Mikrazim

Mikrazim – the fermental drug providing higher digestive activity.

Form of release and structure

Dosage form – capsules: gelatinous firm with the transparent case of two types: the size No. 2 – with a lid of brown color, the size No. 0 – dark orange, in capsules – pellets kishechnorastvorimy spherical, cylindrical or irregular shape from brown till light brown color with a specific smell (on 10 pieces in a blister strip packaging, in a cardboard pack of 2 or 5 packagings).

Active ingredient of Mikrazim – Pancreatinum, in 1 capsule:

• The size No. 2 – 10 000 PIECES (125 mg) that is equivalent to nominal lipolytic activity of 168 mg or activity: amylases of 7500 PIECES, lipases of 10 000 PIECES, proteases of 520 PIECES;
• The size No. 0 – 25 000 PIECES (312 mg) that is equivalent to nominal lipolytic activity of 420 mg or activity: amylases of 19 000 PIECES, lipases of 25 000 PIECES, proteases of 1300 PIECES.

Auxiliary components: a kishechnorastvorimy cover pellet – copolymer of ethyl acrylate and methacrylic acid (1:1) (in the form of 30% of the dispersion containing in addition sodium lauryl sulfate and polysorbate 80), triethyl citrate, симетикон an emulsion of 30% (32,6% in a dry form) as a part of which: methyl cellulose, silicon, sorbic acid, the silicon colloid weighed colloid besieged talc, water.

Structure of the case of the capsule: gelatin, water.

Structure of a lid of the capsule: gelatin, dye crimson (Ponso 4R), dye patent blue, dye quinolinic yellow, titanium dioxide, water.

Indications to use

• Fermental insufficiency of a pancreas: pancreas fibrosis (mucoviscidosis), pancreas tumors, chronic pancreatitis, the period after an operative measure on a pancreas – as replacement therapy;
• Symptomatic treatment as a part of complex therapy for correction of disorder of the digestive process which arose against the background of: states after a resection of a gall bladder, a stomach, a part of intestines; the pathologies of a small and large intestine, duodenum proceeding with disturbance of advance of contents of intestines; the states and diseases which are followed by disorder of process of a zhelchevydeleniye including cholecystitis, liver diseases, stones in a gall bladder, chronic pathologies of biliary tract, squeezing of biliary tract cystous growths and new growths;
• Improvement of process of digestion at adults and children with normal function of the digestive tract (DT): at errors in a diet (including an overeating, the use of rough and greasy food, irregular food), at a slow-moving way of life, disturbance of chewing function, a long immobilization;
• Use in complex preparation for ultrasonic and X-ray inspection of abdominal organs.

Contraindications

• Acute pancreatitis;
• Chronic pancreatitis in an aggravation stage;
• Hypersensitivity to drug components.

Mikrazim's appointment during pregnancy and breastfeeding is shown if the expected therapeutic effect for mother exceeds possible risk for a fruit and the child.

Route of administration and dosage

Capsules accept orally, washing down with a small amount of water or fruit juice (an exception – alkaline liquid). At purpose of a single dose from 2 and more capsules it is recommended to accept ½ total quantities of drug before food, other half – directly during meal. The dose at a rate of 1 capsule is accepted during food.

Children or patients of advanced age for simplification of a proglatyvaniye can accept drug without capsule cover, having dissolved its contents in the liquid or liquid food (рН lower than 5,0) which is not needing a chewing (yogurt, apple puree). Chewing, crushing of pellets or mixing with food (рН higher than 5,5) destroys their cover protecting from influence of a gastric juice. It is necessary to prepare mix of pellets with liquid or food before direct reception.

Individual selection of a dose of Mikrazim taking into account structure of a diet, level of expressiveness of symptoms of a disease and age of the patient is recommended.

Administration of drug can last of several days at disturbance of digestion up to several months and years at long replacement therapy.

The most admissible daily dose for children: up to one and a half years – 50 000 PIECES, at the age of one and a half years are also more senior – 100 000 PIECES.

The recommended dosing for replacement therapy of different types of exocrine insufficiency of a pancreas:

• Steatorrhea, at the content of fat in Calais more than 15 g a day: on 25 000 PIECES of a lipase with each meal for patients with diarrhea, weight reduction and lack of effect of a dietotherapy. At good tolerance of drug for achievement of clinical effect increase in a single dose to 30 000-35 000 PIECES of a lipase is shown. In the absence of improvement of results of treatment it is necessary to specify the diagnosis or to reduce consumption of fat and to consider a question of purpose of a concomitant use of inhibitors of the proton pump. In the absence of diarrhea and weight reduction against the background of poorly expressed steatorrhea Mikrazim appoint 10 000-25 000 PIECES of a lipase in a single dose;
• Mucoviscidosis: an initial single dose for children up to 4 years – at the rate of 1000 PIECES of a lipase on 1 kg of weight of the child and on 500 PIECES of a lipase on 1 kg – at the age of 4 years and more. The dose should be adjusted taking into account the nutritive status and weight of a steatorrhea. Purpose of a maintenance dose more than 10 000 PIECES of a lipase on 1 kg of body weight a day is not recommended.

Side effects

• Perhaps: development of allergic reactions;
• Seldom: against the background of reception of high doses – nausea, discomfort in epigastric area, diarrhea or a lock;
• Others: prolonged use of high doses can promote development of a hyperuricemia, hyper uricosuria.

Special instructions

Prolonged use of Mikrazim in high doses has to be followed by regular observation of the doctor.

Inefficiency of therapy can be observed against the background of an inactivation of enzymes as a result of acidulation of contents of a duodenum, associated diseases of a small bowel (including дисбиоз and helminthic invasions), non-compliance with the recommended mode, reception of the enzymes which lost activity.

Influence of Pancreatinum on the speed of psychomotor reactions of the patient, including on ability to control of vehicles and mechanisms is not established.

Medicinal interaction

Simultaneous use of Pancreatinum reduces absorption of iron preparations.

Terms and storage conditions

To store in the place protected from light and moisture at a temperature up to 25 °C. To protect from children.

Period of validity – 2 years.