the diet.
It is recommended to prescribe at the beginning of treatment 1 to 2 capsules during each main meal, one capsule during each snack. An effective daily dose is approximately 4 to 15 capsules.
In cases of cystic fibrosis in children under 4 years of age, the dose for each meal should not exceed 500 PIECES of Ph. Eur./kg, and for older children – 1000 PIECES Ph. Eur./kg
During the course of taking the drug, it is necessary to ensure a constant sufficient intake of fluids.
Side effects of
Disorders of the gastrointestinal tract
Very often (? 1/10): pain in the abdomen. Often (? 1/100, less than 1/10): nausea, vomiting, constipation, bloating, diarrhea. Frequency is unknown: ileum, cecum, and colon strictures (fibrosing colonopathy). Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of adverse reactions such as abdominal pain and diarrhea was lower or similar to that with placebo. Iliac strictures, of the cecum and colon (fibrosing colonopathy) were observed in patients with cystic fibrosis who received high doses of pancreatin preparations.
Disorders of the skin and subcutaneous tissue: Infrequently (? 1/1000, less than 1/100): rash. Frequency unknown: pruritus, urticaria.
Immune System Disorders: Unknown frequency: Hypersensitivity (anaphylactic reactions). Allergic reactions were observed mainly from the skin, but other allergy manifestations were also noted. Messages about these side effects were received during the period of post-marketing use and were spontaneous. There is insufficient data to accurately assess the incidence of cases. When used in children, no specific adverse reactions were noted. Frequency, the type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.
Overdose of
Symptoms: hyperuricosuria and hyperuricemia.
Treatment: drug withdrawal, symptomatic therapy.
Storage conditions
Do not store above 25 C in a tightly closed container. Keep out of reach of children!
Deystvuyuschee substances
Pancreatin
Sardlkp pharmacy terms and conditions without a prescription
Medication NAIA form
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