White, round, biconvex film coated tablet, bevelled on both sides with engraved REB on one side and 100 on the other.
Each film coated tablet contains Rebamipide 100 mg.
Pharmacology: Pharmacodynamics: Rebamipide increases prostaglandin E2 in gastric mucosa, decreases gastric mucosa injury, increases gastric mucous, increases blood flow of gastric mucosa, increases secretion of gastric alkaline, stimulates growth of gastric mucosa cells.
Pharmacokinetics: The drug is rapidly absorbed. The absorption tended to be slow when the drug was administered orally after a meal. However, food did not affect bioavailability.
Peak plasma concentration: 210 ng/mL.
Time to peak concentration: 2 hours.
Elimination half-life: 1.5 hours.
Protein binding: 98.4%-98.6%.
Approximately 10% of the administered dose was excreted in the urine as the unchanged compound. A metabolite with a hydroxyl group at the 8th position was identified in the urine. The excretion of this metabolite was only 0.03% of the administered dose. The enzyme involved in the formation of the metabolite was CYP3A4.
Gastric ulcer or lesion: For treatment of gastric ulcer or lesion associated with acute gastritis and exacerbation of chronic gastritis.
Prevention of NSAIDs-induced ulcer: For the prevention of gastric ulcers in patients taking NSAIDs who are considered at risk for developing gastrointestinal symptoms associated with NSAIDs administration.
Gastric ulcer or lesion: 100 mg orally 3 times daily in the morning, evening, and before bedtime.
Prevention of NSAIDs-induced ulcer: 100 mg orally 3 times daily.
Hypersensitivity to Rebamipide or any component of the formulation.
May cause drowsiness or dizziness.
May cause thrombocytopenia (unknown incidence) or leukopenia (incidence <0.1%). Discontinue use if signs/symptoms of hematologic abnormalities appear.
Rare liver dysfunction (incidence <0.1%) has been reported with use.
Discontinue if early signs/symptoms of hepatic toxicity arise (eg, fever, rash, jaundice) or with significant elevation of hepatic enzymes.
Hypersensitivity and anaphylactoid reactions including hives, rash, itching, eczema, and shock have been reported. Discontinue if symptoms of allergic or hypersensitivity reactions occur.
Use in Children: The safety of this drug in children has not been established.
Use in the Elderly: Special care is required in elderly patients to minimize the risk of gastrointestinal disorders, because these patients may be physiologically more sensitive to this drug than younger patients.
Pregnancy: The safety of this drug in pregnant women has not been established.
Administer Rebamipide during pregnancy only if the anticipated therapeutic benefit thought to outweigh any potential risk.
Lactation: Rat studies have shown that Rebamipide is excreted in the breast milk.
Breast-feeding is not recommended.
Clinically significant adverse reactions: Leukopenia (incidence <0.1%) and thrombocytopenia (incidence unknown) may occur. Patients should be closely monitored. If abnormal laboratory findings are observed, the drug should be discontinued and appropriate measures taken.
Hepatic dysfunction (incidence <0.1%) and jaundice (incidence unknown), as indicated by increases in AST (GOT), ALT (GPT), γ-GTP, and alkaline phosphatase levels have been reported in patients receiving Rebamipide. If abnormal laboratory findings are observed, the drug should be discontinued and appropriate measures taken.
Other adverse reactions: See table.
Click on icon to see table/diagram/image
There are no known significant interactions.
A02BX14 - rebamipide ; Belongs to the class of other drugs used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Bapid FC tab 100 mg
10 × 10's
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