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

Active ingredient

Composition

1 tablet contains:

the active ingredient: rebapid – 100 mg;

excipients: microcrystalline cellulose 102 -56.70 mg, pregelatinized starch (Starch 1500) – 46.80 mg, hypromellose (hydroxypropyl methylcellulose) – 5.80 mg, collidone 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.

How to take, the dosage

In the mouth, 1 tablet 3 times a day, with a small amount of liquid. The course of treatment is 2 to 4 weeks; if necessary, it can be prolonged up to 8 weeks.

The drug has no particular effect when taken for the first time or when it is discontinued.

If you miss one dose, take the next dose of the drug at the prescribed time; you should not take a double dose of the drug.

Interaction

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

The reactions of interaction with other drugs have not been studied.

Contraindications

Individual intolerance to rebampide or other components of the drug.

Pregnancy.

Lactation period.

Children under 18 years of age.

With caution

Cautiousness is recommended when first prescribing rebampide in elderly patients due to the possibility of hypersensitivity to the drug.

Side effects

Gastrointestinal tract: constipation, flatulence, diarrhea, nausea, vomiting, abdominal pain, taste disorders, heartburn.

Liver disorders: signs of liver dysfunction, increased serum glutamic alanine aminotransferase (ALT) and serum glutamic aspartate aminotransferase (ACT).

Hematopoietic system: leukopenia, granulocytopenia.

Allergic reactions: itching, skin rash, eczematous rash.

Other: menstrual disorders.

Overdose

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

Aid measures: no specific antidote is known. In case of overdose, gastric lavage and symptomatic therapy should be carried out.

Pregnancy use

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

As rebamipide penetrates into the breast milk, breastfeeding should be stopped or artificial feeding of the child should be considered if it is necessary to prescribe rebamipide to the mother during breastfeeding.

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