Micrasim® 25,000 units

Instructions for Use of Micrasim® 25,000 units

Trade name: Mikrazim®

Grouping name: Pancreatin

Dosage form: capsules

Composition per 1 capsule:

* calculated based on nominal lipolytic activity.

Excipients included in the enteric coating of the pellets:

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, triethyl citrate- 5.1  mg/12.6 mg, simethicone emulsion 30%, dry mass (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 %, Ponceau 4R dye – 0.6666 % / 0.7999 %, Quinoline Yellow dye – 0.1000 % / 0.3166 %, Patent Blue dye - 0.0200 % / 0.0053 %, Titanium dioxide - 1.2999 % / 2.9574%. 

Description

Hard gelatin capsules No. 2 with a transparent body and brown cap (for 10000 IU dosage) and No. 0el with a transparent body and dark orange cap (for 25000 IU dosage). The capsule contents are cylindrical, spherical, or irregularly shaped pellets ranging from light brown to brown in color, with a characteristic odor. Color heterogeneity is allowed.

Pharmacotherapeutic Group

Digestive enzyme preparation.

ATC Code: A09AA02.

Pharmacological Properties

Mikrazim® - pancreatin  pellets in capsules. The preparation contains natural enzymes from animal pancreas - protease, lipase and amylase, which ensure the digestion of dietary proteins, fats, and carbohydrates.

After taking Mikrazim® the capsule quickly dissolves in the stomach, releasing enteric-coated pancreatin pellets. Due to their small size, the pellets rapidly and uniformly mix with food and, together with the food bolus, easily enter the duodenum and then the small intestine. Here, the pancreatic enzymes are released and begin to work actively, promoting the rapid and complete digestion of dietary proteins, fats, and carbohydrates. 

The rapid mixing of pancreatin pellets with gastric contents, their uniform distribution within it, simultaneous passage with chyme, as well as the preservation of enzyme activity until they begin working in the intestine (thanks to the enteric coating of the pellets), ensure higher digestive activity and bring the drug's action closer to the natural digestive process. The enzymatic activity of Mikrazim® peaks within 30 minutes after oral administration, ensuring a rapid onset of effect.

After interacting with substrates, protease, lipase and amylase lose their activity in the lower intestines and are excreted from the body along with intestinal contents. 

Mikrazim^® is not absorbed from the gastrointestinal tract and acts only within the intestinal lumen.

Indications for Use

Replacement therapy for exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, post-radiation condition, dyspepsia, cystic fibrosis; flatulence, diarrhea of non-infectious origin.

Impaired food absorption (status after gastric and small intestine resection); to improve food digestion in individuals with normal gastrointestinal tract function in cases of dietary indiscretions (consumption of fatty foods, large amounts of food, irregular eating) and  in cases of impaired masticatory function, sedentary lifestyle, prolonged immobilization. Roemheld syndrome (gastrocardiac syndrome).

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

Contraindications

Hypersensitivity to pancreatin or any components of the drug. Acute pancreatitis, exacerbation of chronic pancreatitis.

Use During Pregnancy and Lactation

Data on potential risks of using pancreatin during pregnancy and lactation are lacking. Therefore, the drug should be prescribed to pregnant women and nursing mothers only if the expected therapeutic benefit outweighs the potential risks.

Information on Possible Effect on Ability to Drive Vehicles and Mechanisms

No specific data available.

Dosage and Administration

The dose is selected individually based on age, severity of symptoms, and dietary composition. Dose selection is carried out using the registered medicinal products Mikrazim^® 10,000 IU and Mikrazim^® 25,000 IU.

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

If swallowing is difficult (e.g., in children or elderly persons), the capsule can be opened and the preparation taken directly as pellets, after mixing them with a liquid or soft food (pH<5.0) that does not require chewing (e.g., applesauce, yogurt). Crushing or chewing the pellets, or adding them to food with a pH above 5.5, destroys their protective coating against gastric juice. Any mixture of pellets with food or liquid must be taken immediately after preparation.

The permissible dose for children under 1.5 years is 50 000 IU/day; over 1.5 years - 100 000 IU/day.

The duration of pancreatin administration can vary from several days (for digestive disorders) to several months or years (for 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 patient's age.

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

In the presence of diarrhea, weight loss, and lack of effect from dietary therapy, 25 000 IU of lipase is prescribed with each meal. If necessary and well tolerated, the dose can be increased to 30 000 - 35 000 IU of lipase per meal. A further dose increase, in most cases, does not improve treatment results and requires review of the diagnosis, reduction of dietary fat content, 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 meal is prescribed.

Cystic Fibrosis.

The initial calculated dose for children under  4 years  of age  - 1 000 IU of lipase per kilogram of body weight with each feeding, for children over 4 years of age – 500 IU of lipase per kilogram of body weight with 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.

Side Effects

Allergic reactions to the drug components are possible. When using high doses, the following are rarely observed: diarrhea, nausea, constipation, discomfort in the epigastric region. With long-term use at high doses, hyperuricuria and hyperuricemia may develop. 

Overdose

Symptoms: Increased uric acid levels in urine (hyperuricosuria) and blood (hyperuricemia). In children – constipation.

Treatment: Discontinuation of the drug, symptomatic therapy.

Drug Interactions

When pancreatin is used concurrently with iron preparations, the absorption of the latter may be reduced. 

Special Instructions

Children and adults receiving long-term pancreatin therapy at significant doses should  be under specialist supervision.

The main reasons for the ineffectiveness of enzyme therapy are: inactivation of enzymes in the duodenum due to acidification of its contents; concomitant diseases of the small intestine (helminthic infestations, dysbiosis); patient non-compliance with the recommended treatment regimen; use of enzymes that have lost their activity. 

Packaging

Capsules 10000 IU and 25000 IU.

3 capsules (for 10000 IU dosage) or 10 capsules per blister strip made of polyvinyl chloride (PVC) film or PVC/polyvinylidene chloride (PVDC) film and printed lacquered aluminum foil.

20, 30, 40, 50 or 100 capsules in polymer jars with screw caps.

Each jar, 1 blister strip of 3 capsules, or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 blister strips of 10 capsules are placed in a cardboard carton together with the instructions for use.

Storage Conditions

Store in a dry place, protected from light and moisture, at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf Life

2 years. Do not use after the expiration date!

Pharmacy Supply Terms

Over-the-counter.

Name and Address of the Legal Entity in whose name the Marketing Authorization is issued / Organization handling complaints:

JSC "AVVA RUS", Russia,

121614, Moscow, ul. Krylatskie Kholmy, 30, building 9.

Tel./Fax: +7 (495) 956-75-54

avva.com.ru

micrazim.com

Manufacturer / Organization handling complaints:

JSC "AVVA RUS", Russia,

610044, Kirov, Kirov region, ul. Luganskaya, 53a.

Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54.

When distributed by JSC "Otisi farm", the instructions state:

Manufactured by order of: JSC "Otisi farm"

Russia, 123112, Moscow, ul. Testovskaya, 10, floor 12, room II, room 29.

Tel.: +7 (495) 221-18-00

www.otcpharm.ru JSC "Pharmstandard"

Russia, 141700, Dolgoprudny,

Likhachevsky proezd, 5 "B",

tel./fax: (495) 970-00-30/32

www.pharmstd.ru