Pharmacodynamics. The preparation contains pancreatin from the pancreas of pigs in the form of enteric-coated (acid-stable) microtablets in gelatin capsules. the capsules dissolve quickly in the stomach, releasing microtablets according to a multi-dose principle, which ensures good mixing with the contents of the stomach, transport from the stomach along with its contents and, after release, a sufficient distribution of enzymes within the contents of the intestine. When microtablets enter the small intestine, the membrane quickly dissolves (at pH 5.5), releasing enzymes with lipolytic, amylolytic and proteolytic activity, which ensures the breakdown of fats, carbohydrates and proteins. the products of pancreatic digestion are then absorbed either immediately or after further hydrolysis by intestinal enzymes.
Pharmacokinetics. Animal studies did not reveal signs of unchanged enzyme absorption, and therefore classical pharmacokinetic studies were not carried out. Pancreatic enzyme supplements do not require absorption to be effective. On the contrary, their full therapeutic effect is manifested in the lumen of the gastrointestinal tract. Moreover, as proteins, they undergo proteolytic digestion, passing through the gastrointestinal tract, before being absorbed in the form of peptides and amino acids.
Preclinical data do not indicate appropriate acute, subchronic or chronic toxicity. No genotoxicity, carcinogenicity, or reproductive toxicity studies have been conducted.
Lack of exocrine pancreatic function in adults and children due to various diseases, including the following:
The dosage of the preparation is based on the individual needs of the patient and depends on the degree of indigestion and the composition of the food. to select an adequate individual dose, there are three doses of the preparation - Ermytal 10,000, Ermytal 25,000, Ermytal 36,000. The preparation is recommended to be taken during or immediately after a meal. capsules and microtablets should be swallowed whole without breaking or chewing, and washed down with sufficient liquid or consumed with a light snack. if the capsule cannot be swallowed whole (children and the elderly), it can be opened and microtablets can be added to liquid food that does not require chewing, for example, applesauce, liquid with a neutral or slightly acidic medium (yogurt, grated apple). such a mixture should be taken immediately and not stored.
During treatment with preparations Ermytal 10,000, Ermytal 25,000, Ermytal 36,000, it is very important to drink enough fluid, especially during the period of increased fluid loss. Fluid deficiency can cause constipation.
Dosing for cystic fibrosis. Based on recommendations from the Cystic Fibrosis Consensus Conference, US Cystic Fibrosis Association case-control studies, and UK case-control studies, the following general guidelines can be proposed for pancreatic enzyme replacement therapy.
The initial dose for children under the age of 4 years is 1000 U of lipase / kg of body weight at each meal and for children aged 4 years and older - 500 U of lipase / kg of body weight at each meal.
The dose should be selected individually, depending on the severity of the disease, control of steatorrhea and maintenance of proper nutritional status.
The maintenance dose for most patients should not exceed 10,000 IU of lipase / kg / day or 4000 IU of lipase per 1 g of fat consumed.
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.
The initial dose is 10,000 to 25,000 IU of lipase at each main meal. However, it is possible that some patients need higher doses to eliminate steatorrhea and maintain proper nutritional status. According to generally accepted clinical practice, it is believed that a minimum of 20,000 to 50,000 U of lipase should be taken with food. The dose for intake during the main meals (breakfast, lunch or dinner) can be from 25,000 to 80,000 IU of lipase, and with additional light meals between main meals, it should be half the individual dose.
Hypersensitivity to the active substance or any other component of the preparation.
When studying the effect of preparations containing pancreatin on patients, gastrointestinal disorders, mainly mild to moderate severity, were most often reported.
Adverse reactions noted during the study of the preparation are given below.
From the gastrointestinal tract: abdominal pain (gastrointestinal disorders were mainly associated with an existing disease), nausea, vomiting, constipation, bloating, diarrhea, narrowing of the ileocecal part of the intestine and colon (fibrosing colonopathy).
On the part of the skin and subcutaneous tissue: rash, itching, urticaria.
From the immune system: hypersensitivity (anaphylactic reactions).
Narrowing of the ileocecal portion 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, manifested by the skin and not only, were identified as side reactions during post-registration use.
Children. No specific adverse reactions have been established in children. The type of severity of adverse reactions in children with cystic fibrosis were similar to those in adults.
There was a narrowing of the ileocecal part of the intestine and colon (fibrosing colonopathy) in patients with cystic fibrosis who took high doses of pancreatin preparations.
As a preventive measure, it is recommended that in case of unusual abdominal symptoms or changes 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 U of lipase / kg / day.
Like other preparations of porcine pancreatin on the market today, Ermytal 10,000, Ermytal 25,000, Ermytal 36,000 are made from the tissue of the pancreas of pigs intended for food purposes. Although the risk of a preparation entering the human body 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 due to 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, patients with allergy to porcine proteins.
Use during pregnancy and lactation. Due to the fact that there are no data from clinical studies of 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 possibility of toxic effects on the reproduction and development of the fetus is not expected.
Since animal studies indicate the absence of systemic exposure to pancreatic enzymes in women during breastfeeding, any exposure to a breastfed baby is not predicted. Therefore, there are no contraindications to the use of pancreatic enzymes during breastfeeding.
If necessary, pregnant women or women who are breastfeeding can take the preparation in doses sufficient to ensure adequate nutritional status.
Children. Used in pediatric practice.
The ability to influence the reaction rate when driving or operating other mechanisms. The effect of the preparation 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 very high doses of pancreatin.
At a temperature not higher than 25 ° C.
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