Kreon
Producer: Solvay Pharmaceuticals, (Solvey Pharmasyyutikalz) GmbH Germany
Code of automatic telephone exchange: A09AA02
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Capsules | 1 капс. |
Pancreatinum | 150 mg |
amylase | 8000 PIECES EPH |
lipase | 10000 PIECES EPH |
proteases | 600 PIECES EPH |
excipients: macrogoal; liquid paraffin; methylhydroxypropyl cellulose phthalate; диметикон 1000; dibutyl phthalate | |
capsule cover: ferrous oxide red (E172); ferrous oxide black (E172); ferrous oxide yellow (E172); titanium dioxide (E171); gelatin |
Capsules | 1 капс. |
Pancreatinum | 300 mg |
amylase | 18000 PIECES EPH |
lipase | 25000 PIECES EPH |
proteases | 1000 PIECES EPH |
excipients: macrogoal 4000; liquid paraffin, phthalate methylhydroxypropyl cellulose; диметикон; dibutyl phthalate | |
capsule cover: ferrous oxide red (E172); ferrous oxide yellow (E172); titanium dioxide (E171); gelatin |
Pharmacological properties:
Pharmacodynamics. The fermental drug improving digestion processes. The pancreatic enzymes which are a part of drug facilitate the proteolysis, fats, carbohydrates that leads to their full absorption in a small bowel. The capsules containing the mini-microspheres covered with a kishechnorastvorimy cover quickly are dissolved in a stomach, releasing hundreds of mini-microspheres. The purpose of the principle of a multisingle dose is hashing of mini-microspheres with intestinal contents, and, eventually, the best distribution of enzymes after their release in intestinal contents.
Pharmacokinetics. When mini-microspheres reach a small bowel, the kishechnorastvorimy cover collapses, there is a release of enzymes to lipolytic, amylolytic and proteolytic activity which provide splitting of fats, starches and proteins.
Indications to use:
- replacement therapy of insufficiency of exocrine function of a pancreas at a mucoviscidosis, chronic pancreatitis, a pancreatectomy, a pancreatic cancer, obstruction of channels (pancreat ducts or the general bilious channel) owing to a new growth, Shvakhmana-Daymond's syndrome, at senile age;
- symptomatic therapy of disturbances of processes of digestion at a partial resection of a stomach (Billroth-I/II), a total gastroektomiya; after a cholecystectomia, at duodeno-and a gastrostaza, biliary obstruction, cholestatic hepatitis, cirrhosis, pathology of terminal department of a small bowel, excess bacterial growth in a small bowel.
Route of administration and doses:
Inside. The dose is selected individually depending on disease severity and structure of a diet. It is recommended to accept 1/3 or 1/2 single doses at the beginning of food, other part — during food. At the complicated swallowing (for example at small children or patients of senile age) capsules carefully open, and mini-microspheres add to the liquid food which is not demanding a chewing or accept with liquid. Any mix of mini-microspheres with food or with liquid is not subject to storage and it should be accepted at once after preparation. Razmelcheniye or chewing of mini-microspheres, and also their addition to food with рН 5,5 gives to destruction of their cover protecting from action of a gastric juice above.
At a mucoviscidosis the dose depends on body weight and makes in an initiation of treatment at children 4 years — 1000 lipazny PIECES/kg on each meal are younger, 4 years — 500 lipazny PIECES/kg are more senior during meal. The dose depends on expressiveness of symptoms of a disease, results of control of a steatorrhea and maintenance of the good nutritive status. At most of patients the dose should not exceed 10000 PIECES/kg/days.
At other states which are followed by exocrine insufficiency of a pancreas, the dose is established taking into account specific features of the patient (degree of insufficiency of digestion, content of fat in food). The dose with the main meal (a breakfast, a lunch and a dinner) makes 20000–75000 PIECES of EF of a lipase, during reception of light meal — 5000–25000 PIECES of EF of a lipase.
The usual initial dosage of Kreona® makes 10000–25000 PIECES of EF of a lipase with the main meal. For reduction of a steatorrhea and maintenance of an optimum condition of the patient increase in a dose is possible. According to customary clinical practice the patient has to receive not less than 20000-50000 PIECES of EF of a lipase together with food.
Features of use:
At the patients with a mucoviscidosis receiving high doses of drugs of Pancreatinum strictures ileal and a caecum, colitis are described. In researches the case control method did not obtain the data testimonial of interrelation with drug Kreon and emergence of a fibroziruyushchy colonopathy. As a precautionary measure for the purpose of an exception of damage of a large intestine at patients with a mucoviscidosis it is recommended to control all unusual symptoms or changes in an abdominal cavity — especially if the patient accepts more than 10000 PIECES of lipases/kg/days.
Drug does not influence ability to driving of the car and to control of cars and mechanisms.
Side effects:
Allergic reactions, it is rare — diarrhea, a lock, sensations of discomfort in a stomach, nausea.
Interaction with other medicines:
Messages on interaction with other HP are not available.
Contraindications:
- the increased individual sensitivity to drug components;
- acute pancreatitis;
- exacerbation of chronic pancreatitis.
Use at pregnancy and feeding by a breast
In view of lack of sufficient data about safety of use of enzymes of a pancreas for women during pregnancy and in the period of a lactation should appoint drug pregnant women and the nursing mothers only if the expected advantage for mother exceeds possible risk for a fruit or the child.
Overdose:
Symptoms: hyperuricuria, hyperuricemia.
Treatment: drug withdrawal, symptomatic therapy.
Storage conditions:
At a temperature not above 25 °C, in densely closed packaging.
To store in the place, unavailable to children.
Issue conditions:
Without recipe
Packaging:
In the blister of 10 pieces; in a pack cardboard 2 blisters; in the blister of 25 pieces; in a pack cardboard 2 or 4 blisters; in bottles polyethylene on 20 and 50 pieces; in a pack a cardboard 1 bottle.