Indications
Replacement therapy of exocrine (enzyme) insufficiency of the pancreas in children and adults due to decreased enzymatic activity of the pancreas due to impaired production, regulation of secretion, delivery of pancreatic enzymes or their increased destruction in the intestinal lumen, which is caused by a variety of diseases of the gastrointestinal tract, and the most common in:- cystic fibrosis;
- chronic pancreatitis;
- pancreatectomy;
- gastrectomy;
- pancreatic cancer;
- conditions following complete or partial gastric resection (e.g., Bilroth II gastroenterostomy);
- obstruction of the pancreatic or common bile duct (e.g., by a tumor);
- Schwachman-Daimond syndrome;
- condition after exacerbation of acute pancreatitis from the moment of transfer of the patient to enteral nutrition.
The drug can be taken to improve digestion in patients with normal GI function in case of dietary errors (consumption of fatty foods, overeating, irregular meals, etc.).
Information on proper use
How to use and dosage
Oral capsules.
The capsules should be swallowed whole without chewing and drunk with enough liquid or eaten with a light snack. It is recommended to take the drug during or immediately after a meal.
If swallowing is difficult (children and the elderly), capsules should be carefully opened and the minimicrospheres should be added to soft food that does not require chewing and has an acidic taste (pH < 5.5) or taken with a liquid that also has an acidic taste (pH < 5.5). For example, the microspheres may be added to applesauce, yogurt, or fruit juice (apple, orange, or pineapple juice) having a pH less than 5.5. Such a mixture should be taken immediately and should not be stored.
Crushing or chewing the microspheres or mixing them with food or liquid with a pH greater than 5.5 may destroy their protective enteric coating. This may lead to early release of enzymes in the oral cavity, decreased efficacy and irritation of mucous membranes. It should be ensured that no microspheres are left in the mouth.
During treatment with Trizim Microcaps® 10 000, Trizim Microcaps® 25 000, it is very important to drink enough fluids, especially during the period of increased fluid loss. Fluid deficiency may cause constipation.
Dosing for adults and children with cystic fibrosis.
The capsules should be swallowed whole without chewing and drunk with enough liquid or eaten with a light snack. It is recommended to take the drug during or immediately after a meal.
If swallowing is difficult (children and the elderly), capsules should be carefully opened and the minimicrospheres should be added to soft food that does not require chewing and has an acidic taste (pH < 5.5) or taken with a liquid that also has an acidic taste (pH < 5.5). For example, the microspheres may be added to applesauce, yogurt, or fruit juice (apple, orange, or pineapple juice) having a pH less than 5.5. Such a mixture should be taken immediately and should not be stored.
Crushing or chewing the microspheres or mixing them with food or liquid with a pH greater than 5.5 may destroy their protective enteric coating. This may lead to early release of enzymes in the oral cavity, decreased efficacy and irritation of mucous membranes. It should be ensured that no microspheres are left in the mouth.
During treatment with Trizim Microcaps® 10 000, Trizim Microcaps® 25 000, it is very important to drink enough fluids, especially during the period of increased fluid loss. Fluid deficiency may cause constipation.
Dosing for adults and children with cystic fibrosis.
The dose for adults and children depends on body weight and should be 1000 lipase units/kg per meal at the beginning of treatment for children under 4 years of age, and 500 lipase units/kg per meal for children over 4 years of age and adults.
The dose should be determined according to the severity of disease symptoms, the results of steatorrhea control, and maintenance of adequate nutritional status.
For most patients, the dose should remain less than or not exceed 10000 lipase units/kg body weight per day or 4000 lipase units/g fat consumed.
Other conditions accompanied by exocrine pancreatic insufficiency
The dose should be set according to the individual characteristics of the patient, which include the degree of digestive insufficiency and the fat content of the food. The dose that a patient requires with the main meal ranges from 25000 to 80000 IU of lipase, and half the individualized dose during a light snack.
The dose to improve digestion in patients with normal GI function in cases of dietary errors depends on body weight and fat content of food, varies from 10000 to 20000 units of lipase per one meal.
In children the drug should be used in accordance with the prescription of a physician.
Changes have been made to the instructions for use. The updated instructions are available above in PDF format.