Pangrol 10000 capsules N50
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Active ingredients
Pancreatin
Release form
Capsules
Composition
1 capsule contains: Active substance: Pancreatin 10,000 ED.
Pharmacological effect
The active ingredient of the drug Pangrol 10000 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 10,000 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 insufficiency in adults and children in the following conditions: - chronic pancreatitis; - cystic fibrosis; - pancreatic cancer; - conditions after surgery on the pancreas and stomach (complete or partial resection of the organ); - after irradiation of the gastrointestinal tract accompanied by impaired food digestion, flatulence, diarrhea (as part of combination therapy); - narrowing of the pancreatic duct (for example, due to a tumor or gallstones); - Shvahm syndrome ana-Diamond; - subacute pancreatitis; - other diseases accompanied by exocrine pancreatic insufficiency. Relative enzyme deficiency in the following conditions and situations: - functional gastrointestinal disorders; - in acute intestinal infections, - in irritable bowel syndrome; - use of indigestible vegetable or fat food. Preparation for X-ray and ultrasound studies of the abdominal cavity organs.
Contraindications
- acute pancreatitis; - exacerbation of chronic pancreatitis; - hypersensitivity to pancreatin of porcine origin or other components of the preparation.
Precautionary measures
Do not exceed recommended doses.
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 toxic effects on reproductive function and fetal development are not expected. Use of Pangrol 10000 during pregnancy is possible if the expected benefit to the mother exceeds the possible risk to the fetus. animal studies during which no negative effect of pancreatic enzymes was detected, no adverse effect of the drug on the baby through the breast mole is expected eye. During lactation, pancreatic enzymes can be taken.
Dosage and administration
The dose of the drug Pangrol 10000 is selected individually depending on the severity of the disease, as well as the volume and composition of the food intake. If there are no other indications, adults are recommended to take 2-4 caps. Pangrol 10000 during each meal, swallowing capsules whole (do not chew), drinking plenty of 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 contents, for example, in a glass, opening the capsule by separating the lid from the body, and then take the contents (mini-pills), washing it down with a certain amount of liquid or add to liquid foods that do not require chewing (for example, applesauce and Do fruit juice). The mixture of mini-pills with food or liquid cannot be stored (taken immediately after preparation). Increasing the dose of the drug should be done only under the supervision of a physician, focusing on the dynamics of symptoms (for example, reducing steatorrhea, easing pain in the abdomen). Daily dose of enzymes, The component of 15000-20000 lipase units / kg of body weight is not recommended to exceed. The duration of the course of treatment is determined by the doctor and depends on the course of the disease. For children, the dosing regimen and the duration of treatment establish h, depending on the degree of severity of the disease and the composition of the food at the rate of 500-1000 lipase units./ kg of body weight of the child for each meal. In cystic fibrosis, the dose of Pangrol 10000 depends on body weight and should be at the beginning of treatment 1000 lipase units / kg for each meal for children under 4 years old, and 500 lipase units / kg the time of 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 the support of an optimal diet. In most patients, the dose should be no more than 10,000 lipase units / kg / day or 4000 lipase units / g of fat consumed.
Side effects
Possible side effects are listed below in descending frequency of occurrence: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1/1000), very rarely (<1/10000), including separate messages. From the side 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 side of the skin and subcutaneous tissues: rarely - a rash; to assess the frequency of cases of data is not enough, 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
Interaction studies were not conducted.
special instructions
In patients with cystic fibrosis who received high doses of pancreatin preparations, the ileum, caecum and colon strictures (fibrosing colonopathy) are described. As a precautionary measure, if unusual symptoms appear or the nature of symptoms of the underlying disease changes, a medical examination is necessary to exclude colon lesions, especially if the drug is used in a dose of more than 10,000 lipase units / kg / day. Impact on the ability to drive vehicles and control mechanisms 10,000 does not affect the performance of potentially hazardous activities that require special attention and quick response.