Micrazyme, Capsules 10000 units 20 pcs

Pharmacotherapeutic group Digestive enzyme drug

ATX code: A09AA02.

Pharmacological properties

Mikrazym® is pancreatin pellets in capsules. The composition of the product includes natural enzymes from the animal pancreas – protease, lipase and amylase, which ensure the digestion of proteins, fats and carbohydrates of food.

After taking Mikrazima® the capsule dissolves quickly in the stomach, releasing enteric-coated pancreatin pellets. Due to their small size pellets are quickly and evenly mixed with food and at the same time with the food lump easily penetrate into the duodenum and then into the small intestine where pancreatic enzymes are released and become active, promoting fast and complete digestion of proteins, fats and carbohydrates of food.

The rapid mixing of pancreatin pellets with the stomach contents, their uniform distribution in it, simultaneous passage with the chyme and also preservation of enzymes before their work in the intestine (due to the presence of enteric-soluble coating of pellets) provide higher digestive activity and maximum approaching of the drug to the natural process of digestion.

The enzymatic activity of Micrazyme® is manifested maximum 30 minutes after oral administration, which provides a rapid onset of effect.

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

Indications

Pancreatic external secretory insufficiency replacement therapy:

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

Preparing for radiological and ultrasonic examination of the abdominal cavity.

Active ingredient

Composition

Composition per 1 capsule:

Active ingredient: 10000 IU 25000 IU

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

containing pancreatin powder, 125 mg 312 mg

which corresponds to the activity:

protease 520 IU 1300 IU

amylase 7500 IU 19000 IU

lipase 10000 IU 25000 IU

*- in terms of nominal lipolytic activity.

The excipients included in the enteric shell of the pellet:

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, triethylcitrate – 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%;

colloidal suspended 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%, colorant crimson (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%.

How to take, the dosage

The dose of the drug is selected individually depending on age, severity of symptoms, and dietary composition. The dose is adjusted with the registered drugs Micrazyme® 10,000 units and Micrazyme® 25,000 units.

The capsules are taken orally with plenty of non-alkaline liquid (water, fruit juices). If a single dose of the drug is more than 1 capsule, half of the total number of capsules should be taken immediately before a meal, and the other half with a meal. If the single dose is 1 capsule, it should be taken with a meal.

If swallowing is difficult (e.g., in children or the elderly), the capsule may be opened and the drug taken directly in pellets, previously mixed with liquid or liquid foods (pH< 5.0) that do not require chewing (apple puree, yogurt). Grinding or chewing the pellets or adding them to foods with a pH higher than 5.5 will destroy their gastric juice-protective shell. Any mixture of pellets with food or liquid should be taken immediately after preparation. The allowable dose for children under 1.5 years of age is 50,000 IU/day; over 1.5 years of age, 100,000 IU/day.

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

Pancreatine replacement therapy for various types of exocrine pancreatic insufficiency.

The dose is chosen individually and depends on the severity of external pancreatic secretory insufficiency, the individual eating habits, and the age of the patient.

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

If there is diarrhea, weight loss, and no effect of diet therapy, 25,000 IU of lipase is prescribed with each meal. If necessary and if tolerated well, the dose is increased to 30,000 to 35,000 IU of lipase per meal.

A further dose escalation in most cases does not improve outcomes and requires reassessment of the diagnosis, reduction of the fat content of the diet and/or additional prescribing of proton pump inhibitors.

In mild steatorrhea that is not accompanied by diarrhea and weight loss, 10,000 IU to 25,000 IU of lipase per administration is indicated.

Mucoviscidosis.

The initial estimated dose for children under 4 years of age is 1,000 IU of lipase per kilogram of body weight at each meal; for children over 4 years of age, 500 IU of lipase per kilogram of body weight at each meal. The dose should be chosen individually depending on the disease severity, steatorrhea severity and nutritive status.

The maintenance dose for most patients should not exceed 10 000 IU of lipase per kilogram of body weight per day.

Interaction

In concomitant use of pancreatin with iron preparations, iron absorption may be reduced.

Special Instructions

Children and adults receiving pancreatin therapy at high doses for a long time should be monitored by a specialist.

The main causes of ineffectiveness of enzyme therapy are: inactivation of enzymes in duodenum as a result of acidification of its contents; concomitant diseases of small intestine (helminth infestation, dysbiosis); non-compliance with the recommended regimen by patients; use of enzymes that have lost their activity.

Information about the possible effect of the drug on the ability to drive vehicles and mechanisms

There are no separate data.

Contraindications

Side effects

Possible: allergic reactions.

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

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

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

Overdose

Symptoms: increased uric acid in the urine (hyperuricuria) and blood (hyperuricemia). In children – constipation.

Treatment: withdrawal of the drug, symptomatic therapy.

Interactions with other medicinal products

In concomitant use of pancreatin with preparations of iron may decrease the absorption of the latter.

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Pregnancy use

There are no data on the potential risks of using pancreatin in pregnant and lactating women, so the drug should be prescribed to pregnant and lactating women only if the beneficial effects outweigh the possible risks.

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