Pangrol 25000 capsules 25000 units 20 pcs

Pharmacodynamics

The active ingredient of Pangrol® 25000 is pancreatin, which is a powder from the pancreas of pigs.

Pancreatin enzymes help to break down fats, carbohydrates and proteins from food.

Pancreatin has proteolytic, amylolytic and lipolytic action; it compensates enzymatic insufficiency of the pancreas, improves functional condition of the gastrointestinal tract and normalizes digestive processes.

Pharmacokinetics

The gelatin capsules of Pangrol® 25000 quickly dissolve in the stomach, releasing mini tablets covered with an enteric-soluble (acid-resistant) coating.

This way the enzymes remain protected from inactivation in the acidic environment of the stomach. The form of release of the drug ensures that the mini-tablets are mixed with the intestinal contents and the enzymes are distributed evenly.

The dissolution of the coating of mini-tablets and enzyme activation occurs at neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed in the gastrointestinal tract and is excreted in the feces.

Indications

Pancreatic replacement therapy for exocrine function insufficiency in adults and children with the following conditions:

Active ingredient

Composition

Actives:

Pancreatin 356.10 mg with minimum activity: lipase 25000 units; amylase 22500 units; proteases 1250 units.

Auxiliary substances:

croscarmellose sodium 11.87 mg,

microcrystalline cellulose 19.77 mg,

castor oil hydrogenated 3.96 mg,

colloidal anhydrous silica 1.97 mg,

magnesium stearate 1.97 mg

Composition of the enteric coating of the mini tablets:

Methacrylic acid and ethyl acrylate copolymer (1:1),

30% dispersion 57.9 mg,

triethyl acetate 5.82 mg,

emulsion of simethicone 30% (dry weight) 0.036 mg,

talc 11.63 mg.

Capsule body composition:

gelatin 65.4 mg,

titanium dioxide (E171) 0.3 mg,
Iron oxide yellow dye (E172) 0.3 mg,

Red iron oxide dye (E172) 0.02 mg.

Capsule cap composition:

gelatin 42.9 mg,

titanium dioxide (E171) 0.8 mg,

p> quinoline yellow dye (E104) 0.3 mg,

indigo carmine (E132) 0.003 mg.

How to take, the dosage

The dose of Pangrol® 25000 is adjusted individually according to the severity of the disease and the volume and composition of the food taken.

Unless otherwise instructed, adults should take 1-2 capsules of Pangrol® 25000 with each meal, swallowed whole (not chewed), with plenty of fluid (e.g. a glass of water). If the whole capsule is difficult for the patient to take (e.g., in small children or elderly patients), the contents can be poured into a glass, for example, by opening the capsule by separating the cap from the body, and then taking the contents (mini-tablets) with some liquid or added to a liquid food that does not require chewing (e.g., applesauce or fruit juice). The mixture of mini-tablets with food or liquid should not be stored (take immediately after preparation).

Increasing the dose of the drug should only be done under the supervision of a physician, with reference to the dynamics of the symptoms (e.g., reduction of steatorrhea, less abdominal pain).

The daily dose of 15000-20000 lipase units/kg of body weight should not be exceeded.

The duration of treatment is determined by the physician and depends on the course of the disease.

In children the dosage regimen and duration of treatment are determined by the doctor depending on the degree of disease and the composition of food at the rate of 500-1000 lipase units/kg of body weight at each meal.

In cystic fibrosis, the dose of Pangrol® 25000 depends on body weight and should be 1000 lipase units/kg at each meal for children under 4 years of age at the start of treatment, and 500 lipase units/kg at each meal for children over 4 years. The dose of the drug should be adjusted individually depending on the severity of the disease, under control of steatorrhea and support for an optimal diet. In most patients, the dose should not exceed 10000 lipase units/kg/day or 4000 lipase units/g of fat consumed.

Interaction

There have been no interaction studies.

Special Instructions

Strictures of the ileum, cecum and colon (fibrosing colonopathy) have been described in patients with cystic fibrosis who have received high doses of pancreatin preparations. As a precautionary measure, if unusual symptoms occur or the nature of symptoms of the underlying disease changes, medical evaluation should be performed to rule out colonic involvement, especially if using the drug at doses over 10,000 lipase units/kg/day.

Impact on ability to drive vehicles and other mechanisms requiring high concentration

Pangrol® 25000 has no effect on performance of potentially dangerous activities requiring special attention and responsiveness.

Contraindications

Side effects

Possible side effects are listed below in descending frequency of occurrence:

Gastrointestinal disorders: frequently – nausea, vomiting and abdominal bloating. Gastrointestinal disorders are associated mainly with the underlying disease. The incidence of the following adverse reactions was lower or similar to that with placebo: very common – abdominal pain; common – diarrhea.

Skin and subcutaneous tissue: rarely – rash; itching, urticaria – there are not enough data to estimate the frequency of cases.

Overdose

Symptoms: Use of high doses of pancreatic enzymes may be accompanied by hyperuricosuria and hyperuricemia in patients with cystic fibrosis.

Treatment: withdrawal of the drug, symptomatic therapy.

Pregnancy use

There are no clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes. In animal studies no absorption of pancreatic enzymes of porcine origin has been detected, therefore no toxic effects on reproductive function and fetal development are expected.

The use of the drug Pangrol® 25000 in pregnancy is possible if the expected benefits to the mother exceed the possible risk to the fetus.

Based on animal studies in which no negative effects of pancreatic enzymes were found, no harmful effects of the drug on the baby through breast milk are expected. Pancreatic enzymes can be taken while breastfeeding.

Similarities