Creon 25000,25000 units 50 pcs

Pharmacodynamics

The enzyme preparation improves digestion processes in adults and children, and thus significantly reduces symptoms of pancreatic enzyme insufficiency, including abdominal pain, flatulence, changes in frequency and consistency of stools.

Pancreatic enzymes contained in the drug facilitate the breakdown of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine. Creon ® 25000 contains porcine pancreatin in the form of minimicrospheres, covered with enteric soluble (acid-resistant) coating, in gelatin capsules. The capsules dissolve rapidly in the stomach, releasing hundreds of minimicrospheres.

This principle is designed to allow for simultaneous passage (ingestion) of the minicrospheres from the stomach into the intestine and thorough mixing of the minicrospheres with the intestinal contents and, ultimately, better distribution of the enzymes once they are released within the intestinal contents.

When the minimicrospheres reach the small intestine, the gut-soluble coating breaks down quickly (at pH > 5.5) and enzymes with lipolytic, amylolytic and proteolytic activity are released, leading to the breakdown of fats, carbohydrates and proteins. The resulting substances are then either directly absorbed or further broken down by intestinal enzymes.

Pharmacokinetics

The lack of absorption of unreduced enzymes has been demonstrated in animal studies, so classical pharmacokinetic studies have not been conducted. Drugs containing pancreatic enzymes do not require absorption to manifest their effects. On the contrary, the therapeutic activity of the indicated drugs is fully realized in the lumen of the gastrointestinal tract.

In terms of their chemical structure they are proteins and, as such, when passing through the gastrointestinal tract the enzyme drugs break down until they are absorbed as peptides and amino acids.

Indications

The replacement therapy of exocrine (enzymatic) pancreatic insufficiency in children and adults caused by decreased pancreatic enzymatic activity due to impaired production, secretion regulation, delivery of pancreatic enzymes or their increased destruction in the gut lumen caused by various diseases of gastrointestinal tract, and most commonly occurring in:

cystic fibrosis;

chronic pancreatitis;

after pancreatic surgery;

p> after gastrectomy;

Pancreatic cancer;

Partial resection of the stomach (e.g., Bilroth II);

obstruction of the pancreatic ducts or common bile duct (e.g., due to a neoplasm);

Schwachman-Daimond syndrome;

State after an attack of acute pancreatitis and resumption of feeding.

To prevent complications, use only after consulting a physician.

Active ingredient

Composition

1 capsule contains:

The active ingredient:

Pancreatin – 300 mg, which corresponds to:

Excipients:

Macrogol 4000 – 75.00 mg,

Hypromellose phthalate – 112.68 mg,

dimethicone 1000 – 2.69 mg,

cetyl alcohol – 2.37 mg,

triethylcitrate – 6.26 mg.

The hard gelatin capsule:

gelatin – 95.08 mg,

iron oxide red dye (E 172) – 0.46 mg,

Iron oxide yellow dye (E 172) – 0.08 mg,

Titanium dioxide (E 171) – 0.19 mg,

sodium lauryl sulfate – 0.19 mg.

How to take, the dosage

Ingestion

The doses of the drug are chosen individually depending on the severity of the disease and the composition of the diet.

The capsules should be taken with or immediately after each meal (including snacks), swallowed whole, without crushing or chewing, and with plenty of fluid.

In case of difficulty in swallowing (e.g., in young children or elderly patients), the capsules are opened gently and the minimicrospheres are added to a 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, minimicrospheres can be added to apple puree, 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 should not be stored and should be taken immediately after preparation.

Crushing or chewing the minimicrospheres or mixing them with food or liquid with a pH greater than 5.5 may destroy their protective, enteric soluble coating. This can lead to early release of enzymes in the mouth, decreased efficacy, and mucosal irritation. It is important to make sure that no minimicrospheres remain in the mouth.

It is important to ensure adequate continued fluid intake by the patient, especially if there is increased fluid loss. Inadequate fluid intake may lead to or increase constipation.

Dose for adults and children with cystic fibrosis

The dose depends on body weight and should be 1000 lipase units/kg at the start of treatment per meal for children younger than four years, and 500 lipase units/kg at meal times for children over four years and adults.

The dose should be determined according to the severity of symptoms, the results of steatorrhea control, and maintenance of adequate nutritional status.

In most patients, the dose should remain less than or less than 10000 lipase units/kg body weight per day or 4000 lipase units/g fat consumed.

Dose in other conditions involving exocrine pancreatic insufficiency

The dose should be set according to the patient’s individual characteristics, which include the degree of digestive insufficiency and the fat content of the food. The dose a patient needs with the main meal ranges from 25,000 to 80,000 IU of lipase, and half the individual dose during a light snack.

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

Interaction

Special Instructions

Strictures of the ileum, cecum, and colon (fibrosing colonopathy) have been described in patients with cystic fibrosis who have received high doses of pancreatin drugs. As a precautionary measure, medical evaluation to rule out fibrosing colonopathy should be performed if unusual symptoms or abdominal changes occur, especially in patients who take the drug at doses greater than 10,000 lipase units/kg per day.

Contraindications

Side effects

Gastrointestinal disorders

very often (≥1/10): abdominal pain.

Often (≥1/100, <1/10): nausea, vomiting, constipation, abdominal bloating, diarrhea.

Prevalence unknown: strictures of the ileum, cecum and colon (fibrosing colonopathy).

Gastrointestinal disorders are mainly related to the underlying disease. The incidence of adverse reactions such as abdominal pain and diarrhea was lower or similar to that of placebo.

Strictures of the ileum, cecum and colon (fibrosing colonopathy) have been observed in patients with cystic fibrosis who received high doses of pancreatin (see section “Special Precautions”).

Skin and subcutaneous tissue disorders

Infrequent (≥1/1000, <1/100): rash.

Infrequent unknown: itching, urticaria.

Immune system disorders

Prevalence unknown: hypersensitivity (anaphylactic reactions).

Allergic reactions have been observed predominantly on the skin, but other manifestations of allergy have also been reported. These side effects have been reported in the post-marketing period and have been spontaneous. There are insufficient data to give an accurate estimate of the incidence.

No specific adverse reactions have been reported in children. The frequency, type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.

Overdose

Symptoms: hyperuricosuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

Pregnancy use

Pregnancy

There are no clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes.

In animal studies no absorption of porcine pancreatic enzymes was found, so no toxic effects on reproductive function and fetal development are expected. The drug should be administered to pregnant women with caution if the estimated benefit to the mother exceeds the potential risk to the fetus.

Breastfeeding

Based on animal studies in which no systemic adverse effects of pancreatic enzymes have been identified, no harmful effects of the drug on the infant through breast milk are expected.

Pancreatic enzymes can be taken while breastfeeding. If administration during pregnancy or lactation is necessary, the drug should be taken in doses sufficient to maintain adequate nutritional status.

Similarities