Rebamipid-SZ, 100 mg 30 pcs

Pharmacodynamics

Rebampide increases prostaglandin E2 (PGE2) in the gastric mucosa and increases 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, acetyl-salicylic acid. It promotes activation of enzymes that accelerate biosynthesis of high molecular weight glycoproteins, and increases the content of mucus on the surface of the stomach wall. Helps improve blood supply to the gastric mucosa, activates its barrier function, activates alkaline gastric secretion, increases proliferation and metabolism 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 gastric mucosa from bacterial damage, has gastroprotective effect when the mucosa is affected by non-steroidal anti-inflammatory drugs (NSAIDs).

Pharmacokinetics

Absorption when taken orally is high. After administration in a dose of 100 mg, peak plasma concentration (Cmax) is reached after approximately 2 hours and is 340 ng/ml. The elimination half-life (T1/2) is approximately 1.0 h. Repeated administration of the drug does not cause its cumulation in the body. Approximately 10% of the drug is excreted by the kidneys, mostly unchanged. When taken in a dose of 600 mg, traces of the hydroxylated metabolite can be excreted.

In in vitro experiments it was shown that 98.4% to 98.6% of the drug is bound to plasma proteins.

Indications

Gastric ulcer.
Chronic gastritis with increased acid-forming function of the stomach in the acute stage, erosive gastritis.
Preventing the occurrence of damage to the mucous membrane while taking non-steroidal anti-inflammatory drugs.
Can be used as part of combination therapy.

Pharmacological effect

Pharmacodynamics

Rebamipide increases the content of prostaglandin E2 (PGE2) in the gastric mucosa and increases the content of PGE2 and GI2 in the gastric juice. It has a cytoprotective effect against the gastric mucosa under the damaging effects of ethanol, acids and alkalis, and acetyl salicylic acid. Promotes the activation of enzymes that accelerate the biosynthesis of high molecular weight glycoproteins and increases the mucus content on the surface of the stomach wall. Helps improve blood supply to the gastric mucosa, activates its barrier function, activates alkaline secretion of the stomach, enhances the proliferation and metabolism of gastric epithelial cells, cleanses the mucosa from 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 the mucosa non-steroidal anti-inflammatory drugs (NSAIDs).

Pharmacokinetics

Absorption when taken orally is high. After taking a dose of 100 mg, the peak plasma concentration (Cmax) is reached after approximately 2 hours and is 340 ng/ml. The half-life (T1/2) is approximately
1.0 hours. 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 unchanged. 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 is bound by plasma proteins.

Active ingredient

Rebamipide

Composition

1 tablet contains:

active ingredient: rebamipide – 100 mg;

excipients: microcrystalline cellulose 102 –56.70 mg, pregelatinized starch (Starch 1500) – 46.80 mg, hypromellose (hydroxypropyl methylcellulose) – 5.80 mg, Kollidon SR (polyvinyl acetate 80%, povidone 19%, sodium lauryl sulfate 0.8%, silicon dioxide 0.2%) – 19.20 mg, citric acid – 2.30 mg, sodium lauryl sulfate – 2.00 mg, talc – 4.80 mg, magnesium stearate – 2.40 mg.

shell composition: hypromellose – 3.57 mg, polysorbate-80 (Tween-80) – 1.49 mg, talc – 1.19 mg, titanium dioxide E 171 – 0.75 mg.

Pregnancy

The safety of rebamipide during pregnancy has not been proven. Do not use during pregnancy.

Since rebamipide passes into breast milk, breastfeeding should be stopped or the issue of artificial feeding of the child should be decided if it is necessary to prescribe rebamipide to the mother during breastfeeding.

Contraindications

Individual intolerance to rebamipide or other components of the drug.

Pregnancy.

Lactation period.

Children under 18 years of age.

With caution

It is recommended to exercise caution 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: itching, skin rash, eczematous rash.

Other: menstrual irregularities.

Interaction

When rebamipide is used as part of traditional treatment regimens for patients with Helicobacter pylori infection, the effectiveness of eradication therapy significantly increases.

Interaction reactions with other drugs have not been studied.

Overdose

Symptoms of overdose with rebamipide have not been described, and to date there have been no reports of cases of intentional overdose. Nausea, vomiting, abdominal pain, diarrhea or constipation, and headache are possible.

Relief measures: No specific antidote known. In case of overdose, the stomach should be rinsed and symptomatic therapy should be carried out.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 oC.

Keep out of the reach of children.

Shelf life

3 years. Do not use after the expiration date stated on the package.

Manufacturer

North Star NAO, Russia