Pangrol (Mezim Neo) enteric capsules 25,000 units 50 pcs. in Moscow

Enzyme preparation Indications Replacement therapy for insufficiency of exocrine pancreatic function in adults and children under the following conditions: - chronic pancreatitis; - cystic fibrosis; - pancreas cancer; — conditions after surgical interventions on the pancreas and stomach (complete or partial resection of the organ); — after irradiation of the gastrointestinal tract, accompanied by impaired digestion of food, flatulence, diarrhea (as part of combination therapy); - narrowing of the pancreatic duct (for example, due to a tumor or gallstones); - Shwachman-Diamond syndrome; - subacute pancreatitis; - other diseases accompanied by exocrine pancreatic insufficiency.

Relative enzyme deficiency in the following conditions and situations: - functional gastrointestinal disorders, - acute intestinal infections; - with irritable bowel syndrome; - consumption of indigestible plant or fatty foods.

Preparation for x-ray and ultrasound examinations of the abdominal organs.

Contraindications: acute pancreatitis; - exacerbation of chronic pancreatitis; - hypersensitivity to porcine pancreatin or other components of the drug.

Use during pregnancy and breastfeeding There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. Animal studies have not revealed the absorption of pancreatic enzymes of porcine origin, therefore toxic effects on reproductive function and fetal development are not expected.

Pangrol 10000 instructions for use

Active ingredients Pancreatin Latin name PANGROL 10000

Release form Enteric capsules

Packaging 20 pcs., 50 pcs.

Pharmacological action Pharmacodynamics The active ingredient of the drug Pangrol® 10000 is pancreatin, which is a powder from the pancreas of pigs. The enzymes that make up pancreatin help break down fats, carbohydrates and proteins coming from food. Pancreatin, having proteolytic, amylolytic and lipolytic effects, compensates for enzymatic insufficiency of the pancreas, improves the functional state of the gastrointestinal tract, and normalizes digestive processes.

Pharmacokinetics Gelatin capsules of the drug Pangrol® 10000 quickly dissolve in the stomach, releasing mini-tablets coated with an enteric (acid-resistant) coating. Thus, the enzymes remain protected from inactivation in the acidic environment of the stomach. The release form of the drug ensures mixing of mini-tablets with intestinal contents and uniform distribution of enzymes. Dissolution of the mini-tablet shell and activation of enzymes occurs at a neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed from the gastrointestinal tract and is excreted in the feces.

Indications Replacement therapy for insufficiency of exocrine pancreatic function in adults and children under the following conditions: chronic pancreatitis; cystic fibrosis; pancreas cancer; conditions after surgical interventions on the pancreas and stomach (complete or partial resection of the organ); after irradiation of the gastrointestinal tract, accompanied by impaired digestion of food, flatulence, diarrhea (as part of combination therapy); narrowing of the pancreatic duct, for example due to a tumor or gallstones; Shwachman-Diamond syndrome; subacute pancreatitis; other diseases accompanied by exocrine pancreatic insufficiency. Relative enzyme deficiency in the following conditions and situations: functional gastrointestinal disorders, acute intestinal infections, irritable bowel syndrome; consumption of indigestible plant or fatty foods; Preparation for x-ray and ultrasound examinations of the abdominal organs.

Contraindications Acute pancreatitis; exacerbation of chronic pancreatitis; hypersensitivity to porcine pancreatin or other components of the drug. Use during pregnancy and breastfeeding There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. Animal studies have not revealed the absorption of pancreatic enzymes of porcine origin, therefore toxic effects on reproductive function and fetal development are not expected. The use of Pangrol® 10000 during pregnancy is possible if the expected benefit to the mother outweighs the possible risk to the fetus. Based on animal studies in which no negative effects of pancreatic enzymes were detected, no harmful effects of the drug on the child through breast milk are expected. You can take pancreatic enzymes while breastfeeding.

Special instructions In patients suffering from cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, cecum and colon (fibrosing colonopathy) have been described. As a precautionary measure, if unusual symptoms appear or the nature of the symptoms of the underlying disease changes, a medical examination is necessary to exclude damage to the colon, especially when using the drug at a dose of more than 10,000 lipase units/kg/day.

