Micrazyme, Capsules 10000 units 40 pcs

Pharmacotherapeutic group

A digestive enzyme agent.

TAC code: A09AA02.

Pharmacological properties

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

After taking Mikrazima® 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 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 an enteric-soluble shell of pellets) ensure higher digestive activity and maximum approximation of the drug to the natural process of digestion. The enzymatic activity of Mikrazim® is manifested maximum 30 minutes after oral administration, which ensures rapid onset of the effect.

After interaction with the substrates, protease, lipase and amylase in the lower intestine lose activity and are excreted with the intestinal contents.

Mikrazym® is not absorbed from the gastrointestinal tract and acts only in the intestinal lumen.

Indications

Substitution therapy in external pancreatic secretory insufficiency: chronic pancreatitis, pancreatectomy, condition after radiation, dyspepsia, cystic fibrosis; flatulence, diarrhea of non-infectious genesis.

Digestive disorders (condition after resection of the stomach and small intestine): to improve digestion in persons with normal gastrointestinal tract function in case of eating disorders (consumption of fatty foods, large amounts of food, irregular meals) and in case of disorders of chewing function, sedentary lifestyle, prolonged immobilization. Remheld’s syndrome (gastrocardia syndrome).

Preparing for radiological examination and ultrasound of the abdominal cavity.

Active ingredient

Pancreatin

Composition

Per 1 capsule:

Active ingredient:

Pancreatin in the form of enteric soluble pellets containing pancreatin powder 168 mg*, corresponding to an activity of 125 mg,

protease 520 UD,

amylase 7500 UD,

lipase 10000 UD.

*- in terms of nominal lipolytic activity.

Excipients in the enteric shell of pellets:

methacrylic acid and ethylacrylate 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%; silicon colloid precipitated -1.3%; silicon colloid suspended -0.9%; methylcellulose -2.5%; sorbic acid -0.1%, water -67.4%, talc -12.6 mg/31.6 mg.

Capsule shell composition:

• casing: gelatin – up to 100%, water -13-16%
• caps: gelatin – up to 100%, water -13-16%, crimson dye (ponceau 4R) – 0.6666% / 0.7999%, quinoline yellow dye – 0.1000% / 0.3166%, patented blue dye – 0.0200% / 0.0053%, titanium dioxide – 1.2999% / 2.9574%.

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How to take, the dosage

The dose of the drug is adjusted individually depending on age, severity of symptoms, and dietary composition. The dose is adjusted using the registered drugs Micrasym® 10,000 units and Micrasym® 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 degree of severity of exocrine insufficiency, individual eating habits, and 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 well tolerated, the dose is increased to 30,000 to 35,000 IU of lipase per meal. Further dose increases, in most cases, do not improve treatment outcomes and require reassessment of the diagnosis, reduction in dietary fat content and/or additional prescribing of proton pump inhibitor drugs.

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 selected individually, depending on the severity of the disease, 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.

Interaction

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

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 the duodenum as a result of acidification of its contents; concomitant diseases of the small intestine (worm infestations, dysbiosis); non-compliance with the recommended regimen by patients; use of enzymes that have lost their activity.

Contraindications

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

Side effects

Allergic reactions to the drug components are possible. When using high doses of the drug, diarrhea, nausea, constipation, discomfort in the epigastric region are rarely observed. During long-term use in high doses, hyperuricosuria and hyperuricemia may develop.

Overdose

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

Treatment: withdrawal of the drug, symptomatic therapy.

Pregnancy use

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 effects of therapy outweigh the possible risks.

Similarities

Mezim forte, Creon 40000, Pancreatin, Creon 25000, Micrazyme, Hermital, Panzinorm forte 20000, Penzital, Pancreatin Forte, Creon 10000, Creon 25000, Mezim 20000, Enzival-P, Mezim