Each tablet contains: Rebamipide 100 mg.
Pharmacology: Pharmacokinetics: Absorption: Absorption rate of Rebamipide following single oral administration at a dose of 150 mg to 6 healthy subjects in a fed state tended to be slower than that in a fasted state.
Distribution: Following single oral administration at 100 mg to 12 healthy individuals, plasma concentrations of Rebamipide reached the peak level (210 ng/mL) in 2 hrs.
Biotransformation: Rebamipide was primarily excreted as the unchanged compound in the urine when after single oral administration to healthy adult males at a dose of 600 mg.
Elimination: Approximately 10% of the administered dose was excreted in the urine when Rebamipide was administered once orally adult males at 100 mg.
As an adjuvant in the treatment of peptic ulcer concomitantly with anti-secretory agents including proton pump inhibitors and H2 receptor antagonist. Rebamipide is also for the use in the prevention of NSAID-induced gastropathy.
Adult: Gastric Mucosal Lesions in acute gastritis and acute exacerbation of chronic gastritis: Usual Dose: 1 tablet orally 3 times daily.
Gastric Ulcers: Usual Dose: 1 tablet orally 3 times daily.
Rebamipide is contraindicated in patients who have exhibited a hypersensitivity reaction to Rebamipide or to any of its components.
Use in pregnancy and lactation: It should be used by pregnant or possibly pregnant women only if the anticipated therapeutic benefit is thought to outweigh any potential risk.
The safety of Rebamipide in pregnant women has not been established.
Nursing should be interrupted when this drug is administered.
Use in Children: The safety of this drug in children has not been established.
Use in Elderly: Special care should be given to elderly patients to minimize the risk of GI disorders because these patients maybe physiologically more sensitive to Rebamipide than younger patients.
Use in Pregnancy: It should be used by pregnant or possibly pregnant women.
Use in Lactation: The safety of Rebamipide in pregnant women has not been established.
Hypersensitivity: Rash, pruritus and eczematous drug eruption may rarely occur. If such signs of hypersensitivity reactions develop, Rebamipide should be discontinued.
Gastrointestinal: Dry mouth, constipations, sensation of abdominal enlargement, diarrhea, nausea, vomiting, heartburn, abdominal pain and belching may rarely occur.
In the treatment of gastritis, acute or chronic, gastric ulcers and patients (arthritis patients) taking NSAIDs (Non Steroidal Anti-Inflammatory Drugs) who are now complaining of stomach pains, the usual adult dose is one Rebamipide 100 mg tablet in the morning, in the evening and before bedtime.
Rebamipide can be safely given with the patients other anti-ulcer drugs.
Store at temperature not exceeding 30°C.
A02BX14 - rebamipide ; Belongs to the class of other drugs used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
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