1. pharmachologic effect
pharmacodynamics
Mikrazim - microgranular pancreatin capsules. The preparation includes enzymes - protease, lipase and amylase provide digesting protein, fat and carbohydrate food. Mikrazim® after ingestion, the gelatin capsule dissolves in the stomach for 1-2 minutes to release the micropellets the pancreatin enteric coated. In the stomach, microgranules quickly and evenly mixed with food and, because of its small size, can easily penetrate into the duodenum simultaneously with the bolus. It enables playback of a natural process of digestion, and a top speed of onset of effect. Acid-shell microgranules allows you to store enzymes completely intact until the beginning of their work in the intestines, which ensures maximum digestive activity. In the small intestine at pH> 5.5 and is soluble microgranules shell of microgranules for 30 minutes, releases not less than 97%. enzymes.
Pharmacokinetics
The pharmacological activity of preparations containing pancreatic enzymes, including drug "Mikrazim® realized in the lumen of the gastrointestinal tract, absorption is not required for the manifestation of their effects. Enteric bioavailability is 100%.
2. Indications for use
Replacement therapy in disorders of the exocrine function of the pancreas, associated with:
- hereditary diseases - cystic fibrosis;
- chronic pancreatitis resulting intoxication or disease;
- surgery on the pancreas pancreatectomy;
- violation permeability and compression pancreatic duct (pancreatic tumor, liver and other organs);
- fermentobrazuyuschey decrease in gastrointestinal function in elderly patients. Replacement therapy in exocrine pancreatic insufficiency can not replace treatment of the underlying disease.
- status after resection of the stomach, removal of the gallbladder, part of the intestine,
- diseases and conditions accompanied by disturbance biliary excretion process (liver disease, cholecystitis, gallstones, chronic biliary tract disease, impaction (obstruction), biliary tract neoplasms, cystic growths and etc.).;
3. Mode of application
Mikrazim can be used in patients of any age, including infants and the elderly, due to the possibility of individual selection of doses by combining drugs with different dosages, as well as due to the possibility to use for receiving content directly gelatin capsules (Microbeads). The capsules taken orally, during or after a meal, without chewing, with a sufficient quantity of liquid (water, juice). If a single dose greater than 1 capsule should be taken half of the total number of capsules immediately before a meal, and the other half - during the meal. If a single dose - 1 capsule, it should be taken during meals. If difficulty in swallowing (eg in young children or the elderly), the capsule is opened and taking the drug directly into the microgranules previously mixing them with slightly acidic (pH <5.0) the liquid or liquid consistency food, does not require mastication (PH <5.0). Any mixture of microgranules with food or liquid must be taken immediately after preparation. When treating Mikrazimom® to prevent amplification of constipation is essential to ensure a normal level of water consumption, especially when enhanced fluid loss. Dose selected individually depending on the age and severity of symptoms. To achieve adequate individual dose capsules except Mikrazim® 40000ED may use Mikrazim® drug with doses of 10,000 IU or 25000ED. Cystic fibrosis. For children older than 4 years, the average dose is 500 units of lipase per kilogram of body weight at every meal. For children under 4 years of initial calculated dose 1000 units lipase per kilogram at each feeding body weight (use the drug Mikrazim® 10,000 IU or 25,000 IU) dose should be adjusted individually, depending on the severity of the disease, the severity of steatorrhea and nutritional status. Maintenance dose for most patients should not exceed 10,000 units of lipase per kilogram of body weight per day., In other states, accompanied by exocrine pancreatic insufficiency, the dose is determined individually, taking into account the degree of insufficiency of digestion and fat content in the food, individual food habits and age of the patient: the patient required dose lipase originating during main meals (breakfast, lunch or dinner) varies from 20 000 IU to 75 000 IU, the treatment drug Mikrazim® average initial dose of lipase 10000-25000 IU during the main receiving food (provided by using drugs Mikrazim 10,000 IU or 25,000 IU Mikrazim), but to achieve a therapeutic effect may be required more high doses. Usually a patient should receive, along with the food of at least 20 000 IU-50,000 IU of lipase When expressed steatorrhoea (more than 15 grams of fat in faeces per day), in the presence of diarrhea, reduction in body weight and no effect of diet, treatment is initiated with a dosage of 25,000 IU of lipase at each meal, but increase the dose to 35,000 IU -40000 U lipase, if necessary, and good endurance to once. Further increase of a dose in most cases does not improve the results of treatment and diagnosis requires a review, reducing fat content in the diet and / or additional prescribing - proton pump inhibitors. The average dose of pancreatin for adults - 150,000 U / day.; full blockade of exocrine function of the pancreas -. 400,000 IU / day, which corresponds to the daily needs of an adult in the lipase. The maximum daily dose - 15,000 IU-20,000 IU / kg. Permissible dose for children under the age of 1.5 years - 50,000 IU / day.; older than 1.5 years - 100,000 U / day. The duration of the pancreatin can vary from a few days (indigestion), to several months or years (long-term replacement therapy).
4. Side effects
Rarely observed: allergic reactions, diarrhea, nausea, constipation, discomfort in the epigastric region.
5. Contraindications
Acute pancreatitis (in the early stages), exacerbation of chronic pancreatitis, hypersensitivity to pancreatin or the individual components of the preparation.
6. Pregnancy and lactation
Application Mikrazima during pregnancy and lactation (breast. feeding) is recommended if the expected positive effect of the therapy for the mother outweighs the potential risk to the fetus or child, due to the lack of reliable clinical data supporting the safety of pancreatic enzymes in this category patients.
7. Interaction with other drugs
With simultaneous application of pancreatin with iron supplementation may decrease the absorption of the latter.
8. Overdose
There may be elevated levels of uric acid in the urine (giperurikuriya) and blood (hyperuricemia), in children - constipation. Treatment: Lifting drug symptomatic therapy, rehydration.
9. release Form
Capsules 10 000 units - 10, 20, 30, 40, 50, 3,000, 5,000 or 10,000 pieces.
10. Storage conditions
In dry and dark place at a temperature not higher than 25 ° C. Keep out of the reach of children.
11. Structure
Composition for 1 capsule
pancreatin - in the form of enteric pellets (micropellets) - 672.0 mg containing pancreatin powder - 512.0 mg corresponding to an activity:
- protease - 2080 IU
- amylase - 30240 IU
- lipase - 40000
12. Conditions of supply of pharmacies
The drug is available without prescription.- Found a mistake? Select it and press Ctrl + Enter
