Bapid 100

Bapid 100

rebamipide

Manufacturer:

Unison

Distributor:

Medispec
Full Prescribing Info
Contents
Rebamipide.
Description
Each film coated tablet contains: Rebamipide 100 mg.
Action
Pharmacology: Prostaglandin-increasing effect: The drug has the effect of increasing the PGE2 content in the gastric mucosa and protected the gastric mucosa from injury caused by Ethanol loading.
Cytoprotective effect: The drug inhibits gastric mucosal injury induced by Aspirin, Ethanol, or HCl-ethanol loading.
Effect on inflammatory cytokine release (interleukin-8) in the gastric mucosa Rebamipide, taken by the oral route, suppressed the increase production of interleukin-8 in the mucosa of patients with Helicobacter pylori. The drug also inhibited the activation of NF-κB and suppressed the expression of interleukin-8 mRNA in epithelial cells cocultured with Helicobacter pylori (in vitro).
Pharmacokinetics: Plasma Concentration: The Table 1 shows the pharmacokinetic parameters of Rebamipide following single oral administration of Rebamipide tablets at the dose 100 mg in a fasted state.
Pharmacokinetic Parameters of Rebamipide: (See Table 1.)

Click on icon to see table/diagram/image

The absorption of Rebamipide following single oral administration at a dose of 150 in a fed state tended to be slower than that in a fasted stage. However, food did not affect bioavailability of the drug in humans. Pharmacokinetic parameters obtained from patients with renal impairment after single oral administration of Rebamipide at 100 mg revealed higher plasma concentrations and a longer elimination half-life compared with those in healthy subjects. At steady-state, Rebamipide plasma concentrations observed in dialyzed renal patients following repeated administration were very close to the values simulated from single administration. Therefore, the drug was not considered to accumulate.
Metabolism: Rebamipide was primarily excreted as the unchanged compound in the urine after single oral administration to healthy adult males at a dose of 600 mg. A metabolite with a hydroxyl group at the 8th position was identified in the urine. However, the excretion of this metabolite was only 0.03% of the administered dose. The enzyme involved in the formation of the metabolite was CYP3A4.
The usual dosage in adults is 100 mg three times daily.
Excretion: Approximately 10% of the administered dose was excreted in the urine when Rebamipide was administered as a single oral dose to healthy adult males at 100 mg.
Protein Binding: Rebamipide at 0.05-5 μg/mL was added to human plasma, in vitro, and 98.4%-98.6% of the drug was bound to plasma proteins.
Indications/Uses
Gastric ulcers.
Treatment of gastric mucosal lesions (erosions, bleeding, redness, and edema) in the following conditions; acute gastritis and acute exacerbation of chronic gastritis.
Dosage/Direction for Use
Gastric ulcers: The usual adult dosage of Rebamipide is one tablet (100 mg of Rebamipide) taken by the oral route three times daily, in the morning, in the evening, and before at bedtime.
Treatment of gastric mucosal lesions (erosion, bleeding, redness, and edema) in the following conditions; acute gastritis and acute exacerbation of chronic gastritis: The usual adult dosage of Rebamipide is one tablet (100 mg of Rebamipide) three times daily taken by the oral route.
Overdosage
There is limited information on overdose. Treatment of overdose should be symptomatic. Close medical supervision and monitoring should continue until the patient recovering.
Contraindications
Patients with a history of hypersensitivity to any ingredient of this drug.
Special Precautions
Patient's Instruction for Use: However, patients should be instructed not ingest any portion of the blister pack. There have been reports that the sharp edges of the sheet can cut or penetrate the esophageal mucosa if accidentally ingested, resulting in mediastinitis or other serious complications.
Use in Children: The safety of this drug in children has not been established.
Use in 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.
Use In Pregnancy & Lactation
Pregnancy: This drug should be administered to pregnant or possibly pregnant women only if the anticipated therapeutic benefit is thought to outweigh any potential risk. The safety of this drug in pregnant women has not been established.
Breastfeeding: Nursing should be interrupted when this drug is administered to.
Adverse Reactions
Clinically significant Side Effects1: Shock or anaphylactoid reactions may occur. Patients should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
Leukopenia and thrombocytopenia may occur. Patients should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
Hepatic dysfunction and jaundice, as indicated by increases in AST (GOT), ALT (GPT), γ-GTP, and alkaline phosphatase levels, have been reported in patients receiving Rebamipide tablets. If abnormal laboratory findings are observed, the drug should be discontinued and appropriate measures taken.
Other Side Effects: (See Table 2.)

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Drug Interactions
Rebamipide had little inhibitory effect on cytochrome P450 enzymes in vitro. Rebamipide is hardly metabolized in the liver and excreted in urine as unchanged compound; thus, the drug has not much influence on metabolization of other drugs.
No drug interactions between Rebamipide and other drugs are reported.
Storage
Store at temperature of not more than 30°C.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BX14 - rebamipide ; Belongs to the class of other drugs used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
FC tab 100 mg x 10 x 10's.
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