MIKRAZYM instructions for use, description of the drug MIKRAZYM: contraindications, side effects, dosages, composition

Instructions for use MIKRAZYM

Doses of the drug are selected individually depending on age, severity of the disease and diet composition.

The 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 during meals. If the single dose is 1 capsule, it should be taken with meals.

If swallowing is difficult and in children, the capsule can be opened and the contents of the capsule (pellet) can be added to food that does not require chewing (for example, applesauce, yogurt). 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. The prepared mixture must be used immediately.

The duration of taking pancreatin can vary from several days (indigestion) to several months or years (long-term replacement therapy).

It is recommended to drink enough fluids during enzyme therapy; a lack of fluid can cause constipation.

Exocrine pancreatic insufficiency

Doses of enzymes depend on the degree of exocrine insufficiency, as well as the individual dietary habits of the patient.

Cystic fibrosis

Initial estimated dose for children under 4 years of age

– 1000 IU lipase/kg body weight at each feeding, for
children over 4 years of age
– 500 IU lipase/kg 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 IU lipase/kg body weight.

Steatorrhea (more than 15 g of fat in stool per day)

In the presence of diarrhea, loss of body weight and no effect from diet therapy, 25,000 units of lipase are prescribed with each meal. If necessary and well tolerated, the dose is increased to 30,000-35,000 IU of lipase per dose. Further increase in dose in most cases does not improve treatment results and requires a revision of the diagnosis, reduction of fat in the diet and/or additional prescription of proton pump inhibitors. For mild steatorrhea not accompanied by diarrhea and weight loss, 10,000 to 25,000 units are prescribed per dose.

Permissible dose for children under 1.5 years of age

— 50,000 units/day;
for children over 1.5 years of age,
the daily dose of the drug should not exceed 100,000 units.

Micrasim®

Micrazim® can be prescribed to patients of any age, including infants and the elderly, due to the possibility of individual dose selection by combining drugs with different dosages, as well as due to the ability to use the contents of gelatin capsules (microgranles) directly for administration.

Capsules are taken orally, during or after meals, without chewing, with a sufficient amount of liquid (water, 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 during meals. If the single dose is 1 capsule, it should be taken with meals.

If swallowing is difficult (for example, in small children or elderly people), the capsule is opened and the drug is taken directly in microgranules, after mixing them with a slightly acidic (pH <5.0) liquid or food with a liquid consistency that does not require chewing (pH <5.0 ). Any mixture of microbeads with food or liquid should be taken immediately after preparation.

When treating with Micrazym®, to prevent increased constipation, it is important to ensure a normal level of water intake, especially with increased fluid loss.

The dose of the drug is selected individually depending on age and severity of symptoms. To achieve an adequate individual dose, in addition to Mikrazim® 40000 IU capsules, it is possible to use the Mikrazim® drug with dosages of 10,000 IU or 25,000 IU.

Cystic fibrosis.

For children over 4 years of age, the average dose is 500 IU of lipase per kilogram of body weight at each meal. For children under 4 years of age, the initial calculated dose is 1000 IU of lipase per kilogram of body weight at each feeding (it is recommended to use the drug Mikrasim® 10,000 IU or 25,000 IU)

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.

For other conditions accompanied by exocrine pancreatic insufficiency

, the dose is set individually, taking into account the degree of digestive insufficiency and fat content in food, individual eating habits and the patient’s age: The dose of lipase required by the patient during the main meal (breakfast, lunch or dinner) varies from 20,000 IU to 75,000 IU ,

When treated with Mikrasim®, the average initial dose of lipase is 10,000-25,000 units during the main meal (provided by using Mikrasim 10,000 units or Mikrasim 25,000 units), however, higher doses may be required to achieve a therapeutic effect. Typically, the patient should receive at least 20,000 units to 50,000 units of lipase with food

In case of severe 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, treatment begins with a dosage of 25,000 IU of lipase at each meal, but if necessary and well tolerated, the dose is increased to 35,000 IU -40,000 units of lipase per dose. Further increase in dose in most cases does not improve treatment results and requires a revision of the diagnosis, reduction of fat in the diet and/or additional prescription of proton pump inhibitors.

The average dose of pancreatin for adults is 150,000 units/day; with complete blockade of the exocrine function of the pancreas - 400,000 units/day, which corresponds to the daily requirement of an adult for lipase. The maximum daily dose is 15,000 IU-20,000 IU/kg. The permissible dose for children under 1.5 years of age is 50,000 units/day; over 1.5 years - 100,000 units/day. The duration of taking pancreatin can vary from several days (digestive disorders) to several months or years (long-term replacement therapy).

