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Indications/Uses
Peptic ulcer disease.
Improvement of gastric mucosa lesions (erosions, bleeding, redness, swelling): acute gastritis, chronic gastritis, acute exacerbation period.
Improvement of gastric mucosa lesions (erosions, bleeding, redness, swelling): acute gastritis, chronic gastritis, acute exacerbation period.
Dosage/Direction for Use
Adult: Administer 100 mg once as Rebamipide, 3 times a day. In case of gastric ulcer, administer 100 mg in the morning and evening or before going to bed.
Administration
May be taken with or without food.
Contraindications
Patients with a history of hypersensitivity to any ingredient of this drug.
Special Precautions
Patients with a history of hypersensitivity to the drug should not administer the drug.
Use in Children: Safety has not been established for low birth weight, neonatal, infant, and pediatric.
Use in the Elderly: There is no difference in incidence of adverse events in elderly compared with the non-elderly. However, be cautious because in general, elderly patients have physiological dysfunction it may affect the gastrointestinal symptoms.
Use in Children: Safety has not been established for low birth weight, neonatal, infant, and pediatric.
Use in the Elderly: There is no difference in incidence of adverse events in elderly compared with the non-elderly. However, be cautious because in general, elderly patients have physiological dysfunction it may affect the gastrointestinal symptoms.
Use In Pregnancy & Lactation
Safety has not been established for pregnant women, thus only administer if therapeutic benefit exceeds the risk of administration.
There has been a report of transition into breast milk in animal experiments, thus avoid breastfeeding during administration of the drug.
There has been a report of transition into breast milk in animal experiments, thus avoid breastfeeding during administration of the drug.
Adverse Reactions
'Rare' means less than 0.1%, 'sometimes' means less than 0.1-5%, 'frequency unknown' means there is no representation or more than 5%.
Serious adverse events: Shock, anaphylaxis symptoms (frequency unknown): fully observe and stop the administration and treat appropriately if any of these symptoms appear.
Leukopenia (rare), thrombocytopenia (frequency unknown): fully observe and stop the administration and treat appropriately if any of these symptoms appear.
Liver dysfunction (rare), jaundice (frequency unknown): fully observe and stop the administration and treat appropriately if any of these symptoms occur accompanied by a rise in the AST, ALT, gamma-GTP, ALP.
Other adverse reaction: Hypersensitivity: stop the administration if any of hypersensitivity such as hives, rashes, itching, and eczema appear.
Nervous system: numbness, dizziness, drowsiness may occur.
Gastrointestinal: dry mouth, constipation, rarely bloating, diarrhea, nausea, vomiting, heartburn, abdominal pain, belching, taste abnormalities may occur.
Liver: stop the administration and treat appropriately if there is rise in AST, ALT, gamma-GTP, ALP or fever, rash appear at the same time.
Blood system: thrombocytopenia, leukocyte sequestration (sometimes), rise in lymphocytes, leucopenia (rare), reduction of granulocytopenia may occur.
Others: gynecomastia, galactorrhea, palpitations, fever, facial flushing, numbness of the tongue, cough, shortness of breath, hair loss, menstrual disorders or elevated BUN (rare), swelling, foreign body sensation in pharyngeal may occur.
Serious adverse events: Shock, anaphylaxis symptoms (frequency unknown): fully observe and stop the administration and treat appropriately if any of these symptoms appear.
Leukopenia (rare), thrombocytopenia (frequency unknown): fully observe and stop the administration and treat appropriately if any of these symptoms appear.
Liver dysfunction (rare), jaundice (frequency unknown): fully observe and stop the administration and treat appropriately if any of these symptoms occur accompanied by a rise in the AST, ALT, gamma-GTP, ALP.
Other adverse reaction: Hypersensitivity: stop the administration if any of hypersensitivity such as hives, rashes, itching, and eczema appear.
Nervous system: numbness, dizziness, drowsiness may occur.
Gastrointestinal: dry mouth, constipation, rarely bloating, diarrhea, nausea, vomiting, heartburn, abdominal pain, belching, taste abnormalities may occur.
Liver: stop the administration and treat appropriately if there is rise in AST, ALT, gamma-GTP, ALP or fever, rash appear at the same time.
Blood system: thrombocytopenia, leukocyte sequestration (sometimes), rise in lymphocytes, leucopenia (rare), reduction of granulocytopenia may occur.
Others: gynecomastia, galactorrhea, palpitations, fever, facial flushing, numbness of the tongue, cough, shortness of breath, hair loss, menstrual disorders or elevated BUN (rare), swelling, foreign body sensation in pharyngeal may occur.
Caution For Usage
Storage and Handling precautions: Placing into another container is not recommended in terms of maintaining quality and preventing accident.
Storage
Store at temperatures not exceeding 30°C.
Shelf-Life: 36 months from manufacturing date.
Shelf-Life: 36 months from manufacturing date.
Action
Pharmacology: Pharmacodynamics: Rebamipide prevents mucosal erosion and damage. The drug augments gastric blood flow, reduce free oxygen radicals mediated oxidative stress and lipid per oxidation and promote prostaglandin biosynthesis in the duodenal wall.
Pharmacokinetics: The effective concentration of Rebamipide is in the range of 1-1000 μm. The following table briefly explains the pharmacokinetic parameter of Rebamipide. (See table.)
Pharmacokinetics: The effective concentration of Rebamipide is in the range of 1-1000 μm. The following table briefly explains the pharmacokinetic parameter of Rebamipide. (See table.)
Up to 98.4% of ingested Rebamipide is bound to plasma proteins. It is metabolized in the liver by human cytochrome P450 enzyme. The cytochrome P450 enzyme acts on Rebamipide through hydroxylation and glucuronidation, resulting in the formation of 6-hydroxy and 8-hydroxyrebamipide. The role of glucuronidation in the metabolism of rebamipide is very low and nonsignificant. Drug interactions of Rebamipide with other drugs is very low and safely used concomitantly with other drugs.
MedsGo Class
Antacids, Antireflux Agents & Antiulcerants
Features
Brand
Mucopid
Full Details
Dosage Strength
100 mg
Drug Ingredients
- Rebamipide
Drug Packaging
Tablet 1's
Generic Name
Rebamipide
Dosage Form
Tablet
Registration Number
DRP-8194
Drug Classification
Prescription Drug (RX)