Description
Release form
Enteric-soluble capsules
Packaging
20 pcs.
Pharmacological action of
Pharmacodynamics of
The active substance of the drug Pangrol ® 25000 is pancreatin, which is a powder of pig pancreas. The enzymes that make up pancreatin contribute to the breakdown of fats, carbohydrates and proteins from food. Pancreatin, having a proteolytic, amylolytic and lipolytic effect, compensates for the enzymatic insufficiency of the pancreas, improves the functional state of the gastrointestinal tract, and normalizes digestion processes.
Pharmacokinetics
Pangrol ® 25000 gelatin capsules dissolve quickly in the stomach, releasing mini-tablets coated with an enteric (acid-resistant) coating. Thus, enzymes remain protected from inactivation in the acidic environment of the stomach. The form of the drug provides mixing of mini-tablets with intestinal contents and a uniform distribution of enzymes. Dissolution of the membrane of mini-tablets and activation of enzymes occurs at a neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed in the digestive tract, excreted in feces.
Indications
Replacement therapy for exocrine pancreatic insufficiency in adults and children in the following conditions:
chronic pancreatitis
cystic fibrosis
pancreatic cancer
condition after surgery in the pancreas or in the pancreas or in the pancreas , 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 biliary
stones
syndrome Schwachman-Diamond subacute pancreatitis
and other diseases of the gland
Relative enzyme deficiency in the following conditions and situations:
gastrointestinal tract disorders, acute intestinal infections,
irritable bowel syndrome
consuming indigestible plant or fatty foods
Preparation for radiological 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 lactation
There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. In animal studies, absorption of porcine pancreatic enzymes was not detected, therefore, toxic effects on reproductive function and fetal development are not expected.
The use of Pangrol ® 25000 during pregnancy is possible if the expected benefit to the mother outweighs the potential risk to the fetus.
Based on animal studies in which no negative effect of pancreatic enzymes was detected, no adverse effect of the drug on the baby through breast milk is expected. During breastfeeding, pancreatic enzymes can be taken.
Special instructions
In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, caecum and colon (fibrosing colonopathy) are described. As a precaution, when unusual symptoms appear or the nature of the symptoms of the underlying disease changes, a medical examination is necessary to rule out colon damage, especially if the drug is used at a dose of more than 10,000 lipase units / kg / day.
Influence on the ability to drive vehicles and other mechanisms that require an increased concentration of attention
Pangrol ® 25000 does not affect the performance of potentially hazardous activities that require special attention and speed of response.
Composition
Active substances:
pancreatin 356.10 mg with a minimum activity: lipases 25000 IU of amylase 2250 EDA.
Excipients:
croscarmellose sodium 11.87 mg,
microcrystalline cellulose 19.77 mg,
hydrogenated castor oil 3.96 mg,
silicon dioxide anhydrous 1.97 mg,
magnesium stearate 1.97 mg.
Composition of enteric-coated membrane of mini-tablets:
methacrylic acid and ethyl acrylate copolymer (1: 1),
30% dispersion 57.9 mg,
triethyl acetate 5.82 mg,
simethicone emulsion 30% (dry weight) 0.036 mg, srdlp 11.63 mg.
Capsule body composition:
gelatin 65.4 mg,
titanium dioxide (E171) 0.3 mg,
dye iron oxide yellow (E172) 0.3 mg,
dye iron oxide red (E172) 0.02 mg.
Composition of capsule caps:
gelatin 42.9 mg,
titanium dioxide (E171) 0.8 mg,
quinoline yellow dye (E104) 0.3 mg,
indigo carmine (E132) 0.003 mg.
Dosage and administration
The dose of Pangrol ® 25000 is selected individually depending on the severity of the disease, as well as the volume and composition of the food taken.
Unless otherwise indicated, adults should take 1-2 caps. Pangrol ® 25000 during each meal, swallowing whole (do not chew), drinking plenty of fluids (for example, a glass of water). If taking a whole capsule for a patient is difficult (for example, in young children or elderly patients), you can pour its contents, for example, into a glass, opening the capsule by separating the lid from the case, and then take the contents (mini-tablets) with a little liquid or add to chewable liquid foods (e.g. applesauce or fruit juice). A mixture of mini-tablets with food or liquid should not be stored (taken immediately after preparation).
An increase in the dose of the drug should be carried out only under the supervision of a doctor, while focusing on the dynamics of symptoms (for example, a decrease in steatorrhea, easing abdominal pain).
A daily dose of enzymes of 15,000-20000 lipase units / kg body weight is not recommended.
The duration of the course 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, based on 500-1000 lipase units / kg body weight of the child for each meal.
In case of cystic fibrosis, the dose of Pangrol ® 25000 depends on body weight and should be 1000 lipase units / kg at the beginning of treatment for each meal for children under 4 years old and 500 lipase units / kg during each meal for children over 4 years. The dose of the drug should be selected individually depending on the severity of the disease, under the control of steatorrhea and support for an optimal diet. In most patients, the dose should be no more than 10,000 lipase units / kg / day or 4,000 lipase units / g of consumed fat.
Side effects of
Possible side effects are listed below in descending incidence:
often (> 1/100, <1/10) infrequently (> 1/1000, <1/100) rarely (> 1/10000, < 1/1000) is very rare (< 1/10000), including individual messages. From the gastrointestinal tract: often – nausea, vomiting and bloating. Gastrointestinal disorders are mainly associated with the underlying disease. The frequency of occurrence of the following adverse reactions was lower or similar to those with placebo: very often – pain in the abdomen often – diarrhea. On the part of the skin and subcutaneous tissues: rarely – rash itching, urticaria – there is insufficient data to estimate the frequency of cases. Drug Interactions No studies have been conducted. overdose Symptoms: High doses of pancreatic enzymes may be associated with hyperuricosuria and hyperuricemia in patients with cystic fibrosis. Treatment: withdrawal of the drug, symptomatic therapy. Storage conditions Do not store above 25 ° C. active substance Pancreatin Conditions of release from drugstores Without prescription Lekarstvennaja form kapsul Berlin-Chemie / Menarini Germany
