MUCOPROTEC Rebamipide 100mg Film-Coated Tablet 1's
RXDRUG-DR-XY42070-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Rebamipide is indicated for use as an adjuvant in the treatment of peptic ulcer disease concomitantly with anti-secretory agents including PPIs and H2 receptor antagonists. Rebamipide is also indicated for use in the prevention of NSAID-induced gastropathy.
Dosage/Direction for Use
Adult: Usual Dose: 100 mg (1 tab) 3 times daily. Or as prescribed by the physician.
Administration
May be taken with or without food.
Contraindications
History of hypersensitivity reaction to rebamipide or to any of the components of Mucoprotec.
Special Precautions
Use in pregnancy: Reproductive and developmental studies conducted in rats showed no toxic effects on reproductive outcome, and fetal development, however since the safety of rebamipide in human pregnancy has not been established, it should not be used in pregnant women or among those who are suspected to be pregnant except in clinical circumstances where there is no appropriate alternative therapy.
Use in lactation: In animal studies, rebamipide has been reported to be excreted in breast milk and should not be administered to nursing mothers until its safety among breastfeeding infants has been clarified.
Use in children: The safety of rebamipide in pediatric patients has also not been established and therefore should not be used in these patients.
Use in the elderly: The adverse events and its frequency of occurrence among the elderly are no different from those that are observed in younger patients but because of the changes in physiologic functions observed in elderly patients, caution should still be taken when administering the drug in this population group with special attention given to the occurrence of gastrointestinal adverse events.
Use in lactation: In animal studies, rebamipide has been reported to be excreted in breast milk and should not be administered to nursing mothers until its safety among breastfeeding infants has been clarified.
Use in children: The safety of rebamipide in pediatric patients has also not been established and therefore should not be used in these patients.
Use in the elderly: The adverse events and its frequency of occurrence among the elderly are no different from those that are observed in younger patients but because of the changes in physiologic functions observed in elderly patients, caution should still be taken when administering the drug in this population group with special attention given to the occurrence of gastrointestinal adverse events.
Use In Pregnancy & Lactation
Use in pregnancy: Reproductive and developmental studies conducted in rats showed no toxic effects on reproductive outcome, and fetal development, however since the safety of rebamipide in human pregnancy has not been established, it should not be used in pregnant women or among those who are suspected to be pregnant except in clinical circumstances where there is no appropriate alternative therapy.
Use in lactation: In animal studies, rebamipide has been reported to be excreted in breast milk and should not be administered to nursing mothers until its safety among breastfeeding infants has been clarified.
Use in lactation: In animal studies, rebamipide has been reported to be excreted in breast milk and should not be administered to nursing mothers until its safety among breastfeeding infants has been clarified.
Adverse Reactions
The adverse events noted in placebo-controlled trials were rare occurring in <1% of the patients and were no more frequent compared to those observed among patients given placebo.
Central Nervous System: Dizziness, drowsiness.
Gastrointestinal: ALT and AST elevation, hyperbilirubinemia, dry mouth, constipation, diarrhea, abdominal distention, nausea, vomiting, eructation.
Renal: Edema, BUN elevation.
Endocrine: Gynecomastia, induction of lactation, menstrual disorders, hot flushes.
Hematologic: Leukopenia, leukocytosis, thrombocytopenia.
Skin/Hypersensitivity: Rash, urticaria, eczema.
Central Nervous System: Dizziness, drowsiness.
Gastrointestinal: ALT and AST elevation, hyperbilirubinemia, dry mouth, constipation, diarrhea, abdominal distention, nausea, vomiting, eructation.
Renal: Edema, BUN elevation.
Endocrine: Gynecomastia, induction of lactation, menstrual disorders, hot flushes.
Hematologic: Leukopenia, leukocytosis, thrombocytopenia.
Skin/Hypersensitivity: Rash, urticaria, eczema.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacokinetics: Rebamipide improves the speed and quality of peptic ulcer healing whether given alone or in combination with proton pump inhibitors (PPIs) or H2 receptor antagonists and has been shown to reduce the rate of recurrence of gastric ulcers, regardless of the status of Helicobacter pylori infection. The ability of rebamipide effect healing of acute gastritis and gastritis ulcers is presumed to be due to its gastric cytoprotective action which results from its ability to increase gastric mucosal endogenous prostaglandin production and to scavenge hydroxyl radicals.
Rebamipide has also been shown to be as effective as misoprostol in preventing nonsteroidal anti-inflammatory drug (NSAID)-induced gastric mucosal injury perhaps by preventing the decrease in gastric mucosal blood flow seen in patients taking NSAIDs. In addition, studies done in animals and human subjects indicate that one of the principal gastric defense mechanisms afforded by rebamipide is through an increased gastric mucus secretion, probably resulting from the stimulation of endogenous prostaglandin production in the gastric mucosa. Furthermore, rebamipide suppresses gastric mucosal inflammation which is thought to be related to inhibition of superoxide anion production from neutrophils, scavenging of hydroxyl radicals and inhibition of interleukin 8 production.
Rebamipide administered orally as 100 mg tablets reaches peak plasma concentrations (Tmax) in 2.4 hrs and has an elimination half-life (t½) of 1.94 hrs. Oral administration of rebamipide after a meal delayed its absorption but did not have any effect on its bioavailability. Rebamipide is highly protein bound with plasma protein-binding of around 98%. Rebamipide is excreted mainly as the unchanged drug in the urine after oral administration. Administration of single doses of rebamipide 100 mg tablets in patient with renal insufficiency resulted in higher plasma concentrations and longer elimination t½ compared to normal healthy subjects.
Repeated oral administrations of rebamipide in steady-state, conditions among renal failure patients undergoing dialysis resulted in plasma concentrations that were almost similar to that observed with single oral administrations indicating that the drug does not accumulate.
Rebamipide has also been shown to be as effective as misoprostol in preventing nonsteroidal anti-inflammatory drug (NSAID)-induced gastric mucosal injury perhaps by preventing the decrease in gastric mucosal blood flow seen in patients taking NSAIDs. In addition, studies done in animals and human subjects indicate that one of the principal gastric defense mechanisms afforded by rebamipide is through an increased gastric mucus secretion, probably resulting from the stimulation of endogenous prostaglandin production in the gastric mucosa. Furthermore, rebamipide suppresses gastric mucosal inflammation which is thought to be related to inhibition of superoxide anion production from neutrophils, scavenging of hydroxyl radicals and inhibition of interleukin 8 production.
Rebamipide administered orally as 100 mg tablets reaches peak plasma concentrations (Tmax) in 2.4 hrs and has an elimination half-life (t½) of 1.94 hrs. Oral administration of rebamipide after a meal delayed its absorption but did not have any effect on its bioavailability. Rebamipide is highly protein bound with plasma protein-binding of around 98%. Rebamipide is excreted mainly as the unchanged drug in the urine after oral administration. Administration of single doses of rebamipide 100 mg tablets in patient with renal insufficiency resulted in higher plasma concentrations and longer elimination t½ compared to normal healthy subjects.
Repeated oral administrations of rebamipide in steady-state, conditions among renal failure patients undergoing dialysis resulted in plasma concentrations that were almost similar to that observed with single oral administrations indicating that the drug does not accumulate.
MedsGo Class
Antacids, Antireflux Agents & Antiulcerants
Features
Brand
Mucoprotec
Full Details
Dosage Strength
100 mg
Drug Ingredients
- Rebamipide
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Rebamipide
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY42070
Drug Classification
Prescription Drug (RX)
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