Pancreatin 10000 - Instructions For Use, Price, Reviews, Tablet Analogs

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Pancreatin 10000

Pancreatin 10000: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Pancreatin 10000

ATX code: A09AA02

Active ingredient: pancreatin (Pancreatin)

Producer: JSC PFC Obnovlenie (Russia)

Description and photo update: 2019-05-11

Pancreatin 10000 is an enzyme agent that improves digestion.

Release form and composition

Dosage form - tablets, film-coated, enteric: biconvex, round, shell color from light to dark pink, may have a specific smell; the kernel at the fracture is light beige with inclusions from light brown to almost white; the surface of the tablets can be rough (10 pcs. in blister packs, 2, 6 or 8 packs in a cardboard box and instructions for use of Pancreatin 10000).

Composition of 1 enteric film-coated tablet:

• active substance: pancreatin - 125 * mg [corresponds to enzymatic activity in IU (International unit) or UNIT (Unit of action): lipase ≥ 10,000; amylase ≥ 7500; proteases ≥ 375];
• auxiliary components: lactose monohydrate - 101.6 ** mg; crospovidone - 18 mg; microcrystalline cellulose - 52 mg; aerosil (colloidal silicon dioxide) - 1.533 mg; magnesium stearate - 1,867 mg;
• film shell: methacrylic acid ÷ ethyl acrylate copolymer (1 ÷ 1) - 12.2 mg; talc (E553b) - 6.78 mg; titanium dioxide (E171) - 5.05 mg; triethyl citrate (E1505) - 3.9 mg; hydroxypropyl methylcellulose - 4.8 mg; polysorbate 80 (E433) - 0.69 mg; sodium carboxymethyl cellulose (E466) - 0.44 mg; polyethylene glycol (macrogol 6000) - 0.21 mg; simethicone emulsion *** (dry weight 30%) - 0.16 mg; dye azorubin (E122) - 0.022 mg.

* The value may vary depending on the lipolytic activity of the parent substance, which normally varies from 44 to 80 U / mg.

** The value may vary depending on the lipolytic activity of the original substance, varies from 0 to 101.6 mg.

*** The composition of the emulsion: emulsifiers - 5-10%, simethicone - 30%, purified water - 60-65%, preservatives - 0.5-1%.

Pharmacological properties

Pharmacodynamics

The active ingredient of the drug is pancreatin, an extract of the contents of the pancreas of pigs and cattle. This enzyme contains the enzymes amylase, lipase and protease to facilitate the digestion of proteins, fats and carbohydrates for more complete absorption in the small intestine.

Pancreatic enzymes in the composition of pancreatin provide its amylolytic, lipolytic and proteolytic effectiveness, improve the function of the gastrointestinal tract (gastrointestinal tract), and normalize food digestion processes.

In patients with diseases of the pancreas, the enzyme remedy compensates for the insufficiency of its exocrine function, which also improves the digestion process.

Pharmacokinetics

Due to the hydrochloric acid-resistant film coating, which covers Pancreatin 10000 tablets, the enzymes contained in the preparation are protected from immediate inactivation. Neutral or slightly alkaline pH of gastric juice is required to dissolve the membrane and release enzymes.

Pancreatic enzymes are not absorbed from the gastrointestinal tract.

Indications for use

• exocrine pancreatic insufficiency (cystic fibrosis, chronic pancreatitis, etc.);
• chronic and inflammatory-dystrophic pathologies of the intestines, stomach, gallbladder, liver;
• digestive disorders, flatulence, diarrhea, other conditions caused by radiation therapy or resection of the gastrointestinal tract - as part of a combination treatment;
• inaccuracies in nutrition in patients with normal gastrointestinal tract function - to improve the digestion process;
• X-ray and ultrasound examinations of the abdominal organs - for preparation;
• functional disorders of the gastrointestinal tract due to acute intestinal infections, irritable bowel syndrome, etc.

Contraindications

Absolute:

• lactase deficiency, hereditary galactose intolerance, glucose-galactose malabsorption syndrome;
• children under 3 years of age (due to the dosage form);
• hypersensitivity to any of the components of the enzyme preparation.

Pancreatin 10000 is contraindicated to take in acute pancreatitis or chronic pancreatitis in the acute stage. However, it is prescribed in the phase of a damped exacerbation in the presence of symptoms of digestive disorders due to an expansion of the diet.

Pancreatin 10000, instructions for use: method and dosage

Pancreatin 10000 tablets are intended for oral administration. They are taken simultaneously with food, whole, without chewing or breaking, drinking a sufficient amount of neutral liquid, for example, water. If the integrity of the tablet is violated, the effectiveness of the drug may decrease, in addition, when released, pancreatic enzymes can irritate the oral mucosa.

The dose of the drug is set individually depending on the indications, response to therapy and the severity of symptoms.

The recommended dosing regimen for adult patients: 2-4 tablets per day.

The maximum permissible daily dose of pancreatic enzymes is determined at the rate of 15,000–20,000 U of lipase / kg of body weight; it is not recommended to exceed it.

The dose should be increased under the supervision of a medical specialist, who should take into account such symptoms as a decrease in the severity of pancreatic steatorrhea, a decrease in abdominal pain, etc.

The duration of therapy is determined by the doctor. The course can vary from several days in the treatment of indigestion caused by an error in the diet, to several months or even years in case of need for permanent substitution treatment.

The dosage regimen and duration of the course for the treatment of children is determined by the doctor.

Treatment of cystic fibrosis

For the treatment of patients with cystic fibrosis, the dose of pancreatin is selected by the attending physician, taking into account the severity of the symptoms of the disease, the results of steatorrhea control and the possibility of ensuring an adequate nutritional status.

