Pangrol 25000 capsules 25000 units 50 pcs

The active ingredient of Pangrol® 25000 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 (GIT) and normalizes digestive processes.

Pharmacokinetics

The gelatin capsules of the drug Pangrol® 25000 rapidly dissolve in the stomach, releasing mini-tablets covered with an enteric-soluble (acid-resistant) coating. In this way, 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 evenly distributed. 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 with the feces.

Indications

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

– chronic pancreatitis;

– cystic fibrosis;

– pancreatic cancer;

p> – 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, flatulence, diarrhea (as part of combination therapy);

– narrowing of the pancreatic duct (e.g., due to a tumor or gallstones);

– Schwachman-Daimond syndrome;

– subacute pancreatitis;

– other diseases accompanied by exocrine pancreatic insufficiency.

Relative enzyme insufficiency in the following conditions and situations:

– GI disorders of a functional nature,

– in acute intestinal infections;

– in irritable bowel syndrome;

– consumption of difficult to digest vegetable or fatty foods.

Preparing for radiological and ultrasound examinations of the abdominal cavity.

Active ingredient

Composition

The contents of the capsule (enteric-coated mini-tablets)

The core:

The active ingredient:

Pancreatin -356.10 mg

with minimal activity:

lipase 25000 IU

amylase 22500 IU

protease 1250 IU

Associated substances: croscarmellose sodium – 11.87 mg, microcrystalline cellulose – 19.77 mg, hydrogenated castor oil – 3.96mg, colloidal anhydrous silica – 1.97 mg, magnesium stearate – 1.97 mg.

Capsule: methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion – 57.9 mg, triethylcitrate – 5.82 mg, simethicone 30% emulsion (dry weight) – 0.036 mg; talc – 11.63 mg;

Capsule: casing: Gelatin, 65.40 mg; titanium dioxide (E 171), 0.30 mg; iron oxide yellow dye (E 172), 0.30 mg; iron oxide red dye (E 172), 0.02 mg; lid: gelatin, 42.900 mg; titanium dioxide (E 171), 0.800 mg; quinoline yellow dye (E 104), 0.300 mg; indigo carmine (E 132), 0.003mg.

How to take, the dosage

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

If not otherwise directed, 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 swallow (e.g. in young children or elderly patients) the contents may be poured into a glass, for example by opening the cap and then taking the capsule contents (mini-tablets) with some liquid or added to a liquid food which does not require chewing (e.g. mashed potatoes 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 food composition at the rate of 500-1000 lipase units/kg of body weight per 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 fat consumed.

Interaction

Interaction studies have not been conducted

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, a medical examination should be performed to rule out colon involvement, especially if the drug is used in doses over 10,000 lipase units.

Impact on driving and operating ability

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

Contraindications

acute pancreatitis;

acute exacerbation of chronic pancreatitis;

Hypersensitivity to porcine pancreatin or other components of the drug.

Side effects

Possible side effects are listed below in descending frequency of occurrence: frequently (> 1/100, < 1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10000, < 1/1000), very rarely (< 1/10000), including individual reports.

Gastrointestinal disorders: frequent – 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; insufficient data to estimate the frequency of cases – itching, urticaria.

Overdose

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 was found, therefore no toxic effects on reproductive function and fetal development are expected.

Pangrol® 25000 usage in pregnancy is possible if the expected benefits for mother exceed the possible risk for fetus

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

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