Pangrol 25,000 capsules 20 pcs
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Active ingredients
Pancreatin
Release form
Capsules
Composition
; Pancreatin 356.10 mg, with minimal activity, lipase 25,000 U, amylase 22,500 U, protease 1250 U. Adjuvants: croscarmellose sodium 11.87 mg, microcrystalline cellulose 19.77 mg, castor oil, hydrogenated, 3.96 mg, anhydrous colloidal silicon dioxide, 1.97 mg, 15 mg, calcium, 15 g, anhydrous, 15 g, crystalline silica, anhydrous, anhydrous, 15 g, crystalline sodium hydroxide, anhydrous, anhydrous, anhydrous; mg.; The composition of the enteric shell of mini-pills: methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion 57.9 mg, triethylacetate 5.82 mg, simethicone emulsion 30% (dry weight) 0.036 mg, talc 11.63 mg; Capsule case : gelatin 65.4 mg, titanium dioxide (E171) 0.3 m g, iron dye yellow oxide (E172) 0.3 mg, iron dye red oxide (E172) 0.02 mg.; Cap of the cap: gelatin 42.9 mg, titanium dioxide (E171) 0.8 mg, quinoline yellow dye (E104) 0.3 mg, indigo carmine ( E132) 0.003 mg.
Pharmacological effect
; The active ingredient of the drug Pangrol 25000 is pancreatin, which is a powder from the pancreas glands. Enzymes that are part of pancreatin, contribute to the breakdown of fats, carbohydrates and proteins from food. Pancreatin, providing a proteolytic, amylolytic and lipolytic effect, compensates for the enzymatic insufficiency of the pancreas, improves the functional state of the gastrointestinal tract, normalizes digestive processes.
Pharmacokinetics
; Gelatin capsules of the drug Pangrol 25000 quickly dissolve in the stomach, releasing mini-pills coated with an enteric (acid-resistant) coating. Thus, the enzymes remain protected from inactivation in the acidic environment of the stomach. The release form of the drug provides mixing of mini-pills with intestinal contents and uniform distribution of enzymes. Dissolution of the mini-tablet shell and enzyme activation occurs at a neutral or weakly alkaline pH in the small intestine. Pancreatin is not absorbed in the gastrointestinal tract, excreted in feces.
Indications
Replacement therapy for pancreatic exocrine function insufficiency in adults and children in the following conditions: - chronic pancreatitis — cystic fibrosis — pancreatic cancer — 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 of food, flatulence, diarrhea (as part of combination therapy) - narrowing of the pancreatic duct (for example, due to a tumor or gallstones) - Shwachman-Diamond syndrome - subacute pancreatitis - other diseases accompanied by exocrine pancreatic insufficiency; enzyme deficiency in the following conditions and situations: - functional gastrointestinal disorders; - in acute intestinal infections - in irritable bowel syndrome - consumed preparation of hard-to-digestible plant or fatty foods; Preparation for X-ray and ultrasound of the abdominal organs.
Contraindications
- acute pancreatitis; - exacerbation of chronic pancreatitis; - hypersensitivity to pancreatin of porcine origin or other components of the drug.
Use during pregnancy and lactation
; Clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes are not available. Animal studies have not revealed absorption of pancreatic enzymes of porcine origin; therefore, no toxic effects on reproductive function and fetal development are expected. The use of the drug Pangrol 25000 during pregnancy is possible if the expected benefit to the mother outweighs the possible risk to the fetus. Based on studies in animals during which no negative effect of pancreatic enzymes was detected, no adverse effect of the drug on the baby through breast milk is expected. During lactation, pancreatic enzymes can be taken.
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 capsules. drug Pangrol 25000 during each meal, swallowing whole (not chewed), drinking enough liquid (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 cap from the case, and then take the contents (mini-pills),washing it down with a certain amount of liquid or adding to liquid food that does not require chewing (for example, apple sauce or fruit juice). A mixture of mini-pills with food or liquid can not be stored (taken immediately after preparation). Increasing the dose of the drug should be carried out only under the supervision of a physician, focusing on the dynamics of symptoms (for example, reduction of steatorrhea, easing pain in the abdomen). The daily dose of enzymes, which is 15,000-20000 lipase units / kg body weight, is not recommended to exceed. The duration of treatment is determined by the doctor and depends on the course of the disease. Children dosing regimen and duration of treatment is determined by the doctor depending on the severity of the disease and the composition of food at the rate of 500-1000 lipase units / kg body weight of the child for each meal. In cystic fibrosis, the dose of Pangrol 25000 depends on body weight and should be at the beginning of treatment 1000 lipase units / kg for each meal for children younger than 4 years, and 500 lipase units / kg for each meal for children older than 4 years. The dose of the drug should be selected individually depending on the severity of the disease, under the control of steatorrhea and the support of 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
; Possible side effects are listed below in descending frequency of occurrence: often (> 1/100, less than 1/10), infrequently (> 1/1000, less than 1/100), rarely (> 1/10000, less than 1/1000), very rarely (less than 1/10000), including individual messages. On the part of the gastrointestinal tract: often - nausea, vomiting and bloating. Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of the following adverse reactions was lower or similar to that with placebo: very often - pain in the abdomen; often - diarrhea. On the part of the skin and subcutaneous tissues: rarely - a rash; there is not enough data to assess the frequency of cases - itching, urticaria.
Overdose
; Symptoms: the use of large doses of pancreatic enzymes may be accompanied by hyperuricuria and hyperuricemia in patients with cystic fibrosis. Treatment: drug withdrawal, symptomatic therapy.
Interaction with other drugs
No interaction studies have been conducted.
special instructions
; Patients with cystic fibrosis who received high doses of pancreatin preparations have described ileal, caecum and colon strictures (fibrosing colonopathy). As a precautionary measure, if unusual symptoms appear or the nature of the symptoms of the underlying disease changes, a medical examination is necessary to rule out colon lesions, especially if the drug is used in a dose of more than 10,000 lipase units / kg body weight per day. Impact on the ability to drive vehicles and control mechanisms Pangrol 25000 does not affect the performance of potentially hazardous activities that require special attention and speed of reaction.