The maximum permissible daily dose of pancreatic enzymes for adults is determined at the rate of 10,000 units of lipase / kg of body weight per day.

For the treatment of children with cystic fibrosis, the dose of pancreatin and the duration of treatment are selected by the attending physician, taking into account the severity of digestive pathologies and the composition of the diet.

In terms of lipase, depending on the age of the child, the dose for each meal should be:

• children under 4 years old: at the rate of 1000 U / kg body weight;
• children over 4 years old: at the rate of 500 U / kg body weight.

If there is no improvement after treatment, worsening of existing or new symptoms, you should seek the advice of a specialist.

It is important to use the drug exclusively for the indications indicated in the instructions, according to the recommended dosing regimen, unless the doctor has prescribed otherwise.

Side effects

When using Pancreatin 10000 in medium therapeutic doses, side effects are observed in less than 1% of cases.

Possible side reactions from systems and organs when taking pancreatin:

• digestive system: extremely rarely - diarrhea / constipation, stomach discomfort, nausea / vomiting (a reliable causal relationship between the development of these reactions and the influence of pancreatin has not been established, since they can also be symptoms of exocrine pancreatic insufficiency); in patients with cystic fibrosis, the formation of strictures in the ascending colon and ileocecal part of the intestine is possible (use of high doses of the drug);
• immune system: extremely rarely - gastrointestinal hypersensitivity, immediate allergic reactions, for example, urticaria, skin rash, lacrimation, sneezing, bronchospasm, dyspnea;
• metabolism: hyperuricosuria (long-term use of high doses), increased levels of uric acid in the blood plasma (use of excessively high doses);
• other reactions: perianal irritation in children (high doses).

The development of the above side effects, their aggravation or the appearance of any other reactions not specified in the instructions, must be reported to the attending physician.

Overdose

Symptoms of an overdose of pancreatin are hyperuricosuria and hyperuricemia (more often observed in cystic fibrosis in patients taking enzyme preparations in high doses).

In case of intoxication, it is recommended to cancel Pancreatin 10000 and carry out symptomatic therapy as needed.

special instructions

Disorders from the digestive system due to taking the drug can develop with hypersensitivity to pancreatin, meconium bowel obstruction (meconium ileus), or a history of bowel resection.

At the stage of exacerbation of exacerbation in patients with acute pancreatitis or exacerbation of chronic pancreatitis, during dietary nutrition in the rehabilitation period, it is advisable to take Pancreatin 10000 against the background of exocrine pancreatic insufficiency.

Patients with cystic fibrosis may need to monitor the concentration of uric acid in urine, especially when taking high doses of pancreatin, since in this case there is a high likelihood of developing hyperuricosuria. In addition, cases of the formation of strictures in the ascending colon and ileocecal part of the intestine have been described in this category of patients. In case of unusual discomfort in the abdominal region or a change in the nature of complaints, especially when taking daily doses of the drug more than 10,000 U / kg of body weight in terms of lipase, the patient should undergo a medical examination to exclude serious pathologies.

Since Pancreatin 10000 contains active enzymes that, when released in the oral cavity, damage the mucous membrane (up to ulceration), the enteric tablet is swallowed whole, without violating the integrity of the film membrane.

Influence on the ability to drive vehicles and complex mechanisms

Pancreatin 10000 therapy does not affect the patient's cognitive and psychophysical abilities.

Application during pregnancy and lactation

The safety of using Pancreatin by 10,000 pregnant and breastfeeding women has not been adequately studied. Application is possible provided that the expected benefit to the mother exceeds the potential risk to the fetus / child.

In the course of experiments to study the effect of pancreatin on pregnancy, it was found that it does not have a teratogenic effect.

Pediatric use

The use of Pancreatin 10000 tablets in pediatrics is possible for the treatment of patients over 3 years of age according to the prescribed dosage regimen.

It is important to take into account that the high activity of lipase contained in pancreatin aggravates the risk of constipation in children. The dose of this category of patients should be increased gradually.

Drug interactions

Enzyme preparations containing pancreatin can inhibit the absorption of folic acid.

The content of carbohydrate-degrading enzymes in pancreatin (eg, amylase) may reduce the hypoglycemic efficacy of oral alpha-glucosidase inhibitors (such as acarbose and miglitol).

Antacids containing magnesium hydroxide and / or calcium carbonate can reduce the pharmacological action of pancreatin.

The simultaneous use of pancreatin with iron preparations may impede the absorption of the latter.

Before you start taking Pancreatin 10000, you should consult with your doctor about the joint use with the above or other drugs, including over-the-counter drugs.

Analogs

The analogues of Pancreatin 10,000 are Gastenorm forte, Creon 10,000, Creon 25,000, Creon 40,000, Creon Micro, Mezim 20,000, Mezim forte, Mezim forte 10,000, Micrasim, Pangrol 25,000, Pancreatin, Penzital, Ermital, Enzistal-P and dr.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Pancreatin 10000

According to reviews, Pancreatin 10,000 is a safe, effective, and affordable digestion aid. It is indispensable for a feeling of heaviness in the stomach and nausea after overeating, helps with eating disorders, improves the function of the pancreas. The tablets act quickly, they are several times cheaper than expensive analogues produced by well-known pharmaceutical companies.

Most often, the lack of the drug in pharmacies is noted as a disadvantage.

Price for Pancreatin 10000 in pharmacies

Due to the lack of the drug currently on sale, the price of Pancreatin 10,000 is unknown.

An analogue of the drug, Pancreatin, 125 mg enteric-coated tablets can be purchased for 52 rubles. (50 pcs in the package).

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!