Pangrol 10000, Capsules 10000 units 20 pcs

Pharmacodynamics

The active ingredient of Pangrol® 10000 is pancreatin, which is a powder from the pancreas of pigs. The enzymes in pancreatin help to break down fats, carbohydrates and proteins from food.

Pancreatin with proteolytic, amylolytic and lipolytic action compensates enzymatic insufficiency of the pancreas, improves functional state of the gastrointestinal tract and normalizes digestive processes.

Pharmacokinetics

The gelatin capsules of Pangrol® 10000 rapidly dissolve in the stomach, releasing mini-tablets covered with an enteric-soluble (acid-resistant) coating. Thus, the enzymes remain protected from inactivation in the acidic environment of the stomach. The form of the drug ensures that the mini-tablets are mixed with the intestinal contents and the enzymes are distributed evenly.

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

Indications

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

Active ingredient

Composition

Active substance:

Pancreatin – 153.5 mg with minimum activity: lipase 10000 UD, amylase 9000 UD, protease 500 UD;

Supplements:

croscarmellose sodium 5.12 mg,

Microcrystalline cellulose 8.52 mg,

hydrogenated castor oil 1.709 mg,

colloidal anhydrous silica 0.849 mg,

magnesium stearate 0.849 mg.

Shell composition:

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

30% dispersion – 25 mg,

triethylcitrate – 2.51 mg,

Qinoline yellow dye (E 104) – 0.2 mg;

Indigo carmine (E 132) – 0.002 mg.

How to take, the dosage

The dose of Pangrol® 10000 is adjusted individually according to the severity of the disease and the amount and composition of the food taken.

If not otherwise directed, it is recommended that adults take 2-4 capsules of Pangrol® 10000 with each meal, swallowing the capsules whole (not chewed), with plenty of fluid (e.g. a glass of water).

If the whole capsule is too difficult for the patient to swallow (e.g. in young children or the elderly) you may pour the capsule contents into a glass, for example by opening the cap and then taking the entire capsule (mini-tablets) with some liquid or added to a liquid food which 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 symptoms (e.g., decrease in 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 per each meal.

In cystic fibrosis the dose of Pangrol® 10000 depends on the body weight and should be 1000 lipase units/kg at each meal at the beginning of treatment for children under 4 years old and 500 lipase units/kg at each meal for children over 4 years old. 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 the drug is used at a dose greater than 10,000 lipase units/kg/day.

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

Pangrol® 10000 has no effect on performance of potentially hazardous activities requiring particular 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:The use of high doses of pancreatic enzymes may be accompanied by hyperuricosuria and hyperuricemia in patients with cystic fibrosis.

Treatment:drug withdrawal, 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® 10000 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 adverse 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