Description
Micrazym Pharmacodynamics
Micrazym® is pancreatin pellets in capsules. The drug contains natural enzymes from the animal pancreas – protease, lipase and amylase, which ensure digestion of proteins, fats and carbohydrates of food.
After taking Micrazyme® the capsule quickly dissolves in the stomach, releasing pancreatin pellets covered with an enteric-soluble coating. Due to the small size, pellets are quickly and evenly mixed with food and simultaneously with the food lump easily penetrate into the duodenum and then into the small intestine, where pancreatic enzymes are released and begin to act actively, contributing to the rapid and complete digestion of proteins, fats and carbohydrates of food.
Fast mixing of pancreatin pellets with stomach contents, their uniform distribution in it, simultaneous passage with chyme, as well as preservation of enzymes before their work in intestine (due to the presence of intestine-soluble shell of pellets), provide higher digestive activity and maximum approximation of the drug to natural digestive process. The enzymatic activity of Mikrazim® is maximal 30 minutes after oral administration, which ensures rapid onset of the effect.
After interaction with substrates protease, lipase and amylase in lower parts of intestine lose their activity and are removed from the body together with intestinal content. Micrasym® is not absorbed from digestive-intestinal tract and acts only in intestinal lumen.
Indications
Substitution therapy for external pancreatic insufficiency: chronic pancreatitis, pancreatectomy, post-radiation conditions, dyspepsia, cystic fibrosis; flatulence, diarrhea of non-infectious genesis.
Digestive disorders (condition after resection of the stomach and small intestine): to improve digestion of food in persons with normal gastrointestinal tract function in case of errors in diet (consumption of fatty foods, large amounts of food, irregular meals) and with disorders of chewing function, sedentary lifestyle, prolonged immobilization. Remheld syndrome (gastrocardia syndrome).
Preparation for X-ray examination and ultrasound of the abdominal cavity.
Contraindications
Individual intolerance to pancreatin or individual components of the drug. Acute pancreatitis, exacerbation of chronic pancreatitis.
Administration during pregnancy and lactation
There is no data concerning potential risks of using pancreatine during pregnancy and lactation, therefore the drug should be administered to pregnant and lactating women only if expected effects of therapy exceed possible risks.
Dosage and administration
- Dosage of the drug is adjusted individually depending on age, degree of severity of symptoms and diet composition. Dosage selection is carried out with the help of registered preparations Mikrazym® 10 000 units and Mikrazym® 25 000 units.
- 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, take half of the total number of capsules immediately before meals, and the other half with meals. If the single dose is 1 capsule, it should be taken with a meal.
- If it is difficult to swallow (e.g., in children or elderly people), the capsule may be opened and the drug may be taken directly in pellets, pre-mixed with liquid or liquid food (pH<5.0) that does not require chewing (apple puree, yogurt). Grinding or chewing the pellets or adding them to foods with a pH above 5.5 will destroy their coating, which protects them from the action of gastric juice. 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).
Replacement therapy for various types of exocrine pancreatic insufficiency.
The dose is chosen individually and depends on the degree of severity of external secretory insufficiency, individual eating habits and age of the patient.
Steatorrhea (more than 15 g of fat in feces per day). - If there is diarrhea, weight loss and no effect from diet therapy, 25 000 units of lipase are prescribed at every meal. If necessary and good tolerability the dose is increased up to 30 000 – 35 000 IU of lipase per one meal. Further dose increases, in most cases, do not improve treatment outcomes and require reassessment of the diagnosis, reduction of fat in the diet and/or additional prescription of proton pump inhibitors.
In mild steatorrhea not accompanied by diarrhea and weight loss, 10,000 IU to 25,000 IU of lipase per administration is prescribed. - Cystic fibrosis.
Initial estimated dose for children under 4 years of age is 1 000 IU of lipase per kg body weight at every meal. For children older than 4 years of age – 500 IU of lipase per kg body weight at every meal. The dose should be selected individually, depending on the severity of the disease, 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.
