Mikrazym capsules 25000 units, 20pcs

Composition

Composition for 1 capsule:

Active ingredient:   10000 UNITS 25000 UNITS

Pancreatin in the form of enteric pellets,168 mg * 420 mg *

containing pancreatin powder,125 mg 312 mg

which corresponds to the activity of:

proteases 520 units 1300 units

amylases 7500 units 19000 UNITS

lipases 10000 units 25000 units

* – in terms of nominal lipolytic activity.

Excipients that are part of the enteric shell of pellets:

methacrylic acid and ethylacrylate copolymer [1: 1] (in the form of 30% of the variance, further comprising Polysorbate-80, sodium lauryl sulfate) was 25.3 mg/ 63,2 mg, triethylcitrate – 5,1 mg/ 12,6 mg, simethicone emulsion 30%, dry weight (32,6%),0.1 mg/ 0.3 mg including:

dimethicone – 27.8%;

precipitated colloidal silicon-1.3%;

suspended colloidal silicon-0.9%;

methylcellulose-2.5%;

sorbic acid-0.1%;

water-67.4%, talc-12.6 mg / 31.6 mg.

Capsule shell composition: 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%, patent blue dye-0.0200% / 0.0053%, titanium dioxide-1.2999% / 2.9574%.

Pharmacological action

Pharmacotherapeutic group Digestive enzyme agent

ATX code: A 09 AA 02.

Pharmacological properties

Micrazim® – pancreatin pellets in capsules. The drug contains natural enzymes from the pancreas of animals-protease, lipase and amylase, which ensure the digestion of proteins, fats and carbohydrates of food.

After taking Micrazim®, the capsule quickly dissolves in the stomach, releasing enteric-coated pancreatin pellets. Due to their small size, pellets are quickly and evenly mixed with food and simultaneously with the food lump easily penetrate 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.

Rapid mixing of pancreatin pellets with the contents of the stomach, their uniform distribution in it, simultaneous passage with chyme, as well as the safety of enzymes before they start working in the intestines (due to the presence of an enteric shell of pellets), provide higher digesting activity and maximum approximation of the drug’s action to the natural digestive process.

The enzymatic activity of Micrazim ® is manifested as much as 30 minutes after ingestion, which ensures the rapid onset of the effect.

After interaction with substrates, protease, lipase and amylase in the lower intestine lose activity and are eliminated from the body together with the intestinal contents. Micrazim® is not absorbed from the gastrointestinal tract and acts only in the intestinal lumen.

Indications

Substitution therapy for external secretory pancreatic insufficiency:

• chronic pancreatitis;
• cystic fibrosis;
• pancreatic tumors;
• surgical interventions on the pancreas.

Symptomatic therapy in complex treatment for correction of digestive disorders that occur in other diseases or pathological conditions of the gastrointestinal tract:

• condition after resection of the stomach, gallbladder, part of the intestine;
• diseases or conditions that are accompanied by a violation of the bile secretion process (liver diseases, cholecystitis, gallstones, chronic diseases of the biliary tract, compression of the biliary tract with neoplasms, cystic growths);
• intestinal diseases that are accompanied by a violation of the movement of intestinal contents.
• To improve food digestion in adults and children with normal gastrointestinal function when:
• errors in the diet (consumption of fatty foods or large amounts of food, irregular nutrition);
• violations of chewing function, with a sedentary lifestyle, prolonged immobilization.

Preparation for X-ray and ultrasound examination of the abdominal organs.

Use during 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.

Contraindications

Individual intolerance to pancreatin or individual components of the drug. Acute pancreatitis, an exacerbation of chronic pancreatitis.

Side effects

Possible:  allergic reactions.

Rarely:  when used in high doses – diarrhea, nausea, constipation, a feeling of discomfort in the epigastrium.

With prolonged use in high doses:  possible development of hyperuricosuria, hyperuricemia.

In cystic fibrosis, if the required dose of pancreatin is exceeded, strictures (fibrous colonopathy) may develop in the ileocecal part of the ascending part of the colon.

Interaction

Concomitant use of pancreatin with iron preparations may reduce iron absorption.

How to take, course of use and dosage

The dose of the drug is selected individually, depending on the age, severity of symptoms and composition of the diet. Dose selection is performed using registered medications Micrazim ® 10 000 units and Micrazim® 25 000 units.

Capsules are taken orally, washed down 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 a meal, and the other half – during a meal. If the single dose is 1 capsule, it should be taken with a meal.

If swallowing is difficult (for example, in children or the elderly), the capsule can be opened and the drug can be taken directly in pellets, after mixing them with liquid or liquid food (pH Crushing or chewing pellets, 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. Any mixture of pellets with food or liquid should be taken immediately after cooking. The permissible dose for children under 1.5 years of age is 50,000 U/day; older than 1.5 years-100,000 U/day.

The duration of taking pancreatin can vary from several days (digestive disorders) 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 external secretory 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 lack of effect from diet therapy,25,000 units of lipase are prescribed at each meal. If necessary and well tolerated, the dose is increased to 30 000 – 35 000 One dose of lipase.

A further increase in the dose, in most cases, does not improve the results of treatment and requires a review of the diagnosis, reduction of fat content in the diet and/or additional use of proton pump inhibitors.

With mild steatorrhea, not accompanied by diarrhea and weight loss, appoint from 10,000 units to 25,000 units of lipase per reception.

Cystic fibrosis.

The initial estimated dose for children under 4 years of age is 1,000 units of lipase per kilogram of body weight at each feeding, for children over 4 years of age-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.

Overdose

Symptoms: increased uric acid content in the urine (hyperuricuria) and blood (hyperuricemia). Children have constipation.

Treatment: drug withdrawal, symptomatic therapy.

Interactions with other medicinal products

Concomitant use of pancreatin with iron preparations may reduce the absorption of the latter.

Special instructions

Children and adults who have been receiving significant amounts of pancreatin therapy for a long time should be monitored 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 infestations, dysbiosis); failure of patients to comply with the recommended treatment regimen; use of enzymes that have lost their activity. There is no information about the possible effect of the drug on the ability to drive vehicles, mechanisms, and individual data.

Form of production

Capsules

Storage conditions

In a place protected from light and moisture, at a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

Pancreatin

Dosage form

Capsules

Purpose

Nursing mothers as prescribed by a doctor, For adults, Pregnant women as prescribed by a doctor, Children as prescribed by a doctor

Indications

Preparation for ultrasound and X-ray of the abdominal cavity, Chronic pancreatitis, Overeating, Diet errors