Description
Release form
caps
Packaging
20 pcs.
Pharmacological action
Micrazim enzyme preparation from animal pancreas, which includes protease, lipase and amylase, which provide the digestion of proteins, fats and carbohydrates of food.
After taking the drug, the gelatin capsule under the action of gastric juice dissolves in the stomach and pancreatin microgranules are resistant to the acidic environment of the stomach, together with the gastric contents, they enter the duodenum 12, and then into the small intestine, where digestive enzymes are released and enzymatic digestion is provided.
Pancreatin in the form of microgranules provides faster mixing of digestive enzymes with intestinal contents and their uniform distribution in it, which provides higher digesting activity. The enzymatic activity of pancreatin is manifested maximally 30-40 minutes after ingestion.
After interaction with substrates, protease, lipase and amylase in the lower intestine lose activity and are excreted along with intestinal contents.
Micrasim is not absorbed in the gastrointestinal tract and acts topically.
Indications
For replacement therapy for pancreatic enzyme insufficiency associated with: hereditary diseases – cystic fibrosis (pancreatic fibrosis),
on the pancreas.
Substitution therapy for pancreatic enzyme deficiency cannot replace the treatment of the underlying disease.
Symptomatic therapy in a complex treatment for the correction of digestive disorders that occur with other diseases or pathological conditions of the gastrointestinal tract: conditions after resection of the stomach, gall bladder, parts of the intestine
diseases and conditions accompanied by impaired biliary excretion (liver disease, cholecystitis, gallbladder stones, chronic biliary tract diseases, compression of the biliary tract by neoplasms, cystic growths, etc.)
diseases of the small intestine and duodenum, colon promoting intestinal contents.
To improve the digestion of food in adults and children with normal gastrointestinal function in case of: errors in diet (eating fatty and coarse foods, overeating, irregular eating)
for violations of chewing function, a sedentary lifestyle, prolonged immobilization.
For use in the comprehensive preparation for x-ray examination and ultrasound of the abdominal organs.
Contraindications
acute pancreatitis,
exacerbation of chronic pancreatitis,
individual intolerance to pancreatin or certain components of the drug.
Use during pregnancy and lactation
There are no data on potential risks of using pancreatin in pregnant women and lactation, therefore, the drug should be prescribed to pregnant and lactating mothers only if the beneficial effect exceeds the possible risks.
Special instructions
Children and adults who have been receiving significant doses of pancreatin therapy for a long time should be monitored regularly 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 invasions, dysbiosis) duodenostasis patients do not use the recommended treatment regimen using enzymes that have lost their activity.
Influence on the ability to drive vehicles and control mechanisms
There is no data on the effect of the drug on the ability to drive vehicles and perform work requiring an increased concentration of attention and speed of psychomotor reactions.
Composition of
Active ingredient:
10000 PIECES Pancreatin in the form of enteric-coated pellets (microgranules).
Excipients:
pellet shell (microgranules):
eudragit E-100 (methyl methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate copolymer),
triethyl citrate, srdlklp
methyl parahydroxybenzoate (methyl paraben, nipagin),
propyl parahydroxybenzoate (propyl paraben)
dyes:
dyes crimson (ponso 4R),
quinoline dye yellow,
dye patented blue,
titanium dioxide.
Dosage and administration
The dose of the drug is selected individually depending on the age, severity of symptoms and diet composition.
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 the pellets, pre-mixed with liquid or liquid food (pH
The permissible dose for children under 1.5 years is 50,000 units / day, older than 1.5 years – 100,000 units / day
The duration of pancreatin administration can vary from several 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 well tolerated, increase the dose to 30,000-35,000 units of lipase in one go.
A further increase in dose, in most cases, does not improve treatment results and requires a review of the diagnosis, a decrease in fat in the diet and / or additional prescription of proton pump inhibitor drugs.
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 1000 units of lipase / kg body weight at each feeding, for children over the age of 4 years – 500 units of lipase / kg 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 / kg body weight per day.
Side effects
Possibly: allergic reaction.
Rarely: when using the drug in high doses, diarrhea, nausea, constipation, discomfort in the epigastric region.
With prolonged use in high doses, the development of hyperuricosuria, hyperuricemia is possible.
Drug Interactions
Reduces iron absorption.
Overdose
Symptoms: Increased uric acid content in the urine (hyperuricuria) and blood (hyperuricemia). Children have constipation.
Treatment: withdrawal of the drug, symptomatic therapy.
Storage Conditions
In a dry, dark place and out of the reach of children, at temperatures not exceeding 25 ° C.
Shelf life
2 years.
Deystvuyushtee substance
Pancreatin
dosage form
capsules
Possible product names
MICRASIM 10000ED N20 CAPS
MICRASIM 10000ED CAPS. N20
Micrasim 10000ED Caps. X20 (blisters) (R)
Micrasim 10000ED Caps. X20 (blisters) (R) /! Until 02.14g /
Mikrazim 10000ED Kaps. X20 / until 08.09g. /