Rebamipid (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmproekt, JSC (Russia)

ATC Code

A02BX14 (Rebamipide)

Active Substance

Rebamipide

Dosage Form

Rebamipide

Film-coated tablets 100 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

10 pcs. – blister packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – blister packs (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – blister packs (15 pcs.) – cardboard packs (150 pcs.) – By prescription
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – blister packs (20 pcs.) – cardboard packs (200 pcs.) – By prescription
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – blister packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – blister packs (7 pcs.) – cardboard packs (70 pcs.) – By prescription
10 pcs. – blister packs (8 pcs.) – cardboard packs (80 pcs.) – By prescription
10 pcs. – blister packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription

Clinical-Pharmacological Group

Gastroprotective agent

Pharmacotherapeutic Group

Drugs for the treatment of diseases associated with acidity disorders; drugs for the treatment of gastric and duodenal ulcer disease and gastroesophageal reflux disease (GERD)

Pharmacological Action

Gastroprotector. Rebamipide increases the content of prostaglandin E2 (PGE2) in the gastric mucosa and in the gastric juice.

It has a cytoprotective effect on the gastric mucosa against the damaging effects of ethanol, acids and alkalis, and acetylsalicylic acid.

It promotes the activation of enzymes that accelerate the biosynthesis of high molecular weight glycoproteins and increases the mucus content on the surface of the gastric wall.

It helps to improve the blood supply to the gastric mucosa, activates its barrier function, activates the alkaline secretion of the stomach, enhances the 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 the gastric mucosa from bacterial damage, and has a gastroprotective effect on the mucosa when exposed to NSAIDs.

Pharmacokinetics

After oral administration of a 100 mg dose, C_max is reached in approximately 2 hours and is 340 ng/ml.

It does not accumulate in the body with repeated administration.

Plasma protein binding in vitro is about 98.5%.

T_1/2 is approximately 1 hour.

About 10% is excreted by the kidneys, mainly unchanged.

When taking a dose of 600 mg, traces of a hydroxylated metabolite can be detected.

Indications

Gastric ulcer; chronic gastritis with increased gastric acid-forming function in the acute phase, erosive gastritis; prevention of mucosal damage during NSAID therapy.

ICD codes

Dosage Regimen

Administer orally.

The standard adult dosage is 100 mg three times daily.

Take tablets after meals to optimize therapeutic effect.

The typical treatment course for acute conditions is 2 to 4 weeks.

For persistent or severe cases, extend the treatment duration up to 8 weeks based on clinical assessment.

Do not exceed the recommended daily dose of 300 mg.

For prophylaxis of NSAID-induced gastric mucosal injury, maintain the same dosage of 100 mg three times daily.

Continue prophylactic administration for the duration of NSAID therapy.

Swallow the tablet whole with water; do not crush or chew.

If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose.

Do not double the dose to make up for a forgotten one.

The safety and efficacy in patients under 18 years of age have not been established.

Dosage adjustment in elderly patients with normal renal and hepatic function is not typically required.

Use with caution in patients with severe hepatic impairment.

Regularly monitor patient response and tolerability throughout the treatment period.

Adverse Reactions

From the digestive system constipation, flatulence, diarrhea, nausea, vomiting, abdominal pain, taste disturbance, heartburn.

From the liver signs of liver dysfunction, increased serum ALT and AST.

From the hematopoietic system leukopenia, granulocytopenia.

Other menstrual cycle disorder.

Contraindications

Pregnancy; lactation period; age under 18 years; hypersensitivity to rebamipide.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Can be used as part of combination therapy.

Drug Interactions

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

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.