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OverviewMechanism of ActionHow To UseUsesBenfitsIndicationsMethod of AdministrationDosage StrengthsDosage FormsDietary RestrictionsContraindicationsWarnings and Precautions for usingAdverse ReactionsSide EffectsUse of Rebamipide in Specific PopulationsClinical Pharmacology Clinical StudiesAuthored by Reviewed by References
Rebamipide

Rebamipide

Indications, Uses, Dosage, Drugs Interactions, Side effects
Rebamipide
Medicine Type :
Allopathy
Prescription Type:
Prescription Required
Approval :
DCGI (Drugs Controller General of India)
Schedule
Schedule H
Pharmacological Class:
Prostaglandin E2Stimulant,
Therapy Class:
Antacids, Anti-reflux agents,

Rebamipide is a Prostaglandin E2 Stimulant belonging to Antacids or anti-reflux agents.

Rebamipide is a gastroprotective agent used in combination with other similar therapies (e.g. proton pump inhibitors) to treat gastritis and protect the gastric mucosa.

The time taken to reach peak plasma concentration 2 hours.Rebamipide is having Plasma protein binding of 98.4-98.6%.Rebamipide is mainly excreted Via urine approximately 10% as unchanged drug.

Rebamipide shows side effects like Itching and skin rash, Nausea and Vomiting, Dizziness, Loss of appetite, Dry mouth, Blurred vision, Eye irritation, Bitter taste, Eye discharge, Constipation.

Rebamipide is available in the form of Oral tablet.

Rebamipide is available in South Korea, China, Malaysia, Philippines, Singapore, and India.

Rebamipide belongs to the Antacids or anti-reflux agents acts as a Prostaglandin E2 Stimulant.

The mechanism of action of Rebamipide in RAU is by preservation of existing cells and replacement of lost tissue. Action of preservation of existing cells occurs through increase in the content of soluble mucus, increase in the gastric concentrations of PGE2 and PGI2, down regulation of 15-hydroxyprostaglandin dehydrogenase, increase in the mucosal blood flow through enhanced nitric oxide synthase activity, decrease in the expression of neutrophil adhesion molecules (CD11b/CD18), inhibition of the secretion of TNF-α by inhibiting the synthesis of inflammatory E-selectin and has a free radical scavenging effect on reactive oxygen species.

The Data of Onset and Duration of action of Rebamipide is not clinically established.

The Tmax of Rebamipide is approximately 2 hours.

Rebamipide is available in the form of Oral Tablet.

Rebamipide tablet taken orally three times a day, usually in the morning, evening and before bedtime.

Rebamipide acts as a mucosal protective agent and used for the treatment of ulcers in the stomach and intestines in adults patients.

Rebamipide is a Prostaglandin E2 Stimulant belonging to Antacids or anti-reflux agents.

Rebamipide works by enhancing the mucosal defense system and scavenging free radicals in the body.

Rebamipide is approved for use in the following clinical indications

  • Gastrointestinal disorders

Rebamipide is a gastroprotective agent used in combination with other similar therapies (e.g., proton pump inhibitors) to treat gastritis and protect the gastric mucosa.

  • Gastric ulcer, Gastritis

Adult: 100 mg three times daily, usually in the morning, evening and before bedtime.

Rebamipide is available in various strengths as 100mg.

Rebamipide is available in the form of Oral Tablet.

  • Hypersensitivity
  • Use in elderly Population

Rebamipide should be used with extreme caution in the elderly population due to the increased risk of severe adverse effects. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.

  • Driving or Operating machinery

Rebamipide may cause dizziness, blurred vision, or visual disturbances in some patients. It is advised to not perform any activities that require high mental alertness like driving a vehicle or operating machinery if you experience any of these symptoms during treatment with this medicine.

  • Liver disease

Rebamipide should be used with caution in patients with liver diseases due to the increased risk of adverse effects. Regular monitoring of liver function tests is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Alcohol Warning

Avoid consumption of alcohol while taking Rebamipide. Alcohol intake leads to increased production of stomach acid, thereby increasing acidity and heartburn.

Breast Feeding Warning

Rebamipide is not recommended for use in breastfeeding women unless necessary. All the risks and benefits should be considered before taking/ administering Rebamipide.

Pregnancy Warning

Rebamipide is not recommended for use in pregnant women unless necessary. The risks and benefits should be considered before taking/administering Rebamipide.

  • Common

Dizziness, drowsiness, thrombocytopenia, leucopenia, hypersensitivity and anaphylactoid reactions (e.g. hives, rash, itching, eczema), shock, jaundice. Rarely, liver dysfunction, Constipation, dry mouth, diarrhea, nausea, vomiting, heartburn, abdominal pain, belching, sensation of abdominal enlargement, taste abnormality, Increased AST, ALT, alkaline phosphatase, or BUN levels.

The common side effectsof Rebamipide include the following

  • Common side effects

Itching and skin rash, Nausea and Vomiting, Dizziness, Loss of appetite, Dry mouth, Blurred vision, Eye irritation, Bitter taste, Eye discharge, Constipation.

  • Pregnancy

Pregnancy Category

Rebamipide is not recommended for use in pregnant women unless necessary. The risks and benefits should be considered before taking/administering Rebamipide.

  • Nursing Mothers

Rebamipide is not recommended for use in breastfeeding women unless necessary. All the risks and benefits should be considered before taking/administering Rebamipide.

  • Pediatric Use

Rebamipide should not be given to children as safety and effectiveness were not established.

  • Geriatric Use

Rebamipide should be used with extreme caution in the elderly population due to the increased risk of severe adverse effects. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.

Pharmacodynamic

Information not available.

Pharmacokinetics

  • Absorption

The time taken to reach peak plasma concentration 2 hours.

  • Distribution

Rebamipide is having Plasma protein binding of 98.4-98.6%.

  • Metabolism and Excretion

Rebamipide is mainly excreted Via urine approximately 10% as unchanged drug.

There are some clinical studies of the drug Rebamipide mentioned below:
  1. Naito Y, Yoshikawa T. Rebamipide: a gastrointestinal protective drug with pleiotropic activities. Expert review of gastroenterology & hepatology. 2010 Jun 1;4(3):261-70.
  2. Haruma K, Ito M. clinical significance of mucosal‐protective agents: acid, inflammation, carcinogenesis and rebamipide. Alimentary pharmacology & therapeutics. 2003 Jul;18:153-9.
  3. Hou D, Yang M, Hu Z, Yang L. Effects of rebamipide for chronic atrophic gastritis: A protocol for systematic review and meta-analysis. Medicine. 2020 Jun 6;99(25).
  • https://www.mims.com/philippines/drug/info/rebamipide?mtype=generic
  • https://go.drugbank.com/drugs/DB11656
  • https://www.practo.com/medicine-info/rebamipide-2133-api
  • https://www.apollopharmacy.in/salt/REBAMIPIDE
  • https://www.medindia.net/doctors/drug_information/rebamipide.htm#Dosage
  • https://www.mims.com/malaysia/drug/info/rebamipide?mtype=generic
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Jyoti Suthar
Jyoti is a Post graduate in Pharmaceutics ( M Pharm) She did her graduation ( B Pharm) From SSR COLLEGE OF PHARMACY And thereafter did her M Pharm specialized in Pharmaceutics from SSR COLLEGE OF PHARMACY
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Dr JUHI SINGLA
Dr JUHI SINGLA has completed her MBBS from Era’s Lucknow Medical college and done MD pharmacology from SGT UNIVERSITY Gurgaon. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
Published on: 26 April 2023 3:42 PM GMT
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