Effect on the ability to drive vehicles and other mechanisms that require increased concentration of attention Pangrol® 10000 does not affect the performance of potentially hazardous activities that require special attention and speed of reaction.

Composition Active substance: pancreatin - 153.5 mg with minimal activity: lipase 10,000 units, amylase 9,000 units, protease 500 units; Excipients: croscarmellose sodium 5.12 mg, microcrystalline cellulose 8.52 mg, hydrogenated castor oil 1.709 mg, colloidal anhydrous silicon dioxide 0.849 mg, magnesium stearate 0.849 mg. Shell composition: methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersive - 25 mg, triethyl citrate - 2.51 mg, simethicone emulsion 30% (dry weight) - 0.015 mg; talc - 5.01 mg. Composition of the capsule body: gelatin - 36.20 mg, titanium dioxide (E 171) - 0.20 mg; iron dye yellow oxide (E 172) - 0.20 mg; red iron oxide dye (E 172) - 0.01 mg. Composition of the capsule cap: gelatin - 23.8 mg; titanium dioxide (E 171) - 0.4 mg; quinoline yellow dye (E 104) - 0.2 mg; indigo carmine (E 132) - 0.002 mg.

Method of administration and dosage The dose of Pangrol® 10000 is selected individually depending on the severity of the disease, as well as the volume and composition of food taken. Unless otherwise indicated, adults are recommended to take 2-4 caps. Pangrol® 10000 during each meal, swallowing the capsules whole (do not chew) with a sufficient amount of liquid (for example, a glass of water). If it is difficult for the patient to take a whole capsule (for example, in small children or elderly patients), you can pour its contents, for example, into a glass, opening the capsule by separating the cap from the body, and then take the contents (mini-tablets) with a small amount liquids or added to liquid foods that do not require chewing (such as applesauce or fruit juice). The mixture of mini-tablets with food or liquid cannot be stored (take immediately after preparation). Increasing the dose of the drug should be carried out only under the supervision of a physician, focusing on the dynamics of symptoms (for example, a decrease in steatorrhea, easing abdominal pain). It is not recommended to exceed the daily dose of enzymes, which is 15,000-20,000 lipase units/kg of body weight. The duration of treatment is determined by the doctor and depends on the course of the disease. For children, the dosage regimen and duration of treatment are determined by the doctor depending on the severity of the disease and the composition of the food at the rate of 500-1000 lipase units. /kg of the child’s body weight for each meal. For cystic fibrosis, the dose of Pangrol® 10000 depends on body weight and at the beginning of treatment should be 1000 lipase units/kg at each meal for children under 4 years of age, and 500 lipase units/kg at each meal for children over 4 years of age . The dose of the drug should be selected individually depending on the severity of the disease, under the control of steatorrhea and the support of an optimal diet. For most patients, the dose should be no more than 10,000 lipase units/kg/day or 4,000 lipase units/g fat consumed.

Side effects Possible side effects are listed below in descending frequency of occurrence: often (> 1/100, < 1/10); uncommon (> 1/1000, < 1/100); rare (> 1/10000, < 1/1000); very rare (<1/10000), including isolated reports. From the gastrointestinal tract: often - nausea, vomiting and bloating. Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of the following adverse reactions was lower or similar to those with placebo: very common - abdominal pain; often - diarrhea. From the skin and subcutaneous tissues: rarely - rash; itching, urticaria - there is not enough data to estimate the frequency of cases.

Drug interactions No interaction studies have been conducted.

Overdose Symptoms: The use of large doses of pancreatic enzymes may be accompanied by hyperuricosuria and hyperuricemia in patients with cystic fibrosis. Treatment: drug withdrawal, symptomatic therapy.

Storage conditions Store at a temperature not exceeding 25°C.

Shelf life: 2 years.

