Composition per 1 capsule:
Active substance: 10000ED 25000ED
Enteric-coated pancreatin, 168 mg * 420 mg *
containing pancreatin powder, 125 mg 312 mg
which corresponds to activity:
proteases 520 IU 1300 IU
amylases 7500 PIECES 19000 PIECES
lipases 10,000 units 25,000 units
* - in terms of nominal lipolytic activity.
Excipients that make up the enteric coating of pellets:
methacrylic acid and ethyl acrylate copolymer [1: 1] (as a 30% dispersion, additionally containing polysorbate-80, sodium lauryl sulfate) - 25.3 mg / 63.2 mg, triethyl citrate - 5.1 mg / 12.6 mg, simethicone emulsion 30%, dry weight (32.6%) - 0.1 mg / 0.3 mg, including:
dimethicone - 27.8%;
silicon colloidal precipitated - 1.3%;
suspended colloidal silicon - 0.9%;
methyl cellulose - 2.5%;
sorbic acid - 0.1%;
water - 67.4%, talc - 12.6 mg / 31.6 mg.The composition of the capsule shell: body: gelatin - up to 100%, water - 13-16% cap: gelatin - up to 100%, water - 13-16%, crimson dye (Ponceau 4R) - 0.6666% / 0.7999%, quinoline yellow dye - 0.1000% / 0.3166%, patented blue dye - 0.0200% / 0.0053%, titanium dioxide - 1.2999% / 2.9574%.
Pharmacotherapeutic group Digestive enzyme agent
ATX Code: A09AA02.
Mikrazim® - pancreatin pellets in capsules. The composition of the drug includes natural enzymes from the pancreas of animals - protease, lipase and amylase, which ensure the digestion of proteins, fats and carbohydrates in food.
After taking Mikrasim®, the capsule quickly dissolves in the stomach, releasing enteric-coated pancreatin pellets. Due to their small size, pellets quickly and evenly mix with food and simultaneously with the food lump easily penetrate into the duodenum and then into the small intestine, where pancreatic enzymes are released and begin to act actively, contributing to the rapid and complete digestion of proteins, fats and carbohydrates of food.
The rapid mixing of pancreatin pellets with the contents of the stomach, their uniform distribution in it, the simultaneous passage with the chyme, and the preservation of the enzymes before they work in the intestine (due to the presence of the enteric coating of the pellets) provide a higher digesting activity and maximize the effect of the drug on the natural process digestion.
The enzymatic activity of Mikrasim® is manifested maximally 30 minutes after ingestion, which ensures the speed of the onset of the effect.After interaction with substrates, protease, lipase and amylase in the lower intestine lose activity and, together with intestinal contents, are excreted from the body. Mikrasim® is not absorbed from the gastrointestinal tract and acts only in the intestinal lumen.
Substitution therapy for exocrine pancreatic insufficiency:
- chronic pancreatitis;
- cystic fibrosis;
- pancreatic tumors;
- pancreatic surgery.
Symptomatic therapy in complex treatment for the correction of digestive disorders that occur with other diseases or pathological conditions of the gastrointestinal tract:
- condition after resection of the stomach, gall bladder, part of the intestine;
- diseases or conditions accompanied by a violation of the process of biliary excretion (liver disease, cholecystitis, gallbladder stones, chronic diseases of the biliary tract, compression of the biliary tract by neoplasms, cystic growths);
- intestinal diseases, accompanied by impaired promotion of intestinal contents.
- To improve the digestion of food in adults and children with normal gastrointestinal function with:
- errors in diet (eating fatty foods or large amounts of food, irregular meals);
- violations of chewing function, with a sedentary lifestyle, prolonged immobilization.
Preparation for x-ray and ultrasound examination of the abdominal organs.
Pregnancy and lactation
There are no data on the potential risks of using pancreatin in pregnant women and during lactation, so the drug should be prescribed to pregnant and lactating mothers only if the beneficial effect exceeds the possible risks.
Perhaps: allergic reactions.
Rarely: when used in high doses - diarrhea, nausea, constipation, a feeling of discomfort in the epigastrium.
With prolonged use in high doses: the development of hyperuricosuria, hyperuricemia is possible.
With cystic fibrosis, if the required dose of pancreatin is exceeded, strictures (fibrotic colonopathy) may develop in the ileocecal section of the ascending part of the colon.
With the simultaneous use of pancreatin with iron preparations, a decrease in iron absorption is possible.
How to take, course of administration and dosage
The dose of the drug is selected individually depending on age, severity of symptoms and diet composition. Dose selection is carried out using registered medicines Mikrasim ® 10 000 units and Mikrasim ® 25 000 units.
Capsules are taken orally with a sufficient amount of non-alkaline liquid (water, fruit juices). If a single dose of the drug is more than 1 capsule, you should take half of the total number of capsules immediately before meals, and the other half with meals. If a single dose is 1 capsule, it should be taken with food.
If swallowing is difficult (for example, in children or the elderly), the capsule can be opened and taken directly in pellets, after mixing them with liquid or liquid food (pH <5.0) that does not require chewing (applesauce, yogurt). Grinding or chewing pellets, as well as adding them to food with a pH above 5.5, leads to the destruction of their membrane, which protects against the action of gastric juice. Any mixture of pellets with food or liquid should be taken immediately after preparation. The permissible dose for children under the age of 1.5 years is 50,000 units / day .; older than 1.5 years - 100,000 units / day.
The duration of pancreatin intake can vary from a few days (digestion disorder) to several months or years (long-term replacement therapy).
Substitution therapy for various types of exocrine pancreatic insufficiency.
The dose is selected individually and depends on the severity of exocrine insufficiency, individual eating habits and the patient's age.
Steatorrhea (more than 15 g of fat in feces per day).
In the presence of diarrhea, weight loss and the absence of the effect of diet therapy, 25,000 units of lipase are prescribed at each meal. If necessary, and good tolerance, the dose is increased to 30,000 - 35,000 units of lipase at a time.
A further increase in the dose, in most cases, does not improve the results of treatment and requires a review of the diagnosis, a decrease in the fat content in the diet and / or additional prescription of drugs - proton pump inhibitors.
With mild steatorrhea, not accompanied by diarrhea and weight loss, from 10,000 units to 25,000 units of lipase are prescribed.
Cystic fibrosis.The initial calculated dose for children under 4 years old is 1,000 units of lipase per kilogram of body weight at each feeding, for children over 4 years old - 500 units of lipase per kilogram of body weight at each meal. The dose should be selected individually, depending on the severity of the disease, the severity of steatorrhea and nutritional status.
The maintenance dose for most patients should not exceed 10,000 units of lipase per kilogram of body weight per day.
Symptoms: increased uric acid in the urine (hyperuricuria) and blood (hyperuricemia). Children have constipation.
Treatment: drug withdrawal, symptomatic therapy.
Interactions with other drugs
With the simultaneous use of pancreatin with iron preparations, a decrease in the absorption of the latter is possible.
Children and adults who have been receiving pancreatin therapy in significant doses for a long time should be observed by a specialist.The main reasons for the ineffectiveness of enzyme therapy are: inactivation of enzymes in the duodenum as a result of acidification of its contents; concomitant diseases of the small intestine (helminthic invasion, dysbiosis); non-compliance by patients with the recommended treatment regimen; the use of enzymes that have lost their activity.
Information on the possible effect of the drug on the ability to drive vehicles, mechanisms
There are no separate data.