GASTENORM FORTE

Active material: Pancreatin
When ATH: A09AA02
CCF: The enzyme preparation
When CSF: 11.05
Manufacturer: ratiopharm INDIA Pvt. Ltd. (India)

Pharmaceutical form, composition and packaging

◊ Pills, covered enteric coated white or nearly white, round, lenticular, slight surface roughness is acceptable.

[Ring] povidone K-30, sodium chloride, microcrystalline cellulose, lactose monohydrate, sodium glycolate, colloidal silicon dioxide, talc, magnesium stearate, opadry white OY-IN-58903 (cellacefat, triacetine, Titanium dioxide, sorbitan oleate).

10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (5) – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

Enzyme agent. Contains pancreatic enzymes – amilazu, lipase and proteases, which facilitate the digestion of carbohydrates, fats and proteins, which contributes to their more complete absorption in the small intestine. In diseases of the pancreas, it compensates for the insufficiency of its exocrine function and helps improve the digestion process..

Pharmacokinetics

The pharmacokinetics of pancreatin have not been studied.

Testimony

Insufficiency of exocrine pancreatic function (incl. in chronic pancreatitis, mukovystsydoze).

Chronic inflammatory-dystrophic diseases of the stomach, bowel, liver, gallbladder; state after resection or irradiation of these bodies, accompanied by digestive disorders, meteorizmom, diarrhea (in a combination therapy).

To improve food digestion in patients with normal gastrointestinal function in case of dietary errors, as well as in cases of chewing dysfunction, forced long-term immobilization, sedentary lifestyle.

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

Dosage regimen

Dose (in terms of lipase) depends on age and degree of pancreatic insufficiency. Average dose for adults – 150 000 U/d. With complete insufficiency of exocrine pancreatic function – 400 000 U/d, which corresponds to the daily requirement of an adult for lipase.

The maximum dose: 15 000-20 000 U / kg / day.

Children under 1.5 years – 50 000 ED/day; senior 1.5 years – 100 000 U/d.

The duration of treatment can vary from a few days (If there is a violation of the digestive process due to errors in the diet) up to several months or even years (If you need constant replacement therapy).

Side effect

When used in average therapeutic doses, side effects are observed less, than 1%.

From the digestive system: in some cases – diarrhea, constipation, the feeling of discomfort in the stomach, nausea. The cause-and-effect relationship between the development of these reactions and the action of pancreatin has not been established., tk. These phenomena are symptoms of exocrine pancreatic insufficiency.

Allergic reactions: in some cases – cutaneous manifestations.

Metabolism: long-term use at high doses may develop hyperuricosuria, in excessively high doses – increased levels of uric acid in blood plasma.

Other: when using pancreatin in high doses in children, perianal irritation may occur.

Contraindications

Acute pancreatitis. Hypersensitivity to pancreatin.

Pregnancy and lactation

The safety of pancreatin use during pregnancy has not been sufficiently studied.. The use is possible in cases, the expected benefit to the mother outweighs the potential risk to the fetus.

In experimental studies, found, that pancreatin does not have a teratogenic effect.

Cautions

Use in the acute phase of chronic pancreatitis is not recommended..

For cystic fibrosis, the dose should be adequate to the amount of enzymes, required for fat absorption in terms of quality and quantity of food consumed.

For cystic fibrosis, it is not recommended to use pancreatin in doses exceeding 10 000 U / kg / day (in terms of lipase) due to an increased risk of developing strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon.

With high lipase activity, contained in pancreatin, increased likelihood of developing constipation in children. Increasing the dose of pancreatin in this category of patients should be carried out gradually.

Digestive system disorders may occur in patients with hypersensitivity to pancreatin, or in patients with a history of meconium ileus or bowel resection.

Drug Interactions

In an application with antacids, containing calcium carbonate and/or magnesium hydroxide, Possible reduction in the effectiveness of pancreatin.

With simultaneous use, it is theoretically possible to reduce the clinical effectiveness of acarbose.

With simultaneous use of iron supplements, a decrease in iron absorption may occur..