Side effects of the drug Pangrol

In some cases, immediate allergic reactions (skin rash, sneezing, lacrimation, bronchospasm). In cystic fibrosis, taking the drug in high doses can lead to the formation of strictures in the ileocecal region and the ascending colon. Constipation and intestinal obstruction are known complications in patients with cystic fibrosis. Therefore, if there are complaints characteristic of intestinal obstruction, the possibility of strictures along the intestinal tract should be taken into account. Also, with long-term use of the drug in high doses, hyperuricosuria may develop in cystic fibrosis, therefore, to prevent the formation of urate stones, it is necessary to control the level of uric acid in the urine.

Special instructions for the use of the drug Pangrol

It is not recommended to exceed the dose of enzymes necessary for sufficient absorption of fats, taking into account the amount and composition of food consumed, especially in cystic fibrosis. During use of the drug, sufficient fluid intake into the body is necessary. When treating patients with cystic fibrosis, one should remember a common complication - intestinal obstruction caused by the formation of intestinal strictures. The drug contains active enzymes that can damage the oral mucosa, so the tablets must be swallowed whole without chewing. The drug is not recommended for use in cases of congenital galactose intolerance, in patients with lactase deficiency or glucose/galactose malabsorption syndrome. Use during pregnancy and lactation. The drug is taken as prescribed by a doctor if the expected benefit to the mother outweighs the potential risk to the fetus/child. Use in children. Do not use in children under 3 years of age. The dose and duration of use of the drug in children over 3 years of age are determined by the doctor individually. The drug does not affect the ability to drive vehicles or operate machinery.

Indications for use of the drug Pangrol

Exocrine pancreatic insufficiency in chronic pancreatitis, cystic fibrosis; dyspeptic phenomena caused by simultaneous resection of the stomach and small intestine, functional disorders of intestinal motility (accelerated passage of chyme through the intestines), dyskinesia of the bile ducts, consumption of indigestible plant, fatty or unusual foods; flatulence; preparation for radiographic and sonographic examinations of the abdominal organs.

The use of enzyme preparations for digestive disorders in children

Digestion is a single, holistic process due to the close relationships between the activities of various parts of the digestive tract. Dysfunction of one part of the gastrointestinal tract, as a rule, leads to dysfunction of other organs. Different processes of absorption of nutrients occur in different parts of the digestive tract. In the stomach - protein breakdown, secretion of internal factor, oxidation of iron ions; in newborns - the breakdown of fats (formation of diglycerides under the action of gastric lipase). In the duodenum - entry of bile acids, emulsification of fat, breakdown of triglycerides, formation of mono- and diglycerides, breakdown of starch and disaccharides, breakdown of protein, absorption of monosaccharides, amino acids, iron, calcium, zinc, magnesium. In the jejunum - breakdown of disaccharides; absorption of monosaccharides, monoglycerides, bile acids, fat-soluble vitamins, folate, calcium, iron, magnesium, zinc, vitamin B12. In the ileum - absorption of bile salts, water, sodium, and the main amount of vitamin B12. In the large intestine - absorption of water, potassium, sodium, calcium, bile salts.

An important digestive organ in the body is the pancreas (PG), which performs an exocrine function. When food enters the gastrointestinal tract, the pancreas secretes into the small intestine not only pancreatic enzymes, but also bicarbonates, which neutralize hydrochloric acid and maintain an alkaline environment in the duodenum, necessary for the normal functioning of pancreatic enzymes. Under physiological conditions, the pancreas produces from 50 to 2500 ml of secretion per day, depending on the age of the person and the nature of the incoming food. Pancreatic juice is a colorless liquid with an alkaline reaction (pH 7.8–8.4). It contains organic substances (proteins) and inorganic components (bicarbonates, electrolytes, trace elements), as well as mucus of the excretory ducts. The enzymatic part of the secretion is formed in acinar cells, and the liquid (water-electrolyte) part - mucin and bicarbonates - by the ductal epithelium. With the help of pancreatic enzymes (lipase, amylase and proteases), which play a key role in the exocrine function of the pancreas, the breakdown of nutrients occurs. Most of them are in an inactive form - these are proenzymes that are activated in the duodenum by enterokinase. Lipase, amylase and ribonuclease are secreted in active form. This mechanism determines the activity of pancreatic juice in the intestinal cavity, which, in turn, protects pancreatic tissue from autolysis.

