Pancreatin 25 IU

Indications

Replacement therapy for exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, post-radiation condition, dyspepsia, cystic fibrosis.

Flatulence, non-infectious diarrhea, Remheld syndrome (gastrocardiac syndrome).

Malabsorption (post-resection state of the stomach and small intestine); to improve digestion in individuals with normal gastrointestinal function in case of dietary indiscretions (consumption of fatty foods, large amounts of food, irregular eating) and in cases of chewing dysfunction, sedentary lifestyle, prolonged immobilization.

Preparation for X-ray and ultrasound examination of the abdominal organs.

Method of administration and doses

Orally. The medication is taken during or after meals, without chewing and with a non-alkaline liquid (water, fruit juices). The dose is determined individually depending on the degree of digestive disturbance. Adults usually take 2-4 tablets 3-6 times a day. The maximum daily dose is 16 tablets. For children over 6 years old, the medication is used as prescribed by a doctor. The dose is determined individually. Usually, 1 tablet is prescribed 3 times a day. The duration of treatment can vary from several days (in case of digestive disturbances due to dietary indiscretions) to several months or years (when continuous replacement therapy is necessary).

Composition per tablet.
Active ingredient: Pancreatin – 100,000 mg
Excipients of the core: potato starch, gelatin, calcium stearate, lactose monohydrate (milk sugar).
Excipients of the coating: methacrylic acid and ethyl acrylate copolymer [1:1], talc, polysorbate (tween-80), povidone (kollidon 30), titanium dioxide (titanium dioxide), dye azorubine (acid red 2C, carmoisine, E 122).
Note. The amount of pancreatin in milligrams is indicated for the substance with protease activity of 250 U/g. In case of higher activity, the amount of pancreatin is correspondingly reduced and the amount of lactose monohydrate is increased.

Section: Description of the medicinal form

Tablets coated with a pink or dark pink color, biconvex in shape. A cross-section reveals two layers: the outer layer is pink or dark pink, and the inner layer ranges from white with a yellowish or brownish tint to brown with specks from light brown to dark brown. A specific odor is permissible.

Contraindications

Increased sensitivity to the components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis, age under 6 years. The drug contains lactose monohydrate, therefore its use is not recommended for patients with rare hereditary diseases associated with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

With Caution

In cystic fibrosis, the drug should be prescribed with caution, as the dose must be adequate to the quantity and quality of food consumed; the use of pancreatin in high doses is not recommended due to the increased risk of developing strictures (fibrous colonopathy). Criteria for an adequately adjusted dose: weight gain, normalization of stool (less than 3 times a day, normalization of consistency), reduction of abdominal bloating.

Special instructions

The dose of the drug should be adequate to the amount of enzymes necessary for the absorption of fats, taking into account the quality and quantity of food consumed.
With prolonged use, iron supplements should be prescribed simultaneously.

Side effects

Allergic reactions. Rarely - diarrhea, constipation, discomfort in the stomach area, nausea (the causal relationship between the development of these reactions and the action of pancreatin has not been established, as the mentioned phenomena are symptoms of exocrine pancreatic insufficiency). With prolonged use in high doses, the development of hyperuricosuria and hyperuricemia is possible. In cystic fibrosis, exceeding the necessary dose of pancreatin may lead to the development of strictures (fibrous colonopathy) in the ileocecal region of the ascending colon. When using pancreatin in high doses in children, perianal irritation and irritation of the mucous membrane of the oral cavity may occur.

Section: Overdose

Symptoms: hyperuricosuria, hyperuricemia. In children - constipation
Treatment: discontinuation of the drug, symptomatic therapy

Interaction

When using pancreatin, there may be a decrease in the absorption of iron and folic acid. Concurrent use of antacid agents containing calcium carbonate and/or magnesium hydroxide may lead to a reduction in the effectiveness of pancreatin.

Pharmacodynamics

Compensates for the deficiency of the exocrine function of the pancreas, exerts proteolytic, amylolytic, and lipolytic effects. The enzymes included in pancreatin (lipase, amylase, trypsin, chymotrypsin) contribute to the breakdown of proteins into amino acids, fats into glycerol and fatty acids, and starch into dextrins and monosaccharides. Improves the functional state of the gastrointestinal tract, normalizes digestive processes. Trypsin inhibits stimulated secretion of the pancreas, providing an analgesic effect.

Pharmacokinetics

Pancreatic enzymes are released from the dosage form in the alkaline environment of the small intestine, as they are protected from the action of gastric juice by a coating. Maximum enzymatic activity is observed 30-40 minutes after oral administration. A large portion of the enzymes is inactivated as a result of autolysis and proteolysis. A small amount of digestive enzymes is excreted through the intestine.

Description

Pancreatin 25 U is a preparation that contains a complex of enzymes necessary for normal digestion and absorption of food in the intestine. It is available in the form of enteric-coated tablets.

In conditions associated with a deficiency of digestive system enzymes, such as pancreatitis, metabolic disorders, pancreaticopathies, and others, the use of this preparation helps to normalize digestion and also reduces pain and discomfort in the stomach.

Pancreatin 25 U is taken during meals, with the tablet being swallowed with a small amount of liquid. It is recommended to take it according to the doctor's prescription and the instructions for the preparation.