Micrazim capsules 10000ed №20
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Composition release form
Mikrasim capsules 10,000 IU and 25,000 IU - solid gelatin No. 2 transparent case with brown cover (for dosage 10,000 IU) and No. 0 transparent case with dark orange cover (for dosage 25,000 IU). The contents of the capsules are pellets (microgranules) of a rounded shape from light brown to brown, with a characteristic odor.
Active substance: | 10,000 IU | 25000 U |
Pancreatin | ||
in the form of enteric pellets (microgranules), | 168 mg | 420 mg |
Containing Pancreatin powder, | 128mg | 320mg |
which corresponds to the activity: | ||
protease not less | 520 U | 1300ED |
amylase not less | 7500 U | 19000ED |
lipase not less | 9000 U | 22500 U |
Excipients:
shell pellets (microgranules): Eudragit E-100 (methyl methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate copolymer), triethyl citrate, talc, simethicone emulsion;
capsule shell composition: gelatin, water, sodium lauryl sulfate, methyl parahydroxybenzoate (methyl paraben, nipagin), propyl parahydroxybenzoate (propyl paraben); dyes: crimson dye (Ponso 4R), quinoline yellow dye, patented blue dye, titanium dioxide.
10, 20, 30, 40 or 50 capsules per pack.
Pharmacotherapeutic group
Digestive enzyme remedy.
Pharmacological properties
Mikrasim - an enzyme preparation from the pancreas of animals, which consists of protease, lipase and amylase, which ensure 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 that are resistant to the acidic environment of the stomach, together with the gastric contents enter the duodenum and then into the small intestine, where the release of digestive enzymes and enzymatic digestion of food is provided. Pancreatin in the form of microgranules provides faster mixing of digestive enzymes with intestinal contents and their even distribution in it, which provides a higher digesting activity. The enzymatic activity of pancreatin appears maximally 30-40 minutes after ingestion. After interaction with substrates, protease, lipase and amylase in the lower intestine lose their activity and, together with the intestinal contents, are removed from the body. Micrasim is not absorbed in the gastrointestinal tract and acts locally.
Indications for use
- For replacement therapy for pancreatic enzyme deficiency associated with:
- hereditary diseases - cystic fibrosis (pancreatic fibrosis),
- chronic pancreatitis;
- pancreatic tumors;
- surgical interventions on the pancreas.
- Replacement therapy in pancreatic enzyme deficiency cannot replace the treatment of the underlying disease.
- Symptomatic therapy in complex treatment for the correction of digestive disorders,arising from other diseases or pathological conditions of the gastrointestinal tract:
- conditions after resection of the stomach, gallbladder, part of the intestine;
- diseases and conditions involving a violation of the process of biliary excretion (liver diseases, cholecystitis, gallbladder stones, chronic diseases of the biliary tract, compression of the bile ducts by tumors, cystic growths, etc.);
- diseases of the small intestine and duodenum, large intestine, accompanied by a violation of the promotion of intestinal contents.
- To improve the process of digestion in adults and children with normal gastrointestinal function in the case of:
- errors in the diet (eating fat and coarse food, overeating, irregular meals);
- with violations of chewing function, sedentary lifestyle, prolonged immobilization.
- For use in complex preparation for X-ray examination and ultrasound of the abdominal organs.
Contraindications
Acute pancreatitis, exacerbation of chronic pancreatitis, individual intolerance to pancreatin or individual components of the drug.
Use during pregnancy and lactation
Data on the potential risks of using pancreatin in pregnant women and during lactation are not available, therefore, the drug should be prescribed to pregnant and lactating mothers only if the beneficial effect exceeds the possible risks.
Way of application and doses
Doses Mikrasima individually selected depending on the severity of the disease and the composition of the diet. If a single dose of the drug is more than 1 capsule, you should take half of the total number of capsules just before a meal, and the other half - with food, drinking a non-alkaline liquid (water, fruit juices). If a single dose is 1 capsule, it should be taken with meals. For difficulty swallowing and for children, the capsule can be opened and microgranules can be added to foods that do not require chewing (for example, applesauce, yogurt). The grinding or chewing of microgranules, as well as adding them to food with a pH above 5.5, leads to the destruction of their shell, which protects against the action of gastric juice. The mixture must be used immediately. During enzyme therapy, it is recommended to consume a sufficient amount of fluid, a lack of fluid can cause constipation.
Cystic fibrosis. The initial calculated dose for children in the first year of life and younger than 4 years is 1000 IU of lipase per kilogram of body weight at each feeding, for children over 4 years old - 500 U of lipase per pound 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 IU of lipase per kilogram of body weight per day.
Other types of exocrine pancreatic insufficiency.
When replacement therapy in patients with chronic pancreatitis, the dose of enzymes depends on the degree of exocrine insufficiency, as well as the patient's individual eating habits.When steatorrhea (more than 15 g of fat in the feces per day), as well as in the presence of diarrhea and weight loss, when the diet does not give a significant effect - 25,000 lipase units are prescribed at each meal. If necessary and well tolerated, the dose is increased to 30,000 - 35,000 IU of lipase per dose. 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 an additional prescription of proton pump inhibitor drugs. When mild steatorrhea, not accompanied by diarrhea and weight loss, appoint from 10,000 to 25,000 IU per reception; Permissible dose for children: up to 1.5 years - 50000 EDper day; for children older than 1.5 years, the daily dose of the drug should not exceed -100000 ED.
Side effects
Allergic reactions to the components of the drug. When using large doses of the drug are rarely observed: diarrhea, nausea, constipation, discomfort in the epigastric region. With prolonged use in high doses, the development of hyperuricuricuria, hyperuricemia. In case of cystic fibrosis, if the required dose of pancreatin is exceeded, it is possible to develop strictures (fibrous colonopathy) in the ileo-caecal region of the ascending colon.
Overdose
Symptoms: an increase in the content of uric acid in the urine (hyperuricuria) and blood (hyperuricemia). Children have constipation.
Treatment: drug withdrawal, symptomatic therapy.
Interactions with other drugs
Reduces iron absorption.
special instructions
Children and adults who have received pancreatin therapy for a long time in large doses should be regularly 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 invasions, dysbiosis); duodenostasis; non-compliance by patients with the recommended treatment regimen; use of enzymes that have lost their activity.
Storage conditions
In a dry place protected from light and inaccessible to children at a temperature not higher than 25 ° C.
Shelf life
2 years. The drug can not be used after the expiration date!
Pharmacy sales terms
Over the counter