Digestive enzymes of the pancreas have their own targets: amylase - α-1,4-glycosidic bonds of starch, glycogen; lipase - triglycerides (formation of di-monoglycerides and fatty acids); phospholipase A - phosphatidylcholine (formation of lysophosphatidylcholine and fatty acids); carboxylesterase - cholesterol esters, esters of fat-soluble vitamins, tri-, di-, monoglycerides; trypsin - internal protein bonds (basic amino acids); chymotrypsin - internal protein bonds (aromatic amino acids, leucine, glutamine, methionine); elastase - internal bonds of proteins (neutral amino acids); carboxypeptidase A and B - external bonds of proteins, including aromatic and neutral aliphatic amino acids (A) and basic (B) amino acids from the carboxyl end.

The last four enzymes are secreted by the pancreas in an inactive form (proenzymes) and are activated in the duodenum.

Exocrine pancreatic dysfunction is observed in various hereditary and acquired diseases and may be caused by impaired formation of pancreatic enzymes or their activation in the small intestine. Due to pancreatic dysfunction, accompanied by enzyme deficiency, a disorder of food digestion (maldigestion) and absorption of nutrients (malabsorption) in the intestine develops.

Maldigestion in children is caused by a number of disorders.

Decreased activity of pancreatic enzymes. It can be caused by chronic or acute pancreatitis, cystic fibrosis, congenital pathology of the pancreas - morphological anomalies of the pancreas (abberant pancreas, ring-shaped pancreas, stenosis of the papilla of Vater or sphincter of Oddi, cysts, bifurcated pancreas), hereditary syndromes accompanied by congenital pancreatic insufficiency (Shwachman syndrome). Diamond, pancreatic insufficiency syndrome with multiple anomalies, deafness and dwarfism (Iohanson-Bizzard), pancreatic insufficiency syndrome with vacuolation of bone marrow cells and sideroblastic anemia (Pearson); isolated enzymatic deficiency (lipase - Sheldon-Rey syndrome; amylase, trypsin, enterokinase) , as well as pancreatic trauma, pancreatic carcinoma, primary sclerosing cholangitis.
Bile acid deficiency in the small intestine associated with functional disorders of the biliary tract, hepatitis, liver cirrhosis, biliary obstruction.
Violation of cholecystokinin synthesis caused by damage to the duodenal bulb (chronic duodenitis, chronic gastroduodenitis).
Inactivation of pancreatic enzymes in the small intestine as a result of intestinal dysbiosis or rapid passage of food.
Impaired mixing of enzymes with food chyme associated with gastro- and duodenostasis.

The cause of malabsorption is a violation of the activity of the secretion of intestinal enzymes, caused by disaccharidase deficiency, a gastrointestinal form of food allergy, a violation of intracellular digestion (celiac disease, Crohn's disease, enteritis, etc.), a violation of the transport of absorbed substances (exudative enteropathy, lymphoma, tumors, tuberculosis).

It is known that the pancreas has great compensatory capabilities, and disorders of pancreatic secretion appear only in cases of severe damage to the gland. There is an opinion that severe steatorrhea and creatorrhea in adults develop in cases where the secretion of pancreatic lipase and trypsin decreases by more than 90%. However, such a threshold has not been established in children.

The causes and mechanisms of development of exocrine pancreatic insufficiency are varied. There are absolute pancreatic insufficiency, caused by a decrease in the volume of functioning pancreatic parenchyma, and relative, which can be associated with various diseases of the gastrointestinal tract.

If symptoms indicating exocrine pancreatic insufficiency are identified, it is necessary to begin replacement therapy with pancreatic enzymes as early as possible, before malabsorption begins to develop.

Clinical signs of exocrine pancreatic insufficiency are:

stomach ache,
loss of appetite,
flatulence,
unstable chair,
steatorrhea,
nausea,
recurrent vomiting,
general weakness,
weight loss,
decreased physical activity,
growth retardation (in severe forms).

There are quite a large number of methods for assessing the digestive capacity of the gastrointestinal tract.

