Gastrostat pills 100mg, 90pcs

Composition

1 film-coated tablet contains:

Active ingredient: rebamipid – 100 mg

. excipients: magnesium carbonate, hypromellose (hydroxypropylmethylcellulose), collidone CL F, sodium lauryl sulfate, citric acid, magnesium stearate.

excipients for the shell: hypromellose (hydroxypropylmethylcellulose), macrogol 6000 (polyethylene glycol 6000), titanium dioxide, talc.

Pharmacological action

Pharmacotherapy group:  gastroprotective agent.

ATX code:  A 02 BX 14

Pharmacological properties

Pharmacodynamics

Rebamipid increases the content of prostaglandin E2 (PGE2) in the gastric mucosa and increases the content of PGE2 and GI2 in the contents of gastric juice. It has a cytoprotective effect on the gastric mucosa under the damaging effects of ethanol, acids and alkalis, acetylsalicylic acid.

Promotes the activation of enzymes that accelerate the biosynthesis of high-molecular glycoproteins, and increases the content of mucus on the surface of the stomach wall.

It improves blood supply to the gastric mucosa, activates its barrier function, activates alkaline gastric secretion, enhances proliferation and exchange of gastric epithelial cells, cleanses the mucosa of hydroxyl radicals and suppresses superoxides produced by polymorphonuclear leukocytes and neutrophils in the presence of Helicobacter pylori, protects the gastric mucosa from bacterial damage, has a gastroprotective effect when exposed to nonsteroidal anti-inflammatory drugs. anti-inflammatory drugs (NSAIDs).

Pharmacokinetics

Absorption by mouth is high. After taking a dose of 100 mg, the peak plasma concentration (_cmax) is reached in approximately 2 hours and is 340 ng / ml. The half-life (T_1/2) is approximately 1.0 h. Repeated doses of the drug do not lead to its accumulation in the body.

Approximately 10% of the drug is excreted by the kidneys, mainly in unchanged form. When taken at a dose of 600 mg, traces of the hydroxylated metabolite can be isolated.

In vitro experiments have shown that from 98.4% to 98.6% of the drug binds to plasma proteins.

Indications

Peptic ulcer of the stomach. Chronic gastritis with increased acid-forming function of the stomach in the acute stage, erosive gastritis. Prevention of mucosal damage while taking nonsteroidal anti-inflammatory drugs. It can be used in combination therapy.

Use during pregnancy and lactation

The safety of using rebamipide during pregnancy has not been proven. Do not use during pregnancy. Since rebamipid penetrates into breast milk, it is necessary to stop feeding or decide on artificial feeding of the child if it is necessary to prescribe rebamipid to the mother during lactation.

Contraindications

Individual intolerance to rebamipide or other components of the drug.

Pregnancy.

Lactation period.

Children under the age of 18.

With caution

Caution is recommended when first prescribing rebamipide to elderly patients due to the possibility of hypersensitivity to the drug.

Side effects

From the gastrointestinal tract: constipation, flatulence, diarrhea, nausea, vomiting, abdominal pain, impaired taste, heartburn.

From the liver: signs of liver dysfunction, increased serum glutamine alanine aminotransferase (ALT) and serum glutamine aspartate aminotransferase (AST).

From the hematopoietic system:  leukopenia, granulocytopenia.

Allergic reactions:  pruritus, skin rash, eczematous rashes.

Other:  violation of the menstrual cycle.

Interaction

When using rebamipide as part of traditional treatment regimens for patients with Helicobacter pylori infection, the effectiveness of eradication therapy significantly increases. Interactions with other drugs have not been studied.

How to take, course of use and dosage

Inside,1 tablet 3 times a day, washed down with a small amount of liquid. The course of treatment is 2-4 weeks, if necessary, it can be extended to 8 weeks. The drug does not have any special effects when taken for the first time or when it is canceled. If you miss taking one dose, you should take the next dose of the drug at the set time, do not take twice the dose of the drug.

Overdose

The symptoms of rebamipide overdose have not been described, and no cases of deliberate overdose have been reported to date. Nausea, vomiting, abdominal pain, diarrhea or constipation, and headache may occur.

Treatment measures: No specific antidote is known. In case of overdose, the stomach should be washed and symptomatic therapy should be performed.

Description

Round biconvex tablets, film-coated in white or almost white color. On a cross-section, the core is white or almost white in color.

Special instructions

Influence on the ability to drive vehicles and mechanisms

The effect of the drug on the speed of psychomotor reactions and / or the ability to drive vehicles or mechanisms has not been studied. In the case of taking the drug, you should be careful when driving a car and other activities that require increased concentration of attention.

Form of production

Film-coated tablets,100 mg. 10,15 or 20 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished. By 1,2,3,4,5,6 or 10 contour cell packages together with the instructions for use are placed in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Rebamipid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets