Creon 25000 enteric capsules 300 mg No. 10x2

Creon 25000 enteric capsules 300 mg No. 10x2

Name

Creon 25000 caps intestinal. 300 mg per bl. in pack №10x2

Description

Two-color hard gelatin capsules (brown opaque cap and transparent colorless base). Capsule contents: enteric beige mini-microspheres.

Main active ingredient

Pancreatin

Release form

Capsules 1 capsule. pancreatin 300 mg amylase 18000 IU EF lipase 25000 IU EF protease 1000 IU EF excipients: macrogol 4000; liquid paraffin, methylhydroxypropylcellulose phthalate; dimethicone; dibutyl phthalate capsule shell: red iron oxide (E172); iron oxide yellow (E172); titanium dioxide (E171); gelatin

Dosage

300 mg per bl. in pack №10x2

special instructions

Strictures of the ileum and cecum and colitis have been described in patients with cystic fibrosis who received high doses of pancreatin preparations. In case-control studies, there was no evidence of a relationship with Creon and the occurrence of fibrosing colonopathy. As a precaution to exclude colonic involvement in patients with cystic fibrosis, it is recommended to monitor any unusual symptoms or changes in the abdominal cavity - especially if the patient is taking more than 10,000 IU lipase/kg/day. The drug does not affect the ability to drive a car or control machines and mechanisms.

pharmachologic effect

Pharmacological action - replenishes the deficiency of pancreatic enzymes.

Pharmacokinetics

When the mini-microspheres reach the small intestine, the enteric coating is destroyed, releasing enzymes with lipolytic, amylolytic and proteolytic activity, which ensure the breakdown of fats, starches and proteins.

Indications for use

replacement therapy for insufficiency of exocrine pancreatic function in cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, duct obstruction (pancreatic duct or common bile duct) due to neoplasm, Shwachman-Diamond syndrome, in old age; symptomatic treatment of digestive disorders during partial gastrectomy (Billroth-I/II), total gastrectomy; after cholecystectomy, with duodeno- and gastrostasis, biliary obstruction, cholestatic hepatitis, liver cirrhosis, pathology of the terminal part of the small intestine, excessive bacterial growth in the small intestine.

Directions for use and doses

Inside. The dose is selected individually depending on the severity of the disease and the composition of the diet. It is recommended to take 1/3 or 1/2 of a single dose at the beginning of a meal, and the rest during meals. If swallowing is difficult (for example, in small children or elderly patients), the capsules are carefully opened, and mini-microspheres are added to liquid food that does not require chewing, or taken with liquid. Any mixture of mini-microspheres with food or liquid cannot be stored and should be taken immediately after preparation. Crushing or chewing mini-microspheres, as well as adding them to food with a pH above 5.5, leads to the destruction of their shell, which protects against the action of gastric juice. For cystic fibrosis, the dose depends on body weight and is at the beginning of treatment in children under 4 years of age - 1000 lipase units / kg for each meal, over 4 years - 500 lipase units / kg during meals. The dose depends on the severity of symptoms of the disease, control of steatorrhea and maintenance of good nutritional status. In most patients, the dose should not exceed 10,000 units/kg/day. For other conditions accompanied by exocrine pancreatic insufficiency, the dose is set taking into account the individual characteristics of the patient (degree of digestive insufficiency, fat content in food). The dose with the main meal (breakfast, lunch and dinner) is 20,000–75,000 IU of EP lipase, while taking a light snack - 5,000–25,000 IU of EP lipase. The usual initial dosage of Creon® is 10,000–25,000 IU of EP lipase with the main meal. To reduce steatorrhea and maintain optimal patient condition, the dose may be increased. According to usual clinical practice, the patient should receive at least 20,000–50,000 units of EP lipase with food.

Use during pregnancy and lactation

Due to the lack of sufficient data on the safety of the use of pancreatic enzymes in women during pregnancy and lactation, the drug should be prescribed to pregnant women and breastfeeding mothers only if the expected benefit to the mother outweighs the possible risk to the fetus or child.

Interaction with other drugs

There are no reports of interaction with other drugs.

Contraindications

increased individual sensitivity to the components of the drug; acute pancreatitis; exacerbation of chronic pancreatitis.

Compound

pancreatin 300 mg amylase 18000 IU EF lipase 25000 IU EF protease 1000 IU EF excipients: macrogol 4000; liquid paraffin, methylhydroxypropylcellulose phthalate; dimethicone; dibutyl phthalate capsule shell: red iron oxide (E172); iron oxide yellow (E172); titanium dioxide (E171); gelatin

Overdose

Symptoms: hyperuricuria, hyperuricemia. Treatment: drug withdrawal, symptomatic therapy.

Side effect

Allergic reactions, rarely - diarrhea, constipation, discomfort in the stomach, nausea.

Storage conditions

At a temperature not exceeding 25 °C, in tightly closed packaging. Keep out of the reach of children.

Kreon® 25000 (Kreon® 25000)

Inside.

Doses of the drug are selected individually depending on the severity of the disease and the composition of the diet.