Determination of the content of pancreatic enzymes in the blood and urine. In acute pancreatitis, the level of amylase in the blood and urine can increase 5-10 times; the level of amylase and lipase in the blood during exacerbation of chronic pancreatitis can be normal or increase for a short time by 1-2 times (from several hours to several days), determination of elastase-1 in the blood plasma, the level of its increase reflects the severity of pancreatitis. The development of hyperenzymemia depends on the period and severity of pancreatitis.
Scatological research. It should be recognized that scatological research has not lost its relevance to this day and is the most accessible method. It should be carried out before prescribing pancreatic enzymes to the patient. However, the accuracy of this method is also influenced by the state of intestinal motility, the volume of bile secreted into the intestinal lumen, its qualitative composition, the presence of inflammatory processes in the intestine, etc.

In case of digestive disorders, the following symptoms are identified: steatorrhea - the presence of neutral fat in the stool (type 1 steatorrhea); fatty acids, soap (type 2 steatorrhea); both (steatorrhea type 3); creativeorrhea - may be a sign of a violation of the exocrine function of the pancreas. Normally, there are very few muscle fibers in feces; amilorrhea - the presence of a large number of starch grains in the stool - indicates a violation of the breakdown of carbohydrates; It is rarely detected in patients with pancreatic insufficiency, since starch hydrolysis is practically not impaired due to the high activity of intestinal amylase. The earliest sign of exocrine pancreatic insufficiency is steatorrhea; creatorrhoea appears somewhat later. Amilorrhea is rarely observed in exocrine pancreatic insufficiency.

Study of the content of pancreatic enzymes in duodenal secretions. The method allows you to determine the type of secretion: normosecretory, hypersecretory, hyposecretory or obstructive. The identified types of secretion reflect different degrees of functional and morphological changes in the pancreas, which allows differentiated treatment measures.
Quantitative determination of fat in feces (stool lipid profile). This method makes it possible to summarize the total amount of fat in feces, taking into account fat of exogenous (food) origin. Normally, the amount of fat excreted in feces should not exceed 10% of the fat introduced with food. In diseases of the pancreas, the amount of fat excreted in feces sometimes increases to 60%. The method can be used to clarify the nature of steatorrhea and assess the effectiveness of enzyme therapy.
Determination of elastase-1 content in feces. Elastase-1 is a proteolytic enzyme of the pancreas. It is known that human pancreatic elastase does not change its structure as it passes through the gastrointestinal tract. This method has certain advantages over those used today in the diagnosis of exocrine pancreatic insufficiency (fecal lipidogram, coprogram, determination of chymotrypsin in feces) due to the high specificity of the method (93%), its non-invasiveness and the lack of influence of enzyme preparations on the results of the elastase test.

Enzyme preparations were first used in gastroenterological practice about 100 years ago. Digestive enzymes are currently widely used for various gastroenterological pathologies. Despite the variety of manifestations of enzymatic digestive disorders, the main direction of treatment for such patients is enzyme replacement therapy. Currently, a large number of enzyme preparations are used in clinical practice, characterized by different combinations of components, enzyme activity, production method and release form. When choosing an enzyme preparation in each specific case, the doctor must first of all pay attention to its composition and the activity of its components.

There are two directions of action of enzyme preparations:

primary - hydrolysis of food substrates, which is the basis for prescribing enzymes as replacement therapy for exocrine pancreatic insufficiency;
secondary - reduction of abdominal pain syndrome (with pancreatitis), dyspepsia (feeling of heaviness, flatulence, belching, stool disorders, etc.).

Indications for prescribing enzyme therapy are:

impaired secretion of pancreatic enzymes;
maldigestion and malabsorption syndrome;
motility disorders of the gastrointestinal tract.

Classification of enzyme preparations

The following groups of enzyme preparations are distinguished.

Preparations containing pancreatin (pancreatin, penzital, mezim forte, panzinorm forte - N, creon, pancitrate).
Preparations containing pancreatin, bile components, hemicellulase and other components (festal, digestal, enzistal, panzinorm forte).
Herbal preparations containing papain, rice fungus extract and other components (pepphys, oraza).
Combined enzymes containing pancreatin in combination with plant enzymes, vitamins (wobenzym, phlogenzyme).

