Project Description

Pancreatin

(tablets with enteric coating, 25 UNITS) Pancreatinum

international nonproprietary name

Pancreatin.

Ref

BP-0099

Pharmacotherapeutic group

Digestivepreparations. Enzymepreparations.

Composition of the preparation

1 tabletcontains 25 Unitsofpancreatin.

Pharmacological action

Pharmacodynamics

Enzymesubstance. Itcontainsexcretorypancreaticenzymes: lipase, alpha-amylase, tripsin, chemotripsin. It provides breaking up of proteins to amino acids and fats – to proteolysis to glycerin, fat acids and starch – to dextrine and monsaccharides.  It stabilizes digestive processes. Tripsin in the upper part of the small intestine inhibits the pancreas stimulated secretion conditioning anaesthetic effect of pancreatin. Maximal enzyme activity of the preparation is registered in 30 – 45 minutes after oral administration.

Pharmacokinetics

Tablets are coated to protect from the impact of gastric juices therefore the enzymes in pancreatin are released in the alkaline medium of the small intestine where they have a pharmacological action.

Indications 

The preparation is used in case of disturbances of pancreas exocrine function (mucoviscidosis, chronic pancreas, pancreatectomy, dyspepsia); achylia, anacidic and hypoacidic gastritis; indigestion related to chronic diseases of liver and bile passages; intake of fat, unusual and indigestible food; for degassing of the intestine before diagnostic tests (radiologic, ultrasound and others).

special indication

Pregnancy and lactation:The use of the medicine during pregnancy and lactation is possible provided that the expected benefit for the mother is higher than the potential risk for the fetus.

No negative effect on the capability to drive or work with potentially dangerous mechanisms.

special warning

Not established

Dosage and method of administration

The medicine is for oral administration 3-6 times a day immediately before meals or while eating without chewing and taking a big amount of liquid with the medicine (water, fruit juice). The dose is determined individually depending on the age and indigestion degree.

The single dose for adults is 50-100 Units (2-4 tablets); the daily dose is 200-400 Units (8-16 tablets).

The average single dose for children 6-7 years old is 25 Units (1 tablet), 8-9 years old – 25-50 Units (1-2 tablets), 10-14 years old – 50 Units (2 tablets).

The duration of treatment may vary from several days (on indigestion as a result of diet fault) up to several months or even years (when constant replacement therapy is necessary).

overdosage

Symptoms:hyperuricocemy, hyperuricemy, in children — constipation.

Treatment:cessation of therapy, symptomatic therapy.

safety measures

On prolonged use of the medicine iron preparations shall be prescribed simultaneously.

In case of mucoviscidosis the recommended dose shall be not exceeded due to an increased risk of structure development in the ileocecal part and ascending colon.

Side effects

The preparation is used in case of disturbances of pancreas exocrine function (mucoviscidosis, chronic pancreas, pancreatectomy, dyspepsia); achylia, anacidic and hypoacidic gastritis; indigestion related to chronic diseases of liver and bile passages; intake of fat, unusual and indigestible food; for degassing of the intestine before diagnostic tests (radiologic, ultrasound and others).

Contraindications

Hypersensitivity to the components of the medicine; acute pancreatitis, pancreatitis exacerbation.

Interactions with other medicinal preparations

The medicine forms insoluble complexes with folates, what reduces significantly their absorption. It reduces iron absorption (especially on prolonged use).

Simultaneous use of antacids containing calcium carbonate and/or magnesium hydroxide may lead to pancreatin deficiency.

The form of release

Enteric tablets 25 Units.