Amylase, Lipase, Protease

Pharmacological properties

the preparation contains pancreatin from the pancreas of pigs in the form of enteric-coated microtablets in gelatin capsules. capsules quickly dissolve in the stomach, releasing microtablets according to the multi-dose principle, which ensures good mixing with the contents of the stomach, transportation from the stomach together with its contents and, after release, a sufficient distribution of enzymes inside the intestinal contents. when microtablets enter the small intestine, the membrane dissolves rapidly (at pH 5.5), releasing enzymes with lipolytic, amylolytic and proteolytic activity, which ensures the breakdown of fats, carbohydrates and proteins. pancreatic digestion products are then absorbed either immediately or after further hydrolysis by intestinal enzymes.

Pharmacokinetics Animal studies did not reveal signs of absorption of enzymes unchanged, and therefore, classical pharmacokinetic studies have not been conducted. Pancreatic enzyme supplements do not require absorption to achieve their effect. 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 digestive tract, before being absorbed in the form of peptides and amino acids.

Preclinical studies do not indicate appropriate acute, subchronic, or chronic toxicity. No studies of genotoxicity, carcinogenicity or toxic effects on reproduction have been conducted.

Indications

Insufficiency of exocrine pancreatic function in adults and children due to various diseases, including the following:

• cystic fibrosis;
• chronic pancreatitis;
• pancreatectomy;
• gastrectomy;
• pancreas cancer;
• gastrointestinal anastomosis operations (for example, Billroth II gastroenterostomy);
• Schwachman-Diamond syndrome;
• condition after an attack of acute pancreatitis and restoration of enteral or oral nutrition.

Application

The dosage of the drug is based on the individual needs of the patient and depends on the degree of digestion and food composition. To select an adequate individual dose, there are three doses of the drug - hermital 10,000, hermital 25,000, hermital 36,000. The drug 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 a sufficient amount of liquid or consumed with a light snack. if the capsule cannot be swallowed whole (children and elderly people), 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 the preparations Hermital 10 000, Hermital 25 000, Hermital 36 000 it is very important to consume a sufficient amount of fluid, especially during its increased loss. A fluid deficiency can cause constipation.

Dosing for cystic fibrosis. Based on the recommendations of the Conciliation Conference on Cystic Fibrosis, Case-Control Studies of the United States Cystic Fibrosis Association and Case-Control Studies in the UK, the following general recommendations can be made for pancreatic enzyme replacement therapy.

The initial dose for children under the age of 4 years is 1000 PIECES of lipase / kg body weight during each meal and for children from 4 years of age - 500 PIECES of lipase / kg body weight during each meal.

The dose should be selected individually, depending on the severity of the disease, control of steatorrhea and maintaining proper nutritional status.

The maintenance dose for most patients should not exceed 10,000 units of lipase / kg / day or 4,000 units of lipase per gram of consumed fat.

Dosage for other types of exocrine pancreatic insufficiency. The dose should be selected individually, depending on the degree of digestion and fat composition of the food.

The initial dose is from 10,000 to 25,000 units of lipase during 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 at least 20,000 to 50,000 units of lipase should be taken with food. The dose for meals during main meals (breakfast, lunch or dinner) can be from 25,000 to 80,000 units of lipase, and with additional light meals between main meals should be half the individual dose.

Contraindications

Hypersensitivity to the active substance or any other component of the drug.

Side effects

When studying the effect of drugs containing pancreatin on patients, gastrointestinal tract disorders, mostly of mild to moderate severity, were most often reported.

Adverse reactions noted during the study of the drug are given below.

From the gastrointestinal tract: abdominal pain (gastrointestinal disorders were mainly associated with the existing disease), nausea, vomiting, constipation, bloating, diarrhea, narrowing of the ileocecal section 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 section of the intestine and colon (fibrosing colonopathy) was reported in patients with cystic fibrosis who took high doses of pancreatin preparations (see SPECIAL INSTRUCTIONS).

Most allergic reactions that occur on the part of the skin and not only are identified as adverse reactions during post-registration use.

Children. Specific adverse reactions in children have not been established. The type of severity of adverse reactions in children with cystic fibrosis was similar to that in adults.

special instructions

A narrowing of the ileocecal section of the intestine and colon (fibrosing colonopathy) was observed 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 a change in the nature of the abdominal symptoms, seek medical advice to exclude the possibility of fibrosing colonopathy, especially if the patient takes more than 10,000 units of lipase / kg / day.

Like other porcine pancreatin preparations on the market today, Hermital 10 000, Hermital 25 000, Hermital 36 000 are made from pig pancreas intended for food purposes. Although the risk that an infectious agent gets into the human body with the drug 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, to date, not a single case of transmission of an infectious disease due to the use of pork pancreatin preparations has been recorded, although they have been used for a long time.

The drug should be used with caution in patients with renal failure, hyperuricemia, patients with allergies to proteins of porcine origin.

Use during pregnancy and lactation.Due to the fact that there are no data from clinical studies of the effect of pancreatic enzymes on pregnancy, the drug should be prescribed 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 a lack of systemic exposure to pancreatic enzymes in women during lactation, any effect on 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 drug in doses sufficient to ensure an adequate nutritional status.

Children. Used in pediatric practice.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. The effect of the drug on the ability to drive vehicles or work with other mechanisms is absent or insignificant.

Interactions

No interaction study was conducted.

Overdose

Cases of hyperuricosuria and hyperuricemia have been reported that have been associated with very high doses of pancreatin.

Storage conditions

At a temperature not exceeding 25 ° C.