Despite the fact that there are currently many pancreatic enzyme preparations in the doctor’s arsenal, it is still not always possible to select adequate enzyme replacement therapy in patients with severe forms of pancreatic insufficiency. The instability of many enzymes in an acidic environment remains a serious problem.

Products containing pancreatin include lipase, amylase, proteases. The raw material for the preparation of these drugs is the pancreas of pigs and cattle. When choosing enzyme preparations, it is necessary to take into account the level of enzymes included in their composition (Table 1).

Preparations containing pancreatic enzymes can be used either continuously, as replacement therapy, or once, with a high food load. The dose is selected individually and depends on the severity of clinical and laboratory parameters of exocrine pancreatic function. The effectiveness of the dose is judged by clinical (disappearance of abdominal pain, normalization of stool frequency and character) and laboratory indicators (disappearance of steatorrhea and creatorrhoea in the coprogram, normalization of triglycerides in the stool lipidogram).

Enzyme-containing preparations, along with pancreatin, may contain bile acids, hemicellulase, plant choleretic components (turmeric), simethicone, etc. (Table 2). The main indication for the use of drugs in this group in children is dysfunction of the biliary tract (hypomotor dyskinesia). Bile acids and salts increase the contractile function of the gallbladder, normalize the biochemical properties of bile, and also regulate the motility of the large intestine in children with constipation. They should be used during or immediately after meals (without chewing) 3-4 times a day in courses of up to 2 months. Enzymes of this group are not used for pancreatitis, as they contain bile components that enhance intestinal motility.

Bile acids included in the preparations increase pancreatic secretion and choleresis; stimulate intestinal and gallbladder motility.

Under conditions of microbial contamination of the intestine, deconjugation of bile acids occurs, and cyclic adenosine monophosphate of enterocytes is activated with the development of osmotic and secretory diarrhea. Bile acids enter the enteropathic circulation and are metabolized in the liver, increasing the load on it. In addition, bile acids can have a direct damaging effect on the intestinal mucosa.

Hemicellulase ensures the breakdown of polysaccharides of plant origin (digestible fiber) and reduces gas formation.

Contraindications to the use of enzyme preparations containing bile components:

acute pancreatitis;
chronic pancreatitis;
acute and chronic hepatitis;
diarrhea;
peptic ulcer of the stomach and duodenum;
inflammatory bowel diseases.

Enzyme preparations of plant origin containing papain, rice fungus extract and other components can be used to correct exocrine pancreatic insufficiency. They are made from plant materials.

The group of enzyme preparations of plant origin includes:

Nigedase - plant lipase (Nigella damascene) - 20 mg; the drug, due to the absence of proteo- and amylolytic enzymes in its composition, is prescribed in combination with pancreatin;
orase - a complex of amylolytic and proteolytic enzymes of fungal origin - Aspergillus oryzae (lipase, amylase, maltase, protease);
pepphys - fungal diastase - 20 mg, papain - 60 mg, simethicone - 25 mg;
solizym - lipase produced by the fungus Penicillum solution (20,000 units);
somilase—solizim and fungal L-amylase;
unienzyme - fungal diastase - 20 mg, papain - 30 mg, simethicone - 50 mg, activated carbon - 75 mg, nicotinamide - 25 mg;
Wobenzym - pancreatin - 100 mg, papain - 60 mg, bromelain - 45 mg, trypsin - 24 mg, chymotrypsin - 1 mg, rutoside - 50 mg;
merkenzyme - pancreatin - 400 mg, bromelain - 75 units, bile - 30 mg;
phlogenzyme - bromelain - 90 mg; trypsin - 48 mg, rutoside - 100 mg.

The preparations pepphys, unienzyme, wobenzym, merkenzyme and phlogenzyme contain bromelain - a concentrated mixture of proteolytic enzymes from the extract of fresh pineapple fruits and its branches. The effectiveness of bromelains does not depend on the amount of hydrochloric acid in the stomach (pH 3-8.0).

All of the listed enzyme preparations of plant origin are contraindicated in patients with fungal and household sensitization, and with bronchial asthma (A. A. Korsunsky, 2000). Solizim and somilase should not be prescribed if you are allergic to penicillin antibiotics.