Capsules should be taken during or immediately after each meal (including snacks), swallowed whole, not broken or chewed, and washed down with sufficient liquid.

If swallowing is difficult (for example, in young children or elderly patients), the capsules are carefully opened and the minimicrospheres are added to soft, non-chewable food that has a sour taste (pH < 5.5), or taken with a liquid that also has a sour taste ( pH < 5.5). For example, minimicrospheres can be added to applesauce, yogurt, or fruit juice (apple, orange, or pineapple) with a pH less than 5.5. It is not recommended to add the contents of the capsules to hot food. Any mixture of minimicrospheres with food or liquid cannot be stored and should be taken immediately after preparation.

Crushing or chewing minimicrospheres, or mixing them with food or liquid with a pH greater than 5.5, can destroy their protective enteric coating. This can lead to early release of enzymes in the mouth, reduced effectiveness and irritation of the mucous membranes. You need to make sure that there are no mini-microspheres left in your mouth.

It is important to ensure that the patient maintains adequate fluid intake, especially if there is increased fluid loss. Inadequate fluid intake may cause or worsen constipation.

Dose for adults and children with cystic fibrosis

- The dose depends on body weight and should be at the beginning of treatment 1000 lipase units/kg at each meal for children under four years of age and 500 lipase units/kg at meals for children over four years of age and adults.

— The dose should be determined depending on the severity of symptoms of the disease, the results of control of steatorrhea and maintenance of adequate nutritional status.

- In most patients, the dose should remain less than or not exceed 10,000 lipase units/kg body weight per day or 4000 lipase units/g fat consumed.

Dose for other conditions accompanied by exocrine pancreatic insufficiency

The dose should be set taking into account the individual characteristics of the patient, which include the degree of digestive insufficiency and the fat content of food. The dose required by the patient with the main meal varies from 25,000 to 80,000 units of lipase, and half the individual dose when taking a snack.

In children, the drug should be used as prescribed by a doctor.

Creon 25000 caps intestinal 25000 units x50

Trade name: Kreon 25000 (Kreon 25000)

International name: Pancreatin

Release form: 300 mg capsules (blisters, polyethylene bottles)

Composition: pancreatin 300 mg [amylase 18 thousand units, lipase 25 thousand units, protease 1 thousand units]

Pharmacological group: digestive enzyme agent

Pharmacological group according to ATK: A09AA02 (Pancreatin)

Pharmacological action: amylolytic, lipolytic, digestive enzyme, proteolytic,

Indications: Replacement therapy for exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, cystic fibrosis, flatulence, diarrhea of ​​non-infectious origin.

Impaired digestion of food (a condition after resection of the stomach and small intestine), to improve the digestion of food in persons with normal gastrointestinal function in case of errors in nutrition (eating fatty foods, large amounts of food, irregular meals) and in cases of disorders of chewing function, sedentary lifestyle, long-term immobilization. Roemheld's syndrome (gastrocardiac syndrome).

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

Dosage regimen: Orally, during or after meals, swallow whole, with plenty of liquid (water, fruit juices). The dose of the drug (in terms of lipase) depends on the age and degree of pancreatic insufficiency. The average dose for adults is 150 thousand units/day, with complete insufficiency of exocrine pancreatic function - 400 thousand units/day, which corresponds to the daily requirement of an adult for lipase. The maximum daily dose is 15-20 thousand units/kg.

Children under the age of 1.5 years - a daily dose of 50 thousand units, over 1.5 years - 100 thousand units / day. The duration of treatment can vary from several days (for indigestion, dietary errors) to several months and even years (if constant replacement therapy is necessary).

Contraindications: Hypersensitivity, acute pancreatitis, exacerbation of chronic pancreatitis.

Side effects: Allergic reactions, rarely - diarrhea or constipation, nausea, discomfort in the epigastric region. With long-term use in high doses - hyperuricosuria; when using high doses in patients with cystic fibrosis - strictures in the ileocecal region and in the ascending colon.

Overdose. Symptoms: hyperuricosuria, hyperuricemia. Children have constipation.

Treatment: drug withdrawal, symptomatic therapy.

Pharmacodynamics: Digestive enzyme agent, replenishes the deficiency of pancreatic enzymes, has proteolytic, amylolytic and lipolytic effects. The pancreatic enzymes included in the composition (lipase, alpha-amylase, trypsin, chymotrypsin) promote the breakdown of proteins into amino acids, fats into glycerol and fatty acids, starch into dextrins and monosaccharides, improves the functional state of the gastrointestinal tract, and normalizes digestive processes.

Trypsin suppresses stimulated pancreatic secretion, producing an analgesic effect.

Pancreatic enzymes are released from the dosage form in the alkaline environment of the small intestine, because protected from the action of gastric juice by the membrane.

The maximum enzymatic activity of the drug is observed 30-45 minutes after oral administration.

Special instructions: For long-term use, Fe preparations are prescribed simultaneously.

Interaction: Reduces Fe absorption.

Dispensed from pharmacies: Dispensed without a prescription

Drug registration number: P No. 015582/01

Date of registration (re-registration) of the drug: 01/31/2005