Micrasim capsules 10000 units, 50 pcs.

Manufacturer

ABVA RUS, Russia

Compound

Composition per 1 capsule:
Active substance: 10000 IU 25000 IU

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

containing pancreatin powder, 125 mg 312 mg

which corresponds to activity:

protease 520 units 1300 units

amylase 7500 IU 19000 IU

lipase 10,000 units 25,000 units

* - in terms of nominal lipolytic activity.

Excipients included in the enteric pellet shell:

methacrylic acid and ethyl acrylate copolymer [1:1] (in the form of 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%;

colloidal precipitated 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.

Composition of the capsule shell: body: gelatin - up to 100%, water - 13-16% lid: gelatin - up to 100%, water - 13-16%, crimson dye (Ponceau 4R) - 0.6666% / 0.7999%, quinoline yellow dye - 0.1000% / 0.3166%, proprietary blue dye - 0.0200% / 0.0053%, titanium dioxide - 1.2999% / 2.9574%.

pharmachologic effect

Pharmacotherapeutic group Digestive enzyme agent

ATX code: A09AA02.

Pharmacological properties

Mikrasim® - 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 Micrasim®, 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 bolus, easily penetrate the duodenum, and then into the small intestine, where pancreatic enzymes are released and begin to actively act, facilitating 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 preservation of enzymes before they begin to work in the intestines (due to the presence of an enteric coating of the pellets), ensure higher digestive activity and maximum approximation of the action of the drug to the natural process digestion.

The enzymatic activity of Mikrazym® appears within 30 minutes after oral administration, which ensures the rapid 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.

Indications

Replacement therapy for exocrine pancreatic insufficiency:

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

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 diseases, cholecystitis, gallstones, chronic diseases of the biliary tract, compression of the biliary tract by neoplasms, cystic growths);
intestinal diseases accompanied by impaired movement of intestinal contents.
To improve food digestion in adults and children with normal gastrointestinal function with:
errors in diet (eating fatty foods or large amounts of food, irregular meals);
disorders of chewing function, with a sedentary lifestyle, prolonged immobilization.

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

Use during pregnancy and breastfeeding

There are no data on the potential risks of using pancreatin during pregnancy and lactation, so the drug should be prescribed to pregnant women and nursing mothers only if the expected effect of therapy outweighs the possible risks.

Contraindications

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

Side effects

Allergic reactions to the components of the drug are possible. When using large doses of the drug, the following are rarely observed: diarrhea, nausea, constipation, discomfort in the epigastric region. With long-term use in high doses, the development of hyperuricosuria and hyperuricemia is possible.

Interaction

With the simultaneous use of pancreatin with iron preparations, a decrease in iron absorption may occur.

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 the registered drugs Mikrasim® 10,000 units and Mikrasim® 25,000 units.

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<5.0) that does not require chewing (applesauce, yogurt). 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 consumed immediately after preparation. The permissible dose for children under 1.5 years of age is 50,000 units/day; over 1.5 years - 100,000 units/day.

The duration of taking pancreatin can vary from several days (digestive disorders) to several months or years (long-term replacement therapy).

Replacement therapy for various types of exocrine pancreatic insufficiency.

The dose is selected individually and depends on the severity of exocrine insufficiency, individual dietary habits and the age of the patient.

Steatorrhea (more than 15 g of fat in stool per day).

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

For mild steatorrhea, not accompanied by diarrhea and weight loss, 10,000 IU to 25,000 IU of lipase per dose is prescribed.

Cystic fibrosis.

The initial calculated dose for children under 4 years of age is 1,000 IU of lipase per kilogram of body weight at each feeding, for children over 4 years of age - 500 IU 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 levels of 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, the absorption of the latter may be reduced.

Special instructions

Children and adults 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 infestations, dysbiosis); failure of patients to comply with the recommended treatment regimen; the 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 or operate machinery.

Release form

Capsules

Storage conditions

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

Best before date

2 years

Active substance

Pancreatin

Dosage form

capsules

Purpose

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

Indications

Chronic pancreatitis, Preparation for ultrasound and x-ray of the abdominal cavity, Error in diet, Flatulence, Overeating, Diarrhea

Information in the State Register of Medicines

Barcode and weight

Barcode: 4607003664619 Weight: 0.037 kg