Enzymes based on plant materials can be used to correct exocrine pancreatic insufficiency, especially in cases where the patient cannot tolerate pancreatic enzymes (allergy to pork, beef).

It should be noted that data have appeared in the literature indicating the low enzymatic activity of enzymes of plant and fungal origin (75 times less effective than drugs of animal origin), and therefore they have not found widespread use in pediatric practice.

Simple enzymes (betaine, abomin) do not belong to the group of pancreatic enzymes. The following drugs with proteolytic activity are currently registered:

abomin (combined preparation from the gastric mucosa of calves and lambs);
acidin - pepsin (the tablet contains 1 part pepsin and 4 parts betaine hydrochloride; when it enters the stomach, betaine hydrochloride is hydrolyzed and hydrochloric acid is released);
pepsidil (contains pepsin and peptones);
pepsin (a proteolytic enzyme obtained from the mucous membrane of pigs and lambs).

These drugs are obtained from the gastric mucosa of pigs, calves or lambs. The presence of pepsin, cathepsin, peptidases, and amino acids in the preparations promotes the release of gastrin, which is a regulatory polypeptide, and therefore drugs of this group can be prescribed for functional disorders of the gastrointestinal tract, for gastritis with secretory insufficiency, which is relatively rare in older children. These drugs are prescribed orally with meals.

These drugs should not be prescribed for exocrine pancreatic insufficiency.

The success of therapy for exocrine pancreatic insufficiency depends on many reasons. Recent studies have not found significant differences in effectiveness when taking enzyme preparations hourly and using them with meals. However, the most convenient and physiological for the patient is to take enzyme preparations with meals.

In the case of an adequately selected dose and form of the enzyme preparation, a significant improvement in the patient’s condition occurs. The criteria for the effectiveness of treatment are the disappearance of polyfecal matter, reduction or elimination of diarrhea, increase in body weight, disappearance of steatorrhea, amilorrhea and creatorrhoea. Creatorrhoea is usually the first to disappear during enzyme therapy. This may be due to the fact that the secretion of pancreatic protease persists slightly longer than lipase.

The dose of the enzyme preparation is selected individually during the first week of treatment, depending on the severity of exocrine pancreatic insufficiency. It is advisable to calculate the dose of the enzyme preparation based on lipase, starting with small dosages (1000 IU of lipase per kg of body weight per day). If there is no effect, the dose of the drug is gradually increased under the control of scatological studies. For severe exocrine insufficiency, 4000–5000 IU of lipase per kg of body weight per day is used in 3–4 doses. The duration of therapy is determined individually. Enzyme intake is stopped if clinical and scatological signs of maldigestion and malabsorption disappear.

Reasons for lack of effect with enzyme therapy:

insufficient dose of the drug;
loss of enzyme activity in the drug due to violation of shelf life;
inactivation of the enzyme in the stomach;
destruction of enzymes during intestinal dysbiosis with high colonization of the stomach and duodenum;
inactivation of enzyme preparations due to high “acidification” of the duodenum (to prevent this phenomenon, antacids and H2-histamine receptor blockers are prescribed);
incorrect diagnosis (type 2 steatorrhea; giardiasis, etc.);
violation of the drug regimen.

Despite the fact that with the help of enzyme preparations the degree of steatorrhea can be significantly reduced, its complete and permanent disappearance cannot always be achieved.

Factors that prevent the disappearance of steatorrhea:

malabsorption syndrome;
low micellar concentration of bile acids due to the fact that they are deposited in the pathologically acidic contents of the duodenum;
non-simultaneous release of enzymes from the stomach with food (microtablets or microspheres with a diameter of no more than 2.0 mm are transported from the stomach faster than tablets or dragees of large diameter);
sensitivity of lipase to the acidic contents of the stomach (up to 92% of the lipase included in “ordinary” enzymes is easily destroyed by hydrochloric acid).

Ways to overcome enzyme inactivation by gastric juice:

increasing the dose of the drug;
prescribing antacids (it must be remembered that antacids containing calcium or magnesium weaken the action of enzymes);
prescription of H2-blockers of histamine receptors.

