Treatment of exocrine pancreatic insufficiency in adults and children caused by various diseases, including the following, but not limited to this list:
The dosage of the preparation is based on the individual needs of the patient and depends on the severity of the disease and the composition of the food. the preparation is recommended to be taken during or immediately after a meal.
Capsules and minimicrospherical granules should be swallowed whole, without crushing or chewing, and with sufficient liquid during or after meals, including a light snack. If the patient cannot swallow the capsule whole (for example, children and elderly patients), it can be opened carefully and the minimicrospherical granules can be added to soft foods with an acidic medium (pH 5.5) that do not require chewing, or to liquids with an acidic medium (pH 5.5).
This can be applesauce or yogurt, or fruit juice with a pH of 5.5, such as apple, orange, or pineapple juice. This mixture should not be stored. Breaking and chewing the mini-spherical granules or adding them to food or liquids with a pH of 5.5 can destroy their protective intestinal lining. This can lead to premature release of enzymes in the oral cavity, as well as a decrease in the effectiveness of the preparation and irritation of the mucous membranes.
It is necessary to control that the preparation does not remain in the oral cavity.
During treatment with the preparations Kreon 10,000, Kreon 25,000, it is very important to consume a sufficient amount of fluid, especially during the period of its increased loss. Fluid deficiency can make constipation worse. Any mixture of mini-spherical granules with food or liquid should be taken immediately and not stored.
Dose for cystic fibrosis. Based on the recommendations of the Cystic Fibrosis Consensus Conference, Cystic Fibrosis Association case-control studies in the United States and the United Kingdom, the following general dosing recommendations for pancreatic enzyme replacement therapy can be proposed:
the initial dose for children under 4 years of age is 1000 units. lipase per 1 kg of body weight during each meal and for children aged 4 years and older - 500 units. lipase per 1 kg of body weight with each meal;
the dose should be selected individually, depending on the severity of the disease, control of steatorrhea and maintenance of proper nutritional status;
maintenance dose for most patients should not exceed 10,000 units. lipase per 1 kg of body weight per day or 4000 units. lipase per 1 g of consumed fat.
Dosing for other types of exocrine pancreatic insufficiency: the dose should be selected individually, depending on the degree of indigestion and the fat composition of the food. When eating, the necessary doses are 25,000–80,000 units. EF lipase and half the individual dose with a snack.
Children. Kreon can be used in children.
Hypersensitivity to the active substance or any other component of the preparation.
In clinical trials, the effect of Kreon has been studied in more than 900 patients. the most frequently reported gastrointestinal disorders, predominantly from mild to moderate severity.
Adverse reactions that have been identified in clinical trials and their frequency are presented below.
From the gastrointestinal tract: very often (≥1 / 10) - abdominal pain *; often (≥1 / 100 to 1/10) - nausea, vomiting, constipation, bloating, diarrhea *; unknown frequency - narrowing of the ileocecal part of the intestine and colon (fibrosing colonopathy).
* Gastrointestinal disorders were mainly associated with an existing medical condition. Diarrhea and abdominal pain were reported at rates similar to or less than placebo.
Skin and subcutaneous tissue disorders: infrequently (≥1 / 1000 to 1/100) - rashes; unknown frequency - itching, urticaria.
From the immune system: unknown frequency - hypersensitivity (anaphylactic reactions).
Narrowing of the ileocecal part of the intestine and colon (fibrosing colonopathy) has been reported in patients with cystic fibrosis who have taken high doses of pancreatin preparations (see SPECIAL INSTRUCTIONS).
Most of the allergic reactions that manifested themselves on the part of the skin, but not only, were noted as adverse reactions during post-registration use. Since the reports of these reactions were spontaneous and received from an undetermined number of patients, the exact frequency of these reactions cannot be estimated.
Children. No specific adverse reactions have been established in children. The frequency, type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.
In patients with cystic fibrosis who received high doses of pancreatin preparations, narrowing of the ileocecal part of the intestine and colon (fibrosing colonopathy) was noted.
As a preventive measure, it is recommended that in the event of unusual abdominal symptoms or a change in the nature of abdominal symptoms, seek medical advice to exclude the possibility of fibrosing colonopathy, especially if the patient is taking more than 10,000 units. lipase / kg / day
Like other porcine pancreatin preparations on the market today, Kreon is made from porcine pancreatic tissue for food purposes. Although the risk that a pathogen will enter the human body with Kreon is reduced by testing and deactivating certain viruses during the manufacturing process, there is a theoretical risk of transmission of viral infections, including those caused by new or undefined viruses. The presence of swine viruses that can infect humans cannot be completely ruled out.
However, so far not a single case of transmission of an infectious disease has been recorded as a result of the use of porcine pancreatin preparations, although they have been used for a long time.
The preparation should be used with caution in patients with renal failure, hyperuricemia, and allergy to porcine proteins.
Application during pregnancy or lactation. Due to the lack of data from clinical studies regarding the effect of pancreatic enzymes on the course of pregnancy, the preparation should be administered with caution to pregnant women. Animal studies have shown no signs of pancreatic enzyme absorption. Thus, the potential for toxic effects on reproduction and development of the fetus is not expected.
Since animal studies indicate that there is no systemic exposure to pancreatic enzymes in a nursing mother, no effect on a breastfed baby is expected. Therefore, pancreatic enzymes can be used during breastfeeding.
If necessary, pregnant or breastfeeding women can take Kreon in doses sufficient to ensure adequate nutritional status.
The ability to influence the reaction rate when driving vehicles or other mechanisms. The effect of Kreon on the ability to drive vehicles or work with other mechanisms is absent or insignificant.
Interaction studies have not been conducted.
Cases of hyperuricosuria and hyperuricemia have been reported that have been associated with extremely high doses of pancreatin.
At a temperature not exceeding 25 ° C in a tightly closed package. Keep out of the reach of children.