Contraindications to the use of enzyme preparations:

acute pancreatitis (first 7-10 days);
exacerbation of chronic pancreatitis (during the first 3-5 days);
allergy to pork and beef products.

Currently, thanks to a large selection of pancreatic enzyme preparations, there is a real possibility of individual correction of digestive disorders in children with exocrine pancreatic insufficiency, functional disorders of the stomach, and biliary tract. Prescribing enzyme preparations requires a differentiated approach from the doctor in each specific case - it is necessary to take into account the mechanisms of development of the disease that led to disruption of the digestive processes.

N. A. Korovina , Doctor of Medical Sciences, Professor I. N. Zakharova , Doctor of Medical Sciences, Professor of RMAPO, Moscow

Use of the drug Pangrol

The dosage of the drug is strictly individual and is determined by the doctor in accordance with the severity of the digestive disorder. Usually take 1-2 capsules (Pangrol 20,000, Pangrol 25,000) or 2-4 capsules (Pangrol 10,000) before each meal. Depending on the type of food and the severity of the digestive disorder, the dose may be significantly higher; The dose is increased under the supervision of a physician and depending on the severity of the manifestations of digestive disorders (steatorrhea, pain syndrome). It is not recommended to exceed the maximum daily dose of enzymes for adults and children over 12 years of age, which is 15,000–20,000 IU of lipase per 1 kg of body weight. The question of increasing the dosage and duration of therapy is decided by the doctor on an individual basis. The question of the dosage of the drug and the duration of treatment for children aged 3–12 years is decided by the doctor; as a rule, the daily dose necessary to normalize stool is prescribed, but not more than 1500 units of lipase per 1 kg of body weight. Capsules/tablets are recommended to be taken without chewing, with a sufficient amount of liquid (1 glass of water or juice); If necessary, you can open the capsule containing the enteric mini-tablets and dissolve its contents in liquid to drink.

Pharmacological properties of the drug Pangrol

Pharmacodynamics . Pancreatin is a pancreatic enzyme that takes part in the digestion of proteins, fats and carbohydrates. The digestive activity of the drug is determined by the activity of the enzymes included in its composition. The determining factor is the enzymatic activity of lipase, as well as the trypsin content, while amylolytic activity is important only in the treatment of cystic fibrosis, since, even with a significant decrease in the secretory activity of the pancreas, amylase has sufficient activity. Pancreatin is a powder made from the pancreas of pigs, containing the main pancreatic digestive enzymes (lipase, amylase, trypsin, chymotrypsin), as well as other substances that do not have enzymatic activity. Pancreatic lipase cleaves fatty acids from the triacylglyceride molecule at positions 1 and 3. The resulting free fatty acids and 2-monoglycerides with the participation of bile acids are quickly absorbed in the upper part of the small intestine. Pancreatic lipase of animal origin, like human lipase, is not acid-resistant, therefore, at a pH value of ≤4, the inactivation of its lipolytic activity irreversibly increases. Activation of trypsin from trypsinogen occurs autocatalytically or under the influence of enterokinase of the small intestine, and trypsin, for its part, causes the activation of other proteolytic enzymes, cleaves peptide bonds in which lysine and arginine are involved, and thus, together with other enzymes, promotes the breakdown of proteins into amino acids and small peptides. It is assumed that stimulated pancreatic secretion is inhibited by a feedback mechanism under the influence of active trypsin in the upper part of the small intestine, which is associated with some analgesic effect of pancreatin preparations. The amylase enzyme quickly breaks down glucose-containing polysaccharides. The acid-resistant coating of the tablet/capsule protects enzymes sensitive to gastric juice when passing through the stomach from inactivation by hydrochloric acid. The dissolution of the membrane and the release of enzymes occurs in the small intestine in an environment optimal for the manifestation of their activity. Enzymes are not absorbed in the digestive tract; they act in the intestinal lumen. Pharmacokinetics. Due to the fact that pancreatin is not absorbed and not detected in blood plasma, it is not possible to provide data on its pharmacokinetics and bioavailability.